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EPA SETTLES WITH PROVIDENCE MANUFACTURER CHARGED WITH VIOLATING PESTICIDE LABEL LAW

Release Date: 10/05/1999
Contact Information: Amy Miller, EPA Press Office (617-918-1042)

BOSTON - A medical products manufacturer in Providence, RI, charged with violating the federal pesticide control law has agreed to pay an $80,200 penalty. This represents the largest penalty ever collected by the New England office of the U.S. Environmental Protection Agency for violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

According to the settlement reached between EPA-New England and Welcon/Accorde Medical Products, Welcon will pay the sum in four equal installments.

The settlement stems from a complaint filed March 5 against Welcon, alleging the company sold or distributed medical storage bags that contained misleading claims. The claims made on the bags wrongly implied that the bags killed or controlled infectious micro-organisms on syringes stored in the bags.

EPA originally proposed a $106,000 fine but reduced that amount to reflect mitigating factors Welcon raised during settlement discussions.

The administrative complaint alleged that Welcon sold or distributed three different pesticide products on 24 occasions in 1996, 1997, and 1998. The complaint also alleged that these products were produced in an establishment that was not registered by EPA, which is also required by FIFRA.

"This settlement serves as a warning that EPA plans to enforce the stringent public health and safety requirements of the federal pesticide law," said John P. DeVillars, EPA's New England Administrator. "Welcon's misleading claims threatened vulnerable patients in health care facilities by increasing the chances for dangerous infections."

FIFRA requires that most products that claim to be effective in controlling insects, micro-organisms, fungi and other pests be registered by EPA before they can be distributed in the United States. The law also prohibits anyone from marketing these products before they are registered. Finally, FIFRA forbids anyone from making any misleading claims, or any claims that their product is effective as a pesticide unless EPA had previously accepted this claim.

The bags distributed by Welcon, called "pole bags" were marketed as the "Germbuster." The bags are made to hang on poles in health care facilities. The bags hold plastic syringes used to flush out feeding lines that drip nutrient solutions into patients. The syringes are put in the bags temporarily between uses.

The action against Welcon began after EPA's headquarters in Washington received information last year regarding Welcon's marketing of the pole bags. In April 1998, EPA-New England asked the R.I. Department of Environmental Management (DEM) to conduct an inspection at Welcon. The information collected by DEM was forwarded to EPA, which worked with the agency's Office of Pesticide Programs (OPP) in Washington DC. EPA determined that the claims on Welcon's pole bags would make the bags subject to FIFRA and that the bags are not registered with EPA, as required by FIFRA

In December 1998, EPA ordered the company to stop selling or using the bags, and not to remove the bags from Welcon's premises until otherwise notified by EPA. This order was later amended to allow Welcon to move the product for the purposes of disposing or recycling the bags only.