[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: [email protected].
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: [email protected].
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 [email protected]
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:
Component 1--Ingredients and the approval process.
Component 2--Limits for animal feed contaminants.
Component 3--Process control for the production of feed
ingredients and mixed feed.
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