[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Notices]
[Pages 3617-3619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-938]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0658]
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments and for scientific data and
information.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
[[Page 3618]]
comments and scientific data and information that would assist the
agency in its plans to conduct a risk assessment of the public health
impact of foodborne Listeria monocytogenes in some ready-to-eat foods
sliced, prepared, and/or packaged in retail facilities. The purpose of
the risk assessment is to ascertain the impact on public health of
current practices and potential interventions that reduce or prevent L.
monocytogenes contamination in ready-to-eat food.
DATES: Submit comments and scientific data and information by April 21,
2009.
ADDRESSES: Submit written comments and scientific data and information
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments, scientific data, and information to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Sherri Dennis, Center for Food Safety
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100
Paint Branch Pkwy, College Park, MD 20740, 301-436-2355, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Health and Human Services' Healthy People 2010 is
a comprehensive set of disease prevention and health promotion
objectives for the Nation to achieve over the first decade of the new
century. Created by scientists both inside and outside of government,
it identifies a wide range of public health priorities and specific,
measurable objectives. One of these objectives calls on Federal food
safety agencies to reduce foodborne listeriosis (Ref. 1). In support of
this goal, in 2003, FDA and the Food Safety and Inspection Service
(FSIS) of the U.S. Department of Agriculture (USDA) issued an
assessment of the relative risk to public health from foodborne
Listeria monocytogenes among selected categories of ready-to-eat (RTE)
foods (Listeria risk assessment, Ref. 2). The Listeria risk assessment
formed the basis of the 2003 FDA and Centers for Disease Control and
Prevention (CDC) Listeria Action Plan (Ref. 3), which identifies
prevention and control activities that FDA and CDC will take to reduce
the incidence of foodborne listeriosis in the United States.
The 2003 Listeria risk assessment provided the first quantitative
estimate of the relative risk of listeriosis from consumption of a
variety of RTE foods. Among the RTE foods evaluated in the 2003 risk
assessment, deli meats (e.g., luncheon meats) were considered to
present the highest risk per serving and the highest risk per annum.
This rank was the result of a moderate contamination frequency, a high
number of servings consumed and high growth rates of L. monocytogenes.
Additional data obtained in California and Maryland showed that L.
monocytogenes prevalence and levels in luncheon meats, deli-style
salads, and seafood salads were higher for in-store-packaged than for
manufacturer-packaged foods (Ref. 4). This observation was confirmed
for meat and poultry products in a study by the National Alliance for
Food Safety and Security performed in northern California, Georgia,
Minnesota, and Tennessee in 2008 (Ref. 5). Using these latter results,
it was estimated that most of the listeriosis cases attributed to
ready-to-eat meat and poultry deli meats are from products sliced and
packaged at retail (FSIS/USDA, unpublished results).
Little is known about how Listeria 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. There is thus a need to identify potential sources and
practices that may increase L. monocytogenes contamination in retail
settings and practices or interventions that could reduce or eliminate
L. monocytogenes contamination of food products (sold to consumers at
the retail level) and resulting human illness.
FDA is engaged in a risk assessment that will evaluate the dynamics
of L. monocytogenes contamination in retail facilities contributing to
listeriosis. It will evaluate how specific practices could affect the
overall level and frequency of contamination, and the relative
effectiveness of various process changes and intervention strategies
intended to reduce human illness. The project will address FDA and USDA
regulated RTE foods. It will focus on RTE foods that are sliced,
prepared, and/or packaged for the consumer in the retail environment
and consumed in the home. Cheeses, deli meats, and deli-type salads (as
defined in Ref. 2) will be studied as representative examples.
This risk assessment of the public health impact of L.
monocytogenes in RTE foods sliced, prepared, and/or packaged in retail
facilities supports the agency's commitment to fulfilling the Listeria
Action Plan (Ref. 3).
II. Request for Comments and for Scientific Data and Information
FDA requests comments on the risk assessment goals outlined in this
document and the submission of scientific data and information relevant
to the risk assessment. Specifically, we request data and information
about the following:
1. Characteristics of ready-to-eat food markets in the United
States, including:
a. Volumes of cheeses and deli meats sliced by manufacturers and
the volumes sliced in retail facilities,
b. Volumes of deli-type salads prepared by manufacturers and the
volumes prepared in retail facilities, and
c. Volumes of ready-to-eat food sold in delicatessen departments of
major grocery chains (i.e., large supermarket facilities) and the
volumes sold in other groceries (i.e., multipurpose independent small
or local facilities).
2. Characteristics of deli departments in groceries, including the
proportion of separated seafood/meat/dairy deli departments in
groceries.
3. Product contamination data, including:
a. L. monocytogenes levels and/or frequencies in wholesale products
(deli meats (chubs), cheeses, fresh produce, seafood) arriving at
retail facilities; and
b. L. monocytogenes levels and/or frequencies in cheeses, deli
meats, and deli-type salads sold by retail facilities.
4. Factors that influence the growth of L. monocytogenes in
cheeses, deli meats, and deli-type salads, including:
a. Growth rates of L. monocytogenes in cheeses, deli meats, and
deli-type salads and the effects of different ingredients in and
compositions of those products;
b. Chemical characteristics of cheeses, deli meats, and deli-type
salads that could influence L. monocytogenes, including pH and water
activity;
c. Proportions of deli meats treated with growth inhibitors, the
inhibitors used, the level of growth inhibitors, and their efficiency;
d. Data on the temperatures to which cheeses, deli meats, and deli-
type salads are exposed at retail, including time and temperature for
walk-in coolers or refrigerators, display cabinets, and ambient
displays; and
e. Data on the use of advisory ``use-by'' or ``best by'' labels for
ready-to-eat food sold by retail facilities.
5. Environmental contamination data, including:
a. Data and information on the prevalence and levels of L.
monocytogenes in the retail environment including, e.g., drains,
countertops, walls, and equipment; and
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b. Data on the growth of L. monocytogenes on non-food surfaces
including environmental biofilm growth.
6. Factors that influence the environmental contamination and the
cross-contamination of food by L. monocytogenes in retail facilities,
including:
a. Data and information on the potential transfer of L.
monocytogenes to food from the retail environment, e.g., experimental
studies on the transfer to food from drains, slicers, food contact
surfaces, and non-food contact surfaces; and
b. Data and information on food handlers' activities, e.g.,
observations of food handlers' practices and monitoring of specific
food safety actions in retail facilities (e.g., glove usage, hand
hygiene practices, and cleaning practices).
7. Identity and effectiveness of control measures or interventions
intended to reduce levels and frequency of L. monocytogenes in the
retail environment, including:
a. Environmental sanitation procedures including the sanitizers and
protocols used, frequency of application, and efficiency; and
b. Worker sanitation procedures including frequencies, protocols,
and efficiency.
8. Any other data related to the occurrence, growth, and control of
L. monocytogenes in retail facilities.
As the project progresses, additional data needs may be identified.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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 the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
III. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the
Web site addresses, but FDA is 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, Healthy People
2010, v. 1. Washington, DC, 2000, http://healthypeople.gov.
2. U.S. Department of Health and Human Services 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.
3. U.S. Department of Health and Human Services, Food and Drug
Administration/Centers for Disease Control and Prevention,
``Reducing the Risk of Listeria monocytogenes FDA/CDC 2003 Update of
the Listeria Action Plan,'' November 2003, http://www.cfsan.fda.gov/
~dms/lmr2plan.html.
4. Gombas, D.E., Chen, Y., Clavero, R.S., and Scott, V.N.
(2003). Survey of Listeria monocytogenes in ready-to-eat foods.
Journal of Food Protection, 66(4), 559-569.
5. Draughon, A.F. (2006). A collaborative analysis/risk
assessment of Listeria monocytogenes in ready-to-eat processed meat
and poultry collected in four FoodNet states. Symposium S-16:
Contamination of ready-to-eat foods: transfer and risk: Listeria
monocytogenes and other microorganisms. International Association
for Food Protection 93rd Annual Meeting, Calgary, Alberta. August
13-16.
Dated: January 12, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-938 Filed 1-16-09; 8:45 am]
BILLING CODE 4160-01-S