Testing of Product Samples for Listeria monocytogenes: Changes in Procedures, 58804-58807 [2012-23462]
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Federal Register / Vol. 77, No. 185 / Monday, September 24, 2012 / Notices
FREQUENCY OF RESPONSE
Number of
respondents
Form
Confidentiality Agreement .................................................................................
Peer Review Forms (Required for all reviewers and they have 2 review assignments on average.).
Expense Report (Only for those reviewers traveling to the review.) ................
Honorarium Form (Only for those reviewers paid by check.) ..........................
Panelist Information Forms ...............................................................................
Recommendations Form (For use only for panels not meeting online.) ..........
Annual frequency
200
200
1 per respondent (Total of 200).
2 per panel respondent (Total of 400).
20
20
200
20
1
1
1
2
per
per
per
per
respondent
respondent
respondent
respondent
(Total of 20).
(Total of 20).
for each form (Total of 200).
(Total of 40).
ESTIMATED TOTAL ANNUAL BURDEN ON RESPONDENTS
Number
completed
annually
Form (time required to complete)
Confidentiality Agreement (10 min.) ............................................................................................................................
Panelist Information Forms (30 min.) ..........................................................................................................................
Peer Review Forms (∼6 hrs) .......................................................................................................................................
Recommendations Form (1 hr) ...................................................................................................................................
Honorarium Form (3 min.) ...........................................................................................................................................
Expense Report (30 min.) ...........................................................................................................................................
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Comments: The Notice is soliciting
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Dated: September 4, 2012.
Caird Rexroad,
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Research Service, USDA.
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS–2012–0032]
Testing of Product Samples for Listeria
monocytogenes: Changes in
Procedures
Food Safety and Inspection
Service, USDA.
ACTION: Notice.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is announcing
changes in procedures for Listeria (L.)
monocytogenes product sampling
programs in ready-to-eat (RTE) meat and
poultry products. Starting 60 days after
issuance of this notice, FSIS will
increase the number of product samples
it collects under its Routine Risk-based
L. monocytogenes (RLm) Sampling
Program and its Intensified Verification
Testing (IVT) protocol from three to five
samples per sampling unit. In addition,
FSIS laboratories will composite the five
25-g product samples from the RLm
sampling program, which will increase
the sample size of the analyzed test
portion from 25 g to 125 g. The Agency
is effecting these changes to make its
sampling procedures more consistent
with international practices, to conserve
its laboratory resources, and to improve
public health. FSIS invites comments on
these changes to its sampling programs.
DATES: To receive full consideration,
comments on this notice should be
received by November 23, 2012.
ADDRESSES: FSIS invites interested
persons to submit comments on this
SUMMARY:
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200
200
400
20
20
20
Total burden
(hours)
33
100
2400
20
1
10
notice. Comments may be submitted by
either of the following methods:
• 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 https://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, Office of Policy and
Program Development, Risk,
Innovations, and Management Division,
Patriots Plaza 3, 8–163A, 1400
Independence Avenue SW., Mailstop
3782, 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–
2012–0032. Comments received in
response to this notice will be made
available for public inspection and
posted without change, including any
personal information, to https://
www.regulations.gov.
Docket: For access to background
documents or comments received, go to
the FSIS Docket Room at the address
listed above between 8:30 a.m. and 4:30
p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT:
Rachel Edelstein, Acting Assistant
Administrator, Office of Policy and
Program Development, Food Safety and
Inspection Service, U.S. Department of
Agriculture, telephone (202) 204–0495.
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Federal Register / Vol. 77, No. 185 / Monday, September 24, 2012 / Notices
FSIS
administers a regulatory program under
the Federal Meat Inspection Act (FMIA)
(21 U.S.C. 601 et seq.) and the Poultry
Products Inspection Act (PPIA) (21
U.S.C. 451 et seq.) that is intended to
ensure that meat, meat food, poultry,
and poultry products distributed in
commerce are wholesome; not
adulterated; and properly marked,
labeled, and packaged. As part of its
inspection program, FSIS collects
samples of these products for laboratory
analysis (21 U.S.C. 642(a) and 460(b)).
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
performed along with an FSA, although
this FSA is for-cause as opposed to
being routine.
Changes to RLMPROD and INTPROD
Sampling Procedures
When conducting sampling of postlethality-exposed RTE product for L.
monocytogenes, FSIS personnel
randomly collect enough finished
product to form a 1-lb sample and ship
it to the FSIS laboratory listed on the
sample request form. They package and
seal the sample using plastic bags
provided for the purpose; refrigerate or
RTE Sampling Programs for Listeria
freeze it; complete the sample request
monocytogenes
form; and send the sample and the form
via a package express service to the FSIS
Since the late 1980s, FSIS has been
Field Service Laboratory or other
sampling RTE meat and poultry
laboratory designated on the sample
products for the pathogen L.
monocytogenes. In 2003, FSIS published request form.
From the 1-lb RLMPROD or INTPROD
the interim final rule, ‘‘Control of L.
sample it receives, the laboratory draws
monocytogenes in RTE Meat and
a 25-g unit which it analyzes according
Poultry Products’’ (68 FR 34208; Jun. 6,
2003), which declares that post-lethality to procedures in the FSIS Microbiology
exposed RTE products are adulterated if Laboratory Guidebook (MLG) (https://
www.fsis.usda.gov/Science/
they test positive for L. monocytogenes
Microbiological_Lab_Guidebook/
or come into direct contact with a foodindex.asp). The MLG contains
contact surface that tests positive for L.
procedures for the detection, isolation,
monocytogenes. Post-lethality exposed
RTE meat and poultry products include confirmation, and identification of L.
monocytogenes in meat and poultry
deli meat and hotdog products. Since
samples.
the rule’s implementation, the Agency
Currently, a sampling unit for both
has moved to more risk-based testing
RLm and IVT sampling programs
programs to verify the adequacy of an
consists of 10 food-contact surface, five
establishment’s food safety system,
non-food-contact environmental surface,
including the measures that an
and three food product samples. FSIS is
establishment implements for the
not making any changes to its foodcontrol of L. monocytogenes.
contact and non-food contact surface
The RLm sampling program is a risksample testing.
based program designed to detect L.
FSIS is planning, however, to change
monocytogenes contamination from
the number of food product samples per
three types of samples: Food-contact
sampling unit it collects when sampling
surfaces (sampling code: RLMCONT),
for L. monocytogenes from three to five
non-food contact environmental
food product samples per sampling unit
surfaces of equipment and facilities
for both the RLm and IVT programs.
(sampling code: RLMENVC), and post(The sampling unit for IVT when
lethality-exposed RTE product
sampling for Salmonella [5 product
(sampling code: RLMPROD). An
Enforcement Investigation and Analysis samples, 8 environmental samples, and
Officer (EIAO) collects samples for RLm 5 food contact samples] will not
change.) In addition, its laboratories will
testing in conjunction with a routine
food safety assessment (FSA) to evaluate composite—physically mix—the five
25-g RLMPROD samples to form a single
the food-safety controls in place at an
125-g analytical unit and then conduct
establishment.
Under another risk-based program,
a microbiological analysis on that
IVT, inspectors (or EIAOs) collect
composited sample (sampling code:
follow-up samples if RTE meat or
RLMPRODC). The Agency will make
poultry product samples or food-contact appropriate changes in the MLG to
surface samples test positive for L.
reflect this new procedure. The
monocytogenes or Salmonella. An IVT,
laboratories will not composite the five
similar to a RLm, is designed to analyze 25-g INTPROD samples because those
three types of samples: food-contact
samples are collected for investigative
surfaces (sampling code: INTCONT),
purposes, and it is necessary for the
non-food contact environmental
Agency to know the specific production
surfaces (sampling code: INTENV), and
information related to those individual
post-lethality-exposed RTE product
samples.
To support an increase in the sample
(sampling code: INTPROD). As with
size analyzed (from 3 × 25 g, or 75 g per
RLm sampling, IVT sampling is
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58805
sampling unit, to 5 × 25 g, a total of 125
g per sampling unit), FSIS performed a
validation study of the current FSIS L.
monocytogenes detection method (MLG
Chapter 8). The study showed that, with
slight modifications to the laboratory
method, there would be no difference in
the sensitivity of the method in
detecting L. monocytogenes using either
25 g or 125 g of product.
FSIS is initiating these changes to its
procedures to make the results of its
analyses more comparable with results
obtained internationally. Many
countries are following the Codex
Alimentarius Commission Guidelines
on the Application of General Principles
of Food Hygiene to the Control of
Listeria Monocytogenes in Ready-to-Eat
Foods (CAC/GL–61 (2007)). Annex II of
these guidelines (Microbiological
Criteria for L. monocytogenes in Readyto-Eat Foods), recommends national
governments use a criteria of five
product samples for microbiological
analysis, with 25-g test portions
analyzed per sample. Under these
guidelines, national governments have
the discretion to decide whether to
composite the samples or analyze each
individually.
FSIS is also initiating these changes to
its procedures to conserve laboratory
resources. While FSIS will be collecting
more product samples, FSIS expects
that compositing five 25-g RLMPROD
samples into a single 125-g test portion
will reduce the overall number of
analyses performed and thus reduce the
associated laboratory costs.
Furthermore, FSIS expects that
increasing the number of product
samples and test portions per sample
will have a positive impact on public
health because implementing these
changes increases the potential for
detecting positive samples. For
example, from July 2010 to June 2012,
with three samples per sampling unit,
FSIS tested around 460 INTPROD
samples per year. Of those samples,
approximately five samples (about one
percent of tested samples) were found to
be positive for L. monocytogenes.
Assuming the current percent positive
detection rate do not change, FSIS
expects that when testing around 760
samples per year, approximately eight
samples (about one percent of 760
samples) will be found to be positive for
L. monocytogenes.1 Increased detection
of adulterated product will reduce the
number of illnesses and deaths caused
by L. monocytogenes and will also likely
improve control for L. monocytogenes in
RTE meat and poultry products.
1 Please
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also see footnote #5 and #6 below.
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Federal Register / Vol. 77, No. 185 / Monday, September 24, 2012 / Notices
need to be discarded and, in turn, yield
less revenue for the establishments.
The Agency used the most recent data
on the average price of deli meats
compiled by FreshLook Marketing
Group as a proxy for the price of RTE
Expected Costs
meat and poultry products, which is
Budgetary Costs to the Agency
$6.98 per pound.4 Agency data on
contaminated products found under
If the Agency had increased the
RLMPROD and INTPROD averaged
number of RLMPROD product samples
about 12.6 million lb per year (2008–
from three to five per sampling unit but
2011). An accurate value for the real
did not decide to composite these
increase in the percent positive rate will
samples, there would have been
be measured after the Agency starts
increased costs to FSIS. Agency data
collecting the number of samples as
shows that the annual number of
proposed by this notice. For the current
product samples analyzed is 1,882 for
analysis, the Agency assumes the
2 The
RLMPROD and 432 for INTPROD.
percent positive value will increase in
increase in the number of samples will
the same proportion as the number of
be around 1,550 ((3,138¥1,882) +
samples increases, which is 67 percent
(720¥432)), as given in Table 1.
[(5–3)/3.] 5 6 It follows that the
However, compositing the RLMPROD
contaminated products would increase
samples will reduce the number of
to about 21 million pounds—an 8.4
analyses performed in the RLMPROD
million-pound increase. Multiplying 8.4
sampling program to about 630 (3,138/
million pounds by $6.98 per pound
5), and the total number of analyses the
gives $58.6 million, which is the
Agency labs will perform annually for
possible loss in market value of the
RLMPROD and INTPROD will decrease
additional detected contaminated
by 964 [(1,882 + 432)¥(630 + 720)].
products.
This reduction in turn will result in
If establishments that are already
decreased costs to the Agency labs.
testing for L. monocytogenes choose to
composite samples, they may incur
Total
validation costs at about $30,000 to
Samples
number
Sampling program
per unit
of sample $60,000 each.7 However, this cost
analyses impact will not be significant for the
RLMPROD (current)
3
1882 following reasons: (1) Very few
establishments are testing for L.
RLMPRODC (proposed composites)
5
* 630 monocytogenes; (2) the Agency is not
INTPROD (current) ...
3
432 mandating compositing, so the methods
INTPROD (proposed)
5
720 change will be voluntary, and
establishments will only choose to do so
* FSIS projects that the number of
RLMPROD samples collected prior to if it is beneficial; and (3) in the long run,
those establishments that make the
compositing will increase from 1882 to 3138.
changes to testing composited product
The Agency has estimated the savings
samples can recover the validation cost
to the laboratories by reducing the
because they will have fewer sample
number of sample analyses performed to
analyses to perform.
be approximately $40,000, which
includes savings for expendable
4 (1) Provided by Ed MacKowiak at FreshLook
supplies such as gloves, plates, etc.3
Marketing Group on July 13, 2011 via personal
Cost-Benefit Analysis for Increasing the
Sample Numbers of RLm Product
Samples (RLMPROD) and IVT Product
Samples (INTPROD) and Compositing
RLMPROD Samples
TKELLEY on DSK3SPTVN1PROD with NOTICES
Costs to the Industry
One major cost to the industry will be
the likely loss from the additional
contaminated RTE products detected by
the additional sampling, which the
establishments will have to destroy.
Even though these adulterated products
should be destroyed and not sold to
consumers, establishments would have
earned revenue selling these products. If
additional testing results in more
positive samples, more product will
2 2009–2010 average. Data from Data Analysis and
Integration Group/Office of Data Integration and
Food Protection (DAIG/ODIFP).
3 Data from the Laboratory Director, Office of
Public Health Science (OPHS), FSIS.
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communication.
(2) Total U.S. traditional grocery store scanner
data. Deli meats include deli beef/pork/bacon,
bologna, frankfurter, ham, loaves, poultry, salami,
sausage, specialty meats/pates, and other. Price is
52-week average as of 6/19/2011.
(3) Most contaminated RTE samples are from deli
meats and hotdogs. Therefore, this price index is a
reasonable proxy.
5 Note that this is an upper-bound assumption,
implying that all the additional positive samples are
from lots that previously tested negative lots, and
none is from lots that previously tested positive.
The number is likely to be lower than 67 percent,
but we will not know what it is likely to be until
we implement the change.
6 As mentioned above, compositing five 25 g
samples to one 125 g test portion will not impact
the sensitivity of the tests, thus will not increase the
percent positive rate.
7 Information from Office of Public Health
Science, FSIS.
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Expected Benefits
The main benefit from increasing the
sample number is the reduction of
illnesses and deaths caused by L.
monocytogenes. A recent risk
assessment (2012) conducted jointly by
FSIS and FDA indicates that any L.
monocytogenes on incoming RTE foods,
both those that support the growth of L.
monocytogenes and those that do not,
that are sliced, prepared, or packaged in
retail grocery stores contributes to retail
cross-contamination of other RTE food
sliced, prepared, or packaged at retail
and, in turn, contributes to increased
risk of listeriosis.8 Prior FSIS risk
assessments showed that most listeriosis
cases attributed to RTE foods were
associated with those exposed to the
retail grocery environment (e.g., sliced,
prepared, or packaged).9 Other studies
supported these findings.10 By
increasing the number and amount of
RTE food product samples being tested
for L. monocytogenes, contaminated
product can be more readily detected
and diverted from going to retail. This
result reduces the risk of listeriosis both
from the contaminated RTE product
being diverted and from other RTE
foods that could become crosscontaminated by these products during
retail slicing, preparation, or packaging
operations.
According to the most recent CDC
analysis, there are about 1,591 (with a
range of 557 to 3,161) domesticallyacquired foodborne illnesses caused by
L. monocytogenes annually. The average
annual number of hospitalization, is
1,455 (with a range of 521 to 3,018), and
the average number of deaths is 255
(with a range of 0 to 733).11 Using this
information and an ERS (Economic
Research Services) model, the Agency
has recently updated the cost of
illnesses of L. monocytogenes to be $1.3
million per case in 2010 dollars. This
estimate represents a lower bound for an
average cost of L. monocytogenes
because it only includes medical costs
8 U.S. Department of Agriculture, Food Safety and
Inspection Service and Food and Drug
Administration, Center for Food Safety and Applied
Nutrition (2012). Interagency Retail Listeria
monocytogenes Risk Assessment. Washington, DC.
9 Endrikat S, Gallagher D, Pouillot R, et al. A
comparative risk assessment for Listeria
monocytogenes in prepackaged versus retail-sliced
deli meat. J Food Prot 2010;73:612–9.
10 Pradhan AK, Ivanek R, Grohn YT, et al.
¨
Quantitative risk assessment of listeriosisassociated deaths due to Listeria monocytogenes
contamination of deli meats originating from
manufacture and retail. J Food Prot 2010;73:620–30.
11 Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV,
Widdowson M, Roy SL, Jones JL, and Griffin PM.
2011. Foodborne illness acquired in the United
States—major pathogens. Emerg Infect Dis, 17(1):7–
11.
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and loss-of-productivity costs. It does
not include pain and suffering costs.
The Agency’s analysis suggests that
the new sampling will reduce the
number of illnesses by an average of 90
cases per year (with a range of 3 to
134).12 This number does not include
the reduced illnesses from reduced
cross-contamination at retail, so the
number could be higher. Multiplying
the average number of reduced illnesses
by the average cost per case results in
reduced illness benefits of about $117
million annually.
The Agency also expects that with the
increased sampling, the establishments
will strengthen their own L.
monocytogenes control measures, which
will further reduce the number of
illnesses. However, FSIS cannot
quantify this impact with any precision.
Net Benefits
As explained in the Expected Costs
and Expected Benefits Sections, there
are uncertainties in the Agency’s cost
and benefit estimates. Consequently, it
is very difficult to arrive at a concrete
estimate of net benefits. The biggest
uncertainty is that FSIS cannot
accurately predict the amount of
adulterated product that will be
detected as a result of increasing the
sampling numbers. The Agency can
only estimate the amount with some
strong assumptions. The Agency
believes that it can have a reasonable
net benefit estimate by adding the
estimated benefits from reduced
illnesses ($117 million), then
subtracting the cost to the industry
($58.6 million). The result is a net
benefit of about $58.33 million
annually.
The changes in FSIS’s sampling
procedures do not impose a testing
requirement on official establishments.
Therefore, these changes will not have
a negative effect on small or very small
establishments.13
USDA Nondiscrimination Statement
TKELLEY on DSK3SPTVN1PROD with NOTICES
The U.S. Department of Agriculture
(USDA) prohibits discrimination in all
its programs and activities on the basis
of race, color, national origin, gender,
religion, age, disability, political beliefs,
sexual orientation, and marital or family
status. (Not all prohibited bases apply to
all programs.)
12 Analysis results are from the Risk Assessment
Division, OPHS.
13 Based on FSIS’s HACCP (Hazard Analysis and
Critical Control Points) size definition: Very small
establishments have fewer than 10 employees or
generate less than $2.5 million in annual sales; and
small establishments have 10 or more but fewer
than 500 employees and generate more than $2.5
million in annual sales.
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Persons with disabilities who require
alternative means for communication of
program information (Braille, large
print, audiotape, etc.) should contact
USDA’s Target Center at 202–720–2600
(voice and TTY).
To file a written complaint of
discrimination, write USDA, Office of
the Assistant Secretary for Civil Rights,
1400 Independence Avenue SW.,
Washington, DC 20250–9410 or call
202–720–5964 (voice and TTY). USDA
is an equal opportunity provider and
employer.
Additional Public Notification
FSIS will announce this notice online through the FSIS Web page located
at https://www.fsis.usda.gov/
regulations_&_policies/Federal_
Register_Notices/index.asp.
FSIS also will make copies of this
Federal Register publication available
through the FSIS Constituent Update,
which is used to provide information
regarding FSIS policies, procedures,
regulations, Federal Register notices,
FSIS public meetings, and other types of
information that could affect or would
be of interest to constituents and
stakeholders. The Update is
communicated via Listserv, a free
electronic mail subscription service for
industry, trade groups, consumer
interest groups, health professionals and
other individuals who have asked to be
included. The Update is available on the
FSIS Web page. Through the Listserv
and the Web page, FSIS is able to
provide information to a much broader
and more diverse audience.
In addition, FSIS offers an email
subscription service which provides
automatic and customized access to
selected food safety news and
information. This service is available at
https://www.fsis.usda.gov/News_&_
Events/Email_Subscription/. Options
range from recalls to export information
to regulations, directives and notices.
Customers can add or delete
subscriptions themselves, and have the
option to password protect their
accounts.
Done in Washington, DC, on: September
18, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012–23462 Filed 9–21–12; 8:45 am]
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DEPARTMENT OF AGRICULTURE
Forest Service
Huron-Manistee National Forests,
Michigan, USA and State South Branch
1–8 Well
Forest Service, USDA.
Withdrawal of notice of intent
to prepare an environmental impact
statement.
AGENCY:
ACTION:
Authority: 36 CFR 220.5(c)
The Huron-Manistee National
Forests (Forest Service) and the Bureau
of Land Management (BLM), as a
Cooperating Agency, proposed to
prepare an environmental impact
statement (EIS) to assess the
environmental impacts of an industry
proposal to drill one exploratory natural
gas well, the USA & State South Branch
1–8 (SB 1–8) well, on National Forest
System lands. The leaseholder has
withdrawn their application for permit
to drill therefore this project has been
cancelled. This notice cancels the notice
of intent to prepare and environmental
impact statement.
DATES: The Notice of Intent to prepare
and environmental impact statement for
the USA and State South Branch 1–8
Well was published on February 24,
2010 with a corrected notice published
on March 12, 2010. A revised Notice of
Intent was published on January 11,
2012. The Draft was expected in
November 2012 and the Final EIS was
expected by June 2013.
FOR FURTHER INFORMATION CONTACT: Ken
Arbogast, Huron-Manistee National
Forests; telephone: 231–775–2421; fax:
231–775–5551. See address above under
Addresses. Copies of documents may be
requested at the same address. Another
means of obtaining information is to
visit the Forest Web page at
www.fs.fed.us/r9/hmnf then click on
‘‘NEPA Projects and Planning’’, then
‘‘Old Project page’’, then ‘‘Mio projects’’,
and then ‘‘USA and State South Branch
1–8’’.
Individuals who use
telecommunication devices for the deaf
(TTY) may call 1–231–775–3183.
SUPPLEMENTARY INFORMATION: The
original notice of intent to prepare the
environmental impact statement for the
USA and State South Branch Well was
published on February 24, 2010 (Vol.
75, No. 36, pages 8297–8299) with a
corrected notice published on March 12,
2010 (Vol. 75, No. 48, pages 11838–
11839). A revised Notice of Intent was
published on January 11, 2012 (Vol 77,
No. 7, page 1665).
SUMMARY:
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[Federal Register Volume 77, Number 185 (Monday, September 24, 2012)]
[Notices]
[Pages 58804-58807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23462]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2012-0032]
Testing of Product Samples for Listeria monocytogenes: Changes in
Procedures
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
changes in procedures for Listeria (L.) monocytogenes product sampling
programs in ready-to-eat (RTE) meat and poultry products. Starting 60
days after issuance of this notice, FSIS will increase the number of
product samples it collects under its Routine Risk-based L.
monocytogenes (RLm) Sampling Program and its Intensified Verification
Testing (IVT) protocol from three to five samples per sampling unit. In
addition, FSIS laboratories will composite the five 25-g product
samples from the RLm sampling program, which will increase the sample
size of the analyzed test portion from 25 g to 125 g. The Agency is
effecting these changes to make its sampling procedures more consistent
with international practices, to conserve its laboratory resources, and
to improve public health. FSIS invites comments on these changes to its
sampling programs.
DATES: To receive full consideration, comments on this notice should be
received by November 23, 2012.
ADDRESSES: FSIS invites interested persons to submit comments on this
notice. Comments may be submitted by either of the following methods:
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 https://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, Office
of Policy and Program Development, Risk, Innovations, and Management
Division, Patriots Plaza 3, 8-163A, 1400 Independence Avenue SW.,
Mailstop 3782, 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-2012-0032. Comments
received in response to this notice will be made available for public
inspection and posted without change, including any personal
information, to https://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at the address listed above between 8:30 a.m.
and 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Acting Assistant
Administrator, Office of Policy and Program Development, Food Safety
and Inspection Service, U.S. Department of Agriculture, telephone (202)
204-0495.
[[Page 58805]]
SUPPLEMENTARY INFORMATION: FSIS administers a regulatory program under
the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the
Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) that is
intended to ensure that meat, meat food, poultry, and poultry products
distributed in commerce are wholesome; not adulterated; and properly
marked, labeled, and packaged. As part of its inspection program, FSIS
collects samples of these products for laboratory analysis (21 U.S.C.
642(a) and 460(b)).
RTE Sampling Programs for Listeria monocytogenes
Since the late 1980s, FSIS has been sampling RTE meat and poultry
products for the pathogen L. monocytogenes. In 2003, FSIS published the
interim final rule, ``Control of L. monocytogenes in RTE Meat and
Poultry Products'' (68 FR 34208; Jun. 6, 2003), which declares that
post-lethality exposed RTE products are adulterated if they test
positive for L. monocytogenes or come into direct contact with a food-
contact surface that tests positive for L. monocytogenes. Post-
lethality exposed RTE meat and poultry products include deli meat and
hotdog products. Since the rule's implementation, the Agency has moved
to more risk-based testing programs to verify the adequacy of an
establishment's food safety system, including the measures that an
establishment implements for the control of L. monocytogenes.
The RLm sampling program is a risk-based program designed to detect
L. monocytogenes contamination from three types of samples: Food-
contact surfaces (sampling code: RLMCONT), non-food contact
environmental surfaces of equipment and facilities (sampling code:
RLMENVC), and post-lethality-exposed RTE product (sampling code:
RLMPROD). An Enforcement Investigation and Analysis Officer (EIAO)
collects samples for RLm testing in conjunction with a routine food
safety assessment (FSA) to evaluate the food-safety controls in place
at an establishment.
Under another risk-based program, IVT, inspectors (or EIAOs)
collect follow-up samples if RTE meat or poultry product samples or
food-contact surface samples test positive for L. monocytogenes or
Salmonella. An IVT, similar to a RLm, is designed to analyze three
types of samples: food-contact surfaces (sampling code: INTCONT), non-
food contact environmental surfaces (sampling code: INTENV), and post-
lethality-exposed RTE product (sampling code: INTPROD). As with RLm
sampling, IVT sampling is performed along with an FSA, although this
FSA is for-cause as opposed to being routine.
Changes to RLMPROD and INTPROD Sampling Procedures
When conducting sampling of post-lethality-exposed RTE product for
L. monocytogenes, FSIS personnel randomly collect enough finished
product to form a 1-lb sample and ship it to the FSIS laboratory listed
on the sample request form. They package and seal the sample using
plastic bags provided for the purpose; refrigerate or freeze it;
complete the sample request form; and send the sample and the form via
a package express service to the FSIS Field Service Laboratory or other
laboratory designated on the sample request form.
From the 1-lb RLMPROD or INTPROD sample it receives, the laboratory
draws a 25-g unit which it analyzes according to procedures in the FSIS
Microbiology Laboratory Guidebook (MLG) (https://www.fsis.usda.gov/Science/Microbiological_Lab_Guidebook/index.asp). The MLG contains
procedures for the detection, isolation, confirmation, and
identification of L. monocytogenes in meat and poultry samples.
Currently, a sampling unit for both RLm and IVT sampling programs
consists of 10 food-contact surface, five non-food-contact
environmental surface, and three food product samples. FSIS is not
making any changes to its food-contact and non-food contact surface
sample testing.
FSIS is planning, however, to change the number of food product
samples per sampling unit it collects when sampling for L.
monocytogenes from three to five food product samples per sampling unit
for both the RLm and IVT programs. (The sampling unit for IVT when
sampling for Salmonella [5 product samples, 8 environmental samples,
and 5 food contact samples] will not change.) In addition, its
laboratories will composite--physically mix--the five 25-g RLMPROD
samples to form a single 125-g analytical unit and then conduct a
microbiological analysis on that composited sample (sampling code:
RLMPRODC). The Agency will make appropriate changes in the MLG to
reflect this new procedure. The laboratories will not composite the
five 25-g INTPROD samples because those samples are collected for
investigative purposes, and it is necessary for the Agency to know the
specific production information related to those individual samples.
To support an increase in the sample size analyzed (from 3 x 25 g,
or 75 g per sampling unit, to 5 x 25 g, a total of 125 g per sampling
unit), FSIS performed a validation study of the current FSIS L.
monocytogenes detection method (MLG Chapter 8). The study showed that,
with slight modifications to the laboratory method, there would be no
difference in the sensitivity of the method in detecting L.
monocytogenes using either 25 g or 125 g of product.
FSIS is initiating these changes to its procedures to make the
results of its analyses more comparable with results obtained
internationally. Many countries are following the Codex Alimentarius
Commission Guidelines on the Application of General Principles of Food
Hygiene to the Control of Listeria Monocytogenes in Ready-to-Eat Foods
(CAC/GL-61 (2007)). Annex II of these guidelines (Microbiological
Criteria for L. monocytogenes in Ready-to-Eat Foods), recommends
national governments use a criteria of five product samples for
microbiological analysis, with 25-g test portions analyzed per sample.
Under these guidelines, national governments have the discretion to
decide whether to composite the samples or analyze each individually.
FSIS is also initiating these changes to its procedures to conserve
laboratory resources. While FSIS will be collecting more product
samples, FSIS expects that compositing five 25-g RLMPROD samples into a
single 125-g test portion will reduce the overall number of analyses
performed and thus reduce the associated laboratory costs.
Furthermore, FSIS expects that increasing the number of product
samples and test portions per sample will have a positive impact on
public health because implementing these changes increases the
potential for detecting positive samples. For example, from July 2010
to June 2012, with three samples per sampling unit, FSIS tested around
460 INTPROD samples per year. Of those samples, approximately five
samples (about one percent of tested samples) were found to be positive
for L. monocytogenes. Assuming the current percent positive detection
rate do not change, FSIS expects that when testing around 760 samples
per year, approximately eight samples (about one percent of 760
samples) will be found to be positive for L. monocytogenes.\1\
Increased detection of adulterated product will reduce the number of
illnesses and deaths caused by L. monocytogenes and will also likely
improve control for L. monocytogenes in RTE meat and poultry products.
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\1\ Please also see footnote 5 and 6 below.
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[[Page 58806]]
Cost-Benefit Analysis for Increasing the Sample Numbers of RLm Product
Samples (RLMPROD) and IVT Product Samples (INTPROD) and Compositing
RLMPROD Samples
Expected Costs
Budgetary Costs to the Agency
If the Agency had increased the number of RLMPROD product samples
from three to five per sampling unit but did not decide to composite
these samples, there would have been increased costs to FSIS. Agency
data shows that the annual number of product samples analyzed is 1,882
for RLMPROD and 432 for INTPROD.\2\ The increase in the number of
samples will be around 1,550 ((3,138-1,882) + (720-432)), as given in
Table 1. However, compositing the RLMPROD samples will reduce the
number of analyses performed in the RLMPROD sampling program to about
630 (3,138/5), and the total number of analyses the Agency labs will
perform annually for RLMPROD and INTPROD will decrease by 964 [(1,882 +
432)-(630 + 720)]. This reduction in turn will result in decreased
costs to the Agency labs.
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\2\ 2009-2010 average. Data from Data Analysis and Integration
Group/Office of Data Integration and Food Protection (DAIG/ODIFP).
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Total
Samples number of
Sampling program per unit sample
analyses
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RLMPROD (current)................................. 3 1882
RLMPRODC (proposed composites).................... 5 * 630
INTPROD (current)................................. 3 432
INTPROD (proposed)................................ 5 720
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* FSIS projects that the number of RLMPROD samples collected prior to
compositing will increase from 1882 to 3138.
The Agency has estimated the savings to the laboratories by
reducing the number of sample analyses performed to be approximately
$40,000, which includes savings for expendable supplies such as gloves,
plates, etc.\3\
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\3\ Data from the Laboratory Director, Office of Public Health
Science (OPHS), FSIS.
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Costs to the Industry
One major cost to the industry will be the likely loss from the
additional contaminated RTE products detected by the additional
sampling, which the establishments will have to destroy. Even though
these adulterated products should be destroyed and not sold to
consumers, establishments would have earned revenue selling these
products. If additional testing results in more positive samples, more
product will need to be discarded and, in turn, yield less revenue for
the establishments.
The Agency used the most recent data on the average price of deli
meats compiled by FreshLook Marketing Group as a proxy for the price of
RTE meat and poultry products, which is $6.98 per pound.\4\ Agency data
on contaminated products found under RLMPROD and INTPROD averaged about
12.6 million lb per year (2008-2011). An accurate value for the real
increase in the percent positive rate will be measured after the Agency
starts collecting the number of samples as proposed by this notice. For
the current analysis, the Agency assumes the percent positive value
will increase in the same proportion as the number of samples
increases, which is 67 percent [(5-3)/3.] \5 6\ It follows that the
contaminated products would increase to about 21 million pounds--an 8.4
million-pound increase. Multiplying 8.4 million pounds by $6.98 per
pound gives $58.6 million, which is the possible loss in market value
of the additional detected contaminated products.
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\4\ (1) Provided by Ed MacKowiak at FreshLook Marketing Group on
July 13, 2011 via personal communication.
(2) Total U.S. traditional grocery store scanner data. Deli
meats include deli beef/pork/bacon, bologna, frankfurter, ham,
loaves, poultry, salami, sausage, specialty meats/pates, and other.
Price is 52-week average as of 6/19/2011.
(3) Most contaminated RTE samples are from deli meats and
hotdogs. Therefore, this price index is a reasonable proxy.
\5\ Note that this is an upper-bound assumption, implying that
all the additional positive samples are from lots that previously
tested negative lots, and none is from lots that previously tested
positive. The number is likely to be lower than 67 percent, but we
will not know what it is likely to be until we implement the change.
\6\ As mentioned above, compositing five 25 g samples to one 125
g test portion will not impact the sensitivity of the tests, thus
will not increase the percent positive rate.
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If establishments that are already testing for L. monocytogenes
choose to composite samples, they may incur validation costs at about
$30,000 to $60,000 each.\7\ However, this cost impact will not be
significant for the following reasons: (1) Very few establishments are
testing for L. monocytogenes; (2) the Agency is not mandating
compositing, so the methods change will be voluntary, and
establishments will only choose to do so if it is beneficial; and (3)
in the long run, those establishments that make the changes to testing
composited product samples can recover the validation cost because they
will have fewer sample analyses to perform.
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\7\ Information from Office of Public Health Science, FSIS.
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Expected Benefits
The main benefit from increasing the sample number is the reduction
of illnesses and deaths caused by L. monocytogenes. A recent risk
assessment (2012) conducted jointly by FSIS and FDA indicates that any
L. monocytogenes on incoming RTE foods, both those that support the
growth of L. monocytogenes and those that do not, that are sliced,
prepared, or packaged in retail grocery stores contributes to retail
cross-contamination of other RTE food sliced, prepared, or packaged at
retail and, in turn, contributes to increased risk of listeriosis.\8\
Prior FSIS risk assessments showed that most listeriosis cases
attributed to RTE foods were associated with those exposed to the
retail grocery environment (e.g., sliced, prepared, or packaged).\9\
Other studies supported these findings.\10\ By increasing the number
and amount of RTE food product samples being tested for L.
monocytogenes, contaminated product can be more readily detected and
diverted from going to retail. This result reduces the risk of
listeriosis both from the contaminated RTE product being diverted and
from other RTE foods that could become cross-contaminated by these
products during retail slicing, preparation, or packaging operations.
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\8\ U.S. Department of Agriculture, Food Safety and Inspection
Service and Food and Drug Administration, Center for Food Safety and
Applied Nutrition (2012). Interagency Retail Listeria monocytogenes
Risk Assessment. Washington, DC.
\9\ Endrikat S, Gallagher D, Pouillot R, et al. A comparative
risk assessment for Listeria monocytogenes in prepackaged versus
retail-sliced deli meat. J Food Prot 2010;73:612-9.
\10\ Pradhan AK, Ivanek R, Gr[ouml]hn YT, et al. Quantitative
risk assessment of listeriosis-associated deaths due to Listeria
monocytogenes contamination of deli meats originating from
manufacture and retail. J Food Prot 2010;73:620-30.
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According to the most recent CDC analysis, there are about 1,591
(with a range of 557 to 3,161) domestically-acquired foodborne
illnesses caused by L. monocytogenes annually. The average annual
number of hospitalization, is 1,455 (with a range of 521 to 3,018), and
the average number of deaths is 255 (with a range of 0 to 733).\11\
Using this information and an ERS (Economic Research Services) model,
the Agency has recently updated the cost of illnesses of L.
monocytogenes to be $1.3 million per case in 2010 dollars. This
estimate represents a lower bound for an average cost of L.
monocytogenes because it only includes medical costs
[[Page 58807]]
and loss-of-productivity costs. It does not include pain and suffering
costs.
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\11\ Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M,
Roy SL, Jones JL, and Griffin PM. 2011. Foodborne illness acquired
in the United States--major pathogens. Emerg Infect Dis, 17(1):7-11.
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The Agency's analysis suggests that the new sampling will reduce
the number of illnesses by an average of 90 cases per year (with a
range of 3 to 134).\12\ This number does not include the reduced
illnesses from reduced cross-contamination at retail, so the number
could be higher. Multiplying the average number of reduced illnesses by
the average cost per case results in reduced illness benefits of about
$117 million annually.
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\12\ Analysis results are from the Risk Assessment Division,
OPHS.
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The Agency also expects that with the increased sampling, the
establishments will strengthen their own L. monocytogenes control
measures, which will further reduce the number of illnesses. However,
FSIS cannot quantify this impact with any precision.
Net Benefits
As explained in the Expected Costs and Expected Benefits Sections,
there are uncertainties in the Agency's cost and benefit estimates.
Consequently, it is very difficult to arrive at a concrete estimate of
net benefits. The biggest uncertainty is that FSIS cannot accurately
predict the amount of adulterated product that will be detected as a
result of increasing the sampling numbers. The Agency can only estimate
the amount with some strong assumptions. The Agency believes that it
can have a reasonable net benefit estimate by adding the estimated
benefits from reduced illnesses ($117 million), then subtracting the
cost to the industry ($58.6 million). The result is a net benefit of
about $58.33 million annually.
The changes in FSIS's sampling procedures do not impose a testing
requirement on official establishments. Therefore, these changes will
not have a negative effect on small or very small establishments.\13\
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\13\ Based on FSIS's HACCP (Hazard Analysis and Critical Control
Points) size definition: Very small establishments have fewer than
10 employees or generate less than $2.5 million in annual sales; and
small establishments have 10 or more but fewer than 500 employees
and generate more than $2.5 million in annual sales.
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USDA Nondiscrimination Statement
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.)
Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape,
etc.) should contact USDA's Target Center at 202-720-2600 (voice and
TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY).
USDA is an equal opportunity provider and employer.
Additional Public Notification
FSIS will announce this notice on-line through the FSIS Web page
located at https://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to constituents and
stakeholders. The Update is communicated via Listserv, a free
electronic mail subscription service for industry, trade groups,
consumer interest groups, health professionals and other individuals
who have asked to be included. The Update is available on the FSIS Web
page. Through the Listserv and the Web page, FSIS is able to provide
information to a much broader and more diverse audience.
In addition, FSIS offers an email subscription service which
provides automatic and customized access to selected food safety news
and information. This service is available at https://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range from recalls to
export information to regulations, directives and notices. Customers
can add or delete subscriptions themselves, and have the option to
password protect their accounts.
Done in Washington, DC, on: September 18, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-23462 Filed 9-21-12; 8:45 am]
BILLING CODE P
