FDA Publishes Frequently Asked Questions and Answers for Proposed FSMA Rules

The Food and Drug Administration's (FDA) proposed food safety rules, "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" and "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food," released in January 2013, are now clarified in two comprehensive "Question and Answer" documents posted on FDA's website. The proposed rules implement the produce safety and preventive controls provisions of the Food Safety Modernization Act (FSMA), which was signed into law on January 4, 2011. Further details on the content of the proposed rules can be found in our January 17, 2013 article.

In brief, the Q&A document pertaining to the proposed rule on preventive controls for human food presents nearly one hundred questions and their detailed answers. The Q&As are organized roughly in keeping with the structure of the proposed rule itself. Some highlights of the Q&As include a detailed chart explaining when exemptions or modified requirements apply under the proposed rules. There also is a simplified explanation of the proposed revisions to and reorganization of the GMP regulations, with rationale for new definitions and wording used in the proposed rule. The Q&As provide a useful example in Question B15 to clarify the small business exemption and how it applies to businesses with multiple facilities, which has been an area of confusion for industry thus far. FDA's answer illustrates that the Agency would not consider a business to be a small business (defined under the proposed rule as a business having 500 employees or fewer) if the business has multiple facilities, each with fewer than 500 employees, where the total number of employees across facilities is over 500. Another important clarification pertains to the requirement that each facility utilize a "qualified individual" to prepare a written food safety plan. The Q&As identify that a "qualified individual" does not need to be an employee of the facility and, moreover, a team of individuals may prepare the food safety plan so long as they are overseen by a qualified individual. In addition, the Q&As provide guidance on the type of documentation that a facility would need to provide to FDA to demonstrate that it is a "qualified facility" subject to certain exemptions under the proposed rule.

With respect to the Q&A document on the proposed produce safety rule, there is significantly less content than included in the Q&As for the proposed preventive controls rule. The produce safety Q&A document provides helpful information about the types of facilities and activities that would be covered by the rule. It also lays out in some detail the exemptions that would exist under the proposed rule, as well as the modified requirements that would apply to exempt facilities. The document includes useful details regarding when community sponsored agriculture farms and "U-pick" farms, for example, would be covered by the proposed produce safety rule. In addition, the Q&As set out when alternative approaches to produce safety would be allowed under the proposed rules and what a facility would be required to do to support the use of an alternative approach.

We are available to answer any questions that you might have regarding the newly posted Q&A documents or the proposed rules themselves. Please contact Mel Drozen at drozen@khlaw.com or Katie Coniglio at coniglio@khlaw.com for further assistance.