Official Testing Service for Vomitoxin

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.

-----------------------------------------------------------------------

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