Bipartisan Proposal May Pave a Path Forward for Federal Chemical Regulation Reform
To the surprise of many, on May 22, 2013, US Senators Frank Lautenberg (D-NJ) and David Vitter (R-LA) announced a bipartisan bill â€“ the Chemical Safety Improvement Act (CSIA) â€“ to modernize the federal Toxic Substances Control Act of 1976 (TSCA).Â TSCAâ€™s approach to regulating chemical safety may have been novel when enacted nearly four decades ago, but in the years that followed, many have argued that it has proved to be largely ineffective.Â In the absence of TSCA modernization, as science and policy have matured, many states have moved ahead with their own rules, focused primarily on chemicals in consumer goods.Â While tirelessly advanced by the late Sen. Lautenberg, TSCA reform legislation has languished in Congress for nearly ten years.Â This time may be different, however. The bill is cosponsored by more than a dozen Democrat and Republican senators and quickly drew support from a wide range of industry and environmental organizations, from the American Chemistry Council to the Environmental Defense Fund. As a bipartisan proposal, the Chemical Safety Improvement Act raises the encouraging prospect that a path forward for chemical regulation reform may now have been paved, even though some bumps along the way may still lie ahead.
Despite initial and wide-ranging praise for the legislation, it is not universal. The legislation has drawn complaints from some states and public interest groups, and it is not evident that it has the support of some key players, such as Senator Barbara Boxer (D-CA), chair of the Senate Committee on Environment and Public Works, who is notably absent from the billâ€™s sponsors. The unfortunate and untimely death of Sen. Lautenberg, less than two weeks after the billâ€™s announcement, can only make bridging differences more difficult.
Nonetheless, the bipartisan proposal presents an encouraging opportunity for national chemical regulatory reform and can serve to focus the debate.Â Key elements of the legislation include:
Safety Assessments for All Chemicals: All new and existing chemicals would be evaluated against a new, risk-based safety standard that â€śensures that no unreasonable risk of harm to human health or the environment will result from exposure to a chemical substanceâ€ť under the intended conditions of use.Â In making these judgments, EPA would be required to make use of best available science, and consider the special risks posed to vulnerable subpopulations, such as children and pregnant women. A chemical judged to have either high hazard or high exposure (relative to other chemicals) would receive a comprehensive assessment and safety determination against the new standard. Chemicals determined not to meet the safety standard under their intended use conditions would be subject to chemical-specific restrictions, from recordkeeping to use restrictions to total bans.
Testing: The proposed legislation would simplify the process, allowing EPA to compel manufacturers and processors to conduct hazard testing.Â Current rules require rulemaking, substantial evidence of risk, and express consideration of a large number of other factors before EPA can compel testing.Â In contrast, under the proposed legislation, EPA would only need to determine that the data is necessary for it to conduct a safety assessment or determination.Â Easing these restrictions to make better risk assessment data available has been a principal aim of reform efforts.
New Chemicals:Â The procedures for premanufacture review of new chemicals would be largely unchanged.Â Unlike European models, such as REACH, and earlier TSCA reform proposals, US manufacturers of new chemicals would not be required to conduct any upfront chemical hazard testing.Â As under current rules, EPA would be required to complete an initial safety assessment of proposed new chemicals within 90 days, based only on what can be inferred from available, existing data on the chemical and analogues.Â More comprehensive review would occur after the chemical is on the market, prioritized among existing chemicals.
Preemption: A principal factor driving industry support of TSCA reform is the desire to simplify the patchwork of state chemical control laws, which TSCA allows but which also complicates nationwide product marketing.Â The CSIA could preempt many state and local chemical control laws.Â For example, states could not compel companies to develop test data on a chemical if the same information was likely to be required under federal rules.Â Similarly, states could not enforce new or existing restrictions on uses of a particular chemical after the chemical has completed a federal safety review, and could not enforce new restrictions on a chemical already prioritized for a future federal safety determination.Â States would be able to petition EPA to waive preemption of particular state laws under limited circumstances, such as if federal assessment was delayed, the state had a compelling local environmental or public health interest in the matter, and the state can show that its requirements were grounded in reasonable scientific concern and would not unduly burden interstate commerce.
Preemption, in particular, is likely to be an important focus of future debate.Â Although a key inducement for industry support, the preemption provisions of the bill have drawn strong opposition, which has since tarnished some of the initial luster of its bipartisan introduction.Â Among the discontented is the California Department of Toxic Substances Control (DTSC), with concerns that the legislation may preempt Californiaâ€™s proposed landmark green chemistry regulation, the Safer Consumer Products Regulation.
On the other hand, despite concerns with protecting state chemical initiatives, a modern, nationwide chemical assessment and control program, without the patchwork of diverse state and local requirements, may be the key to achieving comprehensive, effective chemical regulatory reform not only at the federal level, but among states as well.Â For instance, Californiaâ€™s Proposition 65, with its bounty hunter litigation approach to chemical regulation, is now widely recognized as being in need of reform, with California Governor Jerry Brown recently initiating a campaign to do so.Â And the launch of Californiaâ€™s green chemistry regulations, which will impact manufacturers nationwide, has been delayed for years by strong criticism from all perspectives, including from as far afield as the European Union.Â While it appears that DTSC is preparing to soon issue its regulation, in its recent Economic and Fiscal Impact Statement, the agency nevertheless found the total statewide benefits of its regulation and the cost for industry were unknown.Â In turn, this may serve as further ammunition for preemption supporters.
The late Senator Lautenberg, who worked up until his last days to improve the nationâ€™s chemical laws, may have reckoned that the proposed bipartisan compromise embodied in the Chemical Safety Improvement Act presented the best path forward for achieving TSCA reform.Â Now, only the future holds the answer as to whether the debate will stay on the course he charted.
Peter R. Duchesneau is a partner in the Los Angeles office of Manatt, Phelps & Phillips, LLP.Â His practice focuses on environmental law involving litigation, administrative proceedings, regulatory compliance and business transactions.Â He holds a B.S. degree in Chemical Engineering, is admitted to practice before the U.S. Patent and Trademark Office, and has significant experience with emerging chemicals and counseling clients on regulatory compliance involving green chemistry and other matters. Mr. Duchesneau can be reached at (310) 312-4209 or firstname.lastname@example.org.
James G. Votaw is a partner in the Washington, D.C. office of Manatt, Phelps & Phillips, LLP. His practice focuses on conventional, nanoscale, industrial, pesticidal and specialty chemical product regulation, policy and approval matters; environmental, health and safety law compliance auditing and enforcement defense, and associated business counseling and litigation issues.Â Mr. Votaw can be reached at (202) 585-6610 or email@example.com.
This column is part of a series of articles by law firm Manatt, Phelps & Phillips, LLPâ€™s Energy, Environment & Natural Resources practice. Earlier columns in the third edition of this series discussed Efforts to Address Climate Change and What the Sequester Means for Environmental Regulation.
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