FDA Extends Food Facility Registration Period to Jan. 31; Updates Info on Suspension of Registration

FDA also updated its Small Entity Compliance Guide Regarding Food Facility Registration to include new information on suspension of registration for food facilities, among other things.

FDA Exercising 'Enforcement Discretion' for Registration Until Jan. 31 Because of Delay

According to FDA’s Q&A on food facility registration, FDA is extending its biennial registration period for 2012, so that the window for food facility registration now lasts from Oct. 22, 2012, to Jan. 31, 2013. The document does not explicitly call the move an extension, but instead says FDA will exercise “enforcement discretion,” as follows:

“Section 415(a)(3) of the FD&C Act requires facilities that are required to register with FDA to renew their registrations every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year. … The failure to register a food facility in accordance with section 415 is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)). Because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.”

Update to Information on Suspension of Registration

FDA also updated its Q&A on food facility registration, as well as its small entity compliance guide on the subject, to provide more information on suspension of registration, as follows:

Can FDA suspend the registration of a food facility? Yes. Section 415(b) of the FD&C Act, as amended by FSMA, provides FDA the authority to suspend by order the registration of a facility registered under section 415.

When can FDA suspend the registration of a facility registered under section 415 of the FD&C Act? FDA can order suspension of a food facility’s registration when FDA determines that food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals (SAHCODHA); and that facility:

a. Created, caused, or was otherwise responsible for that reasonable probability of SAHCODHA; or

b. Knew of, or had reason to know of, the reasonable probability of SAHCODHA, and packed, received, or held such food (section 415(b) of the FD&C Act).

When are registered food facilities subject to the suspension of registration provisions of section 415 of the FD&C Act? Registered facilities became subject to the suspension of registration provisions in section 415(b) of the FD&C Act on July 3, 2011, which was 180 days after the January 4, 2011 enactment of FSMA (section 415(b)(6)(B) of the FD&C Act).

What is the effect of an order to suspend a food facility’s registration? If the registration of a food facility is suspended, no person can import or export food into the U.S., offer to import or export food into the U.S., or otherwise introduce food into interstate or intrastate commerce in the U.S. from such facility (section 415(b)(4) of the FD&C Act).

Who may issue an order to suspend a food facility’s registration? The authority to issue an order to suspend a registration or to vacate an order of suspension may not be delegated by the Secretary of Health and Human Services to any officer or employee other than the FDA Commissioner (section 415(b)(7) of the FD&C Act).

Does the registrant have an opportunity for a hearing on a registration suspension? FDA will provide the registrant subject to a suspension order with an opportunity for an informal hearing. The hearing must be held as soon as possible but not later than two business days after the issuance of the suspension order or at such other time period as agreed upon by FDA and the registrant. The registrant will have an opportunity for an informal hearing on actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. FDA shall reinstate a registration if it determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration (section 415(b)(4) of the FD&C Act).

What happens if FDA determines that the suspension of registration remains necessary after providing opportunity for an informal hearing? FDA will require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by FDA (section 415(b)(3)(A) of the FD&C Act).

When may a registration suspension order be vacated? FDA (the Commissioner) will vacate the suspension order and reinstate the registration of the facility subject to the order upon a determination that adequate grounds do not exist to continue the suspension actions required by the order (section 415(b)(3)(B) of the FD&C Act).

Will FDA promulgate regulations on suspension of registration? Section 415(b)(5)(A) of the FD&C Act requires FDA to promulgate regulations to implement the suspension of registration provisions. FSMA provides that FDA may promulgate the regulations on an interim final basis. However, FDA’s authority to suspend a food facility’s registration under section 415(b) became effective on July 3, 2011. Thus, registered facilities are currently subject to the suspension of registration provisions of section 415.

Updated Q&A on facility registration is available here.

Small Entity Compliance Guide Regarding Food Facility Registration (5th Edition) is available here.