Memoranda

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of Toxic Substances Control Act (TSCA) Section 14 concerning substantiation of confidential business information (CBI) claims for information submitted to EPA.  82 Fed. Reg. 6522.  Under the interpretation, EPA expresses its view that new TSCA requires substantiation of all non-exempt CBI claims at the time the information claimed as confidential is submitted to EPA.  In the notice, EPA...

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) proposed a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. 82 Fed, Reg. 7562. The process would not consider costs or other non-risk factors. Risk evaluation is the second step, after prioritization, in a new...

The U.S. Environmental Protection Agency (EPA) proposed on January 17, 2017, procedures to establish the risk-based screening process and criteria that EPA will use to identify chemical substances under the Toxic Substances Control Act (TSCA) as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. 82 Fed. Reg. 4825. The proposed rule describes the processes for identifying potential candidates for...

On January 13, 2017, the U.S. Environmental Protection Agency (EPA) published a proposed rule that would require an electronic notification for chemical substances listed on the Toxic Substances Control Act (TSCA) Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016. 82 Fed. Reg. 4255. EPA would also accept such notices for chemical substances that were processed. The recent TSCA amendments require EPA to...

In an expected action, on January 11, 2017, the Administrator of the U.S. Environmental Protection Agency (EPA) signed a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to regulate the use of trichloroethylene (TCE) in vapor degreasing.  The proposed rule has not yet been published in the Federal Register, but a pre-publication version of the proposed rule is available on EPA’s website, along with a fact sheet and other information.  The...

EPA Issues Final RMP Rule: On January 13, 2017, EPA published in the Federal Register its final rule amending the Accidental Release Prevention Requirements for Risk Management Programs (RMP) under Clean Air Act (CAA) Section 112(r)(7). 82 Fed. Reg. 4594. The amendments are intended to modernize EPA’s RMP regulations as required under Executive Order (EO) 13650, which directs the federal government to carry out certain tasks intended to prevent chemical incidents, such as...

In a final rule issued on January 12, 2017, EPA adjusted the level of statutory civil monetary penalty amounts under the statutes EPA administers. 82 Fed. Reg. 3633. The adjustments are mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The latter law prescribes a formula for annually adjusting statutory civil penalties to reflect inflation, maintain the deterrent effect of...

After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. 82 Fed. Reg. 3641. Manufacturers and processers, or persons who intend to manufacture or process new discrete forms of certain existing chemical nanoscale...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology.  The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the...

Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2017 Click here for a PDF brochure of the memorandum 2016 was full of surprises, two of which will drive much of the agenda for OCSPP during 2017. First, Congress significantly amended the Toxic Substances Control Act (TSCA). The changes are intended to reform the program to address the widely recognized deficiencies in the law, especially regarding existing chemicals, chemical testing,...