HACCP in Juice.

Friday,
January 19, 2001
Part V
Department of
Health and Human
Services
Food and Drug Administration
21 CFR Part 120

Hazard Analysis and Critical Control
Point (HAACP); Procedures for the Safe
and Sanitary Processing and Importing of
Juice; Final Rule
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6138 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations
DEPARTMENT OF HEALTH AND C. Prerequisite Program Standard the HACCP proposal was inappropriate.
HUMAN SERVICES Operating Procedures Comments received 15 days after
D. Hazard Analysis publication of the notice of intent are
Food and Drug Administration E. HACCP Plan
discussed in this final rule.
F. Legal Basis
G. Corrective Actions B. The Proposal
21 CFR Part 120 H. Verification and Validation
I. Records In the Federal Register of April 24,
[Docket No. 97N–0511] 1998 (63 FR 20450) (Ref. 2), FDA
J. Training
RIN 0910–AA43 K. Application of Requirements to published a proposed rule to establish
Imported Products requirements relating to the processing
Hazard Analysis and Critical Control L. Process Controls of juice and juice products (hereinafter
Point (HAACP); Procedures for the M. HACCP Enforcement Issues referred to as the HACCP proposal).1
Safe and Sanitary Processing and N. Miscellaneous Issues The proposal would have required the
IV. Effective Date
Importing of Juice V. Final Regulatory Impact Analysis application of HACCP principles by
A. Introduction processors and importers to ensure juice
AGENCY: Food and Drug Administration, safety to the maximum extent
B. Factors Considered in Developing This
HHS. practicable. FDA proposed these
Analysis
ACTION: Final rule. C. Benefits regulations because there had been a
D. Costs number of food hazards, including some
SUMMARY: The Food and Drug E. Summary of Benefits and Costs directly affecting children, associated
Administration (FDA or the agency) is VI. Regulatory Flexibility Analysis with juice products. The agency
adopting final regulations to ensure the A. Objectives
tentatively concluded that the most
safe and sanitary processing of fruit and B. Definition of Small Business and
Number of Small Businesses Affected effective way to ensure the safety of
vegetable juices. The regulations juice products is to process the products
C. Description of the Impact on Small
mandate the application of Hazard under a system of preventive control
Entities
Analysis and Critical Control Point D. Minimizing the Burden on Small measures based on HACCP principles.
(HACCP) principles to the processing of Entities Interested persons were given until July
these foods. HACCP is a preventive E. Summary 8, 1998, to comment on the HACCP
system of hazard control. FDA is taking VII. Paperwork Reduction Act of 1995 proposal. The agency subsequently
this action because there have been a VIII. Environmental Impact
extended the comment period to August
number of food hazards associated with IX. Federalism
X. References 7, 1998 (63 FR 37057; July 8, 1998) (Ref.
juice products and because a system of 3).
preventive control measures is the most I. Background In addition to publishing the HACCP
effective and efficient way to ensure that proposal, FDA published in the same
these products are safe. A. Notice of Intent
issue of the Federal Register (63 FR
DATES: Effective Dates: This rule is In the Federal Register of August 28, 20486) (Ref. 4) a proposed rule (the juice
effective January 22, 2002. 1997 (62 FR 45593)(Ref. 1), FDA labeling proposal) to require warning
Compliance Date: For small published a notice of intent (hereinafter labels on juice that has not been
businesses as defined in 21 CFR referred to as the notice of intent) that processed to prevent, reduce to
120.1(b)(1), the final rule will be announced a comprehensive program to acceptable levels, or eliminate
binding January 21, 2003. For very small address the incidence of foodborne pathogens that may be present. As fully
businesses as defined in 21 CFR illness related to consumption of fresh discussed in the juice labeling proposal,
120.1(b)(2), the final rule will be juice and ultimately to address the FDA proposed that untreated juice
binding January 20, 2004. safety of all juice products. In the notice products bear a warning statement
FOR FURTHER INFORMATION CONTACT:
of intent, the agency invited comment informing at risk consumers of the
Shellee Anderson, Center for Food on the appropriateness of its strategy to: hazard posed by untreated juices to
Safety and Applied Nutrition (HFS– (1) Initiate rulemaking on a mandatory allow them to make informed decisions
366), Food and Drug Administration, HACCP program for some or all juice on whether to purchase and consume
200 C St. SW., Washington, DC 20204, products; (2) propose that the labels or such products. The labeling proposal
202–205–5023. the labeling of juice products not was finalized on July 8, 1998 (63 FR
specifically processed to prevent, 37030) (Ref. 5).
SUPPLEMENTARY INFORMATION:
reduce, or eliminate pathogens bear a FDA issued in the Federal Register of
Table of Contents
warning statement informing consumers May 1, 1998 (63 FR 24254) (Ref. 6) a
of the risk of illness associated with single Preliminary Regulatory Impact
I. Background consumption of the product; and (3) Analysis (PRIA) that addressed both the
A. Notice of Intent
B. The Proposal
initiate several educational programs to
C. Additional Opportunities for Public minimize the hazards associated with 1 As defined in § 120.1 (21 CFR 120.1) ‘‘juice’’
consumption of fresh juices. The agency refers both to beverages that are composed
Participation exclusively of an aqueous liquid or liquids
D. NACMCF Public Meeting stated that it would address comments extracted from one or more fruits or vegetables and
II. Response to the Comments received within 15 days of publication to the juice ingredient in those beverages that
A. Alternatives to HACCP Considered by of the notice of intent as part of any rule contain other ingredients in addition to juice. In
the Agency proposed by the agency. FDA also stated this document, the term ‘‘juice product’’ refers both
B. Response to the Decision to Propose to beverages that contain only juice and to the juice
that it would consider all comments to ingredient of beverages that are composed of juice
HACCP the notice of intent received after 15 and other ingredients.
C. Significance of Illness Data
D. Comparison of the Proposal and this
days in any final rulemaking. FDA In the remainder of this document, products not
reviewed all of the comments received processed to prevent, reduce, or eliminate hazards
Final Regulation will be referred to as ‘‘untreated juice products.’’ In
III. The Final Regulation within 15 days of publication and found addition, processing to ‘‘prevent, reduce, or
A. Applicability that they provided no information that eliminate’’ hazards will be referred to as processing
B. Definitions would cause the agency to conclude that to ‘‘control’’ hazards.
Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6139
juice labeling proposal and the juice pathogen reduction interventions that The NACMCF held a public meeting
HACCP proposal. Interested parties may be effective for apple cider on December 8 to 9, 1999 (64 FR 63281;
were given until May 26, 1998, to production and the methods used to November 19, 1999) (Refs. 11 and 12) to
comment on aspects of the PRIA relating measure and validate such discuss recent research and other
to the juice labeling proposal and until interventions. Results of research information related to performance
July 8, 1998, to comment on aspects of conducted by Federal, State, private, criteria for fresh citrus juices. FDA
the PRIA relating to the juice HACCP and academic institutions were sought advice from the NACMCF on two
proposal. presented. issues. In addition, the meeting agenda
In the Federal Register of November provided an opportunity for public
C. Additional Opportunities for Public 23, 1999 (64 FR 65669) (Ref. 10), FDA comment.
Participation announced the availability of new data First, FDA asked the NACMCF about
Under the juice labeling rule and information regarding the safe the potential internalization and
(§ 101.17(g) (21 CFR 101.17(g))), juice processing of citrus juice and juice survival of pathogens in citrus fruits and
and juice products that have not been products, and reopened the comment citrus juices. The NACMCF members
specifically processed to attain a 5-log period for the juice HACCP proposal generally agreed that it is theoretically
reduction in the pertinent pathogen until January 24, 2000, in order to possible for microorganisms to enter the
must bear a warning label. Similarly, receive comment on the new data and interior of apparently sound, intact
under the juice HACCP proposal other information. In that same notice, citrus fruit under certain conditions
(proposed § 120.24), covered processors in order to develop the most complete (e.g., temperature difference between
must attain a 5-log reduction in the administrative record possible, FDA fruit and wash water), and that human
pertinent pathogen in their HACCP requested additional data and pathogens appear to be able to survive,
systems. Accordingly, in November information relating to four separate at least under defined laboratory
1998, FDA held two technical areas: Internalization and survival of conditions, in the fruit itself (Ref. 12).
workshops on how processors could pathogens in produce used to produce However, the NACMCF members
attain a 5-log (i.e., 105) reduction in the juice, especially citrus fruit; application concluded, based on the current
pertinent pathogen in citrus juices (63 and measurement of the 5-log reduction information, that the potential for
FR 57594; October 28, 1998) (Ref. 7). standard; current methods used by juice microorganisms to enter and survive in
The transcripts from the two workshops processors to monitor the application of intact fruit is not likely to result in a
were placed on display in the docket for heat treatment to juice; and certain significant public health risk. In
the juice HACCP proposal and on the economic matters related to juice particular, the Committee members
FDA/CFSAN website http:// regulation. The notice discussed in concluded, based upon the limited data
www.fda.gov/). On December 17, 1998 detail the particular issues in each of the available, including data presented by
(63 FR 69579) (Ref. 8), the comment four areas in which the agency was the industry, that although it is
period for the juice HACCP proposal seeking comments (64 FR 65669 at theoretically possible, it is unlikely that
was reopened until January 19, 1999, to 65670 through 65671). Two of these pathogens will enter and grow in sound,
allow public comment on data and other areas (internalization and survival of intact fruit under actual current
information that were presented at or pathogens and application and industry processing practices.
developed as a result of these measurement of the 5-log reduction Second, the agency asked the
workshops. In addition, FDA expressly standard) were also to be the subject of NACMCF about the application and
sought comments on the following four the December 8 to 9, 1999, public measurement of the 5-log pathogen
specific topics related to the application meeting of the National Advisory reduction standard to citrus fruit. In
Committee on Microbiological Criteria response, the NACMCF outlined the
of the 5-log pathogen reduction
for Foods (NACMCF) (discussed in more following five basic consensus decisions
standard: (1) Appropriate baselines for
detail below), and the comment period related to the application and
the calculation of the 5-log pathogen
extension was established so as to measurement of the 5-log reduction
reduction; (2) feasible interventions or
permit comments on the identified standard to citrus juices:
practices for the cultivation and harvest
issues in light of any information or 1. The 5-log reduction need not start
of fruits and vegetables, and acquisition
recommendations coming out of that with the extracted juice but may begin
of supplies and materials that may
meeting of the NACMCF. with the exterior decontamination of
contribute to achieving a 5-log pathogen
citrus fruit. However, processors should
reduction; (3) feasible interventions for D. NACMCF Public Meeting not start a cumulative 5-log reduction
the production process that may NACMCF is an advisory committee until after the fruit is cleaned (i.e.,
contribute to achieving a 5-log pathogen chartered under the U.S. Department of washed) and culled (i.e., damaged or
reduction; and (4) acceptable methods Agriculture (USDA) and has members dropped fruit is removed so that the
for measuring and validating 5-log from USDA (Food Safety and Inspection remaining fruit is USDA choice level or
reductions. Service), the Department of Health and higher quality).
On July 15 and 16, 1999, FDA held a Human Services (U.S. Food and Drug 2. One possible method to minimize
workshop on food safety controls for the Administration and the Centers for potential microbial infiltration into the
apple cider 2 industry (64 FR 34125; Disease Control and Prevention (CDC)), fruit would be by controlling fruit and
June 25, 1999) (Ref. 9). The workshop the Department of Commerce (National wash water temperatures, as well as
dealt with issues related to the Marine Fisheries Service), the excluding fruit that is split, punctured,
implementation of the agency’s Department of Defense (Office of the or otherwise not intact. Laboratory
regulations requiring a warning Army Surgeon General), academia, studies indicate that microbial
statement for certain juice products. industry and State agencies. The infiltration of fruit occurred when warm
Specifically, the workshop addressed NACMCF provides guidance and fruit was washed or submerged into
2 Although the terms ‘‘apple cider’’ and ‘‘apple
recommendations to the Secretary of cold water (Refs. 13 and 14).
juice’’ may have different meanings throughout the
Agriculture and the Secretary of Health 3. The entire 5-log process must occur
United States, these terms are used interchangeably and Human Services regarding the under one firm’s control and in one
throughout this final rule. microbiological safety of foods. processing facility, i.e., all steps from
fruit receiving to final juice packaging issues are discussed to the extent that systems. Even when producing
(and all points included in the 5-log they fall within the scope of issues comparable products, no two processors
reduction process) must occur at one presented by the juice HACCP proposal. use the same source of incoming
facility. If processors transport fruit or Some of the comments supported the materials or the same processing
juice to another facility for extraction, proposal. Other comments opposed, or technique, or manufacture in identical
blending, or final packaging, the 5-log suggested modifications of various facilities. Each of these factors (and their
reduction must be accomplished in the provisions of, the proposal. The agency many combinations) presents potential
second facility. discusses below the significant opportunities for contamination of the
4. If the expressed juice is aseptically comments bearing on the proposed food. HACCP focuses the processor on
packaged in a single-use sanitary non- HACCP regulation and, when understanding his own process and the
reusable tote (sterile bag in box type applicable, any revisions to the hazards that may be introduced during
package form) and the bulk packed juice proposed regulation made in response that process, and identifying specific
will be repackaged at another facility, a to these comments. Responses to the controls to prevent, reduce, or eliminate
5-log reduction process must be notice of intent that bear on the juice the identified hazards.
performed on that juice prior to final fill HACCP proposal and that were not The flexibility of the HACCP
and packaging. If the juice is used addressed in that proposal also are approach is a critically important
directly from the tote (e.g., used to addressed in this document. For attribute. This flexibility allows
dispense juice and juice beverages at simplicity, the agency’s discussion does manufacturers to adjust CCP’s, adjust
retail), the 5-log reduction process need not identify comments as to whether techniques used to address CCP’s when
not be repeated. Because juice in tanker they were received in response to the changes occur in the system (e.g., use of
trucks is not juice in a final package notice of intent or in response to the new ingredients), and readily
form, juice shipped in bulk tankers must juice HACCP proposal. incorporate new scientific
undergo a 5-log reduction process after developments (e.g., use of new control
transport and prior to final fill and A. Alternatives to HACCP Considered by techniques, new preventive
packaging. the Agency technologies, identification of new
5. As part of a HACCP verification In developing a strategy to address the hazards). Another important strength of
program, firms should conduct hazards associated with juice, FDA HACCP is the development of a plan
microbial testing on the final product if considered the following alternatives to written by the processor detailing the
the 5-log reduction process relies in part HACCP: (1) Increased inspections, (2) control measures to be used at CCP’s. By
on fruit surface treatment. This testing current good manufacturing practices developing a written plan, juice
would not be batch-by-batch testing for (CGMP’s), (3) mandatory pasteurization, processors gain a working knowledge of
lot acceptance prior to shipping, but (4) labeling as a long-term solution, (5) their processing system, its effect on the
would be used to verify the 5-log education, and (6) an approach that food, and where in the system potential
reduction process. The testing should would draw a distinction between contamination may occur. Both the
use generic E. coli as a means to assess untreated apple cider and all other processor and the agency are able to
the control of the process and should be juices. The agency discussed each derive the full benefits of a HACCP
conducted as specified in the HACCP alternative in the HACCP proposed rule system. The hazard analysis and HACCP
plan, utilizing an appropriate sampling (63 FR 20450 at 20454) and its reasons plan allow both the processor and the
plan. However, if results indicate (i.e., for proposing the use of HACCP systems agency to verify and validate the
the presence of generic E. coli) that the rather than the alternatives (Ref. 2). FDA operation of the system. HACCP’s
5-log reduction has not been achieved, received a number of comments flexibility also permits processors to
processors should consider testing the questioning the agency’s rejection of select the appropriate control measures
juice for specific pathogens of concern, certain alternatives. The agency’s in the context of how the whole system
such as Salmonella or any other responses to those comments are set functions, allowing processors to use
microorganisms of concern, according to forth in this section (section II.A). To the most appropriate and economical
an appropriate sampling plan and provide a meaningful context for the methods to control food hazards that are
processors should take suitable discussion of the alternatives, FDA is reasonably likely to occur in their
corrective actions. If the 5-log reduction providing the following discussion of operation. The ability to choose among
is applied after the juice is expressed, HACCP. various control methods encourages
microbiological testing would not be HACCP is a focused, efficient, research on and development of new
required as part of a HACCP verification preventive system that minimizes the and innovative technologies to better
program. chance that foods contaminated with address individual situations. Because
hazardous materials or microorganisms of its flexibility, HACCP is particularly
II. Response to the Comments will be consumed. The strength of advantageous to small businesses and
FDA received approximately 85 HACCP lies in its ability to enable the seasonal processors.
responses, each containing one or more processor to identify, systematically and HACCP provides the processor with a
comments, to the notice of intent. FDA scientifically, the primary food safety record of identified food hazards. It
addressed some of these comments in hazards of concern for the specific allows quick identification of a
the juice HACCP proposal. FDA products, the specific processes, and the breakdown in the processing system and
subsequently received approximately specific manufacturing facilities in thus, prevents products with food
800 responses, each containing one or question, and then to implement on a hazards from entering the marketplace
more comments, to the juice HACCP focused, consistent basis, steps (critical and causing illness. Moreover, review of
proposal. Comments received in control points (CCP’s)) in food records over a longer period of time
response to the notice of intent and to production, processing, or preparation (days or weeks) may reveal a trend
the juice HACCP proposal came from that are critical to prevent, reduce to toward a breakdown in the system, such
industry, trade organizations, acceptable levels, or eliminate hazards as a critical processing temperature that
consumers, consumer interest groups, from the particular food being is slowly drifting down. HACCP records
academia, and State government processed. Flexibility in how to address allow evaluation of whether changes in
agencies. Comments concerning labeling identified hazards is inherent in HACCP the processing system require changes
in CCP’s or their critical limits (CL’s), approach that effectively ensures the of these principles affects other
thus ensuring that the HACCP system is production of food that is safe and products made in these facilities.
up-to-date and adequate to control all wholesome (Ref. 17). Importantly, the The agency disagrees that CGMP’s
food hazards that are reasonably likely HACCP approach clearly delineates the and SSOP’s alone are adequate to
to occur. This recordkeeping also allows processor’s responsibility to make safe control microbial hazards in juice
regulatory investigators to readily products and FDA’s responsibility to although it does believe that CGMP’s
review the long term performance of a monitor conformance with the act play an important role in juice safety.
firm’s processing system, rather than through inspections and record review. The survey referenced by the comment,
relying on a time-limited inspection, (Comment 2) One comment was conducted by the Florida
which provides only a snapshot of how advocated a short-term solution of Department of Agriculture & Consumer
well the firm is doing in producing and increased inspections for adherence to Services and found that 17 out of 383
distributing safe product on any given sanitation standard operating samples analyzed (4.4 percent) were
day. procedures (SSOP’s) and CGMP’s with positive for generic E. coli and did not
HACCP is ideally suited to respond to zero tolerance for noncompliance. indicate what, if any, other
emerging problems because a HACCP Another comment stated that the juice microorganisms were present. While
system is a dynamic system that must be industry would welcome increased generic E. coli are not pathogens, their
validated periodically to ensure that all inspections as it implements new safety presence is indicative of fecal
hazards reasonably likely to occur are measures. contamination and may be indicative of
identified and controlled via CCP’s. The agency has been actively the presence of pathogens such as E. coli
Validation of both the hazard analysis monitoring the juice industry, especially O157:H7. (The significance of fecal
and the HACCP plan entails a thorough the fresh juice industry, in response to contamination is discussed in more
review to ensure that all hazards that are recent outbreaks. In addition, FDA has detail in the response to comment 143.)
reasonably likely to occur are addressed conducted inspections to determine Therefore, it is unclear how the
in the HACCP system. compliance with the label warning comments concluded that CGMP’s and
Because of its preventive yet flexible SSOP’s provide adequate control of
statement required by § 101.17(g). The
nature, HACCP is recognized by food potential food hazards to assure the
agency will continue this additional
safety professionals as the single most safety of the food by relying on the
oversight of the juice industry during
effective means to assure the safety of survey data.
implementation of part 120 until it has
foods. It has been endorsed by the The NCIMS procedures (i.e., the
assurance that the industry is in
National Academy of Sciences (Ref. 15), Pasteurized Milk Ordinance (PMO)
compliance.
the Codex Alimentarius Commission (an (Ref.18)) were developed to assure the
international food standard-setting (Comment 3) One comment safety of milk. While there may be some
organization) (Ref. 16), and the suggested that cider operations be fundamental principles, such as basic
NACMCF (Ref. 17). Increasingly, use of inspected and graded for cleanliness by sanitation procedures, that apply to both
HACCP systems is an indication to the States, like restaurants. the production of milk and juice, the
importing countries that food safety The agency disagrees with the products are vulnerable to different
systems that provide a standardized comment. Although sanitation (i.e., hazards. Moreover, States administer
level of public health protection are in cleanliness) is important in cider and all the PMO, and the agency has no
place and being used by producers in other food production operations, it is information indicating consistency in
exporting countries. only a starting point for ensuring that the application of the PMO to juice
safe food is produced and distributed to inspections in dairies. Thus,
1. Increased Inspection consumers. This limitation exists investigators in some States may use the
(Comment 1) Several comments regardless of the regulatory agency PMO as a guide in conducting dairy
suggested that the increased FDA inspecting for sanitation. juice operations and others may not.
inspection approach would be (Comment 4) Several comments Therefore, the agency does not believe
preferable to HACCP. suggested that industry-funded that application of NCIMS procedures in
The agency disagrees. FDA’s inspections could be used to ensure safe some dairies that process juice negates
responsibility is to implement and juice. the need for juice-specific HACCP
enforce the Federal Food, Drug, and FDA disagrees with these comments. regulations.
Cosmetic Act (the act), i.e., to oversee As discussed above, inspections are not (Comment 6) Several comments
the manufacture of safe food. Increased an adequate substitute for HACCP. argued that the examples of
inspection by FDA is a resource- Moreover, the agency does not have the nonmicrobial hazards (e.g., tin, lead,
intensive activity that puts the authority to require or accept funds nitrates, patulin, glass, or plastic) cited
responsibility and burden for ensuring from the industry for inspections of in the juice HACCP proposal are CGMP
food safety on the agency rather than on juice processors. violations and would not be included in
the juice processors. Inspections can, of a processor’s HACCP plan.
course, provide food processors with 2. Current Good Manufacturing The agency does not agree with the
valuable information about improving Practices comments. Whether or not a
the safety of their products. However, (Comment 5) Comments maintained nonmicrobial food hazard jeopardizes
safety cannot be effectively inspected that a survey of several small citrus the safety of a juice product is
into foods. Rather, food processing producers and juice bars showed that determined by the processor during the
systems themselves must be designed SSOP’s and CGMP’s are sufficient to hazard analysis of his process. If
and implemented in a manner that produce safe juice. One comment stated potential nonmicrobial food hazards are
results in the production of safe food. that no additional regulations are not reasonably likely to occur, then the
Part 120 (21 CFR part 120) provides a needed for dairies that process juice HACCP plan does not need to address
flexible standard that both the juice because dairies follow sanitation and these hazards with CCP’s. Thus, FDA
industry and the agency will use to other procedures outlined by the does not believe that it is reasonable to
determine the adequacy of a process. National Conference on Interstate Milk make a global statement that CGMP’s in
HACCP has been shown to be an Shipments (NCIMS) and the application part 110 (21 CFR part 110) are adequate
to control nonmicrobial hazards in all thus, must be included in the HACCP may become contaminated after
systems, because that determination plan. treatment and still put consumers at
must be made by each individual (Comment 8) Several comments risk; and the apple cider and fresh juice
processor through a hazard analysis of maintained that the enforcement of industry would be destroyed.
the individual system. CGMP’s or sanitation standards would Based upon the available information,
(Comment 7) Several comments ensure the safety of all juices. FDA does not believe that it is necessary
noted that the risks posed by the The agency disagrees with the or appropriate to mandate
nonmicrobial hazards identified by FDA comments. Outbreaks of foodborne pasteurization or other thermal
cannot be quantified for economic disease have been associated with juice treatment of juice. The agency is aware
purposes, that microbial hazards alone despite the fact that the processors of the reasons why processors
are not an adequate basis on which to appear to have been actively pasteurize or elect not to pasteurize
mandate HACCP, and that CGMP’s are implementing CGMP’s. Increased their juice products. Pasteurization, a
adequate. compliance with the CGMP regulations heat treatment sufficient to destroy
FDA disagrees with these comments. in part 110, including all sanitation pathogens, is an effective and proven
There are nonmicrobial food hazards provisions, is certainly desirable. technology that will attain the 5-log
that may be reasonably likely to occur However, CGMP’s are general in nature reduction in pathogens and, thus ensure
in juice. Some non-microbial hazards, and apply to all types of facilities that microbiologically safe juice.
such as glass, tin, and copper, present process all types of food products from Pasteurization also results in a longer
acute risks (Ref. 6), and result in acute highly processed foods to raw foods that shelf-life of refrigerated juices. With
illnesses or injuries that generate are merely packaged and labeled. proper post-processing handling,
medical and hospital costs, as well as CGMP’s were not designed specifically pasteurization assures consumers and
to address individual production regulators that the potential microbial
lost productivity costs.
facilities (for juice or any other hazards associated with juice are
The adverse health effects of other
commodity) or the unique attributes prevented. However, pasteurization is
nonmicrobial hazards are chronic (long-
associated with specific foodborne not the only method for addressing
term) in nature. For example, long-term
hazards. HACCP systems, as discussed potential microbial contamination. This
exposure to the mycotoxin, patulin, has in section II.A of this document, provide was discussed extensively in the juice
been shown to be toxic in safety focused, product- and process-specific HACCP proposal (63 FR 20450 at 20454)
assessments conducted in the United prevention and control of potential (Ref. 2) and again in the juice labeling
States (Refs. 19 and 20) and by hazards. HACCP augments the controls final rule (63 FR 37030 at 37041) (Ref.
international organizations (Refs. 21 and established through CGMP’s by: (1) 5). This approach is supported by the
22). Patulin is produced by several Determining the food hazards that are NACMCF recommendation that FDA
species of mold that can grow on apples, reasonably likely to occur in a specific establish safety performance criteria for
particularly if bruised or otherwise facility and process and thus, warrant appropriate target organisms rather than
damaged, and has been found to occur extra consideration beyond application mandating a specific intervention
at high levels in some apple juice of routine food safety measures, (2) technology (Ref. 25). Mandating a
products. The long-term toxic effects in identifying a specific CGMP or specific intervention technology such as
young children are of particular concern additional control measure that must be pasteurization would limit the
because children consume larger undertaken to prevent this food hazard development of new, potentially less
quantities of apple juice relative to body that is reasonably likely to occur from costly technologies that may be as
weight than other age groups. A reaching the consumer, and (3) effective as pasteurization. New
compilation of data from three surveys developing a verifiable procedure for nonthermal technologies (e.g., UV
showed that nearly one-fifth of the assuring that each control measure was irradiation and pulsed light, as
samples of apple juice contained levels applied and was effective. This focused approved by FDA; high pressure) may
of patulin in excess of 50 microgram/ consideration of hazards and their be able to achieve the required pathogen
liter (µg/L) (Ref. 23), the level recently prevention provides a higher degree of reduction. The use of non-thermal
established by FDA in draft guidance as safety assurance than application of technologies will provide consumers
the maximum level that should be CGMP’s. with a greater selection of safe products
present in foods (Ref. 24). to purchase. Furthermore, mandatory
The agency recognizes that 3. Mandatory Pasteurization
pasteurization would not control non-
quantifying the economic effects of (Comment 9) Several comments microbial hazards in juice. Therefore,
chronic non-microbial hazards is requested that the agency mandate FDA is declining to mandate
difficult. Given the difficulties in pasteurization or use of a universal pasteurization for juice.
quantification, FDA chose to not thermal process (thermal kill) to ensure (Comment 10) One comment stated
include nonmicrobial hazards with juice safety. The comments maintained that pasteurization should be mandatory
chronic health risks in the PRIA, that mandatory pasteurization is a for apple cider to eliminate a major
thereby underestimating the benefits of reasonable, science-based solution that source of health risks.
the proposal. Nevertheless, hazards with would ensure safe juice, is consistent FDA disagrees with the comment.
chronic health risks exist and the with FDA’s mission to protect the Under § 120.24, apple cider processors
potential effects on health are real. public health, and would assure must treat their juice to achieve a 5-log
Thus, hazards with chronic health risks consumers and regulators that the reduction in the pertinent pathogen. At
must be considered, along with microbial hazards associated with juice the present time, the agency is not
nonmicrobial hazards with acute health are being prevented in the most effective aware of any technology that can
consequences and microbial hazards, manner. Conversely, a number of accomplish the 5-log reduction in apple
during the hazard analysis and a comments opposed mandatory juice products except by treating the
determination made as to whether the pasteurization. They argued that extracted juice with a ‘‘kill step.’’
potential hazard is reasonably likely to nutritional value is lost from heat However the ‘‘kill step’’ does not
occur (comment 63 discusses how a treatment; some consumers prefer necessarily have to be pasteurization.
hazard analysis must be conducted) and unpasteurized juice; pasteurized juice This approach allows for innovation in
the development of new processes to recommendations for implementing choose between HACCP with a
achieve the 5-log pathogen reduction. measures that will assure safe juice at performance standard and labeling and
retail. Therefore, the agency concludes (2) require processors of all other juices
4. Labeling
that its current regulations and to choose between HACCP, a
(Comment 11) Two comments programs are balanced and appropriate performance standard, and labeling.
suggested that FDA require either for juice and juice products. The agency has evaluated the
pasteurization or a permanent warning (Comment 12) Several comments alternative approaches and concludes
label statement for producers who do asked that FDA make the warning label that HACCP with a performance
not pasteurize. One comment stated that statement a permanent option because, standard is the most effective and
FDA should require HACCP with a CCP if it is adequate to ensure consumer efficient approach to ensure safe juice.
of either a 5-log performance standard safety with products exempt from FDA notes that no data or other
for pathogen reduction or a warning HACCP, it should be adequate for all information were submitted to persuade
label. juice products. the agency that the alternative approach
FDA disagrees with the comments. FDA disagrees with the comments. As described in the proposal would
Under § 120.24, juice processors must noted in the previous response, while provide adequate public health
achieve the 5-log reduction in their the warning label statement may be assurance as would be provided by the
juice. As discussed in both the HACCP effective, particularly with consumers
proposal and in this final rule, it is HACCP regulation set forth below.
aware of juice safety problems, it has
possible for firms to manufacture juice Although more outbreaks have been
limitations as a public health measure.
to achieve this reduction by means other traced to the consumption of apple juice
The warning label statement simply
than pasteurization. The alternative than other juices, a fact reflected in the
informs consumers that the juice
presented in the comments, labeling, proposed alternative approach, the
bearing the statement has not been
has some limitations as a public health agency concludes that, because
treated to control pathogens and that the
measure. The effectiveness of labeling microbial, chemical, and physical
consumption of untreated juice may
untreated juice to alert consumers to hazards may occur in all juices, and
pose a risk of illness. As noted, the
possible harmful effects from its outbreaks have been associated with a
effectiveness of any warning label relies
consumption relies on consumers’ variety of juices, there is a need to
on consumer education and action. FDA
reading, comprehending, and acting on regulate all juices in the same general
is not changing the warning label
the information in the labeling. manner. Furthermore, the performance
statement requirements in this
Although labeling can provide standard and the label warning
rulemaking.
consumers with the information to make statement only address microbial
food safety related choices, education is 5. Education hazards. In contrast, HACCP systems
an important factor in a consumer’s (Comment 13) Several comments address physical and chemical, as well
choice. Therefore, there are limitations maintained that increasing industry as microbiological, hazards, thus
to the effectiveness of labeling. education is all that is needed to ensure providing greater assurance that juice is
The agency mandated the use of the safety of all juices. safe. Therefore, the agency is requiring
warning label statements on juice The agency disagrees. While FDA that all juice processors with the
largely as an interim step to establishing supports and encourages processor exception of those specifically
the HACCP regulation. For most juice education as a way to improve the safety exempted by § 120.3(j)(2) use HACCP
products, the warning label is a short of the food supply, such measures systems as set forth in part 120.
term solution. While FDA is reluctant to alone, without being teamed with B. Response to the Decision to Propose
rely on labeling as the sole safety implementation of an effective food HACCP
measure, the agency recognizes that in safety control program, such as HACCP,
certain circumstances, labeling may, on and government oversight, will not FDA proposed to require HACCP for
balance, provide the most reasonable ensure consumer protection from juice products because it had tentatively
approach to protect the public health. hazards that may be present in juice. concluded that HACCP was an
FDA believes that HAACP, as required Training and education is only one step appropriate system of preventive
in this final rule, is a reasonable in the effective implementation of any controls necessary to produce safe juice
approach because, in contrast to some food safety system, including HACCP. products. The evidence presented in the
other food safety problems, the facts Effectively, this final rule requires the proposal demonstrated that juice has
show that, for juice, processor control of industry to improve their education in been a vehicle for pathogens that have
pathogens is reasonably achievable. food safety in order to implement caused a number of foodborne illness
Moreover, a warning label does not effective HACCP systems. outbreaks. While pathogens can be
substitute for adequate processing of Implementation of an effective HACCP controlled through heat treatment, the
juice, is not an appropriate substitute for system demonstrates a processor’s data (Ref. 2) clearly demonstrate that
the 5-log performance standard, and understanding of HACCP principles and there are potential nonmicrobiological
would not be considered a CCP for juice the ability to translate theory into hazards associated with juice that
under part 120. production of safer food. Therefore, the cannot be controlled through heat
For juice produced by retailers (as agency concludes that increased treatment. For these reasons, FDA
defined in the rule), however, the industry education alone would not be tentatively concluded that a HACCP
warning statement is a long term sufficient to ensure the safety of all program that addresses all potential
solution. The agency discussed its juices. hazards (i.e., microbiological, chemical,
reasons for exempting retail and physical), allows each juice
establishments from part 120 in the 6. Alternative Approach manufacturer to evaluate its own
juice HACCP proposal (63 FR 20450 at (Comment 14) Many comments process, and to institute appropriate
20464) (Ref. 2), and these reasons are supported the alternative approach controls for all hazards identified as
further discussed in section III.B.2.b of outlined in the proposed rule (63 FR reasonably likely to occur in that
this document. The agency intends to 20450 at 20456) (Ref. 2) that would: (1) manufacturer’s process should be
work closely with the States to provide Require producers of apple cider to established.
(Comment 15) Several comments compilation of data from three surveys reasonably likely to be contaminated
advocated HACCP limited to pathogen showed that 19 percent of samples of with lead, that processor would not
control. apple juice contained levels of patulin need to identify lead as a hazard in its
The agency disagrees with the in excess of 50 µg/L (Ref. 23). FDA has HACCP plan. Importantly, processors
comments. While pathogen control is a recently issued guidance describing 50 who are currently implementing HACCP
significant part of any HACCP system parts per billion (ppb) as a to address microbial hazards only
for juice, there are potential chemical recommended level for patulin (Refs. 19 already have the infrastructure in place
and physical hazards that can occur in and 24). For apple juice processors, to analyze their processing system and
juice, with significant public health patulin may represent a hazard that is can then determine if there are chemical
implications, and these hazards may be reasonably likely to occur when juice is or physical hazards that are reasonably
most effectively controlled through made from bruised or damaged fruit, as likely to occur. Therefore, with minimal
application of HACCP (Ref. 2). HACCP even moderate bruising can result in effort, these processors can readily
provides a way to focus on specific mold growth on apples. Moreover, expand the scope of their HACCP
CCP’s addressing specific hazards, both patulin may be a chronic potential system to include consideration of all
microbial and non-microbial (e.g., tin, hazard and therefore particular attention potential hazards.
lead, nitrates, patulin, glass, or plastic) must be given to the frequency of Based upon the foregoing, the agency
that are relevant to juice processing occurrence. Therefore, a prudent concludes that chemical and physical
operations and products. These hazards processor must determine whether the hazards, as well as pathogens, may pose
may be appropriately identified in the frequency of occurrence of this potential public health risks in juice products.
hazard analysis as hazards that are hazard in juice is unacceptable without These hazards, when they are
reasonably likely to occur and controls. If patulin is reasonably likely reasonably likely to occur, require
controlled through a HACCP plan. to occur at unacceptably high levels, specific preventive controls. HACCP is
There are a number of potential processors must include it as a hazard the most appropriate system to control
hazards for juice that are nonmicrobial in their HACCP plans. Patulin is not the both microbial and nonmicrobial
in nature. For example, juice products sole mycotoxin that may be a hazard in hazards that are reasonably likely to
have become contaminated with juice. There is evidence that other occur in juice products.
cleaning solution. If this contamination mycotoxins, such as ochratoxin in (Comment 16) Several comments
is a hazard that is reasonably likely to grapes and Alternaria toxins in fruit and suggested that quality assurance systems
occur in a particular process (e.g., there vegetable products (Ref. 28), may be devised specifically for juices would be
is a repeated history of its occurrence), emerging public health problems in appropriate alternatives to mandatory
the processor must establish controls in juices and at least warrant monitoring of HACCP with a performance standard.
its HACCP plan to prevent the future developments.
The comments contended that the
contamination rather than address the quality assurance systems developed by
contamination in their SSOP’s. Lead contamination has also been and for the citrus industry in
Similarly, some juice products have associated with juices. In 1996, infant conjunction with the University of
been recalled due to the presence of apple prune and prune juices were Florida (Ref. 34) are adequate to ensure
glass. Glass shards in juice represent a recalled for unacceptable levels of lead the safety of citrus juices and that the
severe and acute public health threat. (Refs. 29 and 30). More recently, Apple Hill Quality Assurance Program
Processors who package in glass must unacceptable levels of lead have been (Ref. 35) is adequate to ensure the safety
consider whether glass in their final found in babyfood containing carrots of apple juice. Some comments asserted
product is reasonably likely to occur in and in carrots in frozen mixed that these programs are just as effective
the absence of control. If so, processors vegetables as a result of lead as HACCP, while being less expensive
must establish controls for glass in their contamination in the soil (Refs. 31 and to implement.
HACCP plans. 32). Juice made from produce with high FDA encourages the efforts by
Excess detinning represents another lead levels will also be high in lead. A industry, universities, State and local
potential nonmicrobial hazard for juice. German survey of lead in foods found government agencies, and others to
Certain juices are purposely packaged to that 12 percent of fruit juices contained develop programs to ensure the safety
allow some detinning of the can in order elevated levels of lead and over 5 and quality of the food supply and is
to protect the color quality of the percent of fruits had elevated levels of aware of several such programs. The
product. However, detinning can be lead (Ref. 33). It is well recognized that agency has reviewed the quality
accelerated by unusually high nitrate lead has no known ‘‘no-effect level’’ and assurance programs mentioned by the
content in the product or by elevated consumption of lead-contaminated food comments and finds that the HACCP
temperatures during storage or shipping is a recognized health problem, system in part 120 provides a greater
(Refs. 26). Excessive detinning has particularly for children in their level of public health assurance. If a
resulted in consumer illness (Refs. 26 developmental stages. Responsible processor can implement a quality
and 27). Thus, processors of juice processors should exercise control to assurance program that also meets the
products that employ detinning as a ensure that their juice products do not requirements of part 120, then FDA does
means of color protection must contain lead at harmful levels. Again, not object to the processor using that
determine whether it is necessary to HACCP provides both the necessary program for its HACCP system.
establish specific control measures, i.e., control and flexibility to address the However, quality and safety are not
a CCP, because excessive detinning is problem of lead contamination. If a necessarily synonymous. Quality
reasonably likely to occur. processor is importing juice from a programs focus on the combination of
Potential hazards may also be caused geographic region known to have a attributes or characteristics of a product
by the nature of incoming materials. problem with lead contamination in that have significance in determining
Patulin in apple juice products is one foods, that processor should identify the degree of acceptability of that
such example. Patulin is a mycotoxin lead as a hazard in their HACCP plan. product by consumers. Safety programs
produced by several species of mold However, if a juice processor determines focus on hazards and public health
that can grow on apples, particularly if through its hazard analysis that, given assurance. Quality assurance systems
bruised or otherwise damaged. A their source, incoming materials are not may not address all public health
hazards just as safety programs may not copy of the thermal process in a especially with regard to science-based
address all quality issues. processor’s hazard analysis will provide analysis, and thus to allow for the
(Comment 17) Several comments evidence that the process is adequate. progression in mastering the HACCP
requested that FDA exempt from the Importantly, pathogen control is not system that accompanies that process.
HACCP regulation processors who the only problem with juice safety. As The progress in implementing HACCP
pasteurize their product, make shelf- discussed in the juice HACCP proposal systems that the seafood industry is
stable product, or meet the 5-log (63 FR 20450 at 20451) (Ref. 2) and in making suggests that other segments of
performance standard because the aim the response to comment 15, there are the food industry, including those
of the rule should be pathogen control. also established chemical and physical populated by small businesses, can also
The comments said that HACCP is risks with juice. A juice product can benefit from a HACCP program, even if
regulatory overkill and it is unfair to only be considered safe if all hazards complete understanding of what
impose HACCP on the 98 percent who (i.e., microbial, chemical, and physical) constitutes full implementation of a
pasteurize in order to control the real are considered and, if these hazards are HACCP system is not immediate.
risk from the 2 percent who do not. The reasonably likely to occur, are (Comment 19) Several comments
comments noted that illness outbreak controlled. Therefore, FDA concludes stated that HACCP presents an undue
evidence only supports the need for that processors of thermally processed burden to the pasteurized juice industry
interventions to control pathogens in juice must comply completely with this with no consumer benefits. The
unpasteurized juice because there have HACCP regulation, but can do so with comments stated that the chemical
been no reported outbreaks of illness minimal added effort. hazards cited by FDA are not reasonably
from consumption of pasteurized juice. (Comment 18) Some comments likely to occur and that there has never
The agency agrees that, when used contended that the HACCP proposal been a foodborne illness outbreak
with appropriate times and goes way beyond establishing necessary associated with pasteurized juice.
temperatures, thermal pasteurization 3 is measures to ensure juice safety and is The agency does not agree. The
a proven and effective method for neither reasonable nor economically preamble to the proposed rule described
controlling pathogens. However, the feasible for an industry characterized by incidents of illness associated with
effectiveness of pasteurization is small producers, family businesses, chemical contaminants in juice (63 FR
dependent on implementation of an seasonal production, and very little 20450 at 20451) (Ref. 2). Chemical
integrated system that validates and prior experience in food safety hazards can occur in juice regardless of
verifies the efficacy of the pasteurization management. Comments also noted that pasteurization. Moreover, for some
process. It is likely that processors who there is a low level of compliance with juices, the risk of chemical
make concentrated, shelf-stable, or seafood HACCP among small producers contamination can be high, depending
pasteurized juices have already and the success of juice HACCP will on the quality of the incoming produce
incorporated HACCP principles, aimed depend upon small processors and the chosen processing steps. In fact,
at control of pathogens, into their complying with costly regulations. in two recent incidents, juice was
processing operations (Ref. 36). Conversely, several comments argued recalled by the processor in one case
Processors already attaining the 5-log that HACCP is the appropriate food due to the presence of dairy and egg
reduction performance standard are safety system for small producers allergens (Refs. 37 and 38), and in the
likely to have established process because it can be implemented without other, due to the presence of cleaning
parameters (i.e., critical limits), are being overly burdensome and forcing solution (Refs. 39, 40, and 41). As
monitoring the process, and are keeping them out of business. discussed earlier in comment 15, the
records of their monitoring. Therefore, it The flexibility of HACCP allows the risk of patulin contamination in apple
should require minimal effort for processor to control hazards identified juice is high if the processor uses
processors that make concentrated, in the hazard analysis in a manner that bruised apples.
shelf-stable, or pasteurized juices to best fits an individual operation, large The agency does not agree that
satisfy the requirements of part 120 or small. In addition, if small producers HACCP for the pasteurized juice
relating to pathogen control. Moreover, actually have very little prior experience industry does not convey benefits to
as discussed in section L of this or knowledge in food safety consumers. While the classic definition
document ‘‘Process Controls,’’ in management, as some comments of pasteurization is a heat-treatment to
recognition of the effectiveness of asserted, then HACCP training and destroy pathogens, the agency has no
thermal treatments for pathogen control, consultation are very much needed by assurance that all juice processors who
FDA is providing in part 120 an this group and will provide specific believe they are pasteurizing their
alternative method for processors food safety goals customized to their products actually have all the controls
making shelf-stable juices or certain individual operations. in place to assure that every particle of
juice concentrates to comply with the 5- Thus, features of the agency’s the juice is receiving sufficient heat to
log reduction in the pertinent pathogen. regulatory strategy will accommodate destroy pathogens. Moreover,
The agency believes that the alternative small processors. First, FDA intends to pasteurization alone does not assure the
method is reasonable because the provide a juice HACCP hazards and safety of juice products. Proper handling
processes for shelf-stable juices and controls guidance that will assist of the product after pasteurization is
concentrates are so rigorous that they processors. Second, this final rule has a required to prevent post-process
exceed the minimum requirements for staggered compliance schedule contamination. A HACCP system based
control of microbiological hazards. A (§ 120.1(b)(1) and (b)(2)), which on CGMP’s provides assurance to the
provides small and very small juice processor, as well as to the agency and
3 FDA has not defined what pasteurization means processors additional time to implement the consumer, that pasteurized products
in terms of juice and juice products because of the fully the final rule. are safe.
unique characteristics of the many various types of The agency’s HACCP strategy for the The agency is required, by Executive
juice and juice products. The scientific literature seafood industry, which is dominated Order and law, to consider both the
provides data on adequate pasteurization times and
temperatures. Prudent processors using
by small processors, has been to costs and benefits to consumers and
pasteurization rely on this research data for their acknowledge that the implementation of industry. This analysis can be found in
particular types of juices. HACCP can be an educational process, the PRIA, and the Regulatory Flexibility
Analysis in sections V and VI of this of adequate controls, not just post- that can be verified as effective by
final rule. Based on FDA’s analysis, the process handling. Processors must company management as well as
benefits (i.e., prevention of illness) of consider prevention of post-process regulatory authorities.
this final rule outweigh the costs to contamination to the extent feasible. For (Comment 23) Many comments
industry. example, post-process piping must questioned the validity of FDA’s risk
A few comments expressed concern prevent contamination from occurring assessment on juice. They stated that it
that HACCP regulations may be prior to packaging. HACCP systems are was not scientific and sound, not
enforced at the expense of CGMP’s. implemented to assure the safety of food probabilistic, didn’t include pasteurized
The agency does not agree with the when it leaves the processor’s control juice, and contains inaccuracies.
comments. In fact, FDA expects that the and under normal handling conditions However, comments did not specifically
opposite will be true. A HACCP system after that. The agency points out that the identify the inaccuracies.
cannot be operating properly if a CAST report cited by the comment FDA maintains that its ‘‘Preliminary
processor is not following CGMP’s includes all foods (not just juice) and all Investigation into the Morbidity and
because CGMP’s provide the foundation food sources (processors, food service, Mortality Associated with the
for an adequate and appropriate HACCP institutions) and is limited to microbial Consumption of Fruit and Vegetable
system. Therefore, to evaluate the contamination of foods. The majority of Juices’’ is sound. As outlined in the
effectiveness of a HACCP system, juice outbreaks have not been caused by juice labeling final rule (63 FR 37030 at
processors and agency inspectors must post-process contamination but rather 37031) (Ref. 5), the agency performed a
also evaluate processors’ adherence to by contaminated incoming product or detailed evaluation of the potential
CGMP’s. contamination during processing (Ref. hazards posed by untreated juices. This
(Comment 20) One comment stated 43). Thus, the performance standard (5- evaluation is part of the record of the
that HACCP as set forth in the proposal log reduction in pathogen level) HACCP proposal and was included as
places the responsibility for product established by this rulemaking is set to an appendix to the PRIA (63 FR 24292;
safety on the government rather than the ensure that the final product is not May 1, 1998) (Ref. 6). The evaluation
processor. contaminated with illness-causing was based on available scientific
FDA does not agree with this bacteria that may have been present on information, included pasteurized juice,
comment. Each juice processor is incoming fruit. In addition, processors and examined both heat-treatable
responsible for developing a system of must use CGMP’s, SSOP’s, and HACCP microbial hazards and non-heat-
preventive controls by adapting the to ensure that product is not treatable hazards. Non-heat-treatable
HACCP principles in new part 120 to its contaminated with pathogens while in hazards are discussed in section VII and
specific operation and needs. Under the processing facility. the evidence is summarized in table 7
HACCP, the manufacturer is responsible (Comment 22) Several comments of FDA’s Investigation. The conclusion
for knowing and understanding its stated that hazards in juice are that the most significant juice-borne
manufacturing process, identifying adequately dealt with under State laws hazards are associated with non-heat-
points where contamination can occur, (i.e., Connecticut, Florida, Illinois, treated juice was based on this
and implementing control measures in Maryland, Massachusetts, Michigan, investigation.
order to produce safe food. To New Jersey, New Hampshire, (Comment 24) One comment stated
accomplish this, the processor must: (1) Wisconsin). that all outbreaks in cider have been
Have an individual who is trained in The agency applauds State efforts to traced to using dropped apples or
HACCP conduct a hazard analysis, ensure the safety of juice produced and unsanitary processing conditions and
determine where controls are needed, sold in their States. However, while that eliminating these circumstances
and validate the adequacy of any there may be some State laws that will stop outbreaks in cider.
HACCP plan that is developed; (2) put govern the manufacture of juices, these FDA disagrees with the comment
those controls in place and verify that laws are generally not as comprehensive because the causes of cider-related
they are working through monitoring as this HACCP rule. In addition, not all outbreaks are not limited to using drops
and recordkeeping; and (3) revalidate juice producing States have applicable or processing in an insanitary facility. In
the HACCP plan at least annually or any State laws. This HACCP final rule fact, from a structural standpoint, apples
time there is a significant change in the provides a uniform minimum level of are susceptible to contamination
process or whenever scientific public health protection across the because they have an open blossom end,
information demonstrates a new risk country for juices. FDA believes that and thus, the interior of the fruit can be
that processors have not previously this final rule will enhance State efforts contaminated while the exterior appears
considered in their hazard analysis. and help extend the food safety efforts clean and blemish free (Ref. 45). This
FDA’s responsibility is to conduct of some States to all States. potential for contamination is confirmed
oversight to ensure that HACCP is by data that show that cider, even when
C. Significance of Illness Data
properly implemented and is effective. it is made from tree-picked fruit and
(Comment 21) Several comments The preamble to the proposed processed under CGMP’s, can contain
stated that HACCP’s cost is not justified regulation described occurrences of pathogens and provide an environment
because most foodborne illness occurs juice-related foodborne illness in the conducive to the survival of pathogens
as a result of problems that originate United States. It is well recognized that of public health significance (Ref. 13).
after juice leaves the processor and foodborne illnesses are significantly (Comment 25) Several comments
HACCP will not remedy these problems. underreported to public health maintained that the risk from juice is
One comment cited a source that authorities (Ref. 44). Consequently, low and does not warrant a HACCP
estimated that food manufacturers are precise data on the numbers and causes regulation.
involved in less than 10 percent of of foodborne illness do not exist. The The agency does not agree with the
foodborne disease outbreaks of known primary purpose of these regulations is comments. There are documented cases
origin (Ref. 42). to ensure that juice is safe through the of lifethreatening foodborne illness
FDA maintains that all steps in juice use of preventive controls that are associated with the consumption of
production and handling are potential systematically and routinely applied in various juice products contaminated
points of contamination in the absence juice processing, and applied in a way with pathogens such as E. coli O157:H7,
Salmonella species, Cryptosporidium, were identified from orange juice the comment. However, as discussed
and Vibrio cholerae. Some of the collected from the implicated firm. throughout this preamble, insanitary
illnesses associated with juices have In October 1999, there was an conditions and workers’ health are not
been very severe (e.g., cases of long-term outbreak of E. coli O157:H7 in the only source of food hazards in juice.
reactive arthritis and severe chronic commercially-processed unpasteurized For example, if juice is made from
illness) (Ref. 2). In one case, apple cider in Oklahoma with 9 contaminated fruit and the 5-log
consumption of contaminated juice illnesses (7 children) and 6 reduction is not accomplished, an
resulted in the death of a child and in hospitalizations (4 cases of hemolytic outbreak could occur. HACCP systems
another case, consumption of uremic syndrome (HUS)) (Ref. 48). do provide greater assurance than
contaminated juice contributed to the While no illnesses were reported in CGMP’s and SSOP’s alone that juice is
death of an elderly man. These reported October 1998, the State of Florida found safe. HACCP recordkeeping provisions
outbreaks likely represent only a Salmonella Manhattan in an allow processors and regulators to
fraction of the outbreaks and sporadic unpasteurized juice blend containing detect process deviations and stop
cases that actually occur (Ref. 44). strawberry, apple, and papaya juice distribution of or recall product before
Chemical and physical hazards have (Ref. 49). it results in an outbreak.
also been associated with juices. In November 1999, the same firm (Comment 28) Several comments
Examples of these hazards were involved in the June 1999 outbreak stated that the rules should cover apple
included in the proposal (63 FR 20450 initiated and subsequently expanded a products only, asserting this is where
at 20451) (Ref. 2) and are discussed in recall because their routine testing problems have occurred.
detail in the response to comment 15. found Salmonella in samples of
The agency disagrees that only apple
unpasteurized orange juice (Ref. 50).
The evidence demonstrates that juice should be covered by part 120, and
The product had been distributed to
hazards can be present in juice. The all other juices should be exempt. There
restaurants and other food service
comments did not provide the agency have been illness outbreaks from other
establishments in eight U.S. States and
with additional data that either types of juice, e.g., orange juice. Some
one Canadian Province and to one retail
contradict FDA’s hazard evaluation (Ref. of these were cited in the proposal (63
store in Oregon. No known illnesses
6) or that can be used to reevaluate the FR 20450) (Ref. 2). As discussed in
were associated with this incident.
health risks associated with In April 2000, there was an outbreak comment 27, additional outbreaks since
consumption of juice products. of Salmonella Enteritidis associated publication of the proposal have
Therefore, FDA believes that the public with unpasteurized orange juice (Ref. occurred. Therefore, FDA concludes
health risk associated with consumption 51). As of May 2000, 143 cases traced that because there are documented
of juices is sufficiently high to justify to this orange juice had been identified foodborne illness risks associated with
mandating use of HACCP systems. in Arizona, California, Colorado, juices other than apple juice, all types
(Comment 26) Many comments Minnesota, Nevada, Washington, and of juice must be covered under part 120.
argued that HACCP is no longer Wyoming. (Comment 29) Many comments
necessary for juice because of the safety Also in April 2000, 24 people who argued that juice regulations should not
improvements made by the juice attended a conference in Atlanta, be more stringent than regulations for
industry since the 1996 outbreak of E. Georgia, were reported ill with viral other foods that are more hazardous,
coli O157:H7 in apple juice. They stated gastroenteritis (Ref. 52). Fresh-squeezed such as seafood or meat and poultry.
that these improvements are evidenced unpasteurized fruit smoothies were Many comments noted that seafood
by the fact that there has not been an implicated in this outbreak. CDC HACCP has no performance standard
outbreak associated with juice since detected Norwalk-like virus in three but is a much higher risk food than
1997. patient stools. juice.
FDA disagrees with the comments. Thus, the potential for juice-related The agency disagrees that juice is
There have been documented outbreaks illness still exists, although the number being regulated more stringently than
of juice-associated foodborne illness of illness outbreaks linked to juice may warranted. HACCP for juice mirrors
since 1997. The agency acknowledges vary from year to year. In addition, the FDA’s HACCP regulations for seafood
the recent steps taken by the industry to agency has no information indicating and USDA’s regulations for meat and
address microbial contamination of that all members of the juice industry poultry. In contrast to most seafood and
juice. Nevertheless, while there were no have implemented adequate safety meat and poultry, juice is generally
reported outbreaks attributed to juice in improvements to address the potential consumed as sold. The record of this
the United States in 1997 and 1998, for microbial contamination and other proceeding demonstrates that microbial
there were several outbreaks in 1999 potential hazards in their products. The contamination of juice is a substantial
and 2000. These outbreaks are discussed fact that outbreaks continue to occur is public health risk and that a
below. evidence to the contrary. performance standard is achievable as a
In early 1999 in south Florida, there (Comment 27) One comment practical matter. Thus, to ensure the
were 16 reported cases from Salmonella asserted that most problems associated safety of juice products, FDA is
typhi linked to the consumption of with citrus juices were a result of establishing a mandatory HACCP
frozen mamey, a product often used to insanitary processing conditions at program that includes a performance
make juice beverages (Ref. 46). small or very small businesses or standard to prevent, reduce, or
During June 1999, there was an contamination by asymptomatic food eliminate levels of pathogens known to
outbreak of Salmonella serotype handlers, and HACCP would not cause foodborne illness. The
Muenchen infection associated with prevent problems in either situation. performance standard ensures that
consumption of unpasteurized orange The agency disagrees with this controls within the HACCP system are
juice (Ref. 47). As of April 2000, a total comment. FDA often finds in their working effectively to reduce the risk of
of 423 cases, including one that investigations into outbreaks that the illness and that the final product is safe.
contributed to a death, from S. exact cause of the outbreak is unknown. (Comment 30) One comment
Muenchen infection had been reported. The agency may find various possible maintained that the physical hazards
Nine additional Salmonella serotypes causes that include those mentioned by related to juice are a result of metal cans
and glass, both of which are not used by • Clarification of application of the 5- and then sold to the ultimate consumer
the fresh juice industry. log pathogen reduction performance within the same State).
FDA recognizes that juices that are standard (comments 115 and 131 to 139) As noted in the proposal, FDA is
minimally processed usually are • Creation of an exemption for shelf- relying upon both its authority under
packaged in plastic to provide for stable juice processors and concentrated the act, 21 U.S.C. 321 et seq., and the
expansion of the product. Whether or juice processors from the requirement Public Health Service Act, 42 U.S.C.
not packaging materials are included in for a pathogen reduction critical control 241, 242l, 264. FDA’s authority to
a processor’s HACCP plan will be point, under specific conditions regulate ‘‘interstate juice’’ is discussed
determined in the processor’s hazard (comment 140) in detail below in comment 74. Under
analysis. If the hazard analysis shows • Establishment of a process section 361 of the Public Health Service
that a particular operation has no verification sampling and testing Act (42 U.S.C. 264), the Surgeon General
physical hazards, such as metal or glass, procedure for citrus juices that use is authorized to issue and enforce
that are reasonably likely to occur, no surface treatment as part of the 5-log regulations to prevent the introduction,
control measures are required for such pathogen reduction process (comment transmission, or spread of
hazards. Even if there are no physical 142 to 143) communicable diseases from one State
hazards in fresh juice that require to another State. (This authority has
III. The Final Regulation been delegated to the Commissioner of
controls, the risk of microbial
contamination of fresh juice is well- A. Applicability Food and Drugs, 5 CFR 5.10(a)(4).)
documented and a HACCP approach is Activities that are wholly intrastate in
The agency proposed in § 120.1(a) character, such as the production and
needed to address these risks. that any juice sold as such or used as
(Comment 31) One comment stated final sale to consumers of a regulated
an ingredient in beverages be processed article within one State, are subject to
that the Bacillus cereus incident cited in accordance with the requirements of
by FDA is not significant and any final regulation under section 361 of the PHS
part 120 (63 FR 20450 at 20462) (Ref. 2). Act State of Louisiana v. Mathews, 427
rule should clearly state that As proposed, juice is the aqueous liquid
sporeformers are not a problem that F. Supp. 174, 176 (E.D. La. 1977). The
expressed or extracted from one or more record in this rulemaking amply
needs to be considered in a treatment fruits or vegetables, purees of the edible
system for juice. demonstrates that juice can function as
portions of one or more fruits or a vehicle for transmitting foodborne
The agency has considered the issues vegetables, or any concentrates of such illness caused by pathogens such as
surrounding hazards from spore forming liquid or puree. Salmonella and E. coli O157:H7.
bacteria. Regulations in parts 113 and (Comment 32) One comment Similarly, the record (Ref. 53)
114 (21 CFR parts 113 and 114) already requested that FDA define juice as the demonstrates that consumers
address the hazard from Clostridium aqueous liquid expressed or otherwise (particularly out-of-State tourists and
botulinum in low acid canned foods and extracted from food and that this other travelers) are likely to purchase
acidified foods. Spore forming bacteria definition should be synonymous with and/or consume ‘‘intrastate’’ juice.
have not been associated with public juice definitions in other regulations, These consumers subsequently take the
health problems in juice that has been i.e., food standards. One comment noted juice back to their home State where the
properly handled (e.g., refrigerated) after that food products (e.g., fruit cocktail) juice is consumed or carry a
leaving the processing plant. Therefore, other than beverages contain fruit juice. communicable disease back to their
FDA does not anticipate that processors’ FDA advises that the purpose of home State, thereby creating the risk
hazard analyses will establish that spore § 120.1(a) is to define the scope of what that foodborne illness may occur in the
forming bacteria are a hazard that is is covered under part 120 rather than to home State as a result of such
reasonably likely to occur. provide a general definition for the term consumption.
D. Comparison of the Proposal and This ‘‘juice.’’ Part 120 only covers products The agency believes that its intent to
Final Regulation sold as juice or used as an ingredient in regulate both ‘‘interstate’’ and
beverages. The agency recognizes that ‘‘intrastate’’ juice was evident from
The comments received generated products other than beverages, e.g., § 120.1(a) of the proposal, which stated
some clarifications of and changes in canned fruit cocktail, may contain fruit that the requirements of part 120 would
provisions of the proposed regulation. or vegetable juice. However, the apply to ‘‘any juice’’ without
These are discussed in detail in the foodborne illness outbreaks prompting qualification as to its ‘‘interstate’’ or
comments noted after each item. Among the juice HACCP proposal were ‘‘intrastate’’ character. However, to
the most significant clarifications and associated with juices and juice clarify further the products to which
changes are the following: products that were beverages rather than this final rule applies, FDA is adding a
• Clarification that the regulation juice ingredients contained in non- sentence to § 120.1(a) as follows: ‘‘The
covers intrastate, as well as interstate beverage products. Therefore, FDA is requirements of this part shall apply to
juice (discussed in comments 33 and 74) not defining ‘‘juice’’ in the general sense any juice regardless of whether the
• Adoption of the most recent requested by the comment. juice, or any of its ingredients, is or has
NACMCF definition of ‘‘food hazard’’ (Comment 33) Several comments been shipped in interstate commerce (as
(comment 39) requested that FDA clarify whether the defined in section 201(b) of the Federal
• Elimination of the proposed juice HACCP regulation covers only Food, Drug, and Cosmetic Act, 21 U.S.C.
exemption from the regulation for retail interstate commerce. 321(b)).’’
establishments that produce juice on FDA intends that this final rule cover (Comment 34) Some comments
their premises and sell 40,000 or less both ‘‘interstate juice’’ (i.e., juice that is requested that FDA exempt citrus juices
gallons of juice per year (comment 47) shipped in interstate commerce or that from the HACCP regulation because
• Addition of a definition of ‘‘retail is made using one or more components these juices contain organic acids that
establishment’’ (comment 48) that were shipped in interstate stop microbial growth, the pH of citrus
• Clarification of how a hazard commerce) and ‘‘intrastate juice’’ (i.e., juices is too low for pathogen growth,
analysis is conducted (comments 63 to juice that is made entirely from and peel oil contains an antimicrobial
70) components grown within a single State agent. One comment included data
indicating that Listeria and E. coli antimicrobial parameters. In addition, that pathogens can occur on incoming
O157:H7 cannot survive in lemon and there may be chemical and physical apples. (The analytical method used for
lime juices under normal storage hazards that are reasonably likely to Salmonella has since been improved to
conditions and requested that these two occur in these types of juices that pH better detect low levels of this pathogen
juices be exempted from the HACCP and acids cannot control. Therefore, in acidic foods, such as apple juice.)
rule. FDA concludes that the chemical Results also showed that samples of
The agency disagrees that citrus juices composition of lemon and lime juices wash water from several firms tested
should be exempt from the requirements does not justify exempting these juices positive for generic E. coli and fecal
of part 120. Although the organic acids, from this rule. If processors can coliforms; overall, generic E. coli was
pH, and peel oil in citrus juice may demonstrate that the inherent found in 15 percent of the finished
inhibit (i.e., prevent or slow down) the antimicrobial qualities of a juice are product samples. The presence of fecal
growth of pathogens, such organisms adequate to accomplish the 5-log coliforms and generic E. coli are widely
can still be present in citrus juice and reduction in the pertinent pathogen recognized as indicators of fecal
may cause illness if consumed. Fruits under refrigerated conditions (or contamination (Ref. 58). Further, the
and vegetables differ in their inherent freezing conditions, if the product is survey concluded that it is likely that
chemical composition; even within frozen) prior to the product leaving the any microbial hazards that are
varieties of particular fruits or processing facility, then the introduced at the beginning of
vegetables, there can be some variation antimicrobial parameters, along with the processing will be carried through to the
in composition depending on growing necessary time to accomplish the 5-log finished product; no microbial
conditions. However, the comments reduction, could constitute CCP’s. FDA reduction will occur during the process
provided no data to show how the notes, however, that under the final (Ref. 45).
chemical composition of a citrus juice rule, processors must establish critical The agency disagrees that these
(pH or antimicrobial compounds in peel limits and monitor each of the CCP’s as results indicate there is no real risk from
oil) will ensure the safety of fresh citrus part of their HACCP systems. pathogens in cider. Contrary to the
juice. In fact, because the amount of (Comment 35) Some comments comments’ contention, the cider survey
peel oil in juice will vary from process maintained that there is less inherent results affirm that risk factors such as
to process, the agency disagrees that the risk from citrus juices because citrus fecal coliforms, an indicator of the
antimicrobial effects of citrus peel oil processing limits contact time of peel possible presence of pathogens, as well
can adequately control pathogens in and juice. The comments included data as pathogenic bacteria, such as
juice. Similarly, the organic acid in from citrus processors that separate the Salmonella, are present in cider
citrus juice (i.e., citric acid) has not been peel from the juice with only a small processing operations and could give
shown to provide any additional fraction of peel contacting the juice. rise to microbiological safety hazards in
protection against pathogen The agency disagrees that there is less finished cider products.
contamination and survival compared to risk from citrus juices such that these Finally, illness outbreaks associated
the acid found in apple juice (Refs. 54, juices should not be subject to part 120. with apple cider continue to occur. In
55, and 56). The significance of peel/juice contact as particular, in October 1999 in
A 1997 study of E. coli O157:H7 a source of pathogens in the juice Oklahoma, there was an outbreak
behavior in apple juice and orange juice, depends on several factors, including related to E. coli O157:H7 in a
particularly under refrigerated the microbial load on the peel and the commercially produced, unpasteurized
conditions, demonstrated that even in amount of contact of the peel with the apple cider, that resulted in nine
the relatively acidic environment of juice. If the small fraction of peel, as reported illnesses. The agency,
these juices, this organism can survive described by the comments, is therefore, is not granting the requested
(Ref. 57). In the study, juice was contaminated and comes into contact exemption.
inoculated with E. coli O157:H7. After with the juice, that contact is (Comment 37) Several comments
a 24-day period at refrigeration significant. As discussed in the requested that FDA clarify whether
temperatures, there was only a small proposed rule (63 FR 20450) (Ref. 2) and concentrates are covered under the rule.
decline in numbers of E. coli O157:H7. also in the response to comment 26, The agency advises that under the
The fact that E. coli O157:H7 can there have been outbreaks of food borne final rule, a juice concentrate satisfies
survive in orange juice and that human illness associated with orange juice. the definition of ‘‘juice’’ in § 120.1, and
illnesses from other pathogens, such as (Comment 36) A few comments thus, producers of concentrates are
S. Muenchen and other Salmonella requested that FDA exempt apple cider required to comply with part 120.
species, have been traced to orange juice from the HACCP regulation because the (Comment 38) One comment
demonstrates that, if contaminated, agency found no pathogen requested that FDA clarify whether
orange juice has the potential to cause contamination in the 1997 cider survey, processors of beverages that include
human illness. which, according to the comment, juice as an ingredient but do not
Lemon and lime juices are more indicates that there is no real risk from produce the juice itself are covered
acidic than other types of citrus juice. pathogens in cider. under the juice HACCP regulation. One
The strong acidity of these juices does FDA’s 1997 survey involved comment stated that dairies using
have an antimicrobial effect as the inspection of fresh unpasteurized apple concentrates that are processed to meet
comment’s data demonstrated. cider operations at 237 processors in 32 the 5-log requirement or untreated
However, the resistance of oocysts to the States (Ref. 45) during which the agency juices that are further pasteurized
strong acidity of these juices is not collected samples at various processing should not be subject to the HACCP
known. In addition, there can be steps. These samples were analyzed for regulation.
differences in acidity between varieties E. coli O157:H7, Salmonella, The agency advises that any juice
of lemons and limes, and thus, Staphylococcus aureus, fecal coliforms, processing activity, including juice
differences in their inherent and generic E. coli. Although the survey ingredient processing, must comply
antimicrobial effects. These juices may did not detect any pathogens in finished with the provisions of part 120. Dairies
be diluted and sweetened to make them juice products, one firm’s apples tested making juice, regardless of whether they
palatable as beverages, thus changing positive for Salmonella, demonstrating use concentrates, must comply with part
120. However, dairies producing a non- occurrence and must be appropriately contamination is very likely to occur in
juice beverage that contains a juice identified as a hazard that is this gap. One comment advocated
ingredient (e.g., a dairy-based beverage ‘‘reasonably likely to occur’’ (Ref. 17). mandatory HACCP that either begins at
containing orange juice) are not required FDA concurs in this view. On the other the farm including harvesting, picking,
to comply with part 120 in terms of the hand, chronic hazards would need to and transport or includes a ‘‘kill step.’’
process for producing that non-juice occur at a higher frequency to be The agency has concluded that it
beverage. Processors of juice used as a identified as a hazard that is would be unduly burdensome to require
beverage ingredient must comply with ‘‘reasonably likely to occur.’’ In the case that harvesting, picking, and
the provisions of part 120. of chronic hazards, it must be transportation be included as part of a
understood that the illness or injury processor’s HACCP system or to require
B. Definitions need not be caused by any specific a kill step. Under HACCP, processors
1. Food Hazard occurrence of the hazard but may occur are responsible for evaluating their
with exposure to the hazard over time. production system for hazards and
FDA proposed in § 120.3(e) (finalized establishing CCP’s. This includes the
Each hazard identified in the hazard
as § 120.3(g)) that ‘‘food hazard’’ means quality of incoming raw materials. FDA
analysis as ‘‘reasonably likely to occur’’
any biological, chemical, or physical encourages farmers and processors to
requires the identification of at least one
property that may cause a food to be evaluate and modify their agricultural
CCP, the critical step or steps in the
unsafe for human consumption. practices in accordance with FDA’s
process that must be controlled to
(Comment 39) One comment ‘‘Guide to Minimize Microbial Food
prevent, reduce to acceptable levels, or
requested that FDA adopt the most Safety Hazards for Fresh Fruits and
eliminate the hazard.
recent NACMCF definition of a food Because hazards can be either acute or Vegetables’’ (Ref. 59). This guidance
hazard to clarify the mechanism by chronic (i.e., having short-term or long- document is based upon certain basic
which a hazard analysis is conducted. term effects, respectively) and the principles and practices associated with
The agency agrees with this comment. purpose of HACCP is to focus on public minimizing microbial food safety
The NACMCF currently defines health hazards that are ‘‘reasonably hazards from the field through
‘‘hazard’’ as a ‘‘biological, chemical, or likely to occur,’’ FDA finds that the distribution of fresh fruits and
physical agent that is reasonably likely NACMCF definition better describes vegetables. Farmers should take all steps
to cause illness or injury in the absence what must be considered in a hazard to ensure their products are safe for the
of its control’’ (Ref. 17). The definition analysis. Therefore, the agency is intended food use, but safe juice can be
differs from, but is not inconsistent modifying § 120.3(g) to state that a ‘‘food produced without these activities at the
with, the definitions for food hazards hazard’’ means any biological, chemical, farm level coming under the processor’s
used in the seafood HACCP and meat or physical agent that is reasonably HACCP system. Processors can control
and poultry HACCP regulations. likely to cause illness or injury in the hazards that may be present on
Adopting the most recent NACMCF absence of its control. incoming produce by: (1) Rejecting
recommendations to the extent feasible produce at receipt that does not meet
will allow the HACCP regulation to 2. Processing
processor specifications; (2) removing
remain current with the science of The agency proposed in § 120.3(h)(1) contaminated produce during initial
HACCP. (finalized as § 120.3(j)(1)) to define processing; (3) cleaning and sanitizing
In the first step of a hazard analysis, ‘‘processing’’ as activities that are produce; (4) using, as a minimum
processors must identify all the hazards directly related to the production of standard, the 5-log reduction in the
that could potentially occur in the juice. juice products. However, for purposes of pertinent pathogen as set forth in
Potential hazards are those microbial, proposed part 120, certain activities § 120.24; and (5) using any other
chemical, and physical agents that are were proposed to be exempted by effective method.
reasonably likely to cause illness or § 120.3(h)(2) (finalized as § 120.3(j)(2)). The agency does not believe it is
injury regardless of the likelihood of These are: (1) Harvesting, picking, or appropriate to mandate a ‘‘kill step’’ in
their occurrence. FDA intends to transporting raw agricultural ingredients the absence of HACCP at the farm. It is
publish a juice HACCP hazards and of juice products, without otherwise the processor’s decision, based on its
controls guidance to assist processors in engaging in processing; (2) the operation hazard analysis whether or not the first
this step of the hazard analysis. of a retail establishment; and (3) the CCP in its HACCP system is at the point
Second, processors must determine operation of a retail establishment that of receipt of raw materials, to control
whether the potential hazards identified is a very small business and that makes hazards that may have occurred earlier.
are ‘‘reasonably likely to occur’’ in their juice on its premises, provided that the The hazard analysis must be based on
particular process. Under § 120.7(b), a establishment’s total sales of juice and experience, illness data, scientific
hazard is ‘‘reasonably likely to occur’’ if juice products do not exceed 40,000 reports, or other information that
a prudent processor would establish gallons per year, and that sells the juice provide a basis to conclude that there is
controls because experience, illness (a) directly to consumers or (b) directly a reasonable possibility that, in the
data, scientific reports, or other to consumers and other retail absence of HACCP controls, the food
information provide a basis to conclude establishments. hazard will occur in the particular type
that there is a reasonable possibility a. Harvesting, Picking, and of product being processed. The
that, in the absence of those controls, Transporting Raw Agricultural performance standard establishes the
the food hazard will occur in the Products. minimum level of microbial pathogen
particular type of product being (Comment 40) Several comments reduction the process must be able to
processed. objected to the definition of processing provide to produce safe juice and this
In the NACMCF’s view, if a hazard in proposed § 120.3(h)(2)(i) (finalized as may be met by a ‘‘kill step’’ or any other
has a severe, acute public health impact 120.3(j)(2)(i)) excluding harvesting, appropriate method. The 5-log
(e.g., illness caused by a pathogen, picking, and transporting raw reduction in the pertinent pathogen is
injury caused by ingestion of glass), that agricultural ingredients of juice adequate to ensure that the juice is safe
hazard presents a significant risk even at products because this will leave a big when done under a HACCP system with
an extremely low frequency of gap in the farm to table system and a foundation of CGMP’s and SSOP’s.
(Comment 41) One comment prudent retailers should take steps to (Comment 44) One comment
suggested that the definition of ensure the safety of their products. FDA requested that FDA establish national
processing should at least mention traditionally provides guidance to the standards for juice processors in the
FDA’s ‘‘Guide to Minimize Microbial retail industry through the Food Code Food Code if the agency excludes retail
Food Safety Hazards for Fresh Fruits and works with the States to implement establishments from the definition for
and Vegetables’’ (GAP’s). Food Code provisions. The States processing. Conversely, several
FDA has considered the comment’s should be aware that the Food Code is comments stated that the provisions of
suggestion and believes that reference to responsive to many of the concerns the Food Code adequately ensure juice
the GAP’s in part 120 would be useful. raised in the comment. FDA encourages safety at retail. A few comments stated
However, the agency finds that it is juice retailers to implement Food Code that the guidelines developed by the
more appropriate to discuss the GAP’s provisions. Also, FDA provides training Fresh Citrus Juice Task Force in
in terms of the application of part 120. and other forms of technical assistance combination with Food Code provisions
Therefore, FDA is modifying § 120.1(a) to States and local Governments who are adequate to ensure the safety of
to state that raw agricultural ingredients inspect retail food establishments citrus juice without mandatory HACCP
are not subject to the requirements of through the agency’s retail Federal/State for retailers.
this part and that processors should cooperative program. The agency will FDA agrees with the comments that
apply existing agency guidance to continue to provide this support maintain that the Food Code describes
minimize microbial food safety hazards through the Federal/State cooperative appropriate controls that can be applied
for fresh fruits and vegetables in mechanism. FDA recognizes that not all to reduce juice hazards at retail. The
handling raw agricultural products. States have adopted the Food Code. agency has traditionally relied on the
b. Retail. Finally, more than 25 States have Food Code to provide guidance to retail
(Comment 42) Several comments adopted the Food Code as law with establishments. As noted in the
were opposed to excluding retail most other States in the process of response to comment 42, FDA will work
establishments from the definition of adopting the Code. However, retail with the States through its Federal/State
processing in proposed § 120.3(h)(2)(ii) establishments pose an inspection mechanism. The agency urges retailers
(finalized as § 120.3(j)(2)(ii)). The burden well beyond the capacity of to implement State and industry
comments expressed concern because FDA. There are not sufficient resources guidance in their establishments to
outbreaks associated with products to adequately inspect the many retail ensure the safety of juice.
processed in retail establishments will establishments in the United States. (Comment 45) One comment
be equally devastating to the industry as Although retail establishments are not suggested that all juice, like milk,
a whole. One comment stated that covered in this final rule, they are should be pastuerized and FDA should
relying on the Food Code and State subject to § 101.17(g), which requires not permit the sale of untreated juice
regulators is inadequate because: (1) The that packaged untreated juice products since raw milk sales are not allowed.
adoption of Food Code provisions is carry a statement informing consumers The agency agrees. Under § 120.24(a),
voluntary and varies widely on a State- that the product has not been processors must include in their HACCP
by-State basis and (2) State regulators do pasteurized and, therefore, may contain plans control measures that will
not have the resources to inspect retail harmful bacteria that can cause serious produce, at a minimum, a 5-log
establishments on a regular basis. illness in children, the elderly, and reduction in the pertinent pathogen.
The agency recognizes that retail is an persons with weakened immune Thus, all juice subject to part 120 will
important segment of the juice industry systems. be treated to control microorganisms.
and that retailers may also mishandle (Comment 43) One comment (Comment 46) One comment
products. FDA is concerned that juice suggested that, rather than exempting all requested information on which
sold at retail be safe. However, retail retail establishments from the definition processors will not be covered under
establishments pose a unique situation for processors, only retailers who either the juice labeling rule or the juice
for the implementation of HACCP. produce in batches of less than 32 HACCP rule and which processors, if
Retail establishments, in general, deal ounces at a time or who sell product in any, have a permanent labeling option.
with a greater variety of products and glass containers that can be washed and The agency advises that § 101.17(g)
processes at relatively lower volumes reused might be exempted because the requires that any packaged juice in
than non-retail producers. For example, less fruit and vegetables that go into a interstate commerce that has not been
cider retailers at farmers’ markets will batch, the lower the risk. specifically processed to prevent,
generally sell other products, including The agency agrees with the concept reduce, or eliminate the presence of
fresh produce, as well as apple cider. that the smaller the batch, the lower the pathogens must bear the warning
Therefore, because retail establishments microbial risk. Larger establishments statement. Under this final rule, a juice
handle lower volumes of a variety of produce larger quantities of juice that retailer as defined in § 120.3(l) is not
products, HACCP systems at retail are are often widely distributed. Retail required to establish a HACCP system;
significantly different from HACCP establishments produce much smaller however, any juice produced by that
systems in processing plants. Because of quantities of juice that are more likely retailer that includes an interstate
the wide variety of products and (but not always) consumed locally. ingredient or is shipped in interstate
processes used by retail establishments, Thus, the public health impact of a commerce must bear the warning label
the relatively low volumes of juices foodborne illness outbreak associated statement. Such a retailer may avoid the
produced, the normally small area of with larger firms is likely to be greater. labeling requirements by treating its
product distribution, and the large However, the special considerations product to achieve a 5-log reduction in
number of retail establishments, FDA discussed in the response to the the pertinent microorganism.
has chosen to focus its regulatory previous comment still exist for retail c. 40,000 gallon exemption.
resources on manufacturers that firms, regardless of batch size. (Comment 47) Most of the comments
produce larger quantities of widely Therefore, FDA concludes that it is on the 40,000 gallon exemption from
distributed products. appropriate that part 120 excludes both large and small processors
Even though retail establishments are operators of retail establishments from requested that FDA withdraw the
not included in this rulemaking, the definition of processor. exemption in proposed § 120.3(h)(2)(iii)
(the definition of ‘‘processing’’). The which juice is produced and sold § 120.3(p) and (q) to include the
comments stated that small processors directly to consumers in stores, from NACMCF definitions of both validation
are just as likely to produce roadside stands, at farmers’ markets, and verification as follows:
contaminated juice as larger processors and in food service operations (such as Validation means that element of
and that company size should not juice bars and restaurants). verification focused on collecting and
dictate compliance with regulations FDA also agrees with the comment evaluating scientific and technical
when public safety is at stake. The that requested that juice retailers who information to determine whether the
comments also noted that this sell to other retailers be subject to the HACCP plan, when properly
exemption does not maximize public HACCP regulation. FDA believes that implemented, will effectively control
health protection. this approach will contribute to public the identified hazards;
The comments have persuaded the health protection. Accordingly, under Verification means those activities,
agency to exclude from this final rule this final rule, only a retail other than monitoring, that establish the
the exemption proposed for very small establishment that limits its juice validity of the HACCP plan and that the
retail businesses who sell less than business to direct consumer sales would system is operating according to the
40,000 gallons of juice annually either qualify for exemption from the plan.
to consumers directly or to other requirements of this HACCP regulation,
C. Prerequisite Program Standard
retailers. FDA agrees that company size and would be subject to regulation by
Operating Procedures
should not dictate compliance with food the State in which it operates. Thus, the
safety rules. The agency also agrees with ‘‘retail establishment’’ definition in this The HACCP proposal discussed two
comments that stated that this regulation is consistent with the Food types of prerequisite program standard
exemption does not protect the public Code, and also describes establishments operating procedures (SOP’s). FDA
health. Although large processing firms that are included and excluded proposed to require the first type,
can be responsible for more widespread specifically for the purpose of this SSOP’s, in § 120.6. SSOP’s cover
outbreaks than the firms in the proposed regulation. For example, a retail sanitary conditions and practices before,
exemption because of their broader establishment, central kitchen, or during, and after processing. The agency
product distribution, those smaller processing facility that provides juice to requested comment (63 FR 20450 at
businesses can make juice that may more than one retail operation (e.g., 20466) (Ref. 2) on a second prerequisite
cause an outbreak. Further, other juice production operation that provides program to provide control over
regulations addressing public health juice to outlets of a chain supermarket) materials as they enter the plant.
concerns (e.g., seafood HACCP in part would not be considered a retail However, the agency did not propose to
123 (21 CFR part 123) mandatory establishment that is exempt from this require incoming material SOP’s in part
pasteurization of milk and milk regulation. However, a retail 120.
products in 21 CFR 1240.61) do not establishment that produces juice for (Comment 50) One comment asked
contain such exemptions. Therefore, the sale directly to consumers at that that if FDA requires prerequisite
agency is removing the exemption from location and at other locations under the program SOP’s, the agency should be
this final rule. FDA notes that those same ownership would be considered a more specific about what is to be
producers who would have been retail establishment exempt from this included in the prerequisite program
covered by the 40,000 gallon exemption regulation. Therefore, the agency is SOP’s. It stated that some SOP’s ensure
and who are strictly engaged in retail adding a § 120.3(l) to define a ‘‘retail wholesomeness and quality and should
sales would not be required to comply establishment’’ as an operation that not be a part of HACCP.
with this final rule consistent with provides juice directly to consumers, The agency advises that it is requiring
§ 120.3(j)(2)(ii). Juice produced by these and does not include an establishment that processors implement SSOP’s in
retailers would be required to bear the that sells or distributes juice to other part 120 at this time and not any other
label warning statement as described in business entities as well as directly to type of SOP. The SSOP’s in § 120.6 do
the response to comment 46. consumers. ‘‘Provides’’ includes storing, include specific standards that must be
preparing, packaging, serving, and maintained. The SSOP’s as described in
3. Retail Establishment § 120.6(a) address insanitary conditions
vending. (Because the agency is
(Comment 48) Several comments establishing an additional definition in and are not directed to ensure
requested that FDA define ‘‘retail § 120.3, it is recodifying the other terms wholesomeness and quality although
establishment’’ for clarity. One in § 120.3 so that they continue to they may have a beneficial effect on
comment requested that FDA revise appear in alphabetical order.) these attributes.
proposed § 120.3(h) so that retailers who
sell to other retailers are covered by the 4. Verification and Validation 1. SSOP’s
definition for processors. (Comment 49) Several comments (Comment 51) Several comments
FDA agrees with the comment that requested that the terms ‘‘validation’’ stated that SSOP’s are covered under
recommended establishing a definition and ‘‘verification’’ be defined and be CGMP’s and should not also be covered
of ‘‘retail establishment.’’ The FDA Food used consistent with NACMCF in HACCP and neither SSOP’s nor
Code has a definition of ‘‘ food principles. CGMP’s should be a written
establishment’’, which, given the FDA agrees with the comments. The requirement for HACCP. One comment
purpose and scope of the Food Code, is agency intends that the terms stated that SSOP’s should not be written
essentially a definition of a retail ‘‘validation’’ and ‘‘verification’’ be used for the same reasons that SSOP’s are not
establishment. In establishing a consistent with NACMCF principles written for seafood HACCP. One
definition for ‘‘retail establishment’’ in throughout this final rule. The NACMCF comment stated that prerequisite
this final rule, FDA is relying on this has established definitions for these program SSOP’s should not be
Food Code definition. The Food Code terms that the agency finds useful (Ref. mandated and that CGMP’s provide an
definition of ‘‘ food establishment’’ has 17). According to the NACMCF adequate basis for HACCP. However,
been in existence for many years, and is definition, validation is a subset of other comments maintained that SSOP’s
recognized by the States. The Food Code verification (Ref. 17). Therefore, in this and CGMP’s should be a part of written
definition includes establishments in final rule the agency is amending HACCP programs.
It is important to understand the maintain records monitoring and hazard that is reasonably likely to occur,
difference between CGMP’s, SSOP’s, documenting corrective actions. Juice is one or more control measures must be
and HACCP. The agency has established significantly different than seafood in included in the HACCP plan for each
CGMP’s in part 110. These regulations that juice is generally consumed as sold hazard identified.
provide general guidance on such whereas seafood is generally cooked, (Comment 54) One comment
matters as facility design, materials, thus sanitation takes on increased requested that FDA clarify whether
personnel practices, and cleaning and importance. Because of the significance § 120.6(a)(5) permits certain amounts of
sanitation procedures. In § 120.5, FDA of sanitary conditions, the agency ‘‘no rinse’’ sanitizers to come into
requires that part 110 apply in concludes that juice processors must contact with product.
determining whether the facilities, maintain SSOP records in the same The agency advises that ‘‘no rinse’’
methods, practices, and controls used to manner as that required for other sanitizers used according to product
process food are safe, and whether the HACCP records. directions do not present a
food has been processed under sanitary (Comment 52) One comment contamination problem and, with
conditions. Processors do not need to requested that FDA require that the appropriate use, their presence would
make a record of these activities for FDA quality and safety of water used in juice not be considered a violation of
review. However, the agency will processing plants be verified. § 120.6(a)(5).
continue to include in its inspections The agency agrees that water used in (Comment 55) One comment
determinations of processor compliance juice processing plants must be safe and requested that FDA set an ‘‘acceptable
with CGMP’s. All appropriate CGMP’s of an adequate sanitary quality for its level of infestation’’ for insect control
must be implemented, whether they are intended use. This is consistent with the and require that processors use insect
incorporated into a processor’s HACCP CGMP requirements in § 110.37(a). light traps as monitoring devices.
system or not, because they reflect Section 120.6(a)(1) of this final rule Another comment requested that FDA
norms of good processing. requires that juice processors have revise § 120.6(a)(8) to read as follows:
SSOP’s are specific sanitation CGMP’s SSOP’s that address the safety of the ‘‘Exclusion of pests from the food plant
that FDA has found are key to the water that comes into contact with food and prevention of contamination from
successful implementation of a HACCP or food contact surfaces or that is used pests within the plant, as well as in
system. Not all CGMP’s deal with in the manufacture of ice. Processors packaging and raw materials delivered
sanitation issues (e.g., contamination must examine the source of the water to the plant.’’
with aflatoxin or other natural toxins in used in their facilities and determine FDA disagrees that it should establish
§ 110.80(a)(3)). As required by the necessary provisions to ensure the an ‘‘acceptable level of infestation’’ for
§ 120.6(a), SSOP’s emphasize sanitation water’s safety. The processor’s insects or that it should revise
conditions and practices before, during, particular obligations may vary, § 120.6(a)(8) as the comment requested.
and after processing. Because of the depending on the source of the water. Exclusion of pests from the food plant
importance of sanitation to a facility, Water from community water supplies is included as a necessary part of
processors must monitor SSOP is tested for many substances and the SSOP’s in § 120.6(a)(8). The comment’s
conditions and practices during processor can obtain the results of that requested modification is already
processing to at least ensure compliance testing from the local water authority. In implied in § 120.6(a)(8). Pests are
with part 110. If sanitation conditions the case of well water, processors must recognized sources of microbial
and practices are not met, processors know that the water they use is safe contamination, as well as filth, in foods.
must take corrective actions because such water could present The agency believes that generally no
(§ 120.6((b)). Insanitary conditions can potential hazards. Thus, processors unusual pest control requirements are
directly result in food hazards, using well water need to test the water. necessary for juice processing
especially microbiological hazards. Moreover, if substances in the water are operations beyond the general
Inadequate sanitation has a direct effect hazards that are reasonably likely to requirements for pest control in all food
on whether the HACCP plan can occur, one or more CCP’s must be processing facilities, as laid out in part
adequately control food hazards. For established and included in the HACCP 110. However, if, during its hazard
example, insanitary conditions can plan. analysis, a processor identifies pests or
cause post process contamination. (Comment 53) One comment contamination from pests as a food
Both CGMP’s and SSOP’s have a requested that FDA require processors hazard that is reasonably likely to occur
broad scope. As noted in section II.A, to monitor for water and cleaning in its particular system, the processor
HACCP is a system to identify specific solution contamination. will need to establish a control measure,
points in a particular manufacturers FDA believes that, given the critical limits, and a means of
process where risks exist and critical regulation as proposed, the requested monitoring.
controls are needed to control the revision is unnecessary. Section (Comment 56) One comment
identified risks. CGMP’s and SSOP’s 120.6(a)(1) already requires processors requested that FDA add the following to
both play an important role in HACCP to have and implement SSOP’s relating § 120.6(b): ‘‘The requirements under this
in that they form the foundation upon to water quality and § 120.6(a)(5) section shall apply both to the
which the HACCP system is built. requires processors to have and processor’s own premises and the
FDA stated in the proposal (63 FR implement SSOP’s relating to the premises of any supplier of raw
20450 at 20467) (Ref. 2) that the records protection of food from cleaning materials and packaging, as far as this is
bearing on the monitoring of relevant compounds. Processors must monitor relevant.’’ The comment concluded that
sanitation conditions and practices and their SSOP’s and take corrective actions this is necessary because packaging and
the agency’s access to such records are for sanitation conditions and practices raw materials are particular sources of
essential if SSOP’s are to be part of an where the specified conditions are not contamination in most food processing
effective regulatory strategy. Although met (§ 120.6(b)). In addition, processors plants.
the agency elected not to require written must maintain records that document FDA agrees that incoming materials
SSOP’s under the seafood HACCP monitoring and any corrective actions can be a possible source of
regulation, it required that seafood taken (§ 120.6(c)). If either water or contamination in juice processing plants
processors establish SSOP’s and cleaning solution contamination is a but points out that the focus of this
regulation is the production of safe juice sanitation controls are being be required only for producers that do
by juice processors. Nevertheless, implemented through the SSOP. not pasteurize their product.
processors are urged to take steps to Insanitary facilities or equipment, poor The agency is not convinced of the
control hazards before the hazards enter food handling, improper personal need for mandatory incoming material
the processing facility. Under part 120, hygiene, and similar insanitary SOP’s because these activities may be
processors must control food hazards in conditions create an environment in adequately controlled under the CGMP’s
the juice products they make. If a which products may become in part 110. However, FDA does
processor’s hazard analysis indicates contaminated with pathogens and other recognize the value of incoming
that a hazard is reasonably likely to substances. A processor may determine material SOP’s, and it encourages
occur in incoming materials, then an that a task normally covered by SSOP’s processors to establish and monitor
appropriate control (such as a supplier may be of such importance that it must incoming material conditions and
agreement concerning that hazard) must be included in the HACCP plan because practices and to take corrective actions
be a part of the processor’s HACCP plan, it controls a hazard that is reasonably when needed. Processors must evaluate
and the processor must monitor the CCP likely to occur. Similarly, an SSOP task the need for controls at all points in
and verify supplier performance. Thus, may simply be more efficiently or their process, including incoming
FDA concludes that raw materials and effectively performed under the HACCP materials. If incoming materials are
packaging are already covered plan rather than SSOP controls, and reasonably likely to present a hazard,
adequately and is not modifying thus, a processor may choose to then the hazard must be controlled by
§ 120.6(b) as the comment requested. incorporate the SSOP task into the one or more CCP’s in the HACCP plan,
(Comment 57) One comment stated HACCP system. However, HACCP even if a processor has an incoming
that corrective actions should not be controls generally focus on discrete material SOP.
required for CGMP’s and SSOP’s. steps or ‘‘points’’ in a processing Many of the controls mentioned in the
FDA advises that there are no system, while sanitation and sanitation comments are addressed in FDA’s
corrective actions specifically required controls generally have broader, ‘‘Guide to Minimize Microbial Food
for CGMP’s in these HACCP regulations. plantwide applicability. Thus, Safety Hazards for Fresh Fruits and
However, part 120 sets forth monitoring sanitation does not always lend itself Vegetables.’’ As noted earlier, FDA
and corrective action requirements for well to HACCP controls. Therefore, the encourages farmers and processors to
SSOP’s. Insanitary conditions create an agency is not modifying § 120.6(d) as evaluate and modify their agricultural
environment in which products may requested. practices in accordance with GAP
become contaminated with pathogens or FDA disagrees that singling out items guidance. Processors may include GAP’s
other substances. If a product becomes to be included in SSOP’s implies that in any SOP’s for incoming materials that
contaminated because of insanitary the other provisions of part 110 are not
they may establish.
conditions, it is important that important. Rather, the items listed in
corrections be made as quickly as Finally, because all processors,
§ 120.6(a) are to assist processors in
possible so as not to subject regardless of whether or not they
identifying and implementing key
subsequently processed product to pasteurize, must meet the performance
sanitation activities. Sanitation controls,
conditions that could introduce food standard required under § 120.24, as
such as controls preventing use of
hazards. Therefore, processors need to well as the other requirements of part
contaminated water in juice making,
monitor the performance of SSOP’s to have a direct impact on the presence or 120, there is no need to differentiate
ensure that the SSOP’s are functioning absence of pathogens during processing, between processors for the purposes of
as designed, and that any problems that which in turn, directly affects the requiring incoming material SOP’s, and
arise are corrected. The comment did effectiveness of the HACCP plan. No thus, to require more SSOP’s from a
not provide data to persuade the agency matter how reliable the process is, processor that does not pasteurize.
to conclude otherwise. insanitary conditions can cause the (Comment 60) One comment
(Comment 58) One comment product to become contaminated with requested that FDA hold a public
suggested that FDA only require SSOP’s pathogens. It is because of the critical meeting for input on incoming material
in a HACCP plan if their control is role that sanitation plays in the SOP’s.
essential to eliminate or control a public production of safe juice that FDA is The agency does not believe that such
health risk, as determined in the hazard requiring SSOP’s, identifying specific a public meeting is necessary. There
analysis. The comment contended that a items to be included, and requiring have been many opportunities for
distinction must be made between recordkeeping. However, processors interested parties to comment on all
failure to meet sanitation requirements must comply with all provisions of part issues related to HACCP, including
and failure to meet a food safety/HACCP 110 in addition to having SSOP’s as incoming material SOP’s (see section I.B
requirement. The comment further required under § 120.5. of this final rule). FDA requested public
stated that singling out items to be input in the HACCP proposed rule (63
included in SSOP’s implies that the 2. Other SOP’s FR 20450 at 20466) (Ref. 2) and in this
other sanitation requirements in part (Comment 59) Several comments final rule has considered all significant
110 are not that important, and this is requested that FDA require written, comments received. In addition, some
not the case. It stated that if FDA monitored, and verified SOP’s for issues surrounding incoming materials
establishes SSOP’s that, at the very incoming materials. One comment for citrus juices were discussed at the
least, no recordkeeping requirements contended that reasonable procedures public NACMCF meeting in December,
should be associated with SSOP’s. for these SOP’s should include no use 1999 (Ref. 12). Finally, FDA intends to
FDA advises that processors are not of dropped apples, no contact with issue a juice HACCP hazards and
required to include sanitation controls water that could contain pathogens, no controls guidance, which will provide
in their HACCP plans. Section 120.6(d) manure as fertilizer, steam cleaning of another opportunity for public input on
allows processors the option of crates in contact with fruit between lots, the incoming materials issue.
including sanitation controls in the and regular inspections of source farms (Comment 61) One comment
HACCP plan, but they are under no and orchards. Another comment suggested that the GAP’s for fresh
obligation to do so as long as the suggested that incoming material SOP’s produce can be used in conjunction
with SOP’s to ensure the safety of which state that scientific a processor must consider both severity
incoming material. determinations of risk are needed to and frequency of potential hazards. The
FDA agrees that the use of GAP’s in form a sound basis for food safety NACMCF stated that consideration of
combination with SOP’s may enhance standards. the likelihood of the hazard’s
the safety of incoming materials. FDA’s The agency agrees that the approach occurrence is usually based upon a
GAP’s for fresh produce provide outlined by the NACMCF will best combination of experience,
valuable guidance for use in the assist processors in conducting a hazard epidemiological data, and information
production and post harvest handling of analysis. First, processors will benefit in the technical literature (Ref. 17). The
raw agricultural commodities. As noted, from using the five preliminary steps set NACMCF also stated that consideration
the agency also intends to publish a forth by the NACMCF, which are to should be given to the effects of short
juice HACCP hazards and controls assemble a HACCP team, describe the term, as well as long-term, exposure to
guidance that will provide additional food and its distribution, identify the the potential hazards. Because this
guidance on ensuring the safety of intended use and consumers of the food, process takes into consideration both
incoming materials. develop a flow diagram that describes frequency and severity, a potential
(Comment 62) One comment stated the process, and verify the flow diagram hazard may be identified as reasonably
that HACCP should include a (Ref. 17). Although the agency is not likely to occur even though it occurs
requirement for incoming materials specifically requiring that processors infrequently because the public health
testing to prevent another outbreak like use these preliminary steps, these steps consequences when it does occur are so
the one in 1996. will aid processors in focusing on their severe, e.g., HUS in small children from
The agency disagrees that it should specific product and process. E. coli O157:H7 in juice. This approach
require incoming materials testing in According to the NACMCF, also provides greater harmony for
part 120, although it encourages processors must accomplish three international trade because it is the
processors to test incoming materials as objectives in the hazard analysis: (1) same approach recommended by the
appropriate. Testing may be used as a Identify hazards that are reasonably Codex Alimentarius Commission, which
control measure for a hazard that is likely to occur and their associated is a recognized standard setting body by
reasonably likely to occur and it may control measures; (2) identify needed the WTO. Hazards that are not
also be used to gather information on a modifications to a process or product so reasonably likely to occur do not require
product or supplier for use in the hazard that product safety is further assured or further consideration within a HACCP
analysis. However, testing may not be improved; and (3) provide a basis for plan but are controlled under CGMP’s.
useful in all cases. Microbial determining CCP’s in the HACCP plan Identification of control measures is a
contamination of fresh produce is (Ref. 17). FDA agrees with these third step in the first NACMCF objective
usually at low levels and is not objectives. in developing a hazard analysis. For
uniformly distributed throughout a lot. The first NACMCF objective is example, juice processors must identify
Thus, while detecting a pathogen, such accomplished in three steps. First, the process they will use to achieve the
as E. coli O157:H7, would allow a processors must list all the potential 5-log reduction in the pertinent
processor to avoid using contaminated hazards that could be present in the pathogen. This may be pasteurization,
produce, failure to detect pathogens by juice. During this step, the processor’s surface treatments for citrus, or other
testing does not provide assurance that HACCP expert or team reviews the effective methods. Therefore, § 120.7
the hazard is not present in incoming ingredients used in the product, the requires that processors identify the
materials. The 5-log reduction in the activities conducted at each step in the measures that they will apply to control
pertinent pathogen as implemented in a process and the equipment used, the the hazards that have been identified as
HACCP system provides the assurance final product and its method of storage reasonably likely to occur. These control
that microbial hazards are under control and distribution, and the intended use measures must be included in the
throughout the process. Therefore, the and consumers of the product. A list of HACCP plan as well as the hazard
agency is not requiring the testing of categories of potential food hazards is analysis.
incoming materials. found in § 120.7(c). Based on this Under the second NACMCF objective,
review, the processor’s HACCP team processors must review their current
D. Hazard Analysis develops a list of potential biological, process to determine deficiencies in
The agency proposed in § 120.7 that chemical, or physical food hazards that controlling food hazards and then
processors develop a written hazard may be introduced, increased, or identify the changes that must be made
analysis to determine whether there are controlled at each step in the to ensure that food hazards are
hazards that are reasonably likely to production process. A hazard analysis controlled. For example, some juice
occur for each type of juice produced by must be conducted for each type of juice beverages may be thinner or thicker
a processor and to identify the control product manufactured by the processor than others, a characteristic that may
measures that the processor can apply to because different hazards may be affect how fast the product flows
control those hazards. associated with different juice products. through the pasteurizer; in this stage of
(Comment 63) One comment (For example, patulin need only be the hazard analysis, the processor must
requested that FDA clarify how a hazard considered in apple juice products.) review its process to determine whether
analysis is conducted. The comment The processor must then identify the product is flowing through the
suggested that FDA emphasize the those food hazards that are reasonably pasteurizer at a rate sufficient to ensure
NACMCF recommendations, including likely to occur. According to NACMCF, that all particles of the juice receive the
consideration of both likelihood of this step takes into account both the appropriate treatment in terms of both
occurrence and severity of hazards. The consequences of exposure (i.e., severity) time and temperature to achieve, at a
comment expressed concern that and the probability of occurrence (i.e., minimum, the 5-log reduction in the
without considering both the likelihood frequency) of the health impact of the pertinent pathogen.
of occurrence and severity of hazards, potential hazards in question (Ref. 17). The third NACMCF objective requires
HACCP plans would not be consistent FDA agrees with the NACMCF that processors use the hazard analysis
with international practice and World approach. Accordingly, when applying to provide a basis for determining CCP’s
Trade Organization (WTO) obligations, the phrase ‘‘reasonably likely to occur,’’ in the HACCP plan. For example, some
processors may run different juice expertise in a single commodity, such as The hazard analysis is where processors
beverages on the same line during the juice. With a written hazard analysis, differentiate between unlikely hazards
same day with only a water flush investigators can more easily determine and hazards that are reasonably likely to
between products. If one juice product whether processors have adequately occur in the absence of controls. This
contains a potential allergen, such as a considered all juice hazards and have determination is made for each type of
soy ingredient, then a possible control adequately identified those hazards that juice processed in a particular facility.
measure is that this product be run last are reasonably likely to occur. Data such as experience, illness data,
in the day with a thorough cleaning of Even though a written hazard analysis scientific reports, or other information
the system before the next day’s startup. is not required by the seafood HACCP may be used as documentation as to
To clarify the necessary steps in regulation, that regulation, as well as whether the hazard is reasonably likely
developing a hazard analysis, as the USDA’s meat and poultry HACCP to occur in juice and, if so, how the
comment requested, the agency is regulations, require a systematic and hazard is best controlled.
codifying them in § 120.7(a). (Because comprehensive hazard analysis. In (Comment 66) One comment
the agency is adding these steps to addition, USDA’s meat and poultry requested that the agency revise
§ 120.7, it is recodifying the other HACCP regulations require a written proposed § 120.7(a) to state generally
paragraphs in § 120.7 for clarity.) hazard analysis. Thus, the only that all physical, chemical, and
(Comment 64) A few comments difference in the juice final rule and the microbiological hazards be considered,
objected to the requirement of a written seafood HACCP regulation is that the instead of providing a numbered list of
hazard analysis because the seafood analysis is written, not that it is or is not potential hazards to be considered in
HACCP regulation does not require a required. FDA believes that the the hazard analysis.
written hazard analysis. However, some additional step of recording the hazard FDA disagrees that all physical,
comments supported such a analysis poses no significant burden, chemical, and microbiological hazards
requirement. economic or otherwise, to juice must be considered, but only those that
FDA acknowledges that a written processors and, on the contrary, has can be introduced both within and
hazard analysis is not required by the advantages for the processor. A written outside the particular processing
seafood HACCP regulation and believes hazard analysis provides processors environment, including hazards that can
that, at the time that the regulation was with a ready record of the decisions occur before, during, and after harvest.
established, this was appropriate. made in conducting a safety analysis of The agency points out that the provision
Although the seafood HACCP regulation their process, which they may use in now codified as § 120.7(c), simply
does not require a written hazard evaluating potential changes to the provides guidance in the form of a
analysis for agency record review, system and for discussions with minimum list of potential physical,
seafood processors are strongly urged to regulatory officials. Further, written chemical, and microbiological hazards
have a written hazard analysis to resolve hazard analyses are useful to processors that processors should consider. The list
differences between the processor and in that they help provide the rationale is not intended to be all-encompassing,
the agency about whether a HACCP plan for the establishment of critical limits and is not so constructed. FDA believes
is needed and about the selection of and other plan components. Having the that this guidance is useful because it
hazards, CCP’s, and CL’s. basis for these decisions available will provides detail about the types of
Since the issuance of the seafood be helpful when processors experience potential hazards that fall into the more
HACCP regulation, the HACCP concept changes in personnel, especially those general categories of physical, chemical,
and how best to implement HACCP has associated with the HACCP process, and and microbiological hazards. For these
evolved in step with industry’s in responding to unanticipated CL reasons, FDA declines to revise
increasing experience with HACCP; part deviations. § 120.7(c) as requested.
of that evolution is the idea that the A written hazard analysis need not be (Comment 67) Several comments
hazard analysis should be written. a highly detailed document, but it must argued that unapproved pesticide
Processors will have a better HACCP reflect consideration of all the potential residues, unapproved food and color
system if they document the hazard hazards that could occur in a additives, and food allergens are not
analysis process. A thorough hazard processor’s system for a product and the appropriate for inclusion in HACCP
analysis is the key to preparing an processor’s decisions about whether because, categorically, they are not a
effective HACCP plan. According to the these hazards are reasonably likely to significant threat to public health and
NACMCF, if the hazard analysis is not occur. The hazard analysis may be as are already covered by other regulations.
done correctly and the hazards simple as a checklist of potential One of the comments supported its
warranting control are not properly hazards and the reason why certain claim of inappropriateness by pointing
identified, the plan will not be effective decisions were made. A written hazard out that FDA failed to give any
regardless of how well it is followed analysis clearly and rationally examples of problems caused by
(Ref. 17). demonstrates that processors have unlawful pesticide residues or
Another aspect of HACCP considered all potential hazards, unapproved food and color additives.
implementation that affects the need for identified those hazards that are Therefore, it stated, these are not
a written hazard analysis is the reasonably likely to occur and are problems that should be covered by
availability of specially trained associated with their product and HACCP, but addressed under CGMP’s.
investigators. At the time the seafood process, and identified CCP’s and CL’s FDA disagrees that certain types of
HACCP program was established, FDA in their HACCP plan. potential hazards, such as those
had sufficient resources to hire and (Comment 65) Several comments mentioned in § 120.7(c), need not be
specifically train investigators in stated that HACCP should only cover considered in a hazard analysis. For
seafood HACCP, as well as to provide hazards that are reasonably likely to example, pesticide residues above
assistance to the industry in occur and that have been documented. tolerance may be potential hazards.
implementing HACCP. With expansion FDA agrees that processors need only However, it is unlikely that pesticide
of HACCP into other commodity areas, control in their HACCP plan those residues above tolerance will need to be
the agency does not have the resources hazards that are reasonably likely to identified during a hazard analysis as
to develop cadres of investigators with occur and that have been documented. hazards that must be included in the
HACCP plan because they occur identify them in its hazard analysis and intended to be all inclusive. Ice and
infrequently and the public health include them in its HACCP plan. water quality are issues that generally
impact of infrequent exposure is not (Comment 68) Several comments will be addressed in the SSOP
severe. suggested that pesticide control should requirement in § 120.6(a)(1). Therefore,
The agency recognizes that there are be handled as an agreement between the agency is not modifying § 120.7(c) as
effective governmental control programs processor and grower, not as a CCP. requested. However, because the list in
in place in the United States to assure The agency advises that if an § 120.7(c) is guidance for processors, it
generally that unlawful pesticide agreement between a processor and a does not preclude a processor from
residues are unlikely to occur. For grower adequately assures that unlawful considering ice and water quality in its
pesticides, these controls include pesticide residues will not be a hazard hazard analysis. If ice or water quality
pesticide registration, applicator that is reasonably likely to occur, then poses a hazard that is reasonably likely
licensure, and government sampling controls for that particular hazard need to occur, then the hazard must be
and enforcement programs. Likewise, not be included in the HACCP plan. addressed in the HACCP plan.
unapproved food and color additives are Agreements between processors and
growers on pesticide issues may be E. HACCP Plan
generally unlikely to occur in juice
products because prudent processors particularly useful for produce grown in The agency proposed that processors
would not intentionally add them to areas where government controls may have and implement a written HACCP
their products. Thus, for crops grown in not be sufficient to ensure that unlawful plan for a given process whenever a
the United States, a processor may pesticide residues are not a hazard that hazard analysis of that process
ordinarily conclude that the controls for is reasonably likely to occur. establishes that there are one or more
(Comment 69) One comment noted food hazards that are reasonably likely
pesticide use are such that it is not
that unapproved food and color to occur during such processing. The
reasonably likely that unlawful
additives are not an issue for orange written HACCP plan is to include the
pesticide residues will be present in
juice because it has a standard of following seven principles: (1) Conduct
crops (including residues at levels above
identity. a hazard analysis, (2) determine the
tolerance). A processor is responsible The existence of a standard of critical control points, (3) establish
for assessing the adequacy of control for identity, such as for orange juice or critical limits, (4) establish monitoring
pesticide use for crops grown outside tomato juice, is no guarantee that an procedures, (5) establish corrective
the United States and determining unapproved food or color additive has actions, (6) establish verification
whether such controls are sufficient to not been intentionally or inadvertently procedures, and (7) establish
make it unlikely that unlawful pesticide added to the juice product. However, as recordkeeping and documentation
residues will be present. If foreign noted previously, if a processor’s hazard procedures. These seven elements are
governmental controls are sufficient, analysis establishes that unapproved derived from the NACMCF principles of
HACCP controls would not likely be food and color additives are not a HACCP.
necessary in the processor’s HACCP hazard that is reasonably likely to occur, (Comment 72) One comment
plan. If foreign governmental controls such additives do not need to be requested that FDA delete the term
are not sufficient, the processor may controlled as part of a HACCP plan. ‘‘during processing’’ in § 120.8(a)
need to include appropriate controls in (Comment 70) One comment because some of the problems in the
its HACCP plan. requested that proposed § 120.7(b) be past have come from fruit contaminated
Similarly, unapproved food and color withdrawn as the list of what a on receipt and the term could be read
additives would be reasonably likely to processor should evaluate because it is to mean that only hazards that could
occur only if, because of their presence already covered under part 110 and can occur during processing should be
in the production plant and the be addressed by prerequisite programs. considered in the hazard analysis.
potential for formulation errors, there The agency stated in the proposal that The agency does not agree with the
was a real likelihood that they may be it was including in proposed § 120.7(b) comment. Section 120.7 requires that
inadvertently added to the product or (now codified as § 120.7(d)) some processors conduct a hazard analysis to
added at higher than the allowable rate. elements that would be useful for juice determine the hazards that are
A food or color additive may also be processors to consider in a hazard reasonably likely to occur in their juice.
used on the product by a processor’s analysis (63 FR 20450 at 20468) (Ref. 2). If a hazard is reasonably likely to occur
supplier. This may pose a hazard where Although CGMP’s and SSOP’s address a in the juice, the source of the hazard is
the food or color additive is a potential wide variety of situations and hazards, immaterial. Therefore, FDA is not
allergen or causes sensitivity reactions a particular food hazard may be revising § 120.8(a) to delete the term
in susceptible individuals. For example, reasonably likely to occur in the absence ‘‘during processing.’’
a processor may make several types of of its control and, therefore, necessitate (Comment 73) One comment
juice drinks, some containing FD&C HACCP controls. To assist processors in requested that FDA delete proposed
Yellow No. 5. The likelihood and identifying all hazards that are § 120.8(b)(2)(ii) because it appears to
severity of a reaction to Yellow No. 5 is reasonably likely to occur in their contradict the definition for processing
a factor that must be considered in products, and their public health in proposed § 120.3(h)(1) (finalized as
determining whether the unintended impact, FDA is, therefore, retaining the § 120.3(j)(1)). The comment asserted that
presence, whether by misformulation or list in § 120.7(d) to guide processors in § 120.8(b)(2)(ii) states that CCP’s should
cross contamination, of the ingredient or their hazard analyses. include food hazards that occur before,
additive in a food is reasonably likely to (Comment 71) One comment during, and after harvesting, yet
occur and, therefore, constitutes a requested that FDA revise the list of processing is defined as excluding
potential hazard. what processors should consider in harvesting, picking, or transporting raw
Therefore, the agency concludes that evaluating the safety of their products to materials, which places it beyond the
if unlawful pesticide residues and include cooling, ice, and water quality control of a processor.
unapproved food and color additives are specifically. The agency is not making the
hazards that are reasonably likely to The list in § 120.7(c) simply provides requested change because the language
occur, it is appropriate that a processor examples to guide processors and is not in question, along with the definition of
processor in § 120.3(k), serves to FDA is issuing these regulations unclean conditions or those that
identify those who are required to under the authority of the act and the promote infection or disease.
comply with part 120 and is not a basis Public Health Service Act (PHS Act). The case law interpreting section
for excluding potential food hazards Specifically, FDA is relying on sections 402(a)(4) of the act is consistent with
from consideration. Specifically, the 402(a)(4) of the act and 701(a) of the act this broad reading of ‘‘insanitary
definition of processing in § 120.3(j)(1) (21 U.S.C. 371(a)) and section 361 of the conditions.’’ In particular, in United
excludes the activities of harvesting, PHS Act (42 U.S.C. 264). States v. Nova Scotia Food Products
picking, or transporting raw materials Under section 402(a)(4) of the act, a Corp., 568 F.2d 240 (2d Cir. 1977), the
even if these materials may be intended food is adulterated if it has been Second Circuit rejected a restrictive
for use in juice processing under prepared, packed, or held under reading of 402(a)(4) of the act,
§ 120.3(k). Only those engaged in insanitary conditions whereby it may concluding that this section provided
‘‘processing’’ juice are ‘‘processors’’ and have been contaminated with filth, or the FDA with authority to establish by
are subject to the requirements in part whereby it may have been rendered regulation processing parameters to
120. However, juice processors are injurious to health. It is important to control or eliminate harmful substances
responsible for addressing the hazards recognize that section 402(a)(4) of the present in food intended for further
that may be present in/on the foods act addresses conditions that may processing. See United States v. Nova
produced during their process, render a food injurious to health, rather Scotia Foods, 417 F.S. 1364, 1368–1369
including hazards that result from than conditions that have actually (E.D.N.Y. 1976), aff’d supra, 568 F.2d
characteristics of the incoming produce. caused the food to be injurious. See 240. At issue in Nova Scotia were FDA’s
One way to address potential hazards United States v. 1,200 Cans, Pasteurized regulations governing the time,
presented by incoming materials is by Whole Eggs, Etc., 339 F. Supp. 131, 141 temperature, and salinity for processing
examining those materials when (N.D. Ga. 1972). See also United States smoked fish, 568 F.2d at 243, 247 to
received and rejecting those that may v. H.B. Gregory, Co., 502 F.2d 700, 705 248, and provisions designed to
contain hazards. Another way is to (7th Cir. 1974), cert. den. 422 U.S. 1007 minimize the outgrowth and toxin
process juice in a manner to control (1975). As noted in the notice of formation of Clostridium botulinum
pathogens or other hazards that may proposed rulemaking, 63 FR 20450 and Type E, 568 F.2d at 243. The regulations
have been present on incoming 20457 (Ref. 2), the question is whether in question defined sanitary conditions
materials. Therefore, FDA believes that the conditions of a juice processing for processing such fish; fish processed
the definition of ‘‘processing’’ does not under conditions not complying with
operation are such that it is reasonably
conflict with § 120.8(b)(2)(ii) and is not the regulation were deemed adulterated
possible that the juice produced by that
making the requested change. within the meaning of section 402(a)(4)
operation may be rendered injurious to
of the act, 21 CFR 128a.2 (1971); 35 FR
F. Legal Basis health. Based upon the information
17401 (November 13, 1970) (Ref. 60).
available to the agency and filed in the
The agency proposed in § 120.9 that Although the Court posited that
record of this proceeding, FDA has
failure of a processor to have and to ‘‘insanitary conditions’’ could be
concluded that, if a juice processor does
implement a HACCP system that narrowly interpreted to refer to
not incorporate certain basic controls
complies with §§ 120.6, 120.7, and insanitary conditions in the plant, such
into its procedures for preparing,
120.8, or otherwise to operate in as the presence of insects and rodents,
packing, and holding juice, it is the Court rejected this narrow
accordance with the requirements of reasonably possible that the juice may
this part, renders the juice products of interpretation, 568 F.2d at 245 to 246,
be rendered injurious to health and, and held that under section 402(a)(4) of
that processor adulterated under section therefore, adulterated under the act. the act, ‘‘insanitary conditions’’ may
402(a)(4) of the act (21 U.S.C. 342(a)(4)). FDA is authorized by 21 U.S.C. 371 to include ‘‘inadequate sanitary conditions
(Comment 74) A number of adopt regulations for the efficient of prevention’’ (568 F.2d at 247). In
comments asserted that FDA lacks the enforcement of the act. rejecting the narrower reading of
statutory authority to require juice FDA believes that the comments 402(a)(4) of the act, the Court recognized
processors to establish HACCP disputing the agency’s authority to issue a ‘‘larger general purpose on the part of
programs. Several comments claimed these regulations advocate an unduly Congress in protecting the public
that section 402(a)(4) of the act cannot narrow interpretation of the act health’’ (568 F.2d at 248).
be read to authorize a broad range of generally and of section 342(a)(4) This final rule requires that juice
HACCP controls and to provide that the specifically. It is well-settled that the act processors implement and maintain
failure to observe any of those controls is to be interpreted broadly so as to HACCP systems. As discussed in detail
would render food prepared under such achieve its goal of public health above, HACCP systems are designed to
conditions adulterated within the protection. United States v. Bacto- prevent, control, or eliminate hazards
meaning of section 402(a)(4) of the act. Unidisk, 393 U.S. 784, 798 (1969). that are reasonably likely to occur
FDA disagrees with these comments. Section 402(a)(4) of the act deems during food production, including
As shown below, the agency has ample adulterated food that is prepared, hazards that are present in in-coming
authority to require juice processors to packed, or held under ‘‘insanitary’’ materials, such as pathogens and other
establish HACCP systems.4 conditions. The term ‘‘insanitary’’ is not contaminants. Under the final rule,
defined in the act. ‘‘Sanitary’’ describes § 120.9, the failure of a juice processor
4 Comments on the seafood HACCP final rule that which ‘‘pertains to health, with to establish and maintain an adequate
raised similar questions as to FDA’s authority to especial [sic] reference to cleanliness HACCP system renders juice produced
require seafood processors to establish HACCP
systems and to require recordkeeping and record
and freedom from infective and under that system adulterated within
access. In response to the proposed juice HACCP deleterious influences,’’ Black’s Law the meaning of section 402(a)(4) of the
rule, one trade associations filed a copy of its Dictionary, 6th Ed.(1990); use of the act. Thus, the provisions of this final
comments on the seafood HACCP proposal. The prefix ‘‘in’’ denotes the absence or rule are essentially comparable to those
agency’s detailed response to the comments on the
seafood proposal, set out at 60 FR 65098–65012, is
opposite of sanitary. Thus, ‘‘unsanitary addressed in Nova Scotia.
incorporated by reference into the preamble of this conditions’’ are those that contribute to In addition, FDA relies on its
final rule. unhealthiness generally, including authority under the Public Health
Service Act in issuing this regulation to FDA is not relying on its authority in ensuring that contaminated juice
the extent that the regulation seeks to section 704 of the act to require the products will not enter the marketplace.
control illnesses caused by pathogenic keeping of HACCP records and to Like the records at issue in
microorganisms. Under section 361 of require official access to such records. Confectioners, the records at issue with
the PHS Act (42 U.S.C. 264), the As discussed in the response to the respect to this final rule are designed to
Surgeon General is authorized to issue previous comment, in terms of the act, prevent the introduction into commerce
and enforce regulations to prevent the this final rule implements section of adulterated foods (569 F.2d at 694).
introduction, transmission, or spread of 402(a)(4) and utilizes FDA’s authority in In this case, the recordkeeping and
communicable diseases from one State section 701(a) of the act to issue access required under this final rule
to another State; this authority has been regulations for the efficient enforcement meet the Confectioners test. First, the
delegated to the Commissioner of Food of the act. FDA is similarly relying on requirements are limited. The HACCP
and Drugs, 5 CFR 5.10(a)(4). See State sections 402(a)(4) and 701 to establish recordkeeping and record access
of Louisiana v. Mathews, 427 F. Supp. the recordkeeping and access to records requirements in the final rule are tied
174, 176 (E.D. La. 1977). The record in requirements of this rule. That this is specifically to the CCP’s, i.e., those
this rulemaking amply demonstrates sufficient authority is established in the points in the process at which control
that juice can function as a vehicle for caselaw. is essential if there is to be assurance
transmitting food-borne illness caused In particular, in National that the resultant product will not be
by pathogens such as Salmonella and E. Confectioners Assoc. v. Califano, 569 injurious to health is to be achieved.
coli O157:H7. Juice produced in one F.2d 690 (D.C. Cir. 1978), the D.C. Second, this limited amount of
State and shipped and sold in another Circuit held that FDA had authority to recordkeeping assists FDA in the
State may be contaminated with establish recordkeeping requirements efficient enforcement of the act. By
pathogens and thus may result in the for food processors. In Confectioners, focusing on the CCP’s, the requirements
transmission of food-borne illness from the recordkeeping provisions of the ensure that the processor and the agency
State to State. The record similarly regulations were challenged on the focus on those aspects of processing that
establishes that juice may be produced grounds that they would permit present the greatest threat to food safety;
and sold to a visiting consumer in one prosecution where processing by documenting whether the HACCP
State, with the consumer subsequently conditions were completely sanitary, plan and its preventive controls are
taking the juice to a second State. Given but required records were deficient. being followed, these records enable
that juice can function as a vehicle for Such an outcome, it was argued, would regulators to verify proper operation of
transmitting human pathogens, this be beyond the scope of section 402(a)(4) the HACCP system or identify
situation creates the possibility that of the act, one of the particular sections malfunctioning of the system, again
food-borne illness will be transmitted relied upon as authority for the ensuring that adulterated foods are not
from one State to another. In light of the regulation as a whole. The court rejected produced and distributed to consumers.
record of this proceeding, FDA has this argument, holding that the As such, the record-keeping
concluded that a system of HACCP principal consideration was whether the requirements assist in the effective and
controls is necessary to prevent the statutory scheme as a whole justified the efficient enforcement of the act. Finally,
spread of communicable disease via regulations. Although the records in the HACCP recordkeeping burden is not
consumption of contaminated juice, and question in Confectioners were coding unduly onerous because the required
that the PHS Act provides the agency and distribution records that FDA records are limited to the development
with the authority to establish such desired in order to facilitate recalls, the of appropriate controls and
HACCP requirements for juice. court’s ruling as to the validity of the documenting those aspects of
(Comment 75) Several comments regulations was not limited to recalls or processing that are critical to food
challenged the agency’s authority to shipping records. Indeed, Confectioners safety. The documentation required in
require that certain records be is appropriately read to authorize FDA the final rule is narrowly tailored to
maintained and that FDA be granted to establish regulations that have a ensure that only essential information
access to those records. The thrust of limited scope, are not unreasonably needs to be recorded and maintained.
these comments is that the act does not onerous, and clearly assist in the Because the preventive controls
explicitly authorize the agency to efficient enforcement of the act (569 required by HACCP are essential to the
require food processors to maintain F.2d 693 n. 9). In addition, the production of safe food as a matter of
records or to require access to records Confectioners court recognized that design, the statutory scheme is benefited
maintained by food processors. The FDA has a role both in preventing and by agency access to records that
comments observed that section 704 of in remedying commerce in adulterated demonstrate that these controls are
the act (21 U.S.C. 374), the act’s general foods, and that the act imposes on the being systematically applied.
records access provision, contains FDA an equal duty to perform each role Similarly, FDA’s authority under the
specific authorization for agency access (569 F.2d at 694). PHS Act (42 U.S.C. 264), provides a
to records relating to drugs and It is widely accepted that separate and sufficient basis for the
restricted medical devices but that, by recordkeeping and inspectional access recordkeeping and records access
its terms, the authority of section 704 to records are essential components of a provisions of this rule, at least to the
does not extend to records relating to HACCP-type system. Through records extent that these requirements relate to
foods. Thus, the comments conclude maintenance and review, a processor the transmission of communicable
that the records access provisions of the can, over time, develop a disease. The record of this proceeding
juice HACCP proposal are unlawful. comprehensive picture of its process clearly shows that juice can function as
FDA disagrees with this comment and identify shortcomings or potential a transmitter of human disease caused
because the agency has adequate shortcomings. Similarly, records by foodborne pathogens, such as
authority under the act and the PHS Act maintenance and access provide the Salmonella and E. coli O157:H7.
both to require the maintenance of appropriate regulatory authorities with Likewise, the record demonstrates that a
records and to compel official access to the opportunity to oversee, in a system of preventative controls, such as
such records for the efficient comprehensive way, the operation of those based upon HACCP, will control
enforcement of the act. Importantly, the processor’s HACCP plan, thereby or eliminate this risk from juice
consumption. As discussed in more Physical hazards cause acute health illness or injury caused by chemical
detail below, records for the HACCP affects, such as cuts in the mouth from hazards is required and there are no
operation, and official access to these glass or metal fragments in the food. data indicating that this type of
records, are central to the effectiveness These hazards are discussed in more monitoring occurs. Some chemical
of HACCP. Thus, the PHS Act clearly detail below. hazards, such as patulin, have known
authorizes the records maintenance and Microbial hazards—There is a long chronic effects of sufficient public
access requirements of this final rule. history of foodborne illness outbreaks health concern that FDA is in the
(Comment 76) A few comments associated with microbial process of issuing guidance documents
stated that the factual and legal contamination of a variety of juices. The concerning maximum levels that should
justifications for mandatory HACCP public health consequences may be be present in foods (Refs. 19 and 24).
relate to the presence of pathogens in minimal (some gastrointestinal distress), Sources of chemical contaminants in
the final product, which is not true of severe (hospitalization, HUS), or fatal. juices include packaging materials,
the pasteurized juice industry. Among the pathogens that have been plant (botanical) material, processing
Comments maintained that section associated with juices are E. coli and cleaning equipment, formulation
402(a)(4) of the act does not authorize a O157:H7, Salmonella, Cryptosporidium, errors, contaminated ingredients, and
broad range of controls and that seafood and certain viruses. Identified sources of contaminated fruit (e.g., patulin in
HACCP was predicated on the pathogens include water, fruit, apples). Unlike microbial contaminants,
conclusion that there were sufficient processing under insanitary conditions, chemical contaminants cannot be
hazards in all fishery products. One and infected workers and food handlers. destroyed or easily removed from
comment stated that the factual Juices, particularly fruit juices, have contaminated foods, and thus,
predicate relied upon in the seafood traditionally not been considered appropriate controls must be established
rule does not exist for juice. The vehicles for human pathogens. Fruit to prevent the contamination in the first
comment maintained that a review of juices, in particular, are acidic, and such instance.
the data in the proposed rule indicates acidity generally would inhibit the Physical hazards—FDA recall data
that microbiological hazards gave rise to growth of most pathogens. Over the past indicate that glass and fragments of
the entire HACCP proceeding and these few decades, however, it has become other packaging materials frequently
hazards do not exist in pasteurized and well documented that some pathogens cause companies to recall juice
shelf stable juices. have adapted to this acidic products. However, the agency has no
The agency addressed the legal environment, making juices susceptible data on illnesses or injuries caused by
authority for this rule in the response to to microbial contamination and those packaging materials.
comment 74. FDA disagrees that the subsequent survival of the pathogens in (Comment 77) One comment stated
factual predicate for juice HACCP is not the juice products. that United States vs. Nova Scotia Foods
adequate. The record demonstrates that Regarding the comment that Products Corporation cannot be read to
there are significant potential hazards in pasteurized juices should not be subject authorize HACCP controls. The
the production of juice, including to HACCP, is without foundation comment maintained that this case
pasteurized and shelf stable juices. because ‘‘pasteurized’’ products may cannot be said to support FDA’s
These potential hazards in juice can be potentially contain chemical or physical proposal to impose a complex and
divided along the lines of the NACMCF hazards. HACCP systems control all detailed regulatory scheme on
food hazard definition: Microbiological, types of food hazards, not just the pasteurized products. Additionally, the
chemical, and physical. Microbiological microbial hazards that adequate heat comment stated that since FDA cannot
hazards can be controlled with some treatments will control. In recognition of demonstrate a need or legal justification
type of heat treatment or other process the lethality of the heat treatment that for HACCP for pasteurized products, its
that prevents, reduces, or eliminates the shelf stable and concentrated juice authority to require recordkeeping and
pathogens. Chemical hazards are not products receive, FDA has modified the record inspection under such a HACCP
normally affected by heat and other pathogen control requirements in program has no statutory basis.
treatments that are used to reduce the § 120.24 for these product groups. This In the response to comment 74, the
microbial contamination of foods and modification to the proposed rule is agency has explained at some length the
thus, must be controlled by other means discussed in detail in the response to basis for its reliance on United States v.
(e.g., rejection of incoming materials comment 140. Nova Scotia Foods, 417 F.S. 1364,
with high lead levels). Likewise, Chemical hazards—There is also a 1368–69 (E.D.N.Y. 1976), aff’d supra,
physical hazards must be controlled in history of foodborne illness outbreaks 568 F.2d 240. Similarly, in the response
some manner other than by thermal or caused by a variety of chemical hazards to comment 75, FDA has explained at
equivalent treatments. All three types of in foods. These hazards include the length the legal basis for the
hazards require that the specific hazard presence of tin, lead, and poisonous recordkeeping and records access
be identified (e.g., bacterial species; plant materials. FDA recall data show provisions of this final rule. In sum,
mycotoxin identity; foreign matter that additional types of chemical both the rule itself and the
present, such as glass), a means for substances with the potential to cause recordkeeping provisions are clearly
preventing or controlling the hazard illness or injury have triggered recalls of authorized by the act and the PHS Act.
identified, and the means of control products from the market (e.g., food
consistently and effectively used. The ingredients that cause allergic-type G. Corrective Actions
public health effects of microbial reactions such as FD&C Yellow No. 5), FDA proposed to require in § 120.10
hazards are most often acute, although cleaning solutions, copper from copper that processors take appropriate
long-term, chronic effects have been pipe fittings on processing equipment. corrective actions whenever a deviation
identified (e.g., arthritis). Chemical Symptoms of reported juice outbreaks from a critical limit occurs. All
hazards are most often associated with usually are limited to acute corrective actions must be fully
chronic adverse health affects, although gastrointestinal effects. Chronic effects documented in records and are subject
they may also have immediate, acute of chemical contaminants are difficult to to verification under § 120.11(a)(iv)(B).
affects (e.g., excess tin leaching from assess because long-term monitoring of (Comment 78) One comment
container lining can cause vomiting). the health of individuals that experience requested that FDA revise § 120.10(a)(1)
and (b)(3) to remove the wording complaints that indicate a deviation in-process tested, except where FDA is
‘‘otherwise adulterated’’ because it should be held for HACCP review. requiring end-product testing.
broadens the scope of the rule beyond The agency disagrees that processors Monitoring could consist of ensuring
food safety and the focus of HACCP should not review consumer complaints that the product was processed within
should be on food safety. The comment as part of their HACCP programs. The time/temperature parameters or time/
further stated that adulteration is agency recognizes that review of sanitizer concentration parameters.
covered in part 110 and should not also consumer complaints is of limited use Therefore, FDA is not making the
be covered in part 120. as a preventive tool because the requested modification.
The agency disagrees that the consumer making the complaint already (Comment 82) One comment
requested revisions are necessary. has the product. However, such review suggested that verification should
HACCP plans only address food hazards may alert the processor to a problem include actual times and temperatures
that are reasonably likely to occur. that, if resolved, would prevent taken and recorded and that there
Under § 120.3(g) a ‘‘food hazard’’ is recurrence of the problem with other should be penalties for noncompliance.
defined as ‘‘any biological, chemical, or consumers. The agency also recognizes The agency agrees with the comment.
physical agent that is reasonably likely that the receipt or absence of complaints Verification activities include timely
to cause illness or injury in the absence does not alone attest to the adequacy of review of monitoring records in
of its control.’’ Thus, a HACCP plan is a HACCP system. However, it is FDA’s accordance with § 120.11(a)(1)(iv).
already focused on food safety. FDA experience that consumer injury or Monitoring records must include actual
also disagrees that adulteration is illness complaints can identify measurements (e.g., times and
addressed exclusively by part 110. In problems traceable to inadequate temperatures) in accordance with
fact, the legal basis for this final rule is, controls at the food processing facility § 120.8(b)(7), except as exempted by
in part an adulteration provision, (Ref. 61). Where information that has § 120.24. Consequently, verification
402(a)(4) of the act and juice not potential relevance to food safety is must include checking the actual
processed under conditions not available to a processor as a result of its measurements that are recorded in the
complying with this final rule is own consumer complaint system, it is monitoring records. As proposed, the
adulterated (see § 120.9). entirely appropriate for the processor to rule has an enforcement mechanism.
(Comment 79) A few comments consider that information in assessing Specifically, under § 120.9, failure of a
suggested that in § 120.10(b)(5) the the adequacy of its HACCP program. juice processor to have and to
words ‘‘timely validation’’ probably FDA concludes, therefore, that implement a HACCP system in
should be ‘‘timely verification’’ or processors should evaluate, as part of accordance with part 120 will render
‘‘timely review’’ and that in their HACCP verification procedures, the juice products of that processor
§ 120.13(a)(3) the term ‘‘verifying’’ the consumer complaints that they adulterated under section 402(a)(4) of
should be used in place of ‘‘validating’’ receive to determine whether the the act. Penalties for noncompliance are
to be consistent with NACMCF’s complaints relate to the adequate FDA refusing entry to imported
HACCP guidelines. performance of control measures or products and instituting legal actions
The agency agrees with the reveal unidentified hazards. such as seizure, multiple seizures, or
comments. When there is a process FDA agrees that it is up to injunction, against unlawful products or
deviation, processors must undertake a management to determine which their producers.
review to see if there have been consumer complaints need followup in (Comment 83) One comment
sufficient changes such that a relation to HACCP compliance as part of maintained that weekly review of
revalidation of the HACCP plan is its verification procedures. This final production records is inadequate and
warranted. The fact that processors have rule does not require that processors suggested that records be reviewed
discovered a deviation indicates that the hold consumer complaints for HACCP before each batch of product leaves the
HACCP plan is working. Therefore, FDA record review, except as the processor plant.
is modifying § 120.10(b)(5) to use the deems necessary as documentation of FDA disagrees with the comment. The
term ‘‘timely verification’’ and verification procedures. agency stated in the proposed rule that
§ 120.13(a)(3) to use the term (Comment 81) One comment weekly review of HACCP monitoring
‘‘verifying.’’ As noted previously, the requested that FDA revise and corrective action records would
agency is defining the terms § 120.11(a)(1)(iii) by adding at the end of provide the industry with the necessary
‘‘validation’’ and ‘‘verification,’’ in the sentence ‘‘where these are other flexibility to move a highly perishable
§ 120.3(p) and (q), respectively. than standard operating procedures or commodity like fresh juice through
CCP’s’’ to clarify that testing required processing and distribution without
H. Verification and Validation under standard operating procedures or interruption, while still facilitating
(Comment 80) One comment CCP’s is not optional. timely feedback of information. FDA
requested that FDA not require a review The agency disagrees that the notes that the comment provided no
of consumer complaints in the HACCP requested revision of § 120.11(a)(1)(iii) information to demonstrate that weekly
program. The comment maintained that is appropriate. The requested revision review of records is inadequate. In fact,
review of consumer complaints is would make the testing mandatory as weekly record review will quickly
untimely because the product has part of verification activities for SOP’s indicate whether the HACCP system is
already been processed and reached the and CCP’s. This was not the intent of out of control on a regular basis, which
consumer. Additionally, the comment the provision. In the preamble to the is a sign that the system is not adequate
stated that consumer complaints, or lack proposal, the agency acknowledged the to assure safety and that revalidation of
thereof, cannot attest to the effectiveness shortcomings of end-product testing as the system is required. Thus, the agency
of a process. Another comment a process control, especially concludes that weekly review of
suggested that it should be up to the microbiological testing, but encouraged monitoring and corrective action
management to determine which inclusion of testing in HACCP systems records is adequate for verification
consumer complaints need followup in where it is appropriate. SOP’s and CCP purposes. FDA notes that the
relation to HACCP compliance. One monitoring requirements do not requirement for weekly review does not
comment stated that only consumer necessarily need to be end-product or preclude a processor from reviewing
production records on a more frequent The agency does not agree with the absence of pathogens during processing,
basis if the processor wishes to do so. comment. All food processors must take which in turn, directly affects the
(Comment 84) One comment safety considerations into account when effectiveness of the HACCP plan. Access
suggested that FDA revise contemplating changes in their to specific SSOP records is important to
§ 120.11(a)(1)(iv)(A) to provide for processes, regardless of whether they investigators making reasonable
values that are outside critical limits are operating under a HACCP system. judgements about whether the HACCP
and for which corrective actions are The agency recognizes that validation plan is working properly. Accordingly,
taken (covered in § 120.11(a)(1)(iv)(B)). could be costly if frequent changes are the final rule requires that SSOP records
The agency disagrees that the made in the process that could affect the must be maintained and made available
requested revision of hazard analysis or alter the HACCP plan during inspections. However, the
§ 120.11(a)(1)(iv)(A) is necessary and, thus, processors may be reluctant agency has no intention of requiring,
because under § 120.11(a)(1)(iv)(B) to make changes, even if the changes and processors need not make available
processors must review records to have the potential to improve the to FDA, any other CGMP-related
ensure that the records are complete and process or the safety of the final records.
to verify that appropriate corrective product. A change in the supplier of raw (Comment 89) One comment
actions were taken. Therefore, FDA is ingredients may be a change requiring recommended that the agency delete
not making the requested modification. revalidation. However, a prudent from the regulation any reference to
(Comment 85) Several comments processor will check new suppliers records for end-product or in-process
pointed out that the proposed annual before making any changes to determine testing. The comment stated that
validation requirement in § 120.11(b) is that the supplier will not be a source of individual processors would keep
not consistent with NACMCF HACCP any safety concerns. Because HACCP testing records for FDA review only if it
guidelines. The comments requested systems need to be revalidated only is part of the verification of their
that, instead, FDA require validation when changes in the process occur that HACCP plan.
could affect the hazard analysis or alter The agency disagrees that any
whenever there are significant process
the HACCP plan in any way, not every modification of the regulation is
changes or equipment/system failures.
change will require revalidation. necessary and is not making the
The agency is not persuaded that it
Similarly, because a hazard analysis requested change. The regulation only
should modify the requirement for
needs to be revalidated only when there requires that end-product or in-process
annual validation. Section 120.11(b) is
are process changes that could testing records associated with
consistent with the NACMCF HACCP verification of the HACCP plan be
guidelines in that processors must reasonably be expected to affect whether
a food hazard exists, not every process available for FDA review and thus, is
validate their process as needed (Ref. consistent with the comment. As
17). The NACMCF provided as change will require revalidation of the
hazard analysis. Therefore, FDA discussed in section III.L.6, the agency
examples whenever there is an is establishing periodic end-product
concludes that the requirements of
unexplained system failure; a significant testing requirements for purposes of
§ 120.11(b) and (c) are important for the
product, process or packaging change process verification of citrus juices that
public safety and will have minimum
occurs; or new hazards are recognized. use fruit surface treatment to achieve
impact on conscientious processors.
FDA has simply defined ‘‘as needed’’ as the 5-log reduction in the pertinent
at least annually or whenever any I. Records pathogen; processors are required to
changes in the process occur that could The agency proposed that processors provide FDA with access to these
affect the hazard analysis or alter the maintain records documenting their records.
HACCP plan in any way. Therefore, HACCP system. FDA also proposed (Comment 90) One comment stated
FDA is not modifying § 120.11(b) as the general record requirements, and other that a processor with only one location
comments requested. provisions or requirements dealing with should not have to provide its location
(Comment 86) One comment documentation, record retention, official on all records, as required in
requested that FDA not require a review, public disclosure, and records § 120.12(b)(1).
processor to validate the HACCP plan maintained on computers. The agency agrees with the comment
any time changes occur in the (Comment 88) One comment was and is modifying § 120.12(b)(1) to read
prerequisite programs. The comment concerned that the agency was trying to as follows: ‘‘The name of the processor
requested that FDA revise § 120.11(b) to get access to processors’ CGMP records or importer and the location of the
delete this requirement. under § 120.12(a)(1) and that this could processor or importer, if the processor
The agency agrees with the comment. be a disincentive for companies to keep or importer has more than one
It is rare that a change in SSOP’s will thorough records. location.’’
make the HACCP plan ineffective. The agency disagrees with the (Comment 91) Two comments stated
Validation is not a paper exercise and comment. Section 120.12(a)(1) requires that date and time may not be necessary
may be time consuming and expensive. that processors maintain records on all records. One comment contended
Therefore, FDA is modifying § 120.11(b) documenting the implementation of the that the date and time are only
to delete the proposed requirement. SSOP’s in § 120.6. SSOP’S are select important on monitoring and corrective
FDA notes that the final rule requires CGMP sanitation requirements that the action records and, therefore, should
revalidation when there is any change agency believes are so important to the only be required on these records.
in the process, including a change in the effective implementation of HACCP that The agency believes that the date of
SSOP’s, that decreases the effectiveness they require separate, specific the activity is important on all HACCP
of the HACCP plan. provisions. The agency believes that the records. The date allows the processor
(Comment 87) One comment sanitation controls in § 120.6 are of and the FDA investigator to assess
expressed concern that the proposed significant importance to the proper whether the record is current, to
validation requirements would have the implementation of HACCP because identify when any deviation occurred,
effect of locking producers into one sanitation controls, such as controls and to track corrective actions.
supplier and that this would stop preventing contamination from pests, However, the time of an activity is not
product development and innovation. have a direct impact on the presence or necessary on records other than
monitoring and corrective action under part 120. Processors are required written communication summarizing
records (i.e., it is not necessary on the to review consumer complaints as a part requirements to achieve an adequate
hazard analysis or HACCP plan). of their verification procedures process would be adequate.
Therefore, the agency is modifying (§ 120.11(a)(1)(i)) to determine whether FDA has reevaluated the provision in
§ 120.12(b)(2) to state that the time of complaints relate to the performance of § 120.12(d)(2) and concludes that it does
the activity need not be included on the HACCP plan or to reveal previously not afford any additional significant
records required under § 120.12(a)(2), unidentified hazards. Processors may protection to consumers and may add
(a)(3), and (a)(5). choose to include consumer complaints unnecessary burdens for processors.
(Comment 92) One comment in their HACCP records to document Therefore, the agency is deleting
suggested that there is no need for the verification of the HACCP system, but it § 120.12(d)(2) and recodifying
hazard analysis to be signed unless is not required. paragraphs § 120.12(d)(3) and (d)(4) as
there is no HACCP plan because the (Comment 95) One comment stated § 120.12(d)(2) and (d)(3), respectively.
hazard analysis did not indicate the that the period that records must be (Comment 98) One comment
need for a HACCP plan. held is out of line with product shelf life suggested that FDA restrict
FDA disagrees with the comment. The because fresh juice only lasts 14 days. recordkeeping requirements to records
signature of the most responsible The comment suggested that records produced at the manufacturing facility.
individual onsite at the processing could be kept for 3 months rather than The comment stated that data used to
facility or by a higher level official of 1 to 2 years. establish processes should be
the company is important for both the FDA disagrees with the comment. maintained by the individual or
hazard analysis and the HACCP plan. Some problems, such as trends in the organization that developed the record,
The signature reflects the fact that frequency of process deviations, may not by the processing plant.
management has reviewed, accepted, not be easily recognized in a ‘‘snapshot’’ FDA disagrees with the comment. It is
and is responsible for the content of the record review. By reviewing records vital that each processing plant
hazard analysis and any resulting plan. covering a longer period of time, a maintain or have access to all records
Therefore, the agency concludes that processor may be able to identify certain required under part 120, that pertain to
both the hazard analysis and any process deviations. Moreover, while it products produced by that plant for
resulting HACCP plan must be signed. may be true that most fresh products purposes of both processor review and
(Comment 93) One comment will be unusable within 3 months, some FDA inspections. The agency has made
suggested that the final rule should products are processed for longer shelf- provision for offsite storage of records,
allow initialing of records instead of a life (such as flash pasteurized, to the extent feasible, to reduce plant
signature, as is done with low acid refrigerated juices), and retention times storage burden. Specifically, under
canned foods. of less than 1 year do not provide for § 120.12(d)(2), electronic records are
The agency disagrees with the sufficient information for the considered to be onsite if they are
comment. The food canning processor’s or FDA’s verification accessible from an onsite location and
establishment registration and the food activities. (See § 120.11(b).) Therefore, comply with § 120.12(g). In addition,
process filing form for low acid canned FDA has made no changes to under § 120.12(d)(2), offsite storage is
foods both require the signature of an § 120.12(d)(1). allowed for certain monitoring records
authorized individual. Other low acid (Comment 96) One comment after 6 months following the date that
canned food records must be signed or requested that FDA revise § 120.12(d)(1) the monitoring occurred as long as the
initialed (§ 113.100). Part 120 has to read ‘‘Subject to part § 120.14, all records can be retrieved and provided
similar requirements for juice product records required by this part * * *,’’ onsite within 24 hours. Finally, under
records. Section 120.12(b)(3) states that because there are other importer § 120.12(d)(3), seasonal processors may
all records shall include the signature or requirements for recordkeeping outlined store records at a reasonably accessible
initials of the person performing the in § 120.14. location at the end of the seasonal pack.
operation or creating the record. The agency disagrees with the Records (such as the hazard analysis,
However, given their centrality in a comment. Section 120.12(d)(1) requires HACCP plans, and verification,
HACCP program, it is important that the both processors and importers to retain including validation, records for
hazard analysis and the HACCP plan be all records required by part 120. Under products processed in the plant) are
reviewed and authorized by the most § 120.12(d)(1), importers must retain the needed by both the processor and FDA
responsible individual onsite at the records required under § 120.14 at the to determine whether the HACCP
processing facility or by a higher level importer’s place of business in the system or systems are properly
official of the processor so as to signify United States. Therefore, the agency implemented and effective. HACCP
that management of the firm is aware of concludes that the modification is not systems and associated records may be
and has accepted these records necessary. tailored to each specific processing
(§ 120.12(c)). Therefore, the agency is (Comment 97) One comment noted facility and for different products
not modifying part 120 to permit the that proposed § 120.12(d)(2) requires processed in the facility. Therefore, the
initialing of the hazard analysis and the processors to maintain records related to agency concludes that all records
HACCP plan. the adequacy of equipment or processes. required by part 120 must be retained at
(Comment 94) One comment argued The comment stated that if equipment is the processing facility to which they
that consumer complaints often involve old or modifications have been made to relate (or reasonably accessible when
quality issues and are primarily handled it, firms may have trouble getting a letter offsite storage is permitted) or at the
at headquarters facilities, not processing to that effect from the manufacturer. importer’s place of business in the
plants. Therefore, the comment stated Therefore, the comment stated, United States. As discussed in previous
that consumer complaint records should scientific studies will have to be comments, FDA recognizes that
not be part of HACCP recordkeeping performed to determine adequacy, processors may review information (e.g.,
requirements. which will be costly, especially for consumer complaints) to develop/
The agency points out that consumer small processors. The comment stated evaluate their systems that is not
complaint records are not required to be that the requirement is not consistent required to be maintained and to which
maintained or access given to them with parts 113 and 114. It stated that a processors are not required to grant FDA
access. Processors may maintain this The agency advises that the agency programs. FDA worked with the
information at any location that is intended that proposed § 120.12(f) not Seafood Alliance to develop a seafood
convenient for the processor. permit public disclosure of processing HACCP curriculum and training
(Comment 99) One comment records except where they have been courses. A similar cooperative effort
pointed out an inconsistency between previously disclosed to the public or would be very beneficial in juice
the preamble to the proposed rule that where they relate to an abandoned processing. Also, the agency is in the
stated that after 6 months the SSOP and product or ingredient and are no longer process of developing a juice HACCP
HACCP monitoring and corrective trade secret or confidential commercial hazards and controls guide, which will
action records could be stored offsite, or financial information. FDA assist juice processors in the
and the codified language in proposed acknowledges that the proposal was less development of their HACCP systems.
§ 120.12(d)(3) that refers to the storage than clear as to the status of an (Comment 104) One comment
of SSOP records and the HACCP plan abandoned product process. To clarify questioned whether the agency will
offsite. the final rule, FDA is striking the work acknowledge the equivalency of juice
FDA agrees that the proposal’s ‘‘thus’’ from § 120.12(f) so that the trade HACCP training, as mentioned in
preamble and codified were secret status of a product process may § 120.13(b), offered by other parties
inconsistent. The agency realizes that be maintained by the processor and the (such as a trade association or academic
some juice processors may be required information not necessarily subject to institution) as it did for seafood HACCP.
to store records that could require a public disclosure even though the The comment asked how and who
great deal of space (e.g., the SSOP and particular product has been abandoned. would determine training adequacy.
HACCP monitoring and corrective The public availability of such Another comment suggested that
action records) and that there may not information will be evaluated by FDA equivalency of training programs would
be adequate storage space in the on a case-by-case basis. be better dealt with by establishing
processing facility for all of these (Comment 102) Several comments training objectives, such as the system
records. However, because of their requested that HACCP documents in used in meat and poultry HACCP, rather
direct relevance to ensuring safe FDA’s possession not be made available than specific materials and curricula.
processing operations at a facility, FDA under the Freedom of Information Act FDA believes that the development of
has concluded that records dealing with (FOIA). seafood HACCP training, through the
FOIA provides consumers and others
the HACCP plan must remain on site for Seafood Alliance, was beneficial for all
with the opportunity to obtain records
at least 6 months. After that period, parties. A basic curriculum was
in the possession of Federal agencies,
such records may be stored off-site if developed, which the agency reviewed,
including FDA, upon request. There are,
they can be retrieved and returned on- that was available for the industry’s use.
however, some restrictions on the types
site to the plant within 24 hours so that The agency has encouraged trainers to
of records available under FOIA. For
plant managers and FDA investigators evaluate their courses against the
example, confidential commercial
have ready access to the records for use materials developed by the Alliance and
information and trade secrets are
in evaluating the effectiveness of the to make modifications necessary to
exempt from disclosure 5 U.S.C.
HACCP plan. Therefore, FDA is ensure that programs were consistent
552(b)(4). The agency concluded in the
modifying § 120.12(d)(2) to refer to with and provided at least an equivalent
seafood HACCP final rule (60 FR 65096
paragraphs (a)(1) and (a)(4) instead of level of instruction to the Alliance
at 65138) (Ref. 62), that HACCP plans,
(a)(1) and (a)(3). course. FDA is very interested in
as a general rule, meet the definition of
(Comment 100) One comment cooperating with all interested parties,
trade secret information, and thus, even
requested that FDA delete § 120.12(e) including academia, consumer groups,
if these plans are in agency files, they
because the agency does not have the and the juice industry, to develop
likely would not be available under
statutory authority to see consumer training programs that incorporate the
FOIA. However, because FDA is bound
complaints. most appropriate objectives and
by FOIA and the agency’s implementing
The agency advises that consumer materials. FDA will acknowledge the
regulation in 21 CFR part 20, the agency
complaints are not required records equivalency of training in the same
is unable to exclude categorically all
under § 120.12(a) and the rule does not manner as is done for seafood HACCP.
HACCP records in agency files from
seek to require that FDA be given access public disclosure. (Comment 105) One comment
to such records. Thus, the agency argued that criteria for adequate HACCP
concludes that no action is necessary in J. Training training should be left up to the States
response to this comment. The agency proposed that only to determine, but did not provide any
(Comment 101) Several comments individuals trained in HACCP be support for this opinion. The comment
expressed concern about the responsible for certain key functions in also asked that FDA provide States with
confidentiality of records associated a HACCP system. The agency is guidance and funding to carry out
with an abandoned process. They stated correcting an error in § 120.13(a)(3), as HACCP training for existing State
that a manufacturer’s processing proposed, so that the section references personnel and to certify HACCP
methods are often considered trade § 120.10(b)(5) instead of § 120.10(c)(5) specialists.
secret even for products that have been because there is no paragraph (c)(5). The agency currently intends to
abandoned. The comments suggested (Comment 103) Several comments provide training to States, through
that the agency make provisions for this requested that FDA provide training for contracts and State partnerships. The
in the final rule and handle abandoned the juice industry. agency recognizes that the effectiveness
product records in the same manner as FDA has limited resources to use for of juice HACCP hinges on consistent
existing product information. One training. Therefore, the agency has no implementation and regulation
comment added that current process plans at present to provide specific throughout the United States and
lines may use technology similar to that HACCP training for the juice industry. training, particularly for investigators,
used for an abandoned product and that However, the agency is interested in plays an important role in such
abandoned products may be brought cooperating with States and the industry consistency. As noted above, FDA is
back into production. in the development of training interested in cooperative work with
States, academia, and industry to or import such juice from a country that reduction in the pertinent
develop training programs. has an appropriate memorandum of microorganism. As proposed, the
(Comment 106) One comment stated understanding (MOU) with the United pertinent microorganism means the
that individual companies should be States. In addition, importers must pathogen that is likely to occur in juice
permitted to determine when maintain records that document the and that is most resistant to the
experience can substitute for HACCP performance and results of the pathogen reduction technology used
training. Another comment argued that affirmative steps taken to demonstrate and, if it occurs, is likely to be of public
experience can never substitute for compliance with § 120.14. health significance. The proposed
training, although the comment (Comment 108) Several comments reduction must be for a period at least
contained no data or other information contended that the juice HACCP as long as the shelf life of the product
to support the claim. regulation should not apply to imports. when stored under normal and
FDA believes that in certain However, other comments disagreed. A moderate abuse conditions.
circumstances, appropriate job few comments suggested that only (Comment 110) Several comments
experience can be an adequate imported fresh juice be covered, not advocated a regulatory scheme of
substitute for formal HACCP training. juices that have been documented to HACCP without the performance
FDA is aware that some juice processors have been thermally processed to meet standard proposed by FDA. The
have had successful HACCP programs the 5-log performance standard. comments argued that a performance
in place for a long period of time and, The agency advises that this final rule standard is not necessary to ensure the
as a result, employees working with will cover all imported and domestic safety of all products (e.g., citrus).
those systems have gained a working fresh or processed juices. First, under Comments stated that requiring a
knowledge about HACCP that is more the act, all products in interstate performance standard negates the
than adequate to meet the training commerce, whether imported or strength and function of HACCP and
requirement. Moreover, FDA’s domestic, must adhere to the same indicates that FDA does not trust
experience is that other segments of the standards. Moreover, imported juices HACCP alone. The comments asserted
food industry have HACCP programs in may have many of the same potential that FDA should require either the
place and employee experience gained food hazards as domestic products. FDA performance standard or HACCP, but
working with those systems may be discussed outbreaks associated with not both.
transferred successfully to juice imported juices in the proposed rule (63 The agency disagrees that having the
processing. It is the responsibility of FR 20450 at 20450) (Ref. 2), and some performance standard as an integral part
processors to determine that their of the recent outbreaks discussed in of HACCP weakens the HACCP system.
HACCP system is functioning response to comment 26 were associated As NACMCF has pointed out, the
appropriately and is in compliance with with imported juice (Refs. 46 and 47). In performance standard enhances HACCP
part 120, a responsibility that includes addition, imported juices may contain by establishing the appropriate level of
ensuring that those individuals involved food hazards not normally associated health protection that must be achieved
in designing and implementing the with domestic products. The differences (Ref. 25). The 5-log reduction
HACCP system are qualified. in the types of food hazards may be the performance standard assures public
(Comment 107) One comment function of a number of factors, health protection for consumers and
suggested that FDA develop a test to including differences in processing assists processors by establishing a
determine whether particular job systems and sources of raw ingredients. minimum microbial standard for safe
experience can substitute for HACCP The fact that HACCP is based on juice. Particularly for non-heat treated
training. The comment asked if FDA is juice, the 5-log reduction requirement
prevention of specific hazards makes it
developing such a test. provides a standard against which
applicable, in general, to food
FDA has no plans to develop a test to processors can measure the
processing wherever the processing
determine whether job experience can effectiveness of combinations of HACCP
occurs. Therefore, the agency agrees
substitute for HACCP training. Job controls. Including a performance
with those comments that stated that the
experience that is equivalent to training standard as part of HACCP sets a goal
rule must apply equally to imported and
gained under an adequate standardized for processors without mandating the
domestic juice products, because the
HACCP curriculum is certainly one way means by which they must achieve that
potential risks are the comparable. The
that individuals may gain the training goal and also provides a means of
safety of juice must be ensured
required in § 120.13(a). However, as determining the equivalence of
regardless of where it is produced. alternative strategies for controlling
noted, it is the responsibility of
(Comment 109) One comment
individual companies to ensure that pathogens. Finally, FDA disagrees with
suggested that FDA clarify the reference
qualified individuals conduct the the suggestion that a performance
to ‘‘imported food’’ in the introductory
hazard analysis and develop the HACCP standard alone will ensure safe juice. As
sentence of § 120.14 to identify that
plan, whether such individual is noted previously, there are hazards in
juice is the specifically covered product.
qualified through training or job addition to microbial contamination,
The agency agrees with this
experience. and a performance standard alone does
suggestion and has revised the
not address the chemical and physical
K. Application of Requirements to introductory sentence of § 120.14 by
hazards that may be present in juice.
Imported Products replacing the word ‘‘food’’ with the (Comment 111) Many comments
The agency proposed in § 120.14 word ‘‘juice.’’ stated that the final rule should identify
specific requirements for importers of L. Process Controls a safety goal instead of a performance
juice products because FDA typically standard and let industry decide how to
does not inspect foreign food 1. Performance Standard meet it.
establishments. Under § 120.14 of the The agency proposed to require that FDA points out that the performance
proposed rule, importers of juice either juice processors, except those that are standard in § 120.24 is a microbial
must ensure that all juice offered for subject to part 113 or part 114, include safety goal and that the final rule allows
entry into the United States has been in their HACCP plans control measures the industry to decide how to achieve
processed in compliance with part 120 that will produce at least a 5-log (105) the safety goal. Elsewhere in this
preamble, FDA has included guidance contamination rather than eliminating implemented to ensure that the full 5-
on the application of the 5-log standard, pathogens that may be present. Thus, log reduction is consistently achieved
and FDA also intends to issue a juice use of GAP’s would not be a substitute under commercial processing
HACCP hazards and controls guidance. for the 5-log reduction treatment. conditions. GAP’s and CGMP’s that do
Both of these forms of guidance are (Comment 114) A few comments not meet these criteria would be in
available to the juice industry to help in suggested that, in addition to the 5-log addition to, but not count as part of, the
deciding how to achieve the safety goal. reduction performance standard, 5-log reduction. The agency notes that it
Therefore, the agency concludes that no producers should be given the option is the responsibility of the processor to
modification is necessary in response to that Food Safety and Inspection Service demonstrate that combinations of
this comment. (FSIS) gives for fermented sausage, preventive steps are adequate to achieve
(Comment 112) A few comments which is batch testing to determine that the 5-log pathogen reduction standard.
suggested that producers who do not the product contains less than a certain (Comment 116) A few comments
use dropped fruit should be able to use level of pertinent pathogens and then expressed concern that no attention was
HACCP without a performance use a 2-log reduction on the batch being given to preventing the presence
standard. One comment contended that tested. of pathogens in juice.
a 5-log reduction is not necessary when FDA disagrees with the comments’ Prevention of pathogens in juice is the
the source of the fruit is known and suggestion. Juice is significantly reason HACCP was proposed and is
processors follow CGMP’s. different from a fermented meat product being finalized. The agency has always
This comment did not provide in that a fermented meat product is taken the position that food safety is
evidence to persuade FDA that using typically inoculated with bacterial enhanced by the use of the highest
tree-picked fruit, along with HACCP, cultures as part of the production quality incoming materials. The agency
would make the 5-log performance process. The growth of the added strongly encourages growers to
standard unnecessary. In fact, produce, microorganisms modifies the food implement preventive controls and has
in general, including tree picked fruit, environment so that pathogenic bacteria issued GAP guidance to assist growers
may not be pathogen free. Agricultural are inhibited or inactivated; there is no in the production of safe produce that
water, birds, insects, and harvesters are comparable inoculation and inhibition is not contaminated. FDA is issuing part
vectors that can potentially contaminate activity with juice. Moreover, this 120 to assist processors in establishing
produce even though the produce has process occurs over an extended period preventive controls. Specifically,
not come into contact with the ground. of time (3 to 6 weeks is common), which § 120.7(b) provides that the hazard
Even if pathogens are present on or in allows time for test results to be analysis shall include hazards that can
the produce used to make juice, completed. Juice, especially juice that is be introduced both within and outside
processors can make safe juice by minimally processed, must be processed the processing plant environment,
attaining the 5-log reduction and consumed within a significantly including hazards that can occur before,
performance standard. shorter period than fermented products during, and after harvest. In addition,
(Comment 113) Many comments and, thus, extensive microbial testing of § 120.7(d) requires that processors
stated that the 5-log performance finished, processed products is not evaluate product ingredients to
standard was not appropriate because practical. Therefore, because there is no determine their potential effect on the
processors would have to pasteurize counterpart in juice processing to the safety of the finished food.
their juice to meet the standard. A few inhibition or inactivation of pathogens (Comment 117) One comment
comments stated that the 5-log by an added bacterial culture, the requested that FDA explain how the
performance standard is unreasonable, agency concludes that batch testing to performance standard applies to each
counterproductive, and precludes establish that juice contains a minimum different juice (apple, citrus, vegetable,
consideration of harvesting and farming level of pertinent pathogens followed by and blends).
practices that help ensure safety. a 2-log reduction in the pertinent FDA advises that the performance
The agency disagrees with the pathogen is not an appropriate standard in § 120.24 applies to all juice,
comments. The performance standard in substitute for the 5-log reduction including blends of more than one type
§ 120.24 allows for the use of alternative performance standard. of juice. Processes for attaining a 5-log
technologies. The basis for 5-log is (Comment 115) Several comments reduction will vary significantly
discussed in response to comment 124. maintained that there are no data to depending on the target pathogen and
As noted in section III.L.4, application show that certain combinations of the type of juice produced. Therefore, it
of 5-log must occur where the treatment preventive steps are not adequate to is up to each processor to determine
has direct contact with any and all ensure juice safety. One comment how best to apply the performance
pathogens that may be present. For most argued that a combination of grading, standard to its process. FDA intends to
juices, this will entail direct treatment washing, sanitation, and current develop a juice HACCP hazards and
of the juice after extraction. For citrus extraction techniques are sufficient to controls guidance for juice that will
juice only, the available data and meet the 5-log reduction. provide processors information on the
information show that surface FDA is not prohibiting the use of application of the performance standard
treatments can be used to meet all or appropriate cumulative controls to in addition to that provided in this final
part of the performance standard. In attain the 5-log reduction for citrus rule. The scientific literature is another
either case, treatments should be products. However, as discussed in source of information for processors on
applied at a single location under the section III.L.4, FDA has determined that recent developments to attain the 5-log
processor’s control and immediately the 5-log reduction must occur where reduction for various types of fruits and
before packaging, in order to prevent the treatment has direct contact with all vegetable juices. Guidance documents
post-process contamination of the juice. pathogens, if they are present. Further, from State agencies may also provide
Although fruit producers and juice cumulative controls must be completed information.
manufacturers are encouraged to follow in a single production facility under the (Comment 118) One comment
GAP’s, GAP’s such as water and manure control of the processor, be effective suggested that all processors should be
management are generally aimed at against the pertinent pathogen, be required to meet the chosen
minimizing the potential for validated, and be vigorously performance standard the same way.
The agency disagrees with the should set pathogen reduction goals be smaller than those estimated here.’’
comment. FDA specifically chose not to similar to those established for meat and The benefits of the rule with regard to
mandate that processors use a particular poultry. illness prevention were developed
method to meet the performance FDA disagrees that the 5-log based on the amount of illness that
standard in order to provide flexibility performance standard is unenforceable. would be prevented if all juices were
and to encourage innovation. Different The reasons FDA did not set a zero pasteurized because, at the time the
methods that have been validated to tolerance for pathogens, as was done for proposal was published, pasteurization
meet the 5-log reduction standard can certain pathogens in meat and poultry, was the primary effective, commercially
be effective in controlling pathogens to already have been discussed in the implemented method for controlling
the appropriate level, which is the goal response to comment 114. By virtue of pathogens in juice that had been
of the performance standard. Mandating the requirements of part 120, FDA validated to meet the performance
a specific technology for processors to believes that the performance standard standard. Since the publication of the
use would eliminate the incentive for is enforceable. That is, as part of their proposal, it has become evident that
processors to develop new and possibly HACCP plan, processors must have a there may be methods other than
improved alternative methods. FDA validated procedure for achieving a 5- pasteurization, some of which may
does not want to limit innovative log reduction in the pertinent pathogen require FDA approval for their use, that
approaches to achieving food safety or for their process and also must have could be used to treat juice (e.g., use of
the flexibility for processors to choose documentation to demonstrate to FDA UV irradiation, high pressure). While it
the most appropriate method for a that the standard is being achieved. is true that pasteurization treatments
particular operation. Processors who cannot meet these significantly exceed the 5-log pathogen
(Comment 119) Some comments requirements will not be in compliance
reduction performance standard, the
requested a zero tolerance for E. coli with part 120 and thus, will be subject
statement in the PRIA was not intended
O157:H7 in juice. One comment was to regulatory action.
(Comment 121) A few comments to imply that methods other than
concerned that the NACMCF may have
suggested that FDA use ‘‘safe harbor’’ pasteurization are not effective at
recommended a higher threshold of risk
than consumers would consider guidelines rather than require the 5-log preventing illness or that these other
acceptable. It stated that there is no reduction to ensure juice safety. methods cannot meet the 5-log
acceptable level of risk with regards to The comment did not define the term reduction performance standard.
E. coli O157:H7 because it is so virulent ‘‘safe harbor.’’ FDA assumes, however, (Comment 123) One comment noted
that a single organism could be deadly. that by ‘‘safe harbor’’, the comment that pasteurization would add a
The comment sought scientific evidence means that FDA would provide complicated and unnecessary step to
that the 5-log performance standard will guidance, such as times and cider production that will take time and
truly kill these organisms, as opposed to temperatures for thermal treatments, require documentation.
represent a reasonable number of that, if complied with, would be
FDA is not requiring in this
organisms killed. deemed to achieve the 5-log reduction,
rulemaking that juice be pasteurized.
The agency disagrees with the thus providing a basis to conclude that
This rulemaking requires that juice be
comments. FDA notes that no food the processor is in compliance with
processed under a HACCP system that
processing method can be shown § 120.24. FDA is currently working with
industry to develop guidance on how to contains a control or controls that have
scientifically to achieve a ‘‘zero’’ level
achieve the 5-log reduction, and has been validated to achieve a 5-log
for a pathogen or any other contaminant
already met with the apple industry and reduction in the target pathogen. A juice
potentially present in the processed
food due to the detection limits of the citrus juice industry to discuss processor may choose to meet the 5-log
relevant analytical methods. For technological options for achieving the reduction requirement by pasteurizing
example, the methods used to detect E. performance standard. Although the product or by any other validated
coli in juice in several State surveys had agency is developing guidance to assist means. Although pasteurization is the
a detection limit of < 1 cell per 3.33 processors in achieving the 5-log primary option available for cider at this
milliliter (mL) juice. Thus, a negative reduction, FDA does not intend such time, this final rule does not preclude
result does not necessarily mean that guidance to provide a ‘‘safe harbor’’. the development or use of alternative
the microorganism is not present, just Thus, juice processors will not be technologies to achieve a 5-log
that it is not present at detectable levels. absolved from adopting HACCP and reduction. For example, FDA recently
Furthermore, if pathogens are not demonstrating through validation and amended the food additive regulations
distributed homogeneously throughout verification that they have met the to provide for the safe use of ultraviolet
a product, they may be present in the performance standard. (UV) irradiation to reduce human
product but not in the sample tested. (Comment 122) One comment noted pathogens and other microorganisms in
Conversely, food processing methods the statement in the agency’s PRIA juice products (65 FR 71056, November
can be shown scientifically to reduce, statement (63 FR 24254 at 24264) (Ref. 29, 2000) (Ref. 75). Importantly,
by mathematical increments (i.e., by 6) that other methods of meeting the however, the processor chooses to meet
‘‘logs’’), the level of pathogens that may performance standard may not be as the 5-log reduction requirement, the
be present in juice and, as a result, to effective as pasteurization or prevent as process utilized by the processor must
reduce the risk of illness from juice. much illness seems to indicate an be validated and verified as achieving a
FDA has received no comments to agency lack of confidence in methods 5-log reduction in the pertinent
undermine the assumption based on the other than pasteurization. microorganism. The risks associated
NACMCF recommendation that the 5- FDA disagrees with the interpretation with consumption of cider and other
log performance standard will of the PRIA statement. The statement juices are well established (see 63 FR
adequately protect consumers from E. referenced from the PRIA reads ‘‘To the 20450 (Ref. 2) and section II.C of this
coli O157:H7 and other pathogens. extent that processors adopt controls for final rule) and justify regulatory
(Comment 120) One comment these hazards other than flash requirements that processors establish
contended that a 5-log performance pasteurization which are less effective, controls for pathogens and the other
standard is unenforceable and that FDA the percentage of cases prevented may hazards associated with juice.
2. Magnitude of Reduction source of E. coli O157:H7. They comment did not reference any specific
(Comment 124) Many comments determined that a 5-log reduction would performance standards. The comment
questioned the scientific basis for the both eliminate the E. coli O157:H7 maintained that a performance standard
5-log reduction performance standard. A contamination and provide a safety should be based on actual levels of
few comments contended that it was too margin. In addition to the information pathogens found in or on fruit plus a 1-
stringent based on actual numbers of factored into determination of the 5-log or 2-log safety factor.
reduction performance standard, FDA has concluded that the 5-log
ubiquitous coliform bacteria found in
regulatory precedents were considered. performance standard recommended by
cider in State surveys. In support, a
The 5-log pathogen reduction the NACMCF is the most appropriate
survey submitted as part of a comment
performance standard is used by FDA standard to assure that juice is safe. In
questioning the basis of a 5-log
for Salmonella inactivation for in-shell the response to comment 124, FDA
reduction standard showed that samples
egg pasteurization and by FSIS for discussed how the Fresh Produce
of apples in cider mills in Maryland
inactivation of E. coli O157:H7 in Working Group of the NACMCF arrived
contained an average of only 3-logs of at the 5-log pathogen reduction
fermented sausage. The agency has
ubiquitous coliform bacteria and no performance standard. This
evaluated the NACMCF advice and
generic E. coli or E. coli O157:H7. Some performance standard includes the
concluded that the 5-log performance
comments asserted that a 5-log customary 100-fold safety factor, not a
standard recommended by the NACMCF
performance standard is premature 1,000-fold safety factor as asserted by
is the most appropriate standard to
considering that the source of E. coli the comment. Therefore, the agency
ensure that juice is safe.
O157:H7 contamination in apple juice is This pathogen reduction performance concludes that the 5-log value is
not known and suggested that FDA standard, in combination with the consistent with other performance
adopt a 3-log performance standard requirement that measurement of the standards set by FDA and, in fact, was
until scientific data are developed to 5-log reduction begins after cleaning arrived at using the 100-fold (2 log)
support the need for a 5-log standard. and culling of citrus fruits and, for all safety factor the comment suggested.
The comments stated that without data other juices, when the treatment has (Comment 126) Several comments
to provide baseline numbers for direct contact with any pathogens in the stated that 5-log is not an appropriate
contamination of juice, any performance juice (discussed in the response to performance standard for citrus juice
standard selected might be comment 131), provides adequate because, in trial studies, researchers
inappropriately stringent or lax. The public health assurance while have not been able to inoculate fruit
comments maintained that the 5-log minimizing the impact of treatments on with sufficient numbers of
standard is particularly excessive if a the sensory attributes of the juices (Ref. microorganisms to measure a 5-log
processor is using CGMP’s and only 64). While a 3-log reduction could be reduction. One comment stated that
uses prime fruit. adequate under certain circumstances, it minimum safety performance criteria
Conversely, one comment suggested does not ensure that juice is safe under should be established for citrus because
that the 7-log performance standard all circumstances that may occur. In the likelihood of contamination in citrus
used by other high risk food processors contrast, the 5-log reduction juices is not high. However, another
would afford more consumer protection. performance standard has a built-in comment suggested that a 5-log
It suggested that the agency compare the safety factor that provides additional performance standard would be
protection offered by 5, 6, and 7 log consumer protection. appropriate for orange juice because it
performance standards because E. coli In light of the comments, FDA has can be attained without heat and a 3-log
keeps proving to be more resistant to considered a 6- or 7-log reduction performance standard would be
controls than previously thought and standard and concluded this additional appropriate for apple juice because this
because a 5-log reduction may not be level of reduction is not necessary to may be the maximum attainable without
adequate for all strains of E. coli. compensate for possible future heat treatment.
FDA discussed the cider survey microbial resistance. The 5-log FDA proposed the 5-log performance
results in the response to comment 36. reduction refers to numbers of standard based on safety considerations
In that discussion, the agency noted the microorganisms, not resistance of and on the recommendation of the
limitations of the analytical methods microorganisms. Strains of NACMCF (Ref. 63). As mentioned in the
and advised that the survey results did microorganisms may become more response to comment 124, while a 3-log
in fact affirm that risk factors such as resistant to heat, acid, sanitizers or other reduction could be adequate under
fecal coliforms, an indicator of the controls over time. Because certain circumstances to ensure that
possible presence of pathogens, are microorganisms are capable of juice is safe, the 5-log performance
present in cider operations and could developing resistance, it is critical that standard has a 2-log safety factor that
give rise to microbial food safety juice processors periodically verify and offers additional consumer protection.
hazards in the finished juice. validate their process to determine the In addition, the agency found in its
In establishing the 5-log standard, continued effectiveness of the process. If review of performance criteria for other
FDA is relying on the advice of a panel resistance occurs, processors may need foods, that a 5-log reduction in
of recognized food safety experts, the to make appropriate changes in their pathogens is the standard for product
NACMCF. In making this process so that their process continues safety in several cases (Ref. 63).
recommendation, the Fresh Produce to attain a 5-log reduction in pathogens. Although the target pathogen may differ
Working Group of the NACMCF Therefore, the agency concludes that among juice types and, thus, change the
considered various situations that could increasing the performance standard to specific processing parameters (e.g.,
occur with juice (Ref. 63). First, they attain a greater log reduction is not temperature, processing time) for
considered what levels of E. coli might necessary to compensate for possible attaining a 5-log reduction, FDA
typically occur in juice and added a future increased resistance of pathogens. maintains that the 5-log performance
standard 100-fold safety margin. The (Comment 125) One comment standard is appropriate for all juices.
Working Group then considered a worst asserted that a 1000-fold safety factor is The one area where FDA has data to
case scenario where produce could be not consistent with other performance suggest differences between citrus juice
contaminated with bovine feces, a standards set by FDA, although the and other juices is with respect to the
potential for pathogen infiltration. agency considered written comments, and the way in which the product is
Specifically, the available data show including comments submitted after the processed. For example, there have been
that the potential internalization of meeting, on the appropriateness of the apple juice outbreaks associated with E.
pathogens in sound, intact citrus fruit is 5-log reduction standard, along with coli O157:H7, Salmonella spp., and
not likely to present a significant public comments presented at the NACMCF Cryptosporidium parvum. Salmonella
health risk (see the response to 132). meetings and the NACMCF species have been associated with
Thus, for citrus juice only, the agency recommendations. outbreaks from orange juice. The
has determined that surface treatments (Comment 128) A few comments NACMCF recommended the use of E.
may be used to achieve the 5-log requested that FDA not require small coli O157:H7 or Listeria monocytogenes
reduction standard. Accordingly, citrus producers to meet the 5-log performance as the target organism, as appropriate.
juice processors have an additional standard until alternatives to This recommendation is based on the
option in how to achieve the pasteurization are validated. The number of known outbreaks of E. coli
performance standard (i.e., 5-log comments argued that pasteurization is O157:H7 in juice and the ubiquitous
reduction), but the standard is the same. too costly for small producers. nature of L. monocytogenes. FDA
FDA also rejects the comment’s The agency understands the small advises that if L. monocytogenes
implicit suggestion that the performance processors’ concerns. However, the becomes a source of outbreaks in the
standard should be based on what is 5-log reduction is based on safety, and future, especially affecting pregnant
technically feasible. In order to assure therefore, processors must meet the women, then processors must consider
safe food, a performance standard must standard in § 120.24, in their HACCP whether L. monocytogenes should serve
be based on safety, not on whether it is systems in order for public health to be as the pertinent microorganism for their
attainable using only certain protected. FDA has documented product.
technologies, such as heat treatment. outbreaks that have been attributed to Processors must also consider the
Presenters at the Florida and California small processors (Ref. 65). In manner in which they are achieving the
FDA workshops on the 5-log pathogen recognition of the circumstances of 5-log reduction and the microbial
reduction (November 12, 1998 and small processors, however, the agency is resistance to the process. For example,
November 19, 1998) and FDA research establishing staggered compliance dates a new technology may be effective in
presented at the December 8 to 10, 1999, such that there is an additional 1 year attaining a 5-log reduction of E. coli
NACMCF meeting demonstrated that for small processors and an additional 2 O157:H7 in apple juice, but may allow
researchers could and had inoculated years for very small processors to the survival of Cryptosporidium. E. coli
fruit with pathogens to a level that comply with the HACCP final rule. O157:H7 is known to be unusually acid-
permits measurement of a 5-log Importantly, such processors must use resistant and L. monocytogenes is
reduction. Therefore, FDA is not the label warning statement if they are relatively heat-resistant. The 5-log
persuaded that the performance not processing their product to achieve pathogen reduction standard applies to
standard should be different for the 5-log reduction. FDA believes that the most resistant microorganism of
different produce used to make juice. this approach does not substantially concern under the processing
(Comment 127) Several comments compromise safety and at the same time conditions used. If the microorganism is
noted that the 5-log performance provides accommodation to small and resistant to a particular treatment and
standard was chosen by NACMCF and very small processors. Therefore, the the treatment does not therefore deliver
that there was no representative of the agency declines to modify the regulation a 5-log reduction in the microorganism,
fresh juice industry on the Committee. to exempt small producers from the then, obviously, the 5-log reduction
The comments maintained that 5-log performance standard. standard has not been met. FDA plans
NACMCF may not have considered to provide additional information in its
3. Pertinent Pathogens
written comments that were submitted Juice HACCP hazards and controls
after the public meeting when making (Comment 129) Some comments guidance to assist producers in
its recommendation. provided views on the types of identifying the pertinent microorganism
The NACMCF based its microorganisms that should be for measuring the 5-log standard.
recommendation for a 5-log considered the pertinent microorganism (Comment 130) Several comments
performance standard for juice on safety for measuring the 5-log reduction. One requested that FDA clarify how
considerations, which included a comment contended that the chosen surrogate microorganisms should be
scientific evaluation and rationale for a target organism must make scientific chosen to validate cumulative steps
5-log reduction standard. FDA reviewed sense based on their extremes of used to achieve a 5-log reduction (e.g.,
the advice from NACMCF and chose to pathogenic viability across multiple use of sanitizers). One comment
propose the same standard for HACCP reduction steps. A few comments stated requested that FDA require industry to
systems for juice because the agency that Listeria monocytogenes should not use an agreed upon ‘‘cocktail’’ of
determined that the 5-log standard is be a target pathogen for the performance surrogates to validate processes.
supported scientifically. The structure standard because there is no history of FDA advises that surrogates should be
of the NACMCF and the way it problems with Listeria in juice. equally or more resistant to the
functions allow for public comment However, other comments stated that E. processing conditions than is the target
during the meeting, which comments coli O157:H7 and L. monocytogenes are pathogen to assure that the process also
the Committee considers in developing both appropriate target pathogens, destroys the pathogen. As noted in the
its recommendations. The fresh juice especially because Listeria response to comment 129, one treatment
industry presented their views to the contamination is a risk to pregnant may be effective in reducing one type of
NACMCF during the meeting in women. One comment also stated that pathogen but have less or no effect on
question. FDA, on the other hand, Salmonella is not an appropriate target another. FDA will be providing
typically announces a period of time microorganism because it is not as acid- additional guidance on the selection
during which comments related to the resistant as E. coli O157:H7. and effective use of surrogate
public NACMCF meeting may be FDA has concluded that target microorganisms for process validation
submitted. In reaching its conclusion to pathogens must be chosen on the basis in its juice HACCP hazards and controls
propose a 5-log reduction standard, the of historical association with a product guidance. FDA believes that it is the
responsibility of the producer to hypothetical because information and grapefruit when there is a transitory
validate the processes it chooses to use data from the scientific literature pressure differential between the
in manufacturing juice products, demonstrate that, under certain interior and exterior of the fruit. At the
including determining appropriate conditions, microorganisms can become December 1999 NACMCF meeting, FDA
surrogate microorganisms. Therefore, internalized. (Refs. 13 and 14) Such asked the NACMCF to consider the
FDA is not requiring use of a ‘‘cocktail’’ internalization may occur through potential for internalization of
of surrogates to validate processes. natural plant structures or through microorganisms by citrus fruits. The
In choosing and using surrogates, it is decayed or damaged sites on the fruit or NACMCF concluded that it is
important to remember that a vegetable. Water, insects, and birds, all theoretically possible for
cumulative 5-log reduction must be of which may carry human pathogens, microorganisms to internalize in sound,
achieved. Therefore, a processor must can serve as pathogen vectors, resulting intact citrus fruit under conditions
have evidence that there is a total in contamination of fruits and where a temperature differential
reduction of 5 logs in the surrogate vegetables. Internalization may occur between fruit and wash water may cause
population and that the same 1- or 2-log before or after harvest although water to be drawn into the fruit. The
reduction is not being counted submerging warm harvested fruit in Committee stated that while this was
repeatedly. In other words, if one step cold water (such as dump tanks and demonstrated in laboratory conditions,
reduces the surrogate by 2 logs, the next flumes) increases the potential for the probability of its actual occurrence
step must reduce the surrogate by an infiltration into susceptible produce. under current industry practices was
additional number of microorganisms. Similarly, exposing vulnerable external not demonstrated. Accordingly, the
In addition, care must be taken that points of fruit or vegetables may also NACMCF concluded, based on the
there is no growth of microorganisms cause water to be taken-up along with available evidence, that the potential
between steps. pathogens if they are present. internalization and survival of
4. Application of the Performance Accordingly, for most fruits and pathogens in sound, intact citrus fruit is
Standard vegetables, this means that the pathogen not likely to present a significant public
reduction treatment must be applied to health risk.
(Comment 131) Several comments the juice after extraction. Moreover, FDA agrees with the NACMCF
maintained that, because of the processors should include in their conclusion. Importantly, the comments
possibility that pathogens may become HACCP plans, where appropriate, did not provide any data for FDA to
internalized into fruit (or vegetables), precautions to avoid or minimize the conclude otherwise. Thus, the agency is
the treatment(s) will need to be applied potential for infiltration (such as by requiring in § 120.24 that the 5-log
after the juice has been extracted so that avoiding submerging warm fruit in standard be met by treatments applied
the treatment has intimate (i.e., direct) colder water). In addition, while directly to the juice, except that citrus
contact with pathogens. One comment CGMP’s and SSOP’s, such as using juice processors may use treatments to
suggested that FDA require at least part potable water and sanitary operating fruit surfaces, provided the 5-log
of the treatment be applied directly to conditions during washing, are a base reduction process for citrus begins after
the juice. Conversely, another comment for HACCP, they will not necessarily cleaning and culling and is
maintained that, except for warm apples prevent or correct pathogen infiltration accomplished in a single production
in cold water, the potential for pathogen into fruits and vegetables. If pathogens facility under the control of the
infiltration is hypothetical. Even then, have become internalized in fruit or processor. (The terms ‘‘cleaning’’ and
according to the comment, use of vegetables, wash treatments, even if ‘‘culling’’ are discussed below in the
potable water and hygienically conducted consistent with CGMP’s, will response to comment 132.)
maintained tanks could control not eliminate them. At the present time, FDA believes that
pathogen internalization despite a In the case of citrus fruits, FDA only citrus fruits have been
temperature differential that could considered in the preamble to the demonstrated to be adequately
cause water to be pulled into the fruit. proposed rule that the structure of citrus impervious to internal contamination
As stated previously, FDA believes fruits prevented internalization of such that it is reasonable to rely on
that, for all fruits and vegetables, the microorganisms, and thus, for citrus surface treatments of these fruits, and
pathogen reduction control process fruits, pathogenic microorganisms are therefore, use of surface treatments to
must begin at the point where the likely to be restricted to the surface of achieve all or part of the required 5-log
pathogen reduction treatment directly the fruit. As such, FDA tentatively pathogen reduction is restricted to citrus
contacts the pathogens. Inherent in the concluded that surface treatments of fruit. Whenever sufficient scientific data
NACMCF recommendation of the citrus fruit would satisfy the criterion are provided to the agency to establish
5-log pathogen reduction standard was for direct contact with all pathogens and that, for other fruits and vegetables, it is
the assumption that the treatment(s) could, therefore, be counted towards the appropriate to begin the 5-log reduction
would be applied in a way that would 5-log reduction standard (see also the process at other points than the
effectively reduce the entire population response to comment 132). extracted juice or that establish that
of the microorganism of concern by 5- In response to comments challenging surface treatment is no longer an
log. In making this recommendation, this agency conclusion and in the acceptable method to contribute to the
NACMCF did not contemplate absence of scientific studies directly on 5-log reduction for citrus fruit, FDA will
treatments that may eliminate some this topic, FDA conducted two studies review this conclusion.
pathogens while not reaching others, as to determine the validity of its (Comment 132) A number of
would be the case for surface treatment assumption, and made the results comments contained suggestions or
of produce susceptible to pathogen available for public comment. The asked for clarification about where to
internalization. In fact, the NACMCF results of one study provided evidence start treatment for purposes of
specifically advised that surface that internalization, survival, and calculating the 5-log pathogen
treatments would have little effect on growth of human bacterial pathogens reduction. A few comments maintained
pathogens if they are internalized. may occur inside oranges. The results of that processors grading fruit to reduce
Contrary to the comment, the the second study demonstrated that potential contamination, and processors
potential for infiltration is not there is uptake of water by oranges and using other best management practices,
should be able to count these practices applicable to the 5-log reduction. This is likely to be more susceptible to
towards the 5-log reduction standard. consistent with the NACMCF pathogen infiltration and, therefore,
One comment claimed that FDA should recommendation that cleaning and should not be used for juice that relies
allow the measuring of pathogen culling of citrus fruits not be considered on surface treatment.
reduction to begin prior to processing to part of the 5-log reduction of pathogens. Furthermore, in some cases, damage
achieve and count reductions in The agency notes that all produce used incurred when fruit drops to the ground
pathogens from proven sources, such as for making juice must be cleaned and may foster nonmicrobial contamination
by cleaning and culling dirty or culled prior to the start of the 5-log such as the mycotoxin patulin, which
damaged fruit. Another comment reduction according to CGMP’s. may occur in damaged apples. Patulin,
maintained that a 2-log reduction is However, FDA is defining these terms to if present in the apples, will not be
possible from using tree picked apples clearly set forth the basic starting decreased by the 5-log performance
instead of drops and that this practice conditions for the 5-log reduction, standard. In these cases, the processor
(i.e., excluding drops) should be especially in regard to surface treated must have controls in place to ensure
counted towards achieving the 5-log citrus. that the final juice does not contain
reduction. (Comment 133) One comment unsafe levels of the mycotoxin.
In contrast, several comments stated suggested developing a standard for (Comment 134) Several comments
that the earliest possible point to start fruit for juicing that includes no urged FDA to define sound fruit. A few
counting the 5-log reduction is with dropped fruit, no blemishes or dimples, comments noted that culling is a
clean, sound fruit. One comment and rinsing with pathogen-free water. subjective process and therefore may
maintained that, while overtly damaged The comment suggested that beginning not be consistently applied. One
fruit carry a greater risk of with fruit of a standardized quality comment suggested that the agency
contamination, apparently sound fruit would not count toward the 5-log establish mandatory common minimum
may also be contaminated and that, reduction, but would ensure that all standards and technologies (e.g., black
therefore, culling is not a screen for processors start with fruit of the same lighting) to ensure consistency in
microbial contamination. high quality. One comment argued that culling operations. Another comment
FDA agrees that food safety is treatments that can achieve a 5-log suggested that FDA specify that fruit be
enhanced by the highest quality reduction in pathogens when applied to culled of unsound fruit before dirty fruit
incoming materials. However, as noted sound, clean fruit may be adequate for is placed into a flume where it might
in response to comment 112, FDA does producing safe product but questioned contaminate sound fruit.
not believe that GAP’s (such as using whether a greater reduction might be In the case of citrus juice where a
tree picked fruit) or CGMP’s (such as necessary if starting with fruit that was surface treatment is used to achieve, at
washing and culling fruit) are a dirty or damaged. least in part, the 5-log reduction, the
replacement for the 5-log reduction. Nor FDA is not setting a standard for fruit agency has specified that the fruit shall
can these practices substitute for a quality or expressly prohibiting the use be ‘‘culled’’ and ‘‘cleaned.’’ As noted,
portion of the 5-log treatment. of drops in most juices. As with any these terms are defined in § 120.3. Fruit
Establishment of the 5-log pathogen food, FDA encourages the highest and vegetable grading criteria (e.g., for
reduction standard as adequate public possible quality incoming materials in USDA choice level or higher, as will be
health protection was based upon the production of juice. The Produce required for surface treated citrus fruit)
certain starting conditions, including Working Group of the NACMCF arrived have been established by USDA.
cleaning and culling the produce, and at the 5-log reduction recommendation Although there may be some degree of
the principal that the pathogen by considering a ‘‘worse case’’ scenario subjectivity in culling citrus fruit,
reduction treatment must directly where fruit was heavily contaminated visibly damaged fruit is apparent and is
contact the microbiological hazard. As with feces, as might occur with the use unlikely to meet the requirements for
noted, for juice made from fruits and of drops. The Committee concluded that USDA choice level or higher.
vegetables in which there is a potential a 5-log reduction treatment would Application of CGMP’s, along with the
for pathogen infiltration, such contact is eliminate pathogens and provide a 100- 5-log performance standard beginning at
likely to occur only after the juice has fold safety margin. Thus, FDA a point after cleaning and culling of
been extracted; for citrus, where concludes that the 5-log reduction citrus fruit, should overcome any
pathogen internalization is unlikely applied directly to the juice will potential risks that may result from
under current industry conditions, the eliminate pathogens that may otherwise subjective processes such as culling.
5-log reduction process does not need to be introduced by the use of drops. FDA As stated in response to comment
start with the extracted juice but may cautions, however, that juice producers 132, FDA is not setting a standard for
begin with exterior decontamination of that are exempt from or that have not fruit where the juice is treated after
fruit after cleaning and culling. yet adopted HACCP, including the 5-log extraction to achieve a 5-log reduction,
FDA is defining in § 123.3(a) and (f) reduction standard, can reduce their although processors may consider
the terms ‘‘cleaned’’ and ‘‘culled’’ as risk of producing contaminated product including standards for incoming fruit
described by NACMCF to establish the by avoiding drops and by culling tree as appropriate to their operations in
starting point for surface treatments for picked fruit before extraction. establishing a HACCP plan. Additional
citrus. Cleaned means washed with The agency is establishing a standard guidance will be provided in the
water of adequate sanitary quality. for citrus fruit that is treated only with agency’s juice HACCP hazards and
Culled means separation of damaged surface treatment. For these juices, controls guidance.
fruit from undamaged. For processors of drops may not be used. The NACMCF (Comment 135) Several comments
citrus juices using treatments to fruit suggested, and FDA agrees, that for requested that FDA develop a guide for
surfaces to comply with § 120.24, culled citrus juices, only tree-picked fruit industry that states the log reduction
means undamaged, tree-picked fruit should be used, and fruit should be achieved for each potential processing
(i.e., USDA choice or higher quality). cleaned and culled to be USDA choice step. A few comments requested that
For all juices, cleaning and culling or higher quality. Although pathogen pasteurization guidelines for juice be
operations would be part of CGMP’s, infiltration is unlikely in sound, intact published in a guide, and one comment
and fruit being tree-picked is not citrus fruit, drops and damaged fruit are asked whether or not heat treatment at
161 °F for 15 seconds results in the FDA agrees with the comments recommendation focused on citrus
appropriate 5-log reduction in juice. expressing concern about the potential juice, based on the comments, FDA
Another comment questioned how to for recontamination or regrowth of believes that this recommendation
calculate a 5-log reduction for banana surviving pathogens if individual should be extended to all juices.
juice. treatments designed to achieve a 5-log Because of the potential for
FDA plans to publish a juice HACCP reduction are separated by time or contamination at a facility over which
hazards and controls guidance to assist space. At the December 8 to 9, 1999, the final processor/packager has little or
the juice industry in implementing meeting of the NACMCF, FDA asked the no control and because of the potential
these regulations. FDA intends that the Committee to consider certain questions for contamination during bulk transport,
guidance will contain pasteurization about the application of the 5-log FDA has concluded that there should
guidelines and information about reduction standard, focusing on citrus not be any carryover from one facility to
achieving the performance standard in juices. Questions included the impact of another of any portion of pathogen
other ways. The agency is unable to separation in time and space between reduction that contributes to a total 5-
comment on whether a heat treatment of cumulative steps in the 5-log reduction log pathogen reduction. If a treated juice
161 °F for 15 seconds results in a 5-log process. The Committee members is transported to another facility for
pathogen reduction without information agreed that separating steps in the 5-log final packaging or blending and
about the characteristics of the juice as reduction by time, and especially by packaging operations, the entire 5-log
well as the thermal resistance location, is likely to increase the risk of reduction must be repeated. To clarify
characteristics of the pathogen of failure of the pathogen reduction this point, the agency is adding
concern. Appropriate 5-log pathogen process (Ref. 12). Thus, the NACMCF paragraph (c) to § 120.24 to state that
reduction treatments for specific juices recommended that all the steps needed processors must complete the 5-log
(such as banana juice) will vary, to achieve the required 5-log reduction performance standard and final product
depending on the characteristics of the should occur under one firm’s control packaging within a single processing
juice (e.g., acidity, viscosity, percentage and within a single production facility. facility under CGMP’s.
of pulp) and processing conditions. These restrictions are designed to FDA also notes that, for citrus juice
Processors may find it necessary to reduce the risk of recontamination of producers relying on surface treatments
consult additional resources to juice already processed to achieve all or for the 5-log reduction, the single
determine and implement the most part of the 5-log reduction. Both time facility criterion also applies to the
and the act of transportation, between requirement that processors start with
appropriate process to achieve the 5-log
processors, present an opportunity for clean, choice or higher grade fruit.
pathogen reduction, such as information
recontamination. Even if a processor Although some juice processors may
from State public health or agriculture
moves product from one building to receive fruit that has been cleaned and
agencies, universities, extension
another within the same facility, this graded at another facility, fruit may
services, and private consultants. The
movement must be accomplished under require additional cleaning and culling
agency emphasizes that it is the
CGMP’s and the processor must insure to remove any fruit damaged in storage
processor’s responsibility to validate the
that recontamination does not occur. As or transit. It is the responsibility of the
chosen pathogen reduction process to
noted, there have been several recent final juice processor (i.e., the processor
assure its effectiveness in consistently
outbreaks of microbially contaminated at the location where the 5-log treatment
achieving a 5-log or greater reduction. will be applied) to ensure that fruit is
(Comment 136) Many comments fresh juice; investigation of these
clean and of appropriate grade before
expressed confusion about the use of outbreaks establish that the concern
beginning the 5-log reduction.
cumulative steps to reach the 5-log about recontamination is not just Even within a single production
pathogen reduction requirement. A few theoretical because the evidence facility, time between cumulative steps
comments also requested that FDA suggests that transportation may have may provide an opportunity for growth
clarify exactly what would be required played a role in these outbreaks. In or recontamination. Therefore,
if two different processors perform steps April 2000, FDA was notified by CDC of processors should include in their
that in the final product add up to a a foodborne disease outbreak involving HACCP plans controls to protect against
5-log reduction. A number of comments over 140 reported cases from 10 States. regrowth of pathogens between steps
stated that separating cumulative CDC determined that the illness was (e.g., limiting hold time and/or
pathogen reduction steps by time and or caused by Salmonella Enteritidis in temperature) and to prevent
by location is not acceptable. These unpasteruized orange juice, a recontamination of the juice during or
comments argued that such separation component of which had been imported after processing (e.g., aseptic handling
provided opportunities for in bulk. Previously, in July 1999, an between steps or between treatment and
recontamination of product and outbreak of Salmonella Serotype packaging).
regrowth of any existing pathogens that Muenchen occurred in 15 States and 2 FDA also agrees with the concern
had not yet been eliminated in the Canadian provinces with over 300 cases expressed by comments on the potential
product, that any multiple step reported. Again, the product was fresh for juice to be contaminated during bulk
intervention should take place in a orange juice, a portion of which was transport. This is an area of particular
single location, and urged FDA to imported. In this second outbreak, concern to the agency because, as
ensure time between treatments is kept several serotypes of Salmonella were mentioned above, bulk transport
to a minimum once an intervention isolated from tanker truckloads of juice appears to be a common factor in
sequence is begun. Several comments tested at the United States/Mexican several recent outbreaks. However, the
on transporting juice between facilities border (Ref. 67). agency has no information nor was any
suggested that FDA require that bulk FDA agrees with the NACMCF information submitted by comments
transport juice (e.g., juice shipped in recommendations that all the steps that the 5-log reduction standard
tanker trucks) be pasteurized upon needed to achieve the required 5-log applied to juice in general would not be
arrival at the final facility because of the reduction should occur under one firm’s sufficient to ensure the safety of juice
potential for contamination during control and within a single production that is shipped in bulk, provided that
transport. facility. Although the NACMCF the transported juice receive the entire
5-log reduction at the facility where it considered in the development of the consideration be given to concentrated
will be packaged. Therefore, FDA is not HACCP plan and appropriate controls juices.
requiring at this time that juice shipped established that are designed to prevent The agency agrees with the comments
in bulk between facilities be subject to recontamination. Processors not and is providing an exemption from the
additional treatment. packaging juice immediately after requirements of § 120.24 for shelf-stable
(Comment 137) One comment treatment should have sufficient and concentrated juices, under specific
expressed concern that a cumulative controls in place (e.g., aseptic conditions. Shelf-stable juice products
process will be more easily equipment) to ensure the safety are generally processed at high
overwhelmed by especially dirty fruit achieved by the 5-log reduction can be temperatures in a single step to destroy
than would a single kill-step process. consistently maintained. spoilage microorganisms and enzymes
The comment contended that the risk of (Comment 139) One comment asked (Ref. 68). These temperatures far exceed
contamination in a multi-step process is if the regulation allowed for the what is needed to attain the 5-log
increased over the risk in a single kill- application of 5-log reduction to a juice reduction in the pertinent pathogen.
step process because of the potential ingredient at any time (e.g., before or Therefore, FDA concludes that it is
that contamination can be introduced after blending). The comment argued reasonable to exempt a processor of
between steps. One comment expressed that the juice ingredient used to shelf-stable juices from the requirements
concern that validation studies on a manufacture dairy beverages usually of § 120.24, if the firm uses a single
cumulative 5-log reduction cannot receives a 5-log treatment by the thermal processing step to attain shelf-
account for all variables and, thus, supplier and that the finished beverage stability.
meeting the performance standard is often pasteurized at the dairy. FDA also recognizes that the
cannot be guaranteed. Juice that is intended for use in production of thermally concentrated
HACCP principles and this final rule further manufacturing is generally juice utilizes thermal treatments similar
require that a processor validate the shipped in bulk. As discussed in the to those used for the production of
HACCP plan for its particular process response to comment 136, the NACMCF shelf-stable juices (Ref. 68). A thermal
under commercial operating conditions. recommended and FDA agrees that if concentration process generally consists
This validation requirement exists for bulk transport juice will be repackaged of an initial thermal treatment, similar
plans utilizing both single-step and at another facility, the 5-log reduction to that used for shelf-stable juices,
cumulative pathogen reduction controls. process must be performed on the juice followed by several thermal evaporation
FDA recognizes that within a processing at the facility where it is packed into steps. For this reason, the agency has
system time delays may occur between final packages. If treated juice is concluded that when a thermal
stages of the treatment; the processor packaged into a bulk-type sterile processing step is used before a thermal
must take any delays into consideration, package, such as a single use sanitary evaporation process, the processor
establish appropriate controls, and tote, then reprocessing is not necessary should be exempt from the 5-log
validate the HACCP plan for that unless it is repackaged. If juice shipped reduction requirement.
system. The 5-log reduction in sterile totes is to be repackaged at a Accordingly, FDA is adding
performance standard was established different facility, the juice product sold § 120.24(a)(2) exempting juice
to ensure the safety of juice regardless to consumers must be retreated to attain processors using a single thermal
of the pathogen reduction system the 5-log reduction at the facility where processing step sufficient to achieve
chosen or the microbial load of the final packaging is performed. As shelf-stability of the juice or a thermal
incoming fruit. Furthermore, as discussed earlier, separation in time and concentration process that includes
discussed in response to comment 132, location increases the risk of failure of thermal treatment of all ingredients
citrus juice processors using surface the HACCP system, including the 5-log from the requirements of § 120.24 (the
disinfection to achieve all or part of the reduction. Therefore, FDA is not 5-log reduction requirement). When
5-log reduction must start with cleaned providing for carryover of any part of completing the written hazard analysis
and culled fruit as defined in § 120.3 (a) the 5-log reduction when juice, not in as required by § 120.7, processors of
and (f). its final packaged form, is transported shelf-stable and concentrated products
(Comment 138) Several comments between two facilities. using a thermal treatment need not
maintained that juice should be Juice destined for use as an ingredient identify pathogens as a hazard that is
packaged immediately before or after in another juice beverage must also reasonably likely to occur. To
the intervention treatment. One undergo a 5-log reduction process. The demonstrate that its process is sufficient
comment stated that a processor could processor may choose either to treat the for the exemption, a processor must
hold and cool a heat treated product juice ingredients before blending or to include a copy of the thermal process
before packaging if sufficient controls treat the final product, so long as the used to achieve shelf-stability or
were in place to preclude entire 5-log reduction is completed in a concentration in its written hazard
recontamination of the product. single production facility under the analysis as required by § 120.7.
As noted earlier, time between control of the processor and the Shelf-stable or concentrated juice
cumulative steps and between processor minimizes time between processors are not exempt from the
application of the 5-log reduction and treatment and packaging. requirement to conduct a written hazard
packaging increases the risk of failure (Comment 140) Several comments analysis because of the possibility that
(see response to comment 136). noted that shelf-stable juices are chemical or physical hazards may be
Therefore, to reduce the risk of processed well in excess of the 5-log reasonably likely to occur. However, if,
recontamination, juice should be reduction necessary for pathogen based on its hazard analysis a processor
packaged immediately before or after control. The comments requested that exempt from § 120.24 determines that
application of the 5-log pathogen FDA exempt shelf-stable juice producers there are no chemical or physical
reduction treatment. The potential for from a CCP for pathogen reduction hazards that are reasonably likely to
recontamination between application of because the shelf-stability of the product occur in its juice product, then that
the 5-log reduction treatment and is proof that their process greatly processor is not required to have a
packaging (such as might occur when exceeds safety performance criteria. HACCP plan. Juice processors that do
product is held and cooled) should be Comments also requested that the same not have a HACCP plan need not
comply with the following provisions of treatments) that have been extensively are made that may have an impact on
part 120: validated, and as such can be readily the effectiveness of the system.
• § 120.8, HACCP plan adopted with minimal need to conduct Validation focuses on collecting and
• § 120.10, Corrective actions in depth microbiological validation evaluating scientific and technical
• § 120.11(a) (except paragraph testing. information to determine whether the
(a)(1)(i)), Verification FDA was unsure what the second HACCP plan, when properly
• § 120.11(b), Validation of the HACCP comment meant when referring to implemented, will effectively control all
plan ‘‘routine testing’’ as a way to validate hazards that are reasonably likely to
• § 120.12(a)(3) and (a)(4), Required HACCP. It may be that the comment was occur. In contrast, verification assesses
records referring to ‘‘verification’’ (e.g., routine whether the HACCP plan, once
• § 120.24(a) (except paragraph (a)(2)), testing and monitoring) to ensure that established, is working properly.
Process controls the HACCP plan is functioning FDA disagrees that microbiological
• § 120.25, Process verification for correctly, rather than ‘‘validation’’. testing of the final juice should be
certain processors Verification and validation are further required of all juice manufacturers. If
FDA anticipates that, in the future, discussed in the following section. juice is treated to achieve a 5-log
processors making shelf-stable or reduction in a target pathogen after the
concentrated juice may use alternative 6. Process Verification
juice is expressed, the extent of the
nonthermal processing technologies. (Comment 142) Several comments reduction (>100,000-fold) in
While the control mechanism of these expressed concern about the combination with the low levels of
nonthermal technologies may eliminate effectiveness of cumulative steps in pathogens that have been detected in
spoilage microorganisms, the effect on meeting the 5-log reduction. One untreated juice would likely result in a
pathogens is uncertain. Therefore, the comment pointed out that the efficacy of post-treatment level of microorganisms
exemption under § 120.24(a)(2) does not a cumulative step process for citrus that is too low to be detected using
extend to nonthermal processes. assumes perfect grading and that the reasonable sampling and analytical
5. Validation of the Performance interior of citrus is sterile. The comment methods. Moreover, microorganisms are
stated that perfect grading is not not likely to be uniformly distributed
Standard
possible because pathogens that may throughout the juice and, accordingly,
(Comment 141) One comment stated have entered the fruit through a may not be present in the sample tested
that the cost of validating a 5-log microperforation may not be detected even though they are in the juice. This
reduction procedure would be and the fruit could have a contaminated can result in false negative test results.
prohibitive to small producers because interior. The comment also maintained Determination that the product has been
the validation studies would have to that no steps in the cumulative process adequately treated is more effectively
take place in a pilot plant. Another described in the proposed rule were verified by review of the monitoring
comment stated that processors should designed to prevent reproduction of records for the appropriate CCP. Thus,
be able to validate procedures and pathogens in the juice during storage. A as a general rule, FDA is not requiring
critical control limits based on literature few comments concerned about the end product testing as part of
reviews, in-plant experience, effectiveness of cumulative treatments verification for processes where the
recommendations from consultants, and argued that FDA should require end- juice itself has been directly treated. The
routine testing. product testing to verify HACCP for all exception to this general rule is that
The agency disagrees with the non-pasteurized juice. One comment processors of citrus juice that use
comment that argued that validation advocated continuous testing for surface treatments to achieve the 5-log
would be too expensive for small unpasteurized juice and periodic testing reduction performance standard will be
processors because it would have to take for pasteurized juice. Conversely, one required to conduct end product testing
place in a pilot plant. FDA notes that comment maintained that, in most to verify that their HACCP system,
validation studies need not occur in a cases, microbial testing is not necessary including the cumulative step 5-log
pilot plant. There are several options nor is it the best method for verifying reduction, is operating as it is designed
available to a processor in validating its HACCP. However, this comment to operate. This verification testing is
5-log reduction procedure and in suggested that microbial testing be discussed in more detail below. Of
establishing critical limits. Although it required for citrus juice using surface course, even where not required,
is preferable to establish limits for CCP’s treatments to achieve 5-log since, processors may elect to use end product
and validate individual processes in a according to the comment, there are few testing as part of the verification of the
pilot plant or in the processing facility other steps that can be used to verify HACCP plan.
where they will be carried out, FDA cumulative processes that include Conversely, except for techniques like
recognizes that this may not be feasible surface treatment. pasteurization, where industry has a
for small processors. As suggested by FDA’s response to these comments long history and experience of using
the second comment, many alternatives requires an understanding of the time-temperature parameters as an
are available. For example, small differences between two HACCP indicator of microbial destruction, a
processors that use identical procedures concepts: validation and verification. processor will likely need to conduct
for producing juice could validate these Verification includes all activities, studies using samples inoculated with
processes cooperatively. It is also except monitoring, that establish the pathogens (or surrogates) to confirm that
acceptable to use referenced procedures soundness of the HACCP plan and that their HACCP process does result in a
for achieving a particular log reduction the system is operating according to the 5-log reduction in the pertinent
provided a processor can demonstrate plan. Many verification activities, such pathogen.
that the referenced procedure is being as process verification, are an on-going In light of comments expressing
followed exactly (or more stringently), (e.g., daily or weekly) part of operating concern about the efficacy of cumulative
as outlined in the literature, and is under a HACCP plan. Validation is a steps, including surface treatment of
effective in the processor’s operation. subset of verification activities that cleaned and culled citrus fruit, FDA has
Small producers may also elect to use occurs when a HACCP plan is first set evaluated the need for additional forms
proven technologies (e.g., thermal up and whenever significant changes of process verification for some
products. As noted, verification is practices, and that surface treatment of that such a requirement would
designed to demonstrate that the intact, healthy citrus fruit should eliminate the need for a HACCP system.
HACCP plan is achieving the level of adequately reduce microbiological risks. FDA disagrees with the comment that
process control intended and thus However, the NACMCF also concluded maintained that end product testing
producing safe food on a continuing that under certain limited conditions, would eliminate the need for HACCP for
basis. Verification is broader than internalization of pathogenic bacteria is juice. As discussed in response to
ongoing process monitoring alone. The possible. Further, the NACMCF noted comment 142, microbial testing is
purpose of monitoring is to measure and that surface treatments of fruits would limited in its ability to detect process
document that those identified steps have little effect on internalized deviations in a timely manner,
that must operate within specified pathogenic microorganisms (Ref. 12). In especially for products with a short
limits on a continuing basis in order to addition, although the NACMCF shelf-life, such as fresh juice.
control a foodborne hazard (i.e., CCP’s) concluded internalization of pathogens FDA agrees with the comment that
are in fact operating within in sound citrus is unlikely under suggested that indicator organisms
specifications. Ideally, monitoring current industry practices, FDA research could be used for process verification.
involves continuous, ‘‘real-time’’ confirmed that if a temperature While microbiological testing for
measurements so that process differential exists between the fruit and specific pathogens might be a direct
deviations can be detected and wash water, washing may cause means of verifying that a surface
corrected immediately. internalization of pathogens in citrus treatment is effective and that pathogens
Conversely, verification entails both and other produce through indiscernible have not been internalized in the fruit,
the periodic review of monitoring data punctures of the skin. analyses for individual pathogens can
and the acquisition of additional data to The NACMCF observed that while be highly complex. Testing for
assess whether the HACCP plan is microbiological testing is seldom pathogens also has limitations,
functioning as intended. The additional effective as a means of monitoring a including the potential for pathogens to
data are not necessarily data relating to CCP, such testing can play a role in be present at low levels compared to
a CCP, but could be data relating to verifying HACCP programs (Ref. 17). other microorganisms and the detection
another step in a process that reflects Similarly, the International Commission limit of the test. There is also the
the effectiveness of a prior CCP(s) (e.g., question of which pathogens that may
on Microbiological Specifications for
sampling of citrus fruit surfaces for be present on the surface of the fruit
Foods (Ref. 69) has recognized
levels of acid resistant mesophilic should be the focus of any testing. For
microbiological testing of product as
aerobic microorganisms after treatment example, testing for Salmonella, E. coli
one type of HACCP verification.
of the fruit with an acidic antimicrobial O157:H7, and Cryptosporidium parvum
In relation to HACCP and citrus juice might be appropriate since all three
wash). Furthermore, since verification
manufacture, the NACMCF (Ref. 12) have been implicated in disease
data are only acquired on a periodic
recommended that periodic outbreaks related to juices. Another
basis, types of analyses that require too
microbiological testing of juice be a limitation of testing for pathogens is that
much time to be effective means for
component of the HACCP verification testing for one pathogen (e.g.
monitoring CCP’s can nevertheless be
activities undertaken by those citrus Salmonella) will not detect another
highly effective tools for verifying a
juice manufacturers who rely on surface (e.g., E. coli O157:H7), even if the
HACCP plan. Verification activities may
treatment of fruit to achieve all or part second pathogen is present. An
include review of CCP-monitoring
records; collection of either in-line or of the microbiological performance alternative would be to select a
finished product samples for standard (5-log reduction). microorganism whose presence is
microbiological, chemical, or physical Because of continuing questions about indicative of a loss of process control.
analysis; and direct observations of the possibility of pathogen Since all three of the pathogens above
monitoring activities and corrective internalization and because of the lack are fecal in origin, the ideal indicator
actions. The frequency of verification of alternative verification steps available microorganism would be one that is
activities will vary depending on factors for processors using cumulative steps, indicative of fecal contamination.
such as the type of process, volume of including surface treatments, to achieve FDA has considered several different
product, the results of prior monitoring the 5-log reduction, FDA concludes that, possible indicator microorganisms and
and verification activities, and past for citrus juices that rely solely or in has concluded that biotype I Escherichia
frequency of process deviations. part on surface treatments, periodic coli (i.e., generic E. coli) is the most
As discussed in detail previously, at microbial testing to verify the suitable indicator microorganism for
its December 1999 meeting, the effectiveness of cumulative processes is verifying the effectiveness of surface
NACMCF considered at length the integral to the process control treatments in attaining the 5-log
effectiveness of surface treatment to verification. Therefore, in § 120.25, FDA reduction standard. This microorganism
eliminate microbiological concerns is requiring microbial testing for such is generally regarded by the scientific
related to citrus fruits. There has been juice products. This testing is in community as the best indicator
a continuing question of whether the addition to verification and validation microorganism for processes intended to
integrity of the outer surface of citrus requirements set forth in § 120.11. control fecal contamination (Refs. 15
fruit is sufficiently impervious such that (Comment 143) As noted above, and 70). When present, generic E. coli
pathogenic microorganisms cannot enter several comments argued that FDA generally occurs at levels several
the fruit. If the surface were sufficiently should require microbial testing for magnitudes greater than the levels of
impervious, surface treatments might some or all juices. Some comments enteric pathogens that are associated
effectively reduce the risk from favored microbial testing of finished with fecal contamination. Consequently,
microbiological hazards. The NACMCF product but did not specify sampling testing for generic E. coli is more likely
(1999) concluded that the potential for plans or methods. A few comments to detect product where the 5-log
the uptake and growth of bacterial suggested that FDA could permit reduction standard has not been
pathogens such as Salmonella Hartford companies to test for indicator achieved. Thus, FDA concludes that any
and E. coli O157:H7 by intact citrus fruit organisms because E. coli O157:H7 is citrus juice manufacturer that relies
is unlikely, given current industry hard to detect. One comment argued solely or in part on surface treatment of
the fruit to achieve the 5-log reduction spell out the specific steps that should processors relatively quickly that their
performance standard shall, for each be taken if a processor subject to the system is not delivering the 5-log
different type of juice product requirements of § 120.25 finds one or reduction and, at the same time, would
produced, conduct analyses of the final more juice samples positive for E. coli. have a relatively small incidence of
product for biotype I Escherichia coli. Generic E. coli is relatively ubiquitous. ‘‘false alarms’’ for processors who are
The next issue is how the analysis Thus, the occasional sample that is achieving a 5-log reduction. The
should be performed. Historically, the positive for E. coli does not necessarily statistical basis for this criterion is
juice industry has used the standard indicate that microorganisms of fecal described in the paper entitled
3-tube MPN (most probable number) origin are not restricted to the surface of ‘‘Derivation of Sampling Plan to Meet
method in FDA’s Bacteriological the fruit or that surface treatments are the Testing Requirement in the Juice
Analytical Manual (BAM) for analysis of insufficient to assure product safety. HACCP Final Rule for Citrus Juices That
coliform and E. coli in juices. However, Nevertheless, an occasional positive Rely Solely Or in Part on Surface
this method has several limitations. sample should prompt a review of the Treatments to Achieve the 5-Log
First, as noted in a paper entitled monitoring records relating to the 5-log Reduction Standard’’ (Surface
‘‘Derivation of Sampling Plan to Meet reduction standard to determine Treatment Sampling Plan) (Ref. 71).
the Testing Requirement in the Juice whether pathogen reduction treatments FDA acknowledges that there were
HACCP Final Rule for Citrus Juices That and post process controls designed to certain limitations in the data it had
Rely Solely Or in Part on Surface prevent re-contamination are being available to estimate E. coli levels that
Treatments to Achieve the 5-Log properly delivered. Because generic E. would be expected in juice not treated
Reduction Standard’’ (‘‘Surface coli is an indicator of fecal to reduce pathogenic microorganisms.
Treatment Sampling Plan’’) (Ref. 71), contamination, processors finding For example, available data on E. coli
the BAM method can only analyze a generic E. coli in a single sample may levels in citrus juice were limited to
small sample size of 3.33 mL with a consider testing another sample of the orange juice. However, FDA believes
detection limit of 0.3 E. coli/mL. In same juice for specific pathogens of that the sampling plan set out in the
addition, the high acidity of some concern, such as Salmonella and E. coli Surface Treatment Sampling Plan (Ref.
juices, including most citrus juices, can O157:H7, to determine whether, in fact, 71) can appropriately be applied to all
interfere with the detection efficiency of pathogens are present in the juice. FDA types of citrus juice. Orange juice
the test. Using an analytical method that is not requiring pathogen testing for the represents a significant portion of the
can test a larger sample size (i.e., 20 mL) occasional, single positive for E. coli. citrus juice market. For those citrus
and by including an enrichment step to However, if the review of monitoring juices that have a lower occurrence of E.
reduce interference by acidity should records or the additional testing shows coli compared to orange juice, using the
improve an analysis for generic E. coli that the 5-log reduction has not been same sampling plan will provide an
and thus assist a citrus juice processor achieved, such as a sample is found to equivalent or greater level of food safety
using surface treatments to verify be positive for the presence of a assurance for consumers without
whether the process is achieving the 5- pathogen or a deviation in the process increasing any burden, such as the risk
log reduction. Consequently, FDA has or its delivery is found, the processor of false alarms, for processors.
developed the method, ‘‘Analysis for shall take corrective action as set forth Moreover, a single standard sampling
Escherichia coli in Juices—Modification in § 120.10 of this final rule. Corrective plan will simplify implementation and
of AOAC Official Method 992.30,’’ to action requirements for a single positive
evaluation of HACCP for citrus juice
detect the presence or absence of E. coli processors using surface treatments.
generic E. coli are set forth in 120.25(d).
in a 20 mL sample of juice (consisting Other aspects of the data, including its
of two 10 mL subsamples) (Ref. 72). In More than an occasional 20 mL limitations, are discussed in the Surface
the future, FDA intends to place this sample positive for generic E. coli is an Treatment Sampling Plan (Ref. 71). FDA
method in the BAM. After publication indication that the HACCP process is believes that the assumptions made,
of this final rule, the method will be not sufficient to assure product safety. based on its review of available data,
available on FDA’s Internet site at Under § 120.25, processors relying in were sufficiently sound and reasonable
www.cfsan.fda.gov. whole or in part on surface treatments to support this sampling plan.
In order to facilitate uniform and of the fruit shall have in place a Therefore, FDA is specifying in
effective application of this sampling and testing plan sufficient to § 120.25(e) that finding two samples
requirement, FDA has added to distinguish between the occasional positive for E. coli out of a series of
§ 120.25, specific requirements for positive sample and more frequent seven sequential tests indicates that the
sample collection and testing. Under positives that are indicative of a failure 5-log reduction was not achieved. As
this provision, one 20 mL sample, to deliver the 5-log reduction. One way additional data become available, the
consisting of two 10 mL subsamples, of to distinguish between a chance event agency will consider those data and
finished juice shall be analyzed for the and an event that results from other make adjustments in the HACCP
presence of generic E. coli from each factors (such as a failure to deliver the regulation or in the Juice HACCP
1,000 gallons of juice produced per day. 5-log reduction) is to examine a defined hazards and controls guide as
If less than 1,000 gallons of juice are series of tests and assess whether the appropriate.
produced per day, samples must be unusual happens too frequently to be Under § 120.25(e), if a processor finds
taken for each 1,000 gallons produced, due to chance alone. FDA has evaluated two positives out of seven tests, the
or once every 5 working days that the the available data and information, and control measures to achieve the 5-log
facility is producing that juice, based on that analysis, has determined reduction would no longer be
whichever comes first. If either 10 mL that two positives in any series of seven considered adequate. This would
subsample is positive for E. coli, then contiguous tests is an appropriate require immediate action to ensure that
the 20 mL sample is recorded as being criterion in a sampling plan designed to no product enters commerce that was
positive for generic E. coli. signal a citrus juice processor relying on produced where the 5-log reduction was
In addition to the general corrective surface treatments that its 5-log not achieved, because inadequately
action requirements in § 120.10, FDA is reduction standard has not been processed juice creates the potential for
also adding requirements in § 120.25 to achieved. This standard would alert the transmission of foodbourne
illnesses. In addition, the processors and controls guide to assist processors rule, that juice be treated to control
would need to determine the source of in ensuring their review is sufficiently pathogens (i.e., meet a 5-log reduction
the failure and to take steps to correct extensive to determine that no trends performance standard) or bear a warning
the failure. Corrective actions must towards loss of control are occurring. label statement. Since that same time,
include a review of the monitoring The agency concludes that new FDA also has been working with the
records for control measures to attain § 120.25 is a highly effective tool for juice industry, through workshops and
the 5-log reduction standard, and the verifying the 5-log reduction standard programs, on the development of
processor must correct those conditions for processors using surface treatments. techniques that meet the performance
and practices that are not met. If the In addition, FDA is modifying standard. Finally, depending on their
review of monitoring records or the § 120.11(a)(1) to include new paragraph size, processors will have 1 to 3 years
additional testing shows that the 5-log (vi) to clarify that the activities in to implement this rule because the
reduction has not been achieved, such § 120.25 are part of the processor’s agency is providing additional time for
as a deviation in the process or its verification activities. small and very small businesses to
delivery, the processor shall take 7. Other Issues implement their HACCP systems.
corrective action as set forth in § 120.10 Therefore, FDA concludes that it has
of this final rule. The processor should (Comment 144) One comment already provided the means and
also review the aspects of the HACCP requested that FDA clarify what is reasonable time for processors to
plan relating to the 5-log reduction meant by moderate abuse conditions. identify and implement available means
standard to determine whether the The comment stated that E. coli may be to meet the 5-log reduction performance
conditions and practices specified in the less tolerant under these conditions, so standard.
plan relating to the 5-log reduction moderate abuse could be a kill step for
E. coli. M. HACCP Enforcement Issues
standard are being met. If those
conditions and practices are being met, FDA discussed what it considered to (Comment 147) One comment
and no other source of the problem can be moderate abuse in the proposal (63 requested that FDA establish a
be found (e.g., post process FR 20450 at 20478) (Ref. 2). FDA preapproval system for HACCP
contamination), the processor should acknowledges that in some including plant registration, filing of
conclude that the treatment, although circumstances moderate abuse such as HACCP plans, regular inspections,
delivered as intended, was not able to slightly elevated temperature in an validation and verification of HACCP
achieve the intended 5-log pathogen acidic juice may actually decrease the plans with microbial testing and
reduction. In such case, the processor numbers of certain microorganisms. If a tracebacks.
shall revalidate its HACCP plan in processor intends to use a specific FDA believes that a preapproval
relation to the 5-log reduction standard. period of elevated holding temperature system for HACCP plans would unduly
While the control measures relating to as a treatment, then the processor must burden the agency’s resources without
the 5-log reduction standard are being validate the treatment as required for substantially increasing public health
evaluated, and until all corrective any CCP. benefits. The effectiveness of a HACCP
actions have been completed, including, (Comment 145) A few comments plan, including monitoring,
if necessary, revalidation of those asked that FDA eliminate the recordkeeping, and verification, can best
aspects of the HACCP plan relating to requirement that the 5-log reduction be be evaluated under actual operating
the 5-log reduction standard, the maintained throughout shelf-life of the conditions. Therefore, as part of its
processor must use an alternative product. The comments maintained that enforcement plan for juice HACCP, FDA
process or processes to achieve the 5-log there is no risk of recontamination once plans to do inspections of juice
reduction after the juice has been the juice is bottled. processing facilities to ensure
expressed. Processors should consider FDA agrees that there is little risk of compliance with the HACCP regulations
why the monitoring and verification recontamination after a juice is bottled after they become effective. These
results are not in accord, such as if the container is not damaged and the inspections will include collection and
through an inadequate process or a juice is handled under CGMP’s. analysis of product samples for
failure in process delivery, and whether However, because of the importance of pathogens and other contaminants.
an alternate approach to achieving the attaining the 5-log reduction for juice to The agency is putting juice processors
5-log reduction is needed. Once these be safe, it is reasonable that juice retain on notice that FDA is committed to
steps have been taken, processors may this characteristic throughout the period inspecting all high risk firms annually,
again use the validated approach that that it is available for consumption by even before the effective date of this
relies solely or in part on surface consumers. Therefore, FDA is not final rule, and intends to include
treatments rather than the alternative amending § 120.24. sample collection and analysis as an
process. (Comment 146) One comment integral part of that process. In the
FDA has concluded that two positive suggested that the performance standard agency’s view, processors of untreated
E. coli samples in a series of seven tests should be phased in as data on meeting juices, including firms producing citrus
indicate that the control measures to the performance standard becomes juices using surface treatments, fall into
attain the 5-log reduction standard are available. Another comment suggested the category of high risk firms.
inadequate and immediate corrective that initially, a 3-log reduction could be (Comment 148) One comment stated
actions are necessary. Two positives in required, then the following year a 4-log that tracebacks are very important and
a window larger than seven tests may be reduction would be required and finally the need for information relating to
due to chance rather than a failure to a 5-log reduction. origin of the product was not covered in
deliver the 5-log reduction. However, The agency does not agree. FDA is the proposed rule.
processors may wish to review test providing ample opportunity to FDA agrees that tracebacks are
results over a larger window as a accommodate processors that may have important and believes that the ability
possible early warning that the process difficulty implementing the 5-log to traceback from a foodborne illness
may be approaching failure. FDA reduction performance standard. First, outbreak to the source is critical to
intends to provide additional the agency has required, since the controlling the size and duration of the
information in its Juice HACCP hazards effective date of the juice labeling final outbreak. The source of an outbreak may
be contaminated raw produce or regulations, and the agency hopes to It is not the aim of this rulemaking to
contamination of product during continue these cooperative relationships scare consumers into buying only
production and distribution. Processors with States in the context of juice certain foods, such as pasteurized
must implement CGMP’s to address raw HACCP. FDA notes that some States juices. However, juices have been the
produce suitability for processing and, if adopt FDA requirements as their own source of a number of outbreaks of
there are hazards that are reasonably laws and regulations; with those States, illness and the death of one child, as
likely to occur in raw produce, the final rule will effectively be well as have contributed to the death of
implement HACCP controls for such enforced by the States. an elderly man. Juices have also been
hazards. The recordkeeping (Comment 152) One comment the source of chemical and physical
requirements of this rule mandate that requested that first inspections of contaminants that have adverse public
all records include the identity of the HACCP systems be nonregulatory. health effects, such as high lead levels,
product and the production code where The agency recognizes the benefits of the presence of patulin, and the
appropriate. The purpose of these a nonregulatory (i.e., educational) first presence of glass pieces. For these
requirements is to ensure that records inspection of implementation of a new reasons, the agency has determined that
maintained under part 120 can be HACCP system. For the seafood HACCP measures are necessary to ensure that
readily linked to a product and to the program, FDA elected to make the first juice is safe and to prevent additional
timeframe in which the product was inspection educational, rather than illnesses and deaths, particularly among
manufactured. Linking a record to a regulatory, as long as there were no at risk groups. The primary purpose of
specific product will be especially urgent public health problems. FDA this rulemaking is to protect the public,
important when a product must be chose that approach because, for most not scare them. FDA believes that these
isolated or recalled. The information processors, the first inspection provided measures will promote public
required in § 120.12 will help ensure the first direct feedback from the agency confidence in the safety of juice
that, when tracebacks are necessary, on the status of the firm’s HACCP products.
they can be carried out efficiently. system. FDA will consider whether the
(Comment 149) One comment IV. Effective Date
same approach is warranted for some or
suggested that third party inspections all juice processors. FDA proposed that any final rule
should be done to validate HACCP and (Comment 153) One comment based on the proposal become effective
the results should be publicized. questioned the type of training that FDA 1 year after its date of publication in the
FDA encourages such self-regulated would be providing its investigators to Federal Register. Further, FDA
programs within industry as third party ensure that they understand the proposed that any final rule based on
inspections. Validation of the HACCP relevance of microbial data and that the proposal would not be binding on
plan may be done by any individual, they will not go on ‘‘witch hunts’’ to small businesses as defined in
including a third party, that has been find something wrong with the facility. § 120.1(b)(1) until 2 years after
trained in accordance with § 120.13. FDA’s food processor investigators publication in the Federal Register; and
The validity of the HACCP plan will have considerable experience with for very small businesses as defined in
ultimately affect the overall compliance HACCP in that most are currently § 120.1(b)(2), the final rule would not be
status of firms, as determined through conducting seafood HACCP inspections. binding until 3 years after publication in
the inspection process. This status is Investigators are trained to look for the Federal Register.
public information. violations of FDA regulations and to (Comment 156) Many comments
(Comment 150) One comment employ discretion and good judgment expressed concern that small businesses
suggested that FDA should model its (e.g., consider the significance of the have the longest time to comply with
HACCP regulation after that of FSIS violation) in determining how the rules, even though outbreak data
with more frequent and less lenient inspectional findings are handled. indicate that these producers are most
inspections and validation testing. Further, an investigator’s significant likely responsible for producing
Differences in the way FDA and FSIS inspectional findings are reviewed by contaminated juice.
implement their HACCP programs are multiple higher level FDA employees to The agency considered, in the HACCP
due to differences in the products being confirm the violation prior to the proposal, the various issues surrounding
regulated. Also, FSIS’s authority and initiation of any regulatory action by the the need for processors to immediately
funding provides for the presence of agency. implement HACCP programs and the
inspectors in meat and poultry plants on need to consider options to minimize
a daily basis, whereas FDA’s authority N. Miscellaneous Issues the burden of the cost of
and resources do not require or allow (Comment 154) One comment implementation to small businesses (63
for such frequent inspections. FDA, to suggested that FDA develop a juice FR 20450 at 20463) (Ref. 2). To address
the extent it is able, will work with juice HACCP pilot program. the most immediate concerns (i.e.,
processors during inspections to FDA currently has a HACCP pilot pathogens) with juice, FDA has since
properly implement part 120. program that includes juice processors. finalized the warning label statement
(Comment 151) A few comments To date, two pasteurized juice regulation in § 101.17(g) and has
questioned whether FDA was planning processors and one fresh juice processor engaged in extensive education to alert
to ask states to enforce the HACCP have completed the HACCP pilot consumers to the problems of
regulations in light of the agency’s program. FDA has used experience consuming untreated juice. All juice
limited resources. Another comment gained from the participation of these shipped in interstate commerce or made
stated that the States should verify juice processors in the HACCP pilot from ingredients shipped in interstate
compliance with any applicable safety program in proposing and finalizing this commerce, including that produced by
regulations. rule (Ref. 73). small businesses, that has not been
FDA cannot mandate that a State (Comment 155) Several comments processed to achieve a 5-log reduction
ensure that a firm is complying with stated that FDA should not impose in pathogens must be labeled with a
FDA regulations. However, FDA has a regulations on industry that will scare warning for consumers (§ 101.17(g)).
long history of working cooperatively consumers into buying only certain Thus, even if not produced under a
with the States to enforce food safety foods (i.e., pasteurized juices). HACCP system, the products of these
small businesses will have some to cause one or more of the following: final rule reflect this change in the
safeguards to protect public health. In an annual effect on the economy of $100 coverage of the rule.
addition to the label warning million; a major increase in costs or Table 1 gives the time to the effective
requirement, FDA encourages prices; significant effects on dates by size of firm in terms of time
processors to implement a HACCP competition, employment, productivity, from the date of publication of this final
system as soon as possible to reduce or innovation; or significant effects on rule.
hazards in juice rather than use the the ability of United States-based
warning label statement. Consequently, enterprises to compete with foreign- TABLE 1.—TIME TO EFFECTIVE DATE
the agency has decided to focus initial based enterprises in domestic or export BY SIZE OF FIRM
implementation of HACCP on markets. In accordance with the Small
processors that produce the largest Business Regulatory Enforcement Time to
quantity of juice and thus have the Fairness Act, OMB has determined that Firm size effective
potential of affecting the largest number this final rule is a major rule for the date
of consumers should contaminated purpose of congressional review.
Large firms ............................ 12 months.
product reach the marketplace. In addition, FDA has determined that
Small firms ............................ 24 months.
(Comment 157) Several comments this rule is not a significant rule under Very small firms .................... 36 months.
requested that the regulations become the Unfunded Mandates Reform Act of
effective for all processors 1 year after 1995 (UMRA) requiring benefit-cost and For purposes of this rule, the agency
the rule is finalized and several other analyses. Under UMRA a is defining large processors as those
comments requested that the regulations significant rule is defined as ‘‘a Federal who have more than 500 employees,
become effective for all processors 2 mandate that may result in the small processors as those who have less
years after the rule is finalized. expenditure by State, local and tribal than 500 employees and very small
The agency disagrees with the governments in the aggregate, or by the processors as those who have: (1) Total
comments. As noted, FDA considered private sector, of $100,000,000 (adjusted annual sales of less than $500,000, or (2)
various options for the implementation annually for inflation) in any 1 year’’. that have total annual sales of greater
of the effective date in the proposed This Final Regulatory Impact Analysis
than $500,000 but total annual food
rule. The final rule requires that the reflects changes made in the regulation
sales of less than $50,000, or (3) that
bulk of juice produced in the United from the proposed rule to the final rule
employ fewer than 100 full-time
States will be processed under a HACCP and changes in estimates as a response
to comments. It also includes responses equivalent employees and annually sell
system within 1 year. The agency less than 100,000 units of the juice in
realizes that it may take longer for small to comments on the PRIA. Where there
were no changes in the estimates the United States.
and very small businesses to fully This rule follows the implementation
implement HACCP systems and has provided in the PRIA, the estimates are
summarized here. Interested persons are of the juice labeling rule, which covers
extended the effective date for one or 2 juice that is packaged and has not been
years, respectively, to give them directed to the text of the PRIA (Ref. 6)
for a fuller explanation of the estimates subjected to a 5-log reduction treatment.
adequate time to comply. Because the coverage of the juice
over which there was no controversy or
V. Final Regulatory Impact Analysis changes. The PRIA discussed a number labeling rule and this juice HACCP rule
of regulatory alternatives. FDA received overlap, and because to some extent
A. Introduction both rules address microbial hazards
some comments on these alternatives,
FDA has examined the impact of this however, none were specifically associated with juice, it is necessary to
final rule under Executive Order 12866. economic in nature. Thus, FDA’s take into account the benefits and costs
Executive Order 12866 directs Federal responses to comments on these estimated for juice labeling to avoid
agencies to assess the benefits and costs alternatives are given in section III.1. double-counting benefits and costs for
of available regulatory alternatives and, There were no specific economic juice HACCP.
when regulation is necessary, to select comments on the regulatory alternatives C. Benefits
regulatory approaches that maximize outlined in the PRIA.
net benefits (including potential This analysis provides estimated
economic, environmental, public health B. Factors Considered in Developing benefits due to reduced adverse health
and safety effects; distributive impacts; This Analysis effects. Presented here is a summary of
and equity). Under the Executive Order, This final rule requires all juice the analysis provided for the proposed
a regulatory action is ‘‘significant’’ if it processors (as defined in the rule), rule. Comments are addressed, and any
meets any one of a number of specified regardless of size, to implement a changes from the analysis for the
conditions, including having an annual HACCP program with a 5-log reduction proposed rule are detailed in each
effect on the economy of $100 million; (that is, a 100,000-fold reduction in section as appropriate.
adversely affecting some sector of the pathogens) performance criterion. In the FDA uses the following steps to
economy in a material way; or adversely proposed rule, FDA tentatively estimate health benefits:
affecting competition or jobs. A exempted retailers. In addition, FDA 1. The most significant hazards in
regulation is also considered a tentatively decided to exempt as juice are described in terms of severity
significant regulatory action if it raises retailers very small businesses that and duration;
novel legal or policy issues. FDA finds make juice on their premises and whose 2. The hazards are described in terms
that this final rule is a significant total sales of juice and juice products do of resulting health effects and symptoms
regulatory action as defined by not exceed 40,000 gallons per year and when they cause illness;
Executive Order 12866. who sell directly to consumers and 3. The health effects and symptoms
The Small Business Regulatory other retailers. Based on the comments are translated into consumer utility
Enforcement Fairness Act of 1996 and other information, FDA has losses;
(Public Law 104–121) defines a major determined that it is necessary to cover 4. The utility losses are translated into
rule for the purpose of congressional such very small businesses. The values in terms of lost dollars (this gives
review as having caused or being likely estimated benefits and costs for this the cost per case for every combination
of level of severity and for the specified 1. Description of Microbial Hazards in experience additional losses from the
duration for each hazard); Juice symptoms of the illness.
5. The average annual number of One comment stated that symptoms
The most significant health risks
reported cases associated with juice and functional effects associated with
associated with juice products are those
covered by this final rule are listed; some cases are more severe than those
that result from microbial
6. The factors used to account for described by FDA. FDA agrees with this
contamination. There are other non-
under reporting of foodborne illness are comment. However, it is equally true
microbial potential hazards related to
explained; that symptoms and functional effects
juice that this rule is designed to
associated with some cases are less
7. The estimates of the average annual control. FDA does not have enough data
severe than those described by FDA.
number of cases are given; to quantify benefits for these non-
The symptoms and functional effects
8. The estimated number of cases is microbial hazards. From 1992 to 1998
described by FDA were developed with
divided according to level of severity; the hazards associated with
the assistance of medical doctors at FDA
9. The percentages of each type of commercially processed, packaged juice
and are those of a typical case for each
hazard expected to be prevented by the produced by nonretail establishments
level of severity for each hazard. Effects
proposal are listed; and included Bacillus cereus,
vary to a considerable degree across
10. The total health benefits of the Cryptosporidium parvum, E. coli
cases of any illness or disease. Such
proposal are derived by multiplying O157:H7, and Salmonella non typhi.
variance is not captured by this
steps 4, 7, and 8. Most of the information in section C of
analysis. However, FDA believes that
this document (Benefits) is taken from
That is, TB = RC x CF x CR x V, where the use of typical cases is appropriate
‘‘Appendix: Preliminary Investigation
TB = total health benefits in dollars, for this analysis.
into the Morbidity and Mortality
RC = number of reported cases, Associated with the Consumption of 3. Utility Losses From Microbial
CF = under reporting correction factor, Fruit and Vegetable Juices’’ (Ref. 6, the Hazards in Juice
CR = percent of cases reduced, Appendix). The Appendix includes Decreases in functional status and
V = dollar value per case averted hazards other than those for which symptoms and problems associated with
(medical costs + value of pain and benefits have been estimated in this illness translate into values of disutility.
lost function). analysis. The hazards considered in Utility losses for survivors are derived
section C of this document are those for by multiplying the total disutility per
One comment stated that FDA had which the risk is highest, meaning that
underestimated the amount of untreated day by the number of days that
they are the most significant in terms of symptoms of the illness persists. This
juice consumed and, therefore, had probability of occurrence and/or
underestimated the number of cases of gives the utility loss for survivors in
severity of outcome. terms of the number of quality adjusted
illness associated with juice. FDA Some comments stated that C. parvum
disagrees that the cases of illness life days (QALD’s) for each case of the
should have been included in the categories of severity for each hazard. A
addressed by the rule have been estimate of benefits for the HACCP
underestimated due to incorrect QALD is a day of perfect health.
proposal. The comments cite FDA’s
consumption estimates. FDA did not inclusion of C. parvum in the list of 4. Value of Losses From Microbial
estimate the number of illnesses based hazards in the Appendix. FDA included Hazards in Juice
on consumption. Instead, the agency C. parvum as a hazard addressed by the FDA values a QALD at $630. The
estimated the number of illnesses by labeling rule but not as a hazard value of utility losses for survivors
multiplying confirmed illnesses addressed by the proposed HACCP rule. comes from multiplying the number of
associated with juice by factors The only documented cases of juice- QALD’s lost due to the illness by the
accounting for under-reporting of related C. parvum illnesses from value of a QALD. This represents the
foodborne illness. Thus, FDA does not commercially produced products from value of pain and function losses that
agree with this comment. 1992 to 1996 were from juice produced individuals experience. Additionally,
One comment questioned the model by processors making less than 40,000 there are the societal costs of medical
used to calculate benefits and asked if gallons per year. Because these treatment. These costs are shared
it has been ‘‘calibrated.’’ The comment processors were included under the generally between insurance companies
did not explain how the word calibrated retail exemption from the proposed and individuals. They include all
is used in this case. FDA assumed that HACCP rule, the proposed HACCP rule aspects of medical expenses (e.g.,
it meant to compare the estimates would not have addressed the C. physician visits, laboratory tests,
obtained using this model with the parvum hazard. Because this final prescriptions and therapies, hospital
actual number of illnesses related to HACCP rule covers all processors stays). The value of losses per case is the
juice. FDA has used this model to regardless of the volume of juice they sum of the value of utility losses for
calculate benefits for rules involving produce, C. parvum is a hazard survivors and the medical costs for the
microbial hazards since 1994. The addressed by this final rule. categories of severity for each hazard.
model is an adaptation of peer-reviewed
research on estimating the costs of 2. Description of Health Effects and 5. Distribution of the Reported Cases per
illness and injury (Ref. 74). The model Symptoms of Microbial Hazards in Juice Year for Microbial Hazards in Juice
is the best method known to FDA for In order to quantify the loss The analysis for the proposed rule
estimating the benefits of rules (disutility) that individuals experience used the average number of reported
involving microbial hazards, and is from becoming ill, the pain, suffering, cases from 1992 through 1996 for each
similar to that used by FSIS for similar and mobility loss must be scaled. hazard for the types of products covered
rules. Because the actual number of Individuals who become ill suffer losses by the rule.
cases of illness is not observable, it is of functional status in terms of mobility, Some comments claimed that FDA
not possible to compare the model’s ability to do other physical activity, and had miscalculated the benefits of the
estimates to the actual number of ability to engage in social activities. HACCP proposal by including outbreaks
illnesses. Individuals who become ill also associated with non-commercially
produced juice. Although other parts of cases per year. These comments used associated with non-commercially
the proposed rule and the Appendix data presented in the Appendix to produced juice were not included in the
refer to outbreaks associated with non- recalculate the average number of cases calculation of the average annual
commercially produced juice, the per year. The comments were confused number of cases. Thus, the average
estimate of the benefits of the HACCP because the Appendix lists several annual number of cases was properly
rule was based only on outbreaks outbreaks that were associated with calculated.
associated with commercially produced non-commercially produced juice. Tables 2 and 3 should clarify which
juice. Because this regulation covers only
Some comments stated that FDA had outbreaks FDA has used in this analysis,
commercially produced juice, outbreaks and why some outbreaks were not used.
miscalculated the average number of
TABLE 2.—JUICE OUTBREAKS (1992 TO 2000) USED TO CALCULATE BENEFITS

Number
Product and year of event Hazard Source of data on event
of cases
Orange juice, 1994 ........................................................................ B. cereus .................................. 85 FDA recall data.

Orange juice, 1995 ........................................................................ Salmonella spp. ........................ 62 Outbreak data.
Apple juice, 1996 .......................................................................... E. coli O157:H7 ........................ 70 Outbreak data.
Apple juice, 1996 .......................................................................... E. coli O157:H7 ........................ 14 Outbreak data.
Apple juice, 1996 .......................................................................... C. parvum ................................. 31 Outbreak data.
Apple juice, 1996 .......................................................................... E. coli O157:H7 ........................ 1 Pennsylvania State Health
Dept.
Orange juice, 1999 ........................................................................ Salmonella muenchen .............. 423 Outbreak data.
Apple juice, 1999 .......................................................................... E. coli O157:H7 ........................ 9 Oklahoma State Health Dept.
Orange juice, 2000 ........................................................................ Salmonella enteritidis ............... 88 Outbreak data.
TABLE 3.—JUICE OUTBREAKS (1992 TO 2000) NOT USED TO CALCULATE BENEFITS

Product and year of Source of data on
Hazard Number of cases Reason not included
event event
Orange juice Mixing Salmonella agona ...... 25 ............................... FDA recall Data ......... Orange Julius compound is mixed with juice
Compound, 1992. at the retail location but does not contain
juice.
Apple juice, 1993 ....... C. parvum .................. 160 ............................. Outbreak Data ........... Juice not made by commercial establish-
ment.
Juice flavored Drinks, C. parvum .................. Unknown .................... FDA recall Data ......... Approved municipal water supply was con-
1993. taminated, rule not expected to prevent
such occurrences.
Carrot juice, 1993 ...... Clostridium botulinum 1 ................................. Washington State Home-made product.
Health Dept.
Orange juice, 1993 .... Unknown .................... 23 ............................... Ohio State Health Contamination likely caused by consumer.
Dept.
Watermelon Juice, S. spp. ........................ 18 ............................... Florida State Health Home-made product.
1993. Dept.
Apple juice, 1996 ....... E. coli 157:H7 ............ 6 ................................. Outbreak data ............ Juice not made by Commercial establish-
ment.
Some comments claimed that FDA’s TABLE 4.—AVERAGE REPORTED (i.e., reported to CDC) is multiplied by
analysis had not taken into account the CASES PER YEAR FOR MICROBIAL factors that are estimated to account for
efforts to control hazards made by the HAZARDS IN JUICE (1992 TO 2000) underreporting.
industry after the October 1996 One comment took issue with the
outbreak. To estimate the number of Average No. of underreporting correction factors used
illnesses that the proposed rule would Hazard cases reported by FDA. The comment stated that no
prevent, FDA used the most recent 5- per year underreporting correction factor should
year period for which final CDC ever exceed 100. In the analysis
B. cereus ........................ 2
numbers were available. In the analysis C. parvum ....................... 3
accompanying the proposed rule, FDA
of the proposed rule, FDA did not E. coli O157:H7 .............. 10 used two estimates of underreporting
include 1997 in the estimate of illnesses Salmonella (non-typhi) .... 64 correction factors that have been widely
that the rule would prevent because cited on this issue. FDA does not agree
there was too great of a possibility that 6. Estimates of Factors Needed To Offset that underreporting correction factors
illnesses that had actually occurred had Underreporting of Foodborne Illness should never exceed 100. The
not yet been reported. FDA can now add appropriate correction factors are those
the 1997 to 2000 experience to the 1992 It is widely recognized that the total based on the best information available,
to 1996 experience. By doing so FDA number of foodborne illnesses is much without any limit created by a
addresses this comments concern. The greater than those numbers reported to predetermined number.
average number of cases reported per the CDC. In order to compensate for the Since the PRIA, CDC has published
year for each hazard is described in rate of underreporting, the number of estimates of foodborne illness; in this
table 4. known cases associated with a hazard final estimate of costs and benefits, FDA
is relying on these recent CDC estimates. discovered through the active TABLE 6.—ESTIMATE OF JUICE-ASSO-
The estimates of underreporting surveillance of the FoodNet system. The CIATED CASES COVERED PER YEAR
correction factors used in the PRIA FoodNet system is designed to identify
relied heavily on research that was over interstate outbreaks and to more Hazard Case
20 years old. In some cases, the research thoroughly discover cases associated
preceded the recognition that E. coli with an outbreak. B. cereus ........................ 3,420
O157:H7 was a pathogen. The correction For B. cereus FDA has used a C. parvum ....................... 3,210
factors based on this research required correction factor based on the ratio of E. coli O157:H7 .............. 200
a significant amount of adaptation, total estimated cases to reported Salmonella (non-typhi) .... 2,430
extrapolation and interpolation by FDA. outbreak cases. FDA has used this factor
By relying on the recent CDC estimates for this hazard because the juice 8. Estimate of Juice-Associated Cases
of foodborne illness to determine outbreaks for this hazard associated per Year Not Prevented by Labeling
correction factors, FDA is reducing its with this rule were discovered through Rule
reliance on dated research and its own the standard outbreak reporting process.
extrapolations. FDA believes that the B. cereus is not a hazard tested for in the FDA estimated that the juice labeling
estimates of benefits based on CDC FoodNet system, and because of its mild rule would prevent up to 140 juice-
estimates of foodborne illness should be symptoms is very likely to be associated illnesses (10 C. parvum, 40 E.
more objective. underreported. coli, 90 Salmonella) as consumers avoid
The underreporting correctiion factors For C. parvum FDA has used a consumption of untreated juice. This
correction factor based on the ratio of HACCP rule will effectively supersede
calculated from the CDC reported by
total estimated cases to 10 percent of the the labeling rule for all those processing
Mead et al, show the relationship
estimated passive surveillance cases. establishments covered by the labeling
between estimated total cases and
According to CDC, reported outbreak rule. Therefore, once it goes into effect,
culture-confirmed total cases. The
cases account for only 10 percent of the the HACCP rule will be responsible for
factors are based on surveys estimating
cases accounted for through passive prevented juice-related illnesses and not
the probability that: (1) A person who
surveillance. FDA has used this factor the labeling rule. However, this analysis
becomes ill seeks medical care, and (2)
for C. parvum because the juice should attribute to the juice HACCP rule
the probability that the physician will
outbreaks for this hazard associated prevention of only those illnesses that
obtain a stool culture from the person,
with this rule were discovered through would not have been prevented by the
and (3) the probability that the the standard passive surveillance
laboratory will test for the pathogen. juice labeling rule had this rule not
process. C. parvum is not a hazard superseded it. To estimate the potential
The factor for a particular pathogen is tested for in the FoodNet system, nor is
the inverse of the multiplicative product benefits of this HACCP final rule, FDA
it on the list of hazards reportable to
of those three probabilities. FDA is subtracted 140 cases that were estimated
CDC. Because of its mild symptoms it is
relying on the CDC point estimates of to be prevented by the labeling rule
very likely to be underreported.
the average number of cases per year The correction factors used in this (assuming that 16 percent of consumers
and the CDC underreporting factor. analysis are given in table 5. read the label and do not consume
Because CDC did not provide ranges for untreated juice) from the estimates
these estimates, FDA has insufficient TABLE 5.—ESTIMATES OF FACTORS provided in table 6. The 16 percent
information to probide a range of NEEDED TO OFFSET UNDER- consumer response estimates are the
estimates for the benefits of this rule. largest estimates of consumer response
REPORTING OF FOODBORNE ILLNESS
FDA’s use of a point estimate for the that FDA has made for the juice labeling
number of illnesses should not, Hazard Correction factor
rule. Therefore, subtracting the 16
however, be interpreted as implying the percent consumer response estimates
absence of uncertainty about these B. cereus ........................ 380 from the estimates of the total number
estimates. C. parvum ....................... 1,071 of juice-related illnesses yields the
For two of the hazards in this E. coli O157:H7 .............. 20 lowest number of illnesses that may be
analysis, E. coli O157:H7 and Salmonella (non-typhi) .... 38 prevented by this juice HACCP final
Salmonella, FDA has used correction rule. Table 7 gives estimates of the
factors based on the ratio of total 7. Estimates of Juice-Associated Cases number of juice-related illnesses per
estimated cases to active surveillance Per Year year not prevented by the juice labeling
cases estimated. FDA has used these In table 6, FDA has estimated ranges rule. The estimates in table 7 come from
factors for these hazards because the of the likely annual number of cases that subtracting the estimated 140 cases
juice outbreaks for these hazards occur for each of the four pathogens prevented by the labeling rule from the
associated with this rule were studied. estimated cases in table 6.
TABLE 7.—THE ESTIMATED NUMBER OF JUICE-ASSOCIATED CASES NOT PREVENTED BY THE LABELING RULE DIVIDED
ACCORDING TO LEVEL OF SEVERITY
Hazard Severity Percent Cases
Mild .................................................................................. 99 3,390

Moderate ......................................................................... 1 30
Severe ............................................................................. .03 1
B. cereus .......................................................................... Total cases ...................................................................... 100 3,421
Mild .................................................................................. 90 2,890
Moderate ......................................................................... 9 290
Severe ............................................................................. .7 20
Death ............................................................................... .02 1
C. parvum ........................................................................ Total cases ...................................................................... 100 3,200
TABLE 7.—THE ESTIMATED NUMBER OF JUICE-ASSOCIATED CASES NOT PREVENTED BY THE LABELING RULE DIVIDED
ACCORDING TO LEVEL OF SEVERITY—Continued
Hazard Severity Percent Cases
Mild .................................................................................. 59 95
Moderate ......................................................................... 38 60
Severe-acute ................................................................... 3 5
Severe-chronic ................................................................ 4 10
Death ............................................................................... .0 0
E. coli O157:H7 ............................................................... Total cases ...................................................................... 100 160
Mild .................................................................................. 68 1,590
Moderate ......................................................................... 31 730
Severe ............................................................................. 1 20
ReA-short term ................................................................ 2 50
ReA-long term ................................................................. 5 120
Death ............................................................................... 5 120
Salmonella (non typhi) ..................................................... Total cases ...................................................................... 100 2,340
9. Percent of Cases Preventable by processors. FDA estimated that the TABLE 8.—PERCENT OF CASES
HACCP Proposal exemption for small retail processors PREVENTABLE BY HACCP PROPOSAL
Table 8 indicates the percent of cases would affect 14 percent of the volume
for each hazard expected to be of unpasteurized juice. Therefore, the Percent of cases
prevented by the rule. In general, most agency estimated that though pathogen Hazard preventable by
HAACP proposal
pathogens will be eliminated when a 5- controls may be 100 percent effective in
log treatment is applied. For example, E. controlling some hazards, such controls B. cereus ........................ 10
coli O157:H7, C. parvum and would only prevent 86 percent of the C. parvum ....................... 100
Salmonella should all be completely cases of illness from these hazards, E. coli O157:H7 .............. 100
eliminated from juice by standard because of the 14 percent of juice not Salmonella (non typhi) .... 100
methods of flash pasteurization (in the covered. The final rule covers all
absence of extraordinarily high counts, processors of juice as defined in the Table 9 indicates the number of cases
detrimental human intervention, or final rule; therefore, controls will affect
equipment failure). However, hazards for each hazard expected to be
the full volume of juice made by prevented by the rule.
associated with B. cereus will not processors. (Retailers are not covered by
necessarily be eliminated by heat this rule. Retailers are those businesses
treatment. This bacterium forms spores that sell only direct to consumers and
that are more difficult to kill by the include grocery stores, supermarkets,
usual heat process applied to juice. farms, roadside stands, restaurants, and
In the proposed rule, FDA tentatively
exempted certain small retail eating places.)
TABLE 9.—ESTIMATES OF JUICE-ASSOCIATED CASES PER YEAR PREVENTED BY HACCP RULE

Percent of
Hazard Severity Cases
cases
Mild .................................................................................. 99 340

Moderate ......................................................................... 1 0
Severe ............................................................................. .3 0
B. cereus .......................................................................... Total case ........................................................................ 100 340
Mild .................................................................................. 90 2,890
Moderate ......................................................................... 9 290
Severe ............................................................................. 7 20
Death ............................................................................... .02 1
C. parvum ........................................................................ Total cases ...................................................................... 100 3,200
Mild .................................................................................. 59 95
Moderate ......................................................................... 38 60
Severe-acute ................................................................... 3 5
Severe-chronic ................................................................ 4 10
Death ............................................................................... .08 0
E. coli O157:H7 ............................................................... Total cases ...................................................................... 100 160
Mild .................................................................................. 68 1,590
Moderate ......................................................................... 31 730
Severe ............................................................................. 1 20
ReA–short term ............................................................... 2 50
ReA–long term ................................................................ 5 120
Death ............................................................................... .04 1
Salmonella (non typhi) ..................................................... Total cases ...................................................................... 100 2,340
10. Estimates of Annual Benefits for 11. Pesticide Residues farms, roadside stands, restaurants, and
HACCP Proposal There are two potential benefits other eating places.
The total benefits for the categories of associated with the regulation of Since FDA published the proposed
severity for each hazard are derived by pesticides: (1) Decreases in cancer and rule, it collected data showing that 24
multiplying the number of cases other illness caused by chronic percent of very small apple juice
prevented by this rule by the estimates consumption of pesticide residues and, processors only sell juice direct to
of the value of utility losses and medical (2) social benefits associated with consumers. FDA assumes that the same
costs per case. The sum of those benefits reductions in the costs of recapturing percentage of very small orange juice
for each hazard is the total benefits of firm goodwill. FDA cannot quantify the processors only sell juice direct to
this rule for pathogen control. Table 10 cost savings that will occur because of consumers. Therefore, about 380 very
gives the estimate of benefits for each more vigilant monitoring of pesticide small apple and 70 very small orange
hazard. residues by firms under a HACCP rule.
juice processors are exempted from the
12. Summary of Benefits rule as retailers.
TABLE 10.—ESTIMATES OF JUICE-
ASSOCIATED CASES PER YEAR PRE- Table 12 summarizes the benefits of FDA estimated that 5 percent (about
VENTABLE BY HACCP RULE
this rule. 50 plants) of the 900 plants in the FDA
Official Establishment Inventory (OEI)
Hazard Severity Dollars TABLE 12.—BENEFITS OF JUICE would have implemented HACCP as
HACCP RULE required by this rule by the effective
Mild .............. $102,000 date of the rule even if FDA had not
B. cereus ...... Total ............. 102,000 Type of benefit Annual value done this rulemaking. No HACCP costs
Mild .............. 5,780,000
Moderate ...... 1,450,000 Reduced illness and $151 million. are attributable to this rule for these
Severe ......... 360,000 death from Control- plants.
Death ........... 5,000,000 ling pathogens. Table 13 shows the estimated number
C. parvum .... Total ............. 12,590,000 Reduced harm from Not quantified, effects
Mild .............. 190,000
of establishments affected by the rule.
physical and chem- often long-term and
Moderate ...... 240,000 ical hazards. probably small. These numbers exclude the retailers and
Severe-acute 165,000 Total Quantified Ben- $151 million the 5 percent of plants already doing
Severe- 12,210,000 efits. HACCP.
chronic.
E. coli Total ............. 12,805,000 D. Costs TABLE 13.—NUMBER OF PLANTS
O157:H7.
Mild .............. 1,590,000 The costs of these rules have been AFFECTED BY THE RULE
Moderate ...... 1,460,000 estimated by multiplying the costs for
Severe ......... 320,000 each proposed requirement on a per- Number of
ReA-short 350,000 Plant type establishments
plant basis by the number of plants affected
term. affected by each requirement. Cost per
ReA-long 117,120,000
term.
plant will vary by current practice, Juice manufacturers in
Death ........... 5,000,000 product, and size. the OEI ........................ 850
Salmonella Total ............. $125,840,000 1. Coverage Very small apple juice
(non typhi). makers ........................ 1,220
In the proposal, FDA tentatively Very small orange juice
Table 11 presents the estimate of decided that retailers would include makers ........................ 230
annual benefits based on table 10. processors that are very small Total ............................ 2,300
businesses, that make juice on their
TABLE 11.—ESTIMATES OF ANNUAL premises, and that directly sell juice or 2. Length of Production Period
MICROBIALLY RELATED BENEFITS juice products to consumers and other
retailers—provided that retail sales of The agency has assumed that 50
FOR HACCP PROPOSAL
juice and juice products do not exceed percent of the 850 plants in the OEI plus
Hazard Dollars 40,000 gallons per year. As noted, FDA all of the 1,450 very small juice makers
has decided in the final rule not to affected by the HACCP rule produce
B. cereus ........................ $102,000 exclude such processors from the rule’s seasonally. Table 14 shows the length of
C. parvum ....................... 12,590,000 requirements. The final rule covers all the production period for plants
E. coli O157:H7 .............. 12,805,000 processors of juice except those who are
Salmonella (non typhi) .... $125,840,000
producing seasonally and year round.
retailers. Retailers are those businesses
Total ............................ 151,000,000 that sell only direct to consumers and
include grocery stores, supermarkets,
TABLE 14.—PLANTS’ PRODUCTION PERIOD

Weeks of Hours of Number of
operation operation plants
per year per day
Seasonal .................................................................................................................................................. 16 12 1,875

Year Round .............................................................................................................................................. 52 24 425
Total ..................................................................................................................................................... 2,300
3. Cost Estimates by Requirement majority of firms are complying with Based on information from inspection
a. HACCP costs. part 110. Therefore, there is no reports, FDA assumes that about 30
i. CGMP’s (§ 120.5) additional cost of complying with this percent of all 2,300 covered juice plants
ii. Prerequisite Program SOP’s (§ 120.6) provision because plants are already (about 690 plants) are likely to have
iii. Hazard Analysis (§ 120.7) complying with part 110. Therefore, sanitation controls that are
iv. HACCP Plan (§ 120.8) FDA assumed that this rule will have no insufficiently implemented, but which
v. Corrective Actions (§ 120.10) effect on the enforcement of the CGMP’s do not warrant administrative or
vi. Verification and Validation for juice products. regulatory action. If it costs each of
(§ 120.11) ii. Prerequisite program SOP’s these 690 plants $500 to implement
vii. Process Verification for Certain (§ 120.6).—Developing SOP’s. The cost sanitation controls and to correct
Citrus Processors(§ 120.25) per plant of developing SOP’s is deviations from SOP’s earlier than they
viii. HACCP Records (§ 120.12) approximately $260. If one half of the would do otherwise, then the total cost
ix. Training (§ 120.13) 850 domestic plants in the OEI and all for this requirement is $345,000.
x. Imports and Foreign Processors of the 1,450 very small juice processors
Because this cost is discounted, it is
(§ 120.14) do not currently have SOP’s, then they
added as a one-time expenditure in the
b. Summary of Costs. will have to develop them to comply
total costs.
c. Take First Year and Recurring Cost with this regulation. Under these
Per Activity. assumptions, the total cost for the Monitoring and documenting of
a. HACCP costs.—i. CGMP’s (§ 120.5). industry to develop SOP’s is SOP’s. Table 15 shows the distribution
No costs are attributed to this section for approximately $488,000 ($260 x 1,875 of per plant and total industry costs
this rulemaking. In 1996, only 6 percent plants). based on the estimate in table 25 for
of the plants inspected were cited for Implementing sanitation controls with SOP monitoring and documenting
official action. Thus, an overwhelming corrections of deviations from SOP’s. needed to comply with this rule.
TABLE 15.—TOTAL ANNUAL COST OF SOP MONITORING AND DOCUMENTING

Annual per Annual SOP
plant SOP Number of monitoring and
monitoring and plants documenting
documenting cost
cost
Seasonal ...................................................................................................................................... $100 1,662 $166,000

Year round ................................................................................................................................... 340 213 72,000
Totals .................................................................................................................................... 1,875 238,000
iii. Hazard analysis (§ 120.7). FDA Adding the categories of processors heat-treating their products are likely to
estimates that performing a hazard that develop HACCP plans yields a total begin doing so. Processors may choose
analysis takes 20 labor hours. At $13 per of about 1,560 out of the original 2,300 any lawful means to achieve the
labor hour the cost of performing a processors that perform a hazard required 5-log reduction. However, costs
hazard analysis is about $250 per plant. analysis. This may be a small here are estimated for pasteurization as
Approximately 2,300 plants will need to overestimate because some of the citrus the lowest-cost technology now
perform a hazard analysis to comply processors that now do not make self- available.
with this rule. Therefore, the total cost stable products may begin to do so In the PRIA FDA estimated that costs
to perform a hazard analysis is because of this rule. It also may be a for initiating pasteurization range from
approximately $575,000. small overestimate because of the small $18,000 for a very small seasonal
iv. HACCP plan (§ 120.8)—HACCP potential for overlap among the operation to $35,000 for a larger year
plan development. FDA estimates that categories. round operation. FDA received many
developing a HACCP plan takes 60 labor comments claiming that the initial cost
hours. At $13 per labor hour the cost of TABLE 16.—NUMBER OF PLANTS WITH for initiating pasteurization was $30,000
developing a HACCP plan is about $750 HACCP PLANS even for a small operation. Because of
per plant. Only those plants that the number of comments claiming that
determine from their hazard analysis Processors with pathogen Hazards 1,460 the initiation of pasteurization would
that they have hazards that are Processors with natural toxin Haz- cost $30,000 for a small operation, FDA
reasonably likely to occur will have to ards ............................................... 20 has used a range for its estimate of the
develop a HACCP plan. Processors with pesticide Hazards .. 80 cost of initiating pasteurization for very
Processors that produce shelf-stable or small processors.
juice concentrate may conclude after Total processors with HACCP Of the 2,300 processors covered by
Plans ...................................... 1,560 the HACCP rule only a portion of these
their hazard analysis that they need not
include pathogen control in any HACCP will need to initiate pasteurization. In
plan as required by § 120.24(a), if they Approximately 1,560 plants will need this final rule, processors of shelf-stable
include a copy of the thermal process in to develop a HACCP plan at a cost of juice and juice concentrate will not
their written hazard analysis. These $750 each to comply with this rule. need to incur additional costs for the
processors only need a HACCP plan if Therefore, the total cost to develop control of pathogens. FDA estimates that
they have other hazards that are HACCP plans is approximately this new provision in the final rule
reasonably likely to occur. $1,170,000. applies to about 600 processors (70
Table 16 shows those processors Pathogen controls. In response to this percent of the processors listed in the
expected to develop HACCP plans. rule, many processors that are not now OEI) affected by this rule.
FDA estimates that all but 20 of the and the several recent outbreaks pasteurization which is also the only
rest of the affected processors listed in associated with fresh citrus juice, it is widely-adopted commerical technology
the OEI (230 plants) and 30 percent of clear that most fresh orange processors for controlling pathogens in juice. Citrus
the 1,220 very small apple juice will need to incur additional costs to processors may choose to adopt a
processors (370 plants) are already implement effective 5-log pathogen technology more expensive that the
operating pasteurization equipment. reduction controls. In the PRIA, FDA $18,000 to $30,000 estimated here for
Therefore, 600 plants do not need to estimated that costs for these processors the implementation of pasteurization.
implement additional pathogen were limited to the costs of creating and However, the more expensive
controls. operating a HACCP system with technologies would likely be adopted
For the purpose of this analysis, FDA appropriate monitoring and
for reasons other than compliance with
has concluded that it is unlikely that recordkeeping of the necessary CCP’s,
fresh orange juice processors will have this rule.
not to purchasing pasteurizing
to pasteurize their products to achieve equipment. In this final analysis, FDA is Therefore, 20 affected processors
a 5-log reduction when a HACCP estimating costs for fresh orange juice listed in the OEI, 300 very small citrus
program is adopted because of the processors to improve pathogen processors and 850 very small apple
nature of the fruits, the availability of controls. Although the measures to juice processors (a total of 1,170 plants)
effective surface treatments and the improve such controls will not will incur costs to implement additional
methods of juice extraction commonly necessarily be pasteurization, FDA is pathogen controls. Table 17 shows the
used by industry. However, given the estimating these costs to be equivalent first year total cost of pathogen control
information gained from the December to the costs for initiating pasteurization. attributable to the HACCP rule.
1999 NACMCF meeting on citrus juice FDA only has cost data for
TABLE 17.—FIRST YEAR COST OF PATHOGEN CONTROL ATTRIBUTABLE TO HACCP PROPOSAL

Number of
Processor type Cost per plant Total
plants
Very small apple juice processors ....................................................................................... $18,000–$30,000 850 $15,300,000–

25,500,000
Very small orange juice processors .................................................................................... 18,000–30,000 300 5,400,000–
9,000,000
Juice processors in the OEI ................................................................................................ 35,000–58,000 20 700,000–
1,160,000
Total .............................................................................................................................. .............................. 1,170 21,400,000–

35,660,000
Pasteurization will require ongoing labor, utilities, and materials subsequent year for processors in the OEI. The total
costs for operation and maintenance. to the first year to be $7,000 per year for cost of pathogen control in subsequent
FDA estimates these annual costs for very small processors and $8,000 per years is given in table 18.
TABLE 18.—SUBSEQUENT YEAR COST OF PATHOGEN CONTROL ATTRIBUTABLE TO HACCP RULE

Number of
Processor type Cost per plant Total
plants
Very small apple juice processors ............................................................................................... $7,000 850 $5,950,000

Very small orange juice Processors ............................................................................................ 7,000 300 2,100,000
Juice processors in the OEI ........................................................................................................ 8,000 20 160,000
Total ...................................................................................................................................... ........................ 1,170 8,210,000
Other costs are related to processing however, although FDA expressly asked agency believes that even if broken glass
for pathogen control. The pasteurization for comments on this issue in its is determined to be a hazard to
of juice causes changes in the November 1999 notice, no comments processors packing juice in glass, these
characteristics of the products, suggested any means of estimating this processors are already currently
primarily in terms of texture and taste. cost. FDA has no information on how implementing every feasible control for
Some current consumers of nonheat- readily consumers will accept this potential hazard in order to limit
treated juice will bear the costs of losing pasteurized juice in the place of fresh their liability and to provide consumer
a particular product as well as costs of juice nor does FDA have any other protection. Additionally, although
searching for products with the information that could be used to approximately 25 percent of the
characteristics that they prefer. Thus, estimate that cost. processing plants pack juice in glass
one cost of these regulations is the Glass and direct food additive HACCP containers, this number is diminishing
limited loss of ‘‘fresh’’ juice: that is, controls. FDA has not attributed any rapidly for economic and safety reasons.
juice that is not heat (or otherwise) costs for control of glass or unapproved Regarding food additives, many juice
processed. direct food additives although these products contain food or color additives
Some consumer comments indicated potential hazards are among those that for the purpose of coloring or extending
a strong preference for fresh juice; are likely to be relevant for juice. The product shelf life. However the agency
believes that even if unapproved food costs for large firms to control this pesticide testing is approximately
additives are determined to be a hazard, potential hazard. This does not mean $98,000 (10 tests x $150/test x 65 firms).
these processors using direct food that FDA believes that no large firms v. Corrective actions (§ 120.10).—
additives in juice are already currently will identify pesticides as a hazard that Corrective action plan. The
implementing sufficient controls for needs to be controlled under HACCP. development of a corrective action plan
these potential hazards as FDA strictly Large and small firms are more likely for juice products is less expensive than
regulates them. than very small firms to use imported revalidation after each deviation from a
Natural toxin controls. FDA believes produce, which may not be subjected to CL. FDA estimates that a corrective
that in most every case processors of as strict controls as U.S. produce in all action plan for juice products can be
domestic apples should be able to cases. FDA believes that 10 percent of developed in 4 hours with a cost per
control natural toxin hazards such as all large and small firms (80 plants total) plant of approximately $50 (about 4
patulin, by processing controls such as will determine that pesticide hazards hours of management time).
washing and culling. This can be are reasonably likely to occur. However,
accomplished at no additional cost. FDA believes that all large firms are All of the plants that develop HACCP
Processors using imported juice already sufficiently addressing this plans as a result of this rule will
concentrate are likely to need to initiate issue with present expenditures. FDA develop corrective action plans to
a sampling regime for natural toxins. made this estimate based on its comply with this rule. The total cost for
FDA assumes that the 23 large plants knowledge of the magnitude of the 1,560 plants at $50 each to develop
will randomly sample 30 shipments per pesticide problem in juice. corrective action plans is approximately
year at a cost of $150 per sample. The If processors determine that pesticide $78,000.
total marginal cost of patulin testing is residues are hazards for their product, Corrective actions. Plants operating
approximately $104,000 (30 tests x then they must run pesticide residue under HACCP plans will take corrective
$150/test x 23 firms). Costs per plant are tests to ensure that there are no actions when CL’s are exceeded for
$4,500. If any lots are found positive, pesticides either over tolerance or used hazards such as pesticide residues,
costs will be incurred for taking on products for which there is no unacceptable fruit for pathogen controls,
corrective action. tolerance. FDA believes that 10 percent and presence of natural toxins. Costs of
Pesticide controls. FDA believes that of the shipments received by small corrective actions are expected to
all 175 affected plants operated by large processors must be covered by a decline as processors gain more
firms are currently doing a sufficient sampling plan. Sixty-five small plants experience under a HACCP system and
amount of sampling and monitoring (or are believed to cover their shipments as the number of corrective actions
receiving supplier certificates) for with a pesticide-sampling plan. Average decreases. Tables 19 and 20 show the
pesticides residues. Therefore, FDA cost per plant is estimated to be $1,500. estimated first year and subsequent year
assumed that there are no additional The total annual marginal cost of costs of corrective actions per plant.
TABLE 19.—COST OF FIRST YEAR CORRECTIVE ACTIONS

Number of
Plant type Cost per plant Total cost
plants
Seasonal ...................................................................................................................................... $450 1,490 $671,000

Year round ................................................................................................................................... 1,460 70 102,000
Totals .................................................................................................................................... 1,560 773,000
TABLE 20.—COST OF SUBSEQUENT YEAR CORRECTIVE ACTIONS

Number of
plants
Seasonal ...................................................................................................................................... $110 1,490 $164,000

Year round ................................................................................................................................... 340 70 24,000
Totals .................................................................................................................................... 1,560 188,000
Verification and validation (§ 120.11).—Verification. The record verification cost per plant per production cycle is
given in table 21.
TABLE 21.—COST OF RECORD VERIFICATION

Number of
plants
Seasonal ...................................................................................................................................... $420 1,490 $626,000

Year Round .................................................................................................................................. 1,350 70 95,000
Totals .................................................................................................................................... ........................ 1,560 721,000
Validation. Processors with HACCP during the first year after whenever any changes occur that could
plans must validate their HACCP plans implementation and at least annually, or affect or alter the hazard analysis, or
HACCP plan. Further, processors who reassess their hazard analysis when any packaging, (5) finished product
have no HACCP plans because there are significant change occurs. Examples of distribution systems, or (6) intended
no hazards that are reasonably likely to things that may change include: (1) Raw consumers or use by consumers.
occur in that process (as may be the case material specifications or sources of raw Tables 22 and 23 give the estimated
with processors of shelf-stable or materials, (2) product formulation, (3) cost for validation in the first and
concentrated juice), the processor must processing methods or systems, (4) subsequent years.
TABLE 22.—COST OF FIRST YEAR VALIDATION

Number of Cost per Number of
Plant type Total cost
validations validation plants
Seasonal Small Business ................................................................................................ 1 $1,000 1,640 $1,640,000

Year Round Business ...................................................................................................... 2 1,000 120 240,000
Year Round Small Shelf-Stable or Concentrate Business .............................................. 1 1,000 130 130,000
Year Round Large Business ........................................................................................... 2 600 80 96,000
Year Round Large Shelf-Stable or Concentrate Business ............................................. 1 600 95 57,000
Totals ........................................................................................................................ 2,265 .................... 2,065 $2,163,000
TABLE 23.—COST OF SUBSEQUENT YEAR VALIDATION

Plant type Total cost
validations validation plants
Seasonal Small Business ................................................................................................ 1 $1,000 1,490 $1,490,000

Year Round Small Business ............................................................................................ 2 1,000 35 70,000
Year Round Large Business ........................................................................................... 2 600 35 42,000
Totals ........................................................................................................................ 1,630 .................... 1,560 1,602,000
vii. Process verification for certain FDA estimates that there are 240 citrus processors operating for only 16 weeks
citrus processors (§ 120.25). Citrus processors that will be affected by this a year. FDA made these assumptions
processors that decide to rely on surface section. To estimate the number of based on its knowledge of microbial
treatments of the fruit to achieve the samples, FDA began with the estimated testing and beliefs about the volume of
requisite 5-log reduction (rather than annual U.S. untreated orange juice untreated packaged juice sold by small
treating the juice directly) are required consumption estimate of 11,700,000 processors. That set of processors
to sample their final product to verify gallons. FDA then assumed that 10 accounts for 2,160,000 gallons annually.
the effectiveness of the HACCP plan. million gallons were packaged for resale The remaining 60 processors share
These processors are required to test and therefore covered by this rule. FDA production of the remaining 7,840,000
two 10 mL subsamples for generic E. then assumed that the 180 processors gallons resulting in about 130 samples
coli every 1,000 gallons or every 5 days that would sample at a frequency of per year per processor.
whichever is more frequent. FDA once every 5 days on average process Table 24 shows the estimated cost for
assumes that the cost of testing two 10 750 gallons during that time. These process verification sampling for these
mL subsamples for generic E. coli is $50. processors are assumed to be seasonal citrus processors.
TABLE 24.—ESTIMATED COST FOR VERIFICATION SAMPLING

Number of Number of Cost per
Sample frequency Total
samples processors sample cost
Every 5 days .................................................................................................................... 16 180 $50 $144,000

Every 1,000 Gallons ........................................................................................................ 130 60 50 390,000
Total .......................................................................................................................... 10,720 240 .................... $534,000
Also, any time that 2 process- treatments to achieve a 5-log reduction that the cost of withdrawing and
verification samples test positive for are fully successful in achieving the 5- destroying the product plus the cost of
generic E. coli in a series of 7 samples log reduction, 2 samples in a series of reviewing monitoring records,
there is a process verification failure. 7 will test positive for generic E. coli reevaluating and revalidating HACCP
The processor must not sell the product once in every 1,000 samples. Based on plan is $20,000. FDA made this
without further processing and must an estimate of 10,720 samples taken per assumption based on its experience
review its monitoring records, year, this will occur about 11 times per with such small lot market withdrawls.
reevaluate its HACCP plan, and if no year. FDA assumes that the cost of Therefore, the additional cost of a
obvious deficiencies in the HACCP plan further processing of the product will be process verification failure is $220,000
are discovered, must revalidate its more expensive than withdrawing and per year. The annualized cost of a
HACCP plan. FDA estimates that even if destroying the product, which should process verification failure is $320 for a
all citrus processors that rely on surface not exceed 1,000 gallons. FDA assumes seasonal processor sampling every 5
days ((16/1,000) × $20,000 = $320) and viii. HACCP records (§ 120.12).— annual cost of additional monitoring
$2,600 for a year round processor Monitoring and recordkeeping. The and recordkeeping per plant. It also
sampling every 1,000 gallons ((130/ additional monitoring and shows the distribution of per plant costs
1,000) × $20,000 = $2,600). recordkeeping that needs to be done and total industry costs for the
The total cost of process verification throughout the entire plant is estimated additional monitoring and
testing for untreated citrus juice is to be equivalent to 5 percent of one recordkeeping needed to comply with
$764,000 per year ($534,000 + $220,000 worker’s time (3 minutes per hour of this final rule.
= $764,000). operation per plant). Table 25 shows the
TABLE 25.—COST OF MONITORING AND RECORDKEEPING

Plant type Cost per plant Number of plants Total cost
Seasonal .................................................................................................................... $900 1,490 $1,341,000

Year Round ................................................................................................................ 5,600 70 392,000
Totals .................................................................................................................. .............................. 1,560 $1,733,000
Record maintenance and storage. The annual cost of record maintenance and storage per plant is described in
table 26.
TABLE 26.—COST OF RECORD MAINTENANCE

Plant type Cost per plant Number of plants Total cost
Seasonal .................................................................................................................... $360 1,490 $536,000

Year Round ................................................................................................................ 830 70 58,000
Totals .................................................................................................................. .............................. 1,560 $694,000
ix. Training (§ 120.13).—HACCP for each of the 2,300 processing plants, HACCP-related responsibilities,
coordinator training. Processors may or a total industry cost of $2,990,000. whichever is greater. Table 27 describes
need to employ a HACCP coordinator to Employee training in HACCP. Each the cost of training each employee for 8
carry out the duties specified for such processor with a HACCP plan will need hours annually (the equivalent of 40
a person. FDA estimates that the cost of to train employees in their HACCP- minutes per month for 10 percent of the
HACCP coordinator training is $1,300 related activities. This analysis assumes employees) and the total cost of this
that each plant must train 5 employees level of training.
or 10 percent of their employees in
TABLE 27.—COST OF EMPLOYEE TRAINING
Average plant employment employees Total cost
employee plants
trained
3 ....................................................................................................................................... 3 $100 1,459 $437,700

7 ....................................................................................................................................... 5 100 10 5,000
15 ..................................................................................................................................... 5 100 19 9,500
35 ..................................................................................................................................... 5 100 28 14,000
75 ..................................................................................................................................... 8 100 29 23,200
175 ................................................................................................................................... 16 100 15 27,000
Totals ........................................................................................................................ 5,160 .................... 1,560 $516,000
x. Imports and foreign processors exporter is approximately $26,000, and implemented HACCP. The agency
(§ 120.14).—Importers. The agency the cost in subsequent years is $22,000. assumes that these costs are
estimates that the cost of these activities Therefore the total cost in the first year representative of foreign plants
will be $10,000 for each of the 120 for 300 foreign processors is exporting to the United States.
importers in the first year, decreasing to approximately $8 million and b. Summary of Costs—The total
$5,000 in subsequent years. Total costs approximately $7 million in subsequent quantified costs are approximately $44
for importers is $1,200,000 in the first years. Tables 33 and 34 in the to $58 million in the first year and $23
year and $600,000 in subsequent years. Regulatory Flexibility Analysis, which million in all subsequent years. Table 28
Foreign juice processors. The follows, shows typical costs for large summarizes costs of the rule by
estimated first year cost per foreign juice plants that have not already provision.
C. TABLE 28.—TOTAL FIRST YEAR AND RECURRING COST PER ACTIVITY

Activity First year costs Recurring costs
Develop SOP’s ............................................................................................................................................ $488,000 ..............................

Prerequisite Program SOP’s ....................................................................................................................... 345,000 ..............................
Monitoring and Documenting for SOP ........................................................................................................ 238,000 238,000
Hazard analysis ........................................................................................................................................... 575,000 ..............................
HACCP plan ................................................................................................................................................ 1,170,000 ..............................
Pathogen controls ........................................................................................................................................ 21,400,000– 8,210,000
35,660,000
Natural toxin controls ................................................................................................................................... 104,000 104,000
Pesticide controls ......................................................................................................................................... 98,000 98,000
Corrective action plan .................................................................................................................................. 78,000 ..............................
Corrective actions ........................................................................................................................................ 773,000 188,000
Verification ................................................................................................................................................... 721,000 721,000
Validation ..................................................................................................................................................... 2,163,000 1,602,000
Process verification ...................................................................................................................................... 764,000 764,000
HACCP monitoring and recordkeeping ....................................................................................................... 1,733,000 1,733,000
Record maintenance and storage ............................................................................................................... 694,000 694,000
HACCP coordinator training ........................................................................................................................ 2,990,000 ..............................
Employee training ........................................................................................................................................ 516,000 516,000
Importers ...................................................................................................................................................... 1,200,000 600,000
Foreign processors ...................................................................................................................................... 8,000,000 7,000,000
Totals .................................................................................................................................................... 44,000,000– 23,000,000

58,000,000
E. Summary of Benefits and Costs VI. Regulatory Flexibility Analysis entities. The HACCP rule is being issued
FDA has examined the impact of this to ensure that juice processors control
FDA has examined the benefits and all physical, chemical, and microbial
costs of this rule as required under rule as required by the Regulatory
Flexibility Act (5 U.S.C. 601–612). If a hazards in their products.
Executive Order 12866. Over time, the
rule has a significant impact on a B. Definition of Small Business and
relationship between benefits and costs substantial number of small entities, the
changes, so that, to compare them Number of Small Businesses Affected
RFA requires agencies to analyze
properly, benefits and costs must be options that would minimize the The RFA requires a statement of the
discounted to the present year (the time economic impact of that rule on small definition of small business used in the
at which the decisions are being made). entities. The agency acknowledges that analysis and a description of the
The quantified benefits (discounted this rule is likely to have a significant number of small entities affected.
annually over an infinite time horizon at impact on a substantial number of small Table 29 shows the definition of small
7 percent) are expected to be about $2 entities. business for each type of establishment
billion ($151 million/7 percent) and the affected and a description of the number
A. Objectives of small entities affected by the rule.
quantified costs (discounted annually
over an infinite time horizon at 7 The RFA requires a succinct The agency has accepted the Small
percent) are expected to be about $400 statement of the purpose and objectives Business Administration (SBA)
million. of any rule that will have a significant definitions of small business for this
impact on a substantial number of small analysis.
TABLE 29.—APPROXIMATE NUMBER OF SMALL PLANTS COVERED BY THESE RULES
North American Percent of No. of
Category defined
Type of establishment industry classifica- SBA definition of small by category small businesses
as small by SBA
tion system codes covered
Juice manufacturers in the OEI ............. 311421, 311411 Less than 500 employees ..................... 75% 675
Roadside-type apple juice Makers ........ 311421, 311411 Less than 500 employees ..................... 100% 1,220
Roadside orange juice Makers .............. 311421, 311411 Less than 500 employees ..................... 100% 230
Totals ..................................................... .............................. ................................................................ .............................. 2,125
C. Description of the Impact on Small can be gained from the following The first example (table 30) is of a
Entities examples. The impacts that the costs small seasonal apple cider plant that is
will have on a firm will vary depending now producing nonheat-treated juice,
1. Costs to Small Entities
on the total revenue derived from juice with fruit from a known source, and that
Because there is a broad distribution by a firm and the profit (return on sales) has not developed or implemented
of products covered, firm types, current associated with juice production. Data sanitation SOP’s. This plant will need to
processing practices and sizes, it would on food manufacturing firms indicates buy a pasteurizer (or find and validate
be misleading to report average per firm that 75 percent of firms have return on a different process that achieves a 5-log
costs. However, some idea of the costs sales of less than 5 percent. reduction). The next example (table 31)
is a small plant that is producing orange unpasteurized orange juice, using operates year round and that imports
juice concentrate year round with fruit commingled fruit, and that has not some apples and therefore must test for
from a known source, and that has developed or implemented sanitation patulin, and has not developed or
already developed and implemented SOP’s. implemented sanitation SOP’s. The
sanitation SOP’s (except that records These three illustrative small plants second large plant (table 34) is a large
have not been kept on SOP’s). The third can be compared to two illustrative shelf-stable tomato juice processor using
example (table 32) is a small plant large plants. The first large plant (table fruit from a known source and with
operating year round producing 33) is a large shelf-stable apple juice sanitation SOP’s fully implemented.
plant with many employees that
TABLE 30.—COSTS FOR ILLUSTRATIVE SMALL SEASONAL APPLE CIDER PROCESSOR
Cost in Cost in
Type of cost first year subsequent years
Develop SOP’s ............................................................................................................................................ $260

Sanitation SOP’s .......................................................................................................................................... 500
Monitoring and Documenting of SOP’s ....................................................................................................... 100 $100
Hazard analysis ........................................................................................................................................... 250
HACCP plan ................................................................................................................................................ 750
Pathogen controls ........................................................................................................................................ 18,000–30,000 7,900
Corrective action plan .................................................................................................................................. 50
Corrective actions ........................................................................................................................................ 450 110
Verification ................................................................................................................................................... 420 420
Validation ..................................................................................................................................................... 1,000 500
HACCP monitoring and recordkeeping ....................................................................................................... 900 900
Record maintenance & storage ................................................................................................................... 360 360
Training of coordinator ................................................................................................................................. 1,300
Employee training ........................................................................................................................................ 300 300
Totals .................................................................................................................................................... 24,700–36,700 10,600
TABLE 31.—COST FOR ILLUSTRATIVE SMALL YEAR ROUND CONCENTRATED ORANGE JUICE PROCESSOR
Cost in
Type of cost Cost in first year subsequent years
Monitoring and documenting of SOP’s ........................................................................................................ $340 $340

Hazard analysis ........................................................................................................................................... 250
Validation ..................................................................................................................................................... 1,000
Totals .................................................................................................................................................... 2,900 300
TABLE 32.—COST FOR ILLUSTRATIVE SMALL YEAR ROUND UNPASTEURIZED ORANGE JUICE PROCESSOR
Cost in
Develop SOP’s ............................................................................................................................................ $260

Monitoring and documenting of SOP’s ........................................................................................................ 340 $340
Hazard analysis ........................................................................................................................................... 250
HACCP plan ................................................................................................................................................ 750
Pathogen controls ........................................................................................................................................ 18,000–30,000 7,900
Corrective action Plan ................................................................................................................................. 50
Corrective actions ........................................................................................................................................ 1,460 340
Verification ................................................................................................................................................... 1,350 1,350
Validation ..................................................................................................................................................... 2,000 1,000
Process verification testing .......................................................................................................................... 7,800 7,800
Annualized cost of Process Verification Failure .......................................................................................... 2,600 2,600
HACCP monitoring and Recordkeeping ...................................................................................................... 5,600 5,600
Record maintenance & storage ................................................................................................................... 830 830
Employee training ........................................................................................................................................ 500 500
Totals .................................................................................................................................................... 43,100–55,100 28,300
TABLE 33.—COSTS FOR ILLUSTRATIVE LARGE YEAR ROUND APPLE JUICE PROCESSOR
Cost in
Develop SOP’s ............................................................................................................................................ $260
TABLE 33.—COSTS FOR ILLUSTRATIVE LARGE YEAR ROUND APPLE JUICE PROCESSOR—Continued
Cost in
Sanitation SOP’s .......................................................................................................................................... 500

Monitoring and documenting of SOP’s ........................................................................................................ 340 $340
Hazard analysis ........................................................................................................................................... 250
HACCP plan ................................................................................................................................................ 750
Natural toxin control ..................................................................................................................................... 4,500 4,500
Corrective action plan .................................................................................................................................. 50
Corrective actions ........................................................................................................................................ 1,460 340
Verification ................................................................................................................................................... 1,350 1,350
Validation ..................................................................................................................................................... 1,200 1,200
HACCP monitoring and recordkeeping ....................................................................................................... 5,600 5,600
Record maintenance .................................................................................................................................... 680 680
Record storage ............................................................................................................................................ 150
Employee training ........................................................................................................................................ 8,300 8,300
Totals .................................................................................................................................................... 24,000 20,000
TABLE 34.—COSTS FOR ILLUSTRATIVE LARGE YEAR ROUND SHELF-STABLE TOMATO JUICE PROCESSOR
Cost in
Hazard analysis ........................................................................................................................................... $250

Validation ..................................................................................................................................................... 600
Totals .................................................................................................................................................... 2,000 $0
Some comments stated that the rule small firms could save each one $900 to and making necessary changes to
would be burdensome on small juice $61,000 (using a 7 percent discount comply with this rule.
processors and that some processors rate). These savings accrue just from
would have to cease producing juice. delaying the time at which the 2. Professional Skills Required for
FDA is issuing a tiered, extended expenditures for compliance must take Compliance
compliance period giving the smallest place. The amount of savings increases The RFA requires a description of the
firms the most time to comply with the as the cost of compliance increases. One
professional skills required for
rule. Extending the compliance period effect of the cost savings will be to
compliance with this rule. Table 35
by 1 year for small firms could save reduce small firm failure. FDA believes
each one $500 to $31,600 (using a 7 that this extended compliance period describes the professional skills
percent discount rate). Extending the will provide small firms with significant required for compliance with the
compliance period by 2 years for very relief in the cost of preparing for HACCP various activities required by this rule.
TABLE 35.—PROFESSIONAL SKILLS REQUIRED FOR COMPLIANCE

Section of
Required activity Professional skills required for compliance
rule
Developing prerequisite program SOP’s ..... § 120.6 Managers familiar with incoming materials and plant sanitation.
Implementing sanitation controls with cor- § 120.6 Production workers who are able to maintain the sanitation controls as described in
rections of deviations from prerequisite the sanitation SOP’s and supervisors or managers who can determine what correc-
program SOP’s. tive actions are necessary for deviations from SOP’s.
Monitoring and documenting of prerequisite § 120.6 Production workers who are appropriately trained to monitor and keep records on ob-
Program SOP’s. servations and measurements for prerequisite program SOP’s.
Developing hazard analysis and HACCP §§ 120.7 Supervisors or managers who fulfill the role of HACCP coordinator as well as micro-
plan.. and 120.8 biologists, chemists, and attorneys.
Implementing pathogen controls ................. § 120.8 Production workers who are appropriately trained to monitor and keep records on ob-
servations and measurements at CCP’s.
Implementing pesticide controls .................. § 120.8 Production workers who are appropriately trained to carry out tests, to monitor, and to
keep records on observations and measurements at CCP’s.
Tracking corrective actions .......................... § 120.10 Production workers who are trained to take corrective action described in corrective
action plans and supervisors or managers who can determine what corrective ac-
tions are necessary for deviations from CL’s.
Verification ................................................... § 120.11 Supervisors or managers who fulfill the role of HACCP coordinator.
Validation ..................................................... § 120.11 Food scientists or food technologists who can perform a scientific review of the proc-
ess.
Process verification ..................................... § 120.25 Microbiologists and production workers who are trained to take process verification
samples and food scientists or food technologists who can perform a scientific re-
view of the process in the event of a process verification failure.
TABLE 35.—PROFESSIONAL SKILLS REQUIRED FOR COMPLIANCE—Continued

Section of
Required activity Professional skills required for compliance
rule
Monitoring and recordkeeping ..................... § 120.12 Production workers who are appropriately trained to monitor and keep records on ob-
servations and measurements at CCP’s.
Record maintenance ................................... § 120.12 Clerical or production workers.
HACCP coordinator training coordinator ..... § 120.13 Supervisors or managers who fulfill the role of HACCP.
HACCP employee training .......................... § 120.13 Clerical and production workers.
Imports ......................................................... § 120.14 Clerical workers as well as supervisors or managers who fulfill the role of HACCP co-
ordinator.
3. Recordkeeping requirements provisions for which records need to be for making each record, and the total
made and kept by small businesses, the number of hours for each provision in
The RFA requires a description of the number of small businesses affected, the the first year and then in subsequent
recordkeeping requirements of the annual frequency that the records need years.
proposed rule. Table 36 shows the to be made, the amount of time needed
TABLE 36.—SMALL BUSINESS RECORDKEEPING REQUIREMENTS

Number of Hours per Total
small enti- Annual Total hours
21 CFR provisions record per subsequent
ties keeping frequency first year
small entity years
records
120.6 Monitoring and Recordkeeping of SOP’s .................................... 1,660 16 0.5 13,300 13,300
210 52 .................... 5,500 5,500
120.7 Hazard analysis ........................................................................... 2,125 1 20 42,500 0
120.8 HACCP plan ................................................................................ 1,930 1 60 115,800 0
120.8 Pesticide Controls by Supplier Certificate ................................... 1,700 160 .02 5,400 5,400
120.11 Verification ................................................................................. 1,450 16 2 46,400 46,400
380 52 18 39,500 39,500
120.11 Validation ................................................................................... 1,450 1 24 11,600 5,800
380 2 .................... 6,100 3,000
120.12 HACCP records ......................................................................... 1,450 1,440 .05 104,400 104,400
380 8,640 .................... 164,200 164,200
120.12 Record maintenance ................................................................. 1,450 16 1 23,200 23,200
Totals ................................................................................................ .................... .................... .................... 598,000 431,000

1First year. 2 Subsequent year.
D. Minimizing the Burden on Small sell directly to consumers or directly to by 1 year for small firms could save
Entities consumers and other retailers. each one $500 to $31,600 (using a 7
The RFA requires an evaluation of Revenue from sales of 40,000 gallons percent discount rate). Extending the
any regulatory overlaps and regulatory of nonheat treated juice may be compliance period by 2 years for very
alternatives that would minimize the approximately $160,000 with annual small firms could save each one $900 to
costs to small entities. profits ranging from $1,600 to $16,000 $61,000 (using a 7 percent discount
There are two alternatives that the per year (1 percent to 10 percent). This rate). These savings accrue just from
agency has considered to provide exemption covered most of the very delaying the time at which the
regulatory relief for small entities. First, small businesses, although less than 15 expenditures for compliance must take
FDA considered and is proposing the percent of the volume of unpasteurized place. The amount of savings increases
option of exempting some small entities juice. However, packaged products sold as the cost of compliance increases.
from the requirements of these rules. by these types of processors are covered Additional savings may come as
Second, FDA considered and is under the labeling rule. smaller firms learn more efficient
proposing the option of lengthening the As detailed in response to comment compliance strategies from larger firms
compliance period for small entities. 47, the comments that FDA received on that must comply earlier and as new,
this exemption were almost entirely less costly technologies that may be
1. Exempt Small Entities critical of the exemption. Based upon employed by small firms are developed
One alternative for alleviating the the comments and other information during the extended compliance period.
burden for small entities would be to available to the agency, FDA has FDA is unable to quantify these
exempt them from the provisions of this decided not to finalize this proposed additional savings of the extended
rule. FDA proposed to exempt retailers exemption. compliance period although one effect
who, for the purposes of this rule, the of the cost savings will be to reduce
2. Extend Compliance Period small firm failure.
agency tentatively decided would
include very small businesses that make FDA is issuing a tiered, extended FDA believes that this extended
juice on their premises and whose total compliance period giving the smallest compliance period will provide small
sales of juice and juice products do not firms the most time to comply with the firms with significant relief in the cost
exceed 40,000 gallons per year and who rule. Extending the compliance period of preparing for HACCP and making
necessary changes to comply with this most effective and efficient way to HACCP proposal. One comment was
rule. ensure that these food products are safe. received. This comment asserted that
FDA’s mandate to ensure the safety of the change in sequence in the proposed
E. Summary
the nation’s food supply is derived rule for the last two steps of the seven
FDA has examined the impact of this principally from the act (21 U.S.C. 321 principles of HACCP is a change that
rule on small businesses in accordance et seq.). Under the act, FDA has will result in many paperwork changes.
with the RFA. This analysis, together authority to ensure that all foods in The seven principles of HACCP have
with the rest of the preamble constitutes interstate commerce, or that have been been articulated by the NACMCF.
the final RFA. FDA has determined that shipped in interstate commerce, are not The agency does not agree with this
this rule is likely to have a significant contaminated or otherwise adulterated, comment. Prior to 1997, the NACMCF
impact on a substantial number of small are produced and held under sanitary listed establishing recordkeeping and
entities. conditions, and are not misbranded or documentation procedures and
deceptively packaged; under 21 U.S.C. establishing verification procedures as
VII. Paperwork Reduction Act of 1995
371, the act authorizes the agency to the sixth and seventh principles of
This final rule contains information issue regulations for its efficient
collection provisions that are subject to HACCP; this is the order in which the
enforcement. The agency also has
review by the Office of Management and principles are reflected in FDA’s
authority under the Public Health
Budget (OMB) under the Paperwork seafood HACCP regulation, part 123.
Service Act (42 U.S.C. 264) to issue and
Reduction Act of 1995 (44 U.S.C. 3501– When the NACMCF revised its HACCP
enforce regulations to prevent the
3520). A description of these principles and application guidelines in
introduction, transmission, or spread of
information provisions is given below 1997, it reversed the order of the last
communicable diseases from one State
with an estimate of the annual two steps. Thus, the sequence in part
to another other State. Information
recordkeeping burden. Included in the 120 for the seven principles of HACCP
development and recordkeeping are
estimate is the time for reviewing is identical to the sequence most
essential parts of any HACCP system.
instructions, searching existing data recently outlined by NACMCF. The
The information collection requirements
sources, gathering and maintaining the 1997 change does not require a change
of this rule are narrowly tailored to
data needed, and completing and in the analytical approach or in the
focus on the development of appropriate
reviewing each collection of information to be assembled by juice
controls and documenting those aspects
information. processors as they apply the HACCP
of processing that are critical to food
Title: Hazard Analysis and Critical principles to their process. The agency
safety. Through this final rule, FDA is
Control Point (HACCP) Procedures for does not anticipate that there will be a
implementing its authority under
the Safe and Sanitary Processing of need for processors to complete
section 402(a)(4) of the act. The
Juice—Recordkeeping requirements for additional paperwork simply because
information development and
processors of fruit and vegetable juices there has been a change in the order of
recordkeeping requirements of this final
Description: This final rule mandates the seven principles of HACCP or
rule are likewise an implementation of
the application of HACCP procedures to because there will be a slight difference
section 402(a)(4) of the act.
fruit and vegetable juice processing. Description of Respondents: in the juice HACCP regulation and the
HACCP is a preventative system of Businesses and other for-profit seafood HACCP regulation. It is FDA’s
hazard control that can be used by all institutions. position that as long as all the essential
food processors to ensure the safety of In the Federal Register of April 24, elements are present in the written
their products to consumers. FDA is 1998, the agency requested comments HACCP plan, the plan will be complete.
finalizing these regulations because a on the proposed collection of FDA estimates the burden of this
system of preventative control is the information provisions contained in the collection of information as follows:
TABLE 37.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Annual
Number of Total annual Hours per
21 CFR sections frequency of Total hours
recordkeepers records record
records
120.6(a) & 120.12(a)(1) & (b) ............................................ 1,875 1 1,875 4 2 7,500
120.6(c) & 120.12(a)(1) & (b) ............................................ 1,875 365 684,375 0.1 68,437.5
120.7; 120.10 (a); & 120.12(a)(2), (b) & (c) ...................... 2,300 1.1 2,530 20 50,600
120.8 (except monitoring records required under
120.8(b)(7)); & 120.12(a)(3),(b)& (c) .............................. 1,840 1 1,840 60 2 110,400
120.8(b)(7) & 120.12(a)(4)(i), & (b) ................................... 1,450 14,600 21,170,000 0.01 211,700
120.10(c) & 120.12(a)(4)(ii), & (b) ..................................... 1,840 12 22,080 0.1 2,208
120.11(a)(1)(iv); 120.11(a)(2); 120.12(a)(5) ...................... 1,840 52 95,680 0.1 9,568
120.11(b) & 120.12(a)(5), & (b) ......................................... 1,840 1 1,840 4 7,360
120.11 (c) & 120.12(a)(5) & (b) ......................................... 1,840 1 1,840 4 7,360
120.14(a)(2); & 120.14 (c) & (d) ........................................ 308 1 308 4 1,232
Totals First year—476,365.5 Subsequent years—358,465.5

1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 First year only.
The burden estimates in table 37 plants (i.e., 2,300) affected by this final plus 1,220 very small apple juice
above are based on an estimate of the rule. Included in this total are 850 manufacturers and 230 very small
total number of juice manufacturing plants currently identified in FDA’s OEI orange juice manufacturers (see table 13
in section V). The figures in table 36 are provide evidence to support this Accordingly, the agency has concluded
derived by estimating the number of assertion. that the rule does not contain policies
plants affected by each portion of this FDA agrees that the recordkeeping that have federalism implications as
final rule and multiplying the requirement in the HACCP final rule defined in the order and, consequently,
corresponding number by the number of may increase paper consumption. a federalism summary impact statement
records required annually and the hours However, the agency disagrees that this is not required.
needed to complete the record. These increase will be significant. The agency
numbers were obtained from the believes that the paper used for the X. References
agency’s final RIA prepared for this final required recordkeeping will be a very The following information has been
rule. small fraction of the overall amount of placed on display in the Dockets
Moreover, these estimates assume that paper used in the United States. Management Branch (address above),
every processor will prepare SSOP’s and Therefore, this use will not significantly and may be seen by interested persons
a HACCP plan and maintain the increase the production, use and between 9 a.m. and 4 p.m. Monday
associated monitoring records and that disposal of paper and, thus, will not through Friday.
every importer will require product result in significant adverse impacts on 1. FDA, Department of Health and Human
safety specifications. In fact, there are the environment. Additionally, FDA Services (DHHS), ‘‘Fruit And Vegetable
likely to be some small number of juice notes that § 120.12(g) of the final rule Juice Beverages: Notice of Intent to
processors that, based upon their hazard permits records to be maintained Develop a HACCP Program, Interim
analysis, determine that they are not electronically. When the regulated Warning Statement, and Educational
required to have a HACCP plan under entities maintain records electronically, Program,’’ 21 CFR part 120, 62 FR
this final rule. the need for paper is reduced. 45593–45596, August 28, 1997.
Table 37 provides a breakdown of the (Comment 159) One comment on the 2. FDA, DHHS, ‘‘Hazard Analysis and Critical
total estimated recordkeeping burden proposed rule stated that efforts to Control Point (HACCP); Procedures for
the Safe and Sanitary Processing and
for the first year and subsequent years. achieve 5-log reduction will lead to
Importing of Juice,’’ proposed rule, 21
The estimates in this table have been possible excessive pollution of the CFR part 120, 63 FR 20450–20486, April
reviewed by the agency’s HACCP environment from disposal of 24, 1998.
experts, who have practical experience unessential sanitizers. This comment 3. FDA, DHHS, ‘‘Hazard Analysis and Critical
in observing various processing did not provide evidence to support this Control Point (HACCP); Procedures for
operations and related recordkeeping assertion. the Safe and Sanitary Processing and
activities. The agency has concluded that even Importing of Juice;’’ extension of
The information collection provisions if some increase in the use of sanitizing comment period, 21 CFR part 120, 63 FR
of this final rule have been submitted to products should result, the products 37057, July 8, 1998.
OMB for review. used would be either registered with the 4. FDA, DHHS, ‘‘Food Labeling: Warning and
Prior to the effective date of this final U.S. EPA or regulated by FDA for use Notice Statements; Labeling of Juice
Products,’’ proposed rule, 21 CFR part
rule, FDA will publish a notice in the on food contact articles under 101, 63 FR 20486–20493, April 24, 1998.
Federal Register announcing OMB’s § 178.1010 (21 CFR 178.1010) or both. 5. FDA, DHHS,‘‘Food Labeling: Warning and
decision to approve, modify, or Environmental review is part of EPA’s Notice Statements; Labeling of Juice
disapprove the information collection pesticide registration process and is part Products,’’ 21 CFR part 101, 63 FR
provisions in this final rule. An agency of FDA’s process for listing sanitizing 37030–37056, July 8, 1998.
may not conduct or sponsor, and a solutions under § 178.1010. FDA 6. FDA, DHHS, ‘‘Preliminary Regulatory
person is not required to respond to, a expects processors to use all sanitizing Impact Analysis and Initial Regulatory
collection of information unless it products according to directions on Flexibility Analysis of the Proposed
displays a currently valid OMB control product labels and under the Rules to Ensure the Safety of Juice and
Juice Products,’’ preliminary regulatory
number. supervision of experienced persons. Use impact anaysis, 21 CFR parts 101 and
of the sanitizing products in this 120, 63 FR 24254–24378, May 1, 1998.
VIII. Environmental Impact
manner should ensure that any 7. FDA, DHHS, ‘‘Food Labeling: Warning and
The agency has previously considered increased use will not result in adverse Notice Statements; Labeling of Juice
the environmental effects of the action effects on the environment. Products; Technical Scientific
being taken in this final rule. As The agency has concluded that these Workshops; Requests for Additional
announced in the proposed rule comments on the potential for adverse Time to Achieve the Pathogen Reduction
published in the Federal Register of environmental effects will not affect its Standard,’’ 21 CFR part 101, 63 FR
April 24, 1998 (63 FR 20450) (Ref. 2), previous determination that this action 57594–57596, October 28,1998.
the agency determined that under 21 will not have a significant impact on the 8. FDA, DHHS, ‘‘Hazard Analysis and Critical
CFR 25.30(j) this action is of a type that Control Point (HACCP); Procedures for
human environment and that an the Safe and Sanitary Processing and
does not individually or cumulatively environmental impact statement is not Importing of Juice: Reopening of
have a significant impact on the human required. Comment Period,’’ 21 CFR part 120, 63
environment. Therefore, neither an FR 69579–69580, December 17, 1998.
environmental assessment nor an IX. Federalism
9. FDA, DHHS, ‘‘Apple Cider Food Safety
environmental impact statement was FDA has analyzed this final rule in Control: Workshop,’’ 21 CFR part 101, 64
required. accordance with the principles set forth FR 34125–34126, June 25, 1999.
(Comment 158) Two comments were in Executive Order 13132. FDA has 10. FDA, DHHS, ‘‘Hazard Analysis and
received in response to the potential determined that the rule does not Critical Control Point (HACCP);
environmental impact of this rule. One contain policies that have substantial Procedures for Safe and Sanitary
comment stated that ‘‘* * * the direct effects on the States, on the Processing and Importing of Juice;
Availability of New Data and
extensive recordkeeping requirements relationship between the national Information and Reopening of Comment
under the juice proposal will increase government and the States, or on the Period,’’ 21 CFR part 120, 64 FR 65669–
paper consumption significantly, which distribution of power and 65671, November 23, 1999.
will not be considered ‘environmentally responsibilities among the various 11. FSIS, USDA, ‘‘National Advisory
friendly.’ ’’ This comment did not levels of government (Ref. 75). Committee on Microbiological Criteria
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Miller, and G. M. Sapers, Washington and Oregon, 1969,’’ 41. FDA health hazard evaluation,
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containing Escherichia coli 27. FDA Memorandum to Samuel I. Shibko July 2, 1992.
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Association for Food Protection meeting, classification, and FDA Enforcement www.plant.uoguelph.ca/safefood/micro-
August 6 to 9, 2000. Report for recall #F–072–7, November 14 haz/juice-outbreaks.htm>
15. National Academy of Sciences (NAS), and 20, 1996. 44. Mead, P. S., L. Slutsker, V. Dietz, L. F.
National Research Council (NCR), An 30. FDA health hazard evaluation, McCaig, J. S. Bresee, C. Shapiro, P. M.
Evaluation of the Role of Microbiological classification, and FDA Enforcement Griffin, and R.V. Tauxe, ‘‘Food-related
Criteria for Foods and Food Ingredients, Report for recall #F–073–7, November 14 illness and death in the United States,’’
pp. 41–54, 308–335, National Academy and 20, 1996. Emerging Infectious Diseases, 5(5):607–
Press, Washington, DC, 1985. 31. FDA Enforcement Report and USDA and 625, 1999.
16. Codex Alimentarius Commission, Heinz news releases for recall #F–095–9 45. CFSAN, FDA Report of 1997 Inspections
Recommended International Code of of Strained Beginner carrots, and of Fresh, Unpasteurized Apple Cider
Practice: General Requirements (Food vegetable chicken dinner baby food, Manufacturers—Summary of Results—
Hygiene) [CAC/RCP 1–1969, Rev. 3 December 23, 1998, and October 9, 1998. January 1999.
(1997), 2nd ed.], HACCP Annex. Food 32. FDA Enforcement Report for recall of 46. FDA, HHS, FDA Announces Voluntary
and Agriculture Organization of the frozen carrots and mixed frozen Nationwide Recall of Certain Frozen
United Nations, World Health vegetables, April 14, 1999. Mamey Brands, HHS News, March 8,
Organization, Rome. 33. Government of the Federal Republic of 1999, Web address: http://www.fda.gov/
17. NACMCF, 1998, Hazard Analysis and Germany, 1999, Comment concerning bbs/topics/NEWS/NEW00676.html>
Critical Control Point Principles and the Codex Committee on Food Additives 47. Anonymous, Outbreak of Salmonella
Application Guidelines, Adopted August and Contaminants, with reference to serotype muenchen infections associated
14, 1997. Journal of Food Protection, Codex Document CX/FAC 99/19, with unpasteurized orange juice—United
61(6):762–775. December 1998 Draft Maximum Levels States and Canada, June 1999. Morbidity
18. FDA, PHS, DHHS, Grade ‘‘A’’ Pasteurized for Lead. and Mortality Weekly Report (MMWR),
Milk Ordinance, 1999 Revision, Public 34. Schmidt, R. H., C. A. Sims, M. E. Parish, 48(27):581–585, July 16, 1999.
Health Service/Food and Drug S. Pao, and M. A. Ismail, A Model 48. OSDH. E. coli Health Warning Issued in
Administration Publication No. 229. HACCP Plan for Small-Scale, Fresh- Northeastern Oklahoma. Oklahoma State
19. FDA, 2000, Patulin in Apple Juice, Apple Squeezed (Not Pasteurized) Citrus Juice Department of Health News Release,
Juice Concentrates and Apple Juice Operations. Publication CIR 1179, Food October 13, 1999.
Products; (Draft) Guidance for FDA Science and Nutrition Department, 49. State of Florida, Food Analysis Report for
Components and Industry: Apple Juice, Florida Cooperative Extension Service, Laboratory No. 98/FO–07398, October
Apple Juice Concentrates, and Apple Institute of Food and Agricultural 27, 1998; Associated Press. State issues
Juice Products—Adulteration with Sciences, University of Florida, 1997. warning about tainted juice, 1998;
Patulin. Web address: http:// 35. Bolster, D., Apple Hill Quality Assurance Garcia, L. M. 1998. Traces of bacteria
vm.cfsan.fda.gov/∼dms/patubckg.html. Program and Guidelines, Presentation found in juice from local farm, October
20. FDA Memorandum to Terry Troxell From during FDA’s Apple Cider Food Safety 25, 1998, The Herald (Miami).
D. Jesse Wagstaff, May 5, 1994, Control Workshop, July 15 to 16, 1999. 50. FDA Enforcement Reports and HHS press
concerning Hazards of Patulin in Apple 36. CFSAN, FDA, Hazard Analysis and release for recall #F–660/661–9, #F–662–
Juice. Critical Control Point (HACCP) Pilot 9, #F–089–0. September 1 and 15, 1999,
21. IARC, Patulin, International Agency for Program for Selected Food November 16 and 19, 1999, and February
Research on Cancer (IARC), Monographs Manufacturers; Interim Report of 2, 2000.
on the Evaluation of the Carcinogenic Observations and Comments, June 19, 51. FDA Memorandum from Robert L. Racer,
Risk of Chemicals to Humans, 40:83–98, 1996. April 21, 2000, concerning April 20
1986. 36a. Katz, F., and J. Giese, ‘‘Science gives Recall of All Fresh, Un-Pasteurized
22. WHO, Patulin, World Health specialty juice a big slice of the market,’’ Citrus Juice Products because of Possible
Organization (WHO) Food Additives Journal Food Technology, 52(11):44–48, Health Risks.
Series 26:143–165, 1990. 1998. 52. CDC, An Outbreak of Norwalk-like Virus
23. Dinovi, M., and S. Carberry, FDA 36b. Cady, J. R., Letter from the National Associated with a Juice Processor in
Memorandum to P. M. Bolger, Patulin in Food Processors Association. May 31, Georgia: Possible Environmental Health
Apple Juice, Estimate of Exposure, CSMP 1994. Antecedents. The Environmental Health
Request of 6–16–93, September 3, 1993. 37. FDA Enforcement Report for recall #F– Services Branch, National Center for
24. FDA, 2000, ‘‘Guidance for FDA 645/657–0 for undeclared egg and milk Environmental Health, Centers for
Components and Industry; Apple Juice, protein, August 2, 2000. Disease Control and Prevention, July 5,
Apple Juice Concentrates and Apple 38. FDA health hazard evaluation, 2000.
Juice Products—Adulteration with classification, and FDA Enforcement 53. Podoski, B.W., FDA Memorandum to the
Patulin; Draft Compliance Policy Guide,’’ Report for recall #F–250–4, January 27, File. Regulation of Intrastate Fresh Juice,
(also 65 FR 37791–37792, June 16, 2000) 1994, and February 9, 1994. 2000.
54. Buchanan, R.L., and M.H. Golden, 69. ICMSF, 1988, Microorganisms in Foods 4: 120.9 Legal basis.
‘‘Interactions between pH and malic acid Application of the Hazard Analysis 120.10 Corrective actions.
concentration on the inactivation of Critical Control Point (HACCP) System 120.11 Verification and validation.
Listeria monocytogenes,’’ Journal of Food to Ensure Microbiological Safety and 120.12 Records.
Safety, 18:37–48, 1998. Quality, Blackwell Scientific 120.13 Training.
55. Buchanan, R.L., and S.G. Edelson, ‘‘pH- Publications, Boston, p. 26. 120.14 Application of requirements to
Dependent Stationary-Phase Acid 70. FSIS, USDA, ‘‘Pathogen Reduction; imported products.
Resistance Response of Hazard Analysis and Critical Control Subpart B—Pathogen Reduction
Enterohemorrhagic Escherichia coli in Point (HACCP) Systems,’’ final rule with
the Presence of Various Acidulants,’’ request for comments, 9 CFR parts 304, 120.20 General.
Journal of Food Protection 62(3):211– 308, 310, 320, 327, 381, 416, and 417, 61 120.24 Process controls.
218, 1999. FR 38806–38855, July 25, 1996. 120.25 Process verification for certain
56. Dock, L.L., J.D. Floros, and R. H. Linton, 71. Garthright, W. E., S. Chirtel, and Q. processors.
‘‘Heat inactivation of Escherichia coli Graves, Derivation of Sampling Plan to Authority: 21 U.S.C. 321, 342, 343, 346,
O157:H7 in apple cider containing malic Meet the Testing Requirement in the 348, 371, 374, 379e, 381, 393; 42 U.S.C. 241,
acid, sodium benzoate, and potassium Juice HACCP Final Rule for Citrus Juices 242l, 264.
sorbate,’’ Journal of Food Protection, that Rely Solely or in Part on Surface
63(8):1026–1031, 2000. Treatments to Achieve the 5-Log Subpart A—General Provisions
57. Parish, M.E., J.A. Narciso, and L. M. Reduction Standard, 2000.
Friedrich, ‘‘Survival of Salmonellae in 72. CFSAN, FDA, Hazard Analysis and § 120.1 Applicability.
orange juice,’’ Journal of Food Safety, Critical Control Point (HACCP) Pilot (a) Any juice sold as such or used as
17:273–281, 1997. Program for Selected Food an ingredient in beverages shall be
58. Jay, J.M. 1996, ‘‘Indicators of Food Manufacturers; Second Interim Report of processed in accordance with the
Microbial Quality and Safety,’’ chapter Observations and Comments, October 31,
18, pp. 387–395, In Modern Food
requirements of this part. Juice means
1997. the aqueous liquid expressed or
Microbiology, 5th ed., Chapman & Hall, 73. Kaplan, R. M., J. P. Anderson, and T. G.
N.Y. extracted from one or more fruits or
Ganiats, ‘‘The Quality of Well-being
59. FDA, DHHS, ‘‘Guidance for Industry; Scale: Rationale for a Single Quality of vegetables, purees of the edible portions
Guide to Minimize Microbial Food Life Index,’’ In Quality of Life of one or more fruits or vegetables, or
Safety Hazards for Fresh Fruits and Assessment: Key Issues in the 1990s, any concentrates of such liquid or
Vegetables,’’ 1998. edited by Stuart R. Walker and Rachel M. puree. The requirements of this part
60. FDA, DHEW, Fish and Seafood Products, Rosser, pp. 65–94 and 442–444, The shall apply to any juice regardless of
Subpart A—Smoked and Smoke- Netherlands: Kluwar Academic whether the juice, or any of its
Flavored Fish, final rule, 21 CFR part Publishers, 1993. ingredients, is or has been shipped in
128a, 35 FR 17401–17402, November 13, 74. FDA, DHHS, ‘‘Irradiation in the
1970.
interstate commerce (as defined in
Production, Processing, and Handling of section 201(b) of the Federal Food,
61. FDA Memorandum to Patricia Spitzig Food,’’ final rule, 21 CFR part 179, 65 FR
from Oliver D. Cook, July 11, 1995, Drug, and Cosmetic Act, 21 U.S.C.
71056–71058, November 29, 2000.
concerning relationships between 75. Bluhm, L. and B. Podoski, FDA 321(b)). Raw agricultural ingredients of
consumer complaints and process Memorandum to the File, ‘‘Federalism juice are not subject to the requirements
controls. Implications’’—Fresh and Processed of this part. Processors should apply
62. FDA, DHHS, ‘‘Procedures for the Safe and Juices/State Regulations and Practices, existing agency guidance to minimize
Sanitary Processing and Importing of May 17, 2000. microbial food safety hazards for fresh
Fish and Fishery Products,’’ final rule, 76. Anderson, S., FDA Memorandum to the fruits and vegetables in handling raw
21 CFR parts 123 and 1240, 60 FR File, ‘‘Federalism Implications’’—Rule agricultural products.
65096–65202, at 65138, December 18, 20–49 of the Florida Department of
1995.
(b) The regulations in this part shall
Citrus, January 10, 2001. be effective January 22, 2002. However,
63. Buchanan, R.L., FDA Memorandum to the
Record, National Advisory Committee List of Subjects in 21 CFR Part 120 by its terms, this part is not binding on
Recommendations on Microbiological small and very small businesses until
Foods, Fruit juices, Imports,
Criteria for Foods, June 15, 1998. the dates listed in paragraphs (b)(1) and
Reporting and recordkeeping
64. FDA, FDA Technical Scientific Workshop (b)(2) of this section.
on How Citrus Juice Firms Can Achieve requirements, Vegetable juices. (1) For small businesses employing
5-log Pathogen Reduction. Transcript of Therefore, under the Federal Food, fewer than 500 persons the regulations
Public Meeting, November 12, and Drug, and Cosmetic Act, under the in this part are binding on January 21,
November 19, 1998. Public Health Service Act, and under 2003.
65. FDA, 2000, ‘‘Compilation of Juice/Cider authority delegated to the Commissioner (2) For very small businesses that
Outbreaks Associated with Microbial of Food and Drugs, 21 CFR chapter I is
Hazards’’ (1974–2000), July 21, 2000.
have either total annual sales of less
66. Kautter, D.A., FDA Memorandum to K.
amended as follows: than $500,000, or if their total annual
Carson, Revised Synopsis of NACMCF 1. Part 120 is added to read as follows: sales are greater than $500,000 but their
Discussions, March 20, 2000 and October total food sales are less than $50,000; or
24, 2000. PART 120—HAZARD ANALYSIS AND the person claiming this exemption
67. FDA memorandum to Robert Buchanan CRITICAL CONTROL POINT (HACCP) employed fewer than an average of 100
from Sherri McGarry and John Sanders, SYSTEMS full-time equivalent employees and
February 23, 2000, concerning fewer than 100,000 units of juice were
Salmonella outbreak associated with Subpart A—General Provisions
sold in the United States, the
orange juice. FDA memorandum from Sec.
Maxine Heinitz, August 19, 1999, 120.1 Applicability.
regulations are binding on January 20,
concerning update to Salmonella 120.3 Definitions. 2004.
database. 120.5 Current good manufacturing practice. § 120.3 Definitions.
68. Larkin, J.W., FDA Memorandum to 120.6 Sanitation standard operating
OPDFB, Microbiological Critical Control procedures. The definitions of terms in section
Point for Certain Shelf-stable and 120.7 Hazard analysis. 201 of the Federal Food, Drug, and
Concentrated Juice Products, September 120.8 Hazard Analysis and Critical Control Cosmetic Act, § 101.9(j)(18)(vi), and part
29, 2000. Point (HACCP) plan. 110 of this chapter are applicable to
such terms when used in this part, in a foreign country, including any adulteration with lubricants, fuel,
except where redefined in this part. The person engaged in the processing of pesticides, cleaning compounds,
following definitions shall also apply: juice products that are intended for use sanitizing agents, condensate, and other
(a) Cleaned means washed with water in market or consumer tests. chemical, physical, and biological
of adequate sanitary quality. (l) Retail establishment is an contaminants;
(b) Control means to prevent, operation that provides juice directly to (6) Proper labeling, storage, and use of
eliminate, or reduce. the consumers and does not include an toxic compounds;
(c) Control measure means any action establishment that sells or distributes (7) Control of employee health
or activity to prevent, reduce to juice to other business entities as well conditions that could result in the
acceptable levels, or eliminate a hazard. as directly to consumers. ‘‘Provides’’ microbiological contamination of food,
(d) Critical control point means a includes storing, preparing, packaging, food packaging materials, and food
point, step, or procedure in a food serving, and vending. contact surfaces; and
process at which a control measure can (m) Shall is used to state mandatory (8) Exclusion of pests from the food
be applied and at which control is requirements. plant.
essential to reduce an identified food (n) Shelf-stable product means a (b) Monitoring. The processor shall
hazard to an acceptable level. product that is hermetically sealed and, monitor the conditions and practices
(e) Critical limit means the maximum when stored at room temperature, during processing with sufficient
or minimum value to which a physical, should not demonstrate any microbial frequency to ensure, at a minimum,
biological, or chemical parameter must growth. conformance with those conditions and
be controlled at a critical control point (o) Should is used to state practices specified in part 110 of this
to prevent, eliminate, or reduce to an recommended or advisory procedures or chapter that are appropriate both to the
acceptable level the occurrence of the to identify recommended equipment. plant and to the food being processed.
identified food hazard. (p) Validation means that element of Each processor shall correct, in a timely
(f) Culled means separation of verification focused on collecting and manner, those conditions and practices
damaged fruit from undamaged fruit. evaluating scientific and technical that are not met.
For processors of citrus juices using information to determine whether the (c) Records. Each processor shall
treatments to fruit surfaces to comply HACCP plan, when properly maintain SSOP records that, at a
with § 120.24, culled means undamaged, implemented, will effectively control minimum, document the monitoring
tree-picked fruit that is U.S. Department the identified food hazards. and corrections prescribed by paragraph
of Agriculture choice or higher quality. (q) Verification means those activities, (b) of this section. These records are
(g) Food hazard means any biological, other than monitoring, that establish the subject to the recordkeeping
chemical, or physical agent that is validity of the HACCP plan and that the requirements of § 120.12.
reasonably likely to cause illness or system is operating according to the (d) Relationship to Hazard Analysis
injury in the absence of its control. plan. and Critical Control Point (HACCP)
(h) Importer means either the U.S. plan. Sanitation standard operating
owner or consignee at the time of entry § 120.5 Current good manufacturing procedure controls may be included in
of a food product into the United States, practice. the HACCP plan required under
or the U.S. agent or representative of the Part 110 of this chapter applies in § 120.8(b). However, to the extent that
foreign owner or consignee at the time determining whether the facilities, they are implemented in accordance
of entry into the United States. The methods, practices, and controls used to with this section, they need not be
importer is responsible for ensuring that process juice are safe, and whether the included in the HACCP plan.
goods being offered for entry into the food has been processed under sanitary
United States are in compliance with all conditions. § 120.7 Hazard analysis.
applicable laws. For the purposes of this (a) Each processor shall develop, or
definition, the importer is ordinarily not § 120.6 Sanitation standard operating have developed for it, a written hazard
procedures. analysis to determine whether there are
the custom house broker, the freight
forwarder, the carrier, or the steamship (a) Sanitation controls. Each processor food hazards that are reasonably likely
representative. shall have and implement a sanitation to occur for each type of juice processed
(i) Monitor means to conduct a standard operating procedure (SSOP) by that processor and to identify control
planned sequence of observations or that addresses sanitation conditions and measures that the processor can apply to
measurements to assess whether a practices before, during, and after control those hazards. The written
process, point, or procedure is under processing. The SSOP shall address: hazard analysis shall consist of at least
control and to produce an accurate (1) Safety of the water that comes into the following:
record for use in verification. contact with food or food contact (1) Identification of food hazards;
(j)(1) Processing means activities that surfaces or that is used in the (2) An evaluation of each food hazard
are directly related to the production of manufacture of ice; identified to determine if the hazard is
juice products. (2) Condition and cleanliness of food reasonably likely to occur and thus,
(2) For purposes of this part, contact surfaces, including utensils, constitutes a food hazard that must be
processing does not include: gloves, and outer garments; addressed in the HACCP plan. A food
(i) Harvesting, picking, or transporting (3) Prevention of cross contamination hazard that is reasonably likely to occur
raw agricultural ingredients of juice from insanitary objects to food, food is one for which a prudent processor
products, without otherwise engaging in packaging material, and other food would establish controls because
processing; and contact surfaces, including utensils, experience, illness data, scientific
(ii) The operation of a retail gloves, and outer garments, and from reports, or other information provide a
establishment. raw product to processed product; basis to conclude that there is a
(k) Processor means any person (4) Maintenance of hand washing, reasonable possibility that, in the
engaged in commercial, custom, or hand sanitizing, and toilet facilities; absence of those controls, the food
institutional processing of juice (5) Protection of food, food packaging hazard will occur in the particular type
products, either in the United States or material, and food contact surfaces from of product being processed. This
evaluation shall include an assessment individual or individuals who have they are not required to be included in
of the severity of the illness or injury if been trained in accordance with the HACCP plan.
the food hazard occurs; § 120.13 and shall be subject to the
(3) Identification of the control recordkeeping requirements of § 120.12. § 120.9 Legal basis.
measures that the processor can apply to A HACCP plan shall be specific to: Failure of a processor to have and to
control the food hazards identified as (1) Each location where juice is implement a Hazard Analysis and
reasonably likely to occur in paragraph processed by that processor; and Critical Control Point (HACCP) system
(a)(2) of this section; (2) Each type of juice processed by the that complies with §§ 120.6, 120.7, and
(4) Review of the current process to processor. The plan may group types of 120.8, or otherwise to operate in
determine whether modifications are juice products together, or group types accordance with the requirements of
necessary; and of production methods together, if the this part, shall render the juice products
(5) Identification of critical control food hazards, critical control points, of that processor adulterated under
points. critical limits, and procedures required section 402(a)(4) of the Federal Food,
(b) The hazard analysis shall include to be identified and performed by Drug, and Cosmetic Act. Whether a
food hazards that can be introduced paragraph (b) of this section are processor’s actions are consistent with
both within and outside the processing essentially identical, provided that any ensuring the safety of juice will be
plant environment, including food required features of the plan that are determined through an evaluation of the
hazards that can occur before, during, unique to a specific product or method processor’s overall implementation of
and after harvest. The hazard analysis are clearly delineated in the plan and its HACCP system.
shall be developed by an individual or are observed in practice.
§ 120.10 Corrective actions.
individuals who have been trained in (b) The contents of the HACCP plan.
accordance with § 120.13 and shall be The HACCP plan shall, at a minimum: Whenever a deviation from a critical
subject to the recordkeeping (1) List all food hazards that are limit occurs, a processor shall take
requirements of § 120.12. reasonably likely to occur as identified corrective action by following the
(c) In evaluating what food hazards in accordance with § 120.7, and that procedures set forth in paragraph (a) or
are reasonably likely to occur, thus must be controlled for each type of paragraph (b) of this section.
consideration should be given, at a product; (a) Processors may develop written
minimum, to the following: (2) List the critical control points for corrective action plans, which become
(1) Microbiological contamination; each of the identified food hazards that part of their HACCP plans in accordance
(2) Parasites; is reasonably likely to occur, including with § 120.8(b)(5), by which processors
(3) Chemical contamination; as appropriate: predetermine the corrective actions that
(4) Unlawful pesticides residues; (i) Critical control points designed to they will take whenever there is a
(5) Decomposition in food where a control food hazards that are reasonably deviation from a critical limit. A
food hazard has been associated with likely to occur and could be introduced corrective action plan that is
decomposition; inside the processing plant appropriate for a particular deviation is
(6) Natural toxins; environment; and one that describes the steps to be taken
(7) Unapproved use of food or color (ii) Critical control points designed to and assigns responsibility for taking
additives; control food hazards introduced outside those steps, to ensure that:
(8) Presence of undeclared ingredients the processing plant environment, (1) No product enters commerce that
that may be allergens; and including food hazards that occur is either injurious to health or is
(9) Physical hazards. before, during, and after harvest; otherwise adulterated as a result of the
(d) Processors should evaluate (3) List the critical limits that shall be deviation; and
product ingredients, processing met at each of the critical control points; (2) The cause of the deviation is
procedures, packaging, storage, and (4) List the procedures, and the corrected.
intended use; facility and equipment frequency with which they are to be (b) When a deviation from a critical
function and design; and plant performed, that will be used to monitor limit occurs, and the processor does not
sanitation, including employee hygiene, each of the critical control points to have a corrective action plan that is
to determine the potential effect of each ensure compliance with the critical appropriate for that deviation, the
on the safety of the finished food for the limits; processor shall:
intended consumer. (5) Include any corrective action plans (1) Segregate and hold the affected
(e) HACCP plans for juice need not that have been developed in accordance product, at least until the requirements
address the food hazards associated with § 120.10(a), and that are to be of paragraphs (b)(2) and (b)(3) of this
with microorganisms and microbial followed in response to deviations from section are met;
toxins that are controlled by the critical limits at critical control points; (2) Perform or obtain a review to
requirements of part 113 or part 114 of (6) List the validation and verification determine the acceptability of the
this chapter. A HACCP plan for such procedures, and the frequency with affected product for distribution. The
juice shall address any other food which they are to be performed, that the review shall be performed by an
hazards that are reasonably likely to processor will use in accordance with individual or individuals who have
occur. § 120.11; and adequate training or experience to
(7) Provide for a recordkeeping system perform such review;
§ 120.8 Hazard Analysis and Critical that documents the monitoring of the (3) Take corrective action, when
Control Point (HACCP) plan. critical control points in accordance necessary, with respect to the affected
(a) HACCP plan. Each processor shall with § 120.12. The records shall contain product to ensure that no product enters
have and implement a written HACCP the actual values and observations commerce that is either injurious to
plan whenever a hazard analysis reveals obtained during monitoring. health or is otherwise adulterated as a
one or more food hazards that are (c) Sanitation. Sanitation controls result of the deviation;
reasonably likely to occur during may be included in the HACCP plan. (4) Take corrective action, when
processing, as described in § 120.7. The However, to the extent that they are necessary, to correct the cause of the
HACCP plan shall be developed by an monitored in accordance with § 120.6, deviation; and
(5) Perform or obtain timely that these activities occurred in been trained in accordance with
verification in accordance with § 120.11, accordance with the processor’s written § 120.13, and, records documenting the
by an individual or individuals who procedures. These reviews shall occur validation shall be subject to the
have been trained in accordance with within a reasonable time after the recordkeeping requirements of § 120.12.
§ 120.13, to determine whether records are made; and
modification of the HACCP plan is (v) The following of procedures in § 120.12 Records.
required to reduce the risk of recurrence § 120.10 whenever any verification (a) Required records. Each processor
of the deviation, and to modify the procedure, including the review of shall maintain the following records
HACCP plan as necessary. consumer complaints, establishes the documenting the processor’s Hazard
(c) All corrective actions taken in need to take a corrective action; and Analysis and Critical Control Point
accordance with this section shall be (vi) Additional process verification if (HACCP) system:
fully documented in records that are required by § 120.25. (1) Records documenting the
subject to verification in accordance (2) Records that document the implementation of the sanitation
with § 120.11(a)(1)(iv)(B) and the calibration of process monitoring standard operating procedures (SSOP’s)
recordkeeping requirements of § 120.12. instruments, in accordance with (see § 120.6);
paragraph (a)(1)(iv)(B) of this section, (2) The written hazard analysis
§ 120.11 Verification and validation. and the performance of any periodic required by § 120.7;
(a) Verification. Each processor shall end-product and in-process testing, in (3) The written HACCP plan required
verify that the Hazard Analysis and accordance with paragraph (a)(1)(iv)(C) by § 120.8;
Critical Control Point (HACCP) system of this section, are subject to the (4) Records documenting the ongoing
is being implemented according to recordkeeping requirements of § 120.12. application of the HACCP plan that
design. (b) Validation of the HACCP plan. include:
(1) Verification activities shall Each processor shall validate that the (i) Monitoring of critical control
include: HACCP plan is adequate to control food points and their critical limits,
(i) A review of any consumer hazards that are reasonably likely to including the recording of actual times,
complaints that have been received by occur; this validation shall occur at least temperatures, or other measurements, as
the processor to determine whether once within 12 months after prescribed in the HACCP plan; and
such complaints relate to the implementation and at least annually (ii) Corrective actions, including all
performance of the HACCP plan or thereafter or whenever any changes in actions taken in response to a deviation;
reveal previously unidentified critical the process occur that could affect the and
control points; hazard analysis or alter the HACCP plan (5) Records documenting verification
(ii) The calibration of process in any way. Such changes may include of the HACCP system and validation of
monitoring instruments; changes in the following: Raw materials the HACCP plan or hazard analysis, as
(iii) At the option of the processor, the or source of raw materials; product appropriate.
performance of periodic end-product or formulation; processing methods or (b) General requirements. All records
in-process testing; except that systems, including computers and their required by this part shall include:
processors of citrus juice that rely in software; packaging; finished product (1) The name of the processor or
whole or in part on surface treatment of distribution systems; or the intended importer and the location of the
fruit shall perform end-product testing use or consumers of the finished processor or importer, if the processor
in accordance with § 120.25. product. The validation shall be or importer has more than one location;
(iv) A review, including signing and performed by an individual or (2) The date and time of the activity
dating, by an individual who has been individuals who have been trained in that the record reflects, except that
trained in accordance with § 120.13, of accordance with § 120.13 and shall be records required by paragraphs (a)(2),
the records that document: subject to the recordkeeping (a)(3), and (a)(5) of this section need not
(A) The monitoring of critical control requirements of § 120.12. The HACCP include the time;
points. The purpose of this review shall plan shall be modified immediately (3) The signature or initials of the
be, at a minimum, to ensure that the whenever a validation reveals that the person performing the operation or
records are complete and to verify that plan is no longer adequate to fully meet creating the record; and
the records document values that are the requirements of this part. (4) Where appropriate, the identity of
within the critical limits. This review (c) Validation of the hazard analysis. the product and the production code, if
shall occur within 1 week (7 days) of the Whenever a juice processor has no any. Processing and other information
day that the records are made; HACCP plan because a hazard analysis shall be entered on records at the time
(B) The taking of corrective actions. has revealed no food hazards that are that it is observed. The records shall
The purpose of this review shall be, at reasonably likely to occur, the processor contain the actual values and
a minimum, to ensure that the records shall reassess the adequacy of that observations obtained during
are complete and to verify that hazard analysis whenever there are any monitoring.
appropriate corrective actions were changes in the process that could (c) Documentation. (1) The records in
taken in accordance with § 120.10. This reasonably affect whether a food hazard paragraphs (a)(2) and (a)(3) of this
review shall occur within 1 week (7 exists. Such changes may include section shall be signed and dated by the
days) of the day that the records are changes in the following: Raw materials most responsible individual onsite at
made; and or source of raw materials; product the processing facility or by a higher
(C) The calibrating of any process formulation; processing methods or level official of the processor. These
monitoring instruments used at critical systems, including computers and their signatures shall signify that these
control points and the performance of software; packaging; finished product records have been accepted by the firm.
any periodic end-product or in-process distribution systems; or the intended (2) The records in paragraphs (a)(2)
testing that is part of the processor’s use or intended consumers of the and (a)(3) of this section shall be signed
verification activities. The purpose of finished product. The validation of the and dated:
these reviews shall be, at a minimum, to hazard analysis shall be performed by (i) Upon initial acceptance;
ensure that the records are complete and an individual or individuals who have (ii) Upon any modification; and
(iii) Upon verification and validation (2) Developing a Hazard Analysis and (A) Obtaining from the foreign
in accordance with § 120.11. Critical Control Point (HACCP) plan that processor the Hazard Analysis and
(d) Record retention. (1) All records is appropriate for a specific processor, Critical Control Point (HACCP) plan and
required by this part shall be retained at in order to meet the requirements of prerequisite program of the standard
the processing facility or at the § 120.8; operating procedure records required by
importer’s place of business in the (3) Verifying and modifying the this part that relate to the specific lot of
United States for, in the case of HACCP plan in accordance with the food being offered for import;
perishable or refrigerated juices, at least corrective action procedures specified
1 year after the date that such products in § 120.10(b)(5) and the validation (B) Obtaining either a continuing or
were prepared, and for, in the case of activities specified in § 120.11(b) and lot specific certificate from an
frozen, preserved, or shelf stable (c); and § 120.7; appropriate foreign government
products, 2 years or the shelf life of the (4) Performing the record review inspection authority or competent third
product, whichever is greater, after the required by § 120.11(a)(1)(iv). party certifying that the imported food
date that the products were prepared. (b) The individual performing the has been processed in accordance with
(2) Offsite storage of processing functions listed in paragraph (a) of this the requirements of this part;
records required by paragraphs (a)(1) section shall have successfully (C) Regularly inspecting the foreign
and (a)(4) of this section is permitted completed training in the application of processor’s facilities to ensure that the
after 6 months following the date that HACCP principles to juice processing at imported food is being processed in
the monitoring occurred, if such records least equivalent to that received under accordance with the requirements of
can be retrieved and provided onsite standardized curriculum recognized as
this part;
within 24 hours of request for official adequate by the Food and Drug
review. Electronic records are Administration, or shall be otherwise (D) Maintaining on file a copy, in
considered to be onsite if they are qualified through job experience to English, of the foreign processor’s
accessible from an onsite location and perform these functions. Job experience hazard analysis and HACCP plan, and a
comply with paragraph (g) of this may qualify an individual to perform written guarantee from the foreign
section. these functions if such experience has processor that the imported food is
(3) If the processing facility is closed provided knowledge at least equivalent processed in accordance with the
for a prolonged period between seasonal to that provided through the requirements of this part;
packs, the records may be transferred to standardized curriculum. The trained (E) Periodically testing the imported
some other reasonably accessible individual need not be an employee of food, and maintaining on file a copy, in
location at the end of the seasonal pack the processor.
but shall be immediately returned to the English, of a written guarantee from the
processing facility for official review § 120.14 Application of requirements to foreign processor that the imported food
upon request. imported products. is processed in accordance with the
(e) Official review. All records This section sets forth specific requirements of this part; or
required by this part shall be available requirements for imported juice. (F) Other such verification measures
for review and copying at reasonable (a) Importer requirements. Every as appropriate that provide an
times. importer of juice shall either: equivalent level of assurance of
(f) Public disclosure. (1) All records (1) Obtain the juice from a country
compliance with the requirements of
required by this part are not available that has an active memorandum of
this part.
for public disclosure unless they have understanding (MOU) or similar
been previously disclosed to the public, agreement with the Food and Drug (b) Competent third party. An
as defined in § 20.81 of this chapter, or Administration, that covers the food and importer may hire a competent third
unless they relate to a product or documents the equivalency or party to assist with or perform any or all
ingredient that has been abandoned and compliance of the inspection system of of the verification activities specified in
no longer represent a trade secret or the foreign country with the U.S. paragraph (a)(2) of this section,
confidential commercial or financial system, accurately reflects the including writing the importer’s
information as defined in § 20.61 of this relationship between the signing parties, verification procedures on the
chapter. and is functioning and enforceable in its importer’s behalf.
(2) Records required to be maintained entirety; or (c) Records. The importer shall
by this part are subject to disclosure to (2) Have and implement written
maintain records, in English, that
the extent that they are otherwise procedures for ensuring that the juice
document the performance and results
publicly available, or that disclosure that such importer receives for import
into the United States was processed in of the affirmative steps specified in
could not reasonably be expected to
accordance with the requirements of paragraph (a)(2)(ii) of this section. These
cause a competitive hardship, such as
this part. The procedures shall provide, records shall be subject to the applicable
generic type HACCP plans that reflect
standard industry practices. at a minimum: provisions of § 120.12.
(g) Records maintained on computers. (i) Product specifications that are (d) Determination of compliance. The
The maintenance of computerized designed to ensure that the juice is not importer shall provide evidence that all
records, in accordance with part 11 of adulterated under section 402 of the juice offered for entry into the United
this chapter, is acceptable. § 120.13 Federal Food, Drug, and Cosmetic Act States has been processed under
Training. because it may be injurious to health or conditions that comply with this part. If
(a) Only an individual who has met because it may have been processed assurances do not exist that an imported
the requirements of paragraph (b) of this under insanitary conditions; and juice has been processed under
section shall be responsible for the (ii) Affirmative steps to ensure that conditions that are equivalent to those
following functions: the products being offered for entry required of domestic processors under
(1) Developing the hazard analysis, were processed under controls that meet
this part, the product will appear to be
including delineating control measures, the requirements of this part. These
adulterated and will be denied entry.
as required by § 120.7. steps may include any of the following:
Subpart B—Pathogen Reduction § 120.25 Process verification for certain (v) MUG positive and negative
processors. controls should be used as reference in
§ 120.20 General. Each juice processor that relies on interpreting fluorescence reactions. Use
This subpart augments subpart A of treatments that do not come into direct an E. coli for positive control and 2
this part by setting forth specific contact with all parts of the juice to negative controls—a MUG negative
requirements for process controls. achieve the requirements of § 120.24 strain and an uninoculated tube media.
shall analyze the finished product for (d) If either 10 mL subsample is
§ 120.24 Process controls. biotype I Escherichia coli as follows: positive for E. coli, the 20 mL sample is
(a) In order to meet the requirements (a) One 20 milliliter (mL) sample recorded as positive and the processor
of subpart A of this part, processors of (consisting of two 10 mL subsamples) shall:
juice products shall include in their for each 1,000 gallons of juice produced (1) Review monitoring records for the
Hazard Analysis and Critical Control shall be sampled each production day. control measures to attain the 5-log
Point (HACCP) plans control measures If less than 1,000 gallons of juice is reduction standard and correct those
that will consistently produce, at a produced per day, the sample must be conditions and practices that are not
minimum, a 5 log (i.e., 105) reduction, taken for each 1,000 gallons produced met. In addition, the processor may
for a period at least as long as the shelf but not less than once every 5 working choose to test the sample for the
life of the product when stored under days that the facility is producing that presence of pathogens of concern.
normal and moderate abuse conditions, juice. Each subsample shall be taken by (2) If the review of monitoring records
in the pertinent microorganism. For the randomly selecting a package of juice or the additional testing indicates that
purposes of this regulation, the ready for distribution to consumers. the 5-log reduction standard was not
‘‘pertinent microorganism’’ is the most (b) If the facility is producing more achieved (e.g., a sample is found to be
resistant microorganism of public health than one type of juice covered by this positive for the presence of a pathogen
significance that is likely to occur in the section, processors shall take or a deviation in the process or its
juice. The following juice processors are subsamples according to paragraph (a) delivery is identified), the processor
exempt from this paragraph: of this section for each of the covered shall take corrective action as set forth
juice products produced. in § 120.10.
(1) A juice processor that is subject to (c) Processors shall analyze each
the requirements of part 113 or part 114 (e) If two samples in a series of seven
subsample for the presence of E. coli by tests are positive for E. coli, the control
of this chapter; and the method entitled ‘‘Analysis for measures to attain the 5-log reduction
(2) A juice processor using a single Escherichia coli in Citrus Juices— standard shall be deemed to be
thermal processing step sufficient to Modification of AOAC Official Method inadequate and the processor shall
achieve shelf-stability of the juice or a 992.30’’ or another method that is at immediately:
thermal concentration process that least equivalent to this method in terms (1) Until corrective actions are
includes thermal treatment of all of accuracy, precision, and sensitivity in completed, use an alternative process or
ingredients, provided that the processor detecting E. coli. This method is processes that achieve the 5-log
includes a copy of the thermal process designed to detect the presence or reduction after the juice has been
used to achieve shelf-stability or absence of E. coli in a 20 mL sample of expressed;
concentration in its written hazard juice (consisting of two 10 mL
(2) Perform a review of the monitoring
analysis required by § 120.7. subsamples). The method is as follows:
records for control measures to attain
(b) All juice processors shall meet the (1) Sample size. Total-20 mL of juice;
the 5-log reduction standard. The
requirements of paragraph (a) of this perform analysis using two 10 mL
review shall be sufficiently extensive to
section through treatments that are aliquots.
(2) Media. Universal Preenrichment determine that there are no trends
applied directly to the juice, except that towards loss of control;
citrus juice processors may use Broth (Difco, Detroit, MI), EC Broth
(various manufacturers). (i) If the conditions and practices are
treatments to fruit surfaces, provided not being met, correct those that do not
that the 5-log reduction process begins (3) Method. ColiComplete (AOAC
Official Method 992.30—modified). conform to the HACCP plan; or
after culling and cleaning as defined in (ii) If the conditions and practices are
(4) Procedure. Perform the following
§ 120.3(a) and (f) and the reduction is being met, the processor shall validate
procedure two times:
accomplished within a single (i) Aseptically inoculate 10 mL of the HACCP plan in relation to the 5-log
production facility. juice into 90 mL of Universal reduction standard; and
(c) All juice processors shall meet the Preenrichment Broth (Difco) and (3) Take corrective action as set forth
requirements of paragraphs (a) and (b) of incubate at 35 °C for 18 to 24 hours. in § 120.10. Corrective actions shall
this section and perform final product (ii) Next day, transfer 1 mL of include ensuring no product enters
packaging within a single production preenriched sample into 10 mL of EC commerce that is injurious to health as
facility operating under current good Broth, without durham gas vials. After set forth in § 120.10(a)(1).
manufacturing practices. Processors inoculation, aseptically add a Dated: December 20, 2000.
claiming an exemption under paragraph ColiComplete SSD disc into each tube. Jane E. Henny,
(a)(1) or (a)(2) of this section shall also (iii) Incubate at 44.5 °C for 18 to 24
process and perform final product Commissioner of Food and Drugs.
hours.
packaging of all juice subject to the (iv) Examine the tubes under Donna E. Shalala,
claimed exemption within a single longwave ultra violet light (366 nm). Secretary of Health and Human Services.
production facility operating under Fluorescent tubes indicate presence of [FR Doc. 01–1291 Filed 1–18–01; 8:45 am]
current good manufacturing practices. E. coli. BILLING CODE 4160–01–P

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Friday,

January 19, 2001

21 CFR Part 120

TABLE 2.—JUICE OUTBREAKS (1992 TO 2000) USED TO CALCULATE BENEFITS

Orange juice, 1994 ........................................................................ B. cereus .................................. 85 FDA recall data.

TABLE 3.—JUICE OUTBREAKS (1992 TO 2000) NOT USED TO CALCULATE BENEFITS

Mild .................................................................................. 99 3,390

TABLE 9.—ESTIMATES OF JUICE-ASSOCIATED CASES PER YEAR PREVENTED BY HACCP RULE

Mild .................................................................................. 99 340

TABLE 14.—PLANTS’ PRODUCTION PERIOD

Seasonal .................................................................................................................................................. 16 12 1,875

TABLE 15.—TOTAL ANNUAL COST OF SOP MONITORING AND DOCUMENTING

Seasonal ...................................................................................................................................... $100 1,662 $166,000

Totals .................................................................................................................................... 1,875 238,000

TABLE 17.—FIRST YEAR COST OF PATHOGEN CONTROL ATTRIBUTABLE TO HACCP PROPOSAL

Very small apple juice processors ....................................................................................... $18,000–$30,000 850 $15,300,000–

Total .............................................................................................................................. .............................. 1,170 21,400,000–

TABLE 18.—SUBSEQUENT YEAR COST OF PATHOGEN CONTROL ATTRIBUTABLE TO HACCP RULE

Very small apple juice processors ............................................................................................... $7,000 850 $5,950,000

Total ...................................................................................................................................... ........................ 1,170 8,210,000

TABLE 19.—COST OF FIRST YEAR CORRECTIVE ACTIONS

Seasonal ...................................................................................................................................... $450 1,490 $671,000

Totals .................................................................................................................................... 1,560 773,000

TABLE 20.—COST OF SUBSEQUENT YEAR CORRECTIVE ACTIONS

Seasonal ...................................................................................................................................... $110 1,490 $164,000

Totals .................................................................................................................................... 1,560 188,000

TABLE 21.—COST OF RECORD VERIFICATION

Seasonal ...................................................................................................................................... $420 1,490 $626,000

Totals .................................................................................................................................... ........................ 1,560 721,000

TABLE 22.—COST OF FIRST YEAR VALIDATION

Seasonal Small Business ................................................................................................ 1 $1,000 1,640 $1,640,000

Totals ........................................................................................................................ 2,265 .................... 2,065 $2,163,000

TABLE 23.—COST OF SUBSEQUENT YEAR VALIDATION

Seasonal Small Business ................................................................................................ 1 $1,000 1,490 $1,490,000

Totals ........................................................................................................................ 1,630 .................... 1,560 1,602,000

TABLE 24.—ESTIMATED COST FOR VERIFICATION SAMPLING

Every 5 days .................................................................................................................... 16 180 $50 $144,000

Total .......................................................................................................................... 10,720 240 .................... $534,000

TABLE 25.—COST OF MONITORING AND RECORDKEEPING

Seasonal .................................................................................................................... $900 1,490 $1,341,000

Totals .................................................................................................................. .............................. 1,560 $1,733,000

TABLE 26.—COST OF RECORD MAINTENANCE

Seasonal .................................................................................................................... $360 1,490 $536,000

Totals .................................................................................................................. .............................. 1,560 $694,000

3 ....................................................................................................................................... 3 $100 1,459 $437,700

Totals ........................................................................................................................ 5,160 .................... 1,560 $516,000

C. TABLE 28.—TOTAL FIRST YEAR AND RECURRING COST PER ACTIVITY

Develop SOP’s ............................................................................................................................................ $488,000 ..............................

Totals .................................................................................................................................................... 44,000,000– 23,000,000

Totals ..................................................... .............................. ................................................................ .............................. 2,125

Develop SOP’s ............................................................................................................................................ $260

Totals .................................................................................................................................................... 24,700–36,700 10,600

Monitoring and documenting of SOP’s ........................................................................................................ $340 $340

Totals .................................................................................................................................................... 2,900 300

Develop SOP’s ............................................................................................................................................ $260

Totals .................................................................................................................................................... 43,100–55,100 28,300

Develop SOP’s ............................................................................................................................................ $260

Sanitation SOP’s .......................................................................................................................................... 500

Totals .................................................................................................................................................... 24,000 20,000

Hazard analysis ........................................................................................................................................... $250

Totals .................................................................................................................................................... 2,000 $0

TABLE 35.—PROFESSIONAL SKILLS REQUIRED FOR COMPLIANCE

TABLE 35.—PROFESSIONAL SKILLS REQUIRED FOR COMPLIANCE—Continued