Bar News - September 21, 2016
Environmental, Telecomm, Utilities & Energy Law: Sweeping Revision of Chemical Control Laws: Understanding the Lautenberg Act
By: Donald W. Stever
In early June of this year, an otherwise do-nothing Congress surprisingly enacted a sweeping revision to the Toxic Substances Control Act of 1976 (TSCA, pronounced “TOSCA” like Puccini’s opera) (15 USC Section 2601 et seq.), which was signed into law by President Obama on June 22, 2016.
Titled the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the “Lauternberg Act”), the law is named after the late senator from New Jersey who had been a tireless advocate for fixing this important, but in many respects fundamentally flawed, chemical regulatory statute. Following his death, the cause was carried forward to its conclusion by US Senator Tom Udall of Arizona. To a degree, the Lautenberg Act brought the TSCA chemical regulatory program closer to the approach taken by the Canadians under that country’s equivalent statute, and by the European Union, pursuant to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) program.
Although it has not been a significant element of everyday practice for most lawyers, TSCA is nonetheless important to large and small chemical manufacturers, chemical processors, importers, and to the general public. It original purpose, which was never fully realized because of flaws that the Lautenberg Act was intended to address, was to determine and, if necessary, limit or eliminate the risks to human health and the environment posed by the thousands of chemical substances already in the stream of commerce, and by proposed new chemical substances or new proposed uses of existing chemicals.
The statute governs tens of thousands of chemicals, but it does not address most pesticides, which are regulated under the Federal Insecticide, Fungicide and Rodenticide Act (7 USC Section 136 et seq.) or chemicals that fall under the exclusive jurisdiction of the US Food and Drug Administration. The US Environmental Protection Agency has the task of implementing TSCA, and although most of the regulatory policy decisions are made at EPA’s headquarters in Washington, DC, enforcement matters can, and often are, handled by EPA’s regional offices.
The Lautenberg Act changed TSCA in three primary regulatory areas: 1) the standard by which EPA determines whether a risk posed by a new chemical substance or mixture is “unreasonable;” 2) the process by which EPA evaluates the risks posed by the thousands of existing chemicals contained on the agency’s inventory of existing chemicals; and 3) how articles (finished goods containing chemicals) are regulated.
New Chemicals and Significant New Uses of Existing Chemicals
The Lautenberg Act made significant substantive changes to both the procedure by which new chemicals are evaluated and the standard by which EPA must determine whether a risk posed is “unreasonable.” The original text of TSCA required EPA to consider cost and other factors in determining whether a chemical presented an “unreasonable risk.” The Lautenberg Act specifically prohibits EPA from considering “cost or other non-risk factors” (such as economic value) and to specifically evaluate potential harm to vulnerable sub-populations in determining whether the health or environmental risk posed by the chemical is unreasonable. However, a cost-benefit analysis is required as part of EPA’s decision on what specific restrictions to place on the chemical.
TSCA requires manufacturers or processors to submit notice of intent to manufacture a new chemical, or of intent of a proposed significant new use of an existing chemical, 90 days before commencing manufacture or processing.
Previously, if EPA failed to reject the application within the 90-day pre-manufacture period, the new chemical or new use could proceed into the marketplace. The Lautenberg Act changed this, requiring EPA, within 90 days, to review the notice and make an affirmative determination that the new chemical our use presents an unreasonable risk of injury to health or the environment, that EPA has insufficient information to assess the risk and the chemical or use may present an unreasonable risk, or that the chemical is unlikely to present an unreasonable risk. Failure of EPA to make an affirmative determination simply results in refund of the processing fee required to be paid by the submitter.
The Lautenberg Act also removed from TSCA the requirement that EPA, in determining whether to ban the chemical or to impose labeling or use restrictions, employ the “least burdensome requirements” but must impose requirements sufficient that the chemical “no longer presents” the identified risk and use the “best available science” in making these determinations.
Although the original TSCA required EPA to differentiate existing chemicals from new chemicals, which resulted in the enormous chemical inventory compiled by EPA, it did not impose any affirmative temporal obligation for EPA to determine which of those chemicals required regulatory restrictions. The Lautenberg Act imposes a series of specific timelines for EPA to prioritize the chemicals on the inventory and perform risk evaluations, largely premised on a plan developed internally by EPA in 2014. Companies can request EPA to assess specific chemicals, but must pay EPA to do so and EPA’s decision to act or not act on such requests is discretionary.
The original text of TSCA allowed EPA to impose restrictions on finished goods that incorporated regulated chemicals, but this authority was rarely used because of the complexity of the procedures and standards the statute imposed on the agency. The Lautenberg Act clarified these, essentially providing that EPA can restrict articles to the extent necessary to address identified risks from exposure to chemicals from the article.
Led by California, which in Proposition 65 imposed its own unique set of regulatory restrictions on chemicals, prior to 2016 several other states had followed suit, particularly to address existing chemicals that TSCA had left essentially unregulated. The Lautenberg Act preserved Proposition 65 but has largely preempted other state chemical regulatory laws. A state can petition EPA for a limited preemption waiver, the grant of which is a matter of discretion on EPA’s part.
Donald W. Stever is of counsel to K&L Gates, based in New York City, and a Fellow of the American College of Environmental Lawyers. Stever worked at the US Department of Justice as a senior environmental litigator, and headed both the Pollution Control Section and later the Environmental Defense Section.