E-Beam Processing

Sadex Corporation
Objectives

z Introduce Sadex and Irradiation Process

z Detail Product Evaluation, Testing Procedures, and
Product/Dose Validation of Products
z Explain Sadex’s Procedures for Processing Products
and Requirements for Integration
z Establish Purpose and Goals for Irradiating
Products: Product Safety, Reduced Liability, and
Extended Shelf-life
z Identify Support and Benefits of Irradiated Products
z Answer Questions
Dr. Acheson spoke to American Farm
Bureau Federation Jan. 14, 2008

z NEW ORLEANS -- The Food and Drug Administration believes

its Food Protection Plan will help the agency move toward
preventing food-borne illness outbreaks rather than reacting to
them, said David Acheson, FDA assistant commissioner for
food protection.
z The U.S. food supply is one of the safest in the world, but he
said consumer risk of encountering pathogens on produce
won't go away in the near future.
z During his presentation, Acheson reviewed details from the
spinach-related foodborne illness outbreak in 2006, as well as
two other outbreaks traced to lettuce that year.
z "We are not ever going to grow something in the dirt, short
of irradiating it or cooking it, with a 100% guarantee," he
said.
z According to the Centers for Disease
Control and Prevention (CDC), 900,000
cases of illness, 8,500 hospitalizations,
and 352 deaths could be avoided annually
if just 50 percent of raw meat and poultry
consumed in the U.S. were irradiated.
Dr. Robert V. Tauxe, Centers for Disease Control and Prevention,
Atlanta
How does Electron Beam
Pasteurization Technology Work?
Electrons disrupt the DNA chains
Injector either destroying or preventing
reproduction by the organism
Input RF
Accelerating Power
Waveguide

Magnetic
Scanning
System

Product
Container
Electron Deposition

¾ Electrons strike electrons in

the product (inelastic
scattering) imparting a
fraction of their energy into
kinetic energy of the
secondary electrons.

¾ All the electrons (primary

and secondary) then suffer
additional collisions until all
their energy is dissipated by
ionization.

¾ 1o electrons 2o electrons
ionization
Depth Dose Distribution
10 MeV Electrons in Water
Dose Distribution (Max / Min)

Max
Min
Max / Min Ratio

z What is it?
The ratio of the maximum dose absorbed by
the product divided by the minimum dose
z Why is it important?
To achieve the necessary pathogen reduction,
a minimum dose is required. If the max/min is
too high you may exceed the FDA limits, or
you may impact the organoleptic qualities of
the product
The Problem -
Food-Borne Pathogens:
A National Health Problem
¾ CDC estimates 76 million illnesses,
325,000 hospitalizations and
5,100 deaths annually

¾ Many pathogens today were not

recognized as causes of
food illness 20 years ago

¾ National Institutes of Health

estimates yearly costs of all
food-borne diseases is $5-6B
of medical expenditures
and lost productivity

¾ Recalls in America cost food producers an

estimated 37 billion dollars per year in
unrecoverable losses
Growing Concern About
Safety of Food Supply
z Bacterial contamination in food is the #1 food safety concern
z In 2002, the USDA recalled 65+ million pounds of food
z In 2006, Beef, Spinach, Cantaloupe, Onions, Lettuce, Tomatoes,
etc. Recall -Thousands ill, 4 known deaths, millions of acres
plowed under, and millions of $’s in lawsuits
z In 2007, 30+ million pounds of beef products, 5+ million pounds
of other food items including pizza, peanut butter, fresh produce,
pot pies, etc. At least one company bankrupt.
z In 2008, Meat and Produce Recalls due to Pathogens which
resulted in Illnesses, Long Term Disabilities, or Deaths
z Many pathogens today were not recognized as causes of food
illness 20 years ago
The Solution -
Patented Electron Beam System

¾ Reduces or Eliminates
dangerous bacteria
¾ Does not compromise
food quality
¾ Extends shelf-life
¾ Consumer friendly
¾ Uses commercial
electricity
¾ Environmentally safe
¾ Refrigerated Facility
What are the Key Processing
Objectives?

¾ Improve Food Safety

¾ Destruction of Microorganisms on surface
and internalized
¾ Food Spoilage
¾ Sickness and Disease - Pathogens
¾ Extend the Shelf-life of the Product
¾ Obtain Certain Biological Effects
¾ Maintain the Quality and Sensory
Characteristics of the Product
¾ Reduce Product Liability
Benefits of Electronic Pasteurization

¾ Reduces or eliminates harmful food-borne pathogens:

• E. coli O157:H7 Campylobactor
• Salmonella Trichinella
• Listeria Many others
¾ Delays ripening of fruits and vegetables
¾ Eliminates insects in fruits and vegetables
¾ Inhibits sprouting in onions, potatoes, etc..
¾ Replaces the need for chemical fumigation

Increases shelf-life – Typical 2-3X

Processor and Retailer Benefits

z Pathogen reduction
z Liability reduction
z Increased shelf-life
z Competitive edge
z Leadership position with revolutionary technology
Research and Development

z Assist With Development of Product/Package

Specifications
z Determine Optimal Product/Package/Dose
Specifications
z Assist in Developing Pre and Post Treatment
Quality Control Procedures (HACCP)
z Outside Laboratory Analysis is Available by
Request and at Additional Cost
Develop Packaging Requirements

z Product Must Be in Final Package Before

Treatment
z Extended Shelf-life Packaging is Widely Available
z Minimum Processing Standards Include Size and
Uniformity
z Optimal Package Decreases Processing
Time/Reduces Cost
z Packaging Materials Must be Approved for Dose
Level and Component Materials Prior to
Processing with Letter of Guarantee
Quality Control

z Refrigerated: Unloading, Handling,

Treatment and Re-loading
z Unit Count, Delivery Temperature and
External Damage Verified
z Processing Documents/Lab Report Available
Upon Shipping
Regulatory Compliance

z Facility is Fully Licensed - USDA Inspectors

Are On-Site
z FDA/USDA Approvals In Place for Meat,
Poultry, Shell Eggs, Fresh Produce, and Pet
Treats
z FDA Approval is Pending for Other Products
z FDA/USDA Dose Limits and Label Rules
Apply
z APHIS Approval is Available
Key Bacterial Pathogens

Organism Illnesses Deaths

Campylobacter 2,500,000 99
Salmonella (non- 1,400,000 553
typhi)
E.coli 0157:H7 75,000 52
Cl. perfringens 250,000 7

S. aureus food 185,060 2

poisoning
Yersinia 86,731 2
enterocolitica
Shigella spp. 89,648 14
L. monocytogenes 2,493 499
Top Hazards Causing Illness

Hazard Cases Fatality Costs

Rate
Norwalk virus 23,000,000 NA NA
Campylobacter 2,500,000 0.10% $1 billion
Salmonella 1,400,000 0.80% $3.5 billion
Clostridium perfringens 250,000 0.05% NA
Stapylococcus aureus 185,000 0.02% NA
E. coli 75,000 0.83% $600 million
Listeria monocytogenes 2500 20% $300 million
Clostridium botulinum <100 8.6% NA
Case-fatality rate of key pathogens

Organism % transmitted Case-fatality rate

by food
L. monocytogenes 99 0.2000
V.vulnificus 50 0.3900
Campylobacter spp 80 0.0010
E.coli 0157:H7 85 0.0083
Salmonella 85 0.0080

Mead et al., 1999

 Effects on Food Quality
Produce, Meat, and Poultry

¾ Approved by USDA and FDA

¾ Typical doses of 1.0 - 2.5 kGy yield excellent quality
¾ Typical shelf-life extension of 2-3X
Organism D10 value (kGy)
Salmonella 0.48 – 0.70
Campylobacter 0.14 – 0.32
Listeria 0.40 – 0.64
Yersinia 0.04 – 0.21
Aeromonas 0.14 – 0.19
Vibrio 0.10 - 0.30
E. coli O157:H7 0.25 – 0.45
 Foods Approved
for Irradiation (USA)
Food Product Approval Date Maximum Dose (kGy)
Wheat & Wheat Flour 1963 0.5
Pork 1985 1.0
Dry Enzyme Preps 1985 10.0
Fresh Fruits/Vegetables 1986 1.0
Dry Seasonings/Spices 1986 30.0
Poultry (fresh and frozen) 1992 3.0
Red Meat (fresh/frozen) 2000 4.5 / 7.0
Shell Eggs 2000 3.0
Seeds for Sprouting 2000 8.0
Pet Food & Animal Feed 2001 50.0
Sweet Potatoes 2003 1.0
Molluscan Shellfish 2005 5.5
Fresh Iceberg Lettuce and Spinach 2008 4.0
All Foods Up To 1.0 kGy Title 21 179.26 1.0
Iceberg Lettuce and Spinach
Recently Approved for Irradiation

z Approved for Irradiation up to 4.0 kGy for Pathogen

Reduction and Extended Shelf-life
z FPA has RTE Petition Before FDA to Approve RTEs
for Irradiation
z Petition Filed in 1999 but Held Up for Further Testing
z Produce from Foreign Countries and Hawaii is being
Irradiated for Disinfestation and Consumer
Acceptance is Good
Visual Quality of Non-irradiated (Control) and
Irradiated (1 kGy) Fresh-cut Vegetables after 14 Days
Storage at 4°C.
X. Fan, USDA

Vegetables Control 1 kGy

Broccoli 8.5a 8.5a
Visual Quality of Non-
Red cabbage 8.4a 8.2a
irradiated (Control) and
Endive 5.8b 6.5a
Irradiated (1 kGy)
Parsley 6.2b 7.6a
Fresh-cut Vegetables
Green leaf lettuce 5.4a 7.1b after 14 days storage at
Cilantro 5.5a 6.2a 4°C.
Iceberg lettuce 6.8a 6.2a 9 =excellent,
Spinach 5.0a 6.9b 1=unusable.
Romaine lettuce 6.8a 6.0a
Alfalfa sprouts 7.8a 8.0a Fan and Sokorai 2005.
Carrots 8.5a 8.5a
Red leaf lettuce 4.0a 4.3a
Green onion 3.7a 5.3b
Celery 3.9a 4.9b
Electrolyte Leakage (%) of Vegetables
as a Function of Radiation Dosage

Fan and Sokorai 2005. Postharvest Biol. Technol. 36.

Effect on nutritional value

Day 1 Day 14

z Folic acid 0 kGy 1 kGy 0 kGy 1 kGy

z Thiamine
z Vitamin C Broccoli 926 902 855 855
z Vitamin A Cilantro 528 538 115 157
(carotenoids)
z Vitamin E Red leaf 74 39 34 15.7
lettuce
Spinach 265 199 198 69

Vitamin C content (µg/g fresh weight)

Fan and Sokorai. J. Food Science. 2008.
Nutritional analysis of irradiated & non-irradiated
ground beef Amounts are for 100 grams of frozen ground beef

Nutrient/Vitamin Non-irradiated Sample Irradiated Sample

Count

Protein (by Dumas) 16.6 16.7

Iron (milligrams) 2.19 2.31

Thiamine (milligrams) .0400 .0400
Zinc (milligrams) 3.89 3.97

Niacin (milligrams) 4.68 4.82

Vitamin B6 (mgs) 0.200 0.140

Vitamin B12 (mgs) 1.60 1.70

Phosphorus (mgs) 135 135

Medallion Laboratories (2002)

Nutritional analysis of irradiated & non-irradiated
ground beef Amounts are for 100 grams of frozen ground beef

Fatty Acid Analysis Non-irradiated Sample Irradiated Sample

w/Profile

Total Fat 16.4% 16.6%

Saturated Fat 6.69% 6.93%
Monounsaturated 7.45% 7.36%
Polyunsaturated 0.550% 0.570%
Trans Fatty Acids 1.02 1.04
Carbohydrates 1.9% 0.0%

Medallion Laboratories (2002)

Nutritional analysis of irradiated & non-irradiate
ground beef Amounts are for 100 grams of fresh ground beef
Nutrient/Vitamin Non-irradiated Irradiated Sample
Count Sample
Protein (by Dumas) 18.1 20.0
Iron (milligrams) 2.07 1.98
Thiamine (milligrams) .0500 .0500
Zinc (milligrams) 4.09 3.96
Niacin (milligrams) 4.16 4.32
Vitamin B6 (milligrams) .230 0.220
Vitamin B12 (milligrams) 1.96 1.78
Phosphorus (milligrams 150 142

Medallion Laboratories-2002
Nutritional analysis of irradiated & non-irradiate
ground beef Amounts are for 100 grams of fresh ground beef

Fatty Acid Analysis Non-irradiated Sample Irradiated Sample

w/Profile

Total Fat 21.7% 22.9%

Saturated Fat 9.77% 10.2%
Monounsaturated 9.34% 9.89%
Polyunsaturated 0.570% 0.63%

Trans Fatty Acids 1.08 1.09

Carbohydrates 2.3% 0.3%

Medallion Laboratories (2002)

Shelf-Life Extension
Non-Irradiated Vs. Irradiated
Product Packaging Non-Irradiated Irradiated
Days Days
Fresh Ground Beef High Ox MAP 6 to 11 16 to 20

Fresh Ground Beef Low Ox MAP 14 to 16 30 to 31

Fresh Ground Beef Non-MAP 2 to 3 22 to 28

Fresh Ground Beef Chub Film 10 to 12 34+

Chubs
Whole Muscle and Case Ready 25 47
Beef Cuts Vacuum Packed
Poultry Skinless and Case Ready MAP 11 30
Boneless
Pork Loins Case Ready 41 91
Vacuum Packed
Shelf-Life Extension
Non-Irradiated Vs. Irradiated
Product Packaging Non-Irradiated Irradiated
Days Days
Fresh Cut Fruit 6 10
Green Beans Bagged 6 90
Carrots Bagged 6 90
Asparagus Bunch 12 to 14 35
Strawberries Box & Plastic Wrap 5 to 7 14+
Blueberries Clam Shell Box 8 to 12 41+
Blackberries Clam Shell Box 10 41+
Raspberries Clam Shell Box 10 41+
Cantaloupe 12 to 14 56+
Shelf-Life Extension
Non-Irradiated Vs. Irradiated

Product Packaging Non-Irradiated Irradiated

Days Days
Mushrooms Box & Plastic 12 30
Wrap
Spinach Bag 12 to 16 30+

Lettuce Bag 12 to 16 28+

Tomatoes Net Bag 12 to 14 25 to 28

Regulatory Issues - Key Changes

¾ Labeling
™ Retail
• Radura, plus “Treated with / by Irradiation”
• Claims: Reduced, Eliminated, or Free (OK if
substantiated)
• If treated product used as an ingredient,
identify in Ingredient Statement
™ Foodservice
• On case to establishment
• No requirement to inform consumer
¾ Packaging
• Equivalency approved for Gamma and E-Beam
• Air permeable for Chicken
Labeling and Packaging Update

z Irradiation Labeling Under Review by FDA if

‘Irradiation’ should be Required on Label
z All Contact Surface Packaging Material
Polymers Approved for Irradiation by FDA
either by CFR or Threshold of Regulation
(TOR) up to 3 kGy or higher
z Produce Packaging Material Availability for
Irradiation Limited Since Additives in
Polymers Currently Not Approved
Cost and Capacity

z Sioux City Facility Has Available Capacity of 200

Million Pounds per Year
z Cost Estimate: 10 to 25 cents per pound
z Cost Determined By “Beam Time” = Dose Applied +
Ease of Handling
z Typical Package Size Ideal for Processing 24 inches
long, by 20 to 22 inches wide, with a product
thickness of 3.5 to 3.7 inches (Bulk Density)
z Air Space within Package to be Minimized
z Ideal Packaging and Product Thickness to be
determined during dose mapping.
Scientific Conclusions

z Process cannot make the product radioactive

no matter how much dose is absorbed
z Compounds formed by irradiating food are
the same as those produced by other processes
z Irradiation causes no toxic problems that
adversely affect human health
z Only intervention to destroy internalized
pathogens with the exception of cooking
z No evidence exists that pathogenic bacteria
become stronger when irradiated
“there is no other means to kill bacterium such as E. coli
O157:H7 in raw ground beef” -USDA
Support for Sadex Technology
z American Council on Science and
Health
z American Dietetic Association
z American Farm Bureau Federation
z American Meat Institute
z American Medical Association
z American Public Health
Association
z Centers for Disease Control
z Council for Agriculture Science
and Technology
z Council of State and Territorial
Epidemiologists
z FDA
z Food Marketing Institute
z Grocery Manufacturers of America
z Institute of Food Technologists
z National Food Processors
Association
z National Pork Producers
z Produce Marketing Association
z USDA
z United Fresh Fruit and Vegetable
Association
z U.S. Public Health Service
z Western Growers Association
z World Health Organization
Support for Sadex Technology
z Health Physics Society
z Codex Alimentarius
z Mayo Clinic
z American Gastroenterological
Association
z American Veterinarian Medical
Association
z Food and Agriculture Organization of
the United Nations
z International Food Information
Council
z Scientific Committee of The
European Union
z New England Journal Of Medicine
z National Confectioners’ Association
z National Cattlemen’s Beef
Association
z United Egg Association
• UK Institute of Food Science and
Technology
• National Fisheries Institute
• American Feed Industry Association
• Animal Health Institute
• Apple Processors Association
• National Turkey Federation
• Chocolate Manufacturers Association
• Northwest Horticulture Association
• Florida Fruit and Vegetable
Association
• Food Distributors International
• U.S. Chamber of Commerce
• United Egg Producers
• Millers’ National Federation
Over 240 Million People Have Seen
or Heard Sadex’s Message
• Prominent Magazines: • Television
Time, Newsweek, ABC, CBS, NBC, Fox,
U.S. & World Report, CNN, CNNFN, CNBC
Good Housekeeping
• Nationwide Radio &
• National Wire Services:
Associated Press, UPI, Talk Radio
Bloomberg, Reuters, • Trade & Health
Dow Jones Publications
• Celebrity Radio • Internet
Charles Osgood • Financial Media
Paul Harvey
Wall Street Journal
Investor Daily
Consumer Research Review

¾ Consumer Perceptions of Meat Irradiation/ Research Report, Meat &

Poultry magazine; March 2000:

• Food Safety ranked as consumers top concern. They expect the

foods they purchase to be safe!
• More than two-thirds of consumers ranked meat processing plants
as the number one source of bacterial contamination
• 60% of consumers surveyed would purchase irradiated meat
• Over 50% surveyed stated they would pay more for irradiated
products
• More public awareness would increase the likelihood that
consumers will purchase irradiated products
Consumer Research Review

¾ Consumer’s Views on Food Irradiation; Food Marketing Institute /

Grocery Manufacturers of America; April, 1998:
• Almost 80% of consumers surveyed would purchase food
labeled, “Irradiated to Kill Harmful Bacteria”
• 77% responded that killing disease causing bacteria was most
important reason to buy irradiated foods

¾ Consumer Attitudes Toward Food Irradiation; Axiom Research

Company for International Food Information Council, July 1998:
• Consumers willing to pay more for irradiated food- at least at
the trial phase- because of safety benefits.
Which is the Biggest “Threat”
to Your Business?
For those involved in food-borne illness recalls;
this man is the most feared person in America

Bill Marler
Foremost food-borne
illness litigator
 “Farm to Fork” or
“Turf to Tort”
American Legal Institute's Third Restatement of the Law,
Torts: Products Liability, adopted in 1998, states in
section 2, ‘Categories of Product Defect’:
"A product is defective when, at the time of sale or distribution, it contains a
manufacturing defect.... A product:
a) contains a manufacturing defect when the product departs from its
intended design even though all possible care was exercised in the
preparation and marketing of the product.

b) is defective in design when the foreseeable risks of harm posed by

the product could have been reduced or avoided by the adoption of a
reasonable alternative design by the seller or other distributor, or a
predecessor in the commercial chain of distribution, and the
omission of the alternative design renders the product not
unreasonably safe."
Bill Marler on MarlerBlog
(August 24, 2008)
“It is time for the big retailers to step up and put
food safety first. Whether it is peppers
procured by Wal-Mart or hamburger handled by
Whole Foods, retailers must require – and pay
for – safe food from suppliers. Safer food
means less ill people, less ill people means less
lawsuits. Wal-Mart, Whole Foods, get the
picture? You stop buying contaminated food
and selling it as safe to your customers and I
will stop suing you - easy enough?”
Consumers are already buying
irradiated products!
z Spices
z Band-Aids
z Pet Treats
z Cosmetics
z Baby Bottles
z Computer Chips
z Feminine Products
z Baby Diapers
z Wound Care
z 50% of all medical devices
z Food Products
z Eye and Contact Solutions
Irradiated Strawberries
(After 2 weeks)
Blackberries

Control vs. Irradiated samples 41 days after storage at 0°C (32°F).

Control 0.50kGy
Raspberries

Control vs. Irradiated samples 41 days after storage at 0°C (32°F).

Control 0.50kGy
Blueberries

Control vs. Irradiated samples 41 days after storage at 0°C (32°F).

Control vs. Irradiated samples 41 days after storage at 32°F

Control 0.50kGy
Mushrooms

Control compared to irradiated (1.0 kGy) mushrooms at 30 days

(Control was not edible at 12 days; Irradiated sample edible at 30 days)
Iceberg Lettuce
after 14 Days in MAP at 4 C

X. Fan, USDA, ARS ERRC

Spinach
after 14 Days in MAP at 4 C

X. Fan, USDA, ARS ERRC

Asparagus

Comparison of asparagus tips by treatment group at day 0

Control X-ray 400Gy X-ray 1,000Gy

Shelf-Life Extension

Control Irradiated at 400Gy

36 days at 34F 36 days at 34F
Questions ???

Should you have questions, please feel free to contact me at:

Sadex Corporation
Harlan E. Clemmons,
President and COO
2650 Murray St.
Sioux City, IA 51111
712-252-3505 (O)
712-252-3503 (F)
hclemmons@sadexsc.com
www.sadexcorp.com