The Food and Drug Administration (FDA) will conduct three public meetings to solicit comments, data, and scientific information about the current state of quality management techniques, quality systems approaches, and voluntary industry standards concerning current good manufacturing practices and other controls used by food manufacturers and processors to prevent, reduce, control, or eliminate food borne hazards that can occur during food production or processing. The meetings are intended to elicit information about FDA's current good manufacturing practice (CGMP) in manufacturing, packing, or holding human food regulations. This information will be useful in determining appropriate revisions to these regulations.

FDA is particularly interested in receiving comments about food manufacturing practices and other controls used by small food manufacturing and processing entities.

FDA asks that those who speak at the meetings or otherwise provide FDA with their comments focus on questions given in section II of the Federal Register (May 21, 2004 Vol. 69, No. 99, Pages 29220-29222) about the CGMP regulations and other quality management techniques. There also will be an opportunity to address small business concerns at the meetings.

I. DATE AND LOCATIONS OF THE PUBLIC MEETINGS:

Friday, June 11, 2004 - Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740-3835.

Friday, July 2, 2004 - Monterey Conference Center, One Portola Plaza, Monterey, CA 93940.

Wednesday, July 21, 2004 - Marriott Chicago Downtown, 540 North Michigan Ave., Chicago, IL 60611.

II. QUESTIONS THAT THE FDA IS SEEKING ANSWERS FROM INDUSTRY ON:

In general, do the current good manufacturing regulations (part 110) need to be revised or otherwise modernized? If yes, please describe generally the shortcomings of the current regulations.

1. Which practices specified in current part 110 are most effective at preventing each type of food hazard? Which practices are least effective at such prevention?
2. In today's food manufacturing environment, what conditions, practices, or other factors are the principal contributors to each type of food hazard?
3. If the CGMP regulations were revised, which type or types of food hazards could be most readily prevented through CGMP-type controls?
4. Are there preventive controls, in addition to those set out in part 110, needed to reduce, control, or eliminate each of the three types of food hazards? If yes, please identify the specific hazard and the particular controls, that would reduce, control, or eliminate the hazard.
5. What concepts or underlying principles should guide FDA's adoption of new preventive controls?
6. How should the effectiveness of preventive controls for each of the three types of hazards be most accurately measured?
7. In today's food manufacturing environment, what are the principal contributors to the presence of undeclared allergens in food? For example, do labeling errors or cross-contamination contribute? Which preventive controls could help reduce, control, or eliminate the presence of undeclared allergens in food?
8. Are there existing quality systems or standards (such as international standards) that FDA should consider as part of the agency's exploration of food CGMP modernization? Please identify these systems or standards and explain what their consideration might contribute to this effort.
9. There is a broad variation within the food manufacturing and processing industry, including variations in size of establishments, the nature of the food produced, the degree to which the food is processed, and the vulnerability of a particular operation to physical, chemical, or microbial hazards. How, if at all, should the CGMP regulations be revised to take into account such variation? For example, should there be different sets of preventive controls for identifiable segments of the food industry, such as different storage temperature limits?
10. There are a number of measures, procedures, and programs that help to ensure that preventive controls are carried out adequately. These include the following items:
    • Training programs for managers and/or workers;
    • Audit programs;
    • Written records, e.g., batch records, sanitation records;
    • Validation of control measures;
    • Written sanitation standard operating procedures;
    • Food label review and control program; and
    • Testing of incoming raw materials, inprocess materials, or finished products.
    Which (if any) of these should be required practices for food and manufacturers and why? Which (if any) of these should be recommended practices for food manufacturers and processors and why?
11. Are there preventive controls in addition to those already set out in part 110 for food distributors, wholesalers, and warehousers that are needed to help ensure the safe and sanitary holding of food? If yes, please identify the controls by hazard and sector of the industry.

III. FOR MORE INFORMATION:

Information on how to register to attend the meetings, and how to submit comments electronically are in the Federal Register on the web at: http://www.cfsan.fda.gov/~lrd/fr040521.html