The Risk Cup: It Is Filling Fast

Would you operate your business without Dursban, Baygon or Diazinon? How about Malathion, Orthene or Sevin? Can customer pest problems be solved without using any pesticides?

PCOs take note: The industry risks losing many chemicals registered for structural pest control under the Food Quality Protection Act (FQPA) of 1996. Never has a law been passed that could change the pest control industry as dramatically as the FQPA.

“This is the most radical change in the way pesticides are regulated since 1970 when the Environmental Protection Agency was created, or perhaps ever in the U.S.,” states Bob Rosenberg, government affairs director for the National Pest Control Association (NPCA).

Although signed into law nearly three years ago, standards set in the Act’s August 1999 deadline hold vast implications for the future of the pest control industry. Industry leaders agree the issue is not whether FQPA will affect PCOs, it’s how much.

THE CUP THAT RUNNETH OVER. FQPA is an immensely complicated law, affecting agricultural, structural pest control, turf and ornamental, and any industry using pesticides. The law uses new criteria to define an acceptable level of pesticide exposure. This level accounts for the combined exposure of pesticides in the environment, food and water, and is characterized as the “risk cup.” New methods of calculating that exposure and safety factors fill up the cup quickly. Exposure that causes the cup to overflow must be eliminated.

The law ammends the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetics Act (FFDCA). It eliminates the outdated Delaney clause that required zero detection of pesticide residues in food, and expedites the review of reduced-risk pesticides.

In the past, acceptable exposure was the total amount of a single pesticide a person could be exposed to every day for 70 years without experiencing health risks. Now, the Environmental Protection Agency is charged with establishing new residue tolerance levels for more than 9,700 pesticides. The deadline for reevaluating the first class of chemicals — carbamates and organophosphates — is August 1999. Standards set for reassessing these chemicals will be used to evaluate all subsequent pesticides. Future deadlines are 2001, 2003 and 2006.

“Here’s the bottom line: If more risk exists than the risk cup allows, you have to get rid of risk,” says Rosenberg. You can do this either by getting rid of uses or reducing the risk associated with existing uses, he says.

FQPA requires the EPA to reevaluate pesticide exposure based on three new criteria: First, all routes of pesticide exposure must be analyzed. This is called aggregate exposure. Exposure to the active ingredient chlorpyrifos, for example, must take into account residues found in the residential environment, as well as food and water, since the chemical likely has agricultural uses and may run-off into the water supply.

Second, the cumulative exposure of pesticides with a common mode of toxicity must be calculated. Chlorpyrifos is one of 40 active ingredients in the organophosphate family. To determine its cumulative exposure, risks and uses for chloryrifos and its 39 siblings would need to be evaluated.

Third, an additional 10x safety factor has been mandated as special protection for infants and children. Current standards have a built-in 100x safety factor: If exposure to 100 parts per million (ppm) of pesticide is safe for rats, exposure limits for humans is automatically reduced by 100 to 1 ppm. The new safety factor will reduce acceptable pesticide limits to .1 ppm. The EPA must use this additional 10x factor unless there is data to show it can be reduced or removed. The result is a risk cup that is smaller and more likely to overflow.

Because limited scientific data exists on pesticides’ aggregate and cumulative exposure levels, the EPA is relying on “default assumptions” to help define the risk cup. Industry leaders say these assumptions exaggerate risk with potentially dire results. Inflated indoor pesticide exposure levels, for instance, would result in a disproportionately large share of the risk cup. The pest control industry may lose products since manufacturers must cut risks, and eliminating a structural pest control product may make more fiscal sense than reducing the use of that active ingredient in the lucrative agriculture market.

“If a pesticide is honestly assessed and found to have unreasonable risks, we don’t want those products. But we do want to make sure we’ve gotten a fair shake,” states the NPCA’s Rosenberg.

“The law changes fundamentally the kind of data the EPA wants to see to regulate chemicals,” adds Joe Yoder, Novartis’ director of research and development for specialty products. Instead of relying on theoretical models, the industry advocates reliance on sound science. Yoder suggests the EPA allow temporary tolerances for individual or classes of pesticides, similar to conditional registrations granted new products, to allow time for scientific study. He also urges the EPA to undertake standard data call-in provisions, in which the agency points out scientific information gaps and manufacturers are given time to conduct the appropriate studies.

LOST PRODUCTS, MORE MITIGATION. “The biggest impact we’re going to see is the loss of products,” says Charles Frommer, president of Evins Pest Control, Long Island, N.Y. Frommer, who is active in the National Pest Control Association’s government affairs committee, believes “the area that will get hit worst is termite work.”

The industry is working with the EPA to find more acceptable reassessment procedures and alternatives for eliminating uses, but experts agree that manufacturers still will face mandates to reduce exposure. “It’s going to be a bottom-line driven thing,” says Terry Henderson, president of Achieva, Inc., an issues management firm working with pesticide manufacturers on FQPA. A manufacturer most likely will eliminate a product from the smaller pest control market rather than limiting its use in the lucrative agricultural industry.

“Companies are going to defend the use that is defensible and economically viable,” Yoder says. “We may lose relatively small but critical uses for products.”

“It’s safe to say that if the risk cup overflows – that the EPA says there’s too much exposure – the minor use will be lost first,” agrees Elizabeth Lawder, program manager for RISE (Responsible Industry for a Sound Environment), a non-profit group representing the interests of the specialty pesticides industry.

Losing cost-effective pesticides will be especially detrimental, Yoder adds. The loss of cost-effective organophosphates for roach control could result in increased roach-allergen-induced asthma among inner city children. And, although alternative controls may exist, their higher price tag may cost people out of the market. Termite control using chlorpyrifos costs approximately $700-$900. If chlorpyrifos is eliminated for structural pest control, PCOs can still turn to newer technologies such as baits. Baits, however, typically cost the homeowner twice as much as the standard treatment. “It will degrade a person’s ability to maintain their home,” Yoder suggests.

In the long term, PCOs may be required to undertake substantial risk mitigation measures, adds Rosenberg. Label changes could dictate increased protective action, such as requiring applicators to wear more protective clothing, stringent no-entry periods following applications, and 90-day waiting periods between applications. Pesticides also may be formulated with less active ingredient.

“PCOs face potential loss of business,” sums up Rosenberg. “There may be certain pest problems for which no tools are available.” Tom Diederich, vice president of government relations for Orkin Pest Control in Atlanta, agrees. “It’s definitely an unsettled time for the industry.”

“The smaller guys are the ones that are going to suffer the most: John PCO and John Farmer,” reminds Frommer. “It’s time to take a cold, hard look at the pesticides you’re using now. Start looking for alternatives, so you’re not caught at the last minute.”

The agency’s newly appointed Tolerance Reassessment Advisory Committee (TRAC), on which the pest control industry is represented, is making some progress with regard to FQPA implementation. This group, comprised of various industries, activists and the EPA, is trying to develop science-based reassessment policies that will be acceptable to all parties. But some recent events within the TRAC committee and FQPA implementation have also proved foreboding for the pest control industry.

In August an EPA advisory group released preliminary safety factor recommendations for a group of organophosphates, including chlorpyrifos. The group’s report suggested retaining the use of the full 10x safety factor for chlorpyrifos, as well as for methyl parathion, and four other OPs.

Another issue of contention is the FQPA’s fast-approaching deadline of August 1999. Orkin’s Diederich says the EPA deadline doesn’t allow for adequate testing. And Achieva’s Henderson points out, “Deadlines are only as important as the people implementing them want them to be.” He says the EPA should go to Congress with a strategy and timeline for incorporating sound science into the law instead of relying on assumptions.

To show exposure effects of their products, and presumably as a last resort, chemical manufacturers have also made plans to test pesticides on humans. They say that because the EPA is basing reassessment standards on worst-case scenarios hypothesized from animal studies, the only way to prove a pesticide is safe for people is to conduct testing on humans. As reported in an article in the Sept. 28, 1998, Wall Street Journal, seven human tests with organophosphates including chlorpyrifos, malathion, diazinon, dichlorvos, azinphosmethyl and methamidiphos are under way or planned. According to a July 24 American Crop Protection Association Media Alert, “In the U.S., [human] testing is done under full medical supervision according to safety standards set by the U.S. FDA. FDA guidelines mandate that ‘the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life during the performance of routine physical or psychological examinations or tests.’” And chemical companies say the tests are legal, low-risk and ethical.

The EPA, which does not require or encourage human testing, expects to enact an agency-wide policy outlining new safety and ethical standards in human testing by February 1999. The EPA will use this policy to evaluate whether human test data on pesticides can be used in administering FQPA.

Some recent personnel changes at the EPA may also have an effect on FQPA implementation. Dr. Lynn Goldman, assistant administrator for the EPA’s Office of Prevention, Pesticides and Toxic Substances (OPPTS) and who played an integral role in TRAC, resigned in September and will leave her post Dec. 31. No replacement has been named, however, Susan Wayland is expected to be named the acting assistant administrator. In addition, Peter Robertson, EPA acting deputy administrator, is likely to become official deputy administrator and chair of TRAC, pending Senate confirmation. Robertson would replace EPA deputy administrator Fred Hansen who recently resigned.

“Goldman played a major role in TRAC as the head of the OPPTS,” says RISE’s Lawder. “I don’t believe her resignation will effect FQPA deadlines, and it’s hard to tell if the process will become easier or harder ... it depends on her replacement.” TRAC initiatives, she says, will continue, as two additional TRAC meetings were scheduled at what was to be the last meeting in September. Experts agree there is much work to be done before August 1999.

SOUND OFF FOR SOUND SCIENCE. The potential loss of pesticide uses is imminent. “If people aren’t focusing on it, they should be,” warns Rosenberg. RISE’s Lawder urges PCOs to write to the White House, the EPA and their congressional representatives. Demand that sound science be used in reassessing pesticides. Insist that the law allow adequate time for scientific studies to be conducted. Stress the invaluable role structural pesticides play in public health. Emphasize the importance pesticides have in your business’ success.

Yoder suggests hand-writing letters instead of using word-processors or typewriters. “We’ve found hand-written letters are most effective.” Letter-writing efforts and the 600 PCOs who marched on Capital Hill last February, for instance, played a critical role in the creation of TRAC.

“The power of the people made a difference right there,” points out Orkin’s Diederich. “A groundswell — letter writing, talking to your representative — might provide relief.”

MAKE YOUR VOICE HEARD

Write today. Industry advocates urge you to put pen to paper, making Washington, D.C., aware of your stance on the implementation of FQPA.

Here are some addresses to help make the task easier:

President William Jefferson Clinton
The White House
1600 Pennsylvania Ave.
Washington, D.C. 20500
Phone: 202/456-1414
Fax: 202/456-2461

Ms. Carol Browner, Administrator
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Phone: 202/260-2090