Opportunity for Public Input on Standards for Pet Food and Other Animal Feeds; Notice of Meeting, 21357-21359 [08-1155]
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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
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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
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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
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21358
Federal Register / Vol. 73, No. 77 / Monday, April 21, 2008 / Notices
view received comments at https://
www.regulations.gov.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA only through FDMS at https://
www.regulations.gov.
SUPPLEMENTARY INFORMATION:
rwilkins on PROD1PC63 with NOTICES
I. Background
FDAAA was signed into law by the
President on September 27, 2007 (Public
Law 110–85). FDAAA Section 1002(a)
directs that within 2 years, FDA must
establish pet food ingredient standards
and definitions, processing standards,
and updated standards for pet food
labeling that include nutritional and
ingredient information. This same
provision of the law also directs that, in
developing these new standards, FDA
obtain input from its stakeholders,
including, but not limited to, AAFCO,
veterinary medical associations, animal
health organizations, and pet food
manufacturers. This public meeting is
an opportunity for interested
stakeholders to present such input and
for FDA to hear directly from the public.
In the Federal Register of January 7,
2008 (73 FR 1225), FDA announced its
intention to hold a public meeting
concerning FDAAA Section 1002(a) to
gather input from the interested
stakeholders and other members of the
public. This announcement includes
further details regarding the date and
location of the public meeting, and also
provides additional information
regarding the topics and questions to be
considered. After the meeting, FDA will
review all of the comments made at the
meeting and those submitted in writing
through the mail or electronically to
Docket No. FDA–2007–N–0442
(formerly Docket No. 2007N–0487).
FDA is sponsoring an additional
public meeting as part of its Animal
Feed Safety System (AFSS) initiative on
May 14, 2008, at the same location as
the May 13, 2008, FDAAA public
meeting. The AFSS is a system that FDA
is developing to minimize the risk to
animals and public health through the
use of risk-based, preventive, and
comprehensive animal feed control
measures. The purpose of the additional
meeting will be for the agency to present
the third draft of the AFSS Framework
and work-in-progress on a method for
ranking animal feed hazards by their
risks to animal and human health.
The revised Framework document
includes, among other things,
recognition of FDA’s Food Protection
VerDate Aug<31>2005
16:59 Apr 18, 2008
Jkt 214001
Plan, which was announced in
November 2007, and changes to the
document necessitated by FDAAA. The
ranking scheme for estimating risks
posed by feed hazards to animal and
human health consists of two
components, health consequence
scoring and exposure scoring, which
were previously presented. At the May
14, 2008, public meeting, FDA will
describe methods for ranking risks
associated with biological and chemical
hazards in feed, using swine feed
examples.
Background material relating to AFSS,
including previous drafts of the AFSS
Framework document, is available at
https://www.fda.gov/cvm/AFSS.htm.
pet foods and those intended for use in
other animal foods and feeds. Therefore,
the agency believes the most
appropriate course of action is to
develop ingredient standards and
definitions and processing standards for
all animal feeds, including pet food.
FDA believes that such an approach
would more effectively carry out the
safety objectives of FDAAA, and the
broader human food safety provisions of
the Federal Food, Drug, and Cosmetic
Act. The agency also seeks comment on
this or other alternative approaches for
implementing Section 1002(a) of
FDAAA.
II. Topics and Questions for
Consideration at the May 13, 2008,
Public Meeting:
FDA seeks input from stakeholders
and other members of the public on the
topics and questions discussed below.
Given that time will be limited at the
public meeting, FDA encourages all
interested persons to submit their
comments in writing to Docket No.
FDA–2007–N–0442 to ensure that their
comments are considered.
1. How could the nutritional
information (e.g., guaranteed analysis,
nutritional adequacy statements/lifestage claims) already present on pet
food labels be improved?
2. How could the ingredient
information already present on pet food
labels (i.e., the ingredient list) be
improved?
3. How could the current feeding
instructions/recommendations section
already present on pet food labels be
improved?
4. Should feeding recommendations
be required on the labels for all types of
pet food?
5. Should a Nutrition Facts box,
similar to the format that appears on
human food labels, replace the current
Guaranteed Analysis that currently
appears on pet food labels? If so, how
could this Nutrition Facts box be made
to clearly distinguish it from human
food labeling?
6. What other information should be
required on pet food labels that is not
generally present on pet food products
sold in the United States?
7. Are there existing state laws,
regulations, guidelines, or other models
that FDA should consider when drafting
the proposed pet food labeling?
A. Scope of Meeting.
In enacting FDAAA Section 1002(a),
Congress specifically directed FDA to
establish, in consultation with relevant
stakeholders and other members of the
public, ingredient standards and
definitions, processing standards, and
updated labeling standards for pet food.
FDA seeks input from stakeholders and
other members of the public on the
development of such standards for pet
food, including on the specific
questions listed below.
In addition, because pet food is wellintegrated into the overall animal foods
and feeds industry, FDA is concerned
that certain new requirements, if limited
to pet food only, would be impractical
to implement, difficult to enforce, and
would not effectively provide the safety
enhancements intended by FDAAA.
Furthermore, because the standards
mandated by FDAAA do not currently
exist for any animal food or feed,
limiting new requirements to pet food
only would fail to address the broader
food safety concerns associated with
food intended for other animal species,
particularly food-producing animals.
FDA is interested in obtaining input
from interested stakeholders and the
public as to whether the ingredient
standards and definitions and
processing standards should be
developed for all animal feeds. There
appears to be little or no difference
between ingredients intended for use in
PO 00000
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B. Pet Food Labeling.
C. Pet Food Ingredient Standards and
Definitions.
1. What kind of ingredient definitions
would provide adequate information to
ensure the safe and suitable use of the
ingredients in pet foods? Should
ingredient definitions also be developed
for other animal feeds in addition to pet
food?
2. Should formal standards be a part
of ingredient definitions? If so, what
information should be considered to
establish a standard? Should such
standards be developed for ingredients
intended for other animal feeds in
addition to pet food?
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Federal Register / Vol. 73, No. 77 / Monday, April 21, 2008 / Notices
D. Pet Food Processing Standards
The AFSS initiative is intended to
cover 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. Some basic elements
of an animal feed safety system are
described at: https://www.fda.gov/ohrms/
dockets/98fr/03n–0312–bkg0002.pdf.
Would standards based on a riskbased, preventive, and comprehensive
feed control measures approach, such as
the approach described as an element of
FDA’s AFSS initiative, adequately
address the processing standards
requirement of section 1002(a) of
FDAAA? If so, what aspects of
procurement, processing and
distribution should be included in such
an approach? Should such standards be
developed and applied to all animal
feeds rather than be limited to pet food?
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Pregnancy and
Neonatology Study Section, June 2,
2008, 8 a.m. to June 3, 2008, 3 p.m.,
Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC, 20015 which was
published in the Federal Register on
April 4, 2008, 73 FR 18539–18542.
The meeting will be held one day
only June 2, 2008, from 8 a.m. to 5 p.m.
The meeting location remains the same.
The meeting is closed to the public.
Dated: April 14, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–8450 Filed 4–18–08; 8:45 am]
BILLING CODE 4140–01–M
III. Other Information for the Public
Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FDA has posted additional
information for the May 13, 2008, public
meeting on the CVM Web site at https://
www.fda.gov/cvm. The agency may
make additional background material
available to the public and will post that
information on the CVM Web site as
well. Additionally, background material
relating to AFSS, including previous
drafts of the AFSS Framework
document, is available at https://
www.fda.gov/cvm/AFSS.htm.
National Institutes of Health
IV. Transcripts
rwilkins on PROD1PC63 with NOTICES
FDA will prepare a meeting transcript
that will be entered into the docket.
FDA anticipates that transcripts will be
available approximately 30 business
days after the meeting. The transcript
will also be available for public
examination at the Division of Dockets
Management (HFA–305), 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. 08–1155 Filed 4–16–08; 3:48 pm]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
17:14 Apr 18, 2008
Jkt 214001
Office of the Director, National
Institutes of Health; Office of
Biotechnology Activities; Recombinant
DNA Research; Notice of a Meeting of
an NIH Blue Ribbon Panel
There will be a meeting of the NIH
Blue Ribbon Panel to advise on the Risk
Assessment of the National Emerging
Infectious Diseases Laboratories (NEIDL)
at the Boston Medical Center. The
meeting will be held on Friday, May 2,
2008, at the National Institutes of
Health, Building 31, Floor 6C,
Conference Room 10, 31 Center Drive,
Bethesda, Maryland 20892, from 8:30
a.m. to approximately 11:30 a.m.
The National Research Council
Committee that provided technical
input on the NIH’s Draft Supplementary
Risk Assessments and Site Suitability
Analyses for the NEIDL will participate
in discussions with Panel members
regarding the scope and design of
additional studies that may be needed to
assess risk associated with the siting
and operation of the NEIDL.
For further information concerning
this meeting contact Ms. Laurie
Lewallen, Advisory Committee
Coordinator, Office of Biotechnology
Activities, Office of the Director,
National Institutes of Health, 6705
Rockledge Drive, Room 750, Bethesda,
MD 20892–7985, 301–496–9838,
lewallla@od.nih.gov.
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The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed above in
advance of the meeting. Any interested
person may file written comments with
the panel by forwarding the statement to
the Contact Person listed on this notice.
The statement should include the name,
address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
NIH campus security procedures
require that all visitor vehicles,
including taxicabs and hotel and airport
shuttles will be inspected before being
allowed on campus. Visitors will be
asked to show one form of identification
(for example, a government-issued
photo ID, driver’s license, or passport)
and to state the purpose of their visit.
An agenda and any additional
information for the meeting will be
posted on the agency’s Web site:
https://www.nih.gov/about/director/acd/
index.htm.
Background information may be
obtained by contacting NIH OBA by email oba@od.nih.gov.
Dated: April 14, 2008.
Amy P. Patterson,
Director, Office of Biotechnology Activities.
[FR Doc. E8–8474 Filed 4–18–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice; 30-day notice and
request for comments; Telephone
Survey, OMB 1660–0057, Revision of a
currently approved collection.
AGENCY:
SUMMARY: The Federal Emergency
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submitted the following information
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and Budget (OMB) for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
describes the nature of the information
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respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
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]]>Agencies
[Federal Register Volume 73, Number 77 (Monday, April 21, 2008)]
[Notices]
[Pages 21357-21359]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-1155]
-----------------------------------------------------------------------
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 [frac1s2] 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, Food and Drug Administration,
7519 Standish Place, Rockville, MD 20855, 240-453-6840, FAX: 240-453-
6880, e-mail: 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
[[Page 21358]]
view received comments at https://www.regulations.gov.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA only through FDMS at https://www.regulations.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDAAA was signed into law by the President on September 27, 2007
(Public Law 110-85). FDAAA Section 1002(a) directs that within 2 years,
FDA must establish pet food ingredient standards and definitions,
processing standards, and updated standards for pet food labeling that
include nutritional and ingredient information. This same provision of
the law also directs that, in developing these new standards, FDA
obtain input from its stakeholders, including, but not limited to,
AAFCO, veterinary medical associations, animal health organizations,
and pet food manufacturers. This public meeting is an opportunity for
interested stakeholders to present such input and for FDA to hear
directly from the public.
In the Federal Register of January 7, 2008 (73 FR 1225), FDA
announced its intention to hold a public meeting concerning FDAAA
Section 1002(a) to gather input from the interested stakeholders and
other members of the public. This announcement includes further details
regarding the date and location of the public meeting, and also
provides additional information regarding the topics and questions to
be considered. After the meeting, FDA will review all of the comments
made at the meeting and those submitted in writing through the mail or
electronically to Docket No. FDA-2007-N-0442 (formerly Docket No.
2007N-0487).
FDA is sponsoring an additional public meeting as part of its
Animal Feed Safety System (AFSS) initiative on May 14, 2008, at the
same location as the May 13, 2008, FDAAA public meeting. The AFSS is a
system that FDA is developing to minimize the risk to animals and
public health through the use of risk-based, preventive, and
comprehensive animal feed control measures. The purpose of the
additional meeting will be for the agency to present the third draft of
the AFSS Framework and work-in-progress on a method for ranking animal
feed hazards by their risks to animal and human health.
The revised Framework document includes, among other things,
recognition of FDA's Food Protection Plan, which was announced in
November 2007, and changes to the document necessitated by FDAAA. The
ranking scheme for estimating risks posed by feed hazards to animal and
human health consists of two components, health consequence scoring and
exposure scoring, which were previously presented. At the May 14, 2008,
public meeting, FDA will describe methods for ranking risks associated
with biological and chemical hazards in feed, using swine feed
examples.
Background material relating to AFSS, including previous drafts of
the AFSS Framework document, is available at https://www.fda.gov/cvm/
AFSS.htm.
II. Topics and Questions for Consideration at the May 13, 2008, Public
Meeting:
FDA seeks input from stakeholders and other members of the public
on the topics and questions discussed below. Given that time will be
limited at the public meeting, FDA encourages all interested persons to
submit their comments in writing to Docket No. FDA-2007-N-0442 to
ensure that their comments are considered.
A. Scope of Meeting.
In enacting FDAAA Section 1002(a), Congress specifically directed
FDA to establish, in consultation with relevant stakeholders and other
members of the public, ingredient standards and definitions, processing
standards, and updated labeling standards for pet food. FDA seeks input
from stakeholders and other members of the public on the development of
such standards for pet food, including on the specific questions listed
below.
In addition, because pet food is well-integrated into the overall
animal foods and feeds industry, FDA is concerned that certain new
requirements, if limited to pet food only, would be impractical to
implement, difficult to enforce, and would not effectively provide the
safety enhancements intended by FDAAA. Furthermore, because the
standards mandated by FDAAA do not currently exist for any animal food
or feed, limiting new requirements to pet food only would fail to
address the broader food safety concerns associated with food intended
for other animal species, particularly food-producing animals.
FDA is interested in obtaining input from interested stakeholders
and the public as to whether the ingredient standards and definitions
and processing standards should be developed for all animal feeds.
There appears to be little or no difference between ingredients
intended for use in pet foods and those intended for use in other
animal foods and feeds. Therefore, the agency believes the most
appropriate course of action is to develop ingredient standards and
definitions and processing standards for all animal feeds, including
pet food. FDA believes that such an approach would more effectively
carry out the safety objectives of FDAAA, and the broader human food
safety provisions of the Federal Food, Drug, and Cosmetic Act. The
agency also seeks comment on this or other alternative approaches for
implementing Section 1002(a) of FDAAA.
B. Pet Food Labeling.
1. How could the nutritional information (e.g., guaranteed
analysis, nutritional adequacy statements/life-stage claims) already
present on pet food labels be improved?
2. How could the ingredient information already present on pet food
labels (i.e., the ingredient list) be improved?
3. How could the current feeding instructions/recommendations
section already present on pet food labels be improved?
4. Should feeding recommendations be required on the labels for all
types of pet food?
5. Should a Nutrition Facts box, similar to the format that appears
on human food labels, replace the current Guaranteed Analysis that
currently appears on pet food labels? If so, how could this Nutrition
Facts box be made to clearly distinguish it from human food labeling?
6. What other information should be required on pet food labels
that is not generally present on pet food products sold in the United
States?
7. Are there existing state laws, regulations, guidelines, or other
models that FDA should consider when drafting the proposed pet food
labeling?
C. Pet Food Ingredient Standards and Definitions.
1. What kind of ingredient definitions would provide adequate
information to ensure the safe and suitable use of the ingredients in
pet foods? Should ingredient definitions also be developed for other
animal feeds in addition to pet food?
2. Should formal standards be a part of ingredient definitions? If
so, what information should be considered to establish a standard?
Should such standards be developed for ingredients intended for other
animal feeds in addition to pet food?
[[Page 21359]]
D. Pet Food Processing Standards
The AFSS initiative is intended to cover 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. Some basic elements of an
animal feed safety system are described at: https://www.fda.gov/ohrms/
dockets/98fr/03n-0312-bkg0002.pdf.
Would standards based on a risk-based, preventive, and
comprehensive feed control measures approach, such as the approach
described as an element of FDA's AFSS initiative, adequately address
the processing standards requirement of section 1002(a) of FDAAA? If
so, what aspects of procurement, processing and distribution should be
included in such an approach? Should such standards be developed and
applied to all animal feeds rather than be limited to pet food?
III. Other Information for the Public Meeting
FDA has posted additional information for the May 13, 2008, public
meeting on the CVM Web site at https://www.fda.gov/cvm. The agency may
make additional background material available to the public and will
post that information on the CVM Web site as well. Additionally,
background material relating to AFSS, including previous drafts of the
AFSS Framework document, is available at https://www.fda.gov/cvm/
AFSS.htm.
IV. Transcripts
FDA will prepare a meeting transcript that will be entered into the
docket. FDA anticipates that transcripts will be available
approximately 30 business days after the meeting. The transcript will
also be available for public examination at the Division of Dockets
Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. 08-1155 Filed 4-16-08; 3:48 pm]
BILLING CODE 4160-01-S
