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The Federal Food, Drug and Cosmetic Act, 21 U.S.C. secs. 301-392, is the primary statute regulating pesticide residues and other potentially harmful additives in food products, as well as the introduction of any misbranded food into interstate commerce. Under the Act, a food is adulterated if it "bears or contains any poisonous or deleterious substance" that is possibly injurious to public health, 21 U.S.C. sec. 342(a), or if the food is missing "any valuable constituents" normally found in that food. 21 U.S.C. sec. 342(b). The act authorizes criminal penalties for violating its provisions, 21 U.S.C. sec. 333, as well as seizure, or enjoinder of delivery, by the Food and Drug Administration (FDA) of any adulterated food that is transported in interstate commerce. 21 U.S.C. sec. 334. The statute was enacted partly in response to consumers' inability to ascertain the safety of the food they purchased.

The FDA, an agency within the Department of Health and Human Services, was established to set safety and quality standards for foods, drugs, cosmetics, and other household substances sold as consumer products. The Administration is primarily concerned with research, inspection, and licensing of drugs for manufacturing anddistribution.

Other federal statutes may also regulate potentially harmful residues and additives.See e.g., FIFRA, 7 U.S.C. secs. 136-136y; TSCA, 15 U.S.C. secs. 2601-2609. Additionally, some states have enacted statutes similar to these federal regulations. See, e.g., Fla. Stat. Ann. sec. 500.10 (West 1972) (regulating foods); Cal. Health and Safety Code sec. 26522 (West 1967 & Supp. 1984) (regulating pesticides). EPA is authorized to protect public health by establishing standards for pesticide residues in raw commodities, processed foods, and animal feed. 40 C.F.R. pts. 180, 185, 186. With respect to raw agricultural commodities, EPA is authorized to set "tolerance levels" for pesticide residues that are "safe." In setting these tolerances, EPA must also consider the need for an adequate, wholesome and economical food supply, and other ways the consumer may be affected by the same or related pesticides. 21 U.S.C. sec. 346; 40 C.F.R. pt. 180 For regulating pesticides as a food additive in processed foods, EPA must set a safe level based entirely on health considerations. 21 U.S.C. sec. 348. This standard also includes the stringent "Delaney Clause" prohibition against any additive "found to induce cancer when ingested by man or animal." 21 U.S.C. sec. 348(c)(3); 40 C.F.R. pt. 177 (regulating pesticide residues as a food additive); 40 C.F.R. secs. 185.100-6300 (pesticide residues on food and animal feed). Food that contains any residue exceeding the allowed tolerances or standards is considered adulterated and is subject to seizure by the FDA.

Under TSCA Section 8(e), any person who manufactures, processes or distributes a chemical substance or mixture must notify the EPA within fifteen days of receiving any information suggesting that a chemical substance presents a substantial risk to human health or the environment. 15 U.S.C. sec. 2607(e); 40 C.F.R. pt. 710; 43 Fed. Reg. 11,110 (1978).

The Consumer Product Safety Act, 15 U.S.C. secs. 2051-2083, protects consumers from hazardous products. See Consumer Product Safety Comm'n. v. Chance Mfg. Co. (D.C. 1977), 441 F.Supp. 228 (1977). The Consumer Product Safety Commission (CPSC) was established on Oct. 27, 1972, Pub. L. No. 92- 573, 86 Stat. 1207 (codified at 15 U.S.C. sec. 2053) to administer and implement the provisions of the Consumer Product Safety Act. The CPSC is responsible for establishing product safety standards to reduce unreasonable risk of injuries to consumers from "consumer products." 15 U.S.C. sec. 2056. The CPSC also has the authority to (1) ban hazardous consumer products, (2) conduct research on consumer product standards, (3) establish a comprehensive consumer injury information clearinghouse, and (4) conduct consumer and industry information and education programs. 15 U.S.C. secs. 2054-2057. Hazardous consumer product bans implemented by the CPSC have included: (1) a ban on extremely flammable contact adhesives, 16 C.F.R. pt. 1302; (2) a ban on lead-containing paint and certain consumer products bearing lead- containing paint, 16 C.F.R. pt. 1303; (3) a ban of certain materials containing free-form asbestos, 16 C.F.R. pt. 1305; (4) a ban of consumer patching compounds containing respirable free-form asbestos, 16 C.F.R. pt. 1304; (5) a ban on unstable refuse bins, 16 C.F.R. pt. 1301; (6) a ban on isopropyl nitrite and other nitrites, 15 U.S.C. sec. 2057b; and (7) a ban on butyl nitrite, 15 U.S.C. sec. 2057a. The CPSC may file in a U.S. district court an action in response to an imminently hazardous consumer product. 15 U.S.C. sec. 2061. Judicial review of consumer product safety rules is available to the regulated community as well as consumers and consumer organizations. 15 U.S.C. sec. 2060.


Civil penalties for violating TSCA can be up to $25,000 per day per violation. In determining the amount of a civil penalty, EPA must consider the nature, circumstances, extent and gravity of the violation, as well as the violator's ability to pay, compliance history and culpability. 15 U.S.C. sec. 2615(a). Any person who knowingly or willfully violates TSCA shall be subject to criminal fines of up to $25,000 per day per violation and/or imprisonment of up to one year. 15 U.S.C. sec. 2615(b). EPA has authority to seek a court order to seize chemical substances or to take other actions to avoid imminent hazards. 15 U.S.C. sec. 2616.

Civil penalties under FIFRA can be up to $5,000 per offense and criminal penalties of up to $50,000 and/or one year imprisonment. 7 U.S.C. sec. 136l. EPA has specific authority under FIFRA to issue administrative orders stopping the sale, use or removal of any pesticide reasonably believed to be in violation of FIFRA. The EPA can also seek a court order to seize a pesticide that violates any of a specified list of provisions. 7 U.S.C. sec. 136k.

State Enforcement.
If EPA has regulated a particular substance under TSCA, states are preempted from imposing additional testing requirements or most other requirements aimed at protecting public health or the environment. 15 U.S.C. sec. 2617. Under FIFRA, EPA can delegate primary enforcement responsibility to a state if EPA determines that the state has adopted adequate pesticide use laws and regulations, including enforcement authorities, and that the State will provide all required records and reports to EPA. 7 U.S.C. sec. 136w- 1.

Citizen Suits and Petitions.
TSCA has a citizen suit provision that allows actions against any person who violates TSCA's testing, notification, manufacturing or use restrictions. Citizens can also sue to force EPA to carry out any non- discretionary duty. 15 U.S.C. sec. 2619(a). Citizen suits cannot be brought without first providing 60-day notice to the defendant nor can any suit be brought if EPA is already diligently prosecuting the same violation. 15 U.S.C. sec. 2619(b). The citizen suit provision specifically does not preempt any other statutory or common law actions. 15 U.S.C. sec. 2619(c). Citizens also have the right to petition EPA to issue a rule regarding a specific chemical. 15 U.S.C. sec. 2620.

From Summary of Enviromental Law in the United States - CEC

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