[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