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###### Department of Agriculture

###### Food Safety and Inspection Service

          - [Docket No. FSIS-2009-0003]

# AGENCY:

Food Safety and Inspection Service, USDA.

# ACTION:

Notice of request for comment.

# SUMMARY:

                        The Food Safety and Inspection Service (FSIS) is requesting public comment on a draft quantitative food safety risk assessment for                         *Listeria monocytogenes*                         (                        *L. monocytogenes*) that compares the risk of listeriosis from consumption of prepackaged ready-to-eat (RTE) deli meat versus RTE deli meat that is sliced and packaged at retail. The risk assessment analyzes the comparative risk of listeriosis from prepackaged RTE deli meat versus RTE deli meat that is sliced and packaged at retail using data from a study by the National Alliance for Food Safety and Security (NAFSS) and new consumer survey data from Research Triangle Institute (RTI) International, Tennessee State University, and Kansas State University.                    

# DATES:

Submit written comments by June 8, 2009.

# ADDRESSES:

FSIS invites interested persons to submit comments on this notice. Comments may be submitted by either of the following methods:
      -  Federal eRulemaking Portal:                          This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to                          http://www.regulations.gov . Follow the online instructions at that site for submitting comments.                    
      -  Mail, Including Floppy Disks or CD-ROMs, and Hand- or Courier-Delivered Items:                          Send to Docket Clerk, U.S. Department of Agriculture, FSIS, 1400 Independence Avenue, SW., Room 2534, South Agriculture Building, Washington, DC 20250-3700.                    

*Instructions:*                         All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2009-0003. Comments received in response to this docket will be made available for public inspection and posted without change, including any                               ( print page 16177)                            personal information, to                         *http://www.regulations.gov*.                    

For access to background documents or comments received, go to the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday.

# FOR FURTHER INFORMATION CONTACT:

                        Dare Akingbade, Office of Public Health Science, FSIS, 1400 Independence Avenue, SW., Aerospace Center, Washington, DC. 20250-3700;                         *Telephone:*                         (202) 690-6462;                         *Fax:*                         (202) 690-6337;                         *Electronic mail:**dare.akingbade@fsis.usda.gov*.                    

# SUPPLEMENTARY INFORMATION:

## I. Background

*L. monocytogenes*                     is estimated to cause approximately 2,500 illnesses, 2,300 hospitalizations, and 500 deaths each year in the United States (Mead                     *et al*., 1999).                     *L. monocytogenes*                     is ubiquitous in nature. It is commonly found in the intestines of animals and humans without causing illness. It can survive for long periods of time in soil, leaf litter, sewage, silage dust, vegetation, and water. The organism has been found in many domestic and wild animals, fish, birds, insects, and snails.                     *L.**monocytogenes*                     has been isolated from a variety of products, including raw milk, cheese made from unpasteurized milk, soft cheese, meat and poultry and their products, cole slaw, and cabbage.                     *L. monocytogenes*                     is found in the food-processing environment and can form biofilms on solid surfaces in food processing plants.                     *L. monocytogenes*                     can also survive adverse conditions on apparently smooth surfaces (                    *http://www.fsis.usda.gov/​Frame/​FrameRedirect.asp?​main=​http://www.fsis.usda.gov/​oa/​topics/​lmguide.htm*).                

                    Consumption of food contaminated with                     *L. monocytogenes*                     can cause listeriosis, a disease that results in high fever, severe headache, neck stiffness, and nausea. Listeriosis can also cause miscarriages and stillbirths, as well as fatal infections in those with weakened immune systems, such as infants, the elderly, and persons with HIV infection or undergoing chemotherapy (                    *http://www.fsis.usda.gov/​News_​&​_​Events/​Recall_​051_​2008_​Release/​index.asp*).                

                    To better understand the sources of foodborne                     *L. monocytogenes*                     infection, the Food and Drug Administration (FDA) and FSIS developed a quantitative risk assessment that compared the risk of listeriosis among 23 categories of RTE foods. The results of the risk assessment, completed in 2003, indicated deli meats pose the greatest risk for listeriosis, accounting for approximately 1,600 illnesses per year (                    *http://www.foodsafety.gov/​~dms/​lmr2-toc.html*).                

                    Because of these findings, FDA and FSIS conducted a preliminary analysis using the deli meat model component of the 2003 FDA and FSIS                     *Listeria monocytogenes*                     risk assessment. This analysis estimated the relative risk of illness from                     *Listeria monocytogenes*                     on deli meat sliced and packaged at Federally inspected processing establishments compared to deli meat sliced at retail facilities. The results of the preliminary analysis indicated that approximately 80% of listeriosis cases related to deli meats were associated with those sliced at retail. However, because these results were based on a retail survey not specifically designed to collect contamination data on deli meats (Gombas                     *et al*. 2003), FSIS sought to gather targeted contamination data for prepackaged and retail-sliced deli meats to further examine the relative risk of listeriosis.                

                    In the risk assessment released today—the Comparative Risk Assessment for                     *Listeria monocytogenes*                     in Ready-To-Eat Meat and Poultry Deli Meats—FSIS reanalyzes the relative risk of illness from                     *Listeria monocytogenes*                     on deli meat sliced and packaged at Federally inspected processing establishments compared to deli meat sliced at retail facilities based on new data.                

## II. The Draft Risk Assessment

                    The Comparative                     *Listeria Monocytogenes*                     in Ready-to-Eat Meat and Poultry Deli Meats risk assessment has undergone an independent external peer review consistent with the requirements in the Office of Management and Budget's “Final Information Quality Bulletin for Peer Review” and review by various government agencies. This quantitative risk assessment provides a science-based, analytical approach to collate and incorporate available data into a mathematical model. It provides risk managers with a decision-support tool to understand and evaluate the relative risk of slicing and packaging deli meat in retail facilities versus slicing and packaging deli meat in federally inspected processing establishments.                

                    The deli meat pathway model of the draft risk assessment consists of four distinct stages: (1) A retail stage that determines the level of                     *L. monocytogenes*                     in prepackaged deli meats and those deli meats sliced at retail; (2) a growth stage that uses an exponential growth rate function to model the growth of                     *L. monocytogenes*                     in deli meat between purchase at retail and consumption; (3) a consumption stage that uses information about deli meat serving sizes and the number of servings consumed to estimate consumer exposure to the pathogen of concern; and (4) a dose-response stage that predicts the probability of death from consuming                     *L. monocytogenes*.                

                    To update the deli meat pathway model of the 2003 risk assessment discussed above, FSIS obtained retail contamination data from the NAFSS study (Draughon, 2006) and used it in conjunction with new consumer survey data obtained by RTI International, Tennessee State University, and Kansas State University (Cates                     *et al*., 2006).                

The results from this comparative Lm risk assessment model indicate that approximately 83% of listeriosis cases and deaths attributed to deli meat consumption are from deli meat sliced and packaged at retail.

                    As part of an evaluation of the draft comparative                     *L. monocytogenes*                     risk assessment, FSIS seeks comments about:                

(1) The assumptions made,

(2) The modeling techniques,

(3) The data used, and

(4) The clarity of the draft risk assessment document.

                    FSIS will review and evaluate all public comments on this draft comparative risk assessment and make modifications to the assessment based on comments, as appropriate. The draft risk assessment is available electronically on the FSIS Web site (                    *http://www.fsis.usda.gov/​Science/​Risk_​Assessments/​index.asp#RTE*).                

## 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                     *http://www.fsis.usda.gov/​regulations/​2009_​Notices_​Index/​*. 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, 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 subscription 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                           ( print page 16178)                        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 e-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, export information, 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 April 3, 2009.

Carol Maczka,

Assistant Administrator, ODIFP.

[FR Doc. E9-8056 Filed 4-8-09; 8:45 am]

BILLING CODE 3410-DM-P