[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.
[[Page 21357]]
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