Sadex Corporation

E-Beam Processing

Objectives

Introduce Sadex and Irradiation ProcessDetail Product Evaluation, Testing Procedures, and Product/Dose Validation of ProductsExplain Sadex’s Procedures for Processing Products and Requirements for Integration Establish Purpose and Goals for Irradiating Products: Product Safety, Reduced Liability, and Extended Shelf-lifeIdentify Support and Benefits of Irradiated Products Answer Questions

Dr. Acheson spoke to American Farm Bureau Federation Jan. 14, 2008

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. 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. 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."We are not ever going to grow something in the dirt, short of irradiating it or cooking it, with a 100% guarantee," he said.

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

Electrons disrupt the DNA chainseither destroying or preventingreproduction by the organism

Product Container

Magnetic Scanning System

Accelerating Waveguide

Input RF Power

Injector

How does Electron BeamPasteurization Technology Work?

Electron Deposition

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

All the electrons (primary and secondary) then suffer additional collisions until all their energy is dissipated by ionization.

1o electrons 2o electrons ionization

Depth Dose Distribution10 MeV Electrons in Water

Dose Distribution (Max / Min)

Max

Min

Max / Min Ratio

What is it?The ratio of the maximum dose absorbed by the product divided by the minimum dose

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 -

CDC estimates 76 million illnesses, 325,000 hospitalizations and5,100 deaths annually

Many pathogens today were notrecognized as causes offood illness 20 years ago

National Institutes of Healthestimates yearly costs of allfood-borne diseases is $5-6Bof medical expendituresand lost productivity

Recalls in America cost food producers an estimated 37 billion dollars per year in unrecoverable losses

Food-Borne Pathogens:A National Health Problem

Growing Concern About Safety of Food Supply

Bacterial contamination in food is the #1 food safety concern

In 2002, the USDA recalled 65+ million pounds of food

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

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.

In 2008, Meat and Produce Recalls due to Pathogens which resulted in Illnesses, Long Term Disabilities, or Deaths

Many pathogens today were not recognized as causes of food illness 20 years ago

Reduces or Eliminates dangerous bacteria

Does not compromise food quality

Extends shelf-life

Consumer friendly

Uses commercial electricity

Environmentally safe

Refrigerated Facility

The Solution -Patented Electron Beam System

What are the Key Processing Objectives?

Improve Food SafetyDestruction of Microorganisms on surface and internalized

Food SpoilageSickness and Disease - Pathogens

Extend the Shelf-life of the ProductObtain Certain Biological EffectsMaintain the Quality and Sensory Characteristics of the ProductReduce Product Liability

Benefits of Electronic Pasteurization

Reduces or eliminates harmful food-borne pathogens:

• E. coli O157:H7 Campylobactor

• Salmonella Trichinella

• Listeria Many others

Delays ripening of fruits and vegetables

Eliminates insects in fruits and vegetables

Inhibits sprouting in onions, potatoes, etc..

Replaces the need for chemical fumigation

Increases shelf-life – Typical 2-3X

Processor and Retailer Benefits

Pathogen reductionLiability reductionIncreased shelf-life Competitive edgeLeadership position with revolutionary technology

Research and Development

Assist With Development of Product/Package SpecificationsDetermine Optimal Product/Package/Dose SpecificationsAssist in Developing Pre and Post Treatment Quality Control Procedures (HACCP)Outside Laboratory Analysis is Available by Request and at Additional Cost

Develop Packaging Requirements

Product Must Be in Final Package Before TreatmentExtended Shelf-life Packaging is Widely AvailableMinimum Processing Standards Include Size and UniformityOptimal Package Decreases Processing Time/Reduces CostPackaging Materials Must be Approved for Dose Level and Component Materials Prior to Processing with Letter of Guarantee

Quality Control

Refrigerated: Unloading, Handling, Treatment and Re-loadingUnit Count, Delivery Temperature and External Damage VerifiedProcessing Documents/Lab Report Available Upon Shipping

Regulatory Compliance

Facility is Fully Licensed - USDA Inspectors Are On-SiteFDA/USDA Approvals In Place for Meat, Poultry, Shell Eggs, Fresh Produce, and Pet TreatsFDA Approval is Pending for Other ProductsFDA/USDA Dose Limits and Label Rules ApplyAPHIS Approval is Available

Key Bacterial Pathogens

Organism Illnesses Deaths

Campylobacter 2,500,000 99Salmonella (non-typhi)

1,400,000 553

E.coli 0157:H7 75,000 52Cl. perfringens 250,000 7

S. aureus food poisoning

185,060 2

Yersinia enterocolitica

86,731 2

Shigella spp. 89,648 14L. monocytogenes 2,493 499

Top Hazards Causing Illness

Hazard Cases Fatality Rate

Costs

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 by food

Case-fatality rate

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 QualityProduce, Meat, and Poultry

Approved by USDA and FDATypical doses of 1.0 - 2.5 kGy yield excellent qualityTypical shelf-life extension of 2-3X

Organism D10 value (kGy)

Salmonella 0.48 – 0.70Campylobacter 0.14 – 0.32Listeria 0.40 – 0.64Yersinia 0.04 – 0.21Aeromonas 0.14 – 0.19Vibrio 0.10 - 0.30E. 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

Approved for Irradiation up to 4.0 kGy for Pathogen Reduction and Extended Shelf-lifeFPA has RTE Petition Before FDA to Approve RTEs for IrradiationPetition Filed in 1999 but Held Up for Further TestingProduce 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

Red cabbage 8.4a 8.2a

Endive 5.8b 6.5a

Parsley 6.2b 7.6a

Green leaf lettuce 5.4a 7.1b

Cilantro 5.5a 6.2a

Iceberg lettuce 6.8a 6.2a

Spinach 5.0a 6.9b

Romaine lettuce 6.8a 6.0a

Alfalfa sprouts 7.8a 8.0a

Carrots 8.5a 8.5a

Red leaf lettuce 4.0a 4.3a

Green onion 3.7a 5.3b

Celery 3.9a 4.9b

Visual Quality of Non-irradiated (Control) and Irradiated (1 kGy) Fresh-cut Vegetables after 14 days storage at 4°C. 9 =excellent, 1=unusable.

Fan and Sokorai 2005.

Electrolyte Leakage (%) of Vegetables as a Function of Radiation Dosage

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

Effect on nutritional value

Folic acidThiamineVitamin CVitamin A (carotenoids)

Vitamin E

Day 1 Day 14

0 kGy 1 kGy 0 kGy 1 kGy

Broccoli 926 902 855 855

Cilantro 528 538 115 157

Red leaf lettuce

74 39 34 15.7

Spinach 265 199 198 69

Vitamin C content (µg/g fresh weight)Fan and Sokorai. J. Food Science. 2008.

Nutrient/VitaminCount

Non-irradiated Sample Irradiated Sample

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

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

Medallion Laboratories (2002)

Fatty Acid Analysis w/Profile

Non-irradiated Sample Irradiated Sample

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 1.04Carbohydrates 1.9% 0.0%

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

Medallion Laboratories (2002)

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

Nutrient/Vitamin Count

Non-irradiated Sample

Irradiated Sample

Protein (by Dumas) 18.1 20.0Iron (milligrams) 2.07 1.98Thiamine (milligrams) .0500 .0500Zinc (milligrams) 4.09 3.96Niacin (milligrams) 4.16 4.32Vitamin B6 (milligrams) .230 0.220Vitamin B12 (milligrams) 1.96 1.78Phosphorus (milligrams 150 142

Medallion Laboratories-2002

Fatty Acid Analysis w/Profile

Non-irradiated Sample Irradiated Sample

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%

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

Medallion Laboratories (2002)

Shelf-Life Extension Non-Irradiated Vs. Irradiated

Product Packaging Non-IrradiatedDays

IrradiatedDays

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 Chubs

Chub Film 10 to 12 34+

Whole Muscle and Beef Cuts

Case Ready Vacuum Packed

25 47

Poultry Skinless and Boneless

Case Ready MAP 11 30

Pork Loins Case Ready Vacuum Packed

41 91

Shelf-Life ExtensionNon-Irradiated Vs. Irradiated

Product Packaging Non-IrradiatedDays

IrradiatedDays

Fresh Cut Fruit 6 10

Green Beans Bagged 6 90Carrots Bagged 6 90Asparagus Bunch 12 to 14 35Strawberries 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 ExtensionNon-Irradiated Vs. Irradiated

Product Packaging Non-IrradiatedDays

IrradiatedDays

Mushrooms Box & Plastic Wrap

12 30

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

LabelingRetail

• Radura, plus “Treated with / by Irradiation”• Claims: Reduced, Eliminated, or Free (OK if

substantiated)• If treated product used as an ingredient,

identify in Ingredient StatementFoodservice

• On case to establishment• No requirement to inform consumer Packaging

• Equivalency approved for Gamma and E-Beam• Air permeable for Chicken

Labeling and Packaging Update

Irradiation Labeling Under Review by FDA if ‘Irradiation’ should be Required on Label All Contact Surface Packaging Material Polymers Approved for Irradiation by FDA either by CFR or Threshold of Regulation (TOR) up to 3 kGy or higherProduce Packaging Material Availability for Irradiation Limited Since Additives in Polymers Currently Not Approved

Cost and Capacity

Sioux City Facility Has Available Capacity of 200 Million Pounds per YearCost Estimate: 10 to 25 cents per poundCost Determined By “Beam Time” = Dose Applied + Ease of HandlingTypical 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)Air Space within Package to be MinimizedIdeal Packaging and Product Thickness to be determined during dose mapping.

Scientific Conclusions

Process cannot make the product radioactive no matter how much dose is absorbedCompounds formed by irradiating food are the same as those produced by other processesIrradiation causes no toxic problems that adversely affect human healthOnly intervention to destroy internalized pathogens with the exception of cookingNo 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

American Council on Science and HealthAmerican Dietetic Association American Farm Bureau FederationAmerican Meat InstituteAmerican Medical AssociationAmerican Public Health AssociationCenters for Disease ControlCouncil for Agriculture Science and TechnologyCouncil of State and Territorial EpidemiologistsFDA

Food Marketing InstituteGrocery Manufacturers of AmericaInstitute of Food TechnologistsNational Food Processors AssociationNational Pork ProducersProduce Marketing AssociationUSDAUnited Fresh Fruit and Vegetable AssociationU.S. Public Health Service Western Growers AssociationWorld Health Organization

Support for Sadex Technology

Support for Sadex Technology

• 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

Health Physics SocietyCodex AlimentariusMayo ClinicAmerican Gastroenterological AssociationAmerican Veterinarian Medical AssociationFood and Agriculture Organization of the United NationsInternational Food Information CouncilScientific Committee of The European UnionNew England Journal Of MedicineNational Confectioners’ AssociationNational Cattlemen’s Beef AssociationUnited Egg Association

Over 240 Million People Have Seen or Heard Sadex’s Message

• Prominent Magazines:Time, Newsweek, U.S. & World Report, Good Housekeeping

• National Wire Services:Associated Press, UPI, Bloomberg, Reuters, Dow Jones

• Celebrity RadioCharles OsgoodPaul Harvey

• TelevisionABC, CBS, NBC, Fox, CNN, CNNFN, CNBC

• Nationwide Radio & Talk Radio

• Trade & Health Publications

• Internet• Financial Media

Wall Street Journal Investor Daily

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

Consumer Research Review

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

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."

“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?”

Bill Marler on MarlerBlog (August 24, 2008)

Consumers are already buying irradiated products!

SpicesBand-AidsPet TreatsCosmeticsBaby BottlesComputer ChipsFeminine ProductsBaby DiapersWound Care50% of all medical devicesFood ProductsEye and Contact Solutions

Irradiated Strawberries (After 2 weeks)

Blackberries

0.50kGyControl

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

Raspberries

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

0.50kGyControl

Blueberries

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

0.50kGyControl

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

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

36 days at 34F

Irradiated at 400Gy

36 days at 34F

Questions ???

Should you have questions, please feel free to contact me at: Sadex CorporationHarlan E. Clemmons, President and COO2650 Murray St.Sioux City, IA 51111712-252-3505 (O)712-252-3503 (F)hclemmons@sadexsc.comwww.sadexcorp.com