[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Notices]
[Pages 9701-9702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1182]


Draft Joint Food and Drug Administration/Health Canada 
Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened 
Cheese Consumption in the United States and Canada

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft ``Joint Food and Drug Administration/Health 
Canada--Sant[eacute] Canada Quantitative Assessment of the Risk of 
Listeriosis From Soft-Ripened Cheese Consumption in the United States 
and Canada.'' This draft Quantitative Risk Assessment (the draft QRA) 
includes an Interpretative Summary, a Technical Report, with 
Appendixes, and a risk assessment model. The purpose of the draft QRA 
is to evaluate the effect of factors such as the microbiological status 
of milk, the impact of cheese manufacturing steps, and conditions 
during distribution and storage on the overall risk of invasive 
listeriosis to the consumer in the United States or Canada of soft-
ripened cheese. The draft QRA makes it possible to evaluate the 
effectiveness of some process changes and intervention strategies in 
reducing the risk of listeriosis. We are making the draft QRA available 
for public comment.

DATES: Submit either electronic or written comments on the draft QRA by 
April 29, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

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, 240-402-1914.

SUPPLEMENTARY INFORMATION:

I. Background

    Listeria monocytogenes (L. monocytogenes) is a widely occurring 
pathogen that can be found in agricultural and food processing 
environments. Ingestion of L. monocytogenes can lead to the development 
of listeriosis, with consequences that may include septicemia, 
meningitis, encephalitis, spontaneous abortion, and stillbirth. 
Epidemiological data show that listeriosis has one of the highest 
hospitalization rates and one of the highest case fatality rates among 
foodborne diseases in the United States (Ref. 1). Serious illness may 
occur in people considered to be more susceptible, such as the elderly, 
individuals who have a preexisting illness that reduces the 
effectiveness of their immune system, and pregnant women (Ref. 2).
    The United States and Canada have experienced sporadic illnesses 
and outbreaks of listeriosis associated with the consumption of soft 
cheese. Both FDA and Health Canada--Sant[eacute] Canada continue to 
evaluate the safety of soft cheese, particularly soft cheese made from 
unpasteurized milk.

II. Quantitative Risk Assessment

    The draft QRA (Refs. 3 to 6) provides a science-based analytical 
approach to collate and incorporate available data into a mathematical 
model. It provides risk managers with a decision-support tool to 
evaluate the effectiveness of current and future interventions to 
reduce or prevent listeriosis from consumption of soft-ripened cheeses. 
The draft QRA also may be used to target risk communication messages, 
identify and prioritize research needs, and provide a framework for 
coordinating efforts with stakeholders. The draft QRA has undergone an 
independent external peer review consistent with the requirements in 
the Office of Management and Budget's ``Final Information Quality 
Bulletin for Peer Review.'' FDA's response to the peer-review is 
available electronically on the FDA Web site (Ref. 7).
    The draft QRA focuses on the sources of L. monocytogenes 
contamination, the effects of individual manufacturing and/or 
processing steps, and the effectiveness of various intervention 
strategies on the levels of L. monocytogenes in the product as consumed 
and the associated risk of invasive listeriosis. The draft QRA's scope 
is:
     Pathogen of concern: L. monocytogenes;
     Food(s) of concern: Camembert, as an example of soft-
ripened cheese;
     Populations of interest: The general populations of the 
United States and Canada, and subpopulations identified as at-risk in 
both countries (i.e., pregnant women, immunocompromised individuals, 
and the elderly population);
     Endpoint of concern: Invasive listeriosis; and
     Risk metric: The probability of invasive listeriosis per 
soft-ripened cheese serving.
    The draft QRA uses a quantitative approach, using mathematical and 
probabilistic modeling, to estimate the risk per serving of soft-
ripened cheese (using Camembert cheese as an example) in both 
countries. The draft QRA tests the effects of some alternatives on 
those risks. The draft QRA uses data from the literature, from 
government nutrition surveys, from a specific survey on home storage 
time and temperature practices, and from specific expert elicitations. 
FDA invites comments that can help FDA and Health Canada--Sant[eacute] 
Canada improve:
     The approach used;
     The assumptions made;
     The modeling techniques;
     The data used; and
     The clarity and the transparency of the draft QRA 
documentation.
    When finalized, FDA intends to use this risk assessment (which is 
limited to one pathogen in one type of cheese), along with other 
information and scientific assessments that more comprehensively 
consider the different pathogens that can be present in all types of 
cheeses made from raw milk, in its reevaluation of the existing 60-day 
aging requirements for cheeses made with raw milk (e.g., 21 CFR 
133.182(a)).

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    The draft QRA is available electronically on the FDA Web site 
http://www.fda.gov/food/scienceresearch/researchareas/

[[Page 9702]]

riskassessmentsafetyassessment/ and at http://www.regulations.gov.

V. References

    The following references have been placed 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, and 
are available electronically at http://www.regulations.gov. (FDA has 
verified the Web site addresses in this reference section, but FDA is 
not responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)

1. Goulet, V., M. Hebert, C. Hedberg, et al., ``Incidence of 
Listeriosis and Related Mortality Among Groups at Risk of Acquiring 
Listeriosis.'' Clinical Infectious Diseases, 54(5): 652-660, 2012.
2. Scallan, E., R. M. Hoekstra, F. J. Angulo, et al., ``Foodborne 
Illness Acquired in the United States--Major Pathogens,'' Emerging 
Infectious Diseases, 17(1): 7-12, 2011.
3. U.S. Food and Drug Administration and Health Canada (2012). 
``Joint Food and Drug Administration/Health Canada--Sant[eacute] 
Canada Quantitative Assessment of the Risk of Listeriosis from Soft-
Ripened Cheese Consumption in the United States and Canada: Draft 
Interpretative Summary.'' Accessible at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/default.htm.
4. U.S. Food and Drug Administration and Health Canada (2012). 
``Joint Food and Drug Administration/Health Canada--Sant[eacute] 
Canada Quantitative Assessment of the Risk of Listeriosis from Soft-
Ripened Cheese Consumption in the United States and Canada: Draft 
Technical Report.'' Accessible at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/default.htm.
5. U.S. Food and Drug Administration and Health Canada (2012). 
``Joint Food and Drug Administration/Health Canada--Sant[eacute] 
Canada Quantitative Assessment of the Risk of Listeriosis from Soft-
Ripened Cheese Consumption in the United States and Canada: Draft 
Technical Report Appendices.'' Accessible at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/default.htm.
6. U.S. Food and Drug Administration and Health Canada (2012). 
``Joint Food and Drug Administration/Health Canada--Sant[eacute] 
Canada Quantitative Assessment of the Risk of Listeriosis from Soft-
Ripened Cheese Consumption in the United States and Canada: Draft 
Risk Assessment Model.'' Analytica file. Accessible at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/default.htm.
7. U.S. Food and Drug Administration and Health Canada (2012). 
``Joint Food and Drug Administration/Health Canada--Sant[eacute] 
Canada Quantitative Assessment of the Risk of Listeriosis from Soft-
Ripened Cheese Consumption in the United States and Canada: Answer 
to the Peer Review.'' Accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.

    Dated: February 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02960 Filed 2-8-13; 8:45 am]
BILLING CODE 4160-01-P