Draft Interagency Risk Assessment-Listeria monocytogenes, 27939-27941 [2013-11298]

Download as PDF Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Notices While the environmental issues evaluated at the local level have not been significant, a decision to implement the proposed action would expand the current program capabilities to a national scale and encourage additional national and local level partnerships to address feral swine conflicts. Comments that identify other issues or alternatives that should be considered in the EIS would be extremely helpful. After the comment period closes, APHIS will review and consider all comments received during the comment period and any other relevant information in the development of the EIS. All comments received will be available for public review. Upon completion of the draft EIS, a notice announcing its availability and an opportunity to comment will be published in the Federal Register. tkelley on DSK3SPTVN1PROD with NOTICES Parking and Security Procedures for the Public Meeting 16:13 May 10, 2013 Jkt 229001 [FR Doc. 2013–11271 Filed 5–10–13; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2013–0019] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0494] Draft Interagency Risk Assessment— Listeria monocytogenes in Retail Delicatessens: Notice of Availability of Documents and Request for Comment Food Safety and Inspection Service, United States Department of Agriculture; Center for Food Safety and Applied Nutrition, Food and Drug Administration, HHS. ACTION: Notice and request for comment. AGENCY: Persons attending the May 23, 2013, meeting in Riverdale, MD, are required to register in advance at https:// www.aphis.usda.gov/wildlife_damage/ feral_swine/index.shtml or by contacting the person listed under FOR FURTHER INFORMATION CONTACT. Travel directions to the USDA Center at Riverside are available on the Internet at https://www.aphis.usda.gov/ plant_health/general_info/ directions_riverdale.shtml. Please note that a fee of $5 is required to enter the parking lot at the USDA Center at Riverside. The machine accepts bills and coins as well as credit and debit transactions. You must display your daily parking receipt and have it visible in your vehicle for parking attendants to recognize. Upon entering the building, visitors should inform security personnel that they are attending the feral swine damage management public meeting. Photo identification is required to gain access to the building, and all bags will be screened. For individuals who are unable to attend the meeting in person, it will be streamed on the Internet as a live Webcast. Information about how to join the live Webcast and conference line will be made available at https:// www.aphis.usda.gov/wildlife_damage/ feral_swine/index.shtml. We recommend that you connect at least 5 minutes prior to the start of the meeting. VerDate Mar<15>2010 Done in Washington, DC, this 8th day of May 2013. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. SUMMARY: The United States Department of Agriculture (USDA)/Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA)/Center for Food Safety and Applied Nutrition (CFSAN) are announcing the availability of the draft ‘‘Interagency Risk Assessment—Listeria monocytogenes in Retail Delicatessens.’’ This draft quantitative risk assessment (QRA) includes an Interpretive Summary and a Technical Report. The purpose of the draft QRA is to evaluate the conditions, such as Listeria (L.) monocytogenes contamination of certain ready-to-eat (RTE) foods, for example cheese, deli meats, and deli salads; in the retail deli environment; in niches (a harborage site); or on incoming RTE foods, that contribute to cross-contamination and ultimately, to the risk of listeriosis. The draft QRA makes it possible to evaluate the effectiveness of some retail practices and intervention strategies in reducing the predicted risk of listeriosis from some RTE foods that are sliced, packaged, or prepared in retail delicatessens and consumed in the home. Comments on the draft QRA should be submitted on or before July 12, 2013. ADDRESSES: Comments to FSIS may be submitted by one of the following methods: DATES: PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 27939 • Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for submitting comments. • Mail, including CD–ROMs, etc.: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8–163A, Washington, DC 20250–3700. • Hand- or Courier-Delivered Submittals: Deliver to Patriots Plaza 3, 355 E Street SW., Room 8–163A, Washington, DC 20250–3700. Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS– 2013–0019. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to https:// www.regulations.gov. Docket: For access to background documents or comments received, go to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 8–164, Washington, DC 20250–3700 between 8:00 a.m. and 4:30 p.m., Monday through Friday. Comments to FDA: Interested persons may submit either electronic comments and scientific data and information to https://www.regulations.gov or 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]. It is only necessary to send one set of comments. Identify comments with the FDA 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 https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: FSIS: Janell Kause, Scientific Advisor for Risk Assessment, Office of Public Health Science, Food and Safety Inspection Service, USDA, 355 E Street SW., Washington, DC 20024; Telephone: (202) 690–0286, Email: Janell.Kause@fsis.usda.gov. FDA: Sherri Dennis, Acting Director, Division of Risk Assessment, Office of Analytics and Outreach, FDA/CFSAN, HFS–005, 5100 Paint Branch Parkway, College Park, Maryland 20740; E:\FR\FM\13MYN1.SGM 13MYN1 27940 Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Notices Telephone: (240) 402–1914, Email: Sherri.Dennis@fda.hhs.gov. SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with NOTICES I. Background Listeria monocytogenes (L. monocytogenes) is a widely occurring pathogen that persists in agricultural, food processing, and retail environments. Ingestion of L. monocytogenes can lead to the development of listeriosis, which could cause septicemia, meningitis, encephalitis, spontaneous abortion, and stillbirth. Epidemiological data show that listeriosis has one of the highest hospitalization rates (approximately 95 percent) and one of the highest case fatality rates (approximately 16 percent) among foodborne diseases in the United States (Ref. 1). To reduce listeriosis, it is important to identify: (1) which RTE foods pose the greatest risk to public health, and (2) which changes in practices are critical for reducing the prevalence and levels of L. monocytogenes in these RTE products. Risk assessment is a decisionsupport tool that has been used to successfully accomplish these goals by prioritizing RTE foods according to risk and linking food safety research to changes in practices that will improve public health outcomes. A 2003 industry survey of L. monocytogenes in RTE foods purchased at retail grocery stores showed a sevenfold higher incidence and level of L. monocytogenes in deli meats sliced and served in retail delis compared to those sliced and packaged in manufacturing plants (Ref. 2). A subsequent survey by academia yielded similar findings (Ref. 3). An FSIS risk assessment, using these data, predicted an estimated 83 percent of all deli meat-related listeriosis cases are associated with deli meat sliced and packaged at retail delis (Ref. 4). A Cornell University comparative risk assessment had similar findings (Ref. 5). Cross contamination in the deli environment is thought to contribute to L. monocytogenes contamination of RTE foods, but little is known about the transfer of this pathogen from one surface to another in the retail setting. L. monocytogenes is present in the environment and can survive and grow in foods held at ambient and refrigeration temperatures. Therefore adequate preventive controls must take into account contamination as well as survival and proliferation of the organism. L. monocytogenes can contaminate foods via cross contamination from one product to another or through contamination from the environment, or both. FSIS and VerDate Mar<15>2010 16:13 May 10, 2013 Jkt 229001 CFSAN (we) jointly developed a risk assessment to better understand L. monocytogenes transmission, survival, and growth in the retail environment and to evaluate how retail practices may impact public health. In 2009, the President’s Food Safety Work Group identified this quantitative risk assessment (QRA) as a priority (Ref. 6). II. Draft Interagency Risk Assessment— L. monocytogenes in Retail Delicatessens The draft ‘‘Interagency Risk Assessment—Listeria monocytogenes in Retail Delicatessens’’ (Ref. 7–8) provides federal risk managers and the retail industry with a science-based decision support tool to evaluate the effectiveness of retail practices and interventions to reduce or prevent listeriosis associated with the consumption of RTE foods commonly prepared and sold in the delicatessen (deli) of a retail food store. It also examines how changes in current retail practices might further mitigate the predicted risk of listeriosis from these RTE foods. We conducted the draft QRA collaboratively, in consultation with the Centers for Disease Control and Prevention (CDC) and with input from industry, academic institutions, and consumer advocacy group stakeholders. It is available on FSIS’s Web site at https://www.fsis.usda.gov/PDF/ Interagency_RA_Lm_Retail_Report_ May2013.pdf and FDA’s Web site at https://www.fda.gov/Food/FoodScience Research/RiskSafetyAssessment/ default.htm. The draft QRA model has undergone an independent external peer review consistent with the requirements for peer review in the Office of Management and Budget’s ‘‘Final Information Quality Bulletin for Peer Review.’’ Our response to the peerreview is available electronically on FSIS’s Web site and FDA’s Web site (Ref. 9). The draft QRA answers the following three broad risk management questions: 1. What is the exposure to L. monocytogenes from consuming RTE foods prepared in retail delis? 2. What are the key processes that increase RTE foods contamination at retail delis? 3. How much is the relative risk per serving reduced according to specific risk management options? The three risk management questions are very broad in nature, and we further refined them to a list of risk mitigations evaluated through scenario analyses within the QRA. We used specific risk management questions provided by federal partners and stakeholders to PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 guide the simulation scenarios conducted with the QRA. Specifically, the QRA model: • Considers L. monocytogenes entering the retail deli area from either contaminated incoming products or from environmental/niche contamination; • Considers a variety of RTE foods (e.g., different types of cheeses, deli meats, and deli salads) entering the retail deli; • Simulates the transmission of L. monocytogenes among multiple pathways (including product-to-slicers, gloves-to-display cases, and utensils-togloves); • Incorporates employee behaviors that contribute either to the spread or inactivation of L. monocytogenes (e.g., cleaning and sanitizing); and • Factors with the potential for affecting bacterial growth (e.g., temperature/time, product pH, water activity, presence of growth inhibitors). The QRA also estimates the risk of listeriosis from the handling and consumption of these products in the home. The QRA models two subpopulations: (1) The subpopulation with increased susceptibility (including neonates, older adults, and the immunocompromised), and (2) the subpopulation with decreased susceptibility (the general healthy population). We coordinated with CDC and several universities to gather data for the QRA. Stakeholders also developed partnerships to fill the data gaps identified in a request for scientific data and information for the project (Ref. 10). In 2009, we held a public meeting to present the background and data needs for this QRA (Ref. 11) (transcripts are available in the FSIS docket room and on the FSIS Web site at https:// www.fsis.usda.gov/PDF/ListeriaTranscript_062309.pdf). As announced by FSIS in the Federal Register (78 FR 23901; April 23, 2013), we will hold a second public meeting on May 22, 2013 to present the supporting data, modeling approach, and findings of the QRA. (More information about this meeting will be available on FSIS’s Web site at https://www.fsis.usda.gov/news/ meetings_&_events/. III. Request for Comments We invite comments on the QRA that can help improve: • The overall risk assessment approach used; • The assumptions made; • The modeling techniques; • The data used; and • The clarity and the transparency of the documentation in this draft QRA. E:\FR\FM\13MYN1.SGM 13MYN1 Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Notices We will review and evaluate all public comments on this draft QRA and make modifications to the assessment based on comments, as appropriate. tkelley on DSK3SPTVN1PROD with NOTICES IV. References The following references are on display in the FSIS Docket Room at the address above between 8:00 a.m. and 4:30 p.m., Monday through Friday, and in the FDA Division of Dockets Management at the address above between 9 a.m. and 4 p.m., Monday through Friday. (We have verified the following Web site addresses, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. Scallan, E., Hoekstra, R.M., Angulo, F.J., Tauxe, R.V., Widdowson, M.A., Roy, S.L., Jones, J.L., and Griffin, P.M., Foodborne illness acquired in the United States—major pathogens. Emerging Infectious Diseases, 2011. 17(1): p. 7–12. 2. Gombas, D.E., Chen, Y., Clavero, R.S., and Scott, V.N., Survey of Listeria monocytogenes in ready-to-eat foods. Journal of Food Protection, 2003. 66(4): p. 559–69. 3. Draughon, A.F. A collaborative analysis/ risk assessment of Listeria monocytogenes in ready-to-eat processed meat and poultry collected in four FoodNet states in International Association for Food Protection 93rd Annual Meeting. 2006. Calgary, Alberta, Canada. Data shown in Endrikat et al. (2010)(Ref. 4). 4. Endrikat, S., Gallagher, D., Pouillot, R., Hicks Quesenberry, H., Labarre, D., Schroeder, C.M., and Kause, J., A Comparative Risk Assessment for Listeria monocytogenes in Prepackaged versus Retail-Sliced Deli Meat. Journal of Food Protection, 2010. 73(4): p. 612–9. 5. Pradhan, A.K., Ivanek, R., Grohn, Y.T., Bukowski, R., Geornaras, I., Sofos, J.N., and Wiedmann, M., Quantitative Risk Assessment of Listeriosis-Associated Deaths Due to Listeria monocytogenes Contamination of Deli Meats Originating from Manufacture and Retail. Journal of Food Protection, 2010. 73(4): p. 620–30. 6. Federal Food Safety Working Group, The Federal Food Safety Working Group Progress Report, 2011. p. 31. Available from: https://www.whitehouse.gov/sites/ default/files/fswg_report_final.pdf. 7. U.S. Department of Agriculture, Food Safety and Inspection Service and Department of Health and Human Service, Food and Drug Administration/ Center for Food Safety and Applied Nutrition. Draft Interagency Risk Assessment—Listeria monocytogenes in Retail Delicatessens: Interpretative Summary. May 2013. https://www.fsis. usda.gov/PDF/Interagency_RA_Lm_ Retail_Summary_May2013.pdf and https://www.fda.gov/Food/FoodScience Research/RiskSafetyAssessment/ default.htm. 8. U.S. Department of Agriculture, Food VerDate Mar<15>2010 16:13 May 10, 2013 Jkt 229001 Safety and Inspection Service and Department of Health and Human Service, Food and Drug Administration/ Center for Food Safety and Applied Nutrition. Draft Interagency Risk Assessment—Listeria monocytogenes in Retail Delicatessens: Report. May 2013. https://www.fsis.usda.gov/PDF/ Interagency_RA_Lm_Retail_Report_ May2013.pdf and https://www.fda.gov/ Food/FoodScienceResearch/RiskSafety Assessment/default.htm. 9. U.S. Department of Agriculture, Food Safety and Inspection Service and Department of Health and Human Service, Food and Drug Administration/ Center for Food Safety and Applied Nutrition. Draft Interagency Risk Assessment—Listeria monocytogenes in Retail Delicatessens: Response to Peer Review Comments. May 2013. https:// www.fsis.usda.gov/PDF/Interagency_RA_ Lm_Retail_Peer_Review_May2013.pdf and https://www.fda.gov/Science Research/SpecialTopics/PeerReviewof ScientificInformationandAssessments/. 10. Federal Register Notice. Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Some Ready-to-Eat Foods Sliced, Prepared, and/or Packaged in Retail Facilities; Request for Comments and for Scientific Data and Information. (74 FR 3617; January 21, 2009), Docket No. FDA–2008–N–0658, https://www.fda.gov/ OHRMS/DOCKETS/98fr/E9–938.pdf. 11. Interagency Retail Listeria monocytogenes Risk Assessment: Notice of a Public Meeting. (74 FR 27276; June 9, 2009). Docket No. FSIS–2009–0012, https://www.gpo.gov/fdsys/pkg/FR–2009– 06–09/html/E9–13378.htm. Additional Public Notification FSIS will announce this notice online through the FSIS Web page located at https://www.fsis.usda.gov/regulations_&_ policies/Federal_Register_Notices/ index.asp. FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. In addition, FSIS offers an electronic mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at https://www.fsis.usda.gov/News_&_ Events/Email_Subscription/. Options PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 27941 range from recalls to export information to regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts. USDA Nondiscrimination Statement USDA prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, or audiotape) should contact USDA’s Target Center at (202) 720–2600 (voice and TTY). To file a written complaint of discrimination, write USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250–9410 or call (202) 720–5964 (voice and TTY). USDA is an equal opportunity provider and employer. Done at Washington, DC, on: April 24, 2013. Alfred V. Almanza, Administrator. Leslie Kux, Assistant Commissioner for Policy, FDA. [FR Doc. 2013–11298 Filed 5–10–13; 8:45 am] BILLING CODE 3410–DM–P DEPARTMENT OF AGRICULTURE Forest Service RIN 0596–AC41 Advertising and Sponsorship in Connection With Concessions Involving Privately Owned Improvements on National Forest System Lands Forest Service, USDA. Notice of issuance of final directive; response to public comment. AGENCY: ACTION: SUMMARY: The Forest Service is amending its internal directives for concessions with privately owned improvements that operate under special use permit on National Forest System (NFS) lands. Subject to certain conditions, the final directive allows holders of concession permits to advertise (1) inside buildings and other interior spaces they own; (2) on chairlift restraining bars in conjunction with trail map displays; (3) at designated ski/ snowboard racing sites; and (4) at venues for short-term competitive events. In addition, the final directive E:\FR\FM\13MYN1.SGM 13MYN1

Agencies

[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Notices]
[Pages 27939-27941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11298]


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

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2013-0019]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0494]


Draft Interagency Risk Assessment--Listeria monocytogenes in 
Retail Delicatessens: Notice of Availability of Documents and Request 
for Comment

AGENCY: Food Safety and Inspection Service, United States Department of 
Agriculture; Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, HHS.

ACTION: Notice and request for comment.

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

SUMMARY: The United States Department of Agriculture (USDA)/Food Safety 
and Inspection Service (FSIS) and the Food and Drug Administration 
(FDA)/Center for Food Safety and Applied Nutrition (CFSAN) are 
announcing the availability of the draft ``Interagency Risk 
Assessment--Listeria monocytogenes in Retail Delicatessens.'' This 
draft quantitative risk assessment (QRA) includes an Interpretive 
Summary and a Technical Report. The purpose of the draft QRA is to 
evaluate the conditions, such as Listeria (L.) monocytogenes 
contamination of certain ready-to-eat (RTE) foods, for example cheese, 
deli meats, and deli salads; in the retail deli environment; in niches 
(a harborage site); or on incoming RTE foods, that contribute to cross-
contamination and ultimately, to the risk of listeriosis. The draft QRA 
makes it possible to evaluate the effectiveness of some retail 
practices and intervention strategies in reducing the predicted risk of 
listeriosis from some RTE foods that are sliced, packaged, or prepared 
in retail delicatessens and consumed in the home.

DATES: Comments on the draft QRA should be submitted on or before July 
12, 2013.

ADDRESSES: Comments to FSIS may be submitted by one of the following 
methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, Patriots 
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A, 
Washington, DC 20250-3700.
     Hand- or Courier-Delivered Submittals: Deliver to Patriots 
Plaza 3, 355 E Street SW., Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2013-0019. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to https://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday 
through Friday.
    Comments to FDA: Interested persons may submit either electronic 
comments and scientific data and information to https://www.regulations.gov or 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]. 
It is only necessary to send one set of comments. Identify comments 
with the FDA 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 https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: FSIS: Janell Kause, Scientific Advisor 
for Risk Assessment, Office of Public Health Science, Food and Safety 
Inspection Service, USDA, 355 E Street SW., Washington, DC 20024; 
Telephone: (202) 690-0286, Email: Janell.Kause@fsis.usda.gov.
    FDA: Sherri Dennis, Acting Director, Division of Risk Assessment, 
Office of Analytics and Outreach, FDA/CFSAN, HFS-005, 5100 Paint Branch 
Parkway, College Park, Maryland 20740;

[[Page 27940]]

Telephone: (240) 402-1914, Email: Sherri.Dennis@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Listeria monocytogenes (L. monocytogenes) is a widely occurring 
pathogen that persists in agricultural, food processing, and retail 
environments. Ingestion of L. monocytogenes can lead to the development 
of listeriosis, which could cause septicemia, meningitis, encephalitis, 
spontaneous abortion, and stillbirth. Epidemiological data show that 
listeriosis has one of the highest hospitalization rates (approximately 
95 percent) and one of the highest case fatality rates (approximately 
16 percent) among foodborne diseases in the United States (Ref. 1).
    To reduce listeriosis, it is important to identify: (1) which RTE 
foods pose the greatest risk to public health, and (2) which changes in 
practices are critical for reducing the prevalence and levels of L. 
monocytogenes in these RTE products. Risk assessment is a decision-
support tool that has been used to successfully accomplish these goals 
by prioritizing RTE foods according to risk and linking food safety 
research to changes in practices that will improve public health 
outcomes.
    A 2003 industry survey of L. monocytogenes in RTE foods purchased 
at retail grocery stores showed a seven-fold higher incidence and level 
of L. monocytogenes in deli meats sliced and served in retail delis 
compared to those sliced and packaged in manufacturing plants (Ref. 2). 
A subsequent survey by academia yielded similar findings (Ref. 3). An 
FSIS risk assessment, using these data, predicted an estimated 83 
percent of all deli meat-related listeriosis cases are associated with 
deli meat sliced and packaged at retail delis (Ref. 4). A Cornell 
University comparative risk assessment had similar findings (Ref. 5).
    Cross contamination in the deli environment is thought to 
contribute to L. monocytogenes contamination of RTE foods, but little 
is known about the transfer of this pathogen from one surface to 
another in the retail setting. L. monocytogenes is present in the 
environment and can survive and grow in foods held at ambient and 
refrigeration temperatures. Therefore adequate preventive controls must 
take into account contamination as well as survival and proliferation 
of the organism. L. monocytogenes can contaminate foods via cross 
contamination from one product to another or through contamination from 
the environment, or both. FSIS and CFSAN (we) jointly developed a risk 
assessment to better understand L. monocytogenes transmission, 
survival, and growth in the retail environment and to evaluate how 
retail practices may impact public health. In 2009, the President's 
Food Safety Work Group identified this quantitative risk assessment 
(QRA) as a priority (Ref. 6).

II. Draft Interagency Risk Assessment--L. monocytogenes in Retail 
Delicatessens

    The draft ``Interagency Risk Assessment--Listeria monocytogenes in 
Retail Delicatessens'' (Ref. 7-8) provides federal risk managers and 
the retail industry with a science-based decision support tool to 
evaluate the effectiveness of retail practices and interventions to 
reduce or prevent listeriosis associated with the consumption of RTE 
foods commonly prepared and sold in the delicatessen (deli) of a retail 
food store. It also examines how changes in current retail practices 
might further mitigate the predicted risk of listeriosis from these RTE 
foods. We conducted the draft QRA collaboratively, in consultation with 
the Centers for Disease Control and Prevention (CDC) and with input 
from industry, academic institutions, and consumer advocacy group 
stakeholders. It is available on FSIS's Web site at https://www.fsis.usda.gov/PDF/Interagency_RA_Lm_Retail_Report_May2013.pdf 
and FDA's Web site at https://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm.
    The draft QRA model has undergone an independent external peer 
review consistent with the requirements for peer review in the Office 
of Management and Budget's ``Final Information Quality Bulletin for 
Peer Review.'' Our response to the peer-review is available 
electronically on FSIS's Web site and FDA's Web site (Ref. 9).
    The draft QRA answers the following three broad risk management 
questions:
    1. What is the exposure to L. monocytogenes from consuming RTE 
foods prepared in retail delis?
    2. What are the key processes that increase RTE foods contamination 
at retail delis?
    3. How much is the relative risk per serving reduced according to 
specific risk management options?
    The three risk management questions are very broad in nature, and 
we further refined them to a list of risk mitigations evaluated through 
scenario analyses within the QRA. We used specific risk management 
questions provided by federal partners and stakeholders to guide the 
simulation scenarios conducted with the QRA.
    Specifically, the QRA model:
     Considers L. monocytogenes entering the retail deli area 
from either contaminated incoming products or from environmental/niche 
contamination;
     Considers a variety of RTE foods (e.g., different types of 
cheeses, deli meats, and deli salads) entering the retail deli;
     Simulates the transmission of L. monocytogenes among 
multiple pathways (including product-to-slicers, gloves-to-display 
cases, and utensils-to-gloves);
     Incorporates employee behaviors that contribute either to 
the spread or inactivation of L. monocytogenes (e.g., cleaning and 
sanitizing); and
     Factors with the potential for affecting bacterial growth 
(e.g., temperature/time, product pH, water activity, presence of growth 
inhibitors).

The QRA also estimates the risk of listeriosis from the handling and 
consumption of these products in the home. The QRA models two 
subpopulations: (1) The subpopulation with increased susceptibility 
(including neonates, older adults, and the immunocompromised), and (2) 
the subpopulation with decreased susceptibility (the general healthy 
population).
    We coordinated with CDC and several universities to gather data for 
the QRA. Stakeholders also developed partnerships to fill the data gaps 
identified in a request for scientific data and information for the 
project (Ref. 10). In 2009, we held a public meeting to present the 
background and data needs for this QRA (Ref. 11) (transcripts are 
available in the FSIS docket room and on the FSIS Web site at https://www.fsis.usda.gov/PDF/Listeria-Transcript_062309.pdf). As announced by 
FSIS in the Federal Register (78 FR 23901; April 23, 2013), we will 
hold a second public meeting on May 22, 2013 to present the supporting 
data, modeling approach, and findings of the QRA. (More information 
about this meeting will be available on FSIS's Web site at https://www.fsis.usda.gov/news/meetings_&_events/.

III. Request for Comments

    We invite comments on the QRA that can help improve:
     The overall risk assessment approach used;
     The assumptions made;
     The modeling techniques;
     The data used; and
     The clarity and the transparency of the documentation in 
this draft QRA.

[[Page 27941]]

    We will review and evaluate all public comments on this draft QRA 
and make modifications to the assessment based on comments, as 
appropriate.

IV. References

    The following references are on display in the FSIS Docket Room at 
the address above between 8:00 a.m. and 4:30 p.m., Monday through 
Friday, and in the FDA Division of Dockets Management at the address 
above between 9 a.m. and 4 p.m., Monday through Friday. (We have 
verified the following Web site addresses, but we are not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

1. Scallan, E., Hoekstra, R.M., Angulo, F.J., Tauxe, R.V., 
Widdowson, M.A., Roy, S.L., Jones, J.L., and Griffin, P.M., 
Foodborne illness acquired in the United States--major pathogens. 
Emerging Infectious Diseases, 2011. 17(1): p. 7-12.
2. Gombas, D.E., Chen, Y., Clavero, R.S., and Scott, V.N., Survey of 
Listeria monocytogenes in ready-to-eat foods. Journal of Food 
Protection, 2003. 66(4): p. 559-69.
3. Draughon, A.F. A collaborative analysis/risk assessment of 
Listeria monocytogenes in ready-to-eat processed meat and poultry 
collected in four FoodNet states in International Association for 
Food Protection 93rd Annual Meeting. 2006. Calgary, Alberta, Canada. 
Data shown in Endrikat et al. (2010)(Ref. 4).
4. Endrikat, S., Gallagher, D., Pouillot, R., Hicks Quesenberry, H., 
Labarre, D., Schroeder, C.M., and Kause, J., A Comparative Risk 
Assessment for Listeria monocytogenes in Prepackaged versus Retail-
Sliced Deli Meat. Journal of Food Protection, 2010. 73(4): p. 612-9.
5. Pradhan, A.K., Ivanek, R., Grohn, Y.T., Bukowski, R., Geornaras, 
I., Sofos, J.N., and Wiedmann, M., Quantitative Risk Assessment of 
Listeriosis-Associated Deaths Due to Listeria monocytogenes 
Contamination of Deli Meats Originating from Manufacture and Retail. 
Journal of Food Protection, 2010. 73(4): p. 620-30.
6. Federal Food Safety Working Group, The Federal Food Safety 
Working Group Progress Report, 2011. p. 31. Available from: https://www.whitehouse.gov/sites/default/files/fswg_report_final.pdf.
7. U.S. Department of Agriculture, Food Safety and Inspection 
Service and Department of Health and Human Service, Food and Drug 
Administration/Center for Food Safety and Applied Nutrition. Draft 
Interagency Risk Assessment--Listeria monocytogenes in Retail 
Delicatessens: Interpretative Summary. May 2013. https://www.fsis.usda.gov/PDF/Interagency_RA_Lm_Retail_Summary_May2013.pdf and https://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm.
8. U.S. Department of Agriculture, Food Safety and Inspection 
Service and Department of Health and Human Service, Food and Drug 
Administration/Center for Food Safety and Applied Nutrition. Draft 
Interagency Risk Assessment--Listeria monocytogenes in Retail 
Delicatessens: Report. May 2013. https://www.fsis.usda.gov/PDF/Interagency_RA_Lm_Retail_Report_May2013.pdf and https://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm.
9. U.S. Department of Agriculture, Food Safety and Inspection 
Service and Department of Health and Human Service, Food and Drug 
Administration/Center for Food Safety and Applied Nutrition. Draft 
Interagency Risk Assessment--Listeria monocytogenes in Retail 
Delicatessens: Response to Peer Review Comments. May 2013. https://www.fsis.usda.gov/PDF/Interagency_RA_Lm_Retail_Peer_Review_May2013.pdf and https://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/.
10. Federal Register Notice. Risk Assessment of the Public Health 
Impact from Foodborne Listeria monocytogenes in Some Ready-to-Eat 
Foods Sliced, Prepared, and/or Packaged in Retail Facilities; 
Request for Comments and for Scientific Data and Information. (74 FR 
3617; January 21, 2009), Docket No. FDA-2008-N-0658, https://www.fda.gov/OHRMS/DOCKETS/98fr/E9-938.pdf.
11. Interagency Retail Listeria monocytogenes Risk Assessment: 
Notice of a Public Meeting. (74 FR 27276; June 9, 2009). Docket No. 
FSIS-2009-0012, https://www.gpo.gov/fdsys/pkg/FR-2009-06-09/html/E9-13378.htm.

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    Done at Washington, DC, on: April 24, 2013.
Alfred V. Almanza,
Administrator.
Leslie Kux,
Assistant Commissioner for Policy, FDA.
[FR Doc. 2013-11298 Filed 5-10-13; 8:45 am]
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