On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule. As noted in our June 29, 2016, memorandum, “TSCA Reform: EPA Publishes First Year Implementation Plan,” the Lautenberg Act included mandatory actions for EPA to complete by June 22, 2018, two years after former President Barack Obama signed the Act, which significantly amended the Toxic Substances Control Act (TSCA).
Completed Milestones
EPA lists the following milestones that it has completed at the two-year anniversary:
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Final strategy to reduce animal testing: The strategy promotes the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing. It also incorporates input from public meetings and written comments. More information will be available in a forthcoming TSCA Blog item.
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Final rule on reporting mercury manufacturing and imports: According to EPA, it will use the information collected through the new reporting requirements to develop future inventories of mercury and mercury-containing product supply, use, and trade in the U.S. More information will be available in a forthcoming Bergeson & Campbell, P.C. (B&C®) memorandum.
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Guidance for state, tribal, and local governments, and medical personnel and emergency responders on sharing CBI: These guidances specify the process that will enable other governmental entities and medical and emergency personnel to request CBI. More information will be available in a forthcoming TSCA Blog item.
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Policy and procedures for assigning unique identifiers to track better information on chemicals while protecting CBI: EPA will apply an identifier to a substance, whose identity is protected as CBI, as well as to other related information or submissions concerning the same substance. EPA states that this will allow the public to connect information related to the same substance, even while the specific identity is protected as confidential. More information will be available in a forthcoming TSCA Blog item.
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Guidance on structurally descriptive generic names: The guidance will allow EPA to share more information with the public about the structure of substances while protecting the confidential elements of the substance’s specific chemical identity. TSCA submitters claiming the specific chemical identity of a chemical substance as CBI are required to supply a structurally descriptive generic name that can be disclosed to the public. More information will be available in a forthcoming TSCA Blog item.
Other Highlights
In addition to these two-year anniversary milestones, EPA states that it has “diligently worked to implement the first major update to an environmental statute in 20 years.” EPA lists the following highlights:
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On June 22, 2017, the one-year anniversary of the Lautenberg Chemical Safety Act, EPA met milestones for three framework TSCA rules: the Prioritization Process Rule, the Risk Evaluation Process Rule, and the TSCA Inventory Notification (Active-Inactive) Rule. According to EPA, its TSCA team “is working hard to implement these important processes.” More information on the final rules is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”
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EPA announced the first ten chemicals to undergo risk evaluations and then issued corresponding scope documents for these chemicals, describing the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and potentially exposed or susceptible subpopulations that EPA expects to consider. As reported in our June 5, 2018, memorandum, “EPA Takes ‘Three Important Steps’ Intended to Ensure Chemical Safety,” on June 1, 2018, EPA released problem formulation documents to refine the scope documents. EPA notes that this is “an important interim step prior to completing and publishing the final risk evaluations by December 2019.”
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As reported in our June 5, 2018, memorandum, EPA also released a systematic review approach document for public comment. The document is intended to guide EPA’s selection and review of studies and provide transparency in how EPA plans to evaluate scientific information. EPA also proposed a significant new use rule (SNUR) for certain uses of asbestos (including asbestos-containing goods), “the first such action on asbestos ever proposed as well.”
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EPA states that it took a number of actions to address the review of new chemical submissions: EPA decreased the backlog of new chemicals awaiting EPA review, increased transparency through a public meeting, as well as published a guidance document for companies and the public to explain better how our analyses are conducted, and added a pre-consultation step to engage early with companies, increase their certainty, and improve new chemical submissions. More information is available in our June 21, 2018, memorandum, “EPA Issues Final Guidance on Points to Consider When Preparing TSCA New Chemical Notifications.”
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Pursuant to the amended law, EPA also proposed a fees rule on certain chemical manufacturers -- including importers and processors -- to provide a sustainable source of funding to support resources implementing EPA’s new responsibilities under the amended law. More information on the proposed rule is available in our February 9, 2018, memorandum, “Administrator Pruitt Signs TSCA User Fee Proposal.”
Commentary
EPA is to be congratulated for the release of the timely issuance of these items on TSCA’s second anniversary. We are preparing more in-depth analyses of these initiatives and will share them next week. We also appreciate EPA having provided a great deal of significant new material just in time for B&C’s June 25, 2018, webinar, “TSCA at 2: An Update on Implementation and Hot Topics.” Registration is still available for the complimentary webinar. Speakers will include:
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Nancy B. Beck, Ph.D., DABT®, Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
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Misty L. Bogle, Global Product Stewardship Manager, Vertellus;
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Michael Gould, EH&S Committee Chairman, RadTech North America; and
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Lynn L. Bergeson, Managing Partner, B&C.
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