Regulatory Developments

EPA Celebrates Anniversary of Lautenberg Act by Releasing Final CBI Guidance, Animal Testing Strategy, and Final Mercury Reporting Rule

June 22, 2018

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:

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:

  • 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.”
     
  • 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.”
     
  • 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.”
     
  • 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.”
     
  • 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:

  • Nancy B. Beck, Ph.D., DABT®, Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
     
  • Misty L. Bogle, Global Product Stewardship Manager, Vertellus;
     
  • Michael Gould, EH&S Committee Chairman, RadTech North America; and
     
  • Lynn L. Bergeson, Managing Partner, B&C.

 
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