§117.3. Definitions. — Inbound Citations

(c) You are deemed to be in compliance with the requirements of this subpart for a food you import, except for the requirements in § 1.509, if you are a receiving facility as defined in § 117.3 or § 507.3 of this chapter and you are in compliance with the following requirements of part 117 or part 507 of this chapter, as applicable:

(1) You implement preventive controls for the hazards in the food in accordance with § 117.135 or § 507.34 of this chapter;

(2) You are not required to implement a preventive control under § 117.136 or § 507.36 of this chapter with respect to the food; or

(3) You have established and implemented a risk-based supply-chain program in compliance with subpart G of part 117 or subpart E of part 507 of this chapter with respect to the food.

(i) The foreign supplier is a qualified facility as defined by § 117.3 or § 507.3 of this chapter;

(1) An attestation that the facility is a qualified facility as defined in § 117.3. For the purpose of determining whether a facility satisfies the definition of qualified facility, the baseline year for calculating the adjustment for inflation is 2011; and

(1) Be a qualified individual as that term is defined in § 117.3—i.e., have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties; and

(i) A qualified facility as defined by § 117.3;

(c) If a supplier is a qualified facility as defined by § 117.3, the receiving facility does not need to comply with paragraphs (a) and (b) of this section if the receiving facility:

(1) Obtains written assurance that the supplier is a qualified facility as defined by § 117.3:

(i) Before first approving the supplier for an applicable calendar year; and

(ii) On an annual basis thereafter, by December 31 of each calendar year, for the following calendar year; and

(2) Obtains written assurance, at least every 2 years, that the supplier is producing the raw material or other ingredient in compliance with applicable FDA food safety regulations (or, when applicable, relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States). The written assurance must include either:

(i) A brief description of the preventive controls that the supplier is implementing to control the applicable hazard in the food; or

(ii) A statement that the facility is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries.

(i) The written assurance that the supplier is a qualified facility as defined by § 117.3, before approving the supplier and on an annual basis thereafter; and