FSIS Directive 12600.1 Voluntary Reimbursable Inspection Services

I. PURPOSE

This transmittal issues an amended FSIS Directive 12,600.1, Revision 1, Voluntary Reimbursable Inspection Services, to revise the questions and answers in Attachment 2. It is necessary to revise the question and answers because one question and answer in the previous version (question 2) has been removed and incorporated in FSIS Directive 12,600.2, Reimbursable Overtime. Question 9 in the previous version has been corrected by removing the references to "monitoring," and the question has been renumbered as Question 8. In addition, there have been a few minor editorial changes.

II. CANCELLATION

This transmittal is cancelled when the contents have been incorporated into FSIS Directive 12,600.1, Revision 1, Amendment 2.

Assistant Administrator
Office of Policy, Program, and Employee Development

I. PURPOSE

This directive addresses non-mandatory inspection services for which the Agency receives reimbursement -- voluntary reimbursable services.

Key Points Covered

- Guides FSIS employees who need to determine whether voluntary inspection facilities meet the requirements to receive the requested services

- Guides FSIS employees on application, approval, and withdrawal procedures for voluntary reimbursable services

- Instructs inspection program personnel on what to inspect when providing voluntary reimbursable services

II. CANCELLATIONS

FSIS Directives 5110.1 Revision 1 and 12,600.1

III. REASON FOR REISSUANCE

This revision updates and combines information from FSIS Directive 5110.1, Revision 1, Reimbursable Services Reference Guide and FSIS Directive 12,600.1, Voluntary Reimbursable Inspection Services. IV. REFERENCES Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621, et seq.); Federal Meat Inspection Act (21 U.S.C. 601, et seq.); Poultry Products Inspection Act (21 U.S.C. 451, et seq.); Egg Products Inspection Act (21 U.S.C. 1031, et seq.) 9 CFR 307.4, 307.5, 307,.6, 307.6(a), 307.6(b), 311.23 (a)(2), Part 318, Part 320, Part 322, 325.11, 350.3, 350.6, Part 351, Part 352, Part 354, Part 355, Part 362, 381.10 (c)(2), 381.37, 81.38, 381.39, 381.39 (a), 381.39 (b), 381.65, 381.66, 381.111, 381.148, subpart O, 391.1-391.4, 416.1 ? 416.6, 416.11 - 416.16, Part 417, 590.136, 590.200, Part 592, 9 CFR 307.4, 307.5, 307,.6, 307.6(a), 307.6(b), 311.23 (a)(2), Part 318, Part 320, Part 322, 325.11, 350.3, 350.6, Part 351, Part 352, Part 354, Part 355, Part 362, 381.10 (c)(2), 381.37, 381.3 8, 381.39, 381.39 (a), 381.39 (b), 381.65, 381.66, 381.104 - 381.111, 381.148, subpart O, 391.1-391.4, 416.1 - 416.6, 416,.16, Part 417, 590.136, 590.200, Part 592 FSIS Directives 5000.1, Revision 2, 5400.5, 8410.1, Revision 2, 9000.1, 9010.1, and 9040.1, Revision 2

FSIS Forms 5110-1, 5200-4, 5200-6, and 5400-4

V. BACKGROUND

A. The Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA) set forth inspections that FSIS performs to ensure that meat, poultry and egg products are not adulterated and are properly labeled. FSIS does not collect fees for these mandatory inspection services at official establishments, except for holiday and overtime pay.

B. In addition to mandatory inspection, FSIS provides inspection services to accommodate business needs, such as obtaining certifications necessary to meet requirements of importing countries or the inspection of nonamenable products. FSIS collects fees from all facilities (including official establishments) that request inspection and certification services that are not required by the statutes. The Agricultural Marketing Act (AMA) through 7 CFR 218 and Subpart H authorizes these types of inspection services, called voluntary reimbursable services. FSIS conducts voluntary reimbursable services only when they are requested by the facility. Facilities apply for these services through the FSIS District Office (DO) in the district where the facility is located. Facilities requesting voluntary reimbursable inspection services are to complete FSIS Form 5200-6, Application/Approval for Voluntary Reimbursable Inspection Service, in Outlook:

Public Folders/All Public Folders/Agency Issuances/Forms/FSIS 5000 Series

C. FSIS requires all facilities where it provides voluntary reimbursable services to maintain themselves, at a minimum, in accordance with 9 CFR 416.1 - 416.6. The facilities may also have to meet other regulatory requirements (e.g., voluntary inspection requirements for rabbits). Non-official facilities are not required to comply with the requirements of Sanitation SOPs and HACCP, and although a non-official facility voluntarily may choose to have Sanitation SOPs and HACCP plans, inspection program personnel are not to perform any of the Sanitation SOP or HACCP verification activities found in FSIS Directive 5000.1, Revision 2.

VI. TYPES OF VOLUNTARY REIMBURSABLE SERVICES

This section describes the various types of voluntary reimbursable services that are available and identifies the applicable regulations for each type of service.

A. Identification Service (ID Service) - 9 CFR 350.3(a) and 362.2(c)

1. ID Service is provided to ensure that the identity of federally-inspected and passed meat and poultry product is maintained throughout the division of such meat and poultry product into smaller portions, its combination into larger units, or its repackaging and relabeling. Product units and portions are officially marked to identify them as inspected and passed.

2. The regulations do not permit product reconditioning, "ice glazing," or other types of further processing operations, such as cutting, boning, or trimming, with only ID service. These operations require a grant of inspection.

NOTE: A warehouse or freezer that only stores frozen or refrigerated, properly packaged, marked, and labeled meat, poultry, or egg products, and does not repackage or otherwise handle exposed product, does not require FSIS inspection coverage.

B. Export Certification Service - 9 CFR 350.3(b) and 362. 2(b)

1. When performed in official establishments, the issuance of export certificates that are required by 9 CFR Part 322 and 381.104 through 381.111, and as described in FSIS Directives 9000.1, Revision 1 and 9040.1, Revision 3, are not reimbursable services. Only the execution of certifications that are in addition to FSIS regulatory requirements, (e.g., additional certifications that are required by the importing country and the transferring of products for export as described in 9 CFR 322.3) are considered reimbursable services.

2. When performed at non-official establishments, the issuance of export certificates as set out in FSIS Directives 9000.1, Revision 1 and 9040.1, Revision 3, are reimbursable services.

3. Facilities where FSIS conducts import inspection services are not official establishments, and inspection operations other than those directly related to import reinspection (such as export certification) conducted at such facilities are reimbursable services.

C. Freezing Pork for Trichinae Certification

FSIS will certify the destruction of live trichinae in pork by refrigeration at non-inspected facilities as a reimbursable service. Facilities are required to effectively treat and handle the pork in accordance with 9 CFR 318.10(c)(2). Facilities are to maintain documentation to demonstrate that the procedures followed for each lot of pork certified meet the time, temperature, and handling requirements of the regulations.

D. Refrigerating Beef for Cysticercus Certification - 9 CFR 311.23(a)(2)

FSIS may certify that beef with lesions of cysticercus bovis was (following removal and condemnation of the lesions and surrounding tissue) held in cold storage under a "U.S. Retained" tag for the proper time, based on the product type, as specified in 9 CFR 311.23(a)(2) at non-inspected facilities as a reimbursable service.

E. Off-Premises Freezing Service for Poultry - 9 CFR 381.66 (f) and 381.148 Inspection service to verify that raw or processed poultry frozen at a non-inspected facility meets a label claim regarding freezing and is handled in the same manner as product frozen at an official establishment in accordance with the requirements specified in 9 CFR 381.66(f) and 381.148 is provided as a reimbursable service.

F. Food Inspection Service- 9 CFR 350.3(c) and 9 CFR 362.2(a)

1. Processing of certain food articles not covered by the FMIA or PPIA (e.g., products containing only nonamenable amounts of meat or poultry) is permitted in establishments under USDA inspection as a reimbursable service.

2. FSIS provides voluntary inspection services to ensure the wholesomeness of a nonamenable food article(s). The time required for FSIS personnel to provide the service is reimbursable.

3. For purposes of voluntary reimbursable services, a food article is an item containing meat, poultry, meat byproducts, or a meat or poultry food product for which an applicant requests and pays for inspection, but for which the FMIA and PPIA do not require inspection. The AMA authorizes inspection of these products, and when FSIS finds these products to be wholesome, FSIS grants the mark of inspection.

NOTE: Nonamenable, Child Nutrition (CN) products that do not contain meat or poultry (e.g., "Cheese Pizza") do not bear the mark of inspection, but FSIS grants the following mark:
                        INSPECTED BY THE U.S. DEPT. OF AGRICULTURE IN ACCORDANCE WITH FNS REQUIREMENTS
FSIS does not require products produced under food inspection to be produced in accordance with 9 CFR Part 417 and 416.11-17.

G. Certified Product for Dogs, Cats, and Other Carnivora - 9 CFR Part 355

Inspection, certification, and identification of products for dogs, cats, and other carnivora are reimbursable services provided to applicants. The product labeling bears an inspection legend (depicted in 9 CFR 355.32 (a)(4)) signifying certified products for consumption by carnivorous animals.

H. Certification of Technical Animal Fats for Export - 9 CFR Part 351

This part provides for the certification of technical animal fat for exportation or storage for exportation in accordance with 9 CFR 325.11.

In order to be certified, technical animal fats must originate from animals slaughtered under federal inspection. The product labeling does not bear the mark of inspection but conspicuously labels the product as "Technical Animal Fats."

I. Voluntary Inspection Service

The regulations provide for the service of voluntary inspection and certification service for the following:

1. 9 CFR Part 352, Exotic Animals; Voluntary Inspection

This part provides for the voluntary inspection and certification service for wholesomeness relating to the slaughter and processing of bison, cattalo, deer, elk, and other exotic animals and the application of a triangular shaped mark of inspection depicted in 9 CFR 352.7.

2. 9 CFR Part 354, Voluntary Inspection of Rabbits and Edible Products Thereof

This part provides for the voluntary inspection of domestic rabbits and parts for condition and wholesomeness and the application of a mark of inspection.

3. 9 CFR Part 362, Voluntary Poultry Inspection Regulations

This part provides for the voluntary inspection of any migratory waterfowl or game bird for wholesomeness and the application of a mark of inspection. This part also provides for export certification and identification service (as discussed above).

4. 9 CFR Part 592, Voluntary Inspection of Egg Products

This part provides for the voluntary services for the inspection of the processing in official plants of products containing eggs, sampling of products, and quantity and condition inspection of products. NOTE: The issuance of certificates for the export of egg products is a voluntary inspection service. Therefore, the execution of export certificates for egg products, whether performed at official establishments or at off-premise freezers, is a reimbursable service.

VII. GRANTING VOLUNTARY INSPECTION SERVICES

This section describes the procedural steps that FSIS follows when evaluating facilities requesting voluntary reimbursable services, and the actions FSIS takes in agreeing to provide the service(s) or in denying the application for service.

A. When a facility submits FSIS Form 5200-6, the District Manager (DM) will instruct a designee to visit the facility to determine whether it meets the general requirements for the service requested. The visit includes verifying that the facility meets the sanitation performance standards and the applicable the regulatory requirements for the service in the area of the facility where FSIS will perform the voluntary inspection service. The designee will evaluate the facility only for meeting the requirements for the type of service(s) requested.

B. If the facility fails to meet the requirements for the service(s) requested, FSIS will not provide the service. The designee will document his or her findings on FSIS Form 5200-4, Recommendation on Application for Inspection.

C. If the facility meets the requirements for the requested service(s), the DM will request the next available number through the Resource Information System segment of the Performance Based Inspection System (PBIS) system, assign the number to the facility, and agree to furnish the requested service by signing FSIS Form 5200-6.

D. Once the application process is complete, on each occasion that the facility requires voluntary inspection services, the management of the facility is to request inspection coverage from the FSIS DO.

NOTE: The DM may deny service for administrative reasons, (e.g., the no availability of FSIS personnel to perform the service or the applicant's reimbursable services account is delinquent) until the condition justifying such denial is alleviated.

VIII. GENERAL INSPECTION PROGRAM PERSONNEL RESPONSIBILITIES

A. FSIS inspection program personnel will record inspection procedures as unscheduled activities in PBIS for each visit. Inspection program personnel verify that the facilities meet applicable requirements by performing the appropriate procedures under Inspection System Procedure codes 04 and 06 using the inspection methodology outlined in FSIS Directives 5400.5, and 5000.1, Revision 1. The verification activities for each inspection procedure only apply to the areas, rooms, or departments where FSIS conducts the voluntary reimbursable service and any surrounding areas that affect the areas identified for voluntary reimbursable services. Inspection personnel will perform and record PBIS Procedure 06A01 as described in FSIS Directive 9000.1 for reimbursable exports whether at inspected establishments or non-inspected facilities.
B. When there is reason to believe that product in a voluntary inspection facility is adulterated or misbranded; inspection program personnel should detain the product as outlined in FSIS Directive 8410.1, Revision 2.

C. When there is reason to believe that product in an official establishment is adulterated or misbranded, inspection program personnel should retain the product as outlined in 9 CFR 318.2.

NOTE: Inspection program personnel should report conditions that could adulterate product or affect product usability that they discover in any other area of the facility to the DO through their Frontline Supervisor (FLS).

D. Inspection program personnel charge fees for all reimbursable services for the time required to render such service, including travel time used in connection with providing the service. In addition, inspection program personnel may charge to cover the cost of other expenses incurred by FSIS in connection with the furnishing of the service (See 9 CFR 350.7). Inspection program personnel will record reimbursable charges on FSIS Form 5110-1, Services Rendered by the FSIS employee. Fees to be charged and collected for service are at the rates specified in 9 CFR 391.2 -391.4 and 592.510 - 592.530. (See attachment for additional information about charging for reimbursable services).

IX. INSPECTION PROGRAM PERSONNEL VERIFICATION ACTIVITIES FOR SANITATION AT ALL REIMBURSABLE OPERATIONS

This section sets out the applicable regulations regarding sanitary requirements for facilities where voluntary reimbursable services are furnished and describes the facility operator's responsibility.

A. As described in FSIS Directive 5000.1, Revision 2, inspection program personnel are to perform ISP code 06D01 when verifying compliance with the sanitation performance standard regulations. FSIS will not provide reimbursable services to facilities that do not meet the requirements of the sanitation performance standards.

B. Inspection program personnel are to:

1. Verify compliance with the requirements of 9 CFR 416.1 - 416.6 or Part 592 (for egg products) at all facilities requesting reimbursable services. Facilities have a responsibility to ensure that they conduct operations in a manner that does not lead to product adulteration or the creation of insanitary conditions. Since the facilities are, in many cases, not official establishments, they are not required to meet the written Sanitation SOP requirements of 9 CFR 416.11 - 416.16.

2. Make observations and review records to verify regulatory requirements for each type of service requested.

3. Document noncompliance with meat and poultry regulations using a Noncompliance Record (NR) (FSIS Form 5400-4) with the appropriate trend indicator. Inspection program personnel are not to certify product until the facility corrects any noncompliances (9 CFR 350.6, 351.20, 352.6, 354.45).

4. Record noncompliance with egg products regulations in the Remarks Section of the "Daily Report of Plant Operations" (PY-203 for liquid egg products and PY-159 for dried egg products).

C. Inspection program personnel are to notify the DO when:

1. the facility does not comply with the requirements of 9 CFR 416.1 through 6 resulting insanitary conditions such that products in the facility are or would be rendered adulterated; or

2. the facility does not have sufficient equipment to fulfill the requirements for the requested service. The DO may take the actions set out in Section XI of this directive.

X. SPECIFIC VERIFICATION ACTIVITIES IN PERFORMING REIMBURSABLE SERVICES

This section sets out applicable regulations and describes some specific verification activities inspection program personnel will perform to verify regulatory compliance for the various types of voluntary reimbursable services FSIS provides.

In addition to the activities described in Section IX of this directive, FSIS personnel are to perform the following verification activities using the appropriate 04 ISP code and instructions found in FSIS Directive 5400.5 in performing specific types of reimbursable services:

A. Identification Service (ID Service) - 9 CFR 350.3(a) and 362.2(c)

1. Inspection program personnel are to review records and observe the handling of product to verify that the facility maintains product identity and are to verify that the facility handles the product in a manner that prevents product adulteration.

2. Inspection program personnel will verify that facilities are using approved labels, wrappers, or containers bearing the official mark of inspection. When facilities label or relabel product at an ID warehouse, freezer, cold storage, or dry storage facility, either the originating official establishment number or the official warehouse number may be used. Facilities may label product with the inspection legend provided they apply the label under FSIS supervision.

3. Whenever labeling with the originating official establishment number is used by an ID facility (i.e., labeling depicting the official number of the establishment that produced the product), inspection program personnel will verify that the ID facility code marks the product in a manner that will clearly indicate that the product was last handled and labeled at the ID facility. The ID facility must maintain records of label transfers and records of products labeled or relabeled at the facility to identify properly the product origin in the event of a product control problem, (e.g., voluntary product recall).

B. Export Certification Service - 9 CFR 350.3(b) and 362. 2(b)

Inspection program personnel are to verify that the information on the export certificate and related documents is accurate and are to carry out export certification activities as set out in FSIS Directive 9000.1 and other applicable instructions.

C. Freezing Pork for Trichinae Certification

Inspection program personnel are to verify the facility's procedures and controls through records review and direct observation to ensure compliance with 9 CFR 318.10 (c) (2), Refrigerating, and that the product undergoing certification has been kept identified, separated, and secured.

D. Refrigerating Beef for Cysticercus Certification - 9 CFR 311.23(a)(2)

Inspection program personnel are to maintain positive control by placing a "U.S. Retain" tag on product from which lesions of cysticercus bovis have been removed and are to verify compliance with the appropriate time and temperature combination set out in 9 CFR 311.23(a)(2) through records review and direct observation. Inspection program personnel are to remove the tag after the facility has held the product in cold storage for the required time and temperature combination specified in the above regulation for the type of product held under refrigeration (i.e., carcasses or boxed product.)

E. Off-Premises Freezing Service for Poultry - 9 CFR 381.66 (f) and 381.148 Inspection program personnel are to perform reviews of records and make necessary observations to verify compliance with 9 CFR 381.66(f), Freezing, for ready-to-cook poultry, and 9 CFR 381.148, Processing and handling requirements for frozen poultry products.

a. Inspection program personnel will verify that facilities freezing ready-to-cook poultry are meeting the label claim for freezing as provided in 9 CFR 381.66(f):

(1) capability of lowering the internal product temperature in the warmest part of the package to 0 degree F. within 72 hours of entering the freezer, and

(2) ability to maintain poultry in a solidly frozen state.

b. As specified in 9 CFR 381.148, a facility freezing processed poultry product to meet a label claim regarding freezing shall operate in a manner to ensure that the product does not become adulterated.

F. Meat and Other Products Food Inspection Service- 9 CFR 350.3(c) and Poultry Inspection Service - 9 CFR 362.2(a)

For nonamenable meat and poultry products produced under Food Inspection Service and Poultry Inspection Service, inspection program personnel will verify, through direct observation of processes, examination of product, and review of records, that the preparation and labeling of the products complies with the applicable provisions of 9 CFR Chapter III.

G. Certified Product for Dogs, Cats, and Other Carnivora - 9 CFR Part 355

Inspection program personnel are to perform inspections, review records, and make direct observations to verify that facilities and operations comply with the requirements in 9 CFR Part 355. These verifications include, but are not limited to:

1. verifying that facilities are adequate to accomplish storage of material used in the production of certified products and the holding of products prepared for certification;

2. verifying that incoming materials are properly marked;

3. reviewing labeling records and observing of product labeling;

4. supervising processes such as canning operations in the production of certified products, and

5. verifying the composition of certified products.

H. Certification of Technical Animal Fats for Export - 9 CFR Part 351

Inspection program personnel are to verify that facilities and operations comply with the requirements in 9 CFR Part 351. These verification activities include, but are not limited to:

1. verifying that facilities and equipment are adequate to maintain the identity of certified animal fats and the materials used in their preparation;

2. reviewing of records substantiating that the technical animal fats originated from animals which were slaughtered under federal inspection;

3. supervising all processes used in the preparation of technical animal fats;

4. verifying, through observation of labeled product, that the product labeling does not bear the mark of inspection and is conspicuously labeled as "Technical Animal Fats"; and,

5. the execution of export certifications as set out in 9 CFR Part 322 and FSIS Directive 9000.1.

I. Voluntary Inspection Service - 9 CFR Part 352, Exotic Animals; Voluntary Inspection:

1. 9 CFR Part 352, Exotic Animals; Voluntary Inspection:

Inspection program personnel are to perform inspections relating to the slaughter and processing of exotic animals and exotic animal products. They are to review records and are to make observations to verify that facilities and operations comply with the requirements of 9 CFR Part 352 (e.g., the condition and wholesomeness of edible product of exotic animals, and the preparation, labeling, marking and separation of such products to prevent commingling with products of other species).

2. 9 CFR Part 354, Voluntary Inspection of Rabbits and Edible Products Thereof:

Inspection program personnel are to perform inspections relating to the slaughter and processing of rabbits, review records, and make observations to verify that facilities and operations comply with the requirements of 9 CFR Part 354, e.g.,

(1) performing ante-mortem and post-mortem inspection activities verifying the condition and wholesomeness of rabbits and any edible products manufactured from rabbits;

(2) verifying that facilities and equipment are in compliance with applicable regulations, observing of the labeling and marking of rabbits and rabbit products, and issuing rabbit inspection certificates and export certificates.

3. 9 CFR Part 362, Voluntary Poultry Inspection Regulations: Inspection program personnel are to perform inspections, review records, and make observations to verify that facilities and operations are in compliance with the requirements of 9 CFR Part 362, e.g.,

(1) performing inspection and certification activities relating to the slaughter, processing, condition, and wholesomeness of nonamenable poultry and poultry products; and

(2) performing Export Certification Service and Identification Service, to verify that product is sound, wholesome, and fit for human food at the time service is furnished.

NOTE: Voluntary Poultry Inspection Service is available only on premises other than those of an official establishment.

4. 9 CFR Part 592, Voluntary Inspection of Egg Products:

Inspection program personnel are to perform sampling as directed; to make such observations, inspections and records reviews as they deem necessary to enable them to determine the class, quality, quantity, and condition of egg products; and to certify that products have been prepared, processed, stored, and handled in compliance with the requirements of 9 CFR Part 592.

XI. DENIAL/WITHDRAWAL OF AGREEMENT TO FURNISH VOLUNTARY REIMBURSABLE INSPECTION SERVICES

This section sets out reasons why FSIS may suspend or withdraw an agreement to provide services and describes the method of notification to the facility of such actions.

The DM may deny or withdraw the agreement to furnish services for any of the following reasons:

A. insanitary conditions found in the facility would render the product unwholesome;

B. improper records or certificates are found;

C. management or employees of the facility fail to comply with any conditions of the FSIS agreement to furnish voluntary reimbursable inspection services, or they violate the applicable FSIS regulations, or the FMIA, PPIA, or EPIA; or

D. the facilities reimbursable services account is delinquent. When violations, as described above, have been noted, the DO will notify the facility in writing that due to the noncompliances, the agreement to furnish voluntary reimbursable inspection service is denied or withdrawn pending final determination (7 CFR 1.133, 9 CFR 350.6, 351.20, 352.6, 354.45). After the DM has given the management of the facility an opportunity to present their views, the DM may notify the facility in writing that he or she is denying or withdrawing the agreement to furnish voluntary reimbursable inspection based on the authority granted by the applicable regulation for the service provided.

Assistant Administrator
Office of Policy, Program, and Employee Development