
[Federal Register: April 21, 2008 (Volume 73, Number 77)]
[Notices]               
[Page 21357-21359]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ap08-96]                         

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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: 
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 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
