[Federal Register Volume 59, Number 117 (Monday, June 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14960]


[[Page Unknown]]

[Federal Register: June 20, 1994]


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DEPARTMENT OF AGRICULTURE
Federal Grain Inspection Service

7 CFR Part 801

 

FGIS to Change Protein Reference Method

AGENCY: Federal Grain Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: This rule revises the regulations under the United States 
Grain Standards Act, as amended, concerning the Tolerances for Near-
Infrared Spectroscopy (NIRS) Analyzers. It incorporates by reference 
the AOAC International (formerly known as the Association of Official 
Analytical Chemists) Method 992.23, Crude Protein in Cereal Grains and 
Oilseeds Generic Combustion Method (1992), into the regulations. FGIS 
will use the Combustion method as the chemical reference method for 
determining the protein content in both wheat and soybeans. This rule 
also eliminates the use of the Kjeldahl method for official protein 
inspections and more clearly describes the application of tolerances to 
official NIRS type instruments.

EFFECTIVE DATE: This regulation is effective July 20, 1994. The 
incorporation by reference of the publication listed in the regulations 
is approved by the Director of the Federal Register as of July 20, 
1994.

FOR FURTHER INFORMATION CONTACT:
George W. Wollam, Federal Grain Inspection Service, USDA, Room 0624, 
South Building, P.O. Box 96454, Washington, DC 20090-6454; Telephone 
(202) 720-0292.

SUPPLEMENTARY INFORMATION: 

Executive Order 12866

    The Department is issuing this final rule in conformance with 
Executive Order 12866. This rule has been determined to be not-
significant for purposes of Executive Order 12866 and therefore has not 
been reviewed by OMB.

Executive Order 12778

    This final rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. This action is not intended to have retroactive 
effect. The United States Grain Standards Act provides in Section 87g 
that no State or subdivision may require or impose any requirements or 
restrictions concerning the inspection, weighing, or description of 
grain under the Act. Otherwise, this final rule will not preempt any 
State or local laws, regulations, or policies, unless they present an 
irreconcilable conflict with this rule. There are no administrative 
procedures which must be exhausted prior to any judicial challenge to 
the provisions of this rule.

Regulatory Flexibility Act Certification

    David R. Shipman, Acting Administrator, FGIS, has determined that 
this final rule will not have a significant economic impact on a 
substantial number of small entities as defined in the Regulatory 
Flexibility Act (5 U.S.C. 601 et seq.), because most users of the 
official inspection and weighing services and those entities that 
perform these services do not meet the requirements for small entities.

Paperwork Reduction

    In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C. 
Chapter 35), the information collection requirements contained in the 
regulations issued under the United States Grain Standards Act have 
been previously approved by OMB under control number 0580-0013.

Background

    On August 9, 1993, FGIS published in the Federal Register (58 FR 
42257), a proposed rule entitled ``Tolerances for Near-Infrared 
Spectroscopy (NIRS) Analyzers''. At the time the proposed revisions to 
the regulations were published the AOAC International (formerly known 
as the Association of Official Analytical Chemists) had not yet 
completed official adoption of the Combustion method. Therefore, the 
Combustion method was referred to as the FGIS Combustion method is the 
proposed revisions. Since the proposed rule was published, the AOAC 
International has completed the approval process and officially 
published the method.
    When the AOAC International published the Combustion method, an 
identifying method number was assigned. The Combustion method is 
identified and referenced in the final rule as AOAC International, 
Method 992.23, Crude Protein in Cereal Grains and Oilseeds Generic 
Combustion Method (1992).
    FGIS currently uses the Kjeldahl method as the primary reference 
method by which NIRS protein-measuring instruments are calibrated. NIRS 
instruments are used to determine protein in wheat and soybeans in both 
domestic and export markets. The final rule incorporates by reference 
the AOAC International Method 992.23, Crude Protein in Cereal Grains 
and Oilseeds Generic Combustion Method (1992) into the regulations. 
FGIS will replace the Kjeldahl method with the Combustion method as the 
chemical reference method for protein determinations. The Combustion 
method uses a nitrogen analyzer consisting of a computer-controlled 
closed-system combustion process and a thermal conductivity detector. 
This method has also been approved (September 1992) by the American 
Association of Cereal Chemists (AACC) for protein determination in 
cereal grains. In addition, this method has been approved as a 
Recommended Practice (April 1993) by the American Oil Chemists' Society 
(AOCS) for protein determination in oilseeds.
    Changing from the Kjeldahl method to the Combustion method will 
provide many benefits to FGIS and other users. The Combustion method 
does not use hazardous chemicals or produce the environmental 
pollutants associated with the Kjeldahl method. Also, the shorter 
analysis time for the Combustion method allows a larger sample 
throughput, permitting a more effective evaluation of the NIRS 
instrument calibrations.
    FGIS has extensively compared the protein results obtained using 
the Combustion method and the Kjeldahl method. Statistical analysis of 
these data shows that each method is capable of providing equally 
precise and reproducible protein results; however, the Combustion 
method has a general tendency to yield slightly higher results than the 
FGIS Kjeldahl method. The results from the Combustion method should 
reflect the true protein content of U.S. wheat and soybeans more 
accurately than the Kjeldahl reference method. The observed differences 
are approximately +0.03 percent protein for wheat and +0.3 percent 
protein for soybeans. The increase in the protein for wheat should have 
a minimal impact on domestic and export wheat markets. The increase in 
protein for soybeans should have a minimal impact on domestic and 
export soybean markets because trading price of soybeans is not 
routinely based on the protein content. The maintenance tolerances for 
NIRS instruments are used to maintain consistent results among official 
protein and oil determinations. All NIRS instruments are adjusted to 
give consistent results on the national Standard Reference Samples 
(SRS). Values for the SRS are assigned using the FGIS national standard 
NIRS instruments. Further, the FGIS national standard NIRS instruments 
are calibrated and routinely standardized to the FGIS chemical 
reference method.

Comment Review

    During the 30-day comment period, 14 comments were filed in 
response to the proposal. Comments were received from two grain 
industry associations. The associations stated that they did not oppose 
the proposal and that they generally supported the adoption of the 
Combustion method.
    One comment was received from a foreign oilseed processor 
association. The association supported the change; however, it 
requested that FGIS continue to use both the Kjeldahl method and the 
Combustion method as references for the NIRS instruments. FGIS after 
considering this comment, has determined that maintaining two reference 
methods is counterproductive for protein uniformity and efficient use 
of space and staff. Consequently FGIS must maintain only one reference 
method for protein.
    One oilseeds processor association stated that it generally 
supported the adoption of the Combustion method. The association was 
concerned about differences among industry Kjeldahl labs and FGIS and 
other labs using the Combustion method. FGIS has recognized the 
existence of a positive bias between methods and reported that in the 
proposed rule. FGIS contends that this small increase in the protein 
will have a minimal impact on domestic and export soybean markets 
because the trading prices of soybeans are not routinely based on the 
protein content and the small bias is insignificant in proportion to 
the total average protein content of soybeans.
    One university professor commented in support of the proposed 
change; however, he requested a delay in implementing the change to 
allow for an industry discussion to promote uniformity throughout the 
soybean industry. FGIS believes that such a delay is unwarranted 
because the Combustion method is currently being used in several 
countries around the world by industry laboratories, commercial and 
private laboratories, and government laboratories.
    Two foreign milling companies expressed interest in the Combustion 
method, but they did not have enough information to comment on the 
proposed changes.
    One international baking and research institute generally supported 
the change. It requested a reprint of the Combustion method be 
published in the Journal of the AOAC International.
    Six additional comments were received in the form of requests for 
reprints of the Combustion method as published in the Journal of the 
AOAC International.

Final Action

    Accordingly, FGIS is revising Part 801 of the regulations, 
Tolerances for Near-Infrared Spectroscopy (NIRS) Analyzers, to 
incorporate by reference the AOAC International Method 992.23, Crude 
Protein in Cereal Grains and Oilseeds Generic Combustion Method (1992).

List of Subjects in 7 CFR Part 801

    Administrative practice and procedure, Grain Export, Incorporation 
by reference.

    For reasons set out in the preamble, 7 CFR Part 801 is amended as 
follows:
    1. The authority citation for Part 801 continues to read as 
follows:

    Authority: Pub. L. 94-582, 90 Stat. 2867, as amended, (7 U.S.C. 
71 et seq.).

PART 801--[AMENDED]

    2. Section 801.7 is revised to read as follows:


Sec. 801.7  Tolerances for near-infrared spectroscopy (NIRS) analyzers.

    The chemical reference protein determinations used to reference and 
calibrate official NIRS instruments shall be performed in accordance 
with ``Comparison of Kjeldahl Method for Determination of Crude Protein 
in Cereal Grains and Oilseeds with Generic Combustion Method: 
Collaborative Study,'' July/August 1993, Ronald Bicsak, Journal of AOAC 
International Vol. 76, No. 4, 1993, and subsequently approved by the 
AOAC International as the Combustion method, AOAC International Method 
992.23. This incorporation by reference was approved by the Director of 
the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51. Copies may be obtained from Director, Quality Assurance and 
Research Division, Federal Grain Inspection Service, 10383 North 
Executive Hills Blvd., Kansas City, MO 64153-1394. Copies may be 
inspected at the above address or at the Office of the Federal 
Register, 800 North Capitol Street, NW., 7th Floor, Suite 700, 
Washington, DC 20408.
    (a) NIRS wheat protein analyzers. The maintenance tolerances for 
the NIRS analyzers used in performing official inspections for 
determination of wheat protein content shall be 0.15 
percent mean deviation from the national standard NIRS instruments, 
which are referenced and calibrated to the Combustion method, AOAC 
International Method 992.23.
    (b) NIRS soybean oil and protein analyzers. The maintenance 
tolerances for the NIRS analyzers used in performing official 
inspections for determination of soybean oil shall be 0.20 
percent mean deviation from the national standard NIRS instruments, 
which are referenced and calibrated to the FGIS solvent oil extraction 
method, and for determination of protein content shall be 
0.20 percent mean deviation from the national standard NIRS 
instruments, which are referenced and calibrated to the Combustion 
method, AOAC International Method 992.23.
David R. Shipman,
Acting Administrator.
[FR Doc. 94-14960 Filed 6-17-94; 8:45 am]
BILLING CODE 3410-EN-M