[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Notices]
[Pages 58089-58091]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23080]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2012-0024]


Availability of FSIS Salmonella Compliance Guidelines for Small 
and Very Small Meat and Poultry Establishments That Produce Ready-to-
Eat Products

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 a revised compliance guide for small and very small 
meat and poultry establishments on the safe production of ready-to-eat 
(RTE) meat and poultry products with respect to Salmonella and other 
pathogens. FSIS has posted this compliance guide on its Significant 
Guidance Documents Web page (http://www.fsis.usda.gov/Significant_Guidance/index.asp). FSIS encourages small and very small meat and 
poultry establishments that manufacture these products to avail 
themselves of this guidance document.

DATES: Effective date: September 19, 2012.

ADDRESSES: A downloadable version of the revised compliance guide is 
available to view and print at http://www.fsis.usda.gov/

[[Page 58090]]

Significant--Guidance/index.asp). No hard copies of the compliance 
guide have been published.

FOR FURTHER INFORMATION CONTACT: Kristina Barlow, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 1400 Independence 
Avenue SW., Mailstop 3782, Washington, DC 20250; email: 
kristina.barlow@fsis.usda.gov; or phone: (202) 690-7739.

SUPPLEMENTARY INFORMATION: 

I. Background

    In April, 2011, FSIS announced the availability of a compliance 
guideline for small and very small meat and poultry establishments on 
the safe production of RTE products (76 FR 22667). FSIS also solicited 
comments on the guidance at that time. In response to comments 
received, FSIS has updated the guidance document to provide more 
options for achieving lethality in RTE meat and poultry products and to 
clarify issues. FSIS has also added an appendix to the document.
    The ``FSIS Salmonella Compliance Guidelines for Small and Very 
Small Meat and Poultry Establishments that Produce Ready-to-Eat 
Products'' provides meat and poultry establishments that manufacture 
RTE meat and poultry products with information on regulatory 
requirements associated with the safe production of these products 
particularly with respect to Salmonella and other pathogens. This 
document also provides information about the processing and safe 
handling of RTE products after the lethality step, so that they are not 
contaminated with pathogens such as Salmonella or Listeria 
monocytogenes (Lm). Though Agency guidance documents are 
recommendations rather than regulatory requirements and are revised as 
new information becomes available, FSIS encourages meat and poultry 
establishments to follow this guidance.

II. Comments and Responses

    FSIS received two comment letters in response to the Salmonella 
Compliance Guidelines for Small and Very Small Meat and Poultry 
Establishments that Produce RTE Products (RTE Salmonella guidelines). 
Both letters were from national trade associations representing the 
interests of primarily small and very small meat packers and 
processors.
    Following is a discussion of these comments and FSIS's responses.

A. Agency Focus on Small and Very Small Establishments

    Comment: Both commenters questioned why the RTE Salmonella 
guidelines focused on small and very small establishments.
    According to one commenter, small and very small meat processors in 
the U.S. represent 5 percent of the total meat production volume, but 
95 percent of the total meat processing businesses in the U.S. This 
commenter suggested that the guidelines not be limited to small and 
very small establishments but rather should be addressed to the whole 
industry.
    Response: FSIS focused the RTE Salmonella Guidelines on small and 
very small establishments in support of the Small Business 
Administration's initiative to provide small and very small 
establishments with compliance assistance. It is important that small 
and very small establishments have access to a full range of scientific 
and technical support, and the assistance needed to establish safe and 
effective HACCP systems. Although large establishments can benefit from 
the guidance that FSIS provides, focusing the guidance on the needs of 
small and very small establishments provides them with information that 
may be otherwise unavailable to them.

B. Request for Clarification on Alternative Processing Options

    Comment: One commenter stated that, in reality, most meat 
processors lack the technology to address or monitor specific aspects 
of Appendix A (64 FR 732; Jan. 6, 1999, at 746) and believes that the 
guidance document fails to adequately present alternative processing 
options.
    This commenter requested clarification about FSIS's expectations 
related to the application of the parameters outlined in Appendix A 
(specifically, relative humidity and dwell time) to all RTE products--
not just cooked, roasted, and corned beef products.
    In addition, both commenters strongly encouraged FSIS to fund 
research that would update existing Agency resources to reflect modern 
processing practices.
    Response: Although this comment is outside the scope of this 
guidance document, FSIS plans to revise Appendices A and B (64 FR 732; 
Jan. 6, 1999, at 748) as part of its efforts to revise guidance 
materials for RTE products. The Agency plans to provide clarification 
of its expectations with respect to dwell time and humidity as part of 
this revision. FSIS has also recently issued ``FSIS Compliance 
Guideline for Meat and Poultry Jerky Products by Small and Very Small 
Establishments,'' which provides more flexible options for achieving 
humidity in RTE products.

C. Demonstrating Adequate Support

    Comment: One commenter stated that although many of the items in 
the RTE Salmonella Compliance Guidelines are especially useful to 
industry, a 5-log10 reduction of Salmonella in finished 
product will be hard to demonstrate for a plethora of products, 
including low-temperature fermented products and non-fermented 
products. The commenter said that if small and very small 
establishments are able to demonstrate adequate support for using a 
science-based approach, the Agency should view the product as 
scientifically safe and wholesome, regardless of whether the 5-
log10 reduction is achieved. The commenter encouraged FSIS, 
in consultation with ARS, to develop more resources, along the lines of 
safe harbors, for small and very small establishments to use as support 
for the processing of non-heat treated RTE products.
    Response: FSIS recognizes that a 5-log10 reduction of 
Salmonella in finished product may be hard to demonstrate for some 
products. To address this difficulty, the guidance provides 
establishments with alternative lethality approaches within the 
guidelines, including utilizing good manufacturing practices and 
incoming product testing to support the safety of lower levels of 
lethality. In addition, FSIS intends to develop further guidance that 
establishments can use to achieve lethality in specific RTE meat and 
poultry products.
USDA Nondiscrimination Statement
    The U.S. Department of Agriculture (USDA) prohibits discrimination 
in all its programs and activities on the basis of race, color, 
national origin, gender, religion, age, disability, political beliefs, 
sexual orientation, and marital or family status. (Not all prohibited 
bases apply to all programs.) Persons with disabilities who require 
alternative means for communication of program information (Braille, 
large print, audiotape, etc.) should contact USDA's Target Center at 
202-720-2600 (voice and TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.
Additional Public Notification
    FSIS will announce this notice online through the FSIS Web page 
located at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.

[[Page 58091]]

    FSIS will also make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The Update is also available on the FSIS 
Web page. In addition, FSIS offers an electronic mail subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range 
from recalls to export information to regulations, directives, and 
notices.
    Customers can add or delete subscriptions themselves, and have the 
option to password protect their accounts.

    Done at Washington, DC, on: September 13, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-23080 Filed 9-18-12; 8:45 am]
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