Attachment_25_MFRPs.pdf

Manufactured Food Regulatory Program Standards

The collection of information has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 and has been assigned OMB control number 0910-0601

To request a copy of the standards go to:

www.fda.gov/MFRPS

U.S. Department of Health and Human Services

Food and Drug Administration Office of Regulatory Affairs

OMB Control No. 0910-0601 Expiration Date: 09-30-2019 http://www.fda.gov/MFRPS

Manufactured Food Regulatory Program Standards September 2016

TABLE OF CONTENTS

Introduction Background Definitions Standard No. 1 - Regulatory Foundation Standard No. 2 - Training Program Standard No. 3 - Inspection Program Standard No. 4 - Inspection Audit Program Standard No. 5 - Food-Related Illness, Outbreak, and Hazards Response Standard No. 6 - Compliance and Enforcement Program Standard No. 7 - Industry and Community Relations Standard No. 8 - Program Resources Standard No. 9 - Program Assessment Standard No. 10 - Laboratory Support Appendix 1: Self-Assessment Worksheet Appendix 2.1: Self-Assessment Worksheet Appendix 2.2: Inspector Training Record Summary Appendix 2.3: Inspector Training Record Appendix 2.4: Curriculum Example Basic Food Inspector Training Appendix 3.1: Self-Assessment Worksheet Appendix 3.2: Risk Classification Criteria for Food Plants Appendix 4.1: Self-Assessment Worksheet Appendix 4.2: Performance Rating for the Field inspection Audits Appendix 4.2a: Summary of Field Inspection Audit Findings Appendix 4.3: Performance Rating for Inspection Report Audits Appendix 4.3a: Summary of Inspection Report Audit Findings Appendix 4.4: Performance Rating for the Sample Report Audits Appendix 4.4a: Summary of Sample Report Audit Findings Appendix 4.5: Contract Audit Form (FDA 3610) Appendix 4.5a: Guidance for Completing the Contract Audit Form (FDA 3610) Appendix 4.6: Inspection Report Audit Form Appendix 4.7: Sample Report Audit Form Appendix 4.8: Corrective Action Plan Appendix 5.1: Self-Assessment Worksheet Appendix 6.1: Self-Assessment Worksheet Appendix 6.2: Calculation of the Level of Conformance to Compliance Procedures Appendix 6.2a: Performance Review of Enforcement Actions Appendix 7.1: Self-Assessment Worksheet Appendix 7.2: Outreach Activity Event and Self-Evaluation Worksheet Appendix 8.1: Self-Assessment Worksheet Appendix 8.1a: Self-Assessment Worksheet Instructions Appendix 8.2: Calculation for Determining a Required Number of Inspectors Appendix 8.3: Inspection Equipment Appendix 9.1: Self-Assessment Summary Report Appendix 10.1: Self-Assessment Worksheet

INTRODUCTION

The Food Safety Modernization Act (FSMA) mandates that the Food and Drug Administration (FDA) establish an Integrated Food Safety System (IFSS). An IFSS requires partnerships between federal, state, local, and tribal agencies to collaborate and leverage resources to ensure the protection of public health.

The Manufactured Food Regulatory Program Standards (MFRPS) is a critical component in establishing FDA’s IFSS. The MFRPS (henceforth also referred to as (“program standards”) establishes a uniform foundation for regulatory agencies responsible for oversight of food manufacturing plants. When fully implemented, the program standards define a set of best practices of a regulatory system.

Conformance with the program standards requires a regulatory agency to continuously assess, evaluate, and take necessary corrective actions to address gaps. MFRPS conformance will facilitate a system of mutual reliance between the FDA and other regulatory agencies and support continued improvements in regulatory manufactured food programs throughout the nation.

The program standards are comprised of ten standards that establish requirements for the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. These elements include the program’s regulatory foundation, staff training, inspection, quality assurance, food defense preparedness and response, foodborne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources, and program assessment. Each standard contains a purpose statement, requirement summary, description of program elements, projected outcomes, and a list of required documentation. The program standards have corresponding self-assessment and supplemental worksheets designed to assist the regulatory program in achieving and sustaining conformance.

FDA will use the program standards as a tool to continuously improve manufactured food contracts and promote the development of a high-quality state manufactured food regulatory program which includes a process for continuous improvement based upon quality management systems. The program standards will assist both FDA and the states in fulfilling their regulatory obligations. States will be expected to develop and implement improvement plans to demonstrate that they are moving toward full implementation and to participate in FDA audits to determine level of conformance. States are encouraged to build sustainable systems including sustainability strategies and plans that will result in the standards being maintained in conformance.

The goal of the MFRPS is to implement a nationally integrated, risk-based, food safety system focused on protecting public health. The program standards establish a uniform basis for measuring and improving the performance of prevention, intervention, and response activities of manufactured food regulatory programs in the United States. The development and implementation of these program standards will help federal and state programs better direct their regulatory activities toward reducing foodborne illness hazards in food plants.

Consequently, the safety and security of the United States food supply will improve as greater focus is placed on prevention.

The collection of information is approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. The OMB control number is 0910-0601.

BACKGROUND

The food safety regulatory system in the United States is a tiered system that involves Federal, state, and local governments. The Food and Drug Administration (FDA) is responsible for ensuring that all foods moving in interstate commerce, except those under United States Department of Agriculture jurisdiction, are safe, wholesome, and labeled properly. State agencies conduct inspection and regulatory activities that help ensure food produced, processed, or sold within their jurisdictions is safe. Many state agencies also conduct food plant inspections under contract with the FDA. These inspections either are performed under the states’ laws and authorities or the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or both.

To maximize the use of resources among the FDA and the states, particularly when their jurisdictions overlap, their inspection programs should be equivalent in effect.

In June 2000, the Department of Health and Human Services’, Office of the Inspector General (OIG) released a report of FDA’s oversight of state contracts. In this report, the OIG recommended that [FDA] take steps to promote “equivalency among Federal and State food safety standards, inspection programs, and enforcement practices.1 In response to their findings, FDA established a committee to develop a set of quality standards for manufactured food regulatory programs. The committee was comprised of officials from FDA and state agencies responsible for regulating manufactured food plants2. The result of the committee was the first edition of the program standards published by FDA in 2007.

In January 2011, FSMA gave the FDA authority to develop a framework to build the capacity of state and local regulatory agencies to support the IFSS model. In 2012, the FDA created the Standards Implementation Staff to give assistance, support and guidance to state programs enrolled in the MFRPS. Additionally, FDA helped establish the Manufactured Food Regulatory Program Standards (MFRPS) Alliance to create a network of state programs and assist with further development and revisions of the program standards.

In December 2011, the OIG released “Vulnerabilities in FDA’s Oversight of State Food Facility Inspections”. In response, the FDA stated, “Collaboration with our state partners is critical to an integrated national food safety system and is also mandated under the FDA Food Safety Modernization Act (FSMA).3 Over the last decade, the FDA has worked to develop and implement the MFRPS which will strengthen states’ food safety programs. These program standards reflect an effort in which FDA has been engaged in for many years of partnering, leveraging and empowering agencies to move the vision of a nationally integrated food safety system.

1 Office of Inspector General, FDA Oversight of State Food Firm Inspections: OEI-01-98-00400 (Department of Health and Human Services, 2000), p. 5.

2 A building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food as defined by 21 CFR Part 110.3 (k) . Manufactured

3 Office of Inspector General, Vulnerabilities in FDA’s Oversight of State Food Facility Inspections: OEI-02-09-00430 (Department of Health and Human Services, 2011), p. 34.

It should be noted that in the 2016 revised version of the MFRPS, definitions have been used and slightly modified from the Field Management Directive 76 titled State Contracts - Evaluation of Inspectional Performance.

DEFINITIONS

1. Assessment: means a systematic, independent, and documented process for obtaining objective evidence and evaluating it to determine the extent to which a requirement is met. The MFRPS assessments are conducted by FDA at approximately 18, 36, and 60 months after enrollment. Assessments after 60 months will be conducted every two years.

The FDA will determine IMPLEMENTATION during each assessment. The FDA will determine CONFORMANCE at 60 months. The FDA may determine CONFORMANCE at 18 and 36 months when a standard is found to be fully implemented.

2. Conformance or Conformity: means the fulfillment of a requirement, specifically a State program is using and can demonstrate the use of a particular element, system, or program listed in the MFRPS.

3. Consumer Complaints: are complaints made by the public regarding food products, facility, practices, labeling, and any other related activities.

4. Contact Hour: an inspector qualifies for one contact hour of continuing education for each clock hour of participation. Contact hours for a specified presentation, course, or training activity will be recognized only one time within a 3-year continuing education period.

5. Critical Violations: are violations which are directly linked to public health risk, food adulteration, and/or known contributors to foodborne illness unless otherwise defined by the State.

6. Current and Fit-for-Use: “current” indicates that documentation is signed and dated in accordance with program policies and procedures that meet criteria in the most current standard. “Fit-for-use” is a quality term used to indicate that a product or service fits the customer’s defined purpose for that product or service. Documentation may be electronic or hard copy.

7. Current Experienced Staff: defined by the State program in their training plan.

8. Document Control: document control ensures that documents are reviewed for adequacy, approved for release by authorized personnel and distributed to and used at the location where the prescribed activity is performed.

9. Environmental Assessment (Also called “Environmental Health Assessment”):

means an on‐site food product investigation, conducted in conjunction with investigations (e.g., traceback) as needed to assess and rule out the potential that the contaminant of concern was introduced at a particular point in the distribution or production system. This is achieved by identifying contributing factors and environmental antecedents.

10. Equivalent: means that the State law directly references the relevant provision or regulation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or Title 21 Code of

Federal Regulations (CFR). The State program specifies the Federal statute or regulation that is incorporated into the State law, including the revision date of the State statutory provision or regulation, the date the Federal statutory provision or regulation was incorporated into the State law, and whether that statutory or regulatory provision is included in whole, in part, or modified from the original.

11. Equivalent in Effect: means that the State law has the same regulatory effect as the relevant FD&C Act provision or CFR regulation. A State law may have the same regulatory effect as the Federal law or regulation if either a single State law or rule has the same regulatory effect as the Federal law or regulation, or when multiple laws of that State are combined and deemed equivalent to a single Federal law or regulation. In conducting such self-assessment, the State program may need to consult with its legal counsel when a provision is determined to be Equivalent in effect.

12. Evaluation: means an inspection in which the ability of an inspector is assessed to determine if they are competent to complete independent inspections. Evaluations are required for GMP and each specialized inspections. The evaluation should assess an inspector’s ability to:

• Prepare for an inspection

• Conduct an inspection

• Follow procedures identified by the State for the specific type of inspection

• Communicate during the inspection and on the inspection report; and

• Assess specialized processes (as applicable).

Appendix 4.5 Field Audit Form, a modified version of the Conference for Food Protection Audit form, or an original form created by the State which evaluates the elements listed above may be used. Two successful evaluations must be completed prior to conducting independent inspection. It is recommended that new inspectors complete evaluations and independent inspections before entering the audit cycle. However, if States use the Appendix 4.5 – Field Audit Form, the evaluations may be counted toward the total audits for that year.

13. Field Inspection Audit: means an inspection in which a state inspector is accompanied by a QUALIFIED AUDITOR (either FDA or State) for the purpose of assessing the quality and performance of inspections either contract or state. These inspections may be counted under 2.3.2.3 and 2.3.3.2 Field Training as evaluations and also under 4.3.2 Field Inspection Audit if Appendix 4.5 is used.

14. Food-Related Incident: means an unintentional or deliberate contamination, threatened or actual, of food that may occur at any point in the production system (e.g., pre‐harvest production, processing, distribution) and may cause food-related illness, injury, outbreaks and HAZARDS. Examples of food related incidents include but are not limited to foodborne illness outbreaks and food tampering.

15. Hazard: means any biological, chemical, or physical agent in food that is reasonably likely to cause illness or injury in the absence of its control.

16. Highly Susceptible Population: include immuno-compromised persons, preschool age children, or older adults; and persons who obtain food at a facility that provides services such as custodial care, health care, assisted living, a child or adult day care center, kidney dialysis centers, hospital or nursing home, or nutritional or socialization services (senior citizen centers)

17. Implementation: means a State program has a particular element, system, or program as required in the Program Elements and documentation requirements for MFRPS.

18. Industry Complaints: are complaints made by Industry about inspections or inspectors.

19. Joint Field Training Inspection: means an inspection conducted jointly by the FDA and/or state personnel for the purposes of training or enforcement. A joint inspection may be used to provide training to a state inspector during an inspection of a firm and may either be trainer led or trainee led.

20. Newly Hired Experienced Staff: staff with manufactured food regulatory experience received outside the manufactured food safety program to which they are currently employed.

21. Not Equivalent: means there is no State law equivalent to the relevant Federal law or regulation, there is such a State law but it does not apply to the State’s food plant or manufacturing establishment program, or the Federal and State laws address the same matter but are inconsistent and do not have the same regulatory effect.

22. Outreach Activity Event: means an outreach activity which the State program hosts, co-hosts or is an invited presenter such as seminars, workshops, conferences, trainings, or meetings that relate to food protection topics and that support communication and information exchange among regulators, industry, academia, and consumer representatives.

23. Primary Servicing Laboratory: means any laboratory used by the State program for ongoing or routine testing.

24. Qualified Field Inspection Auditor: means an individual who is recognized by the regulatory jurisdiction’s food safety program manager as having field experience and communication skills necessary to audit other inspectors/investigators and who has:

• Demonstrated the competency for basic food inspection auditing to the food safety program manager;

• Successfully completed advanced food inspection training coursework and field training in any areas where the auditor performs advanced auditing, such as low acid foods, acidified foods, seafood HACCP, or juice inspections;

• Been assigned this auditing responsibility; and

• Completed the required audit training per the State program requirements.

25. Qualified Date: qualified date begins when an inspector has completed all basic course and field elements and has been signed off to do independent inspections. This date is used to calculate the start of the continuing education hours in 2.3.4.

26. Qualified Field Inspection Trainer: means an individual who is recognized by the regulatory jurisdiction’s food safety program manager as having field experience and communication skills necessary to train or supervise other inspectors/investigators and who has:

• Demonstrated the competency for basic food inspection training to the food safety program manager;

• Successfully completed advanced food inspection training coursework and field training in any areas where the trainer performs advanced training, such as low acid foods, acidified foods, seafood HACCP, or juice inspections; and

• Been assigned this training responsibility.

• State program includes a definition of “qualified trainer” within their training plan.

27. Recall Audit Checks: are conducted by the State Agency to verify that the firm’s recall was successful as defined by the State’s recall procedures.

28. Regulatory Foundation: means laws, regulations, rules, ordinances, or other regulatory requirements that govern the operation of a food plant or manufacturing establishment.

29. Sampling Program: means a program in which the state collects samples as part of their manufactured food program in one or more of the sampling types as defined in the Partnership for Food Protection’s Food/Feed Testing Laboratories Best Practices Manual4 (Draft) (Final Draft 11/1/2013). The program can be based on state defined sampling frequency and does not have to be continuous or routine.

30. Start Date: date of newly hired into the manufactured food program or newly reassigned into the manufacturing food program as the start time for training timelines for employees.

31. Strategic Improvement Plan: means a type of improvement plan that includes the following information: (1) the individual element or documentation requirement of the standard that was not met, (2) improvements needed to meet the program element or documentation requirement of the standard, (3) projected completion dates for each task,

(4) personnel responsible, and (5) date completed.

32. Traceback: [a] The method used to determine the source and scope of the product/processes associated with an outbreak and document the distribution and

4 Reference: PFP Food/Feed Testing Laboratories Best Practices Manual can be found:

http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM404716.pdf http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM404716.pdf production chain of the product that has been implicated in a foodborne illness or outbreak.5 and [b] The process by which the origin or source of a cluster of contaminated food is identified.6

33. Traceforward: [a] once the source of an implicated food item is established, investigators may do a "traceforward" to document the distribution of all implicated lots of food from the source. This can help epidemiologists with case finding and can be used to test hypotheses about the outbreak. Traceforwards should only be used when there is a reasonable degree of confidence that the traceback correctly identified the source of the implicated product. A product recall also involves a traceforward to determine the suppliers that received the product. [b] Tracking a recalled product from the origin or source through the distribution system. 6

34. Verification Audit Inspection: means an inspection in which a qualified FDA or State auditor observes a State qualified auditor performing an audit of a State inspector conducting an inspection.

5 Reference: Multistate Foodborne Outbreak Investigations Guidelines for Improving Coordination and Communications. Glossary can be found at: http://www.cifor.us/clearinghouse/tooldetail.cfm?id=212

6 Reference: Council to Improve Foodborne Outbreak Response (CIFOR). Guidelines for Foodborne Disease Outbreak Response, 2009.

Appendix 1: Glossary which can be found at: http://www.cifor.us/documents/CIFORGuidelinesAppendices.pdf http://www.cifor.us/clearinghouse/tooldetail.cfm?id=212 http://www.cifor.us/documents/CIFORGuidelinesAppendices.pdf

STANDARD No. 1 Regulatory Foundation

1.1 Purpose

This standard describes the elements of the REGULATORY FOUNDATION used by a State program to regulate food plants.

1.2 Requirement Summary

The State program evaluates the scope of its legal authority and regulatory provisions to ensure the protection of manufactured food within its jurisdiction. The State program’s evaluation includes a determination of how the State’s REGULATORY FOUNDATION corresponds to the U.S.

FDA’s REGULATORY FOUNDATION.

1.3 Program Elements

1.3.1 Written Procedure for Evaluation of Legal Authority

The State program has a written procedure to evaluate the legal authority and regulatory provisions to inspect and investigate food plants, gather evidence, collect and analyze samples, and take enforcement actions. The written procedure must:

1.3.1.1 Include timeframes for a REGULATORY FOUNDATION assessment;

1.3.1.2 Describe the REGULATORY FOUNDATION assessment process, to include whenever significant changes are made to applicable Federal and/or state laws and regulations; and

1.3.1.3 Address the statutes, regulations, rules, ordinances, and other prevailing regulatory requirements that:

1.3.1.3.1 Apply to the regulation of manufactured food;

1.3.1.3.2 Delegate authority to the State program;

1.3.1.3.3 Describe the State program’s administrative procedures for rulemaking to protect public health; and

1.3.1.3.4 Identifies and lists other State or Federal agencies that have authority for any area of the REGULATORY FOUNDATION that the State program lacks.

1.3.2 REGULATORY FOUNDATION Assessment

1.3.2.1 The State program must complete Appendix 1 or equivalent form. The State program conducts a baseline self-assessment to determine if they are EQUIVALENT, EQUIVALENT IN EFFECT, or NOT EQUIVALENT to sections of the current Federal Food, Drug, and Cosmetic Act (FD&C Act) and Code of Federal Regulations (CFR) Title 21 specified in Appendix 1.

1.3.2.2 If the State program has not adopted the current version of a CFR provision the State must provide the revision date of the CFR that was adopted for each regulation.

Note: If the State program has laws and regulations pertinent to the regulation of manufactured food, for which there are no Federal provisions, these laws and regulations can also be listed in Appendix 1 or equivalent form.

Note: In conducting a self-assessment, the State program may need to consult with legal counsel when regarding whether a provision is EQUIVALENT IN EFFECT.

1.4 Outcome

The State program has the legal authority and regulatory provisions to protect the public health by ensuring the safety and security of the manufactured food supply within its jurisdiction. For any part of the REGULATORY FOUNDATION that the State program lacks, the State program identifies another State or Federal program with that regulatory authority to protect public health.

1.5 Documentation

The State program maintains the records listed here.

1.5.1 Written procedure for evaluation for legal authority

1.5.2 State program’s written REGULATORY FOUNDATION assessment process

1.5.3 The statutes, regulations, rules, ordinances, and other prevailing regulatory requirements that: (1) apply to the regulation of manufactured food, (2) delegate authority to the State agency, and (3) describe the State agency’s administrative procedures for rulemaking to protect public health

1.5.4 Appendix 1 - Self-Assessment Worksheet or equivalent form

1.5.5 If applicable, review by legal counsel

STANDARD No. 2 Training Program

2.1 Purpose

This standard defines the essential elements of a training program for inspectors.

2.2 Requirement Summary

The State program uses a written training plan that promotes development and demonstrates that all inspectors who will conduct manufactured food inspections complete course curriculums, field training, and continuing education to adequately perform their work.

2.3 Program Elements

2.3.1 Training Plan and Training Records

2.3.1.1 The State program uses a written training plan that ensures all inspectors receive training required to adequately perform their work assignments. The training plan includes course curriculums which provides for basic and advanced food inspection training as well as continuing education.

2.3.1.2 Appendix 2.2 or equivalent form must be used to document and summarize all training provided to inspectors.

2.3.1.3 The State program maintains a training history for active inspectors.

The training history for all inactive inspectors must be kept for three years or per the state’s record retention policy.

2.3.1.4 Appendix 2.3 or equivalent form must be used to document training for each inspector.

2.3.1.5 The State training record summary and individual training records must include the inspector’s START DATE. Equivalent forms including electronic records may be used for required appendices.

2.3.2 Basic Food Inspection Training

The State program requires that each inspector complete a basic food inspection training curriculum that consists of coursework and field training described here.

2.3.2.1 Timeframe

The Basic Food Inspection Training course curriculum shall be successfully completed within 24 months of the inspector’s START DATE with the manufactured food program.

2.3.2.2 Course Curriculum:

The Basic Food Inspection Training consists of coursework in the subject areas listed in this section.

2.3.2.2.1 Prevailing statutes, regulations, and ordinances

2.3.2.2.2 Public health principles

2.3.2.2.3 Emergency management

2.3.2.2.4 Communications skills

2.3.2.2.5 Microbiology

2.3.2.2.6 Epidemiology

2.3.2.2.7 Basics of HACCP

2.3.2.2.8 Allergen management

2.3.2.2.9 Basic food labeling

2.3.2.2.10 Food defense awareness training

2.3.2.2.11 Sampling technique and preparation

Note: States may further subdivide their basic training by identifying courses required for inspectors who only inspect non high risk warehouses. These courses must be clearly defined in the state training plan.

Note: Appendix 2.4 provides a list of available Basic Food Inspection Training Coursework that may be used to satisfy the requirements in 2.3.2.2.

2.3.2.3 Field training

2.3.2.3.1 Each inspector who will inspect general manufactured food firms must complete:

2.3.2.3.1.1 Ten JOINT FIELD TRAINING INSPECTION, FIELD INSPECTION AUDITS, or EVALUATIONS with a QUALIFIED FIELD INSPECTION TRAINER; and

2.3.2.3.1.2 Of the ten, two must be acceptable FIELD

INSPECTION AUDITS or EVALUATIONS by a QUALIFIED FIELD INSPECTION TRAINER or QUALIFIED FIELD INSPECTION

AUDITOR.

2.3.2.3.2 Each inspector who will only inspect non high risk food warehouses must complete:

2.3.2.3.2.1 Five JOINT FIELD TRAINING INSPECTION, FIELD INSPECTION AUDITS, or EVALUATIONS with a QUALIFIED FIELD INSPECTION TRAINER; and

2.3.2.3.2.2 Of the five, two must be acceptable

FIELD INSPECTION AUDITS or

EVALUATIONS by a QUALIFIED FIELD INSPECTION TRAINER or QUALIFIED FIELD

INSPECTION AUDITOR.

2.3.2.3.3 Inspectors who meet 2.3.2.3.2 and advance to conduct general manufactured food firms must complete:

2.3.2.3.3.1 Five additional JOINT FIELD TRAINING

INSPECTIONS, FIELD INSPECTION AUDITS,

or EVALUATIONS to fulfill requirements identified in 2.3.2.3.1; and

2.3.2.3.3.2 Of the five, two must be acceptable

FIELD INSPECTION AUDITS or EVALUATIONS by a QUALIFIED FIELD INSPECTION TRAINER or QUALIFIED FIELD

INSPECTION AUDITOR.

2.3.2.3.4 JOINT FIELD TRAINING INSPECTION or FIELD INSPECTION AUDITS/EVALUATIONS are conducted in firms that are representative of the firms to be inspected by the inspector. Each inspector will complete the minimum field training requirements prior to conducting independent inspections.

2.3.3 Advanced Food Inspection Training

The State program requires each inspector who will conduct specialized food inspections to complete an advanced inspection training curriculum which consists of relevant coursework and field training as described here.

2.3.3.1 Coursework

The state program requires each inspector who will perform specialized food inspections to successfully complete the coursework specific to the type of specialized food inspections they will be performing. Specialized food inspection courses include, but not limited to:

2.3.3.1.1 Acidified foods

2.3.3.1.2 Low acid canned foods

2.3.3.1.3 Juice HACCP

2.3.3.1.4 Seafood HACCP

2.3.3.1.5 Traceback Investigations7

2.3.3.1.6 Foodborne Illness Investigations7

2.3.3.2 Field training

7 These advanced food inspection training courses are not subject to 2.3.3.2 Field Training requirements.

The State program requires that each inspector successfully complete the following before performing independent specialized food inspections.

2.3.3.2.1 Participate in two JOINT FIELD TRAINING INSPECTIONS;

2.3.3.2.2 After successful completion of the course participate in one EVALUATION or FIELD INSPECTION AUDIT that is found to be acceptable by a QUALIFIED FIELD INSPECTION TRAINER or QUALIFIED FIELD INSPECTION AUDITOR prior to conducting independent inspections;

and

2.3.3.2.3 Within one year after being released to do specialized food inspections complete a second EVALUATION or FIELD INSPECTION AUDIT that is found to be acceptable by QUALIFIED FIELD INSPECTION TRAINER or QUALIFIED FIELD INSPECTION AUDITOR in the area of specialty.

2.3.4 Experienced Inspectors

The criterion for conducting a minimum of 10 JOINT FIELD TRAINING INSPECTIONS and/or required coursework is intended for new employees or employees new to the food safety program. For CURRENT EXPERIENCED STAFF or NEWLY HIRED EXPERIENCED STAFF, a State program’s training plan shall include the following unless the state determines in their training plan that all staff will be required to complete the program elements in 2.3.2 and 2.3.3:

2.3.4.1 CURRENT EXPERIENCED STAFF

Missing Record Documentation in Employee Training

File

2.3.4.1.1 JOINT FIELD

TRAINING

INSPECTIONS

Statement or affidavit explaining the background or experience that justifies a waiver of the basic or specialized JOINT

FIELD TRAINING INSPECTIONS.

2.3.4.1.2 Basic Course

Work

Document training records available.

Create a statement or affidavit explaining the background or experience that justifies a waiver of the missing Basic Course Work.

2.3.4.1.3 Specialized Food

Inspection Course Work Certificates

Statement or affidavit explaining the date and location that they have successfully completed the specialized training.

2.3.4.2 NEWLY EXPERIENCED STAFF

Missing Record Documentation in Employee Training

File

2.3.4.2.1 JOINT FIELD

TRAINING

INSPECTIONS

Statement or affidavit explaining the background or experience that justifies a waiver of some or all of the basic or specialized JOINT FIELD TRAINING INSPECTIONS. Conduct two successful EVALUATION or FIELD INSPECTION AUDIT within 6 months of the Inspector’s

QUALIFIED DATE.

2.3.4.2.2 Basic Course

Work

Document training records available.

Statement or affidavit explaining the background or experience that justifies a waiver of the Basic Course Work.

2.3.4.2.3 Specialized Food

Inspection Course Work Certificates

Statement or affidavit explaining the date and location that they have successfully completed the specialized training.

2.3.5 Continuing education

Within the scope of this standard, the goal of continuing education and training is to enhance the inspector’s knowledge, skills, and ability to perform manufactured food inspections. The objective is to build upon the inspector’s knowledge base.

2.3.5.1 Each inspector must accumulate 20 CONTACT HOURS of continuing education in food safety every 36 months.

2.3.5.2 The 36-month continuing education interval starts at the QUALIFIED

DATE, when the basic training cycle is completed.

2.3.5.3 The program may establish an alternate timeframe to track continuing education as long as the alternate timeframe and how that timeframe still meets or exceeds the intent of the standard (at least 20 CONTACT HOURS every 36 months) are clearly identified in program procedures.

2.3.5.4 The inspector qualifies for CONTACT HOURS for participation in any of the following activities that are related specifically to manufactured food safety or manufactured food inspectional work:

• Attendance at national or regional seminars / technical conferences;

• Professional symposiums / college courses;

• Food-related training provided by government agencies (e.g., USDA, State, local);

• Food safety related conferences and workshops;

• Distance learning opportunities that pertain to food safety; or

• Training approved by a QUALIFIED FIELD INSPECTION TRAINER.

2.3.5.5 Of the accumulated 20 CONTACT HOURS of continuing education, a maximum of ten (10) CONTACT HOURS may be accrued from the following activities:

• Delivering presentations at professional conferences;

• Providing classroom and/or field training to newly hired inspectors, or being a course instructor in food safety; or

• Publishing an original article in a peer-reviewed professional or trade association journal/periodical.

2.3.5.6 Of the accumulated 20 CONTACT HOURS of continuing education, a maximum of four (4) CONTACT HOURS may be accrued for reading technical publications related to manufactured food safety.

2.3.5.7 Documentation must accompany each activity submitted for continuing education credit. Examples of acceptable documentation may include:

• Certificates of completion indicating the course date(s) and number of hours attended or CE credits granted;

• Transcripts from a college or university;

• A letter from the administrator of the continuing education program attended;

• A copy of the peer-reviewed article or presentation made at a professional conference; or documentation to verify technical publications related to food safety have been read including completion of self-assessment quizzes that accompany journal articles, written summaries of key points/findings presented in technical publications, and/or written book reports; and

• An agenda and attendance roster.

• Documentation approved by the QUALIFIED FIELD INSPECTION

TRAINER.

2.3.6 Coursework Sources

Basic, advanced, and continuing education coursework must be obtained from one of the sources listed here:

2.3.6.1 Training provided by a government agency (including in house training);

2.3.6.2 Distance learning, for example, satellite downlinks or web-based training8;

2.3.6.3 Colleges, schools, research centers, and institutes;

8 FDA/ORA U classroom and long distance learning courses are listed at: http://www.fda.gov/ora/training/course_ora.html http://www.fda.gov/ora/training/course_ora.html

2.3.6.4 Food Safety Alliances recognized by FDA.

2.4 Outcome

The State program has trained inspectors with the knowledge, skills, and abilities to competently inspect, conduct investigations, gather evidence, collect samples, and take enforcement actions with manufactured food plants.

2.5 Documentation

2.5.1 Appendix 2.1 Self-Assessment Worksheet

2.5.2 Appendix 2.2 State Training Record Summary

2.5.3 Appendix 2.3 Individual training record

2.5.4 Documents verifying successful completion of required courses

2.5.5 Course description or agendas for non-FDA courses

2.5.6 Signed statements for experienced inspectors

2.5.7 EVALUATIONS or FIELD INSPECTION AUDITS

2.5.8 Documentation for continuing education credit

STANDARD No. 3 Inspection Program

3.1 Purpose

This standard describes the elements of an effective inspection program for manufactured food establishments.

3.2 Requirement Summary

The State program has a manufactured food inspection system. This system provides the foundation for inspecting food firms to determine compliance with the laws administered by Federal, State, and local governments. In addition, the State program has: (1) a risk based inspection program, (2) an inspection procedure, (3) an inspection report procedure, (4) a system to respond to CONSUMER COMPLAINTS, (5) a system to resolve INDUSTRY COMPLAINTS about inspections, (6) a recall system, and (7) a sampling procedure.

3.3 Program Elements

3.3.1 Risk-based Inspection Program

The State program has an inventory of food establishments for which the State has regulatory oversight. The inventory is categorized by the risk associated with the likelihood that a food safety or defense incident will occur.

3.3.1.1 Inspections are prioritized and frequencies assigned based on established risk categories. The State program has written procedure documenting their classification criteria and inspection frequencies.

3.3.1.2 The state program must use the risk factors and classification criteria as described in:

• Appendix 3.2; or

• FD&C Act, Section 421 (a)(1); or

• Develop its own risk factor and classification criteria. If the state chooses to develop its own risk factor and classification criteria a written rationale must be provided that demonstrates how public health is protected.

3.3.2 Inspection Procedure

The State program has a written procedure for inspecting food plants that require the inspectors to:

3.3.2.1 Review the previous inspection report and CONSUMER COMPLAINTS.

3.3.2.2 Have appropriate equipment9 and forms (if necessary). Equipment must be verified and maintained as defined by the State’s standard operating procedures or manufacture’s recommendations.

3.3.2.3 Make appropriate introductions, and explain the purpose and scope of the inspection.

3.3.2.4 Establish jurisdiction.

3.3.2.5 Select an appropriate product for the inspection and, if necessary, make appropriate adjustments based on what the plant is producing.

3.3.2.6 Assess employee practices critical to the safe and sanitary production and storage of food.

3.3.2.7 Properly evaluate the likelihood that conditions, practices, components, and/or labeling could cause the product to be adulterated or misbranded or otherwise in violation of applicable law.

3.3.2.8 Recognize significant violative conditions or practices, if present, and record findings consistent with State program procedures.

3.3.2.9 Distinguish between significant and insignificant observations, and isolated incidents versus trends.

3.3.2.10 Review and evaluate the appropriate records and procedures for the establishment’s operation and effectively apply the information obtained from this review [during the inspection].

3.3.2.11 Collect adequate evidence and documentation to support inspection observations in accordance with State program procedures.

3.3.2.12 Verify correction of deficiencies identified during the previous inspection.

3.3.2.13 Behave professionally and demonstrate proper sanitary practices during the inspection.

3.3.2.14 Use current versions of applicable hazard guides or other guidance, to identify and evaluate the HAZARDS associated with product(s) and process(es) when conducting inspections of specialized food and processes.

3.3.2.15 Assess the firm’s implementation of sanitation monitoring for the applicable eight key areas of sanitation when required by regulation.

3.3.2.16 When appropriate review the firm’s: scheduled process; HACCP plan or necessary process controls in the absence of a HACCP plan; food safety control plan and applicable monitoring, verification and deviation or corrective action records, including those related to sanitation.

3.3.2.17 Recognize deficiencies in the firm’s monitoring controls and sanitation procedures through in-plant observations.

3.3.2.18 Use suitable interviewing techniques.

3.3.2.19 Explain findings clearly and adequately throughout the inspection.

3.3.2.20 Alert the firm’s person in charge when an immediate corrective action is necessary.

9 Standard number 8, Appendix 8.3 Inspection Equipment

3.3.2.21 Answer questions and provide information in an appropriate manner.

3.3.2.22 Write findings accurately, clearly, and concisely on the State document and provide a copy to the firm’s person in charge.

3.3.3 Inspection Report

The State program has a written inspection report procedure that requires inspectors to:

3.3.3.1 Submit the inspection report within designated timeframes;

3.3.3.2 Complete the inspection report form completely and accurately;

3.3.3.3 Document violations and observations clearly, legibly, and concisely;

and

3.3.3.4 Follow up with corrective action, compliance and enforcement.

3.3.4 Food Recalls10

The State program has a food recall system with written recall procedures for:

3.3.4.1 Sharing information about recalls with relevant agencies;

3.3.4.2 Ensuring recalled products are removed promptly from the market;

and

3.3.4.3 Performing RECALL AUDIT CHECKS.

3.3.5 Consumer Complaints

The State program has a system for handling CONSUMER COMPLAINTS. The system contains written procedures for:

3.3.5.1 Receiving;

3.3.5.2 Tracking;

3.3.5.3 Evaluating;

3.3.5.4 Responding to; and

3.3.5.5 Closing CONSUMER COMPLAINTS.

3.3.6 Complaints Resulting from State Program Inspection Activities

The State program has a system for handling INDUSTRY COMPLAINTS about inspections.

The system contains written procedures for:

3.3.6.1 Receiving;

3.3.6.2 Evaluating; and

3.3.6.3 Responding to INDUSTRY COMPLAINTS.

10 Reference: PFP Best Practices for Improving FDA and State Communication During Recalls can be found:

http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM460013.pdf?source =govdelivery&utm_medium=email&utm_source=govdelivery http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM460013.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM460013.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

3.3.7 Sampling Procedure11

The State program has a written sampling procedure to ensure its SAMPLING PROGRAM is carried out in a manner that is consistent with state procedure. The sampling procedures must be reflective of the types of food and samples that the state collects and must include:

3.3.7.1 Procedures that require sample collectors to:

3.3.7.1.1 Use the appropriate method and equipment to collect the sample.

3.3.7.1.2 Record sample chain of custody per state procedure.

3.3.7.1.3 Handle, package, and ship sample using procedures

appropriate to prevent compromising condition of the sample and ensuring security of the sample.

3.3.7.1.4 Deliver or ship sample to the appropriate laboratory program within prescribed timeframes.

3.3.7.2 Instructions for documenting the sample collection must include the following unless specified by the State’s SAMPLING PROGRAM:

3.3.7.2.1 Date of Sample Collection

3.3.7.2.2 Product Identification Including:

3.3.7.2.2.1 Name of Product

3.3.7.2.2.2 Unique Manufacturing Identification

references

3.3.7.2.3 Description of the product

3.3.7.2.4 Collection information including:

3.3.7.2.4.1 Method of Collection

3.3.7.2.4.2 Lot Sampled

3.3.7.2.4.3 Lot Size

3.3.7.2.4.4 Special Sample techniques if used to

collect the sample

3.3.7.2.5 Location where sample was collected.

3.3.7.2.6 Name and address of responsible party, guarantor, possessor, or distributor.

3.3.7.2.7 Sample type

3.3.7.2.8 Analysis requested if applicable.

3.3.7.2.9 Product labels or specific labeling information that is collected or reproduced per state policies.

11 Reference: PFP Food/Feed Testing Laboratories Best Practices Manual can be found:

http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM404716.pdf http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM404716.pdf

3.3.7.2.10 Identification of the sample with the sample number assigned by the sampler at the time of collection.

3.3.7.3 State programs are not required to have a written sampling procedure unless they collect samples. However, these programs must have a statement in lieu of sampling procedures that explains why a SAMPLING PROGRAM is not supported and how the public health is protected in the absence of such a program. An example may include:

Stating that public health is protected because another state or federal agency collects samples and fulfills this need. The statement should include the name of the agency and the type of samples that it collects.

3.3.8 Records Retention

The State program must maintain records as required under Section 9.3.2.2 for the following:

3.3.8.1 Inspection reports which includes follow up activities;

3.3.8.2 Essential recall information;

3.3.8.3 CONSUMER COMPLAINTS;

3.3.8.4 INDUSTRY COMPLAINTS about inspections12; and

3.3.8.5 Documentation associated with sample collection.

3.4 Outcome

The State program is based on an inspection program that reduces the occurrence of foodborne illness, injury, or allergic reaction.

3.5 Documentation

3.5.1 Appendix 3.1 Self-Assessment Worksheet

3.5.2 An inventory of food plants for which the state has regulatory oversight13

3.5.3 Written procedure documenting the classification criteria and inspection frequencies

3.5.4 Written rationale of the risk factor and classification criteria if a State program develops its own risk factor and classification criteria

3.5.5 Written procedures for inspecting food plants.

3.5.6 Written inspection reports procedure

12 Records dealing with personnel actions are not subject to review during an ASSESSMENT.

13 Refer to PFP Document Data Elements and Definitions for recommended but not required data elements for each food plant.

http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM404717.pdf http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM404717.pdf

3.5.7 Written inspection reports, which includes follow-up activities

3.5.8 Written procedures for food recalls

3.5.9 Essential recall information

3.5.10 Written procedures for CONSUMER COMPLAINTS

3.5.11 CONSUMER COMPLAINTS

3.5.12 Written procedures for INDUSTRY COMPLAINTS about inspections

3.5.13 INDUSTRY COMPLAINTS about inspections14

3.5.14 Written procedures for sampling or, in the absence of any SAMPLING PROGRAM, a statement stating how public health is protected

3.5.15 Sample collection reports

3.5.16 Documentation associated with sample collection

14 Records dealing with personnel actions are not subject to review during an ASSESSMENT.

STANDARD No. 4 Inspection Audit Program

4.1 Purpose

This standard describes the Quality Assurance Program (QAP) and auditing procedures necessary for a State program to (1) evaluate the effectiveness and accuracy of the inspection program, inspection records, and sampling records; and (2) identify best practices used to achieve quality inspections and sample collections.

4.2 Requirement Summary

The State program has a Quality Assurance Program that conducts audits to assess the effectiveness and accuracy of its inspections and sample collections. The QAP has two components: (1) a FIELD INSPECTION AUDIT component, which is an on-site performance EVALUATION of inspections and (2) a desk audit component, which is a performance review of the written reports of inspections and sample collections.

4.3 Program Elements

4.3.1 Quality Assurance Program

The State program has a written Quality Assurance Program that contains written procedures for:

4.3.1.1 Conducting field inspection audits as described in section 4.3.2; and

4.3.1.2 Conducting inspection report audits as described in section 4.3.3; and

4.3.1.3 Conducting sample report audits as described in section 4.3.4; and

4.3.1.4 A corrective action plan as described in section 4.3.5.

4.3.2 Field Inspection Audit

QUALIFIED FIELD INSPECTION TRAINER or QUALIFIED FIELD INSPECTION AUDITOR conducts FIELD INSPECTION AUDITS or VERIFICATION AUDIT INSPECTIONS to verify that inspections are consistently performed according to the State’s written procedures described in Standard 3.

4.3.2.1 Frequency. The QAP requires a minimum of two FIELD INSPECTION AUDITS of each inspector be conducted every 36 months. Inspections selected for audits should include the highest risk firms that the inspector is trained for including specialized food inspections.

4.3.2.2 Performance is documented on…