EPA is responsible under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for determining that pesticides will not pose unreasonable risks to human health or the environment when used according to label directions. FIFRA also requires EPA to balance the risks of pesticide use against the benefits to society and the economy when allowing a particular use.

These registration decisions are based on EPA's review and evaluation of test data generated by the registrant in a variety of scientific areas, according to Paul Schuda. He is deputy director of EPA's Office of Pesticide Programs' Policy and Special Projects Staff. These general areas include toxicology and oncogenicity, ecological effects, environmental fate, and residue chemistry.

EPA may require as many as 90 to 100 specific tests in all of these areas and the manufacturer's cost for completing these tests can be up to $10 million. Industry has estimated that the total cost of a registration for all phases, from research and development through production, may exceed $50 million. And it can take from 9 to 10 years. Most pesticide registrations can cost significantly less than this, depending on their proposed uses; for example, a proposed use on cut flowers (enclosed areas; not food uses requiring tolerances) will probably cost less than a use for corn or soybeans (many acres; food crops).

"And the specific scientific studies required are determined by the proposed use of the pesticide. Furthermore, if the proposed use is on a food crop, the registrant must petition the agency to establish a tolerance, or maximum residue level,"Schuda explains. "Because of these critical and sensitive cost and timing factors, the amount of data required becomes a sensitive issue also."

Three sets of documents describing the tests are available: 40 CFR Part 158 describes which tests are required, the Pesticide Assessment Guidelines give detailed guidance for how the tests may be performed, and the Standard Evaluation Procedures (SEP's) describe how the scientific reviewers at EPA evaluate test results for use in risk assessment.

"If someone wants to get a pesticide registered at EPA, the first step should be a preregistration conference where the potential registrant visits EPA to get the information and forms necessary to process the application," Schuda says. "This conference informs the registrant of scientific and technical data needed to support the registration for the proposed specific uses, and answers questions about EPA's review and decision-making processes."

After this conference, the registrant develops the required data and submits it to EPA, along with an application to register the product, draft labeling, and a tolerance petition (if the proposed use is for a food crop). The scientific information is reviewed and sometimes questions are raised that require the interaction and meeting of scientific and management personnel from both parties. Additional information may be needed, studies may need to be repeated, or additional studies may need to be conducted and new data submitted. After issues are resolved, the risk and benefits assessment portions of the process are completed and forwarded to the decision maker. Keeping in mind the proposed use of the pesticide, risk managers evaluate assessment results and make a decision based on risks versus benefits. During the decision-making process, EPA may require changes in proposed labeling, uses, and application methods to mitigate risks to human health or the environment.

Each year EPA makes a large number of various types of regulatory decisions. In 1996, those included:

Special Local Needs [Section 24(c)'s] ............................ 373

Emergency Exemptions [Section 18's] ............................. 452

Tolerances ...................................................................... 141

Total ............................................................................ 5,416

An example of the magnitude of EPA's responsibilities concerning pesticides is the 1995 figures, which indicate 610 active ingredients currently in production and 19,000 formulated pesticide products registered for marketing and use in the United States.

Another part of EPA's mandate is to bring the scientific databases of registered pesticides up to current standards through the reregistration process. As pesticides pass through this process, modifications may need to be made to registrations, labels, and tolerances to protect human health and the environment. This has become a very resource-intensive undertaking. Since 1991, EPA has made Reregistration Eligibility Decisions on 201 of the 382 chemical cases (53%), meaning that these active ingredients may proceed through the product-specific reregistration phase in which each formulated product is registered again according to its use. The remaining 181 chemical cases (47%) are projected to complete product specific registration by the year 2004.

Registration Questions: Biopesticides
EPA Contact: Biopesticides and Pollution Prevention Division
(703) 308-8128

Registration Questions: Antimicrobials
EPA Contact: Antimicrobials Division
(703) 305-5440