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The primary Federal statute regulating the manufacture, import, and distribution of chemical substances is the Toxic Substances Control Act (TSCA). 15 U.S.C. secs. 2601-2629. Pesticides and other agricultural chemicals are covered by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. secs. 136-136y. The Federal Food, Drug, and Cosmetic Act (FFDCA) regulates pesticide residues in raw agricultural products and processed food, 21 U.S.C. secs. 301-392. Both FIFRA and FFDCA were amended in 1996 by the Food Quality Protection Act of 1996, P.L. No. 104-170. The Occupational Safety and Health Act (OSH Act), 29 U.S.C. secs. 651-678, protects employees from chemical hazards.
TSCA imposes notification, testing, and reporting requirements on manufacturers or importers of new chemicals, existing chemicals for significant new uses, and certain listed chemicals. Premanufacture Notification
No person may manufacture a new chemical substance or manufacture any chemical substance for a "significant new use," before submitting a premanufacture notice to the Environmental Protection Agency (EPA). 15 U.S.C. sec. 2604; 40 C.F.R. pt. 721. New uses are significant if they: increase the projected volume of production for the chemical; increase exposure to humans or the environment; or, substantially change production or disposal methods. 40 C.F.R. pt. 721. TSCA defines "manufacture" to include importation, thus the premanufacture notice requirements apply equally to importers of chemical substances. 15 U.S.C. sec. 2602(7). Documentation underlying the premanufacture notice, production levels in the first three years, and certain other information must be retained for five years. 40 C.F.R. pt. 720. In addition, any person who proposes to manufacture, import, or process any listed chemical substance must submit a list or copies of all health or environmental impact studies on the chemical within 60 days of the chemical being listed. 40 C.F.R. pt. 716.
When submitting a premanufacture notice, the manufacturer must also submit any test results required under section 4 of TSCA which requires manufacturers and distributors of chemicals to test and collect data about the risks of the chemicals. If EPA finds that a chemical may present "an unreasonable risk of injury to health or the environment," or if production of a chemical may result in substantial release in the environment or substantial exposure to humans, then EPA can require a wide range of tests to provide sufficient data to determine the risks. There is a detailed procedure for determining when EPA can require the tests, what can be required in the tests, and who is exempted. 15 U.S.C. sec. 2603.
Under FIFRA, all pesticide producers must register with EPA and receive an establishment registration number, which must be used when submitting reports under FIFRA. 7 U.S.C. sec. 136(e). Although pesticides can be manufactured without further notification, they cannot be distributed or sold without first being registered as described in Section 11.2. The Food Quality Protection Act of 1996 requires EPA to design and implement an estrogenic substances screening program to address the effects of chemicals that mimic human hormones. 21 U.S.C. sec. 346a(p).
See Section 24.4: Occupational Health and Safety.
If EPA finds a "reasonable basis" for concluding that the production, importation, use, or disposal of a chemical substance presents an "unreasonable risk" of injury to health or the environment, then EPA can prohibit, restrict, or otherwise regulate the production, import, or use of the chemical "to protect adequately against such risk using the least burdensome requirements". 15 U.S.C. sec. 2605; 40 C.F.R. pt. 750.
Reporting and Recordkeeping
TSCA imposes a variety of detailed reporting and recordkeeping requirements. 15 U.S.C. sec. 2607. Certain manufacturers, importers, and processors are required to provide specified information relating to the manufacturing, processing, waste treatment, and exposure of a long list of chemicals under a standardized system known as the Comprehensive Assessment Information Rule. 40 C.F.R. pt. 704. EPA also requires the one-time reporting of production, use, and exposure information on listed chemicals. 40 C.F.R. pt. 712. Under TSCA section 8(c), any producer or distributor of a chemical substance must retain records of any significant adverse reaction to health or the environment alleged to have been caused by the chemical substance or mixture. 15 U.S.C. sec. 2607(c). Under TSCA section 8(d), any manufacturer or importer of any chemical substance found to pose an unreasonable risk to health or the environment must submit a list or copies of all health or safety studies relating to the chemical. 15 U.S.C. sec. 2607(d); 40 C.F.R. pt. 716.
Imports and Exports
Importers are expected to certify that they have complied with all TSCA requirements or that TSCA does not apply to the shipment. Any substance that is not in compliance with TSCA will be barred from entry. 15 U.S.C. sec. 2612. Most of TSCA's provisions do not apply to chemicals that are exported from the United States, unless they present an unreasonable risk during manufacture or transport in the United States. EPA does require annual written notice of exports of certain chemicals regulated under TSCA. EPA then provides this information to the importing country's embassy. 15 U.S.C. sec. 2611; 40 C.F.R. pt. 707, subpt. C.
Under FIFRA, all pesticides must be registered before they can be distributed or sold. 7 U.S.C. sec. 136a. To register a pesticide, an applicant must submit their name, the name and complete formula of the pesticide, the proposed pesticide label, any claims of effectiveness, directions for use, a request that the pesticide be classified for general or restricted use, and a full description of any test results supporting the claims for the pesticide. 40 C.F.R. sec. 152.50. Applicants must also satisfy the detailed data submission requirements of 40 C.F.R. pt. 158. EPA must register the pesticide if it determines that: (1) the pesticide's composition warrants the proposed claims for it; (2) the labelling and other material are adequate; (3) it will perform its intended purpose without causing "unreasonable adverse effect on the environment;" and (4) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment. 7 U.S.C. sec. 136a(c)(5). "Unreasonable adverse effects" are defined to take into account economic, social, and environmental costs and benefits; this cost-benefit standard is decidedly less strict than environmental laws based on technological or economic feasibility. 7 U.S.C. sec. 136(bb).
Because many old pesticides were registered under even more lax standards, they must be re-registered under detailed procedures set forth in the 1988 FIFRA amendments. 7 U.S.C. sec. 136a-1. Moreover, the Food Quality Protection Act of 1996 requires EPA to reregister existing pesticides no less frequently than every 15 years, 7 U.S.C. sec. 136a(g). A pesticide registration can be cancelled, if the EPA determines it no longer meets the standards for registration. 7 U.S.C. sec. 136d, 40 C.F.R. pts. 153, 164.
Under FIFRA, a pesticide producer is under a continual obligation to provide the EPA with any new information, including, for example, certain toxicological, epidemiological, or efficacy studies or reports of specific incidents of injury, which suggest any "unreasonable adverse effects" of a registered pesticide on the environment or human health. 7 U.S.C. sec. 136(bb); 40 C.F.R. pt. 153. Pesticide producers must also report annually the types and amounts of pesticides and the amount of active ingredients used in pesticides produced and distributed during the past year. 40 C.F.R. pt. 167, subpt. E.
Occupational Health and Safety (OSH) Act
Under the OSH Act, chemical manufacturers must provide material safety data sheets (MSDSs) and certain container labels along with their shipments. The requirements apply to over 50,000 chemicals that may pose physical hazards, such as flammability or explosivity, or health hazards, such as toxicity or carcinogenicity. There is no comprehensive list of hazardous chemicals for the purposes of the OSH Act. 29 C.F.R. sec. 1910.120
Restrictions on the storage, transport, and use of chemical products are regulated by TSCA, the OSH Act, FIFRA, and state regulations.
TSCA does not impose generally applicable regulations on the storage, transport, or use of toxic chemicals. If EPA finds a "reasonable basis" for concluding that the production, use, or disposal of a chemical substance presents an "unreasonable risk" of injury to health or the environment, the EPA can prohibit, restrict, or otherwise regulate the production, import, or use of the chemical "to protect adequately against such risk using the least burdensome requirements." 15 U.S.C. sec.2605; 40 C.F.R. pt. 750.
All chemical products must meet the hazard communication standard (HCS) under the OSH Act. The HCS ensures that employees receive "as much information as needed concerning workplace hazards." The HCS requires employers: to label containers of hazardous chemicals in the workplace; to provide detailed material safety data sheets (MSDS's) for each hazardous chemical present on the facility; and, to offer employee training programs. 29 U.S.C. sec. 655; 29 C.F.R. sec. 1910.1200. The HCS applies to over 50,000 chemicals that may pose physical hazards, such as flammability or explosivity, or health hazards, such as toxicity or carcinogenicity. There is no comprehensive list of hazardous chemicals for purposes of the OSH Act. For more information on the OSH Act, see Section 24.4.
As part of the FIFRA pesticide registration, EPA must classify any pesticide for "general" or "restricted" use. 7 U.S.C. sec. 136a. Restrictions may be set on such factors as method of applications, qualification of applicators, amount to be used, geographic area or time of use, and species of targeted pests. 7 U.S.C. sec. 136i. EPA also sets certain minimum worker protection standards for pesticide handlers, 40 C.F.R. pt. 170, and has issued minimum standards for certifying pesticide applicators. Pesticide applicators must maintain certain records, including the product name, amount, and approximate date and location of application of each pesticide used in the past two years. 40 C.F.R. pt. 171.
EPA has also issued specific regulations for the labeling of pesticides. All pesticides must be labeled according to specific rules that require, among other things, identification of the manufacturer, description of the product, the product registration number, directions and restrictions for use, and a warning statement if necessary. 40 C.F.R. pt. 156.
Where EPA has issued a rule on testing for a specific substance, or a rule designed to protect public health, state law may be preempted. Otherwise, states may continue to regulate the manufacture and use of chemical substances in their state. 15 U.S.C. sec. 2617. States can regulate the sale or use of any federally registered pesticide or device in the state, but only if the regulation does not allow any sale or use prohibited by FIFRA. 7 U.S.C. sec. 136v(a). To ensure uniformity in labeling and packaging, FIFRA preempts states from .imposing any labeling or packaging requirements different from those required under FIFRA. 7 U.S.C. sec. 136v(b).
The Federal Food, Drug and Cosmetic Act (FFDCA), 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 and civil fines up to $US50,000 for individuals and $US500,000 for businesses 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.
Under FFDCA, EPA is authorized to protect public health by establishing standards or "tolerance levels" for pesticide residues in raw commodities and processed foods. 40 C.F.R. pts. 180. Any commodity or food that contains concentrations of a pesticide in excess of a tolerance level or for which no tolerance level has been set is adulterated and subject to the enforcement provisions of the FFDCA. The FFDCA, as amended by the Food Quality Protection Act of 1996, sets a new health based standard for tolerance levels and requires EPA to reexamine all existing tolerance levels within ten years in light of the new standard. For both raw agricultural commodities and processed foods (which were treated differently under prior law), EPA must set tolerance levels for pesticide residues that are "safe." Safe is defined as "a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other [non-occupational] exposures for which there is reliable information." 21 U.S.C. sec. 346a(b)(2)(A). EPA must consider any relevant international tolerance levels set by the Codex Alimentarius Commission and explain any departure from such levels.
In setting tolerance levels, EPA must make a specific determination regarding the safety of the pesticide chemical residue for infants and children and is authorized to use up to a tenfold increase in the margin of safety that would otherwise apply under the "safe" standard to ensure protection of infants and children. 21 U.S.C. sec. 346a(b)(2)(C). Certain existing tolerance levels that do not meet the new "safe" standard will be allowed to remain in effect if the pesticide prevents even greater health risks than it causes or if the absence of the pesticide would cause a "significant disruption in domestic production of an adequate, wholesome, and economical food supply." 21 U.S.C. sec. 346a(2)(B).
Some states have enacted statutes similar to these federal regulations. See for example, Fla. Stat. Ann. sec. 500.10 (West 1972) (regulating foods); Cal. Health and Safety Code sec. 26522 (West 1967 & Supp. 1984) (regulating pesticides).
Under TSCA section 8(e), any person who manufactures, processes, or distributes a chemical substance or mixture must notify the EPA within 15 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 US$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 US$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 US$5,000 per offense and criminal penalties of up to US$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.
The FFDCA authorizes criminal penalties and civil fines up to $US50,000 for individuals and $US500,000 for businesses 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.
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.