[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 /
[[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