EPA UPDATE

Subject: EPA UPDATE
Date:     Tue, 18 Jun 2002 08:00:24 -0400
From:      Stephen Tvedten <steve@getipm.com>
Organization:     Get Set Inc. (www.getipm.com)

To: Paul Helliker <phelliker@cdpr.ca.gov>
Director, State of California, Department of Pesticide Regulation

1) DRAFT REPORT IDENTIFIES POTENTIAL CHANGES FOR EPA'S HEALTH RISK ASSESSMENT PROCEDURES

2) STOP SALE ORDER ISSUED TO MISSOURI DISINFECTANT COMPANY (Press Release 6/14/02)

1) DRAFT REPORT IDENTIFIES POTENTIAL CHANGES FOR EPA'S HEALTH RISK ASSESSMENT PROCEDURES

On June 4th, the Environmental Protection Agency (EPA) published on the Web for public comment a draft report entitled A Review of the Reference Dose and Reference Concentration Processes. This report reviews the Agency's health risk assessment process, which determines whether chemicals pose a risk to human health. The report offers a series of recommendations to harmonize the Agency's health risk assessment procedures and thus make more efficient use of animal testing and other resources.

A 30-day comment period, from June 4th to July 5th, has been established for this report, and there will be a peer review workshop on June 19th, 2002. EPA's Risk Assessment Forum drafted this report with input from the Office of Pesticide Programs and other offices.

In assessing a chemical, EPA scientists develop reference values, which are estimates of exposure levels that are not likely to adversely affect the health of an individual coming into contact with that chemical. Reference values serve as important benchmarks for the Agency in making decisions that set acceptable levels of human exposure to air and water pollutants, pesticides in food and around the home, and other toxic chemicals. The draft report reviews the current process for developing reference values, in particular with respect to how well children and other potentially susceptible subpopulations are protected from possibly dangerous chemicals.

This report concludes that certain data, such as data from non-lethal acute toxicity studies, may be lacking from Agency databases, and additional data are desirable. The report outlines the type of testing which would be conducted at non-lethal dose levels to observe possible toxic chemical effects, which would then allow risk assessors to develop more accurate reference values to protect sensitive subpopulations. This approach to acute toxicology testing is markedly different from acute lethality tests such as the Up and Down Procedure, where the median lethal doses (LD50) are estimated to aid in hazard classification and labeling.

2) STOP SALE ORDER ISSUED TO MISSOURIDISINFECTANT COMPANY (Press Release 6/14/02)

On June 7, EPA ordered Wexford Labs, of Kirkwood, Mo., to immediately stop selling and distributing three ineffective antimicrobial disinfectant products. The products are: Wex-Cide Concentrated Germicidal Detergent (EPA Reg. No. 34810-8); Phenex-Cel Concentrated Germicidal Detergent (EPA Reg. No. 34810-16) and Ready-To-Use Wex-Cide Germicidal Detergent (EPA Reg. No. 34810-21). In addition, EPA is requesting that Wexford voluntarily recall all quantities of these products on sale since July 2001 from its distributors and their customers. Selling or distributing ineffective pesticides is prohibited under the Federal Insecticide, Fungicide and Rodenticide Act, which authorizes EPA to issue orders stopping the sale of ineffective products. EPA has an efficacy testing program for tuberculocides and hospital disinfectant products to ensure that products marketed in commerce to protect public health work as claimed. Disinfectant products play an important role in infection control. Health care providers, consumers and others rely on EPA's registration of these products as evidence that they work as claimed on the label. Because Wexford's products are ineffective tuberculocidal disinfectants, they may pose a potential public health threat, if used.

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