[Federal Register Volume 80, Number 112 (Thursday, June 11, 2015)]
[Pages 33228-33230]
From the Federal Register Online via the Government Publishing Office 
[FR Doc No: 2015-14330]

                                                Federal Register

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.


Federal Register / Vol. 80, No. 112 / Thursday, June 11, 2015 / 

[[Page 33228]]


Food Safety and Inspection Service

[Docket No. FSIS-2013-0038]

Best Practices Guidance for Controlling Listeria monocytogenes in 
Retail Delicatessens

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of its updated ``Best Practices Guidance for 
Controlling Listeria monocytogenes (Lm) in Retail Delicatessens'' and 
responding to comments received on the guidance that FSIS posted on its 
Web site and announced in April 2014 in the Federal Register. The best-
practices guidance discusses steps that retailers can take to prevent 
certain ready-to-eat (RTE) foods that are prepared or sliced in retail 
delicatessens (delis) and consumed in the home, such as deli meats and 
deli salads, from becoming contaminated with Lm and thus a source of 
listeriosis. FSIS encourages retailers to review the guidance and 
evaluate the effectiveness of their retail practices and intervention 
strategies in reducing the risk of listeriosis to consumers from RTE 
meat and poultry deli products.

Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495, or by Fax: (202) 720-2025.



    Lm is a bacterium that is found in moist environments, soil, and 
decaying vegetation and can persist along the food continuum. Transfer 
of the bacterium from the environment (e.g., deli cases, slicers, and 
utensils), employees, or contaminated food products is a particular 
hazard of concern in RTE foods, including meat and poultry products, 
because they generally receive no further processing for food safety 
before consumption. Listeriosis is a serious infection usually caused 
by eating food contaminated with Lm.
    On April 21, 2014, FSIS announced the availability of its ``Best 
Practices Guidance for Controlling Listeria monocytogenes (Lm) in 
Retail Delicatessens'' and requested comment on the guidance (79 FR 
22082). As explained in the 2014 Federal Register notice, FSIS used the 
key findings from the FSIS and Food and Drug Administration (FDA) 
``Interagency Risk Assessment--Listeria monocytogenes in Retail 
Delicatessens'' available on FSIS's Web site at http://www.fsis.usda.gov/wps/portal/fsis/topics/science/risk-assessments, the 
available scientific knowledge, the 2013 FDA Food Code,\1\ and lessons 
learned from controlling Lm in FSIS-inspected meat and poultry 
processing establishments to develop the Best Practices Guidance for 
Controlling Lm in Retail Delis. The guidance provides practical 
recommendations that retailers can use to control Lm contamination and 
outgrowth in the deli. Retailers can use the best-practices guidance to 
help ensure that RTE meat and poultry products in the deli area are 
handled under sanitary conditions and are not adulterated under the 
Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) or the 
Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) (see 21 
U.S.C. 623(d) and 464(e)). While these practices are specifically 
designed to control Lm, they also may help control other foodborne 
pathogens that may be introduced into the retail deli environment and 
other facilities where consumers take possession of food.

    \1\ The FDA 2013 Food Code is a model to assist food control 
jurisdictions at all levels of the government by providing them with 
a scientifically sound technical and legal basis for regulating food 
service, retail food stores, or food vending operations. For 
additional information on the FDA Food Code visit the FDA Web site 
at http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/default.htm.

Final Guidance

    The final guidance is posted at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.
    FSIS updated the guidance to replace the previous version of the 
document which was issued and announced in the Federal Register (79 FR 
22082, April 21, 2014). FSIS updated this guidance based on comments 
received during the public comment period which closed on June 20, 
2014. FSIS made the following changes to the guidance in response to 
comments: Clarified that food processing equipment should be 
disassembled during cleaning and sanitizing, added a recommendation 
that retailers scrub surfaces during cleaning to prevent biofilm 
formation, and clarified that retailers should rotate (change) 
sanitizers to help prevent Lm from establishing niches in the 
environment and forming biofilms. The response to comments section 
below contains a more detailed summary of the comments and FSIS's 
responses to those comments. Although comments will no longer be 
accepted through www.regulations.gov on this guidance document, FSIS 
will update this document as necessary should new information become 

Response to Comments

    FSIS received six comments on the ``FSIS Best Practices Guidance 
for Controlling Lm in Retail Delicatessens'' (FSIS Retail Lm 
Guideline). The comments were from a meat-processing company, a trade 
organization that represents retail stores, two companies that provide 
sanitation services, one company that produces antimicrobial agents, 
and one trade organization that represents meat-processing companies. 
The following is a summary of the comments that were received and 
FSIS's responses to the comments.
    Comment: Several commenters supported FSIS issuing the Retail Lm 
Guideline and recommended that FSIS issue other guidelines that 
retailers and food service operators can use. One commenter stated that 
the hazard of Lm does not change with production at a smaller facility 
and recommended that delis use the FSIS Compliance Guideline: 
``Controlling Lm in Post-lethality Exposed Ready-to-Eat Meat and 
Poultry Products'' (FSIS Listeria Guideline). The FSIS Listeria 
Guideline is posted at http://www.fsis.usda.gov/wps/wcm/connect/d3373299-50e6-47d6-a577-e74a1e549fde/Controlling-Lm-RTE-Guideline.pdf?MOD=AJPERES.

[[Page 33229]]

    Response: FSIS agrees that it is important to provide guidance for 
retailers and may issue additional guidelines as needed. While the FSIS 
Listeria Guideline for industry discussed in the preceding paragraph 
provides useful information about controlling Lm in federally inspected 
establishments, it does not provide information for deli operators. 
Because the requirements, processing conditions, and practices are 
different at retail than in processing facilities, issuing this 
separate guideline provides the specific information retailers can use 
to control Lm in the deli area.
    Comment: Three commenters questioned whether the recommendation to 
rotate sanitizers to help prevent Lm from developing resistance to 
sanitizers and forming biofilms was necessary. One commenter stated 
that there is no scientific evidence that Lm develops resistance to 
sanitizers. The commenters recommended that retailers focus on removing 
the biofilm during the washing step and not the sanitizing step.
    Response: Research has shown that Lm may become resistant to 
chlorine and other sanitizers,\2\ and several industry guidelines 
recommend rotating sanitizers.3 4 5 6 Therefore, in the 
guidance, FSIS continues to recommend this practice to help prevent Lm 
from establishing niches in the environment and forming biofilms. FSIS 
agrees with the commenters that biofilm formation is a concern in the 
deli environment and should be addressed during the cleaning step. To 
address this concern, FSIS has added a new recommendation to scrub 
surfaces during cleaning to prevent biofilm formation.

    \2\ Folsom, JP and JF Frank. Chlorine resistance of Listeria 
monocytogenes biofilms and relationship to subtype, cell density, 
and planktonic cell chlorine resistance. Journal of Food Protection. 
Volume 69, number 6, pages 1292-1296, June 2006.
    \3\ Pennsylvania State University (Penn State), College of 
Agricultural Sciences, Agricultural Research and Cooperative 
Extension. Control of Listeria monocytogenes in Small Meat and 
Poultry Establishments, 2003.http://extension.psu.edu/food/safety/other-topics/controlling-listeria/Cotrolling-Listeria-2.pdf/view 
(Sampling for Lm, rotating sanitizers).
    \4\ FDA, Guidance for Industry: Control of Listeria 
monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft 
Guidance, February, 2008. Found at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodProcessingHACCP/ucm073110.htm.
    \5\ Food Safety Authority of Ireland. The Control and Management 
of Listeria monocytogenes Contamination of Food. 2005. Found at: 
    \6\ Tompkin RB, Scott VN, Bernard DT, Sveum WH, and Gombas KS. 
1999. Guidelines to prevent post-processing contamination from 
Listeria monocytogenes. Dairy, Food and Environmental Sanitation 19 
(8): 551-562.

    Comment: One commenter recommended that FSIS compliance 
investigators treat the best practices as guidance and not regulatory 
requirements when performing in-commerce surveillance at retail. The 
commenter requested that FSIS instruct its compliance investigators 
that the best practices are recommendations and not requirements. The 
commenter also recommended that compliance investigators provide the 
retail store management with FSIS guidance and other guidance documents 
that are available if they determine that store management is not aware 
of Listeria control actions.
    Response: FSIS agrees that the guidance represents FSIS's best 
practices recommendations and does not represent requirements that 
retailers must meet. FSIS issued instructions to its compliance 
investigators to make them aware that this guidance did not include 
requirements. FSIS is not aware of any instance in which compliance 
investigators have enforced FSIS guidance as though it were a 
regulatory requirement. FSIS is instructing its compliance 
investigators through training materials that they should inform 
retailers that the guidance is available on the FSIS Web site. 
Retailers are required by the FMIA and PPIA to maintain sanitary 
conditions and otherwise not produce adulterated or misbranded product. 
The guidance provides actions retailers can take to help ensure that 
they are meeting the requirements of the FMIA and PPIA. Retailers also 
should be aware that the recommendations in the guideline, especially 
those based on the 2013 FDA Food Code, may be requirements in State, 
local, or Tribal regulations.
    Comment: One commenter stated that it is important to disassemble 
equipment when cleaning to find hard-to-reach areas where Lm can hide. 
The commenter stated that FSIS should amend the recommendation to clean 
and sanitize RTE food-processing equipment every four hours to include 
recommendations to disassemble the equipment during cleaning.
    Response: FSIS agrees that it is important to disassemble equipment 
(e.g., slicers) when cleaning every four hours as recommended by the 
2013 FDA Food Code and has clarified this information in the guidance.

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/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.

How To File a Complaint of Discrimination

    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: program.intake@usda.gov.
    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: 
    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.

[[Page 33230]]

    Done in Washington, DC, on June 8, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-14330 Filed 6-10-15; 8:45 am]