FDA food safety plan taps others for inspection help

Nov 7, 2007 (CIDRAP News) – A new food protection plan from the US Food and Drug Administration (FDA), released yesterday as part of a comprehensive import safety plan, places a heavy emphasis on preventing food contamination by enlisting other groups to help the agency focus inspection efforts on high-risk food products.

The FDA's 25-page plan spells out a host of actions it will take, such as writing food protection guidelines for industry and helping foreign countries enhance their regulatory systems. It also specifies new legislative authority it will need to pursue several other safety initiatives, such as enhancing access to a food company's records during emergencies.

Federal efforts to improve food safety focus not only on recent cases of tainted imports, but also on recent contamination episodes involving domestic food products, such as Salmonella in peanut butter and Escherichia coli in fresh produce.

In May, FDA Commissioner Andrew C. von Eschenbach, MD, appointed David Acheson, MD, to the new job of assistant commissioner for food safety and asked him to develop an "agency-wide, visionary strategy for food safety and defense." Acheson was formerly chief medical officer and director of the Office of Food Defense, Communication and Emergency response at the FDA's Center for Food Safety and Applied Nutrition.

Officials who spoke at a press conference yesterday to introduce the import and food safety plans declined to estimate what the FDA plan might cost. Tevi Troy, deputy secretary of the Department of Health and Human Services (HHS), said staff needs and cost decisions "will be determined through the normal budget process."

When asked whether cost constraints would prevent immediate implementation of parts of the plan, von Eschenbach said, "I'm not prepared to say what we can't do right away. . . . There are many things that we're currently in the process of implementing and others that will come."

"We're working with Congress so they understand the plan . . . and hopefully will provide the support needed," he added.

Strategies address new challenges
The plan identifies several trends that present food safety challenges. An aging US population will be increasingly susceptible to foodborne illnesses, and Americans eat more fresh fruit and vegetables and rely more on convenience foods that carry a greater risk of cross-contamination.

Though the FDA said imported food doesn't pose greater risks than domestic food, "increases in the volume and complexity of imported foods have taxed the limits of FDA's approach to handling imports."

"America's food supply is among the safest in the world, and we enjoy unprecedented choice and convenience in filling the cupboard. Yet, we face new challenges to meet both the changing demands of a global economy and consumers' expectations," said HHS Secretary Mike Leavitt in a press release yesterday.

With strategies based on prevention, intervention, and response, the plan incorporates safety into every step of the food supply chain, Leavitt added. The FDA also said it believes the strategies would also effectively address deliberate contamination such as a criminal action or terrorist attack.

Using third-party inspectors
The number of domestic and foreign food production businesses that are subject to FDA inspections is growing faster than the FDA can manage on its own, the report notes. The plan asks Congress to allow the FDA to accredit third parties, or to recognize another agency that accredits third parties, to handle some inspection duties.

Third-party inspectors could be federal, state, local, or foreign government agencies or private entities that don't have conflicts of interest, the report said. The FDA would not be bound by their inspection findings.

The FDA would develop best practices for and solicit industry input on a system for third-party inspectors. In addition, the agency would audit the work of the third-party inspectors, review their inspection reports, and provide them with ongoing training.

Corporate responsibility
Several of the plan's components increase the responsibility of companies for preventing foodborne illnesses, and some would require legislative action. For example, the FDA would like the authority to require some food supply companies to implement specific safety measures to guard against intentional adulteration. The authority would apply to vulnerable bulk or batch links in the food supply chain, such as requiring locks on tanker trucks that transport food.

Also, for certain types of products that have been linked to serious human or animal foodborne illnesses, the FDA seeks the authority to require manufacturers to implement Hazard Analysis and Critical Control Point (HACCP) systems, which the US Department of Agriculture requires for meat packers.

"Promoting increased corporate responsibility is key in shifting FDA's food protection effort to a proactive rather than a reactive one," the FDA said in its report.

Research and technology measures
The report mentions several technological enhancements that could help the FDA improve food safety. More basic research is needed on identifying, managing, and preventing contamination. Also, the agency said new diagnostic tools are needed to speed the identification of and response to foodborne outbreaks.

New data management systems across federal agencies could also improve food safety, the FDA said. "For example, assigning a unique identifier [for each food company] will eliminate duplicate records and make risk data about a firm easier to access," the report added.

Certification of foods before shipment
For imported products that have been shown to pose a public health threat to the US population, the FDA would like the authority to require electronic certificates of compliance with FDA standards. Such a system would require the FDA to seek agreements whereby foreign governments or other accredited inspectors would certify each shipment or class of shipments before export. The FDA would have to take steps to ensure that the system was not vulnerable to counterfeiting or other security breaches such as transshipment to avoid certification.

"This approach shares the burden of ensuring the safety of food products with the exporting country. Shipments that fail to meet the requirements would be refused entry," the FDA report says.

Improving the ability to detect food safety signals is also a focus of the FDA's plan. The agency proposes improving its adverse-event and consumer-complaint reporting systems and creating a food-safety database for veterinarians.

Speeding outbreak response
The report highlighted several actions that could improve response to food outbreak emergencies. As reported previously, the FDA plan, like the overall import safety plan, asks Congress for the authority to order mandatory recalls when companies are unwilling to issue voluntary recalls.

Also the FDA said it needs more streamlined access to company records in the event of a foodborne illness outbreak. The agency would like the authority to access company records on related food items, such as food produced on the same manufacturing line as a product suspected of contamination.

The agency also proposes to remove the requirement that a product must be shown to be adulterated before inspectors can access records in an emergency. Instead, officials should be able to investigate company records when they have a reasonable belief that a food presents a serious health threat.

"The recent melamine situation in which the FDA had early clinical evidence that a specific food was causing illness in pets but did not have clear evidence of a specific adulteration is an example of such a scenario," the report states.

Risk communication is also addressed in the plan, and the agency proposes enhancing systems of contacting retailers and other groups during a foodborne illness outbreak. The agency also plans to build a Web site to communicate important food-protection information to consumers.

Mixed reviews
The FDA plan drew mixed reviews from consumer groups.

Consumers Union welcomed the proposal to equip the FDA with mandatory recall authority but criticized some other aspects of the food and import safety plans.

In a news release, Jean Halloran, Consumers Union's director of food policy initiatives, faulted the administration's proposal for not including a budget increase to cover the costs. She also said the plan doesn't increase the penalties for safety rule violations enough to serve as a deterrent.

"And the focus on the 'carrot' approach—enticing companies to buy from 'certified' producers to import products more quickly—appears to shift the emphasis towards increasing trade and away from the number one priority—ensuring that all products entering the US are safe," Halloran said.

In a similar vein, the nutrition watchdog group Center for Science in the Public Interest (CSPI) hailed the proposal for FDA recall authority but criticized the administration plans on some other counts.

In a statement, Sarah Klein, CSPI's food safety staff attorney, called the safety plans "woefully short on specifics" about improving the traceability of food imports. She also said it was "very disappointing" that the proposals don't call for "a single strong food safety agency" to end the current division of food safety responsibilities between the FDA and the US Department of Agriculture.

On the industry side, the Grocery Manufacturers Association (GMA) praised the food safety plan, including the FDA recall authority.

Hailing the plan's focus on prevention, GMA President Cal Dooley said many elements of the plan resemble measures in the GMA's own food safety plan, unveiled in September. The GMA plan calls for doubling the FDA's budget over the next 5 years and for "strengthening the food safety private-public partnership," he said in a statement.

Concerning the recall authority issue, Dooley said, "We believe mandatory recall authority should be granted to FDA to expedite the agency's ability to more rapidly respond whenever there is a significant risk of an adverse outcome, or whenever food companies refuse FDA's request to voluntarily recall a product."

A report in today's Wall Street Journal said most of the administration's proposals are not new. The story quoted William Hubbard, a former associate commissioner of the FDA, as saying, "I see this as the administration falling into line with the other groups, with the industry, the Congress, consumer groups and the FDA career scientists. You've got a strong groundwork upon which to craft legislation.

See also:

Nov 6 HHS press release
http://www.hhs.gov/news/press/2007pres/11/20071106a.html

Nov 2007 FDA Food Protection Plan
http://www.fda.gov/Food/GuidanceRegulation/FoodProtectionPlan2007/default.htm 

Nov 6 CIDRAP News story "US food safety plan calls for FDA recall power"

Nov 6 Consumers Union news release
http://www.consumersunion.org/news/cu-urges-strong-action-on-the-safety-of-imports/

Nov 6 CSPI statement
http://www.cspinet.org/new/200711062.html

May 1 CIDRAP News story "New FDA job to focus on food safety strategy"

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