CFR Subpart C

CFR Subpart C
in effect

21 C.F.R. § 507.31 Food safety plan.

(a) You must prepare, or have prepared, and implement a written food safety plan. (b) One or more preventive controls qualified individuals must prepare, or oversee the preparation of, the food safety plan. (c) The written food safety plan must include: (1) The written hazard analysis as required by § 507.33(a)(2); (2) The written preventive controls as required by § 507.34(b); (3) The written supply-chain program as required by subpart E of this part; (4) The written recall plan as required by § 507.38(a)(1); (5) The written procedures for monitoring the implementation of the preventive controls as required by § 507.40(a); (6) The written corrective action procedures as required by § 507.42(a)(1); and (7) The written verification procedures as required by § 507.49(b). (d) The food safety plan required by this section is a record that is subject to the requirements of subpart F of this part.

21 C.F.R. § 507.33 Hazard analysis.

(a)(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 animal food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control; and (2) The hazard analysis must be written regardless of its outcome. (b) 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 nutrient deficiencies or toxicities (such as inadequate thiamine in cat food, excessive vitamin D in dog food, and excessive copper in food for sheep); and (iii) Physical hazards (such as stones, glass, and metal fragments); and (2) Known or reasonably foreseeable hazards that may be present in the animal 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)(1) 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 to humans or animals if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls. (2) The hazard evaluation required by paragraph (c)(1) of this section must include an evaluation of environmental pathogens whenever an animal food is exposed to the environment prior to packaging and the packaged animal 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. (d) The hazard evaluation must consider the effect of the following on the safety of the finished animal food for the intended animal: (1) The formulation of the animal food; (2) The condition, function, and design of the facility and equipment; (3) Raw materials and other ingredients; (4) Transportation practices; (5) Manufacturing/processing procedures; (6) Packaging activities and labeling activities; (7) Storage and distribution; (8) Intended or reasonably foreseeable use; (9) Sanitation, including employee hygiene; and (10) Any other relevant factors such as the temporal (e.g., weather-related) nature of some hazards (e.g., levels of some natural toxins).

21 C.F.R. § 507.34 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 animal food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act; and (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 animal food safety. (b) Preventive controls must be written. (c) Preventive controls include, as appropriate to the facility and animal food: (1) Process controls. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing, irradiating, and refrigerating animal food. 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) 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 and biological hazards due to employee handling. Sanitation controls must include, as appropriate to the facility and the animal food, procedures, practices, and processes for the: (i) Cleanliness of animal food-contact surfaces, including animal food-contact surfaces of utensils and equipment; and (ii) Prevention of cross-contamination from insanitary objects and from personnel to animal food, animal food-packaging material, and other animal food-contact surfaces and from raw product to processed product. (3) Supply-chain controls. Supply-chain controls include the supply-chain program as required by subpart E of this part; (4) A recall plan as required by § 507.38; and (5) Other preventive controls. These 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.

21 C.F.R. § 507.36 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.

(a) 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 animal food 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 animal food, in accordance with the practice of the trade, that the animal food is “not processed to control [identified hazard]”; and (ii) Annually obtain from your customer written assurance, subject to the requirements of § 507.37, that the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the identified hazard (except as provided in paragraph (c) of this section); (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 animal food in accordance with applicable animal food safety requirements and you: (i) Disclose in documents accompanying the animal food, in accordance with the practice of the trade, that the animal 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 animal food in accordance with applicable animal food safety requirements; (4) You rely on your customer to provide assurance that the animal 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 animal food, in accordance with the practice of the trade, that the animal food is “not processed to control [identified hazard]”; and (ii) Annually obtain from your customer written assurance, subject to the requirements of § 507.37, that your customer: (A) Will disclose in documents accompanying the animal food, in accordance with the practice of the trade, that the animal 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 subpart C of this part), except as provided in paragraph (d) of this section, or manufacture, process, or prepare the animal food in accordance with applicable animal food safety requirements (if the entity is not subject to the requirements for hazard analysis and risk-based preventive controls in subpart C of this part); or (2) Obtain a similar written assurance from the entity's customer, subject to the requirements of § 507.37, 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 animal food you distribute and you document the implementation of that system. (b) 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 animal 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 animal food you distribute. (c) For the written assurance required by paragraph (a)(2)(ii) of this section, if your customer has determined that the identified hazard in paragraph (a) of this section is not a hazard in the animal food intended for use for a specific animal species, your customer's written assurance may provide this determination (including animal species and why the identified hazard is not a hazard) instead of providing assurance of procedures established and followed that will significantly minimize or prevent the identified hazard. (d) For the written assurance required by paragraph (a)(4)(ii)(B) of this section, if the entity in the distribution chain subsequent to your customer is subject to subpart C of this part and has determined that the identified hazard in paragraph (a) of this section is not a hazard in the animal food intended for use for a specific animal species, that entity's written assurance may provide this determination (including animal species and why the identified hazard is not a hazard) instead of providing assurance that the identified hazard will be significantly minimized or prevented.

21 C.F.R. § 507.37 Provision of assurances required under § 507.36(a)(2), (3), and (4).

A facility that provides a written assurance under § 507.36(a)(2), (3), or (4) must act consistently with the assurance and document its actions taken to satisfy the written assurance.

21 C.F.R. § 507.38 Recall plan.

(a) For animal food with a hazard requiring a preventive control you must: (1) Establish a written recall plan for the animal food; and (2) Assign responsibility for performing all procedures in the recall plan. (b) The written recall plan must include procedures that describe the steps to perform the following actions as appropriate to the facility: (1) Directly notify direct consignees about the animal food being recalled, including how to return or dispose of the affected animal food; (2) Notify the public about any hazard presented by the animal food when appropriate to protect human and animal health; (3) Conduct effectiveness checks to verify the recall has been carried out; and (4) Appropriately dispose of recalled animal food, e.g., through reprocessing, reworking, diverting to another use that would not present a safety concern, or destroying the animal food.

21 C.F.R. § 507.39 Preventive control management components.

(a) Except as provided by paragraphs (b) and (c) of this section, the preventive controls required under § 507.34 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 § 507.40; (2) Corrective actions and corrections in accordance with § 507.42; and (3) Verification in accordance with § 507.45. (b) The supply-chain program established in subpart E 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 § 507.42, taking into account the nature of any supplier non-conformance; (2) Review of records in accordance with § 507.49(a)(4)(ii); and (3) Reanalysis in accordance with § 507.50. (c) The recall plan established in § 507.38 is not subject to the requirements of paragraph (a) of this section.

21 C.F.R. § 507.40 Monitoring.

As appropriate to the nature of the preventive control and its role in the facility's food safety system you must: (a) Establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive controls; and (b) Monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed. (c)(1) You must document the monitoring of preventive controls in accordance with this section in records that are subject to verification in accordance with § 507.45(a)(2) and records review in accordance with § 507.49(a)(4)(i); (2)(i) Records of refrigeration temperature during storage of animal 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; and (ii) Exception records may be adequate in circumstances other than monitoring of refrigeration temperature.

21 C.F.R. § 507.42 Corrective actions and corrections.

(a) 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 animal food detected as a result of product testing conducted in accordance with § 507.49(a)(2); and (ii) The presence of an environmental pathogen or appropriate indicator organism detected through the environmental monitoring conducted in accordance with § 507.49(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 animal food is evaluated for safety; and (iv) All affected animal food is prevented from entering into commerce if you cannot ensure the affected animal food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act. (b)(1) Except as provided by paragraph (c) of this section, you are subject to the requirements of paragraph (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 § 507.49(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; (ii) Reduce the likelihood that the problem will recur; (iii) Evaluate all affected animal food for safety; (iv) As necessary, prevent affected animal food from entering commerce as would be done following the corrective action procedure under paragraph (a)(2) of this section; and (v) When appropriate, reanalyze the food safety plan in accordance with § 507.50 to determine whether modification of the food safety plan is required. (c) 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 sanitation controls in § 507.34(c)(2)(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) 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 § 507.45(a)(3) and records review in accordance with § 507.49(a)(4)(i).

21 C.F.R. § 507.45 Verification.

(a) 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 § 507.47; (2) Verification that monitoring is being conducted as required by § 507.39 (and in accordance with § 507.40); (3) Verification that appropriate decisions about corrective actions are being made as required by § 507.39 (and in accordance with § 507.42); (4) Verification of implementation and effectiveness in accordance with § 507.49; and (5) Reanalysis in accordance with § 507.50. (b) All verification activities conducted in accordance with this section must be documented in records.

21 C.F.R. § 507.47 Validation.

(a) You must validate that the preventive controls identified and implemented in accordance with § 507.34 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 animal 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 animal 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. (c) You do not need to validate: (1) The sanitation controls in § 507.34(c)(2); (2) The recall plan in § 507.38; (3) The supply-chain program in subpart E of this part; and (4) 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.

21 C.F.R. § 507.49 Verification of implementation and effectiveness.

(a) 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 animal food, and the nature of the preventive control and its role in the facility's food safety system: (1) Calibration of process monitoring 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 an animal 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 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) 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), and 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) 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 § 507.42(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 § 507.42(a)(1)(ii).

21 C.F.R. § 507.50 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 animal food; (3) Whenever appropriate after an unanticipated animal food safety problem in accordance with § 507.42(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 animal 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 animal 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.

21 C.F.R. § 507.51 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food.

(a) If a facility that is solely engaged in the storage of unexposed packaged animal food stores any such refrigerated packaged animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin formation by pathogens, the facility must conduct the following activities as appropriate to ensure the effectiveness of the temperature controls: (1) Establish and implement temperature controls adequate to significantly minimize or prevent the growth of, or toxin formation by, pathogens; (2) Monitor the temperature controls with adequate frequency to provide assurance that the temperature controls are consistently performed; (3) If there is a loss of temperature control that may impact the safety of such refrigerated packaged animal food, take appropriate corrective actions to: (i) Correct the problem and reduce the likelihood that the problem will recur; (ii) Evaluate all affected animal food for safety; and (iii) Prevent the animal food from entering commerce, if you cannot ensure the affected animal food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act; (4) Verify that temperature controls are consistently implemented by: (i) Calibrating temperature monitoring and recording devices (or checking them for accuracy); (ii) Reviewing records of calibration within a reasonable time after the records are created; and (iii) Reviewing records of monitoring and corrective actions taken to correct a problem with the control of temperature 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 (5) Establish and maintain the following records: (i) Records (whether affirmative records demonstrating temperature is controlled or exception records demonstrating loss of temperature control) documenting the monitoring of temperature controls for any such refrigerated packaged animal food; (ii) Records of corrective actions taken when there is a loss of temperature control that may impact the safety of any such refrigerated packaged animal food; and (iii) Records documenting the verification activities. (b) The records that a facility must establish and maintain under paragraph (a)(5) of this section are subject to the requirements of subpart F of this part.

21 C.F.R. § 507.53 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 (§ 507.31(b)); (2) Validation of the preventive controls (§ 507.47(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 animal food; (4) Determination that validation is not required (§ 507.47(c)(4)); (5) Review of records (§ 507.49(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 (§ 507.50(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 animal food. (b) A qualified auditor must conduct an onsite audit (§ 507.135(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; and (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.

21 C.F.R. § 507.55 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 § 507.36(b), of the basis for not establishing a preventive control in accordance with § 507.36(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.

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