[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