2016_Food_Solicitation.doc

FDA-16-FOOD

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 the majority 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 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 $_____ for food Inspections, $_____ for Visits/Out of Business (OOB’s), $___ Seafood HACCP, $____Juice HACCP, $____LACF, $_____Samples,$____ Imported Food Products, $_____ Preventive Control (PC) Inspections, $_____ Environmental Sampling,$_____ Audit Program Phase II, $_____Audit Program Phase III, $____, Manufactured Food Regulatory Programs Standards (MFRPS), $___Domestic and Import Samples, $____Official Establishment Inventory (OEI) Improvement, for a total contract amount of $__________ .

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.

E. Schedule Base Year Period of Performance: ____________ to _____________

Food Inspections

Visits/Out of Business

Total

Elective Work

Seafood HACCP Inspections

Juice HACCP Inspections

LACF Inspections

Samples

Imported Food Products

Environmental Sampling

Audit Program Phase II

Audit Program Phase III

MFRPS

OEI Improvement

PC Rules Inspections

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

Period of Performance: ____________ to _____________

Basic Work

Food Inspections

Visits/Out of Business

Total

Elective Work

Seafood HACCP Inspections

Juice HACCP Inspections

LACF Inspections

Samples

Imported Food Products

Environmental Sampling

Audit Program Phase II

Audit Program Phase III

MFRPS

OEI Improvement

PC Rules Inspections

Select one:

Option 1: Inspection OOBs/Visits are included as a separate line item in this contract. OOBs/Visits 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.

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 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 2015 (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/downloads/ICECI/Inspections/IOM/UCM150576.pdf).

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 (GMP), 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); 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 year-round 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 Preventative Controls for Human Food (21 CFR Part 117, also abbreviated as the Human PC Rule). The Human PC Rule became final in September 2015 with compliance dates for some firms in September 2016. As discussed in the PC Rules Inspections elective, inspectional assignments for firms subject to the Human PC Rules may be made available. We strongly encourage States to take advantage of training (web-based, classroom, and joint inspections) related to the Human PC Rules in preparation for future contract opportunities.

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).

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 eSAF.

All information collected during the performance of this contract shall be considered to be 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)

· Official Establishment Inventory (OEI) Improvement Elective

· PC Rules 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. User Fee Requirements under the Food Safety Modernization Act of 2011

i. Information Sheet – Assessment of Reinspection and Recall User Fees by the FDA The Food Safety Modernization Act (FSMA), signed into law January 2011, authorized FDA to collect new user fees for specific domestic and foreign food re-inspections. FSMA authorizes FDA to assess and collect user fees to capture 100% of the costs related to certain domestic and foreign food facility re-inspections. The user fee for re-inspection is to cover re-inspection-related costs when the initial inspection, initiated on or after October 1, 2011, has a final Official Action Indicated (OAI) classification supported by “violations materially related to food safety requirements.” The re-inspection must be conducted specifically to determine whether compliance has been achieved.

To assist FDA in communicating the User Fee requirement to industry, the contractor shall print and hand out the attached FSMA User Fee 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 provides the statutory authority granted to FDA by FSMA to collect user fees for re-inspections, who will be assessed user fees and the rates (Attachment 6, or most recent version when notified by FDA).

ii. Documentation

The contractor shall document that the user fee information sheet was provided to the firm in the summary section of the inspection report.

2. BioTerrorism Act of 2002

i. Food Defense Security Preventative Measure Guidance

During the inspection, the contractor should determine if the facility is aware of food defense security preventative 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 must establish at 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 as of 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.

3. Preventative Controls for Human Food and Other Proposed Rules under the Food Safety Modernization Act (FSMA) of 2011

i. The FDA FSMA Preventative Controls for Human Food rule became final on September 10, 2015. The compliances dates are staggered over the next several years 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 Preventative Controls rule, the contractor shall print and hand out 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) provides the key requirements and compliance dates.

ii. The goal of the proposed rule on Sanitary Transportation of Human and Animal Food 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 proposed rule would establish requirements for vehicles and transportation equipment, transportation operations, information exchange, training, records, and waivers.

To assist FDA in communicating the proposed rule on Sanitary Transportation of Human and Animal Food under FSMA, the contractor is encouraged to print and hand out 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. FDA’s proposed rule on Protecting Food against Intentional Contamination, which is required by FSMA, would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation. The proposed rule would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm. FDA is proposing a tiered compliance dates based on facility size.

To assist FDA in communicating the proposed rule, the contractor is encouraged to print and hand out the attached FSMA Facts Proposed Rule on Protecting Food against Intentional Contamination (Attachment 9 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.

iv. Documentation

The contractor shall document if the Preventative Controls Rule, Proposed Rule on Sanitary Transportation of Human and Animal Food, and Proposed Rule on Protecting Food against Intentional Contamination Fact Sheets were provided to the firm as part of the EIR and in eSAF.

4. Assistance with Creating FDA’s Outreach Strategy for the Preventive Control Rules

i. Outreach strategy As FDA prepares to implement additional sections of FDA, specifically the Preventative Control Rules, baseline information on industry knowledge is being obtained. FDA is also further defining our Official Establishment Inventory (OEI) to determine compliance dates based on corporate firm size. The information obtained during inspections will help to target FDA’s outreach efforts.

ii. Documentation

The contractor shall include the following information as part of the establishment inspection report (EIR) and in eSAF:

A. Facility information

1. FEI number

2. Firm legal name

3. DUNS number

4. Firm physical address

5. Mailing address (if different from firm address)

6. Number of employees at the firm

7. Gross annual food sales

B. Corporate information (if applicable)

1. Name of corporate entity

2. Corporate address

3. Number of employees in corporation

4. Corporate gross annual food sales

5. Applicable human food industry types and product code information

C. GMP/Preventative Controls

1. Firm has Good Manufacturing Practices (GMPs) in place

2. Firm has a written Food Safety Plan

3. Firm has conducted a Hazard Analysis

4. Firm has an environmental monitoring program

5. Firm has a recall plan

6. Firm is an importer

5. 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 an 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 any 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 include:

· Responding to a consumer complaint or recall

· Reportable Food Registry (RFR) follow-up

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

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. 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. Potential problems may be discovered through the use of 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, or most recent version when notified by FDA).

· Juice HACCP inspections must be performed in accordance with CPGM 7303.84 7 (Attachment 11, or most recent version when notified by FDA).

· Domestic Acidified (AF) and Low-Acid Canned foods (LACF) Inspections shall be performed in accordance with CPGM 7303.803A (Attachment 12, or most recent version when notified by FDA).

iv. Firms selected on the basis of the violative history of the 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.

6. 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 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. 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.

iv. 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.

v. 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.

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

vii. Review the utilization of eSAF and data entry requirements.

viii. 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.

ix. 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 take into account the availability of the firms for inspection (such as seasonal firms), District performance goals, and State resources.

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

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

xii. 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.

7. 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 and requires the frequency of inspection to increase immediately. High-risk (HR) facilities must be inspected at least once in the first 5 years following enactment of FSMA and then once every 3 years thereafter. Non-high-risk (NHR) facilities must be inspected at least once in the first 7 years following enactment and then once every 5 years thereafter. These inspection frequencies are minimums and some firms may be inspected on a more frequent basis at the discretion of the District.

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.

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 OEI Improvement 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 a combination of contacting the local US Postal Service for a forwarding address, records research, talking with neighboring businesses, Internet research, and using other means to contact the firm (such as phone and email) The contractor shall perform all 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 also be charged.

NOE is defined as an establishment that is no longer manipulates product or is engaged in activities subject to FDA regulation, but still 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.

8. 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. The FDA Regional/District 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, or most recent version when notified by FDA).

· Domestic Fish and Fishery Inspection Program (CPGM 7303.842), PAC 03S002 (Attachment 10, or most recent version when notified by FDA).

· Juice HACCP Compliance Program (CPGM 7303.847), PAC 03S004 (Attachment 11, or most recent version when notified by FDA).

· Domestic Acidified and Low-Acid Canned Foods (CPGM 7303.803A), PAC 03S005 (Attachment 12, or most recent version when notified by FDA).

· Domestic and Imported Cheese & Cheese Products Program (CPGM 7303.037), Assigned under PAC 03S001 (Attachment 14, or most recent version when notified by FDA).

· http://www.fda.gov/Food/ComplianceEnforcement/FoodCompliancePrograms/ucm238066.htm

· Domestic and Import NLEA, Nutrient Sampling and Analysis, and General Food Labeling Program (CPGM 7321.005), Assigned under PAC 03S003 (Attachment 15, or most recent version when notified by FDA).

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 regulations as required under the Nutrition Labeling and Education Act of 1990 (NLEA) which includes specific requirements for the nutrition labeling of foods. All food products, with the exception of exempt foods, labeled on or after August 8, 1994 are subject to the NLEA regulations.

During contract inspections of manufacturers, labelers, or re-labelers, States shall review labels being used to determine if they are in compliance with the 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.

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 of violative labels shall be collected and 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.

9. 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 must 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 must 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. The State inspector shall discontinue conducting contract inspections until remedial training is completed and audits performed by the State program and District verify the deficiency has been corrected. The State program may be required to address performance issues noted during an inspection audit.

Refer to FMD-76 for additional details.

v. Contract Program Audit Performance Evaluation and Correcting Deficiencies The District will coordinate with the State to take appropriate action when the Audit Program identifies deficiencies in the program’s performance of the contract inspections as described in the most recent version of FMD-76. An unacceptable audit will not cause a contract to be altered or unpaid, nor will payment for the contract inspection be withheld. The contractor will be evaluated on its overall work performance and all audits conducted during the contract year, not the outcome of one contract audit. Audit findings may indicate an overall program deficiency or a deficiency with a specific performance element. Program performance deficiencies will require the completion of a Corrective Action Plan for Program and Individual Performance Deficiencies (Appendix J of FMD-76). The State program may be required to address performance issues noted during an inspection audit.

Refer to the most recent version of FMD-76 for additional details.

vi. Contract Performance Standard

In accordance with contract requirements, the contractor shall conduct assigned initial inspections, necessary re-inspections, and visits within the State and report all completed inspection results to the FDA District Office no later than thirty (30) business days after completion of the inspection. Inspections are defined as completed when the inspectional activity at the firm has concluded, the Form FDA 483 (or equivalent form) has been issued to the firm (if appropriate), and the closeout discussion has been held. The inspection results must be entered in eSAF and submitted to the District office within thirty (30) business days after completion of the inspection. Submission of the establishment inspection report may be electronic or hard copy via mail, as determined by the District. Within thirty (30) business days of receipt, the State shall submit to the District the responses received from the firm detailing corrective actions in response to a contract inspection. In addition, the State must notify the District via email within three (3) business days upon determination that significant violations are identified during the inspection or State regulatory action is being considered or planned.

The District and FDA/ORA/Office of Regulatory Science (ORAHQORSMANAGEMENT@fda.hhs.gov) shall be notified within one (1) business day of potentially significant positive laboratory results, preliminary positive (Can’t Rule Out (CRO)) pending confirmation, or when a sample is determined to be confirmed positive. Sample reports for positive (violative) samples shall be submitted to the District within three (3) business days of final determination. Sample reports for negative samples (non-violative) shall be submitted to the District within (30) business days of final determination.

At least 90% of all submitted reports shall be timely, accurate, and acceptable for data entry, analyses, and processing.

vii. Contract Performance Measurement

The Government will measure compliance with contract inspection requirements by reviewing inspection records and conducting audits or joint inspections. Results of all FDA quality assurance reviews will be furnished to the contractor. A sample of inspection records will be reviewed by FDA to verify that the required data and information are complete and accurate.

viii. Delay in Contract Payments If FDA finds an inspection record, sample report, quarterly report, or invoice to be unacceptable, the Contractor will be advised and given an opportunity to correct and/or resubmit the required documentation. Each instance whereby the Contractor fails to submit or correct the required report shall result in the delay of invoice payment until the corrected document(s) are received and accepted by the FDA.

10. Electronic State Access to Field Accomplishments (eSAF) and Compliance Tracking System

The FDA has an automated Field Accomplishment and Tracking System (FACTS) in which all food firm inspection data is captured and tracked. In an effort to automate some processes and to streamline communications between the States and FDA, the eSAF concept was developed.

The eSAF system automates the issuance of work requests to the State food firm contractors and allows the contractors to enter and update inspection results electronically. Additionally, the contractors will have access to the firm’s data that FDA has maintained in FACTS for the past several years. This data will enable the contractors to identify firms considered to be “high risk” and to obtain information about past inspections and violations for firms within their jurisdictional area. Attachment 2, “Electronic State Access to Field Accomplishments (eSAF) and Compliance Tracking System,” represents the requirements associated with eSAF.

Guidance on FDA product codes and OEI development and maintenance procedures may be found in FMD-130 (Attachment 18, or most recent version when notified by FDA). .

The FDA Product Code Builder may be found at: http://www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM

Inspections should be classified using the guidance found in FMD-86 Establishment Inspection Reports and Decisions and provided by the District (Attachment 19, or most recent version when notified by FDA).

Inspection conclusions found in eSAF may transfer differently into FACTS. The table below summarizes the eSAF classifications that may be chosen and the final inspection conclusion found in FACTS. Guidance from the District on the proper use of eSAF inspection classification will be provided to the State.