[Federal Register Volume 77, Number 185 (Monday, September 24, 2012)]
[Pages 58804-58807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23462]



Food Safety and Inspection Service

[Docket No. FSIS-2012-0032]

Testing of Product Samples for Listeria monocytogenes: Changes in 

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.


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) 

[[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.

    \1\ Please also see footnote 5 and 6 below.


[[Page 58806]]

Cost-Benefit Analysis for Increasing the Sample Numbers of RLm Product 
Samples (RLMPROD) and IVT Product Samples (INTPROD) and Compositing 

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.

    \2\ 2009-2010 average. Data from Data Analysis and Integration 
Group/Office of Data Integration and Food Protection (DAIG/ODIFP).

                                                     Samples   number of
                 Sampling program                    per unit    sample
RLMPROD (current).................................          3       1882
RLMPRODC (proposed composites)....................          5      * 630
INTPROD (current).................................          3        432
INTPROD (proposed)................................          5        720
* 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\

    \3\ Data from the Laboratory Director, Office of Public Health 
Science (OPHS), FSIS.

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.

    \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.

    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.

    \7\ Information from Office of Public Health Science, FSIS.

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.

    \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.

    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 

    \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.

    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.

    \12\ Analysis results are from the Risk Assessment Division, 

    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\

    \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.

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 
    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,
[FR Doc. 2012-23462 Filed 9-21-12; 8:45 am]