[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.

    Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

    Follow the instructions for submitting comments on the agency Web 
site.
     E-mail: fdadockets@oc.fda.gov. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: pvardon@cfsan.fda.gov.

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