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Food Safety and Inspection Service.


Notice of availability.


The Food Safety and Inspection Service is announcing the availability of two question and answer (Q&A) documents concerning FSIS Directives 5000.2 (“Review of Establishment Data by Inspection Program Personnel”), 6420.2 (“Verification of Procedures for controlling Fecal Material, Ingesta, and Milk in Slaughter Operations”), and 10,010.1, Revision 1 (“Microbiological Testing Program and Other Verification Activities for Escherichia coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components”) (see ADDRESSES). The Agency is announcing the availability of these documents now because they contain information about Escherichia coli (E. coli) O157:H7, which is particularly relevant at this time because the United States is in the seasonal period when the prevalence of E. coli O157:H7 may be higher than during other times of the year.


The Q&A documents are available in Room 102, Cotton Annex, 300 12th Street, SW., Washington, DC 20250-3700, between 8:30 a.m. and 4:30 p.m., Monday through Friday. They are also available on the Internet at​OPPDE/​rdad/​fsisdirectives/​10010_​1/​Ecoli_​QA.pdf and​OPPDE/​rdad/​fsisdirectives/​10010_​1/​Directives_​Q&​A.pdf.

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Rachel Edelstein, Regulations and Petitions Policy Staff, Food Safety and Inspection Service, U.S. Department of Agriculture (202) 720-5627.

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Significance of E. Coli O157:H7 and FSIS' Actions To Address the Pathogen

Exposure to E. coli O157:H7 has been linked to serious, life-threatening human illnesses (hemorrhagic colitis and hemolytic uremic syndrome). In the United States, outbreaks of human illnesses caused by foodborne E. coli O157:H7 infection have often been linked to ground beef.

FSIS administers a regulatory program under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) to protect the health and welfare of consumers by preventing the distribution of meat products that are unwholesome, adulterated, or misbranded.

In 1994, FSIS notified the public that raw ground beef products contaminated with E. coli O157:H7 are adulterated within the meaning of the FMIA (21 U.S.C. 601(m)(1)), unless the ground beef is further processed to destroy this pathogen. On January 19, 1999, FSIS published a policy statement in the Federal Register that explained that, if non-intact beef products (e.g., beef that has been mechanically tenderized by needling or cubing) or intact cuts of muscle that are to be further processed into non-intact product prior to distribution for consumption are found to be contaminated with E. coli O157:H7, they must be processed into ready-to-eat product, or they would be deemed to be adulterated (64 FR 2803).

In the October 7, 2002, Federal Register, FSIS informed the public that E. coli O157:H7 prevalence may be higher in April through September than during other times of the year, based on several studies and establishment testing data (67 FR 62332).

Availability of Qs&As

FSIS is making available two documents that include Qs&As concerning FSIS Directives 5000.2, 6420.2, and 10,010.1, Revision 1. The Qs&As address concerns that were raised by interested parties at public meetings conducted by FSIS in 2004. At those meetings, FSIS presented information on these directives to the public, particularly small and very small plants. The Qs&As regarding Directive 10,010.1, Revision 1, provide information on establishment verification testing for E. coli O157:H7, establishment controls for E. coli O157:H7, and establishment responsibilities in the event that the establishment finds raw beef product positive for the pathogen or positive in a screening test for the pathogen.

The information concerning E. coli O157:H7 is particularly relevant at this time because the United States is in the seasonal period when the prevalence of this pathogen may be higher than during other times of the year. Based on information from the Qs&As, establishments may decide to take actions to improve their E. coli O157:H7 verification testing programs or their controls to address the pathogen.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that the public and in particular minorities, women, and persons with disabilities, are aware of this notice, FSIS will announce it on-line through the FSIS web page located at​regulations/​2005_​Notices_​Index/​index.asp.

FSIS also will 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, recalls, and other types of information that could affect or would be of interest to our constituents and stakeholders. The update is communicated via Listserv, a free e-mail Start Printed Page 31415subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The update also is available on the FSIS web page. Through Listserv and the web page, FSIS is able to provide information to a much broader, more diverse audience.

In addition, FSIS offers an email subscription service which provides an automatic and customized notification when popular pages are updated, including Federal Register publications and related documents. This service is available at​news_​and_​events/​email_​subscription/​ and allows FSIS customers to sign up for subscription options across eight categories. 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 account.

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Done at Washington, DC, on May 25, 2005.

Barbara J. Masters,

Acting Administrator.

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[FR Doc. 05-10790 Filed 5-31-05; 8:45 am]