[Federal Register Volume 72, Number 60 (Thursday, March 29, 2007)]
[Notices]
[Pages 14820-14821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0312]


Meeting to Present Work-in-Progress on a Method for Ranking Feed 
Contaminants According to the Relative Risks They Pose to Animal and 
Public Health; Part 2: Exposure Scoring for Feed Contaminants; Public 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following 
public meeting: ``Meeting to Present Work-in-Progress on a Method for 
Ranking Feed Contaminants According to the Relative Risks They Pose to 
Animal and Public Health; Part 2: Exposure Scoring for Feed 
Contaminants.'' The topic to be discussed will present work-in-progress 
on a method for ranking animal feed contaminants by their relative 
risks to animal and human health. The relative risk posed by feed 
contaminants to animal and human health consists of two components, 
namely, health consequence scoring and exposure scoring. At a meeting 
held in September 2006, the agency presented its current thinking on 
health consequence scoring. At this public meeting, the agency will 
describe the methods it plans to use to develop animal and human 
exposure scoring for chemical, physical, and microbiological feed 
contaminants. At a subsequent public meeting, FDA will present 
information on its relative risk-ranking model and how the health 
consequence scoring and exposure scoring will be combined to determine 
the relative risks of contaminants in feed.
    Date and Time: The public meeting will be held on May 22, 2007, 
from 9 a.m. to 4 p.m.
    Location: The public meeting will be held at the Holiday Inn, 2 
Mongomery Village Ave., Gaithersburg, MD 20879.
    Contact: For general information: Zoe Gill, Center for Veterinary 
Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl.,

[[Page 14821]]

Rockville, MD 20855, 240-453-6867, FAX: 240-453-6882, or e-mail: 
[email protected].
    For registration: Nanette Milton, Center for Veterinary Medicine 
(HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-453-6840, FAX: 240-453-6880, or e-mail: 
[email protected].
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) to the contact person 
(see Contact). To obtain the registration form via the Web site, go to 
http://www.fda.gov/cvm/AFSS052007PM.htm. Due to limited meeting space, 
registration will be required. We strongly encourage early 
registration.
    If you need special accommodations due to a disability, please 
contact Nanette Milton (see Contact) no later than May 15, 2007.
    Comments: Written comments should be submitted to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Electronic comments may be 
submitted to the docket at the following Web site: http://www.fda.gov/dockets/ecomments. Submit a single copy of electronic comments or two 
paper copies of any written comments, except that individuals may 
submit one paper copy. 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. The docket will remain open for 
written or electronic comments through June 21, 2007, 30 days following 
the meeting.

SUPPLEMENTARY INFORMATION:

I. Background

    The Animal Feed Safety System (AFSS) is FDA's program for animal 
feed aimed at protecting human and animal health by ensuring animal 
feed is safe. It covers the entire spectrum of agency activities from 
preapproval of food additives and drugs for use in feed, to 
establishing limits for feed contaminants, providing education and 
training, conducting inspections, and taking enforcement actions for 
ensuring compliance with agency regulations. The AFSS includes 
oversight of all feed ingredients and mixed feed at all stages of 
manufacture, production, distribution and use, whether at commercial or 
non-commercial establishments.
    During the past several years, FDA has been considering changes 
that need to be made to the AFSS to ensure that it is comprehensive, 
preventive and risk-based. As part of this effort, the agency is 
developing a model for ranking the relative risks to human and animal 
health from contaminants in animal feed. An effective model will permit 
the agency to systematically distinguish among feed hazards based on 
the relative risks they pose to animals or humans. Such a model will 
consider the risks of hazards present in incoming materials or feed 
ingredients and will also consider how activities at feed 
manufacturing, storage, distribution, and transportation facilities may 
modify such risks. For the purpose of the AFSS, FDA defines a feed 
hazard as a biological, chemical, or physical agent in, or condition 
of, feed with the potential to cause an adverse health effect in 
animals or humans.
    Previously, FDA held three public meetings to discuss the AFSS. The 
first two meetings were held on September 23 and 24, 2003, in Herndon, 
VA and on April 5 and 6, 2005, in Omaha, NE. These public meetings 
included active participation by consumers, animal feed processors, 
animal producers, and State and other Federal government agencies. 
Following the meetings, we placed a number of documents in FDA's docket 
for the AFSS project (see docket number found in brackets in the 
heading of this document). These documents included transcripts of the 
meetings, summaries of break-out discussion groups, presentations of 
invited speakers and meeting summaries. We also placed in FDA's docket 
a number of other documents relating to the AFSS, including a framework 
for the AFSS that lists the principal components of the AFSS and the 
gaps the agency has identified which are being addressed by the agency 
team working on the AFSS project. These documents provided general 
background material on the AFSS for the third public meeting that was 
held on September 12, 2006, in Rockville, MD.
    The September 2006 meeting was the first of several planned by FDA 
to discuss aspects of the AFSS relative risk ranking model during the 
model's development by the agency. In this model, information about the 
health consequences posed by the hazardous contaminants will be 
combined with information about exposures to the contaminants in animal 
feed. At the September 2006 meeting, the agency presented its current 
thinking on the development of a health consequences scoring system to 
represent the animal and human health consequences associated with the 
feed contaminants. The meeting also afforded the opportunity for 
attendees and agency presenters to have an open discussion concerning 
the health consequences approach being considered by the agency. The 
presentations and the transcript of the meeting have been added to the 
AFSS docket.
    At the May 22, 2007, meeting, which will be held in Gaithersburg, 
MD, FDA will continue its discussions on the development of the AFSS 
relative risk ranking model by focusing on the exposure component of 
the model. The exposure scoring system under development intends to 
address the presence of contaminants in source materials for feed 
ingredients and those factors in manufacturing and/or processing that 
may affect the levels of contaminants in final feed formulations. At 
the May 2007 meeting, the agency will use the production of swine feed 
as an example exposure scenario to illustrate its approach to exposure 
assessment.
    At one or more subsequent meetings, the agency will present 
information about how health consequences and exposure are combined to 
determine the relative risks of contaminants in animal feed and various 
aspects of the relative risk model developed by the agency.

II. Meeting

    We are holding the public meeting in an effort to gather further 
information from you, our stakeholders, on changes to the AFSS that 
will help minimize risks to animal and human health associated with 
animal feed. Prior to the public meeting, FDA will place a document 
entitled ``Exposure Scoring for Feed Contaminants--A Swine Feed 
Example'' in the docket found in brackets in the heading of this 
notice. The document will summarize the agency's methods for 
determining exposures to physical, chemical, and microbiological 
contaminants that may be present in swine feed. 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.

    Dated: March 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5820 Filed 2-28-07; 8:45 am]
BILLING CODE 4160-01-S