California Ag Network

Tag: The U.S. Food and Drug Administration

  • FDA Intends to Extend Compliance Date for FSMA Food Traceability Rule

    The U.S. Food and Drug Administration (FDA) has announced its intention to extend the compliance date for the Food Traceability Rule (the “final rule”) by 30 months. The FDA intends to extend the compliance date using appropriate procedures at a later time, including publishing a proposed rule in the Federal Register.

    The FDA remains committed to successful implementation of the full requirements of the final rule, as they will allow for faster identification and removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Accordingly, the compliance date extension does not amend, nor do we intend to amend, the requirements of the final rule, which will improve food safety and protect public health. Instead, the compliance date extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.

    The final rule establishes additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods on the Food Traceability List. The final rule requires a higher degree of coordination between members of the food industry than has been required in the past. Therefore, to achieve the full public health benefits of the final rule, all covered entities must be in compliance. Even those few entities who are well positioned to meet the final rule’s requirements by January 2026 have expressed concern about the timeline, in part because of their reliance on receiving accurate data from their supply chain partners, who are not similarly situated. Therefore, FDA intends to allow industry additional time, across all regulated sectors, to fully implement the final rule’s requirements.

    The FDA intends to use the extended time period to continue the agency’s work with stakeholders, including by participating in cross-sector dialogue to identify solutions to implementation challenges and by continuing to provide technical assistance, tools, and other resources to assist industry with implementation.

    The final rule applies to domestic and foreign entities producing food for U.S. consumption and was issued in 2022 in accordance with the FDA Food Safety Modernization Act.

  • First Annual Animal Drug User Fee Educational Conference

    The U.S. Food and Drug Administration is announcing the first of a series of five public meetings to provide educational sessions for stakeholders who are interested in the new animal drug approval process. The annual educational conferences the FDA will host over the next four years are described in the “Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028.”

    The Animal Drug User Fee Act (ADUFA) was originally signed into law in 2003 and was subsequently reauthorized by Congress in 2008, 2013, 2018, and 2023. ADUFA authorizes the FDA to collect fees for certain new animal drug applications, products, establishments, and sponsors. Resources generated under ADUFA supplement the agency’s funding to enhance the performance of the drug review process, ensuring that new animal drug products are safe and effective for animals and that food derived from treated animals will be safe for consumption. The FDA considers the timely review of the safety and effectiveness of new animal drug applications to be central to the agency’s mission to protect and promote human and animal health.

    The Animal Drug User Fee Amendments of 2023 (ADUFA V), the most recent reauthorization of ADUFA, authorizes the FDA to collect user fees through fiscal year 2028. “The Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028” sets forth the agency’s performance goals for the period covered by ADUFA V.  Among other goals, the document commits the agency to hosting triannual meetings (three meetings per calendar year) with Animal Health Institute (AHI) members. Each year, during one of these meetings, the FDA will commit up to 8 hours for an educational conference intended for the animal drug industry; however, the meeting is open to the public.

    The first educational conference will be held on July 17, 2024, from 9 a.m. to 5 p.m. Eastern Time. Attendees can join in-person or virtually. The in-person conference will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Great Room Conference Center, Silver Spring, MD 20993–0002. For more information, please see the meeting webpage.

    This initial conference will provide a high-level overview of the animal drug approval process; communication pathways with the FDA’s Center for Veterinary Medicine; best practices in the approval process; target animal safety technical section overview; effectiveness technical section overview; chemistry, manufacturing and controls technical section overview; human food safety technical section overview; environmental impact technical section overview; and minor technical sections overview.

    The conference will also contain Q&A sessions during which the FDA will address specific questions from the in-person and virtual audience as time allows. Future educational conferences will take a more in-depth approach to these and other topics based on questions and comments received during this meeting, as well as questions and comments submitted to the docket.

    All stakeholders are welcome to submit comments to the docket requesting topics to be included for future educational conferences. The FDA is accepting public comments at any time for this series of educational conferences; however, the agency requests that you submit either electronic or written comments by 90 days after each annual educational conference to ensure that the agency considers your comment on a topic discussed at that conference.

    Early registration is recommended for persons who wish to attend the conference. Registrants will receive confirmation when their registration has been received and they will be provided the webcast link. Persons interested in attending this conference virtually may register until the start time of the meeting. Persons interested in attending this conference in-person are encouraged to register online at https://fda.zoomgov.com/webinar/register/WN_cSFEyfDpQK6RuGrwPznG9AExternal Link Disclaimer no later than July 10, 2024. On-site registration will be provided on the day of the meeting on a first-come, first-served basis, until the room capacity is reached. For more information about registration, please see the meeting webpage.

    For more information:  

  • Webinar on Investigational Food Use Authorizations for Genetically Altered Animals

    The U.S. Food and Drug Administration is announcing the availability of a pre-recorded webinar for developers who are interested in learning more about the process of requesting an Investigational Food Use Authorization (IFUA) for animals with investigational intentional genomic alterations (IGAs). IGAs in animals are alterations to the animal’s genome that are made using genome editing or rDNA technologies.

    An IFUA permits edible tissues (such as meat, milk, eggs, honey) from animal species treated with investigational products like new animal drugs, food additives, and IGAs in animals to be used for food. The FDA will issue a letter authorizing the food use of a specific set of animals after evaluating data to identify any potential food safety hazards and ways to avoid them to ensure the safety of the edible products entering the human food chain. IFUAs are helpful to developers because they allow animals (or their products) to be used for food instead of being wasted.

    The webinar covers what an IFUA is; when it is appropriate to make an IFUA request; the types of data and information the FDA reviews in support of an IFUA request; three case study examples that cover different types of scenarios where developers of IGAs in animals might request IFUAs; and administrative procedures that developers of IGAs in animals follow when submitting an IFUA request.

    Any developer or sponsor of a genetically altered animal for food use can apply for an IFUA as long as they have an investigational file established with the agency. In order to receive an IFUA, the developer must submit sufficient data to demonstrate that food from these investigational animals is safe for human or animals to eat. The agency reviews the data submitted, and if appropriate, will issue an authorization allowing the developer to send the specified animals to slaughter or rendering for animal food. If an authorization is granted for human food use and slaughter of the animal is subject to inspection by USDA’s Food Safety and Inspection Service (FSIS), the FDA will notify FSIS. The developer or sponsor must also notify FSIS and the FDA 10 days before sending the animals to slaughter. All products must be in compliance with any other applicable USDA requirements.

    To watch the webinar, please visit FDA Animal Biotechnology Case Study Webinar for Investigational Food Use Authorizations of Animals with Investigational Intentional Genomic Alterations. Please submit any questions following the webinar to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov by June 30, 2023. If needed, we will post a follow-up with answers to the commonly asked questions.

    For more information:

  • FDA to Hold Public Meetings for Proposed Changes to Ag Water Requirements in Produce Safety Rule

    The U.S. Food and Drug Administration (FDA) will be holding two virtual public meetings on the recently released proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” The purpose of the public meetings is to discuss the proposed rule, which was issued under the FDA Food Safety Modernization Act. These public meetings are intended to facilitate and support the public’s evaluation and commenting process on the proposed rule.

    The public meetings will be held according to the schedule below.  The times for each meeting have been adjusted to provide persons in different regions of the country an opportunity to comment.

    First Virtual Public Meeting
    February 14, 2022
    11:45 am – 7:45 pm EST

    Second Virtual Public Meeting
    February 25, 2022
    8:45 am – 4:45 pm EST

    Registration is required to attend the virtual meetings. Registered participants will receive details on how and when to view the public meetings online.

    Register for the February 14 Meeting

    Register for the February 25 Meeting

    For questions about the meetings, contact Juanita Yates, FDA, Center for Food Safety and Applied Nutrition: e-mail Juanita.Yates@fda.hhs.gov. For additional information, see the Federal Register Notice announcing the meetings and the Meeting Page.