07-4975. Non-Escherichia coli

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice of public meeting.

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 [e-mail].

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 [phone], fax [phone], e-mail: [e-mail] 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 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 [phone], fax [phone], e-mail: [e-mail], 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.