On February 23, 2012, the Food and Drug Administration (“FDA”) issued an interim final rule and new guidance regarding provisions of the Food Safety Modernization Act (“FSMA”) that amended recordkeeping requirements of the Food, Drug, and Cosmetic Act (“FDCA”) for entities that manufacture, process, pack, transport, distribute, receive, hold, or import food. FSMA, which was enacted in January 2011, significantly expands FDA record access to allow FDA to view and copy records relating to an article of food where FDA has a reasonable belief that the food is reasonably likely to cause serious adverse health consequences or death to humans or animals, as well as records pertaining to food that FDA reasonably believes is likely to be affected in the same manner. FSMA’s expanded records access provisions are designed to help FDA better protect public health by enabling the agency to “focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.”
The interim final rule, which was published without the use of prior notice and comment procedures, amends Section 1.361 of FDA regulations to make the language of this section consistent with record access provisions of FSMA and to require that “records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request.” FDA stated that it had good cause to promulgate the interim rule without notice and comment procedures because FDA’s expanded records access authority was effective upon the enactment of FSMA; thus, “in the interest of protecting the public health and eliminating any possible confusion about how to comply with FDA’s expanded authority” FDA believed that regulations should be promulgated as quickly as possible. The interim final rule becomes effective on March 1, 2012.
Along with the interim final rule, FDA also published “Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act” (“Draft Guidance”). The Draft Guidance updates a November 2005 guidance, which described FDA authority to access records prior to FSMA, to explain how FDA interprets certain provisions of FSMA including (1) the type of records FDA may access to investigate foods that FDA reasonably believes are likely to be affected in a similar manner as suspect food articles; and (2) the scope of exemptions for certain types of records and categories of data.
In conjunction with issuance of the records access interim final rule and draft guidance, FDA also issued an update to the corresponding guidance document, “Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold or Import Food” (“Guidance”). The Guidance provides numerous question and answer examples designed to help a broad spectrum of food transport industry participants–from farm stands to airlines that haul food products–determine their recordkeeping obligations. FDA updated the Guidance to reflect its expanded authority to access records and to address the type of records that are excluded from FSMA requirements (e.g., recipes, financial data, pricing data, personnel data, research data, sales data, etc.). Comments regarding the interim final rule are due to the agency by May 23, 2012.
Comments regarding the FDA’s two guidance documents may be provided to the agency at any time, however, FDA recommends that interested parties provide comments regarding the Draft Guidance by May 23, 2012 to ensure that FDA has adequate time to consider comments before publishing the final guidance.