[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Rules and Regulations]
[Pages 35178-35188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13507]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 430

[Docket No. FSIS-2014-0033]
RIN 0583-AD53


Control of Listeria monocytogenes in Ready-to-Eat Meat and 
Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Affirmation of the interim final rule with amendments; request 
for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is affirming, 
with changes and a request for comment, the interim final rule 
``Control of Listeria monocytogenes in Ready-to-Eat Meat and Poultry 
Products,'' which was published in the Federal Register on June 6, 
2003. FSIS is making minor changes to the regulatory provisions in 
response to comments that the Agency received, on the basis of 
experience in implementing the provisions, and because the way FSIS 
obtains establishment profile information electronically has changed. 
FSIS is clarifying in the regulations that establishments may not 
release into commerce product that has been in contact with Listeria 
monocytogenes (Lm)-contaminated surfaces without reprocessing the 
product. In addition, FSIS is removing the requirement for 
establishments to report production volume and related information to 
FSIS because the Agency now routinely collects this information through 
its Public Health Information System (PHIS).

DATES: Effective September 17, 2015. Comments must be received on or 
before August 18, 2015.

ADDRESSES: FSIS invites interested persons to submit comments on the 
changes. Comments may be submitted by one 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, Patriots 
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A, 
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-2014-0033. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel L. Engeljohn, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On February 27, 2001, FSIS proposed (66 FR 12589) to establish 
several new requirements for the processing of ready-to-eat (RTE) and 
other meat and poultry products. The Agency proposed food safety 
performance standards for all RTE and all partially heat-treated meat 
and poultry products. FSIS also proposed to eliminate its regulations 
that require both RTE and not-ready-to eat pork and products containing 
pork to be treated to destroy trichina (Trichinella spiralis).
    Finally, FSIS proposed environmental testing requirements for 
establishments to verify whether their processes were addressing Lm in 
RTE meat and poultry products. Specifically, FSIS proposed to require 
establishments that produce RTE meat and poultry products to test food 
contact surfaces for Listeria species to verify that the establishments 
are controlling the presence of Lm within their processing 
environments. Under the proposal, establishments that developed and 
implemented Hazard Analysis and Critical Control Point (HACCP) controls 
for Lm would have been exempt from these testing requirements.

Interim Final Rule

    On June 6, 2003, FSIS published the interim final rule ``Control of 
Listeria monocytogenes in Ready-to-Eat Meat and Poultry Products'' (68 
FR 34208). In the interim final rule, FSIS amended its regulations only 
in regard to the control of Lm in RTE products. The Agency decided to 
adopt these regulations before completing action on the other

[[Page 35179]]

provisions of the proposed rule because of outbreaks of foodborne 
listeriosis, and because of recalls of meat and poultry products 
adulterated by Lm. FSIS plans to address the other proposed provisions 
in future Federal Register publications.
    The interim final regulations remain in effect. Under these 
regulations, an establishment that manufactures post-lethality-exposed 
RTE meat or poultry products must control Lm in the processing 
environment through its HACCP plan or prevent contamination of products 
by the pathogen through sanitation standard operating procedures 
(Sanitation SOPs) or other prerequisite program. The regulations (9 CFR 
430.4(b)(1)-(3)) identify three alternative means of controlling Lm: 
Alternative 1--use of a post-lethality treatment (e.g., steam 
pasteurization, hot water pasteurization, radiant heating, high 
pressure processing (HPP), ultraviolet treatment, infrared treatment, 
or drying) that reduces or eliminates populations of the organism and 
use of an antimicrobial agent (e.g., potassium lactate or sodium 
diacetate) or process (e.g., freezing) that suppresses or limits growth 
of the organism; Alternative 2--use of either a post-lethality 
treatment that reduces or eliminates Lm or an antimicrobial agent 
(Alternative 2a) or process that suppresses or limits growth of the 
organism (Alternative 2b); Alternative 3--use of only sanitation to 
control the organism. The regulations require an establishment that 
uses a post-lethality treatment for controlling Lm to validate the 
treatment's effectiveness and incorporate it in its HACCP plan. Under 
the regulations (9 CFR 430.4(b)(1)-(3)), an establishment that uses an 
antimicrobial agent (Alternative 2a) or process that suppresses or 
limits growth of Lm (Alternative 2b), or that uses only a sanitation 
program (Alternative 3) for controlling the pathogen must include food-
contact surface testing in its sanitation program.
    Under the regulations, an establishment that produces hotdog or 
deli-meat products considered to be at high risk for Lm contamination 
and that uses only sanitation to control the pathogen must, after two 
tests of food-contact surfaces that are positive for Lm or an indicator 
organism under the conditions described in the regulation, withhold 
affected product from commerce until the food-contact surface 
contamination problem is corrected. The establishment may release the 
held product only after statistically valid sampling shows the product 
not to be adulterated with Lm, or after the product has been reworked 
using a process that destroys Lm (9 CFR 430.4 (b)(3)(ii)).
    The regulations include requirements for proper documentation of an 
establishment's Listeria controls, the verification of those controls, 
and the availability of the documentation to FSIS personnel. In 
addition, the regulations require an establishment that produces post-
lethality-exposed RTE products to provide FSIS, at least annually, with 
estimates of annual production volume and related information on the 
types of products it processes under each of the Lm control 
alternatives (9 CFR 430.4(d)).
    FSIS decided to establish the regulatory requirements for 
preventing Lm contamination of RTE meat and poultry products based on 
two studies on the public health risk posed by the pathogen in RTE food 
products. The first study, an FSIS-Food and Drug Administration (FDA) 
risk ranking of RTE food products, placed hotdog and deli-meat products 
among products that pose the highest risk in terms of listeriosis cases 
per annum.\1\ The second study, a quantitative risk assessment by FSIS 
of Lm in deli meats, identified combinations of in-plant control 
measures that showed the greatest potential for reducing the public 
health risks posed by Lm.\2\ The second study enabled FSIS to determine 
that the first Lm control alternative identified in the interim final 
rule--post-lethality treatment plus growth limitation or suppression--
provided the greatest risk reduction potential, while the third 
alternative--sanitation only--provided the least.
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    \1\ FDA/Center for Food Safety and Applied Nutrition; USDA/FSIS. 
September 2003. Quantitative Assessment of the Relative Risk to 
Public Health from Foodborne Listeria Monocytogenes among Selected 
Categories of Ready-to-Eat Foods. Washington, DC. http://www.fda.gov/downloads/Food/FoodScienceResearch/UCM197329.pdf.
    \2\ USDA/FSIS. May 2003. FSIS Risk Assessment for Listeria 
monocytogenes in Deli Meats. Washington, DC. http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/97-013F/ListeriaReport.pdf.
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    In the regulations, FSIS advised establishments that it would 
conduct more testing at establishments if their Lm control measures 
provide less potential risk reduction than other available control 
measures. Thus, the regulations provide that FSIS will conduct more 
testing at an establishment that chooses alternative 2 and uses a post-
lethality treatment of product than if it had chosen Alternative 1. 
Similarly, FSIS will conduct more testing at an establishment that 
chooses alternative 2 and uses an antimicrobial agent or process that 
suppresses or limits the growth of Lm than at an establishment that 
uses a post-lethality treatment (9 CFR 430.4(b)(2)(iv)). FSIS conducts 
more testing at an establishment that chooses Alternative 3 than at an 
establishment that has chosen Alternative 1 or 2 (9 CFR 
430.4(b)(3)(iii)).
    Finally, the regulations allow establishments that use post-
lethality treatments or antimicrobial agents or processes that are 
effective in destroying Lm or in limiting its growth to declare this 
fact on the labels of their products (9 CFR 430.4(e)). The purpose of 
the voluntary labeling is to inform consumers about measures that have 
been taken to ensure the safety of the products and thus to enable the 
consumers to select such products in preference to others.
    On October 6, 2003, the Agency supplemented the interim final rule 
with the ``FSIS Compliance Guideline: Controlling Listeria 
monocytogenes in Post-lethality Exposed Ready-to-Eat Meat and Poultry 
Products'' (the Compliance Guideline). The Agency also conducted a 
series of workshops on the interim final rule at several locations 
around the country during the pre-implementation period before October 
6, 2003, when the interim final rule became effective. On January 10, 
2014, FSIS made available an updated version of the Compliance 
Guideline is available on FSIS's Web site at http://www.fsis.usda.gov/wps/wcm/connect/d3373299-50e6-47d6-a577-e74a1e549fde/Controlling-Lm-RTE-Guideline.pdf?MOD=AJPERES.
    Based on available data, FSIS is confident that it is successfully 
carrying out its mission to protect public health by enforcing 
safeguards designed to control Lm. In the 10 years since FSIS issued 
the interim final rule described above, the percent positive in FSIS 
testing for Lm in RTE products has decreased from 0.76 percent in CY 
2003 to 0.34 percent in CY 2013. The Agency considers the RTE 
regulatory results to be an excellent indicator of the trends in 
pathogen presence in RTE products over several years. This downward 
trend shows that the interim final rule has been effective in 
controlling Lm in RTE meat and poultry products. Therefore, FSIS is 
affirming the interim rule as final with only the minor changes 
discussed below.

Opportunities To Comment

    Because some of the approaches to Lm control addressed in the 
interim final rule were novel, FSIS provided an 18-month comment period 
(69 FR 70051; December 2, 2004). FSIS also assembled a team of Agency 
experts to make a

[[Page 35180]]

preliminary assessment of the interim final rule. FSIS announced in the 
Federal Register (69 FR 70051; December 2, 2004) that the report 
``Assessing the Effectiveness of the Listeria Monocytogenes Interim 
Final Rule'' was available in the Agency's Docket Room and on line at 
http://www.fsis.usda.gov/wps/wcm/connect/4174b07e-8b39-4617-acdf-adc38a249cd7/LM_Assessment_Report_2004.pdf?MOD=AJPERES.
    In addition, FSIS asked the National Advisory Committee on Meat and 
Poultry Inspection (NACMPI) to review the interim final rule and the 
assessment team's report and to make its own recommendations (69 FR 
29124). NACMPI made recommendations on the assessment at its June 2-3, 
2004, meeting. The Agency responded to the recommendations at the 
NACMPI meeting held on November 16-17, 2004 (69 FR 64902). NACMPI 
recommended that the assessment team focus on the differences among 
small, very small, and large plants and assess the economic impact on 
very small and large plants. NACMPI also recommended that FSIS conduct 
focus groups to determine whether consumers are confused by the 
provisions for labeling statements explaining that product has 
undergone post-lethality treatments or has been treated with an 
antimicrobial. Finally, NACMPI recommended that FSIS determine whether 
the assumptions on product risk made in the FDA/USDA Quantitative Risk 
Assessment are accurate.
    FSIS agreed to consider variables such as product types and the 
frequency of production, which reflect differences among small, very 
small, and large plants. The Agency also agreed to review whether the 
rule has caused firms, particularly small firms, to go out of business. 
FSIS also continued to assess the effects of the informational labeling 
statements allowed under the rule. However, FSIS stated that the 
informational labeling provision should remain in the final version of 
the Lm rule as an encouragement to industry to declare that products 
have undergone post-lethality treatments or have been treated with 
anti-microbial agents or processes to destroy Lm. FSIS agreed to assess 
the three alternatives in the rule and evaluate their effectiveness for 
risk mitigation.
    NACMPI's recommendations and FSIS's responses can be viewed at 
http://www.fsis.usda.gov/wps/wcm/connect/d8be3905-5f3c-458d-a5e7-f5149457b20e/LM_Assessment_Response.pdf?MOD=AJPERES.
    Finally, FSIS received comments on the impact of the interim final 
rule on small businesses from the Office of Management and Budget (OMB) 
in response to OMB's 2004 Draft Report to Congress on the Costs and 
Benefits of Federal Regulation (69 FR 7987; February 20, 2004). The 
commenters stated that FSIS underestimated the costs and overestimated 
the benefits of the interim final rule. The commenters stated that the 
rule should be rescinded or amended to replace the regulatory 
requirements for small and very small processors with a pre-HACCP 
regulatory environment. In response, FSIS stated that the Agency would 
consider all comments and respond to them in a final rule.
    A summary of the comments and FSIS's response is reflected in the 
March 2005 OMB report ``Regulatory Reform in the U.S. Manufacturing 
Sector,'' which is available at http://www.whitehouse.gov/omb/inforeg_regpol_reports_congress.
    In developing this final rule, FSIS considered all comments 
received in response to the documents described above. Based on 
information provided by comments, FSIS's experience enforcing the 
interim final regulations, and analysis of available data, FSIS has 
decided to affirm the provisions in the interim final rule with two 
minor changes. The minor changes are explained below and are discussed 
in more detail in the Agency's responses to comments.

Summary of Amendments to the Interim Final Rule

    FSIS is clarifying that product that has tested positive for Lm or 
that has been in contact with an equipment surface that has tested 
positive for Lm is adulterated and may not be released into commerce. 
FSIS is also making explicit in 9 CFR 430.4(a), however, that the 
product may be reprocessed using a method that destroys Lm.
    9 CFR 430.4(a) clearly states that ``RTE product is adulterated if 
it contains L. monocytogenes or if it comes into direct contact with a 
food contact surface which is contaminated with L. monocytogenes.'' 
However, the wording of paragraphs 9 CFR 430.4(b)(2)(iii)(B), 
(b)(3)(i)(B), and (b)(3)(ii)(B) and (C) has led some establishments to 
question whether they may perform further confirmation testing after a 
finding of Lm in RTE product and then release the product into 
commerce. Therefore, FSIS removed from paragraphs 9 CFR 
430.4(b)(2)(iii)(B), (b)(3)(i)(B), and (b)(3)(ii)(B) provisions 
concerning additional establishment testing in response to Lm results. 
As revised, the regulations will refer only to additional establishment 
testing in response to positive indicator organism results. In addition 
in paragraph 9 CFR 430.4(b)(3)(ii)(C), FSIS has removed provisions that 
may suggest that establishments may ``be able to release into commerce 
the lots of product that may have become contaminated with L. 
monocotogenes'' because, as is stated in 9 CFR 430.4(a), such product 
is adulterated and cannot be released into commerce.
    FSIS is also removing the requirement that establishments report 
production volume and related information to FSIS because the Agency 
now collects this information through PHIS.
    In accordance with section 553 of the Administrative Procedure Act 
(5 U.S.C. 553), the Agency finds good cause for making these changes 
effective September 17, 2015. This rule provides minor conforming 
amendments to FSIS's regulations and imposes no new or substantive 
requirements on the public. For these reasons, FSIS has determined that 
notice and opportunity for public comment on these changes are 
unnecessary. However, FSIS is providing the public with an opportunity 
to comment on these minor, conforming changes.

Comments and Responses

    FSIS received comments from five trade associations that represent 
meat and poultry processors, two consumer organizations, an association 
that represents small businesses, an association that represents 
manufacturers, an organization that represents scientists, a very small 
establishment, and an individual consumer on the interim final and on 
the other opportunities for comment described above. Following are 
FSIS's responses to the issues that they raised.

Applicability of Rule; Exemption of Certain Products

    Comment: Several commenters stated that certain classes of products 
should be exempt from the rule. For example, these commenters stated 
that products that are exposed to the environment but that receive a 
validated, post-packaging lethality, such as products that are cooked, 
repackaged, and then irradiated, thermally processed, or high-pressure 
processed in their final package, should be exempt from the 
requirements in the rule. These commenters stated that the fact that 
there was product exposure to the post-lethality processing environment 
during the repackaging operation that followed the initial cook should 
not subject such a product to the Lm control rule. In addition, the

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commenters stated that, products that remain at a temperature lethal to 
Lm until the products are filled into the final packaging should be 
exempt.
    Response: An establishment that produces post-lethality exposed RTE 
products is appropriately required to control Lm through HACCP or a 
sanitation program because an RTE product that is not free of 
pathogens, including Lm, can easily cause illness because it will not 
be subject to a lethality step before consumption. Therefore, FSIS is 
not exempting such post-lethality-treated products from the 
requirements in this rule.
    Post-lethality exposed product may be at risk of contamination and 
thus needs to be subject to the requirements in this rule. However, a 
product that is not post-lethality exposed (not removed from the 
container in which it is processed) is not subject to the requirements 
in this rule.
    Regarding HPP of RTE product, in most cases that FSIS is aware of, 
HPP is applied to an RTE product that was previously subject to a 
lethality treatment, such as cooking, and then was exposed to the 
environment before being packaged. Thus, HPP is considered a post-
lethality treatment that is subject to the Alternative 1 or Alternative 
2 requirements of 9 CFR 430.4.
    There may be cases in which a treatment is applied to a post-
lethality exposed RTE product in such a manner that the product could 
no longer be regarded as post-lethality exposed and thus would be 
exempt from the interim final rule. For example, if HPP is validated to 
achieve at least a 5-log reduction of Lm and other pathogens of concern 
(e.g., Escherichia coli O157:H7 and Salmonella) for cooked uncured meat 
patties or at least a 7-log reduction in cooked chicken strips, the 
process would be considered to achieve full lethality, and the product 
would not be considered to be post-lethality exposed (see 9 CFR 
318.23).
    FSIS has explained in its Compliance Guideline (http://www.fsis.usda.gov/wps/wcm/connect/d3373299-50e6-47d6-a577-e74a1e549fde/Controlling-Lm-RTE-Guideline.pdf?MOD=AJPERES) that it considers certain 
RTE products as not post-lethality exposed; that is, they are not 
exposed to the environment after the lethality treatment and before 
packaging. They include fully cooked ``cook-in-bag'' product that is 
shipped from the establishment in an intact cooking bag, thermally 
processed commercially sterile products, and products that receive a 
lethality treatment and are hot-filled at the lethality temperature.
    A product that has undergone a lethality treatment and is hot-
filled into packaging may be considered to be an RTE product that has 
not been post-lethality exposed if the temperature lethal to pathogens 
and the sanitary handling of the product are continuously maintained to 
the point where the product is packaged. In this situation, the 
establishment needs to have documentation on file showing that the 
lethality temperature and sanitary handling are maintained continuously 
from the point of lethality to the point of packaging.
    Comment: A few commenters objected to the assessment team's 
statement that Lm is reasonably likely to occur in the production of 
RTE meat and poultry products. The commenters argued that the 
assessment team ignored the value of post-lethality treatments.
    Response: In the assessment report, the assessment team was 
expressing a view that Lm is reasonably likely to occur in the absence 
of controls to eliminate or reduce it. Many in industry, Government, 
and academe share the view that Lm is ubiquitous in the RTE processing 
environment, and that a prudent establishment would maintain controls 
in its production process to prevent the contamination of its food 
products. Establishments use post-lethality treatments because the 
pathogen is reasonably likely to occur in the product in the absence of 
the treatment. For this reason, the regulations require that an 
establishment that uses a post-lethality treatment include the 
treatment in its HACCP plan or Sanitation SOP or other prerequisite 
program (9 CFR 430.4(b)(1)(i)).
    Comment: A few commenters suggested that the statements in the 
questions and answers accompanying FSIS Form 10,240-1 should be 
reflected in the final rule. According to one such statement on the 
questions and answers accompanying FSIS Form 10,240-1, products 
intended for further processing and labeled for further processing are 
not subject to the rule. According to another, products that otherwise 
would be considered RTE, but that are shipped to another establishment 
for use in a non-RTE product (e.g. frozen entr[eacute]e), should not be 
subject to the rule.
    Response: FSIS has addressed these issues in the Compliance 
Guideline. A product that is intended for further processing at another 
FSIS inspected establishment and that is labeled ``for further 
processing'' is not considered RTE and, therefore, is not covered by 
the rule. However, products that are commonly understood to be RTE, 
such as cooked sausages subject to the standard of identity in 9 CFR 
319.180, are commonly understood to be RTE and cannot be labeled for 
``further processing'' as a non-RTE product. In addition, a product 
that otherwise would be considered RTE, but that is shipped to another 
FSIS inspected establishment for use in a non-RTE product, is not 
considered RTE and therefore, is not covered by the rule.
    It should be noted that FSIS Form 10,240-1 was discontinued on 
September 30, 2011. As mentioned above, FSIS continues to collect the 
same information through PHIS.
    Comment: One commenter asked FSIS to explain the criteria for 
determining when antimicrobial processes also act as post-lethality 
treatments. In particular, the commenter wanted FSIS to explain why 
products with a water activity (aw) of less than 0.85 rather 
than of 0.92 or less will not support Lm growth.
    Response: FSIS has addressed this issue in the Compliance 
Guideline. Low water activity limits the amount of water available to 
pathogens such as Lm and will not allow them to grow. An aw 
less than or equal to 0.92 will not support the growth of Lm, and an 
aw of 0.85 or less (the aw for achieving shelf 
stability) can sometimes even reduce Lm numbers. FSIS will consider an 
aw of <=0.85 at the time the product is packed to be a post-
lethality treatment and to be an antimicrobial treatment if the 
establishment provides supporting documentation that Lm is reduced by 
at least 1-log before the product leaves the establishment, and that no 
more than 2-logs of growth of Lm occurs over the shelf life of the 
product.
    Comment: One commenter asked FSIS to clarify for establishments the 
distinction between RTE and not-RTE products. The commenter stated that 
documentation for making the determination is not available for a 
number of products.
    Response: In Attachment 1.2 of the Compliance Guideline, FSIS 
provides a chart that distinguishes three types of products, two not-
RTE and one RTE. One type of not-RTE product is a product that contains 
a meat or poultry product ingredient that has not received a full 
lethality treatment sufficient to destroy pathogens (e.g., raw 
products, partially cooked products, or products that are irradiated or 
HPP-treated and do not achieve at least a 5-log reduction of Lm and 
other pathogens of concern). This type of not-RTE product could also be 
a product that has received an adequate lethality for Salmonella but is 
not defined by a standard of identity or bear a common or usual name 
that consumers understand to refer to RTE product. The product also 
does not meet

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the definition of RTE in 9 CFR 430.1 (e.g., not-RTE ham). The other 
type of not-RTE product is a product that contains a meat or poultry 
component that has received a full lethality treatment for pathogens 
and that also contains non-meat or non-poultry components to which the 
intended user must apply a lethality treatment (e.g., a meal, dinner, 
or frozen entr[eacute]e). An RTE product, on the other hand, may be a 
heat-treated or not-heat-treated shelf-stable product, a fully cooked, 
not-shelf-stable product (e.g., hotdogs), or a not-shelf-stable product 
containing secondary inhibitors (e.g., RTE sausage). The chart in the 
Compliance Guideline lists HACCP process categories for each product 
type, the applicability of safe handling labeling, and significant 
matters that the HACCP plan should address for the product and process.

Listeria Control Alternative Requirements

    Comment: A few commenters recommended that the determination of 
which Lm control alternative is being used at a given establishment 
should take into account documented processes applied at the 
establishment to which its RTE product is shipped. For example, the 
commenters stated that if an Alternative-3 product is shipped to an 
establishment where it is subject to an Alternative 2-type of process, 
then FSIS should consider the product as an Alternative 2 product.
    Response: The Compliance Guideline discusses situations in which an 
establishment implementing one type of Lm control to prevent 
contamination of its post-lethality exposed product ships the product 
to another establishment that applies the same or another type of Lm 
control. The determination of which Lm control Alternative requirements 
apply to the product would depend on the extent of documentation and 
documentation-sharing by each establishment, as well as on the product 
distribution controls actually applied by the establishments. If an 
Alternative-3 product is shipped to an establishment where it is 
subject to an Alternative 2-type of process, and this process is 
properly documented in the first establishment's HACCP system, FSIS 
would consider the product as an Alternative 2-type of product.

Verification Sampling and Testing

    Comment: One commenter agreed with FSIS's recommendation that 
establishments hold all product tested by establishments until test 
results are known but urged FSIS to say more about when and how tests 
should be conducted (e.g., before or during production). The commenter 
stated that FSIS needs to provide specific details and flow diagrams, 
with examples. FSIS also should provide a hold-and-test scenario flow 
chart.
    Response: The Compliance Guideline includes recommendations on 
verification testing, methods to be used, recommended sampling plans, 
and a hold-and-test scenario flow chart. The Compliance Guideline also 
includes examples of verification sampling programs for the product 
classes that are subject to the interim final rule.
    Establishments are required to hold or maintain control of RTE 
products that FSIS has tested for Lm and other pathogens, and RTE 
products that have passed over food-contact surfaces that FSIS has 
tested for Lm and other pathogens. In addition, establishments in 
Alternative 3 (who only use sanitation controls) are required to hold 
product after a second consecutive food-contact surface positive for Lm 
or an indicator organism until the establishment corrects the problem 
indicated by the test result (9 CFR 430.4(b)(3)(ii)(B)).
    Establishments in Alternative 3 must sample and test the lots of 
product using a method that will provide a level of statistical 
confidence that the product is not adulterated (9 CFR 
430.4(b)(3)(ii)(C)). FSIS recommends that establishments use the 
International Commission on Microbiological Specifications for Foods 
(ICMSF) Tables. The ICMSF Tables provide examples of statistically-
based sampling plans that are commonly used for demonstrating lot 
acceptance. The ICMSF Tables are included in the Compliance Guideline. 
FSIS also recommends that establishments collect samples at least three 
hours after the start of operations, if possible, to allow Lm to work 
its way out to the surface of the equipment. If establishments 
typically produce RTE product for less than three hours, then the 
samples can be collected less than three hours after the start of 
operations.
    FSIS recommends that establishments in Alternatives 1 and 2a hold 
and test product after multiple contact surface positives for an 
indicator organism. The finding of three consecutive positive food 
contact surface samples increases the risk that the product is 
contaminated with Lm. If the establishment does not hold and test the 
product after the third positive, it should provide other support 
demonstrating that the product is not likely to be contaminated. The 
establishment should take preventative steps such as: increase its 
routine sampling for Lm; collect intensified samples to find sources of 
harborage and cross contamination; reassess its Sanitation SOPs to 
determine whether sanitation issues could be leading to positive 
results; assess the effectiveness of its post-lethality treatment or 
antimicrobial agents and processes; or reassess its HACCP plan to 
determine whether the actions it is taking are effective in controlling 
Lm.
    Comment: One commenter stated that FSIS verification sampling 
should be conducted after the use of Lm control techniques (such as 
Alternative 3 controls) that are more economically feasible than post-
lethality treatments and the use of growth inhibitors. The commenter 
stated that FSIS should conduct risk-based inspection and data 
collection on risk factors in the establishment and should use sound 
statistical techniques in environmental sampling. The commenter also 
stated that intensified verification testing (IVT) is a return to the 
command-and-control mode of inspection that FSIS should avoid. (An IVT 
is an FSIS sample collection activity that the Agency may conduct when, 
in either FSIS or establishment testing, a surface that comes into 
contact with post-lethality exposed RTE product tests positive for a 
pathogen of public health concern. IVTs are performed with a ``for 
cause'' Food Safety Assessment (FSA) to provide an in-depth evaluation 
of food safety systems at the establishment. The FSA may find the 
vulnerability or the noncompliance that led to the positive result.)
    Response: The regulations in 9 CFR part 430 state that products and 
the processing environment under Alternative 3 are likely to be subject 
to more frequent verification testing by FSIS than products and the 
processing environment under Alternative 1 or 2. In fact, Alternative 3 
products are sampled at a higher rate in the FSIS risk-based sampling 
code RTEPROD_RISK (9 CFR 430.4(b)(2)(iv) and (b)(3)(iii)).
    FSIS agrees that inspection should be risk-based. To that end, FSIS 
has developed risk-based verification sampling that focuses the 
Agency's testing on those products or environments in a process where a 
problem is most likely to occur. As of August 1, 2013, FSIS combined 
its random ALLRTE and risk-based RTE001 product sampling projects into 
a single project called RTEPROD. The RTEPROD sampling project uses two 
project codes: RTEPROD_RAND for product samples selected randomly, and 
RTEPROD_RISK for post-lethality-exposed product samples selected based 
on risk. Under the RTEPROD_RISK project code,

[[Page 35183]]

establishments are identified for sampling based on a risk-ranking 
algorithm, which takes into account the control alternative, the 
production volume, the type of product produced, and the 
establishment's sampling history.
    FSIS also uses the Routine Lm Risk-based (RLm) sampling project. 
While RTEPROD involves sampling and testing of the RTE meat and poultry 
products themselves, the RLm program includes sampling and testing of 
products, product contact surfaces, and environmental surfaces. Thus, 
RLm provides a means of identifying establishments that present a 
higher risk of Lm contamination in the food processing environment 
before product contamination actually occurs.
    A routine FSA is conducted at the establishment in conjunction with 
RLm sampling and testing. Under RLm, samples are scheduled using a FSA 
prioritization model, which takes into account levels of inspection, 
control alternative, and type of product produced. Starting in August 
2009, RLm sampling was increased so that establishments that produce 
post-lethality exposed RTE product are sampled at least once every four 
years under this project.
    FSIS also agrees that, to be successful, risk-based verification 
must be carried out on the basis of solid information. The IVT activity 
can be a valuable source of information for both the Agency and the 
inspected establishment when potentially serious problems are found in 
an establishment's food safety system. The results of an IVT can be 
used to help the Agency focus its inspection resources where they are 
most needed and can help the establishment plan improvements in its 
food safety system. In this regard, the IVT does not constitute a 
return to a command-and-control system of inspection in which FSIS told 
the establishment explicitly what it had to do to produce a safe 
product. Rather, the IVT provides the information on which an 
establishment may base its own decisions on the most effective control 
measures to take.
    Comment: While conceding that IVT may be appropriate in some 
circumstances, such as multiple Lm positives on product or food-contact 
surfaces, a few commenters strongly opposed the assessment team's 
recommendation that an IVT be performed for multiple contact or product 
positives for Listeria spp. or Listeria-like organisms. The commenters 
also urged the Agency not to penalize establishments for trying to 
actively detect and eliminate potential harborage areas but to verify 
that appropriate corrective actions have been taken. The commenters 
also questioned whether the Agency would have the resources necessary 
to conduct IVT each time an establishment surpasses arbitrary yearly 
limits, as recommended by the Agency's assessment team.
    Response: The FSIS assessment team addressed the actions that the 
Agency should take with regard to Lm-positive results from tests 
performed on official samples. It should be understood that every 
inspected establishment is required by regulation to operate under a 
HACCP plan and to take corrective actions whenever there is a deviation 
from critical limits for the CCPs identified in the plan. FSIS 
personnel are trained to take enforcement action only if there has been 
a violation of the regulations. If an establishment has found a 
deviation through its normal HACCP monitoring and verification 
activities and takes some corrective action based on its findings, the 
Agency has no regulatory grounds for taking enforcement action because 
of the deviation.
    However, if the Agency has verification testing results or other 
information that an establishment may have shipped adulterated product, 
an IVT is one of a number of appropriate actions, including an 
enforcement action, that the Agency may take in the interest of 
protecting the public health. Repeated findings of Listeria spp. or Lm 
on food-contact surfaces or on product may lead to an enforcement 
action if FSIS determines that the establishment is not properly 
addressing insanitary conditions.
    Comment: One commenter stated that the FSIS sampling program should 
be modified to provide baseline surveillance information to permit 
progress to be gauged. The comment said that verification sampling 
should target the riskiest products, and that there should be a 
properly designed and conducted annual survey of RTE establishments.
    On the results that were available in 2004, when the FSIS 
assessment team prepared its report, the commenter questioned why FSIS 
had found no difference among the prevalence levels of Lm in randomly 
sampled RTE foods (3 of 345 or 0.9%) and in RTE foods for which 
sampling was targeted (11 of 1,349 or 0.8%). (The results are presented 
in the ``Agency Accomplishments'' section of the assessment team's 
report.) The commenter recommended the reevaluation of establishment 
HACCP plans and Sanitation SOPs and other prerequisite programs in the 
event of an FSIS positive Lm sample in a product that supports the 
growth of the organism. The commenter said that uniform criteria for 
such reevaluation should be developed.
    Response: FSIS's verification sampling and testing program for Lm 
is designed to focus Agency resources on those products and processes 
that may pose higher risks of adulteration.
    Regarding the apparent similarity in Lm prevalence among RTE 
products that were sampled randomly and RTE products that were sampled 
according to risk, the Agency found that, when both ALLRTE and RTE001 
samples were scheduled in one month, often only the RTE001 products 
were collected. In addition, FSIS found that the highest-risk products 
produced by the establishment were often collected for the ALLRTE 
project, rather than products collected at random. FSIS determined that 
combining the ALLRTE and RTE001 sampling projects into the new RTEPROD 
project would reduce redundancy in sample scheduling and make the 
sample selection process more efficient. Under RTEPROD, the sampling 
project codes specify more clearly whether FSIS personnel should select 
samples randomly (RTEPROD_RAND) or based on risk (RTEPROD_RISK). In 
addition, FSIS personnel receive either a RTEPROD_RAND or a 
RTEPROD_RISK sampling request at most once per month per establishment 
(see FSIS Directive 10340.4, Verification Activities for the Listeria 
monocytogenes Regulations and the Ready-to-Eat (RTE) Sampling Program). 
FSIS personnel are not requested to collect both RTEPROD_RAND and 
RTEPROD_RISK samples in one month to avoid overlap and to increase 
sampling efficiency.
    Regarding the suggestion that establishment HACCP plans and 
prerequisite programs be reevaluated in the event of an Lm-positive 
product test, such a reevaluation may be necessary depending on the 
circumstances of the positive test. If an establishment made such a 
finding in the course of testing that was part of its HACCP 
verification procedures, the establishment would follow the corrective 
actions procedures in its HACCP plan. If the establishment determined 
that a change affecting the validity of the hazard analysis had 
occurred, the establishment would reassess its HACCP plan. On the other 
hand, an Lm-positive test on an official FSIS RTE product sample might 
indicate that the establishment's HACCP system had failed to prevent 
the production of adulterated food. In that case, under the HACCP 
regulations, FSIS would have grounds for finding the establishment's 
HACCP system to be

[[Page 35184]]

inadequate. In addition, if the establishment failed to take 
appropriate corrective action, as required by 9 CFR 417.3, FSIS would 
have further grounds for finding the establishment's HACCP system to be 
inadequate.
    In the Compliance Guideline, FSIS has listed and explained the 
elements of adequate validation for post-lethality treatments and 
growth-suppressing or limiting formulations or processes.
    Comment: One commenter noted that the rule did not have a uniform 
recordkeeping requirement for the results of environmental sampling. 
Sanitation SOP records are required to be kept for only six months, 
HACCP records from one to two years. The commenter requested that FSIS 
explain that an effective environmental sampling program must provide 
for long-term trend analysis.
    Response: Records that are generated under the Lm control 
regulations may be Sanitation SOP records, HACCP records, or other 
prerequisite program documentation and records. As the commenter points 
out, retention requirements apply to Sanitation SOP records and HACCP 
records. Prerequisite program documentation and records of activities 
conducted under the Lm control regulations affect hazard analysis 
decisions and are required to be maintained for at least two years 
under 9 CFR 417.5 because they are documents used to inform decisions 
in the establishment's hazard analysis.
    FSIS agrees that it is important that an establishment analyze 
trends in product, food-contact surface, and environmental test 
results. In the Compliance Guideline, FSIS advises establishments to 
keep monitoring records, including test results, for use in evaluating 
their Sanitation SOPs. The monitoring records should be designed to 
show trends in the development of insanitary conditions. Establishments 
should review at least the previous month's testing results to 
determine whether a trend is emerging, or whether it is necessary to 
revise their sampling plans. Persistent problems may indicate the 
pathogen's presence in niches in the processing environment. FSIS also 
advises establishments to adjust their testing frequencies on the basis 
of data that they have collected over time. FSIS is not, however, 
proposing to change its record retention requirements because the 
Agency believes that the requirements are adequate.
    Comment: One commenter stated that while the interim final rule 
required establishments to verify the effectiveness of their Listeria 
control program through testing, they have no obligation to conduct 
such testing at any particular frequency, even if they produce high-
risk products such as deli meats and hot dogs. The commenter argued 
that, without mandatory minimum testing frequencies, establishments 
simply cannot be assured that their controls are working effectively 
every day to control Listeria.
    Response: After reviewing comments on the 2001 proposed rule (66 FR 
12589) and the results of the FDA/FSIS risk ranking and the FSIS risk 
assessment, FSIS concluded that a mandatory testing frequency was not 
well-founded. The FDA/FSIS risk ranking and FSIS risk assessment showed 
that post-lethality interventions and formulation of RTE meat and 
poultry products with growth inhibitors was much more effective in 
preventing listeriosis than testing product or food contact surfaces. 
Therefore, FSIS is not making changes to the regulations to require a 
minimum testing frequency for establishments.
    Nevertheless, the Agency regards establishment verification testing 
of the processing environment and especially of food-contact surfaces 
to be important in monitoring the sanitary conditions under which post-
lethality exposed RTE products are processed. Establishments that 
produce RTE products and that rely on sanitation procedures alone to 
control Lm (Alternative 3) should carry out effective verification 
procedures, including food-contact surface testing, to ensure that 
their controls are effective, and that the products are not 
contaminated. Such is the Agency's regard for the value of food-contact 
surface testing that the Agency has incorporated food-contact surface 
testing into its RLm sampling program that it is carrying out in RTE 
establishments.
    Comment: One commenter stated that, even though the rule required 
establishments to make their own testing results available to FSIS 
inspection personnel upon request, nothing in the interim final rule 
imposed on establishments an affirmative obligation to disclose test 
results, particularly positive results, to FSIS at the time the results 
are obtained. The commenter argued that, without immediate access to 
these data when a problem is first identified, inspection personnel may 
be unaware that there is a sanitation problem at a facility, that 
interventions are not working properly, or that those problems may be 
persistent and uncorrected.
    Response: As the comment acknowledges, when FSIS personnel request 
testing records, the establishment is required to make them available 
(9 CFR 430.4(e)) so that FSIS personnel can complete the required 
verifications. From the verification results FSIS can know whether 
there is a sanitation problem at the establishment, whether 
antimicrobial interventions are working properly, whether a corrective 
action was appropriately taken to address a non-recurring problem, or 
whether there is mounting evidence of a persistent problem that must be 
corrected.
    Changing the regulations to require immediate notification of FSIS 
when a positive test is obtained would not affect what either the 
establishment or FSIS is required to do with respect to product safety 
in response to the positive test result. Therefore, FSIS is not 
proposing to change the regulations in this respect.

Compliance Guidance

    Comment: A few commenters stated that the Agency should 
periodically update the Compliance Guideline. Also, commenters stated 
that the Agency should make available to the industry guidance on 
acceptable procedures for evaluating the effectiveness of new post-
lethality treatments and antimicrobial agents or processes.
    Response: FSIS has updated the Compliance Guideline four times 
since the interim final rule published. The first update in October 
2004 responded to comments and questions that FSIS received about the 
rule and addressed questions that participants asked during the 
workshops that the Agency held in preparation for the implementation of 
the interim final rule. The second update in May 2006 included new 
information on FSIS's risk-based sampling algorithm and acceptable 
procedures for evaluating the effectiveness of new post-lethality 
treatments and antimicrobial agents or processes. The third update in 
September 2012 provided updated technical information on the control 
alternatives and on how establishments could take corrective actions in 
response to positive results and new information on developing a 
listeria control program. The fourth update in January 2014 responded 
to comments and questions that FSIS received in response to the 
previous version. FSIS will continue to update the Compliance Guideline 
as necessary.

Labeling; Consumer Education

    Comment: One commenter stated that the labeling claims about 
treatments that eliminate, suppress, or limit the growth of Lm could be 
misleading. The commenter argued that allowing companies to provide 
information about

[[Page 35185]]

technologies, without also including safe handling instructions, may 
create further potential to mislead consumers, including susceptible 
groups, into a false sense of safety and lead to improper handling.
    Response: Safe handling instructions are required if the meat or 
poultry component of a product is raw or partially cooked (i.e., not 
considered RTE), and if the product is destined for household consumers 
or institutional users (9 CFR 317.2(1) or 381.125(b)). All food 
products, including shelf-stable RTE products, must be handled with 
appropriate care to prevent product adulteration. Findings of a survey 
conducted by the International Food Information Council (IFIC), which 
is described in more detail in the response to the next comment, do 
indicate that label statements about processing for improved product 
safety may cause some consumers to feel safe about eating product after 
a ``use-by'' date. This could be a concern if the ``use-by'' date were 
a safety-based date.
    FSIS believes, nevertheless, that the processed-for-safety 
statements can be made if they are adequately supported. Also, as the 
Agency's own assessment team has recommended, the Agency should give 
industry flexibility to develop labeling statements that are truthful 
and not misleading. FSIS will review and approve labels that bear such 
statements before they are used, as it approves all labels that make 
special claims. The Agency also will ensure that its food safety 
education materials for consumers include information about the labels 
and about Lm.
    Comment: IFIC submitted the results of a study that it conducted in 
collaboration with FSIS. In the study, IFIC tested several different 
informational statements to determine the impact such labeling has on 
consumer perceptions of food safety. The IFIC survey found that, while 
food-safety information can assist consumers in the purchase, 
preparation, and handling of foods, the food-safety labeling messages 
that were tested may not achieve this goal. None of the statements 
tested performed better than control product labeling. Only a very 
small segment of the population of consumers in the study felt that 
enhanced food safety was an important reason to purchase a product. 
Most statements did not enhance consumer perceptions of food safety, 
although the statements were likely to make consumers feel safe eating 
product after the ``use by'' date. Also, the results appeared to 
indicate that use of labels with certain food safety information may 
actually drive some consumers away from the product category.
    Response: FSIS understands the challenge of providing consumers 
with useful and important food safety information on product labels. 
That is why the Agency is not requiring labeling statements about Lm 
controls but only permitting and encouraging their use.

Retail

    Comment: A few commenters stated that FSIS should conduct research 
to determine the magnitude of retail-level contamination. A few 
commenters agreed with the assessment team finding that efforts to 
control Lm contamination at retail are warranted. The commenters stated 
that, in addition to training, there must be measurement, monitoring, 
and enforcement of best practices at retail. The commenters agreed with 
the assessment team's finding that regulatory strategies aimed at FSIS-
inspected establishments may not be effective in reducing retail-level 
contamination. Another commenter strongly agreed with the assessment 
team's recommendation to educate and train retail and food service 
personnel but noted that this matter is usually outside USDA/FSIS 
jurisdiction.
    One commenter stated that additional training for retail staff is 
appropriate for reducing Lm contamination of RTE products at that 
level. The commenter also recommended the use of antimicrobial agents 
in products sold at retail. The commenter recommended that FSIS 
investigate the practicality of freezing or other practices during 
transport of RTE products. In addition, the commenter stated that the 
FSIS Lm control strategy should focus on preventing cross-contamination 
at the deli counter.
    Response: State and local governments have chief responsibility for 
the administration of inspections and regulation of retail facilities 
on a regular basis. Although FSIS does not inspect retail 
establishments, it may visit them to ensure that the meat, poultry, and 
egg products that they sell remain safe for human consumption and are 
not adulterated or misbranded.
    FSIS provides information, materials, and assistance to help State 
and local agencies to achieve food safety goals and conducts outreach 
programs that are aimed at retail and food service personnel. FSIS also 
participates with FDA in the development of the Food Code model 
ordinance. The Food Code sets forth model standards that State and 
local public health authorities may adopt in their own regulatory 
programs for the retail sector.
    To help minimize the public health burden of listeriosis, FSIS and 
the FDA conducted an interagency risk assessment to better understand 
the risk of foodborne illness associated with eating certain RTE foods 
prepared in retail delis and developed recommendations for changes in 
current practices that may improve the safety of those products. In 
2013, FSIS and FDA made their findings available to the public in the 
``Interagency Risk Assessment--Listeria monocytogenes in Retail 
Delicatessens'' (Interagency Retail Lm Risk Assessment), which is 
available on FSIS's Web site at http://www.fsis.usda.gov/wps/portal/fsis/topics/science/risk-assessments.
    The agencies conducted the risk assessment to better understand how 
retail practices (e.g., temperature control, sanitation, worker 
behavior) influence the risk of listeriosis associated with eating 
meat, cheeses, and salads sliced or prepared in retail delicatessens. 
The risk assessment also examines how effective various interventions 
are in limiting the survival, growth, or cross contamination of Lm.
    The risk assessment is based on observations of deli employees' 
work routines; concentrations of Lm on incoming products and in the 
deli environment; studies on the ability of Lm to spread in retail 
delis, such as from a slicer to food; and an existing dose-response 
model. The study was designed to apply to a range of deli 
establishments, from small independent operations to the deli 
departments in large supermarkets.
    FSIS agrees that care should be taken in storage, handling, and 
distribution of RTE meat and poultry products, and that strict 
temperature controls are important in preventing the outgrowth of any 
Lm that may be present in products. Using the key findings of the 
Interagency Retail Lm Risk Assessment along with available scientific 
knowledge, the FDA Food Code, and lessons learned from controlling Lm 
in FSIS-inspected meat and poultry processing establishments, FSIS 
developed the ``FSIS Best Practices Guidance for Controlling Listeria 
monocytogenes (Lm) in Retail Delicatessens,'' which provides practical 
recommendations that retailers can use to control Lm contamination and 
outgrowth in the deli. The best-practices guidance is available at 
http://www.fsis.usda.gov/wps/wcm/connect/29d51258-0651-469b-99b8-e986baee8a54/Controlling-LM-Delicatessens.pdf?MOD=AJPERES. FSIS 
encourages retailers to use the best-practices guidance to help ensure 
that

[[Page 35186]]

RTE meat and poultry products in the deli area are handled under 
sanitary conditions and are not adulterated.

Risk Assessment

    Comment: One commenter noted that the draft of the second risk 
assessment, initiated in early 2001, was not completed until February 
2003--two years after publication of the proposed rule, which addressed 
control of Lm. The commenter stated that the Agency limited the new 
assessment to deli meats only (ignoring hot dogs and other high-risk 
meat and poultry products) and did not include sampling of non-food 
contact surfaces in the risk model. The commenter also stated that the 
risk assessment excluded consideration of whether the risk would be 
reduced if, in addition to other steps, final product testing was 
required. The final version of FSIS's risk assessment,\3\ released in 
May 2003, found that the minimal testing frequency in the proposed 
Listeria rule would result in a small reduction in Listeria levels, and 
that a combination of interventions (sanitation and testing of food-
contact surfaces, lethality interventions, and growth inhibitors) 
appeared to be more effective than any single intervention.
---------------------------------------------------------------------------

    \3\ FSIS, FSIS Risk Assessment for Listeria Monocytogenes in 
Deli Meats (May 2003) available at http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/97-013F/ListeriaReport.pdf. A final version of the Joint 
FDA/FSIS risk assessment was released in September 2003. It included 
a number of revisions to and refinements of the draft assessment, 
but still classified both deli meats and unheated frankfurters as 
``Very High Risk.'' See FSIS/FDA, Quantitative Assessment of the 
Relative Risk to Public Health from Foodborne Listeria Monocytogenes 
Among Selected Categories of Ready-to-Eat Foods (Sept. 2003) 
available at http://www.fda.gov/downloads/Food/FoodScienceResearch/UCM197330.pdf.
---------------------------------------------------------------------------

    Response: The focus of the risk assessment was narrowed on the 
basis of available data. The available data on hotdogs was not 
sufficient to be included in a plant-to-table risk assessment. 
Moreover, deli meat was believed to be the vehicle in most listeriosis 
cases. From the 2003 FDA-FSIS Quantitative Assessment of the Risk of 
Listeriosis due to Selected Food Categories (FDA, 2003), the median 
number of cases of listeriosis per annum from deli meats was estimated 
to be 1598.7. For frankfurters (reheated and not reheated combined) the 
number of cases was estimated to be less than 31. For p[acirc]t[eacute] 
and meat spreads, the estimated number of illnesses was less than 4, 
and for dry/semi-dry fermented sausages, the estimated number of 
illness was less than 0.1. Clearly, this document pointed to deli meats 
as the high-risk food category in 2003.
    While FSIS is aware of the limitations of its model, the Agency has 
concluded that the model is adequate to inform decision-making based on 
the specific risk management questions posed by FSIS risk managers. A 
more detailed model would require additional data. The Agency noted in 
the final version of the risk assessment that the data available in the 
published literature on Listeria in the processing plant environment 
are limited. In addition to data limitations, the limited time 
available and the intended use of the model dictated other restrictions 
on the scope of the assessment. While the risk model addressed only 
food-contact surfaces as the source of contamination by Lm, the 
Agency's risk assessors acknowledged that Lm contamination could arise 
from inadequate lethality treatment or from cross-contamination from 
non-food contact surfaces. The risk assessment also made simplifying 
technical assumptions, such as those regarding a generic food-contact 
surface, the distribution of Listeria on the surface, and the 
assumption of a generic product lot.
    The comment that the model excluded the effect of product testing, 
however, is not accurate. The in-plant model incorporated, in addition 
to food-contact surface testing, product testing and pre- and post-
packaging interventions and the effect of growth inhibitors (or product 
reformulation). The risk assessment describes the role of product 
testing in the model and discusses the probability of detecting Lm in 
product samples and the contribution of information from such testing 
to the development of risk reduction measures.
    FSIS is affirming the 2003 risk assessment without updates or 
changes.

Economic Impact; Effect on Small Establishments; Regulatory Reform

    Comment: One commenter disagreed with the assessment team's finding 
that the interim final rule was not disproportionately affecting small 
establishments because the number of noncompliance records (NRs) that 
FSIS issued related to this rule to very small plants was twice that 
for large plants. Similarly, the commenter stated that FSIS issued more 
NRs to small plants than large. Another commenter stated that the 
assessment team's finding that FSIS issued most NRs to very small 
establishments evidences the need for a much stronger effort at 
compliance assistance to the small processor.
    A few comments that were submitted in response to OMB's February 
2004 solicitation of nominations for regulatory reform (69 FR 7987) 
argued that the Agency greatly underestimated the costs and 
overestimated the benefits of the interim final rule.
    One commenter that responded to the OMB request asserted that the 
economic analysis of the interim final rule understated the costs to 
small businesses, particularly to small and very small processing 
plants, and overstated the benefits of the rule. The commenter noted 
that FSIS estimated the annual cost of the rule to the industry in the 
range of $16.6 million, and that benefits were in the range of $44 
million to $154 million. However, the commenter estimated that the 
actual costs were closer to $115 million per year. The commenter 
charged that for each of the ``10,000 plants'' (sic) that are subject 
to the rule, the true costs are closer to $11,500 per year and over 
$1.15 billion over ten years. According to the commenter, the costs 
reflect the purchase of new equipment, reconfiguration of plant 
facilities, accumulated interest of $50,000 per plant, and estimated 
annual costs of $6,500 for testing to ensure compliance and for 
consultants. The grand total then would be $115,000 per plant.
    The commenter asserted that the rule puts American firms at a 
competitive disadvantage with foreign firms, and that the burden of the 
rule is so great that some small and very small plants may cease 
operations.
    The commenter did not present an alternative benefit estimate in 
dollar terms but asserted that FSIS based its estimates on data that 
the Centers for Disease Control and Prevention (CDC) gathered through 
1997, while CDC data for 1996 to 2000 show a 38 percent decrease in 
incidence of, and mortality from, Lm. Also the commenter asserted on 
the basis of the Q&A provided with the 2003 FDA/FSIS joint risk 
assessment that FSIS used for the interim final rule that it is likely 
that the annual total cases were less than 1,500, with 300 deaths.
    Another commenter recommended that FSIS review the compliance costs 
of the rule and increase the calculation of those costs to a more 
reasonable figure.
    Response: The commenters misstated the regulatory impact analysis 
of the interim final rule on key points. For example, rather than 
10,000 plants, as one commenter stated, the rule was estimated to 
affect 2,930 total Federal establishments. In actual fact, the rule 
affected 2,473 Federal establishments in 2006 and 2,307 Federal 
establishments in 2013. Thus, the comment, on that basis alone, 
increased the arguable costs of the rule.
    The comment stated that the costs of new equipment, plant 
reconfiguration, testing, and outside expert technical

[[Page 35187]]

assistance are a substantial burden on small plants that the Agency 
ignored in its analysis. However, the interim final rule did not 
require these plants to upgrade their operations. For this reason, such 
costs are not a direct effect of the rule. The regulatory impact 
analysis estimated that the vast majority of very small plants, such as 
the one submitting the comment, would use Alternative-3 type controls 
(sanitation only) to control Lm instead of changing from Alternative 3 
to Alternative 2 or 1. Costs for Alternative 3 are minimal because it 
only requires an establishment to control Lm through its sanitation 
program. An establishment would not need to purchase new equipment for 
post-lethality treatment or apply antimicrobial agents. Comparing FSIS 
PHIS data of calendar year (CY) 2013 and the baseline in the 2003 
interim final rule, the Agency found that about 77 percent of the small 
and very small establishments that used alternative 3 still use 
alternative 3.\4\ The percentage increases from the baseline to CY 2013 
for small and very small establishments using Alternative 2b, 
Alternative 2a, and Alternative 1 are 17 percent, 1 percent and 1.5 
percent, respectively. Therefore, the costs the small and very small 
establishments would incur would mostly be those attributable to 
initial and on-going compliance with the sanitation program 
requirements of the rule.
---------------------------------------------------------------------------

    \4\ Note that the composition, and the relative statistics of 
the RTE establishments subject to this rule changed somewhat between 
2003 and 2013, So the comparisons are approximate, not exact.
---------------------------------------------------------------------------

    As to the benefit estimates in the economic analysis of the interim 
final rule, these were based on the potential risk reductions to be 
achieved through the adoption by industry of the Listeria control 
alternatives set out in 9 CFR 430.4. While the comment stated that the 
CDC data for 1996 to 2000 show a 38 percent decrease in incidence of, 
and mortality from, Lm, the comment did not take into account an ``up 
spike'' in listeriosis illness that occurred in 2002-2003 before the 
rule went into effect. Thus, when the rule was promulgated, there were 
a significantly higher number of illnesses to be averted than the 
comment considered. Finally, the benefit estimates in the interim final 
rule were based on the differences in the number of illnesses in the 
risk assessment model results under different scenarios. The risk 
assessment model estimated the number of illnesses using FSIS 
simulation models that assess how the in-plant contamination level 
transfers to the retail contamination level and then assessed the 
number of illnesses based on the dose-response relationship from the 
FDA/FSIS exposure retail-to-table model where all models were 
calibrated for deli meat.\5\
---------------------------------------------------------------------------

    \5\ For details of these models, see footnote 3.
---------------------------------------------------------------------------

    For these reasons, FSIS is affirming the basic conclusions reached 
by the Final Regulatory Impact Analysis that was submitted in support 
of the interim final rule.

Executive Orders 12866 and 13563, and the Regulatory Flexibility Act

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This rule has been designated a ``non-significant'' 
regulatory action under section 3(f) of Executive Order (E.O.) 12866. 
Accordingly, the rule has not been reviewed by the Office of Management 
and Budget under E.O. 12866.
    FSIS is affirming the basic conclusions reached by the Final 
Regulatory Impact Analysis that was submitted in support of the interim 
final rule. The two changes do not affect the basic conclusions reached 
by the Final Regulatory Impact Analysis that was submitted with the 
interim final rule. FSIS is making two changes in this document, making 
clear in the regulation that products that have been in contact with a 
Lm contaminated surface would be adulterated if not reprocessed (9 CFR 
430.4(a)) and removing the requirement for establishments to report 
production volume and related information to FSIS because the Agency 
now routinely collects this information through PHIS (9 CFR 430.4(d)). 
Neither change will cause establishments to change their practices to 
comply with the regulation. Therefore, there is no need to conduct a 
cost or benefit analysis to affirm the interim final rule.

Regulatory Flexibility Act Assessment

    The FSIS Administrator certifies that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601-602), the rule will not have a 
significant economic impact on a substantial number of small entities 
in the United States.

Paperwork Reduction Act

    There are no paperwork or recordkeeping requirements associated 
with this rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520).

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the Internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

Executive Order 12988

    This rule has been reviewed under the Executive Order 12988, Civil 
Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) no 
administrative proceedings will be required before parties may file 
suit in court challenging this rule.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' E.O. 13175 requires Federal agencies to consult 
and coordinate with tribes on a government-to-government basis on 
policies that have tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that have substantial direct effects on one or 
more Indian tribes, on the relationship between the Federal Government 
and Indian tribes or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.
    FSIS has assessed the impact of this rule on Indian tribes and 
determined that this rule does not, to our knowledge, have tribal 
implications that require tribal consultation under E.O. 13175. If a 
Tribe requests consultation, the Food Safety and Inspection Service 
will work with the Office of Tribal Relations to ensure meaningful 
consultation is provided where changes, additions and modifications 
identified herein are not expressly mandated by Congress.

USDA Nondiscrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/

[[Page 35188]]

parental status, income derived from a public assistance program, or 
political beliefs, exclude from participation in, deny the benefits of, 
or subject to discrimination any person in the United States under any 
program or activity conducted by the USDA.
    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
    Fax: (202)690-7442.
    Email [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.) should contact 
USDA's TARGET Center at (202)720-2600 (voice and TDD).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this 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 our constituents and 
stakeholders. The Update is available on the FSIS Web page. Through the 
Web page, FSIS is able to provide information to a much broader, 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/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

List of Subjects in 9 CFR Part 430

    Food labeling, Meat inspection, Poultry and poultry products 
inspection.

    For the reasons set forth in the preamble, FSIS is adopting as 
final the interim final rule that amended Title 9, Chapter III, of the 
Code of Federal Regulations and that was published at 68 FR 34208 on 
June 6, 2003, with the following amendments:

PART 430--REQUIREMENTS FOR SPECIFIC CLASSES OF PRODUCT

0
1. The authority citation for part 430 continues to read as follows:

    Authority: 7 U.S.C. 450; 7 U.S.C. 1901-1906; 21 U.S.C. 451-470, 
601-695; 7 CFR 2.18, 2.53.


0
2. Amend Sec.  430.4 by:
0
a. Revising paragraph (a).
0
b. Revising paragraph (b)(2)(iii)(B).
0
c. Revising paragraph (b)(3)(i)(B).
0
d. Revising paragraphs (b)(3)(ii)(B) and (C).
0
e. Removing and reserving paragraph (d).
    The revisions read as follows:


Sec.  430.4  Control of Listeria monocytogenes in post-lethality 
exposed ready-to-eat products.

    (a) Listeria monocytogenes can contaminate RTE products that are 
exposed to the environment after they have undergone a lethality 
treatment. L. monocytogenes is a hazard that an establishment producing 
post-lethality exposed RTE products must control through its HACCP plan 
or prevent in the processing environment through a Sanitation SOP or 
other prerequisite program. RTE product is adulterated if it contains 
L. monocytogenes, or if it comes into direct contact with a food 
contact surface that is contaminated with L. monocytogenes. 
Establishments must not release into commerce product that contains L. 
monocytogenes or that has been in contact with a food contact surface 
contaminated with L. monocytogenes without first reworking the product 
using a process that is destructive of L. monocytogenes.
    (b) * * *
    (2) * * *
    (iii) * * *
    (B) Identify the conditions under which the establishment will 
implement hold-and-test procedures following a positive test of a food-
contact surface for an indicator organism;
* * * * *
    (3) * * *
    (i) * * *
    (B) Identify the conditions under which the establishment will 
implement hold-and-test procedures following a positive test of a food-
contact surface for an indicator organism;
* * * * *
    (ii) * * *
    (B) During this follow-up testing, if the establishment obtains a 
second positive test for an indicator organism, the establishment must 
hold lots of product that may have become contaminated by contact with 
the food contact surface until the establishment corrects the problem 
indicated by the test result.
    (C) In order to release into commerce product held under this 
section, the establishment must sample and test the lots for L. 
monocytogenes or an indicator organism using a sampling method and 
frequency that will provide a level of statistical confidence that 
ensures that each lot is not adulterated with L. monocytogenes. The 
establishment must document the results of this testing. Alternatively, 
the establishment may rework the held product using a process that is 
destructive of L. monocytogenes or the indicator organism.
* * * * *

Done, at Washington, DC: May 29, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-13507 Filed 6-18-15; 8:45 am]
 BILLING CODE 3410-DM-P