In general, if a facility says that they are controlling or verifying control of potential hazards by one of these programs, (programs traditionally termed as prerequisite programs), then that facility must have formalized programs. Below, I have clipped those sections from the proposed regulation for easier reference.
Product Testing and Environmental Monitoring - these are included in the Verification and Corrective Action sections. (117.165 and 117.150 below) Formalized programs will be needed when you are using these programs for verification of control. For example, if you have identified Listeria as a post process contaminate in an RTE food, then a program specific to that pathogen must be developed including written procedures, sampling locations within the facility, testing protocols, and identification of the laboratory conducting the testing.
Supplier Control (117.136) – The receiving company “must establish and implement a risk-based supplier program for those raw materials and ingredients for which the receiving facility has identified a significant hazard when the hazard is controlled before receipt of the raw material or ingredient.” There is a list of requirements as to what must be done including the need for on-site audits.
It would be worth reviewing the sections below.
FDA.gov
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm
FSMA Proposed Rule for Preventive Controls for Human Food Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
Based on FDA’s outreach efforts and public comments, the FDA is proposing revisions to its proposed rule on preventive controls for human food that are more flexible and less burdensome in key areas.
Commenting
FDA is accepting comments for 75 days after the publication date. The FDA published the original proposed rule on January 16, 2013, and the comment period rule closed on November 22, 2013; no additional comments are being accepted on the originally proposed rule.
The FDA will accept comments on the revised provisions while continuing to review comments already received on the original proposed rule. The comment period opens September 29, 2014.
At a Glance
Summary of Key Revisions
1. Farms that pack or hold food from other farms are not subject to the preventive controls rule
· A farm would no longer be required to register as a food facility merely because it packs or holds raw agricultural commodities grown on another farm under a different ownership. FDA proposes to define such packing and holding as a traditional farming activity.
· In general, on-farm packing and holding of produce would be subject to the proposed produce safety rule, not the human food preventive controls rule.
· Farms that conduct additional processing or manufacturing may be subject to preventive controls rule for those activities.
2. Definition of a very small business proposed at less than $1 million in sales
· A “very small business” would be defined as firms having less than $1 million in total annual sales of human food, adjusted for inflation. Previously, three options were proposed: annual sales of $250,000, $500,000, and $1 million. The new proposed definition would exempt less than 1 percent of the dollar value of food produced in the United States.
3. Withdrawal of qualified exemptions process further clarified
· The proposed revisions would establish procedures to guide the FDA in withdrawing an exemption for a qualified facility for food safety reasons as specified in the proposed regulation:
o The FDA first may consider alternatives to protect public health and would provide advance notification to the facility and an opportunity for the facility to respond. The revisions also provide procedures for re-instating a withdrawn exemption.
o The FDA must provide an additional 60 days (for a total of 120 days) after the receipt of the order for a facility whose exemption is withdrawn to comply with the full requirements for hazard analysis and risk-based preventive controls.
4. Product testing, environmental monitoring, supplier controls proposed
· While these potential provisions were referenced in the preamble of the proposed rule, they were not included in the regulatory text. The FDA is now providing an opportunity for input on specific language and seeking comment on whether to include it in the final rule. FDA is seeking comment on whether the preventive controls for human food should require:
o A facility, as appropriate to the facility, the food, and the nature of the preventive control, to conduct product testing to verify implementation and effectiveness of preventive controls.
o A facility, as appropriate to the facility, the food, and the nature of the preventive control, to conduct environmental monitoring to verify implementation and effectiveness of preventive controls if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard.
· Supplier controls are proposed when the receiving facility’s hazard analysis identifies a significant hazard for a raw material or ingredient, and that hazard is controlled before the facility receives the raw material or ingredient from a supplier.
If these provisions were to be included, the facility would have flexibility to determine the appropriate verification activity (such as onsite audit, sampling and testing) unless there is reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans.
o In that instance, an annual onsite audit of the supplier would be required unless the facility can show that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazards are controlled.
5. Economically motivated adulteration language proposed
· The FDA is asking for input on whether a facility should be required to address hazards that may be intentionally introduced for purposes of economic gain as part of its hazard analysis.
Compliance Dates
· Small businesses—a business that employs fewer than 500 persons and that does not qualify for an exemption would have to comply two years after publication of the final rule.
· Very Small Businesses—defined as having less than $1 million in total annual sales of human food, adjusted for inflation, would have three years after publication of the final rule to comply. Considered “qualified facilities,” they would be subject to modified preventive control requirements.
· Other Businesses—a business that is not small or very small and does not qualify for an exemption would have to comply one year after publication of the final rule.
Selected Sections from the proposed Preventive Controls Regulation
§ 117.165 Verification of implementation and effectiveness. Pg 167
(a) Verification activities. You must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the significant 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:
(1) Calibration of process monitoring instruments and verification instruments;
(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 significant hazard, by collecting and testing environmental samples; and
(4) Review of the following records within the specified timeframes, by (or under the oversight of) a 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 a week after the records are created.
(ii) Records of calibration, product testing, environmental monitoring, and supplier verification activities within a reasonable time after the records are created.
(b) Written procedures. As appropriate to the facility, the food, and the nature of the preventive control, you must establish and implement written procedures for the following activities:
(1) The method and frequency of calibrating process monitoring instruments and verification instruments 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).
§ 117.150 Corrective actions and corrections.
(a) Corrective action procedures. As appropriate to the preventive control, except as provided by paragraph (c) of this section:
(1)(i) You must establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented.
(ii) The corrective action procedures required by paragraph (a)(1)(i) of this section must include procedures to address, as appropriate:
(A) 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
(B) 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 paragraph (b)(2) of this section if any of the following circumstances apply:
(i) A preventive control is not properly implemented and a specific corrective action procedure has not been established;
(ii) A preventive control 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 applicable to food allergen controls and sanitation controls. You do not need to comply with the requirements of paragraphs (a) and (b) of this section for 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) if you take action, in a timely manner, to correct such conditions and practices.
(d) Documentation. 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).
§ 117.136 Supplier program. Pg 154
(a) Supplier program. (1)(i) Except as provided in paragraph (a)(1)(ii) of this section, the receiving facility must establish and implement a risk-based supplier program for those raw materials and ingredients for which the receiving facility has identified a significant hazard when the hazard is controlled before receipt of the raw material or ingredient.
(ii) [EXCEPTIONs] The receiving facility is not required to establish and implement a supplier program for raw materials and ingredients for which:
(A) There are no significant hazards;
(B) The preventive controls at the receiving facility are adequate to significantly minimize or prevent each of the significant hazards; or
(C) The receiving facility relies on its customer to control the hazard and annually obtains from its customer written assurance that the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the hazard.
(2) The supplier program must be written.
(3) The supplier program must include:
(i) Verification activities, as appropriate to the hazard, and documentation of these activities, to ensure raw materials and ingredients are received only from suppliers approved for control of the hazard(s) in that raw material or ingredient (or, when necessary and appropriate, on a temporary basis from unapproved suppliers whose raw materials or ingredients the receiving facility subjects to adequate verification activities before acceptance for use); and
(ii) Verification activities and documentation of these activities, as required by paragraph
(b) of this section, to verify that:
(A) The hazard is significantly minimized or prevented;
(B) The incoming raw material or ingredient 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: and
(C) The incoming raw material or ingredient is produced in compliance with the requirements of applicable FDA food safety regulations.
(4) When supplier verification activities are required under paragraph (c) of this section for more than one type of hazard in a food, the receiving facility must conduct the verification activity or activities appropriate for each of those hazards.
(5) For some hazards, in some situations under paragraph (b) it will be necessary to conduct more than one verification activity and/or to increase the frequency of one or more verification activities to provide adequate assurances that the hazard is significantly minimized or prevented.
(b) Determination and documentation of the appropriate verification activities. In determining and documenting the appropriate verification activities, the receiving facility must consider the following:
(1) The hazard analysis, including the nature of the hazard, applicable to the raw material and ingredients;
(2) Where the preventive controls for those hazards are applied for the raw material and ingredients – such as at the supplier or the supplier’s supplier;
(3) The supplier’s procedures, processes, and practices related to the safety of the raw material and ingredients;
(4) Applicable FDA food safety regulations and information relevant to the supplier’s compliance with those regulations, including an FDA warning letter or import alert relating to the safety of the food;
(5) The supplier’s food safety performance history relevant to the raw materials or ingredients that the receiving facility receives from the supplier, including available information about results from testing raw materials or ingredients for hazards, audit results relating to the safety of the food, and responsiveness of the supplier in correcting problems; and
(6) Any other factors as appropriate and necessary. Examples of factors that a receiving facility may determine are appropriate and necessary are storage and transportation practices.
(c) Supplier verification activities for raw materials and ingredients. (1) Except as provided in paragraph (c)(2) or (3) of this section, the receiving facility must conduct and document one or more of the following supplier verification activities as determined by the receiving facility under paragraph (b) of this section, for each supplier before using the raw material or ingredient and periodically thereafter:
(i) Onsite audits;
(ii) Sampling and testing of the raw material or ingredient, which may be conducted by either the supplier or receiving facility.
(iii) Review by the receiving facility of the supplier’s relevant food safety records; or
(iv) Other appropriate supplier verification activities based on the risk associated with the ingredient and the supplier.
(2)(i) Except as provided by paragraph (c)(2)(ii) of this section, when a hazard in a raw material or ingredient will be controlled by the 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, the receiving facility must have documentation of an onsite audit of the supplier before using the raw material or ingredient from the supplier and at least annually thereafter.
(ii) The requirements of paragraph (c)(2)(i) of this section do not apply if the receiving facility documents its determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazards are controlled.
(3) If a supplier is a qualified facility as defined by § 117.3, the receiving facility need not comply with paragraphs (c)(1) and (2) of this section if the receiving facility:
(i) Documents, at the end of each calendar year, that the supplier is a qualified facility as defined by § 117.3; and
(ii) Obtains written assurance, at least every 2 years, that the supplier is producing the raw material or ingredient in compliance with applicable FDA food safety regulations and that the raw material or ingredient 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.
The written assurance must include a brief description of the processes and procedures that the
supplier is following to ensure the safety of the food.
(4) If a supplier is a farm that is not subject to the requirements established in part 112 of this chapter in accordance with § 112.4 regarding the raw material or ingredient that the receiving facility receives from the farm, the receiving facility does not need to comply with paragraphs (c)(1) and (2) of this section if the receiving facility:
(i) Documents, at the end of each calendar year, that the raw material or ingredient provided by the supplier is not subject to part 112 of this chapter; and
(ii) Obtains written assurance, at least every 2 years, that the supplier is producing the raw material or ingredient in compliance with applicable FDA food safety regulations and that the raw material or ingredient is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act.
(d) Onsite audit. (1) An onsite audit of a supplier must be performed by a qualified auditor.
(2) If the raw material or ingredient at the supplier is subject to one or more FDA food safety regulations, an onsite audit must consider such regulations and include a review of the supplier’s written plan (e.g., HACCP plan or other food safety plan), if any, including its implementation, for the hazard being audited.
(e) Substitution of inspection by FDA or an officially recognized or equivalent food safety authority.
(1) Instead of an onsite audit, a receiving facility may rely on the results of an inspection of the supplier by FDA or, for a foreign supplier, by FDA or the food safety authority of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States, provided that the inspection was conducted within 1 year of the date that the onsite audit would have been required to be conducted.
(2) For inspections conducted by the food safety authority of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent, the food that is the subject of the onsite audit must be within the scope of the official recognition or equivalence determination, and the foreign supplier must be in, and under the regulatory oversight of, such country.
(f) Supplier non-conformance. If the owner, operator, or agent in charge of a receiving facility determines through auditing, verification testing, relevant consumer, customer or other
complaints, or otherwise that the supplier is not controlling hazards that the receiving facility has
identified as significant, the receiving facility must take and document prompt action in
accordance with § 117.150 to ensure that raw materials or ingredients from the supplier do not
cause food that is manufactured or processed by the receiving facility to be adulterated under
section 402 of the Federal Food, Drug, or Cosmetic Act or misbranded under section 403(w) of
the Federal Food, Drug, and Cosmetic Act.
(g) Records. The receiving facility must document the following in records and review such records in accordance with § 117.165(a)(4).
(1) The written supplier program;
(2) Documentation of the appropriate verification activities;
(3) The annual written assurance that a receiving facility’s customer who is controlling a significant hazard has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the hazard;
(4) Documentation demonstrating that products are received only from approved suppliers;
(5) Documentation of an onsite audit. This documentation must include:
(i) Documentation of audit procedures;
(ii) The dates the audit was conducted;
(iii) The conclusions of the audit;
(iv) Corrective actions taken in response to significant deficiencies identified during the audit; and
(v) Documentation that the audit was conducted by a qualified auditor.
(6) Records of sampling and testing. These records must include:
(i) Identification of the raw material or ingredient tested (including lot number, as appropriate) and the number of samples tested;
(ii) Identification of the test(s) conducted, including the analytical method(s) used;
(iii) The date(s) on which the test(s) were conducted;
(iv) The results of the testing;
(v) Corrective actions taken in response to detection of hazards; and
(vi) Information identifying the laboratory conducting the testing.
(7) Records of the review by the receiving facility of the supplier’s relevant food safety records. These records must include:
(i) The date(s) of review;
(ii) Corrective actions taken in response to significant deficiencies identified during the review; and
(iii) Documentation that the review was conducted by a qualified individual.
(8) Records of other appropriate supplier verification activities based on the risk associated with the ingredient.
(9) Documentation of any determination that verification activities other than an onsite audit, and/or less frequent onsite auditing of a supplier, provide adequate assurance that the hazards are controlled;
(10) Documentation of an alternative verification activity for a supplier that is a qualified facility, including:
(i) The documentation that the supplier is a qualified facility as defined by § 117.3; and
(ii) The written assurance that the supplier is producing the raw material or ingredient in compliance with applicable FDA food safety regulations and that the raw material or ingredient 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.
(11) Documentation of an alternative verification activity for a supplier that is a farm that
supplies a raw material or ingredient that is not subject to part 112 of this chapter, including:
(i) The documentation that the raw material or ingredient provided by the supplier is not subject to part 112 of this chapter; and
(ii) The written assurance that the supplier is producing the raw material or ingredient in compliance with applicable FDA food safety regulations and that the raw material or ingredient is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act.
(12) Evidence of an inspection of the supplier by FDA or the food safety authority of another country.
(13) Documentation of actions taken with respect to supplier non-conformance.
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