FSMA Rules: “We Are Here”

With the issuance of the first of its proposed rules for the Food Safety Modernization Act (FSMA)—Produce Safety and Preventive Controls, FDA published a few accompanying documents and fact sheets, including explanations of the rulemaking process. With the flack that FDA has taken over the lagging of rule publication in the two years since the signing of the act, it’s not surprising that the agency would go on the offense to ward off further criticism of the time it is taking to make the rules. (For information on the two proposed rules, see Legislative Update by Dr. David Acheson, page 12.)

One of the documents that FDA issued is entitled What You Need to Know. Available at www.fda.gov/Food/FoodSafety/FSMA/ucm334554.htm#coverage, the page includes a section titled: The Produce Safety Rule: It Won’t Happen Overnight, with the first sentence stating, loud and clear, “The process of issuing a rule takes time.”

As the publication goes on to explain, there are several steps that FDA is mandated to follow in the issuing of a rule, and as the agency again clearly states in its listing of the steps, it is only on the first of four time-consuming steps. As listed by FDA, those steps are:

• “FDA proposes rule on January 4, 2013, and requests comments. *WE ARE HERE*” Both the Produce Safety and Preventive Controls rules were published in the Federal Register, as required, on January 4.
   
• “Public has until (insert date) (120 days) to comment and FDA holds three public meetings during this time.” Comments are due by May 16, 2013, and most industry experts are expecting that FDA will receive a substantial number of comments on both of the proposed rules. In fact, as Acheson notes, FDA includes numerous requests for comment in the proposed rules.
   
• “FDA considers comments received and considers revising the proposed rule based on the comments.” This is where a great deal of time could be spent, as FDA not only takes the time to consider all comments, but also, with the need to integrate the components of FSMA, FDA will need to consider the impact of each rule on all other parts of the Act and the other rules yet to be issued.
   
• “FDA issues final rule, setting dates for companies to comply, with additional time for small and very small businesses.” Say that FDA is able to consider comments, make revisions, and issue the final rule within nine months from issuance. The rules would then be in effect as of the beginning of October 2013, however, there will be additional time given for compliance primarily based on business size.

This is but a brief overview of the process, with exceptions allowed in specific cases, such as FDA’s ability to immediately issue Interim Final Rules if it believes it to be necessary, such as for public safety. Comments are still requesed and considered, but the rule takes effect immediately. FDA invoked this authority in February 2012 for the FSMA amendment on records access. [FR Doc No: 2012-4165]

While the FSMA rules are (finally) moving forward, there is a lot of work to be done before any are final or compliance is required. To integrate the words of FDA and Dr. Acheson: We are here, but it is only the beginning.

More information on the rulemaking process is available in an FDA video, The Rulemaking Process: A Primer by FDA. (www.fda.gov/Food/FoodSafety/FSMA/ucm334766.htm).

The author is Editor of QA magazine. She can be reached at llupo@gie.net.