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TRAC 5/27/98

Staff Background Paper # 2.1


TOPIC: THE REGISTRATION AND REREGISTRATION PROCESSES

BACKGROUND:

The Agency's registration or reregistration process begins when the required chemical data base identified to support registration or reregistration has been submitted by the registrant. The Agency examines these data for health and environmental effects. In both programs, mitigation of effects of concern is developed once the risk assessments are complete. This evaluation and risk management process is complete when the Agency is satisfied that the pesticide, when use in accordance with the label, will not pose unreasonable risks to humans and the environment.

REGISTRATION AND REREGISTRATION PROCESSES (Flow Chart)

The following will describe the existing registration and reregistration processes.

Initiation

The Registration Division (RD) initiates the registration process upon receipt of an application for registration and/or petition for tolerance. The Special Review and Reregistration Division (SRRD) initiates the reregistration process. All data, use, and usage information enters the science review processes for evaluation of ecological risks (Environmental Fate and Effects Division (EFED)) and human health risks (Health Effects Division (HED)).

Process Change in the Reregistration Program: SRRD is now consulting with pesticide registrants and other appropriate stakeholders in the beginning of the reregistration process ("SMART Meetings"), before the development of the risk assessments, to get the most accurate use and usage information. This process improvement saves the Agency time and results in more accurate risk assessments. For example, the Agency uses label rates in its risk assessments. Obtaining information on typical use rates allows the Agency to examine potential risks from both typical and maximum use rates. Such a change may not be as appropriate to the registration program since the Agency is evaluating a proposed use, rather than an existing use.

Human Health Evaluation

HED characterizes pesticide risks to humans (toxicity and exposure potential) by evaluating toxicity, residue levels on food, and occupational and residential exposure.

Process Changes: In light of FQPA, HED also now conducts aggregate assessments, including all routes of exposure (dietary, drinking water, and residential). In addition, HED's assessment process now includes the additional infants and children's safety factor (10X). The Agency consulted with the Scientific Advisory Panel in developing the criteria used in retaining, reducing, or removing this extra safety factor.

HED has established 3 Science Advisory Councils (SACs) to provide technical assistance, as needed, on difficult science issues during the drafting of the risk characterizations. The three SACs are 1) Occupational and Residential; 2) Dietary Exposure; and 3) Toxicology.

In addition, HED has instituted 6 internal committees to ensure consistency in the application of these new risk assessment tools and processes. The Science Assessment Review Committees (SARCs) are comprised of experienced toxicologists and exposure scientists who peer review various aspects of hazard assessment as follows:

EFED characterizes the fate of the chemical in the environment (persistence and mobility), and ecological hazards.

Process Changes: In light of the FQPA requirement that all dietary routes of pesticide exposure be assessed for potential aggregate risk, EFED also conducts an assessment of pesticide exposure through drinking water. EFED's evaluation uses the pesticide's known environmental fate characteristics, modeling, and monitoring data that is available from various sources. The Agency solicited comment from the Scientific Advisory Panel (SAP) during the development of EFED's procedures for evaluating drinking water risks.

EFED has instituted several internal committees and panels to ensure consistency in the application of risk assessment tools and processes.

Risk Management

Completed science risk assessments are received by the originating regulatory division (RD or SRRD) and are routinely shared with the pesticide registrant. Risk assessments are modified if additional information becomes available that would alter the Agency's assessment of risks. Risk mitigation measures are identified, if warranted, and risk management decisions are made (e.g., registration, issuance of the tolerance, and eligibility for reregistration).

Results of Process Changes in the Reregistration Program: SRRD's institution of "SMART Meetings" has improved the accuracy of science assessments and, therefore, has resulted in the need for fewer revisions at the end of the reregistration eligibility decision (RED) development.

At the end of the registration process, the Agency publishes a final rule in the Federal Register establishing the tolerance for the pesticide residue. This document details the Agency's risk assessment findings and how establishment of the tolerance complies with the requirements of FQPA. RED documents generated through the reregistration process are made publicly available OPP's public docket and document center. In addition, RED documents are published on OPP's Internet site.


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updated May 22, 1998