[Federal Register Volume 70, Number 24 (Monday, February 7, 2005)]
[Notices]
[Pages 6448-6449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2210]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0312]


Animal Feed Safety System: A Comprehensive Risk-Based Safety 
Program for the Manufacture and Distribution of Animal Feeds; Notice of 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss our progress on development of a comprehensive, 
risk-based Animal Feed Safety System (AFSS) describing how animal feeds 
(individual ingredients and mixed feeds) should be manufactured, 
distributed, and used to minimize risks to humans and animals. We are 
seeking comments and assistance in our consideration of this safety 
program to effectively minimize the hazards to public health posed by 
animal feed products.
    Date and Time: The public meting will be held on Tuesday, April 5, 
2005, from 8 a.m. to 5 p.m., and Wednesday, April 6, 2005, from 8 a.m. 
to 12:15 p.m. You may submit written or electronic comments at any 
time, but they would be most helpful if received on or before March 4, 
2005.
    Location: The public meeting will be held at The Crowne Plaza, 655 
North 108th Ave., Omaha, NE 68154, 402-496-0850.

ADDRESSES: You may submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting 
comments. You can view comments FDA has received on the Internet at 
http://www.fda.gov/ohrms/dockets/.
    Contacts:
    For General Information: Zoe Gill, Center for Veterinary Medicine 
(HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-453-6867, FAX: 240-453-6882, or e-mail: <a href="/cdn-cgi/l/email-protection#52283d377c353b3e3e123436337c353d24"><span class="__cf_email__" data-cfemail="d7adb8b2f9b0bebbbb97b1b3b6f9b0b8a1">[email protected]</span></a>.
    For Information About Registration: Brenda Boateng, Center for 
Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-453-6850, FAX: 240-453-6882, or 
e-mail: <a href="/cdn-cgi/l/email-protection#97f5e5f2f9f3f6b9f5f8f6e3f2f9f0d7f1f3f6b9f0f8e1"><span class="__cf_email__" data-cfemail="e88a9a8d868c89c68a87899c8d868fa88e8c89c68f879e">[email protected]</span></a>.
    Registration: Registration forms are available on the Division of 
Dockets Management Web site at http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm. Although there is no 
registration fee for this meeting, registration is required. Due to 
limited meeting space, and to permit the agency to adequately prepare 
for the meeting, early registration is strongly encouraged. We are 
asking that registration occur by March 11, 2005. You may register by 
telephone, fax, or e-mail by contacting Brenda Boateng (see Contacts).
    If you need special accommodations due to a disability, please 
contact Toni Wooten at 301-595-0796 or by e-mail at <a href="/cdn-cgi/l/email-protection#87f3e8e9eea9f0e8e8f3e2e9c7e1e3e6a9e0e8f1"><span class="__cf_email__" data-cfemail="295d464740075e46465d4c47694f4d48074e465f">[email protected]</span></a> 
at least 7 days in advance of the meeting.
    Transcripts: You may request a transcript of the meeting's general 
session in writing from the Freedom of Information Office (HFI-35), 
Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, 
MD 20857. The transcript will not include the individual breakout 
sessions, although their summaries will be included in the general 
session transcript. The transcript of the public meeting will be 
available after the meeting, at a cost of 10 cents per page. You may 
also examine the transcript of the meeting at the Division of Dockets 
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 
Friday and on the CVM Web site at http://www.fda.gov/cvm.

SUPPLEMENTARY INFORMATION:

I. Background

    We envision the AFSS as an umbrella regulatory program aimed at 
protecting human and animal health, It is intended to cover the 
labeling, production, and distribution of all feed ingredients and 
mixed feeds at all stages of manufacture, distribution, and use.
    On September 23 and 24, 2003, we held a public meeting in Herndon, 
VA to discuss the AFSS. The public meeting included active 
participation of people

[[Page 6449]]

representing consumers, animal feed processors, animal producers, and 
State and other Federal Government agencies. Following the meeting, we 
placed a number of documents in the FDA Docket named at the beginning 
of this notice. These documents included a transcript of the meeting, 
summaries of breakout discussion groups, presentations of invited 
speakers, and a summary of the meeting. We stated our view that an AFSS 
should be comprehensive and risk-based, and we have since drafted 
definitions for these terms and placed them in this Docket. Likewise, 
we created and placed in the Docket a listing of elements we felt would 
be essential for process control under an AFSS. After reviewing 
comments to these items in the Docket, we drafted the following 
framework for the AFSS, including the four major components we see as 
comprising the AFSS:
    <bullet> Component 1--Ingredients and the approval process.
    <bullet> Component 2--Limits for animal feed contaminants.
    <bullet> Component 3--Process control for the production of feed 
ingredients and mixed feed.
    <bullet> Component 4--Regulatory oversight.
    This new document has been added to our Web site and the Docket and 
will be discussed at the meeting. We also intend to discuss a draft 
risk-ranking model under development by the agency for determining the 
relative risks of the numerous hazards that may be present in animal 
feed. Your comments on our proposed framework, including Components 1 
through 4, and any risk-related topics would be most appreciated. 
Please submit all comments by March 4, 2005.

II. Meeting

    We are holding the meeting in an effort to further gather 
information from you, our stakeholders, on the design of an effective, 
comprehensive, preventive, risk-based AFSS that is intended to help 
minimize risks associated with animal feeds.
    Resources and costs are important considerations in any such 
undertaking, and we are receptive to suggestions about how these can be 
controlled or used most effectively while focusing preventive efforts 
on important known and emerging health risks associated with animal 
feeds. We are particularly interested in your thoughts on the 
application of Hazard Analysis and Critical Control Point (HACCP) 
(mandatory or voluntary) to any or all segments of the industry, 
development of risk standards for contaminants, revising existing good 
manufacturing practices (GMPs) to make them more risk-based, 
development of GMP-type regulations and/or guidance for producers of 
feed ingredients and nonmedicated feeds, extending regulatory control 
to users of feed, and the role of State and first-party inspections.
    On the morning of the first day of the meeting, we will summarize 
the aforementioned documents placed in our docket, followed by breakout 
sessions in the afternoon to discuss each topic. Additionally, one 
group will be asked to discuss the perceived benefits of the AFSS. The 
breakout group(s) on risk analysis and risk-ranking is likely to be of 
greatest interest to meeting attendees who have a scientific 
background. If you are interested in participating in the breakout 
group on risk analysis and risk-ranking, please indicate this on your 
registration form. We will do our best to accommodate these requests.
    Discussions will be summarized in breakout group reports on the 
final day of the meeting. The meeting will wrap up with an open 
discussion and closing remarks.

III. Comments

    Interested persons may submit written or electronic comments to the 
Division of Dockets Management (see ADDRESSES). Comments should be 
identified with the full title and the docket number found in brackets 
in the heading of this document. A copy of the received comments will 
be available for public examination in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2210 Filed 2-4-05; 8:45 am]
BILLING CODE 4160-01-M


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