Attachment_25.pdf

Manufactured Food Regulatory Program Standards

September 2013

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:

http://www.fda.gov/ora/fed_state/default.htm

U.S. Department of Health and Human Services Food and Drug Administration

Office of Regulatory Affairs

OMB Control No. 0910-0601 Expiration Date: 09-30-2016 http://www.fda.gov/ora/fed_state/default.htm

Manufactured Food Regulatory Program Standards September 2013

Table of Contents

Introduction Background 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 and Outbreaks and Response .................. ……….……. 15 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 -- Standard No. 1 Appendix 2.1 Self-Assessment Worksheet -- Standard No. 2 Appendix 2.2 Individual Training Record Appendix 3.1 Self-Assessment Worksheet -- Standard No. 3 Appendix 3.2 Risk Classification Criteria for Food Plants Appendix 4.1 Self-Assessment Worksheet -- Standard No. 4 Appendix 4.2 Summary of Field Inspection Audit Findings Worksheet 4.2 Calculation of the performance ratings for the field inspection audits Appendix 4.3 Summary of Inspection Report Audit Findings Worksheet 4.3 Calculation of the performance rating for the inspection report audits Appendix 4.4 Summary of Sample Report Audit Findings Worksheet 4.4 Calculation of the performance rating for the sample report audits Appendix 4.5 Contract Audit – FDA Form 3610 Appendix 4.5a Guidance for Completing the Contract Audit Form 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 -- Standard No. 5 Appendix 5.2 Memorandum of understanding between the department of health and the department of agriculture concerning the investigation of foodborne illnesses associate with food service establishments and food plants Appendix 6.1 Self-Assessment Worksheet -- Standard No. 6 Appendix 6.2 Performance Review of Enforcement Actions Worksheet 6.2 Calculation of the level of conformance to compliance procedures Appendix 7 Self-Assessment Worksheet -- Standard No. 7 Appendix 8.1 Self-Assessment Worksheet -- Standard No. 8 Appendix 8.2 Calculation for determining a required number of inspectors Appendix 8.3 Inspection Equipment Worksheet 9 Self-Assessment and Improvement Tracking Appendix 10 Self-Assessment Worksheet -- Standard No. 10

INTRODUCTION

The Manufactured Food Regulatory Program Standards (program standards) establish a uniform foundation for the design and management of State programs1 responsible for the regulation of food plants. The elements of the program standards describe best practices of a high-quality regulatory program. Achieving conformance with them will require comprehensive self-assessment on the part of a State program and will encourage continuous improvement and innovation.

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 has corresponding self-assessment worksheets and certain standards have supplemental worksheets and forms for determining a level of conformance with such standards. The State program is not required to use the forms and worksheets contained herein; however, alternate forms should be comparable to the forms and worksheets for program standards.

These program standards do not address the performance appraisal processes that a State agency may use to evaluate individual employee performance.

FDA will use the program standards as a tool to improve contracts with States. The program standards will assist both FDA and the States in fulfilling their regulatory obligations. The implementation of the program standards will be negotiated as an option for payment under the State contract. States that are awarded this option will be expected to implement the program standards to evaluate and improve their manufactured food program. FDA recognizes that full use and implementation of the program standards by those States will take several years. Such States will, however, be expected to implement improvement plans to demonstrate that they are moving toward full implementation.

The goal is to implement a risk-based food safety program by establishing a uniform basis for measuring and improving the performance 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.

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.

1 Program defined as an operational unit(s) that is responsible for the regulatory oversight of food plants.

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 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.2” 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 from State agencies responsible for the regulation and inspection of food plants3.

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

3 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) .

STANDARD No. 1 Regulatory Foundation

1.1 Purpose

This standard describes the elements of the regulatory foundation4 used by a State program to regulate food plants.

1.2 Requirement Summary

The State program has the legal authority and regulatory provisions to perform inspections and investigations, gather evidence, collect samples, and take enforcement actions under Federal and State laws. If the State adopts FDA laws and regulations by reference, the terms of adoption must be clearly defined.

NOTE: When State code does not provide for adopting FDA laws and regulations by reference, which includes subsequent amendments and editions of the Title 21 Code of Federal Regulations (CFR), a legal review by the State agency’s counsel to determine if State laws and regulations are equivalent in effect to the current Federal laws and regulations listed in appendix 1 is needed. If it has not adopted the current version of the CFR, the State must provide the revision date of the CFR that was adopted for each regulation in the box under “State citation or alternate provision” of appendix 1.

1.3 Program Elements

a. The State program has the legal authority to inspect food plants, gather evidence, collect and analyze samples, and take enforcement actions for adulteration or misbranding of foods equivalent in effect to sections of the current FD&C Act specified in appendix 1.

b. The State program enforces regulatory provisions equivalent in effect to the Federal regulations specified in appendix 1. In the absence of a corresponding law or regulation, a legal review by the State agency’s counsel to determine if State laws and regulations are equivalent in effect to the current Federal laws and regulations listed in appendix 1 is needed.

c. The State program uses its laws and regulations to broaden its scope of regulatory authority.

4 Laws, regulations, rules, ordinances, or other regulatory requirements that govern the operation of a food plant or manufacturing establishment.

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 food supply.

1.5 Documentation

The State program maintains the records listed here.

• Appendix 1 Self-assessment worksheet

• The statutes, regulations, rules, ordinances, and other prevailing regulatory requirements that: (1) apply to the operation of food plants, (2) delegate authority to the State agency, and (3) describe the process by which the State agency establishes its authority and adopts rules by reference, for example, the administrative rulemaking process

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 has a training plan that ensures all inspectors receive training required to adequately perform their work assignments. The plan provides for basic and advanced food inspection training as well as continued training for professional development in the field of food processing.

The State program has written basic and advanced food inspection training programs that include course curriculums. ORA-U offers courses that the State program should consider when developing basic and advanced training curriculums.

2.3 Program Elements

The State program maintains a history of the training provided to all inspectors.

Appendix 2.1 may be used to document all training provided to inspectors. Or, the training history may be recorded and retained electronically.

The State program provides, or otherwise makes available, inspection training for all inspectors. A training record similar to appendix 2.2 is maintained for all inspectors.

The individual training record should have the inspector’s start date.

NOTE: All required basic and advanced courses must be listed on the inspector’s training record. Documentation to verify that an inspector has successfully completed a course must be retained.

a. 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.

Coursework

The State program requires each inspector to complete coursework in the following areas within 24 months of his or her start date with the State program.

• Prevailing statutes, regulations, and ordinances

• Public health principles

• Food defense awareness training

• Communications skills

• Microbiology

• Epidemiology

• Basics of HACCP

• Basic labeling

• Control of allergens (when available)

• Sampling technique and preparation

Coursework is obtained from sources listed here.

• In-house training provided by a government agency

• Distance learning, for example, satellite downlinks or web-based training5

• Colleges, schools, and research centers

Field training

The State program requires that each inspector participate in a minimum of ten joint or audit inspections with a qualified trainer and receive a minimum of two acceptable evaluations from the trainer. Joint or audit inspections are conducted in firms that are representative of the food plants in the State program’s establishment inventory. Each inspector will complete the minimum field training requirements within 18 months of his or her start date with the State program and prior to conducting independent inspections.

b. Advanced Food Inspection Training

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

Coursework

The State program requires each inspector who will perform specialized food inspections to complete coursework listed here.

• Applications of epidemiology & foodborne illness investigations

• Traceback investigations

• National Incident Management System (incident command system)

• Nutrition labeling

• Acidified foods

• Low acid canned foods

• Juice HACCP

• Seafood HACCP

5 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

Field training

The State program requires that each inspector who will conduct specialized food inspections participate in three joint inspections with a qualified trainer and receive a minimum of two acceptable evaluations from the trainer. The joint inspections are conducted in food plants representative of the specialty area. The inspector will complete the minimum field training requirements prior to performing independent inspections.

c. Continuing education

The State program requires that each inspector participate in continuing education that includes coursework and inspections. Every 36-month interval, each inspector is required to receive 36 contact hours of classroom training and participate in at least two joint or audit inspections with a qualified trainer. These joint inspections are intended to assist the inspector with applying what was learned in the classroom to what should be covered during an inspection.

[Note: The 36-month continuing education interval starts when the basic training cycle is complete -- 24 months after the employee’s start date.]

One contact hour is earned for each hour of participation in the continuing education activities from sources described in Section 2.3a.

2.4 Outcome

The State program has trained inspectors with the knowledge, skills, and abilities to competently inspect food plants.

2.5 Documentation

• Appendix 2.1 Self-assessment worksheet

• Appendix 2.2 Individual training record

• Documents verifying successful completion of required courses

• Course description, if necessary

• Field training and evaluations

• Continuing education certificates

STANDARD No. 3 Inspection Program

3.1 Purpose

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

3.2 Requirement Summary

The State program has an inspection system. This system provides the foundation for inspecting food plants to determine compliance with the laws administered by Federal, State, and local governments. In addition, the State program has: (1) an established recall system, (2) a system to respond appropriately to consumer complaints, (3) a system to resolve industry complaints about inspections, and (4) a recordkeeping system for all elements of the inspection program.

3.3 Program Elements

a. Risk-based inspection program

The State program updates its inventory of food plants. The inventory is categorized by the degree of risk associated with the likelihood that a food safety or defense incident will occur. Inspections are prioritized, frequencies assigned, and resources allocated based on risk categories assigned to a food plant or product, the manufacturing processes, and the inspection history of the food plant. Appendix 3.2 provides factors that may be considered when defining risk categories.

b. Inspection protocol

The State program has written policies and procedures for inspecting food plants that require the inspectors to:

1. Review the previous inspection report and consumer complaints

2. Have appropriate equipment6 and forms needed to conduct inspections

3. Establish [FDA] jurisdiction

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

5. Assess employee activities critical to the safe and sanitary production and storage of food

6. Properly evaluate the likelihood that conditions, practices, components, and/or labeling could cause the product to be adulterated or misbranded

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

6 Standard number 8, appendix 8.3 Inspection Equipment

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

9. 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]

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

11. Verify correction of deficiencies identified during the previous inspection

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

As appropriate for seafood and juice processors subject to HACCP regulations:

13. Use the Fish and Fishery Products Hazards and Controls Guide or the Juice

HACCP Hazards and Controls Guide, when and as appropriate, to identify and evaluate the hazards associated with the product and process

14. Assess the firm’s implementation of sanitation monitoring for the applicable eight key areas of sanitation

15. Review the firm’s HACCP plan (or necessary process controls in the absence of a HACCP plan) and applicable monitoring verification and corrective action records, including those related to sanitation

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

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

18. Use suitable interviewing techniques

19. Explain findings clearly and adequately throughout the inspection

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

21. Answer questions and provide information in an appropriate manner

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

c. Food recalls

The State program has a food recall system.

The State program has written recall procedures for:

1. Sharing information about recalls with affected government agencies

2. Promptly removing recalled food products from the market

3. Performing recall audit checks

4. Identifying and maintaining records about essential recall information

d. Consumer complaints

The State program has a system for handling consumer complaints. The system contains written procedures for receiving, tracking, evaluating, answering, closing, and maintaining records of consumer complaints.

e. Food industry inspection complaints

The State program has a system to resolve complaints from industry about inspections.

The system contains written procedures for receiving, evaluating, answering, and maintaining records of industry complaints about inspections.

3.4 Outcome

The State program has an inspection program that reduces the occurrence of foodborne illness, injury, or allergic reaction by:

1. Focusing inspection resources on high risk plants, products, and processes

2. Obtaining immediate corrections and long-term improvements from manufactured food processors

3. Responding efficiently to prevent unsafe products from reaching consumers or to remove unsafe food from the human food system

3.5 Documentation

• Appendix 3.1 Self-assessment worksheet

• An official establishment inventory of food plants

• Written procedures and rationale used for grouping establishments based on food safety risk, including the inspection frequency assigned to each defined risk-based establishment category

• Inspection policies and procedures including guidelines for performing inspections that require immediate corrective action and re-inspection

• Written procedures for food recalls, consumer complaints, and industry complaints about inspections

• Records for the three previous years including inspection reports and reports pertaining to food recalls and follow-up activities, consumer complaints, and industry complaints about inspections

STANDARD No. 4 Inspection Audit Program

4.1 Purpose

This standard describes the basic quality assurance reviews necessary to: (1) evaluate the effectiveness of the inspection program, (2) recognize trends in inspectional coverage, and (3) identify best practices used to achieve quality inspections and sample collections.

4.2 Requirement Summary

The State program conducts quality assurance reviews to assess the effectiveness of its inspections and sample collections. The data used to determine such performance is obtained from observing an inspector conducting an inspection and the inspector’s written reports. This standard is not intended, however, to evaluate individual performance.

4.3 Program Elements

The State program implements a quality assurance program (QAP) that identifies elements of its inspection and sample collection processes that need improvement.

The QAP has two components: (1) a field 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.

Worksheets 4.2, 4.3, and 4.4 will be used to: (1) calculate an overall audit rating for each review (field inspection performance and written reports of inspections and samples collections) and (2) evaluate ratings for a single performance factor.

Managers use the ratings to identify specific aspects of its inspection program that need improvement. When performance ratings fall below 80 percent, a corrective action plan (appendix 4.8 or comparable form) is required.

The State program compiles and summarizes the results of the field and desk audits annually and determines an overall performance rating, which is reported on the self-assessment worksheet (appendix 4.1). The results of the audits are evaluated every 12 months to: (1) determine the effectiveness of the food inspection program,

(2) recognize trends in inspectional coverage, and (3) identify best practices used to achieve quality inspections and sample collections.

The worksheets contained in appendices 4.1-4.4 are used to record and summarize audit findings. Or, the State program may use comparable worksheets to record audit findings.

a. Field Inspection Audit

Supervisory inspector, senior inspector, or team leader conducts field inspection audits to verify that inspections are consistently performed according to the established policies and procedures. The quality of each inspection is audited using the performance factors identified on appendix 4.5 and follows the process described in FDA’s Field Management Directive No. 76. An overall rating for field inspection performance is calculated using worksheet 4.2.

Frequency The QAP requires a minimum of two field inspection audits of each inspector be conducted every 36 months.

Inspections selected for audit should include high-risk food firms such as seafood facilities, juice processors, and low-acid canned food operations.

Performance Appendices 4.5 and 4.2 (including worksheet 4.2) Documentation

Performance Inspection procedures and policies described in Factors standard number 3 and appendix 4.5

b. Inspection Report Audit

The QAP requires periodic review of inspection reports to verify that inspectional findings are obtained and reported according to established procedures and policies.

The quality of each inspection report is audited using the performance factors listed in appendix 4.6. An overall inspection report rating is calculated using worksheet 4.3.

Frequency The State program determines the number of reports for review based on its inventory of food plants and the number of inspections completed in the past 12 months. At least

75 reports, including inspection reports from field inspection audit, are randomly selected across inspectors and supervisors, and geographical locations. If less than

75 inspections were conducted; all inspection reports will be reviewed. Seven percent of the inspection reports reviewed should be taken from inspections that were audited.

Performance Appendices 4.6 and 4.3 (including worksheet 4.3)

Performance Performance factors listed on appendix 4.6, and policies Factors and procedures established by the State program.

c. Sample Report Audit

The QAP requires periodic review of sample reports to verify that samples were properly collected, identified, and submitted according to established procedures and policies and that appropriate information was recorded. The quality of each sample report is audited using the performance factors listed in appendix 4.7. An overall sample report rating is calculated using worksheet 4.4.

Frequency The State program determines the number of reports for review based on the number of samples collected in the past 12 months. At least 75 reports are randomly selected across inspectors and supervisors, and according to sample type, for example, microbiology, aflatoxin, or low-acid canned foods. If less than 75 samples were collected, all reports will be reviewed.

Performance Appendices 4.7 and 4.4 (including worksheet 4.4)

Performance Performance factors listed in appendix 4.7, and Factors policies and procedures established by the State program.

d. Corrective Action Plan

A corrective action plan is required when an overall audit rating falls below 80 percent or when an individual performance factor is rated as “needs improvement.” Appendix 4.8 is used to document how the deficiency was corrected.

4.4 Outcome

The State program systematically evaluates and improves its inspection and sample collection systems to ensure that activities and information are accurate, complete, and comply with the jurisdiction’s procedures and policies.

4.5 Documentation

• Written procedures that describe the quality assurance program

• Appendix 4.1 Self-assessment worksheet

• Appendix 4.2 Summary of field inspection audit findings

(includes worksheet 4.2)

• Appendix 4.3 Summary of inspection report audit findings

(includes worksheet 4.3)

• Appendix 4.4 Summary of sample report audit findings

(includes worksheet 4.4)

• Appendix 4.5 Contract Audit - FDA Form 3610

• Appendix 4.5a Guidance for completing contract audit form

• Appendix 4.6 Inspection report audit form

• Appendix 4.7 Sample report audit form

• Appendix 4.8 Corrective action plan (includes table 4.8)

STANDARD No. 5 Food-related Illness and Outbreak Response

5.1 Purpose

This standard describes the functions and related activities necessary to investigate food-related illnesses, outbreaks, and hazards as well as coordinating roles and responsibilities with other jurisdictions and notifying the public.

5.2 Requirement Summary

The State program establishes systems to:

a. Use epidemiological information from local, State, or Federal agencies to detect incidents or outbreaks of foodborne illness or injury

b. Investigate reports of illness, injury, and suspected outbreaks

c. Correlate and analyze data

d. Rapidly notify customers and consumers

e. Share outbreak reports and surveillance summaries with other agencies

f. Disseminate current guidance to industry on food defense

g. Provide guidance for immediate notification of law enforcement agencies when intentional food contamination or terrorism is suspected or threatened

h. Collaborate as necessary with FDA and other Federal authorities under conditions of increased threat of intentional contamination

5.3 Program Elements

The State program has procedures for investigating food-related illnesses and outbreaks that include coordinating roles and responsibilities with other authorities and notifying the public. If the responsibility for food-related illness and outbreak investigations is assigned to another agency, a memorandum of understanding with this agency is needed to fulfill the requirements of this standard. Appendix 5.2 is an example of a memorandum of understanding between the department of health and the department of agriculture.

If a State program contracts for support of foodborne illness or injury investigations, it will:

a. Develop and coordinate the operation of written support service agreements between the food program and the epidemiology support program.

b. Ensure the support service contract or agreement identifies and describes the roles, duties, and responsibilities of each program for: (1) receiving reports of foodborne illness or injury, (2) performing investigational activities to identify the source of the problem, (3) reporting and recording the results of the investigations, (4) containing or mitigating the incident, and (5) preventing recurrence.

Whether foodborne illness support activities are performed by the State program or under a contractual agreement, it must have [or contract for] a system to:

a. Conduct illness or injury investigations and collect information using established epidemiology procedures similar to those found in the “International Association for Food Protection Procedures to Investigate a Foodborne Illnesses, Fifth Edition" and the “Guidelines for Foodborne Disease Outbreak Response.”7

b. Provide laboratory support8 for investigations of illness, injury, or outbreaks

c. Maintain a current list of relevant agencies and emergency contacts

d. Coordinate the traceback and trace-forward of food implicated in an illness, injury, or outbreak

e. Identify contributing factors for reports of illness, injury, or incidents implicating food

f. Maintain investigational findings

g. Distribute the final report of illness or injury implicating food to relevant agencies, e.g. the State epidemiologist and Centers for Disease Control

h. Immediately notify all relevant agencies if intentional contamination is suspected or threatened, e.g. tampering or terrorism

i. Establish criteria for releasing information to the public (includes identifying a media person and developing guidelines for coordinating media information with other jurisdictions)

j. Mitigate and contain food-related illness and injury using enforcement activities and public awareness programs

k. Provide guidance to prevent or reduce the incidence of food-related illness, injury, and intentional contamination, e.g. tampering or terrorism

l. Collaborate as necessary with FDA and other Federal authorities under conditions of increased threat or intentional contamination

5.4 Outcome

The State program has written procedures for documenting and investigating alleged food-related illnesses, injuries, and unintentional or deliberate food. Additionally, the State program must have a rapid response system and team that is capable of detecting and distinguishing between outbreaks of foodborne disease and possible intentional contamination.

5.5 Documentation

The program maintains the records listed here.

• Appendix 5.1 Self-assessment worksheet- Food-related Illness and Outbreak Response

7 Council to Improve Foodborne Outbreak Response (CIFOR). Guidelines for Foodborne Disease Outbreak Response. Atlanta:

Council of State and Territorial Epidemiologists, 2009.

8 Specific requirements for laboratory support are contained in standard number 10.

• A written description of epidemiology support or an agreement that defines epidemiology support similar to appendix 5.2

• A complaint log or database

• Up-to-date emergency contact list for all relevant jurisdictions

• Procedure and contact person for releasing information to the public

• Documented timeframes for responding to complaints

• The illness, injury, or outbreak response procedures and the data collection forms

• Policies and procedures for handling incidents and threats of deliberate contamination and for collaborations with FDA and other jurisdictions under conditions of increased threat or intentional contamination

• Written agreements that identify and describe sources of supplemental laboratory capacity and expertise including laboratory support9 to detect contaminants not normally found in food

• Investigation reports and summaries

9 Standard number 10 describes the elements of laboratory support for a manufactured food regulatory program.

STANDARD No. 6 Compliance and Enforcement Program

6.1 Purpose

This standard describes the State agency’s strategies, procedures, and actions to enforce the laws and regulations to achieve compliance and to evaluate the effectiveness of its compliance and enforcement program.

6.2 Requirement Summary

The State program has a compliance and enforcement program, which describes its compliance strategy and procedures. The compliance and enforcement program conducts an annual review of its enforcement actions. The State program records the enforcement actions on appendix 6.2 and calculates an overall rating used to interpret compliance and enforcement procedures were followed. Results of the review are used to identify improvements, modify procedures, and develop enforcement strategies.

6.3 Program Elements

The State program has a compliance and enforcement program that: (1) contains written enforcement strategies, (2) tracks critical and chronic violations and violators, (3) uses a risk-based system to determine when a directed investigation, follow-up, or re-inspection is needed, (4) establishes a timeline for progressive actions, and (5) has a system to communicate verbal and written policy and guidance to managerial and non-managerial staff. Appendix 6.1 is a framework for explaining the compliance and enforcement program required by this standard. This outline is a means through which the State should describe its program. Other aspects that may be pertinent to the State’s program that have not been included in the outline should be added.

The State program conducts a performance review of enforcement actions. Enforcement actions10 are recorded on appendix 6.2 and an overall rating is calculated to determine if internal procedures for enforcement and compliance actions (which include licensing and permitting procedures) are followed. Performance ratings that fall below 80 percent indicate a need for improvement and require corrective action.

10 Actions in the enforcement strategy may include, but are not limited to:

• Preventive actions such as promoting voluntary compliance through education program and consultation;

• Field actions such as verbal warnings, documented warnings, re-inspections, and product embargos;

• Supervisory/management actions such as warning letters or informal hearings;

• Administrative actions such as complaints and evidentiary hearings to suspend or revoke a business license; and

• Civil or criminal sanctions.

Frequency The performance review is conducted every 12 months. Results of the review are used to identify improvements, modify procedures, and develop enforcement strategies.

Performance Appendix 6.2 (including worksheet 6.2) or Documentation equivalent form

Written description of compliance and enforcement program (refer to appendix 6.1)

Performance Performance factors listed in appendix 6.1 Factors

6.4 Outcome

The State program has a compliance and enforcement program that has written procedures to ensure that compliance actions are supported by sound judgment, adequate evidence, and appropriate documentation that is submitted in program-prescribed formats and timeframes.

6.5 Documentation

• Written description of compliance and enforcement program (refer to appendix 6.1)

• Appendix 6.2 Performance Review of Enforcement Actions (includes worksheet 6.2)

• Applicable laws, regulations, and guidance documents referenced in standard number 1

STANDARD No. 7 Industry and Community Relations

7.1 Purpose

This standard describes the elements of industry and community outreach activities developed and accomplished by the State program.

7.2 Requirement Summary

The State program participates in activities that foster communication and information exchange among the regulators, industry, academia, and consumer representatives. It also coordinates or participates in outreach activities that provide educational information on food safety and defense issues. Outreach activities are documented on Appendix 7.

7.3 Program Elements

The State program interacts with industry and consumers by sponsoring or actively participating in meetings such as task forces, advisory boards, or advisory committees.

Appendix 7 is completed for each outreach activity.

Outreach efforts are tailored to a target population and may include dissemination of information using electronic sources and traditional methods such as mailings. Topics at outreach efforts may include food defense, investigation strategies, and regulatory requirements. Representatives from affected food industries, consumers, academia, and other Federal, State, and local food protection agencies are invited to these meetings.

7.4 Outcome

The State program uses outreach activities to inform varied populations about food-related issues.

7.5 Documentation

• Appendix 7 Self-assessment worksheet for each outreach activity

• Meeting summaries, agendas, or other records documenting interaction with food industries and consumers

STANDARD No. 8 Program Resources

8.1 Purpose

This standard describes the elements for assessing the resources (staff, equipment, and funding) needed to support a manufactured food regulatory program.

8.2 Requirement Summary

Staff, equipment, and funding are managed to accomplish the elements detailed in these standards.

8.3 Program Elements

Staffing

a. General Administration and Management

The State program has adequate staff to provide the direction, support, and oversight needed to implement the program standards. Capability may be needed in program management and direction, general administration, clerical support, office services, and coordination with laboratories.

b. Training Program (standard number 2)

The State program has adequate staff to coordinate a training curriculum and ensure it is properly delivered and tracked.

c. Inspection Program (standard number 3)

The State program has adequate staff to inspect food plants in its establishment inventory at an adequate frequency that is based on the plant’s risk classification and the necessary inspection and travel time. The risk categories and inspection frequencies found in the statement of work for the food contracts should be considered.

Appendix 8.2 is only an example of how to calculate the number of field staff needed to conduct inspections of food plants. State programs should use verifiable data to determine the required number of inspectors.

d. Inspection Audit Program (standard number 4)

The State program has adequate staff to administer and monitor its inspection quality assurance program.

e. Food-related Illness and Outbreaks and Food Defense Preparedness and Response

(standard number 5) The State program has adequate staff to prepare for and respond to emergency situations.

f. Compliance and Enforcement Program (standard number 6)

The State program has adequate staff to implement compliance and enforcement strategies.

g. Industry and Community Relations (standard number 7)

The State program has adequate staff to participate in outreach and education activities.

h. Program Assessment (standard number 9)

The State program has adequate staff to conduct self-assessments of the manufactured food regulatory program.

Equipment

a. Calibration and Repair

Equipment including thermometers is calibrated as required by the State’s standard operating procedures or industry recommendation. Government-owned vehicles are maintained and repaired following manufacturer’s recommendations.

b. Program administration and recordkeeping

The State program has computers, software, and equipment necessary to maintain and secure records.

c. Communication systems and equipment

The State program has equipment needed for routine and emergency communications.

d. Inspections The State program provides inspectors with equipment needed to conduct quality inspections. Appendix 8.3 is a list of inspection equipment.

Program funding

The State program is adequately funded to cover the following expenses:

a. Salary and benefits

b. Training costs

c. Travel-related expenses

d. Equipment and supplies

e. Industry and community outreach expenses

f. Laboratory expenses

g. Legal services fees

h. Indirect costs

i. Overhead costs

8.4 Outcome

The State program assesses and allocates resources needed to support a manufactured food regulatory program.

8.5 Documentation

The State program maintains the records listed here.

• Appendix 8.1 Self-assessment worksheet

• Document showing the calculations used to determine an adequate number of inspectors such as appendix 8.2

• Inventory of assigned and available inspection equipment similar to appendix 8.3

• Document containing the number and function of administrative support staff

STANDARD No. 9 Program Assessment

9.1 Purpose

This standard describes the process a State program uses to assess and demonstrate its conformance with each of the program standards.

9.2 Requirement Summary

Managers conduct periodic self-assessments of its manufactured food regulatory program against the criteria established in each program standard. These self-assessments are designed to identify the strengths and weaknesses of the State program by determining the level of conformance with the program standards.

The results of the self-assessments are used to determine areas or functions of the State program that need improvement. The results of the baseline self-assessment are used to develop an improvement plan and establish timeframes for making improvements.

Subsequent self-assessments are used to track progress toward meeting and maintaining conformance with the program standards.

9.3 Program Elements

In the first year of implementing the program standards, the State program conducts a baseline self-assessment to determine if they meet the elements of each standard. The State program should use the worksheets and forms contained herein; however it can use alternate forms that are equivalent.

The State program maintains the documents required by each standard and records of all self-assessments, improvement plans, and program assessment validation audits.

The information contained in the documents must be current and fit-for-use.

The State program uses the results of its self-assessments to complete the Self-Assessment and Improvement Plan Report (also known as Worksheet 9).

The State program should update this worksheet each year.

If the State program fails to meet all program elements and documentation requirements of a standard, it develops a written strategic 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, and (3) projected completion dates for each task.

After the State has completed their baseline self-assessment and improvement plan, FDA conducts a program assessment validation audit (hereafter known as validation audit). The validation audit should occur within 18 months. A subsequent validation audit will be conducted at 36 months to evaluate the State’s progress toward fully implementing the standards. Then, at 60 months, FDA will conduct a comprehensive program audit. As part of the program audit, the auditor reviews the records and supporting documents required by the criteria in each standard to determine if the self-assessment and improvement plan accurately reflect the State program’s level of conformance with each of the standards.

9.4 Outcome

The State program conforms to the program standards through well-defined and written evaluation activities and a process for continuous improvement.

9.5 Documentation

The State program maintains the records listed here.

• Worksheet 9 Self Assessment and Improvement Plan Report

• Completed appendices 1, 2.1 – 6.1, 7, 8.1, 10

• Documents required under Section x.5 of each standard

• Records and supporting documents required in the elements for each standard

STANDARD No. 10 Laboratory Support

10.1 Purpose

This standard describes the elements of laboratory support for a manufactured food regulatory program.

10.2 Requirement Summary

The State program has access to the laboratory services needed to support program functions and documents its laboratory capabilities including agreements with external laboratories.

10.3 Program Elements

a. The State program has access to a laboratory that is capable of analyzing a variety of samples including food, environmental, and clinical samples.

b. The State program maintains a list of services for routine and non-routine analyses such as biological hazard determinations.

c. The State program has a contract or written agreement with its primary servicing laboratories11.

d. The State program utilizes laboratories that have a current A2LA12 accreditation.

e. Or, the State program utilizes laboratories that have quality assurance programs that incorporate management and technical requirements found in ISO/IEC 17025:2005.

10.4 Outcome

The State program has access to laboratory services described in this standard.

11 Primary laboratory is a laboratory that analyzes more than 51 percent of the samples collected by the State program. State programs are not required to have written agreements with FDA laboratories.

12 American Association for Laboratory Accreditation

10.5 Documentation

The State program maintains records listed here.

• Appendix 10 Self-assessment worksheet

• Contracts or written agreements with primary servicing laboratories

• A list of all servicing laboratories used by the State program

Appendix 1 Self-Assessment Worksheet

The State program describes how equivalency is accomplished when it lacks authority to enforce the sections of the current FD&C Act and the parts of the CFR listed in the following tables and subsequent final rules.

For example, the State program may comply with standard number 1 either by identifying its equivalent State authorities or by describing how equivalency is attained through alternative procedures or agreements.

a. Federal Food, Drug, and Cosmetic Act (FD&C Act)

The State law must be equivalent in effect to the sections of the current FD&C Act. The language used does not have to be identical if the same outcome is achieved. If the provisions contained in the relevant sections of your food laws and codes are not the same as those contain the corresponding Federal citations, please identify the difference between the two.

Section Title State citation or alternate provision

Differences with Federal law

201 Definitions (f), (k), (m), and (ff)

301 Prohibited acts (a), (b), (c), (d), (e), (f), (k), and (v)

303* Penalties 304** Seizure 401 Definitions and standards for food 402 Adulterated food 403 Misbranded food (a)-(s) 413 New dietary ingredients 701 Regulations and hearings

703*** Records of interstate shipments 704 Factory inspection

*Penalties may vary from Federal statute.

**Seizure authority is not required under this standard. The agency, however, should have legal authority to stop adulterated and misbranded products from moving in commerce, for example, detention, stop-sale orders, and embargoes.

***This section covers records in interstate commerce. State law should include intrastate records.

b. Code of Federal Regulations (CFR)

The State regulation must be equivalent in effect to the sections listed in the current CFR. The language used does not have to be identical if the same outcome is achieved. States may have more stringent regulations unless preempted. If a specific version of the CFR is adopted, please provide the date of the CFR.

If the provisions contained in the relevant sections of your food regulations differ from the corresponding Federal citations found in the current CFR, please report the difference between the two. Differences between the CFR adopted by the State and the current CFR should be reported.

Part Title State citation or

Differences with Federal code

1 General enforcement regulations

(ONLY § 1.20-1.24)

Appendix 1

Part Title State citation or alternate provision

Differences with Federal code

7 Enforcement policy (ONLY § 7.1-7.13 and § 7.40-7.59)

70 Color additives (ONLY § 70.20- 70.25)

Listing of colors exempt from certification

(ONLY § 73.1- § 73.615)

Listing of color additives subject to certification

(ONLY § 74.101-706)

General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics

Listing of certified provisionally listed colors and specifications

(ONLY § 82.3- § 82.706)

100 General

(ONLY § 100.155)

101 Food labeling (EXCEPT § 101.69 and § 101.108)

Common or usual name for nonstandardized foods

(EXCEPT § 102.19)

104 Nutritional quality guidelines for foods

105 Foods for special dietary use

Infant formula quality control procedures

(EXCEPT § 106.120)

107 Infant formula

(EXCEPT § 107.200- § 107.280)

108 Emergency permit control

(ONLY § 108.25- § 108.35)

Unavoidable contaminants in food for human consumption and food-packaging materials

Current good manufacturing practice in manufacturing, packing, or holding human food

111 Current good manufacturing practice for dietary supplements