----------------------------Original message----------------------------

FROM: James C. Wright, Esq.
      703-791-0500 (phone)
      wright@pestlaw.com (e-mail)

DATE: July 2, 1997




James C. Wright, an attorney specializing in pesticide regulatory
issues who also maintains a prominent pesticide-related web site on
the Internet, has publicly called for the resignation of Steven A.
Herman, EPA's Assistant Administrator for Enforcement and Compliance
Assurance (OECA). Mr. Wright's demand, contained in a recent letter to
Mr. Herman and EPA Administrator Carol M. Browner, was prompted by the
continued failure of Mr. Herman's office to stop the widespread sale
of numerous unregistered and ineffective hospital disinfectants.

Hospital disinfectants are used not only in hospitals, but also in
dental offices, nursing homes, child day care centers and other public
health settings to stop the spread of microorganisms that cause
life-threatening diseases such as HIV, tuberculosis and hepatitis. The
need for these products to work effectively is becoming increasingly
important due to the emergence of new microbial strains that can
increasingly survive outside the human body and infect people who come
into contact with contaminated blood and other body fluids. For
example, approximately 80,000 deaths a year occur in the United States
due to hospital-borne infections, and the hospital-borne infection
rate has increased over 50% during the last ten years.

EPA's scandalous failure to stop the sale of illegal hospital
disinfectants is revealed in an investigative report by
Jacques Leslie that appears in the July/August 1997 issue of Mother
Jones magazine, which recently hit newsstands across the country.
However, the few products discussed in the Mother Jones article are
only the tip of the iceberg.

Although the issues raised in the Mother Jones article were
independently confirmed, they largely are based on James Wright's
ongoing work on behalf of companies that sell legal and effective
disinfectants. Those companies are concerned about the health threats
posed by ineffective and unregistered products. After continued
frustration with inaction by Steven Herman's offices and what the
Mother Jones article calls "bureaucratic inertia and indifferent
leadership" within OECA, those legitimate registrants have decided to
take their concerns public. They also are calling on Congress to
conduct hearings on why EPA has failed to stop the sale of the
numerous illegal products that the Agency has known about for years.

Under the federal law, hospital disinfectants may not legally be
advertised, distributed or sold in the United States unless they are
registered with EPA as pesticides. To register a hospital disinfectant
product, EPA requires that the manufacturer submit extensive
"efficacy" studies proving that it kills all human pathogenic
microorganisms listed on the product's label.

As revealed in a 1990 GAO report, EPA has known since the 1980s that
up to 20% of the thousands of disinfectant products registered by the
Agency do not effectively kill disease-causing microorganisms. Yet
over the last seven years, EPA has independently evaluated the
efficacy of only 17 of those products and OECA has brought enforcement
actions against only two illegal hospital disinfectants.

OECA's failure to protect the public is inexcusable. According to the
Mother Jones article, OECA has known for over three years that
market-leading products have been registered using apparently false
efficacy studies from a particular researcher. Studies by independent
laboratories and government scientists years ago confirmed that those
products contain ineffective formulations, yet OECA still has not
acted to remove them from the market.

In addition to ineffective registered products, OECA also has known
for over a year about numerous unregistered and thus unproven
products that continue to be marketed and sold by unscrupulous
companies. Some of these products are sold for decontaminating
medical devices that are inserted into patients' bodies after being
use on a prior patient, even though such uses are illegal for even
EPA-registered products. As James Wright has stated to EPA officials,
"I doubt you would want medical devices to be inserted into your body
after being used on someone else and then 'decontaminated' or
'disinfected' with unregistered and unproven products. I therefore am
at a lost as to why you would sanction such activities on an
unsuspecting public." Yet Steven Herman's office, which has the power
to act, so far has failed to stop the sale of such products or
require that EPA's regional offices do so.

Due to EPA's historic indifference regarding such products, new
unregistered products are entering the market on a monthly basis. For
example, EPA has samples of an unregistered hospital disinfectant that
a national distributor began selling earlier this year in a dental
supply catalog. The product's label claims it kills in record time
nearly every human pathogen imaginable, and includes other efficacy
claims that have never been approved by EPA for any legitimate,
registered product. Yet dentists have no way of knowing that the
product is illegal because the label bears a fictitious
EPA-registration number. Despite numerous complaints regarding the
product, OECA has yet to issue even a simple stop sale order.

By knowingly permitting the continued sale of illegal products for
many years, Steven Herman must bear responsibility for the countless
individuals who have become ill or possibly died due to ineffective
and unregistered public health disinfectants. As stated in Mr.
Wright's recent letter to Mr. Herman: "For the good of the country, I
urge you to resign and let someone fill your position who is able to
do an effective job protecting the public from illegal products."

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For further information, please contact James Wright at his law
offices. Phone 703-791-0500, fax 703-791-5367, or e-mail
wright@pestlaw.com. James Wright also maintains the leading source of
pesticide regulatory news and information on the Internet at: