FDA Outlines Internal Reviews Before Requesting FSMA Record Access
(originally published in Food Chemical News)
Thursday September 06 2012
FDA has laid out the internal decision tree that must be followed before it can use its new authority and request access to food company records under the FDA Food Safety Modernization Act (FSMA).
The agency updated its Regulatory Procedures Manual Aug. 27 to include a new section on inspection of food records to reflect FSMA's changes. The manual, which contains regulatory procedures for use by FDA personnel, is the most recent instruction to the field about sec. 101 of FSMA, which amended 414(a) and 704(a) of the Federal Food, Drug, and Cosmetic Act (www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074292.pdf).
Under the FSMA provision, which went into effect upon enactment of the law, FDA has authority to access records for inspection and photocopying if it has a reasonable belief a product or similar product is adulterated or there's a reasonable probability its use will cause serious health consequences. The law gives companies up to 24 hours to hand over records. It exempts farms and restaurants, but covers all other facilities that process, transport, import or handle food.
Records that cannot be reviewed by inspectors are food recipes, financial data, pricing data, research data (except test marketing a food), or sales data (other than shipment data). A recipe is defined as the formula, including ingredients, quantities and instructions necessary to make a food product, the updated procedures manual clarifies. All three elements must be present to shield the information from FDA inspectors, FDA says. If all three elements are not present, FDA has authority to access a list of ingredients in a records request.
Industry associations raised multiple concerns in response to FDA's draft guidance on record access, published on Feb. 23 (see FCN Feb. 24, 2012, Page 11). In particular, the industry wanted to know what legal hoops FDA would have to jump through before using its new enforcement tool. It complained that the draft guidance omitted language found in a November 2005 document that required record access requests to involve the appropriate Center, Office of Enforcement and the Office of General Counsel before emergency access is authorized.
"These procedures ensure that use of the Section 414(a) authority is only invoked once senior personnel from FDA headquarters authorize the request, after determining that the legal standard predicating use of the authority is met," said Daniel Felton, vice president of government relations for the International Bottled Water Association, in comments to the agency (see FCN June 15, 2012, Page 11). "Therefore, it is not clear to our members whether FDA intends to continue to follow this existing approach, as we believe it should."
For the first time, FDA spells out the level of involvement among FDA headquarters staff.
The updated manual to FDA staff directs district offices to obtain concurrence from the Office of Enforcement before making the request. For domestic inspection requests, the district office or other FDA personnel must notify FDA's Emergency Operations Center. For foreign inspections, the FDA investigator must notify the director of the Division of Foreign Field Investigations (DFFI), who then notifies the Emergency Operations Center.
The next step is for the appropriate FDA center -- Center for Food Safety and Nutrition and/or Center for Veterinary Medicine -- and the Office of Enforcement (OE) to come into the loop.
"The appropriate Center, with the concurrence of OE, determines that there is a reasonable belief that the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or that there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals," the updated manual says.
OE must concur with any requests for records and work with the Center and the Office of Chief Counsel in determining the scope of the request.
"Once all the necessary determinations are made, OE conveys the information to the district director for the facility being inspected (domestic inspection) or the director, DFFI (foreign inspection). The director, DFFI will convey the information to the appropriate foreign office director or to the DFFI foreign inspection cadre member."
FDA personnel will issue written notices (Form FDA 482c) to the owner/operator/agent in charge of the company to show the agency has legal authority to access the documents, the updated manual advises.