Today’s Class: Additives, Pesticides, and Natural Toxicants

1. Today’s Class:Additives, Pesticides, and Natural Toxicants MAIN POINTS: • What is an “additive”? • How are additives treated legally? • What is a “toxin” sources and types • How are natural toxicants treated under the law?

2. ADDITIVESThere are about 3,000 approved food additives

4. Additives subject to 1958 Amendments to FD&C (Food Drug and Cosmetic) Act • Regulates any substance..which becomes a component of food, *if* not generally recognized as safe (by experts) or in use prior to Jan 1, 1958. • GRAS = Generally Recognized as Safe • The Act excludes spices, smoke derivatives, plant deivatives • GRAS concept, ways to gain GRAS status • Grand-fathered • FDA GRAS-affirmation (Flavors- Flavor Extract Manufacturers Association) • Self-affirmation • Petition to FDA

5. Other additive requirements • Intentional additive must “work” • Cannot be deceptive or conceal defects • Cannot reduce nutritional value • Cannot substitute for Good Manufacturing Practices • Must have method of analysis

6. The FD&C Act also brought us THE DELANY CLAUSE “no additive shall be deemed safe if it is found to induce any cancer in humans or animals when ingested in any amount” Many compounds naturally occurring in food cannot meet this test. Remember furfural in bread? Aflatoxins in peanut butter? DELANY reflects a 1958 understanding of carcinogens

7. Types of Food Additives

8. Antioxidants • Lipid oxidation gives rise to rancidity, off flavors, off odors, and free radicals • Anything that can be oxidized (Vit E, C) can serve as antioxidant • Can also exclude oxygen, use oxygen impermeable packaging. • BHA, BHT

9. Preservatives • Salt • Organic acids • Benzoates • Acetic, Citric, Lactic • Sulfur dioxide • Nitrite

10. Other additives • Flavors, “natural flavor” from yeast • Flavor enhancers (MSG) , can be “natural” • Acidulants • Sweeteners (ingredient) • Gums, thickeners and stabilizers • Surfactants • Nutrients (vitamins and minerals) • Emulsifiers • Enzymes • Chelators (EDTA) (Metals accelerate degradative reactions)

11. Toxins in FoodMother nature can be...…well, a real “mother.”

12. Case Study 1 Patulin in Apple JuiceWould limiting patulin in apple juice to50ppb protect public?(FDA Advisory Committee) NoObservableEffectLevel (NOEL) = 0.3 mg/kg bodyweightper week Add 100-fold safety factor Provisional Max Tolerated Daily Intake (PMTDI) = 0.43ug/kg bw per day

13. Patulin is in Apple Juice at 500 ug/ bottleWould limiting patulin in apple juice to 100 ug per bottle protect public? ( assume they consume 1 bottle per day at 100 ug) NOEL = 5,000 ug/ bottle – So the regulation is unneeded because NOEL is much higher than consumption WRONG Add 100-fold safety factor (PMTDI) = 50 ug per bottle Regulation is needed because consumption is greater than 50 ug/bottle, but the regulation (100 ug) doesn’t go far enough

14. “Human intake of nature’s pesticides is about 10,000 times higher than human intake of synthetic pesticides that are rodent carcinogens.”-American Council on Science and Health.

15. Three sources of toxins in food • Endogenous toxins • Naturally occurring toxins • Synthetic toxins Risk Assessment = Dose Response + Exposure Assessment Dose Response: Threshold or no Threshold?

16. Toxicology- Questions for Synthetic Chemicals Dose response: Threshold or no Threshold? (Relationship to Delany?) Response Dose Risk Assessment = Dose Response + Exposure Assessment

17. ENDOGENOUS TOXINSNaturally toxic chemicals in plants • Hemaggultinins – castor and soy beans “ricin” • Cyanogens- cassava, beans • Phytoalexins – potato • Safarole – sassafras, black pepper • Nitrites – celery, dark green vegetables • Cyanide – apricot pits

18. “Solely the dose determines that a thing is … a poison.”Parcelis, 16th century(i.e. “The dose makes the poison.”)Myristicin in carrots is a halluncinogen> 400 mg required*Carrots contain 0.6 ug/kgYou need to consume ~ 667 kg (> 1,000 pounds) to reach the effective dose*Nutmeg also contains myristicin, and a fewtablespoons can get you high (or sick)

19. NATURALLY OCCURING TOXINSFungal Toxicants Ergot alkaloids- associated with rye, delusions and hallucinations

20. Aflatoxin – corn and peanuts 15 ppb ok(legally)

21. FUGU FISH One Fish, Two Fish, Blowfish, Blue FishHomer à manger du Fugu, un poisson mortel, dans un restaurant japonais. Il ne lui reste plus alors que 24 heures à vivre. Marine Toxins Saxitoxin – clams, paralytic shell-fish poisoning, red tide Domoic Acid - muscles

22. Bioaccumulation

23. Animal Testing

24. Animal Testing “Animal foods tested on humans”

25. Pesticides – act against insects -Organochlorides – persist (DDT) -Organophosphates – degrade Herbicides – act against weeds Integrated Pest Management Use of Pesticides and Herbicides has decreased 50% since 1980 Chemicals in the environment

26. 300 active ingredient 10,000 uses 1.2 billion pounds ~ 8 lbs/ person (applied) $20 billion crops destroyed (w/ pesticides) Fungicides prevent aflatoxin Increase yield, decrease crop losses Regulated by EPA, USDA, FDA Pesticides Many arguments for and against pesticides -impact of genetic engineering

27. Pesticide Testing (is limited) • No detectable pesticides in 60% of conventional produce

28. Pesticide Testing (is limited) • No detectable pesticides in 60% of conventional produce • Pesticides are detected in 40% of produce

29. Pesticide Testing (is limited) • No detectable pesticides in 60% of conventional produce • Pesticides are detected in 40% of produce • In 39%, detection is at less than one-tenth of tolerance level (which has 100-fold safety factor) • Only 1 % of produce tested has pesticides in excess of tolerance • Wash with warm soapy water

30. Other nasty beasties • Carcinogens in smoked foods • Pyrolysis products • PCBs – chloroacne, headache, numbness

31. “The hypothetical risk posed by food additives is greatly exceeded by the very real risk posed by not eating.” -Prof. Don Schaffner, Rutgers University