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 perfluorinated...
Category: FDA
January 5, 2016
Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2016
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 short list of notable...
December 17, 2015
Congressional Negotiators Reach Deal on LWCF Reauthorization and Include Language Concerning Labeling Guidelines for GE Salmon
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...
On November 19, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved AquaBounty Technologies' application for the genetically engineered (GE) salmon (AquAdvantage Salmon), the first time FDA has approved a GE animal. FDA regulates GE animals under the new animal drug requirements through the Center for Veterinary Medicine in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA states in the news release that it "thoroughly...
On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term "natural" in the labeling of human food products. The notice states that it is establishing "a docket to receive information and comments on the use of the term 'natural' in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering." FDA states that this action is a result of three...
November 6, 2015
Inside EPA Includes Comments From Richard E. Engler, Ph.D. In Article “Agencies Receive Conflicting Comments On Update Of Biotech Reviews”
On November 6, 2015, Inside EPA included comments made by Richard E. Engler, Ph. D. at a public meeting held by EPA, USDA, and FDA to update the federal coordinated framework for how the three agencies regulate biotechnology. […]Industry officials, meanwhile, emphasized biotechnology's growing importance in food production and cautioned that over-regulation will stifle innovation. Officials with Dupont and the law firm Bergeson & Campbell, P.C., which represents...
November 2, 2015
BNA Daily Environment Report Article “New Authority Not Expected for Biotech Framework Update,” Quotes Richard E. Engler, Ph.D.
The November 2, 2015, BNA Daily Environment Report article, “New Authority Not Expected for Biotech Framework Update,” included comments made by Richard E. Engler, Ph.D. at the “Modernizing the Regulatory System for Biotechnology Products” public meeting held by FDA, USDA, and EPA. […DuPont global director of corporate regulatory affairs Terry] Medley and Richard Engler, a senior chemist working for Bergeson & Campbell P.C., said the...
November 1, 2015
Public Meeting Announced To Discuss Modernizing The Regulatory System For Biotechnology Products Memorandum
On October 30, 2015, a public meeting was held to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology (Framework). FDA's role in responding to the July 2015 memorandum issued by OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative (USTR), and the Council on Environmental Quality (CEQ) entitled "Modernizing...
October 23, 2015
Public Meeting Announced To Discuss Modernizing the Regulatory System For Biotechnology Products Memorandum
On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA), announced in the Federal Register a public meeting to be held on October 30, 2015, to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the...
October 23, 2015
Public Meeting Announced To Discuss Modernizing the Regulatory System For Biotechnology Products Mem
On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) announced in the Federal Register a public meeting Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology. The meeting is...
October 21, 2015
Lynn L. Bergeson, “Industrial Biotechnology: Coordinated Framework Make-Over and Lots More,” Industrial Biotechnology, Vol. 11 No. 5, October 2015.
The summer of 2015 was surprisingly busy in the industrial biotechnology policy and regulatory arenas with three important announcements regenerating lots of buzz. On July 2, 2015, the White House Office of Science and Technology Policy, the Office of Management and Budget, the US Trade Representative, and the Council on Environmental Quality issued a memorandum directing EPA, FDA, and USDA to update and modernize the Coordinated Framework for the Regulation of Biotechnology. A few...
October 9, 2015
Bergeson & Campbell, P.C. and the Wilson Center Release Report on Synthetic Biology’s Challenge to U.S. Regulatory Systems
Panel Discussion to Be Held Wednesday, October 15, 2015, from 12:00 p.m. - 2:00 p.m. (EDT) On October 15, 2015, the Woodrow Wilson International Center for Scholars (Wilson Center) will host "Leveraging Synthetic Biology's Promise and Managing Potential Risk," a panel discussion featuring Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincides with...
October 9, 2015
Bergeson & Campbell, P.C. and the Wilson Center Release Report on Synthetic Biology’s Challenge to U.S. Regulatory Systems
Panel Discussion to Be Held Wednesday, October 15, 2015, from 12:00 p.m. - 2:00 p.m. (EDT) On October 15, 2015, the Woodrow Wilson International Center for Scholars (Wilson Center) will host "Leveraging Synthetic Biology's Promise and Managing Potential Risk," a panel discussion featuring Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincides with...
On October 6, 2015, the National Science and Technology Council, Science and Technology Policy Office published a notice of request for information (RFI) on "Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (CF) and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology" in the Federal Register. The purpose of the RFI is to obtain relevant data that will be used to update the CF to...
On October 6, 2015, the White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) to solicit relevant data and information, including case studies that may assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF). The RFI will assist OSTP in clarifying the current roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and...
On August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled “Guidance for Industry: Use of Nanomaterials in Food for Animals.” The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology. FDA states that the Guidance is...
August 5, 2015
Lynn L. Bergeson, “FDA Issues Final Guidance on Use of Nanomaterials in Food for Animals,” Nanotechnology Now, August 5, 2015.
On August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled "Guidance for Industry: Use of Nanomaterials in Food for Animals." The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.
The U.S. Environmental Protection Agency (EPA) has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology. EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches. EPA’s recently posted document, US Environmental Protection Agency Biotechnology Algae Project, states...
On July 20, 2015, the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) issued OSHA Directive Number CPL 02-02-079. The Directive is intended to establish "policies and procedures to ensure uniform enforcement of the Hazard Communication standard" (HCS 2012). The Directive repeals previous instructions CPL 02-02-038 and CPL 02-02-039. It also cancels both enforcement memorandums effective February 9, 2015, and May 29, 2015, respectively. For more...
July 16, 2015
Lynn L. Bergeson, “White House Targets Biotechnology,” Chemical Processing, July 16, 2015.
With little fanfare, on July 2, 2015, the White House 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 issued 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. Last updated in 1992 and first rolled out...