Mycotoxin Test Kit Design Specifications and Performance Criteria, 67859-67861 [2022-24520]
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Federal Register / Vol. 87, No. 217 / Thursday, November 10, 2022 / Notices
In Iowa
Authority: 7 U.S.C. 71–87k.
Bounded on the north by the northern Iowa
State line from the Big Sioux River east to U.
S. Route 169; bounded on the east by U.S.
Route 169 south to State Route 9; State Route
9 west to U.S. Route 169; U.S. Route 169
south to the northern Humboldt County line;
the Humboldt County line east to State Route
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Interstate 35 northeast to C55; C55 east to
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Route 218; U.S. Route 218 north to
Chickasaw County; the western Chickasaw
County line; and the western and northern
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County lines; V49 south to D38; D38 west to
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bounded on the south by the southern
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northern Iowa State line.
In Minnesota
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In Nebraska
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Route 20), and Thurston Counties.
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In South Dakota
Bounded on the north by State Route 44
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11 south to A54B; A54B east to the Big Sioux
River; Bounded on the East by the Big Sioux
River; and bounded on the south and west by
the Missouri River. The following grain
elevators are not part of this geographic area
assignment and are assigned to Omaha Grain
Inspection Service, Inc.: Scoular Elevator,
Elliot, Montgomery County and two Scoular
elevators, Griswold, Cass County, Iowa.
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17:43 Nov 09, 2022
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Melissa Bailey,
Associate Administrator, Agricultural
Marketing Service.
[FR Doc. 2022–24519 Filed 11–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
[Doc. No. AMS–FGIS–20–0061]
Mycotoxin Test Kit Design
Specifications and Performance
Criteria
Agricultural Marketing Service,
USDA.
ACTION: Notice.
AGENCY:
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 https://
www.ams.usda.gov/services/fgis/
standardization/tke.
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:
Thomas.A.Weber@usda.gov.
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
SUMMARY:
1 Worldwide regulations for mycotoxins in food
and feed in 2003 [Online]. Food and Agriculture
Organization of the United Nations, Rome, Italy,
2004. https://www.fao.org/3/y5499e/y5499e00.htm
(accessed 5/24/2022).
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67859
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.
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
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Federal Register / Vol. 87, No. 217 / Thursday, November 10, 2022 / Notices
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
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17:43 Nov 09, 2022
Jkt 259001
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 HorwitzThompson 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,
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Fmt 4703
Sfmt 4703
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
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Federal Register / Vol. 87, No. 217 / Thursday, November 10, 2022 / Notices
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
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2020–0030]
State University of New York College
of Environmental Science and
Forestry; Availability of a Draft
Environmental Impact Statement and
Draft Plant Pest Risk Assessment for
Determination of Nonregulated Status
for Blight-Tolerant Darling 58 American
Chestnut (Castanea dentata)
Developed Using Genetic Engineering
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of availability.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service has prepared a draft
environmental impact statement (EIS)
and draft plant pest risk assessment
(PPRA) evaluating the potential
environmental impacts and plant pest
risk that may result from the approval
of a petition for nonregulated status for
blight-tolerant Darling 58 American
chestnut (Castanea dentata) from the
State University of New York College of
Environmental Science and Forestry.
The trees have been developed using
genetic engineering to express an
oxalate oxidase enzyme from wheat as
a defense against the fungal pathogen
Cryphonectria parasitica, making
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SUMMARY:
VerDate Sep<11>2014
17:43 Nov 09, 2022
Jkt 259001
Darling 58 American chestnut tolerant
to chestnut blight. We are making the
draft EIS and draft PPRA available for
public review and comment.
DATES: We will consider all comments
that we receive on or before December
27, 2022.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
www.regulations.gov. Enter APHIS–
2020–0030 in the Search field. Select
the Documents tab, then select the
Comment button in the list of
documents.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2020–0030, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
The petition and any comments we
receive on this docket may be viewed at
Regulations.gov or in our reading room,
which is located in Room 1620 of the
USDA South Building, 14th Street and
Independence Avenue SW, Washington,
DC. Normal reading room hours are 8
a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure
someone is there to help you, please call
(202) 799–7039 before coming.
FOR FURTHER INFORMATION CONTACT: Mr.
Subray Hegde, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737–
1238; (301) 851–3901; email:
subray.hegde@usda.gov.
SUPPLEMENTARY INFORMATION:
Background
Under the authority of the plant pest
provisions of the Plant Protection Act,
as amended (7 U.S.C. 7701 et seq.), the
regulations in 7 CFR part 340,
‘‘Movement of Organisms Modified or
Produced Through Genetic
Engineering,’’ regulate, among other
things, the importation, interstate
movement, or release into the
environment of organisms modified or
produced through genetic engineering
that are plant pests or pose a plausible
plant pest risk.
The Animal and Plant Health
Inspection Service (APHIS) issued a
final rule, published in the Federal
Register on May 18, 2020 (85 FR 29790–
29838, Docket No. APHIS–2018–0034),1
revising 7 CFR part 340. However, this
petition (APHIS Petition Number 19–
309–01p) 2 for a determination of
1 To view the final rule, go to
www.regulations.gov and enter APHIS–2018–0034
in the Search field.
2 To view the petition, go to https://
www.aphis.usda.gov/aphis/ourfocus/biotechnology/
regulatory-processes/petitions/petition-status.
PO 00000
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67861
nonregulated status is being evaluated
in accordance with the regulations at 7
CFR 340.6 (2020), which were effective
at the time it was received by APHIS on
January 21, 2020.
APHIS received a petition from the
State University of New York College of
Environmental Science and Forestry
(ESF) seeking a determination of
nonregulated status for blight-tolerant
Darling 58 American chestnut (Castanea
dentata). The petition states that Darling
58 American chestnut is unlikely to
pose a plant pest risk and, therefore,
should not be regulated under APHIS’
regulations in 7 CFR part 340.
According to our process 3 for
soliciting public comment when
considering petitions for determination
of nonregulated status of regulated
organisms, APHIS accepts written
comments regarding a petition once
APHIS deems it complete. On August
19, 2020, we announced in the Federal
Register (85 FR 51008–51009, Docket
No. APHIS–2020–0030) the availability
of the blight-tolerant chestnut petition
for public comment.4 We solicited
comments on the petition for 60 days to
help us identify potential environmental
and interrelated economic issues and
impacts that APHIS should consider in
evaluation of the petition. We received
4,320 comments on the petition from
the academic sector, farmers, nongovernmental organizations, nonprofit
organizations, industry, tribes, and
unaffiliated individuals.
As part of our evaluation of the
petition and consideration of public
comments, APHIS concluded that the
proposed determination of nonregulated
status has the potential to significantly
affect the quality of the human
environment.5 In a notice 6 published in
the Federal Register on August 6, 2021
3 On March 6, 2012, APHIS published in the
Federal Register (77 FR 13258–13260, Docket No.
APHIS–2011–0129) a notice describing our public
review process for soliciting public comments and
information when considering petitions for
determinations of nonregulated status for organisms
developed using genetic engineering. To view the
notice, go to www.regulations.gov and enter APHIS–
2011–0129 in the Search field.
4 To view the notice, supporting documents, and
the comments that we received, go to
www.regulations.gov and enter APHIS–2020–0030
in the Search field.
5 Human environment means comprehensively
the natural and physical environment and the
relationship of present and future generations of
Americans with that environment. Impacts/effects
include ecological (such as effects on natural
resources, and on the components, structures, and
functioning of affected ecosystems), aesthetic,
historic, cultural, economic (such as the effects on
employment), social, or health effects (see 40 CFR
1508.1).
6 To view the notice and the comments we
received, go to www.regulations.gov and enter
APHIS–2020–0030 in the Search field.
E:\FR\FM\10NON1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 217 (Thursday, November 10, 2022)]
[Notices]
[Pages 67859-67861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
https://www.ams.usda.gov/services/fgis/standardization/tke.
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:
[email protected].
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. https://www.fao.org/3/y5499e/y5499e00.htm (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
