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Accufilter International, Inc.; Notice and Order of Revocation of Registrations

 [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, 9512f 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

 
 

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