[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
