I. PURPOSE

      This directive instructs inspection program personnel on how to verify that plants comply with regulatory requirements designed to protect the consumer in ways other than ensuring food safety. It also issues new Inspection System Procedures (ISP) descriptions for all 04 and 05B procedures, except 04C02, Humane Handling. FSIS is retiring procedure code 04C01, and therefore, inspection program personnel are not to use it. Inspection program personnel are to follow FSIS Directive 6900.1, Revision 1 and 6900.2, Revision 1 when verifying humane handling requirements.

      Key Points Covered

      Verification activities performed by inspection program personnel are to be predominantly food safety focused, but it is also necessary to verify compliance with requirements that provide non-food safety protections to consumers.

      Methodology and documentation for verifying that there is compliance with these non-food safety requirements.

ll. CANCELLATIONS

FSIS Directive 5400.5, Attachment 6, "Inspection System Procedure Guide," pages 4-1 through 4-10, 5-3 and 5-4
FSIS Directive 7110.2, Revision 1, "Update of Protein Fat Free (PFF) Instructions"
FSIS Directive 7130.3, "Inspection Procedure for Fat and Added Water in Cooked Sausage"
FSIS Directive 7140.2, "Determining Added Water in Cooked Sausage"
FSIS Directive 7140.3, "Determining Added Water in Fresh Sausage"
FSIS Directive 7236.2, "Nutrition Labeling of Meat and Poultry Products"
FSIS Directive 7240.1, "Compliance Testing for Net Weight Labeling of Meat and Poultry Products"
FSIS Directive 7310.6, "Bacon Yield Determinations"
FSIS Directive 7330.1, "Sampling Frequencies for Cooked Sausage Produced Under a Quality Control Program"
FSIS Directive 10,230.1, "Species Identification Sampling for Cooked Products"
MPI Manual Part 11-D and Part 18
MPI Bulletins 75-56, 78-111, 79-42, 80-4, and 83-54
Any Regional Notices, MPI Bulletins or other written instructions related to reinspection of livestock product for reasons other than public health and food safety.

Ill. [RESERVED]

IV. REFERENCES

Federal Meat Inspection Act (FMIA)
Poultry Products Inspection Act (PPIA)
9 CFR Parts 301, 313, 316, 317, 318, 319, 327, 381 Subpart P, 424, 441, and 500
FSIS Directive 5000.1, Revision 3, "Verifying An Establishment's Food Safety System"
FSIS Directive 5400.5, Attachment 5, "Inspection System Activities"
FSIS Directive 6120.1, "Finished Product Standards Program for the New Line Speed Inspection System and the Streamlined Inspection System"
FSIS Directive 6700.1, "Retained Water in Raw Meat and Poultry Products"
FSIS Directive 6810.1, "Grademark Labeling on Meat and Poultry Products"
FSIS Directive 6900.1, Revision 1, "Humane Handling of Disabled Livestock" FSIS Directive 6900.2, Revision 1, "Humane Handling and Slaughter of Livestock"
FSIS Directive 7000.2, "Experimental and Sample Products Policy"
FSIS Directive 7120.1, "Safe and Suitable Ingredients Used in the Production of Meat and Poultry Products"
FSIS Directive 7124.1, "Standards of Identity or Composition - Use of Cooked or Cured Product"
FSIS Directive 7140.1, "Questions and Answers Relating to Ingredients That May Be Designated as Flavors, Flavorings, Natural Flavors or Natural Flavorings in the Ingredients Statements on the Labels of Meat and Poultry Products"
FSIS Directive 7160.1, "Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery Systems"
FSIS Directive 7160.2, "'Meat' Prepared Using Advanced Mechanical Meat/Bone Separation Machinery and Meat Recovery Systems"
FSIS Directive 7160.3, Revision 1, "Advanced Meat Recovery Using Beef Vertebral Raw Materials" FSIS Directive 7220.1, "Policy Memoranda"
FSIS Directive 7221.1, Amendment 1, "Prior Labeling Approval"
FSIS Directive 7222.1, "Inspection Requirements for Food and Nutrition Service In-plant Control Programs"
FSIS Directive 7235.1, "Mandatory Safe Handling Statements on Labeling of Raw and Partially Cooked Meat and Poultry Products"
FSIS Directive 7237.1, Revision 1, Amendment 1, "Labeling of Ingredients" FSIS Directive 7270.1, Revision 1, "Sampling and Testing Procedures for Raw Poultry Products Labeled 'Fresh'"
FSIS Directive 7355.1, Revision 2, "Use of Sample Seals for Laboratory Samples and Other Applications"
FSIS Directive 7620.3, "Processing Inspectors' Calculations Handbook"
FSIS Directive 8080.1, Revision 4, Amendment 1, "Recall of Meat and Poultry Products"
FSIS Directive 10,200.1, "Accessing Laboratory Sample Information via LEARN"
FSIS Directive 10,210.1, "Unified Sampling Form"
FSIS Directive 10,520.1, Revision 1, "Pumped Bacon Sampling Program - Nitrosamine Analysis"
Part 3, Section 3, "Import Inspection Manual of Procedures for the Species Verification Testing Program"
Policy Memos 42, 44A, 57A, 66C, and 84A
NBS Handbook 133
NIST Handbook 44

V. BACKGROUND

FSIS' highest priorities are protecting public health and food safety. By making the procedural changes announced in this directive, the Agency is ensuring that inspection program personnel focus on food safety, yet still verify other protections extended by the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). The Agency is making changes in the verification procedures that relate to these other protections to ensure that they align with FSIS' responsibilities and priorities.

VI. VERIFICATION METHODOLOGY FOR NON-FOOD SAFETY ISP CODES (ALL 04A AND 04B CODES AND 04C03 and 04C04 CODES)

        A. When the Performance Based Inspection System (PBIS) schedules one of these non-food safety procedures per one of the above codes, inspection program personnel are to perform the appropriate verification procedure. This includes observing establishment product formulation, verifying the accuracy of labeling, observing preparation or processing procedures; reviewing establishment records; examining product; checking product identification, condition and temperature; or performing a variety of other in-plant measurements, testing, and calculations.

        B. Inspection program personnel are not to perform unscheduled non-food safety consumer protection verification procedures unless, during the performance of food safety verification activities, they observe conditions or activities that cause them to suspect that the establishment is not meeting non-food safety regulatory requirements. Conversely, if while performing a scheduled non-food safety consumer protection verification procedure inspection program personnel identify food safety concerns, they should perform the food safety procedure as an unscheduled procedure and take any necessary enforcement actions. For example, if an inspector is performing a routine labeling verification procedure and discovers that the establishment has used an ingredient of public health concern without properly declaring the ingredient, the inspector should pursue the food safety aspects of the findings and perform the appropriate unscheduled food safety procedures as instructed in FSIS Directive 5000.1, Revision 3.

        C. Attachment 1 to this directive reissues and replaces all of the 04 and 05B codes from FSIS Directive 5400.5, Attachment 5. When verifying compliance with a non-food safety requirement, inspection program personnel are to use attachment 1 to find:

              1. Procedure code (column 1)

              2. Examples of products (column 2)

              3. Regulatory references (column 3)

              4. FSIS issuance references (column 4)

              5. Verification instructions (column 5) NOTE: Lists of example products, regulatory references, FSIS issuances, and verification instructions provide guidance. They are not "all inclusive" lists.

        D. Inspection personnel need only examine product when they have reason to believe that product does not meet regulatory requirements. However, there are no designated sampling plans or sample sizes that inspection program personnel are to use when examining products to assure that the products meet non-food safety regulatory requirements, nor are inspection program personnel to examine all products. Inspection program personnel examine product to determine whether the product complies with regulatory requirements (see Attachment 1), such as product standards, net weight standards, regulatory minimum or maximum limits of ingredients or components, or product defects. If inspection program personnel find that product exceeds any of the maximum limits, falls below the minimum requirements, or fails to meet any of the other non-food safety regulatory requirements, there is regulatory noncompliance. Inspection program personnel are to determi ne whether product complies with the regulations based on production lots or process controls rather than on individual units of product. For example, if one package of product exceeds its net weight, inspection program personnel are to investigate whether there have been problems in the process that will cause all packages to exceed the net weight requirements.

        E. Verification Activities Under 04A and 04B (Formulation and Labeling)

                1. Inspection program personnel are to verify that the establishment is producing product in compliance with the appropriate Title 9 Code of Federal Regulations (CFR) reference (see Attachment 1).

                2. Inspection program personnel are to determine whether the product complies with the regulations by comparing the product to the relevant regulatory requirements and determining whether:

                        a. the product meets requirements that are specified in the applicable standards of identity;

                        b. the net weight of the product is accurately reflected on its label;

                        c. all ingredients have been added in amounts that come within the maximum or minimum level specified in the applicable standard;

                        d. ingredients are accurately declared on the product label in descending order of predominance; and

                        e. the product defect levels are consistent with applicable standards.

NOTE: When import inspectors perform inspections at official import inspection establishments, the establishment may place the official inspection legend on containers of imported product before inspectors complete their inspections. (9 CFR 327.10 (d)).

        F. Verification Activities Under 04C03 (Livestock Product Examination)

                1. Under 04C03, inspection program personnel are to verify that the establishment complies with 9 CFR 318.2, 318.5, and 318.6. Inspection program personnel are no longer to perform activities known as livestock carcass re-inspection, boneless meat re-inspection, and other product re-inspection duties to verify compliance with the relevant regulations. Instead, inspection program personnel should be able to determine the extent of the procedures needed based on conditions observed in the establishment. Where effective establishment processing controls are evident, (i.e., the establishment has procedures in place to examine incoming product for acceptability, uses control programs to monitor product processing, and such controls and procedures are documented), inspection program personnel will limit non-food safety verification activities. Inspection program personnel will, in these cases, dir ect their inspection to those parts of the processing operation that the establishment does not cover by control procedures. Inspection program personnel need not count individual defects to make a judgment on a finished production lot. Inspection program personnel need to base determinations of product compliance by making determinations regarding product usability. The products should not pass inspection if defects are severe or numerous enough to affect the usability of the product. The condition of product should be clearly evident and sufficient to allow inspection personnel to determine that the product is in compliance. The purpose of product examination that inspection program personnel are to perform is to determine whether standards are being met. Determinations of acceptability should be based on production lots and process controls rather than on individual units of product. Inspection program personnel should consult with their Frontline Supervisor for assistance when nece ssary.

                Examples of noncompliance situations include:

                        a. inspection program personnel find that a carcass in the cooler has a large and heavy blood clot that would increase the weight of carcass in such a way to reduce its quality, and the establishment has failed to address the situation.

NOTE: The blood clot is an example of an "inferiority that has been concealed" because it could not be seen until the carcass chilled.

                        b. inspection program personnel find that after the boning process, the boneless product does not represent "boneless meat" because of the number of bone fragments, and the establishment has failed to address the situation.

                2. Inspection program personnel may also observe establishment's quality control programs and review associated records to verify whether the establishment meets regulatory requirements.

                3. When necessary, inspection program personnel are to consult with their Frontline Supervisor for assistance in determining noncompliance. The Technical Service Center (TSC) will provide additional guidance to assist with determining noncompliance.

        G. Verification Activities Under 04C04 (Poultry Product Examination)

                1. Under the 04C04 procedure, inspection program personnel are to verify that the establishment complies with the relevant regulations for poultry finished product standards, Giblet Acceptable Quality Levels, and rework product standards. Inspection program personnel inspect raw or unprocessed poultry products and return of questionable poultry products under the 04C04 procedure.

                2. In addition, the 04C04 procedure is used to verify conformance with good commercial practices for poultry slaughter that comply with 9 CFR 381.65 (b), (i.e., thorough bleeding of the carcasses, ensuring that breathing has stopped prior to scalding, and that blood from the killing operation is confined to a relatively small area).

                3. Inspection program personnel verifying compliance with finished product standards (FPS) are to use the criteria as listed in the regulations (see Attachment 1). Inspection program personnel should verify compliance by performing pre-chill FPS testing, post-chill FPS testing, reinspection of carcasses and giblets, inspection of returned products, inspection of rework products, and condition inspection of products in the establishment. Inspection program personnel are to perform the activities at the frequencies prescribed in 9 CFR 381.76. Each time inspection program personnel perform the finished product standard activities they are to record the activities in PBIS as unscheduled.

VII. SAMPLE COLLECTION FOR NON-FOOD SAFETY CONSUMER PROTECTION VERIFICATION (05B01)

        A. PBIS will schedule non-food safety sampling under ISP code 05B01 (see Attachment 1). Inspection program personnel may perform unscheduled non-food safety sampling activities when, during the performance of food safety or non-food safety verification activities, they observe conditions or activities that cause them to suspect that the establishment is not meeting non-food safety regulatory requirements and testing is the only means available to determine noncompliance, e.g., finished product in which inspection program personnel cannot verify formulation and composition without laboratory testing.

NOTE: Inspection program personnel will no longer receive the Species Identification Field Test (SIFT) kits to conduct in-plant tests to determine whether a product contains a species that is not accurately declared on the product label. When inspection program personnel have concerns about the species in a product, they are to collect the sample as described in Attachment 2. Import inspection personnel should follow the instructions provided in the Import Inspection Manual of Procedures for the Species Verification Testing Program.

        B. When inspection program personnel perform any sampling, they are to inform the establishment management when they are taking a sample and the reason why FSIS is analyzing the sample. This notification will afford establishment management the option to hold all product represented by the sample pending the sample results.

        C. Code 05B01 is the procedure code inspection program personnel should enter on the schedule when they collect a non-food safety sample. However, if the sample result indicates that the product does not comply with the regulations, inspection program personnel document a Noncompliance Record (NR) (FSIS Form 5400-4) under the appropriate ISP code, not 05B01. NOTE: The Office of Public Health Science (OPHS) directs food safety sampling. When directed by OPHS to perform food safety sampling, inspection program personnel should document the collection of the samples as an unscheduled procedure under code 05B02.

VIII. ENFORCEMENT

        A. Inspection program personnel are to issue an NR when a product does not comply with a non-food safety regulatory requirement and are to notify the establishment orally of the finding. Inspection program personnel are to consider all relevant factors when determining the amount of noncompliant product that is involved. Factors inspection program personnel should consider include facts such as the establishment's lot identification procedures, receiving records, and production records, as well as those facts that can reasonably be ascertained based on the average amount of product produced per shift or per production line. When necessary, inspection program personnel will consult with their Frontline Supervisor for assistance in determining the extent of product involvement.

        B. Inspection program personnel are to take the appropriate regulatory control actions, such as retention of product, rejection of equipment or facilities, stopping lines, or refusing to allow the processing of specifically identified product (9 CFR 500.1(a)), if they determine that misbranded or economically adulterated product, e.g., under-weight product, the product does not meet requirements that are specified in the applicable standard of identity for the product, etc., would otherwise enter commerce (be shipped from the establishment). Additionally, FSIS may rescind or refuse approval of false or misleading marks; labels; or sizes or forms of any container for use with any meat or poultry product per 9 CFR 500.8.

        C. Inspection program personnel are to issue NRs when they determine the processes are out of control, resulting in economically adulterated or misbranded product. Inspection program personnel should link the NRs when noncompliances are from the same cause, as described in FSIS Directive 5000.1, Revision 3 and are to notify the District Office (DO) through supervisory channels when plant management is unwilling or unable to take necessary steps to re-establish control of its process necessary to meet regulatory requirements.

        D. The DO is to notify the establishment, in writing, that repeated noncompliances may lead to a regulatory control action (9 CFR 500.1-3) that would affect the entire production of the product in question because product may be economically adulterated or misbranded. Whenever inspection program personnel take such regulatory control action, the action will remain in place until the DO receives written assurances from the establishment as to what procedures the establishment has instituted to regain and maintain the control of its process necessary to meet regulatory requirements. The DO will make a determination whether those procedures appear to correct the problem. Additionally, to determine the effectiveness of the actions, inspection program personnel will verify that the establishment's corrective and preventive actions are adequate and are operating as described in the establishment's response.

        E. The DO should notify the Regional Manager of the Compliance and Investigations Division whenever there is reason to believe that non-food safety noncompliances involve the shipment of economically adulterated or misbranded product or criminal intent to defraud the consumer. Questions are to be directed to the Technical Service Center at 1-800-233-3935.

Assistant Administrator
Office of Policy, Program, and Employee Development