[Federal Register Volume 71, Number 147 (Tuesday, August 1, 2006)]
[Notices]
[Pages 43488-43489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12266]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0312]
Meeting to Present Work-In-Progress on a Method for Ranking Feed
Contaminants According to the Relative Risks They Pose to Animal and
Public Health; Part 1: Health Consequence Scoring for Feed Contaminants
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 it will hold to present work-in-progress on a method for
ranking animal feed contaminants by their relative risks to animal and
human health. The relative risk posed by feed contaminants to animal
and human health consists of two components, namely health consequence
scoring and exposure scoring. At this meeting the agency will describe
the methods it plans to use to develop animal and human health
consequence scoring for chemical, physical, and biological feed
contaminants. At one or more subsequent public meetings, FDA will
present information about how the health consequence scoring will be
combined with information about the exposure of animals and humans to
feed contaminants to determine the relative risks of such contaminants
in feed.
Date and Time: The public meeting will be held on September 12,
2006, from 9 a.m. to 4:30 p.m.
Location: The meeting will be held at the Center for Drug
Evaluation and Research Conference Room, third floor, 7519 Standish
Pl., Rockville, MD 20855.
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.
FOR FURTHER INFORMATION CONTACT: 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, e-mail:
[email protected].
Registration: You may register by telephone, fax, or e-mail by
contacting Nanette Milton, Center for Veterinary Medicine (HFV-200),
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855,
240-453-6840, FAX 240-453-6880, e-mail: [email protected].
Send registration information (including name, title, firm name,
address, telephone, and fax number to Nanette Milton. To obtain the
registration form via the Internet go to http://www.fda.gov/cvm/AFSS.htm#Meetings. Due to limited meeting space, registration will be
required. We strongly encourage early registration.
SUPPLEMENTARY INFORMATION:
I. Background
The Animal Feed Safety System (AFSS) is FDA's program for animal
feed aimed at protecting human and animal health by ensuring animal
feed is safe. It covers the entire spectrum of agency activities from
preapproval of food additives and drugs for use in feed, to
establishing limits for feed contaminants, providing education and
training, and conducting inspections and taking enforcement actions for
ensuring compliance with agency regulations. AFSS includes oversight of
all feed ingredients and mixed feed at all stages of manufacture,
production, distribution, and use, whether at commercial or non-
commercial establishments.
During the past several years, FDA has been considering changes
that need to be made to AFSS to ensure that it is comprehensive,
preventive, and risk-based. As part of this effort, the agency is
developing a model for ranking the relative risks to human and animal
health of contaminants in animal feed. An effective model will permit
the agency to systematically distinguish among feed hazards based on
the relative risks they pose to animals or humans. Such a model will
consider the risks of hazards present in incoming materials or feed
ingredients and will also consider how activities at feed
manufacturing, storage, distribution, and transportation facilities may
modify such risks. For the purpose of AFSS, FDA defines a feed hazard
as a biological, chemical, or physical agent in, or condition of, feed
with the potential to cause an adverse health effect in animals or
humans.
Previously, FDA held two public meetings to discuss AFSS, including
discussions of the agency's plan to develop a risk ranking model for
determining the relative risks to animal or human health of feed
hazards. The first meeting was held on September 23 and 24, 2003, in
Herndon, VA, and the second meeting was held on April 5 and 6, 2005, in
Omaha, NE. The public meetings included active participation by
consumers, animal feed processors, animal producers, and State and
other Federal Government agencies. Following the meetings, we placed a
number of documents in FDA's docket for the AFSS project (found in
brackets in the heading of this document). These documents included
transcripts of the meetings, summaries of break-out discussion groups,
presentations of invited speakers, and meeting summaries. We also
placed in the docket a number of other documents relating to AFSS,
including a framework for AFSS that lists the principal components of
AFSS and the gaps the agency has identified which are being addressed
by the agency team working on the AFSS project. These documents provide
excellent, general background material on AFSS for the public meeting
that will be held on September 12, 2006.
[[Page 43489]]
This meeting is the first of several planned by FDA to discuss
aspects of the AFSS relative risk ranking model during the model's
development by the agency. To determine the relative risks of chemical,
physical, and biological contaminants in animal feed, information about
the health consequences posed by the contaminant (represented by a
health consequence scoring) is combined with information about the
amount of the contaminant in animal feed (represented by an exposure
scoring). This meeting will describe the methods used by the agency to
develop the animal and human health consequence scoring for feed
contaminants. At one or more subsequent meetings, FDA will present
information about exposure of animals and humans to contaminants in
feed and information about how health consequence scoring is combined
with exposure scoring to determine the relative risks of contaminants
in animal feed.
II. Meeting
We are holding the meeting in an effort to gather further
information from you, our stakeholders, on changes to AFSS that will
help minimize risks to animal and human health associated with animal
feed. Prior to the public meeting, FDA will place in the docket (found
in brackets in the heading of this document) two documents, entitled
``List of Potentially Hazardous Contaminants in Animal Feed and Feed
Ingredients'' and ``Determining Health Consequence Scoring for Feed
Contaminants.'' The documents will summarize the agency's methods for
assigning animal and human health consequence scoring to physical,
chemical, and biological contaminants that may be present in animal
feed. Details of these methods will be discussed at the meeting. A
draft agenda for the meeting will also be placed in the docket prior to
the meeting.
III. Comments
If you would like to submit written comments to the docket, please
send you comments to the Division of Dockets Management (see
ADDRESSES). Submit a single copy of electronic comments or two paper
copies of any written comments, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
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. You can view comments FDA has received on the Internet
at http://www.fda.gov/ohrms/dockets/.
Dated: July 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12266 Filed 7-31-06; 8:45 am]
BILLING CODE 4160-01-S