[Federal Register Volume 78, Number 138 (Thursday, July 18, 2013)]
[Notices]
[Pages 42963-42965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17211]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and for scientific data and 
information.

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SUMMARY: 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.

DATES: Submit either electronic or written comments and scientific data 
and information by October 16, 2013.

ADDRESSES: 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    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 nuts

[[Page 42964]]

and 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:
     The frequency of detecting the presence of Salmonella in 
different types of domestically produced or imported tree nuts, sampled 
at different stages of the farm-to-fork continuum as described 
previously. If available, for each data point, we also invite 
information regarding the following: (1) How the nuts were handled 
prior to analysis (e.g., pre-processing storage conditions, processing 
treatments and conditions, post-processing storage, etc.); (2) the size 
of the analytical unit; (3) number of positives; (4) total number 
tested and the time period in which the testing was conducted; (5) test 
method; and (6) sampling protocol (e.g., simple random, stratified 
random, targeted);
     The number of Salmonella present per amount (i.e., unit 
volume or weight) of contaminated domestically produced or imported 
tree nuts, sampled at different stages of the farm-to-fork continuum as 
described previously. If available, for each data point, we also invite 
information regarding the following: (1) How the nuts were handled 
prior to analysis (e.g., pre-processing storage conditions, processing 
treatments and conditions, post-processing storage, etc.); (2) the 
analytical method used; and (3) sampling protocol (e.g., simple random, 
stratified random, targeted). We ask that the testing data be provided 
in unaggregated form and that Most-Probable Number (MPN) patterns as 
well as raw data (e.g., number of positive and negative tubes per 
dilution step in the MPN analysis) be provided if available;
     The frequency of detecting the presence of Salmonella in 
tree nut lots associated with outbreaks of human salmonellosis. If 
available, for each data point, we also invite information regarding 
the following: (1) How the nuts were handled prior to analysis (e.g., 
pre-processing storage conditions, processing treatments and 
conditions, post-processing storage, etc.); (2) size of the analytical 
unit; (3) number of positives; (4) total number tested; (5) analytical 
test method; and (6) sampling protocol (e.g., simple random, stratified 
random, targeted); and
     The number of Salmonella present per amount (i.e., unit 
volume or weight) of contaminated tree nuts associated with outbreaks 
of human salmonellosis. If available, for each data point, we also 
invite information regarding the following: (1) How the nuts were 
handled prior to analysis (e.g., pre- processing storage conditions, 
processing treatments and conditions, post-processing storage, etc.); 
(2) analytical method used; and (3) sampling protocols (e.g., simple 
random, stratified random, targeted). We ask that the testing data be 
provided in unaggregated form and that MPN patterns as well as raw data 
(e.g., number of positive and negative tubes per dilution step in the 
MPN analysis) be provided if available; in addition, we would ask that 
data regarding the variability in the number of Salmonella cells 
present in different samples from the same lot of contaminated nuts 
associated with an outbreak also be provided if available.
    2. Salmonella survival, growth or inactivation dynamics in 
different tree nuts during transportation and storage, including:
     Data or models on survival, growth or inactivation of 
Salmonella in specific tree nuts, including the potential effects of 
nut composition, water activity, and storage temperature;
     Data or models on survival, growth, or inactivation of 
Salmonella at different stages along the tree nut farm-to-fork 
continuum, potentially as a function of relative humidity during 
storage, geographic region, or season; and
     Data or models on survival, growth or inactivation of 
Salmonella in different foods made with Salmonella-contaminated tree 
nuts as ingredients.
    3. Current food consumption practices in the United States, 
including:
     The frequency with which different tree nuts or foods 
containing tree nuts are consumed by population subgroups (e.g., 
general adult population, immunocompromised persons, and the elderly);
     The frequency with which different tree nuts are consumed 
raw (i.e., without undergoing any treatment designed to reduce 
bacterial contamination on tree nuts between the time of harvest and 
the time of consumption) by different population subgroups;
     The frequency with which tree nuts that have undergone 
treatments designed to reduce bacterial contamination are consumed by 
different population subgroups; and
     Serving sizes for different tree nuts, including serving 
sizes for consumption of raw tree nuts and/or tree nuts that have 
undergone treatments designed to reduce bacterial contamination between 
the time of harvest and the time of consumption.
    4. Storage, handling and processing conditions that may affect 
Salmonella survival, growth, or inactivation along

[[Page 42965]]

the farm-to-fork continuum and the impact of these conditions on 
Salmonella concentrations on tree nuts, including:
     Typical storage conditions (e.g., time, temperature, 
relative humidity) for different tree nuts, from the time of harvest 
until the application of treatments designed to reduce bacterial 
contamination, and whether those storage conditions change Salmonella 
contamination levels;
     The types of treatments designed to reduce bacterial 
contamination that are typically applied to different tree nuts before 
retail, the frequency with which these treatments are applied to 
different types of tree nuts, the exact processing conditions (e.g., 
time, temperature, relative humidity), and the efficacy of these 
treatments in reducing Salmonella contamination on different tree nuts;
     Typical storage conditions (e.g., time, temperature, 
relative humidity) for different tree nuts, from the time treatments 
designed to reduce bacterial contamination are applied to the time the 
tree nuts are consumed, including typical storage conditions at retail 
and in the consumer home.
     The types of handling practices that are typically applied 
to different tree nuts by the consumer before consumption that may 
change Salmonella contamination levels, and the typical conditions 
(e.g., time, temperature) that are applied during these practices.
    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.

III. Comments

    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 (see ADDRESSES). 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.

IV. 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. 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 the Federal 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.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17211 Filed 7-17-13; 8:45 am]
BILLING CODE 4160-01-P