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EPA-NEW ENGLAND ISSUES HIGHEST FINE EVER FOR VIOLATION OF PESTICIDE LABEL LAW

Release Date: 03/24/1999
Contact Information: Amy Miller, EPA Press Office (617-918-1042)

BOSTON - The U.S. Environmental Protection Agency today announced a $106,600 penalty action against Welcon/Accorde Medical Products of Providence, R.I., a medical products manufacturer, for violations of federal pesticide control laws. This administrative complaint represents the largest penalty ever proposed by EPA's New England Office against a company for violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

EPA alleged that Welcon 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.

"Product claims that mislead health care providers pose significant health risks," said John P. DeVillars, EPA's New England Administrator. "Patients in health care facilities are vulnerable enough and products that provide misleading information can increase the chances for dangerous infections."

FIFRA requires that most products that claim to be effective in controlling bugs, 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," 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 stems from information EPA's headquarters in Washington received last year regarding Welcon's marketing of the pole bags. In April 1998, EPA-New England requested that the R.I. Department of Environmental Management (DEM) conduct an inspection at Welcon. The information collected by DEM was then 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.

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