Are You Registered?

The FDA made bioterrorism registration easier, but will this make the act more effective?

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With speculation rampant that many food companies won't be able to comply with a provision of the Bioterrorism Act mandating they register their facilities with the FDA by December 12, the agency has responded with what appears to be a shortcut to meeting this requirement: the easy access link, http://www.cfsan.fda.gov/~furls/ovffreg.html. However, food industry leaders still need to work to ensure that all food companies comply or the efficacy of the measure will be lost.

To briefly review, The Bioterrorism Act of 2002 includes a provision requiring the Secretary of Health and Human Services to "develop regulations mandating domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. FDA." This includes the registering every food manufacturing facility that conducts business in -- or with -- the U.S. Exemptions are relatively few. One can only imagine the scope of this endeavor, considering it's almost impossible to quantify the number of food companies it affects.

Which brings to mind a potentially serious flaw in the measure. This is an ex post facto exercise in traceability: Should there be problems with adulterated food products, the FDA presumably can determine the source and notify "the facilities that might be impacted by the outbreak."

Needless to say, companies that are more vulnerable to tampering will be essential links in the traceability chain. They arguably will be the most challenging to register as well. While the FDA's easy access link makes it easier for smaller businesses to register, these companies must take additional steps to be reach full compliance. Since even small companies can send large ripples though the U.S. food chain, diligence is vital.

It will be important for food industry leaders to assist others in ensuring the measure is effective and not simply another registry. Smaller firm may have a tougher time understanding the nuances of federal architecture, and things do get a bit complex for companies with partners outside the U.S. Though the measure's methodology is relatively user-friendly, some of the information required is quite detailed. Responses must be complete in order to be effective.

For assistance with online registration, call 800/216-7331 or 301/575-0156 in the U.S.; from elsewhere call 301/575-0156; or send a fax to 301/210-0247. Requests for assistance also may be e-mailed to furls@fda.gov. The online registration help desk will be staffed on business days from 7 a.m. until 11 p.m. EST.

E-mail Steve at sennen@putman.net.

 

Registration requirements for compliance with the Bioterrorism Act

* Name, physical address, phone number of the facility

* Same information for the parent company, if the facility is a subsidiary

* All trade names the facility uses

* Food product categories (21 CFR 170.3)

* A statement certifying that the information submitted is true and accurate and submitter is authorized to register the facility

* Name and contact information of the person submitting the certification statement

* Name of foreign facility's U.S. agent and the agent's contact information

* Emergency contact information

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