[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Pages 38683-38686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15422]



Food Safety and Inspection Service

[Docket No. FSIS-2011-0033]

Availability of Guidance: Establishments Guidance for the 
Selection of a Commercial or Private Microbiological Testing Laboratory

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of final guidance for federally inspected 
establishments in the selection of commercial and private 
microbiological testing laboratories. FSIS has posted this policy 
guidance on its Web page http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. FSIS encourages 
establishments that prepare meat, poultry, or processed egg products to 
consider the criteria in the guidance in selecting commercial or 
private microbiological testing laboratories and in determining the 
laboratories' capability to produce accurate and reliable results. 
Regulated establishments are required to introduce into commerce only 
meat, poultry, or processed egg products that are safe and not 
adulterated or misbranded. Establishments that select laboratories that 
do not apply appropriate testing methods or maintain effective Quality 
Control or Quality Assurance (QC/QA) practices may not receive reliable 
or useful test results and thus run the risk of not being aware that 
the food that they have produced is unsafe.

DATES: The guidance is effective August 26, 2013.

FOR FURTHER INFORMATION CONTACT: Evelyne Mbandi, Deputy Director, Risk, 
Innovations, and Management Staff, U.S. Department of Agriculture, Food 
Safety and Inspection Service, 1400 Independence Avenue SW., Patriots 
Plaza 3, Mailstop 3782, Room 163-B, Washington, DC 20250; Phone: (301) 
504-0897; Email: evelyne.mbandi@fsis.usda.gov.



    In a Federal Register notice published March 8, 2012 (77 FR 13999), 
FSIS made available its ``Establishment Guidance for the Selection of a 
Commercial or Private Microbiological Testing Laboratory'' and 
requested comment on it. As FSIS explained in the 2012 Federal Register 
notice, this guidance document provides establishments that prepare 
meat, poultry, and processed egg products with criteria for selecting a 
commercial or private laboratory to analyze their samples. Regulated 
establishments are ultimately responsible for the testing methods and 
practices that the laboratory employs on the establishments' behalf.
    An FSIS-regulated establishment may perform microbiological testing 
for various reasons, including, but not limited to: Fulfilling 
regulatory requirements; performing on-going verification of the 
establishment's Hazard Analysis and Critical Control Point (HACCP) 
plan; supporting decisions made in the establishment's hazard analysis; 
evaluating the effectiveness of the establishment's sanitation program; 
and complying with purchase specifications or requirements.

[[Page 38684]]

    In response to the comments it received, FSIS has revised the 
guidance to clarify that establishments that select laboratories that 
meet the guidance provided in the International Organization for 
Standardization (ISO) 17025 accreditation schemes would meet the 
applicable criteria set out in FSIS's guidance. FSIS also revised the 
guidance to explain that establishments that have samples analyzed 
using an accredited laboratory and an FSIS Microbiology Laboratory 
Guidebook (MLG) method would meet the applicable criteria recommended 
in the guidance. FSIS also revised the guidance to state that 
proficiency testing (PT) should be performed on a regular basis. FSIS 
made other technical changes to the guidance discussed below in the 
response to comments.
    FSIS encourages establishments to use the guidance in selecting 
commercial or private laboratories and for ensuring that 
microbiological testing performed on their behalf meets their food 
safety needs.

Discussion of Comments

    FSIS received seven comments on the guidance in response to the 
2012 Federal Register notice. These comments were from suppliers of 
laboratory services and products, providers of proficiency testing, 
commercial laboratories, trade associations, and meat packing and 
processing establishment representatives.
    The following is a discussion of the relevant issues raised in the 
    Comment: A commenter asked, if an establishment required a 
commercial laboratory to follow the guidance and provide a written 
guarantee to the establishment to this effect, would FSIS consider the 
establishment to be following the guidance? The commenter also asked 
whether FSIS would instruct IPP to write a noncompliance record (NR) if 
the laboratory did not follow the guidance. In addition, the commenter 
asked what scientific criteria a small establishment owner might 
provide a laboratory to help ensure that the laboratory used acceptable 
methods and provided reliable results.
    Response: Following this guidance is not a requirement for 
establishments. If an establishment chooses to follow this guidance, 
FSIS recommends that it do more than provide a copy to the 
laboratories. FSIS recommends that the establishment ask the laboratory 
to do more than give the establishment a written guarantee that it is 
following the guidance. For example, in addition to completing the 
checklist (Appendix I), the laboratory should provide documentation for 
the establishment to be able to determine that the laboratory is using 
validated methods to test its samples, and that the methods are fit for 
the purpose. The establishment is responsible for performing on-going 
HACCP verification activities (9 CFR 417.4(a)) and documenting those 
activities and their frequency (9 CFR 417.5(a)(3)) to support its 
decisions in its hazard analysis. The establishment should ensure that 
the laboratory is providing reliable results by understanding their 
significance and how they apply to its food safety system, e.g., 
whether the results evidence that the product is adulterated.
    Because following the guidance is not required, FSIS will not issue 
an NR if an establishment has chosen not to follow it or does not 
ensure that a laboratory that tests product samples on its behalf 
follows it. However, FSIS will continue to verify that establishments 
comply with the regulations.
    Small establishments can provide a copy of this guidance to 
laboratories they employ to help ensure that these laboratories use 
acceptable methods and provide reliable results. In addition, small 
establishments can request a copy of the completed checklist (Appendix 
I) from the laboratory.
    Comment: Commenters noted that similar guidance is available that 
addresses how establishments should select a testing laboratory and is 
used by FSIS, FDA, and many other federal laboratories: Association of 
Analytical Communities (AOAC) International Guidelines for Laboratories 
Performing Microbiological and Chemical Analyses of Food and 
Pharmaceuticals. The commenter recommended that all laboratories, 
regardless of size, or whether they are third-party or on-site, be 
required to meet the same criteria to provide consistency of test 
    Response: FSIS recognizes that the AOAC International Guidelines 
for Laboratories Performing Microbiological and Chemical Analyses of 
Food and Pharmaceuticals is useful for laboratory staff and as guidance 
for laboratories seeking to implement the ISO 17025 standards. FSIS has 
developed its guidance to assist industry plant managers and support 
staff in assessing and selecting laboratory services. While FSIS 
acknowledges that there is some technical overlap between these 
documents, the FSIS document provides language and content intended for 
a non-technical industry audience. Regarding the suggestion that all 
laboratories meet the same criteria regardless of size, FSIS is 
providing guidance, not proposing to mandate laboratory accreditation.
    Comment: A commenter stated that the guidance should state that 
some accreditation schemes, e.g. ISO, meet the criteria in FSIS's 
    Response: In the final guidance, FSIS has added an explanation that 
laboratories that meet the guidance provided in the ISO 17025 
accreditation schemes would meet the criteria in the guidelines. 
Similarly, FSIS has explained that establishments that analyze samples 
using an accredited laboratory and an FSIS Microbiology Laboratory 
Guidebook (MLG) method would also meet the criteria in the guidance.
    Comment: One commenter asked whether FSIS has developed a list of 
minimally acceptable test protocols.
    Response: FSIS has not developed a list of minimally acceptable 
test protocols. However, FSIS has posted a web-based list of validated 
methods commonly used by regulated establishments to test for pathogens 
of interest (E. coli O157:H7 and STECs; Listeria monocytogenes and 
Listeria species; and Salmonella and Campylobacter species) in meat, 
poultry, and processed egg products. The list of these methods is 
available at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/New+Technologies. FSIS will revise the Web-based 
database of commonly used methods on a quarterly basis. However, 
establishments or laboratories can use other methods. As stated in 
Chapter 2, Part D, Method of Selection and Implementation, in this 
guidance, the method should be capable of detecting the target pathogen 
and have been validated using a scientifically robust study by a 
recognized entity, as outlined in the FSIS validation guidance document 
for test kit manufacturers and laboratories, available at: http://www.fsis.usda.gov/wps/wcm/connect/966638c7-1931-471f-a79e-4155ce461d65/Validation_Studies_Pathogen_Detection_Methods.pdf?MOD=AJPERES. 
Internationally recognized independent organizations include AOAC, 
AFNOR, MicroVal, and NordVal. Any modifications introduced to a 
validated method should also be validated using a scientifically robust 
study. Samples could also be analyzed by a laboratory that is ISO 
17025-accredited, using a method in the FSIS MLG. Although ISO 
accreditation is not required, accreditation provides increased 
confidence in the accuracy of the test results. Using either an 
acceptable validated method or any other sample testing method the 
establishment can support would be acceptable to the Agency. Additional 
information on the FSIS MLG Methods and ISO

[[Page 38685]]

accreditation is available at: http://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-procedures/guidebooks-and-methods/microbiology-laboratory-guidebook/microbiology-laboratory-guidebook ; 
http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/production-and-inspection/key-facts-iso-accreditation/key-facts-iso-accreditation; and http://www.isoiec17025.com/.
    Comment: A commenter stated that the guidance did not state whether 
proficiency testing (PT) should be required of the laboratory or of the 
individual analyst or technician and requested clarification regarding 
necessary PT qualifications for individual analysts of technicians. The 
commenter also suggested that instructions in the guidance should 
change the definition of ``routine PT'' to reflect the reality that PT 
is regularly administered more than once or twice a year.
    Response: FSIS has revised the document to state that PT should be 
performed on a regular basis (at least 2 to 3 times annually). FSIS 
explains that PT programs are designed to critically evaluate the 
accuracy, precision, and efficiency of the laboratory. PT provides 
evidence of a laboratory's ability to produce credible analytical 
results with a method, and laboratories may use PT as a means to 
evaluate individual analysts' initial and ongoing competency to perform 
a method.
    Comment: A commenter stated that the guidance should provide 
clarification on some of the instructions on how PT should be utilized 
operationally by a laboratory. Specifically, the commenter stated that 
FSIS should clarify that worksheets for PT are not provided by the PT 
program. The commenter also noted that PT organizations do not 
``certify'' laboratories. The commenter suggested that portions of this 
guidance may benefit from a better explanation of FSIS's compliance 
process and recommended that the establishment make the completed 
checklist (Appendix I) available to FSIS personnel as supplemental 
data. Finally, the commenter stated that, when choosing a laboratory, 
the establishment should consider whether the result of the 
laboratory's previous year's PT was acceptable.
    Response: FSIS has revised the guidance to incorporate the 
commenter's suggestion by referring to PT records rather than 
worksheets and made the other necessary technical changes recommended 
by the commenter. In addition, FSIS has revised the Quality Assurance 
Management System section of the guidance document and added questions 
regarding the verification of laboratory's past year's PT results.
    Comment: One commenter stated that the guidance document would 
almost preclude the use of microbiological testing data generated by 
private and commercial laboratories because, the commenter thought, the 
document requires criteria similar to ISO 17025. The commenter added 
that the guidance document had the same guidance for selection of a 
laboratory that completes very basic tests as that for a lab that 
completes complex pathogenic tests. The commenter also noted that the 
guidance on collection of samples should reflect that food samples in 
finished packages need not be transferred to a ``sterile primary 
container'' as long as the receiving laboratory verifies that the 
package is intact. Finally, the commenter requested clarification or 
examples of how methods could be validated in foods representative of 
those likely to be sampled at the establishment.
    Response: This document is only guidance, and it does not set new 
requirements for laboratories or the regulated industry. The final 
document explains that pathogen testing laboratories should follow 
requirements for Biosafety Level II laboratory operation as outlined in 
Biosafety in Microbiological and Biomedical Laboratories. The guidance 
continues to recognize the critical data provided by on-site 
laboratories. FSIS also explains that food samples in intact retail 
packs do not have to be placed in sterile containers but should be 
placed in a secondary container, such as a sealed plastic bag. This 
approach is consistent with the Agency's sample collection methods.
    The guidance document provides information on lab validation. 
Representative food matrices are available at the AOAC-RI Performance 
Tested Web page. The Agency is providing links to the AOAC-RI 
Performance Tested Methods and AOAC Official Methods of Analysis in the 
Reference section of the guidance document. Manufacturers of 
microbiological testing products, including pathogen screening tests, 
often provide useful information on the validation of their products.
    Comment: A commenter stated that wording in the FSIS guidance 
document was vague with regard to the risk of contamination that could 
spread from an on-site laboratory to manufacturing areas of an 
    Response: FSIS has revised the guidance to recommend that, because 
of safety concerns and to prevent cross-contamination, a pathogen 
testing laboratory should be segregated from manufacturing areas, and 
that access to the laboratory space be limited.

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/wps/portal/fsis/topics/regulations/federal-register/federal-register-notices.
    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/wps/portal/fsis/programs-and-services/email-subscription-service. 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 

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    Done at Washington, DC, on June 21, 2013.
Alfred V. Almanza,
[FR Doc. 2013-15422 Filed 6-26-13; 8:45 am]