Constructively commenting on revised Food Safety Modernization Act rule

Effective comments are critical to shaping a final rule that ensures public safety and is fair to all involved. Here are pointers on how to comment effectively and be the best advocate for changes in the proposed rule.

With the release of the draft produce safety rule under the Food Safety Modernization Act (FSMA) and subsequent comment period extensions, growers and other industry professionals spoke loud and clear about their concerns over the rule in over 15,000 comments. These comments and interactions with industry gave the FDA insight that ultimately led to the Agency revising a number of portions and reopening only these portions for comment. The comment period ends Dec. 15, so time is of the essence.

There are a number of things to keep in mind when making comments on the rule in order to make them more effective. First, it is helpful to reference the section of the rule you have particular issues with. The regulation is broken up into individual chunks and labeled to easily reference a particular section. Referencing these sections reduces the confusion on what aspects of the rule you have an issue with. In addition, it frames the discussion and can improve the credibility of the comments. Keep in mind that the only parts of the rule that are open for comment are the revised sections. If the regulation you want to comment on wasn’t part of the revision, it isn’t up for comment.

Another component of an effective comment is being specific about the issue you are presenting. Disparaging the institution or the rule in total generally is ineffective in changing the content of the rule, despite possibly improving a commenter’s mood. By making specific comments about proposed produce safety practices, there is a greater likelihood that the content or scope of the rule will change in the commenter’s favor. At the ends of each section, the FDA has taken pains to outline specifically the kind of information they need guidance on from you, the commentator. Use these statements to provide structure to your own comments.

Finally, offering alternatives is an important way to create the most effective rule. As much as it is important to state the food safety recommendations that growers feel are untenable, it is important to share ideas that provide similar outcomes that would be tenable.

These rules will become law and all growers, irrespective of size, will need to make at least some changes as a result of them. Taking the time now to become familiar with what is being proposed and commenting when necessary is the only way to shape the process. Waiting until Dec. 15 is too late.

You can submit comments online. Comments can also be written and faxed to the FDA at 301-827-6870 or mailed to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Go to the FSMA website to read more about the rule or if you would like to comment on the proposed rule. Also, see “Food Safety Modernization Act proposed revisions to produce rule made public” from Michigan State University Extension for more information.

If you have specific questions about the produce rule or have difficulty tailoring GAPs to your farm, contact the Agrifood Safety Work Group at or 517-788-4292.

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