(a) The FD&C Act means the Federal Food, Drug, and Cosmetic Act.

(b) Except as otherwise defined in paragraph (c) of this section, the definitions of terms in section 201 of the FD&C Act apply when the terms are used in this subpart.

(c) In addition, for the purposes of this subpart:

Accreditation means a determination by a recognized accreditation body (or, in the case of direct accreditation, by FDA) that a third-party certification body meets the applicable requirements of this subpart.

Accreditation body means an authority that performs accreditation of third-party certification bodies.

Accredited third-party certification body means a third-party certification body that a recognized accreditation body (or, in the case of direct accreditation, FDA) has determined meets the applicable requirements of this subpart and is accredited to conduct food safety audits and to issue food or facility certifications to eligible entities. An accredited third-party certification body has the same meaning as accredited third-party auditor as defined in section 808(a)(4) of the FD&C Act.

Assessment means:

(i) With respect to an accreditation body, an evaluation by FDA of the competency and capacity of the accreditation body under the applicable requirements of this subpart for the defined scope of recognition. An assessment of the competency and capacity of the accreditation body involves evaluating the competency and capacity of the operations of the accreditation body that are relevant to decisions on recognition and, if recognized, an evaluation of its performance and the validity of its accreditation decisions under the applicable requirements of this subpart.

(ii) With respect to a third-party certification body, an evaluation by a recognized accreditation body (or, in the case of direct accreditation, FDA) of the competency and capacity of a third-party certification body under the applicable requirements of this subpart for the defined scope of accreditation. An assessment of the competency and capacity of the third-party certification body involves evaluating the competency and capacity of the operations of the third-party certification body that are relevant to decisions on accreditation and, if accredited, an evaluation of its performance and the validity of its audit results and certification decisions under the applicable requirements of this subpart.

Audit means the systematic and functionally independent examination of an eligible entity under this subpart by an accredited third-party certification body or by FDA. An audit conducted under this subpart is not considered an inspection under section 704 of the FD&C Act.

Audit agent means an individual who is an employee or other agent of an accredited third-party certification body who, although not individually accredited, is qualified to conduct food safety audits on behalf of an accredited third-party certification body. An audit agent includes a contractor of the accredited third-party certification body but excludes subcontractors or other agents under outsourcing arrangements for conducting food safety audits without direct control by the accredited third-party certification body.

Consultative audit means an audit of an eligible entity:

(i) To determine whether such entity is in compliance with the applicable food safety requirements of the FD&C Act, FDA regulations, and industry standards and practices;

(ii) The results of which are for internal purposes only; and

(iii) That is conducted in preparation for a regulatory audit; only the results of a regulatory audit may form the basis for issuance of a food or facility certification under this subpart.

Direct accreditation means accreditation of a third-party certification body by FDA.

Eligible entity means a foreign entity in the import supply chain of food for consumption in the United States that chooses to be subject to a food safety audit under this subpart conducted by an accredited third-party certification body. Eligible entities include foreign facilities required to be registered under subpart H of this part.

Facility means any structure, or structures of an eligible entity under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, holds, grows, harvests, or raises animals for food for consumption in the United States. Transport vehicles are not facilities if they hold food only in the usual course of business as carriers. A facility may consist of one or more contiguous structures, and a single building may house more than one distinct facility if the facilities are under separate ownership. The private residence of an individual is not a facility. Non-bottled water drinking water collection and distribution establishments and their structures are not facilities. Facilities for the purposes of this subpart are not limited to facilities required to be registered under subpart H of this part.

Facility certification means an attestation, issued for purposes of section 801(q) or 806 of the FD&C Act by an accredited third-party certification body, after conducting a regulatory audit and any other activities necessary to establish whether a facility complies with the applicable food safety requirements of the FD&C Act and FDA regulations.

Food has the meaning given in section 201(f) of the FD&C Act, except that food does not include pesticides (as defined in 7 U.S.C. 136(u)).

Food certification means an attestation, issued for purposes of section 801(q) of the FD&C Act by an accredited third-party certification body, after conducting a regulatory audit and any other activities necessary to establish whether a food of an eligible entity complies with the applicable food safety requirements of the FD&C Act and FDA regulations.

Food safety audit means a regulatory audit or a consultative audit that is conducted to determine compliance with the applicable food safety requirements of the FD&C Act, FDA regulations, and for consultative audits, also includes conformance with industry standards and practices. An eligible entity must declare that an audit is to be conducted as a regulatory audit or consultative audit at the time of audit planning and the audit will be conducted on an unannounced basis under this subpart.

Foreign cooperative means an autonomous association of persons, identified as members, who are united through a jointly owned enterprise to aggregate food from member growers or processors that is intended for export to the United States.

Recognized accreditation body means an accreditation body that FDA has determined meets the applicable requirements of this subpart and is authorized to accredit third-party certification bodies under this subpart.

Regulatory audit means an audit of an eligible entity:

(i) To determine whether such entity is in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations; and

(ii) The results of which are used in determining eligibility for certification under section 801(q) or under section 806 of the FD&C Act.

Relinquishment means:

(i) With respect to an accreditation body, a decision to cede voluntarily its authority to accredit third-party certification bodies as a recognized accreditation body prior to expiration of its recognition under this subpart; and

(ii) With respect to a third-party certification body, a decision to cede voluntarily its authority to conduct food safety audits and to issue food and facility certifications to eligible entities as an accredited third-party certification body prior to expiration of its accreditation under this subpart.

Self-assessment means an evaluation conducted by a recognized accreditation body or by an accredited third-party certification body of its competency and capacity under the applicable requirements of this subpart for the defined scope of recognition or accreditation. For recognized accreditation bodies this involves evaluating the competency and capacity of the entire operations of the accreditation body and the validity of its accreditation decisions under the applicable requirements of this subpart. For accredited third-party certification bodies this involves evaluating the competency and capacity of the entire operations of the third-party certification body and the validity of its audit results under the applicable requirements of this subpart.

Third-party certification body has the same meaning as third-party auditor as that term is defined in section 808(a)(3) of the FD&C Act and means a foreign government, agency of a foreign government, foreign cooperative, or any other third party that is eligible to be considered for accreditation to conduct food safety audits and to certify that eligible entities meet the applicable food safety requirements of the FD&C Act and FDA regulations. A third-party certification body may be a single individual or an organization. Once accredited, a third-party certification body may use audit agents to conduct food safety audits.