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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,...

On September 16, 2016, the White House posted a blog item, “Building on 30 Years of Experience to Prepare for the Future of Biotechnology,” releasing two documents intended to modernize federal regulation of biotechnology products. In July 2015, the White House directed the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to develop a long-term strategy to ensure that the system is prepared for...

Scientists Issue Letter Criticizing EDC Criteria: On July 6, 2016, a group of 15 European and U.S. researchers wrote to the European Union’s (EU) Health and Food Safety Directorate, criticizing recent proposals for the identification of endocrine disrupting chemicals (EDC) under the Plant Protection Products (PPP) Regulation and the Biocidal Products Regulation (BPR). The scientists addressed two major concerns relating to the proposed criteria: The...

On October 15, 2015, the Brazilian Ministry of Environment (Ministério do Meio Ambiente, or MME) announced plans to develop a national chemical Inventory (Inventory), with initial legislation expected by December 31, 2015. Due to a sometimes contentious debate between industry and the MME (Authority), the Inventory process had been considerably delayed. In a Brazilian chemical industry forum on June 23, 2016, it was announced that significant progress has been made toward implementing...

Bergeson & Campbell, P.C. (B&C®) announced today the launch of the Toxic Substances Control Act (TSCA) Blog (TSCAblog™) to track and report regulatory, scientific, legal, and policy developments under the “new TSCA.” On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), which makes important changes to TSCA and is the first revision of U.S. domestic chemical management law in 40 years. Stakeholders...

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), which makes important changes to the Toxic Substances Control Act (TSCA). Lautenberg results in fundamental shifts in the requirements and approach under TSCA, while introducing important new concepts and approaches. It is our view that the body of changes, including the careful balancing of competing needs and interests and the deft and assiduous drafting,...

On June 14, 2016, Richard E. Engler, Ph.D., Senior Chemist at Bergeson & Campbell, P.C. (B&C®), presented “U.S. Market Pressure and the Battle between Hazard and Risk” at the 2016 Green Chemistry & Engineering Conference. Dr. Engler discussed the various risk-based regulations at play in the U.S., including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food, Drug, and Cosmetic Act (FFDCA), the Toxic Substances Control...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Michael S. Wenk, M.S., has joined our teams as Senior Regulatory Consultant. Mr. Wenk has managed global regulatory affairs and product stewardship divisions at Fortune 500 chemical and chemical product companies for over 20 years and is an internationally-recognized expert in chemical registration and regulation in Central and South America, and the Middle East. With a Master’s Degree in...

On June 2, 2016, Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), presented “The Nanotechnology Legal and Regulatory Landscape” at the 2016 International Nanotoxicology Congress in Boston. Ms. Bergeson stated that there are many ongoing global initiatives involving diverse governance aspects of nanoscale materials and many countries continue to make progress in defining nanoscale materials, addressing related definitional challenges, developing suitable...

On March 18, 2016, the National Academies of Science, Engineering, and Medicine (NAS) announced the appointment of its provisional committee on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.” This study is being commissioned pursuant to the White House Office of Science and Technology Policy’s (OSTP) July 2, 2015, memorandum, “Modernizing the Regulatory System for Biotechnology Products,” that states...

On March 2, 2016, EPA and other federal agencies announced that the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products” would be held March 9, 2016, in Dallas, Texas. 81 Fed. Reg. 10858. According to EPA, the March 9, 2016, meeting was convened to solicit comment on the current federal roles and responsibilities regarding biotechnology products. The July 2, 2015, memorandum was jointly issued by the...

The second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products” will be held March 9, 2016, from 9:30 a.m. to 1:00 p.m. (CT) in Dallas, Texas. Registration is now open. To participate in person, registration should be completed by March 4, 2016. Registration is also required to view and participate in a live streaming of the public meeting. According to the U.S. Environmental Protection Agency...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Oscar Hernandez, Ph.D. has joined our teams as Senior Regulatory Chemist. Dr. Hernandez is the former Director of the Risk Assessment Division (RAD) in the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), where he managed a multi-disciplinary science group that provided expert scientific support in the areas of hazard and risk assessment of...

According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to “prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.” The notice...

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products.” The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency’s (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas. The third public meeting...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Susan M. Kirsch has joined our teams as Government Affairs Advisor. Ms. Kirsch brings substantial regulatory and technical policy expertise at the local, state, and federal levels, with experience at the New York State Department of Environmental Conservation, the U.S. Department of Justice, Environmental and Natural Resource Division, and most recently the Association of Clean Water...

On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule amending its food additive regulations to no longer allow the use of three specific perfluoroalkyl ethyl-containing food contact substances (FCS) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods. All three of the FCSs contain extended perfluorinated alkyl chains greater than or equal to eight carbons in length and as such are long-chain...

Click here for a PDF version of the memorandum. Even if Toxic Substances Control Act (TSCA) legislation is not enacted, 2016 will be a momentous year. As the curtain closes on eight years of the Obama Administration, there are a number of items expected to be among the “legacy” issues in the chemical and pesticide regulation space. Enhanced protections for farmworkers, more protective assessment policies, and a re-energized toxic chemical assessment program are among the...

On December 16, 2015, the House Appropriations Committee released the Consolidated Appropriations Act, 2016. The 2,009-page bill includes full appropriations legislation and funding for the 12 annual appropriations bills through the end of fiscal year (FY) 2016. The bill would reauthorize the Land and Water Conservation Fund (LWCF), which expired on September 30, 2015. This reauthorization is likely what prompted Senator Richard Burr (R-NC) to inform Senate Majority Leader Mitch...