Proposed FDA Rules Would Strengthen Foodborne Illness Prevention

The Food and Drug Administration (FDA) announced two proposed rules that would drastically change food safety regulations to provide for foodborne illness prevention. The proposed rules, if codified, would implement the Food Safety Modernization Act (FSMA) (P.L. 111-353) and are open for public comment until May 16, 2013. According to the FDA, the two rules are part of an integrated reform effort focusing on prevention, and to further this goal, additional rules will be published shortly. The proposed rules were published after outreach with the public and industry, including five federal public meetings, hundreds of presentations, and FDA visits to farms and facilities of all sizes. The FDA noted that rules regarding importer verification and accreditation standards to strengthen the quality of third-party safety audits overseas will be published soon.

Formal Plan Requirements

The first proposed rule, titled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food” would require the makers of food sold in the United States to develop a formal plan to prevent their food from causing foodborne illness, as well as plans for correcting problems as they arise. More specifically, facilities would be required to: (1) maintain a food safety plan; (2) perform a hazard analysis; (3) institute preventative controls for the migration of the hazards; (4) monitor controls; (5) verify the effectiveness of controls; (6) take corrective actions as needed; and (7) maintain records documenting their actions. This rule would apply to both foreign and domestic based facilities, and compliance would be mandatory one year after the final rules are published in the Federal Register, excepting small and very small businesses. These entities would be given additional time for compliance. The rule also updates and clarifies certain requirements of the FDA’s Current Good Manufacturing Practice (CGMP) regulations and clarifies the scope of exemptions for “farms” regarding food facility regulations. The rule also clarifies which entities would be exempt from the new hazard analysis and risk-based preventative control requirements, which includes businesses with average annual sales of less than $500,000 (with at least half the sales to consumers or local retailers) and “very small businesses.” Small and very small farms that conduct low risk activities such as repacking intact fruits and vegetables would also be exempt.

Farm Standards

The second proposed rule provides enforceable safety standards for the production and harvesting of produce on farms. Titled “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption” the rule provides standards, which are science-and-risk based, that would oversee the safe production of fruits and vegetables in the United States. These standards would not apply to produce that receives commercial processing that reduces the presence of microorganisms, is rarely consumed raw, is for personal or on-farm consumption, or is not a raw agricultural commodity.

The proposed rule provides for new regulations regarding a variety of topics including:

  1. worker training and hygiene, including training requirements for all personnel who handle covered produce or food contact surfaces and their supervisors; 
  2. agricultural water;
  3. biological soil amendments;
  4. domesticated and wild animals;
  5. equipment, tools and buildings; and
  6. sprouts, including a requirement that the sprout growing environment be tested for listeria or L. monocytogenes and the spent irrigation water and sprouts be tested for E. coli 0157:H7 and Salmonella species.

The proposed rule, if codified, would become effective 60 days after the final rule is published in the Federal Register, but there would be a longer timeline for farms to come into compliance, with small businesses having three years to comply generally and five years to comply with some of the water requirements.