Regulatory RoundUP opened this week with an impressive array of speakers who addressed several pressing issues in the dairy industry, and the Food Safety Modernization Act was at the top of the list. Mike Taylor, deputy commissioner for Foods and Veterinary Medicine for the Food and Drug Administration, said the agency was on track for getting the FSMA rules finalized on time and is now focusing on developing strategies for effective implementation.  

“We’re very grateful for the extensive participation we’ve had from industry in the rulemaking process,” Taylor said. Promoting the theme of “strategic alignment,” he called for continued partnership among government, industry and consumers during the implementation phase. “You can’t do something as big as the Food Safety Modernization Act without having basic alignment with all involved,” he explained.

Taylor underscored that, under FSMA, FDA will be taking a fundamentally different approach to inspections than it has in the past. Rather than focus on violations and enforcement types of inspections, FDA will now be focusing on prevention systems and controls.  

Recognition of Great Performers

The premise, Taylor said, is that there is a “tier of great performers and some who are not such great performers,” and FDA wants to recognize the great performers while deploying more resources to facilities that aren’t as far along and need more attention. The agency currently is in the process of retraining thousands of FDA and state inspectors to “reorient the mindset” to the new approach and make sure all inspectors have a consistent understanding of the regulations.

He also mentioned the challenge presented by Listeria monocytogenes, saying “It’s important to embrace the fundamental idea that preventing food safety problems is first and foremost an industry responsibility” independent from FSMA. Taylor added that he applauded the steps the industry has taken on food safety issues in general and sees FSMA as a framework for verifying to the public that the industry is doing the right thing.

Successful Collaboration

In keeping with the strategic alliance theme, Taylor noted two recent examples of successful collaboration, starting with the Pasteurized Milk Ordinance. FDA worked with the National Conference on Interstate Milk Shipments and its decision-making process to get the PMO aligned with what FDA expects will be the final regulations in the preventive controls rule under FSMA.

The second example was the recent release of the milk sampling survey results regarding drug residues. He noted that the collaborative effort between industry and government was effective in large part because each group was working toward the common goal of verifying to the public that the milk supply is safe.

Importance of Environmental Monitoring

Another key speaker was John Sheehan, director of the Division of Dairy, Egg and Meat Safety, Center for Food and Safety and Applied Nutrition, FDA, who talked about the recent product recalls related to Listeria monocytogenes. He encouraged companies to continue their emphasis on environmental monitoring, saying FDA recognizes that companies won’t always have negative results. The agency expects positive results and also expects to see corrective actions, he added.  Sheehan also underscored the need for adherence to FDA’s current good manufacturing practices regulation as a foundation for any food safety program.

Sheehan discussed upcoming agency activities, including a sampling assignment for Hispanic and Mexican cheeses to come later this year and an Advanced Notice of Proposed Rulemaking on raw milk cheeses to be released in late July or early August. He said the industry should expect that the 60-day aging standard for raw milk cheeses will be replaced with a performance standard.

The program included several other speakers and panelists who covered cyber security, food litigation, dairy’s role in federal nutrition programs, labeling reform, enforcement activities related to ammonia refrigeration systems and trade agreements.

For more information, contact Marti Pupillo, IDFA director of communications, at mpupillo@idfa.org.