The TSCA requires manufacturers to notify the EPA at least ninety days prior to manufacturing a new chemical substance or placing it in the market for a new use. The notice must contain health and safety data and an assessment of the impact of that chemical on human health and the environment. The TSCA applies to chemical manufacturers and processors. A processor is any person who prepares a chemical substance or mixture after its manufacture for distribution into commerce (TSCA §§3[10-11], 15 USC §§2602[10-11]).
The TSCA (§4, 15 USC §2603) authorizes the EPA to require testing of chemical substances. The EPA has published testing guidelines pursuant to this authority. Moreover, the EPA can compel manufacturers to test chemical substances for which insufficient data exist to determine their effects on human health and the environment (40 CFR pts. 796, 797, 798). To determine if such chemicals present unreasonable risks, this requirement applies to both new chemical substances, as well as those on the market. The EPA can require toxicity tests on a substance "when there is [a] more-than-theoretical basis for suspecting that some amount of exposure occurs and that the substance is sufficiently toxic at that exposure level to present 'unreasonable risk of injury to health' " (Chemical Manufacturers Assn. v. EPA, 859 F.2d 977, 984 (D.C. Cir. 1988).
The act creates the Interagency Testing Committee (ITC) to recommend chemicals for testing (TSCA §4[e], 15 USC §2603[e]). The ITC consists of members from eight separate federal agencies who recommend testing. The ITC gives priority to those chemical substances likely to cause or contribute "to cancer, gene mutations, or birth defects."
Upon listing a chemical substance, the EPA has one year to either initiate a rulemaking proceeding requiring testing or publish in the FR the reason why a proceeding was not initiated. The EPA initiates action if testing data or other information provide a basis to conclude that a chemical substance presents a significant risk of human cancer, genetic mutation, or birth defects. Where such significant risk exists, the EPA must act within 180 days of receipt of the information. This period can be extended up to ninety days for good cause.
Chemical manufacturers must provide the EPA with pre-manufacture notice before any new chemical is manufactured, processed, or put on the market (TSCA §5, 15 USC §2604). The manufacturer must also provide notice if an existing chemical substance is being used in a new manner. The EPA has regulations to assess the safety of potentially marketable chemicals (40 CFR pts. 720-723).
The manufacturer gives the premanufacture notice at least ninety days prior to the intended manufacturing or processing. This notice includes test data showing that the chemical does not present an unreasonable risk. The EPA
can prohibit or limit the manufacturing or processing of the chemical if it receives insufficient information from the manufacturer to make a proper evaluation.
The EPA requires manufacturers, processors, distributors, and importers of chemical substances to report information on chemicals so that the EPA can effectively administer and enforce the TSCA (§8[a], 15 USC §2607[a]). The EPA promulgated the Preliminary Assessment Information Rule (40 CFR pt. 712, subpt. B) and the Comprehensive Assessment Information Rule (40 CFR pt. 704) pursuant to this authority. These rules designate chemical substances which, together with the ITC list, must be reported by manufacturers and processors. Both rules provide forms and instructions for reporting and request information on the qualities of chemicals and worker exposure.
Manufacturers and processors must also maintain records of any allegations of harmful effects caused by chemicals (TSCA §8[c], 15 USC §2607[c]; 40 CFR pt. 717). The EPA can inspect these records upon request. Sources of allegations include lawsuits, workers compensations claims, and employee or customer complaints. A company must retain records of adverse reactions of employees for thirty years from the time an incident is reported. All other records of adverse reactions must be retained for a five-year period.
The EPA can also request and obtain health and safety studies on chemical substances from persons dealing in chemicals (TSCA §8[d], 15 USC §2607[d]). The EPA defines health and safety studies as "any study of any effect of a chemical substance or mixture on health or the environment" (40 CFR §716.3). The studies encompass those conducted or initiated by the person, known to the person, or reasonably ascertainable to the person.
Finally, the EPA requires persons dealing in chemicals to report any information which suggests a chemical substance may substantially risk injury to human health or the environment (TSCA §8[e], 15 USC 2607[e]). The EPA does not have the authority to publish regulations for this requirement, but it has published several guidance documents (43 FR [16 March 1978]; TSCA §8[e]).
The EPA has broad authority to regulate the manufacture, processing, distribution, use, or disposal of chemical substances (TSCA §6, 15 USC §2605). The EPA can limit or prohibit the manufacture or distribution of a chemical substance or may simply require public warnings. This regulatory authority is based on a finding that a reasonable basis exists that such activities "present or will present an unreasonable risk of injury to health or the environment." The EPA must also consider the benefits of the chemical substance, any economic effects of the regulatory action, and the health risks created by the chemical's manufacture. When the EPA regulates a chemical substance, it must apply the least burdensome means of providing adequate protection.
TSCA's LIMITED REGULATORY PRACTICE
The EPA has promulgated regulations directed at poly-chlorinated biphenyls (PCBs), chlorofluorocarbons (CFCs), asbestos, and 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) waste. The controls on the use of PCBs are a good example of this regulation.
PCBs were developed for use in industrial equipment such as electrical transformers and capacitors. PCBs are regulated under section 6 of the TSCA (§6[e], 15 USC 2605[e]) and under the rule promulgated pursuant to section 6.34 Section 6 bans the manufacturing, processing, or distribution of PCBs with a few exceptions. The rule also requires a tracking and manifest system with notification and recordkeeping requirements similar to the RCRA. Moreover, the EPA has a PCB Penalty Policy (August 1990) which subjects violators to penalties of up to $25,000 per day.
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