My most recent blog provided a short summary of chemical evaluation and reporting requirements under the Toxic Substances Control Act (TSCA) of 1976. These requirements apply when a manufacturer or importer is preparing to introduce a “new chemical substance” into commerce in the U.S., to provide the Environmental Protection Agency (EPA) with information to evaluate whether chemical hazards require regulatory restrictions (up to and including outright bans) to provide adequate protections to human health and the environment. TSCA does not include any blanket requirement for ongoing studies or updated evaluations of an “existing chemical substance” after it has entered commerce—including those already in commerce when TSCA took effect, so some chemicals have never undergone a regulatory review of their hazards.
Many environmental and health advocates view TSCA’s lack of blanket review requirements as a critical shortcoming. Other advocates, including most industry representatives, point to evaluation and review requirements incorporated by EPA into targeted review programs under TSCA (which I also identified in my last blog), and other environmental health and safety (EH&S) protection laws—Occupational Safety and Health Act, Clean Air Act, Resource Conservation and Recovery Act, etc. These disagreements appear as political controversy, producing years of hearings before Congressional committees, and failed legislative amendments.
Earlier this month, 17 U.S. Senators introduced the latest TSCA reform bill—the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” (S.697) The primary authors are New Mexico Democrat Tom Udall and Louisiana Republican David Vitter, who have spearheaded two years of review, hearings, and negotiations. Senator Frank Lautenberg was a New Jersey Democrat who spent many years attempting to develop and pass amendments to TSCA.
It’s impossible to judge the legislative prospects for S.697, but the bill starts with some significant bipartisan support in the Senate (8 Democrats and 9 Republicans), general support from industry, and at least some support from environmental groups (the national organization Environmental Defense Fund supports it, while Earthjustice opposes it). States have yet to weigh in, but it’s important to note that this bill curtails preemption provisions from earlier initiatives that drew state opposition.
The remainder of this blog provides a short summary of the most important proposed revisions to TSCA—the bill itself is 175 pages long, so interested readers should follow the links at the end of this blog and conduct their own detailed review.
How Would S.697 Revise TSCA?
As introduced, the bill offers important revisions to TSCA’s regulatory framework, including:
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Eliminates the requirement that EPA select the “least burdensome” option for restricting a chemical it determines poses an “unreasonable risk” to human health or the environment, and instead directs the agency to consider only the risks, not the cost to address the risks.
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Adds requirement that EPA consideration of risks identifies risks to exposed and vulnerable populations, specifying these to include at least infants, children, pregnant workers, and the elderly.
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Directs EPA to adjust its TSCA Inventory to distinguish “active” chemical substances from “inactive” chemical substances, and to undertake the following regulatory actions.
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Creates the new term “safety standard” as the standard necessary to ensure that a chemical does not pose an “unreasonable risk” to human health or the environment.
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New chemical substances can only be commercialized (i.e., after Premanufacture Notice or Sigificant New Use Notice) if EPA determines the chemical is likely to meet the applicable safety standard.
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Directs EPA to create a risk screening process (within 1 year after enactment) to identify “high priority” substances that may exceed an applicable safety standard, and “low priority” substances that EPA determines will not exceed an applicable safety standard, for purpose of safety assessments and determinations, and possible regulation.
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Provide interim designation of at least 10 chemicals in each priority within 180 days after enactment.
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Designate at least 20 chemicals in each priority within 3 years.
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Designate at least 25 chemicals in each priority within 3 years.
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At least half of designated chemicals must be those on EPA’s TSCA Work Plan, until all those chemicals have been designated.
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Complete evaluation of all chemicals “in a timely manner” (note there is no firm deadline)
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As each high priority chemical is assessed, designate another to take its place.
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Gives EPA explicit authority to obtain chemical information at every stage of safety evaluations.
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Requires substantiation of confidential business information (CBI) claims when made, and limits effective period for such claims to 10 years (renewable).
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Clarifies and limits TSCA preemption of state regulation of chemicals.
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No additional preemption of any state regulation enacted prior to 2015.
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No preemption of state regulation until EPA has addressed the same use(s) for the same chemical.
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Once EPA establishes a new standard, that standard applies nationwide and preempts inconsistent state requirements.
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Expands provisions allowing EPA to charge fees (goal is to recover 25% of program costs); Manufacturers can pay 100% of costs to accelerate review (“additional priority” program).
Self-Evaluation Checklist
Does the organization manufacture, import and/or process and “any chemical substance” subject to TSCA?
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Did the organization meet PMN/SNUN requirements applicable to each chemical substance when it was introduced?
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Does the organization comply with any subsequent information requirements under TSCA programs (PAIR, Section 8(e), etc.)?
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Does the organization incorporate chemical information, including information developed to meet TSCA requirements, into disclosures and compliance requirements under other applicable EH&S programs?
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Has the organization developed additional information subsequent to initial TSCA review?
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Does the organization develop information about “chemical substances” that it withholds from disclosure under claim of confidential business information, trade secret, etc.?
Where Can I Go For More Information?
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Congressional webpage for S.697
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EPA’s Office of Pollution Prevention and Toxics
Specialty Technical Publishers (STP) provides a variety of single-law and multi-law services, intended to facilitate clients’ understanding of and compliance with requirements. These include:
About the Author
Jon Elliott is President of Touchstone Environmental and has been a major contributor to STP’s product range for over 25 years. He was involved in developing 12 existing products, including Environmental Compliance: A Simplified National Guide and The Complete Guide to Environmental Law.
Mr. Elliott has a diverse educational background. In addition to his Juris Doctor (University of California, Boalt Hall School of Law, 1981), he holds a Master of Public Policy (Goldman School of Public Policy [GSPP], UC Berkeley, 1980), and a Bachelor of Science in Mechanical Engineering (Princeton University, 1977).
Mr. Elliott is active in professional and community organizations. In addition, he is a past chairman of the Board of Directors of the GSPP Alumni Association, and past member of the Executive Committee of the State Bar of California's Environmental Law Section (including past chair of its Legislative Committee).
You may contact Mr. Elliott directly at: tei@ix.netcom.com.