Testing requirements

The Administrator of the U.S. Environmental Protection Agency (EPA) shall by rule, order, or consent agreement require that testing be conducted on any chemical substance or mixture that may present an unreasonable risk of injury to health or the environment. [TSCA §4(a)(1)] The statute sets out guidelines for such rules, orders, and consent agreements. [TSCA §4(b)]

Testing of substances must develop information with respect to the health and environmental effects for which there is an insufficiency of information and experience, and which is relevant to determining whether they do or do not present unreasonable risks of injury to health or the environment. [TSCA §4(a)(1)].

When testing is required for a substance, the Administrator shall provide a statement of need that (1) identifies the need for the new information, (2) describes how information reasonably available to the Administrator was used to inform its decision to require new information, (3) explains the basis for any decision that requires the use of vertebrate animals, and (4) explains, if applicable, why an order was warranted instead of promulgating a rule or entering a consent agreement. [TSCA §4(a)(3)]

Testing exemptions

Any person required by rule or order to conduct tests and submit information on a chemical substance may be exempted from conducting tests if the Administrator determines that the substance is (1) equivalent to a substance for which information has been submitted to the Administrator or for which information is already being developed, and (2) submission of new information for such substance would be duplicative of information that has already been submitted to the Administrator or that is already being developed. [TSCA §4(c)(2)]

 Any person that is granted an exemption from testing shall fairly and equitably reimburse, in an amount determined by the Administrator, any person who previously submitted the information for a portion of the costs incurred in submitting the information or each person who is developing the information for a portion of the costs incurred in developing the information. [TSCA §4(c)(3)-(4)]

Addressing risks

The Administrator shall act within 180 days of receiving information which indicates that a chemical substance presents significant risk of serious or widespread harm to humans. The Administrator cannot consider costs or other nonrisk factors in determining that a risk is not unreasonable. Applicable action may include requiring premanufacture or processing notices, promulgating regulations concerning the distribution and handling of the substance, or commencing a civil action to obtain the relief necessary to address an imminent hazard. [TSCA §4(f)]

Reducing vertebrate animal testing

The Administrator shall reduce and replace, to the extent practicable, scientifically justified, and consistent with the statute, the use of vertebrate animals when testing chemical substances. [TSCA §4(h)(1)]

The Administrator shall develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances. [TSCA §4(h)(2)]

Premanufacture notice requirement

Manufacturers and processors of new chemical substances, or substances that will be applied to significant new uses, must notify the Administrator within 90 days that they intend to manufacture or process the substance and submit information from any required testing. [TSCA §5(a)(1)]

A person may apply for an exemption from the premanufacture notice requirement if (1) a substance is being produced only in small quantities for purposes of scientific research, (2) a substance is being manufactured or processed for purposes of test marketing, and (3) a substance exists temporarily as a result of manufacturing or processing of another substance and will not be exposed to humans or the environment. [TSCA §5(h)]

Evaluation of new chemical substances

The Administrator shall review all premanufacture notices for new chemical substances and significant new uses, make a determination as to whether the substance or significant new use presents an unreasonable risk of injury to health or the environment, and take required action within 90 days of receiving the notices. [TSCA §5(a)]

If the Administrator determines that a substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, the Administrator shall take action to protect against such risk by either promulgating a significant new use rule or ordering that the manufacture, processing, or distribution of the substance be prohibited or limited. [TSCA §5(f)]

If the Administrator determines that (1) there is insufficient information on a substance or significant new use to permit a reasoned evaluation of the health and environmental effects of the substance or use, (2) the substance may present an unreasonable risk in the absence of sufficient information, or (3) the substance is or will be produced in substantial quantities, and it enters or is anticipated to enter the environment in substantial quantities or this is or may be significant human exposure, the Administrator shall order that the manufacture, processing, distribution, use, or disposal of the substance be prohibited or limited to the extent necessary to protect against an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors. [TSCA §5(e)]

If the Administrator determines that the substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, the manufacturer or processor who submitted the premanufacture notice can commence manufacturing of the substance or manufacturing or processing the significant new use. [TSCA §5(a)(3)(C)]

Risk evaluations and regulation of chemical substances

If the Administrator determines that a substance presents an unreasonable risk of injury to health or the environment, the Administrator shall prohibit, limit, or otherwise restrict the manufacture, processing, or distribution of the substance to the extent necessary so that the substance no longer presents such risk. [TSCA §6(a)]

The Administrator shall establish a risk-based screening process for designating substances as either high or low priority that includes considerations such as hazard and exposure potential, conditions of use, and volume. High priority substances are those that present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation. Lower priority substances are those that do not meet the standard for a high priority designation. [TSCA §6(b)]

The Administrator shall conduct a risk evaluation for any substance that is designated as a high priority substance to determine whether the substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation. [TSCA §6(b)(3)-(4)]

Within six months of initiating a risk evaluation, the Administrator shall publish the scope of the evaluation, including the hazards, exposures, conditions of use, and potentially exposed or susceptible subpopulations. [TSCA §6(b)(4)(D)]

In conducting a risk evaluation, the Administrator shall (1) integrate and assess available information on hazards and exposures for the conditions of use of the substance, (2) describe whether aggregate or sentinel exposures to a substance under the conditions of use were considered, (3) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use of the substance, and (4) describe the weight of the scientific evidence for the identified hazard and exposure. [TSCA §6(b)(4)(F)]

The Administrator shall complete a risk evaluation for a substance as soon as practicable, but no later than three years after the date the evaluation is initiated. [TSCA §6(b)(4)(G)]

If the Administrator determines that a substance presents an unreasonable risk of injury to health or the environment, the Administrator shall propose a rule within one year of the date on which the final risk evaluation for the substance is published. When promulgating the rule, the Administrator shall consider and publish a statement based on reasonably available information concerning: (1) the effects and magnitude of exposure for humans and the environment; (2) the benefits of the substance; and (3) reasonably ascertainable economic consequences of the rule. [TSCA §6(c)]

The Administrator may grant exemptions to rule promulgations if it is found that (1) the use is critical or essential with no technically and economically feasible alternative; (2) compliance would significantly disrupt the national economy; or (3) the specific condition of use provides a substantial benefit to health, the environment, or public safety when compared to reasonably available alternatives. [TSCA §6(g)]

Imminent hazards

In the case of an imminently hazardous substance, the Administrator may commence a civil action in a U.S. district court for seizure of the substance and other appropriate relief, including mandatory notification, recall, and replacement or repurchase of the substance by the manufacturer, processor, or distributor of the substance. [TSCA §7]

Reporting and retention of information

The Administrator shall promulgate rules establishing required recordkeeping procedures and reporting requirements for manufacturers and processors. The rules may impose different reporting and recordkeeping requirements on manufacturers and processors, and must include the level of detail necessary to be reported, including the manner by which use and exposure information may be reported. [TSCA §8(a)]

The Administrator shall compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the United States. [TSCA §8(b)]

The Administrator shall publish an inventory of mercury supply, use, and trade in the United States every three years. In carrying out the inventory, the Administrator shall identify any manufacturing processes or products that intentionally add mercury and recommend actions, including proposed revisions of federal law or regulations, to achieve further reductions in mercury use. To assist in the preparation of the inventory, every person who manufactures mercury or mercury-added products or uses mercury in a manufacturing process must submit periodic reports to the Administrator. [TSCA §8(b)(10)]

Manufacturers, processors, and distributors shall maintain records of significant adverse reactions to health or the environment alleged to have been caused by their substances. [TSCA §8(c)]

Inspections

The Administrator, and any duly designated representative of the Administrator, may conduct limited inspections of premises on which chemical substances are manufactured, processed, stored, or held before distribution and of conveyances used to transport such substances. [TSCA §11] 

Exports and imports

The statute’s requirements generally do not apply to substances being distributed for export from the United States unless the Administrator determines that the substance presents an unreasonable risk of injury to health within the United States or to the environment of the United States. [TSCA §12(a)]

Notice of intent to export shall be given to the Administrator for any substance whose manufacture or processing requires submission, under the statute, of test information or a premanufacture notice. [TSCA §12(b)]

The export of certain mercury compounds, as identified in the statute, is prohibited. [TSCA §12(c)]

Imports of any substances are subject to the statute’s requirements, and any noncomplying substance shall be refused entry into U.S. customs territory. [TSCA §13]

Enforcement

The statute provides for civil and criminal penalties for violations. [TSCA §§15, 16, 17(a), 19]

Substances produced in violation of the statute may be seized. [TSCA §17(b)]

The Administrator shall waive compliance with the statute on a request from the President that the waiver is necessary in the interest of the national defense. [TSCA §22] 

Preemption

A state may not establish laws or regulations that (1) address development of information about a chemical substance already regulated by the Administrator, (2) restrict the development of a chemical substance that the Administrator has determined does not pose an unreasonable risk, (3) impose new use notification requirements for chemical substances already subject to federal notification requirements, or (4) impose penalties more stringent than the penalties imposed under the statute for identical requirements unless a compelling reason for a discretion exemption is presented. [TSCA §18]

Federal testing requirements for a substance generally preempt state testing requirements for the substance. Federal rules governing premanufacture notice and regulation of hazardous chemicals generally preempt any state regulations designed to address the same risks. [TSCA §18]

Citizen suits

Any person may commence a citizen suit against alleged violators or the Administrator, subject to certain limitations. [TSCA §20]

Any person may petition the Administrator for promulgation, repeal, or amendment of certain rules issued under the statute. [TSCA §21]

Asbestos hazard emergency response

The Administrator shall promulgate regulations that (1) prescribe inspection procedures to determine whether asbestos-containing material is present in school buildings, (2) define the appropriate levels of response actions, (3) require the implementation of maintenance and repair programs, (4) require periodic surveillance of school buildings where asbestos is located, and (5) prescribe standards for transportation and disposal of asbestos-containing material to protect human health and the environment. All of the activities are to be carried out under the authority of local educational agencies. [TSCA §203(a)-(h)]

The Administrator shall promulgate regulations that require each local educational agency to develop for its school buildings an asbestos management program, which shall include inspection statements, plans for response actions, long-term surveillance, and use of warning labels for asbestos remaining in the buildings, among other things. [TSCA §203(i)] Local educational agencies that fail to comply shall be subject to civil penalties. [TSCA §207(a)]

Any person may file a complaint with the governor alleging the presence of asbestos in a school building. The Administrator or the governor shall investigate and respond to any such complaint within a reasonable time. [TSCA §207(d)]

Whenever there is an imminent and substantial endangerment, and the local educational agency is not taking sufficient action, the Administrator or the governor is authorized to act to protect human health and the environment. [TSCA §208]

Indoor radon abatement

The national long-term goal of the United States with respect to radon levels is that the air inside buildings be as free of radon as the ambient air outside of buildings. [TSCA §301]

EPA shall publish an updated version of its document A Citizen’s Guide to Radon, which shall include information on the health risks associated with exposure to radon, the cost and technical feasibility of reducing radon concentrations, the relationship between long-term and short-term testing techniques, and outdoor radon levels around the country. [TSCA §303]

EPA shall develop model construction standards and techniques for controlling radon levels in new buildings. [TSCA §304]

The federal government shall develop and implement activities to assist state radon programs, including, among other things, establishing a radon information clearinghouse, designing and implementing training seminars for state and local officials, and developing and demonstrating radon measurement and mitigation techniques. [TSCA §305(a)]

The Administrator is authorized to make grants to states to assist them in developing and implementing their radon programs. [TSCA §306]

EPA shall conduct a study to determine the extent of radon contamination in the nation’s schools. [TSCA §307(a)] 

Lead exposure reduction

The Administrator shall promulgate regulations to require that individuals involved in lead-based paint activities are properly trained, that training programs are accredited, and that contractors involved in such activities are certified. [TSCA §402]

States may obtain authorization to enforce lead-exposure reduction standards, regulations, or other requirements under the statute. [TSCA §404] Such state programs may impose more stringent requirements than the federal program. [TSCA §404(e)]

The Administrator, in cooperation with other federal agencies, shall conduct a program to promote lead-exposure abatement, which shall include exposure studies, public education, establishment of a clearinghouse and hotline to provide technical assistance, and establishment of testing protocols and performance characteristics to ensure that lead-based paint polychlorinated biphenyls (PCBs) hazard evaluation and reduction products are effective for their intended use. [TSCA §405]

The Administrator shall prescribe methods for disposal of PCBs and require them to be labelled with adequate warnings. [TSCA §6(e)]

The Administrator shall publish and revise a lead-hazard information pamphlet. [TSCA §406]