On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of...
Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements. According to EDF’s May 14, 2020, blog item, the non-governmental organizations (NGO) called on EPA to revise the...
May 15, 2020
Find B&C’s Updates And Analysis Of Chemical Regulatory Impacts Of COVID-19 In One Place
From new product or new use approvals, to impact on chemical supply chains, Bergeson & Campbell, P.C. (B&C®) monitors key federal and international chemical legislative and regulatory initiatives to keep firm clients and friends informed. We have compiled a comprehensive and frequently updated listing of our content related to the coronavirus crisis that we hope will serve as a useful, one-click source of information: www.lawbc.com/uploads/docs/COVID-19.pdf.
Bergeson & Campbell, P.C. (B&C®) is pleased to announce that Managing Partner Lynn L. Bergeson has again been recognized by Thomson Reuters’ Super Lawyers as one of the “Top 50 Women” practicing law in Washington, D.C. in 2020. She was also named a Super Lawyer in Environmental Law, a distinction she has earned consistently since 2008. B&C is also pleased to announce that Ms. Bergeson has earned the highest ranking attainable in Chambers and Partners USA Guide 2020 for...
By Lynn L. Bergeson On May 11, 2020, a total of 70 Mayors from various cities in the United States submitted a letter to Andrew Wheeler, U.S. Environmental Protection Agency (EPA) Administrator, criticizing the decision not to uphold the Renewable Fuel Standard (RFS) and not to reject proposed waivers under Section 211(o)(7) of the Clean Air Act. The Mayors state that this decision on waivers is already causing damage to the economy and will continue to devastate farmers, workers, and families...
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On May 12, 2020, a bill was introduced in the U.S. House of Representatives, which would make emergency supplemental appropriations for the fiscal year ending on September 30, 2020. Titled the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act), this bill addresses various issues, many of which have been worsened by the COVID-19 pandemic. Some of these issues include provisions of revenue, health, retirement, government...
By Lynn L. Bergeson On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature allowing users to download reports. Historical reports now include highlighted...
May 15, 2020
New Reporting Procedure For Co-Manufacturers Under TSCA CDR Rule May Catch Certain Manufacturers Off
By Lynn L. Bergeson One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) rule, issued in final on April 9, 2020, is that in the 2020 cycle, EPA has changed the way that toll manufacturing must be reported. In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals. As in years’ past, EPA states in its...
May 15, 2020
EPA’s Updated Small Manufacturer Definition Will Apply To CDR Reporting Period Beginning June 1
By Lynn L. Bergeson On May 12, 2020, EPA released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under TSCA. According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the Agency’s ability to receive the information it needs to understand exposure to chemical...
May 15, 2020
EPA Will Hold Webinar On CDR Requirements On May 19
By Lynn L. Bergeson EPA will host a webinar on May 19, 2020, from 1:00 p.m. to 3:00 p.m. (EDT) to provide an overview of the 2020 CDR requirements. The webinar will include information about the revised reporting requirements, including: New requirements for making confidential business information (CBI) claims; Reporting refinements related to byproducts, including exemptions; Phasing in certain processing and use data codes; and Process improvements for reporting co-manufacturing. The webinar...