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—Santé 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—Santé 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—Santé 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—Santé 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—Santé 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.