[Federal Register Volume 59, Number 223 (Monday, November 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28703]
[[Page Unknown]]
[Federal Register: November 21, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-66203; FRL-4915-2]
Accufilter International, Inc.; Notice and Order of Revocation of
Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice; Notice and Order of Revocation of Registrations and
Final Determination Governing Sale and Use of Existing Stocks.
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SUMMARY: On November 6, 1992, EPA issued registrations for Accufilter
Straw, EPA Registration Number 64906-1, and Accufilter Sport Bottle,
EPA Registration Number 64906-2. These silver-activated carbon filters
are intended to remove the taste of chlorine and other sources of bad
taste, odor, and color from drinking water. These registrations were
based, in part, on receipt and review of water samples analyzed for
silver content. EPA has subsequently determined that the registrant did
not report the actual silver content in those water samples, but
instead submitted false information showing the silver values to be
lower than those actually obtained by the laboratory that conducted the
sampling. Registrations obtained through the submission of false data
are invalid for any purpose. By this notice, EPA announces and orders
the revocation of registrations 64906-1 and 64906-2. As a result of
these revocations, the sale, distribution, or use of existing stocks of
these water filters after November 21, 1994 would be unlawful.
EFFECTIVE DATE: November 21, 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 November 6, 1992, EPA issued
registrations to Accuventure, Inc., Beaverton, OR, for the drinking
water filters Accufilter Straw, EPA Registration Number 64906-1, and
Accufilter Sport Bottle, EPA Registration Number 64906-2. The company
name was subsequently changed to Accufilter International, Inc., at the
Beaverton, OR, address.
These registrations were for drinking water filters in which silver
was impregnated on activated carbon. The filters are intended to remove
sources of odors and taste from drinking water. Silver is an element,
and a secondary standard for silver in drinking water has been
established. Under provisions of the Safe Drinking Water Act, a
secondary standard for a drinking water contaminant is not enforceble;
rather, it is established for aesthetic purposes. Exposure to silver
can cause argyria, a discoloration of skin or other tissues, which is
usually permanent. Although not a toxic response, it is an undesirable
cosmetic change.
The registration applications for these filters include analyses of
water samples from tests utilizing these filters. The testing was
intended to reflect actual use conditions and included sufficient
flushing of the filters to represent use over varying portions of the
filter's useful life (new filters, 10%, 60%, 95% of filter life).
Twenty four (24) sample analyses were reported from the laboratory. EPA
has learned that in the testing performed by the laboratory and
reported to the registrant, 14 samples were at or exceeded 0.05
milligram/liter (mg/L) of silver in drinking water. At the time of
registration (1992) the secondary drinking water standard (maximum
contaminant level) for silver was 0.05 mg/L. (This standard has
subsequently been increased to 0.1 mg/L). When this report was
forwarded to EPA in support of the registration applications, all 14
values had been reduced below the standard. The original data suggest
that some of the filters may leak silver, that higher levels of silver
than reported occur in drinking water as a consequence of use of the
filters, and that quality control of the filters may be inadequate.
This Notice has two parts: Part I describes the basis for the
revocation of registrations for Accufilter Straw and Accufilter Sport
Bottle; 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
The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7
U.S.C. 135 et. seq., does not prescribe procedures to be used to revoke
a registration that has been obtained through a willful act of
misrepresenting data submitted in support of registration. In the
absence of such procedures, the termination of a license such as a
pesticide registration is governed by section 558 of the Administrative
Procedure Act (APA), 5 U.S.C. 558. 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 registrant submitted data which were changed from
the original, and did not reflect true results of the analyses of the
samples. The altered results suggested lower silver content in the
drinking water than actually occurred as a consequence of use of the
filters. This 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 section 558 does not require that EPA provide notice
to the registrant or an opportunity to demonstrate or achieve
compliance prior to revocation of the registration.
Although not required in this case, the Agency did provide the
registrant written notice as well as an opportunity to respond to the
allegations against him. The registrant has responded that he did not
alter the data, but has not provided evidence to support his
contention. 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
registrations for Accufilter Straw and Accufilter Sport Bottle. As a
consequence of this revocation, the sale, distribution, or use of any
existing stocks of either filter in the United States is unlawful.
Existing stocks are those currently in the United States and which have
been packaged, labeled, released for shipment, and/or distributed to
dealers, retailers, or other sellers.
List of Subjects
Environmental protection, Administrative practice and procedures,
Agricultural commodities, Drinking water, Pesticides and pests, Records
and recordkeeping.
Dated: November 8, 1994.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 94-28703 Filed 11-18-94; 8:45 am]
BILLING CODE 6560-50-F
