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Caswell 1996
Caswell 1996
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(e.g., as part of a "due diligence" defense), and differences between regulatory systems, of-
to provide and promote confidence in the prod- ten based on voluntary international codes
uct. In addition, a HACCP system can increase of practice (sometimes called alignment).
the participation of all of the work force, as ad-
vocated by management systems such as Total It is useful to consider these strategies as a
Quality Management; serve as a step toward a spectrum, as presented in figure 1. The con-
larger quality management program, such as In- tinuum begins with no rapprochement; moves
ternational Organization for Standardization to coordination, which is a broad range of weak
(ISO) accreditation; and prove to be a cost-ef- forms of rapprochement;then to mutual recog-
fective technique by which the process is up- nition; and finally to the strongest level of rap-
dated (Mortimore and Wallace). prochement, harmonization.
Harmonization has most often been applied
via minimum input, process, or product perfor-
HACCPin the Context of Recent Trade mance standards for particular food attributes.
Agreements Mutual recognition involves agreement among
a group of countries that a good legally pro-
Barriers to trade posed by tariffs have been duced within the bloc will be legal for sale
steadily declining under evolving international throughout the bloc regardless of whether it
trade relationships. The recently completed meets the host country's domestic standards. It
Uruguay Round of the General Agreement on has most often been applied to value attributes
Tariffs and Trade/World Trade Organization (e.g., recipe standards) because countries fre-
(GATT/WTO), for example, continues this pro- quently do not like to give up control over food
cess by reducing tariff levels on agri-food prod- safety. Coordinationcovers a wide variety of ef-
ucts and initiating tariffication of some forts to align policy through consultations, adop-
nontariff barriers to trade. In this setting, con- tion of voluntary standards,and other means. A
cern has focused on the potential for an open- total lack of rapprochement is possible but in-
ing of the floodgates of other types of nontariff creasingly rare as international trading relation-
barriers to trade. To keep the gates closed, trade ships take on growing importance for countries.
agreements and trading blocs have turned to The efficacy of HACCP as an international
adoption of provisions such as those in the trade standard will depend on the degree to
WTO and North American Free Trade Agree- which regulatory rapprochementbetween coun-
ment (NAFTA) on sanitary and phytosanitary tries is exercised in its adoption. Trade facilita-
(SPS) regulations. These agreements for the tion requires that differences in applying
first time specify that national-level regulations HACCP principles between nations and trading
must be based on appropriate science and risk blocs be reconciled by some form of regulatory
assessment processes and be applied evenly to rapprochement that works out the degree of
domestic and imported products. The overall equivalency between HACCP regimes. HACCP
goal is an equivalency of the effect of regula- as a case study will highlight the relative abili-
tions, not the regulations themselves. These ties of the rapprochement approaches used by
agreements also strongly emphasize increasing trading partners to lessen nontariff barriers to
the openness and transparencyof national-level trade that can arise as it is applied.
regulations (Hooker and Caswell). Regulations
that do not fit these criteria may be challenged
under the WTO agreement. HACCPas an InternationalRegulatory
A concerted, cooperative effort to address Standard
nontariff barriers to trade arising from country-
level regulation requires coordinated activity,Differences arise when HACCP becomes a
which we term regulatory rapprochement. regulatory regime rather than maintaining its
Strategies for rapprochement can be grouped original form as a voluntarily adopted manage-
into three categories (Jacobs): ment tool. When used by a company, HACCP is
a process-oriented means to attain a perfor-
* Harmonization: standardization of regula- mance goal of safe products. But is HACCP a
tions in identical form; performance or process standard when it be-
* Mutual recognition: acceptance of regulatory comes a government regulatory requirement?
diversity as meeting common goals (some- The answer depends on how the government
times called reciprocityor equivalency);and implements HACCP. It will predominantly be a
* Coordination: gradual narrowing of relevant performance standardif regulators require com-
Level of Rapprochement
Methodsof Rapprochement
panies to develop and implement a HACCP Canada and the United States pursuing HACCP
plan but do not specify its elements in detail. If plans in parallel.3 Canada's adoption is most
particular elements are specified (e.g., carcass advanced (with a planned implementation date
chilling temperaturesin the processing plant), it of April 1996 for all agri-food sectors), while
becomes a process standard. U.S. HACCP plans for seafood, meat, and poul-
Whether HACCP is implemented primarily as try are at the proposal or early implementation
a performance or process standardwill be a sig- stage. While the parallel movement toward
nificant determinant of how it functions as an HACCP may ease regulatory differences be-
international trade standard. Codex and other tween the United States and Canada, neither
consensus-building groups have formally full mutual recognition or harmonization is an-
adopted the same HACCP principles but do not ticipated in the foreseeable future. For example,
give detailed guidance on HACCP implementa- in its HACCP proposal for meat and poultry, the
tion. Thus, for example, countries may follow U.S. Departmentof Agriculture'sFood Safety and
Codex on HACCP but still have markedly dif- Inspection Service (FSIS) anticipates relying on
ferent regulatory programs. Performance stan- current procedures to review foreign countries'
dards are thought to be more amenable to har- inspection systems to ensure their approaches
monization across countries and more condu- to food safety are equal to that of the United
cive to trade. They are encouraged over process States. Differences in microbiological food
standards in recent trade agreements. safety regulation between the trading partners
are likely to continue to have the potential to
pose significant nontariff barriersto trade.
HACCP in Practice The Codex/WTO approach to regulatory rap-
prochement is weaker still, reflecting the vast
To date there are real differences between Euro- differences in regulatory regimes around the
pean Union (EU), North American, and World world. The WTO encourages member countries
Trade Organization approaches to regulatory to ratify the Codex HACCP standards but has
rapprochement for HACCP. In the European no means of leveraging this adoption except if
Union, the development of HACCP-based regu- one country challenges another's food safety
latory regimes has been harmonized across system as unscientific and an unjustified
countries. In 1992, Council Directive 92/5 (Ar- nontariff barrier to trade. However, countries
ticle 7 of the Annex, EEC 1992) for meat prod- will have strong incentives to adopt HACCP
ucts advocated HACCP-like principles. Subse- approaches so their companies can compete ef-
quently, more direct HACCP principles were fectively in international markets.
advanced in the 1993 directive on the hygiene In the short run, the EU approach is likely to
of foodstuffs (EEC 1993) and extended to cover be most effective in facilitating food product
all food companies. Now being implemented, trade, limiting nontariff barriers to trade, and
these directives and associated guidelines targeting microbiological food safety attributes.
should result in a reasonably homogeneous The North American and WTO approaches are
level of food safety assurance within the EU. at an earlier stage of development, resulting in
This will facilitate within-bloc trade and trade a higher continuing potential for such SPS
between third party countries and EU members. regulation to generate barriersto trade.
The North American approach to regulatory
rapprochement for HACCP corresponds most
3We are not awareof any Mexicanplansto adoptan HACCPregime.
directly to a weak form of coordination, with
On the Equivalency of National-Level HACCP factor is that most HACCP regulatory require-
Systems ments are either in the proposal or very early
The use of a HACCP framework for regulatory implementation stages. In this transitional
phase at least, HACCP is frequently imple-
oversight of food safety, especially microbio- mented as an additional layer of regulation,
logical safety, by more countries has the poten- with existing process and performance stan-
tial to facilitate a move to the right on the rap- dards still in place. This may satisfy regulators'
prochement spectrum shown in figure 1, away goals of improving food safety, but it compli-
from little coordination to stronger forms, in- cates compliance.
cluding possible mutual recognition or harmo- The larger regulatory systems in which
nization of standards. An obstacle to stronger HACCP is embedded seek to control the envi-
levels of rapprochement are difficulties in as- ronment in which food is processed and sold.
sessing the equivalence of different HACCP For example, the current draft of the revised
programs. Assessing this equivalence is an ex- Codex General Principles of Food Hygiene
ample of the central dilemmas involved in all classifies eight broad programs that define
SPS-related trade problems. First, a central minimal conditions for the production of safe
body, Codex, has determined a set of minimum food. These cover, often in extensive detail, pri-
HACCP principles without giving much detailed
mary production, plant design and facilities,
guidance on how they should be applied. Second, operation control, establishment maintenance
countries may put in place stricter-than-minimum and sanitation, personal hygiene, transporta-
programs as long as they can be scientifically tion, product information and consumer aware-
justified and are the least trade-restrictive pos- ness, and training. For food processing opera-
sible (FAO). Finally, equivalency requires that
tions, national-level regulatory programs cover-
the burden of proof of product quality be
ing these program areas are in place in addition
placed on the exporting country. Recognition of to any HACCP requirements. Called prerequi-
equivalency between national programs thus re- sites or Good Manufacturing Practices (GMPs),
quires a large number of bilateral or multilat- these requirements are intended to be a base on
eral negotiations between trading partners. which HACCP plans are built, allowing them to
Debate on equivalency issues is under way, be more concise and focused on truly critical
most notably at the Food and Agriculture control points. Codex's intent to link these
Organization's Expert Technical Meeting held methods of ensuring food safety is evident in
in Vancouver, Canada, in 1994 (FAO). A series its inclusion of its HACCP guidelines as an ap-
of papers was presented discussing the role of
pendix to the more general food hygiene docu-
governments in developing and applying mentation.
HACCP-based systems, the constraints faced Both regulators and industry appear eager to
by developing countries in implementing such keep some separation between prerequisite and
advanced food control systems, and how HACCP requirements for safe food production.
HACCP can be applied to different sectors of For example, John Cady of the National Food
the food industry. The meeting concluded that Processors Association voiced an industry posi-
Codex must play a key role in providing leader- tion that U.S. HACCP requirements should be
ship in the implementation and coordination of applied only to specific food safety hazards and
HACCP plans, as well as being the basis for all not to (other) quality and financial concerns
discussions on determining equivalency. It also such as economic adulteration. He went on to
called for a concerted effort, to ensure that advocate that "GMPs and detailed sanitation
HACCP and other SPS regulations are truly
practices should not be included in HACCP
food safety related and thus justified, and for an
plans unless they directly impact food safety"
expanded role for mutual recognition agree- (Cady, p. 4). In practice, any company that en-
ments, especially between developing and de- forces comprehensive prerequisites or GMPs
veloped economies. that address the significant hazards found in
food processing plants will find the transition
Problems with Prerequisites to HACCP easier. But these practices have not
necessarily considered chemical or microbio-
In practice, use of HACCP is embedded in logical hazards, the food safety concerns that
larger national or trading bloc regulatory sys- have fueled the increased use of HACCP-based
tems whose goal is to assure food quality. Har- regimes.
monizing HACCP will lower only a section of The clear lesson from this is that for HACCP
the regulatory hurdles. A further complicating to operate as an effective internationaltrade stan-
dard that facilitates food trade, both HACCP and elements of the regulatory systems, especially
prerequisite requirements must be coordinated. prerequisite requirements, are coordinated. An
Prerequisite requirements can pose nontariff interesting sidebar to this discussion is the in-
barriers to trade even when HACCP regimes teraction and possible interdependency of the
are coordinated. For example, potential prob- use of HACCP as an international regulatory
lems with prerequisites are evident in the U.S. standard and as a private standard in industry
and Canadian programs now being developed. quality assurance programs. For example, the
As proposed, the USDA Food Safety and In- ISO 9000 certification series for food compa-
spection Service's (FSIS) HACCP system for nies incorporates HACCP principles and is be-
meat and poultry would work in conjunction coming a forum for private and public (Article
with several other regulatory requirements. In 6, EEC 1993) harmonization of standards
addition to GMPs that FSIS considers to be a across boundaries. HACCP's private and public
minimum basis for the production of safe food, efficacy in trade facilitation ultimately will de-
it would require companies to have in place pend on the ability and willingness of govern-
written Standard Operating Procedures (SOPs) ments to engage in regulatory rapprochement.
for sanitation programs, at least one antimicro-
bial treatment process that targets levels of mi-
croorganisms at key processing steps, and mea- References
sures to maintain specific time and temperature
requirements for cooling carcasses post-slaugh- Cady, J.R. "Making HACCP Work." Address to
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more countries adopt it as a regulatory standard Direct Investmentand ProcessedFood Trade."
for improving food safety. Widespread HACCP Agribusiness,in press.
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adopt similar regulatory approaches. Whether pendentWorld:Issuesfor Government." Regula-
HACCP becomes a really effective interna- tory Co-operation for an Interdependent World,
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