EPA Enforcement May Look at Dow Pesticide Registration

By David Schultz

Dec. 10 — The Environmental Protection Agency's top chemical regulator told Bloomberg BNA that he is asking the agency's enforcement division to look into whether Dow Chemical Co. violated the law by failing to report information on its blockbuster new pesticide, Enlist Duo.

Jim Jones, head of the EPA's Office of Chemical Safety and Pollution Prevention, said in an interview Dec. 9 that enforcement officials are trying to figure out whether Dow was required to inform the EPA about data it had showing that the mixture of the weed-killing chemicals in Enlist Duo could combine to become more potent than each chemical on its own.

Jones said he asked the EPA's Office of Enforcement and Compliance Assurance, or OECA, to look specifically at Dow's actions in the context of a part of the Federal Insecticide, Fungicide and Rodenticide Act (Pub. L. No. 61–152) that requires pesticide makers to notify the EPA if they become aware of any new environmental effects for their products.

Even if OECA ultimately finds that Dow didn't violate this section of the law, Jones said, the company still “dropped the ball” by not providing the EPA with data on the synergistic effects of the chemicals in Enlist Duo.

“Whether it's a … requirement or not, I do think they should have been able to figure out that it was relevant to the decision in front of us,” Jones said.

Garry Hamlin, a spokesman with the company's subsidiary Dow AgroSciences, told Bloomberg BNA that his company is unaware of any pending EPA investigation into the matter.

But Hamlin said in an e-mail that Dow “believes that we are in full compliance with all disclosure rules. … We will continue to cooperate with EPA concerning its review of data.”

Synergistic Effects

The Enlist Duo weed killer is a mixture of the chemicals glyphosate and 2,4-D. Almost a year after granting Dow final approval to begin selling the pesticide, the EPA learned that the company claimed in a patent application that these two chemicals can amplify each other's effects, creating a synergism that the agency worries would make the product more toxic than it had initially thought.

After it learned of the information in the patent application, the EPA took the unusual step on Nov. 24 to ask a court to nullify the agency's own approval of Enlist Duo (39 CRR 1415, 11/30/15).

The chemical company had predicted that Enlist Duo would help Dow AgroSciences bring in $1 billion in revenue over the next three years, according to a 2014 company report, so the EPA's request had an immediate impact. Dow's stock price fell by almost 3 percent the day the news was first reported by Bloomberg BNA.

Patent Gets Closer Look

When reviewing new pesticides, the EPA typically doesn't look at the information contained in patent applications, Jones said. In this case, he said, the agency only decided to review the patent application because it was preparing to defend its approval of the pesticide in court against a lawsuit from several environmental activist groups (Nat. Res. Def. Council v. EPA, 9th Cir., 14-73353, 10/30/14).

But that policy may be about to change. Jones said pesticide regulators in his office will be scrutinizing patent applications for all of the chemicals they're looking at moving forward.

“I don't think we had knowledge that was going to be a treasure trove of information that may be relevant to our decisions,” Jones said. “Right now we're trying to get our arms around what it means for applications that are in front of us right now.”

Dow Opposes Nullification

Meanwhile, Dow is fighting back in court against the EPA's request to nullify the registration it granted to Enlist Duo in 2014.

In a Dec. 7 legal filing, the company said it acknowledges the EPA's need to revisit its approval of Enlist Duo and even agreed to voluntarily stop selling the pesticide until this matter is resolved.

Dow has said it believes it can supply the EPA with the data it needs to allow the agency to re-approve the pesticide in time to get Enlist Duo back on shelves and into the hands of farmers for the spring 2016 planting season.

However, Dow strongly opposed the EPA's request to have the court vacate the agency's actions. If the EPA wants to undo what it has already done, Dow's attorneys argue in the filing, it should do so itself through the agency's well-established administrative procedures—not by asking the court to do an end run around these procedures.

“An agency's desire for an opportunity to review an earlier decision,” the attorneys wrote, “provides no basis for either the agency or a court summarily to annul that decision.”

Attorney Disagrees With Assessment

Lori Ann Burd, an attorney with the Center for Biological Diversity, one of the plaintiffs in the case, disagreed with this assessment. She said it's standard practice for a court to wipe out the decision of a federal agency if the court determines that the agency's decision was flawed.

Burd also said she was puzzled by Dow's opposition to vacating the EPA's decision, given the company's belief that this matter will be resolved quickly.

“If EPA rushes out a new registration, vacatur will cost Dow little to nothing,” she told Bloomberg BNA. “If Dow is really confident, I don't know why they're so vehemently opposing [it].”

To contact the reporter on this story: David Schultz in Washington at dschultz@bna.com

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com