(April 4, 5:15 p.m., PACKER WEB EXCLUSIVE) The comment box is open for the Food and Drug Administration’s Food Protection Plan.

The U.S. Food and Drug Administration is asking for comments related to its comprehensive Food Protection Plan, said FDA spokesmen Sebastian Cianci.

The comment period is open until July 31, according to a notice published in the Federal Register April 2.

Industry leaders expressed general support for the FDA’s plan to improve food safety oversight.

“The PMA supports any activity that gives us safer food supply, as long as the programs put forward are based in science and are commodity-specific, then we are very much in support of FDA,” said Robert Whitaker, chief scientific officer of the Produce Marketing Association, Newark, Del.

At the same time, PMA believes FDA must have additional support from Congress to make the plan work.

“It will require additional manpower and money to make it work,” Whitaker said.

Debate about food safety is ramping up in Washington, said Robert Guenther, senior vice president of public policy for the Washington, D.C.-based United Fresh Produce Association.

“We will form a working group through the Food Safety Technology Council to develop comments to the FDA,” said.


The FDA’s Food Protection Plan was released in November 2007, and proposes a strategy to protect the U.S. food supply from both unintentional contamination and deliberate attack.

Through the Federal Register notice, the FDA referred to new challenges in the U.S. food supply.

For example, consumer preference has popularized the convenience of bagged salads.

“In the past a single head of lettuce that was contaminated may have resulted in one family being ill. … Now, a contaminated head of lettuce may be processed with many others and be placed into bags of convenience salad that many consumers can buy,” according to the notice.

What’s more, the U.S. now imports food from 150 countries through 300 ports. The agency said 15% of all food comes from other countries, with 75% of seafood products and 60% of fresh fruits and vegetables are imported.

The FDA’s comment period specifically asks for stakeholder input on these (and other) questions:

  • What, if any, are the limitations to a risk-based approach to food safety? What criteria should the agency consider in defining high risk?

  • What are potential data sources other than FDA data to inform the risk-based approach? What are the obstacles to obtaining such data?

  • The plan proposes new legislative authorities to strengthen FDA’s ability to prevent food problems. They include: (1) Allowing FDA to require controls against intentional adulteration by terrorists or criminals at points of high vulnerability in the food chain, (2) authorizing FDA to issue additional preventive controls for high-risk foods, and (3) requiring FDA facilities to renew their FDA registration every two years and allowing FDA to modify the registration categories. What would be the principal benefits and limitations of each of these proposed authorities? In implementing these proposed authorities, how could the benefits be best leveraged and the limitations mitigated?

  • The plan proposes legislative authority for FDA to accredit highly qualified third parties for food inspections. What would be the principal benefits and limitations of an accreditation program?

  • The plan proposes two new legislative authorities to strengthen FDA’s response capability: (1) Empowering FDA to issue a mandatory recall of food products when voluntary recalls are not effective, and (2) providing FDA enhanced access to food records during emergencies. What would be the principal benefits and limitations of each of these proposed authorities?