
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46027-46028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18960]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of the ``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.'' We are making available an interpretative summary, a 
technical Quantitative Risk Assessment (QRA) report with appendices, a 
risk-assessment model, and a document responding to public comments 
that we received regarding the 2013 ``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.'' The purpose of the QRA 
is to evaluate the effect of factors such as the microbiological status 
of milk, cheese-manufacturing steps, and conditions during distribution 
and storage on the overall risk of invasive listeriosis to the consumer 
of soft-ripened cheese in the United States or Canada. The QRA

[[Page 46028]]

makes it possible to evaluate the effectiveness of some process changes 
and intervention strategies in reducing the risk of listeriosis.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic 
access to the QRA and related documents.

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

    In the Federal Register of February 11, 2013 (78 FR 9701), we made 
available a document entitled ``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.'' We gave interested 
parties an opportunity to submit comments by April 29, 2013, for us to 
consider on the approach used, the assumptions made, the modeling 
techniques, the data used, and the clarity and the transparency of the 
QRA documentation. We received nearly 100 comments on the draft QRA and 
have revised the QRA where appropriate (See Refs. 1 to 5).
    Elsewhere in this issue of the Federal Register, we are issuing a 
notice requesting comments and scientific data and information that 
would assist us in understanding potential intervention measures to 
reduce the risk of foodborne illness from consumption of cheeses 
manufactured from unpasteurized milk.

II. Electronic Access

    The QRA and related documents are available electronically on the 
FDA Web site at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm, http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm, and http://www.regulations.gov.

III. 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 we 
are not responsible for any subsequent changes to the Web sites after 
this document publishes in the Federal Register.)

1. FDA and Health Canada, ``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: Interpretative Summary,'' 2015. Accessible 
at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.
2. FDA and Health Canada, ``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: Technical Report,'' 2015. Accessible at 
http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.
3. FDA and Health Canada, ``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: Technical Report Appendices,'' 2015. 
Accessible at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.
4. FDA and Health Canada, ``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: Risk Assessment Model,'' 2015. Accessible 
at http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.
5. Joint FDA/Health Canada Quantitative Assessment of the Risk of 
Listeriosis from Soft-Ripened Cheese Consumption in the United 
States and Canada: Replies to Public Comments, 2015. Accessible at 
http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.

    Dated: July 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18960 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P


