[Federal Register Volume 77, Number 185 (Monday, September 24, 2012)]
[Notices]
[Pages 58804-58807]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2012-23462]
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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
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 http://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 http://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) (http://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 http://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 http://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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