Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Notices 82427 

mailing such a request. The Secretary 

will conduct a referendum if requested 

by 10 percent or more of the number of 

cotton producers and importers voting 

in the most recent referendum (July 

1991), with not more than 20 percent of 

such request from producers in one state 

or importers of cotton. 

Current procedures for the conduct of 

a sign-up period appear at 7 CFR 

1205.10–1205.30. These procedures will 

be updated as appropriate prior to the 

beginning of the sign-up period. 

Authority: 7 U.S.C. 2101–2118. 

Bruce Summers, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2020–27877 Filed 12–17–20; 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 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Notice; request for comments. 

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-fgis20-0061.pdf. 

To submit Comments: Go to 

Regulations.gov (http://

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 http://

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, 

Thomas.A.Weber@usda.gov. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
82428 Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Notices 

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

Aflatoxins 

(ppb) 

Acceptable range 

(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

Deoxynivalenol 

(ppm) 

Acceptable range 

(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

Fumonisins 

(ppm) 

Acceptable range 

(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 

Ochratoxin A 

(ppb) 

Acceptable range 

(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

Zearalenone 

(ppb) 

Acceptable range 

(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] 

BILLING CODE P 

DEPARTMENT OF AGRICULTURE 

Food and Nutrition Service 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request—Generic Clearance 

for the Special Nutrition Programs 

Quick Response Surveys (SNP QRS) 

AGENCY: Food and Nutrition Service 

(FNS), USDA. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995, this 

notice invites the general public and 

other public agencies to comment on 

this proposed information collection. 

This collection is a revision of a 

currently approved collection to 

conduct short, quick-turnaround 

surveys of State and local agencies 

providing food, education, and other 

services in the Child Nutrition and 

Supplemental Nutrition and Safety 

Programs administered at the federal 

level by the Food and Nutrition Service 

(FNS). These programs include the 

Special Supplemental Nutrition 

Program for Women, Infants, and 

Children; National School Lunch 

Program; School Breakfast Program; 

Special Milk Program; Fresh Fruit and 

Vegetable Program; Summer Food 

Service Program; Child and Adult Care 

Food Program; USDA Foods in Schools; 


khammond on DSKJM1Z7X2PROD with NOTICES