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Statute

FSMA

302 published works

  1. Food Poison Journal

    Raw Food in Hot Cars – What Possibly Could Go Wrong?

    By Bill Marler

    I got this email yesterday morning: Bill…I have followed you since the book on Jack in the Box. The National Food Safety Cause needs your help. We need to change…

  2. The Daily Intake

    FDA Releases Fiscal Year 2020 Fee Rates and Reconfirms Policy of Not Invoicing for FSMA Food Facility Reinspection, Recall, and Importer Reinspection Fees

    By Keller and Heckman LLP

    The FDA Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect fees from (1) The responsible party for each domestic facility and the U.S. agent for each foreign…

  3. The Daily Intake

    FDA Announces FSMA Third-Party Certification Program User Fee Rates for Fiscal Year 2020

    By Keller and Heckman LLP

    On July 23, 2019, FDA published a notice in the Federal Register announcing the fiscal year 2020 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the…

  4. A Seat at the Table

    FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive Controls Regulations

    By Joe Levitt, Maile Hermida, Elizabeth Fawell, Leigh Barcham

    The U.S. Food and Drug Administration (FDA) recently finalized its  “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507…

  5. The Daily Intake

    FDA Finalizes Guidance on “Small Business” Definition under CGMP and Preventive Controls Regulations for Human and Animal Food

    By Keller and Heckman LLP

      The FDA Food Safety Modernization Act’s (FSMA) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food are implemented by…

  6. A Seat at the Table

    Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions

    By Maile Hermida, Elizabeth Fawell, Leigh Barcham

    The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions…

  7. The Daily Intake

    FDA Updates Produce Safety FAQ

    By Keller and Heckman LLP

    On June 11, 2019, FDA updated its Frequently Asked Questions (FAQ) on FSMA to include additional questions and answers related to the Produce Safety Rule that the Agency received through the…

  8. The Daily Intake

    FDA Publishes Draft Guidance to Assist in Developing Alternate Curricula to Satisfy Produce Safety Rule Requirements

    By Keller and Heckman LLP

    FDA published a draft guidance to help farmers and educators develop or select alternate curricula to meet the training requirements of the Produce Safety Rule mandated by the Food Safety…

  9. A Seat at the Table

    FSMA Intentional Adulteration Vulnerability Assessments Training Course

    By Elizabeth Fawell, Maile Hermida

    On May 31, Hogan Lovells will offer an important training program on conducting a vulnerability assessment under the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule (IA rule), which is…

  10. Food Safety News

    There’s good call for optimism, but grave reasons for concern remain

    By Coral Beach

    The pattern is well established. Bad things happen, and then good things happen as a result.  But, one man who is uniquely positioned to peer into the future with an…