Todays 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?

ADDITIVES
There are about 3,000 approved food additives

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

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

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

Types of Food Additives

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

Preservatives
Salt Organic acids
Benzoates Acetic, Citric, Lactic

Sulfur dioxide Nitrite

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)

Toxins in Food
Mother nature can be... well, a real mother.

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

12

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) doesnt go far enough

13

Human intake of natures pesticides is about 10,000 times higher than human intake of synthetic pesticides that are rodent carcinogens.
-American Council on Science and Health.

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?

Toxicology- Questions for Synthetic Chemicals

Dose response: Threshold or no Threshold?
(Relationship to Delany?)

Response

Dose

Risk Assessment = Dose Response + Exposure Assessment

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

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)

NATURALLY OCCURING TOXINS

Fungal Toxicants
Ochratoxin Patulin 50 ppb Alimentary toxic alukia Zeraralenone Cereal grains Kidney Apple products Kidney Cereal grains Bone marrow 80% fatality Hyper-estrogenisms

Corn, wheat

Ergot alkaloids- associated with rye, delusions and hallucinations

Aflatoxin corn and peanuts

15 ppb ok (legally)

Marine Toxins
FUGU FISH
One Fish, Two Fish, Blowfish, Blue Fish Homer manger du Fugu, un poisson mortel, dans un restaurant japonais. Il ne lui reste plus alors que 24 heures vivre.

Saxitoxin clams, paralytic shell-fish poisoning, red tide Domoic Acid - muscles

Bioaccumulation

Animal Testing

Animal Testing

Animal Testing

Animal foods tested on humans

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

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

Pesticide Testing (is limited)

No detectable pesticides in 60% of conventional produce

Pesticide Testing (is limited)

No detectable pesticides in 60% of conventional produce

Pesticides are detected in 40% of produce

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

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

Other nasty beasties

Carcinogens in smoked foods Pyrolysis products PCBs chloroacne, headache, numbness

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