Inspections, Compliance, Enforcement, and Criminal Investigations
3-1 - INTRODUCTION; OBJECTIVES
This chapter describes the Food and Drug Administration’s (FDA) policies, procedures, and responsibilities for commissioning other government officials. This chapter also sets out the circumstances for FDA officials to accept state commissions.
A FDA commission is a delegated authority from the Commissioner of Food and Drugs to an individual to act on his/her behalf. A health, food, or drug officer or employee of any State, Territory, or political subdivision thereof (herein referred to as "state and local officials") may be commissioned to conduct examinations and investigations on FDA’s behalf for the purposes of the Act. For example, a commissioned official may work on behalf of the FDA under contract, partnership, or for the purposes of other worksharing agreements. It may be necessary for state or local officials to carry pocket credentials in cases where they are conducting assignments under FDA authority, such as conducting examinations, inspections, investigations or collecting samples, and copying and verifying records. In other cases, it may be necessary for them to only be commissioned with certificate to receive and review information.
FDA developed its commissioning program to make inter-agency cooperation more effective thereby increasing the amount of public health protection afforded to the American consumer. FDA achieves its goal by:
- Permitting commissioned Federal, state and local officials to operate under Section 702(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (hereafter referred to as the Act).
- Enabling those commissioned officials to effectively carry out their responsibilities by reviewing FDA information, such as draft policy, that is protected from disclosure to the public by the Freedom of Information Act (FOIA).
Each state or local official commissioned by FDA will receive a certificate of commission. In addition, certain commissioned officials who will be doing work in the field under FDA authority will be provided with a set of pocket credentials.
This chapter focuses on commissioning of state and local officials, and references FDA’s authority to commission officials from other Federal government departments and agencies under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (hereafter referred to as the BT Act).
FDA’s Office of Regulatory Affairs Office of Partnerships (OP) - HFC-150 has primary responsibility for overseeing the implementation of FDA’s Commissioning Program. For state or local officials, ORA Regional Food and Drug Directors (RFDDs) have primary responsibility for carrying out the program. For Federal officials, the inter-agency Memorandum of Understanding (MOU) that is required by the BT Act should include provisions regarding the implementation of the commissioning procedures. For that reason, those provisions are briefly mentioned.