[Federal Register Volume 68, Number 144 (Monday, July 28, 2003)]
[Notices]
[Pages 44344-44345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19030]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0312]
Discussion of Animal Feed Safety System: A Comprehensive Risk-
Based Safety Program for the Manufacture and Distribution of Animal
Feeds; Notice of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a meeting
to discuss the potential development of a comprehensive, risk-based
animal feed safety system (AFSS) describing how animal feeds
(individual ingredients and mixed feeds) should be manufactured and
distributed to minimize risks to animals consuming the feed and people
consuming food products from animals. We are informing you (consumers,
animal feed processors, animal producers, State and local officials,
and other interested persons) of this meeting in an effort to solicit
comments and seek your assistance in our consideration of a safety
program to effectively minimize the hazards to public health, both
human and animal health, posed by animal feed products.
Date and Time: The public meeting will be held on Tuesday,
September 23, 2003, from 1 p.m. to 5 p.m., and Wednesday, September 24,
2003, from 8 a.m. to 3 p.m. You may submit written or electronic
comments at any time, but they would be most helpful if received either
before or within 30 days after the close of the meeting.
Location: The meeting will be held at the Hyatt Dulles
International Airport, 2300 Dulles Corner Blvd., Herndon, VA, 1-800-
233-1234 or 703-713-1234.
Comments and Electronic Access: 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 a single copy of electronic comments or two
paper copies of any mailed comments, except that individuals may submit
one copy. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments should be identified with docket number found in
brackets in the heading of this document. A copy of the received
comments will be available for public examination in the Dockets
Management Division between 9 a.m.
[[Page 44345]]
and 4 p.m., Monday through Friday. You can view comments FDA has
received on the Internet at http://www.fda.gov/ohrms/dockets/.
For General Information Contact: George Graber, Center for
Veterinary Medicine (HFV-220), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6651; FAX 301-827-1484 or e-
mail: [email protected].
For Information About Registration Contact: Linda Grassie, Center
for Veterinary Medicine (HFV-12), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-3796; FAX 301-827-4065 or e-
mail: [email protected].
Registration: There is no registration fee for the meeting, but
registration is required. Limited space is available (maximum of 200),
so early registration is encouraged. You may register by phone, Fax or
e-mail (see For Information About Registration Contact). Registration
forms are also available on the Division of Dockets Management Web site
at http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm.
If you need special accommodations due to a disability, please
contact Linda Grassie (see For Information About Registration Contact)
at least 7 days in advance.
Transcripts: You may request a transcript of the meeting's general
session in writing from the Freedom of Information Office (HFI-35),
Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville,
MD 20857. The transcript will not include the individual breakout
sessions, although their summaries will be included in the general
session transcript. The transcript of the public meeting will be
available after the meeting, at a cost of 10 cents per page. You may
also examine the transcript of the meeting at the Division of Dockets
Management (see Comments and Electronic Access) between 9 a.m. and 4
p.m., Monday through Friday and on the Center for Veterinary Medicine
Web site at http://www.fda.gov/cvm.
SUPPLEMENTARY INFORMATION:
I. Background
The regulation of animal feed by FDA has focused on areas
recognized as having an important impact on human health. Medicated
feed good manufacturing practice regulations (GMPs) help prevent
potentially unsafe drug residues in edible animal tissue. The
regulation that prohibits the feeding of mammalian proteins to ruminant
animals is intended to help prevent bovine spongiform encephalopathy in
our cattle herd and the potential for variant Creutzfeldt-Jakob disease
in humans. FDA believes it may be of value to develop a comprehensive
preventive program for the manufacture and distribution of animal feed.
While emphasis for fostering safety has been placed on end product
sampling, only a limited number of samples are tested for potential
contaminants. More and more, industry is considering preventative,
risk-based system controls to augment end product testing. We are
exploring risk-based, preventative measures as an approach designed to
help prevent feed-related hazards from occurring and to detect problems
prior to distribution and sale of feed products. Control systems vary,
but generally they have a number of common basic elements. These
include the following elements: (1) A thorough analysis of
manufacturing and distribution for each product, (2) identification of
risks associated with the process and product, (3) identification and
implementation of controls to effectively prevent identified risks, (4)
employee training programs, (5) controls focused on critical steps, (6)
assurances such steps are accurately and consistently performed, and
(7) recordkeeping and validation of the system.
Although the purpose of an AFSS would be to reduce the risks
associated with animal feeds, the design of a final program would
consider costs, technological limitations, and other resource
limitations. Some available approaches include hazard analysis and
critical control points and GMPs, International Organization for
Standardization procedures, statistical process controls, and standard
sanitary operating procedures. These have been used by regulatory
agencies and industry to help ensure the production and distribution of
safe human foods.
II. Meeting
We are holding the meeting in an effort to gather information from
you, our stakeholders, on the design of an effective, comprehensive,
preventive, risk-based program to help minimize risks associated with
animal feeds. Resources and costs are important considerations in any
such undertaking, and we are receptive to suggestions about how these
can be controlled or used most effectively (such as use of State
inspections and self-inspections) while focusing preventive efforts on
important known and emerging health risks associated with animal feeds.
The meeting will feature stakeholder and government speakers
discussing safety measures currently in use and others which could be
adapted to the feed industry. We plan several facilitated break-out
discussion groups to explore topics such as the following:
1. What are the strengths of the current Federal and State
regulatory programs for feed safety?
2. What are the weaknesses of the current Federal and State
regulatory programs for feed safety?
3. What are the strengths and weaknesses of current industry feed
safety programs?
4. What are the potential benefits of a comprehensive, risk-based
Federal feed safety program?
5. What components should be included in an AFSS?
6. What is the potential burden (increased cost and manpower) of a
comprehensive, risk-based Federal feed safety program, and what options
are available to minimize the burden?
Dated: July 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-19030 Filed 7-25?-03; 8:45 am]
BILLING CODE 4160-01-S