The Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, makes significant changes to the Federal Food, Drug and Cosmetic Act with respect to FDA’s authority over food. Intended to strengthen the authority of the U.S. Food and Drug Administration (FDA) to ensure the safety of the U.S. food supply, FSMA will change regulatory requirements of all aspects of the food and agriculture industry, including methods for growing of crops, importation of food, animal feed, transportation, and warehousing.

FDA is currently under a court order to issue the remaining rules mandated under FSMA. According to the order, all final rules are to be issued by June 30, 2015. Comment periods for most rules may not be extended past March 31, 2014, with the one exception being the comment period for the sanitary transport rule. Given the vast number of regulations currently being drafted, the following bullet list provides a brief update on the status of all outstanding rules:

• Preventive Controls for Human Food (Hazard Analysis and Risk-based Preventative Controls, or HARPC)

  • The rule has two major features. The first feature is new provisions requiring hazard analysis and risk-based preventive controls (HARPC) in the production of food. The second feature is a revision of the existing Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR part 110.

  • The proposed rule will require food processors to impose a system similar to Hazard Analysis and Critical Control Points (HACCP) requirements for juice and seafood processors. CGMP requirements will be strengthened with regards to prevention of food allergen contamination and cross-contact by including controls over food-packaging materials, foods and food-contact surfaces.

  • The comment period for the proposed rule closed on November 22, 2013. The final rule is still pending.

• Produce Safety Rule

  • The proposed rule would establish science-based minimum standards for the safe production and harvesting of raw agricultural commodities to minimize the risk of serious adverse health consequences or death.

  • The proposed rule, if implemented, will require farmers to apply hygienic practices to the growing of crops, including monitoring the quality of water used to produce crops, restrictions on the use of manure, and training requirements for employees.

  • The main comment period for the proposed rule closed on November 22, 2013. FDA is still accepting comments on the Environmental Impact Statement (EIS) until March 15, 2014. The EIS comments are to help FDA determine relevant issues that will influence the scope of the environmental analysis, including potential alternatives, and the extent those environmental issues will be analyzed.

• Foreign Supplier Verification Programs (FSVPs)

  • The proposed regulations, issued on July 29, 2013, would require importers to implement FSVPs that provide adequate assurances that foreign suppliers produce food in compliance with processes and procedures, including risk-based preventive controls.

  • The proposed rule, if implemented, will impose significant requirements on foreign food producers and importers.

  • The original comment period was extended, and comments were due on January 27, 2014.

• Accreditation of Third-Party Auditors/Certification Bodies

  • The proposed rule, issued on July 29, 2013, would establish a program for accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities and the foods they produce for both humans and animals.

  • As with the proposed FSVPs rule, the comment period was extended to January 27, 2014.

• Preventive Controls for Animal Food

  • The proposed rule, issued on October 29, 2013, would create new current good manufacturing practice (CGMP) regulations for manufacturing, processing, packing, and holding animal food, and implements FSMA’s preventive control provisions.

  • Similar to the proposed rule for Preventive Controls for Human Food, this proposed rule imposes a HACCP-like system and CGMP requirements on animal food processors.

  • The comment period was just recently extended to March 31, 2014.

• Intentional Contamination

  • The proposed rule, issued on December 24, 2013, would require registered domestic and foreign food facilities to address hazards that may be intentionally introduced by acts of terrorism.

  • Under the proposed rule, all registered food facilities would be required to identify and implement focused mitigation strategies to minimize or prevent significant terrorism vulnerabilities identified at actionable process steps in a food operation.

  • Comments are due on March 31, 2014.

• Sanitary Transport of Food and Feed

  • The proposed rule, which was just released on January 31, 2014, would establish regulations governing the transport of food and feed originally required under the Sanitary Food Transportation Act of 2005.

  • The proposed rule would establish requirements for shippers, receivers, and carriers transporting food by motor or rail to ensure the safety of food being transported.

  • Among other requirements, under the proposed rule, shippers, receivers and carriers would be responsible to ensure vehicles and equipment do not cause transported food to become contaminated, and for maintaining records on cleaning, prior cargos and temperature control. These proposed regulations, if implemented, are anticipated to have a significant effect on the transportation and warehousing of food.

  • Comments are due by May 31, 2014. In particular, FDA has requested comments regarding whether the proposed rule should apply to anyone other than shippers, receivers and carriers, and whether the proposed rule should apply to intrastate activities.

Given the tremendous impact these rules will have on industry, companies should carefully review the proposed rules and submit substantive comments where comment periods are still open.