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FDA Food Safety Modernization Act (FSMA): A Foreign Suppliers Guide

The FDA Food Safety Modernization Act (FSMA) represents the most sweeping reform of the food safety laws in the United States in over 70 years. FSMA was signed into law by President Obama on January 4, 2011, and it gives FDA new tools to address food safety from both a preventive and a responsive approach. FSMA has broad implications, and its requirements will have an impact on those who grow, process, transport, import, export and store food on a global scale. The requirements will affect finished food producers, as well as ingredient and raw material suppliers. Some requirements will even affect the producers and suppliers of food-contact substances, such as packaging materials. 

Among the key food safety enhancements included in FSMA are:

  • Preventive controls: FDA will now require comprehensive, risk-based preventive controls at facilities across the food supply chain.

  • Inspection and Compliance: FDA has enhanced inspection targets and broader record access, in recognition of the important role that on-site inspections play in promoting accountability for safety.

  • Imported Food Safety: The legislation provides significant enhancements to FDA's ability to achieve greater oversight of imported foods. It also imposes a new supplier verification-based framework for the import market. 

  • Response: FDA now has mandatory recall authority over all food products.

  • Enhanced Partnerships: The legislation recognizes the importance of strengthening existing collaborations among international, regional, and local food safety agencies to achieve public health goals.

FSMA implementation is well underway, and FDA has finalized rules to implement the following key provisions of the law:

  • Good Manufacturing Practice & Hazard Analysis and Risk-Based Preventive Controls for Human Food;

  • Good Manufacturing Practice & Hazard Analysis and Risk-Based Preventive Controls for Food for Animals;

  • Produce Safety Standards; and

  • Foreign Supplier Verification Program (FSVP).

Below, we provide a brief synopsis of each final rule, as well as links to the full text of the final rules and links to Keller and Heckman's summaries of the requirements and implications of each rule.

  • Human Food GMP/HARPC Rule

    • The final GMP/HARPC rule for human food modernizes and recodifies existing Current Good Manufacturing Practices (CGMPs); requires food facilities to establish and implement a food safety plan that includes a hazard analysis and risk-based preventive controls (HARPC); and clarifies the definition of a "farm," which is central to the determination of whether certain entities must register as food facilities (thus generally becoming subject to the HARPC requirements). Companies generally have 1 year from the date of publication to comply with the final rule (including both the revised CGMPs and the new HARPC requirements), i.e., September 19, 2016. 
    • Text of the final rule: Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, 80 Fed. Reg. 55908 (Sept. 17, 2015) is available here . 
    • Keller and Heckman's summary of the requirements and implications of the final rule is available here
  • Animal Food GMP/HARPC Rule

    • The final GMP/HARPC rule for animal food establishes for the first time CGMPs for food for animals, which are akin to the CGMPs that have long applied to human food. The rule also requires animal food facilities to develop a written food safety plan that includes a hazard analysis and risk-based preventive controls, also similar in key respects to the human food HARPC requirements. For the GMP requirements, food facilities generally have 1 year from publication of the final rule (September 19, 2016) to comply. For the HARPC requirements, the general compliance date is 2 years from publication of the final rule (September 18, 2017).
    • Text of the final rule: Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170 (Sept. 17, 2015) is available here

    • Summary of the requirements and implications of the final rule is available here.

  • Produce Safety Standards

    • The produce safety standards apply to farms engaged in the growing, harvesting, packing, or holding of raw agricultural commodities (e.g., fruits, vegetables) for human consumption. The final rule sets standards related to agricultural water; biological soil amendments; sprouts; domesticated and wild animals; worker training and health and hygiene; and equipment, tools and buildings, among other things. The final rule became effective January 26, 2016, but companies generally have 2 years from the effective date to comply, i.e., January 26, 2018. Covered farms have an additional 2 years to comply with certain agricultural water requirements, and compliance dates for covered activities related to sprouts are sooner (generally, 1 year from the effective date, i.e., January 26, 2017).  

    • Text of the final rule: Final Rule for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 80 Fed. Reg. 74354 (Nov. 27, 2015) is available here.

    • Summary of the requirements and implications of the final rule is available here

  • Foreign Supplier Verification Program (FSVP)

    • The FSVP rule generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions, e.g., HARPC requirements or produce safety standards. Companies generally have 18 months from the date of publication to comply, i.e., May 28, 2017. 

    • Text of the final rule: Final Rule for Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, 80 Fed. Reg. 74226 (Nov. 27, 2015) is available here.

    • Summary of the requirements and implications of the final rule is available here

We will continue to monitor and update you on the latest developments related to FSMA. In the meantime, we hope you can join us for our complimentary webinar on April 27.

© 2019 Keller and Heckman LLP

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About this Author

David J. Ettinger, Keller Heckman, Partner, Food and Drug Corporation, International Trade Lawyer, Attorney, Shanghai, China
Partner

David Ettinger joined Keller and Heckman in 1999. Mr. Ettinger represents domestic and foreign corporations in the area of food and drug law.

Mr. Ettinger relocated to Keller and Heckman's Shanghai office in November 2012 to focus on the Asian market and counsel companies in the Far East on food, drug, and chemical regulatory matters. He has extensive experience counseling clients on product development and product protection of food and drug packaging in the United States, Europe, Asia, Canada, and South America. From 2006-2007, Mr. Ettinger...

86 21-6335-1000
Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm
Partner

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven years. At the FDA, he represented the agency in a variety of food and drug litigation and provided agency personnel with counsel on food, drugs, and veterinary product matters.

Mr. Drozen's practice also extends to the international regulation and requirements for food and drugs and he has interfaced with relevant regulators in South America, Europe, Asia and Australia on these subjects. As part of his practice, Mr. Drozen also frequently counsels clients on topics being considered by the various committees of the Codex Alimentarius Commission and the International Conference on Harmonization.

202-434-4222
Natalie E. Rainer, Keller Heckman, US Regulatory Compliance Attorney, Environmental Torts Lawyer,
Associate

Natalie Rainer joined Keller and Heckman in 2007. She practices in the area of food and drug law.

Ms. Rainer advises corporate clients regarding regulatory compliance in North America, Latin America, Europe, and Asia. During graduate school, Ms. Rainer worked at the U.S. Department of Justice, Civil Division as an intern in the Environmental Torts Section. In this position she participated in the defense of the federal government in multi-million dollar environmental lawsuits and wrote a successful U.S. Court of Appeals brief defending the...

415-948-2821
Jenny Li, Keller Heckman, China Food, Drug Regulation, Shanghai, International Trade
Legal Consultant

Jenny Li joined Keller and Heckman in October 2007.

Ms. Li counsels clients on regulatory issues focusing on food and drug, with an emphasis on regulatory regimes in the Asia-Pacific region. She also counsels clients on food labeling, food claims, food additives, as well as, important issues regarding food imports in Asian countries.

86-21-6335-1000