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NCBFAA seeks clearer FDA agent designation
Thursday, November 03, 2011
The National Customs Brokers and Forwarders Association of America has asked the U.S. Food and Drug Administration to revise its process for designating a U.S. agent before implementing foreign facility re-inspection fees under the Food Safety Modernization Act.
U.S. agents designated under FDA’s current process, which was developed under the Bioterrorist Act (BTA), serve for the limited purpose of notification, the Washington-based organization said in a Nov. 1 letter to the FDA.
“Many customs brokers have knowingly agreed to be designated as a U.S. agent for this limited purpose,” said NCBFAA President Jeffrey Coppersmith. “Still others are designated as an agent by the foreign entity without the knowledge of the customs broker.”
If the FDA now enlarges the role of the FDA agent, the NCBFAA warned there must be significant changes to the agent designation process to avoid having “an ‘agent’ sign up for one very limited task and…instead [be] held accountable for potentially open-ended liability.” These changes include:
- Notify all existing BTA agents of the list of foreign entities who have designated them as a U.S. agent.
- Allow them to confirm their acceptance of the responsibility or opt out.
- In the alternative, start over with a new, more rigorous system for BTA registration.
- Notify foreign facilities if an agent opts out.
- Maintain a Web-enabled “Master List of Agents” for automated query by involved parties.
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| Coppersmith |
The NCBFAA further noted that, because many BTA agents will not accept the open ended liability associated with this measure, it “has the potential to create serious disruptions to the food import process, as food shipments arriving at the border with deficient foreign facility registrations (because the agent has suddenly ‘resigned’) will be inadmissible.”
Coppersmith said the details of the process for fee billing/collection are critical and must be identified at the outset. He further urged that the BTA agent designation must not be extended to other sections of the Food Safety Modernization Act where the term "U.S. agent" or "U.S. representative" is used. Instead, FDA regulation should require presentation of an affirmative statement of representation signed by both parties be filed with FDA or a similar transparent process whereby the agent explicitly accepts this specific role for the purpose of FDA food importations.
“The responsibilities of being a U.S. agent for a foreign food supplier are significant, and no one should have that responsibility forced on them by virtue of their presence in the supply chain,” Coppersmith said.
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