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Proposed Bioterrorism Regs Could Affect Converters

Some converting industry members will have to register their facilities with the Food and Drug Administration (FDA) and give FDA prior notice before importing materials into the US, under two proposed rules published in the Federal Register February 3.

The rules, intended to implement requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, are slated to go into effect in December.

Although the legislation was intended primarily to address threats to the food supply, converters are affected because the definition of “food” includes “substances that migrate into food from food packaging and other articles that contact food,” creating major questions for converting industry members.

In a meeting held February 12, FDA staffers indicated the rules are intended to cover only packaging materials intended for direct contact with food (e.g., the liner in a cereal box, not the box itself), and specifically indicated polymers, additives, and monomers would not be covered. The proposals must be modified, however, to reflect FDA's intent, and the homeland security benefit of requiring registration and import notices by finished packaging manufacturers is debatable.

Registration will allow FDA to notify affected facilities of the location and cause of a threatened or actual terrorist attack on the US food supply. The proposed requirements apply to owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the US. Domestic “food” facilities are required to register whether or not their products enter interstate commerce. Foreign facilities must register unless “food” from that facility undergoes further processing or packaging — more than minimal in nature — before export to the US.

Registration information includes the name, trade name, and address of each facility at which the registrant conducts business, and the categories of food the facility handles. Foreign facilities also must include the name of a US agent. Failure to register could result in civil and criminal penalties. Food shipped into the US from a foreign facility that has failed to register will be held at the port of entry.

The import notification proposal is to help FDA target inspections more effectively and ensure the safety of imported food products before they enter US markets. The Bioterrorism Act requires FDA receive prior notice of foods imported or offered for import into the US, beginning December 12. FDA has proposed a purchaser or importer provide such notice by noon the calendar day before the day the food arrives at the border crossing at the port of entry. Prior notice may not be submitted more than five days before arrival at a US port.

FDA will seek data in the prior notice, including the identity of the submitter, manufacturer, grower, shipper, importer, owner, consignee, and carrier; US Customs information; information about the food itself, including an FDA product code, the common name, market name, trade name, brand name, and quantities within packages and containers; the originating country and the country from which the food was shipped; and anticipated arrival information.

FDA is developing a system to enable Internet-based registration and import notifications. FDA hopes to have both electronic and paper registration systems in operation — and begin accepting registrations — by October 12, the day it plans to publish the final registration rule or notice of the address to which paper registrations should be sent, if either the final rule or electronic system is not complete.

Import notices will be submitted through an electronic, Web-based notification system. FDA estimates about 20,000 prior notices will be submitted daily.

Comments on the proposals are due April 4, with comments on the information collection portions of the proposals due March 5. Stay tuned for more, since FDA also will be issuing proposed rules to implement administrative detention and recordkeeping requirements. Converting industry members will want to consider submitting formal comments on all of the proposed regulations.

Sheila A. Millar, a partner with Keller and Heckman LLP, counsels both corporate and association clients. Contact her at 202/434-4143; This email address is being protected from spambots. You need JavaScript enabled to view it.; PackagingLaw.com

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