[Federal Register Volume 72, Number 228 (Wednesday, November 28, 2007)]
[Notices]
[Pages 67310-67311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23104]


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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