----------------------------Original message---------------------------- PRESS RELEASE FROM: James C. Wright, Esq. 703-791-0500 (phone) wright@pestlaw.com (e-mail) DATE: July 2, 1997 FOR IMMEDIATE RELEASE ----------------------------------------------- ATTORNEY CALLS FOR RESIGNATION OF EPA ASSISTANT ADMINISTRATOR STEVEN A. HERMAN 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." # # # 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: www.pestlaw.com.