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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Notices
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produced under the retail exemption need not bear all required features for labeling. One firm stated that such clarification would avoid manufacturer confusion about whether meal kits that include a recipe card would be eligible for the retail exemption.
Response: The guideline does not apply to facilities preparing kits under the retail exemption from FSIS
inspection 9 CFR 303.1d and 381.10a1 because these facilities were not previously required to assemble kits under FSIS inspection.
The retail exemption remains unchanged by the guideline. Kits prepared under the retail exemption may only be sold directly to the end consumer and cannot be sold for resale.
FSIS has updated the guideline to clarify that the scope of the document does not include products produced under the retail exemption. The original version and updated version of the guideline explain that FSIS labeling regulations, other than the requirement of the official inspection legend, apply to kits that are assembled under the retail exemption 9 CFR 303.1f, 381.10d4.
Bulk Labeling Comment: One firm that prepares kits requested clarification on whether FSIS
inspection and label approval requirements apply to firms that receive and further process bulk product as part of final kit assembly, including portioning and packaging the meat component. Another firm that prepares kits using bulk-packed FSIS-inspected products asked whether the firm may make copies of the label on the bulk container and apply them to the product components that have been separated and rewrapped.
Response: FSIS has updated the guideline to clarify that Agency guidance on the preparation of kit products without FSIS inspection does not apply when the meat or poultry component is processed, including portioned or packaged, by the firm assembling the kit. Such processing activities would require FSIS inspection if the production does not qualify for the retail exemption. Further, the resulting assembled kit product would require label approval by FSIS if the outer kit label met any of the conditions for required label approval under the regulations at 9 CFR 412.1. A firm portioning and repackaging bulk-packed products typically would not be permitted to make a copy of the original label since that label would likely bear the original establishments USDA
legend, company name, and a net weight.

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Component Standard of Identity Comment: One consumer requested clarification on whether, if the finished product of the meat or poultry component of a kit is labeled as a product that has a standard of identity, must the fully assembled kit label meet that standardized product name.
Response: FSIS updated the guideline to clarify that if a kit is labeled as a product with a standard of identity as defined under the regulations in 9 CFR
part 319 or 381 subpart P, the components, once assembled, must meet the applicable standard of identity.
For example, a Beef Chili Kit must contain 40 percent beef computed based on the weight of the fresh meat as described in 9 CFR 319.300.
Shipping Container Labeling Comment: A USDA employee asked whether a shipping container comprising one or multiple kit products that were assembled at an official establishment without FSIS inspection would need to bear a USDA legend.
Response: The regulatory requirement that the shipping container bear a USDA
legend 9 CFR 316.13 and 381.27 only applies to products that have been inspected and passed. FSIS updated the guideline to clarify that when a kit is assembled in an official establishment without FSIS inspection, the shipping container into which the kit is placed may not bear a USDA legend. In such case, the mark of inspection will be displayed on the label and packaging of the meat or poultry component included in the kit.
Outer Package Labeling Comment: Comments from several trade associations, firms that prepare kit products, individuals, and one USDA
employee asked FSIS to clarify what language should be used on the kit label to describe the product as a single unit of individual components. These commenters also asked where the description of the individual components should be displayed on the outer label.
Response: FSIS has updated the guideline to clarify that the requirements for the language on the outer kit label that identify the product as a kit are flexible. The outer label for the kit should identify all the individual components in the kit, as well as identify the product as a single unit.
The use of the word kit on the outer label is not required, nor is a specific location on the outer label for the identification of the individual components. For example, the outer label could display the product name
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Chicken Barbecue Dinner Kit or Beef Lasagna Meal.
Immediate Package Labeling Comment: One consumer asked whether FSIS would require safe handling instructions on the immediate package of a not ready to eat NRTE
meat or poultry component in a kit.
Response: As stated in the guideline, if the meat or poultry component of a kit product is NRTE, the immediate package must include safe handling instructions in order to meet the regulatory requirements for kit assembly without FSIS inspection.
Export Labeling Comment: One firm that exports kit products to Canada asked which package components need to include bilingual labels.
Response: FSIS does not require bilingual labels; however, Canada does have such labeling requirements i.e., French and English. More information about Canadas requirements can be found on the Import and Export Library available at: https www.fsis.usda.gov/
inspection/import-export/import-exportlibrary. FSIS inspectors verify and certify that products intended to be exported to a foreign country meet the foreign countrys requirements.
Labeling Claims and Declarations Comment: An animal welfare organization requested that FSIS require pre-market label approval for animalraising claims on the exterior packaging of kit products.
Response: As a kit meeting the criteria as described in the guideline may be assembled without FSIS inspection and, as such, the outer label does not bear a USDA legend, the outer label is not subject to label approval requirements under the regulations at 9 CFR 412.1.
Outer kit labels for products assembled without FSIS inspection under the conditions described in the guideline are required to comply with FSIS
labeling requirements.
Comment: One firm that prepares kits requested that FSIS require allergen declarations to be displayed on the outer packaging and to prohibit ingredient statements on the meat or poultry component. The commenter stated that such requirements would reduce consumer confusion by identifying all allergens and other ingredients in a central location on the retail package.
Response: If the only component within the kit that includes an ingredients statement is the meat or poultry component, that should not cause any confusion. FSIS does not
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