Procedure and Submission Guidelines for the Evaluation of 

Technology for Official Grain Inspection

User Guide for Manufacturers

July 28, 2021

United States Department of Agriculture

Agricultural Marketing Service

Federal Grain Inspection Service

Technology and Science Division
Procedure and Submission Guidelines for the Evaluation of Technology 

for Official Grain Inspection 

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Table of Contents 

1. Purpose and Scope ...............................................................................................................................3

2. Authority...............................................................................................................................................3

3. ITE Process Summary ...........................................................................................................................3

4. Additional Requirements for Specific Technologies...........................................................................3

5. Contact Information.............................................................................................................................4

6. Definitions ............................................................................................................................................4

7. ITE Process Description ........................................................................................................................5

8. Initial Review Criteria...........................................................................................................................6

8.1 Need..............................................................................................................................................6

8.2 Accuracy........................................................................................................................................6

8.3 Quality Control, Calibration, and Standardization......................................................................7

8.4 Automation...................................................................................................................................7

8.5 Testing Time .................................................................................................................................7

8.6 Testing Cost ..................................................................................................................................7

9. Submission Requirements and Manufacturer Validation Study ........................................................7

References....................................................................................................................................................9

Appendix A: ITE Submission Form ............................................................................................................10

Appendix B: Protocol and Notification Agreement Statement...............................................................11
Procedure and Submission Guidelines for the Evaluation of Technology 

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1. Purpose and Scope 

Inspection Technology Evaluation (ITE) is the process the Agricultural Marketing Service’s Federal Grain 

Inspection Service (FGIS) will utilize for the evaluation and approval of technology for use in official grain 

inspection. In this document, “technology,” includes instrumentation, equipment, and the associated 

methods for measuring grain quality factors. Factor means a measurable grain quality attribute. This 

evaluation process is not applicable to research and development efforts necessary before the 

technology is deemed fit-for-purpose; that is, the instrument or method must have already been 

developed so that it generates factor-specific results with sufficient accuracy for official grain inspection. 

The ITE process encompasses all instrument, equipment, and methodology approvals for official grain 

inspection.

2. Authority 

AMS provides inspection services under the authority of the United States Grain Standards Act (7 U.S.C. 

71–87k) (USGSA), as amended, and the Agricultural Marketing Act of 1946 (7 U.S.C. 1621–1627), as 

amended. Section 74 of the USGSA states that the primary objective of the United States standards for 

grain is to certify the quality of grain as accurately as practicable and to accommodate scientific 

advances in testing and new knowledge concerning factors related to, or highly correlated with, the enduse performance of grain. The primary focus of the ITE evaluation and approval process is on the need 

and suitability of the technology for official grain inspection.

3. ITE Process Summary 

When a manufacturer develops technology for determining a specific grain factor, they have the option 

of submitting it to FGIS for evaluation and possible approval. The submission must first pass an initial 

evaluation that focuses on the need and benefits of the technology for official grain inspection. If the 

submission is accepted, it enters a more detailed evaluation sequence that provides a validation of the 

technology against specific performance criteria developed by FGIS. Validation data submitted by the 

manufacturer are compared with these criteria, and if met, a verification is performed by FGIS. If the 

technology is approved, it receives a certificate of conformance, which allows for its use in official grain 

inspection.

4. Additional Requirements for Specific Technologies 

Specific technologies have additional or separate requirements that must be met as part of a submission 

to the ITE process. Examples include scales, moisture meters, near-infrared instruments, and mycotoxin 

and biotechnology test kits. The requirements for these technologies are listed below.

Diverter-type Samplers, Dockage Testers, Hand Sieves, Lighting, Manual Sampling Devices, and Test 

Weight Devices: These are examples of technology that are approved by device dimensions and 

specifications as documented in the FGIS Equipment and Mechanical Sampling Handbooks.

Scales and Near-Infrared Analyzers: Must hold an active National Conference on Weights and 

Measures, National Type Evaluation Program (NTEP) Certificate of Conformance. For information on 

how to apply for and obtain this certificate, please see https://www.ncwm.com/ntep-faqs.
Procedure and Submission Guidelines for the Evaluation of Technology 

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Moisture Meters: The process for approval of moisture meters is separate from this process. Moisture 

meters must have an NTEP Certificate of Conformance and meet the FGIS Unified Grain Moisture 

Algorithm requirements as specified in

https://www.ams.usda.gov/services/fgis/standardization/moisture-equipment.

Mycotoxin and Biotechnology Test Kits: Approvals of rapid mycotoxin and biotechnology testing 

methods are performed through the FGIS Rapid Test Kit Evaluation Program. For more information on 

how to submit this technology, see https://www.ams.usda.gov/services/fgis/standardization/tke.

5. Contact Information 

Please send submissions or questions to FGIS.ITE.Program@usda.gov.

6. Definitions 

FGIS program definitions

Equivalent Technology: A system of instruments and associated methods that can be used 

interchangeably and give results that are indistinguishable, taking into account measurement 

uncertainty.

FGIS Reference Method: The analytical method by which the accuracy of an alternate or new 

instrumental method will be measured or evaluated.

Inspection Factor: A measurable attribute of a specific grain type or class. 

Official Grain Inspection: The process of examining and certifying grain according to the United States 

Grain Standards by, or under the supervision of, the Federal Grain Inspection Service.

Standardization: A process to align multiple instruments in order to increase overall system accuracy.

Technology: Instrumentation, equipment, and/or methods for measuring specific grain quality factors.

Internationally-accepted definitions derived from references [1], [2], [3], [4].

Accuracy: The closeness of agreement between a test result and an accepted reference value. When 

applied to test results, accuracy includes a combination of random and systematic errors. When 

applied to test methods, accuracy refers to a combination of trueness and precision.

Calibration: Act of determining the relationship between the observed analyte signal generated by an 

instrumental measuring system and the quantity of the analyte present in the sample measured to 

assure that the measurement is accurate.

Fit-for-purpose: Degree to which data produced by a measurement process enables a user to make 

technically and administratively correct decisions for a stated purpose.

Measurement Range: The interval over which the method generates results with acceptable accuracy.
Procedure and Submission Guidelines for the Evaluation of Technology 

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Trueness: Closeness of the agreement between the average value obtained from a large series of test 

results and an accepted reference value.

Precision: Closeness of agreement between independent test results obtained under prescribed 

conditions.

Quality Control: Measures taken to ensure that data produced by the laboratory are fit-for-purpose.

Repeatability: Precision under conditions where independent test results are obtained with the same 

method on identical test items in the same laboratory by the same operator using the same equipment 

within short intervals of time.

Reproducibility: Precision under conditions where independent test results are obtained with the 

same method on identical test items in different laboratories with different operators using different 

equipment.

Validation: Process of providing objective evidence that the method is fit for its intended purpose.

7. ITE Process Description 

The ITE process starts with the submission of a written proposal by a manufacturer of technology for 

a specific inspection factor. Manufacturers must provide an overview of the technology for which 

they are seeking approval. This overview should describe the technology solution, provide to which 

grains and inspection factor or factors it applies, and the steps required to analyze a sample.

The proposal must thoroughly address the following six criteria: 

• Need

• Accuracy 

• Quality Control, Calibration, and Standardization 

• Automation 

• Testing Time

• Testing Cost

Note: All documents submitted to USDA AMS are subject to the Freedom of Information Act (FOIA), 

which requires that records submitted to federal agencies be made available to the public. 

Submissions should not contain any confidential business information as defined under section (b) 

(4) of the FOIA.

An FGIS review team will provide an initial evaluation of the proposal to determine if it meets these

criteria. When the review team completes the initial evaluation, a decision will be made to accept or 

not to accept the proposal. This decision will be documented and communicated to the manufacturer. 

If a proposal is not accepted, the manufacturer will be informed of the specific deficiencies and the 

requirements for resubmission. If accepted, the proposal will enter a queue, and the manufacturer will 
Procedure and Submission Guidelines for the Evaluation of Technology 

for Official Grain Inspection 

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be notified and provided with an estimate for the start date along with various factors that may affect 

the length of the evaluation process.

The remaining steps of the evaluation process focus on validating the performance of the submitted 

technology using criteria and/or specifications developed by FGIS for the specific inspection factor. This 

allows for refinement of the initial review criteria to account for specific inspection needs and for a 

statistically-sound evaluation of accuracy of the technology. FGIS will develop performance criteria and 

specifications, if not already established, and determine whether a Federal Register notice is needed to 

finalize the criteria.

When the performance criteria and specifications are established, FGIS will request information and 

data from the manufacturer supporting them. When all requested information has been submitted and 

accepted, FGIS will conduct an independent verification that focuses on trueness, repeatability, and 

reproducibility. If all criteria are met and existing technology is already approved for official inspection, 

FGIS will perform a final assessment to determine if the submitted technology will deliver results that 

are equivalent to currently approved technology. If the equivalence test passes, all stakeholders will be 

notified and provided with the implementation plan. If either the verification or equivalence test fails, 

the manufacturer will be notified of the deficiencies and specific requirements for resubmission.

8. Initial Review Criteria 

8.1 Need 

Manufacturers should provide information and data that supports the need including the criteria 

listed below. FGIS will assess the need through a review of the manufacturer provided information, 

input from stakeholders including the Grain Inspection Advisory Committee, and from internal 

information.

• Demand – There must be sufficient demand for the testing technology from FGIS customers and 

stakeholders to offset the costs of providing the testing service, including standardization, 

calibration, and quality control efforts. Manufacturers should provide information from a 

market assessment of the technology that supports this demand.

• Compatibility – For existing inspection factors, the technology must be compatible with existing 

official procedures such as subsample size requirements. See FGIS Grain Inspection Handbooks.

• Benefit to the Official System – For a test factor with an existing single approved instrument 

model, the new instrument must offer an added benefit to official inspection.

• Equivalence – For a test factor with an existing single approved instrument model, there must 

be evidence that the new instrument can provide results in terms of accuracy that are 

equivalent to, or better than the currently approved instrument model.

• Regulatory Requirements – If pertinent, provide national or international regulatory 

requirements the technology addresses that may include, but are not limited to, maximum 

levels for toxic substances.

8.2 Accuracy 

Manufacturers must provide relevant data detailing the accuracy of their submitted technology that 

includes measurement trueness and measurement precision compared with the existing FGIS 

reference method under reproducibility conditions and across the specified measurement range. 
Procedure and Submission Guidelines for the Evaluation of Technology 

for Official Grain Inspection 

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Manufacturers must provide relevant data on the repeatability within and reproducibility between 

copies of the same model of their submitted technology. The samples included in the study data 

must be sufficient in number and kind to fully cover the scope claimed by the manufacturer. If the 

submission is for a factor new to FGIS, the manufacturer must provide data that demonstrates the 

technology is fit-for-purpose with measurement trueness and precision data based upon a 

collaboratively-studied reference method, preferably published by an international standards 

developing organization.

∗

 The trueness, repeatability, and reproducibility data must meet FGIS 

tolerances, where established. For technology meant to replace visual inspection factors, FGIS Grain 

Inspection Handbooks should be consulted to apply the appropriate trueness and precision 

requirements.

8.3 Quality Control, Calibration, and Standardization 

Manufacturers must provide recommended working instructions and quality control procedures 

necessary to ensure that the technology is delivering results within established tolerances. Working 

instructions should include troubleshooting guidance to resolve problems when quality control 

measures are unacceptable. When calibrations are needed by the end-users to maintain accuracy 

over time, manufacturers must provide the recommended procedures for updating and/or 

developing calibrations on their instrument. Manufacturers must also provide recommended 

procedures for standardization to accomplish alignment of a network of instruments in different 

laboratories. The assessment will include the completeness, clarity, and validity of the working 

instructions, standardization, quality control, and calibration procedures.

8.4 Automation 

If the technology generates an electronic result, the manufacturer must provide procedures for 

automatic data capture and the ability to modify the output.

8.5 Testing Time 

Manufacturers must provide the estimated testing time required from sample receipt to the final 

result. The testing time will be assessed by comparison to existing or similar technologies. Longer 

testing times must be justified by providing a significant advantage over existing technology.

8.6 Testing Cost 

The manufacturer must provide itemized cost estimates for the technology, maintenance, 

consumables, and all materials and equipment needed to perform the test. This criterion will also 

include the estimated costs of the recommended quality control, calibration, and standardization 

procedures. The testing cost will be assessed by comparing it to existing or similar technologies. 

Higher testing costs should provide significant advantages over existing technologies.

9. Submission Requirements and Manufacturer Validation Study 

Submission documents must include an overview that describes the technology solution, the grains and 

inspection factor or factors to which it applies, and the steps required to analyze a sample. The 

 ∗

Such as the Association of Analytical Collaboration International, the Cereals and Grains Association, the American 

Oil Chemists Society, or the International Organization for Standardization. 
Procedure and Submission Guidelines for the Evaluation of Technology 

for Official Grain Inspection 

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document must also include six sections with each section addressing one of the review criteria. In 

addition, the submission must include the completed form given in Appendix A.

To address accuracy, a validation study must be performed that includes an assessment of the trueness 

and precision of the technology across the full range of the inspection factor being measured. For 

specific technologies such as near infrared, there may be a need to demonstrate accuracy over multiple 

crop years. The study should include a description of the scope of the method that includes the 

inspection factor and grain type, a description of the validation design including the number and type of 

samples, a description of the statistical analysis, a summary of results, and the conclusions supporting 

the study outcomes. The study should be of publication quality and follow the format and content of 

typical method validation studies as presented in peer-reviewed journals such as the Association of 

Official Analytical Collaboration International. For guidance on conducting validation studies, see 

references [1] and [5].

If the technology meets all requirements in sections 7 and 8, an FGIS certificate of conformance (COC) 

will be issued that allows for use in official grain inspection. If any alterations to the technology are 

made that could affect measurement results, the manufacturer must inform FGIS in writing to 

determine the significance. In addition, if the manufacturer finds that the technology is not meeting 

FGIS performance criteria, they must immediately inform FGIS. Failure to inform FGIS, in either case,

could result in cancellation of the COC. If issued a COC, manufacturers must sign the statement given in 

Appendix B.
Procedure and Submission Guidelines for the Evaluation of Technology 

for Official Grain Inspection 

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References 

[1] M. Thompson, S. L. R. Ellison, and R.Wood, Harmonized Guidelines for Single-Laboratory Validation 

of Methods of Analysis, (IUPAC Technical Report), Pure and Applied Chemistry, vol. 74, pp. 835-855, 

2002. 

[2] JCGM 200:2012, International Vocabulary of Metrology - Basic and General Concepts and 

Associated Terms, 2012. [Online]. Available: 

http://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf. [Accessed 07 01 

2021].

[3] Codex Alimentarius Commission, Guidelines on Analytical Terminology, Standard CAC/GL 72-2009, 

2009. [Online]. Available: http://www.fao.org/input/download/standards/11357/cxg_072e.pdf. 

[Accessed 07 01 2021].

[4] V. Barwick and E. Prichard, Eurachem, Terminology in Analytical Measurement - Introduction to VIM 

3, 2011. [Online]. Available: 

https://www.eurachem.org/index.php/publications/guides/terminology-in-analyticalmeasurement. [Accessed 07 01 2021].

[5] B. Magnusson and U. Ornemark (eds.), Eurachem Guide: The Fitness for Purpose of Analytical 

Methods - A Laboratory Guide to Method Validation and Related Topics (2nd ed.), 2014. [Online]. 

Available: https://www.eurachem.org/images/stories/Guides/pdf/MV_guide_2nd_ed_EN.pdf. 

[Accessed 2 February 2021].
Procedure and Submission Guidelines for the Evaluation of Technology 

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Appendix A: ITE Submission Form 

Contact Information

Company

Primary Contact

Primary Contact Email Address

Primary Contact Telephone Number

Street Address

City, State, Zip Code

Website (if applicable)

Instrument or Device Information

Name and Model Number

Product or Catalog Number

Measurement Technology or Description

(NIR, NMR, Moisture Meter, Scale, etc.)

National Type Evaluation Certificate Number

(Applicable to NIR, Moisture Meters, and Scales)

Operating Temperature Range (°C)

Operating Humidity Range (%)

Method Scope

Applicable Grains or Commodities

(barley, beans, buckwheat, canola, corn, flaxseed, hops, 

lentils, mustard seed, peas, rice, rye, safflower, sorghum, 

soybeans, sunflower seed, triticale, wheat, or processedgrain commodity)

Type or Class of Grain or Commodity

(six-row barley, two-row barley, malting barley, dent corn, 

flint corn, milled rice, paddy rice, hard red spring wheat, hard 

red winter wheat, hard white wheat, soft red winter wheat, 

soft white wheat, durum wheat, etc.)

Inspection Factor

Measurement Range (and units)

Minimum Sample Size (g)

Maximum Sample Size (g)

Sample Preparation

(whole grain, ground, etc.)

Sample Temperature Range (°C)
Procedure and Submission Guidelines for the Evaluation of Technology 

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Appendix B: Protocol and Notification Agreement Statement 

This is to certify that I am an official representative of 

that I fully understand the conditions that FGIS will use to determine if our technology marketed under 

the trade name

will be given a Certificate of 

Conformance for use in the Official grain inspection system. FGIS monitors the performance of all 

approved technologies and reserves the right to check and verify its performance at any time. I 

understand that if the technology fails to meet FGIS performance criteria, the manufacturer will be 

contacted to resolve the issue as soon as possible. If the issue cannot be resolved, the Certificate of 

Conformance may be revoked. I further understand that any changes made to the technology that 

could affect measurement results must be communicated to FGIS in writing. These changes may require 

resubmission through the FGIS evaluation process. I accept these conditions and agree to abide by the 

Manufacturer's Notification Responsibilities provided in this document.

Name Date

Title