On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and...more
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...more
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...more
On September 16, 2016, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), in collaboration with the White House, released two documents...more
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...more
On March 18, 2016, the National Academies of Science, Engineering, and Medicine (The Academies) announced the appointment of its provisional committee on "Future Biotechnology Products and Opportunities to Enhance...more
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...more
TSCA/FIFRA/IRIS/NTP/TRI - EPA Extends Comment Period On Chlorinated Paraffins Risk Assessments: On February 22, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft risk...more
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...more
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...more
After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology recently announced that meetings two...more
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...more
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)...more
On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, "The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic...more
On October 15, 2015, the Food and Drug Administration (FDA) posted notice of a public meeting to be held on Friday October 30th, in order to clarify the current roles and responsibilities described in the Coordinated...more
The U.S. Environmental Protection Agency (EPA) announced last week that it is developing a project intended to support public dialog concerning the development and use of synthetic biology (synbio). EPA has oversight...more
EPA Seeks Comment On Series 810 Test Guidelines: On June 17, 2015, the U.S. Environmental Protection Agency (EPA) announced the availability for comment of several Series 810, non-binding, draft test guidelines developed by...more
With little fanfare or advanced notice to the general public, 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...more
Last week, the White House waded into the GMO regulatory fray with the Office of Science and Technology Policy’s (OSTP) announcement of a major overhaul of GMO regulation. In a statement released July 2, OSTP noted that...more
The White House, through the Office of Science and Technology Policy (OSTP), announced a major initiative to overhaul the regulation of biotechnology products (OSTP Memo), which are products developed through genetic...more
In a bit of a surprise announcement, 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 released...more