WASHINGTON, Aug. 1 /EMWNews/ -- In a report issued yesterday, the

Center for Public Integrity (Perils of the New Pesticides) inappropriately

attacks the safety profile of pyrethrins. Derived from flowers grown in

Africa and Australia, these natural insecticides have been used for

centuries to protect crops and homes from insect infestation. They have the

additional attribute of breaking down quickly in the environment, which

makes them favored in organic agriculture, pest control, and other

applications.



    "We are concerned that this report was issued without apparent

understanding of how human incident reports are collected and managed and

without a broader understanding of the safety profile of pyrethrins," said

Dr. Thomas Osimitz, a board-certified toxicologist, and

internationally-recognized expert on pyrethrins. He is a consultant to the

Pyrethrin Steering Committee/Joint Venture (PJV), an alliance of pyrethrin

growers, formulators, and refiners. He was interviewed by the reporter.



    "While the author of the report spoke at length late in July to me and

to Dr. Richard Kingston, one of the architects of the reporting systems

used by the nation's poison control centers and relied on by the

Environmental Protection Agency, he failed to communicate the limitations

in using raw incident report data in making conclusions about safety

profiles," Osimitz said. "Instead, the author used raw data incorrectly to

derive the conclusions used in his story. So, the basis for his conclusions

is flawed and represents a grossly inaccurate picture of the safety profile

of pyrethrins."



    Dr. Kingston, senior clinical toxicologist with the SafetyCall

International Poison Center and clinical professor of pharmacy at the

University of Minnesota, is one of the world's foremost authorities on the

collection and evaluation of adverse event incident data for a wide range

of consumer products. He was instrumental in the development of the

reporting structure for incident data that is provided to the EPA. His

organization, a licensed medical facility, is one of the largest

surveillance centers in the world responsible for collecting, monitoring

and reporting adverse incidents to the EPA involving pyrethrins.



    According to Kingston, he cautioned the author in extended

conversations about serious concerns regarding the report's accuracy, if

the author persisted in simply conducting his own statistical analysis.

"The basic premise behind the story is that the EPA's raw database shows an

increase in reports of adverse events. But taking all incident data at face

value in its raw form is a fundamentally flawed approach," Kingston said.

He also explained to the author the difficulties of drawing conclusions

regarding this data without assistance from those who understand how the

data was collected, tabulated and reported and what it means.



    "In an effort to conduct responsible product stewardship, companies

encourage consumers to call with any concerns and then must report all

incident allegations to the EPA. But, the incident details are often

incomplete, cannot be confirmed or not valid and the incidents may have no

health implications whatsoever," Kingston said. "In the database, these

incidents are aggregated further with reports of individuals who, for

example, used products to commit or attempt to commit suicide, but both are

treated as being equal. They're not."



    According to Drs. Osimitz and Kingston, there are several important

factors to consider in determining if there is a meaningful increase in

reports:



    -- Products containing pyrethrins are among the most preferred products

available to consumers for insect management. Because of their quick

removal from the environment by sunlight and because they have an excellent

safety profile, use of pyrethrins has increased. With increased usage, one

would logically anticipate more reports, but the overall percentage of

valid reports versus usage has NOT increased significantly.



    -- Reporting requirements for incidents associated with products have

changed dramatically. Previously only reports validated by independent

medical professionals were submitted to the EPA for its database. When EPA

rules changed, ALL reports, no matter how inconsequential, must be

submitted without having gone through appropriate medical analysis and

validation. This rule change, not the products themselves, has contributed

to a substantial increase in the number of reports in the database.



    -- The reporter equates an incident report with a poisoning. That is

simply incorrect and inappropriate. Reports are added to the EPA dataset

with no investigation, confirmation or validation. Every reported incident

in the EPA database was taken at face value as factual and was assumed to

have been related to serious exposures. The author of the report based his

thesis and conducted his own analysis using this raw, unaudited data. There

was no evaluation by expert clinical and medical toxicologists to evaluate

incidents that, in many cases, would not have been considered to result

from exposure to pyrethrins. Many, in fact, are without any symptoms. As a

result, the conclusions in the report are seriously misleading and flawed.



    "The PJV will continue to reach out to consumers, healthcare

professionals, news media representatives and others to share concerns

about the nature of the story and its many other misrepresentations,"

according to Susan Little, executive director of the PJV. "This

'investigative' feature raises serious questions about editorial

integrity," she said, "when the science is completely ignored and

sensationalism becomes the focus. Additionally, to suggest that the

industry and the EPA are not working to provide sufficient safeguards is

simply absurd."