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



Food Safety and Inspection Service

[Docket No. FSIS-2013-0019]


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 
     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 http://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 http://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 http://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 http://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.


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 
    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 

    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 http://www.fsis.usda.gov/PDF/Interagency_RA_Lm_Retail_Report_May2013.pdf 
and FDA's Web site at http://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 
    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 
     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 

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 
    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 http://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 http://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 

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: http://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. http://www.fsis.usda.gov/PDF/Interagency_RA_Lm_Retail_Summary_May2013.pdf and http://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. http://www.fsis.usda.gov/PDF/Interagency_RA_Lm_Retail_Report_May2013.pdf and http://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. http://www.fsis.usda.gov/PDF/Interagency_RA_Lm_Retail_Peer_Review_May2013.pdf and http://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, http://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, http://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 http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
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of the Assistant Secretary for Civil Rights,
    1400 Independence Avenue SW., Washington, DC 20250-9410 or call 
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    Done at Washington, DC, on: April 24, 2013.
Alfred V. Almanza,
Leslie Kux,
Assistant Commissioner for Policy, FDA.
[FR Doc. 2013-11298 Filed 5-10-13; 8:45 am]