94-6736. Official Testing Service for Vomitoxin  

  • [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
    
    
    

Document Information

Published:
03/24/1994
Department:
Grain Inspection, Packers and Stockyards Administration
Entry Type:
Uncategorized Document
Action:
Final rule.
Document Number:
94-6736
Dates:
April 25, 1994.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: March 24, 1994
CFR: (1)
7 CFR 800.71