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Download transcript. This week, I sat down with David Cragin, Ph.D., DABT®, Quality Assurance and External Affairs Director for a large multinational pharmaceutical company, to discuss his experience living and working in China. For many listeners, working with foreign regulators can be particularly challenging for a variety of reasons, including language barriers, cultural differences, and differing regulatory standards. Dave shares his experience working in China and explains his...

On July 20, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on a draft revision to the risk determination for the 1-bromopropane (1-BP) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 43265. EPA states that the draft revision to the 1-BP risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is...

The U.S. Environmental Protection Agency (EPA) issued a final rule on July 18, 2022, updating the list of chemicals subject to toxic chemical release reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 87 Fed. Reg. 42651. The final rule updates the regulations to identify five per- and polyfluoroalkyl substances (PFAS) that must be reported pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA)...

The Department for Environment, Food and Rural Affairs (Defra) has begun a public consultation on extending the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) submission deadlines for transitional registrations — the registrations under UK REACH of substances that were registered in the European Union (EU) in accordance with EU REACH on or before December 31, 2020, the end of the Brexit transition period. Defra seeks comment on two options to...

As reported in our May 19, 2022, memorandum, the Superfund excise tax on certain chemical substances was reinstated beginning on July 1, 2022, under the Infrastructure Investment and Jobs Act. The newly reinstated tax has caught many off guard, and most subject to the tax are struggling with computing and reporting the tax. We offer some guidance below and stand ready to assist. Overview There are two separate Superfund chemical excise taxes: a tax on the...

On July 11, 2022, Chemical Week quoted Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), regarding a Supreme Court ruling that limits the US Environmental Protection Agency’s (EPA) authority to combat climate change by regulating emissions from existing power plants. Legal experts say the decision could have broader implications for EPA’s ability to regulate chemicals. “The Court seems to have put a name to what some believe is a...

The U.S. Environmental Protection Agency (EPA) recently released draft revisions to the risk determinations for perchloroethylene (PCE) (87 Fed. Reg. 39085), N-methylpyrrolidone (NMP) (87 Fed. Reg. 39511), methylene chloride (87 Fed. Reg. 39824), and trichloroethylene (TCE) (87 Fed. Reg. 40520). Each draft revision to the risk determinations for these chemicals reflects EPA’s announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is...

The U.S. Environmental Protection Agency (EPA) published on June 29, 2022, the final scope of the risk evaluation to be conducted for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. 87 Fed. Reg. 38746. EPA will evaluate the conditions of use (COU) of asbestos, including other types of asbestos fibers in addition to chrysotile, that EPA had excluded from Part 1 as legacy uses and associated disposals, as well as any COUs of...

Download Transcript This week, I sat down with Sheryl Lindros Dolan, Senior Regulatory Consultant with B&C and Senior Regulatory Specialist with our consulting affiliate, The Acta Group, and Meibao Zhuang, Ph.D., Senior Scientist/Regulatory Consultant with B&C and Acta, to discuss pesticide tolerances, what are they, how does the U.S. Environmental Protection Agency (EPA) develop them, and how well government and industry stakeholders communicate their utility in ensuring a...

On July 2, 2021, the Federal Trade Commission (FTC) announced its modified ten-year regulatory review schedule. 86 Fed. Reg. 35239. FTC reviews its rules and industry guides on a ten-year schedule to ensure they remain relevant and not unduly burdensome. FTC publishes its review schedule each year, with adjustments made in response to public input, changes in the marketplace, and resource demands. FTC, in its discretion, may modify or reorder the schedule in the future to...