FGIS to Change Protein Reference Method

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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