[Federal Register: July 2, 2004 (Volume 69, Number 127)]
[Rules and Regulations]
[Page 40312-40313]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jy04-4]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 110
[Docket No. 2004N-0230]
Food; Current Good Manufacturing Practice Regulations; Public
Meetings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meetings.
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SUMMARY: The Food and Drug Administration (FDA) is announcing 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 (CGMPs) 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 CGMP in
manufacturing, packing, or holding human food regulations. This
information will be useful in determining appropriate revisions to
these regulations. We ask that those who speak at the meetings or
otherwise provide FDA with their comments focus on our questions given
in section II of this document about the CGMP regulations and other
quality management techniques. There also will be an opportunity to
address small business concerns at the meetings. This document
reschedules meetings announced in the Federal Register of May 21, 2004
(69 FR 29220).
DATES: The revised dates for the public meetings are as follows: in
College Park, MD, on Monday, July 19, 2004, from 9 a.m. to 12 noon; in
Chicago, IL, on Wednesday, July 21, 2004, from 2 p.m. to 5 p.m.; and in
San Jose, CA, on Thursday, August 5, 2004, from 9 a.m. to 12 noon. You
should register for any of the meetings by fax or e-mail (see FOR
FURTHER INFORMATION CONTACT). For security reasons and due to space
limitations, we recommend that you register at least 5 days prior to
the meeting you wish to attend. You may register by fax or e-mail until
close of business 5 days before the meeting you wish to attend,
provided that space is available. In addition to participating at the
public meetings, you may submit written or electronic comments until
September 10, 2004.
ADDRESSES: The public meeting on Monday, July 19, 2004, will be held at
the Food and Drug Administration, Center for Food Safety and Applied
Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740-3835. The
public meeting on Wednesday, July 21, 2004, will be held at the
Marriott Chicago Downtown, 540 North Michigan Ave., Chicago, IL 60611.
The public meeting on Thursday, August 5, 2004, will be held at the
County of Santa Clara, Department of Environmental Health, 1555 Berger
Dr., San Jose, CA 95112-2716
You may submit comments, identified with Docket No. 2004N-0230, by
any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web
site.
E-mail: . Include Docket No. 2004-
0230 in the subject line of your e-mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions): Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No. for this rulemaking. All comments received will be
posted without change to http://www.fda.gov/dockets/ecomments,
including any personal information provided. For detailed instructions
on submitting comments and additional information on the rulemaking
process, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/dockets/ecomments and/or
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Peter J. Vardon, Center for Food
Safety and Applied Nutrition (HFS-726), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD, 301-436-1830, FAX: 301-436-
2626, or e-mail: .
SUPPLEMENTARY INFORMATION:
I. Background
FDA last revised its CGMP regulations for food in part 110 (21 CFR
part 110) in 1986 (51 FR 22458, June 19, 1986). The primary purpose of
the revision was to establish new, updated, or more detailed provisions
concerning food industry personnel; plants and grounds; sanitary
facilities, controls, and operations; equipment and utensils,
warehousing, and distribution; and natural or unavoidable defect
levels. FDA designed the revised CGMP regulations to help ensure the
safe and sanitary manufacturing, processing, and holding of food for
human consumption.
In the almost 20 years since the food CGMPs were revised, the food
industry has undergone considerable change, and the agency believes
that it is now time to revisit these regulations and determine
appropriate revisions to better ensure a safe and sanitary food supply.
FDA believes that a good first step is to obtain the views of the
industry and the public generally by holding a series of public
meetings. The three public meetings are intended to provide interested
parties an opportunity to comment on what revisions to the CGMPs FDA
should consider. The meetings are also intended to fulfill part of the
outreach requirement of the Small Business Regulatory Enforcement
Fairness Act of 1996.
FDA has drafted the questions set out in this document to help
focus comments presented at the public meetings or otherwise
communicated to the agency. One area of particular agency focus is
potential hazards in the food supply. Generally speaking, there are
three categories of hazards that may be present during the production
or warehousing of food: Physical hazards (such as the presence of glass
fragments in food), chemical hazards (such as the unintended presence
of a cleaning solution in food), and microbiological
[[Page 40313]]
hazards (such as the presence of Listeria monocytogenes in ready-to-eat
foods).
In responding to the questions set out in this document, please
address, to the extent you are able, each of the three types of hazards
discussed in the previous paragraph. FDA is particularly interested in
receiving comments about food manufacturing practices and other
controls used by small food manufacturing and processing entities.
II. Questions
In general, how should the CGMP regulations in part 110 be revised
or otherwise modernized? Please describe, generally, the short comings
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, in process 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. Registration
You should register for any of the meetings by fax or e-mail (see
FOR FURTHER INFORMATION CONTACT). For security reasons and due to space
limitations, we recommend that you register at least 5 days prior to
the meeting you wish to attend. Registration will be accepted on a
space-available basis. You may register until close of business on July
14, 2004, for the College Park meeting, close of business on July 16,
2004, for the Chicago meeting, and close of business on July 30, 2004,
for the San Jose meeting. If you need special accommodations due to a
disability, please inform the contact person at least 7 days in advance
(see FOR FURTHER INFORMATION CONTACT). Please include your name, title,
firm name, address, telephone number, and e-mail address (if available)
when you register. FDA encourages individuals or firms with relevant
data or information to present such information at the meeting or in
written comments to the record. If you would like to make oral comments
at one of the meetings, please specify your interest in speaking when
you register. The amount of time for each oral presentation may be
limited due to the number of requests to speak.
IV. Transcripts
A transcript will be made of the proceedings of each meeting. You
may request a copy of a meeting transcript in writing from FDA's
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 30
working days after the public meetings at a cost of 10 cents per page.
The transcript of each public meeting and all comments submitted will
be available for public examination at the Division of Dockets
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through
Friday.
V. Comments
In addition to presenting oral comments at a public meeting,
interested persons may submit (see ADDRESSES) written or electronic
comments on the subject of these meetings. Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in the brackets in the heading
of this document. Received comments may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15197 Filed 6-30-04; 1:38 pm]
BILLING CODE 4160-01-S
