Proposed Reform of the Toxic Substances Control Act (TSCA) in the 113th Congress: S. 1009 Compared with S. 696 and Current Statute

July 8, 2013 – October 23, 2013 R43136

Thirty-seven years of experience implementing and enforcing the Toxic Substances Control Act (TSCA) since its enactment have demonstrated the strengths and weaknesses of the law and led many to propose legislative changes to TSCA’s core provisions. The Safe Chemicals Act (S. 696) and the Chemical Safety Improvement Act (S. 1009) introduced in the 113th Congress would amend TSCA Title I. This CRS report compares key provisions of S. 696 and S. 1009 with the language of the current statute (15 U.S.C. 2601 et seq.).

Existing Law

TSCA as enacted authorizes the Environmental Protection Agency (EPA) to require manufacturers to develop data about chemical toxicity and exposure if EPA determines that a chemical may pose an unreasonable risk, or if chemical exposure is expected to be substantial. TSCA allows a chemical to enter and remain in commerce unless EPA can show that it poses “an unreasonable risk of injury to health or the environment.” EPA then must regulate to control unreasonable risk, but only to the extent necessary using the “least burdensome” means of available control. This TSCA standard has been interpreted to require cost-benefit balancing. The current statute preempts state and local laws regarding chemicals specifically regulated by EPA.

Proposed Legislation

S. 696 would amend TSCA to require chemical manufacturers and processors to submit specified information about the toxicity and usage of chemicals in commerce to EPA. The information would be used by EPA to determine whether a chemical would meet the safety standard of “a reasonable certainty of no harm from aggregate exposure,” given the imposition of any needed restrictions on manufacture, processing, distribution, use, or disposal. S. 696 would prohibit uses of evaluated chemical substances unless they were determined by EPA to meet the safety standard. S. 696 would increase public access to information about EPA’s decisions and to some information about chemicals that currently is treated as confidential business information. S. 696 would rarely preempt state and local laws.

S. 1009 would authorize EPA to require manufacturers to develop new information if EPA can show need in the context of an evaluative framework for chemical risk assessment and management. The bill would require EPA to screen all chemicals in commerce and assign each to one of three categories:

high priority for risk assessment,

low priority for risk assessment, or

in need of additional information.

S. 1009 would require EPA regulation, by rule or order, ensuring “no unreasonable risk of harm from exposure” to a chemical under the intended conditions of use. S. 1009 would preempt new state and local laws for chemicals identified as high or low priority.

Both Senate bills would evaluate the existing inventory of chemicals in U.S. commerce since 1976 to allow prioritization of the estimated 9,000 chemicals currently produced and used in the United States. In addition, both bills would explicitly require manufacturers to substantiate some requests for protection of confidential business information from public disclosure.

S. 696 (but not S. 1009) also would add a new section to TSCA to allow U.S. implementation of three international agreements. S. 1009 would amend an existing section of TSCA to allow implementation of one treaty. Other provisions included in S. 696 would authorize EPA to support research in “green” engineering and chemistry, promote alternatives to toxicity testing on animals, encourage research on children’s environmental health, require biomonitoring of pregnant women and infants, require EPA to identify “hot spots” where residents are exposed disproportionately to pollution, and direct EPA to develop strategies for reducing their risks.

Key provisions of S. 696 and S. 1009 are compared with current statute in Tables 1 through 6 of this CRS report.

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Proposed Reform of the Toxic Substances Control Act (TSCA) in the 113^th Congress: S. 1009 Compared with S. 696 and Current Statute

October 23, 2013 (R43136)

Introduction
Effects of the Proposed Legislation on the Current Statute
Data Development Requirements
Notice Requirements
Prioritization for Safety Assessments
Safety Standards, Restrictions, and Prohibitions
Breadth of and Limits to EPA Authority
State Preemption
Confidential Business Information
Miscellaneous Provisions

Tables

Table 1. Titles and Definitions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)
Table 2. Testing and Data Evaluation in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)
Table 3. Notices and Priorities in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)
Table 4. Safety Standard Determinations and Restrictions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)
Table 5. Reporting Requirements in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)
Table 6. Other Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)

Summary

Thirty-seven years of experience implementing and enforcing the Toxic Substances Control Act (TSCA) since its enactment have demonstrated the strengths and weaknesses of the law and led many to propose legislative changes to TSCA's core provisions. The Safe Chemicals Act (S. 696) and the Chemical Safety Improvement Act (S. 1009) introduced in the 113^th Congress would amend TSCA Title I. This CRS report compares key provisions of S. 696 and S. 1009 with the language of the current statute (15 U.S.C. 2601 et seq.).

Existing Law

TSCA as enacted authorizes the Environmental Protection Agency (EPA) to require manufacturers to develop data about chemical toxicity and exposure if EPA determines that a chemical may pose an unreasonable risk, or if chemical exposure is expected to be substantial. TSCA allows a chemical to enter and remain in commerce unless EPA can show that it poses "an unreasonable risk of injury to health or the environment." EPA then must regulate to control unreasonable risk, but only to the extent necessary using the "least burdensome" means of available control. This TSCA standard has been interpreted to require cost-benefit balancing. The current statute preempts state and local laws regarding chemicals specifically regulated by EPA.

Proposed Legislation

S. 696 would amend TSCA to require chemical manufacturers and processors to submit specified information about the toxicity and usage of chemicals in commerce to EPA. The information would be used by EPA to determine whether a chemical would meet the safety standard of "a reasonable certainty of no harm from aggregate exposure," given the imposition of any needed restrictions on manufacture, processing, distribution, use, or disposal. S. 696 would prohibit uses of evaluated chemical substances unless they were determined by EPA to meet the safety standard. S. 696 would increase public access to information about EPA's decisions and to some information about chemicals that currently is treated as confidential business information. S. 696 would rarely preempt state and local laws.

high priority for risk assessment,
low priority for risk assessment, or
in need of additional information.

S. 1009 would require EPA regulation, by rule or order, ensuring "no unreasonable risk of harm from exposure" to a chemical under the intended conditions of use. S. 1009 would preempt new state and local laws for chemicals identified as high or low priority.

S. 696 (but not S. 1009) also would add a new section to TSCA to allow U.S. implementation of three international agreements. S. 1009 would amend an existing section of TSCA to allow implementation of one treaty. Other provisions included in S. 696 would authorize EPA to support research in "green" engineering and chemistry, promote alternatives to toxicity testing on animals, encourage research on children's environmental health, require biomonitoring of pregnant women and infants, require EPA to identify "hot spots" where residents are exposed disproportionately to pollution, and direct EPA to develop strategies for reducing their risks.

Key provisions of S. 696 and S. 1009 are compared with current statute in Tables 1 through 6 of this CRS report.

Proposed Reform of the Toxic Substances Control Act (TSCA) in the 113^th Congress: S. 1009 Compared with S. 696 and Current Statute

Introduction

In 1976, President Gerald R. Ford signed the Toxic Substances Control Act (TSCA)¹, giving the U.S. Environmental Protection Agency (EPA) authority to regulate production and use of industrial chemicals in U.S. commerce in the interest of protecting health and the environment from unreasonable risks. Thirty-seven 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 Based on hearing testimony, a diverse set of stakeholders generally concur that TSCA needs to be updated, although there is disagreement about the extent and nature of any proposed revisions.³ 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, by [author name scrubbed].

Legislation to amend TSCA Title I was introduced in the 111^th and 112^th Congresses. The Safe Chemicals Act (SCA), S. 847, was reported by the Senate Committee on Environment and Public Works in the 112^th Congress. In the 113^th Congress, Senator Lautenberg reintroduced the reported bill as S. 696. A few weeks later, Senator Lautenberg and 14 co-sponsors introduced a second comprehensive bill, the Chemical Safety Improvement Act (CSIA), S. 1009.

This CRS report compares key provisions of S. 696 and S. 1009 with provisions of TSCA Title I (15 U.S.C. 2601 et seq.) that would be affected if either bill became law. These provisions are summarized in Tables 1 through 6 of this report.

Effects of the Proposed Legislation on the Current Statute⁴

Neither S. 1009 nor S. 696 would affect Titles II through VI of TSCA (except that S. 696 would change the definition of "asbestos" in Title II), nor would they change the basic organization of TSCA Title I. For example, provisions related to testing would remain in Section 4, requirements for notifying EPA when a new chemical or new use is proposed would remain in Section 5, and regulatory authorities would remain in Section 6. Also unaffected would be changes to TSCA Title I that were enacted during the 110^th Congress, such as a provision that bans exports of elemental mercury.⁵ However, S. 696 would amend or delete most of the original Title I provisions and would make substantial additions to the current statute. S. 1009 also would amend TSCA Title I provisions significantly but without adding most of the new provisions in S. 696. Some key differences between the current statute and the bills are summarized in the following sections.

Data Development Requirements

S. 696, as introduced, would direct the EPA Administrator to establish, by rule, various "minimum information sets" that would be required for different chemical substances or categories of substances. The bill would direct EPA to include in each minimum information set any information that the EPA deems necessary for the conduct of a screening-level risk assessment, "sufficient for the Administrator to administer this Act" with regard to categorization of new and existing chemical substances, assignment of priority classes, and safety standard determinations and redeterminations. S. 696 would require submission to EPA of a minimum information set by each manufacturer and processor of a new chemical substance or, as specified by the Administrator, of an existing chemical. The bill would authorize EPA to require, by rule or order, testing and submission by a specified date of additional results of tests not included in any applicable minimum information set "as necessary for making any determination or carrying out any provision" of TSCA. S. 696 would authorize EPA, by order, to take regulatory action if a manufacturer or processor failed to submit required information. Finally, S. 696 would direct EPA to accommodate use of testing methods and strategies to generate information quickly, at low cost, and with reduced use of animal-based testing, to the extent that such methods and strategies would yield information of equivalent quality and reliability.

Neither S. 1009 nor the current statute requires development and submission of specified data for either new or existing chemicals. Instead, S. 1009 would direct the Administrator to develop a general framework, policies, and procedures for collecting, evaluating and developing data, and would require integration of relevant information from multiple sources into a tiered testing framework. The bill would authorize EPA to require manufacturers to develop new data if the agency promulgates a rule, enters into a testing consent agreement, or issues an order based on a determination that additional data are needed to

perform a safety assessment,
make a safety determination, or
meet testing needs of an "implementing authority under another Federal statute."

S. 1009 would require EPA to publish a statement identifying and explaining the need for data. It also would require EPA to specify a period for test data submission, "which period must not be of an unreasonable duration." Failure to submit any required information is a prohibited act and subjects the manufacturer or processor to penalties.

Finally, S. 1009 would direct the Administrator to minimize the use of animals in testing of chemical substances or mixtures through various means. The bill would require the Administrator to promote the development and timely incorporation of new testing methods that are not laboratory animal-based. S. 1009 would authorize the Administrator to adapt or waive animal-testing requirements on request from a manufacturer or processor under specified circumstances.

Under the current statute, there is no specific framework or minimum information set, but EPA has the authority to require data submission if it promulgates a rule, including a finding that a chemical "may present an unreasonable risk of injury to health or the environment," or is produced in very large volume and there is a potential for substantial quantity to be released into the environment or for substantial or significant human exposure. The agency also must demonstrate a need for data.

EPA also may promulgate such rules for categories of chemicals, but is prohibited by Section 25(c)(2) from promulgating a rule for a group of chemicals that are grouped together solely on the basis of their being new chemical substances. Failure to submit any required information is a prohibited act and subjects the manufacturer or processor to penalties.

Notice Requirements

Under the current statute, EPA maintains an inventory of all chemicals that have been in U. S. commerce since 1976. Manufacturers and importers must notify the EPA prior to manufacturing or importing a chemical not on the EPA inventory (that is, a "new" chemical). Based on information submitted with that notice (see TSCA 5(d) in Table 3 under the heading "Notice content for new chemical substances"), EPA has up to 90 days to determine whether a new chemical may present an unreasonable risk of injury to health or the environment. In addition, under the current statute EPA has authority to require notification 90 days prior to a significant new use of a chemical on the inventory, but the agency first must promulgate a Significant New Use Rule (SNUR) naming the chemical and defining the uses for which notice is required. Based on information submitted with that notice (see TSCA 5(d)), EPA must decide whether the new use may present an unreasonable risk.⁶

S. 696 and S. 1009 would continue the new chemical pre-manufacture notification requirement. S. 1009 is similar to the current statute in that it also would require notice prior to a significant new use of a chemical, if EPA has issued a SNUR. S. 696 would add a notification requirement for all chemicals already on the inventory prior to manufacture or processing for any new use or at a new production volume. For chemicals that had undergone a safety evaluation and determination by EPA, notice also would be required prior to a change in the manner of production or processing under S. 696 as introduced.

In response to a pre-manufacture notice from a manufacturer to EPA, both bills would require EPA to categorize chemicals based on available information within 90 days of receiving a notice (but the period may be extended). S. 1009 also requires categorization of chemicals with proposed new uses.

S. 696 would establish the following categories for new chemicals:

Substances of Very High Concern,
Substances Unlikely to Meet the Safety Standard,
Substances with Insufficient Information, and
Substances Likely to Meet the Safety Standard.

S. 1009 would categorize new substances and uses as

Not Likely to Meet the Safety Standard,
Additional Information Is Needed, or
Substances Likely to Meet the Safety Standard under Intended Conditions of Use.

Prioritization for Safety Assessments

Under the current statute, the Interagency Testing Committee (ITC)⁷ advises the EPA Administrator regarding chemicals that should receive priority consideration for promulgation of a test rule. The ITC reports to EPA biannually, establishes a prioritized list of chemicals, and designates 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." The EPA Administrator also is authorized under TSCA 5(b)(4) to compile and keep current a list of chemical substances that the Agency has determined present or may present an unreasonable risk of injury to health or the environment. This list of chemicals of concern must be promulgated by notice and comment rulemaking under the Administrative Procedure Act (5 U.S.C. 553) and must provide opportunity for oral and written presentation of data, views, or arguments. In addition, EPA routinely prioritizes chemicals in commerce using its knowledge of chemistry and biology.

S. 696 would eliminate the ITC provisions as well as the provision at TSCA 5(b)(4). Instead the bill would direct the Administrator to establish a system for assigning chemical substances into batches, categorizing them, and assigning priorities for testing and regulation. The bill would require the EPA Administrator to screen and prioritize all chemicals on the inventory for the purposes of risk assessment, safety standard determinations, and risk management. EPA would initially assign chemicals to batches. The first batch generally would include chemicals currently in commerce in the United States—that is, chemicals for which manufacturers submitted information to EPA in response to the most recent Chemical Data Reporting rule (issued under TSCA 8(a)). The bill then would direct EPA to assign all of the chemicals in the first batch to one of four categories based on available information:

Substances of Very High Concern,
Substances with Insufficient Information,
Substances of Very Low Concern, and
Substances to Undergo Safety Standard Determinations.

S. 696 also would direct EPA to add new chemical substances categorized previously by EPA as Substances Likely to Meet the Safety Standard to the inventory of existing chemicals, assign each to a batch, and further categorize each as a Substance of Very Low Concern or a Substance to Undergo a Safety Standard Determination. All chemicals on the inventory categorized as Substances to Undergo a Safety Standard Determination would be prioritized further (Priority 1, Priority 2, or Priority 3) for risk assessment. After the initial categorization and prioritization, S. 696 would direct EPA to review information continually with an eye toward revising chemical assignments.

S. 1009 retains the ITC but would require it to advise EPA with regard to testing consent agreements and test orders in addition to test rules. S. 1009 eliminates the chemicals of concern listing provisions of TSCA 5(b)(4), but would direct the Administrator to establish a risk-based screening process as well as criteria for identifying whether existing chemical substances are a high or a low priority for a safety assessment and determination. Priorities would be determined based on: (1) the ability of EPA to schedule and complete safety assessments and determinations in a timely manner; and (2) reasonably available data and information concerning the hazard, exposure, and use characteristics at the time the decision is made. The agency's proposed prioritization screening process and criteria would be published for public comment. Using the screening process, EPA would be required "in a timely manner" to evaluate all existing chemical substances or categories of substances on the active inventory (created under proposed TSCA 8(b)). Substances would be removed from the list of high-priority substances when a safety determination is published.

Safety Standards, Restrictions, and Prohibitions

The current statute allows chemicals to remain in U.S. commerce until EPA promulgates a rule and publishes a finding that a chemical presents or will present an "unreasonable risk" to human health or the environment. If EPA demonstrates that a risk associated with a chemical is unreasonable (relative to the benefits provided by the chemical and the estimated risks and benefits of any alternatives), the Agency is required to initiate rulemaking, but only to the extent necessary to reduce that risk to a reasonable level and using "the least burdensome" restriction.

Under S. 696, as introduced, continued production and use of a chemical would be permitted only if EPA made, or expected to make, an affirmative safety determination for the chemical. S. 696 would require manufacturers of chemicals to supply scientific data sufficient for EPA to conclude, based on a risk assessment, that the chemical would meet the safety standard: "there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance" under the use conditions evaluated and specified by EPA. The bill would require EPA to base these safety determinations "solely on considerations of human health and the environment, including the health of vulnerable populations." An EPA determination that a chemical would not meet the safety standard would not require a risk assessment.

S. 696 would prohibit manufacture, processing, and distribution of a chemical substance⁸ that EPA

decided did not meet the safety standard;
assigned to the category Substances of Very High Concern;
assigned to the category Substances Unlikely to Meet the Safety Standard; or
assigned to the category Substances with Insufficient Information (pending submission of the applicable minimum information set and re-categorization).

In addition, S. 696 would prohibit manufacture of a chemical for any proposed new use that had not been considered in the safety determination issued for that chemical.

S. 696 would allow production and use of a chemical

determined by EPA to meet the safety standard;
pending completion of the safety standard determination for a chemical assigned to the category Substances to Undergo Safety Standard Determinations; or
assigned to the category Substances of Very Low Concern.

S. 696 would authorize EPA to impose restrictions on the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance, mixture, or article containing a chemical substance to ensure that a chemical use would meet the safety standard.

S. 1009 is similar to the current statute in that it would allow manufacture and processing of, and commerce in, a chemical until EPA identified it as high priority and determined that it did not meet the safety standard for the intended conditions of use. EPA would be required to base its safety determinations on risk-based safety assessments considering hazard, use, and exposure (including exposure of vulnerable populations) for the chemical substance under the intended conditions of use. Under S. 1009, the safety standard that each chemical would be required to meet "ensures that no unreasonable risk of harm to human health or the environment will result from exposure to the chemical."

Before conducting the safety assessment, S. 1009 would require that EPA develop a science-based framework for making decisions, including a methodology for conducting safety assessments that addresses specified issues and that is subjected to public comment and scientific peer review. Also included in the framework would be procedural rules for safety determinations.

S. 1009 would direct EPA to impose various restrictions on high-priority chemicals that do not meet the safety standard for the intended conditions of use. To ban or phase out manufacture, processing, or use of a chemical substance, EPA would first have to consider and publish a statement discussing

"availability of technically and economically feasible alternatives for the substance under the intended conditions of use;"
relative risks posed by those alternatives;
"economic and social costs and benefits of the proposed regulatory action and options considered, and of potential alternatives; and"
"the economic and social benefits and costs of" "the chemical substance," "alternatives to the chemical substance," and "any necessary restrictions on the chemical substance or alternatives."

Breadth of and Limits to EPA Authority

The current statute provides EPA with broad authority, as well as mandates, to require data and to restrict chemical use to prevent unreasonable risk of injury. In the exercise of this authority, manufacturers and processors produce and provide data, while EPA bears responsibility for collecting, analyzing, and evaluating the information and making a case in the public record for each of its risk management decisions for each chemical substance. Under the current statute, EPA is obligated to follow procedures laid out in the Administrative Procedure Act and to provide opportunities for persons to present data, views, or arguments orally and in written submissions. The current statute requires that a transcript be made of oral presentations, and the EPA Administrator must publish findings. TSCA Section 19 [15 U.S.C. 2618 ] authorizes any person to file a petition with the U.S. Court of Appeals for the District of Columbia Circuit or for the circuit in which the person resides or in which the person's principal place of business is located, for judicial review of specified TSCA rules within 60 days of issuance. The appropriate circuit court is directed to set aside specified rules if they are not supported by "substantial evidence in the rulemaking record … taken as a whole." "Rulemaking record" is defined at length in TSCA 19(a)(3).

S. 696 would expedite regulatory action relative to the process under the current statute by authorizing EPA to issue administrative orders with respect to specific chemical substances instead of rules (which must be promulgated under the current statute). In addition, S. 696 would exempt certain EPA decisions from judicial review and remove TSCA rulemaking requirements not specified in the Administrative Procedure Act (5 U.S.C. 553) for informal notice and comment rulemaking. The proposed amendments to TSCA also would increase public access to information about EPA's decisions and to some information about chemicals that currently is treated as confidential business information. S. 696 provides for judicial review of safety determinations, in addition to all rules and orders. In the event that a safety determination is challenged in court, S. 696 would require that each manufacturer and processor "at all times bear the burden of proof in any legal proceeding relating to a decision of the Administrator regarding whether the chemical substance meets the safety standard." The bill imposes a duty on the manufacturer or processor of a chemical to provide sufficient information for EPA to determine whether the chemical meets the safety standard, and imposes a duty on EPA to determine whether a chemical meets the safety standard.

The scope of EPA oversight also would be expanded by S. 696. As introduced, the bill includes 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. S. 696 also might broaden the scope of environmental risks that EPA is authorized to manage by defining "environment" to include the indoor environment.

S. 696 would authorize EPA activities not currently authorized under TSCA to allow implementation of three international agreements pertaining to persistent organic pollutants and other hazardous chemicals. For example, the proposal would authorize EPA to regulate chemicals manufactured solely for export. The authority provided by the bill would be specific to three international agreements, rather than more generally authorizing regulatory activity to implement any ratified international agreement concerning chemicals. The bill would prohibit production and use of chemicals when it was inconsistent with U.S. obligations under any of the three international agreements after they had entered into force for the United States.⁹

S. 1009 is similar to the current statute, providing EPA with broad authority and mandates to require data and to restrict chemical use to ensure no unreasonable risk of harm from exposure. In the exercise of this authority, manufacturers and processors would produce and provide data, while EPA would bear responsibility for collecting, analyzing, and evaluating the information and making a case on the public record for each of its risk management decisions for each chemical substance. S. 1009 would allow EPA to negotiate consent agreements or to issue orders rather than rules in some cases. EPA uses consent agreements currently. Under S. 1009, EPA would be required to justify its use of orders. The proposed legislation would direct EPA to develop and use a framework for decision making that incorporates most of the analytic, data quality control, publication, and notice and comment requirements of rulemaking and the Information Quality Act (Section 515 of P.L. 106-554). Under S. 1009, EPA would still be obligated to follow procedures laid out in the Administrative Procedure Act when promulgating a rule but TSCA requirements beyond those in the APA would be eliminated.

Like the current statute, S. 1009 would authorize any person to file a petition with the U.S. Court of Appeals for the District of Columbia Circuit or for the circuit in which the person resides or in which the person's principal place of business is located, for judicial review of a Title I rule (not an order) requiring data development, imposing a restriction or prohibition, including restriction or prohibition for elemental mercury, or requiring information reporting. Judicial review would not be authorized for significant new use determinations, rules regarding PCBs, or rules regarding asbestos or lead-based paint under Titles II and IV, respectively. Proposed TSCA Section 19 would retain the current standard of evidence for rules requiring data development or imposing a restriction or prohibition (including a restriction or prohibition for elemental mercury), but would define "evidence" to mean any matter in the rulemaking record and would prohibit review of the contents and adequacy of the statement of basis and purpose, except as part of the rulemaking record as a whole.

State Preemption

Currently, TSCA Section 18 includes certain preemptions of state and local authority, and limitations to those preemptions. 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 risk than the EPA requirement does, but does not "unduly burden interstate commerce."

S. 696 would significantly simplify this section of TSCA. As amended, TSCA would not preempt laws relating to a chemical substance, mixture, or article unless compliance with both federal and the state or local laws was impossible.

S. 1009 would preempt state laws, new and existing, that (1) require testing or information "reasonably likely to produce the same data and information required" by rule, consent agreement, or order under proposed TSCA Section 4, 5, or 6; (2) prohibit or restrict the manufacturing, processing, distribution in commerce, or use of a chemical after issuance of a completed safety determination under proposed TSCA Section 6; or (3) require notification for a significant new use of a chemical if EPA requires notification under proposed TSCA Section 5. Proposed TSCA Section 18 also would preempt new state prohibitions or restrictions for any high-priority and low-priority substance. Exceptions to the general preemption provision would include laws—adopted under the authority of any other federal law; implementing a reporting or information collection requirement not redundant of federal law; or adopted pursuant to state authority related to water quality, air quality, or waste treatment or disposal, as long as it does not impose a restriction on the manufacture, processing, distribution in commerce, or use of a chemical and is not redundant or inconsistent with an EPA action under proposed TSCA Section 5 or 6.

Confidential Business Information

TSCA Section 14 [15 U.S.C. 2613] protects proprietary confidential information submitted to EPA about chemicals in commerce. Disclosure by EPA employees of such information generally is not permitted, except to other federal employees or when relevant in any proceeding under TSCA. Manufacturers, processors, or distributors in commerce may designate information that they believe is entitled to confidential treatment. If EPA proposes to release such data to the public (in the limited cases where it is authorized to do so), then the EPA Administrator must notify the manufacturer, processor, or distributor who designated the information confidential. Disclosure of confidential business information (CBI) is required when "necessary to protect health or the environment against an unreasonable risk of injury to health or the environment."

S. 696 would increase public access to information about EPA's decisions and to some information about chemicals that currently is treated as CBI. Like the current statute, S. 696 would prohibit disclosure of CBI by EPA employees except to other federal agencies and EPA contractors or if the disclosure is necessary to protect human health or the environment (the qualifier "against an unreasonable risk" is omitted). Proposed TSCA Section 14 also would direct EPA to disclose information upon request to a state or tribal government for the purpose of administration or enforcement of a law, if an agreement ensured that appropriate steps would be taken to maintain the confidentiality of the information. EPA also would be directed to disclose information to public health or environmental health professionals or medical personnel under certain conditions. S. 696 would categorize and specify types of CBI as (1) information always eligible for protection, (2) information that may be eligible for protection, and (3) information never eligible for protection. The bill would direct EPA to promulgate rules specifying acceptable bases on which written requests to maintain confidentiality might be approved and documentation and justification that must accompany such a request. The Administrator would be required to review and respond to requests for confidentiality within 90 days of receiving the information. S. 696 would require those designating CBI to justify such claims and to certify that the information is not otherwise publicly available. If approved, submitted information generally would be protected from disclosure for up to five years.

S. 1009 is similar to the current statute, but the bill would require persons to substantiate any claim that information qualifies for disclosure protection. As in the current statute, the proposed requirements of S. 1009 would not apply if the Administrator determined that disclosure was necessary to protect human health or the environment (the qualifier "against an unreasonable risk" is omitted) nor to disclosure of information to an officer, employee, contractor or employees of that contractor of the United States. Information also may be disclosed to a state or political subdivision of a state, or to a health professional under specified circumstances. Information may be disclosed when necessary in a proceeding under proposed TSCA or to any duly authorized committee of the Congress. If enacted, the bill would prohibit the Administrator from disclosing trade secrets and other information defined as presumed to be protected. Also, S. 1009 would identify information not protected from disclosure, including

identity of a chemical unless the person meets substantiation requirements;
specified health and safety information and determinations; and
certain general information.

The bill would require the submitter to justify why information qualifies for confidentiality protection, and to certify that the information submitted is true and correct. In addition, for claims related to chemical identity, S. 1009 would require the submitter to provide specified information demonstrating that confidentiality of the identity has been and is likely to be protected, and disclosure is likely to cause substantial harm to the competitive position of the person. In such cases, the submitter would have to identify a time period for which disclosure protection is necessary and a generic name for the chemical.

S. 1009 would require the Administrator to protect CBI from disclosure for the period of time requested by the person submitting and justifying the claim, or for such period of time as the Administrator determines to be reasonable. The Administrator would be authorized to request "redocumentation" of a claim. S. 1009 would dictate a process for receiving and acting on claims for protection from information disclosure, and for providing recourse in the event the Administrator decides to release such data. Finally, S. 1009 would ensure that EPA may not require substantiation of a confidentiality claim for protection from disclosure of information submitted to EPA prior to the date of enactment of S. 1009 or to require more substantiation than proposed TSCA Section 14 requires.

Miscellaneous Provisions

Several new provisions would be included in an amended TSCA under S. 696, but not under S. 1009. One provision under S. 696, 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."

S. 696 also would require EPA to establish a program to create market incentives for the development of safer alternatives to existing chemical substances that reduce or avoid the use and generation of hazardous substances. The program would be required to expedite review of a new chemical substance if an alternatives analysis by a manufacturer or processor indicated the substance was a safer alternative, and to recognize a substance or product determined by EPA to be a safer alternative.

Another new provision of S. 696 would direct the EPA Administrator to coordinate with the Secretary of Health and Human Services to conduct a biomonitoring study for any chemical that research indicated might be present in human tissues and that could have adverse effects on human development. The study would be designed to determine whether the chemical in fact was present in pregnant women and infants. If the chemical were found to be present, manufacturers and processors would have to disclose to EPA, commercial customers, consumers, and the general public all known uses of the chemical and all articles in which the chemical was expected to be present.

Children's environmental health also is addressed by S. 696. It 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.

S. 696 also would establish at least four research centers to encourage the development of safer alternatives to existing hazardous chemical substances. In addition, "green chemistry and engineering" would be promoted through grants.

In the remainder of this CRS report, Tables 1 through 6 summarize selected provisions of S. 696 and S. 1009, as introduced, and current TSCA.

Table 1. Titles and Definitions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)

Provision	TSCA, 15 U.S.C. 2601 et seq.	Safe Chemicals Act (S. 696)	Chemical Safety Improvement Act (S. 1009)
Title	Toxic Substances Control Act (TSCA)	Safe Chemicals Act of 2013 (SCA)	Chemical Safety Improvement Act of 2013 (CSIA)
Revised definitions	TSCA definitions are in alphabetical order in Section 3 (15 U.S.C. 2602).	The SCA, Section 4 would amend definitions in TSCA Section 3.	The CSIA would retain the definitions in TSCA Section 3, but add new definitions.
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)]	Proposed TSCA 3(5) is the same as 15 U.S.C. 2602(2), but also authorizes EPA to determine that "a variant of a chemical substance is a new chemical substance," notwithstanding molecular identity.	Same as TSCA.
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)]	Proposed TSCA 3(8) amends the TSCA 3(4) definition to include "to export or offer for export the substance, mixture, or article."	Same as TSCA.
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)]	Proposed TSCA 3(10) amends the TSCA 3(5) definition to include "ambient" and "indoor air."	Same as TSCA.
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)]	Proposed TSCA 3(15) revises the definition, 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 proposed TSCA Section 8(a).	Same as TSCA.
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)]	This definition would be eliminated by the SCA Section 4(1).	Same as TSCA.
New definitions
Aggregate exposure	No comparable definition.	Total exposure to a chemical substance regardless of the source of exposure, including activities involved in the manufacture, processing, distribution, use, or disposal of chemicals; contamination of food, air, water, soil, and house dust from current or prior uses or activity; accidental releases; permitted sources of pollution; nonpoint sources of pollution; documented background levels from natural and anthropogenic sources; and a mixture or article containing that chemical substance. The term would include exposure from a chemical substance that is not considered a chemical substance under TSCA solely because of its use as, or in, food, cosmetics, or medical devices. [Proposed TSCA 3(2)]	No comparable definition.
Bioaccumulative	No comparable definition.	As determined by the EPA Administrator, the ability to significantly accumulate in biota, or highly likely to accumulate in biota. [Proposed TSCA 3(3)]	No comparable definition.
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. [Proposed TSCA 3(4)]	No comparable definition.
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 the same or a similar adverse effect." [Proposed TSCA 3(7)]	No comparable definition.
End consumer	No comparable definition.	An "individual or other entity that purchases and uses or consumes a chemical substance (or mixture or article containing that chemical substance)." [Proposed TSCA 3(9)]	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." [Proposed TSCA 3(11)]	No comparable definition.
Persistent	No comparable definition.	Determined by the EPA Administrator to significantly persist in one or more environmental media. [Proposed TSCA 3(16)]	No comparable definition.
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." Includes "each Federal agency and any officer, agent, or employee of a Federal agency." [Proposed TSCA 3(17)]	No comparable definition.
Special substance characteristics	No comparable definition.	Defines "special substance characteristic" to mean "such physical, chemical, or biological characteristic, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting that characteristic." Allows consideration of size, shape, reactivity, and any other properties that may significantly affect risks posed. [Proposed TSCA 3(20)]	No comparable definition.
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." [Proposed TSCA 3(22)]	No comparable definition.
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." [Proposed TSCA 3(23)]	No comparable definition.
Vulnerable human population	No comparable definition.	A "human population that is subject to a disproportionate exposure to, or the 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." [Proposed TSCA 3(25)]	No comparable definition.
Best available science	No comparable definition.	No comparable definition.	"Science that (a) maximizes the quality, objectivity, and integrity of information, including statistical information; (b) uses peer-reviewed and publically available data; and (c) clearly documents and communicates risks and uncertainties in the scientific basis for decisions." [Proposed TSCA 3(2)]
Intended conditions of use	No comparable definition.	No comparable definition.	"The circumstances under which a chemical substance is intended or reasonably anticipated to be manufactured, processed, distributed in commerce, used, and disposed of." [Proposed TSCA 3(8)]
Safety assessment	No comparable definition.	No comparable definition.	"A risk-based assessment of the safety of a chemical substance that (a) integrates hazard; use; and exposure information about a chemical substance; and (b) includes (1) an assessment of exposure under the intended conditions of use; and (2) reference parameters that may be appropriate with regard to a specific chemical substance (such as a margin of exposure)." [Proposed TSCA 3(14)]
Safety determination	No comparable definition.	No comparable definition.	"A determination by the Administrator as to whether a chemical substance meets the safety standard under the intended conditions of use." [Proposed TSCA 3(15)]
Safety standard	No comparable definition.	No comparable definition.	"A standard that ensures that no unreasonable risk of harm to human health or the environment will result from exposure to a chemical substance." [Proposed TSCA 3(16)]

Source: Compiled by the Congressional Research Service from the U.S. Code, S. 696, and S. 1009.

Table 2. Testing and Data Evaluation in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)

Provision	TSCA, 15 U.S.C. 2601 et seq.	Safe Chemicals Act (S. 696)	Chemical Safety Improvement Act (S. 1009)
Framework for data development and evaluation	No comparable provision.	No comparable provision, but see proposed TSCA 6 (b)(2) under "Prioritizing chemicals within categories" below.	The CSIA Section 4 amends TSCA 4. Proposed TSCA 4(a)(1) directs the Administrator to develop a framework for evaluating the safety of chemical substances in commerce.
Framework policies and procedures	No comparable provision.	No comparable provision.	Proposed TSCA 4(a)(2) directs the Administrator to "promptly develop appropriate policies and procedures for implementing the framework, including procedures on the collection, evaluation, and development of data and information." Also directs the Administrator to require collection of existing data and information, evaluation of the quality of such information, analysis of the information, determination of the need for additional information, and transparency of "information considered by the Administrator, including both positive and negative findings". Proposed TSCA 4(a)(3) requires the Administrator to ensure that the safety evaluation framework is transparent; assures that information is valid; addresses the strengths and limitations of the framework design, reliability of the test methods, and the quality of the data and information; and "pursues the goal of maximizing the quality, objectivity, utility, and integrity of the data and information."
Data and information quality	No comparable provision.	New TSCA 33 would direct EPA by order to establish and implement procedures to ensure data reliability by annually inspecting laboratories and performing an annual data audit. Requires that EPA establish a registry of studies. Provides the EPA Administrator with access to all records of health and safety studies initiated in response to requirements of Title I, and requires each submitter of a research study conducted by a third party to disclose the sources of any funding used to conduct or publish the study.	Proposed TSCA 4(b) directs the Administrator to establish and publish scientifically sound criteria for evaluating all of the data and information on which the Administrator relies in making any decision under the proposed TSCA. Requires disclosure of funding sources for those who submit health and safety studies to EPA, to the extent reasonably ascertainable. Requires that the Administrator encourage use of good laboratory practices, peer review, scientifically reliable and relevant test methods, standardized protocols, and other methods to ensure scientific quality for all data and information submitted under TSCA. EPA is authorized to consider data and information that do not meet the quality criteria established by this subsection, but must identify the data and information on which EPA relies, describe the quality of such information and the extent to which it departs from the criteria, indicate any limitations on its usefulness, and explain how it was used and the basis for reliance on the data.
Evaluative framework for decision making	No comparable provision.	No comparable provision, but see proposed TSCA 6(d) under "Safety standard" and "General process for safety determinations" below	Proposed TSCA 4(b)(5) directs the Administrator to "develop and use a structured evaluative framework consisting of science-based criteria, consistent with the protection of human health and the environment, for making any decision" under TSCA, "and for determining the relevance, quality, and reliability of data and information." Requires the framework to "at a minimum" use "sound and objective scientific practices in assessing risks;" "consider the current best available science;" consider "whether available data support or do not support the identification of threshold doses of a chemical substance;" and "include a description of the weight of the scientific evidence concerning risks."
Data and information sources	No comparable provision.	No specific comparable provision, but see proposed TSCA 6 (b)(2) under "Prioritizing chemicals within categories" below. In prioritizing chemicals for evaluation, proposed TSCA 6(b)(2) requires the Administrator to consider information available at the time decisions are made, including information obtained from manufacturers or processors, included in a minimum information set, relevant to categorization or prioritization and submitted to EPA, or identified by EPA through an active search of information sources.	Proposed TSCA 4(c) directs the Administrator to consider information relevant to the substance and reasonably available at the time a decision is being made under proposed TSCA 4(e), 5, or 6. Potential information sources include: submissions to EPA by manufacturers and processors of the substance, the public, a governor of a state or state agency with responsibility for protecting health or the environment; if accessible to the Administrator, submissions to a governmental body in another jurisdiction under a governmental requirement relating to the protection of human health and the environment; derived through application of scientifically reliable and relevant methods or models to estimate effects or exposure potential; inferred based on the similarity of structure or properties of a substance to those of other substances for which reliable information exists; and identified through an active search of information sources accessible to the Administrator.
Transparency	No specific comparable provision, but see TSCA 4(d).	No specific comparable provision, but see proposed TSCA 4(e) "Public notice of receipt of data." Also, proposed TSCA 5(f) directs the Administrator to post any submitted test data on a publicly available Internet site. Proposed TSCA 6(d)(2) requires that risk assessments be transparent and understandable to the public and to risk managers. Proposed TSCA 8(i) 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.	Proposed TSCA 4(d) states that information considered by the Administrator in taking action under TSCA must be available to the public, in accord with proposed TSCA 14. In addition, the CSIA directs the Administrator to make available to the public the guidance, procedures and tools used in evaluating information under proposed Section 4. Any written guidance prepared under TSCA must be subject to public notice and an opportunity for comment.
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.	The SCA Section 5 amends TSCA 4. Proposed TSCA 4(a) directs the EPA Administrator within one year of enactment of the SCA to promulgate a rule establishing varied or tiered requirements for "minimum information sets" for different chemical substances "appropriate to evaluate chemical substances under proposed TSCA Sections 5 and 6." The rule must require information sets "sufficient for the Administrator to administer this Act" with regard to categorization of new and existing chemical substances, assignment of priority classes, and safety standard determinations and redeterminations. Proposed TSCA 4(b) authorizes EPA to require, by rule or order, testing and submission of test results by a specified date in addition to the information specified in any applicable minimum information set "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. Proposed TSCA 4(a) directs EPA to include in the minimum information set information that the EPA anticipates will be necessary for the conduct of a screening-level risk assessment of the chemical. Allows EPA to provide for varied or tiered testing for different chemicals. Information sets must accommodate use of alternative testing methods and strategies to generate information quickly, at low cost, and with reduced use of animal-based testing, to the extent that such methods and strategies would yield information of equivalent quality and reliability. The rule must specify quality and reliability requirements for the information to be submitted.	Proposed TSCA 4(f) authorizes EPA to require development of new test data if EPA determines that information is needed to perform a safety assessment, to make a safety determination, or to meet testing needs of an "implementing authority under another Federal statute." EPA may require development of test data by promulgating a rule, entering into a testing consent agreement, or issuing an order. Directs EPA to require use of an evaluation framework that integrates relevant information from multiple sources, including toxicity information, bioinformatics, computational toxicology, high through-put screening methods, and scientifically reliable and relevant alternatives to vertebrate animal tests. Requires tiered testing and EPA to publish an explanation of its tiering decisions. Proposed TSCA 4(h) requires EPA to develop "an evidence-based review system for conducting consistent evaluations of the relevance and reliability of studies" and "a structured evaluative framework to provide a systematic and transparent approach for assessing the overall weight of the evidence ." The framework must have two tiers, a screening tier and a tier of more targeted tests. Proposed TSCA 4(i) directs the Administrator to reduce the use of animals in testing. For more on these provisions, see section "Animal-based Testing" below.
Deadlines for initial test data submission	TSCA 4(b) requires that EPA specify a period within which test data must be submitted for a chemical substance that is not new or for a mixture. "Such period may not be of unreasonable duration."	Proposed TSCA 4(a) requires submission to EPA of the minimum information set for an existing chemical at the time specified in proposed TSCA 6 or otherwise specified by the Administrator in the rule promulgated under this section. For existing chemicals categorized as Substances with Insufficient Information under proposed TSCA 6(b)(3)(iv), EPA must require submission of the applicable minimum information set. Information required for the initial batch of such chemicals must be submitted within five years of enactment of the SCA. Submission of the minimum data set is required for a new chemical at the time notice is provided to EPA [under proposed TSCA Section 5(b)] that a new chemical will be manufactured.	Proposed TSCA 4(f) requires EPA to specify a period within which test data must be submitted, which period must not be of an unreasonable duration. Directs EPA to consider costs and resources in determining the period.
Persons required to submit test data	TSCA 4(b) [15 U.S.C. 2603(b)] requires manufacturers and processors who manufacture or process or who "intend to" manufacture or process a chemical substance 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.	Proposed TSCA 4(c)(4) directs EPA to specify in any rule or order persons required to conduct tests and submit information, but allows designation of a single information provider, as is allowed under the current statute. The rule must require submission to EPA of such information by each manufacturer and processor of a new chemical substance or, as specified by the Administrator, of an existing chemical. In the event that a single information provider is designated, all parties remain individually liable for testing requirements.	Proposed TSCA 4(j) is similar to current TSCA 4(b) and the SCA, but omits the statement that the parties remain individually liable for testing requirements. The CSIA is more specific than the SCA in that it requires test data from manufacturers and processors who have manufactured or processed or who "begin to" manufacture or process a chemical substance.
Failure to submit test data	No comparable provision.	Proposed TSCA 4(a)(3) and 4(b)(3) authorize EPA, by order, to take any regulatory action authorized under Section 6(f) if a manufacturer or processor fails to submit required information or a required chemical sample.	No comparable provision.
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.	Proposed TSCA 4(d) would have the same effect as TSCA 4(c), except exemptions could apply to orders as well as rules, and the bill does not provide that the EPA Administrator's order to reimburse is a final agency action for the purpose of judicial review.	Similar to the SCA but also applies to testing consent agreements. If the manufacturers and processors cannot agree on a fair and equitable reimbursement, the amount must be determined by arbitration. If no one complies with the test requirement, the exemption will be terminated and EPA will notify each exempted person in writing of the termination.
Cessation of manufacture or processing	No comparable provision.	Proposed TSCA 4(b)(4) explicitly exempts from testing requirements any manufacturer or processor who ceases all manufacturing or processing of a chemical substance pursuant to its submission of a declaration of cessation of manufacture or processing of a chemical substance (under proposed TSCA 8(b)(4)).	No comparable provision.
Test rule requirements	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, for an existing chemical, specify the period during which test results must be submitted.	Proposed TSCA 4(c) is similar to 15 U.S.C. 2603(b), but is applicable to EPA orders as well as rules.	Proposed TSCA 4(f) is similar to 15 U.S.C. 2603(b) but requires specification of reliable non-animal test procedures. Directs EPA to consider costs and resources in determining testing procedures.
Judicial review of test rules	TSCA 19 [15 U.S.C. 2618 ] subjects rules promulgated under TSCA 4(f) to judicial review.	Proposed TSCA 19 subjects all rules and orders issued under TSCA to judicial review.	Proposed TSCA 19 subjects rules promulgated under proposed TSCA 4(f) to judicial review.
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.	Proposed TSCA 4(a) directs EPA to gather information on characteristics, toxicological properties, environmental and biological fate and behavior, exposure, and use of a chemical substance. Proposed TSCA 4(c) authorizes EPA to prescribe information development standards for health and environmental information, including information pertaining to: any effect that may be considered in a safety standard determination; exposure, including presence in human tissues and fluids; and any characteristic of a chemical 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).	Proposed TSCA 4(g) requires the Administrator to issue a statement identifying and explaining the need for data and encouraging use of nonanimal test methods. Proposed TSCA 4(j)(2) authorizes the Administrator to prescribe guidelines for the development of test data and information for health and environmental information, including data related to toxicity "that may be indicative of an adverse effect," exposure (including bioaccumulation, persistence, and presence in human tissue) and aggregate exposure, or other effects that may be considered in a safety assessment. Authorizes EPA to prescribe methodologies in guidelines for the development of data and information. Requires the Administrator to encourage the use of nonanimal methodologies. Authorizes the Administrator to develop guidelines for evaluating data from biomonitoring studies.^a
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.	Proposed TSCA 4(c)(3)(C) changes the interval between required reviews and revisions, if necessary, from one to three years.	Proposed TSCA 4(j) requires review and revision if necessary of the adequacy of the data development guidelines at least once every five years.
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 EPA Administrator must publish findings required by TSCA 4(a)(1)(A) or (B).	Proposed TSCA 4(c) omits current TSCA requirements for rulemaking that go beyond the notice and comment requirements of 5 U.S.C. 553. Proposed TSCA 4(b) authorizes EPA to issue orders in lieu of rules.	Proposed TSCA 4(j) is similar to the SCA but also authorizes the use of testing consent agreements. Proposed TSCA 4(g)(2) requires EPA, when it issues a test order, to issue a statement containing a discussion of the readily accessible data and information.
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 TSCA Section 14).	Proposed TSCA 4(e) is similar to 15 U.S.C. 2603(d) in requiring public notice of the receipt of information, but applies also to information submitted in accord with an EPA order, and requires that information be made "available on a publicly accessible Internet site."	Proposed TSCA 4(k) directs EPA to make available to the public all testing consent agreements and orders and all data and information submitted under proposed TSCA 4.
Interagency testing committee (ITC)	TSCA 4(e) [15 U.S.C. 2603(e)] establishes the ITC to advise the EPA Administrator regarding chemicals that should receive priority consideration for promulgation of a test rule [under subsection (a)].	This provision is eliminated. The Administrator is directed by proposed TSCA 6(a) to establish a system for assigning chemical substances into batches, categorizing them, and assigning priorities for testing and regulation.	Proposed TSCA 4(l) is the same as current TSCA 4(e) except that the ITC advises EPA with regard to testing consent agreements and test orders as well as test rules.
Committee recommendations for testing	TSCA 4(e) [15 U.S.C. 2603(e)] directs the ITC to establish a prioritized list of chemicals for the EPA 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."	This provision is eliminated, but see proposed TSCA 6 below.	Proposed TSCA 4(l) is the same as current TSCA 4(e).
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.	This provision is eliminated, but see proposed TSCA 6 below.	This provision is eliminated, but see proposed TSCA 6 below.
Requests from other federal agencies	No comparable provision.	Proposed 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 within 60 days to collect and provide such information to the requesting agency, collect information under TSCA 8, issue a rule or order to develop the data, or publish in the Federal Register the reason for not taking any of these actions.	Proposed TSCA 4(f) authorizes EPA to issue test rules, enter testing consent agreements, or to issue orders to meet testing needs of an "implementing authority under another Federal statute."
Certification of data submitted	No comparable provision.	Proposed TSCA 4(g) requires that each person who submits information under a rule or order accompany that information with 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.	No comparable provision.
Scientific standards for data assessment	No comparable provision.	Proposed TSCA 6(d)(2)(D) requires the EPA Administrator to "use the best available science" in conducting a risk assessment considering the recommendations of the National Academy of Sciences in the report entitled "Science and Decisions." Every five years, the EPA Administrator is required to review the methodology and may revise it "to reflect new scientific developments or understandings."	Proposed TSCA 4(a)(1) directs the Administrator to use "the 'best available science' and risk assessment principles in existence at the time the Administrator is developing the framework."

a. EPA has stated that it "... 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).

Source: Compiled by the Congressional Research Service from the U.S. Code, S. 696, and S. 1009.

Table 3. Notices and Priorities in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)

Provision	TSCA, 15 U.S.C. 2601 et seq.	Safe Chemicals Act (S. 696)	Chemical Safety Improvement Act (S. 1009)
"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.	The SCA Section 6 amends TSCA 5. Proposed TSCA 5(a) provides the same definition as current TSCA 5(i).	The CSIA Section 5 amends TSCA 5. Proposed TSCA 5(h) is the same as 15 U.S.C. 2604(i).
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.	Proposed TSCA 5(b) prohibits manufacture of new chemicals and processing of a new chemical for an exempted use (see proposed TSCA 6(h)(2)(B)) unless notice is submitted to EPA. For an existing chemical for which EPA has made a safety determination, proposed TSCA 5(c)(2) requires notice prior to manufacture or processing for a new use, at new production volume, or in a manner other than specified in the safety determination. For an existing chemical for which EPA has not yet made a safety determination, proposed TSCA (c)(1) requires a notice prior to manufacture or processing for a new use or at a significantly increased production volume.	Proposed TSCA 5(a)(1) is the same as current TSCA 5(a).
New use determination	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."	Prior to a safety standard determination for an existing chemical, proposed TSCA 5(c) designates a use to be a new use if at the time of enactment of the Safe Chemicals Act that use was not ongoing, or if manufacture or processing of the substance would be at a significantly increased volume. After a safety standard determination has been made for an existing chemical, a new use is any use, production volume, or manner other than those the EPA Administrator specified in the safety standard determination.	Proposed TSCA 5(a)(2) is the same as current TSCA 5(a).
Special substance characteristics	No comparable provision.	Proposed TSCA 5(e) directs the EPA Administrator to determine by order or rule whether a variant of a chemical substance exhibiting one or more "special substance characteristics" [such as size or reactivity, as defined in proposed TSCA 3(20)] is a new use or a distinct substance. Manufacturers of substances determined to be distinct must satisfy the requirements for new chemicals under proposed TSCA 5(b).	No comparable provision.
Notice content for new chemical substances	TSCA 5(d) [15 U.S.C. 2604(d)] requires that notices contain: trade name or common name; chemical identity and molecular structure; categories of use; amount of each chemical manufactured or processed; byproducts resulting from such manufacture or processing; number of individuals exposed; in the initial report, the manner of disposal; any test data related to the effect of activities with respect to the chemical on health or the environment; and a description of any other data concerning environmental and health effects of such substance, insofar as reasonably ascertainable.	Proposed TSCA 5(g)(1)(A) requires a notice for a new chemical substance to include: the chemical identity and any special substance characteristics; identity and primary business location of the manufacturer; a list of health and safety studies with respect to the chemical substance; upon request of the Administrator, a copy of each study not previously submitted; the projected annual manufacturing or processing volume of the chemical substance for each of the subsequent three years; the name and location of each facility to which the chemical substance is expected to be sent for subsequent processing, distribution, or use; and all other existing information not previously submitted regarding toxicological properties of the chemical substance and the uses of, and exposure and fate information relating to, the chemical substance; the minimum information set established under proposed TSCA 4(a), where applicable; and a statement that either the chemical is likely to meet the safety standard under proposed TSCA 6(d), or the uses proposed for the new chemical substance meet the criteria for being exempt (in proposed TSCA 6(h)(2)(B)).	Proposed TSCA 5(b) eliminates the explicit notice requirements in the current statute, but includes similar requirements by reference to EPA's current implementing regulations at 40 CFR 720.45 (information that must be included with a notice) and 720.50 (existing test data that must be included with a notice) and successor regulations. Also requires information about intended conditions of use and reasonably anticipated exposure.
Notice content for new uses of existing chemical substances	TSCA 5(d) [15 U.S.C. 2604(d)] requires that notices contain: trade name or common name; chemical identity and molecular structure; categories of use; amount of each chemical manufactured or processed; byproducts resulting from such manufacture or processing; number of individuals exposed; in the initial report, the manner of disposal; any test data related to the effect of activities with respect to the chemical on health or the environment; and a description of any other data concerning environmental and health effects of such substance, insofar as reasonably ascertainable.	Proposed TSCA 5(g)(1)(B) requires that a notice for a new use of an existing substance that has not yet been subject to a safety determination include all updates to the declaration in proposed TSCA 8(b)(2) as well as (to the extent it is relevant to new use, new production volume, or other new manner of manufacturing or processing): a list of health and safety studies with respect to the chemical substance; upon request of the Administrator, a copy of each study not previously submitted; the projected annual manufacturing or processing volume of the chemical substance for each of the subsequent three years; the name and location of each facility to which the chemical substance is expected to be sent for subsequent processing, distribution, or use; and all other existing information not previously submitted regarding toxicological properties of the chemical substance and the uses of, and exposure and fate information relating to, the chemical substance.	Proposed TSCA 5(b) eliminates the explicit notice requirements in the current statute, but includes similar requirements by reference to EPA's current implementing regulations at 40 CFR 720.45 and 720.50 and successor regulations. Also requires information about intended conditions of use and reasonably anticipated exposure.
Notice content for new uses of existing chemical substances that meet the safety standard	No comparable provision	Proposed TSCA 5(g)(1)(C) requires that a notice for a new use of an existing substance that meets the safety standard include all updates to the declaration in proposed TSCA 8(b)(2) as well as (to the extent it is relevant to new use, new production volume, or other new manner of manufacturing or processing): a list of health and safety studies with respect to the chemical substance; upon request of the Administrator, a copy of each study not previously submitted; the projected annual manufacturing or processing volume of the chemical substance for each of the subsequent three years; the name and location of each facility to which the chemical substance is expected to be sent for subsequent processing, distribution, or use; and all other existing information not previously submitted regarding toxicological properties of the chemical substance and the uses of, and exposure and fate information relating to, the chemical substance; all relevant updates to the minimum information set; and a statement that the chemical will continue to meet the safety standard if the new use is allowed.	No comparable provision.
Notice of commencement	No comparable requirement in the statute, but a notice of commencement must be filed within 30 days of the beginning of manufacture, according to EPA ("How to File a Notice of Commencement," http://www.epa.gov/oppt/newchems/pubs/filenoc.htm).	Proposed TSCA 5(d) requires a manufacturer or processor to notify EPA within 30 days of the commencement of manufacturing or processing of a new chemical substance. The notice is required to include the information required to be in the declaration by proposed TSCA 8(b)(5).	Proposed TSCA 5(c)(2) states that a chemical substance may be the subject of a notice of commencement at the end of the applicable review period unless the Administrator determines that the substance is not likely to meet the safety standard. Proposed TSCA 5(d) requires a manufacturer or processor to notify EPA within 30 days of the commencement of nonexempt manufacture of a new chemical substance or nonexempt manufacture or processing of an existing chemical substance for a new use. Notice must contain the name of the manufacturer or processor and the initial date of nonexempt commercial manufacture or processing. Allows withdrawal of such notice if commercial manufacture or processing does not commence.
Certification	No comparable provision.	Proposed TSCA 5(i) 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.	No comparable provision.
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 EPA 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."	At the time a manufacturer or processor notifies EPA that it plans to manufacture or process a chemical substance that is new or that is not new but for which a new use is proposed, proposed TSCA 5(f) requires submission of any data for that chemical substance that are required by rule or order under Section 4(b), 5(b), or 5(c). The Administrator may require submission of information prior to, or as a condition of, categorization, commencement of manufacturing or processing, or exceeding a specified volume or expanding use of the substance, unless the substance is in the category of substances with insufficient information.	This provision is eliminated; no data need be developed prior to submitting a notice.
EPA's response to notice and categorization of chemical substances subject to notice requirements	EPA has 90 days to decide whether the chemical or chemical use may present an unreasonable risk of injury to health or the environment.	Proposed TSCA 5(b)(2)(C) requires EPA to categorize new chemicals within 90 days of receiving a pre-manufacture notice. Proposed TSCA 5(c)(2)(C) requires EPA to determine within 180 days after receiving notice and data regarding a new use of a chemical substance that meets the safety standard, whether it has been established that the chemical substance or mixture would continue to meet the safety standard under proposed TSCA Section 6(b). Proposed TSCA 5(b)(2) requires the Administrator to promulgate a rule designating categories and specifying the process and criteria that will be used to categorize new chemical substances. Requires EPA to categorize all new chemical substances. The required categories include (1) Substances of Very High Concern, (2) Substances Unlikely to Meet the Safety Standard, (3) Substances with Insufficient Information, and (4) Substances Likely to Meet the Safety Standard. Chemicals in the last category would be added to the inventory of existing chemicals (see proposed TSCA 8(b)), assigned to a batch (see below proposed TSCA 6(a)), and further categorized as either Substances of Very Low Concern or Substances to Undergo a Safety Standard Determination.	Proposed TSCA 5(c) directs the Administrator, not later than 90 days after receipt of a notice, to conduct an initial review of the notice, including information submitted with the notice; develop a profile of the substance and the potential for exposure; and make any necessary determination that— (1) the chemical substance is not likely to meet the safety standard; (2) the chemical substance is likely to meet the safety standard under the intended conditions of use (in which case the review period shall expire and manufacture may commence); or (3) additional information is necessary in order to make a determination (in which case, EPA must provide opportunity for the submitter of the notice to submit additional information, may extend the review period for that purpose, on receipt of such information must promptly make a determination as to whether the substance or use is likely to meet the safety standard. EPA also is authorized to allow manufacture pending submission of additional information.)
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 EPA Administrator issues a proposed rule, it is effective on the date it is issued.	This provision would be eliminated. S. 696 requires risk management prior to production and distribution.	If EPA determines that a new chemical or use is unlikely to meet the safety standard, proposed TSCA 5(c) directs EPA to, by consent agreement or by order, prohibit manufacture of the chemical substance, or manufacture or processing of the chemical substance for a significant new use, or prohibit manufacture or processing without compliance with specified restrictions.
Regulation pending development of information	TSCA 5(e) [15 U.S.C. 2604(e)] authorizes the EPA 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 EPA Administrator determines that the information available "is insufficient to permit a reasoned evaluation of the health and environmental effects" of the chemical; and either "in the absence of sufficient information" 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 (and new information) that the determination cannot be made.	This provision would be eliminated. Proposed 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.	If the Administrator determines that additional information is necessary to make a safety determination, proposed TSCA 5(c) authorizes EPA to prohibit manufacture of the chemical substance, or manufacture or processing of the chemical substance for a significant new use, or manufacture or processing of the chemical substance without compliance with specified restrictions pending receipt of information.
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 EPA Administrator to publish a statement of reasons for not taking action.	This provision would be eliminated.	This provision would be eliminated.
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."	Proposed TSCA 5(c)(2)(C) authorizes EPA to extend the determination deadline for periods not to exceed one year in the aggregate.	Proposed TSCA 5(c) is the same as current TSCA 5(c) .
Publication of notice	TSCA 5(d)(1) [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.] TSCA 5(d)(2) 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.	Proposed TSCA 5(g) is similar to the current statute, but specifies that EPA must make notices available on a publicly accessible Internet site and requires disclosure of the availability of the minimum data set and specification of each chemical category. In addition, requires EPA to make available on the Internet monthly a list of chemical substances for which notice has been received. [Also, see "Disclosure of data" section below.]	The CSIA eliminates the provision at current TSCA 5(d)(1). Proposed TSCA 5(f) directs the Administrator to make available to the public all notices, rules and orders, and all data and information submitted or issued under proposed TSCA 5, subject to disclosure restrictions at proposed TSCA 14. Proposed TSCA 5(b)(2) is the same as current TSCA 5(d)(2) except that EPA is not required to publish a description of the nature of tests performed and data that were developed pursuant to a rule.
Exemptions from notice requirements
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 EPA 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 in Table 4 at "Procedure for issuing rules").	Proposed TSCA 5(h)(1) authorizes the Administrator to order an exemption from particular notice requirements when scientific consensus exists that the intrinsic properties of a new chemical substance are such that it "does not and would not pose any risk of injury to human health or the environment under any intended or reasonably anticipated levels of production, patterns of use, or exposures arising at any stage across the lifecycle of the chemical substance." Prohibits EPA from basing its determination upon a finding or assumption of low human or environmental exposure.	Proposed TSCA 5(g)(3) is similar to current TSCA 5(h)(4) but the EPA Administrator must determine that the substance "is expected to meet the safety standard under the intended conditions of use." Note that the rulemaking provision in the current version of TSCA is retained, but refers to TSCA 6(c)(2) and (3), sections which are struck in the CSIA.
Intermediate production chemicals	TSCA 5(h)(5) [15 U.S.C. 2604(h)(5)] authorizes exemptions upon application for production-related (temporary, so-called "intermediate") chemicals when no human or environmental exposure will occur.	Proposed TSCA 5(h)(5) is the same as the current statue.	Proposed TSCA 5(g)(4) is the same as current TSCA 5(h)(5). (The new provision would exempt persons from notification requirements, not data requirements because those latter requirements have been eliminated).
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."	Proposed TSCA 5(h)(2) is similar to the current statute, but a person must show that it "will not endanger human health or the environment." "Test marketing" is defined in proposed TSCA 5(a)(2) to exclude provision of a chemical or article containing a chemical to an end consumer.	Proposed TSCA 5(g)(1) is the same as current TSCA 5(h)(1). (The new provision would exempt persons from notification requirements, not data requirements because those latter requirements have been eliminated).
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 TSCA 4(b) data submission requirement to request from EPA an exemption from the TSCA 5(b) requirement 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 substance 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.	Proposed TSCA 5(h)(3) 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 the current statute.	This provision is eliminated (because data requirements have been eliminated).
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.	Proposed TSCA 5(h)(4) is the same as the current statute.	Proposed TSCA 5(g)(2) is the same as current TSCA 5(h)(3). (The new provision would exempt persons from notification requirements, not data requirements because those latter requirements have been eliminated).
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.	Proposed TSCA 5(h)(6) is the same as the current statute.	Proposed TSCA 5(g)(5) is the same as current TSCA 5(h)(6).
Prioritizing existing chemicals for evaluation and action (Chemicals of Concern, Batches, and Priorities)	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 EPA 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 EPA 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."	The SCA would eliminate this provision, but Section 7 of the SCA proposes to amend TSCA 6(a) to direct EPA to establish a system for assigning chemical substances into batches and prioritizing them for evaluation in accordance with proposed TSCA 6. Proposed TSCA 6(b) directs EPA to assign chemical substances on the active portion of the inventory (see proposed TSCA 8) to batches and to publish lists of substances assigned to each batch. The initial batch generally should include chemicals for which reports are submitted to EPA under its Chemical Data Reporting rule as of the date of enactment of the SCA, but EPA is allowed to include and exclude particular substances if they are used or released into the environment in a manner that might warrant, or not warrant, early evaluation. EPA shall assign chemical substances to subsequent batches reflecting the extent to which each warrants earlier or later evaluation. Proposed TSCA 6(b) directs EPA to promulgate regulations establishing categories and specifying the process and criteria for categorizing chemical substances, beginning with substances assigned to the initial batch. Within 180 days of promulgating regulations under this section, EPA is required to publish lists of chemicals assigned to each category for the initial batch using the following four categories: Substances of Very High Concern, Substances of Very Low Concern, Substances to Undergo Safety Standard Determinations, and Substances with Insufficient Information.	The CSIA also would eliminate this provision, but proposed TSCA 4(e) directs the Administrator within one year of enactment of the CSIA to establish a risk-based screening process for identifying whether existing chemical substances are a high or a low priority for a safety assessment and determination under proposed TSCA 6. Proposed TSCA 4(e) directs the Administrator "in a timely manner" to screen existing chemical substances or categories of substances on the active inventory created under proposed TSCA 8(b). Substances are to be removed from the list of high-priority substances when a safety determination is published. Priorities must be determined based on: the ability of EPA to schedule and complete safety assessments and determinations under proposed TSCA 6 in a timely manner; and reasonably available data and information concerning the hazard, exposure, and use characteristics at the time the decision is made. When proposing its process and criteria for screening, the Administrator must include an initial list of chemical substances and indicate whether each is high or low priority. This list must include substances prioritized by EPA before the enactment of the CSIA and for which an assessment or determination has not been completed. Proposed TSCA 4(e)(3)(I) authorizes the Administrator to revise the priority designation of a chemical substance based on information made available after the date of the previous designation.
Prioritizing existing chemicals for evaluation and action (Chemicals of Concern, Batches, and Priorities) (cont.)	(see above)	(see above)	Proposed TSCA 4(e)(4) provides EPA 180 days to make a prioritization screening decision for an active chemical substance after EPA receives a recommendation and relevant information from a Governor or state agency. This decision is not subject to judicial review. Proposed TSCA 5(e) authorizes prioritization screening for a chemical substance at any time after the Administrator receives a notice of commencement under proposed TSCA 5(d) or significant new information regarding the chemical substance.
Criteria for categorizing existing chemical substances	No comparable provision, but EPA currently categorizes some chemicals as persistent, bioaccumulative, and toxic (PBT) or as persistent organic pollutants (POPs) (http://www.epa.gov/pbt/). Other chemicals are categorized as hazardous substances under other environmental laws. (For example, see 40 Code of Federal Regulations (CFR), Part 355, Appendix A for a list of "extremely hazardous substances" under the Emergency Planning and Community Right-to-Know Act, 42 USC 11011 et seq.)	Proposed TSCA 6(b)(3)(i) directs the Administrator to designate chemicals as Substances of Very High Concern (SVHC) if there is evidence of widespread exposure and the chemical substances (1) are toxic, persist in the environment, and are bioaccumulative or (2) are highly hazardous. In addition, the category is to include chemicals subject to regulation under TSCA 6 or 7 (as in effect on the day before enactment of the Safe Chemicals Act) or that are subject to a voluntary phase-out, administered by EPA that has been completed or is underway at the time the category designation is made. Proposed TSCA 6(b)(3(ii) directs the Administrator to designate chemicals as Substances of Very Low Concern (SVLC) if they possess intrinsic low-hazard properties and require no further action by EPA. Proposed TSCA 6(b)(3)(iv)directs the Administrator to designate as Substances with Insufficient Information those chemicals for which information is not available or not sufficient to allow for an informed categorization decision.	Proposed TSCA 4(e)(2)(C) requires the criteria for prioritization include: the recommendation of a Governor or state agency; hazard and exposure potential; intended conditions of use; evidence and indicators of exposure potential to humans; volume manufactured or processed; significant changes in production or processing volume; availability of information needed for conducting a safety assessment or determination (with limited availability a factor in designating a substance as a high priority); and the extent of federal or state regulation (with existing federal or state regulation of any uses a factor in designating a substance to be a low priority for a safety assessment and determination.) Proposed TSCA 4(e)(3)(E) requires EPA to identify a substance as high priority if, relative to other substances, it has the potential for high hazard and high exposure. Authorizes the Administrator to identify a substance as high priority if, relative to other substances, it has the potential for high hazard or high exposure. Authorizes EPA to identify an inactive substance (see proposed TSCA 8(b)(7)) as
Criteria for categorizing existing chemical substances (cont.)	(see above)	Proposed TSCA 6(b)(3)(iii) requires the Administrator to designate chemicals to the category of Substances to Undergo Safety Standard Determinations if, based on a screening of available use, hazard, and exposure information, the chemicals do not meet the criteria for SVLC or SVHC and have sufficiently robust information to inform prioritization decisions. Requires EPA to designate the process and criteria to prioritize chemicals within the category for safety assessments and determinations.	high priority if it has not been subject to a regulatory action to ban or phase out the substance, and it demonstrates high hazard and high exposure. Proposed TSCA 4(e)(3)(F) directs EPA to identify a chemical as low priority if it is likely to meet the safety standard under the intended conditions of use.
Notice and comment	Rulemaking under TSCA 5(b)(4) [15 U.S.C. 2604(b)(4)] must be promulgated pursuant to the procedures specified in the Administrative Procedure Act (5 U.S.C. 553) providing for notice and public comment, 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 EPA 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."	Proposed TSCA 6(b) directs EPA to promulgate regulations establishing categories and specifying the process and criteria for categorizing chemical substances. EPA also is required to publish lists of chemicals assigned to each category.	Proposed TSCA 4(e) requires EPA to publish for public comment a proposed prioritization screening process and to establish criteria for prioritizing substances. Proposed TSCA 4(e)(3)(G) subjects chemical prioritizations to notice and opportunity for comment. Proposed TSCA 4(e)(3)(J) directs EPA to publish and keep current a list of high-priority substances and a list of low-priority substances and to justify changes to the lists. Requires the Administrator to publish a list of substances being screened and to request information on those substances "from time to time." Any recommendation from a Governor or state agency shall be subject to public notice and comment, and EPA is required to publish its explanation, including a description of the information relied upon, for why it prioritized a chemical substance as it did.
Prioritizing chemicals within categories	No comparable provision.	Proposed TSCA 6(b)(4) provides that within 270 days of promulgating regulations under this section, EPA must publish priority class assignments (see below) for the initial batch of chemicals assigned to the category of Substances to Undergo Safety Standard Determinations.	Proposed TSCA 4(e)(3)(H) authorizes the Administrator to determine and to revise the order for performing safety assessments on high-priority substances under proposed TSCA 6.
Judicial review of EPA priorities	Rules promulgated under TSCA 5(b)(4) are subject to judicial review under TSCA 19 (see Table 6. at "Judicial review of restrictions and other rules" below).	Proposed TSCA 6(c) prohibits judicial review of EPA's decisions about batching, categorization, and prioritization. However, failure to designate or publish a list of chemical substances assigned to a batch, category, or priority class is subject to judicial review and considered a failure to perform a nondiscretionary duty.	Proposed TSCA 4(e)(5) prohibits judicial review of EPA action under proposed TSCA 4(e).

Source: Compiled by the Congressional Research Service based on the U.S. Code, S. 696, and S. 1009.

Table 4. Safety Standard Determinations and Restrictions in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)

Provision	TSCA, 15 U.S.C. 2601 et seq.	Safe Chemicals Act (S. 696)	Chemical Safety Improvement Act (S. 1009)
Risk management	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.	Proposed TSCA 6(f) would authorize EPA to impose conditions on the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance, or mixture or article containing a chemical substance. Many of the conditions that EPA is authorized to impose are the same as the regulatory options listed in the current statute, but the proposed legislation authorizes EPA to manage risk in any manner that the Administrator determines is appropriate, and specifically 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 EPA 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. In addition, the SCA differs from the current statute 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.	Proposed TSCA 6(a) requires the Administrator to establish requirements, as appropriate, for risk management of each high-priority substance or mixture. Proposed TSCA 6(c)(9) requires EPA to impose various restrictions on high-priority chemicals that do not meet the safety standard for the intended conditions of use. Many of the conditions that EPA is authorized to impose are the same as the regulatory options listed in the current statute, but the proposed legislation also authorizes EPA to manage risk in any manner that the Administrator determines is appropriate and to require testing under proposed TSCA 4(f). Like the SCA, the CSIA 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.
Procedure for issuing rules	TSCA 6(c) [15 U.S.C. 2605(c)] specifies procedures for rulemaking that allow for informal hearings. Requires that EPA's decisions be based on the rulemaking record.	The SCA eliminates current TSCA requirements for rulemaking that go beyond the notice and comment requirements of 5 U.S.C. 553.	Same as the SCA; eliminates the requirement.
Restrictions on substances that do not meet the safety standard	No specific 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 EPA 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."	Proposed TSCA 6(d)(5)(F) prohibits manufacture, processing, and distribution in commerce of a chemical substance 18 months after EPA determines that the substance fails to meet the safety standard. A manufacturer or processor may be granted a one-time extension of the deadline for a period of no more than five years if the manufacturer or processor demonstrates a compelling technological need to continue a restricted activity or that a factor wholly beyond the control of the manufacturer or processor prevents compliance within the 18-month time period.	Proposed TSCA 6(c)(9) requires EPA to promulgate rules imposing various restrictions (see above) for high-priority chemical substances that do not meet the safety standard for the intended conditions of use (based on weight of the evidence and magnitude of risk).
EPA statement	TSCA 6(c) [15 U.S.C. 2605(c)] requires for any rule promulgated under TSCA 6(a) that EPA 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."	This provision is eliminated. The Administrator would be authorized under proposed TSCA 6(f) to impose needed restrictions by order.	Proposed TSCA 6(c)(9)(D) requires the Administrator to base a determination that a ban or phase out of manufacture, processing, or use of a chemical substance is necessary on the following considerations (which shall be published): availability of technically and economically feasible alternatives for the substance under the intended conditions of use; relative risks posed by those alternatives; economic and social costs and benefits of the proposed regulatory action and options considered and of potential alternatives; and the economic and social benefits and costs of the chemical substance, alternatives to the chemical substance, and any necessary restrictions on the chemical substance or alternatives.
Exemptions from prohibitions and other restrictions	No comparable provision.	Proposed TSCA 6(h) authorizes EPA to grant, by order, exemptions (and renewals of exemptions) to restrictions proposed to be established under Sections 5(b)(1)(C)(ii)(I), 6(d)(5), 6(e), and 6(f). Exemptions and renewals may be granted, by order, for up to five 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 for which there is no safer feasible and available alternative, or the specified use compared to available alternatives provides a substantial net benefit to human health, the environment, or public safety. The manufacturer or processor must notify customers and the public of any exemptions granted. EPA is authorized to impose on a granted exemption any condition that is necessary to ensure the protection of human health and the environment.	Proposed TSCA 6(c)(10) authorizes EPA to exempt use of a chemical substance from any restriction under proposed TSCA 6(c)(9) if the Administrator determines: the exemption is in the interest of national security; lack of availability of the chemical substance would cause significant disruption in the national economy; the use is a critical or essential use "no feasible alternative for the use would materially reduce risk to health or the environment;" or no feasible alternative for the use is economically, technically, or efficiently available; or use provides a net benefit to human health, the environment, or public safety.
Regulation under other EPA-administered federal laws	TSCA 6(c)(1) directs EPA to promulgate needed rules under other environmental laws, unless it is in the public interest to issue rules under TSCA. This directive is repeated in TSCA 9(b).	Proposed TSCA 6(f) does not require EPA to promulgate rules under other environmental laws rather than under TSCA Section 6. However, the provision in current TSCA 9(b) is retained.	The CSIA eliminates the provision in current TSCA 6(c)(1), but not the provision in 9(b).
Safety standard	No specific comparable provision, but in general terms, the standard embedded in TSCA is that EPA should protect against "unreasonable risk of injury to health or the environment," a standard that appears to require risk assessment but allows balancing of risks and benefits.	For a chemical to meet the safety standard, proposed TSCA 6(d)(2)(B)(ii)(II) requires the EPA Administrator to find that "there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance." Proposed TSCA 6(d) directs the EPA Administrator to base a determination of whether a chemical meets its safety standard "solely on considerations of human health and the environment, including the health of vulnerable populations." To the extent practicable, the EPA Administrator is required to incorporate "any available scientific information relating to the effect of cumulative exposure … on human health and the environment." Proposed TSCA 6(d)(1)(B)(i) states that each manufacturer and processor "shall at all times bear the burden of proof in any legal proceeding relating to a decision of the Administrator regarding whether the chemical substance meets the safety standard." The bill imposes a duty on the manufacturer or processor of a chemical to provide sufficient information for EPA to determine whether the chemical meets the safety standard, and imposes a duty on EPA to determine whether a chemical meets the safety standard.	Proposed TSCA 3(16) defines the safety standard as "a standard that ensures that no unreasonable risk of harm to human health or the environment will result from exposure to a chemical substance."
General process for safety assessments	No comparable provision.	Proposed TSCA 6(d)(2) requires that EPA produce a risk assessment addressing health and environmental impacts in support of any determination that a manufacturer or processor of a chemical substance has met the applicable safety standard. Proposed TSCA 6(d)(2)(H) would require no risk assessment when EPA determined that a manufacturer or processor has not met the burden of proof that the safety standard is met, and such determination is not subject to judicial review.	Proposed TSCA 6(a) requires the Administrator to conduct a safety assessment for each high-priority substance. Proposed TSCA 4(e)(3)(F) prohibits the Administrator from performing a safety assessment on a low-priority substance. Proposed TSCA 6(b) requires that safety assessments are risk-based; consider hazard, use, and exposure information (including exposure of vulnerable subpopulations) for the chemical substance under the intended conditions of use; and are based "solely on considerations of risk to human health and the environment."
Requirements for safety assessments	No comparable provision.	Risk assessments must be transparent and understandable to the public and to risk managers. Risk assessments to support safety determinations must be conducted by EPA employees with no financial interest in the outcome. Peer reviewers of such assessments also must have no financial interest in the outcome. Assessments must address health or environmental impacts including potential or demonstrated cancer and non-cancer endpoints.	Directs EPA to establish procedural rules for safety assessments, including schedules for data submissions and safety assessments. Rules must identify the basis for decisions about the relative priority of high-priority substances for safety assessment and determination. Rules must require the Administrator to inform the public about the process, schedule, deadlines, and informational needs of assessments. Rules also must allow interested persons to submit information, and must make available to the public information taken into consideration in preparing each safety assessment and determination. Requires the Administrator to develop and at least every five years to review and possibly revise a science-based methodology (using the best available science) for conducting safety assessments. Methodology must address specified issues and be subject to public comment and scientific peer review. Directs the Administrator to provide an opportunity for interested persons to submit additional information, and authorizes the Administrator to promulgate a rule, enter into a testing agreement, or issue an order under Section 4 to require development of information. (See proposed TSCA 4(f) above.)
Safety of chemicals for export	No comparable provision.	Proposed TSCA 6(d)(2)(G) directs EPA to consider risks that a chemical manufactured in whole or in part for export may pose in the United States during production and distribution in commerce, including in imported products containing the substance.	No comparable provision.
Safety determinations for existing chemicals
EPA's determination	No comparable provision.	Beginning with substances assigned to the first batch and designated as Priority Class 1, the Administrator is directed to conduct and publish safety standard determinations for all chemical substances in the category Substances to Undergo Safety Standard Determinations within five years of the date of enactment of the Safe Chemicals Act. For subsequent batches, EPA is given five years from the date on which EPA designates substances as Priority Class 1to complete safety standard designations. [Proposed TSCA 6(d)(4)] Proposed TSCA 6(d)(5) directs EPA to seek to publish safety standard determinations and risk management decisions concurrently, to the maximum extent practicable, but is directed to not unduly delay issuance of a safety standard determination if more information or analysis is required to make decisions regarding risk management. Requires EPA to provide reasonable public notice and opportunity for comment on all published safety standard determinations.	Proposed TSCA 6(a) and (c) requires the Administrator to determine (using the best available science) whether each high-priority chemical substance meets the safety standard under the intended conditions of use based solely on considerations of risk to human health and the environment. Proposed TSCA 6(b) directs EPA to establish procedural rules for safety determinations, including schedules for data submissions, safety assessments, and safety determinations. Proposed TSCA 6(c) requires the Administrator to make a determination whether each high-priority chemical substance: meets the safety standard under the intended conditions of use; does not meet the safety standard under intended conditions of use; or requires additional information to make a determination. Requires the Administrator to take into consideration and publish a statement that includes: the safety assessment, range of exposure; weight of the evidence of risk; and magnitude of risk posed. Requires EPA to provide notice and an opportunity for public comment on each proposed safety determination. If EPA determines additional information is needed, requires EPA to provide an opportunity for interested persons to submit additional information, and authorizes the Administrator to promulgate a rule, enter into a testing agreement, or issue an order under Section 4 to require development of information.
Manufacturer failure to meet a duty	No comparable provision.	Proposed TSCA 6(d)(4)(D) authorizes the Administrator, by order, to take any action authorized under proposed TSCA 6(f) if a manufacturer or processor fails to meet any duty related to a safety standard determination.	No comparable provision.
Failure by EPA to meet required deadline	No comparable provision.	If EPA fails to meet the deadline for a safety determination, proposed TSCA 6(d)(4)(C) provides that manufacturers and processors are required to notify EPA, the public, their employees, and customers in writing that a determination by EPA of the safety of the chemical is pending.	No comparable provision.
Redetermination	No comparable provision.	Proposed TSCA 6(d)(5)(E) requires EPA to initiate a redetermination of whether a chemical meets the safety standard if new information raises a question in that regard. Authorizes EPA to initiate a redetermination if significant changes have occurred in the methodologies used in conducting safety standard determinations. Requires that EPA continually assess new information to decide whether it raises a credible question about the safety of a chemical substance.	No comparable provision.
Petition for redetermination	No comparable provision.	Proposed TSCA 6(d)(5)(E) also authorizes any person to petition the EPA Administrator for a redetermination. The Administrator must decide whether to make the requested redetermination and publish that decision and its basis in the Federal Register within 180 days. If EPA decides to conduct a redetermination, it must be completed within three years of the decision.	No comparable provision.
Statement of reasons for not taking action	If EPA does not take action with respect to a chemical that is covered by a test rule [under TSCA 4(a)] or a significant new use rule [under TSCA 5(a)(1)(B)], or is listed as a chemical of concern under TSCA 5(b)(4), then TSCA 5(g) directs the EPA Administrator to publish a statement of reasons for not taking action.	This provision would be eliminated.	This provision would be eliminated.
Use restrictions for substances meeting the safety standard	No comparable provision.	For chemical substances and uses that meet the safety standard, proposed TSCA 6(d)(5)(D) requires the Administrator to specify allowed uses and to prescribe conditions of use to ensure the safety standard is met. Prohibits manufacture, processing, and distribution in commerce of the substance, mixture, or article containing the chemical substance for any use not specified in the safety determination. Compliance is required 90 days after the standard is issued if no new conditions are imposed on chemical use. The deadline for compliance is18 months after the safety determination is issued when new conditions are imposed. A manufacturer or processor may be granted a one-time extension of the deadline for a period of no more than five years if the manufacturer or processor demonstrates a compelling technological need to continue a restricted activity or that a factor wholly beyond the control of the manufacturer or processor prevents compliance within the 18-month time period.	No comparable provision.
Judicial review of rules	TSCA 19 [15 U.S.C. 2618] subjects rules promulgated under TSCA 6(a) to judicial review.	Proposed TSCA 19 subjects all rules and orders issued under TSCA to judicial review.	Proposed TSCA 6(b)(6) declares that safety assessments are not final agency actions and are not subject to judicial review. However, proposed TSCA 6(c)(11) makes a safety determination a final agency action subject to judicial review, including review of the associated safety assessment.
Expedited action for SVHCs	No comparable provision.	Within 180 days of categorization of a chemical as a Substance of Very High Concern, proposed TSCA 6(e) authorizes the Administrator to require, by order, submission of additional information as necessary to conduct an expedited assessment of the known uses of, and exposures to, the chemical substance. Within one year of such categorization, requires that EPA complete and publish an identification and assessment of the known uses of, and exposures to, the chemical substance. As soon as practicable, but no later than 18 months following categorization, the Administrator must impose, by order, use restrictions and other conditions, on the manufacturing, processing, use, distribution in commerce, and disposal of the chemical substance as needed "to achieve the maximum practicable reduction in human or environmental exposure." Compliance generally is required within 18 months of the issuance of the order restricting the chemical. Within one year of the compliance deadline, the Administrator is required to determine whether the substance meets the safety standard and to impose any additional restrictions necessary to ensure that the chemical substance meets the safety standard.	No comparable provision.
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.	Proposed TSCA 6(m) directs EPA to specify a date on which a rule or order shall take effect and that such date should be "as soon as practicable."	Eliminates this provision.
Quality control of manufacturing and processing	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.	Proposed TSCA 6(g) is similar to the current statute, 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.	Eliminates this provision.
Resale of used articles	No comparable provision.	Proposed TSCA 6(h)(3) provides that restrictions established under Sections 5(b)(1)(C)(ii)(I), 6(d)(5), 6(e), or 6(f) would not apply to resale of an article if the article has previously been used.	No comparable provision.
Delay of effective date of restrictions	No comparable provision.	Proposed TSCA 6(h)(4) authorizes EPA to order delay in the effective date of a restriction for three years for retail sales to an end consumer of a chemical substance, mixture, or article subject to a restriction under proposed TSCA Sections 5(b)(1)(C)(ii)(I), 6(d)(5), 6(e), or 6(f), if it "(i) is necessary and appropriate to allow for depletion of the existing retail inventory; and (ii) 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 proposed TSCA Section 8.	No comparable provision.
Certification of the quality of submitted information	No comparable provision.	Proposed TSCA 6(l) 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.	No comparable provision.
Mercury	TSCA Section 6(f) [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.	Proposed TSCA 6(j) is similar to the current statute, but exempts mercury contained within an article from the general prohibition.	Proposed TSCA 6(e) is the same as current TSCA 6(f).
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).	Proposed TSCA 6(i) is similar to existing TSCA 6(e), but removes the requirement for rulemaking under current TSCA 6(c).	Proposed TSCA 6(d) is similar to existing TSCA 6(e), but removes the requirement for rulemaking under current TSCA 6(c).
Asbestos	No comparable provision, although TSCA Title II addresses emergency response to asbestos hazards. TSCA 202(3) defines asbestos as "asbestiform varieties of—(A) chrysotile (serpentine), (B) crocidolite (riebeckite), (C) amosite (cummingtonite-grunerite), (D) anthophyllite, (E) tremolite, or (F) actinolite."	Proposed TSCA 6(k) requires the Administrator to designate asbestos a Substance of Very High Concern, to complete and publish a report within 90 days of categorization, and within 12 months to impose use restrictions and conditions to achieve the maximum practicable reduction in human or environmental exposure to asbestos. Section 7(b) of the SCA proposes an expanded definition for asbestos. Proposed TSCA 202(3) would include "(G) any material formally classified as tremolite, including—(i) winchire asbestos, and (ii) richterite asbestos, and (H) any asbestiform amphibole mineral."	No comparable provision, but the definition of asbestos in TSCA 202(3) is retained.
Imminent hazards
Relief	TSCA 7 [15 U.S.C. 2606] authorizes an appropriate district court to grant relief necessary to protect health or the environment from "unreasonable risk."	Section 8 of the SCA amends TSCA 7 but relief afforded is similar to the current statute. Proposed TSCA 7 would authorize the District Court to grant relief necessary to protect health or the environment from "the risk associated with the activity involved in the civil action."	Proposed TSCA 7 is the same as current TSCA 7.
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."	Proposed TSCA 7 is similar to the current statute, but authorizes EPA civil action against a person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance or mixture, or any article containing a chemical substance or mixture, when a chemical, mixture, or article "may present an imminent and substantial endangerment to health or the environment, as determined by the Administrator." Does not require EPA to commence action if the agency has not made a rule effective immediately concerning the chemical. Authorizes EPA to issue an order to protect health or the environment from a substance or mixture or article containing such substance or mixture that may present an imminent and substantial endangerment to health or the environment.	Proposed TSCA 7(a) is similar to the current statute, but does not require EPA to commence civil action if the agency has not made a rule under proposed TSCA 6(a) effective immediately. The proposed definition of an "imminently hazardous" chemical substance eliminates the adjective "unreasonable."

Source: Compiled by the Congressional Research Service from the U.S. Code, S. 696, and S. 1009.

Table 5. Reporting Requirements in Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)

Provision	TSCA, 15 U.S.C. 2601 et seq.	Safe Chemicals Act (S. 696)	Chemical Safety Improvement Act (S. 1009)
Definition of "known to, or reasonably ascertainable by"	No comparable provision.	The SCA Section 9 amends TSCA Section 8. Proposed TSCA 8(a)(1) defines "known to, or reasonably ascertainable by" to have the meaning contained in 40 CFR 704.3 (or successor regulations), which currently reads: "all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know."	No comparable provision.
Declaration	No comparable provision.	Proposed TSCA 8(b) requires each manufacturer of a chemical substance in which the manufacturer has a current commercial interest to submit within 180 days of the enactment of the Safe Chemicals Act a declaration of interest in the chemical substance. A processor of a chemical substance in which the processor has a current commercial interest also may submit a declaration voluntarily within one year following enactment of the SCA. A manufacturer or processor may voluntarily submit a declaration for a chemical substance in which there is potential commercial interest.	No comparable provision.
Scope and criteria for declarations	No comparable provision.	Proposed TSCA 8(b) applies only to chemical substances in commerce (as of the date of enactment of the SCA) in which a manufacturer or processor has a current commercial interest, or chemicals of potential commercial interest because they may serve as substitutes for chemicals of current interest.	No comparable provision.
Content of the declaration	No comparable provision.	Proposed TSCA 8(b)(5) requires the declaration to include: the chemical identity and substance characteristics; identity and primary business location of the manufacturer or processor; and information supporting the declaration of commercial interest.	No comparable provision.
Declaration of cessation of manufacturing or processing	No comparable provision.	Proposed TSCA 8(b)(4) authorizes a former or current manufacturer or processor to voluntarily submit a Declaration that manufacture or processing has ceased or will cease not later than 180 days after the date on which the declaration is submitted.	No comparable provision.
Reporting and record keeping	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. TSCA 8(a)(2) authorizes collection of "all existing data concerning the environmental and health effects," number of individuals exposed, and, in the initial report, the manner of disposal. 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.	Proposed TSCA 8(c) is similar to TSCA 8(a), but requires the Administrator to maintain a periodic reporting program for manufacturers of chemical substances. Authorizes exemptions. Proposed TSCA 8(d) requires each manufacturer and processor of a chemical substance distributed in commerce to maintain records of the information submitted to EPA as well as supporting information. Proposed TSCA 8(e) directs the Administrator to specify, by rule, information that chemical processors are required to record and submit periodically for each chemical processed for use and intentionally added to each consumer or commercial product category specified by the Administrator. Proposed TSCA 8(g) authorizes the Administrator, by rule or order, to require any person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance, or a mixture or article containing the chemical substance, to maintain records of, and report by a specified date, any existing information concerning the substance that would assist the Administrator in administering TSCA.	Proposed TSCA 8(a) is the same as the current statute, but the CSIA adds at the end two new paragraphs TSCA 8(a)(4) and (5), which direct the Administrator to promulgate rules requiring the reporting of information known by, or reasonably ascertainable by the manufacturer or processor making the report sufficient to permit EPA to carry out proposed TSCA 4 and 6. Proposed TSCA 8(a)(4) provides that the rules: may impose different reporting requirements on manufacturers and processors; shall be limited to active substances or mixtures containing active substances; and shall apply only to the extent the Administrator determines submission is necessary for the effective enforcement of proposed TSCA. Directs EPA to develop guidance relating to the information required. Proposed TSCA 8(d) is the same as the current statute.
Exemptions	TSCA 8(a)(1) exempts small manufacturers and processors from most reporting under the subsection, but TSCA 8(a)(3) authorizes EPA to require a small manufacturer or processor to submit needed information for the purpose of developing the inventory under TSCA 8(b). In addition, the Administrator is authorized to require reporting by small entities when they manufacture or process a chemical substance or mixture subject to a rule proposed or promulgated under TSCA 4, 5(b)(4), or 6, or an order in effect under Section 5(e), or with respect to which relief has been granted pursuant to a civil action brought under Section 5 or 7. TSCA 8(b)(1) excludes from the inventory "any chemical substance which is manufactured or processed only in small quantities (as defined by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including such research or analysis for the development of a product."	Proposed TSCA 8(c)(2)(B) authorizes EPA to promulgate a rule or order exempting from specified reporting requirements certain manufacturers involved in activities with small quantities of a chemical substance for purposes of scientific experimentation or analysis or chemical research, including product development. Also authorizes exemptions for small businesses if EPA determines that their participation would not assist in the administration of TSCA.	Proposed TSCA 8(a)(1) and (3) and 8(b)(1) are the same as the current statute.^a
Inventory of chemicals in commerce	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.	Proposed TSCA 8(h) requires development and publication of two inventories, one for active and the other for inactive chemicals. The proposed legislation omits the authority in the current statute to list chemicals by category rather than individually.	Proposed TSCA 8(b)(1) and (2) are the same as the current statute, but new paragraphs (3) through (8) are added. Proposed TSCA 8(b)(3) provides directives regarding the use of Class 2 nomenclature and the Soap and Detergent Association Nomenclature System, and treatment of specified "components of categories that are considered to be statutory mixtures" under TSCA. Also directs EPA to maintain nomenclature conventions and develop new guidance allowing for multiple nomenclature conventions.
Development of an inventory of active chemicals in commerce	No comparable provision.	Proposed TSCA 8(h) is similar to TSCA 8(b) except that it includes all chemicals for which notice is submitted under proposed TSCA 5(d) and for which a declaration of current commercial interest or manufacture or processing is submitted under proposed TSCA 8(b)(2). The proposed legislation omits the authority in the current statute to list chemicals by category rather than individually. Proposed TSCA 8(b)(6) directs the Administrator to review each declaration and to add to the inventory of active substances created under proposed TSCA 8(h) each chemical substance in which current interest is declared, and to remove from the inventory any chemical for which EPA received no declaration or only declarations of cessation of manufacturing or processing.	Proposed TSCA 8(b)(4) directs EPA to develop and make publically available a list of candidate active chemical substances to include any chemical substance that has been reported to EPA under 40 CFR 711 (which contains the TSCA chemical data reporting requirements) at any time during the 10 years prior to enactment of the CSIA; has been the subject of a submitted notice of commencement of manufacture or significant new use; has been the subject of an export notification during the 10 years before the date of enactment of the CSIA; or the Administrator is likely to qualify as active. Proposed TSCA 8(b)(4) directs EPA to issue a rule requiring manufacturers and processors to notify EPA that they have manufactured or processed a chemical substance on the candidate list compiled by the Administrator under proposed TSCA 8(b)(4) or on the current inventory list compiled in response to current TSCA 8(b)(1) for a nonexempt commercial purpose during the 5-year period prior to the date of enactment of the CSIA. Proposed TSCA 8(b)(5) directs the Administrator to designate each chemical substance on the proposed TSCA 8(b)(1) inventory as active or inactive. Designations must be updated as soon as practicable following publication of the most recent information reported under 40 CFR 711.
Confidential chemical substances	No comparable provision.	No comparable provision.	Proposed TSCA 8(b)(4) also directs EPA to provide public "guidance relating to the rule for chemical substances on the confidential portion of the candidate list of active substances" and of the current inventory list compiled in response to TSCA 8(b)(1). Guidance is required with regard to accession numbers, premanufacture notice case numbers, if applicable, and generic names. The rule must require a manufacturer or processor to indicate whether the specific identity of the substances is claimed to be confidential, to certify the accuracy of each report, and to retain a record supporting certification for five years.
Active chemicals	No comparable provision.	Proposed TSCA 8(h) requires the Administrator to list as active chemical substances for which notice of commencement of manufacture is submitted under proposed TSCA 5(d) or for which a valid declaration is submitted under proposed TSCA 8(b)(2).	Proposed TSCA 8(b)(6) directs the Administrator to designate a chemical substance "active" if it: has been manufactured or processed for a nonexempt commercial purpose at any point during the 5-year period prior to the date of enactment of the CSIA; is added to the TSCA 8(b)(1) inventory after enactment of the CSIA; is the subject of a notice received that a person intends to manufacture or process a chemical designated as inactive; or is reported under 40 CFR 711 after the date of enactment of the CSIA.
Inventory of inactive chemicals	No comparable provision.	Proposed TSCA 8(h)(5) directs EPA to compile, keep current, and publish an inactive list of chemical substances for which the only declarations submitted are for chemicals of potential commercial interest. If a manufacturer or processor plans to begin manufacture or processing of a chemical substance on this list, at least 30 days prior to beginning, notice must be provided to the Administrator along with specified information. EPA must move such substances onto the inventory of active chemicals, add the substance to the current batch of chemical substances, and categorize the substance.	Proposed TSCA 8(b)(7) directs the Administrator to designate a chemical substance inactive if it has not been manufactured for processed for a nonexempt commercial purpose in the 5-year period before enactment of the CSIA. Such chemical substances remain on the TSCA 8(b)(1) inventory. Directs any person who intends to manufacture or process for a nonexempt commercial purpose a chemical substance designated as an inactive substance to notify EPA before the date on which the substance is manufactured or processed. The Administrator must then designate the chemical substance as active and review its priority for a safety assessment.
Chemical specific identity disclosure	No comparable provision.	No comparable provision.	Proposed TSCA 8(b)(8) directs the Administrator to make available to the public specified information about chemicals on the non-confidential portion of the TSCA 8(b)(1) inventory; the accession number, generic name, and, if applicable, premanufacture notice case number for each chemical substance on the confidential portion of the TSCA (8)(b)(1) inventory for which a claim of confidentiality was received; and the specific identity of any active or inactive substance on the confidential portion of the TSCA 8(b)(1) inventory for which no claim of confidentiality was received, after publishing a notice in the Federal Register identifying the accession number, generic name, and, if applicable, premanufacture notice case number for the substance and providing an opportunity for any person to claim confidentiality for the specific identity of the substance. Prohibits the Administrator from making available to the general public the specific chemical identity of any substance for which EPA receives such notice of intent to manufacture or process and a claim for confidentiality.
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 or mixture.	Proposed TSCA 8(j) is similar to current TSCA 8(c).	Proposed TSCA 8(c) is the same as the current statute.
Information from other federal agencies	No comparable provision.	Proposed TSCA 8(k) 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 three 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 or article containing that chemical substance).	No comparable provision.
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.	Proposed TSCA 8(l) is the same as current TSCA 8(e).	Proposed TSCA 8(e) is the same as the current statute, but adds paragraph (2) providing that any person may submit data and information reasonably supporting the conclusion that a chemical substance or mixture does not present a substantial risk of injury to health and the environment.
Certification	No comparable provision.	Proposed TSCA 8(m) 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.	Proposed TSCA 8(b)(4) directs EPA to issue a rule requiring manufacturers and processors to notify EPA that they have manufactured or processed a chemical substance on the candidate list. The rule must require a manufacturer or processor to certify the accuracy of each report, and to retain a record supporting certification for five years.
"Manufacture" and "process"	TSCA 8(f) [15 U.S.C. 2607(f)] defines "manufacture" and "process" to mean manufacture or process for commercial purposes.	Proposed TSCA 8(a) is the same as current TSCA 8(f).	Proposed TSCA 8(f) is the same as the current statute.
Additional authority to enforce	No comparable provision.	EPA may by order prohibit manufacture, processing, or distribution of any substance if a manufacturer or processor violates EPA requirements under proposed TSCA 8(n).	No comparable provision.

Source: Compiled by the Congressional Research Service from the U.S. Code, S. 696, and S. 1009.

a. However, current TSCA 8(a)(3) refers to other sections that are proposed to be amended or omitted by the CSIA. For example, there is no proposed TSCA 5(b)(4) in the CSIA. This may be a drafting oversight.

Table 6. Other Selected Provisions of TSCA (15 U.S.C. 2601 et seq.), the Safe Chemicals Act (S. 696), and the Chemical Safety Improvement Act (S. 1009)

Provision	TSCA, 15 U.S.C. 2601 et seq.	Safe Chemicals Act (S. 696)	Chemical Safety Improvement Act (S. 1009)
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.	The SCA Section 10 amends TSCA 9. Proposed TSCA 9(a) is similar to the current statute, but does not apply to mixtures and the criterion for EPA action differs. If the EPA Administrator determines "that the manufacture, processing, distribution in commerce, use, or disposal of a chemical … does not meet a 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 whether action may be taken under a federal 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 civil action under federal law within 90 days, EPA may not take action under proposed TSCA with respect to the civil 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 a safety standard.	Proposed TSCA 9(a) is similar to the current statute, but requires EPA to conclude that chemical activity "does not meet the safety standard under the intended conditions of use." If EPA makes a report and the other federal 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 require development of additional data to permit a safety determination under proposed TSCA 6(c)(8), and may not restrict chemical activity under proposed TSCA 6(c)(9) or proposed TSCA 7.
Regulation under other EPA-administered federal laws	TSCA 9(b) directs EPA to promulgate needed rules under other environmental laws, unless it is in the public interest to issue rules under TSCA. This directive is repeated in TSCA 6(c)(1).	Proposed TSCA 9(b) is the same as the current statute. However, the SCA eliminates the provision in TSCA 6(c)(1).	Proposed TSCA 9(b) is the same as the current statute, but the CSIA eliminates the provision in current TSCA 6(c)(1).
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 the current statute. In addition, the SCA directs EPA to ensure that any EPA actions to address workplace exposures "are consistent with the industrial hygiene hierarchy of controls."	Proposed TSCA 9(c) is the same as the current statute.
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.	The Safe Chemicals Act Section 10(3) strikes the requirement that coordination for the purpose of enforcement should impose the least burden of duplicative requirements.	Proposed TSCA 9(d) is the same as the current statute.
Inspections	TSCA 11 [15 U.S.C. 2610] authorizes EPA to inspect premises in which chemicals are manufactured, processed, stored, or held before or after distribution in commerce and any conveyance used to transport chemicals in commerce. Limits inspections by requiring presentation of appropriate credentials and written notice to the person in charge of the premises or conveyance to be inspected on each occasion of inspection. Requires inspections to begin and end with reasonable promptness and to "be conducted at reasonable times, within reasonable limits, and in a reasonable manner." Prohibits inspection of financial, sales, pricing, personnel, or research data, unless they are described specifically in the required written notice.	The SCA 11 amends TSCA 11. Proposed TSCA 11(a) and (b) are similar to current TSCA 11 but also apply to premises and conveyances handling articles subject to TSCA. Inspections are not limited by requiring presentation of credentials or provision of written notice. Authorizes EPA to inspect any place where records relating to compliance with the law are held and to inspect and obtain samples of any chemicals, containers, or labeling. Does not prohibit inspection of any data.	Proposed TSCA 11 is the same as the current statute.
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.	Proposed TSCA 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 believe that the provisions" of the law have been violated, proposed TSCA 11(d) empowers EPA to obtain and to execute warrants authorizing entry, inspection, and copying of records, or seizures of any chemical in violation.	Proposed TSCA 11 is the same as the current statute.
Exports
Exclusion from requirements	TSCA 12(a)(1) [15 U.S.C. 2611(a)(1)] excludes chemical products manufactured for export (other than elemental mercury) from TSCA requirements except for reporting and record keeping requirements in Section 8. This exclusion applies as long as the products are labeled for export only. TSCA 12(a)(2) excepts from this provision chemicals manufactured for export if the Administrator finds that manufacture, processing, or distribution will present an unreasonable risk within the United States. EPA may require testing to allow assessment of the risk within the United States.	The SCA 12 would eliminate TSCA 12(a) which provides an exclusion from TSCA requirements for chemicals manufactured, processed, or distributed in commerce solely for the purpose of export.	Proposed TSCA 12(a)(1) is the same as the current statute, but proposed TSCA 12(a)(2) does not exclude from TSCA requirements those chemicals manufactured for export if they are new chemicals unlikely to meet the safety standard or existing chemicals that do not meet the safety standard. Authorizes EPA to determine that export also is not permitted for articles and mixtures containing such chemicals above a threshold concentration.
Notice of export	TSCA 12(b) [15 U.S.C. 2611(b)] requires anyone who exports or intends to export a substance that is subject to a test rule or order under Section 4 or a proposed or final rule under Section 5 or 6, or for which action is pending or relief has been granted under Section 5 or 7, to notify EPA of such exportation or intent, and EPA must then notify the countries that will be receiving the substance that data are available or that restrictions are in place in the United States for such substance.	Proposed TSCA 12(a) is similar to current TSCA 12(b), but excludes from requirements those who "intend" to export, and applies to exports of chemicals subject to data submission requirements under proposed TSCA 4, 5, or 6(b), or for which action has been taken under proposed TSCA 6 or 7. Also, the SCA would specify that exporters must notify EPA within 30 days of the date of export, and that EPA must provide notice to countries "promptly thereafter." Requires exporters to notify EPA, and EPA to notify receiving countries, of any change in the status of a chemical. EPA also must notify receiving countries that it has received new data or if there is any change in risk management action taken under proposed Section 6 or 7. Requires EPA to maintain copies of current notices provided to other governments and to make them available to the public electronically.	Proposed TSCA 12(b) requires any person to notify EPA if that person is exporting or intends to export: a new chemical substance or mixture not likely to meet the safety standard under the intended conditions of use; an existing chemical substance or mixture that does not meet the safety standard under the intended conditions of use; or a chemical substance for which the United States is obligated by treaty to provide export notification. Requires the Administrator to promulgate regulations to implement these provisions. Requires the Administrator to submit to the government of each country to which a substance is exported a notice that information can be obtained from EPA about the substance. Requires EPA to provide notice that satisfies the obligation of the United States under the applicable treaty if the chemical substance is covered by treaty.
Mercury	TSCA 12(c) [15 U.S.C. 2611(c)] prohibits the export of elemental mercury (but not of coal containing mercury). Requires a report to Congress on mercury compounds. Authorizes exemptions from this prohibition for essential uses.	Proposed TSCA 12(b) is the same as the current statute, but adds a requirement that EPA maintain copies of all current notices provided to other governments and make such copies available to the public in electronic format.	Proposed TSCA 12(c) is the same as the current statute, but excludes the requirement for a report to Congress on mercury compounds.
Imports	TSCA 13 [15 U.S.C. 2612] directs the Secretary of the Treasury to refuse entry into the United States of chemicals that fail to comply with a rule under TSCA or that are in violation of TSCA.	Proposed TSCA 13 is similar to the current statute, but transfers authority to the Secretary of the Department of Homeland Security. In addition, a new paragraph (3) in proposed TSCA 13(a) explicitly subjects to TSCA requirements chemical substances and mixtures imported as part of an article, except "as the Administrator may provide by rule under this Act, or as the Secretary of Homeland Security may provide by rule."	Proposed TSCA 13 is similar to the current statute, but authorizes the Secretary of Homeland Security to refuse entry into the United States of chemicals that do not meet the safety standard under the intended conditions of use or that are in violation of a rule or order in effect under proposed TSCA. In addition, proposed TSCA 13(c) requires a person offering a chemical substance or mixture for entry into the United States to certify that the chemical is in compliance with any applicable rule, consent agreement, or order under proposed TSCA 5 or 6 and included on the list under Section 8(b) or exempt from the inventory requirements. Such person also is required to notify the Secretary of Homeland Security if the chemical is a high-priority substance, a chemical for which the United States is obligated to provide export notification by treaty, or has been found not to meet the safety standard and is identified in a rule promulgated as meriting notification due to the potential impact of the chemical substance or mixture or article on human health or the environment. Requires the Secretary of Homeland Security to issue rules implementing proposed TSCA 13(c).
Protection from disclosure of confidential business information (CBI)	TSCA 14 [15 U.S.C. 2613] provides broad protection of proprietary confidential information about chemicals in commerce. Disclosure by EPA employees of such information generally is not permitted, except to other federal employees or when relevant in any proceeding under TSCA. Disclosure of information is required when "necessary to protect health or the environment against an unreasonable risk of injury to health or the environment." Manufacturers, processors, or distributors in commerce may designate data that they believe is entitled to confidential treatment. If EPA proposes to release such data the EPA Administrator must notify the manufacturer, processor, or distributor who designated the data.	Proposed TSCA 14 requires conformance to the standards of the Freedom of Information Act (FOIA). Like the current statute, the SCA prohibits disclosure of proprietary confidential information by EPA employees except to other federal agencies and EPA contractors or if the disclosure is necessary to protect human health or the environment (the qualifier "against an unreasonable risk" is omitted). Proposed TSCA 14 also directs EPA to disclose information upon request to a state or tribal government for the purpose of administration or enforcement of a law, if an agreement ensures that the recipient government will take appropriate steps to maintain the confidentiality of the information with procedures equivalent to those used by EPA. EPA also is directed to disclose information to public health or environmental health professionals or medical personnel if disclosure is in the public interest, the recipient does not have a conflict of interest, and agreements are in place to ensure comparable protections to those provided by EPA to maintain confidentiality. Proposed TSCA 14(b) categorizes and specifies types of CBI as (1) information always eligible for protection, (2) information that may be eligible for protection, and (3) information never eligible for protection.	Proposed TSCA 14 is similar to the current statute, but is clarified and explicitly requires persons to substantiate any claim that information qualifies for disclosure protection.^a Proposed TSCA 14(a) prohibits the Administrator from disclosing information exempt from disclosure under 5 U.S.C. 552(b)(4), as well as information specifically defined as presumed to be protected. Also identifies information not protected from disclosure, including: identity of a chemical unless the person meets substantiation requirements of proposed TSCA 14(d); specified health and safety information and determinations; and certain general information. Proposed TSCA 14(d) requires the submitter to justify why information qualifies for protection, and to certify that the information submitted is true and correct. In addition, CBI claims related to chemical identity require submitter to provide specified information demonstrating that confidentiality of the identity has been and is likely to be protected, and disclosure is likely to cause substantial harm to the competitive position of the person. In such cases, submitter must identify a time period for which disclosure protection is necessary and a generic name for the chemical.
Protection from disclosure of information (cont.)		Directs EPA to promulgate rules specifying acceptable bases on which written requests to maintain confidentiality may be approved, documentation and justification that must accompany such a request, and types of information that warrant protection for an indefinite period of time. The Administrator is required to review and respond to requests for confidentiality within 90 days of receiving the information. Requires those designating data as confidential to justify such claims and to certify that the information is not otherwise publicly available. If approved, submitted information will be protected from disclosure for up to five years.	As in the current statute, the proposed requirements do not apply if the Administrator determines that disclosure is necessary to protect human health or the environment (the qualifier "against an unreasonable risk" is omitted) nor to disclosure of information to an officer, employee, contractor or employees of that contractor of the United States. Information also may be disclosed to a state or political subdivision of a state, or to a health professional under specified circumstances. Information may be disclosed when necessary in a proceeding under proposed TSCA or to any duly authorized committee of the Congress. Requires the Administrator to protect from disclosure information for the period of time requested by the person submitting and justifying the claim, or for such period of time as the Administrator determines to be reasonable. Authorizes the Administrator to request redocumentation of a claim. Dictates process for receiving and acting on claims for protection from disclosure. Details process and recourse in the event the Administrator decides to release such data. Ensures that EPA may not require substantiation of a claim for protection from disclosure of information submitted to EPA prior to the date of enactment of the CSIA or to require more substantiation than proposed TSCA 14 requires.
Penalties for disclosure and inappropriate designation	TSCA 14(d) provides that knowing and willful disclosure of protected information by a federal employee may result in a fine of up to $5,000 or imprisonment for up to one year, or both.	Proposed TSCA 14(d) is similar to current TSCA 14(d), but willful disclosure may subject an employee to disciplinary action and a monetary penalty of up to $10,000, but not imprisonment. Knowing designation of information as eligible for confidential treatment when it is in fact ineligible also is subject to a monetary penalty of up to $10,000.	Penalties for unlawful disclosure include fines under title 18 of the U.S. Code, and removal from office or employment. Other penalties are similar to the current statute.
Risk information for workers	No comparable provision.	Proposed TSCA 14(f) requires EPA to facilitate sharing of information about chemical substances or mixtures or articles that workers may be exposed to with those workers and representatives of each certified or recognized bargaining agent.	No comparable provision.
Prohibited Acts	TSCA 15 [15 U.S.C. 2614] prohibits any person from failing or refusing to comply with rules, orders, or other requirements of TSCA, using for commercial purposes a chemical substance or mixture that was known to be manufactured, processed, or distributed in commerce in violation of the law, failing or refusing to establish and maintain records, submit reports, notices, or other information, or to permit access to or copying of records, or failing or refusing to permit entry or inspection.	Proposed TSCA 15 is similar to the current statute and prohibits all the same actions, but also prohibits manufacturing, processing, distributing in commerce, or disposing of a chemical or article or using an article that was known to have been manufactured, processed, or distributed in commerce in violation of the law. Proposed TSCA 15 also prohibits failing or refusing to establish and maintain "accurate and complete" records, reports, notices, information, disclosures, declarations, certifications, or other information. Prohibits submitting information "that is materially false" or falsifying or concealing "any material fact." Prohibits taking any action prohibited by proposed TSCA.	Proposed TSCA 15 is similar to the current statute, but also prohibits failure or refusal to comply with consent agreements or orders.
Penalties	TSCA 16 [15 U.S.C. 2615] authorizes civil penalties, not to exceed $25,000 per violation per day, and affords the defendant an opportunity to request a hearing before an order is issued and to petition for judicial review of an order after it is issued with the U.S. Court of Appeals for the District of Columbia Circuit or for any other circuit in which the person resides or transacts business. Criminal penalties of up to $25,000 per day of violation or up to one year of imprisonment, or both, also are authorized for knowing or willful violations.	Proposed TSCA 16 increases the maximum civil penalty per violation per day to $37,500 and authorizes EPA to commence a civil action in an appropriate U.S. District Court to assess penalties. Changes the court in which a person may file a petition for judicial review to the District Court for the district in which the person resides or transacts business. Removes criminal sanctions for "willfully" violating any provision of TSCA, as proposed, but increases the maximum penalty for "knowing" violations to $50,000 per day or up to five years of imprisonment, or both. Adds a fine of up to $250,000 or imprisonment of up to 15 years, or both for a knowing violation that places a person in imminent danger of death or serious bodily injury. A person who is not an individual is subject to a fine of not more than $1,000,000.	Proposed TSCA 16 is the same as the current statute.
Seizure	TSCA 17 [15 U.S.C. 2616] makes substances produced in violation of Title IV (Lead Exposure Reduction) liable to be proceeded against, by process of libel, for seizure and condemnation in any district where the substance is found.	Proposed TSCA 17 is similar to the current statute, but the SCA applies to "articles" rather than "products" and to any articles, substances, or mixtures that are subject to any title of TSCA.	Proposed TSCA 17 is the same as the current statute.
Enforcement	TSCA 17 [15 U.S.C. 2616] provides jurisdiction to district courts over civil actions to restrain any violation or any person from taking any action prohibited, to compel the taking of any action required, or to direct any manufacturer or processor in violation of Section 5 or 6 or of Title IV (or a rule or order under those provisions): to give notice to distributors and to others in possession of the substance, to give public notice of risk, and to replace or repurchase the substance. Authorizes civil actions brought in the U.S. district court for the judicial district wherein any violation occurred or where the defendant is found or transacts business.	Proposed TSCA 17 authorizes the EPA Administrator to commence a civil action in the appropriate district court to compel compliance of any person with any provision of TSCA or any rule or order promulgated pursuant to TSCA. Authorizes EPA to seek civil or criminal penalties, enjoin any violation, or order compliance, through an administrative proceeding, with any provision of TSCA or with any rule or order issued under it. Provides district courts jurisdiction for civil actions to seek penalties or enjoin violations in the U.S. District Court for the district wherein any violation occurred or where the defendant is found or transacts business. Provides jurisdiction for civil actions ordering compliance to the U.S. District Court for the judicial district where the defendant is found or transacts business.	Proposed TSCA 17 is the same as the current statute.
Preemption of state law	TSCA 18 [15 U.S.C. 2617] does not preempt new and existing state laws, with two exceptions: (1) when EPA requires testing of a chemical under Section 4, no state may require testing of the same substance for similar purposes; and (2) if EPA prescribes a rule or order under Section 5 or 6 to protect against a risk, no state or political subdivision may have a requirement for such substance to protect against such risk unless it is identical to the EPA requirement, is adopted under authority of the Clean Air Act or another federal law, or prohibits the use of such substance in such state or political subdivision (other than use in manufacture or processing of other substances or mixtures).	Proposed TSCA 18 does not preempt laws of states or political subdivisions relating to a chemical substance, mixture, or article unless compliance with both the law of the state or political subdivision and federal law is impossible.	Proposed TSCA 18 is similar to the current statute. It preempts new and existing state laws that (1) require testing or information "reasonably likely to produce the same data and information required" by rule, consent agreement, or order under proposed TSCA 4, 5, or 6; (2) prohibit or restrict the manufacturing, processing, distribution in commerce, or use of a chemical after issuance of a completed safety determination under proposed TSCA 6; or (3) require notification for a significant new use of a chemical if EPA requires notification under proposed TSCA 5. Proposed TSCA 18 also preempts new state prohibitions or restrictions for any high-priority and low-priority substance. Exceptions to general preemption include: laws adopted under the authority of any other federal law; implementing a reporting or information collection requirement not redundant of federal law; adopted pursuant to state authority related to water quality air quality, or waste treatment or disposal as long as it does not impose a restriction on the manufacture, processing, distribution in commerce, or use of a chemical and is not redundant or inconsistent with an EPA action under proposed TSCA 5 or 6.
Exemption from state or local law preemption	TSCA 18 [15 U.S.C. 2617] authorizes EPA, upon application by a state or political subdivision, by rule to exempt a law in effect in the state or political subdivision, if compliance with the requirement would not cause activities involving the substance to be in violation of the EPA requirement, and the requirement of the state or political subdivision provides a significantly higher degree of protection from the risk than the federal requirement does and does not "unduly burden interstate commerce."	No comparable provision. (Since state laws are not preempted, there is no need for an exemption.)	Proposed TSCA 18(d) authorizes application by a state or political subdivision for an exemption from preemption for any state or local requirement (other than a new prohibition or restriction on a low-priority substance) that relates to the effects or exposure to a chemical substance under the intended conditions of use. Requires various state and EPA determinations and certifications, subjects applications to public notice and comment, and subjects the Administrator's decision to judicial review.
Legal evidence	No comparable provision.	No comparable provision.	Proposed TSCA 18(e) makes a safety determination admissible as evidence in any public or private action in any court of the United States or state court for recovery of damages or for equitable relief relating to injury to human health or the environment from exposure to a chemical substance.
Judicial review of restrictions and other rules	TSCA 19 [15 U.S.C. 2816] authorizes any person to file a petition with the U.S. Court of Appeals for the District of Columbia Circuit or for the circuit in which such person resides or in which the person's principal place of business is located, for judicial review of rules promulgated under TSCA Section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8 or Title II or Title IV within 60 days of issuance. The appropriate district court is directed to set aside rules promulgated under TSCA 4(a), 5(b)(4), 6(a), or 6(e) if they are not supported by "substantial evidence in the rulemaking record … taken as a whole," which is defined in TSCA 19(a)(3).	Similar to the current statute, but TSCA 19, as proposed, authorizes filing a petition for judicial review of any rule or order issued under TSCA, as proposed, rather than only specified rules, and would eliminate the directive in the current statute to the court (to set aside a rule not supported by substantial evidence in the rulemaking record taken as a whole).	Proposed TSCA 19 is similar to the current statute, but authorizes filing a petition for judicial review of a rule (not an order) under proposed TSCA 4(f), 6(c), 6(e), or 8. Judicial review is not authorized for significant new use determinations under proposed TSCA 5(a)(2), rules regarding PCBs under proposed TSCA 6(d), or rules regarding asbestos or lead-based paint under Titles II and IV, respectively. However, judicial review would be authorized for rules regarding elemental mercury under proposed TSCA 6(e). Would retain the standard of evidence for rules promulgated under proposed TSCA 4(f), 6(c) or 6(e), but would define "evidence" to mean any matter in the rulemaking record and prohibit review of the contents and adequacy of the statement of basis and purpose except as part of the rulemaking record as a whole.
Citizen suits	TSCA 20 [15 U.S.C. 2619] authorizes civil suits by any person against any person in violation of TSCA or rules or orders promulgated under specified sections of TSCA. It also authorizes suits against EPA to compel performance of nondiscretionary actions under TSCA.	Proposed TSCA 20 is similar to the current statute, but authorizes suits against any person in violation of rules or orders promulgated under any provision of TSCA, as proposed.	Proposed TSCA 20 is the same as the current statute.
Citizen petitions	TSCA 21 [15 U.S.C. 2620] provides the public with the right to petition EPA to initiate rulemaking or repeal of specified rules. Requires the EPA Administrator to grant or deny the petition within 90 days of its filing.	The SCA 21 amends TSCA 21. Proposed TSCA 21 is similar to the current statute, but authorizes petitions for EPA to initiate any action authorized under the law.	Proposed TSCA 21 is similar to the current statute, but places different requirements on petitioners, depending on the rule or order that is the subject of the petition.
Employment effects	TSCA 24 [15 U.S.C. 2623] directs the EPA Administrator to continually evaluate the potential effects of specified rules, orders, and requirements under specified TSCA provisions on employment.	The SCA 22 amends TSCA 24. Proposed TSCA 24 is similar to the current statute, but directs the EPA Administrator to evaluate potential effects of the law as a whole, rather than specific provisions, and reporting is to be "periodic," rather than continual.	Proposed TSCA 24 is the same as the current statute.
Administration and fees	TSCA 26(a) [15 U.S.C. 2625(a)] authorizes federal agencies, upon request from EPA, to provide services, personnel, facilities, and information to EPA to assist in implementation of TSCA. TSCA 26(b) [15 U.S.C. 2625(b)] authorizes EPA to collect fees from persons required to submit data under Section 4 or 5 to defray the cost to EPA of administering the Act. Such fees may not exceed $2,500, or in the case of a small business $100. TSCA 26(c) [15 U.S.C. 2625(c)] authorizes EPA to impose regulatory controls on categories of chemicals, rather than on a case-by-case basis. Prohibits regulation of a group based solely on the fact that it consists of new chemical substances. TSCA 26(d) [15 U.S.C. 2625(d)] directs EPA to establish an office to assist the regulated community. TSCA 26(e) [15 U.S.C. 2625(e)] requires that EPA establish a procedure to ensure disclosure of financial interests in the regulated community by EPA employees. TSCA 26(f) [15 U.S.C. 2625(f)] provides that final orders issued under TSCA must contain a statement of basis and purpose. TSCA 26(g) [15 U.S.C. 2625(g)] requires appointment of an Assistant Administrator for Toxic Substances.	The SCA 23 amends TSCA 26. Proposed TSCA 26, as amended, is similar to the current statute, except for proposed subsections (b) and (c) and a new subsection (h). Proposed TSCA 26(b) authorizes collection of fees from any data submitter (not just those submitting under Section 4 or 5) to defray the cost of administering TSCA. It removes the restrictions in the original TSCA 26(b) on the amount of such fees. Proposed TSCA 26(c) also authorizes the EPA Administrator to take an action with respect to a mixture if such action is authorized or required under any provision of the Act with respect to a chemical substance, if the Administrator determines it is "reasonable and efficient" to do so. New TSCA 26(h) authorizes the EPA Administrator to issue orders and prescribe regulations as necessary to carry out the law.	Proposed TSCA 26 is the same as the current statute. However, with regard to categories authorized by both current and proposed TSCA 26(c), proposed TSCA 8(b)(7)(D) states that inactive chemical substances may not be considered a category subject to EPA actions.
State programs	TSCA 28 [15 U.S.C. 2627] authorizes grants to states to establish and operate programs to prevent or eliminate unreasonable risks to health or the environment which EPA is unable or is not likely to address under TSCA.	The SCA 24 amends TSCA 28. Proposed TSCA 28 is similar to the current statute, but grants are authorized to prevent or eliminate any risks that EPA has not addressed. In addition, EPA is directed to establish a process to coordinate with the states "to share data and priorities relating to the management of chemical substances" under TSCA, as proposed, and under state programs.	Proposed TSCA 28 is similar to the current statute, but a reporting requirement and authorization for appropriations for grants are eliminated.
Authorization of appropriations	TSCA 29 authorizes appropriations for 1982 and 1983.	The SCA 25 proposes to redesignate TSCA 29 as TSCA 38 and to authorize such sums as may be necessary to carry out the Act for the fiscal years 2013 through 2020.	This provision is eliminated.
Children's environmental health research	No comparable provision.	The SCA 26 adds new Sections 29 through 36. Proposed TSCA 29(a) would establish a Children's Environmental Health Research Program at EPA and authorize the EPA Administrator to enter into contracts and make grants to conduct research that will "further understanding of the vulnerability of children to chemical substances and mixtures." Proposed TSCA 29(b) establishes an Interagency Science Advisory Board on Children's Health Research and makes it subject to the Administrative Procedure Act and Chapter 7 of Title 5 of the U.S. Code, which pertains to judicial review. The purpose of the Board is to provide independent advice upon request of the EPA Administrator or Congress relating to the implementation of the proposed TSCA "with respect to protecting children's health and research." The committee members would include representatives of the National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, the National Toxicology Program, the National Cancer Institute, the National Tribal Science Council, and not fewer than 3 centers of children's health at leading institutions of higher education.	No comparable provision.
Monitoring exposures	No comparable provision.	New TSCA 29(c) would direct EPA to coordinate with the Secretary of Health and Human Services (HHS) to conduct a biomonitoring study to determine the presence of a chemical in human biological media in pregnant women and infants, if research has indicated that it may be present and may have adverse effects on development. Study results must be published. If the study finds that the chemical is present in human biological media, manufacturers and processors must disclose to EPA, commercial customers, consumers, and the public all known uses of the chemical and all articles in which the chemical is expected to be present.	No comparable provision.
Animal-based testing	No comparable provision.^b	New TSCA 30 would direct the EPA Administrator to minimize the use of animals in testing of chemical substances or mixtures. Establishes an Interagency Science Advisory Board on Alternative Testing Methods subject to Title 5, Chapter 5, Subchapter 11 and Chapter 7. The Board is directed to provide independent advice and peer review to the EPA Administrator and Congress and to publish a list of testing methods that reduce the use of animals in testing under proposed TSCA 4. Directs the EPA Administrator in consultation with the Board to develop a strategic plan, biennially report to Congress on progress in implementing this section, and fund and carry out research, development, performance assessment, and translational studies to accelerate the development of test methods and strategies for use in safety standard determinations under proposed TSCA 6(b). Authorizes the EPA Administrator, on request of a manufacturer or processor, to adapt or waive animal-based testing of a chemical substance or mixture under specific conditions.	Proposed TSCA 4(i) directs the Administrator to minimize the use of animals in testing of chemical substances or mixtures through various means. Requires the Administrator to promote development and timely incorporation of new testing methods that are not laboratory animal-based. Authorizes the Administrator to adapt or waive animal-testing requirements on request from a manufacturer or processor under specified circumstances.
Safer alternatives	No comparable provision.^c	New TSCA 31(a) would establish a program to create market incentives for the development of safer alternatives to existing chemical substances that reduce or avoid the use and generation of hazardous substances. Requires that the program include expedited review of new chemical substances for which an alternatives analysis indicates it is a safer alternative, and recognition for a substance or product determined by EPA to be a safer alternative.	No comparable provision.
Green chemistry and green engineering	No comparable provision.^c	New TSCA 31(b) would direct the EPA Administrator to establish a network of at least four green chemistry and engineering centers in various U.S. regions. New TSCA 31(c) would direct EPA to make grants to promote and support research, development, and adoption of safer alternatives. New TSCA 31(d) would create a program to facilitate the development of a workforce that produces safer alternatives to existing chemical substances.	No comparable provision.
International cooperation	No comparable provision.	New TSCA 32 would direct the EPA Administrator to cooperate with the Secretary of State and the head of any other appropriate federal agency "with international efforts as appropriate" to develop a common protocol or electronic database relating to chemical substances or to develop safer alternatives for chemical substances.	No comparable provision.
Hot spots	No comparable provision.	As proposed, a new TSCA 34 requires that EPA promulgate a rule to establish criteria to identify any locality that is disproportionately exposed. Defines "disproportionate exposure" to mean residential population exposure to one or more toxic chemical substances and mixtures at levels that are significantly greater than the average exposure in the United States. Directs EPA, within 120 days of promulgation of the rule, to identify localities subject to such exposure using data in EPA's National Air Toxic Assessment Database and other available data, and providing an opportunity for public nominations of localities. Requires EPA to publish a list of such localities, and to update it at least once every five years. The locations on the list are not subject to judicial review. Publication of a list is a nondiscretionary duty and subject to judicial review. Requires the EPA Administrator to develop and publish an action plan that includes an identification of the chemicals that contribute to the disproportionate exposure, and a description of actions to be taken to reduce exposure. Directs EPA to report annually to Congress.	No comparable provision.
Federal agencies subject to TSCA	No comparable provision.	New TSCA 35 would provide that all federal agencies are subject to the provisions of TSCA, as proposed, and expressly waive any immunity otherwise applicable to the United States. However, no agent, employee, or officer of the United States is personally liable for any civil penalty under TSCA with respect to any act or omission within the scope of the official duties of that person. Such persons are subject to any criminal sanction under proposed TSCA. The President is authorized to grant an exemption for any federal agency from compliance with any requirement of TSCA, as proposed, if "the President determines it is in the paramount interest of the United States." An exemption may be granted due to lack of appropriation if the President specifically requested such appropriation and Congress failed to make available such requested appropriation. Directs the President annually to report to Congress all exemptions granted during the previous year. Authorizes enforcement action against any federal agency, as well as voluntary resolution or settlement set forth in a consent order.	No comparable provision.
International agreements	No comparable provision	New TSCA 36 would authorize EPA to implement three international agreements: the Stockholm Convention on Persistent Organic Pollutants, the Aarhus Protocol to the Convention on Long-Range Transboundary Air Pollution, and the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (known as the PIC Convention). Directs the EPA Administrator to implement the three agreements that have entered into force for the United States. Prohibits manufacture, processing, distribution in commerce, use, disposal, or any other action with respect to a covered chemical, mixture, or substance that is part of an article in a manner inconsistent with applicable international obligations. Directs EPA to provide timely public notice and opportunity to comment on: a chemical proposed for listing, a recommendation made to list a chemical on any Annex in advance of any meeting of the Parties at which the recommendation is to be considered, and any decision by the Meeting of the Parties to list a chemical. Authorizes the EPA Administrator to prescribe regulations to carry out provisions of the three agreements or to ensure compliance with obligations under them. Prohibitions and other requirements shall be enforced in the same way as final rules or orders under proposed TSCA 6.	No comparable provision, but see proposed TSCA 12 and 13 above with regard to chemicals subject to treaties to which the United States is obligated.

Source: Compiled by the Congressional Research Service from the U.S. Code, S. 696, and S. 1009.

a. Although there is no explicit authority in TSCA, EPA currently requires substantiation of confidentiality claims for specific chemical identity. See title 40 of the Code of Federal Regulations at 720.85.

b. EPA has stated that it "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.

c. Although there is no explicit authority in TSCA, EPA currently promotes green chemistry (http://www.epa.gov/greenchemistry/), safer products (http://www.epa.gov/dfe/product_label_consumer.html), green engineering (http://www.epa.gov/oppt/greenengineering/pubs/whats_ge.html), and other "green" initiatives.

Acknowledgments

This report was written by [author name scrubbed], who has retired from CRS.

Footnotes

1.	15 U.S.C. 2601 et seq.
2.	For more information about issues revolving around TSCA, see CRS Report RL34118, The Toxic Substances Control Act (TSCA): Implementation and New Challenges, by [author name scrubbed].
3.	U.S. Congress, Senate, Committee on Environment and Public Works, Subcommittee on Superfund, Toxics and Environmental Health, Hearing, "Assessing the Effectiveness of U.S. Chemical Safety Laws." February 3, 2011, http://epw.senate.gov/public/index.cfm?FuseAction=Hearings.Hearing&Hearing_ID=cd4fd6b9-802a-23ad-4d18-eac94d1414b3. Also, see U.S. House Committee on Energy and Commerce webpage on the hearing held June 13, 2013, "Title I of the Toxic Substances Control Act: Understanding its history and reviewing its impact" at http://energycommerce.house.gov/hearing/title-i-toxic-substance-control-act-understanding-its-history-and-reviewing-its-impact.
4.	In examining the effects of the proposed legislation on the current statute, this report confines itself to the text of the statute and does not delve into case law interpretation of the text.
5.	S. 906, which became P.L. 110-414.
6.	In response to a notice submitted for a new chemical or a significant new use, current TSCA 5(d) authorizes EPA to issue an order limiting manufacture and other activities related to the substance, if the agency determines that the available information is insufficient to make a reasoned determination, and that the chemical may present an unreasonable risk, or that it will be produced in substantial quantities and either may reasonably be anticipated to enter the environment in substantial quantities or there is significant or substantial human exposure to the substance.
7.	TSCA Interagency Testing Committee, an independent advisory committee that includes representatives of 14 U.S. government organizations, http://www.epa.gov/oppt/itc/index.htm.
8.	An exemption from any prohibition on manufacture would be allowed for a particular use only if: it were "in the paramount interest of national security"; lack of the chemical use "would cause significant disruption in the national economy"; the use were essential or critical and there were no safer feasible alternative; or the chemical use, relative to alternatives, provided a benefit to health, the environment, or public safety.
9.	For more information about these agreements, see CRS Report RS22379, Persistent Organic Pollutants (POPs): Fact Sheet on Three International Agreements, by [author name scrubbed].

Proposed Reform of the Toxic Substances Control Act (TSCA) in the 113th Congress: S. 1009 Compared with S. 696 and Current Statute

Proposed Reform of the Toxic Substances Control Act (TSCA) in the 113th Congress: S. 1009 Compared with S. 696 and Current Statute

Contents

Tables

Summary

Introduction

Effects of the Proposed Legislation on the Current Statute4

Data Development Requirements

Notice Requirements

Prioritization for Safety Assessments

Safety Standards, Restrictions, and Prohibitions

Breadth of and Limits to EPA Authority

State Preemption

Confidential Business Information

Miscellaneous Provisions

Footnotes

Proposed Reform of the Toxic Substances Control Act (TSCA) in the 113^th Congress: S. 1009 Compared with S. 696 and Current Statute

Effects of the Proposed Legislation on the Current Statute⁴