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December 22, 2015

TSCA Reform: Detailed Summary of Key Changes in Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) as Compared with S. 697 Passed by Senate EPW in June

Bergeson & Campbell, P.C.

This analysis reviews the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) as passed by the Senate on December 17, 2015, and compares it to the previous version of S. 697 (identified as Lautenberg2 in this analysis), passed by the Senate Environment and Public Works (EPW) Committee in June 2015. This review also briefly compares S. 697 to H.R. 2576, the [Toxic Substances Control Act (TSCA)] Modernization Act of 2015, which passed the House of Representatives on June 23, 2015, to identify areas of alignment and dissonance. Bergeson & Campbell, P.C.’s (B&C®2016 Forecast memorandum, to be distributed in early January, will provide further analysis and discussion of likely legislative next steps regarding TSCA reform and other significant legislative and regulatory initiatives. Our review of Lautenberg2 is available online.

Section 2. Findings, Policy, and Intent. This section is largely unchanged relative to that in Lautenberg2.

Relative to S. 697, H.R. 2576 proposes to retain TSCA Section 2 unchanged.

Section 3. Definitions. This section appears to be unchanged relative to that in Lautenberg2.

Relative to H.R. 2576, S. 697 includes several additional definitions (safety assessment and safety determination, for example), and includes a U.S. Environmental Protection Agency (EPA) determination in S. 697’s definitions for potentially exposed or susceptible population and conditions of use.

Section 3A. Policies, Procedures, and Guidance (PP&G). Much of this section is substantively unchanged from that in Lautenberg2, although the language has been tightened up at several spots. All deadlines in this section have been retained unchanged from Lautenberg2. Animal welfare provisions that had appeared in Section 3A(g) have been moved without amendment to Section 4(c). The requirement to form a Science Advisory Committee on Chemicals is unchanged. Several of the changes to this PP&G section are discussed below.

Section 3A(d) concerning existing EPA PP&G retains the general thrust of the subsection relative to Lautenberg2, although some specificity has been lost in that it no longer enumerates the different areas, such as hazard, exposure, risk, testing methodologies, and related provisions that are to be incorporated into the PP&G. In addition, S. 697 now requires that existing guidance “shall” be incorporated “as appropriate and consistent with this Act” (redlining shows additions).

Section 3A(h)(1)(A) on safety assessments (SA) and safety determinations (SD) has changed the requirements of EPA in developing the schedule for conducting SAs and SDs. EPA is now required to inform the public “regarding the schedule and the resources necessary” (redlining shows changes) for completion of each SA and SD.

Section 3A(h)(1)(C) (Annual Plan) includes new requirements for what is to be included in the Plan. Lautenberg2 had required only that the substances to be completed that year be identified, while S. 697 also requires that EPA describe the status of SAs and SDs initiated but not completed and, if there are any changes to the schedule for an SA or SD, for that schedule to be updated.

Section 3A(h)(2)(C)(ii) regarding policies and procedures for SAs and SDs has both softened and strengthened the requirements on EPA relative to those in Lautenberg2. The previous bill had required EPA to define the scope of the SA/SD that it expects to consider, while S. 697 requires that EPA provide a description of the scope that it has identified as relevant.

The language in S. 697 Section 3A regarding “aggregate exposures” (Subsection (h)(2)(C)(ii)(I)(bb)(II)) is generally the same as that in Lautenberg2.

Relative to H.R. 2576, S. 697 is much more specific and detailed:

  • Both require development of PP&G within two years, with S. 697 specifying PP&G for implementing Sections 4, 4A, 5, and 6 whereas in H.R. 2576, the requirement is limited to the amended areas (this provision appears in H.R. 2576, Section 26(k)(1)).
  • S. 697 also allows “interested persons” to develop and submit safety assessments for consideration by EPA, provides specifics for developing and implementing both a tiered testing regime and a prioritization scheme, and forms a Science Advisory Committee on Chemicals. H.R. 2576 is silent on these aspects.

The concept of “aggregate exposure” does not appear in H.R. 2576.

Section 4. Testing of Chemical Substances and Mixtures. This section remains generally the same as that in Lautenberg2, although it deletes TSCA Section 4(e) (concerning the Interagency Testing Committee, ITC) and adds specificity in other areas as discussed below. All deadlines remain unchanged.

While TSCA Section 4(e) concerning the ITC has been deleted, a new subsection 4(a)(5) was added that requires EPA to consider and give priority under Section 4 to recommendations received from other federal agencies.

Section 4(d)(3) (Exemptions) has been expanded to allow exemption requests based on an “equivalent chemical substance or mixture” for which information has been submitted to EPA or is being developed.

As noted earlier, provisions regarding reduction of vertebrate testing that had appeared in Section 3A of Lautenberg2 have been moved unchanged to Section 4(c).

Section 4 thus retains the approaches in Lautenberg2 that:

  • Give EPA rule, order, and consent agreement authority;
  • Allow EPA to develop information “necessary” for purposes of Section 5 or 6 while dropping the TSCA “findings” requirement for test rules;
  • Allow “limited” prioritization testing;
  • Discuss a number of animal welfare aspects; and
  • Require EPA to publish a statement of need in requiring testing, particularly for orders.

Relative to H.R. 2576, S. 697 broadly expands EPA’s testing authority, including for prioritization, and removes the requirement to develop Section 4 “findings.” In addition:

  • While H.R. 2576 allows EPA to require testing needed for preparation of Section 6 Risk Evaluations (RE), it otherwise retains the requirement that EPA make TSCA Section 4 findings.
  • Both give EPA rule, order, and consent agreement authority.
  • H.R. 2576 is silent on the provisions in S. 697 concerning animal welfare and the requirement that EPA develop a “statement of need” for any required testing.
  • The House bill also retains the ITC.

Section 4A. Prioritization Screening. Much of this section has been retained seemingly unchanged, including all deadlines, although some important wording changes have been made and new points included at various points, including those discussed below. The net effect seems to be one of giving EPA more discretion in some areas while adding a few new requirements, including that EPA consider storage near significant sources of drinking water as a criterion for prioritization, and directs that EPA use its established Framework for Metals Risk Assessment regarding assessment of metals and metal compounds.

Lautenberg2 Section 4A Prioritization Screening, Establishment and List of Substances, subsection (a)(1) had required that EPA establish “explicit” criteria for identifying high-and low-priority chemicals. The modifier has been deleted. At subsection (a)(2)(B)(iii), concerning designation of high-priority chemicals, S. 697 has expanded the considerations to be applied in developing the high-priority list. Lautenberg2 had limited this subsection to chemicals scored high for both persistence and bioaccumulation (using the Work Plan Methods Document). S. 697 changed this to high for 1 and either high or moderate for the other and applies this approach in Sections 4A, 5, and 6. S. 697, thus, mirrors the approach in H.R. 2576 Section 6 concerning designation of persistent, bioaccumulative, and toxic (PBT) chemicals of concern. S. 697 adds new provisions requiring that EPA also give preference to chemicals on the October 2014 TSCA Work Plan that are known human carcinogens and chemicals with high acute and chronic toxicity. In another change, and as noted, S. 697 requires that EPA use the Framework for Metals Risk Assessment in prioritizing and assessing metals and metal compounds.

Section 4A(a)(4) (Criteria) subsection (D), concerning evidence and indicators of human or environmental exposure, has been expanded to include “potentially exposed or susceptible populations and storage near significant sources of drinking water” (redlining shows changes).

Section 4A(b) (Prioritization Screening Process and Decisions) subsection (2), has been modified to remove the requirement that EPA “shall integrate” hazard and exposure information and now requires that EPA “shall consider” such information.

S. 697 retained provisions relating to designation of chemicals as low-priority. These required that EPA be able to “conclude” that information is “sufficient to establish” that the chemical is likely to meet the safety standard. We had identified this language as potentially problematic in earlier analyses as well as in the TSCA Reform Legislation and its Workability: Thoughts on Steps to Help Ensure Successful Implementation at the Outset and Over Time.

H.R. 2576 is silent on the concept of prioritization, although it requires EPA to create a PBT list under Section 6. S. 697 allows manufacturers and processors to request and pay for EPA-prepared SAs and SDs, while H.R. 2576 allows manufacturers to request and pay for EPA REs under Section 6.

Section 5. New Chemicals and Significant New Uses. S. 697 seems to closely follow the approach in Lautenberg2, with modifications, including the following:

  • In submitting a notice, Section 5(c)(1)(B) now requires companies to submit “all known or reasonably ascertainable information regarding conditions of use and reasonably anticipated exposures” (redlining shows changes).
  • Whereas TSCA had not allowed new chemicals to commence manufacture before the end of the 90-day review period, S. 697 at Section 5(d)(4)(A)(ii) allows manufacture to commence once EPA has determined that the new chemical or significant new use is likely to meet the safety standard.
  • As noted above, regarding identification of persistent and bioaccumulative chemicals, S. 697 Section 5 applies the same approach as in Section 4A. Thus, chemicals determined to score high for one and high or moderate for the other will be identified as persistent and bioaccumulative new chemicals, and EPA is required (as in Lautenberg2) to impose exposure reduction requirements to the “maximum extent practicable.”

S. 697 retains a number of changes relative to TSCA Section 5 that had appeared in earlier versions of the bill, including: requiring that EPA take a decision on all new chemicals, shifting the regulatory determination from what may present an unreasonable risk/substantial exposure to whether the safety standard is likely to be met by the new chemical, and requiring that EPA implement a Significant New Use Rule (SNUR) on all regulated new chemicals or explain why such action is not being taken.

H.R. 2576 proposes no changes to TSCA Section 5.

Section 6. Safety Assessments and Safety Determinations. S. 697 generally follows the approach and requirements, including deadlines, as in Lautenberg2 with tweaks including the following:

  • It adds a new provision in Section 6(a)(6) concerning extension of deadlines for information required to be developed under Section 4 that has not yet been submitted or was submitted within 120 days before expiration of the current deadline. In these cases, deadlines can be extended “for not more than 1 year.”
  • Section 6(d) Rule, subsection (2)(A)(ii)(I), adds additional specificity to the requirement for compliance dates on control actions which “shall be as soon as practicable, but not later than 4 years after the date of promulgation of the rule, except in the case of a use exempted under paragraph (5)” (redlining shows additions).
  • Subsection 6(d)(2)(A)(ii)(IV) adds a new provision whereby EPA can further extend the compliance date by up to 18 additional months when the Agency determines that compliance is “technologically or economically infeasible” within the four year extension discussed in the preceding bullet.
  • Section 6(d)(2)(A)(v) adds a new requirement that when EPA determines that the chemical does not meet the safety standard for a potentially exposed or susceptible population, EPA shall apply prohibitions or restrictions necessary to ensure that the safety standard is met for that population.
  • The approach to persistent and bioaccumulative chemicals at Section 6(d)(2)(B) applies the approach (regarding high for one and high or moderate for the other of persistence or bioaccumulation) used in Section 5 including requiring imposition of exposure reduction actions to the “maximum extent practicable.”
  • Section 6(d)(5)(D), concerning the EPA analysis required in the case of an exemption for a ban or phase-out action, has been modified from that in Lautenberg2 to apply to both the proposed and final rules and to involve a determination by EPA of the technically and economically feasible and the most likely to be used alternatives. The changes are shown below in redline:In determining whether an exemption should be granted under this paragraph for a chemical substance for which a ban or phase-out is included in a proposed or final rule under paragraph (1), the Administrator shall take into consideration, to the extent practicable based on reasonably available information, the quantifiable and nonquantifiable costs and benefits of the 1 or more alternatives to the chemical substance the Administrator determines to be technically and economically feasible and most likely to be used in place of the chemical substance under the conditions of use if the rule is promulgated.
  • Finally, S. 697 includes a new Section 6(g) which states that EPA cannot extend any deadline for a high priority chemical otherwise listed on the 2014 update to the TSCA Work Plan “without adequate public justification” that demonstrates that the Agency cannot complete a SA and SD, or a final Section 6(d) rule without additional information.

In making these changes to Section 6, S. 697 has otherwise retained the following elements from Lautenberg2:

  • A SA and SD must be developed for all high-priority chemicals with deadlines including six months for publishing the scope of the assessment, three years for completing the SA and SD, and two years for promulgating any necessary final rule, with extensions possible for not more than two years due to the need for additional information.
  • EPA is to determine if the chemical meets or does not meet the safety standard and in the latter case shall impose necessary restrictions to ensure the standard can be met. If the safety standard cannot be satisfied, EPA is required to move to a ban or phase-out action. In the case of a chemical that is determined to meet the persistence and bioaccumulation requirement, control must be to the maximum extent practicable.
  • EPA is required to conduct and consider the results from regulatory analyses on the quantifiable and nonquantifiable costs and benefits of the proposed action and of the one or more primary alternative actions considered by EPA.
  • Various exemptions are available if requirements can be satisfied. These include an exemption which can be applied to replacement parts for articles.
  • There are also certain limitations on EPA in regulating articles.
  • EPA has some limited flexibility to extend deadlines for compliance with risk management actions (including as discussed above regarding Section 6(d)(2)(A)(ii) provisions).
  • SAs, SDs, and any final Section 6(d) rules are considered final agency actions.

Relative to S. 697, H.R. 2576 Section 6 requires preparation of an RE if EPA determines a chemical “may present an unreasonable risk … because of potential hazard and a potential route of exposure under the intended conditions of use.” In our Workability paper (cited above) we identified “potential route of exposure” and the entire “because” phrase as presenting issues. Also, as noted above, H.R. 2576 allows manufacturers to request and pay for REs. In addition:

  • Both bills deal with the “least burdensome” language in TSCA Section 6, and preclude consideration of cost/benefit aspects in their respective risk/safety evaluations.
  • Decisions not to proceed further with a chemical are considered final agency actions in both bills. This includes the “no unreasonable risk” determination in H.R. 2576 and the determination that a chemical “meets the safety standard” in S. 697.
  • The bills apply somewhat different risk management standards (although both include the concept of “unreasonable risk” in that standard), regulatory review (i.e., cost-benefit) analyses in taking risk management actions, and requirements for risk management of PBTs.
  • Although the specifics differ in some respects, both allow for risk management exemptions, including for replacement parts, and both limit EPA’s ability to regulate articles.
  • Both bills also include protection of vulnerable populations in their respective risk management standards.

Section 8. Information Collection and Reporting. The general approach to Section 8 in S. 697 is consistent with that in Lautenberg2, including the deadlines and time periods (such as the ten-year window for the Inventory reset), with changes adding new aspects and clarifying or making provisions more explicit. Key changes include:

  • Adding a new Section 8(a)(3)(C) that requires, within 180 days of enactment and every ten years thereafter, EPA to consult with the Small Business Administration regarding companies that quality as small manufacturers and processors.
  • S. 697 has revised Section 8(a)(4) from that in Lautenberg2. The provision requires that EPA, within 2 years, promulgate rules to obtain the “information necessary to carry out this title Sections 4 and 6” (redlining shows changes). The effect is to considerably broaden the provision.
  • S. 697 has slightly reworded but retains language in Section 8(a)(4)(A)(i) that would require reporting by processors of information needed by EPA to carry out the title. Manufacturers are also subject to this requirement.
  • Adding a new provision at Section 8(b)(4)(A)(iii) regarding the Inventory reset which makes explicit that EPA will designate chemicals with no reports under the reset as “inactive.”

S. 697 Section 8 also retains provisions in Lautenberg2 such as continued use of certain Inventory nomenclatures, the ability for companies to shift chemicals from the inactive list to the active list by notifying EPA in advance, requires companies to substantiate confidential chemical substance claims for chemical identity as well as EPA review of such claims, and disallows confidential claims for the identity of chemicals on the non-confidential portion of the Inventory.

H.R. 2576 proposes no changes to TSCA Section 8.

Section 14. Confidential Information. The approach to confidential information in S. 697 seems to be materially unchanged from that in Lautenberg2 other than some rewording and changes in subsection designations.

Relative to H.R. 2576, S. 697 is less clear in its protection of chemical identity information from disclosure; the House bill explicitly protects “molecular structure” information from disclosure. Both bills require assertion and substantiation of confidential information claims and limit the time period for protection unless claims are reasserted and resubstantiated. The Senate bill includes numerous additional provisions (unique identifier, requirements and deadlines applicable to EPA, and related provisions) that do not appear in H.R. 2576.

Section 18. State-Federal Relationship. S. 697 is largely similar to Lautenberg2 with some important changes related to the provisions concerning state-federal relationships or preemption.

There are no changes proposed to Section 18(a), that prohibits states from establishing or continuing to enforce statutes or administrative actions that would: (1) require testing similar to information required under TSCA Sections 4, 5, or 6; (2) restrict the manufacture, processing, or distribution in commerce or use of a chemical substance found to meet the Section 6 safety standard or found not to meet the safety standard after the effective date of the rule issued under Section 6(d); or (3) require notification of a use that is already subject to a Section 5 significant new use rule.

With regard to Section 18(b), setting forth effective dates for when states cannot establish statutes or administrative actions prohibiting or restricting the manufacture, processing, distribution, or use of high priority chemicals, the provisions of S. 697 for the most part align with Lautenberg2, with some distinctions. Under Lautenberg2, the timeframe within which states can regulate such chemicals was from the time the scope of the safety assessment is defined to the time when the safety determination is published. Under S. 697, the time frame is between when EPA defines and publishes the scope of a safety determination to the date on which the deadline established pursuant to Section 6(a) for completion of a safety determination expires, or on the date on which EPA publishes the safety determination under Section 6(a), whichever is earlier. By comparison, H.R. 2576 preempts once EPA makes a final determination under Section 6(b) that a chemical substance does, or does not, present an unreasonable risk of injury to health or the environment under the intended condition of use.

Section 18(c), describing the scope of preemption, is largely the same, except that S. 697 clarifies that preemption does not apply only to uses or conditions of use of applicable chemical substances but also to the “hazards, exposures, risks, and uses or conditions of use of such substances.”

The exceptions from preemption set forth in Section 18(d) are also similar to Lautenberg2 with one modification. It adds a new requirement that when a state or political subdivision of a state has assessed a penalty for a specific violation, EPA may not assess a penalty for that violation “in an amount that would cause the total of the penalties assessed for the violation by the State or political subdivision of a State and the Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16.” This appears to be a provision that was not included in Lautenberg2, but is included in H.R. 2576.

Section 18(e), which addresses the Preservation of Certain State Law, is unchanged from Lautenberg2, which preserves any state action taken before August 1, 2015, that prohibits or otherwise restricts manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance, as well as any action taken pursuant to a state law that was in effect on August 31, 2003.

With regard to the provisions in Section 18(f) establishing the criteria that EPA must determine are met for it to approve a state waiver application and exempt a statute or administrative action from preemption and the process under which EPA will review and either grant or deny a waiver application, there are several changes. First, S. 697 clarifies that for discretionary exemptions, one of the criteria to be satisfied is that the proposed requirement “is designed to address a risk of a chemical substance, under the conditions of use, that was identified (i) consistent with the best available science; (ii) using supporting studies conducted in accordance with sound and objective scientific practices; and (iii) based on the weight of the scientific evidence.” Although the terms are generally the same, this language arguably provides more clarity than the language in Lautenberg2, that stated only that the requirement be “consistent with sound objective scientific practices, the weight of the evidence, and the best available science.” In addition, S. 697 extends by 20 days the timeframe within which EPA must grant or deny a waiver for required exemptions, from 90 to 110 days after the date on which the application is submitted. With regard to judicial review of waivers, S. 697 removes provisions from Lautenberg2 related to the reinstatement of waivers and judicial review of low-priority decisions (but see Section 18 below), such that S. 697 states only that a waiver granted under paragraph (f)(2) or approved under paragraph (f)(9) shall remain in effect until such time that EPA publishes a safety determination. Finally, S. 697 removes a clause for when a petition for judicial review can be filed which stated that a petition could be filed not later than 60 days after the date on which EPA fails to make a determination under paragraph (f)(3), thus indicating that no judicial review is available for such determinations. H.R. 2576 has no provisions regarding waivers.

Section 19. Judicial Review. The provisions from Lautenberg2 related to judicial review of low-priority decisions that was removed from the preemption section has been added to the judicial review section, where it more likely belongs. S. 697 also retains one of the most significant legal changes from Lautenberg2, that is, altering the prescriptive definition in the current TSCA of the administrative record upon which judicial review of rules will be based, while retaining the same unusual standard of review “substantial evidence” rather than the more common “arbitrary and capricious” standard for such rules. The current TSCA establishes a hybrid form of judicial review in which a reviewing court utilizes the “substantial evidence” standard of review, that is typically reserved for formal rulemaking and adjudication, to review informal rulemaking. The substantial evidence standard is widely believed to be more demanding than the conventional “arbitrary, capricious, or abuse of discretion” standard of review. The language proposed in S. 697 also clarifies that judicial review applies not just to a rule but to a “rule or order.”

Section 26. Administration. The fee provisions in S. 697 are generally similar to those in Lautenberg2, although the language was tweaked in multiple areas, subsections were reorganized, and some of the numbers and specifics were changed. Of note, the cap on annual fees that can be collected has been changed from $18 million and now sets the fees to the lower of 25 percent of the costs of conducting the relevant activities or $25 million (S. 697 also allows this total amount to be adjusted for inflation). In addition, reporting under Section 8(a)(1), such as the Chemical Data Reporting (CDR) rule, would be subject to fees. Other changes include:

  • Section 26(b)(2)(D) has been reworded to soften a “shall” requirement: EPA “shall… (D) insofar as possible, not collect excess fees or retain a significant amount of unused fees” (redlining shows changes).
  • Deletes an explicit requirement in Section 26(b)(3)(A) that had required EPA to take its costs of conducting relevant activities into account in setting fees. Seemingly the text relies on other provisions that speak to the concept of accounting for EPA’s costs, particularly Section 26(b)(3)(B) and (D).

S. 697 thus retains earlier provisions allowing fee collection from manufacturers and processors for various activities including submitting Section 5 notices, certain Section 8 reporting (now including CDR reporting in addition to that for Inventory reset purposes), Section 4A prioritizations, Section 6 SAs, SDs, and risk management actions, and for chemical reviews requested by manufacturers and processors. The bill also retains a termination provision under which the fee authority is sunset after ten years unless reauthorized or modified by Congress.

Relative to S. 697, the approach to fees in H.R. 2576 is much narrower and lacks the detail and specifics found in the Senate bill. H.R. 2576, consistent with TSCA, limits fees to submissions under Section 4 and 5 (manufacturers can also request and pay for Section 6 REs as discussed above).

Section 27. Development and Evaluation of Test Methods and Sustainable Chemistry. S. 697 has substantially changed the approach from that outlined in Lautenberg2 concerning development and implementation of federal efforts relating to sustainable chemistry. The new scheme includes the following:

  • The Office of Science and Technology Policy (OSTP) is to convene a National Coordinating Entity (Entity) for Sustainable Chemistry made up of various federal entities and chaired by the Director of the National Science Foundation (NSF) and the EPA Assistant Administrator for the Office of Research and Development (ORD). The Entity has several duties including:
    • Those related to establishing the Sustainable Chemistry Initiative (described in detail in Section 27(d));
    • Development of a national strategy for sustainable chemistry;
    • Supporting establishment, through financial, technical, and other assistance, of partnerships between academia, nongovernmental organizations, and companies to advance research, training, development of curricular materials and courses, etc.;
    • Reporting to Congress two years after enactment of S. 697 on the Entity’s efforts and progress; and
    • Submitting an implementation plan for sustainable chemistry to Congress three years after enactment.
    There is no corresponding provision in H.R. 2576.

Section 29. Elemental Mercury. This is an entirely new provision relative to Lautenberg2, that amends Section 5 of the Mercury Export Ban Act of 2008. The Act was intended to reduce the availability of elemental mercury in domestic and international markets. Section 29 amends the Act to, among other changes, extend the date by which a facility or facilities intended to manage and store elemental mercury generated in the U.S. are to be “operational” from 2013 to 2019.

There is no corresponding provision in H.R. 2576.

Section 30. Trevor’s Law. This is an entirely new provision relative to Lautenberg2, although it is similar to provisions appearing in the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act introduced by Senators Boxer and Markey in March 2015. That bill had focused the provision on investigations of disease clusters, while Section 30 now focuses on helping federal investigations of potential cancer clusters. Section 30 amends Part P of Title III of the Public Health Service Act implemented by the Department of Health and Human Services.

There is no corresponding provision in H.R. 2576.