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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 2018.

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, 2018]
[CITE: 21CFR117]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
 
PART 117CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
 

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

Sec. 117.126 Food safety plan.

(a) Requirement for a food safety plan. (1) You must prepare, or have prepared, and implement a written food safety plan.

(2) The food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals.

(b) Contents of a food safety plan. The written food safety plan must include:

(1) The written hazard analysis as required by 117.130(a)(2);

(2) The written preventive controls as required by 117.135(b);

(3) The written supply-chain program as required by subpart G of this part;

(4) The written recall plan as required by 117.139(a); and

(5) The written procedures for monitoring the implementation of the preventive controls as required by 117.145(a)(1);

(6) The written corrective action procedures as required by 117.150(a)(1); and

(7) The written verification procedures as required by 117.165(b).

(c) Records. The food safety plan required by this section is a record that is subject to the requirements of subpart F of this part.

Sec. 117.130 Hazard analysis.

(a) Requirement for a hazard analysis. (1) 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 manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control.

(2) The hazard analysis must be written regardless of its outcome.

(b) Hazard identification. The hazard identification must consider:

(1) Known or reasonably foreseeable hazards that include:

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

(ii) Chemical hazards, including radiological hazards, substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens; and

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

(2) Known or reasonably foreseeable hazards that may be present in the 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)(i) The hazard analysis must include an evaluation of the hazards identified in paragraph (b) of this section to assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls.

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

(2) The 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 facility and equipment;

(iii) Raw materials and other ingredients;

(iv) Transportation practices;

(v) Manufacturing/processing procedures;

(vi) Packaging activities 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 some natural toxins).

Sec. 117.135 Preventive controls.

(a)(1) You must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.

(2) Preventive controls required by paragraph (a)(1) of this section include:

(i) Controls at critical control points (CCPs), if there are any CCPs; and

(ii) Controls, other than those at CCPs, that are also appropriate for food safety.

(b) Preventive controls must be written.

(c) Preventive controls include, as appropriate to the facility and the food:

(1) Process controls. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing, acidifying, irradiating, and refrigerating foods. Process controls must include, as appropriate to the nature of the applicable control and its role in the facility's food safety system:

(i) Parameters associated with the control of the hazard; and

(ii) The maximum or minimum value, or combination of values, to which any biological, chemical, or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process control.

(2) Food allergen controls. Food allergen controls include procedures, practices, and processes to control food allergens. Food allergen controls must include those procedures, practices, and processes employed for:

(i) Ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and

(ii) Labeling the finished food, including ensuring that the finished food is not misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.

(3) Sanitation controls. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards. Sanitation controls must include, as appropriate to the facility and the food, procedures, practices, and processes for the:

(i) Cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment;

(ii) Prevention of allergen cross-contact and cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product.

(4) Supply-chain controls. Supply-chain controls include the supply-chain program as required by subpart G of this part.

(5) Recall plan. Recall plan as required by 117.139.

(6) Other controls. Preventive controls include any other procedures, practices, and processes necessary to satisfy the requirements of paragraph (a) of this section. Examples of other controls include hygiene training and other current good manufacturing practices.

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]

Sec. 117.137 Provision of assurances required under 117.136(a)(2), (3), and (4).

A facility that provides a written assurance under 117.136(a)(2), (3), or (4) must act consistently with the assurance and document its actions taken to satisfy the written assurance.

Sec. 117.139 Recall plan.

For food with a hazard requiring a preventive control:

(a) You must establish a written recall plan for the food.

(b) The written recall plan must include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions as appropriate to the facility:

(1) Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food;

(2) Notify the public about any hazard presented by the food when appropriate to protect public health;

(3) Conduct effectiveness checks to verify that the recall is carried out; and

(4) Appropriately dispose of recalled food--e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.

Sec. 117.140 Preventive control management components.

(a) Except as provided by paragraphs (b) and (c) of this section, the preventive controls required under 117.135 are subject to the following preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system:

(1) Monitoring in accordance with 117.145;

(2) Corrective actions and corrections in accordance with 117.150; and

(3) Verification in accordance with 117.155.

(b) The supply-chain program established in subpart G of this part is subject to the following preventive control management components as appropriate to ensure the effectiveness of the supply-chain program, taking into account the nature of the hazard controlled before receipt of the raw material or other ingredient:

(1) Corrective actions and corrections in accordance with 117.150, taking into account the nature of any supplier non-conformance;

(2) Review of records in accordance with 117.165(a)(4); and

(3) Reanalysis in accordance with 117.170.

(c) The recall plan established in 117.139 is not subject to the requirements of paragraph (a) of this section.

Sec. 117.145 Monitoring.

As appropriate to the nature of the preventive control and its role in the facility's food safety system:

(a) Written procedures. You must establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive control; and

(b) Monitoring. You must monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed.

(c) Records. (1) Requirement to document monitoring. You must document the monitoring of preventive controls in accordance with this section in records that are subject to verification in accordance with 117.155(a)(2) and records review in accordance with 117.165(a)(4)(i).

(2) Exception records. (i) Records of refrigeration temperature during storage of food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens may be affirmative records demonstrating temperature is controlled or exception records demonstrating loss of temperature control.

(ii) Exception records may be adequate in circumstances other than monitoring of refrigeration temperature.

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

Sec. 117.150 Corrective actions and corrections.

(a) Corrective action procedures. As appropriate to the nature of the hazard and the nature of the preventive control, except as provided by paragraph (c) of this section:

(1) You must establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented, including procedures to address, as appropriate:

(i) The presence of a pathogen or appropriate indicator organism in a ready-to-eat product detected as a result of product testing conducted in accordance with 117.165(a)(2); and

(ii) The presence of an environmental pathogen or appropriate indicator organism detected through the environmental monitoring conducted in accordance with 117.165(a)(3).

(2) The corrective action procedures must describe the steps to be taken to ensure that:

(i) Appropriate action is taken to identify and correct a problem that has occurred with implementation of a preventive control;

(ii) Appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur;

(iii) All affected food is evaluated for safety; and

(iv) All affected food is prevented from entering into commerce, if you cannot ensure that the affected food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.

(b) Corrective action in the event of an unanticipated food safety problem. (1) Except as provided by paragraph (c) of this section, you are subject to the requirements of paragraphs (b)(2) of this section if any of the following circumstances apply:

(i) A preventive control is not properly implemented and a corrective action procedure has not been established;

(ii) A preventive control, combination of preventive controls, or the food safety plan as a whole is found to be ineffective; or

(iii) A review of records in accordance with 117.165(a)(4) finds that the records are not complete, the activities conducted did not occur in accordance with the food safety plan, or appropriate decisions were not made about corrective actions.

(2) If any of the circumstances listed in paragraph (b)(1) of this section apply, you must:

(i) Take corrective action to identify and correct the problem, reduce the likelihood that the problem will recur, evaluate all affected food for safety, and, as necessary, prevent affected food from entering commerce as would be done following a corrective action procedure under paragraphs (a)(2)(i) through (iv) of this section; and

(ii) When appropriate, reanalyze the food safety plan in accordance with 117.170 to determine whether modification of the food safety plan is required.

(c) Corrections. You do not need to comply with the requirements of paragraphs (a) and (b) of this section if:

(1) You take action, in a timely manner, to identify and correct conditions and practices that are not consistent with the food allergen controls in 117.135(c)(2)(i) or the sanitation controls in 117.135(c)(3)(i) or (ii); or

(2) You take action, in a timely manner, to identify and correct a minor and isolated problem that does not directly impact product safety.

(d) Records. All corrective actions (and, when appropriate, corrections) taken in accordance with this section must be documented in records. These records are subject to verification in accordance with 117.155(a)(3) and records review in accordance with 117.165(a)(4)(i).

Sec. 117.155 Verification.

(a) Verification activities. Verification activities must include, as appropriate to the nature of the preventive control and its role in the facility's food safety system:

(1) Validation in accordance with 117.160.

(2) Verification that monitoring is being conducted as required by 117.140 (and in accordance with 117.145).

(3) Verification that appropriate decisions about corrective actions are being made as required by 117.140 (and in accordance with 117.150).

(4) Verification of implementation and effectiveness in accordance with 117.165; and

(5) Reanalysis in accordance with 117.170.

(b) Documentation. All verification activities conducted in accordance with this section must be documented in records.

Sec. 117.160 Validation.

(a) You must validate that the preventive controls identified and implemented in accordance with 117.135 are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility's food safety system.

(b) The validation of the preventive controls:

(1) Must be performed (or overseen) by a preventive controls qualified individual:

(i)(A) Prior to implementation of the food safety plan; or

(B) When necessary to demonstrate the control measures can be implemented as designed:

(1 ) Within 90 calendar days after production of the applicable food first begins; or

(2 ) Within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 90 calendar days after production of the applicable food first begins;

(ii) Whenever a change to a control measure or combination of control measures could impact whether the control measure or combination of control measures, when properly implemented, will effectively control the hazards; and

(iii) Whenever a reanalysis of the food safety plan reveals the need to do so;

(2) Must include obtaining and evaluating scientific and technical evidence (or, when such evidence is not available or is inadequate, conducting studies) to determine whether the preventive controls, when properly implemented, will effectively control the hazards; and

(c) You do not need to validate:

(1) The food allergen controls in 117.135(c)(2);

(2) The sanitation controls in 117.135(c)(3);

(3) The recall plan in 117.139;

(4) The supply-chain program in subpart G of this part; and

(5) Other preventive controls, if the preventive controls qualified individual prepares (or oversees the preparation of) a written justification that validation is not applicable based on factors such as the nature of the hazard, and the nature of the preventive control and its role in the facility's food safety system.

Sec. 117.165 Verification of implementation and effectiveness.

(a) Verification activities. You must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards. To do so you must conduct activities that include the following, as appropriate to the facility, the food, and the nature of the preventive control and its role in the facility's food safety system:

(1) Calibration of process monitoring instruments and verification instruments (or checking them for accuracy);

(2) Product testing, for a pathogen (or appropriate indicator organism) or other hazard;

(3) Environmental monitoring, for an environmental pathogen or for an appropriate indicator organism, if contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control, by collecting and testing environmental samples; and

(4) Review of the following records within the specified timeframes, by (or under the oversight of) a preventive controls qualified individual, to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food safety plan, the preventive controls are effective, and appropriate decisions were made about corrective actions:

(i) Records of monitoring and corrective action records within 7 working days after the records are created or within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 7 working days; and

(ii) Records of calibration, testing (e.g., product testing, environmental monitoring), supplier and supply-chain verification activities, and other verification activities within a reasonable time after the records are created; and

(5) Other activities appropriate for verification of implementation and effectiveness.

(b) Written procedures. As appropriate to the facility, the food, the nature of the preventive control, and the role of the preventive control in the facility's food safety system, you must establish and implement written procedures for the following activities:

(1) The method and frequency of calibrating process monitoring instruments and verification instruments (or checking them for accuracy) as required by paragraph (a)(1) of this section.

(2) Product testing as required by paragraph (a)(2) of this section. Procedures for product testing must:

(i) Be scientifically valid;

(ii) Identify the test microorganism(s) or other analyte(s);

(iii) Specify the procedures for identifying samples, including their relationship to specific lots of product;

(iv) Include the procedures for sampling, including the number of samples and the sampling frequency;

(v) Identify the test(s) conducted, including the analytical method(s) used;

(vi) Identify the laboratory conducting the testing; and

(vii) Include the corrective action procedures required by 117.150(a)(1).

(3) Environmental monitoring as required by paragraph (a)(3) of this section. Procedures for environmental monitoring must:

(i) Be scientifically valid;

(ii) Identify the test microorganism(s);

(iii) Identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring. The number and location of sampling sites must be adequate to determine whether preventive controls are effective;

(iv) Identify the timing and frequency for collecting and testing samples. The timing and frequency for collecting and testing samples must be adequate to determine whether preventive controls are effective;

(v) Identify the test(s) conducted, including the analytical method(s) used;

(vi) Identify the laboratory conducting the testing; and

(vii) Include the corrective action procedures required by 117.150(a)(1).

Sec. 117.170 Reanalysis.

(a) You must conduct a reanalysis of the food safety plan as a whole at least once every 3 years;

(b) You must conduct a reanalysis of the food safety plan as a whole, or the applicable portion of the food safety plan:

(1) Whenever a significant change in the activities conducted at your facility creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard;

(2) Whenever you become aware of new information about potential hazards associated with the food;

(3) Whenever appropriate after an unanticipated food safety problem in accordance with 117.150(b); and

(4) Whenever you find that a preventive control, combination of preventive controls, or the food safety plan as a whole is ineffective.

(c) You must complete the reanalysis required by paragraphs (a) and (b) of this section and validate, as appropriate to the nature of the preventive control and its role in the facility's food safety system, any additional preventive controls needed to address the hazard identified:

(1) Before any change in activities (including any change in preventive control) at the facility is operative; or

(2) When necessary to demonstrate the control measures can be implemented as designed:

(i) Within 90 calendar days after production of the applicable food first begins; or

(ii) Within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 90-calendar days after production of the applicable food first begins.

(d) You must revise the written food safety plan if a significant change in the activities conducted at your facility creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or document the basis for the conclusion that no revisions are needed.

(e) A preventive controls qualified individual must perform (or oversee) the reanalysis.

(f) You must conduct a reanalysis of the food safety plan when FDA determines it is necessary to respond to new hazards and developments in scientific understanding.

Sec. 117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor.

(a) One or more preventive controls qualified individuals must do or oversee the following:

(1) Preparation of the food safety plan (117.126(a)(2));

(2) Validation of the preventive controls (117.160(b)(1));

(3) Written justification for validation to be performed in a timeframe that exceeds the first 90 calendar days of production of the applicable food;

(4) Determination that validation is not required (117.160(c)(5));

(5) Review of records (117.165(a)(4));

(6) Written justification for review of records of monitoring and corrective actions within a timeframe that exceeds 7 working days;

(7) Reanalysis of the food safety plan (117.170(d)); and

(8) Determination that reanalysis can be completed, and additional preventive controls validated, as appropriate to the nature of the preventive control and its role in the facility's food safety system, in a timeframe that exceeds the first 90 calendar days of production of the applicable food.

(b) A qualified auditor must conduct an onsite audit (117.435(a)).

(c)(1) To be a preventive controls qualified individual, the individual must have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum. This individual may be, but is not required to be, an employee of the facility.

(2) To be a qualified auditor, a qualified individual must have technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function.

(d) All applicable training in the development and application of risk-based preventive controls must be documented in records, including the date of the training, the type of training, and the person(s) trained.

Sec. 117.190 Implementation records required for this subpart.

(a) You must establish and maintain the following records documenting implementation of the food safety plan:

(1) Documentation, as required by 117.136(b), of the basis for not establishing a preventive control in accordance with 117.136(a);

(2) Records that document the monitoring of preventive controls;

(3) Records that document corrective actions;

(4) Records that document verification, including, as applicable, those related to:

(i) Validation;

(ii) Verification of monitoring;

(iii) Verification of corrective actions;

(iv) Calibration of process monitoring and verification instruments;

(v) Product testing;

(vi) Environmental monitoring;

(vii) Records review; and

(viii) Reanalysis;

(5) Records that document the supply-chain program; and

(6) Records that document applicable training for the preventive controls qualified individual and the qualified auditor.

(b) The records that you must establish and maintain are subject to the requirements of subpart F of this part.

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.

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