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TSCA Modernization Disputes Continue with Revised House Republican Discussion Draft

Beveridge & Diamond, P.C., May 21, 2014

Despite diminishing chances for enactment this Congress, Republicans in the House of Representatives have continued their work on the Chemicals in Commerce Act (CICA), their proposal to modernize the Toxic Substances Control Act (TSCA)  that was originally released on February 27, 2014.  (For more details on the  CICA, please see our earlier client alert.[1])  Rep. John Shimkus (R-IL), Chairman of the Environment and the Economy Subcommittee of the House Energy and Commerce Committee, released a revised discussion draft on April 22 and held a hearing on April 29.[2]  Although the new draft includes some significant revisions, it has not quieted controversies regarding preemption of state and local laws, appropriate safety standards, deadlines and quotas, risk management options, and other contentious issues.  These controversies were demonstrated vividly at the April 29 hearing. 

Changes in New House Discussion Draft

Among other changes, the revised discussion draft differs from the February 2014 draft in the following respects:

Testing and Information Gathering, §§ 4 and 8

  • In section 4, the revised draft expands the grounds on which EPA could require testing.  Under the revision, EPA could require development of information whenever needed for designation of chemical substances as high or low priority. 
  • The revised draft requires EPA to take burden-limiting measures in implementing TSCA section 8 information gathering to limit the potential for duplication in reporting requirements, minimize the impact of rules on small manufacturers and processors, and ensure that the rules impose reporting obligations only on the entities most likely to have relevant information.

New Chemicals, § 5

  • In section 5, the revised draft changes the standard for imposition of restrictions on a new chemical substance from “likely to result in an unreasonable risk” to “may present an unreasonable risk,” language which appears in TSCA today.  It also adds a standard that requirements and restrictions on new chemicals be imposed “to the extent necessary to protect adequately against an unreasonable risk.”

Existing Chemicals, § 6

  • In section 6 and conforming changes throughout, the revised draft changes the term “safety determination” to “risk evaluation.”
  • For the standard for designation of a chemical as “low priority” and as the general standard for risk evaluation of existing chemicals, the term “unreasonable risk” is changed to “significant risk”.  The term “significant risk” is not defined, but it may be intended to refer to the “significant risk” standard articulated by the Supreme Court in the OSHA context.[3]  The “unreasonable risk” terminology is retained in the section 5 provisions for new chemicals, the section 6 provisions for risk management rules, and elsewhere.  Some observers have objected to this terminology on the basis that it is too similar to current TSCA and would therefore fail to correct deficiencies in current law.
  • The revised draft also changes the manner of assigning priorities for risk evaluations, including by imposing a greater emphasis on obtaining available information and accounting for potentially exposed subpopulations. However, limited availability of relevant information is no longer a factor toward designating a chemical substance as a high priority; rather, it is a ground for development of additional information.  The revised draft preserves the feasibility standard for timing of prioritization, rather than setting express deadlines.
  • A provision from the initial draft expressly declaring low priority chemicals not subject to risk evaluation/safety determination was removed.  However, the new draft still requires EPA to conduct risk evaluations only on high priority chemicals.  A new provision allows EPA at any time to conduct an “alternative risk evaluation” on a chemical substance that is not designated as high priority at any time, but such alternative risk evaluations are subject to no deadlines.  EPA may also reconsider risk evaluations to account for new information as it deems necessary.  The revised draft also imposes a deadline for completion of risk evaluations 4 years after designation as high priority, subject to extension.
  • The revised draft makes changes to the substantive requirements for risk evaluations.  It removes references to “best available science” and sets forth a standard of “presents or will present, in the absence of regulation under subsection (c), a significant risk of harm to human health or the environment under its intended conditions of use” (changed from “will result in an unreasonable risk”).  The revised draft more clearly prohibits EPA from considering economic costs or benefits in the risk evaluation.
  • The revised draft imposes a deadline for EPA to issue a risk management rule within 3 years of a risk evaluation determining that a chemical substance presents or will present a significant risk, subject to extension.  Any extensions for the risk evaluation and/or risk management rule for a chemical substance could be a cumulative maximum of 3 years.  A finding of no significant risk would be considered a final agency action, but a finding of significant risk would only be considered a final agency action upon the issuance of the final risk management rule. 
  • The revised draft overall slightly expands EPA’s authority to regulate chemicals found to present a significant risk.  It would require that risk management requirements or restrictions under TSCA section 6(c) be those that EPA “determines are necessary to protect adequately against an unreasonable risk of harm.”  The previous draft had no such standard.  EPA would no longer have to find that its risk management standards would be proportional to the risks or would result in net benefits, but would still have to find that they were “cost-effective,” although not specifically in comparison to reasonable alternatives.  “Reasonably available,” “economically feasible alternatives” would have to be considered if EPA decided to prohibit or substantially prevent a specific use of a chemical substance.  EPA would also have to provide for a reasonable transition period for implementation.
  • The revised draft expands the exemption from section 6 risk management to include any vehicular replacement parts, regardless of when they are manufactured. 
  • EPA would have to establish guidance, after notice and opportunity for public comment, regarding how to account for aggregate exposures in carrying out TSCA section 6. 

Preemption

  • The revised draft leaves the preemption provisions largely unchanged, except that only new, and not existing, state or local restrictions on a chemical substance’s intended conditions of use would be preempted on the basis of designation of that chemical substance as low priority.

Other Provisions

  • In section 14 on confidential information, the revised draft adds a provision that “health and safety information” does not include specific chemical identity for purposes of exemptions to protection from disclosures.
  • In general, the revised draft expands the scope of “intended conditions of use” to expressly include disposal conditions.
  • The import certification provisions would be essentially aligned with their present scope, whereas the previous draft would have narrowed their applicability.
  • While references to “best available science” have been removed, the revised draft adds a general requirement to base all decisions under TSCA on the weight of the scientific evidence.  The section 26 information quality standards would be revised to provide, as “scientific standards,” a set of factors which EPA would be required to consider, such as uncertainty characterization, independent validation, and consistency of the methods and procedures with the intended application. 

Reactions to the Revised Discussion Draft

The revised discussion draft makes some changes that clearly respond to Democratic and NGO comments on the prior draft.  These include the risk evaluation and risk management rule deadlines, expansion of testing for prioritization purposes, provisions on aggregate exposures, the use of the term “significant risk” instead of “unreasonable risk” in section 6, the removal of the requirement that risk management actions under section 6 be “proportional” or provide “net benefits,” and the elimination of preemption of existing state or local laws based on designation of a substance as low priority.  However, the fundamental structure of the CICA remains unchanged, including controversial provisions regarding preemption, cost effectiveness, and the safety standard. 

While lauding Rep. Shimkus’s efforts and recognition of the need for TSCA modernization, Democrats have expressed opposition on many of these grounds and more.  Reps. Henry Waxman (D-CA) and Paul Tonko (D-NY), Ranking Members of Committee and Subcommittee, respectively, released a letter asserting that the draft preemption language in the CICA would preempt a variety of state laws regulating the practice of hydraulic fracturing.[4]  In addition, Attorneys General from thirteen states also submitted a letter opposing the CICA, saying that “the draft bill’s broad preemption language would effectively eliminate the existing federal-state partnership on the regulation of toxic chemicals by preventing states from continuing their successful and ongoing legislative, regulatory and enforcement work that has historically reduced the risks to public health and the environment posed by toxic chemicals.”[5]

In testimony at the April 29 hearing, Jim Jones, Assistant Administrator of the EPA Office Of Chemical Safety And Pollution Prevention, expressed his view that the discussion draft was not aligned with the Obama Administration’s “Essential Principles for Reform of Chemicals Management Legislation.”  He highlighted, in particular, the absence of deadlines or a mechanism for timely review of existing chemicals; his interpretation of the safety standard as being too similar to that of current TSCA; and new chemical provisions that do not require EPA to conclude that chemicals are safe before allowing them on the market.  He also critiqued the scope of the provisions for risk management for new chemicals, asserting that they do not contain the full range of risk management options as under current law, such as workplace protections.  He did concede, however, that the draft CICA would allow EPA to restrict methods of commercial use of the chemical substance.  This authorization arguably does encompass workplace protections and other risk management strategies under the long-accepted broad interpretation of the term “use” in the context of significant new use rules. 

Other witnesses at the hearing critical of the CICA emphasized the lack of definition of “significant risk”; the requirement for risk management to be “cost effective,” which some stakeholders view as uncomfortably close to the existing law’s “least burdensome” requirement; and, especially, the draft CICA’s broad preemption provision. 

Context and Senate Bill; Next Steps

The CICA is likely to be further revised before being introduced for markup, possibly as early as this month.  It is unclear whether it will have Democratic co-sponsors when introduced.

In the Senate, no revisions to the bipartisan Chemical Safety Improvement Act (CSIA), S. 1009, have yet been released, but discussions are ongoing.  Sen. David Vitter (R-LA), Ranking Member of the Senate Environment and Public Works Committee, recently announced additional support for the CSIA from the National Hispanic Medical Association and five labor groups.[6]  Sen. Vitter is working across the aisle with Sen. Tom Udall (D-NM), Chairman of the Subcommittee on Superfund, Toxics and Environmental Health.  The CSIA has been controversial as well, however. 

The time remaining in the 113th Congress is short.  Given the continuing controversies with the CSIA and the draft CICA, it is increasingly likely that TSCA modernization efforts will roll over yet again to another Congress. 

For more information on the CICA discussion draft, CSIA, or issues related to TSCA generally, please contact Mark Duvall at mduvall@bdlaw.com, or Andie Wyatt at awyatt@bdlaw.com.

For a PDF version of this alert, please click here.

Beveridge & Diamond’s Chemicals, Products & Nanotechnology Practice Group provides strategic, business-focused advice to the global chemicals industry. Working alongside our clients’ legal, EHS and technical teams, we help resolve critical environmental and sustainability issues relating to their facilities, products, and operations.

We work with large and small chemical companies from industries including basic and specialty chemicals, pharmaceuticals, electronics, crop protection, food contact materials and additives, and consumer products, and have substantial experience representing clients whose products and activities are subject to EPA's broad chemical regulatory authority under the Toxic Substances Control Act.


[1] Beveridge & Diamond, P.C., “House Republicans Release Draft TSCA Modernization Legislation,” March 6, 2014, http://www.bdlaw.com/news-1571.html; see also Chemicals in Commerce Act, H.R. __ [Discussion Draft, Feb. 27, 2014], available at http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/CICADD.pdf. [2] House Energy and Commerce Committee, Chemicals in Commerce Act, https://energycommerce.house.gov/hearing/chemicals-commerce-act-0 (linking background memo, revised Discussion Draft and redline comparison, opening statements, witness testimony, and hearing video and transcript).
[3] Industrial Union Dep’t, AFL-CIO v. API, 448 U.S. 607 (1980) (the Occupational Safety and Health Act of 1970 “requires the Secretary, before issuing any standard, to determine that it is reasonably necessary and appropriate to remedy a significant risk of material health impairment . . . . [T]he requirement that a ‘significant’ risk be identified is not a mathematical straitjacket.  It is the Agency’s responsibility to determine, in the first instance, what it considers to be a ‘significant’ risk.  Some risks are plainly acceptable and others are plainly unacceptable.  If, for example, the odds are one in a billion that a person will die from cancer by taking a drink of chlorinated water, the risk clearly could not be considered significant.  On the other hand, if the odds are one in a thousand that regular inhalation of gasoline vapors that are 2% benzene will be fatal, a reasonable person might well consider the risk significant and take appropriate steps to decrease or eliminate it.  Although the Agency has no duty to calculate the exact probability of harm, it does have an obligation to find that a significant risk is present before it can characterize a place of employment as ‘unsafe.’” (emphasis added)).
[4] Letter from Rep. Waxman and Rep. Tonko to Rep. Shimkus, Apr. 28, 2014, available at http://democrats.energycommerce.house.gov/sites/default/files/documents/Shimkus-Chemicals-in-Commerce-Act-Bill-Language-2014-4-28.pdf.
[5] Letter from Attorneys General to Rep. Shimkus and Rep. Tonko re Chemicals in Commerce Act Draft Bill, Apr. 17, 2014, available at http://www.ag.ny.gov/pdfs/ltr_house_subcmmtee_ldrs_f_w_ex.pdf.
[6] Sen. David Vitter, Press Release, Vitter Announces Growing Support for Bipartisan Chemical Safety Reform Bill, Apr. 15, 2014, http://www.vitter.senate.gov/newsroom/press/vitter-announces-growing-support-for-bipartisan-chemical-safety-reform-bill.