[Federal Register Volume 59, Number 57 (Thursday, March 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6736]


  Federal Register / Vol. 59, No. 57 / Thursday, March 24, 1994 /
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[[Page Unknown]]

[Federal Register: March 24, 1994]


                                                    VOL. 59, NO. 57

                                           Thursday, March 24, 1994
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DEPARTMENT OF AGRICULTURE

Federal Grain Inspection Service

7 CFR Part 800

 

Official Testing Service for Vomitoxin

AGENCY: Federal Grain Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Federal Grain Inspection Service (FGIS) is adopting 
without change the provisions of an interim final rule to offer 
official vomitoxin testing services for grain under the authority of 
the United States Grain Standards Act and to establish a fee to recover 
the cost of this service. Due to the widespread occurrence of scab this 
year and the market's demand for rapid, onsite testing capabilities, 
FGIS decided it is in the best interest of the grain industry to offer 
vomitoxin testing as an official service at field locations using quick 
test kits under the authority of the United States Grain Standards Act 
(USGSA). This action permits FGIS, delegated States, and designated 
agencies to provide the grain industry with official service to 
facilitate the orderly and timely marketing of grain.

EFFECTIVE DATE: April 25, 1994.

FOR FURTHER INFORMATION CONTACT:
George Wollam, FGIS, USDA, room 0624-S, P.O. Box 96454, Washington, DC 
20090-6454, Telephone (202) 720-0292.

SUPPLEMENTARY INFORMATION:

Executive Order 12866

    We are issuing this 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. Most users of the official 
inspection and weighing services and those persons who perform those 
services do not meet the requirements for small entities as defined in 
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

Information Collection Requirements

    In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C. 
chapter 35), the information collection requirements contained in the 
rule being amended have been previously approved by OMB under control 
number 0580-0013.

Background

    The Federal Grain Inspection Service (FGIS) published an interim 
rule in the Federal Register on September 23, 1993, (58 FR 49421), 
announcing the immediate availability of official vomitoxin testing 
services for grain as official criteria under the authority of the 
United States Grain Standards Act. This service is available upon 
request.
    Wheat scab, also known as head blight, pink mold, white heads, and 
tombstone scab, is a disease caused by certain fungal species in the 
genus Fusarium. This disease occurs in wheat and other grains; the 
severity of the infection depends on weather conditions. This year's 
weather was favorable for scab infection in wheat, resulting in its 
more prevalent occurrence.
    Wheat infected with scab has a tendency to have lighter weight 
kernels, some of which are removed during normal harvesting and some 
during normal cleaning operations. The Fusarium may cause the 
occurrence of the mycotoxin deoxynivalenol (more commonly known as 
vomitoxin or DON).
    In 1982, the Food and Drug Administration (FDA) developed advisory 
levels for vomitoxin in wheat and wheat products to assist States and 
others in use and disposition. On September 16, 1993, FDA issued 
updated advisories for certain human food and animal feed products 
containing vomitoxin.
    FDA's new advisories set the level for vomitoxin in finished wheat 
products intended for human consumption at 1 part per million (ppm). 
Levels were not established for wheat intended for milling because 
milling processes used to produce flour substantially reduce vomitoxin 
levels, to varying degrees.
    FDA's new advisories also set levels for products intended for use 
as animal feed. Grains and grain by-products destined for ruminating 
beef and feedlot cattle older than 4 months or chickens were set at 10 
ppm provided these products do not exceed 50 percent of their diet. 
Grains and grain by-products destined for swine and all other animals 
were set at 5 ppm provided these products do not exceed 20 percent of 
the swine diet or 40 percent of the diet for all other animals.
    To assist the grain industry in the marketing of wheat, FGIS had 
offered vomitoxin testing at its Commodity Testing Laboratory in 
Beltsville, Maryland, using thin-layer chromatography (TLC) under the 
authority of the Agricultural Marketing Act of 1946. The TLC analysis 
is very time consuming, thus limiting the number of analyses available 
in a single day. Providing the service under the authority of the 
Agricultural Marketing Act of 1946 also limits the availability of 
service since it is provided only by FGIS and State cooperators.
    Due to the widespread occurrence of scab this year in certain areas 
of the country and the market's demand for rapid, onsite testing 
capabilities, FGIS decided it is in the best interest of the grain 
industry to offer vomitoxin testing as an official service at field 
locations using quick test kits under the authority of the United 
States Grain Standards Act. This action permits FGIS, delegated States, 
and designated agencies to provide the grain industry with official 
service.
    FGIS evaluated the cost of providing this service and established 
different fees for qualitative and quantitative analyses. FGIS fees for 
vomitoxin testing will also vary depending on whether the service is 
initiated as an original FGIS inspection or as an appeal inspection of 
an original service provided by an official agency. FGIS fees for 
vomitoxin testing services initiated as an original FGIS inspection 
service are $7.50 per test for qualitative analysis and $12.00 per test 
for quantitative analysis plus the applicable hourly rate per service 
representative required to obtain a sample and perform the test.
    FGIS fees for vomitoxin testing services initiated at the appeal 
inspection level are $35.00 per test (regular workday) and $44.00 per 
test (nonregular workday) for qualitative analysis, except as otherwise 
provided for in fee Schedule A. For quantitative testing, the fees are 
$40.00 per test (regular workday) and $50.00 per test (nonregular 
workday). This fee per test does not include a sampling fee. Delegated 
States and designated agencies are responsible for establishing their 
fees subject to approval by FGIS.

Comment Review

    FGIS received two comments during the comment period announced in 
the September 23, 1993, interim rule (58 FR 49421). Both comments 
supported the action to offer the service as official criteria under 
the authority of the United States Grain Standards Act.
    One commenter encouraged FGIS to place emphasis on ensuring 
vomitoxin testing is done at origin, and to promote further test kit 
research and development to increase test speed and reduce costs, and 
to improve accuracy and consistency. The commenter also requested that 
FGIS confirm that the rule would not mandate ``official'' testing or 
prohibit or restrict unofficial vomitoxin testing agreed to by the 
buyer and seller.
    Widespread occurrences of vomitoxin in the United States are very 
unusual in wheat and similar grains. This year's (1993) weather 
conditions in certain areas of the country led to scab infection in 
wheat. Thus the occurrence of vomitoxin is a localized problem. FGIS 
believes that requiring vomitoxin testing at origin would impede the 
orderly marketing of grain. In addition, this action permits FGIS, 
delegated States, and designated agencies to provide, upon request, to 
the grain industry official vomitoxin testing services for grain under 
the authority of the USGSA. An applicant for service can request 
vomitoxin testing at any time. However, buyers and sellers may agree to 
do otherwise. FGIS has and will continue to encourage vomitoxin test 
kit research and development to increase test speed and reduce costs, 
and to improve accuracy and consistency.
    The other commenter questioned the manner in which FGIS determined 
that the Neogen test kit was the best method to be declared official 
and suggested that the agency publicly release the testing data 
regarding the test kit. FGIS announced its intent to examine vomitoxin 
(deoxynivalenol) test kits in the February 4, 1992, Federal Register 
(57 FR 4184). Specifically, FGIS solicited input regarding the 
availability of commercial test kits for qualitatively and 
quantitatively determining the presence of vomitoxin to conduct a study 
under field conditions. Manufacturers were requested to notify FGIS of 
the commercial availability of test kits and to provide information on 
the performance of these test kits.
    In response to this request, only Neogen Corporation submitted 
information regarding their test kit for vomitoxin. FGIS, after 
examining the Neogen test kit, determined that it was suitable for 
official use. The test kit provides qualitative or quantitative results 
and is adaptable to the existing environment of official aflatoxin 
laboratories. Further, the chemical compounds used in the test 
procedure comply with FGIS' established safety and waste disposal 
programs.
    FGIS examined the Neogen test kit for accuracy at several different 
known contamination levels in wheat and corn samples. Overall, the FGIS 
field study revealed that the kit was capable of producing accurate 
results in 89 percent of the wheat tests and 91 percent of the corn 
tests. For more specific information regarding the comparative analysis 
and future research plans, contact the FGIS Research and Development 
Branch, USA-FGIS Technical Center, 10383 North Executive Hills Blvd., 
Kansas City, Missouri, 64153-1394; (816) 891-0464.

Final Action

    FGIS has determined that offering official vomitoxin testing 
services for grain under the authority of the United States Grain 
Standards Act and establishing a fee to recover the cost of this 
service would facilitate the orderly and timely marketing of grain. 
Accordingly, the interim rule amending 7 CFR part 800 which was 
published in 58 FR 49421 on September 23, 1993, is adopted as a final 
rule without change.

List of Subjects in 7 CFR Part 800

    Administrative practice and procedure, Grain.

PART 800--GENERAL PROVISIONS

    For reasons set out in the preamble, 7 CFR part 800 is amended as 
follows:
    1. The authority citation for part 800 continues to read as 
follows:

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


Sec. 800.71  [Amended]

    2. Accordingly, the interim final rule revising Sec. 800.71(a), 
Schedule A, of the regulations, which was published on September 23, 
1993, (58 FR 49421), is adopted as a final rule without change.

    Dated: March 15, 1994.
David R. Shipman,
Acting Administrator.
[FR Doc. 94-6736 Filed 3-23-94; 8:45 am]
BILLING CODE 3410-EN-M