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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.
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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.
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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
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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. 185.1006300 (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
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Consumer Environmental Protection>
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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 leadcontaining paint and certain
consumer products bearing
lead- containing paint, 16
C.F.R. pt. 1303; (3) a ban of
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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
TCSA.
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
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actions to avoid imminent
hazards. 15 U.S.C. sec.
2616.
FIFRA.
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. 136w1.
Citizen Suits and Petitions.
TSCA has a citizen suit
provision that allows actions
against any person who
violates TSCA's testing,
notification, manufacturing
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or use restrictions. Citizens
can also sue to force EPA to
carry out any nondiscretionary duty. 15
U.S.C. sec. 2619(a). Citizen
suits cannot be brought
without first providing 60day 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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