[Federal Register Volume 73, Number 77 (Monday, April 21, 2008)]
[Notices]
[Pages 21357-21359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-1155]
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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.
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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:
[email protected]; 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: [email protected].
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 [email protected] 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 http://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 http://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 http://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 http://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 http://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: http://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 http://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 http://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