Category: FDA

June 23, 2016

Bergeson & Campbell, P.C. Launches TSCAblog.com to Provide News and Analysis on TSCA Reform Implementation and Related Legal and Policy Developments

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 will need...
June 22, 2016

TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended 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 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, yield a...
June 14, 2016

Richard E. Engler Presents “U.S. Market Pressure and the Battle between Hazard and Risk” at the Green Chemistry & Engineering Conference

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...
June 8, 2016

Michael S. Wenk, Expert on South American and Middle Eastern Chemical Regulatory Programs, Joins Bergeson & Campbell, P.C. and The Acta Group

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...
June 2, 2016

Lynn L. Bergeson Presents “The Nanotechnology Legal and Regulatory Landscape” at the 2016 International Nanotoxicology Congress

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...
May 20, 2016

Weekly Roundup of Other Biobased News

? Energy.gov, "Energy And Commerce Departments Announce Lab Partnership Opportunities for U.S. Small Businesses and Manufacturers" ? EPA, "EPA Awards 18 Grants For Environmental Workforce Development and Job Training" ? The New York Times, "Biofuels Plant in Hawaii Is First to Be Certified as Sustainable" ? The Motley Fool, "Can The U.S. Military Afford to Run on Biofuels?" ? Quad-City Times, "Guest View: for the Farmers, the Biofuel Bubble Has...
April 7, 2016

NAS Releases Agenda for First Future Biotechnology Products and Regulatory System Committee Meeting

On April 5, 2016, the National Academies of Science, Engineering, and Medicine (NAS) posted the Agenda for the first open session of its committee on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.”  The Committee is beginning a study to provide an independent and objective examination of the future products of biotechnology, as commissioned pursuant to the White House Office of Science and Technology...
March 25, 2016

Sign Up For The Third And Final Public Meeting On Modernizing The Regulatory System For Biotechnolo

On July 2, 2015, the Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality jointly issued Modernizing the Regulatory System for Biotechnology Products, a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology...
March 18, 2016

Biotechnology:  NAS to Study Future Products of Biotechnology

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 it would "commission an...
March 17, 2016

Biotechnology: Case Studies of Hypothetical, Genetically Engineered Organisms Are Discussed at Seco

On March 9, 2016, the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products,” was convened in the U.S. Environmental Protection Agency’s (EPA) Region 6 Office in Dallas, Texas.  Representatives from EPA, the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the White House Office of Science and Technology Policy (OSTP) discussed their current roles and...
March 4, 2016

More Information Available On Upcoming “Modernizing The Regulatory System For Biotechnology Products

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the final two public engagement sessions covering the July 2, 2015 memorandum "Modernizing the Regulatory System for Biotechnology Products." The memorandum, issued under the Executive Office of the President (EOP) and jointly by (OSTP), the Office of Management and Budget, the U.S. Trade Representative, and the Council on Environmental Quality, directs...
March 3, 2016

Agencies Convene Second Meeting On Modernizing Regulatory System For Biotechnology Products

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 Office of Science and...
February 29, 2016

Biotechnology: Second Meeting on Modernizing the Regulatory System for Biotechnology Products Will Be Held March 9

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 (EPA),...
February 9, 2016

Oscar Hernandez, Former Head of EPA’s Office of Pollution Prevention and Toxics Risk Assessment Division, Joins Bergeson & Campbell, P.C. and The Acta Group

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 chemicals...
February 5, 2016

Biotechnology: APHIS Seeks Comment on Potentially Significant Changes to Regulations Regarding GE Organisms

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 identifies "reasonable...
February 5, 2016

Dates And Locations Of “Modernizing The Regulatory System For Biotechnology Products” Meetings Annou

On February 1, 2016, the dates and locations for the last two public engagement sessions discussing the "Modernizing the Regulatory System for Biotechnology Products" memorandum were announced. The first meeting occurred on October 30, 2015, and a record of the meeting is available on the U.S. Food and Drug Administration (FDA) website. The second of the three meetings will be held on March 9, 2016, at the U.S. Environmental Protection Agency's (EPA) Region 6 office in Dallas,...
February 5, 2016

Biotechnology: APHIS Seeks Comment on Potentially Significant Changes to Regulations Regarding GE Or

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 identifies...
February 3, 2016

OSTP Announces Second and Third Public Engagement Sessions for Modernizing the Regulatory System for Biotechnology Products

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...
February 2, 2016

OSTP Announces Second and Third Public Engagement Sessions for Modernizing the Regulatory System for Biotechnology Products

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 will be held...
January 26, 2016

Susan M. Kirsch Joins Bergeson & Campbell, P.C. and The Acta Group as Government Affairs Advisor

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...