F.D.A. seeks to mine additional information

by Jay Sjerven
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The Food and Drug Administration announced in a notice in the May 11 Federal Register it seeks public comment on its proposal to collect “additional food/feed facility profile information on a voluntary basis from firms that complete the F.D.A. food facility registration process.”

Under the Bioterrorism Act of 2002, all facilities that manufacture, process, pack or hold food for human or animal consumption in the United States must register with the F.D.A. The aim was information provided the F.D.A. under the act would help the agency to quickly notify facilities that may be affected by a deliberate or accidental contamination of the food supply.

The Food Safety Modernization Act of 2010 further directed the F.D.A. to allocate resources to inspect all food facilities registered with the agency, with the frequency of inspection based on the known safety risks of the facilities. In general, high-risk facilities must be inspected once every three years, and non-high-risk facilities must be inspected once every five years.

Should the F.D.A.’s current proposal be implemented, the agency would request facilities supply on a voluntary basis additional information it said will help it determine whether a company is high-risk or non-high-risk.

“We will use the profile information to assist us in determining the frequency at which we will inspect the firm,” the F.D.A. said. “Facilities that voluntarily submit the food facility profile information would benefit from our advance preparation through better-informed investigators and potentially reduced inspection time.”

The additional information the F.D.A. proposed to request would include, among other things:

• The facility type (e.g. manufacturer/processor, repacker/packer, or warehouse/holding facility);

• The products and hazards (e.g. biological, physical, chemical) and preventive control measures associated with the products where either there is a regulation in place requiring identification of hazards and preventive control measures, e.g. seafood and juice, or the firm as a matter of its own business practices voluntarily identifies hazards and implements preventive control measures; and

• Other facility information (e.g.. food safety training, facility size, operations schedule and number of employees).

The F.D.A. said companies would be offered the opportunity to voluntarily complete a food/feed facility profile when they initially register with the agency or when they renew or update their current registrations using the electronic system known as the Food Facility Registration Module.

“The use of an electronic form would enhance our ability to store the information in a searchable form,” the F.D.A. notice said. “Ideally, a searchable electronic system could allow F.D.A. to assess information when a problem occurs with certain types of foods or controls, so that we could target inspections to facilities that manufacture, process, or pack foods that are at increased risk for a food safety problem.”

The F.D.A. estimated it receives about 13,560 new domestic facility registrations and 23,370 new foreign facility registrations each year. The agency suggested it expected half of the new domestic registrants and half the new foreign registrants to voluntarily provide the additional profile information. This would mean the agency expects to collect additional profile information from 6,780 new domestic registrants and 11,685 new foreign registrants annually. Additionally, the agency estimated it will receive 118,530 registration updates annually, and half of the companies updating their registrations, or around 59,265, may be expected to provide the additional profile information.

Finally, under the F.S.M.A., during the period beginning on Oct. 1 and ending on Dec. 31 of each even-numbered year, which would include the current year, a facility that previously registered with the F.D.A. must submit a renewal registration, and these companies, too, would be given the option of updating their profile and providing the additional information.

Should its proposal be implemented, the F.D.A. potentially would accumulate a vast amount of additional information on domestic and foreign food facilities.

David Acheson of Leavitt Partners, observed, “While the request and voluntary aspect of the proposal seems fairly straight forward, it does bring to mind a few questions, specifically that since the form is voluntary, how will the information be evaluated? Will it move a facility that supplies information to a better spot — ostensibly penalizing those who do not fill it out? Or might a facility put itself in the crosshairs based on its response?

“Will the input data be electronically analyzed, or will a person review it? Because the forms include the naming of hazards and preventive controls, it seems that it must be subject to some sort of human evaluation — which raises a few more questions in and of itself, including the availability of resources to do so. And while F.D.A. states that it expects only half of those registering to complete the profile information, does it actually see the voluntary aspect as a precursor or trial to mandated submission of profile information?”

Asked since some of the additional information relates to a facility’s preventive controls, might the information gathered be used in developing new good manufacturing practices (G.M.P.s). Mr. Acheson said that may be the case, but he added the development of new G.M.P.s has been a long-standing goal, and the additional information may or may not be used to advance the process.

The comment period ends on July 10, which would give the F.D.A. ample time to implement its proposal in advance of the Oct. 1-Dec. 31, 2012, timeframe for registered food facilities to renew their registrations with the F.D.A.

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