Requiring manufacturers to establish preventive controls for all food products and integrating local and state governments into the national food safety network are at the top of FDA's to-do list for improving the system.

David Acheson, FDA's food protection chief, and Center for Food Safety and Applied Nutrition Director Stephen Sundlof discussed reforming the system April 22 at the Food and Drug Law Institute/FDA conference in Washington.

Acheson and Sundlof acknowledged holes in the current system and that improvements are needed to help prevent food-borne illness outbreaks, such as the salmonella contamination of peanut butter products sourced from the Peanut Corporation of America (¹ Also see "Salmonella Outbreak Reveals “Gaping Loophole” In Food GMPs – Sen. Harkin" - Pink Sheet, 9 February, 2009., p. 5).

While prevention, contamination, identification and response are all key areas for improvement, the agency is moving in the direction of putting emphasis on the prevention of outbreaks, "rather than reacting to them as we have done in the past," Sundlof said.

He added that to be more successful with food safety, FDA must work with state agencies, as they are usually the first responders.

FDA officials "think we could be doing a lot more" with the state and local governments, which "will factor into the overall program," Sundlof said.

Acheson said the current food safety system was not built for current challenges, both foreign and domestic. While FDA works with foreign governments and industry to beef up inspections in other countries, he pointed out that achieving better coordination among domestic agencies requires more resources at the local level.

"Clearly, there is a desperate need for better integration of regulatory individuals that are safeguarding food," Acheson said. "It is critical to build a national food safety system that integrates" local, state and federal governments.

Sundlof said FDA has improved its response since the 2008 salmonella outbreak linked to peppers, which was the largest case of human illness related to an outbreak in a decade. Salmonella contaminations in peanut products and most recently in pistachios have followed the peppers problem.

Sundlof said FDA is moving more quickly to remove adulterated products from the market. "We want to do it in such a way as to minimize collateral damage to the industry as much as possible," he observed.

He noted it is a "very complex and time-consuming effort" to follow the supply chain in investigations such as the peanut product recall, which was more complicated than the pepper situation because of the number of products and companies involved. Not only did PCA supply ingredients to numerous firms, but some of those companies sold those same ingredients to multiple manufacturing customers.

Acheson noted FDA's traceback system works, but must become more efficient. "It takes too long," he said. He pointed out the contaminated peppers were traced to a farm in Mexico.

Report Sets Integration Costs At $350M

Mike Taylor, a policy professor at the George Washington University and a former FDA deputy commissioner, and GWU colleague Stephanie David recently released a report detailing the need for state and local governments to be integrated into food safety enforcement.

The report - Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation's Food Safety System - says a lack of coordination between the agencies hinders each agency's ability to effectively do its job.

The report recommends Congress fund local and state agencies with $350 million over the next five years in efforts to coordinate them with federal systems and better equip them to prevent and respond to outbreaks.

Taylor and David note food safety reform is "on the front burner in Washington," but will not be completed until federal, state and local "agencies are strengthened and integrated more fully into the national food safety system."

Their report includes recommendations for implementing the integration, including that Congress establish and fund an intergovernmental food safety leadership council to develop a program incorporating enforcement by agencies from all levels of government.

Food safety concerns have spawned multiple bills on Capitol Hill. While some would provide additional authorities for FDA, others propose moving food safety out of the agency and into a separate agency in the Department of Health and Human Services (see item p. 14).

On April 23, Sen. Chuck Schumer, D-N.Y., introduced S. 893 to establish a division in the Department of Commerce, to be called the Office of Imported and Domestic Product Safety, to improve coordination and oversight of safety enforcement for food and other products.

HACCP-Like Components Needed Across Food

Sundlof also discussed requiring food firms to establish preventive plans similar to the Hazard Analysis and Critical Control Point systems applied to certain foods. HACCP requires producers to identify hazards and develop plans to prevent them.

HACCP currently applies to high-risk conventional foods regulated by the Department of Agriculture like meat and poultry, and to juice and seafood under FDA.

When asked if FDA currently has authority to implement HACCP-like requirements across the industry, Sundlof responded that FDA believes under current law it can, although agency attorneys would like more "explicit" language saying so.

Acheson hesitated to call new preventive controls "HACCP," but he acknowledged the future of food safety should include requirements for risk-based preventive controls.

It is not clear how these potential elements of food safety reform would impact supplements, which are covered by separate good manufacturing practices.

Sundlof said other authorities important to improving the system include accrediting third-party labs to do analyses and inspections.

He also said it is necessary that all firms registering with the agency provide more and higher-quality information to FDA than currently required.

Food Safety On FDA Table, Before Breakfast

Sundlof also noted FDA has food safety at the top of its priority queue. Acting Commissioner Josh Sharfstein leads a meeting each day at 7:45 a.m. to discuss food safety efforts, he said.

During those meetings top officials discuss "the food safety system - the critical parts, the parts that would really benefit from changes," Sundlof added.

The White House has "great interest" in food safety efforts and the recently appointed Interagency Food Safety Working Group has started meeting, Sundlof said. "There is going to be a lot of pressure on this Food Safety Working Group to move rapidly" and produce "a high-quality product," he said.

Predictions Of More Recalls

The FDA officials also noted that tracing food contamination has improved over the years, leading to more identification of outbreaks.

Sundlof said one lesson from the investigation of PCA-sourced ingredients is "how one bad actor can taint the whole industry."

FDA says PCA knowingly shipped products that previously tested positive for salmonella (³ Also see "Ounce Of Prevention Would Have Saved Pounds Of Peanut Pain – Experts" - Pink Sheet, 16 February, 2009., p. 11).

FDA will likely find more contamination problems as the agency gets even better at detecting problems. "I can almost guarantee it," Sundlof said, adding, "It has a lot of us concerned we will be nothing but recalls."

He is not so certain whether the food industry is changing due to the spate of recalls. "Will this be a wake-up call for industry to change? Or will it continue to be an ongoing series of recalls? It concerns me greatly."

Sundlof said the recent outbreaks may lead CFSAN to develop new guidelines for processing certain nuts that may be more susceptible to contamination.

- Katie Stevenson (k.stevenson@elsevier.com)

Federal-State Food Safety Coordination Becoming A Key Reform Ingredient

More from Archive

More from Pink Sheet