Title 21

SECTION 1.601

1.601 Who is subject to this subpart

§ 1.601 Who is subject to this subpart?

(a) Accreditation bodies. Any accreditation body seeking recognition from FDA to accredit third-party certification bodies to conduct food safety audits and to issue food and facility certifications under this subpart.

(b) Third-party certification bodies. Any third-party certification body seeking accreditation from a recognized accreditation body or direct accreditation by FDA for:

(1) Conducting food safety audits; and

(2) Issuing certifications that may be used in satisfying a condition of admissibility of an article of food under section 801(q) of the FD&C Act; or issuing a facility certification for meeting the eligibility requirements for the Voluntary Qualified Importer Program under section 806 of the FD&C Act.

(c) Eligible entities. Any eligible entity seeking a food safety audit or a food or facility certification from an accredited third-party certification body under this subpart.

(d) Limited exemptions from section 801(q) of the FD&C Act - (1) Alcoholic beverages. (i) Any certification required under section 801(q) of the FD&C Act does not apply with respect to alcoholic beverages from an eligible entity that is a facility that meets the following two conditions:

(A) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type that, if it were a domestic facility, would require obtaining a permit from, registering with, or obtaining approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States; and

(B) Under section 415 of the FD&C Act, the facility is required to register as a facility because it is engaged in manufacturing/processing one or more alcoholic beverages.

(ii) Any certification required under section 801(q) of the FD&C Act does not apply with respect to food that is not an alcoholic beverage that is received and distributed by a facility described in paragraph (d)(1)(i) of this section, provided such food:

(A) Is received and distributed in prepackaged form that prevents any direct human contact with such food; and

(B) Constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.

(iii) Any certification required under section 801(q) of the FD&C Act does not apply with respect to raw materials or other ingredients that are imported for use in alcoholic beverages provided that:

(A) The imported raw materials or other ingredients are used in the manufacturing/processing, packing, or holding of alcoholic beverages;

(B) Such manufacturing/processing, packing, or holding is performed by the importer;

(D) The importer is exempt from the regulations in part 117 of this chapter in accordance with § 117.5(i).

(2) Certain meat, poultry, and egg products. Any certification required under section 801(q) of the FD&C Act does not apply with respect to:

(i) Meat food products that at the time of importation are subject to the requirements of the United States Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);

(ii) Poultry products that at the time of importation are subject to the requirements of the USDA under the Poultry Products Inspection Act (21 U.S.C. 451 et seq.); and

(iii) Egg products that at the time of importation are subject to the requirements of the USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).