The New Policy on Pesticides

The Food Quality Protection Act, passed in August of 1996, profoundly changes the way pesticides are regulated. No longer are pesticide products looked at individually with regard to their likely toxicological effects on humans. And for the first time, special consideration will be given to infants and children.

Under the law, all labeled uses of a pesticide will be analyzed together. At the basis of all this is the rule requiring “reasonable certainty of no harm.” In other words, for each registered product, the registrant must show EPA there is a reasonable certainty that no one will be harmed by its use.

Because of the way the law works, many experts fear the pest control industry, which accounts for a small portion of the pesticides used each year, stands to lose the most from this law. While the pest control industry uses substantially less pesticides than such groups as agriculture, the risks associated with this use are considered to be greater. And for manufacturers which have numerous uses for which to register their products, the pest control industry is among the smallest users.

A detailed presentation on the FQPA and what it means to this industry was given recently by Joseph Yoder, director of Research and Development for Novartis Crop Protection, Greensboro, N.C. Dr. Yoder addressed the annual meeting of the United Producers, Formulators & Distributors Association, held this April in Tarpon Springs, Fla.

WHAT IS FQPA? The FQPA amended the nation’s two primary pesticide laws, the Federal Insecticide, Fungicide and Rodenticide Act, and the Federal Food, Drug and Cosmetic Act. Under the act, all pesticide tolerances must be reassessed by August 4, 2006. One-third of the 9,728 tolerances must be reassessed within three years, two-thirds within six years, and 100% within 10 years.

Pesticides will be categorized into a number of groups, based on their mechanism of toxicity, and for each group established, one cumulative, maximum level of exposure will be established. This exposure level is referred to as the “risk cup.” For the average person, the estimated lifetime exposure to a certain group of chemicals must not exceed this “risk cup.” The risk cup will be determined using the reference dose: the amount of the pesticide a person can be exposed to from birth until age 70 without experiencing any ill effect.

To arrive at estimated exposure levels, the Agency must consider all possible non-worker related sources of exposure a person may have to a particular pesticide, including foods eaten, drinking water consumed and residential areas treated. This has been referred to as the “aggregate risk” for each particular chemical — all routes of exposure must be added together.

The EPA will then look at cumulative exposure, i.e. the sum of all the aggregate exposures from each chemical within a given group of chemicals. This sum will then be compared against the risk cup for that group of chemicals.

THE TEN-FOLD FACTOR. In addition to the maximum allowed exposure limit, the FQPA also requires that the EPA impose an additional ten-fold safety margin for children. Individuals inside and outside of the EPA agree, it will be difficult to ascertain exposure levels from such things as indoor uses of pesticides. In fact, experts say, there is very little information on the amount of non-food exposure the typical American receives, and the risks associated with this exposure are also unclear. “This kind of database is not available for 95-plus percent of all chemicals,” Yoder said. “It’s not the kind of database that EPA had required in the past.” Making the law even more complex is the additional safety factor. The EPA will determine if, for each group of chemicals, an additional safety factor should be applied to adequately protect infants and children who may be exposed to these chemicals. To reduce or eliminate the additional safety factor, registrants must conclusively prove to EPA that children and infants aren’t more susceptible to ill health effects than are adults, from exposure to these pesticides.

After making decisions about aggregate risk, cumulative risk, and the additional margin of safety for children, the Agency must then revisit the issue of the risk cup. As long as the risk cup for a particular class of chemicals is not full, the EPA may continue to grant registrations for a given class of pesticides. The EPA will consider each new tolerance by how much room is left in the “risk cup.” If the risk cup is full for a particular class of chemicals, the EPA may not grant any additional uses unless someone proves either that the cup was not full or that some risk can be removed. In fact, some uses will have to be dropped. In the past, the EPA has reserved about 10% to 20% of the risk cup for non-food exposures.

IMPLEMENTATION TIMELINE. In reviewing the pesticide tolerances, the EPA will begin with those pesticides they consider to pose the greatest risk to public health: the cholinesterase-inhibiting chemicals (organophosphates and carbamates). These two classes of chemicals are important insecticides and fungicides used on major and minor crops, as well as by the pest control industry. Of the U.S. crop acres treated with insecticides, 70% are treated with OPs or carbamates. This first phase of tolerance reassessment includes 145 active ingredients with more than 3,000 associated tolerances. New tolerances are expected to be set by August 1999. Currently worldwide sales of organophosphates and carbamates totals about $100 million. There is no transitional period built in to the law, and the EPA must reassess all tolerances. They also must identify and collect the needed additional data requirements.

There are several major challenges in front of EPA in implementing FQPA. First, the EPA must determine how to assess aggregate exposure in individuals. They must also include all pesticides with a common mechanism of toxicity. Thirdly, they must apply the additional 10-fold margin of safety for infants and children, unless there is strong proof as to why the margin can be reduced.

Another problem is that EPA tends to rely on default assumptions when it has determined there are gaps in the available data. These default assumptions are often exaggerated, unrealistic and not based on sound data, Yoder said. Using them could lead to substantially overestimated risks.

What concerns the pest control industry now, is the information the EPA currently lacks in making its decisions. FQPA introduces many new requirements to assessing pesticide risks and for the registration process. But to date, the EPA has largely ignored provisions for developing new data to conduct tolerance reassessments. There are indications that the EPA has employed unrealistic default assumptions in implementing the law. For example, the Agency tends to assume products are being used at the maximum rates, on the shortest possible interval. In turn, industry insiders fear the EPA will grossly overestimate the amount of exposure each person receives. The risk assessments, therefore, Yoder pointed out, should be based on sound scientific research. And the Agency, as well as the registrant community need time to collect, evaluate and organize these data.

All applicators of pesticides stand to lose valuable pesticides, jeopardizing all pest management. “This is likely to bring about mass cancellations of a lot of products,” Yoder said. “In many cases, the oldest products will be the ones taken off the market…In many cases there are no alternatives.”

Manufacturers, given a choice about which uses to retain and which to drop, will be forced to delete the riskiest uses and/or least profitable uses from their products. In many cases, uses for structural pest control will be the first to go, some speculate. And how the EPA arrives at a decision about organophosphate chemicals will set the tone for future decisions. “We care about the organophosphates because that’s the first inning of the FQPA game,” Yoder said. “We’ve got to act forcefully in the first inning.”

THE INDUSTRY’S JOB. The FQPA requirements are strict, but they are attainable, provided that EPA allows development of the best scientific methodology and data to meet the new safety standards and revised objectives for protecting children’s health. They must secure data on non-food uses of pesticides. And perhaps, Yoder pointed out, the Agency needs more time in making its decisions. Therefore, the industry must encourage EPA to use its full authority to require new data development. Decisions must be based on actual pesticide use. Congress must be educated, and in turn, must influence the EPA and the White House.

To successfully manage these challenges, the industry must show its belief in our practices and our products, Yoder said. The industry must also promote the use of sound science, and communicate these beliefs to all audiences. “The industry has not been vocal enough about what we bring to America,” Yoder said. “We need to be taking our case to the public. We’ve got to be telling our story, the benefits we bring to society.”

Dr. Yoder contributed to this story. In part 2 of PCT’s ongoing coverage of FQPA, we’ll take a look at where the EPA stands in implementing this profound new law and how the industry fares to date.