RFP_Final.docx

FDA-17-FEED

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 state contractor shall review and consider the following:

A. Background

Under contract since 1973, the Medicated Feeds Program has been implemented with the assistance of the States. For the last several years, States have accomplished surveillance inspections to determine whether firms manufacturing medicated feeds were in compliance with key good manufacturing practices (GMP) regulations.

Published by the FDA in 1986, the Second Generation Medicated Feed Regulations set forth revised requirements concerning approval procedures for the manufacture of animal feeds containing new animal drugs. These regulations focus on high-risk drugs, i.e., carcinogens, and drugs requiring withdrawal times at their lowest use level. Firms using Category II, Type A medicated articles to make medicated feeds are required to register with FDA as drug establishments and hold an approved license. The inspection of these facilities shall be performed on a risk-based schedule, but not more frequently than once every two years.

The previous medicated feeds program is now officially titled the Medicated Feed Manufacturing Compliance Program. With the passage of the Animal Drug Availability Act of 1996, the Federal Food, Drug and Cosmetic Act was amended and replaced the requirement for feed mills to obtain an approved medicated feed application (MFA) for the manufacture of each medicated feed with the requirement for medicated feed mills to be licensed with FDA. FDA's Center for Veterinary Medicine (CVM) uses the 21 CFR part 225 Current Good Manufacturing Practices (Part 225 CGMP) inspection classification to determine the approval decisions for pending medicated feed mill license applications. Classification of Official Action Indicated (OAI) shall result in recommendations to refuse license approvals, while No Action Indicated (NAI) and Voluntary Action Indicated (VAI) classifications shall not. An OAI classification for a licensed firm may start the process to withdraw the license based on egregious objectionable conditions found during the firm’s inspection.

On June 5, 1997, FDA published its first rule prohibiting the use of certain animal-origin materials in the feed of ruminant animals. A second rule was published on April 25, 2008, prohibiting the use of certain cattle-origin materials in the food of all animals. These actions were taken to prevent the spread of bovine spongiform encephalopathy (BSE) in the United States which is commonly referred to as the "BSE rule". The original rule, which is codified in 21 CFR 589.2000, provides for labeling, record keeping, and clean out requirements for renderers, feed manufacturers, haulers of feed, and livestock producers. The new rule, codified in 21 CFR 589.2001, became effective April 27, 2009, and prohibits the use of certain cattle-origin materials as ingredients in the food of all animals.

The FDA Food Safety Modernization Act (FSMA) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (also referred to as the Preventive Controls for Animal Food rule or PCAF rule) is now final and effective with compliance dates for businesses other than small or very small businesses which began in September 2016. This final rule is the product of an unprecedented level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, territorial, and tribal regulatory counterparts, academia and other stakeholders. FSMA embraces preventing food safety problems as the foundation of a modern food safety system and recognizes the need for a global approach to animal food safety.

The PCAF rule establishes for the first time requirements for Current Good Manufacturing Practice (Part 507 CGMP) that specifically address the manufacturing, processing, packing, and holding of all animal food (21 CFR Part 507, subpart B and related requirements in subparts A and F). It is important to establish Part 507 CGMPs for animal food to ensure that these products are manufactured under conditions and practices that protect against contamination. The rule also establishes requirements for Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (PCAF PC) (21 CFR Part 507, subpart C and E and related requirements in subparts A, D, and F).

With some exceptions, the PCAF rule requirements, including requirements for Part 507 CGMPs and PC, for animal food applies to facilities that manufacture, process, pack, or hold animal food and are required to register as a food facility under section 415 of the FD&C Act. This rule does not apply to farms that manufacture food for their own animals or other food facilities not required to register under section 415 of the FD&C Act (such as food facilities regulated by USDA FSIS). The PCAF rule requirements apply to domestic and imported animal food, including food for pets and livestock, as well as raw materials and other ingredients used in animal food.

B. Objectives

This contract is designed to obtain State and local assistance in the inspectional coverage of feed establishments, specifically:

1. To conduct inspections of licensed and non-licensed medicated feed establishments to determine compliance with 21 CFR Part 225, the Federal Food, Drug, and Cosmetic Act (FD&C Act), and/or State feed law (if the contractor's State feed law has incorporated the provisions of the current Association of American Feed Control Officials (AAFCO) Model Bill and Regulations, or FDA’s Ruminant Feed Ban Regulations), or both.

2. To verify compliance with the Veterinary Feed Directive (VFD) regulations in 21 CFR 558.6 by feed manufacturers, distributors, veterinarians, and animal producers involved in the distribution of VFD drugs, the manufacture or distribution of VFD feeds, the issuance of VFD orders and the feeding of VFD feeds, respectively.

3. To verify compliance with 21 CFR 589.2000 and 21 CFR 589.2001 by licensed and non-licensed medicated feed manufacturers, ingredient manufacturers such as rendering facilities, and other types of operations engaged in the manufacturing, distribution, retail, and use of animal feed.

4. To conduct inspections and verify compliance with 21 CFR Part 507 as it relates to Part 507 CGMP requirements (subpart B and related requirements of subparts A and F) and/or PCAF PC requirements (subparts C and E and related requirements of subparts A, D, and F) for animal food facilities that are registered with FDA to manufacture, process, pack or hold food for animals in the United States or State feed law (if the state contractor’s State feed law has incorporated the provisions into their law), or both.

5. To encourage voluntary corrective action by the establishment when appropriate.

6. To prepare and submit reports of assigned inspections and sample collections, as well as, reports on any compliance follow-up and corrections achieved by the state 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 state contractor $________ for Licensed Medicated Feed Part 225 CGMP Inspections, $________ for BSE Only Manufacturing Inspections, $________ for Visits/Out of Business (OOB), $________ for BSE Non-Manufacturing Inspections, $________ for Non-Licensed Medicated Feed Part 225 CGMP Inspections, $________ for Samples, $________ for OEI Improvement, $________ for Veterinary Feed Directive (VFD) Inspections, $_______ for Part 507 Current Good Manufacturing Practice (CGMP) Inspections, $_______ for PCAF Preventive Controls (PC) Inspections, $________ for Animal Feed Regulatory Program Standards (AFRPS), and $________ for travel/ training, 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 E Inspection and Acceptance, F-1 Reports/Deliverables and Section G-3 Invoice Submission, and in accordance with the schedule in part D.

D. Travel/ Training

Total expenditures for domestic travel (such as transportation, lodging, meals, and incidental expenses) and training not to exceed $ ________ incurred in direct performance of this contract, shall be allowed based on Federal Travel Regulations and the Health and Human Services (HHS) Travel policy Manual. All travel/training shall be approved prior to attendance by the Contracting Officer Representative (COR) and the Contracting Officer (CO).

Domestic Travel allowance for training under this contract shall be paid on a cost reimbursement basis. The estimated travel and training costs are subject to FAR Clause 52.216-7 “Allowable Cost and Payment” and FAR Clause 52.232-20 “Limitation of Cost”. These FAR clauses are included by reference in Section I of the contract.

E. Schedule

Base Year: $____________________________________

Period of Performance: ___________ to ____________

Basic Work

Licensed Medicated Feed Part 225 CGMP Inspections

BSE Only Manufacturing Inspections

Visits/ Out of business (OOB)

Elective Work

BSE Non-Manufacturing Inspections

Non-Licensed Medicated Feed Part 225 CGMP Inspections

Samples

OEI Improvement

Veterinary Feed Directive (VFD) Inspections

Part 507 Current Good Manufacturing Practice (CGMP) Inspections

PCAF Preventive Controls (PC) Inspections

Animal Feed Regulatory Program Standards (AFRPS)

Travel/ Training

Visits/OOB

Select one:

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

The state contractor shall not perform nor shall be paid for any Visit/OOB that exceeds 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. The state contractor shall submit a proposed unit cost and number of anticipated Visits/OOB to be conducted under this contract.

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

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

C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C-1 SCOPE OF WORK

Independently and not as an agent of the Government, the state 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 as described below:

As assigned by the District, the state contractor may conduct a combination of medicated feed (licensed and non-licensed feed establishments) and BSE-only inspections at feed establishments. The medicated feed inspection of licensed and non-licensed feed manufacturing facilities shall include BSE coverage (NOTE: BSE coverage during medicated inspections of licensed and non-licensed facilities is not considered to be a separate contract inspection for the purpose of contract reimbursement). 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 of Findings section of the inspection report and electronic State Access to FACTS (eSAF). The Contractor shall also conduct follow-up to any open consumer complaints, corrective actions taken due to a recall, or other significant, identified animal health issue.

The Contractor’s establishment inspections shall comply with the General Requirements for Conducting Inspections of this contract. The State and District shall 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 (IOM) 2016 (Attachment 1, or most recent version when notified by FDA), for guidance on conducting inspections, collecting evidence, and writing Establishment Inspections Reports (EIRs).

The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. FSMA greatly expands FDA’s authority to regulate the U.S. animal food supply by focusing on preventing animal food safety problems, developing new prevention-focused standards and new enforcement tools, establishing a clear regulatory framework, and enhancing partnerships with Federal, State, local, territorial, and tribal agencies. The FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) rule (21 CFR Part 507) became final on September 17, 2015. Compliance dates for businesses other than small or very small businesses began in September 2016 for implementation of Part 507 CGMP requirements and shall begin in September 2017 for PCAF PC requirements, respectively. Compliance dates for small businesses (generally those with fewer than 500 full time equivalent employees) to comply with Part 507 CGMP requirements in September 2017. As discussed in the Part 507 CGMP Inspections elective and the PCAF PC Inspections elective, inspectional assignments for firms subject to the PCAF rule requirements may become available. In preparation for future contract opportunities, attendance of specific FSMA training (Food Safety Preventive Controls Alliance course, regulator training, and training inspections) focused on the PCAF rule requirements, which includes provisions for both Part 507 CGMP and PCAF PC is strongly encouraged by the Contractor’s inspectional personnel. The Part 507 CGMP and PCAF PC training inspections can be performed with a qualified FDA or State instructor. As specific training information and dates become available, the details shall be provided to the Contractor.

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 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. COVERAGE

Medicated feed inspections are to be conducted by the Contractor at licensed medicated feed manufacturing sites which are required to comply with 21 CFR Part 225 that have an FDA Feed Mill License and to annually register with FDA as drug establishment. Additionally, for the non-licensed, medicated feed mill, these establishments are required to comply with 21 CFR 225.120 through 225.202. Most of these facilities are also required to be registered with FDA as food facilities. These establishments are included in FDA's active Official Establishment Inventory (OEI).

Feed manufacturing facilities, both licensed and non-licensed medicated feed mills, may be inspected for compliance with the requirements of 21 CFR 589.2000 and 21 CFR 589.2001 and/or as a follow-up to a tissue residue investigation that implicates a feed mill as the source of the contaminant. All feed manufacturing facilities shall comply with the same set of BSE rules.

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

1. Bioterrorism Act of 2002

i. 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. (Attachment 2, or most recent version when notified by FDA).

All food facilities that are required to register with FDA under section 415 of the FD&C Act shall renew their registrations with FDA biennially. Food facility registration renewal takes place in even number years, and shall next take place in 2018. The state contractor shall inform the firm that changes to the BT Act requires food facilities to submit registrations to FDA containing information previously considered optional.

The FDA Unified Registration and Listing System (FURLS) was built to electronically register all domestic and foreign facilities that export food to the U.S. Contractors shall establish user accounts for at least two (2) key personnel in the FDA Unified Registration and Listing System (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. In addition, at least two (2) key personnel shall attend a training session not to exceed two (2) hours on the use of FURLS. 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/

ii. Documentation

The Contractor shall document the registration status of the firm and registration 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 state contractor is to notify the local FDA District office.

2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) rule and the Sanitary Transportation of Human and Animal Food (Sanitary Transport) rule under the Food Safety Modernization Act (FSMA) of 2011

i. The FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (also referred to as the Preventive Controls for Animal Food rule or PCAF rule) became final on September 17, 2015. The new rule established Current Good Manufacturing Practice (Part 507 CGMP) requirements for all registered food facilities that manufacture, process, pack, or hold animal food (21 CFR Part 507, subpart B and related requirements in subparts A and F). The PCAF rule also established Hazard Analysis and Risk-Based Preventive Control (PCAF PC) requirements for registered animal food facilities (21 CFR Part 507, subparts C and E and related requirements in subparts A, D, and F). Under the PCAF PC provisions, animal food production facilities are required to establish a food safety system that includes an analysis of hazards and implements risk-based preventive controls for the animal food manufactured, processed, packed, or held by the facility. Businesses have between one year and three years to comply with the Part 507 CGMP requirements, and between two years and four years to comply with the PCAF PC requirements. The compliance dates are based on the size of the business. For example, businesses that are not small or very small businesses shall need to comply with Part 507 CGMP requirements by September 19, 2016, and the PCAF PC requirements by September 18, 2017. Small businesses (generally those with less than 500 full time equivalent employees) shall need to comply with the Part 507 CGMP requirements by September 18, 2017.

To assist FDA in communicating the PCAF rule, the Contractor shall print and distribute the FSMA Fact Sheet on the PCAF Final Rule (Attachment 3 or the most recent version when notified by FDA) to the most responsible individual at the inspected establishment during the opening meeting.

ii. The goal of the proposed rule on Sanitary Transportation of Human and Animal Food (Sanitary Transport) 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 motor vehicles (such as trucks and railcars, and excluding transportation by ship, barge or air) and transportation equipment, transportation operations, information exchange, training, records, and waivers. The rule was published April 6, 2016. Small businesses (businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts) have two years after publication to comply (April 6, 2018). Other businesses (a business that is not small and is not otherwise excluded from coverage) have one year after publication to comply (April 6, 2017).

To assist FDA in communicating the Sanitary Transport final rule, the Contractor shall print and distribute the FSMA Fact Sheet (Attachment 4 or most recent version when notified by FDA) addressing the Sanitary Transport rule to the most responsible individual at the inspected establishment during the opening meeting. The fact sheet explains key requirements. An updated fact sheet on the final rule shall be provided once it is available.

iii. Documentation

The Contractor shall document if the PCAF and Sanitary Transport Fact Sheets were provided to the firm in the summary section of the inspection report.

3. Assistance in Creating FDA Outreach Strategy for the PCAF rule, including requirements for Part 507 CGMP and PCAF PC

FDA is implementing the new PCAF rule (21 CFR Part 507), which includes requirements for Part 507 CGMP (21 CFR Part 507, subpart B and related requirements in subparts A and F) and PCAF PC (21 CFR Part 507, subparts C and E and related requirements in subparts A, D, and F). Baseline information on industry knowledge and understanding of the rule is needed and shall be acquired by the state contractor. In addition, data on corporate firm size and revenue is needed to further refine FDA Official Establishment Inventory (OEI). Such data shall be used to classify firms by business size according to the rule and to determine the appropriate compliance date for the firm.

i. Documentation

The Contractor shall include the following information as part of the establishment inspection report (EIR) and in eSAF (as applicable under the appropriate designated information tabs):

A. Facility information

· FEI number

· Firm legal name

· DUNS number (optional)

· Firm physical address

· Mailing address (if different from firm address)

· Number of employees at the firm

· Gross annual food sales plus the market value of animal food manufactured, processed, packed, or held without sale.

B. Corporate information (if applicable)

· Name of corporate entity

· Corporate address

C. CGMP and Preventive Controls

· Firm has Part 507 Current Good Manufacturing Practices (Part 507 CGMPs) in place

· Firm has a written Food Safety Plan

· Firm has conducted a Hazard Analysis

· Firm has an environmental monitoring program (only if applicable)

· Firm has a recall plan

· Firm is an importer

B. METHOD OF COVERAGE

1. GENERAL

The activities under the contract shall be conducted using the procedures, techniques, and reporting forms specified by FDA in the current Medicated Feed Manufacturing Compliance Program (Attachment 5, or most recent when notified by FDA) ) and BSE/Ruminant Feed Ban Inspection Compliance Program (Attachment 6, or most recent when notified by FDA). The Contractor shall be notified by FDA as additional Compliance Programs become effective that address the PCAF rule requirements. The applicable sections of these documents are incorporated by reference. The Government shall furnish updated copies to the state contractor or provide reference to the online location. The FDA Regional/District office shall provide guidance and interpretations as necessary.

As referenced in C-1 Scope of Work, the Contractor shall conduct establishment inspections based on the plans and requirements established during the Work Planning meetings and indicated in the General Requirements for Conducting Inspections section of this contract.

If the contract State has adopted all applicable sections of Title 21 of the Code of Federal Regulations, or can demonstrate equivalent State requirements, the contracting agency can conduct the inspections under State credentials.

It is the responsibility of the Contractor to determine whether the State regulatory requirements are equivalent to the Federal 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.

If the contracting State has not adopted all applicable sections of Title 21 of the Code of Federal Regulations 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, Food and Drug Administration, as set forth in section 704(a) (1) of the FD&C Act. Commissioned officials shall 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 state contractor should also provide appropriate BSE Guidance for Industry documents to the firm during the inspection (Attachment 7, or most recent when notified by FDA).

2. ENFORCEMENT

Compliance actions are not provided for under this contract. However, it is anticipated the Contractor shall vigorously pursue any necessary compliance follow-up to violative conditions encountered during inspections made under this contract and under using State authorities. Such actions may include stop-sales, administrative plant closures or orders, warnings, license revocations, court actions, etc. The state 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 FD&C Act.

If an inspection conducted under contract results in a final District classification of “OAI” and details violations that are “materially related to food safety”, the FDA District office shall notify the State and shall conduct any re-inspection of the firm. An FDA warning letter that results from an inspection classified OAI shall be signed by the FDA District Director and shall be based on the model warning letter supplied in the Compliance Program. An FDA warning letter may be based on a State inspection report that contains adequate evidence and other documentation.

As a result of a Part 507 CGMP inspection or a PCAF PC inspection, a deficiency letter may be issued to a firm. Per request of the District, the Contractor may be asked to perform a follow up inspection of the facility. In this case, the Contractor shall invoice FDA for conducting the follow up inspection at the unit price of a Part 507 CGMP inspection or PCAF PC inspection, as appropriate.

C. INSPECTIONS

1. PRIORITIES

A. BSE INSPECTIONS (PRIORITY 1)

The Contractor shall conduct inspections (and re-inspections, as approved by the District) of both licensed and non-licensed medicated and non-medicated feed establishments for compliance with the requirements of 21 CFR 589.2000 and 21 CFR 589.2001. Similar inspections are to be conducted when inspecting all establishments under this contract subject to the BSE Rule, including Part 225 CGMP inspections at licensed and non-licensed medicated and non-medicated feed mills and BSE inspections at non-manufacturing establishments.

Personnel performing BSE inspections are required to complete the web-based courses: Bovine Spongiform Encephalopathy (BSE01) and BSE Inspectional Approach (BSE02). These courses can be found at: http://www.fda.gov/Training/ForStateLocalTribalRegulators/ucm119016.htm and review Compliance Program Guidance Manual 7371.009 (Attachment 6).

As an alternative to the web-based courses, the State may view CVM “BSE Inspection Training, 7 Modules” video or attend VM 213 BSE Inspection Training. The State shall maintain and make available to the District documentation demonstrating that all inspectors conducting contract BSE inspections have successfully completed the training requirements.

After completing these courses and reviewing the Compliance Program Guidance Manual (7371.009), inspectors shall be familiar with the BSE inspection checklist and with the requirements for labeling and recordkeeping. Finally, they shall be able to determine a firm’s status for compliance with the BSE feed regulation.

B. MEDICATED FEED PRE-APPROVAL INSPECTIONS (PRIORITY 2)

Conduct pre-approval inspections of all firms submitting feed mill license applications for the first time. This inspection is required to take place before a license application can be approved and should take place within 60 days of the filing of license application. FDA has a 90-day statutory obligation to act on a license application. If the inspection is not made, CVM is obligated by the Act to approve the license application. New applicants may be newly constructed or acquired facilities, or active feed mixers that wish to secure a license. A new facility does not have to be in operation to demonstrate capability and obtain license approval. The investigator shall determine the applicant’s knowledge of the medicated feed manufacturing regulations and whether the firm is prepared and able to comply.

C. MEDICATED FEED INSPECTIONS (PRIORITY 3)

Conduct licensed medicated feed inspections of firms subject to 21 CFR Part 225 whose most recent medicated feed inspection was classified NAI or VAI. If the firm is using Veterinary Feed Directive (VFD) drugs, the inspection shall include coverage of Veterinary Feed Directive.

New State personnel performing Medicated Feed inspections are required to complete ORA U classroom course, Medicated Feed Inspection (VM206) or its online equivalent (if available) before conducting medicated feed mill Part 225 CGMP inspections. This requirement is applicable only to new State personnel. Current State inspectors are “grandfathered in” regarding this requirement, but are still strongly encouraged to complete VM206. When State personnel are able to attend VM206, the State shall maintain and make available to the District documentation demonstrating their attendance and completion of the course. If VM206 is not available, on-the-job training, or a combination of classroom, online, and on-the-job training, may be used to qualify personnel to conduct these inspections. Regardless of the specific training method used, personnel shall be familiar with medicated feed regulations that apply to licensed medicated feed mills, typical feed manufacturing operations, the manufacturing of quality medicated feeds, and proper reporting and documentation of significant deviations from the regulations identified during medicated feed inspections.

D. WORKPLANNING SESSION(S)

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 shall draft the work planning session(s) minutes for review by the State within thirty (30) business days. Corrections shall be agreed upon by both the State and District. The goals of the session(s) are to:

i. Coordinate an inspection schedule that shall avoid duplication of inspection work to be accomplished by FDA and State personnel. The inspection schedule should be risk-based taking into account the inspection requirements in the Food Safety Modernization Act (FSMA), the individual programs covered under the contract, and public health priorities of FDA.

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 shall be made during the work planning session.

· All remaining assignments shall 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 work planning meeting may be necessary.

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.

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, FDA shall provide the Firm Establishment Identification (FEI) numbers for all firms on the inspection schedule. For States conducting BSE Non-Manufacturing Establishment inspections, the State shall provide the District with a list of proposed firms for inspection. By an agreed upon method, the State shall notify the District of any new firms identified after an inspection and shall provide all information required by the District in order to enter the firm into FDA inventory and to assign an FEI.

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 state contractor.

vi. Confirm that State regulatory authorities are equivalent to Federal requirements, or the State officials are commissioned, and the state contractor has the contractual obligations to accomplish the inspection schedule.

vii. Review the utilization of eSAF and data entry requirements (Attachment 8, or newest version when notified by FDA).

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 establishment inspection reports or other reporting forms shall 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. Target completion goals may include either a certain percentage or specific firms that shall be inspected or audited by a specified 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. Discuss training needs, sharing of resources, and other collaborative efforts. State inspectors are encouraged to attend courses offered by FDA, including ORAU on-line courses and classroom training, including but not limited to, VM101 (Grain and Feed Mill Operations), VM206 (Medicated Feed), and VM213 (BSE Inspection).

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

xii. Discuss corrective action plan requirement and triggers for submission.

xiii. Discuss and determine appropriate samples to be collected under the contract (if applicable).

xiv. 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.

xv. State shall brief FDA on planned activities by their agency at the facilities identified in the contract work plan, such as feed sampling, or work done under other programs (seed, fertilizer, pesticide, weights and measures, for example), so the FDA has an understanding of what other obligations or activities state personnel may be performing at these facilities.

2. TYPES OF INSPECTIONS (BASIC WORK)

A. BSE FEED MANUFACTURING ESTABLISHMENT INSPECTIONS

The state contractor shall conduct "BSE Rule" compliance inspections at both licensed and non-licensed medicated feed manufacturing establishments concurrently when a medicated feed Part 225 CGMP inspection is done. The “BSE Rule” only inspections may include initial inspections and re-inspections, as assigned by the District. During the inspection, complete the FDA Form 3719 (Attachment 9, or most recent when notified by FDA or equivalent state form).

The PAC code for all contract BSE Inspections is PAC 71S011, BSE State Contract Inspections/All Firm Types.

B. MEDICATED FEED INSPECTIONS FOR LICENSED MEDICATED FEED FIRMS

Routine licensed medicated feed inspections are applicable to establishments that have undergone an inspection and have received NAI or VAI status. The inspections shall not be made more frequently than once every two years to satisfy the statutory biennial requirement for licensed medicated feed manufacturing firms. Re-inspections as a follow-up to non-OAI violative practices may be made under this contract when assigned by the FDA District. Re-inspections of firms with a final FDA classification of OAI shall be performed by the FDA District.

The state contractor shall verify the firm has completed the annual drug registration requirements and document the registration status in the inspection report.

If VFD drugs are present in the feed mill, coverage of those products shall be included under the Part 225 CGMP inspection, as has been done since the late 1990’s. The Part 225 CGMP inspection would not include any trace forward to customer, trace back to prior distributor, or other work related to VFD’s beyond the basic Part 225 CGMPs.

Pre-approval inspections are surveillance inspections of medicated feed firms submitting a feed mill license application for the first time or for firms whose workload obligation has been set to “no”. The state contractor may be assigned firms for pre-approval inspections by the District based on a request from the Center for Veterinary Medicine (CVM). As the Center has statutory 90-day timeframe to act on the application of the license, these inspections should be completed as soon after assignment as possible.

Compliance with the BSE Rule shall also be confirmed and Form 3719 (Attachment 9) or equivalent state form completed. The PAC code for Part 225 CGMP inspections for contract Licensed Medicated Feed Facilities is 71S004, State Contract Medicated Feed Inspections - Licensed Facilities. Time shall be split appropriately between PAC codes 71S004 for contract licensed medicated feed and 71S011 for contract BSE inspections.

C. INSPECTION VISITS

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 feed contract, relocated outside of the state contractor’s geographical jurisdiction, or when a complete inspection cannot be accomplished during the contract period of performance for unforeseen circumstances. Investigational state 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 shall 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, contacting the local US Postal Service for a forwarding address, and records research.

The state 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 state contractor’s geographical jurisdiction, a complete inspection shall be conducted at the new location and a visit shall not be charged. If a firm has relocated to a new location out of the state contractor’s jurisdiction, a visit may be charged and documented as indicated below.

NOE is defined as an establishment that no longer manipulates (manufactures) a 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 may be found in Field Management Directive (FMD-130) (Attachment 10 or most recent when notified by FDA).

Due to errors in the FDA inventory or, changes in business management or practices, 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 state contractor may charge for a visit if the firm is determined by the District to not be eligible for inspection under the contract and the origin of the assignment is not the OEI Improvement Elective.

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

D. ELECTIVE WORK

1. BSE NON-MANUFACTURING FEED INSPECTIONS

Elective work may be performed to conduct additional BSE Inspections at Non- Manufacturing Feed Establishments that are not listed as part of Official Establishment Inventory (OEI). Options for inspections may include inspection of a farm’s animal food operations, transportation of animal food (trucks, etc.), animal food establishments that salvage foods for use in animal foods, and animal food retailers.

The state contractor shall provide the District Technical Advisor an inventory list of proposed establishments to be inspected under this elective during the work planning session. The inventory list shall contain the firm name, location, and type of facility. The list of firms shall assist the FDA District in entering the firms into eSAF for the State and provide an understanding of the work that shall be accomplished under this elective.

The PAC code for all contract BSE Inspections is PAC 71S011, BSE State Contract Inspections/All Firm Types.

2. MEDICATED FEED INSPECTIONS AT NON-LICENSED FEED MANUFACTURERS

Elective work may be performed to conduct medicated feed Inspections at Non-Licensed Medicated Feed Manufacturing Establishments. The firm shall be a manufacturer of a medicated feed that does not require a license. While these facilities are not required to be registered as a drug establishment, the firms may be part of the Official Establishment Inventory (OEI), and many shall (or should) be registered as food facilities. Options for inspections may include: inspection of a farm’s feed manufacturing operations (farms are a type of firm that do not usually have to register as food facilities), integrators, and commercial feed establishments that are not required to register as a drug establishment, but manufacture medicated feeds that do not require an FDA medicated feed license.

Non-Licensed Medicated Feed manufacturer shall comply with the requirements of 21 CFR 225.120 - 225.202; these sections of the regulations are sometimes referred to as the ‘less stringent Part 225 CGMPs’. The Non-Licensed Medicated facilities shall be inspected using a systematic approach to identify and verify compliance with various aspects of these requirements. This shall allow inspections to focus on the specific issues related to the manufacture of a safe medicated feed and identify significant concerns or deviations from these regulations.

Compliance with the BSE Rule shall also be confirmed and Form 3719 or equivalent state form shall be completed. For the medicated feed inspection at non-licensed medicated feed mills, state contractors may elect to use the model form found in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) to record the non-licensed medicated feed inspection. That form is found on pages 287-292 of the 2016 AAFCO Official Publication. If VFD drugs are encountered, their use shall be reviewed.

The PAC code for contract medicated feed Part 225 CGMP inspections at Non-Licensed Medicated Feed Facilities is 71S012, State Contract Medicated Feed Inspection – Non-Licensed Facilities. Time shall be split between PAC codes 71S012 for contract non-licensed medicated feed and 71S011 for contract BSE inspections. The appropriate medicated animal feeds product code(s) covered during the inspection should be used in eSAF.

3. SAMPLES

Types of samples

a. GENERAL/ROUTINE Elective work may be performed to collect animal feed and feed ingredients produced, imported, or distributed within the State. The State should use discretion and inspectional findings to guide sampling. Surveillance samples should give priority to coverage of locally grown or produced animal feed and feed ingredients. Samples collected should be based on past violative samples, current analytical findings, and on information obtained through intelligence gathering activities, such as inspections, complaints, adverse events, and recalls. Animal feed for food-producing animals, especially lactating dairy cows and laying hens, should have priority over feeds for non-food producing animals.

Physical samples should not normally be collected during surveillance Part 225 CGMP or BSE inspections. An exception occurs under the circumstances where cross contamination with specific drugs could occur and the State laboratory can confirm cross contamination using appropriate methodology, samples may be collected. Information on the sample collection and analysis shall be reported on State forms.

Samples shall consist of sufficient units, size, etc., necessary to meet the requirements for the selected analytical methodology to be used. FDA shall make appropriate Sample Schedules available (Attachment 1 or most recent when notified by FDA). Samples shall be collected in accordance with currently recognized sampling procedures and analyzed with analytical methods that are appropriately validated and fit-for-purpose for the required analysis of the sample. For more information on method validation and fit-for purpose methodology, please refer to the “The Very Best Practices for Laboratory Work Draft Document” (http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/ProgramsInitiatives/PartnershipforFoodProtectionPFP/UCM404716.pdf). These samples may be collected to demonstrate violations to Federal Law, or for survey purposes, for example, through laboratory analysis. The state contractor may also be asked to collect documentation of interstate commerce on a sample if FDA is considering pursuing regulatory action based upon the State’s sample results.

Examples of sample analyses that may be performed:

· Toxins (such as mycotoxins)

· Potency or cross-contamination of samples during medicated feed mill inspections for compliance or cause

· Presence of animal tissue

· Pesticides/industrial chemicals

· Elements

· Microbes

When developing the sampling plans, the state contractor and District should take into consideration:

· Inspectional findings and observations

· FDA performance goals, priorities, and sampling assignments

· Investigations Operations Manual (IOM)

· Relevant Compliance Program Guidance Manuals

· Products or firms with a history of being associated with animal illness or injury, compliance issues, or regulatory actions being pursued by FDA or the State, including recalls, seizures, injunctions, import alerts, and consumer complaints

· Firms assigned for inspection under contract

· State laboratory capabilities

b. SPECIAL NON-ROUTINE SAMPLES This request is limited to 10 non-routine sample requests over the performance of the contract. The Government may request that the Contractor collect samples to protect the public health under the auspices of this contract for emergencies and other special purposes. At the direction of FDA Headquarters, the FDA District may request that a non-routine sample be collected.

i. PURPOSE The reason for the collection may be, but not limited to, special sampling assignments as a result of: targeting of specific commodities as a result of…