[Federal Register Volume 74, Number 109 (Tuesday, June 9, 2009)]
[Notices]
[Pages 27276-27278]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13378]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2009-0012]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0658]


Interagency Retail Listeria monocytogenes Risk Assessment: Notice 
of a Public Meeting

AGENCIES: Food Safety and Inspection Service, USDA; Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, DHHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food Safety and Inspection Service (FSIS) and the Food and 
Drug Administration/Center for Food Safety and Applied Nutrition (FDA/
CFSAN) are holding a public meeting to present the background, 
approach, scope, and data needs for a recently initiated interagency 
risk assessment of the public health impact of foodborne Listeria 
monocytogenes (L. monocytogenes) in some ready-to-eat foods that are 
sliced, prepared, or packaged in retail facilities. The purpose of this 
``Interagency Retail L. monocytogenes Risk Assessment'' is to ascertain 
the effect on the public health of current practices and potential 
interventions that reduce or prevent L. monocytogenes contamination in 
ready-to-eat foods. FSIS and FDA invite interested individuals, 
organizations, and other stakeholders to participate in the meeting and 
comment on this topic.

DATES: The public meeting will be held on Tuesday, June 23, 2009, 8:30 
a.m. to 5 p.m.

ADDRESSES: The meeting will be held at the L'Enfant Plaza Hotel, 480 
L'Enfant Plaza, SW., Washington, DC 20024, Telephone: 202-484-1000.
    Registration: Pre-registration for this meeting is encouraged. To 
pre-register, access the FSIS Web site, http://www.fsis.usda.gov/News/Meetings_&_Events/.
    Contact Sheila Johnson for more information on logistics at 202-
690-6498. Persons requiring a sign language interpreter or other 
special accommodations should notify Sheila Johnson by June 16, 2009.

[[Page 27277]]

    Regardless of attendance at the public meeting, FSIS and FDA invite 
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. 
Comments to FSIS:
    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 to FSIS by mail or electronic 
mail must include the Agency name and docket number FSIS-2009-0012. 
Comments received in response to this docket will be made available for 
public inspection and posted without change, including any 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.
    Comments to FDA: Interested persons may submit written or 
electronic comments to the FDA Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
Rockville, MD 20857. Submit a single copy of electronic comments or two 
paper copies of any mailed comments, except that individuals may submit 
one paper copy. Comments are to be identified with docket number FDA-
2008-N-0658. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: 
    FSIS: Janell Kause, Director, Risk Assessment Division, Office of 
Public Health Science, USDA, 901 D Street, SW., Washington, DC 20024, 
Telephone: 202-690-0286, FAX: 202-690-6337, e-mail: 
Janell.Kause@fsis.usda.gov.
    FDA: Sherri Dennis, FDA/CFSAN, Risk Assessment Coordination Team, 
HFS-005, 5100 Paint Branch Parkway, College Park, Maryland 20740, 
Telephone: 301-436-1914, FAX: 301-436-2641, e-mail: 
Sherri.Dennis@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In 2003, FDA and FSIS issued a quantitative assessment of the 
relative risk to public health from foodborne L. monocytogenes among 
selected categories of ready-to-eat foods (Reference 1). Among the 
ready-to-eat foods evaluated in the assessment, deli meats were 
considered to present the highest risk per serving and the highest risk 
per annum. In 2008, FSIS conducted a comparative risk assessment on L. 
monocytogenes in ready-to-eat meat and poultry deli meats to estimate 
the relative risk of illness from L. monocytogenes on deli meat sliced 
and packaged at federally inspected processing establishments compared 
to deli meat sliced at retail facilities (Reference 2). The result of 
that risk assessment indicated that approximately 83 percent of all 
listeriosis cases and deaths attributed to deli meat consumption are 
associated with deli meat sliced and packaged at retail.
    However, little is known about how L. monocytogenes contamination 
occurs in retail facilities. Retail practices may result in either 
cross-contamination from one product to another or through 
contamination from the retail environment. Therefore, it is important 
for the Agencies to identify potential sources and practices that may 
contribute to L. monocytogenes contamination in retail settings. Also, 
it is important for the Agencies to identify interventions that could 
control, reduce, or eliminate L. monocytogenes contamination of ready-
to-eat foods sliced, prepared or packaged in retail facilities.
    In light of the need for the Agencies to identify how L. 
monocytogenes contamination occurs at retail, FSIS and FDA initiated a 
joint interagency risk assessment that will evaluate the dynamics of L. 
monocytogenes contamination in retail facilities. The risk assessment 
will evaluate how retail practices could affect contamination, and the 
relative effectiveness of various process changes and intervention 
strategies intended to reduce listeriosis. It will address both FSIS- 
and FDA-regulated ready-to-eat foods. It will focus on foods that are 
sliced, prepared, or packaged for the consumer in the retail 
environment and consumed in the home. Cheeses, deli meats, and deli-
type salads (as defined in Reference 1) Will be studied as 
representative examples. A request for comments and scientific data and 
information was published for this risk assessment on January 21, 2009 
(74 FR 3617) (Reference 3).

II. Purpose of the Meeting and Agenda

    The purpose of the meeting is to introduce and discuss the scope 
and the objectives of this interagency retail L. monocytogenes risk 
assessment and to solicit input and comments on how FSIS and FDA may 
conduct this risk assessment.
    A copy of the agenda will be made available for viewing prior to 
the meeting at FSIS: http://www.fsis.usda.gov/News/Meetings_&_Events/ 
and at FDA: http://www.cfsan.fda.gov/register.html.
    The meeting agenda will include presentations on background 
information relevant to L. monocytogenes at retail and specific 
information about the scope of the risk assessment, the risk 
assessment's conceptual model, data sources, and needs. Time will be 
provided for questions from the participants and also for comments.

III. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. The transcript may be 
viewed at FSIS: FSIS Docket Room, Docket Clerk, U.S. Department of 
Agriculture, FSIS, 1400 Independence Avenue, SW., Room 2534, South 
Agriculture Building, Washington, DC 20250-3700, and will also be 
posted on the Agency Web site (http://www.fsis.usda.gov). It may also 
be viewed at FDA: Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD. A 
copy of the transcript will also be available in either hardcopy or on 
CD-ROM, after submission of a Freedom of Information request. Written 
requests are to be sent to Division of Freedom of Information (HFI-35), 
Office of Management Programs, Food and Drug Administration, 5600 
Fishers Lane, Room 6-30, Rockville MD 20857.

IV. References

    The following references are on display in the FSIS Docket Room at 
the address above between 8:30 a.m. and 4:30 p.m., Monday through 
Friday, and in the FDA Division of Dockets Management at the address 
above between 9 a.m. and 4 p.m., Monday through Friday. (FSIS and FDA 
have verified the following Web site addresses, but FSIS and FDA are 
not responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)
    1. U.S. Department of Health and Human Services, Food and Drug

[[Page 27278]]

Administration and U.S. Department of Agriculture, Food Safety and 
Inspection Service, ''Quantitative Assessment of Relative Risk to 
Public Health from Foodborne Listeria monocytogenes Among Selected 
Categories of Ready-to-Eat Foods,'' September 2003, http://
www.foodsafety.gov/~dms/lmr2-toc.html.
    2. U.S. Department of Agriculture, Food Safety and Inspection 
Service, ``Draft FSIS Comparative Risk Assessment for Listeria 
monocytogenes in Ready-to-eat Meat and Poultry Deli Meats,'' March 
2009, http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp#RTE.
    3. Risk Assessment of the Public Health Impact from Foodborne 
Listeria monocytogenes in Some Ready-to-Eat Foods Sliced, Prepared, 
and/or Packaged in Retail Facilities; Request for Comments and for 
Scientific Data and Information. (74 FR 3617 (January 21, 2009)), 
Docket No. FDA-2008-N-0658, http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-938.pdf.

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 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: June 3, 2009.
Alfred V. Almanza,
Administrator, FSIS.
    Done at Washington, DC, on: June 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning, FDA.
[FR Doc. E9-13378 Filed 6-8-09; 8:45 am]
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