Sol__(004).doc

18-223-SOL-00019

SECTION B – SUPPLIES OR SERVICES AND PRICES/ COSTS

B-1 – Background and Objectives

In performing the work as described in Section C – Description/Specifications/Statement of Work, the contractor shall review and consider the following:

A. Background

This contract is designed to obtain State assistance in inspectional coverage of food establishments. The Food and Drug Administration (FDA) plays a key role in overseeing the nation’s food supply. It is responsible for the oversight of most foods involved in interstate commerce, with the major exceptions of meat and poultry. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA’s primary role in food safety is to inspect the conditions under which food is manufactured, processed, packed, distributed, or held.

States play a critical role in overseeing the nation’s food supply. State and local governments conduct most of inspections in the U.S., including food retailers, manufacturers, processors and distributors within their State boundaries in accordance with their own laws and authorities. Many of the food firms inspected by States may also fall under Federal jurisdiction if they are involved in interstate commerce. State food inspectors are generally in the field more frequently than FDA food inspectors and offer an important source of front-line experience and expertise.

This contract is designed to assist in creating a national food safety system that includes State Agencies at all levels of safety to minimize consumers’ exposure to adulterated and contaminated food. The Contractor shall conduct inspections of food establishments to determine compliance with the food provisions of the Federal FD&C Act and/or State laws.

B. Objectives

1. To obtain State and local assistance in the inspections of food establishments to determine compliance with the Federal FD&C Act, State law, or both;

2. To obtain State and local assistance in the collection of official follow-up samples as dictated by inspectional observations, inspection program, in support of enforcement actions, and risk;

3. To obtain State and local assistance for analytical support of samples collected using the Association of Official Analytical Chemists (AOAC) or FDA accepted methodology;

4. To obtain State and local reports of the inspections and sample collections as well as State and local reports on any compliance follow-ups and corrections achieved by the actions executed by the contractor under its own program.

B-2 – Compensation

A. The Contract Type is Firm Fixed Price.

B. As consideration for full performance of the work stated in Section C, “Scope of Work”, the Government shall pay the Contractor the not to exceed price of $_______. The Government shall have no obligation to make payment in excess of the ceiling price. The Government may increase the ceiling price of the contract. If this occurs, a bilateral contract modification will be required.

C. Payment Payment up to the full amount of this contract shall be contingent upon receipt and acceptance by the Government of inspection reports and proper invoices as required by Section F-2 “Reports/Deliverables” and Section G-3 “Invoice Submission,” and in accordance with the schedule in part E.

D. Training/Travel Training and domestic travel for training are not provided for in this contract. The Contractor is responsible for ensuring staff are trained in accordance with the State’s Training Plan as identified under the Manufactured Food Regulatory Program Standards (MFRPS) Standard 2, or equivalent requirements, in addition to meeting the training requirements specified in the contract.

E. Schedule Base Year, Total NTE Price $____________________________

Period of Performance: ____________ to _____________

Total

The Contractor shall propose to perform on the additional elective inspections that apply to their state as listed below:

PC Rules Inspections

Domestic and/Import Samples

*See page 42 of the RFP for description Select one:

Option 1: Inspection OOB/Visits are included as a separate line item in this contract. Visits/OOBs shall be reimbursed at the negotiated fixed unit price specified above.

The Contractor shall not perform nor will be paid for any OOB Inspections that exceed 20% of the total number of all inspections stated above, including all Elective Inspections. Note that the total number of inspections is an aggregate of all types of inspections and electives, excluding samples and the OEI Improvement elective.

Option 2: Inspection OOBs/Visits are excluded and not reimbursed under this contract. If this is selected the contractor shall not be reimbursed for any visits/OOBs conducted under this contract.

The Government reserves the right to bilaterally increase the number of Inspections as stated above.

Option Year 1, Total NTE Price $___________________________ Period of Performance: ____________ to _____________

Total

The Contractor shall propose to perform on the additional elective inspections that apply to their state as listed below:

Domestic and/Import Samples

Option 1: Inspection OOB/Visits are included as a separate line item in this contract. Visits/OOBs shall be reimbursed at the negotiated fixed unit price specified above.

The Contractor shall not perform nor will be paid for any OOB Inspections that exceed 20% of the total number of all inspections stated above, including all Elective Inspections. Note that the total number of inspections is an aggregate of all types of inspections and electives, excluding samples and the OEI Improvement elective.

Option 2: Inspection OOBs/Visits are excluded and not reimbursed under this contract. If this is selected the contractor shall not be reimbursed for any visits/OOBs conducted under this contract.

Option Year 2, Total NTE Price $____________________________ Period of Performance: ____________ to _____________

Total

The Contractor shall propose to perform on the additional elective inspections that apply to their state as listed below:

MFRPS

Each

Domestic and/Import Samples

Option 1: Inspection OOB/Visits are included as a separate line item in this contract. Visits/OOBs shall be reimbursed at the negotiated fixed unit price specified above.

The Contractor shall not perform nor will be paid for any OOB Inspections that exceed 20% of the total number of all inspections stated above, including all Elective Inspections. Note that the total number of inspections is an aggregate of all types of inspections and electives, excluding samples and the OEI Improvement elective.

Option 2: Inspection OOBs/Visits are excluded and not reimbursed under this contract. If this is selected the contractor shall not be reimbursed for any visits/OOBs conducted under this contract.

Option Year 3, Total NTE Price $____________________________ Period of Performance: ____________ to _____________

Total

The Contractor shall propose to perform on the additional elective inspections that apply to their state as listed below:

Audits

*See page 42 of the RFP for description

Sprout Inspections

Domestic and/Import Samples

Option 1: Inspection OOB/Visits are included as a separate line item in this contract. Visits/OOBs shall be reimbursed at the negotiated fixed unit price specified above.

The Contractor shall not perform nor will be paid for any OOB Inspections that exceed 20% of the total number of all inspections stated above, including all Elective Inspections. Note that the total number of inspections is an aggregate of all types of inspections and electives, excluding samples and the OEI Improvement elective.

Option 2: Inspection OOBs/Visits are excluded and not reimbursed under this contract. If this is selected the contractor shall not be reimbursed for any visits/OOBs conducted under this contract.

Option Year 4, Total NTE Price $______________________________ Period of Performance: ____________ to _____________

Total

The Contractor shall propose to perform on the additional elective inspections that apply to their state as listed below:

Domestic and/Import Samples

Option 1: Inspection OOB/Visits are included as a separate line item in this contract. Visits/OOBs shall be reimbursed at the negotiated fixed unit price specified above.

The Contractor shall not perform nor will be paid for any OOB Inspections that exceed 20% of the total number of all inspections stated above, including all Elective Inspections. Note that the total number of inspections is an aggregate of all types of inspections and electives, excluding samples and the OEI Improvement elective.

Option 2: Inspection OOBs/Visits are excluded and not reimbursed under this contract. If this is selected the contractor shall not be reimbursed for any visits/OOBs conducted under this contract.

SECTION C – DESCRIPTION/ SPECIFICATIONS/ STATEMENT OF WORK

Scope of Work Independently, and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, except as provided in the schedule, and otherwise do all things necessary for or incidental to the performance of the work.

The Contractor shall conduct establishment inspections, consisting of initial inspections, necessary re-inspections (as assigned by the District), visits, and other work as assigned by the District as needed. The Contractor shall also conduct follow-up to any open consumer complaints associated with the firm unless otherwise directed by the District. In limited situations, the District may request immediate follow-up at a firm due to a consumer complaint, verification of corrective actions, or investigation of other significant public health and regulatory issues.

The Contractor’s establishment inspections shall comply with the General Requirements for Conducting Inspections (a. General Requirements for Conducting Inspections, of this document). The Contractor shall ensure staff is trained in accordance with the State’s Training Plan as identified under the Manufactured Food Regulatory Program Standards (MFRPS) Standard 2, or equivalent requirements, in addition to meeting the training requirements specified in the contract. The State and District will agree upon the specific requirements for conducting and reporting inspections and other work performed as part of the work planning meeting. The Contractor may refer to the Investigations Operations Manual 2017 (or most recent version when notified by FDA), Chapter 5 – Establishment Inspections (specifically, Sections 5.3.6, 5.4, and 5.10.4.3) for guidance on conducting inspections, collecting evidence, and writing Establishment Inspection Reports (EIRs) (http://www.fda.gov/ICECI/Inspections/IOM/default.htm).

The inspections can be accomplished under the authority of the State's law and the inspector’s State credentials if the contracting State has adopted all applicable sections of Title 21 of the Code of Federal Regulations (CFR) or can demonstrate equivalent State requirements. A legal review should be conducted by the State agency’s counsel to determine if the State regulatory requirements are equivalent in effect to the current Federal requirements. It is the responsibility of the Contractor to determine whether the State regulatory requirements are equivalent to the Federal requirements.

If the contracting State has not adopted all applicable sections of Title 21 of the CFR or demonstrated equivalent State requirements, the Contractor shall conduct inspections under this contract using State officials who have been commissioned and credentialed as officers of the Department of Health and Human Services (DHHS), FDA, as set forth in section 704(a)(1) of the Federal FD&C Act. Commissioned officials will use current credentials and use FDA forms as necessary during an inspection.

The Contractor shall discuss and verify compliance with the above delineated regulatory authority requirements with the District prior to commencing contract inspection work.

The Contractor will place major inspectional emphasis upon determining significant violations to the Food Good Manufacturing Practices (GMPs), unsanitary conditions, and practices that may render the food adulterated or injurious to health. During inspections of assigned firms, practices and conditions that involve the introduction, lack of controls, and/or growth promotion of pathogenic organisms or other conditions that may result in the food becoming filthy, putrid, decomposed, or contaminated with foreign objects shall be determined and documented.

Compliance with federal law, such as the “Public Health Security and Bioterrorism Preparedness and Response Act of 2002;” the Federal FD&C Act, Section 402(a)(3) and (4); Federal Regulations, e.g. the GMP Regulations (21 CFR 110); modernized cGMP and Risk-Based Preventive Controls (21 CFR 117) or Section 10(a)(3) and (4) of the Uniform State Food, Drug and Cosmetic Bill; or equivalent State GMPs will be determined. Where applicable, use the Hazard Analysis and Critical Control Point (HACCP) concept to evaluate a firm's quality assurance program and its operations.

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. FSMA enables FDA to focus more on prevention of food safety problems, provides new enforcement tools, and encourages partnerships with States, locals, territories, and tribes. One of the foundational rules for FSMA implementation is the Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Human Food (21 CFR Part 117, also abbreviated as the Human Food PC Rule). The Human Food PC Rule became final in September 2015 with compliance dates for some firms in September 2016. All firms are required to comply with the Human Food PC Rule by September 2018.

Inspectors must complete the 21 CFR 117 Modernized Good Manufacturing Practice (GMP) Inspections Webinar, FD8000L, found in Pathlore prior to conducting modernized cGMP inspections. Modernized cGMP inspections are also referred to as limited scope PC rule inspections. Refer to Attachment 6 for instructions on accessing the course in Pathlore. This webinar provides introductory overview of some of the subparts of the new 21 CFR 117 Modernized Good Manufacturing Practice (GMP) Inspections. This is also pre-work for the classroom training for food safety staff to support for overseeing industry compliance with the PC rules through inspection and compliance activities.

In addition, the contractor shall conduct establishment inspections based on the plans and requirements established during the Work Planning Sessions (a. General Requirements for Conducting Inspections, No. 5 of this document). Inspections may also be assigned outside of the workplanning meeting in follow-up to a recall (typically Class I), consumer complaint, or Reportable Food Registry (RFR); a violative inspection; confirm corrective actions have been completed; or to address other regulatory or public health concerns. These types of follow-up inspections can be billed under the appropriate inspection type.

The Establishment Inspection Report (EIR) and form FDA 483 (Inspectional Observations), or equivalent forms, shall detail the conditions found by the Contractor with sufficient narrative and evidence to enable an FDA assessment of the significance of any objectionable conditions or practices. Where microbiologically oriented inspections are conducted, a more detailed description of the manufacturing process, routes of contamination, etc., shall also be made. The Contractor shall record the corrective actions taken by the firm in response to identified significant violations, including the firm’s response to the Contractor, in the summary section of the inspection report and Electronic State Access to Facts (eSAF) (or other FDA-approved systems, such as the National Food Safety Data Exchange (NFSDX)).

All information collected during the performance of this contract shall be considered as confidential commercial information, including the Establishment Inspection Report (EIR), FDA 483, or equivalent forms, evidence collected, and all other supporting documentation. Evidence and supporting documentation may include supplier, receiving, and distribution records, photographs, complaint records, laboratory results, and other documents collected during the performance of the contract. The Contractor shall notify the District within three (3) business days after receipt of a public records request for information obtained during the performance of the contract is received. The Contractor is not authorized to release confidential commercial information. Refer to Section H – Special Contract Requirements for additional requirements for maintaining confidential commercial information.

a. Elective Work (Refer to Detailed Tasks, Part b. Electives)

· Seafood HACCP Inspections

· Juice HACCP Inspections

· Acidified/Low-Acid Canned Food Inspections

· Samples

· Import Products

· Environmental Sampling

· Domestic/Import Samples

· Audit Program

· Manufactured Food Regulatory Program Standards (MFRPS)

· Investigations – Official Establishment Inventory (OEI) and Direct Recall Audit Checks (RACs)

· Preventive Control (PC) Rules Inspections

· Sprout Inspections

b. Training (Refer to Detailed Tasks, Part c. Training)

Detailed Tasks

a. General Requirements for Conducting Inspections The contractor shall comply with the following requirements when conducting inspections under this contract:

1. BioTerrorism Act of 2002

i. Food Defense Security Preventive Measure Guidance

During the inspection, the contractor should determine if the facility is aware of food defense security preventive measures. If the facility is not aware of these measures, the inspector should facilitate an exchange of information to heighten awareness of the subject of food defense. Inform the establishment management of the appropriate security preventive guidance or provide information on how to obtain the guidance from FDA. Guidance related to Food Defense and Emergency Response efforts are available on FDA/CFSAN’s web site: http://www.fda.gov/Food/FoodDefense/default.htm

ii. Registration

As assigned by the District Office, the contractor shall make sure that the firm’s management is aware of the BioTerrorism Act (BT Act) registration requirements and any updates to that information. The firm’s management shall also be informed that information regarding food security, the BT Act, facility registration, required and optional information, definitions, exemptions, and penalties for failure to register, etc., is available at the following website: http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.htm All food facilities that are required to register with FDA under section 415 of the Federal FD&C Act must renew their registrations with FDA biennially. The contractor shall inform the firm that changes to the BT Act require food facilities to submit registrations to FDA containing information previously considered optional.

Additional information regarding Registration Renewal may be found at: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm314178.htm#new .

The FDA Unified Registration and Listing System (FURLS) was built to register all domestic and foreign facilities that export food to the U.S. electronically. Contractors shall establish user accounts for at least two (2) key personnel in the FDA Unified Registration and Listing Systems (FURLS) within the first 60 calendar days of the contract period of performance. Key personnel should have direct responsibility for meeting the obligations of the contract. Contractors are required to access FURLS to determine the registration status of the firm prior to conducting an inspection.

For facilities that are required to register, but have not yet done so, the contractor shall encourage electronic registration at the following website: https://www.access.fda.gov/

iii. Documentation

The fact that the discussion regarding the firm’s security measures took place and, if applicable, guidance documents were provided should be recorded in the Summary section of the inspection report. The details of inspectional findings regarding security should NOT be recorded.

The contractor shall document the registration status of the firm and registrations discussions with firm management in the “Summary of Findings and Discussion with Management” sections in their inspection report. Observations about failure to register or implement food defense measures are NOT to be placed on the FDA 483 or equivalent form. If a facility is not registered and they do not intend to register, the contractor is to notify the local FDA District office.

2. Preventive Controls for Human Food and Other Finalized Rules under the Food Safety Modernization Act (FSMA) of 2011

i. The FDA FSMA Preventive Controls for Human Food rule became final on September 10, 2015. The compliances dates are staggered with compliance dates for some firms beginning in September 2016. The new rule requires that food facilities have safety plans that set forth how they will identify and minimize hazards. Requiring preventive measures at facilities that produce human food is an important step in reducing foodborne illness.

To assist FDA in communicating the Preventive Controls rule, the contractor shall print and hand out or provide electronically the attached FSMA Facts Final Rule on Preventive Controls for Human Food Information Sheet (or most recent version when notified by FDA) to the most responsible individual at the inspected establishment during the opening meeting. The information sheet (Attachment 7 or most recent version when notified by FDA) provides the key requirements and compliance dates.

ii. The goal of the Sanitary Transportation of Human and Animal Food rule under FSMA is to prevent practices that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles, and failure to properly protect food during transportation. Specifically, the rule establishes requirements for vehicles and transportation equipment, transportation operations, information exchange, training, records, and waivers.

To assist FDA in communicating the rule on Sanitary Transportation of Human and Animal Food under FSMA, the contractor shall print and hand out or provide electronically the attached FSMA Facts Proposed Rule on Sanitary Transportation of Human and Animal Food Fact Sheet (Attachment 8 or most recent version when notified by FDA) to the most responsible individual at the inspected establishment during the opening meeting. The information sheet provides the key requirements and compliance dates.

iii. The FDA FSMA rule on Mitigation Strategies to Protect Food Against Intentional Adulteration requires the covered facilities to conduct a vulnerability assessment and create a written food defense plan to address significant vulnerabilities in a food operation. The rule aims to prevent acts on the food supply intended to cause wide-scale public harm. The rule has staggered compliance dates based on business size.

To assist FDA in communicating the final rule and its requirements, the contractor shall print and hand out or provide electronically the attached rule fact sheet (Attachment 9 or most recent version when notified by FDA) to the most responsible individual at the inspected establishment during the inspection. The fact sheet provides information on key requirements, exemptions, and compliance dates.

iv. Final Rule on Foreign Supplier Verification Programs (FSVP)

The FDA FSMA Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates began May 30, 2017. The final rule requires that importers perform certain risk-based activities to verify that food imported into the US has been produced in a matter to meet applicable US food safety standards.

To assist FDA in communicating the final rule and its requirements, the contractor shall print and hand out or provide electronically the attached rule fact sheet (Attachment 29 or most recent version when notified by FDA) to the most responsible individual at the inspected establishment during the inspection. The fact sheet provides information on key requirements and exemptions.

v. Documentation

The contractor shall document if the Preventive Controls Rule, Sanitary Transportation of Human and Animal Food Rule, Protecting Food Against Intentional Adulteration Rule, and FSVP Rule Fact Sheets were provided to the firm as part of the EIR and in eSAF (or other FDA-approved systems, such as NFSDX).

3. Inspection Priorities

The establishments available for inspection by the contractor are those that come under the jurisdiction of both the Contractor and FDA and are considered an inspection priority by FDA. FDA may add firms to the Official Establishment Inventory (OEI) during work planning sessions (reference No 5. below), or as needed.

Shellfish establishments which are a State inspection responsibility only under the National Shellfish Sanitation Program are not eligible for coverage under this contract. Grade A milk facilities where only Grade A products are produced under the Interstate Milk Shippers Program are not eligible for coverage under this contract. In addition, firms that solely engage in the manufacture and distribution of Dietary Supplements are not covered under this contract.

Inspection of firms is to be consistent with Agency objective of reducing foodborne outbreaks by determining compliance with various regulations that cover potentially high risk products, such as unpasteurized juices, non-Grade A dairy products, and egg containing products, where the contractor has jurisdiction over those establishments. However, inspection assignments will include a mix of both High Risk and Non-High Risk establishments. The contractor shall have the contractual obligation to perform each type of inspection selected and assigned during workplanning. The contractor shall ensure that the inspection is performed by personnel that have completed the necessary training requirements.

The firm must be operational and in production during the inspection unless otherwise approved by the District. Examples of exceptions that may be approved by the District and billed as an inspection include:

· Responding to a consumer complaint or recall (typically Class I)

· Reportable Food Registry (RFR) follow-up

· Verification of deficiency letter responses and corrective actions taken by a firm

· Verification of corrective actions following an inspection with egregious or significant violations

· Other inspections of regulatory or public health significance

Prioritization and assignment of establishments by FDA for coverage under the contract will result from the Work Planning Session (reference No. 6 below) and take into consideration the following priorities from FDA Compliance Programs:

The greatest inspection priority is placed on “High Risk” firms, Performance Goals (PGs), and meeting mandatory inspection frequency mandates established by FSMA as identified by the FDA District Office. To meet FDA mandated inspection frequencies, assignments will include a “cover-by” date. The State shall complete the inspection by the cover-by date.

High risk firms are identified utilizing a decision-making process based on the risk factors identified in section 421(a)(1) of the Federal FD&C Act (http://www.fda.gov/food/guidanceregulation/fsma/ucm295345.htm).

i. Firms classified OAI, one or more times during the past three (3) years. Also, firms with a pattern and history of violations or other items of regulatory concern over this time period, whether or not inspections were classified as OAI.

ii. Firms that could have potential problems or which produce a product with a history of known or potential health hazards, such as Class I recalls or outbreaks. Potential problems may be discovered using District and State intelligence information (e.g., past inspections, industry information, consumer complaints, news reports, etc.). Examples of such firms are the producers of:

· cream filled baked goods,

· ice cream,

· soft cheeses, which comprise soft fresh, soft ripened, soft unripened cheeses,

· other items which receive little or no further processing before consumption by the consumer (e.g., ready-to-eat, heat & serve),

· products in which time/temperature problems could occur (e.g., commodities which support microbial growth when abused), and

· fish and fishery products manufacturers

iii. In addition to the GMP and other relevant regulations, inspections of certain food processors shall be conducted in accordance with the following guidelines:

· Domestic Fish and Fishery Products Inspection Program (Seafood Hazard Analysis and Critical Control Points (HACCP) shall be performed in accordance with CPGM 7303.842 (Attachment 10).

· Juice HACCP inspections shall be performed in accordance with CPGM 7303.84 7 (Attachment 11).

· Domestic Acidified (AF) and Low-Acid Canned foods (LACF) Inspections shall be performed in accordance with CPGM 7303.803A (Attachment 12).

iv. Firms selected because of the violative history of the firm or overall industry.

v. Firms never inspected by FDA or never inspected under the Food Safety Program should be given precedence over firms previously inspected or inspected under the Food Safety Program and classified as No Action Indicated (NAI).

vi. Warehouse establishments considered “high risk”; ones that have had previous violative inspections; consumer complaints; new establishments; or have not been inspected in the past 5 years.

4. Work Planning Sessions

An annual work planning session(s) between the appropriate FDA District Office and State contractor personnel shall occur no later than thirty (30) business days after the start of the contract period of performance. The District Technical Advisor will draft the work planning session(s) minutes for review by the State within thirty (30) business days. Corrections must be agreed upon by both the State and District. The goals of the session(s) are to:

i. Coordinate an inspection schedule that will avoid duplication of inspections and ensure that the work obligated on the contract is aligned with anticipated work assignments.

For contracts with periods of performance that start on or before September 1:

· A minimum of twenty (20%) of the assignments required to meet the contract obligation will be made during the workplanning session.

· All remaining assignments will be issued by the start of the 2nd quarter of the contract period of performance.

· At the discretion of the State and District, an additional workplanning meeting may be necessary.

For contracts with periods of performance that begin after September 1, all assignments required to meet the contract obligation will be assigned during the workplanning meeting.

ii. Develop a consensus of the priority in the selection of firms to inspect. Firms with the highest priority for inspection should be agreed upon. Discuss and select firms for environmental sampling, if selected as an option.

iii. To meet FDA mandated inspection frequencies, assignments may include a cover-by date. The inspection shall be completed by the cover-by date.

iv. Discuss types of follow-up inspections that may be assigned outside of the workplanning session and expectations. For example, follow-up to a recall, RFR, or consumer complaint or verification of corrective actions taken by a firm.

v. Discuss and ensure clarity in regards to the definition of a “visit” per the contract, criteria for considering a firm “OOB” or out of business, and reporting requirements.

vi. Review FDA and State firm inventories for the identification of new firms and updating firm information, such as operational status, products being manufactured or stored, distribution of products, name, address, etc. In addition, the FDA will provide the Firm Establishment Identification (FEI) numbers for all firms on the inspection schedule.

vii. Develop an audit schedule when assigning the firms to be inspected under contract. Firm selection should be based on the inspection priorities listed in the “Statement of Work” section of the contract and contractual obligation of the contractor, including the current audit phase.

viii. Confirm that State regulatory authorities are equivalent to Federal requirements, or the State officials are commissioned.

ix. Review the utilization of eSAF (or other FDA-approved systems, such as NFSDX) and data entry requirements.

x. Establish and exchange primary contact information. Along with program management, it is recommended that senior management from the State and District are also part of the process.

xi. Confirm understanding of key contract deliverables and schedules. The requirements and critical elements of the reporting requirements for establishment inspections and other work will be agreed upon by the State and District. Target completion goals for meeting the contract obligation in established limits shall be also agreed upon by the State and District. Examples of target completion goals are completion of a specified percentage or firms that must be inspected by an agreed upon date. The target completion goals should consider the availability of the firms for inspection (such as seasonal firms), District performance goals, and State resources.

xii. Confirm training requirements are met by State officials to perform inspections, audits, and other work obligated under the contract.

xiii. Determine appropriate samples to be collected under contract, if selected as an option.

xiv. Discuss the corrective action plan requirement and triggers for submitting a corrective action plan.

xv. Discuss training needs, sharing of resources, and other collaborative efforts.

A minimum of one additional meeting shall be held with the District and State during the second or third quarter of the contract performance period to review the progress of the State and verify the contract deliverables are being satisfactorily met.

5. Frequency of Inspection

The inspections conducted under this contract shall be scheduled in accordance with the provisions of the FDA Compliance Programs referenced below in the section titled “Compliance Documents” and any other relevant guidance.

The FSMA establishes a mandated inspection frequency, based on risk, for food facilities. High-risk (HR) facilities must be inspected once every 3 years. Non-high-risk (NHR) facilities must be inspected once every 5 years. These inspection frequencies are minimums and some firms may be inspected on a more frequent basis at the discretion of the District.

In addition, firms with an assigned “cover-by” dates shall be inspected by the date specified. The District and State will confirm the firm assignments and priorities for completion during the workplanning session.

A complete inspection requires the firm to be operational and in production unless approved by the District. If a complete inspection cannot be performed due to the firm not being operational or in production, then a visit should be charged. The Contractor is strongly encouraged to use electronic resources (such as licensing, Secretary of State records, and Internet research) to verify the firm’s operational status prior to conducting a physical on-site visit. The Contractor is encouraged to communicate concerns about the firm’s operational status with the District prior to conducting the inspection.

HR firms are identified based on the risk factors identified in section 421(a)(1) of the FD&C Act. Each District has access to the Official Establishment Inventory (OEI).

i. Inspections for cause may be scheduled more frequently than described above, e.g., follow-up to a consumer complaint or reinspection as assigned by the District.

ii. An Inspection Visit is defined as when an inspection is attempted as assigned by the District and the establishment is found to be: “Out of Business” (OOB), not an official establishment (NOE) as defined by FDA, not subject to coverage under the food contract, relocated outside of the contractor’s geographical jurisdiction, or when a complete inspection cannot be accomplished during the contract period of performance for unforeseen circumstances. Investigational contractor activities completed under the Investigative elective are not considered a visit, even if the result is a finding of OOB or NOE.

A visit shall be documented by providing the District with an establishment inspection report or other form as directed by the District. The report shall document all efforts made by the Contractor to conduct a full inspection and research performed to verify the operational status, location, and activities of the firm. The Contractor should request a replacement assignment or inspection within twenty (20) business days of a visit being encountered, if necessary.

OOB is defined as a firm that is no longer in business for reasons other than having moved. Reasonable efforts to verify a firm is OOB shall include a physical visit and at least one additional verification step. Options include: 1. Verification with the local post office that the firm no longer receives mail at the address and does not have a forwarding address. 2. Verification of the suspension or dissolution of the corporate entity with the applicable State. 3. Interview of representatives of neighboring establishments, current tenants at the indicated address, or others (such as real estate agents) who may have knowledge of the disposition of the firm’s operations at the location.

The contractor shall perform similar reasonable efforts to locate firms that have moved or relocated. If a firm has relocated to a new location within the contractor’s geographical jurisdiction, a complete inspection shall be conducted at the new location. Payment for the inspection at the new location will be made. A visit, in addition to the inspection, may be charged if the firm has moved more than 50 miles. If a firm has relocated to a new location out of the contractor’s jurisdiction, a visit may be charged.

NOE is defined as an establishment that is no longer manipulates product or is engaged in activities subject to FDA regulation, but remains in business. The activities performed by an NOE firm shall be fully documented in the report to allow for a correct determination of the firm’s status by FDA. Additional guidance is found in Field Management Directive (FMD)-130 OEI Development and Maintenance Procedures (Date Revised July 17, 2006), http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096034.htm

Due to errors in the FDA inventory, firms that are not subject to contract inspection may still engage in activities under FDA jurisdiction. While the firm may not be considered OOB or NOE by FDA, the contractor may charge for a visit if the firm is determined by the District to not be eligible for inspection under the contract.

Reasonable efforts to conduct a complete inspection must be approved by the District.

iii. Joint inspections with FDA personnel to achieve nationwide uniformity, training, evaluation, and audits should be planned and included within the inspections to be accomplished by the Contractor.

iv. Compliance actions are not provided for under this contract. However, it is anticipated the Contractor will vigorously pursue any necessary compliance follow-up to violative conditions encountered during inspections made under this contract under State authorities. Such actions may include embargo, stop-sales, administrative plant closures or orders, civil penalties, warnings, license revocations, court actions, etc. The contractor shall notify and coordinate such State actions with the FDA District. Where appropriate correction has not been achieved by the Contractor, FDA may initiate compliance actions under the Federal FD&C Act.

v. If an inspection conducted under contract results in a final District classification of OAI, and is supported by violations that are “materially related to food safety,” the State will be notified by the District. Any re-inspections of the firm will be conducted by the FDA District office.

6. Compliance Documents

The activities under the contract shall be conducted using procedures, techniques, and reporting forms equivalent to FDA or as required by State law. The contract inspections shall be conducted in accordance with the applicable sections of the following current FDA Compliance Programs and/or any other documents including assignments issued by FDA. FDA offices will provide technical guidance or any necessary documents to the Contractor.

i. Reference Documents

The following food compliance programs are incorporated by reference as guidance for the conduct of contract inspections. FDA will furnish updated copies to the Contractor where appropriate.

· Domestic Food Safety Program (CPGM 7303.803), Program Assignment Code (PAC) 03S001 (Attachment 13).

· Domestic Fish and Fishery Inspection Program (CPGM 7303.842), PAC 03S002 (Attachment 10).

· Juice HACCP Compliance Program (CPGM 7303.847), PAC 03S004 (Attachment 11).

· Domestic Acidified and Low-Acid Canned Foods (CPGM 7303.803A), PAC 03S005 (Attachment 12).

· Domestic and Imported Cheese & Cheese Products Program (CPGM 7303.037), Assigned under PAC 03S001 (Attachment 14).

· Domestic and Import NLEA, Nutrient Sampling and Analysis, and General Food Labeling Program (CPGM 7321.005), Assigned under PAC 03S003 (Attachment 15). http://www.fda.gov/Food/ComplianceEnforcement/FoodCompliancePrograms/ucm238066.htm

ii. Bottled Water Plants

Bottled water plants shall be inspected to determine compliance with the bottled water GMP regulation, 21 CFR 129, which includes testing requirements. If indicated by inspectional observations, one finished product sample may be collected to determine compliance with the standard of identity and quality for bottled water in 21 CFR 165.110 (formerly 103.35; See FEDERAL REGISTER 60 57076-57130, Effective date: May 13, 1996). If a sample is collected, contractor shall analyze the sample for: microbiological quality, benzene and chloroform via a screen for volatile organic compounds, and for the heavy metals lead, cadmium, mercury, and arsenic. The Contractor shall submit Sample Reports upon final results determination to the FDA District Office and enter the results into eLEXNET.

iii. Additives and Allergens

Other factors which could affect the safety of a food product should also be covered. During an inspection of a food manufacturer, the use of color additives, food additives, and food allergens shall be determined and reported in accordance with compliance programs required herein. The Contractor shall focus on the specific additives identified in the Domestic Food Safety Compliance Program Guidance Manual (CPGM) 7303.803.

iv. Nutrition Labeling

Nutrition labeling is required in 21 CFR 101.9 for all food products offered for sale, except for exempt foods under 21 CFR 101.9(j). On May 20, 2016, the FDA announced the new Nutrition Facts label for packaged foods, which includes updates to the required nutrient declarations, serving sizes, and formatting requirements.

For more information on the new requirements, please visit: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm https://www.fda.gov/Food/ComplianceEnforcement/FoodCompliancePrograms/ucm238066.htm.

Manufacturers may begin revising labels now to meet the new requirements or they may continue to follow existing requirements. However, firms should not use labels which mix the old and new format (hybrid labels). During contract inspections of manufacturers, labelers, or re-labelers, States shall review labels being used to determine if they comply with the old or new nutrition labeling regulations. The inspections shall also include the determination and reporting on the exempt status of the firm or labels, and whether the products are shipped in interstate commerce.

The label review shall be conducted in accordance with the current Compliance Program and the current Guidelines for State Coverage of NLEA Under Food Inspection Contracts, included as Attachment 1 (or most recent version after notified by FDA).

When the District Technical Advisor determines the Contractor is accurately identifying the violations emphasized in the assignment/program, submission of non-violative labels will not be required. The Contractor shall collect and submit to the District interstate documentation for all violative labels. Three (3) copies or photos of violative labels shall be collected along with any other supporting evidence for the violations referenced in the report.

All follow-up action, including regulatory actions, shall be coordinated with the appropriate FDA District Office unless an immediate public health risk exists.

v. Listeria

The Contractor shall perform inspections in accordance with the FDA published draft guidance entitled ``Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods, February 2008” (Attachment 16). This draft guidance complements FDA's current good manufacturing practices (CGMP) regulations by providing specific guidance on the control of Listeria monocytogenes in the processing of refrigerated or frozen ready-to-eat foods (RF-RTE foods). The draft Listeria guidance and the CGMP regulations are intended to assist processors in controlling Listeria monocytogenes in the food processing environment during the manufacture of RF-RTE foods.

7. Quality Control/ Performance Standards

FDA will evaluate the Contractor’s overall performance throughout the contract period. This will be accomplished by a variety of techniques. Inspectional performance evaluation will include review of inspection reports, audits, and joint inspections conducted as contract inspections. Such inspections will be scheduled by the FDA District Office in concert with the Contractor. For comprehensive information regarding the FDA Audit Program, refer to Field Management Directive (FMD)-76 State Contracts – Evaluation of Inspectional Performance (Attachment 17, or most recent version when notified by FDA).

i. Analytical Support Evaluation

Analytical support evaluation will include, where appropriate: review of sample reports, joint bench work in FDA or State laboratories, on-site review of State laboratory facilities and equipment, and participation in split sample programs, wherein microbiological and microanalytical (filth) split samples will be analyzed by State laboratories supporting contract inspections. These split samples will be a part of the FDA-State Laboratory Quality Assurance Programs.

ii. Inspector Performance Audit Standard

All contractor inspectors shall be audited at the frequency described in the most recent version of FMD-76.

iii. Inspector Performance Measurement

All contractor inspectors shall successfully pass audit requirements with an acceptable rating. For audit requirements, refer to the most recent version of FMD-76.

iv. Inspector (Individual) Performance Deficiencies and Correction The District or State agency shall document and correct inspector (individual) performance deficiencies as described in the most recent version of FMD-76, including the completion of a Corrective Action Plan for Program and Individual Performance Deficiencies (Appendix J of FMD-76). All contractor inspectors who receive an overall score of “needs improvement” shall receive remedial training in deficient areas as agreed upon by the District and State program.