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. ADDITIVES There 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 Sulfur dioxide Nitrite 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 Food Mother nature can be... …well, a real “mother.”

12. Case Study 1
Patulin in Apple Juice Would limiting patulin in apple juice to 50 ppb protect public? (FDA Advisory Committee)
NoObservableEffectLevel (NOEL) = 0.3 mg/kg bodyweight per week
Add 100-fold safety factor
Provisional Max Tolerated Daily Intake (PMTDI) = 0.43ug/kg bw per day

13. NOEL = 5,000 ug/ bottle – So the regulation is unneeded because
Patulin is in Apple Juice at 500 ug/ bottle Would 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 TOXINS Naturally 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
“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/kg You need to consume ~ 667 kg (> 1,000 pounds) to reach the effective dose *Nutmeg also contains myristicin, and a few tablespoons can get you high (or sick)

19. NATURALLY OCCURING TOXINS Fungal Toxicants
Ochratoxin
Cereal grains
Kidney
Patulin
50 ppb
Apple products
Alimentary toxic alukia
Bone marrow
80% fatality
Zeraralenone
Corn, wheat
Hyper-estro-genisms
Ergot alkaloids- associated with rye, delusions and hallucinations

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

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

22. Bioaccumulation

23. Animal Testing

24. Animal Testing

25. Animal Testing
“Animal foods
tested on humans”

26. Chemicals in the environment
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

27. Pesticides 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
Many arguments for and against pesticides
-impact of genetic engineering

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

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

30. 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

31. Antibiotics and the danger of antibiotic resistance
Is agricultural use of antibiotics a significant part of the problem?
Antibiotics, 60 years - Bacteria, millions of years

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

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