[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