NGFA seeks changes to FSMA registration requirement

The NGFA has urged FDA to remove burdensome changes the agency proposed be made in requirements to be imposed on facilities required to register with the agency under federal law.

The National Grain and Feed Association (NGFA) has urged the Food and Drug Administration (FDA) to remove several burdensome changes the agency proposed be made in requirements to be imposed on facilities required to register with the agency under federal law.

FDA’s proposed rule would modify aspects of the food facility registration process first initiated under the Bioterrorism Act, and implement certain additional registration refinements made for food and feed facilities under the Food Safety Modernization Act (FSMA) – adding new requirements for food facility registration.

“While NGFA appreciates the FDA’s attempt to improve the food facility registration database, we believe several elements proposed in the rule would create an undue burden on facilities,” said David Fairfield, NGFA vice president of feed services.

A chief concern voiced by NGFA was FDA’s proposed requirement to require facilities to obtain and include a facility-specific, nine-digit identifier provided by Dun and Bradstreet – referred to as a DUNS number – with their FDA registrations.

While it “supports the FDA’s efforts to maintain an accurate list of registered food facilities and more efficiently conduct its inspection activities,” the NGFA said it opposed the DUNS requirement as impractical because many companies do not have such numbers for individual facilities, while others have “experienced significant difficulties” when attempting to obtain one. “FDA’s proposal to require facilities to submit a DUNS number has the potential to cause major disruptions to the registration process,” NGFA cautioned, noting that any discrepancy between the DUNS number and a firm’s annual animal drug establishment registration – even something as innocuous as abbreviating St. in one but not the other would cause FDA’s system to reject the facility registration.

NGFA said it believes the burden on facilities to submit a DUNS number would be significantly greater than what was estimated by FDA in its proposal, and would create the “potential to cause major disruptions” in the registration process.

The NGFA also opposed the agency’s proposal to require email verification of facility registrations as ineffective in fulfilling FDA’s stated purpose of preventing unauthorized registrations. NGFA said the provision would be largely unworkable, as most companies with multiple facilities have designated persons assigned the task of submitting such registrations, who typically are different from the owner, operator or agent-in-charge of the facility to which the verification acknowledgment would be sent – the latter of whom would not have direct knowledge of the registration action.

Further, NGFA said such a requirement would not effectively prevent unauthorized facility registrations from being sent by those parties wishing to make false submissions, since such activities could be masked by submitting a false email address to which to send the email verification.

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