The U.S. Food and Drug Administration has now released all seven of the major proposals required under the Food Safety Modernization Act (FSMA)—preventive controls for human food, produce safety, the foreign supplier verification program, third-party certification, preventive controls for animal feed, sanitary transportation, and intentional adulteration.
The comment period has closed for the first four proposals. Now FDA is tasked with reviewing the tens of thousands of comments the agency received and developing a set of final rules. FDA has, however, already stated it will reopen the comment period for several issues that are especially challenging in both the preventive controls and produce safety proposed rules.
Reducing the risk to consumers from contaminated food is an important public health challenge and FSMA shifts FDA’s approach to food safety from reaction to prevention. For the most part, FDA’s proposed rules embrace that preventive approach, establishing new requirements for food processors, food producers and food importers to better assure the safety of the food supply. Consumer Federation of America and other consumer groups have provided comments to the agency on the first four proposals, generally supporting the rules but urging changes in several areas to better protect consumers. Here is a summary of those comments:
Under the proposed rule for preventive controls for human food, FDA did not require food companies to conduct environmental or other testing of raw materials and finished product. Neither did FDA require food manufactures to develop and maintain a supplier verification program. Both of these are common practices in the food industry and FDA should require testing and a supplier verification program in the final rule.
Under the produce safety proposed rule, FDA’s approach of regulating risky practices rather than products is appropriate. However, FDA’s decision to exempt foods “commonly consumed raw” is not a preventive approach. FDA should ensure that all produce meet food safety regulations. In addition, water used in growing produce should meet a numerical standard demonstrating safety; though that issue will be further debated when FDA issues a revised proposal later this year.
In the proposed rule on the foreign supplier verification program, FDA provided importers with two options on how to verify that their suppliers are producing safe food. One option requires annual onsite verification of suppliers, while the other option allows the importer to choose from several verification options. Annual onsite audits are essential to provide assurances that suppliers are producing food safely, and FDA should require importers to conduct onsite audits rather than choose from a range of options which may not provide the same level of assurance.
Finally, FDA’s proposed rule on third-party certification is uncharted territory for the agency. Consumer confidence in these types of programs is low due to several high profile incidents in which food producers (PCA, Jensen Farms and Wright County Eggs) were given high marks by third-party auditors only to be later linked to huge nationwide foodborne outbreaks. Consequently, adequate transparency and effective oversight, including unannounced audits, will be essential to build credibility into the system. Also important is a requirement that auditors notify FDA if they discover a condition in the plant which could cause a serious risk to public health.
Waldrop will be among the presenters discussing implementation of FSMA at the Farm Foundation® Forum on Wednesday, Feb. 19. For other speakers or to register for the live event or the audiocast, visit the Farm Foundation website, www.farmfoundation.org.