[Federal Register Volume 59, Number 187 (Wednesday, September 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23763]


[Federal Register: September 28, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
[OPP-38510; FRL-4910-2]


Alfred Waldner Co.; Notice and Order of Revocation of 
Registrations and Final Determination Governing Sale and Use of 
Existing Stocks

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: On October 29, 1990, EPA issued registrations for Insecticidal 
2000 Concentrate, EPA Reg. No. 66410-1, and Insecticidal 2000 Ready to 
Use, EPA Reg. No. 66410-2. The original registrant certified that acute 
toxicity data submitted in support of these registration applications 
were obtained using a test substance identical to the Insecticidal 2000 
Concentrate and representative of both insecticides. EPA subsequently 
determined that the tests were conducted on a substance which differed 
in concentration from the registered insecticides and that the tests 
were willfully misrepresented to EPA. By this notice, EPA announces and 
orders the revocation of registrations No. 66410-1 and No. 66410-2. EPA 
also announces that no sale or use of existing stocks of these 
insecticides will be permitted.

EFFECTIVE DATE: September 28, 1994.

FOR FURTHER INFORMATION CONTACT: By mail: Richard F. Mountfort, 
Registration Division, Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Rm. 713, 1921 Jefferson Davis Hwy., 
Arlington, VA 22202, 703-305-5446.

SUPPLEMENTARY INFORMATION: On October 29, 1990, EPA issued 
registrations to Microft Systems International for the insecticides 
Insecticidal 2000 Concentrate, EPA Reg. No. 62212-1, and Insecticidal 
2000 Ready To Use, EPA Reg. No. 62212-2. On September 10, 1992, the 
registrations were transferred to Alfred Waldner Co. under new 
registration numbers 66410-1 and 66410-2, respectively.
    These registrations were originally issued after a review of acute 
effects toxicity data submitted with the Insecticidal 2000 Concentrate. 
Microft Systems certified that the tests were conducted with a test 
substance identical to Insecticidal 2000 Concentrate. Insecticidal 2000 
Concentrate and Insecticidal 2000 Ready To Use each contain two active 
ingredients: Permethrin and Bioresmethrin. The Ready To Use product is 
a dilution of the concentrate.
    The acute toxicity data submitted with the 2000 Concentrate were 
conducted by RCC-Research and Consulting Co. AG of Basel, Switzerland. 
The following five studies were submitted:

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                                                     EPA Identification 
         Project No.               Study Type                No.        
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#064383.....................  Oral................  MRID 41110401       
#064394.....................  Dermal..............  MRID 41110402       
#064372.....................  Inhalation..........  MRID 41110403       
#064416.....................  Eye irritation......  MRID 41110404       
#064405.....................  Skin irritation.....  MRID 41110405       
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    EPA's review of these studies indicated that they were adequate to 
support registration of a concentrate identical to the proposed 
concentrate and indicated a classification for acute effects in 
Toxicity Category 3: a caution label and associated precautions (40 CFR 
156.10(h)).
    On October 24, 1991, the Agency issued a registration to Bio-
Environmental Products Corp. for the insecticide BEP Insecticide, EPA 
Reg. No. 64321-1. This insecticide is a dilution of a concentrate 
containing the single active ingredient permethrin. The same five acute 
studies described above were submitted by Bio-Environmental Products 
Corp. to support that application.
    It has subsequently been established that the studies referred to 
above were sponsored by Jesmond, Ltd. BioEnvironmental Products Corp. 
is a wholly owned subsidiary of Jesmond, Ltd. The test substance in 
these studies contained the single active ingredient permethrin. It did 
not include bioresmethrin and is not identical to the Insecticidal 2000 
Concentrate. EPA has concluded that the registrations for Insecticidal 
2000 Concentrate and Insecticidal 2000 Ready To Use are not supported 
by the acute toxicity data that were submitted with the registration 
applications and that the precautionary labeling cannot be confirmed to 
be adequate for these insecticides.
    This notice is organized into two parts. Part I describes the basis 
for the revocation of registrations for Waldner's Insecticidal 2000 
Concentrate and Insecticidal 2000 Ready To Use. Part II describes the 
procedures which will be followed in implementing the regulatory 
actions set forth in this notice, including the treatment of existing 
stocks.

I. Basis For Revocation

    Section 558 of the Administrative Procedure Act (APA) (5 U.S.C. 
558) spells out the procedural requirements agencies must follow when 
terminating a license. Section 558 states:

    Except in cases of willfulness or those in which public health, 
interest, or safety requires otherwise, the withdrawal, suspension, 
revocation, or annulment of a license is lawful only if, before the 
institution of agency proceedings therefore, the licensee has been 
given--(1) notice by the agency in writing of the facts or conduct 
which may warrant the action; and (2) opportunity to demonstrate or 
achieve compliance with all lawful requirements.

    Courts have interpreted willfulness to mean ``an intentional 
misdeed or such gross neglect of a known duty as to be the equivalent 
thereof.'' Hutto Stockyard, Inc. v. USDA (903 F.2d 299, 304 (4th Cir. 
1990) (quoting Capitol Packing v. United States, 350 F.2d 67, 78-79 
(10th Cir. 1965); Capital Produce Co. v. United States, 930 F.2d 1077, 
1079 (4th Cir. 1991). To establish willfulness, one need only show that 
an act or failure to act was intentional, as opposed to accidental, and 
proof of an evil motive is unnecessary. Emil Lawrence v. Commodity 
Futures Trading Commission, 759 F.2d 767, 769 (9th Cir. 1985).
    In this case, the original registrants submitted data which were 
developed using a product with one active ingredient when, in fact, 
their product contained two active ingredients. Registrants certified 
that the information submitted was accurate. That certification and 
submission of data which did not represent the registered product was 
an intentional act, not an accidental one; therefore, it falls squarely 
within the definition of ``willful.'' Because the registrations were 
obtained through misrepresentation and a willful violation of the 
provisions of FIFRA, the registrations were not valid when granted and 
the procedural requirements for revocations in APA section 558 do not 
apply.
    Although not required in this case, the Agency did provide 
registrants written notice as well as an opportunity to respond to the 
allegations against them. Registrants did not respond to that notice. 
These procedures go beyond what is required by the APA in cases of 
willful violations of law.

II. Order

    This notice announces EPA's decision and order revoking Alfred 
Waldner's registrations for Insecticidal 2000 Concentrate and 
Insecticidal 2000 Ready To Use. It is also notification that the Agency 
will not permit sale, distribution, or use of any existing stocks of 
either insecticide in the United States.

Dated: September 16, 1994.

Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 94-23763 Filed 9-27-94; 8:45 am]
BILLING CODE 6560-50-F