[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23080]
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-
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice of availability.
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/
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:
firstname.lastname@example.org; or phone: (202) 690-7739.
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
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
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
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
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
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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.
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
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Done at Washington, DC, on: September 13, 2012.
Alfred V. Almanza,
[FR Doc. 2012-23080 Filed 9-18-12; 8:45 am]
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