The F.D.A. wants more information

by Jay Sjerven
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In a draft guidance for industry issued in late August, the Food and Drug Administration specified additional food categories it intends to include as mandatory fields in its food facility registration form.

Under the Food Safety Modernization Act, food facilities must register with the F.D.A. Registration entails completion of a form that provides the agency with basic information about the food facility, including its owners, agents and trade names, as well as the types of activity conducted at the facility and the general categories of food products manufactured, processed, packed or stored in the facility.

Companies that already reg-istered their facilities with the F.D.A., which should be all companies engaged in manufacturing, processing, packing and storing food products, must renew their registrations between Oct. 1 and Dec. 31 of each even-numbered year. The renewal process begins this year, and the changes to food product categories contained in the new draft guidance may be reflected in the forms companies must complete to renew their registrations.

Currently, the food facility registration form contains a “mandatory” list of 35 general categories of food for human consumption. If a facility manufactures, processes, packs or stores items in one or more of the general product categories, it must so indicate on the registration form.

The form also includes a list of 25 general food categories that apply to food for animal consumption. Currently, while a facility must indicate if it is an animal food manufacturer, processor or holder, it is not required to be more specific by indicating which of the general product categories of food for animal consumption applies to its operations. Reporting this additional information is “optional.”

In the new guidance, “Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories,” which was distributed for comment, the F.D.A. noted that the list of additional food categories on which reporting would become mandatory includes categories on the current food facility registration form that are optional fields, including the general product categories for food for animal consumption.

With regard to the list of general product categories relating to food for human consumption,
under the new guidance, entirely new categories would be established, including “acidified food,” “fruit or vegetable juice, pulp or concentrate products,” and “low acid canned food products.” And many existing product categories would be expanded or made more specific. For instance, the current “vegetable and vegetable products” category would become more specific by explicitly requiring mandatory reporting on “fresh cut vegetable products; raw agricultural commodities; and other vegetable and vegetable products.”

The aim is greater specificity and a more accurate accounting of what each food facility manufactures, processes, packs or stores.

The F.D.A. said it believes information about the categories of foods manufactured, processed, packed or held at food facilities is a key element in allowing rapid communication between the agency and facilities directly affected by actual or potential bioterrorist attacks, other food-related emergencies, or food safety incidents.

“Information about the categories of food a facility handles currently assists the F.D.A. in conducting investigations and surveillance operations in response to food-related emergencies,” the F.D.A. said. “These categories also enable the F.D.A. to quickly alert facilities potentially affected by such an incident if the F.D.A. receives information indicating the type of food affected. The proposed additional categories enhance the agency’s ability to respond quickly and accurately to an actual or potential bioterrorist incident or other food-related emergency.”

The F.D.A. emphasized the guidance was different from others issued by the agency. The F.D.A. pointed to sections of the Bioterrorism Act and the F.M.S.A. authorizing the agency to include food categories it deems “appropriate” in registration of food facilities.

“Because of Congress’s explicit statutory authorization to establish a binding requirement based on a finding in guidance, this document is not subject to the usual restrictions in F.D.A.’s good guidance practice, such as the requirements that guidances not establish legally enforceable responsibilities and that they prominently display a statement of the document’s nonbinding effect,” the F.D.A. said.

The F.D.A. guidance documents ordinarily contain standard language explaining that guidance documents should be viewed only as recommendations unless specific regulatory or statutory requirements are cited.
“F.D.A. is not including this language in this draft guidance because it is not an accurate description of the effect of this guidance,” the agency said. “This guidance contains findings that serve as the predicates for binding requirements on the industry.”

David Acheson, a partner in the law firm Leavitt Partners, observed, “While most guidance recommends, ‘Thou canst,’ this new guidance commands, ‘Thou shalt.’” Mr. Acheson added, “This mandatory inclusion of these additional categories makes me wonder if this is something like what the high-risk food list might look like. It is, at least, an interesting speculation.”

A spokesman for the Grocery Manufacturers Association told Food Business News, “We are looking at the new food categories and will be drafting some official comments to be shared with the F.D.A. highlighting the impact these changes will have on the overall registration process beginning Oct. 1.”

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