FDA's New Guidance on FSMA Intentional Adulteration Rule
Thursday, July 12, 2018 (2pm - 3pm US/Eastern)
FDA Issues New Guidance to Protect Food Production, IDFA offers Compliance Webinar
The Food and Drug Administration (FDA) recently released guidance to protect the food supply from intentional sabotage. In May 2016 FDA issued the final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration
with requirements for covered facilities to prepare and implement food defense plans. To assist with compliance, the agency released the first of three guidance documents to help food production industry comply with the new rule. To aid dairy food producers in understanding the rule and the new information from FDA, IDFA is offering a webinar to its members.
The rule is new regulatory territory for both FDA and the industry, so as the first compliance date draws near—July 2019—it is critical to fully understand the FDA’s thinking so that you can properly plan and allocate resources.
To help the dairy industry in interpreting this new guidance and understanding FDA’s expectations for compliance, IDFA is holding a webinar on Thursday, July 12, 2018, from 2–3:00 p.m. Eastern Time.
IDFA’s Vice President of Regulatory Affairs and International Standards, John Allan, will be joined by Elizabeth Fawell, an attorney with Hogan Lovells US, LLP, IDFA’s outside legal counsel, to help review the guidance and its impact. There will be ample opportunity provided to respond to attendee questions.
FDA’s Draft Guidance
This first part of the draft guidance includes chapters on:
• the components of the food defense plan;
• how to conduct vulnerability assessments using the key activity type method;
• how to identify and implement mitigation strategies; and
• food defense monitoring requirements.
The second installment will contain additional information on conducting vulnerability assessments, including inherent characteristics of process steps and how they should be considered. Training requirements will also be covered. The third installment will include greater detail on corrective action, verification, reanalysis, and recordkeeping requirements.
John T. Allan III
Vice President, Regulatory Affairs and International Standards, International Dairy Foods Association
John Allan directs all aspects of IDFA's food safety training initiatives, leads efforts related to product safety issues and has responsibilities in federal and state regulatory affairs. He engages on behalf of IDFA members with 3-A Sanitary Standards, Inc., and the National Conference on Interstate Milk Shipments (NCIMS). Allan also helps represent IDFA’s international trade interests through his seat on the U.S. Department of Agriculture/U.S. Trade Representative Agricultural Technical Advisory Committee (ATAC) for Trade of Processed Foods, as well as through engagement with the International Dairy Federation and the Codex Alimentarius Commission (Codex).
Prior to joining IDFA, Allan was the director of regulatory and international affairs for the National Yogurt Association, the American Frozen Food Institute (AFFI) and AFFI’s affiliated associations: the National Frozen Pizza Institute, Frozen Potato Products Institute and the Frozen Food Foundation.
Allan also has regulatory and technical affairs experience in the infant formula industry and has worked for the U.N. Food and Agriculture Organization helping develop Codex international food standards. He graduated from the University of Georgia with a Bachelor of Science in microbiology and a Master of Science in food science and technology.
Elizabeth B. Fawell
Partner, Hogan Lovells
Successfully navigating the detailed and often complex regulatory issues confronting the food industry, Elizabeth Fawell helps companies understand both the rules and various risks involved to make the most informed and strategic decisions.
Elizabeth has worked with every segment of the food industry, including manufacturers, distributors, retailers, restaurants, and food service operators, as well as their trade associations.
Her work on behalf of food industry clients with the Food Safety Modernization Act (FSMA) since its inception and her understanding of Hazard Analysis Critical Control Point (HACCP) systems provides her with the experience and perspective needed to counsel clients on how to comply with new requirements under the law. Elizabeth is also a Preventive Controls Qualified Individual (PCQI) and has completed the FSPCA PCQI training.
Elizabeth understands how laws, regulations, and guidance documents are developed, interpreted, and enforced. Her extensive knowledge enables clients to prevent or respond to enforcement actions such as Warning Letters, Import Alerts, and agency investigations. She helps clients in determining whether an RFR report is necessary and whether a recall is warranted. If so, she helps manage the recall to minimize business impacts.
Elizabeth provides real-time advice during factory inspections, helps clients prepare 483 responses, and drafts inspection manuals. She assists clients in lawfully and creatively promoting their products; such as the development of labels, claims, and website and promotional campaigns. Elizabeth also supports clients in advertising disputes and with responses to FTC and Attorney General investigations.
Elizabeth helps clients stay informed of and ahead of public policy issues and develops strategies for effective advocacy before regulators. She also counsels clients on compliance with Consumer Product Safety Commission (CPSC) safety standards, testing and certification requirements, and reporting obligations.
Elizabeth is also a member of the Food and Dietary Supplements Committee of the Food and Drug Law Institute.
These fees are available through
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