[Federal Register Volume 73, Number 77 (Monday, April 21, 2008)]
[Notices]
[Pages 21355-21357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-1154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0189] (formerly Docket No. 2003N-0312)


Meeting to Present Changes to the Animal Feed Safety System 
Project and the Ranking of Feed Hazards According to the Risks They 
Pose to Animal and Public Health; Part 3: Swine Feed Example; 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 the 
following public meeting: ``Meeting to Present Changes to the Animal 
Feed Safety System (AFSS) Project and the Ranking of Feed Hazards 
According to the Risks They Pose to Animal and Public Health; Part 3: 
Swine Feed Example.'' We are holding the public meeting in an effort to 
gather further information from you, our stakeholders, on changes to 
AFSS that will help

[[Page 21356]]

minimize risks to animal and human health associated with animal feed. 
The following topics will be discussed: The third draft of the AFSS 
Framework and work-in-progress on a method for ranking animal feed 
contaminants by their risks to animal and human health. Elsewhere in 
this issue of the Federal Register, FDA is announcing a related public 
meeting notice.
    Date and Time: The public meeting will be held on May 14, 2008, 
from 9 a.m. to 4:30 p.m.
    Location: The public meeting will be held at the Gaithersburg 
Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, MD 20877. There 
is parking adjacent to the building. The building is also accessible by 
public transportation. (Take Metro Red Line to Shady Grove Station and 
board Ride-On bus 124 to Frederick Rd. at Perry Pkwy. Then, cross the 
roadway and walk approximately 1 [frac1s2] blocks north to building 
entrance.)
    Contact Person:  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, 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 Web site, go to http://www.fda.gov/cvm/AFSS.htm#Meetings. Due to limited meeting space, registration will be 
required. We strongly encourage early registration.
    Additionally, please notify Nanette Milton if you need any special 
accommodations (such as wheelchair access or a sign language 
interpreter) at least 7 days in advance of the meeting.
    Comments: Regardless of attendance at the public meeting, 
interested persons may submit written or electronic 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.regulations.gov. 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 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. The docket 
will remain open for written or electronic comments for 30 days 
following the meeting.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov

SUPPLEMENTARY INFORMATION:

I. Background

    AFSS is FDA's program for animal feed aimed at protecting human and 
animal health by ensuring animal feed is safe. AFSS covers the entire 
spectrum of agency activities from preapproval of food additives 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. It 
includes oversight of all feed ingredients and mixed feeds at all 
stages of manufacture, production, distribution, and use, whether at 
commercial or non-commercial establishments. Further, AFSS includes 
feed intended for food-producing and non-food-producing (companion) 
animals.
    During the past several years, FDA has been considering needed 
changes to AFSS to ensure it is comprehensive, preventive, and risk-
based. As part of this effort, the agency released its AFSS Framework 
document in February 2005 and discussed it at a public meeting held in 
April 2005 in Omaha, NE. Subsequently, a revised Framework document was 
made available to the public in December 2006. The revised Framework 
document includes, among other things, changes necessitated by FDA's 
Amendments Act of 2007 (FDAAA), which was signed into law September 28, 
2007. The ranking scheme for estimating risks posed by feed 
contaminants to animal and human health consists of two components, 
namely health consequence scoring and exposure scoring, which were 
covered at previous meetings in 2006 and 2007, respectively. At this 
meeting, the agency will describe the model it has developed to rank 
the risks of the more common hazards in swine feed. The Framework 
document identifies numerous projects including the development of a 
model for ranking the 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 comparative 
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 during feed manufacturing, storage, 
distribution, or transportation 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 four public meetings to discuss AFSS. The 
first two meetings, held in September 2003 and April 2005, focused on 
obtaining input on what was lacking and where and how to address 
identified deficiencies in the agency's feed safety program. At the 
next two meetings, held in September 2006 and May 2007, the agency 
covered developmental aspects of the AFSS risk-ranking model. To 
determine the comparative 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). During the 2006 and 
2007 meetings, we described the methods used by the agency to develop 
scoring systems for ranking animal and human health consequences 
arising from feed hazards and for ranking exposure to those feed 
hazards, respectively. The public meetings included active 
participation by consumers, animal feed processors, animal producers, 
and State and other Federal Government agencies. Both before and 
following the meetings, we placed a number of documents in FDA's docket 
(found in brackets in the heading of this document) for the AFSS 
project. These documents included transcripts of the meetings, 
summaries of breakout 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 
listing 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 May 14, 
2008.

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    As a result, in part, of recent actions by the Congress and the 
Administration, a third draft of the AFSS Framework will be presented 
at the public meeting. We will also discuss in more detail, where 
appropriate, several of the gaps identified in the Framework document. 
In addition, we will show how health consequence scoring is combined 
with exposure scoring to rank the risks of contaminants in animal feed. 
Swine feed will be used as the example. We also plan to briefly present 
the risk-based method being developed to rank feed inspectional 
programs.

II. Public Meeting

    We are holding the public 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 
``Draft AFSS Framework, 3rd Edition'' and ``Risk-Ranking of Feed 
Hazards: Swine Feed Example.'' The Framework document will summarize 
the agency's current efforts to modernize its animal feed safety 
program. The Risk-Ranking document will provide the methods for ranking 
potential biological and chemical hazards in feed, using swine feed as 
an example. 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.
    An additional public meeting sponsored by the Center for Veterinary 
Medicine (CVM) will be held on May 13, 2008, at the same site as the 
AFSS public meeting. The purpose of the CVM meeting will be for the 
agency to receive comments on the pet food safety section of FDAAA 
(Public Law 110-85). Information on the CVM public meeting will be 
publishing elsewhere in this issue of the Federal Register.

III. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. 
It may be viewed at the Division of Dockets Management (see Comments). 
A transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. 08-1154 Filed 4-16-08; 3:47 pm]
BILLING CODE 4160-01-S