(Feb. 4) A torrent of proposed regulations from the Food and Drug Administration may have laid the groundwork for fundamental changes in the way the produce industry does business.

But the proposed changes won’t be made without significant opposition from fruit and vegetable lobbyists.

The FDA on Jan. 29 proposed a regulation requiring that notice be given to FDA before food is imported or offered for import into the U.S. In addition, the FDA proposed a regulation requiring domestic and foreign food facilities that manufacture, process, pack or hold food to register with the agency by Dec. 12.

Both proposals help implement measures in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The FDA will accept comments on the proposals through early April, and final rules are expected by October.

Donna Garren, vice president of scientific and technical affairs for the United Fresh Fruit & Vegetable Association, Washington, D.C., said both of the FDA’s proposals have flaws.

While United had yet to formalize its position on the proposals as of Feb. 3, Garren said it was apparent the proposals needed to be changed.

She said the proposal on notice was too restrictive for importers and the proposal on registering food facilities did not provide a broad enough definition of farms, which are given an exemption from the registration requirement.

The notice provision would give the FDA advance information of imported food shipments, which the FDA said would allow it to plan inspections more effectively and improve food safety.

Under the proposal, the FDA must be notified by noon of the day before the food will arrive at the U.S. border crossing or port of entry.

The proposed rule would require the notice to be submitted electronically through an FDA Internet-based system that would work 24 hours a day, seven days a week. The agency said it anticipates that an average of 20,000 notices will be submitted daily.

The bioterrorism act requires that the FDA receive notice beginning Dec. 12, even if final regulations have not issued by that date. The final rule will be issued by Oct. 12, the agency said.

If the regulations are not issued by the deadline, the industry would still be required by Congress to provide the FDA notice of shipping of no less than eight hours and no more than five days.

The proposed rule would allow product identity to be amended if complete information does not exist by the deadline.

Even so, Lee Frankel, president of the Fresh Produce Association of the Americas, Nogales, Ariz., said he was disappointed with the proposal. He said the notice provision fails to give enough flexibility to growers and shippers of perishable foods who may not know what will be harvested and shipped later that same day.

What’s more, Frankel said the FDA’s data requirements are not integrated with those of the U.S. Customs Service, which he fears will create inefficiency and expense for consumers.

“It will be my task to do the FDA’s work for them and come up with a system that accomplishes the goals of Congress with minimal disruptions to the trade,” he said.

Garren agreed that the rule had several problems, chief among them being the lack of flexibility.

She said the industry is constantly reworking orders and manifests. Harvest and shipping often take place on the same day, she said.

Although the FDA does allow for correction to the manifest, Garren said there was not enough consideration for the nature of shipping perishables.

Another leg of the bioterrorism bill is the registration of food facilities, and the FDA released a proposed regulation Jan. 29 that would require domestic and foreign food facilities that manufacture, process, pack, or hold food in the U.S. to register with the agency by Dec. 12.

The measure will bolster the FDA’s ability to regulate the more than 400,000 domestic and foreign facilities that deal with food within the U.S., said FDA Commissioner Mark McClellan in a news release.

The proposed regulation would require the owner, operator or agent in charge of a domestic or foreign facility to submit a registration to FDA.

The registration must include the name and address of each facility at which, and trade names under which, the registrant conducts business, and the categories of food the facility handles. For a foreign facility, the registration must include the name of the U.S. agent for the facility.

Garren said the requirements of the rule are overwhelming for a multinational shipper like Dole Food Co. Inc., Westlake Village, Calif.

The U.S. agent may register a foreign facility if it is authorized to do so by the facility. The proposal also would require facilities to update any changes to the information previously submitted within 30 days of the change.

The proposal excludes farms, restaurants and other retail food establishments.

The law requires FDA to notify the registrant of receipt of registration and to assign each facility a unique registration number.

The registration may be electronic, via the Internet, or by paper through surface mail. The FDA said its Internet system of accepting electronic registrations will be available 24 hours a day, seven days a week. There is no fee associated with registration.

Under the bioterrorism act, facilities must register by Dec. 12 FDA plans to issue a final rule by Oct 12.

If a firm does not register by the deadline, the U.S. can bring a civil action.

The bioterrorism act requires food from unregistered foreign facilities to be held at the port of entry unless the FDA directs that the food be moved to a secure location.

Garren said the FDA’s definition of farm is too narrow for the produce industry and expressed disappointment the FDA did not consider United’s previously submitted comments on the issue.

Even growers with mobile packing operations may have to register with the FDA under the proposed rule, she said.

Garren said the new regulations promise to cost produce firms many hours of labor to comply with.

“This could be somebody’s full time job, filling out registrations,” she said.