• Navigating FDA and USDA Reporting/Notification Requirements for Adulterated and Misbranded Food
  • January 22, 2015
  • Law Firm: Keller Heckman LLP - Washington Office
  • When incidents of adulterated or misbranded food arise that trigger a need to report to or notify a federal agency, food companies face a number of somewhat confusing, and not always congruent, requirements.

    Both the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA-FSIS) have reporting/notification requirements with regard to adulterated and misbranded food. USDA-FSIS has jurisdiction over meat, poultry, and egg products[1] and administers the Federal Meat Inspection Act (21 U.S.C. § 621, et seq.), the Poultry Products Inspection Act (21 U.S.C. § 451, et seq.), and the Egg Products Inspection Act (21 U.S.C. § 1031, et seq.). FDA has jurisdiction over all other food products and administers the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 301, et seq.). In this article, we compare and contrast the FDA and USDA-FSIS reporting/notification requirements with regard to adulterated and misbranded food.

    FDA’s Reportable Food Registry Reporting Requirements

    The FDA Reportable Food Registry (RFR) is a tool for industry and the FDA to work together in the interest of protecting public health.[2] The RFR applies to all FDA-regulated categories of food and feed, except dietary supplements and infant formula.[3]

    Section 417(d) of the FD&C Act requires registered food facilities to report a food to FDA through the RFR electronic portal when “there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals” (emphasis added; i.e., a Class I recall situation). For example, a food product contaminated with listeria monocytogenes (Listeria) would be considered a “reportable food.”[4]

    As soon as a determination has been made that an article of food is a reportable food, a “responsible party” should submit a report to the FDA “as soon as practicable, but in no case later than 24 hours after” such determination has been made. A “responsible party” is defined as “a person that submits the registration under section 415(a) for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held.” FDA does not provide any time frame for how long a company has to conduct its investigation prior to reaching the conclusion that it has a reportable food.

     Importantly, a report does not have to be submitted to FDA when all of the following criteria are met: (1) the adulteration originated with the responsible party; (2) the responsible party detected the adulteration prior to any transfer to another person of such article of food; and (3) the responsible party corrected such adulteration; or destroyed or caused the destruction of the product.

    In addition, products that are under the “exclusive jurisdiction” of USDA-FSIS are not subject to FDA’s reporting requirement.[5] So, for example, Listeria contamination of seafood salad would need to be reported through the RFR to FDA, whereas the Listeria contamination of chicken salad falls within the exclusive jurisdiction of USDA-FSIS and would not need to be reported to FDA, but would have to be reported to USDA-FSIS, as discussed further below.

    USDA-FSIS Notification Requirements

    On May 8, 2012, USDA-FSIS published a final rule that requires official establishments to notify FSIS of adulterated or misbranded products.[6] The final rule created 9 C.F.R. § 418.2, which provides that an official establishment must notify the FSIS District Office within 24 hours of learning or determining that an adulterated or misbranded meat or poultry product received by or originating from the official establishment has entered commerce. As part of the notification, USDA-FSIS requires the official establishment to provide the FSIS District Office with the type, amount, origin, and destination of the adulterated or misbranded product.

    “Official establishments” are defined at 9 C.F.R. § 381.1 as “any establishment as determined by the Administrator at which inspection of the slaughter of poultry, or the processing of poultry products, is maintained pursuant to the regulations.” Product is considered to be in commerce if it is out of the producing establishment’s direct control and is in distribution (e.g., in a warehouse, distribution center, retail facility, restaurant, or other institution). Product is considered to be under an establishment’s direct control if it is:

    • At the establishment;
    • Located on the premises owned by the producing establishment;
    • At a sister establishment owned by the same corporation when no portion of the lot has been released for sale or use;
    • At a warehouse owned by the establishment or corporation;
    • On a truck or other conveyance owned or operated by the establishment or corporation; or
    • Offsite under company control (e.g., under seal) or FSIS control (FSIS seal accompanied by FSIS Form 7350-1).
    USDA-FSIS interprets the 24-hour period requirement under 9 C.F.R. § 418.2 to begin when an official establishment has reason to believe that a product in commerce is adulterated or misbranded under the Federal Meat Inspection Act (FMIA) or the Poultry Products Inspection Act (PPIA).[7] For example, raw ground beef would be considered adulterated if the raw ground beef contains E. coli O157:H7.

    When an official establishment notifies an FSIS District Office of a misbranding or adulteration incident, FSIS policy dictates that the District Office then evaluate the report of the adulterated or misbranded product in commerce to determine an appropriate action with regard to the product at issue, including requesting a recall.
    Finally, if the establishment has shipped adulterated or misbranded product, then FSIS policy directs FSIS inspection program personnel to perform a Hazard Analysis & Critical Control Points (HACCP) verification task for the product in the Public Health Information System; the establishment must also generate HACCP reassessment documentation including records of each reassessment.[8]

    Comparing and Contrasting FDA and FSIS Reporting/Notification Requirements

    FDA and FSIS both require regulated entities to report or notify them of adulterated and misbranded foods falling under their respective jurisdictions. However, there are two main differences between the FDA’s reporting requirements and the USDA-FSIS notification obligations.

    First, with regard to FDA reporting requirements, only reportable food that rises to the level of a Class I recall must be reported to FDA’s RFR. Class I recalls are where “there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.” In contrast, the FSIS notification requirements are applicable to all adulterated or misbranded meat and poultry products regardless of their classification.[9] Thus, the FSIS notification requirements are much broader in scope than the FDA reporting requirements. For example, minor labeling errors that do not create a health or safety issue could trigger the need to notify FSIS, whereas FDA regulated products that have minor labeling errors would not be the subject of a report to FDA (assuming they are not the omission of an undeclared allergen, which would be considered a major misbranding violation and one that results in a risk to public health).

    Second, the trigger for reporting to FDA and notifying FSIS appears to differ. For FDA regulated products, a report must be submitted within 24 hours after the responsible party has reached a determination that the food is a reportable food and there is a “reasonable probability” that the food will cause serious adverse health consequences or death (Class I). For FSIS regulated products, a notification must be made within 24 hours after the official establishment learns of or has determined that an adulterated or misbranded product has entered commerce and the official establishment must “believe or have reason to believe” this has happened. Thus, while a report must only be submitted to FDA if the responsible party believes there is a “reasonable probability” that a food is reportable, a notification must be made to FSIS if the official establishment “believes or has reason to believe” that an adulterated or misbranded food has entered commerce. For example, one could interpret “reason to believe” loosely in that a presumptive positive on a meat or poultry product could prompt notification to FSIS while only a confirmed positive would trigger the need to submit a report to FDA’s RFR.

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    We do hope that this article has helped to clarify the regulatory framework with regard to FDA reporting and USDA-FSIS notification requirements for adulterated and misbranded foods. Keller and Heckman attorneys are well-positioned to assist you with navigating the FDA reporting and USDA-FSIS notification requirements. Should you have any questions regarding this topic, or if we may be of assistance in any other way, please do not hesitate to contact us.

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    [1] Shell eggs fall under FDA jurisdiction. See 21 C.F.R. Part 118.

    [2] See Reportable Food Registry For Industry, available at: http://www.fda.gov/Food/ComplianceEnforcement/RFR/default.htm.

    [3] Under Section 761 of the FD&C Act (21 U.S.C. § 379aa-1), “[a] manufacturer, packer, or distributor of a dietary supplement whose name appears on the label of a dietary supplement marketed in the United States must submit to FDA any report received of a serious adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the dietary supplement’s label.” Under 21 C.F.R. § 107.240, “[i]nfant formula manufacturers must comply with notification requirements for violative infant formula.” See 79 Fed. Reg. 16698 (March 26, 2014), Implementation of the Food and Drug Administration Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act.

    [4] SeeGuidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007,” available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm180761.htm.

    [5] SeeDraft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2),” Question D.8, available at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/rfr/ucm212793.htm; “D.8 Are products regulated exclusively by the USDA subject to the reportable food registry requirements? No. Food that is within the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.) is excluded from the requirements of the reportable food registry while that food is under the exclusive jurisdiction of USDA.”

    [6] See 77 Fed. Reg. 26929 (May 8, 2012); see also FSIS Notice 36-13 (May 23, 2013).

    [7] See FSIS Notice 36-13 (May 23, 2013).

    [8] See FSIS Notice 36-13.

    [9] Class I, II, and III situations must all be notified to USDA-FSIS. Class I is a health-hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death; Class II, a health-hazard situation where there is a remote probability of adverse health consequences from the use of the product; and Class III, a situation where the use of the product will not cause adverse health consequences.