[Federal Register: July 28, 2003 (Volume 68, Number 144)]
[Page 44344-44345]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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: ggraber@cvm.fda.gov.    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: Linda.Grassie@fda.gov.    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.


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]