[Federal Register Volume 68, Number 197 (Friday, October 10, 2003)]
[Notices]
[Page 59078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25850]



  Federal Register / Vol. 68, No. 197 / Friday, October 10, 2003 / 
Notices  

[[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]
BILLING CODE 4160-01-P