82 FR 27680 - Availability of FSIS Compliance Guidelines for Small and Very Small Meat and Poultry Establishments Regarding Lethality and Stabilization in Meat and Poultry Products (Previously Referred to as Appendices A and B)

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 82, Issue 115 (June 16, 2017)

Page Range		27680-27682
FR Document		2017-12563

The Food Safety and Inspection Service (FSIS) is announcing the availability of and requesting comments on two updated compliance guidelines for small and very small businesses. The new guidelines will assist small and very small meat and poultry establishments understand and comply with the regulatory requirements associated with the destruction of Salmonella and other pathogens (lethality) in ready-to- eat (RTE) products and the control of pathogen growth in heat-treated RTE and not-ready-to-eat (NRTE) products during cooling and hot-holding (stabilization). FSIS is including the time-temperature tables and cooling options in these guidelines that were previously in Appendices A and B, originally made available in 1999, along with new recommendations establishments can use to achieve lethality and stabilization of these products.

Federal Register, Volume 82 Issue 115 (Friday, June 16, 2017)

[Federal Register Volume 82, Number 115 (Friday, June 16, 2017)]
[Notices]
[Pages 27680-27682]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12563]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2017-0016]


Availability of FSIS Compliance Guidelines for Small and Very 
Small Meat and Poultry Establishments Regarding Lethality and 
Stabilization in Meat and Poultry Products (Previously Referred to as 
Appendices A and B)

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and request for comment

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of and requesting comments on two updated compliance 
guidelines for small and very small businesses. The new guidelines will 
assist small and very small meat and poultry establishments understand 
and comply with the regulatory requirements associated with the 
destruction of Salmonella and other pathogens (lethality) in ready-to-
eat (RTE) products and the control of pathogen growth in heat-treated 
RTE and not-ready-to-eat (NRTE) products during cooling and hot-holding 
(stabilization). FSIS is including the time-temperature tables and 
cooling options in these guidelines that were previously in Appendices 
A and B, originally made available in 1999, along with new 
recommendations establishments can use to achieve lethality and 
stabilization of these products.

DATES: Submit Comments on or before August 15, 2017.

ADDRESSES: Downloadable versions of the compliance guidelines are 
available to view and print at https://www.fsis.usda.gov/wps/wcm/connect/bf3f01a1-a0b7-4902-a2df-a87c73d1b633/Salmonella-Compliance-Guideline-SVSP-;RTE-Appendix-A.pdf?MOD=AJPERES and https://
www.fsis.usda.gov/wps/wcm/connect/

[[Page 27681]]

9ac49aba-46bc-443c-856b-59a3f51b924f/Compliance-Guideline-
Stabilization-Appendix-B.pdf?MOD=AJPERES once copies of the guidelines 
have been published. FSIS invites interested persons to submit comments 
on this guidance. 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: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 
Independence Avenue SW., Mailstop 3782, Room 8-163B, 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, FSIS, and document title: FSIS Compliance 
Guideline for Stabilization (Cooling and Hot-Holding) of Fully and 
Partially Heat-Treated RTE and NRTE Meat and Poultry Products Produced 
by Small and Very Small Establishments and Revised Appendix B 2017 
Compliance Guideline. Comments received will be made available for 
public inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or to comment received, 
go to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 
164-A, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., 
Monday through Friday.
    For Further Information Contact: Roberta Wagner, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    FSIS is making available an updated compliance guideline regarding 
the requirements for the destruction of Salmonella and other pathogens 
(lethality) in RTE meat and poultry products, entitled FSIS Salmonella 
Compliance Guideline for Small and Very Small Meat and Poultry 
Establishments that Produce Ready-to-Eat (RTE) Products and Revised 
Appendix A. The updated guideline provides clarification regarding 
options for establishments to support an alternative lethality (i.e., 
at least a 5-log reduction of Salmonella, rather than a 6.5-log 
reduction) for roast, cooked, and corned beef per 9 CFR 318.17(a)(1); a 
definition of ``pasteurization'' and guidance on how establishments can 
label products as ``pasteurized''; and updated information gathered 
from FSIS Food Safety Assessments (FSAs), which are in-depth 
assessments of establishments' food safety systems to verify that 
regulatory requirements are met. The guideline also combines and 
replaces information from the following previously issued guidance 
documents:
     Appendix A Compliance Guidelines for Meeting Lethality 
Performance Standards for certain Meat and Poultry Products.
     Appendix A Guidance on Relative Humidity and Time/
Temperature for Cooking/Heating and Applicability to Production of 
Other Ready-to-Eat Meat and Poultry Products (Appendix A Humidity 
Guidance).
     Time-Temperature Tables for Cooking Ready-to-Eat Poultry 
Products.
     FSIS Guidance on Safe Cooking of Non-Intact Meat Chops, 
Roasts, and Steaks (5-log Table).
    FSIS also is making available an updated guideline on the control 
of pathogen growth in heat-treated RTE and NRTE meat and poultry 
products during cooling and hot-holding (stabilization), entitled FSIS 
Compliance Guideline for Stabilization (Cooling and Hot-Holding) of 
Fully and Partially Heat-Treated RTE and NRTE Meat and Poultry Products 
Produced by Small with Very Small Establishments and Revised Appendix 
B. Hot-holding is the process of holding meat and poultry products at 
hot temperatures (typically above 130[deg]F) prior to distribution. 
Although stabilization is commonly associated with RTE products, the 
concepts and many of the recommendations in this guideline can apply to 
heat-treated NRTE products as well.
    This updated stabilization guideline contains recommendations 
previously found in FSIS Appendix B: Compliance Guidelines for Cooling 
Heat-Treated Meat and Poultry Products (Stabilization) and FSIS 
Directive 7110.3, Rev. 1, Time/Temperature Guidelines for Cooling 
Heated Products. It also contains additional guidance not previously 
found in either document, including:
     The regulatory requirements associated with stabilization 
(cooling and hot-holding);
     The scientific support documents available to help develop 
a safe process and product;
     Recommended corrective actions in the event of a cooling 
deviation; and
     Additional options for cooling meat and poultry products, 
including requesting a waiver.
Specifically in regard to waivers, this stabilization guideline 
describes information that establishments may use to request a waiver 
from the regulatory performance standards in 9 CFR 318.17(a)(2), 
318.23(b)(3)(ii)(c), and 381.150(a)(2) to allow up to a 2-
log10 multiplication of C. perfringens within a product, 
provided no multiplication of C. botulinum occurs. The Agency will 
evaluate waiver requests and use this information to potentially amend 
the regulations. Notably, FSIS has determined that establishments do 
not have to provide data that allowing up to 2-log10 
multiplication of C. perfringens will result in no multiplication of C. 
botulinum as part of the waiver request.

Small Business Regulatory Flexibility Act Compliance

    Both guidance documents are targeting small and very small 
establishments in support of the Small Business Administration's 
initiative to provide small and very small establishments with 
compliance assistance under the Small Business Regulatory Flexibility 
Act (SBRFA). It is important that small and very small establishments 
have access to the scientific and technical support needed to establish 
safe and effective HACCP systems. However, all FSIS regulated meat and 
poultry establishments may be able to apply the recommendations in this 
guideline.

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

[[Page 27682]]

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.

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.
    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).

    Done at Washington, DC on: June 8, 2017.
Alfred V. Almanza,
Administrator.
[FR Doc. 2017-12563 Filed 6-15-17; 8:45 am]
 BILLING CODE P

Federal Register / Vol. 82, No. 115 / Friday, June 16, 2017 / Notices 27681

9ac49aba-46bc-443c-856b- provides clarification regarding options • The scientific support documents
59a3f51b924f/Compliance-Guideline- for establishments to support an available to help develop a safe process
Stabilization-Appendix- alternative lethality (i.e., at least a 5-log and product;
B.pdf?MOD=AJPERES once copies of the reduction of Salmonella, rather than a • Recommended corrective actions in
guidelines have been published. FSIS 6.5-log reduction) for roast, cooked, and the event of a cooling deviation; and
invites interested persons to submit corned beef per 9 CFR 318.17(a)(1); a • Additional options for cooling meat
comments on this guidance. Comments definition of ‘‘pasteurization’’ and and poultry products, including
may be submitted by one of the guidance on how establishments can requesting a waiver.
following methods: label products as ‘‘pasteurized’’; and Specifically in regard to waivers, this
Federal eRulemaking Portal: This updated information gathered from FSIS stabilization guideline describes
Web site provides the ability to type Food Safety Assessments (FSAs), which information that establishments may use
short comments directly into the are in-depth assessments of to request a waiver from the regulatory
comment field on this Web page or establishments’ food safety systems to performance standards in 9 CFR
attach a file for lengthier comments. Go verify that regulatory requirements are 318.17(a)(2), 318.23(b)(3)(ii)(c), and
to http://www.regulations.gov/. Follow met. The guideline also combines and 381.150(a)(2) to allow up to a 2-log10
the on-line instructions at that site for replaces information from the following multiplication of C. perfringens within
submitting comments. previously issued guidance documents: a product, provided no multiplication of
Mail, including CD–ROMs: Send to C. botulinum occurs. The Agency will
• Appendix A Compliance
Docket Clerk, U.S. Department of evaluate waiver requests and use this
Guidelines for Meeting Lethality
Agriculture, Food Safety and Inspection information to potentially amend the
Performance Standards for certain Meat
Service, Patriots Plaza 3, 1400 regulations. Notably, FSIS has
and Poultry Products.
Independence Avenue SW., Mailstop determined that establishments do not
3782, Room 8–163B, Washington, DC • Appendix A Guidance on Relative have to provide data that allowing up to
20250–3700. Humidity and Time/Temperature for 2-log10 multiplication of C. perfringens
Hand- or courier-delivered submittals: Cooking/Heating and Applicability to will result in no multiplication of C.
Deliver to Patriots Plaza 3, 355 E Street Production of Other Ready-to-Eat Meat botulinum as part of the waiver request.
SW., Room 8–163A, Washington, DC and Poultry Products (Appendix A
20250–3700. Humidity Guidance). Small Business Regulatory Flexibility
Instructions: All items submitted by • Time-Temperature Tables for Act Compliance
mail or electronic mail must include the Cooking Ready-to-Eat Poultry Products. Both guidance documents are
Agency name, FSIS, and document title: • FSIS Guidance on Safe Cooking of targeting small and very small
FSIS Compliance Guideline for Non-Intact Meat Chops, Roasts, and establishments in support of the Small
Stabilization (Cooling and Hot-Holding) Steaks (5-log Table). Business Administration’s initiative to
of Fully and Partially Heat-Treated RTE FSIS also is making available an provide small and very small
and NRTE Meat and Poultry Products updated guideline on the control of establishments with compliance
Produced by Small and Very Small pathogen growth in heat-treated RTE assistance under the Small Business
Establishments and Revised Appendix B and NRTE meat and poultry products Regulatory Flexibility Act (SBRFA). It is
2017 Compliance Guideline. Comments during cooling and hot-holding important that small and very small
received will be made available for (stabilization), entitled FSIS Compliance establishments have access to the
public inspection and posted without Guideline for Stabilization (Cooling and scientific and technical support needed
change, including any personal Hot-Holding) of Fully and Partially to establish safe and effective HACCP
information, to http:// Heat-Treated RTE and NRTE Meat and systems. However, all FSIS regulated
www.regulations.gov. Poultry Products Produced by Small meat and poultry establishments may be
Docket: For access to background able to apply the recommendations in
with Very Small Establishments and
documents or to comment received, go this guideline.
Revised Appendix B. Hot-holding is the
to the FSIS Docket Room at Patriots
process of holding meat and poultry Additional Public Notification
Plaza 3, 355 E Street SW., Room 164–
products at hot temperatures (typically Public awareness of all segments of
A, Washington, DC 20250–3700
above 130°F) prior to distribution. rulemaking and policy development is
between 8:00 a.m. and 4:30 p.m.,
Although stabilization is commonly important. Consequently, FSIS will
Monday through Friday.
For Further Information Contact: associated with RTE products, the announce this Federal Register
Roberta Wagner, Assistant concepts and many of the publication on-line through the FSIS
Administrator, Office of Policy and recommendations in this guideline can Web page located at: http://
Program Development; Telephone: (202) apply to heat-treated NRTE products as www.fsis.usda.gov/federal-register.
205–0495. well. FSIS also will make copies of this
SUPPLEMENTARY INFORMATION:
This updated stabilization guideline publication available through the FSIS
contains recommendations previously Constituent Update, which is used to
Background found in FSIS Appendix B: Compliance provide information regarding FSIS
FSIS is making available an updated Guidelines for Cooling Heat-Treated policies, procedures, regulations,
compliance guideline regarding the Meat and Poultry Products Federal Register notices, FSIS public
requirements for the destruction of (Stabilization) and FSIS Directive meetings, and other types of information
Salmonella and other pathogens 7110.3, Rev. 1, Time/Temperature that could affect or would be of interest
sradovich on DSK3GMQ082PROD with NOTICES

(lethality) in RTE meat and poultry Guidelines for Cooling Heated Products. to our constituents and stakeholders.
products, entitled FSIS Salmonella It also contains additional guidance not The Update is available on the FSIS
Compliance Guideline for Small and previously found in either document, Web page. Through the Web page, FSIS
Very Small Meat and Poultry including: is able to provide information to a much
Establishments that Produce Ready-to- • The regulatory requirements broader, more diverse audience. In
Eat (RTE) Products and Revised associated with stabilization (cooling addition, FSIS offers an email
Appendix A. The updated guideline and hot-holding); subscription service which provides

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Document Created: 2017-06-16 00:52:09
Document Modified: 2017-06-16 00:52:09

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability and request for comment
Dates		Submit Comments on or before August 15, 2017.
Contact		Roberta Wagner, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205-0495.
FR Citation		82 FR 27680

82 FR 27680 - Availability of FSIS Compliance Guidelines for Small and Very Small Meat and Poultry Establishments Regarding Lethality and Stabilization in Meat and Poultry Products (Previously Referred to as Appendices A and B)

DEPARTMENT OF AGRICULTUREFood Safety and Inspection Service

Federal Register Volume 82, Issue 115 (June 16, 2017)

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service