# Proposed Amendments to the Toxic Substances Control Act (TSCA): Senate and House Bills Compared with Current Law > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/crs%3AR41335 ## Record - **Collection:** Congressional research report - **Document type:** CRS Report - **Published:** August 12, 2010 - **Citation:** R41335 ## Text Proposed Amendments to the Toxic Substances Control Act (TSCA): Senate and House Bills Compared with Current Law (name redacted) Specialist in Environmental Policy August 12, 2010 Congressional Research Service 7-.... www.crs.gov R41335 CRS Report for Congress Prepared for Members and Committees of Congress Proposed Amendments to the Toxic Substances Control Act Summary On April 15, 2010, Senator Lautenberg introduced legislation (S. 3209) to amend the core provisions of the Toxic Substances Control Act (TSCA) Title I. Representatives Waxman and Rush introduced comprehensive legislation to amend TSCA (H.R. 5820) on July 22, 2010. This report compares key provisions of S. 3209, as introduced, H.R. 5820, as introduced, and current law (15 U.S.C. 2601 et seq.). Both bills would amend the 35-year-old law to shift the burden of demonstrating safety for chemicals in commerce from the U.S. Environmental Protection Agency (EPA) to manufacturers and processors of chemicals. Both bills also would prohibit manufacture, processing, and distribution of any chemical substance or mixture for which safety has not been demonstrated. Although they propose somewhat different safety standards for EPA to enforce, both bills suggest a health-based standard. In contrast, current law requires that a chemical not pose “an unreasonable risk of injury to health or the environment,” and that any regulation should control unreasonable risk to the extent necessary using the “least burdensome” means of available control. This TSCA standard has been interpreted to require cost-benefit balancing. To facilitate safety assessment, the proposals would require data development and submission to EPA for all chemicals in commerce. TSCA amendments would direct EPA to target chemicals with particular characteristics (for example, persistence in the environment) for earlier evaluation and possible risk management. Any regulatory action would be expedited, for example, by allowing EPA to issue orders rather than rules. The bills also would add new sections to TSCA. Of particular significance is a section authorizing actions that would allow U.S. implementation of three international agreements, which the United States has signed but not yet ratified. Other new sections would provide authority for EPA to support research in so-called “green” engineering and chemistry, promote alternatives to toxicity testing on animals, encourage research on children’s environmental health, and require biomonitoring of pregnant women and infants. A “hot spots” provision would require EPA to identify locations where residents are disproportionately exposed to pollution and to develop strategies for reducing their risks. The proposals differ in many details and in several noteworthy ways. For example, for all existing chemicals that have not been placed on a priority list, data sets must be submitted within 14 years of the date of enactment of S. 3209, but within five years of enactment of H.R. 5820. The proposals also treat the identification of chemicals of highest concern differently. H.R. 5820 directs EPA to expedite action for 19 specified chemicals, while S. 3209 leaves identification of such chemicals to the Administrator’s discretion. These and other provisions of the two legislative proposals are compared with current law in Tables 1 through 6. Congressional Research Service Proposed Amendments to the Toxic Substances Control Act Contents Introduction ................................................................................................................................1 Effects of the Proposals on Current Law......................................................................................1 Alternative Approaches to Reform ..............................................................................................3 Tables Table 1. Titles and Definitions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced...............................................................................................5 Table 2. Testing in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced ..................................................................................................... 13 Table 3. Notices in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced ..................................................................................................... 20 Table 4. Restrictions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced ..................................................................................................... 30 Table 5. Reporting Requirements in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced .................................................................................. 39 Table 6. Other Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced ......................................................................................................................... 45 Contacts Author Contact Information ...................................................................................................... 66 Congressional Research Service Proposed Amendments to the Toxic Substances Control Act Introduction In 1976, President Gerald R. Ford signed the Toxic Substances Control Act (15 U.S.C. 2601 et seq.; TSCA).1 Thirty-five years of experience with TSCA implementation and enforcement have demonstrated the strengths and weaknesses of the law and led many to propose legislative changes to TSCA’s core provisions in Title I.2 On April 15, 2010, Senator Lautenberg introduced comprehensive legislation (S. 3209) to amend TSCA, and Representatives Waxman and Rush posted draft TSCA reform legislation on the home page of the House Committee on Energy and Commerce. The latter House draft was subjected to stakeholder comments and critiques in a series of meetings during the spring. The proposal was revised and introduced July 22, 2010, as H.R. 5820. This report compares key provisions of S. 3209, as introduced, H.R. 5820, as introduced, and current law. The major provisions of TSCA Title I are summarized in Tables 1 through 6. The first column of each table describes the provisions of TSCA Title I. The second and third columns summarize provisions of S. 3209 and H.R. 5820, respectively, that are related to the TSCA provisions in the first column. New provisions that would be added to the end of TSCA Title I by one or both proposals—for example, those related to reduced use of animals for toxicity testing— are summarized in Table 6. Effects of the Proposals on Current Law The basic organization of TSCA would be unaffected by the proposals. For example, provisions related to testing would still be in Section 4, requirements for notifying EPA when a new chemical or new use is proposed would still be in Section 5, and regulatory authorities would remain in Section 6. Also unaffected would be recently enacted changes, such as a provision that bans exports of elemental mercury. However, most of the original Title I provisions would be amended or deleted by the proposed legislation, and both proposals would make substantial changes to current law. For example, both proposals would shift the burden of demonstrating the safety of chemicals from the U.S. Environmental Protection Agency (EPA) to manufacturers and processors, and would prohibit manufacture, processing, and distribution of any chemical substance or mixture for any use for which safety had not been demonstrated to EPA’s satisfaction. Exemptions from prohibitions would be allowed for particular uses only if a use was “in the paramount interest of national security”; lack of the chemical use “would cause significant disruption in the national economy”; the use was essential or critical and there was no safer feasible alternative; or the chemical use, relative to alternatives, provided a benefit to health, the environment, or public safety. In addition, the proposals would require data development and submission to EPA for all chemicals in commerce, rather than only for chemicals that EPA has found “may present an unreasonable risk of injury to health or the environment” and for which EPA has demonstrated a 1 For a summary of TSCA provisions and history, see CRS Report RL31905, The Toxic Substances Control Act (TSCA): A Summary of the Act and Its Major Requirements. 2 For more information about issues revolving around TSCA, see CRS Report RL34118, The Toxic Substances Control Act (TSCA): Implementation and New Challenges. Congressional Research Service 1 Proposed Amendments to the Toxic Substances Control Act data need, as required under current law. The proposed amendments to TSCA would increase public access to information about EPA’s decisions as well as to some information about chemicals that currently is treated as confidential business information. Based on the data received, EPA would be directed to target chemicals with particular characteristics (for example, persistence in the environment) for early evaluation and possible risk management. Once a chemical has been evaluated and EPA has determined whether (or under what conditions) use of the chemical was safe, the proposals would require risk management action to promptly reduce use of, or exposure to, the chemicals of highest concern, and to encourage development of “safer alternatives.” Action would be expedited by allowing EPA to issue administrative orders instead of rules (which must be promulgated under current law), exempting certain EPA decisions from judicial review, and removing certain TSCA requirements that are in addition to requirements specified in the Administrative Procedure Act (5 U.S.C. 553) for notice and comment rulemaking. The scope of EPA oversight also would be expanded by S. 3209 and H.R. 5820. Both include language that would allow EPA to define various distinct forms of substances that are the same in terms of molecular identity but differ in structure and function, such as manufactured nanoscale forms of carbon and silver. Both proposals also broaden the scope of environmental risks that EPA may manage to include risks found in the indoor environment; currently, TSCA applies only to chemicals in the ambient environment. The proposed amendments also appear to more clearly authorize EPA control of risks posed by articles formed from a substance. Both proposals would authorize EPA activities not currently authorized under TSCA to allow implementation of international agreements pertaining to persistent organic pollutants and other hazardous chemicals. For example, the proposals would authorize EPA to regulate chemicals manufactured solely for export. The authority provided by S. 3209 is specific to three international agreements, while the authority provided by H.R. 5820 applies more generally to any international agreement concerning chemicals. Both proposals would prohibit production and use of some chemicals, but S. 3209 prohibits production and use when it is inconsistent with U.S. obligations under the treaties that have entered into force for the United States. H.R. 5820 directs EPA to ban activities only for specified chemicals that are intentionally produced and are not already regulated under U.S. law. The effect of TSCA on state and local chemical laws also would be modified by the proposals. Current law, TSCA Section 18, generally does not preempt state laws. However, if EPA requires testing of a chemical under section 4, no state may require testing of the same substance for similar purposes. Similarly, if EPA prescribes a rule or order under section 5 or 6, no state or political subdivision may have a requirement for the same substance to protect against the same risk unless the state or local requirement is identical to the federal requirement, is adopted under authority of another federal law, or generally prohibits the use of the substance in the state or political subdivision. TSCA authorizes states and political subdivisions to petition EPA, and authorizes EPA to grant petitions, by rule, to exempt a law in effect in a state or political subdivision under certain circumstances. A petition may be granted if compliance with the requirement would not cause activities involving the substance to be in violation of the EPA requirement, and the state or local requirement provides a significantly higher degree of protection from the risk than the EPA requirement does, but does not “unduly burden interstate commerce.” The proposed amendments would simplify this section of TSCA. S. 3209 provides that TSCA would not preempt laws relating to a chemical substance, mixture, or article unless they were less stringent than federal law. H.R. 5820 provides that the act does not affect the right Congressional Research Service 2 Proposed Amendments to the Toxic Substances Control Act of a state or locality to adopt or enforce its own requirements unless compliance with both the state or local requirements and TSCA is “impossible.” Several novel provisions are included in both legislative proposals. One provision, for example, would require definition and listing of localities with populations that are “disproportionately exposed” to toxic chemicals. EPA would be directed to develop an action plan to reduce exposure in such “hot spots.” Another provision would direct the EPA Administrator to coordinate with the Secretary of Health and Human Services to conduct a biomonitoring study to determine whether a chemical that research has indicated may be present in human biological substances and that may have adverse effects on human development in fact is present in pregnant women and infants. If the chemical is found to be present, manufacturers and processors must disclose to EPA, commercial customers, consumers, and the general public all known uses of the chemical and all articles in which the chemical is expected to be present. Children’s environmental health also is addressed by the bills. Both proposals would establish a children’s environmental health research program at EPA and an advisory committee to provide independent advice relating to implementation of TSCA and protection of children’s health. The proposals also would establish at least four research centers to encourage the development of safer alternatives to existing hazardous chemical substances. “Green chemistry and engineering” also would be promoted through grants. Finally, the proposed amendments would direct EPA to minimize use of animals in toxicity testing. An advisory committee would be established to publish a list of testing methods that reduce use of animals. So-called “alternative testing methods” have been under development for many years, but remain a minor component of toxicity testing programs. Alternative Approaches to Reform The proposals differ in many details (which will not be discussed here) and in several noteworthy ways that are summarized in Tables 1 through 6. One significant difference is the length of time each proposal allows before all chemicals in commerce must be tested for toxicity. For all existing chemicals that have not been placed on a priority list, data sets must be submitted within 14 years of the date of enactment of S. 3209. H.R. 5820 allows five years for data development. Another difference that may spur debate is the definition of the safety standard that chemicals are required to meet. H.R. 5820 would require that a chemical substance or mixture “is not reasonably anticipated to present a risk of injury to health or the environment,” “provides a reasonable certainty of no harm, including to vulnerable populations,” taking into account aggregate and cumulative exposure to a chemical, “and protects the public welfare from adverse effects, including effects on the environment.” S. 3209 would require that EPA ensure “aggregate exposure and cumulative exposure of the general population or of any vulnerable population to the chemical substance or mixture presents a negligible risk of any adverse effect.” Although they propose somewhat different safety standards, both proposals propose a health-based standard, which might generally discourage consideration of other factors, such as benefits of chemical use or costs of alternative chemicals in similar applications. (However, EPA would be authorized to consider such benefits and costs under certain circumstances. See in Table 4 under the heading “Exceptions to prohibitions and other restrictions” the description of TSCA 6(e) as it would be amended.) In contrast, current law requires that a chemical not pose “an unreasonable risk of Congressional Research Service 3 Proposed Amendments to the Toxic Substances Control Act injury to health or the environment,” and that regulation should control any unreasonable risk to the extent necessary using the “least burdensome” means of available control. This TSCA standard has been interpreted to require cost-benefit balancing. The proposals also treat the identification of chemicals of highest concern differently. H.R. 5820 directs EPA to expedite action for 19 specified chemicals. S. 3209 leaves identification of such chemicals to the Administrator’s discretion, directing her to “act quickly to manage risks from chemical substances that clearly pose the highest risks to human health or the environment.” Finally, only H.R. 5820 addresses “persistent, bioaccumulative, and toxic” chemicals (PBTs) directly. The bill directs EPA to promulgate a rule establishing criteria for identifying PBTs and requires listing of all PBTs within 18 months of enactment and every three years thereafter. EPA is required to impose conditions on the manufacture, processing, distribution, use, and disposal of PBTs to achieve the “greatest practicable reductions in exposure.” EPA then is required to conduct the safety evaluation for all PBTs and to impose further risk management controls as needed. These and other similarities and differences are summarized in Tables 1 through 6. Congressional Research Service 4 Table 1.Titles and Definitions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Title Toxic Substances Control Act (TSCA) Safe Chemicals Act of 2010 (SCA) Toxic Chemicals Safety Act of 2010 (TCSA) Revised definitions TSCA definitions are in alphabetical order in section 3 (15 U.S.C. 2602.) S. 3209 section 4 amends definitions in TSCA section 3. Section 3 of H.R. 5820 amends definitions in TSCA section 3. Chemical substance “[A]ny organic or inorganic substance of a particular molecular identity, including (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and (ii) any element or uncombined radical.” The term does not include any mixture, pesticide, tobacco, nuclear material, firearms, shells or cartridges for firearms, food, food additive, drug, cosmetic, or devices regulated by other specified federal laws. [TSCA 3(2)] Amended TSCA 3(2) is the same as 15 U.S.C. 2602(2), but also includes in the definition “any chemical substance contained in or formed into an article.” In addition, adds a new subparagraph to the definition authorizing EPA to determine that “a variant of a chemical substance is a new chemical substance,” notwithstanding molecular identity. Amended TSCA 3(2) is the same as 15 U.S.C. 2602(2), but excludes alcoholic beverages and does not exclude pesticides, firearms, shells or cartridges for firearms, foods, food additives, drugs, cosmetics, or devices regulated under other federal laws. Does not include articles. New clause includes in the definition “any form of a substance determined by the Administrator to be a chemical substance under subsection (b)(1)” which refers to a new TSCA 3(b)(1). Distribute in commerce / Distribution in commerce “[T]o sell, or the sale of the substance, mixture, or article in commerce; to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce of, the substance, mixture, or article; or to hold, or the holding of, the substance, mixture, or article after its introduction into commerce.” [TSCA 3(4)] Amends the TSCA 3(4) definition to include “to export or offer for export the substance, mixture, or article.” Amended TSCA 3(4) is the same as S. 3209, but excepts export of a substance “for demonstrated use solely as a pesticide, … food, food additive, drug, cosmetic, or device ...” Environment “[I]ncludes water, air, and land and the interrelationship which exists among and between water, air, and land and all living things.” [TSCA 3(5)] Amends the TSCA 3(5) definition to include “ambient” and “indoor air.” Amended TSCA 3(5) is the same as S. 3209. CRS-5 Provision 15 U.S.C. 2601 et seq. S. 3209 Health and safety study “[S]tudy of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a chemical substance or mixture, and any test performed pursuant to this chapter” [which corresponds to TSCA]. [TSCA 3(6)] Amends the TSCA 3(6) definition to specifically include any test that relates to a chemical substance or mixture or to a specific chemical identity. Same as S. 3209. Manufacture To import into the United States, produce, or manufacture. [TSCA 3(7)] Same as TSCA 3(7). Amended TSCA 3(7) is the same as 15 U.S.C. 2602(7) “except for demonstrated use solely as a pesticide, … food, food additive, drug, cosmetic, or device …” Mixture “[A]ny combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the combination is a new chemical substance and if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined.” [TSCA 3(8)] Same as TSCA 3(8) [15 U.S.C. 2602(8)] but amends the definition to include any mixture contained in or formed into an article. H.R. 5820, section 10(a) amends TSCA 3(8) [15 U.S.C. 2602(8)] to authorize the Administrator to determine different mixtures comprised of the same chemical substances to be the same mixture if the substance characteristics of the mixtures are identical. New chemical substance “[A]ny chemical substance which is not included in the chemical substance list compiled and published under section 2607(b) of this title, [corresponding to TSCA section 6(b)].” [TSCA 3(9)] Revises the definition of TSCA 3(9), eliminating reference to listing under 15 U.S.C. 2607(b) and instead referring to any chemical substance that does not have a submitted declaration under amended TSCA section 8(a). Amended TSCA 3(9) is the same as S. 3209, “except that, with respect to the first year after the date of enactment … such term shall not include a chemical substance distributed in commerce as of such date of enactment.” CRS-6 H.R. 5820 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Process Preparation of a chemical, after its manufacture, for distribution in commerce. [TSCA 3(10)] Same as TSCA 3(10). Amended TSCA 3(10) is the same as 15 U.S.C. 2602(10) but excepts preparation for use as a pesticide, food, food additive, drug, cosmetic, or device. Also states that relabeling, redistributing, or repackaging an article does not constitute processing. Standards for the development of test data A “prescription of (A) the - (i) health and environmental effects, and (ii) information relating to toxicity, persistence, and other characteristics which affect health and the environment, for which test data for a chemical substance or mixture are to be developed and any analysis that is to be performed on such data, and (B) to the extent necessary to assure that data respecting such effects and characteristics are reliable and adequate (i) the manner in which such data are to be developed, (ii) the specification of any test protocol or methodology to be employed in the development of such data, and (iii) such other requirements as are necessary to provide such assurance.” [TSCA 3(12)] Eliminates this definition. Same as S. 3209. CRS-7 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 New definitions Adverse effect No comparable definition. “A biochemical change, anatomic change, functional impairment, or pathological lesion, or its known precursor, that” either (a) “affects or alters performance of an anatomic structure of a vital system of an organism or progeny”; (b) “causes irreversible change in homeostasis of an organism”; (c) “increases the susceptibility of an organism or progeny … to other chemical or biological stressors or reduces the ability of an organism or progeny of an organism to respond to additional health or environmental challenges”; or (d) “affects, alters, or harms the environment such that the health of humans or other organisms is directly or indirectly threatened.” [Amended TSCA 3(14)] Amended TSCA 3(14) is similar to S. 3209, except that the effect is one that “has the potential to impair” rather than one that “affects or alters” the performance of an anatomic structure of a vital system of an organism or progeny of an organism. The definition does not specify that it includes a “pathological lesion.” Finally, H.R. 5820 authorizes the Administrator to revise this definition, by rule, to reflect the state of the science and provide for equal or greater protection of health and the environment. Aggregate exposure No comparable definition. Total exposure to a chemical substance or mixture regardless of the source of exposure, including activities involved in the manufacture, processing, distribution, use, or disposal of chemicals used in food, cosmetics, or medical devices. [Amended TSCA 3(15)] Amended TSCA 3(15) is similar to S. 3209, but omits mention of exposure from mixtures and explicitly includes exposure from contamination of food, air, water, soil, house dust, and any other environmental media from current or prior uses or activity. Bioaccumulative No comparable definition. As defined in the policy statement entitled “Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances” (64 Federal Register 60194, Nov. 4, 1999). EPA is authorized to revise this definition. [Amended TSCA 3(16)] Can significantly accumulate in biota, as indicated through monitoring data, or is highly likely to accumulate in biota. EPA is authorized by rule to revise the definition to reflect the state of the science and to provide “equal or greater protection of health and the environment.” [Amended TSCA 3(16)] CRS-8 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Chemical identity No comparable definition. Each common and trade name, the most current internationally standardized name, the Chemical Abstracts Service registration number, and the molecular structure of a chemical substance, and for a mixture, the chemical identities and proportions of the components. [Amended TSCA 3(17)] Amended TSCA 3(17) is similar to S. 3209, but refers to the 9th Collective Index of the internationally standardized name (rather than the most current index) and the molecular identity, as well as the molecular structure, and does not specifically refer to chemical identities in a mixture. Cumulative exposure No comparable definition. The sum of aggregate exposure to each chemical substance that is known or suspected to contribute “appreciably to the risk of an adverse effect,” and mixtures containing those chemical substances. [Amended TSCA 3(18)] Amended TSCA 3(18) is similar to S. 3209, but exposure is cumulative across chemical substances and mixtures that are known or, “where supported by scientific consensus, suspected to contribute appreciably to the risk of the same adverse effect.” End consumer No comparable definition. An “individual or other entity that purchases and uses or consumes a chemical substance, mixture, or article.” [Amended TSCA 3(19)] No comparable definition. Federal agency No comparable definition. “[A]ny department, agency, or other independent agency or establishment of the Federal Government including any Government corporation, and the Government Printing Office.” [Amended TSCA 3(20)] Amended TSCA 3(19) is similar to S. 3209, but also refers to any “other instrumentality” of the Federal Government. Importer No comparable definition. No comparable definition. “[A]ny person who imports a chemical substance or mixture, or any article containing a chemical substance or mixture, for distribution in commerce.” [Amended TSCA 3(20)] Persistent No comparable definition. As defined in the policy statement entitled “Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances” (64 Federal Register 60194, Nov. 4, 1999). Authorizes EPA to revise this definition by rule. [Amended TSCA 3(21)] Significantly persists in one or more environmental media, as indicated by monitoring data or other evidence. Authorizes EPA to revise the definition by rule to reflect the state of the science and provide for equal or greater protection of health and the environment. [Amended TSCA 3(21)] CRS-9 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Person No comparable definition. An “individual, trust, firm, joint stock company, corporation (including a government corporation), partnership, association, State, municipality, commission, political subdivision of a State, or any interstate body and shall include each Federal agency and any officer, agent, or employee thereof.” [Amended TSCA 3(22)] No comparable definition. Reasonable certainty of no harm No comparable definition. “[I]n establishing whether a chemical substance or mixture meets the safety standard under this subchapter, aggregate exposure and cumulative exposure of the general population or of any vulnerable population to the chemical substance or mixture presents a negligible risk of any adverse effect …”[Amended TSCA 3(23)] No comparable definition. Special substance characteristics No comparable definition. Defines “special substance characteristics” to mean “such physical, chemical, or biological characteristics, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting those characteristics.” Allows consideration of size, shape, reactivity, and any other properties that may significantly affect risks posed. [Amended TSCA 3(24)] Defines “substance characteristic” as “the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties or the exposure potential of the chemical substance.” Includes structure and composition, size, shape, surface structure, reactivity, and “other characteristics that may bear on toxicological properties.” [Amended TSCA 3(22)] CRS-10 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Toxic No comparable definition. Satisfies one of the following conditions: has a toxicological property meeting criteria for Category 1 or 2 for any toxicity endpoint established by the Globally Harmonized System for the Classification and Labeling of Hazardous Substances; “causes an adverse effect that has been demonstrated in humans or other exposed organisms”; or “the weight of evidence … demonstrates the potential for an adverse effect in humans or other exposed organisms.” [Amended TSCA 3(25)] Similar to S. 3209, but includes a metabolite or degradation product of a substance or mixture and omits the first condition—that is, it does not define the term by reference to the categories of the Globally Harmonized System for the Classification and Labeling of Hazardous Substances. Also, the word “exposed” is omitted from the third defining condition. [Amended TSCA 3(23)] Toxicological property No comparable definition. “[A]ctual or potential toxicity or other adverse effects of a chemical substance or mixture, including actual or potential effects of exposure” on mortality, morbidity, reproduction, growth and development, the immune system, the endocrine system, brain or nervous system, other organ systems, or “any other biological functions in humans or nonhuman organisms.” [Amended TSCA 3(26)] Amended TSCA 3(24) is similar to S. 3209 but includes established precursors to such toxicity or adverse effects and explicitly includes effects on genetics, including mutagenicity, genotoxicity, and epigenetics. Use No comparable definition. No comparable definition. Any utilization of a chemical substance or mixture that is not otherwise covered by the terms manufacture or process, such as “any composition of the chemical substance with other chemical substances” or any group of utilizations determined by EPA to be a single use under new TSCA 3(b)(2). [Amended TSCA 3(25)] CRS-11 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Vulnerable population No comparable definition. A “population that is subject to a disproportionate exposure to, or potential for a disproportionate adverse effect from exposure to, a chemical substance or mixture …” and includes those who work with chemical substances and mixtures, individuals with preexisting medical conditions, the elderly, pregnant women, infants, children, adolescents, and “members of any other appropriate population identified by the Administrator.” [Amended TSCA 3(27)] Amended TSCA 3(26) is similar to S. 3209, except that workers are included in the definition without regard to their work with chemicals and effects on pregnant women include effects on fetal development. Other appropriate populations may be identified based on consideration of socioeconomic status, racial or ethnic background, cultural practices, or similar factors identified by the Administrator. EPA authority to define No comparable provision. No comparable provision. Adds a new subsection (b) to TSCA section 3 (15 U.S.C. 2602). New TSCA 3(b)(1) authorizes the Administrator to determine different forms of a chemical substance with a particular molecular identity to be different chemical substances for purposes of the act based on variations in the substance characteristics. Such distinct substances are to be considered new chemical substances. New TSCA 3(b)(2) authorizes the Administrator to determine different uses of a chemical substance or mixture to be the same use for purposes of the act, based on industry classification systems or factors determined by the Administrator to indicate similarity in use and exposure. CRS-12 Table 2.Testing in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Testing authorities and requirements TSCA 4(a) [15 U.S.C. 2603(a)] directs the EPA Administrator to promulgate a rule requiring that testing be conducted on a substance or mixture to develop health and environmental effects data if: (1) the manufacture, processing, distribution, use, or disposal of the chemical “may present an unreasonable risk of injury to health or the environment,” or (2) the chemical is produced in very large volume and there is a potential for a substantial quantity to be released into the environment or for substantial or significant human exposure. In either case, EPA also must find that (a) existing data are insufficient to resolve the question of safety, and (b) testing is necessary to develop the data. S. 3209, section 5, amends TSCA 4. Amended TSCA 4(a) directs the EPA Administrator within one year of enactment of S. 3209 to promulgate a rule establishing a minimum data set and requiring submission to EPA of such data by manufacturers and processors of new chemical substances or existing chemical substances on a priority list [established in amended TSCA 6(a)]. Also requires updates of minimum data set submissions. H.R. 5820, section 4, amends TSCA 4. Similar to S. 3209, but amended TSCA 4(a) requires manufacturers and processors to submit a minimum data set for mixtures as well as chemical substances. In addition, the Administrator is required to update the rule establishing the minimum data set at least once every 5 years. Amended TSCA 4(a)(3) excepts several categories of chemical substances (see Exemptions below). Amended TSCA 4(b) explicitly authorizes EPA to issue a rule or order, after notice and opportunity for comment, for collection of data in addition to the minimum data set, but the bill does not authorize chemical sample collection (except for enforcement purposes under amended TSCA 11). TSCA 4(b) [15 U.S.C. 2603(b)] requires EPA in any test rule to identify the chemical substance or mixture for which testing is required, specify standards for the development of test data, and specify the period during which test results must be submitted. Amended TSCA 4(c) is similar to 15 U.S.C. 2603(b), but is applicable to EPA orders as well as rules. Test rule requirements CRS-13 Amended TSCA 4(b) authorizes EPA to require, by rule or by order, testing and submission of test results by a specified date “as necessary for making any determination or carrying out any provision” of TSCA. Authorizes EPA to require submission of a sample of any chemical for the purpose of conducting tests and making a determination or carrying out any provision of the act. Like S. 3209 in applying to orders as well as rules, but EPA is authorized rather than required to specify test protocols and methodology, and the bill does not refer to “standards for the development of test data.” Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Deadlines for data submission No comparable provision. Amended TSCA 4(a) requires submission to EPA of the minimum data set within 18 months of the date that EPA places a chemical on the chemical substance priority list, or at the time notice is provided to EPA [under revised TSCA section 5(a)] that a new chemical will be manufactured. Amended TSCA 6(b)(2) requires submission of the minimum data set within 30 months of the date that EPA places a chemical on the chemical substance priority list, or for existing chemicals not placed on the priority list, within 14 years of the date of enactment of S. 3209. Amended TSCA 4(a) requires minimum data set submission within 18 months of the date that EPA places a chemical or mixture on the chemical substance priority list; at the time notice is provided to EPA that a new chemical will be manufactured; or, for existing chemicals (but not mixtures) not placed on the priority list, within 3 years of the date of enactment of H.R. 5820 for high production volume chemicals, within 4 years for chemicals produced in moderate volumes, and within 5 years for chemicals produced in low volumes, as determined by the Administrator. Persons required to submit data TSCA 4(b) [15 U.S.C. 2603(b)] requires manufacturers and processors to conduct tests in response to a rule issued by EPA, but allows EPA to permit such persons to designate one person or a qualified third party to conduct such tests and submit data on their behalf. Amended TSCA 4(c) directs EPA to specify in any rule or order persons required to conduct tests and submit data, but allows designation of a single data provider, as is allowed under current law. In the event that a single data provider is designated, all parties remain individually liable for testing requirements Amended TSCA 4(b)(5) is the same as S. 3209. Failure to submit data No comparable provision. Amended TSCA 4(b)(3) authorizes EPA to, by order, prohibit manufacture, processing, or distribution in commerce for a chemical if a manufacturer or processor fails to submit required data. Amended TSCA 4(a)(4) authorizes penalties for noncompliance as provided in amended TSCA section 16, or imposition of conditions, by order, including prohibitions on the manufacture, processing, or distribution in commerce of the chemical substance, mixture or article containing the substance. Failure to submit required information is grounds for determining that the chemical substance or mixture does not meet the safety standard under amended TSCA 6(b)(3)(D). CRS-14 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Data exemption TSCA 4(c) [15 U.S.C. 2603(c)] allows manufacturers and processors to request an exemption, and directs EPA to grant an exemption if data would be duplicative. Provides for reimbursement by the exempted persons to manufacturers and processors who collected and submitted data. EPA is required to order a manufacturer or processor who is exempt to reimburse the entity that submitted data. Such an order is a final agency action for the purpose of judicial review. Amended TSCA 4(d) would have the same effect as TSCA, except exemptions could apply to orders as well as rules, and the bill does not provide that the Administrator’s order to reimburse is a final agency action for the purpose of judicial review. Similar to 15 U.S.C. 2603(c), but amended TSCA 4(c) applies to orders as well as rules. In addition, amended TSCA 4(a)(3) exempts from data requirements: (1) chemicals for which EPA first is required to make a safety determination under amended TSCA 6(a)(1)(A); (2) chemicals determined by the Administrator to be persistent, bioaccumulative, and toxic and to which people are exposed; (3) chemicals EPA exempts because, due to their intrinsic properties, they do not pose any risk of injury to health or the environment; and (4) chemicals that EPA determines are safer substitutes for chemicals already in commerce. Cessation of manufacture or processing No comparable provision. Amended TSCA 4(b)(4) explicitly exempts from requirements any manufacturer or processor who has submitted a declaration of cessation of manufacture or processing of a chemical substance. Amended TSCA 4(b)(5) is the same as S. 3209, but only if the declaration is of permanent cessation. Contents of minimum data set No comparable provision. Amended TSCA 4(a) directs EPA to include in the minimum data set information on substance characteristics and on hazard, exposure, and use of chemical substances and mixtures, information that the EPA anticipates will be useful in conducting safety standard determinations as required by amended TSCA section 6(b). Allows EPA to provide for varied or tiered testing for different chemicals or categories of chemicals. Similar to S. 3209, but amended TSCA 4(b)(3) also requires that the set include information on chemical identity; biological and environmental fate and transport; toxicological properties; volume manufactured, processed, or imported; intended uses; and “exposures from all stages of the chemical substance or mixture’s lifecycle that are known or reasonably foreseeable to the party submitting the data set.” CRS-15 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Prescribed data needs TSCA 4(b) [15 U.S.C. 2603(b)] authorizes EPA to prescribe data development standards for effects which may present an unreasonable risk of injury to health or the environment and for characteristics of chemical substances and mixtures which may present such a risk, as well as for methodologies including epidemiological studies, serial or hierarchical tests, in vitro tests, and whole animal tests. Amended TSCA 4(c) authorizes EPA to prescribe data development standards for effects which may be considered in a safety determination, assessing exposure, including presence in human tissues and fluids, and characteristics of chemicals that may present an adverse effect. Also authorizes EPA to prescribe biomonitoring studies, in addition to methodologies already permitted under 15 U.S.C. 2603(b). Similar to 15 U.S.C. 2603(b) but amended TSCA 4(b)(4)(A) does not refer to test standards, and it provides broad authority to prescribe testing for “any toxicological property and any other adverse effect which may be considered in a safety standard determination under [amended TSCA] section 6(b).” Specifies exposure information for which testing may be prescribed, and explicitly authorizes testing for bioaccumulation, biomonitoring studies, and in amended TSCA 4(b)(4)(B), industrial hygiene surveys. Petition for standards for development of test data TSCA 4(g) [15 U.S.C. 2603(g)] authorizes manufacturers to petition EPA to prescribe standards for the development of test data for a new chemical. Eliminates this provision. Same as S. 3209. Alternatives to animal testing No comparable provision.3 Requires that animal tests are consistent with provisions of amended TSCA section 31, promoting alternatives to animal testing. Amended TSCA 4(b)(4)(B) requires that whole animal studies be consistent with amended TSCA section 34. Biomonitoring by the Centers for Disease Control and Prevention No comparable provision. No comparable provision. New TSCA 4(b)(6) requires that any biomonitoring study of the public regarding a chemical substance or any metabolite or degradation byproduct be conducted by the Director of the Centers for Disease Control and Prevention in collaboration with the Administrator at the expense of the manufacturers and processors of the substance. 3 However, EPA “is committed to examining alternative test methods that reduce the number of animals needed for testing, reduce pain and suffering of test animals, and whenever possible, replace animals in testing with validated in vitro (non-animal) test systems. EPA has released guidance on this issue …” (U.S. EPA, “Fact Sheet on Animal Welfare,” April 2001, EPA 745-F-99-003, http://www.epa.gov/HPV/pubs/general/anfacs.pdf. CRS-16 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Review and revision of data needs TSCA 4(b) [15 U.S.C. 2603(b)]requires annual review and revision, if necessary, of standards for the development of data. Changes the interval between required reviews and revisions, if necessary, from one to 3 years. Similar to 15 U.S.C. 2603(b), but amended TSCA 4(b)(4)(C) refers to “methodology” rather than “standards for the development of test data.” Rulemaking process TSCA 4(b) [15 U.S.C. 2603(b)] directs EPA to issue test rules pursuant to 5 U.S.C. 553 (Administrative Procedure Act, procedures for informal notice and comment rulemaking). In addition, persons must be given an opportunity for oral presentation of data, views, or arguments and to make written submissions; a transcript must be made of oral presentations; and the Administrator must publish findings required by TSCA 4(a)(1)(A) or (B). Amended TSCA 4(c) omits TSCA requirements for rulemaking that go beyond the requirements of 5 U.S.C. 553. Amended TSCA 4(b) authorizes EPA to issue orders in lieu of rules. Amended TSCA 4(b)(8) is the same as S. 3209. Interagency testing committee TSCA 4(e) [15 U.S.C. 2603(e)] establishes the Interagency Testing Committee (ITC) to advise the Administrator regarding chemicals that should receive priority consideration for promulgation of a test rule [under subsection (a)]. Amended TSCA 6(a)(3) establishes the Interagency Prioritization and Testing Committee, which is similar to the ITC in composition. Amended TSCA 4(e) is similar to current law, but amended TSCA 4(e) directs the ITC also to make recommendations for listing chemical substances and mixtures under amended TSCA 6(a)(1). The bill raises the number of committee members from 8 to 10, including a representative of the Food and Drug Administration and one from the Consumer Product Safety Commission. CRS-17 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Committee recommendations for testing TSCA 4(e) [15 U.S.C. 2603(e)] directs the interagency testing committee to establish a prioritized list of chemicals for the Administrator to consider testing and to designate up to 50 chemicals on the list as the highest priority. In selecting chemicals, the committee is authorized to consider all relevant factors, including “the extent to which the substance or mixture is closely related to a chemical substance or mixture which is known to present an unreasonable risk of injury to health or the environment.” Priority attention is to be given to chemicals “known to cause or contribute to or which are suspected of causing or contributing to cancer, gene mutations, or birth defects.” Amended TSCA 6(a)(3) changes the directive to the committee with respect to the basis for recommendations for issuance of test rules or orders. The committee is directed to make recommendations for issuance of test rules or orders based on “all factors relevant to risk” including presence in biological and environmental media, use, production volume, toxicity, persistence, or bioaccumulation. The committee also is to make recommendations for placement of chemical substances on the priority list based on criteria identified pursuant to amended TSCA 6(a)(1). Recommendations are to be in the form of one or more lists of chemical substances and mixtures and are to be updated annually, if necessary. The Administrator is directed to provide reasonable opportunity to any interested person to file written comments on the recommendations. Amended TSCA 4(e) is similar to 15 U.S.C. 2603(e), but authorizes consideration of chemicals posing a “substantial risk” rather than those posing “an unreasonable risk” of injury to health or the environment, and directs the committee to provide priority attention to chemicals suspected of causing or contributing to “adverse effects on health or the environment” rather than those that might cause or contribute to cancer, gene mutations, or birth defects. The requirement that the list of chemicals designated for testing should remain less than 50 is eliminated. The chemicals listed are to be those that should be subject to test rules or orders, in the view of the committee. Public notice of receipt of data TSCA 4(d) [15 U.S.C. 2603(d)] requires that EPA provide public notice of receipt of data and make data available for examination by any person (subject to section 14). Amended TSCA 4(e) is similar to 15 U.S.C. 2603(d) in requiring public notice of the receipt of data, but applies also to data submitted in accord with an EPA order, and requires that data be made available on the internet. Similar to 15 U.S.C. 2603(d), but amended TSCA 4(d) applies also to data submitted in accord with an EPA order and requires that notices be added to the public database established in amended TSCA 8(d). Judicial review prohibited for committee recommendations No comparable provision. Amended TSCA 6(a)(4) protects from judicial review recommendations by the Interagency Prioritization and Testing Committee. No comparable provision. CRS-18 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Required agency actions TSCA 4(f) [15 U.S.C. 2603(f)] requires the EPA Administrator to respond within 180 days to new information indicating “that there may be a reasonable basis to conclude that a chemical substance or mixture presents or will present a significant risk of serious or widespread harm to human beings from cancer, gene mutations, or birth defects.” Requires EPA to “initiate appropriate action under section 5, 6, or 7 to prevent or reduce to a sufficient extent such risk or publish in the Federal Register a finding that such risk is not unreasonable.” A finding that a risk is not unreasonable is a final agency action for purposes of judicial review. Eliminates this provision, but TSCA 4(a) as amended requires EPA, within 180 days of receipt of a data submission, to determine, by order, whether the manufacturers and processors of the substance have established that the substance meets the safety standard. If data are not submitted, S. 3209 authorizes EPA to prohibit, by order, manufacture, processing, or distribution in commerce of the substance, mixture, or article containing the substance. Eliminates this provision, but amended TSCA 6(b)(3)(D) requires that the Administrator complete and publish the safety standard determination within 30 months of the date on which the chemical substance or mixture is placed on the priority list, or, within 18 months of the date of enactment of H.R. 5820 for chemicals listed in amended TSCA 6(a)(1)(A). However, if additional information is needed, the determination must be completed and published within 12 months after submission of all required information. Requests from other federal agencies No comparable provision. Amended TSCA 4(f) authorizes any federal agency to request that EPA seek information unavailable to that other agency which it has determined would assist it in carrying out its duties or exercising its authority. Requires EPA to collect and provide such information to the requesting agency or to publish in the Federal Register the reason for not doing so. Amended TSCA 4(f) is the same as S. 3209. Certification of data submitted No comparable provision. Amended TSCA 4(g) requires that each submission of information under a rule or order be accompanied by a certification of the accuracy, reliability, and completeness (to the extent reasonably ascertainable) of the information provided. Such certification must be signed by a responsible official of the manufacturer or processor. Amended TSCA 4(a)(2)and 8(i) require each submission of a minimum data set to be accompanied by a certification of the accuracy, reliability, and completeness (to the extent reasonably ascertainable) of the information provided. Such certification must be signed by a responsible official of the manufacturer or processor. CRS-19 Table 3. Notices in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Notices concerning new chemicals or uses TSCA 5(a)(1) [15 U.S.C. 2604(a)(1)] prohibits manufacture of a new chemical and prohibits manufacture or processing of any chemical for a use which is a significant new use unless notice is submitted to EPA 90 days prior to such manufacture or processing. Amended TSCA 5(a)(1)-(3) is similar to current law, but it also requires notice prior to processing of a new chemical substance or mixture. Requires notice prior to manufacture or processing of an existing chemical that has met the safety standard for a use, at a production volume, or in a manner other than specified in the safety determination. Amended TSCA 5(a) is similar to S. 3209 in that it prohibits manufacturing and processing of new chemical substances and mixtures unless notice is provided to EPA. H.R. 5820 also requires notice prior to manufacture or processing of a new mixture or an existing chemical or mixture for a use that EPA determines is a new use [see “New use determination” below]. It is unclear whether notice is required for an existing chemical for which EPA has not made a safety determination when a new use is proposed. However, it appears that the law would require a new declaration under amended TSCA 8(a) and data submission under amended TSCA 5(b) prior to manufacturing or processing. New use determination CRS-20 TSCA 5(a)(2) [15 U.S.C. 2604(a)(2)]directs EPA to designate a significant new use of an existing chemical by promulgating a rule after considering “all relevant factors, including—(A) the projected volume of manufacturing and processing of a chemical substance, (B) the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance, (C) the extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance, and (D) the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.” Amended TSCA 5(a)(2) and (3) designate use of an existing chemical as new if at the time of enactment of S. 3209—such use was not ongoing, use would be at a significantly increased volume, or the person who would be manufacturing or processing the chemical had not previously done so. Amended TSCA 5(a)(2) designates a use as new if—1) the substance or mixture already received a safety standard determination which did not include the use; or (2) the proposed use will result in manufacturing or processing of the chemical substance or mixture at a significantly increased volume from that previously considered in the safety determination made under amended TSCA 6(b). Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Special substance characteristics No comparable provision. Amended TSCA 5(a)(6) directs Administrator to determine by order or rule that a variant of a chemical substance exhibiting one or more “special substance characteristics” [such as size or reactivity, as defined in amended TSCA 3(24)] is a new use or a new chemical substance. No comparable provision. Notice content TSCA 5(d) [15 U.S.C. 2604(d)] requires that notices contain the information required by TSCA 8(a)(2)(A)-(D), (F), and (G). [See “Reporting and record keeping” below.] Amended TSCA 5(c) requires a notice to include the declaration made under amended TSCA 8(a)(2), the minimum data set, and a statement that the chemical will meet the safety standard. Amended TSCA 5(c) is similar to S. 3209, but the statement required is that the chemical is “reasonably anticipated to meet the safety standard under section 6(b),” and H.R. 5820 requires a justification for such statement. Certification No comparable provision. Amended TSCA 5(e) requires that each submission of information under a rule or order be accompanied by a certification of the accuracy, reliability, and completeness (to the extent reasonably ascertainable) of the information provided. Such certification must be signed by a responsible official of the manufacturer or processor. Amended TSCA 8(i) requires each submission of information that is required pursuant to “this title” to be accompanied by a certification of the accuracy, reliability, and completeness (to the extent reasonably ascertainable) of the information provided. Such certification must be signed by a responsible official of the manufacturer or processor. CRS-21 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Submission of test data with notice TSCA 5(b) [15 U.S.C. 2604(b)] requires persons who propose to manufacture a new chemical or to manufacture or process a chemical for a significant new use to submit with such notice any test data that are required by rule under TSCA 4(a). If no test data are required under TSCA 4(a), but the chemical has been listed under TSCA 5(b)(4), indicating that the Administrator has determined that it “presents or may present an unreasonable risk,” manufacturers and processors must submit data showing that manufacture, processing, distribution in commerce, use, and disposal (in the case of a new chemical or mixture), or the new use (in the case of a significant new use), “will not present an unreasonable risk of injury to health or the environment.” Amended TSCA 5(b) requires submission to EPA of any data required for a chemical under a test rule or order, as well as the declaration and minimum data set at the time notice is provided to EPA. Amended TSCA 5(b) is similar to S. 3209 in requiring data submission for chemicals subject to test rules or orders at the time notice is provided, but requires submission for new mixtures as well as new chemical substances. H.R. 5820 also requires submission of the declaration and minimum data set when notice is provided regarding production of a chemical substance or mixture. Public availability of data TSCA 5(b)(3) [15 U.S.C. 2604(b)(3)] directs EPA to make such data publicly available, subject to protections for confidential business information in section 14. Amended TSCA 5(b)(2) requires EPA to make data available on the internet, subject to amended TSCA 14. Requires EPA to publish each new chemical and new use pre-manufacture notice. Also requires that EPA publish notice regarding the chemical identity, intended uses, the nature and results of tests performed, and availability of the declaration under amended section 8(a) and the minimum data set under amended TSCA 4(a). Internet publication is not explicitly required. EPA’s response to notice No comparable provision, but EPA has 90 days to decide whether the chemical or chemical use may present an unreasonable risk of injury to health or the environment. Amended TSCA 5(a)(4) requires EPA to determine within 180 days after receiving notice and data whether it has been established that the chemical substance or mixture meets the safety standard under amended TSCA section 6(b). Requires EPA to determine within 90 days after receiving notice and data whether the use is a critical use or whether a safety standard determination is required by amended TSCA 5(a)(1)(B). Within 9 months of that determination, the Administrator is required to “complete any such required safety standard determination.” CRS-22 With respect to a new use of a chemical for which the Administrator previously has made the safety determination, manufacturers must provide an update for the minimum data set. With respect to a new use of a chemical which has not been evaluated for safety, manufacturers must submit to EPA a new or updated declaration under amended TSCA 8(a) and comply with amended TSCA 5(b). Also requires that any chemical substance subject to a Significant New Use Rule as of the date of enactment of H.R. 5820 remain subject to that rule until it receives a safety standard determination and any conditions are imposed. Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Extension of the notice period TSCA 5(c) [15 U.S.C. 2604(c)] authorizes EPA to extend the period between notice and manufacture for additional periods of up to a total of 90 days “for good cause.” Eliminates this provision. Same as S. 3209. Publication of notice TSCA 5(d) [15 U.S.C. 2604(d)(1)] requires notice to be available for examination by interested persons, subject to disclosure restrictions at TSCA 14 [15 U.S.C. 2613]. [See “Disclosure of data” section below.] Directs EPA to publish a notice identifying the chemical, listing the intended uses, and describing the nature of tests performed and data that were developed pursuant to a rule. Amended TSCA 5(b)(3)-(4) is similar to current law [TSCA 5(d)(1)], but specifies that EPA must make notices available on the internet and requires disclosure of the availability of the minimum data set. In addition, requires EPA to make available on the internet a list of chemical substances for which notice has been received monthly. [Also, see “Disclosure of data” section below.] Amended TSCA 5(c)(3) is similar to current TSCA 5(d), but H.R. 5820 specifies that data must be placed in the public database established pursuant to amended TSCA 8(d). Eliminates specific content requirements for published notices. [Also, see “Disclosure of data” section below.] “Manufacture” and “process” TSCA 5(i) [15 U.S.C. 2604(i)] defines “manufacture” and “process” as used in TSCA section 5 to mean manufacturing and processing for commercial purposes. Amended TSCA 5(f) provides the same definition as current law. Same as current law [TSCA 5(i)]. CRS-23 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Safety determination for new chemical or new use No specific provision, but TSCA requires an EPA finding that manufacture, processing, distribution in commerce, use, and disposal of a chemical “may present an unreasonable risk of injury to health or the environment,” when the agency issues a test rule under TSCA 4(a). Similarly, EPA must find that a chemical substance “presents an unreasonable risk” before EPA can issue a rule to ensure that risks are adequately regulated. Amended TSCA 5(a) prohibits manufacture and processing of a chemical for which notice is required unless the Administrator finds either: (1) that the manufacturers and processors have established that the chemical meets the safety standard under proposed TSCA 6(b), or (2) that the new chemical substance or its metabolite or degradation product is not, and is not expected to be—manufactured in a volume of more than one million pounds annually or released into the environment in a volume of more than 100,000 pounds annually; a known, probable, or suspected reproductive, developmental, neurological, or immunological toxicant, carcinogen, mutagen, or endocrine disruptor, or has other toxicological properties of concern; persistent and bioaccumulative; found in human cord blood, or otherwise found in human blood, fluids, or tissue, unless it is naturally present at the level commonly found in that medium; or found in food, drinking water, ambient or indoor air, residential soil, or house dust, unless it is naturally present at the level commonly found in that medium. Amended TSCA 5(a) imposes an additional condition on any new chemical or use: manufacture or processing is permitted only if the Administrator finds—the use is a critical use as determined pursuant to amended TSCA 6(e), or the substance or mixture meets the safety standard for all intended uses under amended TSCA 6(b). With respect to a new use of a chemical for which the Administrator previously has made the safety determination, manufacturers must provide evidence that permits the Administrator to amend the safety determination. CRS-24 Provision 15 U.S.C. 2601 et seq. Protection against unreasonable risks TSCA 5(f) [15 U.S.C. 2604(f)] directs EPA to control an unreasonable risk posed by a new chemical or a significant new use of a chemical in the interim between the expiration of the notification period and the effective date of a rule that is being developed to control such risk. EPA is directed to issue a proposed rule or an order. If the Administrator issues a proposed rule, it is effective on the date it is issued. This provision is eliminated. S. 3209 requires risk management prior to production and distribution. Same as S. 3209. Regulation pending development of information TSCA 5(e) [15 U.S.C. 2604(e)] authorizes the Administrator to issue a proposed order to prohibit or limit manufacture, processing, distribution in commerce, use, or disposal of a new chemical or significant new use in the event that the Administrator determines that: the information available “is insufficient to permit a reasoned evaluation of the health and environmental effects” of the chemical; and either the chemical may present an unreasonable risk, or it will be produced in substantial quantities and “may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance.” If EPA makes such a determination but no order is issued or objections are filed to the order, then EPA must apply to the District Court to prohibit or limit activities with respect to the chemical, unless EPA finds on the basis of the objections that the determination cannot be made. This provision is eliminated. Amended TSCA 5(a) requires submission of data and a safety determination prior to production and distribution of a new chemical or of an existing chemical for a new use. Same as S. 3209. CRS-25 S. 3209 H.R. 5820 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Statement of reasons for not taking action If EPA does not take action with respect to a chemical covered by a test rule [under TSCA 4(a)], a significant new use rule [under TSCA 5(a)(1)(B)], or listed under TSCA 5(b)(4), then TSCA 5(g) directs the Administrator to publish a statement of reasons for not taking action. This provision is eliminated. This provision is eliminated. General authority TSCA 5(h)(4) [15 U.S.C. 2604(h)(4)] authorizes EPA upon application and by rule to exempt a manufacturer of a new chemical substance from notification and data requirements, if the Administrator determines it will not “present an unreasonable risk of injury to health or the environment.” Any such rule must be promulgated in accord with TSCA section 6(c)(2) and (3) (see below). Eliminates this provision. Same as S. 3209, but amended TSCA 39(d) directs EPA to review existing exemptions granted under TSCA 5(h)(4) within a year of enactment of H.R. 5820 to determine whether chemicals exempted under current law meet the “intrinsic properties” requirements to qualify for an exemption under amended TSCA 39(d). Intermediate production chemicals TSCA 5(h)(5) [15 U.S.C. 2604(h)(5)] authorizes exemptions upon application for production-related (temporary, socalled “intermediate”) chemicals when no human or environmental exposure will occur. Amended TSCA 5(d)(4) is the same as current law. Same as current law. Test marketing TSCA 5(h)(1) [15 U.S.C. 2604(h)(1)] authorizes EPA to exempt any person from notification or data requirements so as to permit manufacture or processing for test marketing purposes, if the person applies for such exemption and demonstrates the chemical will not present an “unreasonable risk.” Amended TSCA 5(d)(1) is similar to current law but a person must show that it “will not endanger the health [sic] or the environment.” Amended TSCA 5(d)(1) is similar to current law but specifies that exemptions are made “by order,” authorizes exemptions for mixtures as well as chemical substances, and requires that the applicant show the chemical or mixture will not present “a substantial” risk. Exemptions from notice requirements CRS-26 “Test marketing” is defined in amended TSCA 5(f) to exclude provision of a chemical or article containing a chemical to an end consumer. Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Equivalent chemicals and duplicative data TSCA 5(h)(2) [15 U.S.C. 2604(h)(2)] allows manufacturers and processors of new chemicals or chemicals with significant new uses that are on the priority list but are not subject to a section 2603 data submission requirement to request from EPA an exemption from the requirement in 2604(b)(2) that they submit data showing that manufacture, processing, distribution in commerce, use, and disposal of the chemical substance, or the significant new use, will not present an unreasonable risk. Directs EPA to grant such exemption if the chemical is equivalent to a substances for which data has been submitted and data would be duplicative. Provides for reimbursement by the exempted persons to manufacturers and processors who collected and submitted data. EPA is required to order a manufacturer or processor who is exempt to reimburse the entity that submitted data. Such an order is a final agency action for the purpose of judicial review. Amended TSCA 5(d)(2) allows manufacturers and processors of new chemicals or chemicals with new uses to request, and EPA to grant, full or partial exemption from data submission requirements if the chemical is equivalent to a chemical substance for which data have been submitted and submission would be duplicative of data previously submitted to EPA. Provides for reimbursement by the exempted persons to those who collected and submitted data in the same manner as current law. Amended TSCA 5(d)(2) concerns any new use of a chemical substance or mixture subject to a data collection rule or order under section 4. H.R. 5820 directs the Administrator upon application to exempt the manufacturer or processor of such a chemical or mixture from the amended TSCA 5 requirement to submit data along with the required new use notice, if the chemical is equivalent to a substance for which data have been submitted previously and submission would be duplicative. Provides for reimbursement by the exempted persons to those who collected and submitted data in the same manner as current law. Small quantities TSCA 5(h)(3) [15 U.S.C. 2604(h)(3)] exempts from notification and data requirements manufacturing and processing of small quantities for purposes of scientific experimentation or chemical research on, or analysis of, such substances or another substance, including product development. Amended TSCA 5(d)(3) is the same as current law. Amended TSCA 5(d)(3) is similar to current law, but it also applies to mixtures. EPA response to exemption requests TSCA 5(h)(6) [15 U.S.C. 2604(h)(6)] requires EPA to publish notices of, and request comments on, requests for exemptions that the agency receives. EPA must issue an approval or disapproval within 45 days. Amended TSCA 5(d)(5) is the same as current law. Same as current law. CRS-27 Provision Safer chemical substances or mixtures CRS-28 15 U.S.C. 2601 et seq. No comparable provision. S. 3209 No comparable provision. H.R. 5820 Amended TSCA 5(d)(1) exempts from section 5 requirements any new chemical substance or mixture approved pursuant to amended TSCA 35 as a safer alternative. Amended TSCA 5(d)(2) authorizes the Administrator to exempt any new chemical substance or new use of a chemical substance or mixture from the requirements of amended TSCA section 5 pursuant to section 39, based on intrinsic properties which render the substance harmless. Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Chemicals of concern list (priority list) TSCA 5(b)(4) [15 U.S.C. 2604(b)(4)] authorizes EPA to “by rule, compile and keep current a list of chemical substances with respect to which the Administrator finds that the manufacture, processing, distribution in commerce, use, or disposal, or any combination of such activities, presents or may present an unreasonable risk of injury to health or the environment.” In listing decisions the Administrator is directed to consider “all relevant factors, including—(I) the effects of the chemical substance to health and the magnitude of human exposure to such substance; and (II) the effects of the chemical substance on the environment and the magnitude of environmental exposure to such substance.” Any rule listing a chemical must identify “uses that the Administrator determines, by rule under subsection (a)(2), would constitute a significant new use of such substance.” Amended TSCA 6(a) directs EPA by order to develop and publish a priority list of not less than 300 chemical substances “for which safety standard determinations shall first be made” within 18 months of S. 3209 enactment. Failure of EPA to establish the priority list or to update it is defined to be a failure to perform a nondiscretionary duty and subject to judicial review. Amended TSCA 6(a) establishes a list of 19 specified chemical substances for which safety standards must first be made. Twelve months after H.R. 5820 is enacted, the Administrator must update the list to consist of at least 300 chemical substances. Listing is at the Administrator’s discretion, “based on available scientific evidence and consideration of their hazard, exposure, or risk relative to other chemical substances, aggregate or cumulative exposure, evidence of exposure to humans including presence in human or animal biological and environmental media including in the workplace, use, volume of manufacture, toxicological properties, persistence, bioaccumulation, or other properties indicating risk.” Otherwise similar to S. 3209, but does not require the list to be developed and published “by order” and may include mixtures. H.R. 5820 also does not explicitly require that EPA consider listing recommendations provided by the Interagency Prioritization and Testing Committee. Any rulemaking under this provision must be promulgated pursuant to the procedures specified in 5 U.S.C. 553 and must provide opportunity for oral and written presentation of data, views, or arguments. In addition, a transcript must be kept of any oral presentation and the Administrator must make and publish with the rule the finding that an activity related to the chemical “presents or may present an unreasonable risk of injury to health or the environment.” CRS-29 Chemicals must be selected based on: available scientific evidence, relative risk, presence in biological and environmental media, use, production volume, toxicity, persistence, bioaccumulation, “or other properties indicating risk.” Requires removal of a substance from the list only after a safety standard determination has been made for it. Requires EPA to add chemical substances or mixtures periodically to keep the number greater than 300 at all times until all substances and mixtures distributed in commerce have had a safety standard determination. EPA must give due consideration in listing decisions to recommendations provided by the Interagency Prioritization and Testing Committee which is to base its recommendations on the criteria listed (above) in amended TSCA 6(a). Amended TSCA 6(a)(4) protects from judicial review EPA’s decisions about whether to place particular chemicals on the priority list, including any EPA response to a petition to list a particular chemical substance. Table 4. Restrictions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced Provision Regulation 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 TSCA 6(a) [15 U.S.C. 2605(a)] directs EPA by rule to apply one or more requirements “to the extent necessary to protect adequately against” an “unreasonable risk” “using the least burdensome requirements,” if EPA finds that “there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture … presents or will present an unreasonable risk of injury to health or the environment.” Specifies various regulatory options. Authorizes regulations to—prohibit or limit the amount of substance manufactured, processed, or distributed in commerce, generally or for a specific use; require labeling, recordkeeping, provision of notice to distributors and to the public of unreasonable risk of injury, or replacement or repurchase of a substance; and specify methods of disposal. S. 3209 does not require rulemaking, but section 7 amends TSCA 6(b) and (c) to authorize EPA to specify allowed uses of any substance that meets the safety standard and to impose conditions on its manufacture, processing, use, distribution in commerce, or disposal to “ensure the safety standard is met.” Many of the conditions that EPA is authorized to impose are the same as the regulatory options listed in current law, but S. 3209 also authorizes EPA to impose a requirement that the manufacturers and processors of a chemical substance or mixture or article containing it develop a risk reduction management plan to achieve a risk reduction specified by the Administrator. The bill does not authorize the option of requiring manufacturers or processors to give notice of unreasonable risk of injury to distributors or the public or to replace or repurchase a substance. Amended TSCA 6(c)(2) is similar to S. 3209, but the bill authorizes prescription for specific control measures to reduce occupational exposures and requires that any such measures must reflect the industrial hygiene hierarchy of controls. Any warnings or instructions required must be consistent with the Globally Harmonized System of Labeling and Classification of Chemicals. In determining the conditions necessary to ensure the substance or mixture meets the safety standard, the Administrator must “consider human health and the environment as the primary and paramount concern, and shall also consider the technological feasibility of compliance, the economic impact of compliance, and benefits of earlier compliance, and other relevant considerations.” TSCA 6(c) [15 U.S.C. 2605(c)] specifies procedures for rulemaking that allow for informal hearings and requires EPA to publish a statement describing the health and environmental effects, level of exposure, benefits of the substance, and “reasonably ascertainable economic consequences of the rule, after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health.” Requires that EPA’s decisions be based on the rulemaking record. Directs EPA to promulgate needed rules under other environmental laws, unless it is in the public interest to issue rules under TSCA. CRS-30 In addition, S. 3209 differs from current law in that the bill does not authorize limiting conditions to specified geographic areas, nor does it prohibit requiring a person to take an action that would be in violation of a law or requirement of a state or political subdivision. Provision General process for safety determinations 15 U.S.C. 2601 et seq. No comparable provision. S. 3209 H.R. 5820 Amended TSCA 6(b)(1) requires that EPA produce a risk assessment addressing health and environmental impacts using “the best available science” in support of any determination that a manufacturer or processor of a chemical substance has met the burden of proof. Risk assessments must be transparent and understandable to the public and to risk managers. Amended TSCA 6(b)(1) requires the Administrator to apply a safety standard that “takes into account aggregate exposure to a chemical substance or mixture and ensures that, for all intended uses—(i) with regard to public health, there is a reasonable certainty that no harm will result, including to vulnerable populations; and (ii) the public welfare is protected.” The Administrator is required to consider the lifecycle of the substance or mixture and “available information concerning the cumulative effects of exposure to chemical substances or mixtures.” No risk assessment is required when EPA determines that the burden of proof has not been met, and such determination is not subject to judicial review. Amended TSCA 6(b)(1) also establishes that manufacturers and processors of a chemical substance are responsible for proving that the substance meets the applicable safety standard, and that the EPA Administrator has the responsibility of determining within 180 days of data submission whether the manufacturers and processors have met the burden of proof. H.R. 5820 is similar to S. 3209 in that amended TSCA 6(b)(2) assigns the burden of proving that a chemical meets the safety standard to manufacturers and processors. Amended TSCA 6(b)(3) requires the Administrator to “determine whether the chemical substance or mixture meets the safety standard, taking into account any existing conditions or controls already in effect, or can be made to meet the safety standard through the imposition of additional conditions … and whether intended uses that do not meet the safety standard are critical.” A safety determination must be completed and published not later than 30 months after the date on which a chemical is placed on the priority list, or within 18 months of the date of enactment for the 19 chemicals listed in amended TSCA 6(a)(1)(A). The determinations must be made in keeping with “standards for assessment” developed by the Administrator under amended TSCA 6(b)(4). CRS-31 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Scientific standards for data assessment No comparable provision. Amended TSCA 6(b)(1)(C) requires The Administrator to “use the best available science” in conducting a risk assessment considering the most recent recommendations of the National Academy of Sciences “on ways to better protect people, including pregnant women, infants, children and other vulnerable populations from harm by exposure to toxic substances when assessing such potential risks.” Within 18 months of the date of enactment of H.R. 5820, amended TSCA 6(b)(4) directs the Administrator, after providing for notice and opportunity for comment, to develop and publish guidance regarding the use of science in making safety determinations. Requires that the Administrator rely on the recommendations of the National Academy of Sciences report entitled Science and Decisions. Such guidance must be reviewed and may be revised to reflect new scientific developments or understanding at least once every 5 years. Safety of chemicals for export No comparable provision. Directs EPA to consider risks that a chemical manufactured for export may pose in the United States during production and distribution in commerce, including in imported products containing the substance. No comparable provision. No comparable provision. Within 180 days of receipt of a data submission, EPA is directed to determine, by order, whether the manufacturers and processors of the substance have established that the substance meets the safety standard. Amended TSCA 6(b)(3)(D) requires that the Administrator complete and publish the safety standard determination within 30 months of the date on which the chemical substance or mixture is placed on the priority list, or, within 18 months of the date of enactment of H.R. 5820 for chemicals listed in amended TSCA 6(a)(1)(A). However, if additional information is needed, the determination must be completed and published within 12 months after submission of all required information. Safety determinations for existing chemicals EPA’s determination CRS-32 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Failure to submit data No comparable provision. If data are not submitted, amended TSCA 6(b)(2) authorizes EPA to prohibit, by order, manufacture, processing, or distribution in commerce of the substance, mixture, or article containing the substance. Amended TSCA 6(b)(3) provides that failure to submit required information is grounds for determining that the chemical substance or mixture does not meet the safety standard. Failure by EPA No comparable provision. If EPA fails to meet the deadline for a safety determination, amended TSCA 6(b)(2) provides that manufacturers and processors are required to notify EPA, the public, their employees, and customers written notice that a determination by EPA of the safety of the chemical is pending. Amended TSCA 6(b)(7) requires EPA promptly to publish notice of a failure to publish or renew a determination by the applicable deadline. Directs the Administrator to prohibit new manufacturers or processors or new uses of the chemical substance or mixture until the determination is published and requires manufacturers and processors to provide written notice to the public, their employees, and their commercial customers that a safety standard determination is pending. Resubmission No comparable provision. Amended TSCA 6(b)(2) provides that at least every 15 years, manufacturers and processors of each chemical substance must submit the minimum dataset and indicate whether the substance and specified uses meet the safety standard. Amended TSCA 6(b)(6) provides that a safety determination remains in effect for up to 15 years, if no new use or information warrants a redetermination. Redetermination No comparable provision. EPA may initiate a redetermination of whether the chemical meets the safety standard if new information raises a question in that regard, on the receipt of a renewal submission, or 15-years following the previous determination. The Administrator may renew a determination for additional 15 year periods but the burden of proof for renewal remains with the manufacturers and processors. Petition for redetermination No comparable provision. Authorizes any person to petition the Administrator for a redetermination. The Administrator must decide whether to make the requested redetermination and publish the decision and its basis in the Federal Register within 180 days. No comparable provision. CRS-33 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Restrictions on substances that do not meet the safety standard No comparable provision, but TSCA 6(a) directs EPA by rule to apply one or more requirements (such as labeling or banning particular uses) “to the extent necessary to protect adequately against” an “unreasonable risk” “using the least burdensome requirements,” if the Administrator finds that “there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment.” Amended TSCA 6(b)(3) prohibits manufacture, processing, and distribution in commerce of a chemical substance, mixture, or article if EPA makes a safety determination and does not determine that a substance meets the safety standard. Such prohibition is effective immediately for a new chemical or after one year for any other chemical. Amended TSCA 6(c)(3) is similar to S. 3209 but also immediately prohibits activities with respect to a new use of an existing substance, mixture, or article if EPA determines that the manufacturers and processors have not shown that the use meets the safety standard. Unrestricted distribution in commerce No comparable provision, but current law allows unrestricted distribution in commerce of chemicals and mixtures unless EPA determines that a substance presents an unreasonable risk and then promulgates a rule to regulate it. No comparable provision. If EPA determines that the substance meets the safety standard, the allowed uses of the substance must be specified as well as any conditions on those specified uses to ensure that the safety standard is met. S. 3209 prohibits manufacture, processing, and distribution in commerce of a chemical substance, mixture, or article for uses not specified in the safety determination. Amended TSCA 6(c)(1) authorizes manufacture, processing, and distribution in commerce for any chemical substance or mixture that EPA determines meets the safety standard without imposition of conditions for uses identified and included in the safety standard determination. EPA is authorized to make the determination contingent on the continuation of conditions or controls already in effect. Uses restricted for substances meeting the safety standard No comparable provision. Amended TSCA 6(b) prohibits manufacture, processing, and distribution in commerce of a chemical substance, mixture, or article for any use not specified in the safety determination if EPA determines that the chemical and its specified uses meet the safety standard. Amended TSCA 6(c)(2) requires EPA to impose conditions on manufacture, processing, use, distribution in commerce, or disposal of a chemical substance or mixture to ensure that it meets the safety standard. Such conditions must “be identified in a manner that ensures effective and efficient protection of health and the environment.” CRS-34 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Effective date of Section 6 rules TSCA 6(d) [15 U.S.C. 2605(d)] directs EPA to make such rules effective “as soon as feasible,” and allows EPA to make a proposed rule effective upon publication until the effective date of the final rule if there is an unreasonable risk of serious or widespread injury to health or the environment and a court has granted relief under section 7. Amended TSCA 6(i) directs EPA to specify a date on which a rule or order shall take effect and that such date should be “as soon as feasible.” Amended TSCA 6(c)(2)(H) requires that conditions be met within one year after publication of the determination, or as quickly as feasible and in no case later than 3 years after publication. Prohibits activities with respect to a chemical if such conditions are not met by the applicable deadline. Quality control TSCA 6(b) [15 U.S.C. 2605(b)] authorizes EPA to review and regulate a manufacturer’s or processor’s quality control procedures if there is “a reasonable basis to conclude” that the manner of manufacturing or processing “unintentionally causes a chemical … to present or which will cause it to present an unreasonable risk of injury to health or the environment.” EPA also is authorized to order the manufacturer or processor to provide notice to its customers of such risk and to replace or repurchase the substance as is necessary to adequately protect health or the environment. Requires any determination that a chemical presents an unreasonable risk to be made on the record after opportunity for hearing. Amended TSCA 6(d) is similar to current law but applies when there is “a reasonable basis to conclude” that the manner of manufacturing or processing “may present a substantial endangerment to health or the environment.” Does not require such determination to be made on the record after opportunity for hearing. Amended TSCA 6(d) is similar to current law but applies when there is a reasonable basis to conclude that the manner of manufacturing or processing “causes the chemical substance or mixture to present or which will cause it to present a significant risk of injury to health or the environment.” Resale of used articles No comparable provision. Restrictions established under sections 4(a)(3), 4(b)(3), 6(b)(2)(A)(iv), 6(b)(3), 8(b)(6), 8(c)(3), or 29 do not apply to resale of an article subject to a restriction under amended TSCA 6(b) if the article has previously been used. No comparable provision. CRS-35 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Delay of effective date of restrictions No comparable provision. Authorizes EPA to order delay in the effective date of a restriction for 3 years for retail sales to an end consumer of a chemical substance, mixture, or article subject to a restriction under sections 4(a)(3), 4(b)(3), 6(b)(2)(A)(iv), 6(b)(3), 8(b)(6), 8(c)(3), or 29, if necessary and appropriate, if it “will not present a substantial endangerment to human health or the environment.” EPA authority does not extend to any retailer who has failed to comply with an order requesting information under amended TSCA section 8. No comparable provision, but conditions may be imposed up to 3 years after they are established (see above “Effective date of Section 6 rules”). Exemptions from prohibitions and other restrictions No comparable provision. Amended TSCA 6(e) authorizes EPA to grant, by order, exemptions (and renewals of exemptions) to restrictions established under sections 4(a)(3), 4(b)(3), 6(b)(2)(A)(iv), 6(b)(3), 8(b)(6), 8(c)(3), and 29 for particular uses. Exemptions and renewals may be granted for up to 5 years, if manufacturers and processors “have established by clear and convincing evidence that the uses to be exempted meet the exemption criteria.” Those criteria are: (1) that the exemption is in the paramount interest of national security; (2) lack of availability would cause significant disruption in the national economy; or (3) the use is a critical or essential use, and there is no safer feasible alternative, or the specified use compared to available alternatives provides benefit to health, the environment, or public safety. The manufacturer or processor must notify customers and the public of any exemptions granted. EPA is directed to impose any condition on a granted exemption that is necessary to ensure the protection of human health and the environment. Amended TSCA 6(e) authorizes manufacturers and processors to request exemptions from restrictions under amended TSCA 6(c) for a specific use by a manufacturer or processor. The procedure for granting exemptions is the same as under S. 3209, but H.R. 5820 requires that EPA impose conditions on any use receiving an exemption “to reduce risk from the chemical substance or mixture to the greatest extent feasible.” CRS-36 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Certification of the quality of submitted information No comparable provision. Amended TSCA 6(h) requires that each submission of information under a rule or order be accompanied by a certification of the accuracy, reliability, and completeness (to the extent reasonably ascertainable) of the information provided. Such certification must be signed by a responsible official of the manufacturer or processor. Amended TSCA 8(i) requires each submission of information that is required pursuant to “this title” or pursuant to a rule or order issued under this title to be accompanied by a certification of the accuracy, reliability, and completeness (to the extent reasonably ascertainable) of the information provided. Such certification must be signed by a responsible official of the manufacturer or processor. Mercury 15 U.S.C. 2605(f) prohibits federal agencies from conveying, selling, or distributing elemental mercury to any federal agency, state or local government, or private entity, except to facilitate storage at a federal agency. Amended TSCA 6(g) is the same as current law. Amended TSCA 6(g) is the same as current law. Polychlorinated biphenyls (PCBs) TSCA 6(e) [15 U.S.C. 2605(e)] directs EPA to prescribe methods of disposal for PCBs and to require PCBs to be marked with clear and adequate warnings and instructions regarding processing, distribution in commerce, use, or disposal. Prohibits use of any PCB other than “in a totally enclosed manner,” unless EPA finds that such activity “will not present an unreasonable risk of injury to health or the environment.” Prohibits manufacture, processing, and distribution in commerce. Authorizes any person to petition for an exemption and authorizes EPA to grant such exemption if EPA finds that an unreasonable risk would not result, and “good faith efforts have been made to develop a chemical substance which does not present an unreasonable risk … and which may be substituted for such [PCB].” Requires use of rulemaking procedure in TSCA 6(c). Amended TSCA 6(f) is similar to existing law but authorizes the Administrator to act by order or rule, and to grant exemptions from the general prohibitions when the activities “will not present a substantial endangerment to health or the environment” rather than when activities “will not present an unreasonable risk.” Amended TSCA 6(f) is similar to current law, but authorizes EPA to grant exemptions if activities will not “present a substantial risk to health or the environment” and will comply with section 37 (concerning data quality). CRS-37 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Relief Authorizes an appropriate district court to grant relief necessary to protect health or the environment from unreasonable risk. Similar to current law, but authorizes court to grant relief necessary to protect health or the environment from “the risk associated with the activity involved in the action.” Similar to current law, but authorizes court to grant relief necessary to protect health or the environment from “imminent and substantial endangerment.” Civil actions TSCA 7(a) [15 U.S.C. 2606(a)] authorizes EPA to begin a civil action: for seizure of “an imminently hazardous” chemical substance, mixture, or article; for relief against any person who manufactures, processes, distributes in commerce, or uses, or disposes of such chemical or article; or for both seizure and relief. Requires EPA to commence such civil action if the agency has not made a rule under TSCA 6(a) effective immediately. Requires that EPA “where appropriate, concurrently with the filing of an action … initiate a proceeding for the promulgation of a rule” under TSCA 6(a). Defines “imminently hazardous chemical substance or mixture” to mean a chemical that “presents an imminent and unreasonable risk of serious or widespread injury to health or the environment.” Similar to current law, but authorizes EPA action against a person when a chemical, mixture, or article “may present an imminent and substantial endangerment to health or the environment.” S. 3209 does not require EPA to commence action if the agency has not made a rule effective immediately concerning the chemical. S. 3209 also authorizes EPA to issue orders to protect health or the environment from a chemical substance or mixture or article containing such substance or mixture that may present an imminent and substantial endangerment to health or the environment. Amended TSCA 7 is similar to S. 3209, but amended TSCA 7(d) directs the Administrator, as appropriate, concurrently with the filing of an action under amended TSCA 7(a)(1), to add the chemical substance or mixture to the priority list under amended TSCA 6(a) or to initiate a redetermination of whether the substance meets the safety standard under amended TSCA 6(b). Imminent hazards CRS-38 Eliminates authority concurrently to initiate a proceeding for the promulgation of a rule under TSCA 6(a) [15 U.S.C. 2605(a)]. Also eliminates the definition for “imminently hazardous chemical substance or mixture.” Table 5. Reporting Requirements in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced Provision Reporting and record keeping (declaration) 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 TSCA 8(a) [15 U.S.C. 2607(a)] authorizes EPA, to the extent necessary for the effective enforcement of the law, to promulgate rules requiring maintenance of records and submission of reports to EPA by persons who manufacture or process or who propose to manufacture or process a chemical substance. Prohibits a rule requiring maintenance of records or submission of reports with respect to changes in the proportions of the components of a mixture unless necessary for effective enforcement. Amended TSCA 8(a) requires each manufacturer and processor of a chemical substance to submit a declaration of current manufacturing or processing for each substance, mixture, or article manufactured or processed containing information that will assist the Administrator in making a safety determination or otherwise in administering the law. Each declaration must be accompanied by certification of its accuracy, reliability, and comprehensiveness. Amended TSCA 8(a) is the same as S. 3209, but in addition authorizes EPA to require submission of a declaration by manufacturers and processors of mixtures, when the Administrator determines that the substance characteristics of the mixture are different from those of the constituent chemical substances, “in kind or in degree.” Amended TSCA 8(b) is similar to S. 3209. Amended TSCA 8(b) authorizes EPA by rule or order to require any person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance, mixture, or article to maintain records of and report any information that would assist the Administrator in administering TSCA. Authorizes EPA to require information concerning chemical identity. Failure to submit declaration CRS-39 No comparable provision. EPA may by order prohibit manufacture, processing, or distribution of any substance if a manufacturer or processor violates EPA requirements for submitting or updating declarations. Amended TSCA 8(a)(6) authorizes the Administrator to impose penalties pursuant to section 16 or, by order, prohibit, or otherwise impose conditions under amended TSCA 6(c) on a manufacturer or processor in violation of an 8(a) reporting requirement. Provision Information submitted CRS-40 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 TSCA 8(a) authorizes collection of information including: trade name or common name, chemical identity, categories of use, amount of each chemical manufactured or processed, byproducts resulting from such manufacture or processing, “all existing data concerning the environmental and health effects,” number of individuals exposed, and, in the initial report, the manner of disposal. Amended TSCA 8(a) requires the declaration to state: the chemical identity and substance characteristics; name and location of each facility where the substance is manufactured or processed or from which it is distributed; a list and copies of health and safety studies that are reasonably ascertainable; and all other information not previously submitted to EPA regarding the physical, chemical, and toxicological properties of the substance, the annual production volume and known uses of, exposure and fate information, and the name and location of each facility to which the substance is sent for processing, distribution, or use. Or, the declaration may say that all production, importation, processing, and export of a substance has ceased or will cease within 180 days. Declarations must be updated and submitted at least every 3 years, and immediately when new information becomes available regarding a physical, chemical, or toxicological property or use of, or exposure to the substance. Similar to S. 3209, but also requires information regarding the number of individuals exposed, classification of the toxicity of the chemical, categories of intended use of the substance or mixture, total amount of substance and mixture manufactured or processed, byproducts resulting from manufacture, processing, use, or disposal, exposure information, any condition currently placed on the substance or mixture due to regulation under any federal law or due to voluntary action, and for a processor of a chemical substance, information indicating that the mixture has substance characteristics that are different from the characteristics of the individual substances. Updates are required when the Administrator receives information “indicating a new potential adverse effect of the chemical substance or mixture, suggesting an adverse effect at a lower dose than previously demonstrated, or otherwise reasonably relevant to an analysis of whether the chemical substance or mixture meets the safety standard under section 6.” Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Inventory TSCA 8(b) [15 U.S.C. 2607(b)] directs EPA to compile, keep current, and publish an inventory of each chemical manufactured or processed in the United States. New chemicals are to be listed when manufacture or processing begins. The list should exclude chemicals produced in small quantities for purposes of scientific experimentation, analysis, or research. Authorizes EPA to list chemicals by category rather than individually. Amended TSCA 8(c) is the same as TSCA 8(b), except that it omits the authority in current law to list chemicals by category rather than individually. In addition, S. 3209 requires that EPA publish in the Federal Register a list of all chemical substances distributed in commerce that categorizes the substances based on existing information available into categories based on known health or environmental effects, exposure, insufficient data, or other category that EPA considers appropriate. Amended TSCA 8(c)(1) directs the Administrator to compile, keep current, publish and enter into the public database established under amended TSCA 8(d) a list of each chemical substance and mixture for which a declaration (under amended TSCA 8(a)) is received which is manufactured or processed in the United States. Omits the authority in current law to list chemicals by category rather than individually. The list shall not include any chemical substance or mixture for which all manufacturers and processors have submitted declarations of permanent cessation. Also requires the categorization of substances as in S. 3209, but includes mixtures. Small quantities for research and development TSCA 8(a)(3) [15 U.S.C. 2607(a)(3)] explicitly authorizes EPA to require by rule reporting from small manufacturers and processors of chemicals substances or mixtures subject to a rule proposed or promulgated under TSCA 4, 5(b)(4), or 6 or an order under TSCA 5(e) or with respect to which relief has been granted under TSCA 5 or 6. Reporting also may be required once under TSCA 8(b) for the original inventory (see below) from processors and manufacturers who are small (as determined by the Administrator after consultation with the Small Business Administration). TSCA 8(b) [15 U.S.C. 2607(b)]directs EPA to limit record keeping and reporting requirements for those who manufacture or process a chemical in small quantities solely for purposes of scientific experimentation or analysis of a chemical substance. Amended TSCA 8(b)(2) authorizes EPA by rule to define manufacture, processing, distribution in commerce, use, or disposal of a chemical substance in small quantities solely for purposes of research, and to issue a rule or order under this subsection only if EPA determines maintenance of records or submission of reports is necessary for effective enforcement of the law. Amended TSCA 8(b)(2) is the same as S. 3209. CRS-41 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Public access No comparable provision. Amended TSCA 8(d) directs EPA to establish an electronic database of information relating to the toxicity and use of and exposure to chemical substances. It is required to include descriptions of “all significant decisions made by the Administrator” and significant information submitted under TSCA Title I. Same as S. 3209. Records of significant adverse reactions TSCA 8(c) [15 U.S.C. 2607(c)] requires all manufacturers and processors to keep records of all reports of significant adverse reactions to health or the environment alleged to have resulted from exposure to a chemical substance. Amended TSCA 8(e) is similar to TSCA but also requires submission of such records to EPA. Similar to S. 3209 but requires submission to EPA annually or immediately upon request by the Administrator, while current law and S. 3209 do not require reports at specific times. Disclosure to commercial purchasers No comparable provision. No comparable provision. Amended TSCA 8(f) requires all manufacturers and processors of chemical substances and mixtures to provide to all known commercial purchasers, with shipment or promptly thereafter, and by request, a disclosure, subject to amended TSCA 14 (which protects confidential business information), of the chemical identity of the substances or mixture ingredients, their toxicological properties, health and safety studies submitted to EPA, and records of significant adverse reactions submitted under amended TSCA 8(e). CRS-42 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Information from other federal agencies No comparable provision. Amended TSCA 8(f) requires each federal agency and institution to submit to EPA a synopsis of the data and records in its control that may be useful to EPA in carrying out TSCA Title I. Such synopsis shall be updated and resubmitted at least once every 3 years. On request by the EPA Administrator, federal agencies are directed to submit information relating to hazard, use, exposure, or risk of a chemical substance or mixture. Similar to S. 3209, but agencies are to respond to a request from EPA, not to submit reports every 3 years, and the bill directs EPA to prescribe by order the format, content, and level of detail of the requested report. Also directs the Administrator to make such a request from each federal agency which the Administrator reasonably expects may have information on chemical substances or mixtures that would assist in making a safety standard determination. Requests must be issued no more than 12 months after a substance or mixture is added to the priority list under amended TSCA 6(a) or within 12 months of enactment of H.R. 5820 for substances listed in amended TSCA 6(a)(1)(A). Health and safety studies TSCA 8(d) [15 U.S.C. 2607(d)] directs EPA to require manufacturers, processors, and distributors to submit lists and copies of health and safety studies for each chemical manufactured or processed. S. 3209 requires submission of such studies as part of the declaration under amended TSCA 8(a). Same as S. 3209. Substantial risk notice TSCA 8(e) [15 U.S.C. 2607(e)] requires manufacturers, processors, and distributors who obtain information “which reasonably supports the conclusion” that a chemical substance or mixture “presents a substantial risk of injury to health or the environment” to inform EPA. Amended TSCA 8(g) is the same as current law. Amended TSCA 8(h) is the same as current law. CRS-43 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Certification No comparable provision. Amended TSCA 8(h) requires that each submission of information under a rule or order be accompanied by a certification of the accuracy, reliability, and completeness (to the extent reasonably ascertainable) of the information provided. Such certification must be signed by a responsible official of the manufacturer or processor. Amended TSCA 8(i) requires each submission of information that is required pursuant to “this title” or pursuant to a rule or order issued under this title, other than a submission under section 8(g) (relating to submissions from federal agencies), to be accompanied by a certification of the accuracy, reliability, and completeness (to the extent reasonably ascertainable) of the information provided. Such certification must be signed by a responsible official of the manufacturer or processor. “Manufacture” and “process” TSCA 8(f) [15 U.S.C. 2607(f)] defines “manufacture” and “process” to mean manufacture or process for commercial purposes. Amended TSCA 8(i) is the same as current law. Amended TSCA 8(j) is the same as current law. CRS-44 Table 6. Other Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 3209), as Introduced, and the Toxic Chemicals Safety Act of 2010 (H.R. 5820), as Introduced Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Action under laws administered by other federal agencies If EPA has a reasonable basis to conclude that activities with respect to a chemical substance or mixture present or will present an unreasonable risk, and EPA determines that such risk may be prevented or reduced to a sufficient extent by action taken under a federal law not administered by EPA, then TSCA 9(a) [15 U.S.C. 2608(a)] directs EPA to submit to the agency which administers such law a report describing the risk and activities that present such risks. The EPA report must request that the other federal agency (1) tell EPA whether the risk may be prevented or reduced under the law the agency administers, and (2) issue an order declaring whether the activities present a risk. If EPA makes a report and the other agency either (1) issues an order declaring that the activities do not present the risk, or (2) initiates action to protect against such risk, then EPA may not take regulatory action under TSCA 6 or 7. Amended TSCA 9(a) is similar to current law, but the criterion for EPA action differs. If the Administrator determines “that the manufacture, processing, distribution in commerce, use, or disposal of a chemical … either does not meet the safety standard … or requires conditions or restrictions” to do so, and “that action may be taken under a Federal law not administered by the Administrator” then EPA must submit a report to the other agency describing the activities that prevent the chemical from meeting the safety standard or restrictions or conditions required to meet the safety standard. The report must request that the other agency (1) determine if the action may be taken under a law administered by the agency, and if so, (2) initiate such action and provide a timetable for action, and (3) respond to EPA’s report. If the other agency initiates action within the timeframe specified, EPA may not take regulatory action, except under TSCA 7. If the other agency determines that action cannot be taken under its authorities; does not initiate action or complete action within the timeframe provided; or fails to respond, then EPA may, by order, initiate action to ensure compliance with the safety standard. Similar to current law, except that EPA must submit a report to another agency if “the Administrator has reasonable basis to conclude that a chemical substance or mixture does not meet the safety standard under section 6(b).” Also, information that is to be published in the Federal Register must be entered into the public database established in amended TSCA 8(d). Action under other EPAadministered laws TSCA 9(b) [15 U.S.C. 2608(b)] directs EPA to coordinate actions taken under TSCA with actions taken under other federal laws administered by EPA. Same as current law. Same as current law. Occupational safety and health TSCA 9(c) states that any EPA exercise of authority under TSCA is deemed to be exercising statutory authority to prescribe or enforce standards or regulations affecting occupational safety and health. Same as current law. In addition, S. 3209 directs EPA to ensure that any EPA actions to address workplace exposures “are consistent with the industrial hygiene hierarchy of controls.” Same as current law. CRS-45 Provision 15 U.S.C. 2601 et seq. S. 3209 H.R. 5820 Coordination TSCA 9(d) directs EPA to consult and coordinate with appropriate federal agency heads to achieve “maximum enforcement” “while imposing the least burdens of duplicative requirements” on those being regulated. S. 3209 strikes the requirement that coordination for the purpose of enforcement should impose the least burdens of duplicative requirements. Same as S. 3209. Mixture survey No comparable provision. No comparable provision. Amended TSCA 8(c)(3) directs EPA to characterize the number of mixtures introduced into commerce and the number of such mixtures that may have different substance characteristics from the constituent chemical substances. Such survey shall be based on declarations and a survey of processors. The characterization of mixtures in commerce must be published in the Federal Register and entered into the public database established in amended TSCA 8(d). Subpoenas and warrants TSCA 11(c) [15 U.S.C. 2610(c)] authorizes EPA to require by subpoena attendance and testimony of witnesses, production of reports, documents, answers to questions, and other information. Authorizes district courts to order compliance in the event of contumacy, failure, or refusal to obey. Amended TSCA section 11(c) authorizes EPA to require attendance, testimony, and production of documents, items, answers to questions and other information deemed necessary. In the event that “there is reason to [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/crs%3AR41335. Public record. Not legal advice.