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CBP Announces that FDA is Modifying its Food Facility Registration Exemption Code Qualifiers

U.S. Customs and Border Protection (CBP) has issued an ABI administrative message stating that the Food and Drug Administration (FDA) is modifying the qualifiers for the Food Facility Registration Exemption (FME) affirmation of compliance code in order to indicate the reason for exemption.

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(CBP states that the prior notice (PN) interim final rule requires submission of a registration number for the producer of the article of food unless the facility is exempt from registration or if the article of food was imported for "transshipment or other export." According to CBP, if the facility is exempt, the FME affirmation of compliance code and qualifier should be transmitted.)

New qualifiers may be transmitted beginning August 13, 2004.According to CBP, filers can begin to transmit the new qualifiers, listed below, beginning August 13, 2004 (i.e., Phase 4 - full enforcement). CBP notes that transmission of the existing "Y" qualifier can continue until filers have been notified of an end-date. CBP adds that filers may want to program for transmission of any one-digit alpha character to accommodate additional exemption reasons.

(See ITT's Online Archives or 06/22/04 news, 04062210, for BP summary of CBP's compliance procedures, etc. for Phases 3 and 4 of the PN enforcement plan.)

QualifierQualifier Description
AFacility is out of business
BFacility is private residence (21 CFR 1.227(b)(2))
CFacility is restaurant (21 CFR 1.226(d); 21 CFR 1.227(b)(10))
DFacility is retail food establishment (21 CFR 1.226(c); 21 CFR 1.227(b)(11))
EFacility is non-processing fishing vessel (21 CFR 1.226(f))
FFacility is non-bottled drinking water collection and distribution establishment (21 CFR 1.227(b)(2))
GIndividual gift - label name/address in lieu of registration number (21 CFR 1.281(a)(6), (b)(5) and (c)(6))
HGrower - satisfies farm exemption (21 CFR 1.226(b); 21 CFR 1.227(b)(3))

CBP Adm: 04-1667 (dated 07/20/04) available via email or fax by emailing documents@brokerpower.com