Assessment of the Risk of Human Salmonellosis Associated with the Consumption of Tree Nuts: Request for Comments, Scientific Data and Information
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0747]
Assessment of the Risk of Human Salmonellosis Associated With the Consumption of Tree Nuts; Request for Comments, Scientific Data and Information
Food and Drug Administration, HHS.
Notice; request for comments and for scientific data and information.
The Food and Drug Administration (FDA or we) is requesting comments and scientific data and information that may help us in performing a quantitative assessment of the risk of human salmonellosis (an infection with bacteria called Salmonella) associated with the consumption of tree nuts. The purpose of the risk assessment will be to quantify the public health risk associated with the consumption of potentially Salmonella contaminated tree nuts and to evaluate the impact of risk-based preventive controls on the risk of human salmonellosis arising from consumption of tree nuts.
Submit either electronic or written comments and scientific data and information by October 16, 2013.
Submit electronic comments and scientific data and information to http://www.regulations.gov. Submit 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.
For Further Information Contact
Sherri Dennis, Center for Food Safety and Applied Nutrition (HFS-06), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1914.
The consumption of whole raw almonds has been associated with outbreaks of human salmonellosis (an infection with bacteria called Salmonella), during the years 2000-2001 (Ref. 1) and the years 2003-2004 (Ref. 2). Salmonellosis has also been associated with other tree nuts such as desiccated coconut (i.e., coconut meat which has been shredded or flaked and then dried to remove as much moisture as possible) (Ref. 3) and pine nuts (Ref. 4). In addition, Salmonella has been found in a variety of tree nuts destined for human consumption including almonds (Ref. 5), cashew nuts and Brazil nuts (Ref. 6), macadamia nuts (Ref. 7), walnuts (Ref. 8) and pistachio nuts (Ref. 9). In the United States, tree nuts have repeatedly been recalled due to Salmonella contamination; between 2009 and 2012 pine nuts, pistachios, shelled hazelnuts, walnuts, cashew nutsand macademia nuts have been recalled because of potential Salmonella contamination (Refs. 10 and 11). These outbreaks, published reports of Salmonella in tree nuts destined for human consumption, and recalls emphasize the need to assess the risk of salmonellosis associated with tree nuts intended for human consumption, and to evaluate the appropriate risk-based preventive controls needed to reduce the risk of human salmonellosis.
The exact sequence of events leading to human salmonellosis outbreaks from consumption of tree nuts is not fully understood. For example, during the 2000-2001 outbreak, investigations supported previous findings (Ref. 12) that contamination and cross-contamination risks exist within tree nut facilities and at preceding points of production (Ref. 1). Notably, the specific 2000-2001 Salmonella outbreak strain was shown to persist in one of the affected orchards for a period of at least 5 years, emphasizing the potential risk of cross-contamination even years after Salmonella is introduced into an orchard (Ref. 13).
Risk assessments can be used to evaluate potential risk reduction strategies; determine the adequacy and expected efficacy of preventive controls; and guide risk management policies, outreach efforts, data collection initiatives, and research priorities. The purpose of this risk assessment will be to quantify the public health risk associated with the consumption of tree nuts potentially contaminated with Salmonella, and to evaluate the impact of risk-based preventive controls on the risk of human salmonellosis arising from consumption of tree nuts. The risk assessment model will be used to evaluate practices used in the United States, as well as policies related to risk-based preventive controls. Specifically, the risk assessment will assist us in determining the levels of contamination reduction appropriate for reducing the risk of human salmonellosis from tree nuts.
II. Request for Comments and Scientific Data and Information
We are requesting comments and the submission of scientific data and information relevant to this risk assessment. We specifically request scientific data and information concerning, but not limited to, the following factors that may affect the risk of human salmonellosis associated with the consumption of tree nuts:
1. Salmonella contamination in different tree nuts sampled at harvest, distribution (including transportation), manufacturing/processing plant (including at times before, during, and after application of treatments designed to reduce bacterial contamination), retail, or anywhere else in the supply chain, including:
2. Salmonella survival, growth or inactivation dynamics in different tree nuts during transportation and storage, including:
3. Current food consumption practices in the United States, including:
4. Storage, handling and processing conditions that may affect Salmonella survival, growth, or inactivation alongthe farm-to-fork continuum and the impact of these conditions on Salmonella concentrations on tree nuts, including:
5. Other comments, including the types of tree nuts that should be evaluated in this risk assessment and information about which types of tree nuts may enter the U.S. market without the application of treatments designed to reduce bacterial contamination.
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 (seeADDRESSES). 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.
The following references have been placed on display in the Division of Dockets Management (seeADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. We have verified the Web site addresses in the References section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in theFederal Register.
1. Isaacs, S., J. Aramini, B. Ciebin, J.A. Farrar, R. Ahmed, D. Middleton, A.U. Chandran, L.J. Harris, M. Whoes, E. Chan, A.S. Pichette, K. Campbell, A. Gupta, L.Y. Lior, M. Pearce, C. Clark, F. Rodgers, F. Jamieson, I. Brophy, A. Ellis, “Salmonella Enteritidis PT30 Outbreak Investigation Working Group. An international outbreak of salmonellosis associated with raw almonds contaminated with a rare phage type of Salmonella enteritidis.”Journal of Food Protection, 68(1): pp. 191-198, 2005.
2. Outbreak of Salmonella serotype Enteritidis infections associated with raw almonds—United States and Canada, 2003-2004. Morbidity and Mortality Weekly Report, 53(22): pp. 484-487, 2004.
3. Ward, L., G. Duckworth, S. O'Brien, “Salmonella java phage type Dundee—rise in cases in England: update.”Eurosurveillance, 3(12): p. 1435, 1999.
4. CDC (Centers for Disease Control and Prevention). Multistate Outbreak of Human Salmonella Enteritidis Infections Linked to Turkish Pine Nuts. Available at: http://www.cdc.gov/salmonella/pinenuts-enteriditis/111711/index.html. Last updated: 11/2011 [accessed 08/2012].
5. Danyluk, M.D., T.M. Jones, S.J. Abd, F. Schlitt-Dittrich, M. Jacobs, L.J. Harris. “Prevalence and amounts of Salmonella found on raw California almonds.”Journal of Food Protection, 70(4): pp. 820-827, 2007.
6. Freire, F.D.O., L. Offord. “Bacterial and yeast counts in Brazilian commodities and spices.”Brazilian Journal of Microbiology, 33(2): pp. 145-148, 2002.
7. StClair, V.J., M.M. Klenk. “Performance of 3 Methods for the Rapid Identification of Salmonella in Naturally Contaminated Foods and Feeds.”Journal of Food Protection, 53(11): pp. 961-964, 1990.
8. Riyaz-Ul-Hassan, S., V. Verma, A. Malik, G.N. Qazi. “Microbiological quality of walnut kernels and apple juice concentrate.”World Journal of Microbiology and Biotechnology, 19(8): pp. 845-850, 2003.
9. CDC (Centers for Disease Control and Prevention). Salmonella in Pistachio Nuts, 2009. Available at http://www.cdc.gov/salmonella/pistachios/update.html. Last updated: 2009 (Accessed 08/2012).
10. FDA (Food and Drug Administration). Recalls, Market Withdrawals, & Safety Alerts. Available at http://www.fda.gov/Safety/Recalls/default.htm. (Accessed 04/2013).
11. FDA (Food and Drug Administration). Enforcement Reports. Available at http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.
12. National Research Council. Committee on Food Protection. 1975. Nuts, macaroni, and noodle products and dry blended foods in prevention of microbial and parasitic hazards associated with processed foods. A guide for the food processor, pp. 68-76. In: National Academies of Sciences (ed.). Prevention of Microbial and Parasitic Hazards associated with Processed Foods—A Guide for the Food Processor. National Academy of Science Publishing Office, Washington, DC.
13. Uesugi, A.R., M.D. Danyluk, R.E. Mandrell, L.J. Harris. “Isolation of Salmonella Enteritidis phage type 30 from a single almond orchard over a 5-year period.”Journal of Food Protection, 70(8): pp. 1784-1789, 2007.
Dated: July 9, 2013.
Assistant Commissioner for Policy.
[FR Doc. 2013-17211 Filed 7-17-13; 8:45 am]
BILLING CODE 4160-01-P
Attachments(14) Return to top
Reference 1 Isaacs S et al An International Outbreak of Salmonellosis Associated with Raw Almonds Contaminated with a Rare Phage...
Reference 2 CDC 2003 2004 Outbreak of Salmonella Serotype Enteritidis Infections Associated with Raw Almonds
Reference 3 Ward L et al Salmonella java phage type Dundee Rise in Cases in England Update
Reference 4 CDC 2011 Multistate Outbreak of Human Salmonella Enteritidis Infections Linnked to Turkish Pine Nuts
Reference 5 Danyluk MD e al revalence and Amounts of Salmonella Found on Raw California Almonds
Reference 6 Friere F DO Offord L Bacterial and Yeast Counts in Brazilian Commodities and Spices
Reference 7 St Clair V J Klenk M M Performance of Three Methods for the Rapid Identification of Salmonella in Naturally...
Reference 8 Riyaz Ul Hassan S et al Microbiological quality of walnut kernels and apple juice concentrate
Reference 10 FDA Recalls Market Withdrawals and Safety Alerts
Reference 11 FDA Home Safety Market Withdrawals and Safety Alerts Enforcement Reports
Reference12 Nuts Macaroni and Noodle Products and Dry Blended Foods
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Comment Period Closed
Oct 16 2013, at 11:59 PM ET
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Date Posted: Jul 18, 2013
Federal Register Number: 2013-17211
TO: FDA Docket No. FDA-2013-N-0747 Comment is attached in file. October 7, 2013 Dr. Manuel Lagunas-Solar RF Biocidics Inc., Vacaville, CA University of...
Please see the attached letter requesting a 90-day extension of the comment period.
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