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
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
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.
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.
LIABILITY AND ENFORCEMENT
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.
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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