Mycotoxin Test Kit Design Specifications and Performance Criteria, 82427-82428 [2020-27850]

Agencies

• Agricultural Marketing Service
• DEPARTMENT OF AGRICULTURE

[Federal Register Volume 85, Number 244 (Friday, December 18, 2020)]
[Notices]
[Pages 82427-82428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27850]


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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; request for comments.

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SUMMARY: The United States Department of Agriculture's (USDA) 
Agricultural Marketing Service (AMS) evaluates the conformance of 
mycotoxin test kits to AMS-established design specifications and 
performance criteria. Only test kits that conform to all of the AMS 
requirements are approved for the official testing of grains and 
related commodities. AMS proposes to make several changes to the 
existing test kit criteria to improve testing services and better 
facilitate domestic and international trade. AMS is seeking public 
comment on the proposed changes to the criteria.

DATES: Comments are due by January 19, 2021.

ADDRESSES: The current criteria documents subject to the changes in 
this notice are available for review at https://www.ams.usda.gov/services/fgis/standardization/tke. Additional technical information 
regarding the proposed changes can be found at https://www.ams.usda.gov/sites/default/files/media/technical-doc-frn-ams-fgis-20-0061.pdf.
    To submit Comments: Go to Regulations.gov (https://www.regulations.gov). Instructions for submitting and reading comments 
are detailed on the site. Interested persons are invited to submit 
written comments concerning this notice. All comments must be submitted 
through the Federal e-rulemaking portal at https://www.regulations.gov 
and should reference the document number and the date and page number 
of this issue of the Federal Register. All comments submitted in 
response to this notice will be included in the record and will be made 
available to the public. Please be advised that the identity of the 
individuals or entities submitting comments will be made public on the 
internet at the address provided above.

FOR FURTHER INFORMATION CONTACT: Thomas A. Weber, Analytical Chemistry 
Branch Chief, Technology and Science Division, Federal Grain Inspection 
Service, AMS, USDA, 816-891-0449, [email protected].

SUPPLEMENTARY INFORMATION: Mycotoxins are toxic chemicals produced by 
certain fungal species under favorable environmental conditions. 
Regulators 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. AMS last updated the 
criteria in 2016. AMS proposes to update the test kit performance 
criteria with the following changes in 2021. AMS is seeking comments on 
the impact of making these changes.

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. The test 
kit must conform to the AMS accuracy requirements throughout this 
range. AMS proposes to expand the minimum ranges of conformance for 
fumonisins, ochratoxin A, and zearalenone test kits to meet the current 
and anticipated testing needs of the grain industry.
    The US Food and Drug Administration has set the highest industry 
guidance level for fumonisins in corn at 100 parts-per-million (ppm). 
As a result, AMS proposes to expand the current minimum range of 
conformance from 0.50-30 ppm to 0.50-100 ppm so that it includes this 
highest guidance level.
    Since the measurement of mycotoxin concentrations is not exact, 
multiple measurements will have results that vary by some amount. To 
ensure a mycotoxin concentration is below the maximum level allowed, 
there is a need to measure sufficiently below that level, considering 
the expected variation in results. For this reason, AMS proposes to 
expand the minimum ranges of conformance for ochratoxin A and 
zearalenone test kits to lower concentrations than currently required.
    Codex Alimentarius, an internationally recognized food safety 
standard setting body, recommends a maximum of 5 parts-per-billion 
(ppb) ochratoxin A in wheat, barley, and rye. Therefore, AMS proposes 
to expand the minimum range of conformance for ochratoxin A from 5.0-
100 ppb to 1.0-100 ppb. AMS is interested in comments on whether the 
maximum conformance limit should also be changed from 100 ppb to 20 
ppb, resulting in a narrower minimum range of conformance (i.e., 1.0-20 
ppb).
    International regulators, including the European Union (EU) have 
established maximum levels for zearalenone at 100 ppb in cereals and 
other grains. To test sufficiently below this regulatory limit, AMS 
proposes to expand the minimum range of conformance from 100-1000 ppb 
to 20-1000 ppb.

Evaluation of Mycotoxin Test Kit Accuracy

    To evaluate test kit accuracy, AMS requires analyses of reference 
materials to be performed at different concentrations across the range 
of conformance. At least 95% of these individual results must be within 
the acceptable range for each of the tested concentrations to meet AMS 
accuracy requirements. AMS proposes to change

[[Page 82428]]

the way the acceptable ranges are calculated to align with 
international standards for evaluating method performance. Tables 1-5 
compare the current acceptable ranges with the revised ranges based on 
the proposed method. The actual ranges may differ slightly from the 
listed ones, because results from the certification of reference 
materials would be included in determining the ranges. The proposed 
change will require greater accuracy from the test kits. Test kit 
manufacturers and other interested parties are encouraged to review the 
additional technical information, which serves as the basis for these 
changes at https://www.ams.usda.gov/sites/default/files/media/technical-doc-frn-ams-fgis-20-0061.pdf.

                           Table 1--Aflatoxins
------------------------------------------------------------------------
                                                 Acceptable range (ppb)
               Aflatoxins (ppb)                -------------------------
                                                  Current      Proposed
------------------------------------------------------------------------
5.0...........................................      2.5-7.5      3.5-6.5
20............................................        12-28        14-26
100...........................................       68-130       69-130
300...........................................      200-400      220-380
------------------------------------------------------------------------


                         Table 2--Deoxynivalenol
------------------------------------------------------------------------
                                                 Acceptable range (ppm)
             Deoxynivalenol (ppm)              -------------------------
                                                  Current      Proposed
------------------------------------------------------------------------
0.50..........................................    0.30-0.70    0.38-0.62
2.0...........................................      1.5-2.5      1.6-2.4
5.0...........................................      4.0-6.0      4.1-5.9
30............................................        24-36        26-34
------------------------------------------------------------------------


                           Table 3--Fumonisins
------------------------------------------------------------------------
                                                 Acceptable range (ppm)
               Fumonisins (ppm)                -------------------------
                                                  Current      Proposed
------------------------------------------------------------------------
0.50..........................................    0.32-0.68    0.38-0.62
2.0...........................................      1.4-2.6      1.6-2.4
5.0...........................................      3.7-6.3      4.1-5.9
30............................................        22-38        26-34
100...........................................       74-130       89-110
------------------------------------------------------------------------


                          Table 4--Ochratoxin A
------------------------------------------------------------------------
                                                 Acceptable range (ppb)
              Ochratoxin A (ppb)               -------------------------
                                                  Current      Proposed
------------------------------------------------------------------------
1.0...........................................  ...........     0.69-1.3
5.0...........................................      3.0-7.0      3.5-6.5
20............................................        12-28        14-26
100...........................................       60-140       69-130
------------------------------------------------------------------------


                          Table 5--Zearalenone
------------------------------------------------------------------------
                                                 Acceptable range (ppb)
               Zearalenone (ppb)               -------------------------
                                                  Current      Proposed
------------------------------------------------------------------------
20............................................  ...........        14-26
100...........................................       50-150       69-130
250...........................................      150-350      180-320
1000..........................................     600-1400     780-1200
------------------------------------------------------------------------

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. Therefore, AMS proposes to 
use three separate readers during the evaluation process.

Test Kit Manufacturer Analysts

    AMS proposes to update the criteria documents to allow up to two 
analysts from the test kit manufacturer to participate in the 
performance verification study conducted at the AMS facility. 
Participation by the test kit manufacturer promotes transparency and 
trust in the program.

Extraction Method

    Each mycotoxin has one or two primary grains, which must be 
included in the scope of the test kit. AMS identifies a primary grain 
based on the known occurrence of the mycotoxin and the frequency of 
official testing requests. Table 6 shows the list of primary grains by 
mycotoxin.

              Table 6--List of Primary Grains by Mycotoxin
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Mycotoxin.................................  Primary Grain(s)
Aflatoxins................................  Corn
Deoxynivalenol............................  Corn and Wheat
Fumonisins................................  Corn
Ochratoxin A..............................  Wheat
Zearalenone...............................  Corn
------------------------------------------------------------------------

    Any other commodities for which a manufacturer seeks test kit 
approval are referred to as ``additional commodities.'' AMS requires 
the use of naturally contaminated samples to evaluate test kit accuracy 
for the primary grain, but allows artificial fortification through the 
addition of standard solutions for additional commodity samples. A 
standard solution is a known amount of the mycotoxin dissolved in a 
solvent. AMS proposes to require that the extraction method used for 
the primary grain(s) be the same extraction method used for additional 
commodities. This change would provide evidence that the method can 
generate accurate results for both naturally contaminated grain and 
artificially contaminated commodities.

Update Criteria Issuance and Conformance

    AMS proposes to issue the updated performance criteria within six 
months after the end of the comment period. Test kit submissions 
received more than one year after issuing the new criteria would be 
required to meet the new performance criteria to earn a certificate of 
conformance. During the transition year, manufacturers could choose to 
submit under the old or new criteria. However, certificates of 
conformance granted under the old performance criteria would expire 
after one year. In contrast, those granted under the new performance 
criteria would expire after three years. The expiration dates for 
existing certificates of conformance would not be affected.

    Authority: 7 U.S.C. 71-87k; 7 US C 1621-1627

Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2020-27850 Filed 12-17-20; 8:45 am]
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