[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]
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