21 C.F.R. §§ 1.504–1.508

5 sections in range

§1.504. What hazard analysis must I conduct?

21 C.F.R. § 1.504

(a)

Requirement for a hazard analysis. Except as specified in paragraph (d) of this section, you must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control. Your hazard analysis must be written regardless of its outcome.

(b)

Hazard identification.

(1)

Your analysis of the known or reasonably foreseeable hazards in each food must include the following types of hazards:

(i)

Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other pathogens;

(ii)

Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, food allergens, and (in animal food) nutrient deficiencies or toxicities; and

(iii)

Physical hazards (such as stones, glass, and metal fragments).

(2)

Your analysis must include known or reasonably foreseeable hazards that may be present in a food for any of the following reasons:

(i)

The hazard occurs naturally;

(ii)

The hazard may be unintentionally introduced; or

(iii)

The hazard may be intentionally introduced for purposes of economic gain.

(c)

Hazard evaluation.

(1)

Your hazard analysis must include an evaluation of the hazards identified in paragraph (b) of this section to assess the probability that the hazard will occur in the absence of controls and the severity of the illness or injury if the hazard were to occur.

(2)

The hazard evaluation required by paragraph (c)(1) of this section must include an evaluation of environmental pathogens whenever a ready-to-eat food is exposed to the environment before packaging and the packaged food does not receive a treatment or otherwise include a control or measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.

(3)

Your hazard evaluation must consider the effect of the following on the safety of the finished food for the intended consumer:

(i)

The formulation of the food;

(ii)

The condition, function, and design of the establishment and equipment of a typical entity that manufactures/processes, grows, harvests, or raises this type of food;

(iii)

Raw materials and other ingredients;

(iv)

Transportation practices;

(v)

Harvesting, raising, manufacturing, processing, and packing procedures;

(vi)

Packaging and labeling activities;

(vii)

Storage and distribution;

(viii)

Intended or reasonably foreseeable use;

(ix)

Sanitation, including employee hygiene; and

(x)

Any other relevant factors, such as the temporal (e.g., weather-related) nature of some hazards (e.g., levels of natural toxins).

(d)

Review of another entity's hazard analysis. If another entity (including your foreign supplier) has, using a qualified individual, analyzed the known or reasonably foreseeable hazards for the food to determine whether there are any hazards requiring a control, you may meet your requirement to determine whether there are any hazards requiring a control in a food by reviewing and assessing the hazard analysis conducted by that entity. You must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual.

(e)

Hazards in raw agricultural commodities that are fruits or vegetables. If you are importing a raw agricultural commodity that is a fruit or vegetable that is “covered produce” as defined in § 112.3 of this chapter, you are not required to determine whether there are any biological hazards requiring a control in such food because the biological hazards in such fruits or vegetables require a control and compliance with the requirements in part 112 of this chapter significantly minimizes or prevents the biological hazards. However, you must determine whether there are any other types of hazards requiring a control in such food.

(f)

No hazards requiring a control. If you evaluate the known and reasonably foreseeable hazards in a food and determine that there are no hazards requiring a control, you are not required to conduct an evaluation for foreign supplier approval and verification under § 1.505 and you are not required to conduct foreign supplier verification activities under § 1.506. This paragraph (f) does not apply if the food is a raw agricultural commodity that is a fruit or vegetable that is “covered produce” as defined in § 112.3 of this chapter.

Notes, amendments, and revision history

Source

Source: 80 FR 74340, Nov. 27, 2015, unless otherwise noted.

Authority

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

§1.505. What evaluation for foreign supplier approval and verification must I conduct?

21 C.F.R. § 1.505

(a)

Evaluation of a foreign supplier's performance and the risk posed by a food.

(1)

Except as specified in paragraphs (d) and (e) of this section, in approving your foreign suppliers and determining the appropriate supplier verification activities that must be conducted for a foreign supplier of a type of food you import, you must consider the following:

(i)

The hazard analysis of the food conducted in accordance with § 1.504, including the nature of the hazard requiring a control.

(ii)

The entity or entities that will be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, such as the foreign supplier, the foreign supplier's raw material or other ingredient supplier, or another entity in your supply chain.

(iii)

Foreign supplier performance, including—

(A)

The foreign supplier's procedures, processes, and practices related to the safety of the food;

(B)

Applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety (or, when applicable, the 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, and information relevant to the supplier's compliance with those laws and regulations); and

(C)

The foreign supplier's food safety history, including available information about results from testing foods for hazards, audit results relating to the safety of the food, and responsiveness of the foreign supplier in correcting problems.

(iv)

Any other factors as appropriate and necessary, such as storage and transportation practices.

(2)

You must document the evaluation you conduct under paragraph (a)(1) of this section.

(b)

Approval of foreign suppliers. You must approve your foreign suppliers on the basis of the evaluation that you conducted under paragraph (a) of this section or that you review and assess under paragraph (d) of this section, and document your approval.

(c)

Reevaluation of a foreign supplier's performance and the risk posed by a food.

(1)

Except as specified in paragraph (d) of this section, you must promptly reevaluate the concerns associated with the factors in paragraph (a)(1) of this section when you become aware of new information about these factors, and the reevaluation must be documented. If you determine that the concerns associated with importing a food from a foreign supplier have changed, you must promptly determine (and document) whether it is appropriate to continue to import the food from the foreign supplier and whether the supplier verification activities conducted under § 1.506 or § 1.511(c) need to be changed.

(2)

If at the end of any 3-year period you have not reevaluated the concerns associated with the factors in paragraph (a)(1) of this section in accordance with paragraph (c)(1) of this section, you must reevaluate those concerns and take other appropriate actions, if necessary, in accordance with paragraph (c)(1). You must document your reevaluation and any subsequent actions you take in accordance with paragraph (c)(1).

(d)

Review of another entity's evaluation or reevaluation of a foreign supplier's performance and the risk posed by a food. If an entity other than the foreign supplier has, using a qualified individual, performed the evaluation described in paragraph (a) of this section or the reevaluation described in paragraph (c) of this section, you may meet the requirements of the applicable paragraph by reviewing and assessing the evaluation or reevaluation conducted by that entity. You must document your review and assessment, including documenting that the evaluation or reevaluation was conducted by a qualified individual.

(e)

Inapplicability to certain circumstances. You are not required to conduct an evaluation under this section or to conduct foreign supplier verification activities under § 1.506 if one of the circumstances described in § 1.507 applies to your importation of a food and you are in compliance with that section.

Notes, amendments, and revision history

Source

Source: 80 FR 74340, Nov. 27, 2015, unless otherwise noted.

Authority

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

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

21 C.F.R. § 1.506

(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.

Notes, amendments, and revision history

Source

Source: 80 FR 74340, Nov. 27, 2015, unless otherwise noted.

Authority

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

§1.507. What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?

21 C.F.R. § 1.507

(a)

Circumstances. You are not required to conduct an evaluation of a food and foreign supplier under § 1.505 or supplier verification activities under § 1.506 when you identify a hazard requiring a control (identified hazard) in a food and any of the following circumstances apply:

(1)

You determine and document that the type of food (e.g., raw agricultural commodities such as cocoa beans and coffee beans) could not be consumed without application of an appropriate control;

(2)

You rely on your customer who is subject to the requirements for hazard analysis and risk-based preventive controls in subpart C of part 117 or subpart C of part 507 of this chapter to ensure that the identified hazard will be significantly minimized or prevented and you:

(i)

Disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]”; and

(ii)

Annually obtain from your customer written assurance, subject to the requirements of paragraph (c) of this section, that the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the identified hazard;

(3)

You rely on your customer who is not subject to the requirements for hazard analysis and risk-based preventive controls in subpart C of part 117 or subpart C of part 507 of this chapter to provide assurance it is manufacturing, processing, or preparing the food in accordance with the applicable food safety requirements and you:

(i)

Disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]”; and

(ii)

Annually obtain from your customer written assurance that it is manufacturing, processing, or preparing the food in accordance with applicable food safety requirements;

(4)

You rely on your customer to provide assurance that the food will be processed to control the identified hazard by an entity in the distribution chain subsequent to the customer and you:

(i)

Disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]”; and

(ii)

Annually obtain from your customer written assurance, subject to the requirements of paragraph (c) of this section, that your customer:

(A)

Will disclose in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]”; and

(B)

Will only sell the food to another entity that agrees, in writing, it will— (1) Follow procedures (identified in a written assurance) that will significantly minimize or prevent the identified hazard (if the entity is subject to the requirements for hazard analysis and risk-based preventive controls in subpart C of part 117 or subpart C of part 507 of this chapter) or manufacture, process, or prepare the food in accordance with applicable food safety requirements (if the entity is not subject to the requirements for hazard analysis and risk-based preventive controls in subpart C of part 117 or subpart C of part 507); or

(2) Obtain a similar written assurance from the entity's customer, subject to the requirements of paragraph (c) of this section, as in paragraphs (a)(4)(ii)(A) and (B) of this section, as appropriate; or

(5)

You have established, documented, and implemented a system that ensures control, at a subsequent distribution step, of the hazards in the food you distribute and you document your implementation of that system.

(b)

Written assurances. Any written assurances required under this section must contain the following:

(1)

Effective date;

(2)

Printed names and signatures of authorized officials; and

(3)

The assurance specified in the applicable paragraph.

(c)

Provision of assurances. The customer or other subsequent entity in the distribution chain for a food that provides a written assurance under paragraph (a)(2), (3), or (4) of this section must act consistently with the assurance and document its actions taken to satisfy the written assurance.

Notes, amendments, and revision history

Source

Source: 80 FR 74340, Nov. 27, 2015, unless otherwise noted.

Authority

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

§1.508. What corrective actions must I take under my FSVP?

21 C.F.R. § 1.508

(a)

You must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, and the implementing regulations, or produces food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act. This determination could be based on a review of consumer, customer, or other complaints related to food safety, the verification activities conducted under § 1.506 or § 1.511(c), a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under § 1.505(c) or (d), or any other relevant information you obtain. The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. You must document any corrective actions you take in accordance with this paragraph.

(b)

If you determine, by means other than the verification activities conducted under § 1.506 or § 1.511(c) or a reevaluation conducted under § 1.505(c) or (d), that a foreign supplier of food that you import does not produce food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, and the implementing regulations, or produces food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act, you must promptly investigate to determine whether your FSVP is adequate and, when appropriate, modify your FSVP. You must document any investigations, corrective actions, and changes to your FSVP that you undertake in accordance with this paragraph.

(c)

This section does not limit your obligations with respect to other laws enforced by FDA, such as those relating to product recalls.

Notes, amendments, and revision history

Source

Source: 80 FR 74340, Nov. 27, 2015, unless otherwise noted.

Authority

Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

21 C.F.R. §§ 1.504–1.508

§1.504. What hazard analysis must I conduct?

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§1.505. What evaluation for foreign supplier approval and verification must I conduct?

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

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§1.507. What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?

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§1.508. What corrective actions must I take under my FSVP?

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Cite this provision

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