To: Seafood Community
Fr: Pamela Tom, University of California Sea Grant Extension Program
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
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
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.
- 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?
- In today's food manufacturing environment, what conditions,
practices, or other factors are the principal contributors to each type
of food hazard?
- If the CGMP regulations were revised, which type or types of food
hazards could be most readily prevented through CGMP-type controls?
- 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
- What concepts or underlying principles should guide FDA's
adoption of new preventive controls?
- How should the effectiveness of preventive controls for each of
the three types of hazards be most accurately measured?
- 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?
- 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.
- 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?
- 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:
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?
- 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
- 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: