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, 21355-21357 [08-1154]
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Federal Register / Vol. 73, No. 77 / Monday, April 21, 2008 / Notices
Dated: April 11, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–8475 Filed 4–18–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Establishment
of a Community-Clinical Partnership
for Primary Prevention of Type-2
Diabetes in Persons at High Risk,
Potential Extramural Project (PEP)
2008–R–09
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting.
rwilkins on PROD1PC63 with NOTICES
Time and Date: 1 p.m.–2:30 p.m., May 20,
2008 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of ‘‘Establishment of a
Community-Clinical Partnership for Primary
Prevention of Type-2 Diabetes in Persons at
High Risk, PEP 2008–R–09.’’
Contact Person for More Information:
Linda Shelton, Program Specialist,
Coordinating Center for Health and
Information Service, Office of the Director,
CDC, 1600 Clifton Road, NE., Mailstop E21,
Atlanta, GA 30333, Telephone (404) 498–
1194.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: April 10, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–8478 Filed 4–18–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Centers for Disease Control and
Prevention
Time and Date: 1 p.m.–2 p.m., May 14,
2007 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of ‘‘Preparing People with
Arthritis to Safely Select and Self Direct their
Physical Activity, PEP 2008–R–16.’’
Contact Person for More Information:
Linda Shelton, Program Specialist,
Coordinating Center for Health and
Information Service, Office of the Director,
CDC, 1600 Clifton Road, NE., Mailstop E21,
Atlanta, GA 30333, Telephone (404) 498–
1194.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Evaluation of
Environmental and Policy
Interventions To Increase Fruit and
Vegetable Intake, Potential Extramural
Project (PEP) 2008–R–11
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting.
Time and Date: 1 p.m.–3 p.m., May 29,
2008 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of ‘‘Evaluation of Environmental
and Policy Interventions to Increase Fruit
and Vegetable Intake, PEP 2008–R–11.’’
Contact Person for More Information:
Linda Shelton, Program Specialist,
Coordinating Center for Health and
Information Service, Office of the Director,
CDC, 1600 Clifton Road, NE., Mailstop E21,
Atlanta, GA 30333, Telephone (404) 498–
1194.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: April 10, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–8480 Filed 4–18–08; 8:45 am]
BILLING CODE 4163–18–P
16:59 Apr 18, 2008
Jkt 214001
Dated: April 10, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–8483 Filed 4–18–08; 8:45 am]
BILLING CODE 4163–18–P
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Preparing
People With Arthritis To Safely Select
and Self Direct Their Physical Activity,
Potential Extramural Project (PEP)
2008–R–16
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
VerDate Aug<31>2005
21355
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
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
E:\FR\FM\21APN1.SGM
21APN1
rwilkins on PROD1PC63 with NOTICES
21356
Federal Register / Vol. 73, No. 77 / Monday, April 21, 2008 / Notices
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 W 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:
zoe.gill@fda.hhs.gov.
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:
nanette.milton@fda.hhs.gov. 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 https://
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 https://
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
VerDate Aug<31>2005
16:59 Apr 18, 2008
Jkt 214001
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
https://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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\21APN1.SGM
21APN1
Federal Register / Vol. 73, No. 77 / Monday, April 21, 2008 / Notices
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 riskbased 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.
rwilkins on PROD1PC63 with NOTICES
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://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.
VerDate Aug<31>2005
16:59 Apr 18, 2008
Jkt 214001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Docket No. FDA–2007–N–0442 (formerly
Docket No. 2007N–0487)
Opportunity for Public Input on
Standards for Pet Food and Other
Animal Feeds; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting to obtain input from
stakeholder groups, including, but not
limited to, the Association of American
Feed Control Officials (AAFCO),
veterinary medical associations, animal
health organizations, and pet food
manufacturers, concerning the
development of ingredient standards
and definitions, processing standards,
and labeling standards for pet food.
These standards were mandated by the
FDA Amendments Act of 2007
(FDAAA). We also would like to obtain
input on whether the ingredient
standards and definitions and
processing standards should cover all
animal feeds. 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 13, 2008, from 8
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 the Metro Red Line to Shady
Grove Station, then take Ride-On bus
124 to Frederick Rd. at Perry Pkwy.,
then cross the roadway and walk
approximately 1 W blocks north to the
building entrance.)
Contact Persons: For general
information, Tracey Forfa, Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Place,
Rockville, MD 20855, 240–276–9000,
FAX: 240–276–9030, e-mail:
Tracey.Forfa@fda.hhs.gov; or for
information on registration, Nanette
Milton, Center for Veterinary Medicine,
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
21357
Food and Drug Administration, 7519
Standish Place, Rockville, MD 20855,
240–453–6840, FAX: 240–453–6880, email: Nanette.Milton@fda.hhs.gov.
Registration: We request that you
preregister to ensure there is sufficient
room. Additionally, to assist us in
scheduling, we ask that you notify us
through the preregistration process if
you wish to make a public comment at
the meeting. To preregister, please send
an electronic mail message to
Nanette.Milton@fda.hhs.gov no later
than May 7, 2008. Your e-mail should
include the following information: Your
name, company or association name and
address as applicable, phone number,
and e-mail address. Please state whether
you are speaking on behalf of an
organization or as an individual. You
will receive a confirmation within 2
business days.
FDA also will accept walk-in
registration at the meeting site, but
space is limited. FDA will try to
accommodate all persons who wish to
make a public comment at the meeting,
including those who register at the
meeting site; however, the time allotted
for public comments may depend on the
number of persons who wish to speak.
Additionally, please notify FDA (see
Contact Persons) if you need any special
accommodations (such as wheelchair
access or a sign language interpreter) at
least 7 days in advance of the meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced public meeting
cannot always be published quickly
enough to provide timely notice.
Accordingly, you should check the FDA
Web site at https://www.fda.gov/cvm to
learn about possible modifications
before coming to the meeting.
Comments: To ensure consideration
of your comments regarding the
development of standards for pet food,
you should submit comments by June
13, 2008. While interested persons may
comment orally at the public meeting,
comments may also be submitted in
writing or electronically in lieu of or in
addition to oral comments. Send written
comment submissions to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. Follow the
instructions for submitting comments.
All 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 may also
E:\FR\FM\21APN1.SGM
21APN1
]]>Agencies
[Federal Register Volume 73, Number 77 (Monday, April 21, 2008)]
[Notices]
[Pages 21355-21357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-1154]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: zoe.gill@fda.hhs.gov.
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: nanette.milton@fda.hhs.gov.
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 https://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 https://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 https://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 https://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
