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By Lisa M. Campbell and Lisa R. Burchi

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 Regulation of the Products of Biotechnology (Framework).

The meeting is intended to discuss FDA’s role in responding to the July 2015 memorandum issued by the OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative (USTR), and the Council on Environmental Quality (CEQ) entitled “Modernizing the Regulatory System for Biotechnology Products,” and will invite oral comments from interested parties.  The July 2015 memorandum and the October 6, 2015, OSTP-issued Request for Information (RFI) to solicit relevant data and information to update the Framework are discussed in our memorandum Biotechnology:  OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology.

The Executive Office memorandum directs FDA, EPA, and USDA -- the three agencies responsible for regulating biotechnology products -- to:

  1. Establish a working group to update the Coordinated Framework to clarify roles and responsibilities, and
  2. Develop a long-term strategy to ensure that the federal regulatory system is equipped to assess any risks while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.

This meeting is another important step in the process to update the Framework, first issued in 1986 and last updated in 1992, to reflect better promising technologies routinely entering the market and, as the July 2015 memorandum provides, “to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.”  Companies with biotechnology interests should monitor and participate in this process as appropriate, given its potential impact on the industry.

The meeting will be held on October 30, 2015, from 9:30 a.m. to 1:00 p.m. (EDT) at FDA’s White Oak Campus, Building 31 Conference Center, the Great Room, 10903 New Hampshire Avenue, Silver Spring, Maryland.  Registering early is recommended due to limited space.  The deadline for written comments is November 13, 2015.

For more information or to register for this meeting, visit FDA’s website.

 


 

By Lisa M. Campbell and Lisa R. Burchi

The U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have executed a Memorandum of Understanding (MOU) on Information Sharing regarding the sharing of data and other confidential information related to substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. EPA and FDA state in the MOU that the sharing of such information will “open[] channels of communication between the agencies” and will “serve to facilitate [EPA and FDA’s] accomplishment[s] of their respective missions.” The MOU sets forth the safeguards to be implemented with regard to the sharing of confidential information to “protect against unauthorized use or disclosure of any non-public information shared or exchanged pursuant to this MOU.”

EPA and FDA’s decision to share information will have a direct impact on companies with substances that have pesticidal and non-pesticidal applications. As noted in an example in the MOU, an antimicrobial food wash that can also be a labeled pesticide for other uses could have data submitted to FDA demonstrating that the product’s use is safe and does not adulterate food and data submitted to EPA demonstrating that the pesticide will not cause unreasonable adverse effects on the environment. Companies that have submitted information to EPA and FDA should be mindful of the potential that such information could be shared between the agencies, and consider whether additional safeguards or data compensation protection may be needed.