[Federal Register Volume 72, Number 194 (Tuesday, October 9, 2007)]
[Notices]
[Pages 57285-57286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-4975]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2007-0041]


Non-Escherichia coli O157:H7 Shiga Toxin-Producing E. coli

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of public meeting.

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SUMMARY: This notice is announcing that the U.S. Department of 
Agriculture's (USDA) Food Safety and Inspection Service (FSIS), the 
Food and Drug Administration's Center for Food Safety and Applied 
Nutrition (FDA CFSAN), and the National Centers for Disease Control and 
Prevention (CDC) will co-sponsor a public meeting on October 17, 2007. 
The purpose of the meeting is to consider the public health 
significance of non-Escherichia coli (E. coli) O157:H7 Shiga toxin-
producing E. coli.

DATES: The public meeting will be held on Wednesday, October 17, 2007, 
8:30 a.m. to 3:30 p.m.

ADDRESSES: The meeting will be held at the Arlington campus of George 
Mason University, 3401 N. Fairfax Drive, Room 244, Arlington, VA 22201.

Registration

    Pre-registration for this meeting is encouraged. To pre-register to 
attend in person or via teleconference, access the FSIS Web site, 
http://www.fsis.usda.gov. Contact Sheila Johnson for more information 
on logistics at 202-690-6498 or via e-mail at 
[email protected].
    All documents related to the meeting will be available for public 
inspection in the FSIS Docket Room, 1400 Independence Avenue, SW., Room 
2534 South Building, Washington, DC 20250, between 8:30 a.m. and 4:30 
p.m., Monday through Friday, as soon as they become available.
    FSIS will finalize an agenda on or before the meeting date and post 
it on the FSIS Web page at: http://www.fsis.usda.gov/News/Meetings_&_Events/. Also, when it becomes available, the official transcript of 
the meeting will be kept in the FSIS Docket Room at the above address 
and will also be posted on the Agency Web site, http://www.fsis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Denise Eblen, phone (202) 690-6238, 
fax (202) 690-6334, e-mail: [email protected] or at the mail 
address: U.S. Department of Agriculture, Food Safety and Inspection 
Service, Office of Public Health Science, 1400 Independence Avenue, 
SW., 357 Aerospace Center, Washington, DC 20250-3766.
    Persons requiring a sign language interpreter or other special 
accommodations should notify Dr. Eblen by October 10, 2007.

SUPPLEMENTARY INFORMATION:

Background

    Shiga toxin-producing E. coli (STEC) was first identified in the 
early 1980s in North America as the cause of outbreaks of bloody 
diarrhea, often leading to severe and fatal illness. These outbreaks 
were associated with ground beef consumption, and E. coli O157:H7 was 
the STEC identified as causing the illnesses. In 1994, FSIS notified 
the public that raw ground beef contaminated with E. coli O157:H7 is 
adulterated under the FMIA unless the ground beef is processed to 
destroy this pathogen. Also in 1994, FSIS began sampling and testing 
ground beef for E. coli O157:H7.
    On January 19, 1999, FSIS published a policy statement in the 
Federal Register that explained that if non-intact raw beef products or 
intact raw beef products that are to be processed into non-intact 
product prior to distribution for consumption are found to be 
contaminated with E. coli O157:H7, they will be deemed to be 
adulterated if not processed to destroy the pathogen (64 FR 2803).
    Shiga toxins are produced by other E. coli serotypes in addition to 
E. coli O157:H7. While many STEC strains have been found in ruminant 
feces, not all of these STECs are pathogenic. The scientific community 
believes that the STECs that are pathogenic not only contain the Shiga 
toxin but also additional virulence determinants that, together with 
the toxin, cause illnesses similar to those caused by E. coli O157:H7. 
The subset of STECs that contain both the toxin and these additional 
virulence determinants, including E. coli O157:H7, is known as 
enterohemorrhagic E. coli (EHEC).
    In the United States, there is growing awareness that STECs other 
than E. coli O157:H7 (non-O157:H7 STECs) cause sporadic and outbreak-
associated illnesses. This awareness is attributable in part to the 
increasing availability of laboratory reagents that can be used to 
diagnose illnesses and to detect strains of STECs in food and other

[[Page 57286]]

environmental samples. The number of non-O157:H7 STEC infections 
reported to the CDC from 2000 to 2005 increased from 171 to 501 cases, 
suggesting a higher burden of illness than previously thought.
    Outbreaks associated with non-O157:H7 STECs have been reported 
worldwide, including thirteen in the United States from 1990 to 2006. 
The 2006 data is still preliminary. Many outbreaks were attributed to 
consumption of fresh produce; none were attributed to ground beef 
consumption. However, in 2006, non-O157:H7 STEC illness was diagnosed 
in a patient in New York who had consumed ground beef shortly before 
illness onset. The same STEC strain, indistinguishable by pulsed field 
gel electrophoresis, was detected in the patient's stool and in 
leftover ground beef that the patient had consumed. In this case, FSIS 
was unable to take further action because the product could not be 
definitively traced to a production lot.
    FSIS, FDA CFSAN, and CDC will hold a public meeting on October 17, 
2007, to solicit input from industry, consumers, academia, and other 
public health and regulatory agencies on the issue of whether non-
O157:H7 STECs should also be considered to be adulterants. This meeting 
will rely on relevant data in addressing the most important questions 
that underlie this issue, including:
     What is the epidemiology of non-O157:H7 STEC illness?
     What can be done to enhance the surveillance and reporting 
of non-O157:H7 STEC illnesses?
     What is the prevalence of non-O157:H7 STEC in livestock 
and in finished product? Are species other than cattle, such as sheep, 
goats, and swine, important sources of non-O157:H7 STECs?
     What are the best methods for detecting pathogenic non-
O157:H7 STECs in food? What are the most relevant markers for 
pathogenic STECs?
     Are interventions designed to remove or destroy E. coli 
O157:H7 in foods or raw products effective against non-O157:H7 STECs as 
well?
     How should regulatory agencies define, monitor, and 
control pathogenic non-O157:H7 STECs in food or raw products?
    All interested parties are welcome to attend the meeting and to 
submit written comments and suggestions through October 15, 2007 to Dr. 
Eblen by phone (202) 690-6238, fax (202) 690-6334, e-mail: 
[email protected], or at the mail address: U.S. Department of 
Agriculture, Food Safety and Inspection Service, Office of Public 
Health Science, 1400 Independence Avenue, SW., 357 Aerospace Center, 
Washington, DC 20250-3766. Individuals who do not wish FSIS to post 
their personal contact information--mailing address, e-mail address, 
telephone number--on the Internet may leave the information off their 
comments.
    The comments and the official transcript of the meeting, when they 
become available, will be posted on the agency's Web site at http://www.fsis.usda.gov.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce it online through the FSIS Web page located 
at http://www.fsis.usda.gov/regulations/2007_Notices_Index/. FSIS 
will also make copies of this Federal Register publication available 
through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The Update is also available on the FSIS 
Web page. Through Listserv and the Web page, FSIS is able to provide 
information to a much broader and more diverse audience. In addition, 
FSIS offers an electronic mail subscription service which provides 
automatic and customized access to selected food safety news and 
information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. Options range from recalls to 
export information to regulations, directives and notices. Customers 
can add or delete subscriptions themselves, and have the option to 
password protect their accounts.

    Done at Washington, DC, on: October 4, 2007.
Alfred V. Almanza,
Administrator.
[FR Doc. 07-4975 Filed 10-4-07; 1:45 pm]
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