FDA issues rules on food shipments, registration

Oct 9, 2003 (CIDRAP News) – The Food and Drug Administration (FDA) today announced final rules designed to make the nation's food supply more secure by requiring food companies to register with the FDA and to give advance notice of imported food shipments.

The rules, which take effect Dec 12, have been revised since they were first proposed last January. One notable change is that food importers can wait till a few hours before a shipment arrives to notify the FDA, instead of having to do it by noon the day before.

The FDA expects to receive about 25,000 notifications of imports daily and estimates that about 420,000 facilities will register under the new rules, the Department of Health and Human Services (HHS) said in a news release.

The new regulations will improve efforts to monitor and inspect imported foods and will allow quick identification and notification of food processors and other businesses involved in any deliberate or accidental contamination of food, HHS officials said. "By requiring advance notice for imported food shipments and registering domestic and foreign food facilities, we are providing critical new tools for the FDA to identify potentially dangerous foods and better keep our food supply safe and secure," said HHS Secretary Tommy Thompson.

The "prior notice" rules, designed to help the FDA decide which food shipments to inspect, cover both human and animal food. Starting Dec 12, importers will be required to notify the FDA of arrivals no longer than 5 days in advance. Notices must be filed no fewer than 2 hours early for shipments by road, 4 hours early for shipments by air or rail, and 8 hours early for shipments by water. For mail shipments, the FDA must be notified before the item is mailed.

The FDA said prior notice is not required for foods that individuals carry into the country for their personal use, food that is imported and then re-exported without leaving the port of arrival, and meat, poultry, and egg products that are regulated exclusively by the US Department of Agriculture.

Most of the information required by the prior notice rule is already submitted by importers to the US Bureau of Customs and Border Protection (CBP) when foods arrive in the country, the FDA said. The new rule means importers will have to provide the information in advance. But the FDA said importers will be able to use a CBP system called the Automated Broker Interface of the Automated Commercial System (ABI/ACS) to submit the information electronically. They also will have the option to use a new FDA electronic system called Prior Notice System Interface.

The agency estimated that importers will be able to use the ABI/ACS for more than 80% of shipment notifications. But they will have to use the FDA system for mail shipments and certain other types of transactions, officials said.

At a press briefing today, FDA officials said the prior notice rule was revised to ease some requirements about notification of changes in shipments. For example, under the proposed rule, if there were a change in the quantity, anticipated arrival time, or estimated date of mailing, the importer would have to submit a new notice, said Bob Lake, regulations and policy director for the FDA Center for Food Safety and Applied Nutrition. The final rule does not require a new notice for those changes, he said.

The new registration rule "requires domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States" to register with the FDA, HHS officials said. They said the aim is to provide the FDA with a complete roster of foreign and domestic food firms so it can quickly identify and locate affected firms in case of food contamination. The FDA estimated it will take about 15 minutes to complete an online registration form if a firm has its information ready. After submitting a completed registration form, firms will receive a confirmation notice immediately, HHS officials said.

The rule covers all firms that handle animal feed, dietary supplements, infant formula, beverages (including alcoholic), and food additives. Exempt from the rule are farms, restaurants, retail food stores, nonprofit facilities that prepare food for consumers, non-processing fishing vessels, and firms that are regulated exclusively by the USDA.

The FDA said food that is imported without prior notice could be refused entry or held at the port, and food firms that fail to register could be subject to court orders or criminal prosecution.

However, Lake said the agency will go slow on enforcement at first. "We'll be doing a lot of outreach between now and December 12, explaining what these new requirements are," he said. "But there will be people who won't get the message by December 12, so we've decided that for the first four months after that, rather than do normal enforcement, we'll focus on education and training. Then we'll begin to phase in our enforcement after four months."

In coming weeks, the FDA will hold national and international meetings and other programs to provide information about the new rules. A satellite downlink public meeting to discuss the rules is scheduled for Oct 28, the agency said.

Both of the new regulations will be published in the Federal Register Oct 10, HHS officials said. A 75-day public comment period will follow. In addition, the FDA will take comments for another 30 days next March.

See also:

HHS news release

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