New Proposed FSMA Regulations: From Farm to Fork

A fter much anticipation and delay, on January 4, 2013, the Food and Drug Administration (FDA) released two proposed regulations under the Food Safety Modernization Act (FSMA) that will have a significant impact on food growers and producers: 1) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food; and 2) Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption. The new rules are part of FDA’s overarching efforts to shift food safety focus from reactive to preventive. FDA met with farmers, industry, consumer groups, the international community, and other key stakeholders to develop new regulations that are practical and not “one-size-fits all.”

CGMP & Hazard Analysis & Risk-Based Preventive Controls

FDA’s proposals would add a new set of regulations implementing the Hazard Analysis and Risk-Based Preventive Controls provision of the FSMA. The new rules focus on preventing problems that can cause foodborne illness through two changes: Revisions to the existing CGMP and the addition of preventive controls.

Revisions to the CGMPs. The proposed rule would update or delete certain requirements in the existing CGMPs and generally “modernize” the language of the CGMPs. It would clarify that existing CGMP provisions requiring protection against contamination of food also require protection against cross-contact of food by allergens. Provisions directed to preventing contamination of food and food contact substances would also include preventing contamination of food packaging materials. Certain other CGMP provisions would be deleted, including provisions recommending temperatures for maintaining refrigerated, frozen, or hot foods. In addition, FDA is requesting comment on whether it should mandate training for food production facility employees and supervisors.

Preventive Controls. The proposed rule would require facilities of a certain size to develop formal, written food safety plans to prevent and correct food safety issues. Specifically, a facility would be required to evaluate “known or reasonably foreseeable” hazards; identify and implement preventive controls to address these hazards; monitor performance of the preventive controls; establish corrective action procedures when needed; and verify that the preventive controls are adequate to control the hazards identified. The preventive controls would include, as appropriate, process controls, allergen controls, sanitation controls, and a written recall plan. In all respects, FDA intends each facility’s food safety plan to be tailored to fit the facility and the risks associated with the facility’s food.

Food facilities are also required to document actions taken under the food safety plan, and those documents must be made promptly available to the FDA upon oral or written request (such as during an inspection), and to reanalyze the plan at least every three years. In addition, food facilities are required to appoint a “qualified individual” to prepare and oversee the food safety plan. The proposed preventive controls align with Hazard Analysis and Critical Control Points (HACCP) systems, but the new rule differs in that preventive controls may be required at points other than at critical control points and critical limits would not be required for all preventive controls.

The tentative proposed rule does not include requirements that companies engage in either environmental monitoring or finished product testing. However, FDA continues to seek comments on these provisions, and FDA recently indicated such provisions would be in the final rule.

In general, with some exceptions, the preventive control provisions would apply to facilities that manufacture, process, pack, or hold human food and are required to register with the FDA under Section 415 of the Federal Food, Drug and Cosmetic Act. Activities within the definition of “farm” would not be subject to the proposed preventive controls. The proposed rules provide exemptions for certain facilities and for certain activities. For example, very small facilities or activities subject to and in compliance with existing HACCP regulations for seafood and juice are exempt from the requirements for preventive controls. In addition, the FDA is proposing modified preventive control requirements in certain circumstances, such as modified requirements for warehouses solely engaged in the storage of packaged food that is not exposed to the environment. Modified requirements would also apply to “qualified facilities” (a very small business or one with three-year average annual sales of less than $500,000, with more than half of sales going directly to consumers or to restaurants/retail food establishments in the same state or within 275 miles).