[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Notices]
[Pages 38683-38686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15422]
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DEPARTMENT OF AGRICULTURE
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.
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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: [email protected].
SUPPLEMENTARY INFORMATION:
Background
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
comments.
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
results.
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
guidelines.
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
establishment.
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
accounts.
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Done at Washington, DC, on June 21, 2013.
Alfred V. Almanza,
Administrator.
[FR Doc. 2013-15422 Filed 6-26-13; 8:45 am]
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