[Federal Register Volume 87, Number 131 (Monday, July 11, 2022)]
[Notices]
[Pages 41096-41097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14671]


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 Notices
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  Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / 
Notices  

[[Page 41096]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

[Doc. No. AMS-FGIS-22-0019]


Process for the Evaluation of Technology for Official Grain 
Inspection

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notice; request for comments.

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SUMMARY: The Agricultural Marketing Service (AMS) currently evaluates 
and approves technology for use in official grain inspection on a case-
by-case basis. AMS proposes a new internal process that is meant to 
facilitate the introduction of new and improved inspection technology 
that promotes competition and transparency. AMS is seeking public 
comment on the proposed process.

DATES: Comments must be received by September 9, 2022.

ADDRESSES: Additional technical information on the evaluation process 
can be found in the ``Procedure and Submission Guidelines for the 
Evaluation of Technology for Official Grain Inspection'' at https://www.ams.usda.gov/sites/default/files/media/FGISUserGuideforManufacturers.pdf.
    Interested persons are invited to submit written comments 
concerning this Notice using either of the following procedures:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. You can access this 
Notice and instructions for submitting public comments by searching for 
document number, AMS-FGIS-22-0019.
     Mail: Dr. Timothy D. Norden, National Grain Center, 10383 
N. Ambassador Drive, Kansas City, Missouri 64153.
    All submissions received must include the docket number AMS-FGIS-
22-0019. All comments received will be included in the record and will 
be posted without change, including any personal information provided. 
Comments will be made available for public inspection at the above 
address during regular business hours or via the at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Timothy D. Norden, Chief Scientist, 
Technology and Science Division, Federal Grain Inspection Service, AMS, 
USDA; Telephone: (816) 702-3803, or Email: [email protected].

SUPPLEMENTARY INFORMATION: AMS provides grain 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. USGSA at 7 U.S.C. 74 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 end-use performance 
of grain. The primary focus of the proposed Inspection Technology 
Evaluation (ITE) Process is on the need and suitability of the 
technology for official grain inspection. Below is a description of the 
proposed ITE Process.
    ``Technology'' refers to instrumentation, equipment, and the 
associated methods for measuring grain quality factors. ``Factor'' 
means a measurable grain quality attribute. This evaluation process 
does not apply to the research and development effort before the 
technology is deemed fit-for-purpose; that is, the instrument or method 
has already been developed so that it generates factor-specific results 
with sufficient accuracy for official grain inspection.

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 provide an overview of the technology for which they seek 
approval. This overview should describe the technology solution, 
indicate to which grains and inspection factor, or factors the 
technology applies, and the steps the technology uses to analyze a 
sample. The proposal should address six criteria, which will form the 
basis of the initial evaluation. These criteria are: (1) need; (2) 
accuracy; (3) quality control; (4) automation; (5) testing time; and 
(6) testing cost.
    An AMS review team conducts an initial evaluation of the proposal 
to determine if it meets these criteria. When the review team completes 
the initial evaluation, AMS decides whether to accept the proposal. 
This decision is documented and communicated to the manufacturer. If a 
proposal is not accepted, the manufacturer is informed of the specific 
deficiencies and the requirements for resubmission. If accepted, the 
proposal enters a queue, and the manufacturer is 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 AMS' developed 
criteria or specifications 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. If not already established, AMS develops 
performance criteria and specifications and determines whether a 
Federal Register notice is needed to finalize the criteria.
    With established performance criteria and specifications, AMS 
requests that the manufacturer provides information and data supporting 
the criteria and specifications. When all requested information has 
been submitted and accepted, AMS conducts an independent verification 
that focuses on accuracy. AMS will also determine if the submitted 
technology delivers results that are equivalent to currently approved 
technology. If this process shows that the technology is accurate and 
it passes the equivalence test, AMS notifies stakeholders and provides 
them with the implementation plan. If AMS is unable to verify the 
accuracy or the technology is not equivalent, the manufacturer is 
notified of the deficiencies and the requirements for resubmission.
    If AMS approves the technology, an AMS certificate of conformance 
(COC) is issued that allows for use in official grain inspection. If 
any alterations to the

[[Page 41097]]

technology are made that could affect measurement results, the 
manufacturer should inform AMS in writing to determine the 
significance. In addition, if the manufacturer finds that the 
technology is not meeting AMS performance criteria, they should 
immediately inform AMS. Failure to inform AMS, may result in 
cancellation of the COC.

Evaluation Criteria

    Need. AMS assesses the need criterion through a review of the 
manufacturer-provided information, input from stakeholders including 
the Grain Inspection Advisory Committee, and from internal information. 
AMS evaluates the demand for the testing technology from AMS customers 
and stakeholders and compares the demand to the costs of providing the 
testing service, including standardization, calibration, and quality 
control efforts. AMS recommends that manufacturers provide information 
from a market assessment of the technology that supports this demand. 
For existing inspection factors, a successful technology should be 
compatible with existing official procedures such as subsample size 
requirements. For a test factor with an existing single approved 
instrument model, a successful new instrument should offer an added 
benefit to official inspection and provide results in terms of accuracy 
that are equivalent to, or better than the currently approved 
instrument model. If pertinent, manufacturers should provide national 
or international regulatory requirements the technology addresses. This 
may include, but is not limited to, maximum levels for toxic 
substances.
    Accuracy and Quality Control. Manufacturers should provide relevant 
data that support both the accuracy and quality control criteria. 
Manufacturers and other interested parties are encouraged to review the 
specific requirements and additional technical information at [insert 
hyperlink to technical document].
    Automation. If the technology generates an electronic result, the 
manufacturer should provide procedures for automatic data capture and 
the method to modify the output.
    Testing Time. Manufacturers should provide the estimated testing 
time required from sample receipt to final result. The testing time 
will be assessed by comparison to existing or similar technologies. 
Longer testing times should be justified by providing a significant 
advantage over existing technology.
    Testing Cost. The manufacturer should provide itemized cost 
estimates for the technology, maintenance, consumables, and all 
materials and equipment needed to perform the test. AMS evaluates the 
estimated costs of the recommended quality control, calibration, and 
standardization procedures. The testing cost is compared to existing or 
similar technologies. Higher testing costs should provide significant 
advantages over existing technologies.

Melissa R. Bailey,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2022-14671 Filed 7-8-22; 8:45 am]
BILLING CODE 3410-02-P