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Die-off tied to pesticide label?

Fyfanon, the pesticide at the
center of the labeling flap

(Newsday / Michael E. Ach)


December 28, 2004

In November 1994, the Environmental Protection Agency wrote Cheminova Inc. that it had rejected the chemical company's proposed label for the pesticide Fyfanon, a brand name for malathion.

The EPA said the label needed a warning that the spray should not be used "around bodies of water where fish or shellfish are grown and/or harvested commercially."

But almost five years later, in September 1999, when tons of Fyfanon were sprayed to kill mosquitoes in neighborhoods that drain to Long Island Sound, the label still did not include the suggested warning.

The restrictive language didn't appear on Fyfanon packaging until the following month, a few weeks after millions of lobsters began to die in the Sound.

The Fyfanon label's painstaking evolution, as charted in documents filed as part of lawsuit lobstermen are waging against Cheminova, illustrates how seemingly minor wording changes can take years to materialize on 55-gallon drums of pesticides, even though they are recommended by the government. The lobstermen say Cheminova was negligent in allowing Fyfanon to be used bearing what they claim was an outdated label.

Whatever the resolution of the label question, it remains unclear whether the spraying had any impact on the lobsters. Scientists agree only that pesticides may have played a role, along with unusually warm water temperatures, a parasitic disease and other environmental factors. To prove negligence, however, the lobstermen have only to prove that the Fyfanon spraying was a substantial factor in the lobster collapse, not the main cause.

Labeling deadline debated

Cheminova, headquartered in Wayne, N.J., and the U.S. subsidiary of Danish chemical maker Cheminova A/S, argues that the EPA never gave it a "specific, immediate starting date for use of the new label," according to papers filed by Christopher Kelly, the company's Manhattan attorney.

In an interview, Kelly also said the EPA was involved with New York City's Fyfanon-spraying program in the summer of 1999, as public concern heightened about mosquitoes that carried the potentially deadly West Nile Virus.

"The EPA has never said there was a problem with what occurred here," Kelly said.

Given two weeks to respond to questions, the EPA said Thursday it was not able to comment on the issue beyond the documents in the court file.

Whether the lobstermen prevail on the label argument may determine whether the $125-million lawsuit will be allowed to proceed. U.S. District Judge Thomas C. Platt Jr. is considering whether to dismiss the suit or allow a trial.

"If this product is misbranded and not in compliance with the EPA mandates ... then we're not taken out of court," said Peter Freiberg, a New Orleans attorney who is on the lobstermen's legal team.

Regulation of the more than 20,000 pesticides registered with the EPA is largely administered through oversight of the labels on such products. Pesticide makers must seek EPA approval when they want to change their labels, which they often do when they discover a new market for their pesticide.

For years, critics have panned the label-based system. They say it is an inadequate substitute for more aggressive regulation and over-reliant on the people who use the chemicals to fully understand what is written on the label.

"Some of the risks are so significant that you could not presume labels are an adequate way to manage that risk," said John Wargo, a professor of risk analysis and environmental policy at Yale University who serves on a review board to the EPA's pesticides program.

EPA, Cheminova exchanges

The lobstermen's lawsuit is highlighting a series of exchanges between the EPA and Cheminova that began in June 1994. At that time, the company sought permission to allow Fyfanon to be used on triticale, a 30-year-old wheat-rye hybrid that is mostly used to feed livestock.

But in November 1994, the EPA rejected Cheminova's proposed label and asked the company to add various restrictions. At the same time, the EPA also told Cheminova it would not need to conduct studies on "the magnitude of residues in ... fish and shellfish resulting from the application of malathion ... " as long as it warned users of the pesticide to refrain from applying the chemical "around bodies of water where fish or shellfish are grown and/or harvested commercially."

As far as Cheminova was then concerned, Kelly said, its old label continued to be legal.

In January 1997, the EPA approved another Cheminova request to make changes to its label. But it did so under the condition the company add various restrictions, including the ban on Fyfanon's use near commercial fishing grounds.

Cheminova then had 18 months to comply. But 17 months later - in June 1998 - Cheminova submitted yet another request to change the label. In effect, that request re-started the EPA's 18-month compliance countdown.

This time, it won approval in six months - in December 1998. Again, the EPA asked for the protective language about fish and shellfish.

A few months later, the West Nile Virus issue mushroomed across the metropolitan area. Fyfanon was sprayed to kill mosquitoes, but it had the 1994 label. Under the law, companies are allowed to use their old stocks of labels until they run out. Kelly said Cheminova prints 10,000 to 15,000 labels at a time for one of its products.

Kelly emphasized that the EPA had the power to order immediate changes to the label at any time, but chose not to do so. He said EPA could even have ordered an "interim" label to be used before any of the 18-month deadlines passed.

Even if the EPA did not act more forcefully, lobstermen's lawyers contend, Cheminova should have changed language it had been told several times to change. "Our argument is, given that EPA had been telling Cheminova this since 1994, they should have put it on the next label re-printing, which was in March of 1999," Freiberg said.

Long road to warning label

It took the Environmental Protection Agency almost five years to get a warning on Fyfanon, a malathion-based pesticide, that the spray should not be used near commercial fishing grounds. A sampling of what happened:

March 3, 1994. EPA accepts Cheminova Inc.'s Fyfanon label, which says the product is "toxic to fish" and should be kept out "of lakes, streams, ponds, tidal marshes and estuaries."

June 23, 1994. Cheminova asks EPA if it can update its label for use on an additional agricultural crop.

Nov. 21, 1994. EPA rejects Cheminova's proposed label but says it would approve if restrictions are added, including: "Application may not be made around bodies of water where fish or shellfish are grown and/or harvested commercially."

Oct. 11, 1996. Cheminova asks again to alter the label, which has not changed.

Jan. 9, 1997. The EPA accepts the new, proposed label. But it again asks for the restrictive wording about areas where fish or shellfish are harvested. Cheminova has 18 months to comply.

June 6, 1998. Just before the deadline to change the label, Cheminova asks again to modify the label.

Dec. 9, 1998. EPA accepts the re-worked label, which contains the language about fish and shellfish.

September 1999. Fyfanon sprayed by New York City and Suffolk County, but the pesticide carries labels that were approved in 1994. So, the language about fish and shellfish is not there.

October 1999. The fish and shellfish warning first appears on barrels of Fyfanon.


The public needs to know. So judge should let lawsuit go to trial

January 1, 2005

The death of millions of lobsters in Long Island Sound in 1999 was a calamity for those who harvested the crustacean delicacy, and it's still the central focus of a lawsuit that may or may not get to trial. We hope it does, so the public can hear more about the role of pesticides in the lobster die-off.

That sad event took place at the same time as governments such as New York City and Suffolk County were spraying a pesticide called Fyfanon from helicopters, to combat mosquitoes thought to be carrying the West Nile virus. Lobstermen in New York and Connecticut believe that the pesticide was a culprit in the die-off. So, in 2000 they sued pesticide companies over the use of Fyfanon and other agents, such as Scourge, which is also involved in lawsuits by the nonprofit environmental organization, Peconic Baykeeper, against Suffolk County.

Now that the plaintiffs have settled with two of the companies, the only defendant remaining is Cheminova, the manufacturer of Fyfanon. U.S. District Judge Thomas C. Platt Jr. will decide whether to let the case go forward or grant Cheminova's motion to dismiss.

A major claim of the lobster industry is that Cheminova negligently used an outdated label on Fyfanon. The company and the federal Environmental Protection Agency have been wrestling since 1994 over EPA's request that the firm add language to the label to warn against its use near bodies of water with commercially harvested fish or shellfish.

Critics rightly argue that the whole system of relying on labels, instead of more effective forms of regulation, is at best questionable. Like it or not, however, the question of labels will be at the heart of Platt's trial-or-no-trial decision.

No one is claiming that pesticides alone killed the lobsters. In fact, scientists at a Stony Brook University symposium last October cited a "perfect storm" of factors, also including sustained high water temperatures. But there's no question that malathion, the nasty chemical in Fyfanon and other pesticides, is dangerous. Like military nerve gas, it attacks the enzyme that makes the nervous system work.

The public needs to hear more about what this stuff may have done to lobsters. So the lobstermen should press their case against Cheminova, rather than settle, and Platt should let the suit go to trial. That's the best way to explore all the facts, for everyone to hear, in open court.

Copyright © 2004, Newsday, Inc.


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