FDA

U.S. Food and Drug Administration

(No developments since 10-30-18)

  • FDA Announces New Plant and Animal Biotechnology Innovation Action Plan

On October 30, 2018, the U.S. Food and Drug Administration (FDA) published its Plant and Animal Biotechnology Innovation Action Plan outlining the key priorities the agency will pursue “to support innovation in plant and animal biotechnology and advance the agency’s public health mission.” According to FDA, the Action Plan’s overall goal is to ensure the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation.  FDA notes that many of the priorities outlined in its Action Plan are already underway and will be rolled out, including for public input as appropriate, over the next year and continuing through 2020. 

Among the key items identified by FDA:

  • Veterinary Innovation Program (VIP)
    FDA’s Center for Veterinary Medicine (CVM) announced the launch of a pilot VIP program to offer intensive technical and programmatic assistance to developers of certain innovative veterinary products, including animal biotechnology products.
  • CVM Genome Editing in Animals Public Webinar
    CVM, along with representatives from FDA’s Center for Biologics Evaluation and Research (CBER), will host a live-cast webinar on Dec. 3, 2018 to discuss FDA’s regulatory approach and current scientific evidence and regulatory science questions that are important for the Agency’s decision-making for genome editing in animals.  When registering, stakeholders are encouraged to submit questions for FDA to address during the webinar.
  • Animal Biotechnology
    Noting its commitment to adopting and clarifying a “comprehensive policy framework for the development and oversight of animal biotechnology products,” FDA highlighted its intent to issue several guidance documents in the area of animal biotechnology in 2019.  According to FDA, these documents will include guidance for industry to clarify FDA’s regulatory approach using risk-based categories for regulatory oversight, give clear criteria and risk questions or data requirements where relevant for each risk-based category, and provide flexibility to move across categories as science and technology progress and FDA gains greater understanding with product risk profiles.
  • Plant Biotechnology for Human and Animal Food Use
    After reviewing information submitted to the 2017 request for comment on the use of genome editing techniques to produce new plant varieties for use in human or animal food, FDA intends to publish draft guidance for industry to explain FDA’s current regulatory policy for human and animal foods produced through modern molecular plant breeding techniques.
  • Continued Collaboration with Stakeholders
    As part of efforts to engage with domestic partners, FDA explained that it will continue to coordinate with the U.S. Environmental Protection Agency and the U.S. Department of Agriculture as the Agency clarifies its oversight of genome edited products, consistent with the U.S. Coordinated Framework for the Regulation of Biotechnology.  FDA will also support international regulatory alignment on risk-based genome editing policies and provide leadership in international forums.

In addition, FDA indicated its intent to work with domestic and international partners and engage in a dialogue about how transformative biotechnology tools, such as gene drives, may eventually strengthen measures to address vector-borne diseases.

  • FDA Submits Proposed Collection of Information for Biotechnology Consultations

On March 27, 2018, the U.S. Food and Drug Administration (FDA) announced the submission of a proposed collection of information in connection with its longstanding voluntary consultation process for foods derived from plant-based biotechnology.

Under the Paperwork Reduction Act, every federal agency must obtain approval from the Office of Management and Budget (OMB) before collecting certain information (including reports, applications, and plans) from ten or more members of the public. Ongoing collection activities like FDA’s biotechnology consultation process must be approved by OMB at least once every three years.

FDA’s voluntary consultation process (first outlined by FDA in a 1997 guidance document) is intended to allow producers who use biotechnology in the manufacture or development of foods and food ingredients to work cooperatively with FDA to ensure that products derived through biotechnology are safe and comply with all applicable legal requirements.

FDA announced an initial opportunity to comment on the proposed information collection associated with this process on December 13, 2017. According to FDA, it received two comments, both of which were supportive of the Agency’s need for the information collection. Accordingly, FDA has proposed retaining the previously approved annual reporting burden (1,960 hours) estimate associated with the consultation process.

Comments on FDA’s proposal may be submitted directly to OMB until April 26, 2018.

On October 4, 2017, the U.S. Food and Drug Administration (FDA) issued final guidance clarifying that mosquito-related products intended to control mosquito populations are regulated by the U.S. Environmental Protection Agency (EPA), while FDA has jurisdiction over products intended to reduce the virus/pathogen load within a mosquito or prevent mosquito-borne disease.  See Guidance for Industry #236.   This final guidance closely tracks, and is in most respects identical to, the draft version that FDA distributed for public comment on January 18, 2017.

  • FDA Extends Comment Periods for Proposed Guidance on Genome-Edited Animals and Docket Seeking Input on Approach to Genome-Edited Plants

On April 12, 2017, the U.S. Food and Drug Administration (FDA) announced extensions of the comment periods associated with its draft guidance document on genome-edited animals (Guidance for Industry #187, proposed on January 18, 2017) and its separate docket requesting input on FDA’s regulatory approach to human and animal foods derived from plants developed using genome editing (opened on January 19, 2017). Both comment periods will now close on June 19, 2017.

On January 19, 2017, the U.S. Food and Drug Administration (FDA) established a docket to receive comments on the use of genome-editing techniques to produce new plant varieties that are used for human or animal food. Comments are due by April 19, 2017.

On January 18, 2017, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents that, if adopted, would clarify how FDA intends to regulate biotechnology and mosquito products under the agency’s new animal drug (NAD) authority. The first, Guidance for Industry # 187: Regulation of Intentionally Altered Genomic DNA in Animals, revises previous FDA guidance that applied solely to genetic modifications achieved using recombinant DNA (rDNA) technology. The second document, Guidance for Industry # 236: Regulation of Mosquito-Related Products, specifies the circumstances under which FDA would regulate products that affect or modify mosquitoes and when FDA will defer to the authority of the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Comments on the draft Guidance for Industry # 187 are due on April 19, 2017.  The public may also comment on FDA’s draft mosquito product guidance through February 21, 2017.