Earlier this week, the Environmental Protection Agency (EPA) sent two letters to DuPont CEO Ellen J. Kullman regarding the agency’s review of its Imprelis herbicide. The EPA letters called DuPont’s warning labels for Imprelis “inadequate,” and criticized the company for classifying much of the information it sent to the EPA as part of the agency’s Imprelis investigation as confidential. Some of the so-called confidential Imprelis information included studies the herbicide’s effect on trees, the agency said.
The EPA began investigating Imprelis last month, after landscapers and property owners began complaining that the herbicide was killing and damaging trees, including Norway spruce and white pine, that were located in the vicinity of Imprelis applications. In one letter sent to the company on Wednesday, the EPA wrote to Kullman stating it has “reason to believe, based on DuPont’s own test data and information gathered during EPA and state investigations, that the directions for use and/or warning or caution statements on the DuPont Imprelis Herbicide … labeling are inadequate to protect non-target plant species, including certain trees …”
As a result, the EPA said it that Imprelis may be misbranded in violation of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The letter states that the EPA was considering enforcement actions against DuPont, including the issuances of a stop sale, use, or removal order (SSURO), as well as the assessment of civil penalties against the company.
The second letter, also dated Wednesday, was a follow-up to the EPA’s meeting with DuPont officials on August 1. According to the letter, DuPont expressed a willingness to stop selling and distributing Imprelis, and to issue a recall of the herbicide. The letter states that such an effort would work best through the EPA’s issuance of an SURRO, and seeks a meeting with DuPont officials to discuss such an order.
According to the same letter, the EPA is evaluating DuPont’s claim that many of the thousands of documents it forwarded to the agency as part of the EPAâ€™s Imprelis probe constitute confidential business information. The EPA voiced concern with the “sweeping nature” of DuPont’s confidentiality claims, and asserts that FIFRA requires that safety and efficacy information be made public. The letter urges DuPont to reconsider its confidentiality claims, â€œespecially for the phototoxicity studies related to effects on trees.”
Just one day after the EPA sent these letters, DuPont issued a statement acknowledging that it was planning to stop sales of the herbicide and issue a recall of Imprelis. According to the statement, the company is in talks with the EPA to â€œ determine the most effective way to implement our recommendation of a voluntary suspension of sale of DuPont Imprelis herbicide, and a product return and refund program.â€
DuPont has already been named in a number of Imprelis class action lawsuits that claim the herbicide damaged and killed trees, including three filed by a legal consortium that includes the national law firm of Parker Waichman LLP. Imprelis lawsuits accuse DuPont of, among other things, negligence and fraud in the marketing of Imprelis. The claims seek injunctive relief barring DuPont from continued sale of Imprelis, as well as compensatory and other damages, including the cost of replacing trees allegedly harmed by Imprelis.