Signed into law in 2011, the Food Safety Modernization Act (FSMA) establishes a new new regulatory framework for the food industry. FSMA adds new requirements for the food industry and vests the U.S. Food and Drug Administration (FDA) with new authorities to enforce these requirements. FSMA’s broad scope affects nearly all members of the food industry, including: producers, importers, distributors, manufacturers, and transporters. The law is also international in scope, requiring foreign suppliers to comply with new FSMA requirements, while also increasing FDA’s authority overseas. Because of the sweeping impact FSMA has on the entire food industry, GMA is leading the charge to ensure that FSMA is implemented using scientific, risk-based standards that take into account industry’s existing food safety expertise.
FSMA’s Guiding Principles
The two overarching principles guiding the implementation of FSMA are 1) FDA’s shift from detection and response to prevention and 2) increased partnerships with stakeholders. First, the shift towards prevention is best seen in the final rules for human and animal foods, where FSMA requires that food consumed in the U.S. be produced in compliance with Hazard Analysis and Critical Control Points (HACCP) principles. In addition, for the first time, FSMA requires farms to take specific measures to prevent food safety hazards. Internationally, foreign suppliers are required to verify that they have met specific preventive requirements before their goods are admitted into the U.S. Second, FDA has reached out to industry, consumer groups, and state and foreign governments in an unprecedented manner. FDA has hosted numerous meetings, both public and private, to educate stakeholders on FSMA and solicit feedback. In addition, FSMA requires FDA to engage in partnerships with industry, academia, state governments, and even foreign governments for the purpose of effectively implementing FSMA
Rulemaking and Guidance Development
The successful implementation of FSMA has been, and will continue to be, a top GMA priority. While several of FSMA’s new requirements and authorities were effective in 2011, the majority of FSMA requirements will be implemented through the rulemaking process. As required by U.S. law, FDA must publish draft regulations implementing the specifics of FSMA and give the industry sufficient time to comment on the proposed regulations (click here for more information on rulemaking). FDA must then consider the comments when drafting the final rules (click here for a timeline on FSMA rulemaking). In 2013, FDA released seven proposed rules (listed below) and GMA provided substantial feedback on the proposals. In 2014, FDA released four supplemental proposed rules to revise specific portions of the original proposals (listed below). Substantive changes in the Supplemental Rules were made in response to GMA’s comments (among others) and generally reflect a more flexible, science-based approach to managing food safety. As of May 2016, FDA has now released all seven final rules. General compliance dates for some companies begin in September 2016. In addition to rulemaking, FSMA requires FDA to develop guidance documents containing specific information on how to comply with the regulations. Similar to rulemaking, FDA will give industry sufficient time to provide comments on each guidance document.
FSMA Training and Enforcement
While FSMA guidance development is still ongoing, FDA and GMA have already shifted gears and are preparing for FSMA implementation, specifically focusing on training and enforcement issues. To accommodate the complexity and diversity of the U.S. food supply, FDA is changing its internal organization to reflect the specialization needed to successfully implement and enforce FSMA (click here for more information on FDA’s operational shift). GMA is actively involved in providing the scientific and technical assistance needed by FDA to make this shift. Please contact us for more information about GMA’s leadership in implementing FSMA.
Supplemental Rules: On September 19, 2014, FDA released Supplemental Rules for the Preventive Controls for Human Foods, the Preventive Controls for Animal Foods, the Foreign Supplier Verification Program, and the Produce Safety Rules. The corresponding dockets were reopened and public comments were accepted until December 15, 2014.
Final Rules: Final Rules for the Preventive Controls for Human Food and Preventive Controls for Animal Food were published to the federal register on September 17, 2015. Final Rules for Produce Safety, Foreign Supplier Verification Program, and Accredited Third-Party Certification were published to the federal register on November 27, 2015. The final rule for Sanitary Transportation was published on April 6, 2016. The Food Defense rule was published on May 27, 2016.
The Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls) final rule covers most facilities that manufacturer, process, pack, or hold food for consumption in the United States.
The Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety) final rule establishes mandatory food safety practices for domestic and foreign farms that grow, harvest, pack, or hold produce for consumption in the U.S.
The Foreign Supplier Verification Program (FSVP) final rule applies to most entities who import food into the United States from abroad, including domestic facilities and food brokers. This rule requires importers to develop, maintain, and follow a Foreign Supplier Verification Program that provides assurances that its foreign supplier is producing the food in compliance with FDA’s standards for preventive controls and produce safety.
The Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third Party Accreditation) final rule is an attempt by FDA to leverage its oversight capabilities, establishing a mechanism whereby private auditors are accredited by FDA to issue food safety certifications to foreign food facilities.
The Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Animal Feed) final rule establishes food safety requirements for facilities that manufacture, process, pack, or hold animal feeds. The rule is intended to ensure the safety of animals consuming the animal feed and prevent the spread of food borne illnesses in humans who handle the animal feed, especially pet food.
The Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (Food Defense) final rule establishes requirements that most food facilities must follow for the purpose of preventing terrorist attacks on the U.S. food supply. The final rule requires most FDA-registered food facilities to prepare and implement a Food Defense Plan.
The Sanitary Transportation of Foods (Sanitary Transport) final rule applies to most food commercially transported in the United States, unless it is specifically exempted. Shippers, carriers, loaders and receivers must employ specific measures to ensure the safety of food during transportation.