Proposed Amendments to the Toxic Substances Control Act (TSCA) in the 114th Congress: S. 697, S. 725, and H.R. 2576
Released: 2015-07-08T00:00:00

Introduction

In 1976, President Gerald Ford signed into law the Toxic Substances Control Act (TSCA; P.L. 94-469 ), which authorized the U.S. Environmental Protection Agency (EPA) to identify and regulate toxic chemicals in U.S. commerce to prevent "unreasonable risk of injury to human health or the environment." In order to determine which chemicals warrant regulation under TSCA, EPA is authorized to evaluate risks that may arise from the entire commercial life-cycle of chemicals, including their production, importation, processing, distribution, use, and disposal. EPA has authority to pursue a range of regulatory options to address risks from chemicals. Since 1976, Congress has added five other titles to TSCA and has also amended the original law, referred to as Title I, to target specific chemical concerns. None of these additions and amendments addresses the core program under Title I of TSCA. Since 2005, a number of bills have been introduced to revise the chemical evaluation process for determining whether regulatory controls are warranted and to address certain other related purposes. These bills were not enacted, as there was and continues to be legislative debate on whether and how to amend the evaluation process, regulatory criteria, and other elements of the law.

Since the enactment of TSCA in 1976, more chemicals have continued to enter the U.S. market. A greater number of studies on chemical risks have been published, and scientific understanding of chemical risks has continued to evolve. Because relatively few chemicals have been evaluated and even fewer regulated under TSCA's risk management provisions, proponents of amending Title I of TSCA argue that the current regulatory framework for chemicals is not sufficiently protective of the public or the environment. EPA's evaluation of risks is ultimately dependent on the resources the agency has available.

As states have enacted statutes to address specific chemical concerns not addressed by EPA under TSCA, there has been greater potential for the same chemical to be regulated differently among states. Manufacturers and processors of chemicals have argued that compliance with different state regulations regarding the same chemical is not efficient given chemicals' movement through interstate commerce. Proponents of state regulations that differ from federal requirements for the same chemicals, in turn, have argued that states can lead the way in trying alternative approaches and that states should be allowed to do so to protect their citizens. Non-governmental programs, such as voluntary measures to label products as "sustainable" or "non-toxic," have also emerged as an alternative approach to regulation.

This report tracks the legislative status in the 114 th Congress of bills that would amend Title I of TSCA and includes a discussion of selected issues that have received more attention. This report does not present a comprehensive analysis of all provisions of relevant legislation, nor is this report intended to provide a detailed analysis of specific language and its legal or regulatory interpretation.

Legislative Status in the 114th Congress

In the 114 th Congress, bills have been introduced in both chambers to amend Title I of TSCA. On March 10, 2015, the Frank R. Lautenberg Chemical Safety for the 21 st Century Act ( S. 697 ) was introduced and referred to the Senate Committee on Environment and Public Works (Senate EPW). Two days later, the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act ( S. 725 ) was introduced and also referred to Senate EPW. On March 18, 2015, Senate EPW held a hearing regarding S. 697 . On April 28, 2015, Senate EPW marked up an amendment in the nature of a substitute for S. 697 , which was ordered to be reported out of the committee for Senate floor consideration on a 15-5 vote. On June 18, 2015, Senate EPW filed the report ( S.Rept. 114-67 ) for S. 697 .

On April 7, 2015, the House Committee on Energy and Commerce, Subcommittee on Environment and the Economy, announced a discussion draft that takes a more targeted approach to amending Title I of TSCA than either Senate bill. The discussion draft is called the TSCA Modernization Act of 2015 and hereinafter is referred to as the House discussion draft. On April 14, 2015, the subcommittee held a hearing regarding the discussion draft. On May 14, 2015, the subcommittee ordered the revised House discussion draft to be forwarded with an amendment to the full House Committee on Energy and Commerce for its consideration on a 21-0 vote. On May 26, 2015, H.R. 2576 , also titled the TSCA Modernization Act of 2015, was introduced. The bill is based on the version of the House discussion draft that was ordered to be forwarded by the subcommittee for full committee consideration. On June 3, 2015, the House Committee on Energy and Commerce approved the bill with technical amendments on a 47-0 vote (with one abstention). The committee's report for the bill is H.Rept. 114-176 . On June 23, 2015, the House passed H.R. 2576 , as amended, under suspension of the rules on a 398-1 vote.

Selected Issues for Congress

Among the various issues regarding the federal role in regulating chemical substances under Title I of TSCA, the following topic areas are among the more debated:

The prioritization of existing chemical substances for the evaluation of risks; The regulatory threshold criteria under which EPA would be authorized to restrict a chemical substance; The regulatory options available to EPA in restricting a chemical substance found to warrant regulation; The authority of EPA to require the development of new information regarding a chemical substance; The preemption of state laws concerning the regulation of chemicals; The disclosure and protection from disclosure of information submitted to EPA; and The resources that may be available for EPA to administer the act.

This report compares approaches among S. 697 , as reported, S. 725 , and H.R. 2576 , as passed by the House, in amending Title I of TSCA to address these key issues.

Prioritization of Chemical Substances for the Evaluation of Risks

Given that the evaluation of risks for the large number of chemicals in the marketplace is limited by finite resources, determining what criteria to use in selecting which chemicals to evaluate has been a perennial issue. Under the current TSCA, EPA has discretion regarding which chemical substances to evaluate for risks and no mandate to review or evaluate chemicals.

The substances that the agency may evaluate for risks include those on the initial inventory of known chemical substances reported to EPA under Section 8(a) of TSCA after enactment of the law and those that manufacturers subsequently report to EPA in premanufacture notices (PMNs) under Section 5 of TSCA. These substances all together number over 83,000 chemical substances, although not all of them are necessarily still in U.S. commerce. In 2012, as part of EPA's TSCA Work Plan, the agency identified more than 1,200 substances that possibly warranted an evaluation based on certain prioritization criteria. These substances were further screened based on hazard, exposure, and bioaccumulation potential, which led EPA to prioritize 90 substances for an evaluation of risks to human health or the environment. Of the 90 prioritized chemical substances, EPA has assessed five, three of which were determined to present risks.

For new chemicals, Section 5 of TSCA requires manufacturers to submit a PMN to EPA 90 days prior to manufacturing the chemical substance, subject to certain exemptions. During this time period, EPA has the opportunity to evaluate risks of the new chemical substance and determine whether regulation may be warranted based on the PMN and any existing data concerning the environmental and health effects of the substance. According to EPA, from July 1979 to September 2010, the agency has received more than 36,000 PMNs and more than 13,000 PMN exemption applications.

S. 697 and S. 725 would direct EPA to prioritize existing chemical substances in multiple steps for evaluation of risks, whereas H.R. 2576 would direct the agency to evaluate chemicals based on specific criteria. H.R. 2576 would give EPA the discretion to evaluate chemicals that the agency identifies as having potential for unreasonable risk arising from the combination of hazards and exposures under the intended conditions of use for the chemical. S. 697 and S. 725 differ in the factors and criteria used to prioritize substances. Both Senate bills would establish a process that includes dividing the inventory of existing chemical substances into those that are reported to be currently in the marketplace (i.e., active substances) and those that are not (i.e., inactive substances), prioritizing the inventory of substances for evaluations based on various factors, conducting risk-based safety evaluations, and taking regulatory action based on the result of each evaluation. All three bills would also address prioritization of persistent, bioaccumulative and toxic (PBT) substances, albeit in slightly different ways.

S. 697 and H.R. 2576 would establish a process by which manufacturers (and, under S. 697 , processors) may request EPA to prioritize certain substances for an evaluation upon payment of a fee. Under S. 697 , EPA would have discretion to grant only a limited number of requests, subject to public notice and opportunity for comment. Under H.R. 2576 , EPA would be required to evaluate risks for every substance for which a manufacturer makes a request so long as the manufacturer has paid the costs of the evaluation to the agency.

S. 697 and S. 725 would establish the prioritization process with varying deadlines for evaluating chemical substances and, if necessary, for taking regulatory actions. Under S. 697 , EPA would be required to "make every effort to complete the designation of all active substances as high-priority substances or low-priority substances in a timely manner" and to publish an annual goal. EPA would be required to designate at least 25 chemicals as high priority and begin safety assessment on them within five years after enactment of S. 697 . Safety assessments and determinations would have to be completed within three years after a chemical's designation as a high-priority substance and a rule promulgated within two years after a negative safety determination, subject to limited extensions. The prioritization and safety assessment procedures proposed by S. 725 are generally comparable to those under S. 697 , with tighter deadlines on EPA and certain other differing conditions and procedures for prioritization and assessment.

In contrast, H.R. 2576 would require risk evaluations to be published within three years after a manufacturer's request for an evaluation or within three years following an EPA finding of potential for unreasonable risk. H.R. 2576 would require EPA to initiate at least 10 risk evaluations (not including manufacturer-requested evaluations) per year, subject to the availability of appropriations. H.R. 2576 would not set a limit on manufacturer requests, except that the requested evaluation be paid for fully by the requesters.

For new chemical substances and significant new uses, S. 697 and S. 725 would amend TSCA Section 5 to establish a process for EPA to review a notice and information submitted by manufacturers and processors. H.R. 2576 would not amend TSCA Section 5, leaving in place the current process for EPA to have the initial opportunity to evaluate risks of new chemicals based on when a notice is submitted. Under the Senate bills, EPA would be required to make a determination of whether regulatory action is warranted for new chemicals following the submission of a PMN. For new chemicals, both Senate bills would direct EPA to conduct an initial review and render a determination within 90 days of receiving a PMN (and accompanying information) and information that the substance is likely or not likely to attain the safety standard or that additional information is necessary to make such a determination. Once the manufacture of a new chemical has commenced and that chemical is added to the TSCA Inventory, it would presumably be subject to the same prioritization, safety assessment, and safety determination procedures and conditions for existing chemical substances as proposed by S. 697 and S. 725 .

Regulatory Threshold for Restricting a Chemical Substance

The current TSCA establishes as a standard for regulation of chemical substances that the chemical presents or will present "an unreasonable risk of injury to [human] health or the environment." This phrase is used in multiple provisions of TSCA as the basis of whether certain actions may be warranted, particularly with respect to various regulatory controls under Section 5 regarding new chemicals and Section 6 regarding existing chemicals. Some have argued that the existing regulatory threshold for restricting a chemical substance in TSCA—that the chemical presents or will present risks that are unreasonable—is difficult for EPA to show and subject to interpretation. A recurring issue of concern in the TSCA debate has been whether or how to amend the regulatory threshold to clarify the criteria and factors to be considered for determining whether certain substances warrant regulatory control.

Under current TSCA, the "unreasonable risk" standard is not defined in statute. However, the "unreasonable risk" standard of TSCA has been interpreted at the circuit court level as, essentially, a multi-factor balancing test. In its influential 1991 decision, Corrosion Proof Fittings v. EPA , which struck down large parts of an asbestos ban under TSCA, the Fifth Circuit interpreted TSCA's "unreasonable risk" standard, stating that "[i]n evaluating what is 'unreasonable,' the EPA is required to consider the costs of any proposed actions and to 'carry out this chapter in a reasonable and prudent manner [after considering] the environmental, economic, and social impact of any action.'" The court also quoted a Supreme Court case regarding "unreasonable risk" language in general, saying that "'unreasonable risk' statutes require 'a generalized balancing of costs and benefits.'" The Fifth Circuit ruled that in its asbestos ban, EPA had "basically ignored the cost side of the TSCA equation" and that potentially "spending $200-$300 million to save approximately seven lives (approximately $30-$40 million per life) over thirteen years" was not reasonable under the "unreasonable risk" standard. Thus, under the "unreasonable risk" standard in current TSCA, whether regulation of a substance is warranted depends on not only the hazards of the chemical and the extent or likelihood of exposure to the chemical but also the costs of risk management and the benefits of the chemical for various uses.

S. 697 would establish a statutory definition for the term "safety standard" that uses the regulatory threshold of "unreasonable risk of injury to health or the environment" in current TSCA and adds some qualifiers. First, S. 697 would establish the regulatory threshold to be whether the "conditions of use" of a chemical substance would attain the safety standard. Additionally, S. 697 would explicitly include "potentially exposed or susceptible populations" among the general population with respect to an evaluation of risks. Also, in the qualifier departing most significantly from current TSCA, S. 697 would expressly prohibit the consideration of "cost and other nonrisk factors" in evaluating risks.

Similar to S. 697 , S. 725 would define a "safety standard" against which chemical risks would be measured. However, under S. 725 , the safety standard would be one that "ensures with reasonable certainty, without taking into consideration cost or other non-risk factors, that no harm to human health or the environment will result from exposure to a chemical substance under the intended or reasonably foreseeable conditions of use, including no harm to the general population or to any potentially exposed or susceptible subpopulation." This "reasonable certainty [of] no harm" language parallels the standard used to evaluate, for example, pesticide residues in or on food.

In contrast to S. 697 and S. 725 , H.R. 2576 would not define a "safety standard." It would retain the language of the regulatory threshold based on "unreasonable risk" in current TSCA but would add certain requirements for EPA's risk evaluation process to determine risks. Some examples of the requirements for evaluating risks include assessing risks to "potentially exposed populations" and not considering information on "cost and other factors not directly related to health or the environment" in evaluating risks. Furthermore, H.R. 2576 would explicitly prohibit EPA from considering "costs or other non-risk factors" when deciding whether to initiate a rulemaking under Section 6(a) of TSCA to address unreasonable risks.

Regulatory Options for Restricting a Chemical Substance

Some statutes that authorize regulatory controls such as TSCA include the concept of balancing costs and benefits. Title I of TSCA acknowledges this balance through various references. As an example, if EPA were to determine that a chemical substance presents or will present "an unreasonable risk of injury to health or the environment," Section 6 of TSCA directs the agency to promulgate a requirement to protect adequately against such risks using the least burdensome requirement while considering certain other factors: for example, the approximate costs of the proposed regulation and the availability of alternatives to the chemical subject to regulatory control. The regulatory requirements that EPA may choose vary in severity from a complete ban to a requirement that manufacturers notify distributors of unreasonable risks. Some have argued that the limit on EPA to choose the least burdensome regulatory requirement that still adequately protects from unreasonable risk requires the agency to do lengthy analyses.

In Corrosion Proof Fittings v. EPA , the Fifth Circuit stated that EPA had not shown substantial evidence that its total ban on most ongoing uses of asbestos was the least burdensome adequate alternative for all circumstances and product categories. Thus, in practice, the "least burdensome" requirement imposes an additional standard on EPA beyond that imposed by the requirement that EPA conduct a cost-benefit analysis of the chosen alternative, because a rule cannot be upheld based only on its benefits outweighing its costs. In order to reject a less burdensome requirement in favor of a more burdensome one, the Fifth Circuit required EPA to show that each less burdensome requirement would not adequately protect against the unreasonable risk.

S. 697 , S. 725 , and H.R. 2576 would eliminate the requirement that EPA choose the least burdensome regulatory option to restrict a chemical substance that warrants regulation. Rather, S. 697 and S. 725 would direct EPA to choose a regulatory option that is "necessary" for the chemical substance to meet the safety standard, subject to consideration of other factors such as costs and alternative regulations. In contrast, H.R. 2576 would require that EPA promulgate a rule that adequately protects against risks including those to potentially exposed subpopulations. Additionally, H.R. 2576 would amend the factors that EPA would be required to consider to promulgate a restriction on a chemical substance and would require rules to be, by EPA's determination, "cost-effective," except where it is determined not practicable to protect against the identified risk using cost-effective requirements.

All three bills would include a provision authorizing EPA to exempt certain uses of chemical substances from any restrictions if certain circumstances are found. S. 697 and S. 725 would authorize EPA to exempt uses if a restriction cannot be complied with without harming national security, causing significant disruption in the national economy, or interfering with a critical or essential use for which no technically and economically feasible safer alternative is available. H.R. 2576 would also authorize EPA to grant "critical use exemptions" for specific uses of a chemical substance if the agency determines that a requirement is not "cost-effective" and finds that the specific use is a critical or essential use or that the requirement would significantly disrupt the national economy, national security, or critical infrastructure. EPA would be authorized only to grant critical use exemptions to reduce risk to the greatest extent feasible. Critical use exemptions under H.R. 2576 would initially be in effect for a maximum period of five years, and the exemption may be renewed for one or more additional five-year periods if the agency finds that the requirements for granting the exemption continue to be met.

Requirement for the Development of Test Information

EPA relies on scientific and technical information regarding chemical substances to evaluate risks and determine if any risks are unreasonable. In order to obtain such information, Section 8 of TSCA authorizes EPA to require reporting and record keeping of existing information on chemicals by manufacturers, processors, and distributors of chemical substances. If the risks are insufficiently known from existing information and testing is necessary to develop new information about the risks, Section 4 of TSCA mandates that EPA promulgate a rule to require manufacturers and processors to conduct testing if the agency is able to render one of the following two threshold findings. The threshold findings are either (1) that the chemical substance may present unreasonable risks, or (2) that "substantial quantities" are or will be produced either in a way that enters or may reasonably be anticipated to enter the environment, or in a way that "there is or may be significant or substantial human exposures." To date, EPA has required additional testing for over 200 chemical substances.

Some have argued that limits on EPA's authority under TSCA to require the development of new information regarding the health and environmental effects of chemicals have limited EPA's ability to assess the risks of chemicals. EPA has argued that finding a chemical substance "may present an unreasonable risk of injury to health or the environment" in order to require the development of new information to determine whether a chemical substance presents an unreasonable risk is a "possible analytical catch-22." Instead, EPA has generally made the other finding, which is based on the production volume of a chemical and the likelihood of exposure. However, the development of new information may take a lengthy amount of time and be costly to those who are required to develop the information.

Whereas Section 4 of TSCA currently mandates that EPA require testing based on certain conditions for which the agency renders a finding, S. 697 and S. 725 would give EPA discretion to require testing if the agency were to determine it necessary for specific purposes. In contrast to the Senate bills, H.R. 2576 would still require that EPA render certain findings to require testing under Section 4 of TSCA. However, EPA would also be authorized to require testing if it is "necessary to conduct a risk evaluation" under Section 6 as would be amended. All three bills would authorize EPA to require the development of new information by promulgating a rule, issuing an order, or entering into a testing consent agreement. The Senate bills would further amend procedures for requiring the development of new information, including a provision that would require EPA to minimize animal testing to the extent practicable.

Preemption of State Requirements

With an increasing number and diversity of state chemical regulations providing a backdrop for TSCA amendment discussions at the federal level, the scope of TSCA preemption has been a long-standing issue. Under the Supremacy Clause of the U.S. Constitution, conflicting state law and policy must yield to the exercise of Congress's enumerated powers. When it acts, Congress can preempt state action within a field entirely, allow states to take different actions, or permit state action to any degree in between. Current TSCA preemption is not at either extreme of the spectrum; it gives EPA a primary role in management of chemicals but leaves states some ability to set their own chemical requirements under certain circumstances.

Specifically, Section 18 of TSCA provides that states are generally preempted from taking action to manage risk from a chemical if EPA has taken action on a similar risk presented by that chemical, although states may apply for waivers. For state requirements other than duplicative testing requirements, a number of exceptions to preemption apply. State requirements that are identical to federal requirements are not preempted, allowing states to co-enforce the federal requirements by adopting them as their own law. States are also authorized to regulate disposal, establish or continue in effect any chemical requirement adopted under the authority of any other federal law, and prohibit use of a chemical within the state (except for its upstream use in manufacture or processing of other chemicals).

In the TSCA amendment context, advocates for broader federal preemption claim that a uniform national regulatory framework with regard to chemicals can provide sufficient protection from chemical risks. They assert that absent preemption, states may implement varying and even conflicting regulations, leading to increased compliance costs, reduced economies of scale, and economic repercussions across industry supply chains and throughout interstate commerce. On the other hand, opponents of preemption argue that the federal regulation should set a minimum standard but that states should be able to experiment with different policies and implement more stringent requirements than those EPA sets in order to protect the safety and welfare of their citizens.

S. 697 would make a number of changes to TSCA preemption and the state-federal relationship in the field of chemical management. As under current TSCA, states could act without preemption if EPA had taken no action with respect to a chemical. However, S. 697 would modify the EPA actions triggering preemption of states' chemical-specific requirements, the scope of state laws that would be preempted or excepted from preemption, and the waiver provisions. Subject to exceptions, a state would be prohibited from restricting the manufacture, processing, sale or distribution in commerce, or use of a chemical substance that EPA either had found to meet the safety standard or had restricted by rule on the basis that it did not meet the safety standard within the scope of uses addressed by EPA. Moreover, states would be prohibited from establishing new restrictions on chemical substances listed by EPA as high priority chemicals for safety assessment if the state restrictions fell within the scope of uses or conditions to be considered in EPA's planned safety assessment. Such preemption of new state restrictions would begin upon EPA's defining the scope of the safety assessment: If EPA determined that the chemical substance met the safety standard, preemption would continue, but if EPA determined that the chemical substance did not meet the safety standard, preemption would be lifted until the effective date of the EPA rule restricting the chemical substance.

S. 697 would generally retain the preemption exceptions provided by current TSCA, except for TSCA's current exception allowing states to prohibit use of chemicals, which would be removed. TSCA's exception allowing states to enforce requirements identical to federal requirements would be refined with new provisions to prohibit states from imposing duplicative or more stringent penalties or sanctions. Other exceptions to preemption would be added, including allowing states to establish or enforce some requirements adopted under the authority of state environmental laws. Certain state actions taken before August 1, 2015, and past or future state actions under the authority of state laws that were in effect as of August 31, 2003 (such as California's Proposition 65), would not be subject to preemption. S. 697 would also add savings clauses clarifying that common law or statutory causes of action, private remedies, or evidentiary or other authorities of courts would not be affected. In addition to discretionary waivers similar to current TSCA, states could apply for waivers on the basis of concerns about a chemical based on peer-reviewed science. EPA would have to grant such waivers if the application met statutory requirements; such waivers would also automatically be granted if EPA failed to make a decision on them within 90 days or if EPA missed the applicable deadline for a safety determination on the chemical.

S. 725 , in contrast, would eliminate TSCA's current preemption provisions. While state laws could be found to be implicitly preempted if they conflicted with federal requirements, S. 725 would generally allow states to impose and enforce different regulations or requirements for chemicals.

H.R. 2576 would make somewhat smaller substantive changes to TSCA preemption than the Senate bills. As under current TSCA and S. 697 , states could impose requirements on chemicals without preemption if EPA had taken no action with respect to a chemical. H.R. 2576 would provide for the preemption of state laws designed to protect against exposure to a chemical that EPA had determined not to present an unreasonable risk to the extent the state laws applied to the conditions of use considered by EPA in its risk evaluation for that chemical. H.R. 2576 would generally maintain TSCA's preemption of state requirements for chemicals on the basis of EPA risk management actions under Sections 5 or 6 for such chemicals, with some additional language to align preemption with the risk evaluation process under amended Section 6. Unlike the current TSCA, state prohibitions on use of such chemicals would not be excepted from preemption.

H.R. 2576 would also add comparable language to that in S. 697 pertaining to a state's ability to enforce, with penalties and sanctions, a state requirement identical to an EPA requirement. As with S. 697 , H.R. 2576 would provide that certain actions taken before August 2015—and past or future state actions under the authority of state laws that were in effect as of 2003—would not be subject to preemption. In addition, all three bills would add several savings clauses regarding the preservation of common law or statutory causes of action under tort or contract law and of court authorities in civil actions, although the wording would differ.

Confidentiality and Disclosures of Information

TSCA requires chemical manufacturers, processors, and distributors to submit certain information to EPA regarding their chemicals. This information can include detailed chemical structures, production volumes, and health and safety data. Thus, another issue of concern in amending TSCA is how to balance the goals of, on the one hand, public access to chemical information and, on the other, protection of information that if disclosed could compromise the submitter's competitiveness.

Section 14 of TSCA prohibits disclosure of information reported to or obtained by EPA that is exempt from disclosure under the Freedom of Information Act (FOIA) as "trade secrets and commercial or financial information obtained from a person and privileged or confidential," with certain exceptions. Under the terms of TSCA, wrongful disclosure by EPA employees or contractors is a criminal act. Confidential business information (CBI) protection under TSCA does not prohibit disclosure of any health and safety study, but any data within any such study that would disclose manufacturing processes or proprietary mixture compositions would remain protected.

Many items of information—including chemical identities—have been protected by EPA as CBI on the TSCA Inventory, in health and safety studies, and in other situations. TSCA Section 14 contains several exceptions requiring disclosure of CBI, including if EPA determines that disclosure is "necessary to protect health or the environment against an unreasonable risk of injury." If EPA makes this determination, or if EPA finds that information that has been designated as CBI does not meet the standard for protection, EPA must provide notice to the information submitter prior to disclosing the information.

Procedurally, to obtain CBI protection for information that the submitter believes is entitled to confidential treatment, the submitter is required only to designate the information as CBI. Neither substantiation nor EPA review of confidentiality claims is expressly required under current TSCA. CBI protection also continues indefinitely, unless EPA determines that the information no longer qualifies for protection under the FOIA exemption and gives the submitter the required prior notice. Since 2010, EPA has increased its review of confidentiality claims, particularly relating to chemical identities in health and safety studies. The agency has also issued a "CBI Declassification Challenge," asking industry to withdraw CBI claims voluntarily, and has engaged in other initiatives to increase public access to non-confidential information.

All three bills would retain current TSCA's basic framework requiring protection of information that falls within the FOIA trade secrets exemption. The three proposals, however, would require or authorize EPA to disclose CBI in additional circumstances, including in response to requests from state, local, or tribal officials for enforcement purposes; requests from certain federal or state professionals in response to an environmental release; or requests from health care professionals to assist in diagnoses or treatments of patients.

The Senate bills would make more extensive revisions and additions to Section 14 of TSCA than H.R. 2576 , with more detailed procedural requirements for information submitters and more review requirements for EPA. They would also enumerate certain categories of information presumed protected from disclosure, including specific chemical identity (chemical formula and molecular structure) prior to the date a chemical is first offered for commercial distribution. On the other hand, information on chemicals subject to a ban or phase-out rule under amended Section 6 would be presumed not protected.

In comparison, H.R. 2576 would protect the confidentiality of chemicals' identities in health and safety studies. All three bills would require submitters to substantiate, and resubstantiate after no more than 10 years, their confidentiality claims. In H.R. 2576 , however, these substantiation requirements would be limited to confidentiality claims made after enactment. H.R. 2576 would also require EPA to notify submitters before the expiration date of their confidentiality claims.

Resources to Administer TSCA

In implementing Title I of TSCA, the pace and thoroughness with which EPA can evaluate chemical risks often depends on the resources made available to the agency. An issue for Congress is whether to continue funding EPA's activities under TSCA through discretionary appropriations or to establish dedicated sources of funding that are supplemental to and not subject to discretionary appropriations.

Under Section 29 of TSCA, appropriations for Title I were authorized through FY1983. Congress has continued to fund EPA's implementation of TSCA through annual appropriations pursuant to the program or "organic" authorities of TSCA that do not have a sunset date and do not expire unless otherwise amended. Additionally, Section 26(b) of TSCA authorizes EPA to assess fees on chemical manufacturers, importers, or processors. The authorization for EPA to assess these fees does not have a sunset date. EPA's authority to collect fees is statutorily limited to a maximum of $2,500 for the following actions required under Section 5 of the statute:

Each PMN that a manufacturer or importer of a new chemical substance is required to submit to EPA, and Each notice that a manufacturer, importer, or processor is required to submit to EPA for a significant new use of a chemical substance.

Section 26(b) currently provides an exception for small businesses under which these fees are limited to a maximum of $100. Furthermore, Section 26(b) authorizes EPA to assess fees within these statutory caps for the costs of evaluating testing data that a manufacturer, importer, or processor of a chemical substance may be required to submit to the agency under Section 4 of the statute.

Under TSCA, there is no dedicated account for fees collected under Section 26(b). As such, these fees are treated as miscellaneous receipts and deposited into the General Fund of the U.S. Treasury as required by the Miscellaneous Receipts Act. The availability of fees collected under TSCA for obligation by EPA is subject to annual appropriations.

S. 697 and S. 725 would repeal the expired authorization of appropriations under Section 29 of TSCA, whereas H.R. 2576 would not amend Section 29. With regard to the authority to collect fees under Section 26(b) of TSCA, all three bills would revise this authority to differing degrees. S. 697 would authorize the collection of fees to accompany certain submissions of information to EPA regarding chemicals that the agency would be directed to evaluate, although the authority to collect fees would be conditional on a minimum level of discretionary appropriations made available to the agency.

S. 697 would direct the agency to set fees at levels such that the fees would, in aggregate, provide a sustainable source of funds to partially defray the cost of conducting various activities. S. 697 would cap the total amount collected at $18 million. The bill does not indicate whether this cap applies annually or indefinitely from the bill's enactment. EPA would be directed to deposit receipts from fees in a dedicated fund. The amounts in the fund would be obligated only to defray the costs of evaluating various submissions of information submitted to the agency. These fees would be made available without fiscal year limitation subject to the availability of appropriations.

In addition to the existing authority to collect fees under TSCA, H.R. 2576 would authorize EPA to collect fees from manufacturers who request a risk evaluation of a chemical substance. The bill would eliminate the current statutory limit for the amount that EPA may collect in fees per notice submission. Instead, the agency would be authorized to collect a fee that is sufficient and not more than reasonably necessary to defray certain costs in administering TSCA. H.R. 2576 and S. 697 would establish a dedicated fund in which receipts from fees would be deposited. The amount of fees would be made available to EPA without fiscal year limitation subject to the availability of discretionary appropriations.

S. 725 would authorize EPA to collect fees from chemical manufacturers for various purposes. Similar to S. 697 and H.R. 2576 , S. 725 would also eliminate the current statutory limit that EPA may collect in fees per notice submission under current TSCA and direct the agency to ensure that fees are set at a level sufficient to enable the agency to perform certain responsibilities. As under the current TSCA, S. 725 does not establish a dedicated account for the deposit of fees collected. Receipts from collected fees would be deposited as miscellaneous receipts into the General Fund of the U.S. Treasury pursuant to the Miscellaneous Receipts Act. Funds would be made available subject to discretionary appropriations.

The Congressional Budget Office has published cost estimates for S. 697 and H.R. 2576 that present estimates of the potential budgetary impacts of the bills. The cost estimate for S. 697 is included in S.Rept. 114-67 , and the cost estimate for H.R. 2576 is included in H.Rept. 114-176 .