Food GMP Modernization: Whole Hog or Piecemeal?November 16, 2008
FDA has announced a pretest of a survey instrument designed to gather information about five issues relevant to modernization of the food CGMP regulations at 21 C.F.R. Part 110. The food CGMP regulations are essentially unchanged since 1986, and the information to be solicited by the survey will assist FDA in its effort to revise the regulations. The survey will focus on five issues: employee training, sanitation and personal hygiene, allergen controls, process controls, and recordkeeping. Selection of these issues was based on a report issued in 2005 by CFSAN’s Food CGMP Modernization Working Group. After considering public comments, that group concluded that there is “generally strong support for limited revision of the CGMP regulation.”
Several factors are likely to influence the outcome of FDA’s food CGMP modernization effort. First and foremost is whether FDA will have sufficient resources to devote to the task given its other existing food safety and defense responsibilities, and the new ones that are almost certain to be heaped upon the agency in the coming year. Second is whether FDA chooses to maintain the relative vagueness of the existing regulations, which has been lauded by some as permitting needed flexibility for a highly heterogeneous industry, but criticized by others as being so flexible as to mean little. If the dietary supplement CGMP final rule is any indication, a revised food CGMP regulation could be considerably more detailed than current Part 110. Third is whether someone chooses to raise a challenge on some of the more contentious issues at play (records maintenance and access requirements other than those mandated under the Bioterrorism Act stand out in this regard).
For the moment, an overhaul of Part 110 appears to be what FDA has in mind. But as events unfold, if that climb proves to be as steep and lengthy as it did with FDA’s issuance of the dietary supplement CGMP final rule (10 years!), FDA could choose to tackle the highest risk food CGMP issues piecemeal by issuing more guidance documents such as those that address fresh-cut fruit and vegetable safety and Listeria in ready-to-eat foods. That approach would not satisfy those who want specific, enforceable requirements, but it’s an approach that could yield a decent return on investment – not a small thing in these lean times.