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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 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....

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 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...

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 a memorandum on July 2, 2015, directing three federal agencies with jurisdiction over products of biotechnology, 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...

On May 28, 2015, several United States and Canadian regulatory agencies announced the release of Regulatory Partnership Statements (RPS) and updated annual Work Plans outlining the framework for how these agencies will cooperate and coordinate specified agency actions.  The RPS and Work Plans are the most recent steps since the United States and Canada established the Regulatory Cooperation Council (RCC) in 2011 to align regulatory systems and boost North American trade and...

On Thursday, April 30, 2015, the U.S. Environmental Protection Agency (EPA) issued interim guidance that it intends to clarify its toxicology data requirements for antimicrobial pesticides used on food contact surfaces.  In addition, EPA issued a letter to antimicrobial registrants that EPA states is intended “to summarize how the Agency has been implementing 158W with respect to existing registered antimicrobial pesticides, as well as new and pending antimicrobial...

FDA Announces GUDID Public Website: On May 4, 2015, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that the data submitted to the Global Unique Device Identification Database (GUDID) are now publicly available. The website, in partnership with the National Library of Medicine, is part of the phase-in for the Unique Device Identification compliance timeline and offers anyone access to search or download information submitted for...

Bioeconomy companies recognize that their products are subject to a variety of federal chemical regulations, especially if they sell food, food additives, cosmetics, or other products regulated by the U.S. Food and Drug Administration (FDA). Unfortunately, companies may not recognize all the ways that the U.S. Environmental Protection Agency (EPA) regulates bioproducts, perhaps because of the understandable focus on the Clean Air Act (CAA) and the various programs under that authority: Renewable...

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidance documents and one draft guidance document that FDA believes will provide greater regulatory clarity for industry and other stakeholders on the use of nanotechnology in FDA-regulated products. In this article, Lynn Bergeson and Carla N. Hutton review the recent guidance and highlight important considerations.

On March 26, 2015, a group of ethanol and agricultural groups sent a letter (the industry letter) to the U.S. House of Representatives Appropriations Committee's Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies to express their strong opposition to including certain language harmful to the ethanol industry in the Fiscal Year 2016 Agriculture, Rural Development, U.S. Food and Drug Administration (FDA) and Related Programs Appropriations bill....

The U.S. Department of Agriculture (USDA) National Organic Program (NOP) issued on March 24, 2015, a policy memorandum clarifying the status of nanotechnology in organic production and handling under the USDA organic regulations.  The memorandum states that NOP has received questions about the use of nanotechnology.  The memorandum uses the term “engineered nanomaterials” to refer to substances specifically designed and manufactured to have unique properties or behavior attributable to...