This directive instructs inspection program personnel (IPP) on voluntary and other reimbursable inspection services that an applicant may request, the tasks that IPP are to perform under these services, and how to charge the applicable fees for these services. This directive instructs District Office (DO) personnel on approving or denying voluntary and other reimbursable inspection services. This directive has been revised in its entirety to clarify existing instructions and provide additional instructions for voluntary and other reimbursable inspection services based on common questions, and input from IPP. This directive has also been updated to include current definitions for exotic species.
? Instructs FSIS employees how to determine whether facilities meet the requirements to receive the requested services
? Instructs IPP what to inspect when providing voluntary and other reimbursable inspection services
? Instructs IPP on the voluntary tasks to perform and how to record these tasks in the Public Health Information System (PHIS)
? Provides instructions on how to charge for voluntary and other reimbursable services
FSIS Directive 12,600.1 Revision 1 Amendment 2, Voluntary Reimbursable Inspection Services, 7/2/07
A. The Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA) provide for FSIS inspection of meat, including fish of the order Siluriformes, poultry, and egg products at official establishments and egg products plants to verify they are not adulterated and are properly labeled. Official establishments and egg products plants are locations that have Grants of Inspection as described in these statutes and are assigned numbers with an ?M,? ?P,? or ?G? designation for meat, poultry, and egg products. Official import inspection establishments are locations where inspections are authorized to be conducted as prescribed in 9 CFR 327.6, 381.199, or 590.925 and are assigned numbers with an ?I? designation.
B. Preparing and processing meat, poultry, and egg products may only be performed at official establishments and egg products plants. For the purposes of this directive, the term official establishment also applies to egg products plants with a grant of inspection.
C. The Agricultural Marketing Act (AMA) provides the Secretary of Agriculture with the authority to prescribe rules for the inspection and certification of products in interstate commerce and to collect fees to cover the cost of the service rendered so agricultural products may be marketed to the best advantage, to facilitate trade, and so consumers may be able to obtain the quality product which they desire (7 U.S.C. 1622(h)). FSIS has developed regulations to perform voluntary and other reimbursable services based on this authority to inspect, certify, and identify the class, quality, quantity, and condition of agricultural products when shipped or received in interstate commerce at warehouses and official establishments. These services are conducted only when requested by the facility and may include obtaining certifications necessary to meet requirements of importing countries, such as voluntary inspection of closed-face sandwiches. FSIS collects fees from all facilities (including official establishments) that request voluntary inspection and other certification services that are not required by the FMIA, PPIA, or EPIA. In this directive, in order to distinguish between official establishments or official import inspection establishments that request voluntary services and facilities that are not official establishments or official import inspection establishments that request voluntary services, a facility is called ?unofficial? when only voluntary or other reimbursable services are requested and no activities that require mandatory inspection are performed at the facility. In this directive, when the term facility is used, without official or unofficial qualifiers, that means the information applies to both official establishments and unofficial facilities. Although the word ?official? is used in some of the definitions (e.g., ?official exotic animal establishment? in9 CFR 352.1) this directive refers to these facilities as ?unofficial? facilities when the in formation applies only to these locations where only voluntary inspection is provided.
D. Facilities that are approved for reimbursable inspection services are assigned establishment numbers with V designations in PHIS. When an unofficial facility only has an assigned V number, the V number indicates that FSIS performs only voluntary or other reimbursable inspection services at the location and, therefore, is not an official establishment or an official import inspection establishment. An official establishment or an official import inspection establishment that is also authorized for voluntary or other reimbursable services is assigned a V number in addition to the M, P, G, or I numbers. It is possible for an official establishment to have a V number, an M number, a P number, a G number, and an I number, and the number assigned with each letter may be different.
E. FSIS requires all facilities where it provides voluntary or other reimbursable services to:
1. Maintain sanitary conditions (e.g., 9 CFR 416.1-416.5);
2. Meet any other regulatory requirements applicable to the products involved (e.g., temperature requirements for rabbits) or services requested;
3. Apply the Federal mark of inspection to products only when voluntary or other reimbursable inspection services are provided; and
4. Remain current on payments to FSIS.
IV. TYPES OF VOLUNTARY OR OTHER REIMBURSABLE SERVICES
A. FSIS provides identification service (ID service) to maintain the identity of federally inspected and passed meat, poultry, and egg products during the division of products into smaller portions and combination of products into larger units as described in 9 CFR 350.3(a), 362.2(c), and 592.300. FSIS also provides ID service for the repackaging and relabeling of damaged packages and labeling of meat and poultry products as described in 9 CFR 317.12 and 381.140 when not performed at an official establishment. This service is discussed in Section VI.
B. FSIS provides export certification service at the request of an exporter to certify products to be exported as described in 9 CFR 350.3(b), 362.2(b), and 592.20(d). This service is reimbursable when the exporter is not an official establishment or when the export involves requirements or certifications beyond those provided for in the FMIA, PPIA, or EPIA in all facilities. This service is discussed in Section VIII.
C. IPP are to charge for any inspection services performed at official import inspection establishments other than those directly related to import re-inspection. IPP are to charge for inspection activities as described in FSIS Directive 9900.8, Meat, Poultry, and Egg Products Refused Entry into the United States. IPP are to refer to the applicable portions of this directive based on the specific voluntary activities performed at the official import inspection establishment, but this directive does not contain any additional instructions for IPP specifically related to official import inspection.
D. FSIS provides food inspection service as a reimbursable service for the processing of certain food articles that contain meat or poultry but do not require mandatory Federal inspection under the FMIA or PPIA as described in 9 CFR 350.3(c) and 9 CFR 362.2(a). This service is discussed in Section VII.
E. FSIS provides voluntary inspection of exotic animals for wholesomeness as a voluntary service described in 9 CFR part 352. Exotic animals are defined in 9 CFR 352.1(k) as any reindeer, elk, deer, antelope, water buffalo, bison, buffalo, or yak. This service is discussed in Section IX.
F. FSIS provides voluntary inspection of rabbits for wholesomeness as a voluntary service described in 9 CFR part 354. This service is discussed in Section X.
G. FSIS provides voluntary inspection of any migratory waterfowl or game bird for wholesomeness as a voluntary service described in 9 CFR part 362. This service is discussed in Section X.
H. FSIS provides voluntary inspection in official plants and off-premise freezers of the processing of products containing eggs, sampling of products, and quantity and condition inspection of products as a voluntary service described in 9 CFR part 592. This service is discussed in Section XI.
V. GENERAL IPP RESPONSIBILITIES
A. Upon receipt of this directive, the inspector-in-charge (IIC)is to use the next weekly meeting for an official establishment, or an ad hoc meeting for an unofficial facility where voluntary or other reimbursable services are performed, to advise management that this directive has been revised and to review the contents of the directive that pertain to the facility?s operations. The IIC is to review what activities are reimbursable and discuss the local arrangements for how services are requested.
NOTE: The Meeting with Establishment Management task is not assigned to unofficial facilities where only voluntary or other reimbursable services are performed and there is no corresponding (V) task. The Inspection Notes, Meeting Agendas, and Memorandum of Interview features in the Inspection Verification Menu are available for inspection personnel to use at unofficial facilities to document ad hoc meetings.
B. IPP are to record inspection tasks in PHIS for each requested visit when instructed by Office of Field Operations (OFO) supervisors or managers to provide a requested service. IPP are not to travel to these locations unless the service has been requested. IPP are to verify that the facilities meet applicable requirements and that products produced under voluntary inspection are wholesome by performing the appropriate tasks for the specific service at the frequencies described in Table 1.
C. The only tasks IPP are to perform while providing voluntary or other reimbursable service other than export tasks are identified with a (V) after the task name. The verification activities for each inspection task only apply to the areas, rooms, or departments where FSIS conducts the voluntary or other reimbursable service and any surrounding areas that directly impact inspected products. The Update Establishment Profile (V), SPS (V), and General Labeling (V) tasks apply to all facilities where voluntary or other reimbursable services are performed. Other tasks performed during voluntary and other reimbursable services only apply in specific instances (e.g., Agricultural Marketing Service (AMS) tasks for closed-face sandwiches, export tasks). IPP are to direct questions about providing any service to their immediate supervisor.
Table 1: PHIS Tasks for Voluntary or Other Reimbursable Inspection Services
|Task Name||Routine Frequency|
|Update Establishment Profile (V)||1 per month when the unofficial facility operates under voluntary or other inspection service any days within the month|
|SPS Verification (V)||1 per shift when services are requested|
|General Labeling (V)||1 per 5 operating days when services are requested (i.e., once per week when operating every weekday)|
|Humane Handling (V)||1 per shift when FSIS inspected exotics slaughter occurs|
|Good Commercial Practices (V)||1 per shift when FSIS provides voluntary poultry slaughter inspection|
|Export tasks||At the frequencies instructed in FSIS Directives 13000.5 and 9000.1|
|AMS -Pre-Op SSOP Record Review (V)||Refer to FSIS Directive 9000.9|
|AMS -Pre-Op SSOP Review and Observation (V)||Refer FSIS Directive 9000.9|
|AMS -Operational SSOP Record Review (V)||Refer FSIS Directive 9000.9|
|AMS -Operational SSOP Review and Observation (V)||Refer FSIS Directive 9000.9|
|AMS -Fully Cooked-Not Shelf-Stable HACCP (V)||Refer FSIS Directive 9000.9|
D. PHIS does not schedule all the inspection tasks for facilities under voluntary or other reimbursable services because these services are performed only when requested. The PHIS task distributor assigns the tasks a minimum number of times to make the tasks available in the task list for each facility identified in the PHIS establishment profile as approved for a voluntary or other reimbursable service. IPP are to schedule as many additional directed tasks as needed to meet the frequencies in Table 1, depending on when the service is requested. IPP are to perform an SPS(V) task every shift when voluntary inspection services are provided even though these tasks are assigned on the PHIS task calendar task list at a minimum frequency.
EXAMPLE: An ID service is provided 10 times in a month, but PHIS only has five routine SPS (V) tasks assigned for that month. IPP are to schedule the five routine tasks and add five directed SPS Verification (V) tasks. IPP are to consult their immediate supervisor for questions on the assignment of work at facilities where the service is requested.
E. IPP are to review FSIS Directive 13000.1, Scheduling In-Plant Inspection Tasks in the Public Health Information System (PHIS) for instructions on how to schedule tasks other than export tasks. IPP are to refer to FSIS Directive 13,000.5, Public Health Information System Export Certification, and FSIS Directive 9000.1, Export Certification, for instructions on how to document export tasks in PHIS.
F. IPP are not to complete Sanitation Standard Operating Procedures (Sanitation SOP) or Hazard Analysis and Critical Control Point (HACCP) tasks when performing voluntary or other reimbursable inspection services, even if the unofficial facility voluntarily has a Sanitation SOP or HACCP program or the official establishment voluntarily has a Sanitation SOP or HACCP program for nonamenable products. When a Sanitation SOP or HACCP program is explicitly stated as a requirement to export to a specific country in the export library, IPP are to verify compliance with the export library requirements under the Export Certification task or, if available, the applicable AMS task. Instructions and frequency for the AMS tasks are found in FSIS Directive 9000.9, Inspection of Closed-Face Sandwiches for Export to Canada.
G. IPP are to perform the Update Establishment Profile (V) task and refer to FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System, for instructions on how to update the establishment profile. IPP are to review the establishment task list and ensure that the following tasks do not appear when the unofficial facility only performs voluntary activities:
1. Food Defense;
2. Big 8 Formulation;
Review of Establishment Data;
4. Livestock or Poultry Zero Tolerance;
5. SRM Control Verification;
6. Livestock or Poultry Finished Product Standards;
7. Livestock Humane Handling; and
8. Poultry Good Commercial Practices.
H. IPP are not to perform the tasks listed under G1-8 above when performing voluntary or other reimbursable services. These tasks may appear on an establishment task list in an official establishment that also requests voluntary or other reimbursable services, but IPP are to perform the tasks only during mandatory inspection activities.
I. IPP are not to complete the requested certification or allow products to receive Federal marks of inspection if IPP observe insanitary conditions, find that products are unwholesome, or cannot determine that those products or conditions conform to applicable requirements. IPP are to contact their immediate supervisor when necessary, for help determining what subsequent actions to take.
J. IPP are to retain products using an FSIS Form 6502-1, U.S. Retained/Reject Tag, when they observe adulterated or misbranded products in an official establishment as authorized in 9 CFR 500.2(a), 9 CFR 561.1, or 9 CFR 590.426. IPP are also to use FSIS Form 6502-1 when they observe adulterated or misbranded products other than meat, poultry, or egg products that have been or are in the process of being inspected by FSIS in an unofficial facility in order to withhold the voluntary mark of inspection (e.g., adulterated or misbranded exotic meat). IPP are to contact their supervisor if the establishment requests to ship the retained products without the FSIS voluntary mark of inspection.
K. IPP are to contact their supervisor when they observe adulterated or misbranded products that have entered commerce in an unofficial facility. IPP are generally not authorized to detain products that have entered commerce. IPP that have been authorized and instructed by their supervisor are to detain adulterated or misbranded products as outlined in FSIS Directive 8410.1, Detention and Seizure, 9 CFR part 329, 9 CFR part 381 subpart U, 9 CFR part 559, or 9 CFR 590.240 using a red FSIS Form 8400-2, U.S. Detained Tag when there is reason to believe that food products under FSIS jurisdiction or that bear the voluntary mark of inspection in an unofficial facility are adulterated or misbranded.
L. IPP are to charge fees for all reimbursable services for the time required to render such service as instructed in Section XII of this directive.
M. IPP are to follow the instructions to verify SPS regulatory requirements as described in FSIS Directive 5000.1, Verifying an Establishment's Food Safety System to complete the SPS (V) task. The SPS (V) task is used to verify wholesomeness in products produced under voluntary or other reimbursable inspection services. IPP are to:
1. Verify that the facility is operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to prevent the adulteration of products;
2. Make observations and review records (if available) to verify regulatory requirements for each type of service requested;
3. Document noncompliance using PHIS. IPP are not to certify or allow marking with voluntary marks of inspection on products until the facility corrects any sanitation related noncompliance (9 CFR 350.6, 351.20, 352.6, 9 CFR 354.45); and
4. Discuss with their supervisor any questions they have about the wholesomeness of a product.
N. IPP are to verify any applicable labeling requirements as described in FSIS Directive 7000.1, Verification of Non-food Safety Consumer Protection Regulatory Requirements, and FSIS Directive 7221.1, Prior Labeling Approval and document the results in the General Labeling (V) task.
VI. SPECIFIC VERIFICATION ACTIVITIES FOR ID SERVICES (9 CFR 350.3(a), 362.2(c), 592.300
A. IPP are to perform the following verification activities using the appropriate PHIS tasks and instructions found below when ID services are requested, in addition to the general activities described above. ID services are only provided at unofficial facilities.
B. IPP are to review records and observe the handling of products to verify that the unofficial facility maintains product identity and to verify that the unofficial facility handles the products in a manner that prevents adulteration.
1. IPP are to perform the General Labeling (V) task to verify that unofficial facilities are using approved labels, wrappers, or containers bearing the mark of inspection. When unofficial facilities label or relabel products at an ID warehouse, freezer, cold storage, or dry storage facility, the voluntary number assigned to the unofficial facility is used unless the producing establishment number is used as described in 2 below. Unofficial facilities may label products with the inspection legend provided they apply the label under FSIS supervision. FSIS supervision includes either physical presence or an assigned inspector covering the unofficial facility for the entire time the label is applied. Net weight is the only required labeling feature that can be applied without inspection coverage at an unofficial facility that receives ID services. Unofficial facilities relabeling under ID services are required to maintain records as described in 9 CFR part 350 and 9 CFR 381.145-381.182 for traceability.
2. IPP are to verify that the unofficial facility maintains evidence of permission from the producing establishment when the unofficial facility labels products with the originating official establishment number (i.e., labeling depicting the official number of the establishment that produced the products). IPP are to verify that unofficial facility employees mark the products in a manner that will clearly indicate that the products were last handled and labeled at the unofficial facility. IPP are also to verify that the unofficial facility employees maintain records of label transfers and records of products labeled or relabeled at the unofficial facility to properly identify the product origin.
3. IPP are to provide inspection coverage for the duration of the time products are marked with the Federal mark of inspection. Labeling includes placing products in containers that will bear the mark of inspection, placing products in containers that are pre-printed with the mark of inspection, and applying a label bearing the mark of inspection. IPP are to charge the unofficial facility for the time they spend at the location providing inspection and for a proportion of the travel time to and from the unofficial facility. IPP are to charge all of the travel time to and from the facility requesting ID services when there is only one facility requesting service and the travel is only to provide that service (i.e., the entire proportion is charged to one facility). IPP are to calculate a percentage of the travel time to charge to each facility based on the amount of time the inspector spends at the facility providing ID services when multiple facilities request ID services and multiple locations are visited on a single trip (i.e., each facility is charged for the time spent at that facility and a proportion of the total travel time that corresponds to the amount of time spent at that facility). The exact proportion will vary depending on the amount of time spent at each facility on the assignment during a given shift.
4. IPP are not required to provide inspection coverage when products are put through X-ray or metal detection provided no other activities that require inspection are performed. X-ray and metal detection alone, with nothing else done to the products, are not preparing, processing, or labeling and can be performed without FSIS inspection. However, when amenable products are removed from a container or packaging in order to X-ray or detect metal the products must be relabeled or repackaged and the relabeling and repackaging is an activity that requires inspection coverage. FSIS considers placing the products back in the same container of origin to be relabeling when the container bears the mark of inspection. When an official establishment sends product for X-ray or metal detection at an unofficial or uninspected facility, the official establishment is required to consider the process in its hazard analysis.
C. IPP are to perform the SPS (V) task to verify that products handled during ID services, including post-lethality exposed products, are handled in a sanitary manner to ensure the products are not adulterated. The unofficial facility where ID services are performed is not required to comply with 9 CFR part 430; however, it is a prohibited act to produce and ship ready-to-eat (RTE) products adulterated with Listeria monocytogenes or Salmonella. When an official establishment sends RTE product for repackaging to an uninspected facility where it will be post-lethality exposed, the official establishment is required to consider the process in its hazard analysis. IPP are to request assistance from the DO if they observe an ID warehouse repackaging post-lethality exposed RTE products and have concerns about the wholesomeness of the products.
D. IPP are to ensure that only permissible activities are performed under ID services. FSIS regulations do not permit product reconditioning, "ice glazing," or other types of further processing operations, such as boning, trimming, or formulation under ID service. Cutting of amenable products for any purpose, including cutting as part of breaking bulk to meet a net weight specification, is not permissible under only ID service. These operations require a Federal grant of inspection. IPP are to contact their supervisor if they observe these activities performed at an unofficial facility.
E. IPP are not to provide FSIS inspection coverage or ID service when a warehouse or freezer only stores meat, fish of the order Siluriformes, poultry, or egg products that are shelf-stable, frozen, or refrigerated, properly packaged, marked, and labeled and does not repackage, apply a label with an official mark, or otherwise handle exposed products. IPP are to refer requests for coverage or ID service at a location that only stores amenable products to the DO. Labeling features that are not required by FSIS regulations (e.g., 9 CFR 317.2) such as promotional stickers or voluntary code dates may be added to inspected products without inspection.
F. IPP are to also provide the following types of label verification services at unofficial facilities if requested and approved by the DO:
1. IPP are to provide inspection service for off-premises freezing of poultry to verify 9 CFR 381.66(f) and 381.148. IPP are to perform the SPS (V) task 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. IPP are to perform the General Labeling (V) task to verify that raw or processed poultry products, frozen at an unofficial facility, meet label claims regarding freezing. IPP are to verify that the facility lowers the internal product temperature in the warmest part of the package to 0ºF within 72 hours of entering the freezer and maintains poultry in a solidly frozen state.
2. IPP are to provide special claims label verification to verify that a label claim, such as ?wet aged? or ?treated to inactivate trichinae,? on a meat product label is accurate. IPP are to verify the labeling claim during the General Labeling (V) task and are to verify that the products are handled in a sanitary manner (9CFR 350.3(b), 362.2(b)) during the SPS (V) task. IPP are to verify these facilities maintain documentation to demonstrate that the products were held per the label claim (i.e., for a set number of days at a set temperature) when they have requested other reimbursable inspection for this service.
VII. SPECIFIC VERIFICATION ACTIVITIES FOR VOLUNTARY OR OTHER FOOD INSPECTION SERVICE (9 CFR 350.3(c), 362.2(a))
A. IPP are to verify, through direct observation of processes, examination of products, and review of records, that the preparation and labeling of the products comply with the applicable provisions in 9 CFR 350.3(c) and 9 CFR362.2(a). For purposes of voluntary or other reimbursable services, a food article is an item containing meat, poultry, meat byproducts, or meat or poultry food products for which an applicant requests and pays for the mark of inspection, but for which the FMIA and PPIA do not require inspection (e.g., meal kit containing a fully-labeled meat or poultry component, closed-face sandwich, casings, or poultry broth).
B. IPP are to perform the SPS (V) task to verify the applicable sanitation and wholesomeness provisions for voluntary food inspection service related to non-amenable poultry (e.g., the slaughter and processing of migratory waterfowl or game birds and any poultry or human food products made from poultry that are not covered by the inspection requirements of the PPIA).
C. IPP are to perform the SPS (V) task to verify livestock origin components of a food article and livestock casings originate from federally inspected and passed carcasses or legally imported livestock origin components.
D. IPP are to perform the General Labeling (V) task to verify:
1. Labeling provisions in 9 CFR 317.2 and 9 CFR part381 Subpart N for voluntary food inspection service related to meat and poultry products that do not require inspection under the Acts;
2. Products found to be wholesome are marked with the mark of inspection using the assigned V number in place of the M or P number of the official establishment in the official inspection legend;
3. Sketch label approval for all products produced under this service; and
4. Product labels are not misleading and list all ingredients, including big 8 allergens and other ingredients of public health concern, if present.
NOTE: Non-amenable products that do not contain any meat or poultry or were not derived from meat products or poultry products (e.g., ?cheese pizza?) are not eligible for this inspection service.
VIII. SPECIFIC VERIFICATION ACTIVITIES FOR EXPORT CERTIFICATION SERVICE (9 CFR 350.3(b), 351, 362.2(b))
A. IPP are to perform and record the applicable PHIS export task as described in FSIS Directive 9000.1 for reimbursable exports whether those services are at official establishments or unofficial facilities.
B. IPP are not to charge for the issuance of export certificates with no additional statements or verification of foreign country requirements as provided in 9 CFR part 322, 381.104-381.111, part 552, 590.407 and as described in FSIS Directive 9000.1 and FSIS Directive 9000.6, Export Certification of Egg Products from Other than Official Egg Products Plants when performed in an official establishment, unless these activities are performed during overtime or holiday coverage.
C. IPP are to charge for the time required to perform the verification and certification of standards described in the export library that are not imposed by or are in addition to those imposed by FSIS regulations listed under B. above in an official establishment because these activities are voluntary. When a country has a requirement listed in the export library, it describes something that is above and beyond the basic FSIS regulatory requirements and the verification of that requirement is, therefore, subject to reimbursement. Some examples of activities that may be listed in the export library that are beyond the requirements specified in FSIS regulations include:
1. Signing of the certificate by a veterinarian when required by the export library;
2. Certifying the freezing of products to destroy live trichinae to meet export library requirements;
NOTE: FSIS removed the regulatory requirement for trichina certification in 83 FR 25302, Elimination of Trichinae Control Regulations and Consolidation of Thermally Processed, Commercially Sterile Regulations in 2018 and no longer provides voluntary certification service unless it is part of export certification.
3. Certifying of technical animal fats for export in accordance with 9 CFR part 351 (see G below for more information);
4. Issuing replacement certificates;
5. Applying the mark of inspection to casings as described in FSIS Directive 9000.2, Inspection and Export Certification of Livestock Intestines or Casings; and
6. Verifying that a product did not come from a disease restriction zone to meet export library requirements.
D. IPP are to charge for other reimbursable services when export certificates are issued, as described in FSIS Directive 9000.1 and Directive 9000.6, at unofficial facilities.
E. IPP are to charge for the time it takes to perform verification and certification of egg products for export when performed at off-premise freezers. IPP are to review FSIS Directive 9000.6 for instructions on how to perform this certification. IPP are not to issue an export certificate for food products containing egg produced under voluntary inspection services that are covered under Food and Drug Administration (FDA) because AMS issues the export certificate for these products.
F. IPP are to verify that facilities and operations comply with the requirements in 9 CFR part 351 when performing export activities related to certification of technical animal fats for export under the applicable export or voluntary task. These verification activities include verification of:
1. Facilities and equipment adequate to maintain the identity of certified animal fats and the materials used in their preparation under the SPS (V) task;
2. Records substantiating that the technical animal fats originate from animals which were slaughtered under Federal inspection under the SPS (V) task;
3. Processes in 9 CFR 351.14 used in the preparation of technical animal fats under the SPS (V) task;
4. Labels to ensure that the labels do not bear the mark of inspection and products are conspicuously labeled as ?technical animal fats not intended for human food? under the General Labeling (V) task; and
5. Export certifications as set out in 9 CFR part322 and FSIS Directive 9000.1 under the applicable PHIS Export Certification task.
IX. SPECIFIC VERIFICATION ACTIVITIES FOR VOLUNTARY INSPECTION OF EXOTIC SPECIES (9 CFR part 352)
A. IPP are to perform inspection tasks relating to the slaughter and processing of exotic animals and exotic animal products as a reimbursable service when requested by an official establishment or unofficial facility that has been approved for this service in accordance with 9 CFR 352.3. IPP are to provide Federal voluntary inspection services for species listed in 9 CFR part 352 (reindeer, elk, deer, antelope, water buffalo, bison, buffalo, or yak). IPP are to review records and make observations to verify that facilities and operations comply with the requirements of 9 CFR part 352 under the SPS (V) and General Labeling (V) tasks.
NOTE: Instructions for rabbits and non-amenable poultry are in Section X.
B. IPP are to consider the amenability of exotic/cattle crosses based on producer documentation, if documentation is available. In the absence of producer documentation, IPP are to consider the appearance of the animal to determine amenability.
1. Beefalo or buffalo beef have an appearance of cattle and are amenable to FSIS mandatory inspection and would be marked with a round Federal mark of inspection.
2. Cattalo (or catalo) are any hybrid animal with bison appearance resulting from direct cross breeding of bison and cattle. Cattalo have an appearance of bison, are not amenable to FSIS inspection, and can be slaughtered under FSIS voluntary inspection service. When slaughtered under FSIS inspection cattalo are marked with a triangle mark of inspection.
C. IPP are to perform ante-mortem on exotic animals presented for voluntary inspection according to FSIS Directive 6100.1, Ante-mortem Livestock Inspection, to determine wholesomeness. IPP are not to apply the requirements for non-ambulatory disabled cattle to exotic species. IPP are to perform field antemortem inspection as described in 9 CFR 352.4 and 352.10 when requested by the facility, provided the District Manager (DM) has approved the field ante-mortem location. The DM or designee is to consider the following before approving field ante-mortem:
1. Sanitation of the field ante-mortem area;
2. Safety of IPP in the field ante-mortem area;
3. Proximity to the slaughter facility; and
4. Availability of a veterinarian assigned to the area to perform post-mortem disposition on all incoming ?U.S. Suspect? tagged animals.
NOTE: When the slaughter occurs in afield immediately adjacent to the slaughter facility, including a mobile slaughter facility, FSIS considers the field as if it were a pen at the facility (9 CFR352.10(c)); the requirements for field ante-mortem do not apply.
D. IPP are to verify that exotic animals are slaughtered and handled in compliance with 9 CFR352.10. 9 CFR 352.10 cross references 9 CFR 313.2 and 9 CFR 313.15 or313.16. IPP are to document findings in the Humane Handling (V) task. IPP are not to perform the Livestock Humane Handling task or document HATS time for exotic species slaughter. When a facility slaughters both exotics and amenable livestock on the same day, IPP are to complete a Humane Handling (V) task for the exotics slaughter and a separate Livestock Humane Handling task where IPP are to include the HATS time spent verifying humane handling related to the amenable species slaughter. IPP are to follow the instructions in FSIS Directive 6900.2, Humane Handling and Slaughter of Livestock for how to verify only 9 CFR 313.2, 313.15, and 313.16 for exotic animals slaughtered at the facility. When exotic species are slaughtered by ritual methods as described by a religious authority, 9 CFR 313.15 or 313.16 may not apply. IPP are to follow the instructions in FSIS Directive 6900.2 to document noncompliance under the Humane Handling (V) Task or notify their supervisor when IPP observe inhumane treatment of exotic animals in connection with slaughter related to these regulatory requirements. IPP are not to apply the Animal and Plant Health Inspection Service (APHIS) 28 Hour Law to exotic species.
E. IPP are to verify that the facility has a written program in place to verify each individual animal identification against the associated Canadian export health certificate for all exotic ruminants (e.g., bison) imported under APHIS restriction for immediate slaughter. For exotic species from Canada arriving for immediate slaughter under APHIS restriction, IPP are to verify before ante-mortem inspection that:
1. The facility is approved by APHIS to receive Canadian ruminants;
2. Loads arrive with an intact Canadian government seal or a U.S. government seal and presents a Canadian export health certificate and either a Veterinary Services (VS) Form 17-36, ?Inspection Report of Establishment [Approved] for Immediate Slaughter of Import Animals? or are listed as an approved establishment on the APHIS website;
NOTE: APHIS requires slaughter facilities that want to receive bison or other exotic ruminants from Canada for immediate slaughter to enter into an agreement with APHIS, so the establishment employees can break APHIS seals.
3. All Canadian exotic ruminants in each load are unloaded and penned separately from domestic livestock or domestic exotics;
4. The facility segregates, identifies, and presents all dead-on-arrival (DOA), and dead-in-pen (DIP)exotics to IPP. IPP are to account for all Canadian DOA and DIP animals on official documents associated with each shipment and in PHIS;
5. The facility has a written program in place to verify each individual animal ID against the associated Canadian health certificate;
6. The facility implements their procedures to verify individual animal identification against the associated Canadian health certificate.
F. During ante-mortem inspection on Canadian exotics imported under APHIS restriction for immediate slaughter, IPP are to verify that:
1. The number of animals on the truck, pen, or lot at the time of ante-mortem inspection is less than or equal to the number of exotics listed on the associated VS Form 17-33, ?Animals Imported for Immediate Slaughter? or the Canadian health certificates; and
2. Each animal in each load of Canadian exotics has an official Canadian Food Inspection Agency (CFIA) ear tag or identification. IPP are to control and withhold from slaughter any individual animal missing an official identification tag or with an incorrect official identification tag with a U.S. Condemned tag or a U.S. Retained/Reject tag (FSIS Form 6502-1) and notify their supervisor.
G. IPP are to perform post-mortem inspection according to 9 CFR 352.11, which refers to 9 CFR part
310. IPP are to record slaughter totals provided by the establishment and slaughter dispositions under the applicable class and subclass in the PHIS Animal Disposition Reporting page and perform post-mortem inspection as instructed in FSIS Directive 6100.2, Post-mortem Livestock Inspection using:
1. Post-mortem inspection procedures for cattle when inspecting mature bison, buffalo, elk, reindeer, yak, and large deer;
2. Post-mortem inspection procedures for calves when inspecting young bison, buffalo, yak, and elk; or
3. Post-mortem inspection procedures for lamb or sheep when inspecting antelope and small deer.
H. During post-mortem inspection on Canadian exotics imported under APHIS restriction for immediate slaughter, IPP are to verify that:
1. The Canadian exotics are slaughtered together as a lot. The establishment may request authorization from the veterinarian to slaughter sub-lots for operational reasons; and
2. The establishment maintains the identity of each animal (or lot of animals) of Canadian origin until PM inspection is completed (9 CFR 352.11, which refers to 9 CFR 310.2).
I. Veterinarians assigned to facilities that slaughter Canadian exotics imported for immediate slaughter are to complete, sign, and date VS Form 17-33 and maintain records in FSIS files for at least5 years. Veterinarians are to send a copy of the signed and dated VS Form 17-33 to the Port of Entry as written on the form within 14 calendar days of receipt.
J. IPP are to perform the following specific verification activities during the voluntary processing and slaughter of exotics:
1. IPP are to verify 9 CFR 310.18, which prohibits visible feces on carcasses and carcass parts, under the SPS (V) task. Under this requirement, establishments are to remove any such contamination from carcasses and parts before they may be found wholesome and receive the mark of voluntary inspection (9 CFR 352.1(i)). IPP are to verify this requirement as part of postmortem inspection and the SPS(V) task. The Livestock Zero Tolerance task does not apply to exotic species.
2. IPP are to verify the labeling of exotic products produced under voluntary inspection under the General Labeling (V) task. IPP are to allow the triangular mark of inspection only on exotic animal products from animals slaughtered and processed under FSIS voluntary inspection as specified in 9 CFR part 352. When inspected by FSIS, these products may be marked with a triangular shaped mark of inspection depicted in 9 CFR 352.7 with the number assigned to the facility printed within the triangle or elsewhere on the packaging material.
a. Carcasses that are further processed in the same facility where they are slaughtered are not required to be stamped with the mark of inspection on the slaughter floor unless stamping is the only method available to maintain the identity of the products (e.g., to separate amenable and exotic carcasses or separate inspected and non-inspected carcasses).
b. IPP are to verify that products are not misbranded and that all ingredients, including any allergens or ingredients of public health concern are accurately identified on the label.
c. IPP are to verify that the label file maintained at the facility matches labels applied to products. If IPP question a label, IPP are to submit a question using askFSIS and supply the label approval number from the sketch along with the V number for the facility.
d. IPP are to verify that only American Bison (Bison bison) and Cattalo are labeled as ?Bison? (9 CFR 352.1(e) and 352.1(g)). Any animal from the genus Bison may be labeled as ?Buffalo?.
e. IPP are to discuss concerns with their supervisor when they observe products produced from animals of the subtribe Bubalina of the tribe Bovini that have been labeled as buffalo or bison. Within this subtribe Bubalus bubalis is commonly known as water buffalo and Syncercus caffer is commonly known as Cape buffalo.
3. IPP are to provide voluntary inspection of processed exotic products only if the exotic animal raw materials are received for processing with the triangular mark of inspection. Exotic animals slaughtered outside of FSIS inspection (e.g., import, FDA, or state inspection) are not eligible for use in voluntary inspected products.
4. IPP are to verify that amenable meat or poultry products (e.g., products formulated with 2% or more cooked or more than 3% raw amenable meat or poultry) are produced under mandatory inspection in an official establishment and labeled as USDA Inspected and Passed. Exotic animal products may be used as ingredients in an amenable product at any proportion if the finished product contains an amenable amount of meat or poultry. IPP are to consider exotic meats that are not slaughtered under FSIS voluntary inspection to be the same as any other FDA ingredient used in amenable products.
5. IPP are not to collect samples of non-amenable products for an amenable livestock sampling program (e.g., NARMS_BC for residue, HC11 and MT60 for pathogens).
6. IPP are not to apply or allow the establishment to apply the triangle USDA mark of inspection to carcasses or parts of cervid animals tested for Chronic Wasting Disease until after ?not detected? test results are received if a carcass is tested. FSIS does not require testing to determine if meat from cervid animals is wholesome. IPP are to allow establishments to hold or further process (e.g., bone) tested carcasses pending test results provided that the establishment properly identifies and maintains control of the affected carcass or parts. IPP are to observe how the establishment addresses cross contamination during further processing of these products and ensure the carcass and parts are handled in a sanitary manner.
NOTE: Exotic animals slaughtered under voluntary inspection do not require the removal of specified risk materials (SRMs); SRMs are only found in cattle as defined in 9 CFR 310.22(a).
X. SPECIFIC VERIFICATION ACTIVITIES FOR POULTRY AND RABBIT VOLUNTARY INSPECTION
A. IPP are to perform inspection activities relating to the slaughter, processing, condition, and wholesomeness of non-amenable poultry and poultry products as a voluntary reimbursable service under 9 CFR part 362. IPP are to perform inspection activities relating to the slaughter and processing of rabbits as a voluntary service under 9 CFR part 354.
B. IPP are to perform ante-mortem and post-mortem activities when providing slaughter services and enter slaughter totals provided by the facility in the Animal Disposition Reporting in PHIS as described in FSIS Directive 6100.3, Ante-Mortem and Post-Mortem Poultry Inspection. IPP are to record both rabbit slaughter totals and voluntary poultry slaughter totals under poultry in the PHIS Animal Disposition Reporting page.
C. IPP are to verify that birds slaughtered under FSIS voluntary inspection are slaughtered in accordance with 9 CFR 362.2(a). 9 CFR 362.2(a) cross references 9 CFR part 381 and does not exclude 9 CFR 381.65(b). IPP are to document findings in the Good Commercial Practices (V) task. IPP are not to perform the Poultry Good Commercial Practices task to document verification of 9 CFR 381.65(b) for poultry slaughtered under voluntary services. When a facility slaughters both amenable poultry and poultry under voluntary services, IPP are to complete a Good Commercial Practices (V) task for the verification done under voluntary services and a separate Poultry Good Commercial Practices task for verification done for amenable poultry slaughter. IPP are to follow the instructions in FSIS Directive 6110.1, Verification of Poultry Good Commercial Practices to verify that the facility operates in compliance with 9 CFR 381.65(b) and notify their supervisor when IPP observe concerns related to Good Commercial Practices.
NOTE: There is no reference to humane handling or good commercial practices in 9 CFR part 354 and no applicable cross references to these requirements for rabbit slaughter.
D. IPP are to perform the SPS (V) task to verify that the facility is maintained in a sanitary condition and the products are wholesome.
E. IPP are to perform the General Labeling (V) task to verify:
1. Labeling records contain sketch approval for each label;
2. Poultry products slaughtered or processed under voluntary inspection are marked with the poultry mark of inspection and the assigned V number;
3. Rabbit products slaughtered or processed under voluntary inspection are marked with the mark of inspection as shown in 9 CFR 354.65 and the digits of the assigned V number (i.e., P-XXXX in the round mark where XXXX are the number digits of the assigned V number); and
4. All ingredients, including allergens or ingredients of public health concern, included in the products are listed so the product is not misbranded.
XI. SPECIFIC VERIFICATION ACTIVITIES FOR EGG PRODUCTS VOLUNTARY INSPECTION (9 CFR Part 592)
A. Reimbursable activities which are outside the scope of mandatory inspection (e.g., voluntary inspection service) in an egg products plant, may include:
1. Collecting samples of products for laboratory analysis for certification purposes. This includes any sampling beyond the mandatory sampling of finished egg products required by regulation. Some examples are USDA Commodity Purchase Programs or other Federal agency specification, and export requirements of foreign governments;
2. Certification of amenable egg products (liquid, frozen, or dried) for export when these activities are voluntary as described in FSIS Directive 9000.1; or
3. Certification of non-amenable food products which contain eggs (9 CFR 592.20).
B. IPP are to verify labeling records to demonstrate label approval under a General Labeling (V)task. IPP are to verify that allergens or ingredients of public health concern are included on the product labels.
C. IPP are to refer to FSIS Directive 5030.1, Inspection Methodology Utilizing the Public Information System for the Verification of Regulatory Compliance in Egg Products and FSIS Directive 5000.1 for instructions on how to perform the corresponding (V) tasks.
XII. CHARGING FOR VOLUNTARY OR OTHER REIMBURSABLE INSPECTION SERVICES
A. IPP are to charge official establishments and unofficial facilities for the time they spend on site performing voluntary inspection or other reimbursable services and the applicable travel time required to perform the reimbursable service. Whenever IPP are performing certification or verification activities associated with voluntary or other reimbursable inspection services, the time is reimbursable, even when the inspector is within the assigned tour of duty (e.g., 01 time). IPP are to charge for voluntary or other reimbursable inspection services provided both during their official tours of duty and for voluntary or other reimbursable services provided on overtime and holidays. IPP are to refer questions on billing, completing paperwork, accounting codes, establishment numbers, and delinquent payments to the DO. IPP are to refer specific questions on how to charge for voluntary or other reimbursable inspection services in a specific assignment or for a specific shift to their supe rvisor.
B. IPP are to record the time for voluntary or reimbursable services rendered in WebTA by selecting the corresponding facility where the reimbursable time was worked in the ?Establishment ID? field. IPP are not to use a paper FSIS Form 5110-1, Services Rendered, and are only to use WebTA to document reimbursable services. FSIS Form 5110-1 is only for use by State Inspectors or Commission Corps Officers to submit to the Financial Services Center (FSC). IPP are to be aware that rates for fees to be charged and collected for service are specified in 9 CFR 391.2-391.4 and 592.510-592.530.
C. IPP are to charge in¼ hour (15 minute) increments for voluntary or other reimbursable services. Reimbursable charges are rounded to the nearest quarter hour as prescribed in FSIS Directive 4550.7, Pay for the Continuous Workday (9 CFR 307.6(a), 381.39(a)).
D. IPP are to charge for the time required to furnish voluntary or other reimbursable inspection services, including the travel time required to provide the service (9 CFR 350.7(c), 351.9, 352.5(c), 354.106, and 362.5(c)). IPP are to prorate the costs (i.e., to divide in a proportional way based on time) charged to each establishment when travel is required for voluntary or other reimbursable services at multiple facilities.
EXAMPLE: An inspector is on a patrol assignment consisting of three locations. While at the first official establishment visited for the day, the Frontline Supervisor assigns the inspector to travel to a warehouse where off-premise freezing of poultry is performed. The inspector completes the scheduled work at the first official establishment and decides to stop at the warehouse, located between the two official establishments, before inspecting at the second official establishment. The warehouse is a 10-minute driving time off the route between the two official establishments. The inspector spends 1.5 hours at the warehouse performing verification activities before continuing to the second official establishment on the patrol assignment. The inspector is to charge for the one and a half hours (90 minutes) of reimbursable services performed at the warehouse. The driving time to and from the warehouse is 10 minutes each way, for a total of 20 minutes and there is no prorating since only one location is receiving reimbursable service. The inspector charges all the time spent traveling to and from the warehouse and the time spent performing the service to the unofficial facility. IPP are to charge the warehouse 90 minutes + 20 minutes, or 110 minutes, then round the charge to the nearest ¼ hour or 1 & 3/4 hours.
E. IPP are to charge an official establishment or unofficial facility for a minimum of 2 hours when instructed by their supervisor to perform a call back. A call back occurs when a facility requests inspection services after the employee has completed the workday and left the premises or after the employee has completed their regularly scheduled workweek and is called back to duty during an overtime or holiday period. IPP are to record the time necessary to perform reimbursable inspection services during a call back with a transaction code of TC 21. IPP are to use TC30, Overtime Call Back No Work Required, for the balance of the time if less than 2 hours are actually worked. To ensure facilities are billed, IPP are to record the time in WebTA by selecting a billable accounting code and entering the corresponding facility where the reimbursable time was worked in the ?Establishment ID? field for each TC 21 and TC 30 entry. IPP are to include travel time in the calculation for a call bac k, however IPP?s normal commute may or may not be included depending on the specific details and if the time is compensable or not. IPP are to refer to FSIS Directive 4550.1, Travel Time Pay Entitlements Under Title 5, U.S. Code, FSIS Directive 4610.9, Travel Compensatory Time, and contact Pay and Leave Guidance (PayAndLeaveGuidance@usda.gov) for assistance to determine when the regular commute is compensable, and therefore reimbursable, for a call back.
EXAMPLE: An inspector arrives home after working his or her regular tour of duty to find a message from the DO, who needs the inspector at a nearby warehouse to certify products for export (a voluntary reimbursable service). The inspector drives 15 minutes to the warehouse to perform Export Certifications. It takes the inspector 30 minutes to perform the requested services and sign the certificates. IPP are to charge for the 30 minutes of reimbursable services performed at the warehouse. IPP are then to calculate the travel time. In this case, the compensable driving time to and from the warehouse is 15 minutes each way, for a total of 30 minutes. There is only one location receiving the reimbursable service, so there is no need to prorate the travel time; the inspector charges the compensable travel to the warehouse. The total time to perform the reimbursable service is 30 minutes + 30 minutes, or 60 minutes. However, the minimum charge for a callbackis2 hours. Therefore, the inspecto r charges the warehouse for 2 hours of reimbursable services using TC 21 for 60 min to reflect the time worked and TC 30 for 60 minutes for the balance of the 2-hourcallbackwhen no work was required. The inspector selects the facility in the ?Establishment ID? field for each.
F. Supervisory personnel are to consider daily duty limitations described in FSIS Directive 4610.6, Daily Duty Limitations for Inplant Inspectors, when assigning coverage for voluntary or other reimbursable services.
XIII. APPROVING AND DENYING VOLUNTARY OR OTHER REIMBURSABLE INSPECTION SERVICES
A. The designated DO employee is to request that applicants for voluntary or other reimbursable inspection services use FSIS Form 5200-6, Application/Approval for Voluntary Reimbursable Inspection Service, to apply for voluntary and other reimbursable services. FSIS Form 5200-6 is a different application than FSIS Form 5200-2, Application for Federal Inspection, the application used to apply for a Federal grant of inspection for mandatory inspection services. The designated DO employee is to request both applications from official establishments that also request voluntary or other reimbursable inspection services. The DM or designee is to refer to FSIS Directive 5220.1, Granting or Refusing Inspection; Voluntary Suspending or Withdrawing Inspection; and Reinstating Inspection under PHIS, for instructions on processing FSIS Form 5200-2 when that form is submitted.
B. When an applicant submits FSIS Form 5200-6, the DM or designee is to visit the facility to determine whether it meets the general requirements for the service requested. The DM or designee is to verify that the facility meets the sanitation requirements and the applicable regulatory requirements for the service in the area of the facility where FSIS will perform the voluntary or other reimbursable inspection service. The DM or designee is to evaluate the facility for the requirements specified by the type of services requested.
C. The DM or designee is not to assign a V number for the facility to use for voluntary or other reimbursable services when facility requirements for the requested services are not in compliance or when the activities described by the applicant require a Federal meat or poultry grant of inspection and are not eligible for voluntary or other reimbursable inspection services.
D. The DM or designee is to document his or her findings on FSIS Form 5200-4, Recommendation on Application for Inspection if the DM determines FSIS will not provide the service.
E. If the facility meets the requirements for the requested services, the DM or designee is to work with the Grant Curator to identify the appropriate V number through PHIS as described below, assign the number to the facility, and agree to furnish the requested service by signing FSIS Form 5200-6. Instructions on how to add a voluntary or other reimbursable service to PHIS are contained in FSIS Directive 5220.1.
F. The Grant Curator is to:
1. Ensure the number on a paper FSIS Form 5200-6 is designated with a ?V? at the beginning (e.g., VXXX), in the same format it appears in PHIS;
2. Reserve the V number that corresponds to an official establishment?s previously assigned number when an official establishment applies for voluntary or other reimbursable services. If the corresponding V number is already assigned, proceed to the next available V number;
3. Verify that the next available V number is not already assigned to an official establishment or official import inspection establishment as an M, P, G, or I number. Only select V numbers where the number for all grant types is currently available;
4. Reserve the corresponding M, P, G, and I numbers so they are not assigned to another official establishment or official import inspection establishment. The grant curator is to reserve the numbers for all grant types even when the unofficial facility is not applying for a Federal grant of inspection to prevent misbranding; and
5. Verify that only the requested numbers (corresponding to the applications submitted) are selected as active in PHIS.
G. The DM or designee is to inform the facility that once the application process is complete, foreach occasion that the facility requires voluntary or other reimbursable inspection services, the management of the facility is to request inspection coverage from the FSIS DO or through the notification process established by the FSIS DO. The DO is to provide the applicant with guidance on how the service is to be requested and how FSIS will confirm coverage of the request.
H. The DM may deny a request for service for administrative reasons, (e.g., no availability of FSIS personnel to perform the service or the applicant?s reimbursable services account is delinquent) until the cause for denial of service is alleviated. However, the DM is to make a reasonable effort to provide all requested reimbursable services.
I. The DM may deny reimbursable services for any of the following reasons:
1. Insanitary conditions found in the facility that would render the products unwholesome;
2. Improper records or certificates;
3. Management or employees of the facility fail to comply with any conditions of the FSIS agreement to furnish voluntary or other reimbursable inspection services;
4. Management or employees of the facility violate the applicable FSIS regulations or the FMIA, PPIA, or EPIA; or
5. Failure to remain current on payments to the reimbursable services account.
J. The DM or designee is to refer the case to the Enforcement Operations Staff, Office of Investigation, Enforcement and Audit (OIEA) as instructed in FSIS Directive 8010.5, Case Referral and Disposition, when there is reason to believe voluntary or other reimbursable inspection service should be indefinitely denied or withdrawn.
Refer questions regarding this directive to your supervisor, or to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select the inquiry type ?Labeling?, ?Export?, or ?General Inspection Policy? based on your question.
NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.
Rachel A. Edelstein
Office of Policy and Program Development