[Federal Register: June 9, 2009 (Volume 74, Number 109)]
[Notices]
[Page 27276-27278]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn09-17]

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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]