[Federal Register: November 28, 2007 (Volume 72, Number 228)]
[Notices]
[Page 67310-67311]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28no07-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0432]
Risk Assessment of the Public Health Impact from Foodborne
Listeria Monocytogenes in Soft-Ripened Cheese: 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 comments
and scientific data and information that would assist the agency in its
plans to conduct a risk assessment for Listeria monocytogenes in soft-
ripened cheese. The purpose of the risk assessment is to ascertain the
impact on public health from the reduction and/or prevention of L.
monocytogenes growth and recontamination during the manufacturing and/
or processing of soft-ripened cheese.
DATES: Submit comments and scientific data and information by January
28, 2008.
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, data, and information to either http://
www.fda.gov/dockets/ecomments or http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Steven M. Gendel, Center for Food
Safety and Applied Nutrition (HFS-06), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2290.
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 issued an assessment of the relative risk to
the public health from foodborne L. 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/
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 Public Health Risk Assessment: Listeria
monocytogenes in Soft-Ripened Cheese supports the agency's commitment
to fulfilling the Listeria Action Plan.
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 dairy foods, soft unripened cheese was
considered to present a high risk, and fresh soft cheese, semi-soft
cheese, and soft-ripened cheese was considered to present a moderate
risk of listeriosis. This risk assessment estimated that the risk of
listeriosis from the consumption of fresh soft cheese made using
unpasteurized (raw) milk could be as much as 40-fold higher than the
risk from consumption of these cheeses made from pasteurized milk.
The United States (U.S.) and Canada have experienced sporadic
illnesses and outbreaks of listeriosis associated with the consumption
of cheese. In both countries, there is a strong epidemiological
correlation between consumption of soft cheese and listeriosis. For
example, a 1985 outbreak of listeriosis associated with the consumption
of a Mexican-style soft cheese resulted in 142 illnesses in Los Angeles
(Ref. 4), a similar outbreak in 2000 in North Carolina resulted in 12
illnesses, and a 2002 soft cheese-
[[Page 67311]]
associated outbreak in Quebec resulted in 17 illnesses including 2
premature births (Ref. 5). Both FDA and Health Canada (HC) continue to
evaluate the safety of soft cheese, particularly soft cheese made from
unpasteurized milk.
As a followup to the Listeria risk assessment, FDA and HC have
agreed to collaborate on the development of a model for the production
of soft-ripened cheese that will evaluate the public health impact of
factors such as the microbiological status of milk used in cheese
production, the impact of various cheese manufacturing steps,
conditions during distribution and storage, and cross contamination
during processing and handling. The risk assessment model also will be
used to evaluate the effectiveness of various process changes and
intervention strategies in reducing human illness.
Specifically, the objectives of the Listeria in soft-ripened cheese
risk assessment model are to quantitatively evaluate the impact on
public health of the following: (1) Variations in L. monocytogenes
levels in the raw materials used to produce cheese; (2) changes in L.
monocytogenes levels as a result of growth, inactivation, or re-
contamination at each step of the manufacturing process, between final
packaging and sale at retail, and between retail sale and consumption;
and (3) the impact of various intervention and control strategies.
II. Request for Comment and for Scientific Data and Information
FDA requests comments on the risk assessment approach outlined
previously in this document and the submission of data and information
relevant to the risk assessment. The agency specifically requests
information for the following:
(1) Characteristics of the manufacturing and marketing processes
for soft-ripened cheese including:
The number of large and small (artisan) facilities
producing soft-ripened cheese in the U.S. and Canada, and
The amount of soft-ripened cheese produced each year in
the U.S. and Canada by large and small facilities including information
on different sizes of cheese that are produced and the relative
production volumes for these sizes.
(2) Factors that influence the levels of L. monocytogenes in milk
used for cheese manufacturing including:
On-farm practices that influence the frequency and level
of L. monocytogenes in raw milk used for cheese making,
L. monocytogenes levels and/or frequencies in raw milk in
the U.S. and Canada,
Bulk tank sizes and mixing practices used by large and
small manufacturers,
Growth of L. monocytogenes in raw milk,
Conditions of storage (temperatures and times) encountered
by milk prior to cheese manufacture, and
The identity and effectiveness of processes other than
pasteurization used to treat raw milk prior to cheese making.
(3) Factors that influence the levels of L. monocytogenes in
products during cheese manufacturing including:
Changes in L. monocytogenes levels and frequency (i.e.,
growth, inactivation, or re-contamination) at each step in cheese
manufacturing (i.e., during curd formation, ripening, packaging,
aging);
Conditions of storage (temperatures and times) encountered
during post-production holding at the producer; and
Pathways for transfer of L. monocytogenes to soft-ripened
cheese from environmental sources during packaging, cutting, transport,
and handling at retail, including data on frequencies or amounts of
transfer.
(4) Factors that influence the levels of L. monocytogenes in cheese
post-production including:
Levels and/or frequencies of L. monocytogenes that occur
in cheese at retail; and
The conditions (temperature and time) encountered during
transport and storage throughout the distribution process, including at
retail, in the U.S. and Canada.
(5) Factors the influence the levels of L. monocytogenes in cheese
at consumption including:
Storage conditions (temperature and times) encountered in
consumers' homes, and
Consumption patterns for soft cheese (including serving
size and frequency) in the U.S. and Canada.
(6) The identity and effectiveness of control measures or
interventions to reduce levels and frequency of L. monocytogenes in
cheese during processing, manufacturing, packaging, storage, and
transportation prior to retail sale.
(7) Any other data related to the occurrence, growth, and control
of L. monocytogenes in soft-ripened cheese.
Interested persons should submit comments, scientific data, and
information to the Division of Dockets Management (see ADDRESSES).
Three copies of all comments, scientific data, and information are to
be submitted. Individuals submitting written information or anyone
submitting electronic comments may submit one copy. Submissions are to
be identified with the docket number found in brackets in the heading
of this document and may be accompanied by supporting information.
Received submissions may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday. Information submitted
after the closing date will not be considered, except by petition under
21 CFR 10.30.
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 we are not responsible for any subsequent
changes to the nonFDA Web sites after this document publishes in the
Federal Register.)
1. U.S. Department of Health and Human Services, Healthy People
2010, vol. 1, Washington, DC, 2000, http://www.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. Linnan et al., ``Epidemic Listeriosis Associated With
Mexican-Style Cheese,'' New England Journal of Medicine, 319
(13):823-8, 1988.
5. Gaulin et al., ``First Documented Outbreak of Listeria
monocytogenes in Quebec, 2002,'' Canada Communicable Disease Report,
29 (21):181-6, 2003.
Dated: November 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23104 Filed 11-27-07; 8:45 am]
BILLING CODE 4160-01-S