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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 2019.

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 2]
[Revised as of April 1, 2019]
[CITE: 21CFR117.136]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION

PART 117 -- CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

Subpart C--Hazard Analysis and Risk-Based Preventive Controls

Sec. 117.136 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.

(a) Circumstances. If you are a manufacturer/processor, you are not required to implement a preventive control when you identify a hazard requiring a preventive control (identified hazard) 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, coffee beans, and grains) 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 this subpart 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 117.137, 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 this subpart to provide assurance it is manufacturing, processing, or preparing the food in accordance with 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 117.137, 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 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 this subpart) 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 this subpart); or

(2 ) Obtain a similar written assurance from the entity's customer, subject to the requirements of 117.137, 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 the implementation of that system.

(b) Records. You must document any circumstance, specified in paragraph (a) of this section, that applies to you, including:

(1) A determination, in accordance with paragraph (a) of this section, that the type of food could not be consumed without application of an appropriate control;

(2) The annual written assurance from your customer in accordance with paragraph (a)(2) of this section;

(3) The annual written assurance from your customer in accordance with paragraph (a)(3) of this section;

(4) The annual written assurance from your customer in accordance with paragraph (a)(4) of this section; and

(5) Your system, in accordance with paragraph (a)(5) of this section, that ensures control, at a subsequent distribution step, of the hazards in the food you distribute.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016]

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