Assessment of the Risk of Human Salmonellosis Associated With the Consumption of Tree Nuts; Request for Comments, Scientific Data and Information, 42963-42965 [2013-17211]
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42963
Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR Section
Total
annual records
Average
burden per
recordkeeper
Total
hours
Equipment and Facilities Records 212.20(c); 212.30(b);
212.50(d); 212.60(f).
Equipment and Facilities Records 212.30(b); 212.50(d);
212.60(f).
Records of Components, Containers, and Closures
212.20(c); 212.40(a) and (b).
Records of Components, Containers, and Closures 212.40(e)
129
15
1,935
1 ................
1,935
129
3,758
484,782
40,237
129
2
258
.08 (5 minutes).
1 ................
129
36
4,644
2,322
Laboratory Testing Records 212.20(c); 212.60(a) and (b);
212.61(a); 212.70(a), (b), and (d).
Laboratory
Testing
Records
212.60(g);
212.61(b);
212.70(d)(2) and (d)(3).
Conditional Final Releases 212.70(f) .......................................
Out-of-Specification Investigations 212.20(c); 212.71(a) .........
Out-of-Specification Investigations 212.71(b) ..........................
Reprocessing Procedures 212.20(c); 212.71(d) ......................
Distribution Records 212.20(c); 212.90(a) ...............................
Distribution Records 212.90(b) ................................................
129
25
3,225
.5 (30 minutes).
1 ................
129
501
64,629
129
129
129
129
129
129
1
36
1
1
1
501
129
4,644
129
129
129
64,629
Complaints 212.20(c); 212.100(a) ............................................
Complaints 212.100(b) and (c) ................................................
129
129
1
1
Total ..................................................................................
........................
........................
1 There
258
3,225
10,728
129
129
.16 (10
min.).
1 ................
1 ................
1 ................
1 ................
1 ................
.25 (15
min.).
1 ................
.5 (30 min.)
........................
...................
149,266
129
4,644
129
129
129
16,157
129
65
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR Section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Sterility Test Failure Notices 212.70(e) ...............................
129
.25
32
1
32
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
Dated: July 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–17213 Filed 7–17–13; 8:45 am]
BILLING CODE 4160–01–P
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,
TKELLEY on DSK3SPTVN1PROD with NOTICES
HHS.
Notice; request for comments
and for scientific data and information.
ACTION:
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
SUMMARY:
VerDate Mar<15>2010
17:20 Jul 17, 2013
Jkt 229001
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 https://
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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
E:\FR\FM\18JYN1.SGM
18JYN1
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Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices
TKELLEY on DSK3SPTVN1PROD with NOTICES
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 crosscontamination 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 riskbased 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
VerDate Mar<15>2010
17:20 Jul 17, 2013
Jkt 229001
(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., preprocessing 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 MostProbable 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-
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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 farmto-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 Salmonellacontaminated 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
E:\FR\FM\18JYN1.SGM
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Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices
TKELLEY on DSK3SPTVN1PROD with NOTICES
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 https://
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 https://
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
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17:20 Jul 17, 2013
Jkt 229001
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: https://www.
cdc.gov/salmonella/pinenuts-enteriditis/
111711/. 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 https://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 https://www.fda.gov/Safety/
Recalls/default.htm. (Accessed 04/2013).
11. FDA (Food and Drug Administration).
Enforcement Reports. Available at https://
www.fda.gov/Safety/Recalls/Enforcement
Reports/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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
42965
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0811]
Guidance for Industry: Enforcement
Policy Regarding Investigational New
Drug Requirements for Use of Fecal
Microbiota for Transplantation To Treat
Clostridium difficile Infection Not
Responsive to Standard Therapies;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Enforcement Policy Regarding IND
Requirements for Use of Fecal
Microbiota for Transplantation to Treat
Clostridium difficile Infection Not
Responsive to Standard Therapies,’’
dated July 2013. This guidance informs
members of the medical and scientific
community and other interested persons
that we intend to exercise enforcement
discretion regarding the investigational
new drug (IND) requirements for the use
of fecal microbiota for transplantation
(FMT) to treat C. difficile infection not
responding to standard therapies. FDA
intends to exercise this discretion
provided that the treating physician
obtains adequate informed consent from
the patient or his or her legally
authorized representative for the use of
FMT products. Informed consent should
include, at a minimum, a statement that
the use of FMT products to treat C.
difficile is investigational and a
discussion of its potential risks. This
policy does not extend to other uses of
FMT. FDA intends to exercise this
discretion on an interim basis while we
further consider the matter. This
guidance has an immediate
implementation date because FDA has
SUMMARY:
E:\FR\FM\18JYN1.SGM
18JYN1
]]>Agencies
[Federal Register Volume 78, Number 138 (Thursday, July 18, 2013)]
[Notices]
[Pages 42963-42965]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17211]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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: https://www.cdc.gov/salmonella/pinenuts-enteriditis/111711/. 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 https://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 https://www.fda.gov/Safety/Recalls/default.htm. (Accessed 04/2013).
11. FDA (Food and Drug Administration). Enforcement Reports.
Available at https://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
