FSIS Sampling for Labeling Claims Verification
FSIS Notice
07-23
Issue Date
Jan 30, 2023
Expiration Date
Feb 01, 2024
Full Notice
- PURPOSE
This notice issues instructions to inspection program personnel (IPP) on verification sampling at establishments that produce products in consumer-ready packaging that bear certain labeling claims or a nutrition facts panel per eligibility criteria. - BACKGROUND
On March 1, 2012, the final rule titled "Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products" (75 F 82148) became effective. This rule amended the Federal meat and poultry products inspection regulations to require nutrition labeling of the major cuts of raw, single- ingredient meat and poultry products on labels or at point-of-purchase, unless an exemption applies. FSIS also amended its regulations to require nutrition labels on all ground or chopped meat and poultry products, with or without added seasonings, unless an exemption applies. FSIS verifies whether establishments meet the requirements through the procedures in FSIS Directive 7130.1, Verifying Nutrition Labeling for the Major Cuts of Single-Ingredient, Raw Meat and Poultry Products and Ground or Chopped Meat and Poultry Products.- FSIS is conducting this exploratory sampling program in order to verify industry's compliance with the Agency's labeling regulations. Labeling claims are required to be truthful and not misleading (9 CFR 317.8(a), and 381.129). Labels are also required to display a complete listing of ingredients (9 CFR 317.2(c)(2), and 381.118) to protect consumers from misbranded and economically adulterated meat and poultry products.
- To verify compliance with nutrition labeling requirements, FSIS began sampling raw ground beef products and conducting nutrient analysis on September 29, 2014. FSIS intends to continue the nutrient content sampling program at Federal establishments as a directed sampling task under the EXP_LV_NUTR sampling project.
- To verify compliance with negative labeling claims related to soy and antibiotics, FSIS expanded the sampling program to ready-to-eat products and raw chicken parts on May 7, 2018. At this time FSIS also began sampling raw ground beef for hormones.
- ELIGIBILITY CRITERIA FOR LABEL VERIFICATION SAMPLING
- Establishment eligibility for this sampling program is determined based on information collected through multiple data sources. FSIS will evaluate eligibility as necessary.
- Eligible products are those in consumer-ready packaging with a label that contains the labeling claim or a nutrition facts panel for the specific product type that corresponds with the labeling feature as described in Table 1.
Table 1 -Label Verification Sampling ProjectsType of Labeling Feature Sample Project
CodeSample To
CollectAnalysis Corresponding
Pathogen
Sampling Project
CodeNutrition facts panel EXP_LV_NUTR Raw ground beef Fat and
sodium contentMT43 Soy-free EXP_LV_SOY Ready-to-eat products Soy RTEPROD_RAND Raised without antibiotics EXP_LV_ABX Raw chicken parts Antibiotic residues HC_CPT_LBW01
HC_CPT_QH01Raised without hormones EXP_LV_HORM Raw ground beef Hormone residues MT43 - Products eligible for the EXP_LV_NUTR and EXP_LV_HORM sampling projects are raw ground beef products that are eligible for Escherichia coli O157:H7 sampling under the MT43 sampling project and meet the standards of identity 9 CFR 319.15(a) ("chopped beef," "ground beef") or 319.15(b) ("hamburger"). Product eligible for the EXP_LV_NUTR bears a nutrition facts panel on the consumer ready packaging. Product eligible for the EXP_LV_HORM bears a label with a negative claim for hormones use.
- Products eligible for the EXP_LV_ABX sampling project are raw chicken parts that are eligible for sampling under the HC_CPT_LBW01 (raw chicken parts - legs, breasts, wings) and HC_CPT_QH01 (raw chicken parts - quarters, halves) projects and are labeled with a negative claim for antibiotic use. A description of eligible products for these projects is available in the Raw Poultry Sampling Guidance which can be accessed through the IPP Help button.
- Products eligible for the EXP_LV_SOY sampling project are ready-to-eat (RTE) products that are eligible for sampling under the RTEPROD_RAND sampling project, as described in FSIS Directive 10240.4, Listeria Rule Verification Activities, and labeled with a negative claim for soy ingredients.
- IPP are to refer to the attachment for examples of labels bearing claims for products eligible for the sampling projects covered in this notice. IPP are to be aware that the description of the claims on the labels may vary.
- IPP RESPONSIBILITIES
- IPP are to be familiar with the establishment's production schedule to determine when it is producing product eligible for this sampling program. IPP are to notify establishment management before collecting the samples. The establishment is not required to hold or control product selected for sampling under the labeling claim verification sampling program. However, IPP are to inform establishment management that RTE product with a "soy-free" or similar labeling claim that tests positive for soy under the EXP_LV_SOY sampling project would be deemed adulterated and misbranded and the product lot represented by the sample would be subject to regulatory action. If the adulterated and misbranded product has been shipped into commerce, FSIS will likely recommend that it be recalled.
- Samples will be assigned under the sampling projects listed in Table 1 and will appear as directed tasks on the establishment task list. The samples will be analyzed by the FSIS Eastern Laboratory (EL).
- Samples for labeling claim verification testing must be submitted to the EL in fully labeled consumer- ready packaging bearing the claim that corresponds to the sampling project; otherwise, the sample will be discarded by the lab. IPP are to refer to the attachment for examples of labels with claims that are eligible for this sampling project.
- IPP are to request sampling supplies at least 72 hours before the day of scheduled sample collection. IPP are to follow the instructions provided in FSIS Directive 13000.2, Performing Sampling Tasks in Official Establishments Using the Public Health Information System, for ordering sampling supplies through the Public Health Information System (PHIS). As an alternative, IPP may send a request for sampling supplies using Outlook to the FSIS - Sampling Supplies - Eastern Lab mailbox. When requesting sampling supplies by e-mail, IPP are to include the sampling project code, establishment number, establishment name, physical address, IPP's name and contact phone number in the e-mail request.
- Sample supplies for the label verification sample:
- 1 - Shipping Box (M-USDA20) with packing materials
- 1 - Two-gallon zipper lock bag, non-sterile
- 1 - 6"x12" Plastic Bags
- 1 - FedEx Billable Stamp for the EL
- 1 - FSIS Form 7355-2A/2B
NOTE: The FSIS Laboratory will not automatically send sampling supplies at the time the sample is scheduled. IPP are to follow instructions in Section D to request sample supplies. - On the scheduled day of sampling, IPP are to determine if the establishment is producing eligible product in consumer-ready packaging that bears a label with the labeling claim that corresponds to the assigned sampling project (see Table 1). IPP are to use a method for randomly selecting the production lot for sampling. If the product is available for sampling, IPP are to:
- Collect a 2 lb. sample of product in fully labeled consumer-ready packaging bearing the labeling claim that corresponds to the sampling project (see Table 1), except for EXP_LV_SOY, which will only require 1 lb. IPP are to collect as many packages of product as necessary to meet the sample size and are to collect a frozen sample only if a fresh sample is not available. IPP are to place the product collected in its final packaging in the large, non-sterile bag provided with the sampling supplies;
NOTE: In situations where product is packaged into consumer-ready packaging in portions larger than 2 lb., or 1lb, for EXP_LV_SOY, IPP can request a slack-filled sample from the establishment, provided the slack-filled sample's packaging includes a label with the labeling claim. - Complete the sampling task in PHIS, following the instructions provided in FSIS Directive 13000.2. When the sample data entry is completed, click the "Submit to Lab";
NOTE: There is no sampling questionnaire to complete for labeling claim verification sampling projects. - Print, sign, and date the sample form. Place the completed sample form in the plastic sleeve provided; and Pack and ship the sample via overnight shipping to the FSIS EL, using the instructions provided in FSIS Directive 7355.1, Use of Sample Seals for Program Samples and Other Applications. IPP are to use only the shipping materials provided by the laboratory.
- Collect a 2 lb. sample of product in fully labeled consumer-ready packaging bearing the labeling claim that corresponds to the sampling project (see Table 1), except for EXP_LV_SOY, which will only require 1 lb. IPP are to collect as many packages of product as necessary to meet the sample size and are to collect a frozen sample only if a fresh sample is not available. IPP are to place the product collected in its final packaging in the large, non-sterile bag provided with the sampling supplies;
- If on the scheduled day of sampling, IPP determine that product eligible for label verification sampling, as described in Section III., is not available for sampling, IPP are to reschedule the sampling task for another day within the sample collection window.
- IPP are to cancel the sampling task and provide the appropriate justification for canceling if:
- Eligible product is not being produced during the assigned collection window, or
- The establishment does not produce product eligible for label verification sampling, as described in Section III.
- TEST RESULTS AND FURTHER ACTIONS
- Test results for the EXP_LV_SOY sampling project will be reported in PHIS as acceptable or unacceptable. In the event that FSIS testing of RTE product with a "soy-free" labeling claim reports as "unacceptable" because it is positive for the presence of soy under the EXP_LV_SOY project, IPP are to document the finding in a noncompliance record (NR) and cite 9 CFR 317.8(a) and 317.2(c)(2) (for meat products) or 381.129 and 381.118 (for poultry products). IPP are to conduct a directed Big 8 Formulation Verification Task and document the findings in PHIS in accordance with FSIS Directive 7230.1, Ongoing Verification of Product Formulation and Labeling Targeting the Eight Most Common ("Big 8") Food Allergens. If any of the product represented by the soy positive lab results has been shipped into commerce, IPP are to verify that the establishment has accounted for all product in the affected lot and has taken appropriate corrective actions under 9 CFR 417.3. If any of the product represented by the soy positive lab results has been shipped into commerce, IPP are to notify the Recall Management and Technical Analysis Staff (RMTAD) through their supervisory chain for further guidance regarding their concerns.
- Test results for the three sampling projects, EXP_LV_NUTR, EXP_LV_ABX and EXP_LV_HORM will not be reported in LIMS-Direct or PHIS. These test results will be reported by the EL to the Office of Policy and Program Development's Labeling and Program Delivery Staff (LPDS) and Policy Analysis Staff (PAS). LPDS and PAS will review the results for consistency in meeting labeling requirements. If there is a discrepancy between the test result and the labeling claim, LPDS will issue a letter to the establishment and copy the Inspector-in-Charge (IIC) and the Office of Field Operations District Office (DO) informing them of the results. The establishment will have 30 days to provide a written response to LPDS on actions taken in response to the test result to demonstrate that it is fulfilling the claim stated.
- If the establishment fails to take appropriate action or fails to demonstrate that it is fulfilling the claim stated, FSIS may take further action, including but not limited to, scheduling additional label verification sampling tasks, recommending a recall of affected product, rescinding label approval for labels bearing the claim and not approving any labels with similar claims, until the establishment can demonstrate its ability to ensure the accuracy of its labels.
- Data collected for this program will be used to inform future label verification sampling programs.
- QUESTIONS
Refer questions regarding this notice or any other export questions to your supervisor or as needed to the Office of Policy and Program Development through askFSIS or by telephone at 1-855-444-9904. When submitting a question, complete the web form and select Labeling for the inquiry type.
NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.