United States: FDA Issues Two Proposed Rules That Will Significantly Change Regulatory Requirements For Food Safety

The FDA Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, proposes the most sweeping reform of U.S. food safety laws in more than 70 years. As part of the changes introduced by the law, Section 103 of FSMA, titled “Hazard Analysis and Risk-Based Preventive Controls,” and Section 105 of FSMA, titled “Standards for Produce Safety,” each amend the Federal Food, Drug and Cosmetic Act by adding new sections 418 (Hazard Analysis and Risk-Based Preventive Controls )and 419 (Standards for Produce Safety ). Section 418 and 419 significantly change the existing legal requirements for food manufacturing and growing. Each section also requires the U.S. Food and Drug Administration (“FDA”) to conduct rulemaking to implement these provisions.

On January 16, 2013, FDA issued two proposed rules to implement the provisions of Sections 103 and 105 of FSMA. The first proposed rule, titled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,” proposes significant changes to the current good manufacturing practice (“cGMP”) requirements applicable to the production of food. The second proposed rule, titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” proposes minimum standards for the safe growing, harvesting, packing, and holding of produce (i.e., fruits and vegetables) grown for human consumption. Comments on the proposed rules are due by May 16, 2013.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

The proposed rule implementing section 103 of FSMA would revise FDA’s cGMP requirements in two ways. First, the proposed rule would add new preventive control requirements mandated by FSMA. These preventive control requirements are somewhat comparable to the Hazard Analysis and Critical Control Point (“HACCP”) requirements for manufacturers of seafood and juice products. The preventive control requirements are proposed to include the need to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of identified hazards. Once a plan is developed, facilities would need to follow the plan by monitoring their controls, verifying that the controls are effective, taking any appropriate corrective actions, and documenting these activities. These new requirements generally apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations, with some exceptions.

FDA is also requesting comments on aspects of preventive controls that are not part of the proposed rule. Those provisions include a product testing program, an environmental monitoring program, and a supplier approval and verification program.

Second, the proposed rule will update the cGMP regulations applicable to food (currently codified in 21 C.F.R. Part 110), including clarifying certain requirements. The cGMP regulations were last updated in 1986. The new preventive control requirements and the modified cGMPs are to be placed in a new Part 117, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.”

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

The proposed rule implementing section 105 of FSMA would establish minimum standards for the safe growing, harvesting, packing, and holding of produce in its raw or natural (unprocessed) state on farms. In developing the proposed rule, FDA conducted a qualitative assessment of risk of hazards related to produce production and harvesting. FDA’s assessment suggested that microbiological hazard pathways may be grouped into different identified routes of microbial contamination which are generally shared among produce of different types. FDA’s proposed rule is intended to minimize the risks associated with those hazards and provide flexibility by allowing the use of alternative measures if they would provide the same level of public health protection as the proposed standard.

Routes of microbiological exposure identified by FDA include:

  • Agricultural Water, where FDA proposes specific criteria for water quality when used for certain purposes, along with requirements for periodic testing;

  • Biological Soil Amendments of Animal Origin (i.e., fertilizer sourced from animals), where FDA proposes requirements for treating biological soil amendments, restrictions on methods of application, and time intervals between the applications, as well as handling and storage of such biological soil amendments of animal origin;

  • Health and Hygiene, where FDA proposes requiring farm personnel use hygienic practices, including hand washing and maintaining adequate personal cleanliness;

  • Domesticated and Wild Animals, where FDA proposes controlling contamination introduced by wild and domesticated animals, including contamination through grazing animals and work animals; and

  • Equipment, Tools and Buildings, where FDA proposes standards for certain equipment and tools, buildings, and sanitation practices.

FDA also proposes introducing training requirements for farm personnel, as well as special requirements for the growing of sprouts. FDA previously sought to address produce safety through guidance. FDA has issued guidance on Good Agricultural Practices (GAPs), as well as commodity-specific guidance on sprouts and draft guidance on tomatoes, melons and leafy greens.

Sheppard Mullin is actively monitoring the comment process on both of these proposed rules, and has extensive experience in counseling food clients on a full range of FDA compliance issues. Those engaged in the food industry should carefully review these proposed rules to evaluate how they might impact their business once they are implemented. Industry should be actively engaged in the comment process, and should prepare contingency plans for the included proposals. Sheppard Mullin can assist clients with participating in the comment process, and advise clients on evaluating what changes may be necessary to come into compliance if and when these proposed rules become effective. The comment deadline is currently set for May 16, 2013.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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