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FDA Food Safety Modernization Act (FSMA) Desk

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FDA Food Safety Modernization Act (FSMA) Desk Investigator’s Desk Aid to the FDA Food Safety Modernization Act (FSMA) Whistleblower Protection Provision Section 1013 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 399d Table of Contents I. FSMA in a Nutshell ................................................................................................................................... 2 A. Covered Entity ................................................................................................................................... 2 B. Protected Activity ............................................................................................................................. 4 II. Procedures for Handling FSMA Complaints ................................................................................... 6 A. Complaint ............................................................................................................................................ 6 B. Investigation ....................................................................................................................................... 7 C. Administrative and Judicial Review ............................................................................................ 8 D. Kickout Provision .............................................................................................................................. 8 Attachment 1 (FDA and USDA Jurisdiction) ......................................................................................... 9 Attachment 2 (Summary of the FD&C Act) ....................................................................................... 10 Attachment 3 (Optional Worksheet: Analyzing FSMA Whistleblower Complaints) .......... 13 This Desk Aid represents the Occupational Safety and Health Administration’s (OSHA’s) summary of the scope of coverage and protected activity and the procedures for investigating and adjudicating retaliation complaints under the FD&C Act, as amended by the FDA Food Safety Modernization Act, and as of the “last revised” date listed below. This Desk Aid is intended for OSHA’s use and the guidance herein is subject to change at any time. This Desk Aid is not a standard or regulation, and it neither creates new legal obligations nor alters existing obligations. Furthermore, there may be a delay between the publication of significant decisions or other authority under this whistleblower protection provision and modification of the Desk Aid. The Federal Register, the Code of Federal Regulations, and decisions of the Department of Labor’s Administrative Review Board remain the official source for the views of the Secretary of Labor on the interpretation of this whistleblower protection provision. Abbreviations Used in this Desk Aid: FSMA FDA Food Safety Modernization Act (used in this Desk Aid to refer just to the Act’s whistleblower protection provision) FDA Food and Drug Administration FD&C Act Federal Food, Drug, and Cosmetic Act (a statute enforced by the FDA; FSMA amended the FD&C Act) USDA U.S. Department of Agriculture Investigator’s Desk Aid to the FDA Food Safety Modernization Act (FSMA) Whistleblower Protection Provision OSHA Whistleblower Protection Program Last Revised: 8/29/2018 Page 1 I. FSMA in a Nutshell FSMA protects employees from discharge or other retaliation by their employers for making complaints about food safety or other violations of the FD&C Act. Under FSMA, no covered entity may discharge or otherwise retaliate against an employee with respect to compensation, terms, conditions, or privileges of employment because the employee (or any person acting pursuant to a request of the employee), whether at the employee’s initiative or in the ordinary course of the employee’s duties, engaged in any FSMA protected activity. A. Covered Entity Covered entity: FSMA applies to any entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food. What does “manufacture, processing, packing, transporting, distribution, reception, holding, or importation” mean? The whistleblower provision does not include definitions of manufacture, processing, packing, transporting, distribution, reception, holding, or importation. The FDA has defined some of these terms in other contexts, such as in the regulations pertaining to the FDA’s registration requirements for food facilities. Although those definitions do not directly apply to the whistleblower provision, OSHA can use the FDA’s definitions for guidance in interpreting these terms for purposes of the whistleblower provision. See, e.g., 21 C.F.R. §§ 1.227, 1.328. These definitions include the following: “Manufacturing” or “processing” means making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms, manufacturing/processing does not include activities that are part of harvesting, packing, or holding. “Packing” means placing food into a container other than packaging the food. “Packing” includes activities performed for the safe or effective packing or re-packing of that food, such as sorting, culling, grading, and weighing or conveying incidental to packing or re- Investigator’s Desk Aid to the FDA Food Safety Modernization Act (FSMA) Whistleblower Protection Provision OSHA Whistleblower Protection Program Last Revised: 8/29/2018 Page 2 packing. (“Packaging” means placing food into a container that directly contacts the food and that the consumer receives.) “Holding” means the storage of food and includes activities performed incidental to the storage of a food, such as fumigating food during storage. “Holding” also includes activities performed as a practical necessity for the distribution of that food (e.g., breaking down pallets). Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks. Therefore, many types of businesses that deal with food at every step of production and distribution—including shipping, storing, and cooking—are covered entities. Restaurants, grocery stores, and food testing laboratories are covered entities. What is “food” under FSMA? The FD&C Act defines “food” as anything used for food or drink for people or animals, chewing gum, or any component or ingredient of those things. This definition of “food” includes items that are commonly thought of as food, such as apples, lettuce, pizza, and cereal, as well as products like dietary supplements, beverages, infant formula, and animal feed. Are any entities engaged in the manufacture, processing, packing, transportation, distribution, reception, holding, or importation of food exempt from FSMA coverage? FSMA does not apply to an entity that is subject to USDA’s mandatory inspection authority (e.g., a meat, poultry, or egg product processing facility) if that entity does not also manufacture, process, pack, transport, distribute, receive, hold, or import food that is regulated by the FDA. If coverage questions arise, investigators should first consult with a supervisor and then confer with the Directorate of Whistleblower Protection Programs (DWPP) or the Regional Solicitor’s Office (RSOL) for assistance in determining whether coverage exists. Examples: An employee of a local grocery store that sells a range of fresh and packaged foods as well as salads, sandwiches, and baked goods prepared on-site, files a FSMA complaint. The grocery store is a covered entity. An employee at a factory that manufactures only nail polish and mascara complains that chemicals used to make those products have gotten into the sandwich she brought to work to eat for lunch. The factory is not a covered entity because it does not engage in the manufacture, processing, packing, transporting, distribution, reception, holding or importation of food; so, she does not have a claim under FSMA. An employee of a chicken processing plant files a FSMA complaint. According to Attachment 1, the USDA has jurisdiction over poultry products in a plant subject to mandatory USDA inspection. Investigators, after consulting with a supervisor, should contact DWPP or RSOL for assistance in determining whether the respondent is a covered entity. Investigator’s Desk Aid to the FDA Food Safety Modernization Act (FSMA) Whistleblower Protection Provision OSHA Whistleblower Protection Program Last Revised: 8/29/2018 Page 3 B. Protected Activity Protected Activity: An employee is protected from retaliation under FSMA if the employee: 1. Provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of the FD&C Act or any order, rule, regulation, standard, or ban under the FD&C Act; 2. Testified or is about to testify in a proceeding concerning such violation;
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