All Knowledge & Insights By Date

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...

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...

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...

The December 2015 issue of Nature Biotechnology included comments by Richard E. Engler, Ph.D. on keeping biotech rules current with scientific progress in the article “A face-lift for biotech rules begins.” To stay up to date with technology, Richard Engler, a senior chemist at the environmental law firm Bergeson & Campbell in Washington, DC, suggested that technology stewards be embedded in each of the relevant federal agencies. Their role would be to monitor...

On January 14, 2016, a report titled "Biobased Chemicals: The Iowa Opportunity" was released by Iowa's Cultivation Corridor and the Iowa Biotechnology Association at the Iowa Statehouse. This report is based on research by Iowa State University professors and outlines opportunities for Iowa to capitalize on bioprocessing developments in the United States. While Iowa has the advantage of a strong biofuel industry, there is still a need for the Iowa legislature to address the needs...

On January 8, 2016, seven biofuel and agriculture groups requested the U.S. Court of Appeals for the D.C. Circuit to review the Renewable Fuel Standards (RFS) for 2014, 2015, and 2016.  The Petition was filed by Biotechnology Innovation Organization, Americans for Clean Energy, American Coalition for Ethanol, Growth Energy, National Corn Growers Association, National Sorghum Producers, and the Renewable Fuels Association.  The groups intend to challenge the authority of EPA to set...

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...

On November 19, 2015, the USDA published Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) Meeting in the Federal Register. The meeting will review the purpose, history, operational process, and member responsibilities of the AC21; update committee members on relevant regulatory developments, initiatives, and USDA activities; and to outline new tasks for the committee to address. There will also be an opportunity for members of the public to make...

? Biofuels Digest, "Innovation to Tackle Climate Change and Feed a Growing Population: Commercializing Synthetic Biology" ? Energy.gov, "BETO-Funded Projects Win at the 2015 R&D 100 Awards" ? Oregon Best, "A New Formaldehyde-Free Wood Adhesive" ? Net Composites, "Laurel Biocomposite Earns USDA Certified Biobased Label for Three Products" ? Business Wire, "World's First Biofuel Facility to Operate Entirely on Renewable Heat and Power to Go...

On November 19, 2015, USDA published a Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) Meeting in the Federal Register. The meeting will review the purpose, history, operational process, and member responsibilities of AC21; update committee members on relevant regulatory developments, initiatives, and USDA activities; and outline new tasks for the committee to address. There will also be an opportunity for members of the public to make oral statements, as...

Biotechnology is an area of growing domestic and international importance to the manufacturing sector, and this summer the federal government announced several important biotechnology initiatives of which stakeholders should be aware. This article from the Winter, 2015, issue of Environmental Quality Management explains each initiative, and outlines why stakeholders are encouraged to engage in each one.

A November 30, 2015 story in Bloomberg BNA Daily Environment Report on the federal approach to regulating bioengineered products and comments submitted by nearly a thousand organizations and individuals on the Coordinated Framework for the Regulation of Biotechnology, featured commentary from B&C: Bergeson & Campbell PC, a law firm that represents companies working with emerging technologies, supported the efforts to update the framework but described structural...

? U.S. Energy Information Administration, "New Biofuels Eliminate Need For Blending With Petroleum Fuels" ? Innovia Films, "Bio Based Packaging Laminate Developed Using Matt NatureFlex™ Film" ? Joule, "Joule And Red Rock Biofuels Announce Intent To Merge, Creating An Industry-Leading Carbon-Neutral Fuel Production Platform" ? DuPont, "DuPont and Entomol Products LLC Sign License Agreement for Bio-Based Insect Repellent" ? Neste, "Neste And...

The U.S. Environmental Protection Agency (EPA) recently reminded stakeholders that new requirements for submitting Toxic Substances Control Act (TSCA) Section 5 notices and support documents will take effect on January 19, 2016. EPA issued a direct final rule on July 20, 2015, amending the TSCA Section 5 electronic reporting regulations. Submitters will be required to use the new Chemical Safety and Pesticide Programs (CSPP) data flow, referred to as the new version of the electronic...

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...

On Monday, October 26, 2015, the U.S. Department of Energy (DOE) presented “Bioproducts in the Federal Bioeconomy Portfolio Webinar,” a webinar on how the federal government is promoting sustainability through three different avenues: bioproducts research; commercialization; and market development.  The presenters on these topics were DOE’s Bioenergy Technologies Office (BETO) Technology Manager Nichole Fitzgerald; U.S. Department of Agriculture (USDA) BioPreferred Deputy...

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...

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...

The October 26, 2015, Inside EPA article, “TSCA Reform Legislation Could Smooth Path For New Biotechnologies,” included comments made by Lynn L. Bergeson at an event hosted by the Wilson Center’s Synthetic Biology Project (synbio). Pending legislation in Congress to reform the 40-year-old Toxic Substances Control Act (TSCA) could make it easier for EPA to assess the potential risks of new technologies, such as synthetic biology, and review requests to...

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...