The TSCA Modernization Act of 2015: Assuring High Quality Science

July 31, 2015

With the Toxic Substances Control Act (TSCA), the primary federal chemical safety law, approaching its 40thyear, all of its constituents (industry, consumers and regulators) are in agreement that it needs to be modernized, albeit with some disagreement as to the particular contours of such reform.

Present Legislative Status

Earlier attempts at TSCA reform having failed to come to fruition, the present Congress is again tackling the matter and has made substantial progress, with the House passing the “TSCA Modernization Act of 2015” (H.R. 2576), by a vote of 398-1, on June 23, 2015.  The bill has been referred to the Senate.

The Senate’s version of a TSCA reform bill, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” (S. 697), was reported out of the Committee on Environment and Public Works (EPW), on June 18, 2015, by a vote of 15-5.  Senators Boxer (D-CA), Cardin (D-MD), Sanders (I-VT), Gillibrand (D-NY) and Markey (D-MA) voted nay and presented minority views to the Committee Report, including criticisms that: (i) States be allowed to regulate chemicals prior to the time at which the Environmental Protection Agency (EPA) issues its rule; (ii) S. 697 fails to adequately prioritize the chemicals to be assessed, and fails to provide for a sufficient number of timely assessments; and (iii) does not provide a sufficiently broad standard to trigger regulation of a chemical .  Senators Boxer and Markey had separately introduced the “Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act” (S. 725), however, this bill was not reported out of the Committee and several amendments offered to S. 697, comprising facets of S. 725, were rejected by the EPW.

In a June 23, 2015 press release, the American Chemistry Council urged Senate leadership to bring S. 697 to the floor for a vote, with its passage thereafter leading to a Conference with the House and delivery of “a much-needed update to TSCA as well as a major environmental and commercial policy accomplishment to the President’s desk for his signature this year.”  Somewhat to the contrary, Senator Boxer, the EPW Ranking Member, has informed Representative John Shimkus (R-IL), Chairman of the House Energy and Commerce Committee’s Subcommittee on Environment and the Economy, that “because of the clarity, simplicity, and overwhelming bipartisan support in the House for H.R. 2576, she would push for the Senate to take up the House bill with a few perfecting amendments,” noting that if S. 697 were to be taken up by the full Senate, she would anticipate “a long, drawn-out process and that she would object at every opportunity because it is convoluted and will lead straight to the court house door.”  (Senator Boxer’s Statement on the Path Forward on TSCA Reform Legislation, June 26, 2015)  Senator Boxer pointed to opposition of the Senate bill and support for the House legislation as the framework for TSCA reform, and a view expressed by the Safer Chemicals Healthy Families coalition that the “simplest path . . . would be to simply fix the House bill in [a] few targeted ways.”

Risk Evaluation According to High Quality Science

At the heart of TSCA, and the present attempts at its modernization, is the who, what, and how of chemical safety assessment.  As expressed by a Past President of the Society of Toxicology,

At its core, TSCA is about protection of human health and the environment through the evaluation and regulation of chemicals in commerce. Evaluation of chemical hazard and risk fundamentally involves toxicological sciences. SOT is deeply committed to providing knowledge and working with all stakeholders so that sound, progressive and protective TSCA legislation will emerge in 2015.

Norbert E. Kaminski, TSCA Reform Should Embrace the Best Application of Toxicological Science — a Perspective From its Practitioners, Roll Call, Feb. 6, 2015.  Likewise, the American Chemistry Council sets forth among its “10 Principles for Modernizing TSCA”:

  • EPA should rely on scientifically valid data and information, regardless of its source, including data and information reflecting modern advances in science and technology.
  • EPA should establish transparent and scientifically sound criteria for evaluating all of the information on which it makes decisions to ensure that it is valid, using a framework that addresses the strengths and limitations of the study design, the reliability of the test methods, and the quality of the data.
  • EPA should encourage use of good laboratory practices, peer review, standardized protocols, and other methods to ensure scientific quality.

Accordingly, as described in the House Committee report, among the intent and purposes of H.R. 2576 are to “restructure[e] the way existing chemicals are evaluated and regulated” and “assur[e] high quality science is used by [EPA].” H.R. REP. NO. 114-176, at 32 (2015).

Under the current law, the EPA Administrator, upon finding “a reasonable basis to conclude” that a chemical “presents or will present an unreasonable risk of injury to health or the environment,” may proscribe the manufacture and use of such chemical by, among other actions,  prohibition, limitation on use, and/or compulsory warnings and notices.  15 U.S.C. § 2605(a).  In determining to issue such a rule, the Administrator is required to consider:

(A) the effects of such substance or mixture on health and the magnitude of the exposure of human beings to such substance or mixture,

(B) the effects of such substance or mixture on the environment and the magnitude of the exposure of the environment to such substance or mixture,

(C) the benefits of such substance or mixture for various uses and the availability of substitutes for such uses, and

(D) the 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.

15 U.S.C. § 2605(c).  But, the process for such determinations in not fully delineated.

The TSCA Modernization Act revises and improves the paradigm for triggering chemical regulation, requiring the EPA Administrator to conduct a “risk evaluation” in accordance with specific guidance and criteria.  H.R. 2576, §4(b) (amending15 U.S.C. § 2605(b)).   A risk evaluation shall be conducted if “the Administrator determines that the chemical substance may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use,” or a manufacturer requests a risk evaluation.  Id., §4(b)(3)(A) (amending15 U.S.C. § 2605(b)).  The risk evaluation shall:

(A) integrate and assess information on hazards and exposures for all of the intended conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed subpopulations;

(B) not consider information on cost and other factors not directly related to health or the environment;

(C) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical substance;

(D) describe the weight of the scientific evidence for identified hazard and exposure; [and]

(E) consider whether the weight of the scientific evidence supports the identification of doses of the chemical substance below which no adverse effects can be expected to occur.

Id., §4(b)(4) (amending15 U.S.C. § 2605(b)).  (Also, in the event that a risk evaluation is requested by a manufacturer, the manufacturer is required to bear EPA’s costs.)

The focus on the “likely duration, intensity, frequency, and number of exposures” and threshold dose reflect the toxicological tenet that “the poison is in the dose”—which is, again, at the heart of chemical regulation, to determine what is a poison and what is not.  Further sensitivity is provided in these evaluations by emphasizing the need to evaluate: (i) the “intended conditions of use,” defined as “the circumstances under which a chemical substance is intended, known, or reasonably foreseeable to be manufactured, processed, distributed in commerce, used, and disposed of”; and (ii) “potentially exposed subpopulations,” defined as “a group of individuals within the general population who, due to either greater susceptibility or greater potential exposure, are likely to be at greater risk than the general population of adverse health effects from exposure to a chemical substance.”   Id., §2 (amending15 U.S.C. § 2602, adding new paragraphs (7) and (11)).

Corresponding with the foregoing requirements for a risk evaluation, the TSCA Modernization Act also explicitly imposes “Scientific Standards” on EPA’s decision-making, so that the Administrator must consider:

(1) the extent to which the scientific and technical procedures, measures, methods, or models employed to generate the information are reasonable for and consistent with the use of the information;

(2) the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture;

(3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented;

(4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, or models, are evaluated and characterized; and

(5) the extent of independent verification or peer review of the information

or of the procedures, measures, methods, or models.

Id., §8 (amending15 U.S.C. § 2625, adding new subsection (h)).  Decision-making is to be “based on the weight of the scientific evidence.”  Id., §8 (amending15 U.S.C. § 2625, adding new subsection (i)).

As explained in the Committee report, imposing these requirements on EPA “to consider the quality of the science it is using” is fundamental to chemical regulation—”The Committee believes that high quality science is the foundation of good public policy.”  H.R. Rep. No. 114-176, at 32 (2015).  The Committee further emphasizes the need for sound scientific determinations:

The criteria in new TSCA section 26(h) are drawn from EPA’s June 2003  “A summary of General Assessment Factors for Evaluating the Quality of Scientific and Technical Information.”  The Committee believes this is a good baseline for the Agency to use in making scientific evaluations for the provisions of TSCA Title I.  These factors relate to the soundness of the means used to generate information, its appropriateness for its intended use, the relevance of the information to the question being asked, the degree of the data’s clarity and completeness, the extent of variability and uncertainty in the underlying data, methods, or analysis of the data, and the use of independent verification, reliable study methods, and peer review.

In addition to these information quality guidelines, the legislation creates a new TSCA section 26(i), which requires the Administrator to make decisions based upon the weight of the scientific evidence.  The term “weight of evidence” refers to a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance. This requirement is not intended to prevent the Agency from considering academic studies, or any other category of study. The Committee expects that when EPA makes a weight of the evidence decision it will fully describe its use and methods.

Id., at 32-33.

Importantly, in addition to the primary goal of ensuring appropriate regulatory decision-making, the process mandated by the “risk evaluation” requirements and “scientific standards” also facilitates potential judicial review of rules promulgated under TSCA, because the “rulemaking record” upon which such judicial review would be based (see 15 U.S.C. § 2618(a)) will be fulsome and transparent.  Put another way, the mandate for “high quality science [as] the foundation of good public policy” will also be enforceable by the courts.

Preemption

One of the other contentious issues in the TSCA reform debate has been preemption.  Dissatisfied with the progress of chemical regulation under the current federal scheme, state regulators have increasingly resorted to state regulation of chemicals.  The propriety of federal preemption, however, is made clear by the TSCA Modernization Act’s mandate for high quality science; that is, the science is the science, and if it is done properly—as the process is spelled out in H.R. 2576—then it only needs to be done once.  From a practical standpoint, moreover, this avoids the inefficiencies and costs of multiple reviews, and the consequences of inconsistent findings.

Chemical Litigation

Lastly, as a few observations on the effect of TSCA reform on chemical litigation, initially, H.R. 2576 explicitly provides that findings made under TSCA should not influence the disposition of any civil action or affect the admissibility of evidence:

It is not the intent of Congress that this title, or rules, regulations, or orders issued pursuant to this title, be interpreted as influencing, in either a plaintiff’s or defendant’s favor, the disposition of any civil action for damages in a State court, or the authority of any court to make a determination in an adjudicatory proceeding under applicable State law with respect to the admissibility of evidence, unless a provision of this title actually conflicts with the State court action.

H.R. 2576, §7(b) (amending15 U.S.C. § 2617, adding subsection (c)(3)); see also H.R. Rep. No. 114-176, at 31 (2015) (“Title I of TSCA should not be interpreted as influencing civil actions for damages in State court, or the admissibility of evidence under State law”).  Notwithstanding this admonition, it can be expected that plaintiffs would continue to rely upon regulatory decisions under TSCA as proof of causation.  EPA’s adherence to the risk evaluation process, described above, would seemingly provide a record by which to effectively refute such reliance; for example, by contrasting the exposure facts of a particular plaintiff with the exposure factors/presumptions upon which EPA relied in making its finding (see H.R. 2576, §4(b)(4)(C) (requiring EPA to “take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical substance” in its risk evaluation)).

Conclusion

By predicating TSCA regulation on “high quality science,” as set forth in the TSCA Modernization Act of 2015, Congress has truly modernized chemical regulation for the benefit of all stakeholders.

Reprinted with permission from the DRI – The Voice of the Defense Bar.  All rights reserved.

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