[Federal Register Volume 80, Number 112 (Thursday, June 11, 2015)]
[Notices]
[Pages 33228-33230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14330]
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Notices
Federal Register
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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.
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Federal Register / Vol. 80, No. 112 / Thursday, June 11, 2015 /
Notices
[[Page 33228]]
DEPARTMENT OF AGRICULTURE
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.
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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.
FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Assistant
Administrator, Office of Policy and Program Development; Telephone:
(202) 205-0495, or by Fax: (202) 720-2025.
SUPPLEMENTARY INFORMATION:
Background
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.
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\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.
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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
available.
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.
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\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:
https://www.fsai.ie/WorkArea/DownloadAsset.aspx?id=1234.
\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.
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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: [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.
[[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]
BILLING CODE 3410-DM-P