It has been almost four years since FDA released a document titled “Food CGMP Modernization - A Focus on Food Safety,” drafted by the CFSAN Food CGMP Modernization Working Group. More recently, the group was charged with examining the current good manufacturing practices (GMP) found in 21 CFR Part 110 and determining if regulations need to be updated. A second charge was to examine risk-based preventive controls, in other words controls that would have the greatest impact on food safety.
The working group determined that due to changes in the food industry and food safety, GMPs should be modernized. It identified seven areas in which regulation could be updated:
1. Mandate that supervisors and workers have the necessary knowledge and expertise in food hygiene, food protection, employee health and personal hygiene to ensure the production of safe foods. This training must be delivered in a manner that is understood by management and staff, and it must be documented.
2. All processors that manufacture foods containing one or more allergens must develop an allergen control program. The plan must include six basic elements: training of processing and supervisory personnel, segregation of food allergens during storage and handling, validating cleaning procedures for food contact equipment, prevention of cross-contact during processing, product label review and label usage and control, and a supplier control program for ingredients and labels.
3. Producers of ready-to-eat foods who support the growth of Listeria monocytogenes must develop and implement an environmental monitoring program. The control program must address the risks posed in processing and packaging operations. In addition, the program must include microbiological monitoring of the processing and packaging environment. Records must be maintained that demonstrate the efficacy of the program.
4. Food processors will be required to develop, document and maintain sanitation procedures. These procedures must include the scope of the program, sanitation objectives, management responsibility, monitoring programs, corrective actions and records that demonstrate the efficacy of the program.
5. Additional comments should be gathered on whether to maintain the exclusion from following the cGMPs currently in place for processors involved in the harvest, storage and distribution of raw agricultural commodities.
6. Mandate that all processors maintain records for complying with GMPs. These records should be available for review by FDA investigators.
7. Further comments and suggestions should be obtained on the use of time-temperature relationships for incorporation into regulations or guidance for proper refrigerated storage or hot holding.
FDA is working on a proposal to modernize existing GMPs based on these seven areas. This document should be published by late 2009 or early 2010.
What does this mean to the food industry? Our regulatory system is unique in that we have the right to comment on any proposed regulation. This helps ensure that the final regulation is something that the industry can live with.
But, is it worth making a comment? Does FDA actually read the submissions? Absolutely! For example, when the seafood HACCP regulation was finalized in December 1995, some points in the final regulation were not in the original proposal. FDA originally proposed that consumer complaint files would be available for examination by investigators. The industry adamantly opposed this and FDA complied.
Food processors should take a serious look at the working group’s original report and be prepared to comment when the proposal is issued. The proposed changes will give FDA more power to examine records. The modernized GMPs will have a significant impact on the relationship between the industry and FDA, and it will be no surprise if the industry pushes for an extended comment period.