Important Information You Need to Know

Pursuant to the Bioterrorism Act of 2002 (www.fda.gov/oc/bioterrorism/PL107-188.pdf), the FDA requires registration of all existing food facilities with the Agency by December 12, 2003 and, in the future, of every such facility prior to importation. If any facility is not registered in a timely fashion with the FDA, whether located in the U.S. or otherwise, its products will not be allowed to enter the U.S. commercial marketplace. ST&R’s program offers the convenience of a single, minimal fee ($500 per year) for multiple facility registrations, including, when necessary, appointment of the U.S. Agent for any facility located outside of the United States and a variety of other services.

Every location throughout the World that manufactures, packs, processes, stores, labels or otherwise “handles” foods or beverages intended for U.S. consumption must be separately registered with the FDA. “Foods or beverages” include (but are not necessarily limited to) food ingredients, packaging, perishable foods, food components, dietary supplements, candies, infant formula, drinking water, alcoholic beverages and even animal foods. There are certain exemptions ---farms, restaurants and retail establishments selling food directly and only to end consumers, in general, do not have to register. Only owners, operators in charge or designated U.S. Agents may register a facility with the FDA.

A U.S. Agent is a party located in the United States designated by a facility located outside of the United States to serve as a type of “middleman” with the FDA. All food facilities throughout the world that are not located within the United States must appoint a U.S. Agent as a part of their registration process with the FDA.

Minimally, the U.S. Agent must be available to the FDA to communicate messages to the food facility in the event the Agency is unable to contact that facility directly and to maintain the facility's registration information with the FDA. Having passed a message to the designated U.S. Agent, the FDA will consider the message delivered to the food facility. Similarly, if the U.S. Agent relays a message to the FDA on behalf of the facility, the FDA will not question the content of the communication. Accordingly, at the very least, the U.S. Agent must be reputable, trustworthy and responsive.

In truth, however, a U.S. Agent can do as much (or as little) as the food facility instructs. The U.S. Agent, for example, is the only party other than the operator in charge or the owner of the facility who can register that facility with the FDA. Accordingly, the facility may wish to provide its U.S. Agent with authorization for timely registration and registration updates. The U.S. Agent can maintain databases of registration information in the case of companies with multiple facilities registered and can be authorized to disseminate that information throughout the supply chain in order to facilitate importation and timely submission of Prior Notice to the Agency.

Importantly, the relationship between the food facility and its U.S. Agent depends solely upon the agreement reached between those particular parties. The FDA will not hold the U.S. Agent responsible or liable for any obligation of the food facility, such liability and responsibility solely being as determined (preferably in writing) by the parties themselves.

It is critical that all food facilities, whether inside or the United States, work with a firm that is reputable, credible and knowledgeable about the FDA BioTerrorism regulations in order to ensure continued timely and thorough compliance with the regulations. Recognizing the impact of these regulations on international trade, ST&R has been on the forefront of educating the international food industry about the BioTerrorism Regulations and serves as General Counsel to the International Food Coalition. Whether appointment of a U.S. Agent is necessary or not, ST&R offers subscribers to its Food Facility Registration Program complete confidentiality, access to the IFC and the wide range of other services. To learn more about Sandler, Travis and Rosenberg, P.A. or Sandler & Travis Trade Advisory Services, Inc., (STTAS) visit our website: www.strtrade.com.

Most importantly, ST&R believes that a food facility should look outside of its supply chain for selection of a U.S. Agent. Concerned with potential liability for a supply chain participant acting with knowledge gained as a result of service as a U.S. Agent, we believe that facilities located outside of the United States should rely upon objective experts to fill the role of U.S. Agent. In addition, such objective representation will help avoid the natural conflicts and disputes that will arise if a party already within the supply chain now assumes additional responsibilities that may require access to confidential or competitive business information.

ST&R is in a unique position to serve as an objective U.S. agent for food facilities located outside of the U.S. ST&R is an international trade and customs law firm in business for over 25 years and with a staff consisting of lawyers and industry specialists such as former senior U.S. Customs officials, import specialists, and auditors; licensed customs brokers; freight forwarders; and foreign-trade zone and warehouse operation specialists. ST&R has offices in Miami, Washington, D.C., Baltimore, New York, Chicago, Los Angeles and San Francisco. Through its affiliate STTAS, ST&R also has offices in Detroit, Ottawa and Portland.

Yes. ST&R offers a full service FDA Certification & Validation Program for food and beverage importers and exporters, including product label and claim review. Please click here to learn more about this Program. Food facilities already subscribed to ST&R's Food Facility Registration Program may qualify for substantial discounts for any of these additional services.

ST&R is hosting seminars throughout the country on these regulations. Click here to learn when we will be in your City and how you can register. Registrants in the food facility registration program are eligible for discounted registration rates to all seminars.

You should also feel free to visit the FDA’s website at www.fda.gov to learn even more about these regulations.