Be Part Of The Process

What retailers should know about the FSMA proposed rules, and how they can get involved.

The U.S. Food and Drug Administration (FDA) has proposed rules on produce safety and preventive controls under the Food Safety Modernization Act (FSMA). Although these rules don't directly regulate retail stores, retailers should be paying attention to the details because the preventive-controls rule will affect their distribution/warehousing and suppliers, and the produce proposal will affect suppliers.

Both of these are only proposals now, not regulation, so companies don't need to make changes based on them. A public comment period is open until May 16. Now is the time to learn about the potential impact of these proposals and offer comment to shape the final rules.

What Would Be Required?

The preventive-controls proposal would apply to food facilities that manufacture, process, pack or hold food for human consumption, both U.S.-grown and imported, and are required to register with FDA under the Bioterrorism Act of 2002, including retail distribution centers and warehouses. Certain registered facilities, such as small businesses engaged in low-risk activities and holding foods that aren't exposed to the environment, would face lesser requirements.

Who Would Be Exempt?

Farms, retail stores and restaurants exempt from the Bioterrorism Act's registration requirements would also be exempt from the preventive-controls rule. Facilities that store only unexposed packaged food are exempt if those foods don't require refrigeration for safety, and are subject to limited requirements if the refrigeration for safety is necessary.

"Qualified facilities," as defined by FDA, would face modified requirements involving certain notifications, either to FDA or directly to consumers. A qualified facility may be either a small business, with average annual sales of less than $500,000 and at least half its sales going directly to consumers or to retailers or restaurants within the same state or within 275 miles of the facility, or a very small business, for which FDA has proposed three definitions and seeks comments on which to adopt in the final rule.

What Would the Produce Rule Require?

The produce safety rule will set standards for the growing, harvesting, packing and holding of raw fruits and vegetables for human consumption, whether grown in the United States or imported.

Exempt from this rule would be produce that's typically cooked or that undergoes enough processing to kill pathogens.

Do the Proposals Include Traceability?

Traceability will come in a later proposed rule on recordkeeping. Before that, FDA must report on a traceability pilot conducted to inform its rulemaking. Independent of FSMA, traceability is still required under the Bioterrorism Act of 2002.

Retailers can look to PMA for guidance on FMSA proposals through its FSMA Resource Center (www.pma.com/fsma), where a wide range of tools and information is available to all industry members.

Also, discuss these proposals with supply partners and others in the retail community and let FDA know your thoughts through the comment process. You can also share your perspective with your trade associations, including PMA, which will then provide comment to FDA on their members' behalf.

The days when retailers could simply buy produce based on quality and price are gone; food safety must be part of the business transaction. By being involved in this current regulatory process, retailers can help generate input to FDA that ensures all final rules incorporate the highest level of food safety to protect consumers in ways practical and efficient for the entire supply chain.

Tom O'Brien is a representative of the Produce Marketing Association in Washington, D.C.

The days when retailers could simply buy produce based on quality and price are gone.