Biobased and Renewable Products News: Federal

September 30, 2016
Update To The Coordinated Framework For The Regulation Of Biotechnology Published In The Federal Register
On September 22, 2016,  Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the  Federal Register . This proposed update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) with respect to the regulation of biotechnology products. More information about what this means for the future of biotechnology and the ... read more >
September 23, 2016
Biotechnology: White House Releases Proposed Update To The Coordinated Framework And National Strategy For Modernizing The Regulatory System For Biotechnology Products
On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology" and released 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 the future products of biotechnology, and commission an expert analysis of the future landscape of ... read more >
July 15, 2016
Senate Passes GMO Bill Creating A National Bioengineered Food Disclosure Standard With Federal Preemption And Exclusion Information
On July 7, 2016, the Senate passed a bill, An Act to Reauthorize and Amend the National Sea Grant College Program Act, and for Other Purposes (S. 764), through agreement to the House's amendment to S. 764, with further amendment. While the bill is being referred to as a genetically modified organism (GMO) labeling bill, there is no actual requirement to print GMO ingredients on labels. Instead, companies would be required to print information on the packaging (through text, a symbol such as a QR code, or an electronic link) directing consumers to a website or phone line for more ... read more >
April 8, 2016
Companies with Commercial Biofuels and Biobased Chemicals -- Get Ready For CDR
In less than two months, renewable fuel and biobased chemical companies that have successfully moved from research and development to commercialization will be required to respond to the U.S. Environmental Protection Agency's (EPA) Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA). This may come as a surprise to some biobased chemicals companies that are under the misperception that they are not regulated under TSCA. This is simply wrong. Unless otherwise regulated as a pesticide, food, food additive, drug, cosmetic, or nuclear material, biobased chemicals ... read more >
April 8, 2016
Biodiesel Companies Can Thank BRAG For Cost Savings On CDR Reporting
As reported in last week's Update, EPA published its final rulemaking expanding the list of chemicals partially exemption from certain additional chemical data under the CDR. This action, which formally amended the list of chemicals that do not have to report the onerous downstream processing and use information under the CDR Form U, Part III, occurred because of the forward thinking actions of the Biobased and Renewable Products Advocacy Group (BRAG®). In October 2014, recognizing an advocacy opportunity to equalize what had been an uneven regulatory reporting field for biodiesel ... read more >
April 1, 2016
EPA Publishes Final Rule on Partial Exemption of Certain Chemical Substances from Reporting Additional Chemical Data In The Federal Register
On March 29, 2016, the U.S. Environmental Protection Agency (EPA) published the Partial Exemption of Certain Chemical Substances from Reporting Additional Chemical Data final rule in the Federal Register. This final rule amends the list of chemical substances that are partially exempt from additional reporting requirements under the Chemical Data Reporting (CDR) rule. The rule applies to six biodiesel chemicals that are very similar to petroleum based biodiesel chemicals that are already on the exempt list. EPA determined that CDR processing and use information for these chemical substances ... read more >
March 25, 2016
EPA Signs Final Rule Granting Partial CDR Exemptions For Biodiesel Products
On March 23, 2016, Bloomberg BNA Daily Environment Report announced that EPA signed a final rule exempting manufacturers of six biodiesel chemicals from reporting processing and use information under the Chemical Data Reporting (CDR) rule under Section 8(a) of the Toxic Substances Control Act (TSCA). In 2014, BRAG filed a regulatory petition to exempt the chemicals, requesting the same exemption that EPA currently provides to manufactures of petroleum-based versions of the chemicals. The rule was originally issued as a direct final rule in February 2015 before being withdrawn due to a single ... read more >
March 18, 2016
Richard E. Engler, Ph.D. Presents On Green Chemistry Issues At Chemical Watch Global Business Summit In Brussels
Richard E. Engler, Ph.D., Senior Chemist at Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), made two presentations at the Chemical Watch Global Business Summit held in Brussels, Belgium from February 22-25, 2016. Dr. Engler presented during the "Green (Sustainable) Chemistry: The business and economic case for sustainable chemistry" seminar. His presentations are described below. For a full copy of either of these presentations, please contact Dr. Engler at rengler@lawbc.com. "Latest Developments in Green Chemistry in the US and possible ... read more >
March 4, 2016
More Information Available On Upcoming "Modernizing The Regulatory System For Biotechnology Products" Meetings
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 the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. ... read more >
February 5, 2016
Dates And Locations Of "Modernizing The Regulatory System For Biotechnology Products" Meetings Announced
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, Texas. The third meeting will be held on March 30, 2016, at the University of California's David ... read more >
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