Notice2022-24520
Mycotoxin Test Kit Design Specifications and Performance Criteria
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 10, 2022
Issuing agencies
Agriculture DepartmentAgricultural Marketing Service
Abstract
The Agricultural Marketing Service (AMS) is announcing its decisions regarding proposed changes to its mycotoxin test kit performance criteria after evaluating public comments received during prior publications in the Federal Register (85 FR 82427 and 86 FR 10531).
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 217 (Thursday, November 10, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 217 (Thursday, November 10, 2022)]
[Notices]
[Pages 67859-67861]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24520]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
[Doc. No. AMS-FGIS-20-0061]
Mycotoxin Test Kit Design Specifications and Performance Criteria
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Agricultural Marketing Service (AMS) is announcing its
decisions regarding proposed changes to its mycotoxin test kit
performance criteria after evaluating public comments received during
prior publications in the Federal Register (85 FR 82427 and 86 FR
10531).
DATES: Applicable: November 10, 2022.
ADDRESSES: For access to the AMS mycotoxin test kit criteria, go to
<a href="https://www.ams.usda.gov/services/fgis/standardization/tke">https://www.ams.usda.gov/services/fgis/standardization/tke</a>.
FOR FURTHER INFORMATION CONTACT: Thomas A. Weber, Analytical Chemistry
Branch Chief, Technology and Science Division, Federal Grain Inspection
Service, AMS, USDA, 816-702-3811; Telephone: (816) 702-3811, or Email:
<a href="/cdn-cgi/l/email-protection#97c3fff8faf6e4b9d6b9c0f2f5f2e5d7e2e4f3f6b9f0f8e1"><span class="__cf_email__" data-cfemail="eabe8285878b99c4abc4bd8f888f98aa9f998e8bc48d859c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Mycotoxins are toxic chemicals produced by
certain fungal species under favorable environmental conditions. Many
countries \1\ have set maximum allowable concentration levels for
specific mycotoxins in food and feed to ensure the safety of consumers.
Mycotoxin levels are a critical factor in the trade of grain and
quantitative mycotoxin testing is an integral part of buyer-seller
contract specifications. Under the authority of the United States
Grains Standards Act (7 U.S.C. 71-87k), as amended, and the
Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), as amended,
AMS provides official mycotoxin testing services throughout the United
States for domestic and export grains, oilseeds, and processed-grain
commodities. Official testing services are provided for aflatoxins,
deoxynivalenol, fumonisins, ochratoxin A, and zearalenone. Testing at
field locations requires rapid, inexpensive, and accurate methods to
effectively assess US grain quality. An essential part of ensuring the
quality of official mycotoxin testing is the AMS test kit evaluation
program, through which test kits are evaluated and certified for
conformance to specific criteria. Only test kits having AMS
certification are approved for official mycotoxin testing. AMS
establishes the test kit performance criteria and periodically updates
them to improve testing accuracy and to meet the official mycotoxin
testing program's operational needs.
---------------------------------------------------------------------------
\1\ Worldwide regulations for mycotoxins in food and feed in
2003 [Online]. Food and Agriculture Organization of the United
Nations, Rome, Italy, 2004. <a href="https://www.fao.org/3/y5499e/y5499e00.htm">https://www.fao.org/3/y5499e/y5499e00.htm</a> (accessed 5/24/2022).
---------------------------------------------------------------------------
AMS requested comments from test kit manufacturers and other
stakeholders on proposed changes to AMS mycotoxin test kit criteria
through a notice that was published in the Federal Register at 85 FR
82427 on December 18, 2020. The original 30-day comment period provided
in the notice closed on January 19, 2021. Comments were received from
ten stakeholders requesting an extension of the comment period. AMS
reopened the comment period in the Federal Register at 86 FR 10531 on
February 22, 2021, for 30 days to allow interested persons additional
time to review and comment on the notice. The second comment period
closed on March 24, 2021. A summary of the public comments, decisions,
and future considerations follows.
Minimum Ranges of Conformance
For each mycotoxin, AMS has established a minimum range of
concentrations that must be covered in the test kit's scope and conform
to AMS accuracy requirements. This range is referred to as the minimum
range of conformance. AMS proposed to expand the minimum ranges for
fumonisins, ochratoxin A, and zearalenone test kits to meet the current
and anticipated future testing needs of the grain industry.
AMS proposed expanding the current minimum range for fumonisins
from 0.50-30 parts per million (ppm) to 0.50-100 ppm to provide testing
up to the U.S. Food and Drug Administration's highest industry guidance
level in corn and corn products. Comments were received from eleven
stakeholders. Four stakeholders endorsed this proposal, while two of
the four supported the change for corn only. Three stakeholders were
against the change, because the grain has no market value at such high
levels or because of the difficulty in sourcing large quantities of
contaminated grains with 100 ppm fumonisins. Six stakeholders were
[[Page 67860]]
against this change due to the risk for increased variation in the test
results and suggested instead that narrowing the ranges would reduce
variability. Five of these stakeholders recommended that the evaluation
of test kits at the 100-ppm level should be optional. AMS believes that
there may be limitations in test kit calibration linearity and
additional sample preparation steps that could lead to increased
variation. As a result, AMS will not implement proposed change at this
time. AMS will follow up with test kit manufacturers to further assess
the risk of increased variation and its impact.
To allow for expected testing variation below the maximum
concentration levels of 5 parts per billion (ppb), required by a
standard set by the Codex Alimentarius Commission, AMS proposed to
expand the minimum range of concentrations for ochratoxin A from 5.0-
100 ppb to 1.0-100 ppb. AMS was interested in comments on whether the
maximum limit should also be lowered from 100 ppb to 20 ppb, resulting
in a narrower minimum range (i.e., 1.0-20 ppb). Comments were received
from ten stakeholders. None of the stakeholders supported the AMS
proposal to expand the minimum range. Five stakeholders asserted that
the change would require test kits to be as accurate as the reference
method, which they thought was an unreasonable expectation. However, no
technical data was provided by the manufacturers to support that claim.
Additionally, three stakeholders expressed concern that producing a 1.0
ppb ochratoxin A reference material may be difficult. However, five
stakeholders supported an alternative lower concentration limit of 2-3
ppb and an upper limit of 20 ppb. AMS needs to gather and evaluate
additional information from test kit manufacturers on their claim
regarding the limitations of technology to quantify ochratoxin A at
lower levels prior to setting a new limit. Therefore, AMS will not
implement its proposed change at this time.
International regulators, including the European Union, have
established maximum concentration levels for zearalenone at 100 ppb in
cereals and other grains. To allow for expected testing variation below
this regulatory limit, AMS proposed to expand the minimum range of
concentrations from 100-1000 ppb to 20-1000 ppb. Comments were received
from ten stakeholders. None of the stakeholders supported the AMS
proposal. Five stakeholders supported changing the lower limit to 50
ppb, while two of the five also wanted an upper limit of 500 ppb. Four
stakeholders requested that the required range of concentrations be
narrower due to the potential for increased variability. AMS believes
that there may be limitations in test kit calibration linearity and
additional sample preparation steps that could lead to increased
variation. As a result, AMS will not implement proposed change at this
time. AMS will follow up with test kit manufacturers to further assess
the risk of increased variation and its impact.
Evaluation of Mycotoxin Test Kit Accuracy
AMS proposed to change the way the acceptable ranges for test
results are calculated to align with the Horwitz-Thompson equation,
which is an internationally accepted benchmark for evaluating
analytical method performance. Comments were received from fourteen
stakeholders. None of the stakeholders supported the AMS proposal. Four
stakeholders were against the proposal because of perceived limitations
of applying the Horwitz-Thompson equation to immunochemistry-based
methods. Four stakeholders stated that the proposed acceptable ranges
would result in more complex and longer test procedures, leading to
higher variation. Six stakeholders stated that increasing the precision
in test kit results would be most effective by minimizing the variation
introduced by sample preparation, which includes grinding to a smaller
particle size, adjusting the sample size, and using uniform sample
extraction procedures. Seven stakeholders stated that narrowing the
required concentration ranges would result in more accurate test
results. AMS believes that the Horwitz-Thompson model should be the
benchmark for the evaluation of mycotoxin test kits, since countries
importing U.S. grain worldwide utilize standardized mycotoxin testing
methods with performance characteristics that conform to this model.
Providing mycotoxin test kits that meet this benchmark would increase
the confidence of importing countries in AMS testing services, thereby
facilitating exports of U.S. grain. However, AMS recognizes the
concerns expressed through the comments received and will not implement
the proposed changes at this time in order to further investigate how
to incorporate the Horwitz-Thompson model into the mycotoxin test kit
criteria.
Number of Readers
Mycotoxin concentrations are determined by an electronic
instrument, often referred to as a ``reader'' by test kit manufacturers
and users. AMS has observed variation in test results during side-by-
side comparisons of identical reader models. In effort to increase the
robustness of the evaluation, AMS proposed to use three separate
readers during the evaluation process. Three readers were chosen as a
practical number, because three analysts are participating in the
evaluation and each could use a separate reader for expediency.
Comments were received from five stakeholders, and all supported the
AMS proposal to use three separate readers during the evaluation
process. AMS will implement this requirement in the mycotoxin test kit
program to account for variability in readers.
Test Kit Manufacturer Analysts
AMS proposed to update the method performance criteria to allow up
to two analysts from the test kit manufacturer to participate in the
verification study conducted at the AMS laboratory. Comments were
received from five stakeholders, all of whom supported this AMS
proposal. AMS will implement this option in the mycotoxin test kit
program to promote transparency in the verification process.
Extraction Method
AMS proposed that the extraction method used for the primary
grain(s) should be the same as that used for additional commodities.
This change would provide evidence that the method can generate
accurate results for both naturally contaminated and artificially
fortified grains and commodities. Comments were received from five
stakeholders. None of the stakeholders supported the AMS proposal. Two
stakeholders recommended that naturally contaminated samples be
required in the evaluation of additional commodities. AMS recognizes
that artificially fortified samples do not truly represent naturally
contaminated samples, and therefore, not the most robust method for
evaluating test kit performance. AMS has allowed for artificially
fortified samples due to the lack of the natural occurrence of specific
mycotoxins in particular commodities. Requiring the use of naturally
contaminated samples is anticipated to reduce the number of additional
grains and commodities for which AMS can provide testing services. AMS
will not implement the proposed change at this time in order to further
engage industry stakeholders on the impacts associated with continuing
to allow the use of artificially fortified samples versus
[[Page 67861]]
requiring naturally contaminated samples in evaluating test kit
performance.
Other Comments
Seven stakeholders made comments, which were beyond the scope of
the changes proposed by AMS. These comments included recommendations to
modify the minimum ranges of concentrations for aflatoxins and
deoxynivalenol, to change the test kit certificate expiration period
from three to five years, to revise the study design for the
performance verification, to require all participants to use reference
materials from one provider, and for AMS to provide guidance or
recommendations on extraction procedures. AMS may engage stakeholders
for further information about these recommendations and consider them
in future program improvements.
Melissa Bailey,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2022-24520 Filed 11-9-22; 8:45 am]
BILLING CODE 3410-02-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on November 10, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.