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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2017]
[CITE: 21CFR1.506]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart L--Foreign Supplier Verification Programs for Food Importers

Sec. 1.506 What foreign supplier verification and related activities must I conduct?

(a) Use of approved foreign suppliers. (1) You must establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on the evaluation conducted under 1.505 (or, when necessary and appropriate, on a temporary basis from unapproved foreign suppliers whose foods you subject to adequate verification activities before importing the food). You must document your use of these procedures.

(2) You may rely on an entity other than your foreign supplier to establish the procedures and perform and document the activities required under paragraph (a)(1) of this section provided that you review and assess that entity's documentation of the procedures and activities, and you document your review and assessment.

(b) Foreign supplier verification procedures. You must establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods you import.

(c) Requirement of supplier verification. The foreign supplier verification activities must provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented.

(d) Determination of appropriate foreign supplier verification activities --(1)(i) General. Except as provided in paragraphs (d)(2) and (3) of this section, before importing a food from a foreign supplier, you must determine and document which verification activity or activities listed in paragraphs (d)(1)(ii)(A) through (D) of this section, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with paragraph (c) of this section. Verification activities must address the entity or entities that are significantly minimizing or preventing the hazards or verifying that the hazards have been significantly minimized or prevented (e.g., when an entity other than the grower of produce subject to part 112 of this chapter harvests or packs the produce and significantly minimizes or prevents the hazard or verifies that the hazard has been significantly minimized or prevented, or when the foreign supplier's raw material supplier significantly minimizes or prevents a hazard). The determination of appropriate supplier verification activities must be based on the evaluation of the food and foreign supplier conducted under 1.505.

(ii) Appropriate verification activities. The following are appropriate supplier verification activities:

(A) Onsite audits as specified in paragraph (e)(1)(i) of this section;

(B) Sampling and testing of a food as specified in paragraph (e)(1)(ii) of this section;

(C) Review of the foreign supplier's relevant food safety records as specified in paragraph (e)(1)(iii) of this section; and

(D) Other appropriate supplier verification activities as specified in paragraph (e)(1)(iv) of this section.

(2) Verification activities for certain serious hazards. When a hazard in a food will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you must conduct or obtain documentation of an onsite audit of the foreign supplier before initially importing the food and at least annually thereafter, unless you make an adequate written determination that, instead of such initial and annual onsite auditing, other supplier verification activities listed in paragraph (d)(1)(ii) of this section and/or less frequent onsite auditing are appropriate to provide adequate assurances that the foreign supplier is producing the food in accordance with paragraph (c) of this section, based on the determination made under 1.505.

(3) Reliance on a determination by another entity. You may rely on a determination of appropriate foreign supplier verification activities in accordance with paragraph (d)(1) or (2) of this section made by an entity other than the foreign supplier if you review and assess whether the entity's determination regarding appropriate activities (including the frequency with which such activities must be conducted) is appropriate. You must document your review and assessment, including documenting that the determination of appropriate verification activities was made by a qualified individual.

(e) Performance of foreign supplier verification activities --(1) Verification activities. Except as provided in paragraph (e)(2) of this section, based on the determination made in accordance with paragraph (d) of this section, you must conduct (and document) or obtain documentation of one or more of the supplier verification activities listed in paragraphs (e)(1)(i) through (iv) of this section for each foreign supplier before importing the food and periodically thereafter.

(i) Onsite audit of the foreign supplier. (A) An onsite audit of a foreign supplier must be performed by a qualified auditor.

(B) If the food is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier must consider such regulations and include a review of the supplier's written food safety plan, if any, and its implementation, for the hazard being controlled (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States).

(C) If the onsite audit is conducted solely to meet the requirements of paragraph (e) of this section by an audit agent of a certification body that is accredited in accordance with subpart M of this part, the audit is not subject to the requirements in that subpart.

(D) You must retain documentation of each onsite audit, including the audit procedures, the dates the audit was conducted, the conclusions of the audit, any corrective actions taken in response to significant deficiencies identified during the audit, and documentation that the audit was conducted by a qualified auditor.

(E) The following inspection results may be substituted for an onsite audit, provided that the inspection was conducted within 1 year of the date by which the onsite audit would have been required to be conducted:

(1 ) The written results of an appropriate inspection of the foreign supplier for compliance with applicable FDA food safety regulations conducted by FDA, representatives of other Federal Agencies (such as the USDA), or representatives of State, local, tribal, or territorial agencies; or

(2 ) The written results of an inspection of the foreign supplier by the food safety authority of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, provided that the food that is the subject of the onsite audit is within the scope of the official recognition or equivalence determination, and the foreign supplier is in, and under the regulatory oversight of, such country.

(ii) Sampling and testing of the food. You must retain documentation of each sampling and testing of a food, including identification of the food tested (including lot number, as appropriate), the number of samples tested, the test(s) conducted (including the analytical method(s) used), the date(s) on which the test(s) were conducted and the date of the report of the testing, the results of the testing, any corrective actions taken in response to detection of hazards, information identifying the laboratory conducting the testing, and documentation that the testing was conducted by a qualified individual.

(iii) Review of the foreign supplier's relevant food safety records. You must retain documentation of each record review, including the date(s) of review, the general nature of the records reviewed, the conclusions of the review, any corrective actions taken in response to significant deficiencies identified during the review, and documentation that the review was conducted by a qualified individual.

(iv) Other appropriate activity. (A) You may conduct (and document) or obtain documentation of other supplier verification activities that are appropriate based on foreign supplier performance and the risk associated with the food.

(B) You must retain documentation of each activity conducted in accordance with paragraph (e)(1)(iv) of this section, including a description of the activity, the date on which it was conducted, the findings or results of the activity, any corrective actions taken in response to significant deficiencies identified, and documentation that the activity was conducted by a qualified individual.

(2) Reliance upon performance of activities by other entities. (i) Except as specified in paragraph (e)(2)(ii) of this section, you may rely on supplier verification activities conducted in accordance with paragraph (e)(1) of this section by another entity provided that you review and assess the results of these activities in accordance with paragraph (e)(3) of this section.

(ii) You may not rely on the foreign supplier itself or employees of the foreign supplier to perform supplier verification activities, except with respect to sampling and testing of food in accordance with paragraph (e)(1)(ii) of this section.

(3) Review of results of verification activities. You must promptly review and assess the results of the verification activities that you conduct or obtain documentation of under paragraph (e)(1) of this section, or that are conducted by other entities in accordance with paragraph (e)(2) of this section. You must document your review and assessment of the results of verification activities. If the results do not provide adequate assurances that the hazards requiring a control in the food you obtain from the foreign supplier have been significantly minimized or prevented, you must take appropriate action in accordance with 1.508(a). You are not required to retain documentation of supplier verification activities conducted by other entities, provided that you can obtain the documentation and make it available to FDA in accordance with 1.510(b).

(4) Independence of qualified individuals conducting verification activities. There must not be any financial conflicts of interests that influence the results of the verification activities set forth in paragraph (e)(1) of this section, and payment must not be related to the results of the activity.

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