10 October 2003

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[Federal Register: October 10, 2003 (Volume 68, Number 197)]
[Notices]
[Page 59078]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc03-190]

[[Page 59078]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0467]

Risk Assessment for Food Terrorism and Other Food Safety
Concerns; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a risk assessment for food terrorism and other food
safety concerns. FDA is making this document available to promote
transparency by communicating publicly the risk to public health of
acts of food terrorism, as well as incidents of unintentional
contamination of food that result in significant foodborne illness. The
development of this risk assessment is one of a number of steps the
agency is taking to improve its ability to prevent, prepare for, and
respond to an incident of food sabotage.

ADDRESSES: Submit written requests for single copies of the risk
assessment to the Office of Regulations and Policy (HFS-24), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed
adhesive label to assist that office in processing your request, or
include a fax number to which the document may be sent. Alternatively,
you may request a copy of the document by calling 301-436-1589, or you
may fax your request to 301-436-2637. See the SUPPLEMENTARY INFORMATION
section for electronic access to the risk assessment.

FOR FURTHER INFORMATION CONTACT: Leslye Fraser, Associate Director for
Regulations, Center for Food Safety and Applied Nutrition (HFS-4), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, 301-436-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    The events of September 11, 2001, and the subsequent anthrax
incidents gave rise to concerns about unconventional terrorist attacks,
including the threat of attacks on the U.S. food supply. In the
aftermath of those incidents, FDA took steps to improve its ability to
prevent, prepare for, and respond to incidents of food sabotage.
    As part of this effort, the agency prepared various assessments of
the risk of food terrorism. Most of these risk assessments were deemed
to be classified. The goal of this document is to communicate publicly
the risk to public health of acts of food terrorism, as well as
incidents of unintentional contamination of food that result in
significant foodborne illness.

II. Risk Assessment for Food Terrorism and Other Food Safety Concerns

    The risk assessment presents scientific evidence and various risk
scenarios, to the extent that such information is unclassified, on both
deliberate and accidental contamination of that portion of the food
supply regulated by FDA. Unlike traditional risk assessments, which
focus on one hazard, this assessment addresses the broad range of
hazards that may be introduced into food intentionally or
unintentionally. In addition, the very nature of ``bioterrorism'' and
the fact that it is a relatively new and evolving threat present
challenges in quantitatively evaluating the associated risks. Thus, FDA
has prepared a qualitative assessment that follows the generally
accepted framework for risk assessments endorsed by the Codex
Alimentarius Commission. This framework involves the following steps:
    (1) Hazard identification. A review of available information on the
range of possible biological and chemical agents that might be used by
terrorists to deliberately contaminate food or that might be introduced
inadvertently into food.
    (2) Hazard characterization. The assessment of the potential for an
act of food terrorism or other food safety emergency to cause illnesses
and deaths, economic effects, and social and political implications.
    (3) Exposure assessment. An evaluation of the likelihood that an
act of food terrorism or inadvertent food contamination that results in
significant foodborne illness will occur.
    (4) Risk characterization. The integration of information on
potential hazards with the exposure assessment.
    The risk assessment also discusses the quality of information
available for, and the uncertainties associated with, the assessment.
    FDA has determined that this risk assessment, which discusses prior
incidents of food contamination and available unclassified information
on prior acts of food sabotage, is appropriate to the circumstances.

III. Electronic Access

    The risk assessment is available electronically at http://www.cfsan.fda.gov 
.

    Dated: October 7, 2003.
Jeffrey Shuren,Assistant Commissioner for Policy.
[FR Doc. 03-25850 Filed 10-9-03; 8:45 am]