Information provided for informational purposes only

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.


TRAC 5/27/98

Staff Background Paper # 3.1


DATA CALL-INS

Data call-ins (DCIs) are requirements by EPA issued to pesticide registrants to obtain data or other information in support of an existing active ingredient or product registration. DCIs are issued when there is no existing, reliable information available to characterize a pesticide's risk, exposure, or to otherwise complete a risk assessment. EPA has authority to issue a DCI under Section 3(c)(2)(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

For pesticide reregistration, FIFRA '88 required that EPA make a finding that a pesticide and its uses will not cause unreasonable adverse effects on human health or the environment. To do so, EPA established data requirements for each pesticide based on its registered uses. The outstanding data requirements were then compiled into DCIs and sent to pesticide registrants. EPA has received more than 27,000 studies in response to DCIs.

EPA may issue a DCI for any registered pesticide, including but not limited to pesticides undergoing:

For reregistration, EPA may require studies for any or all of these scientific disciplines:

Time frames for studies can vary, depending on the length of time needed to generate data and analyze it. For example, chronic rat studies or residue studies take two years. Acute studies take only 30 days to complete.

For Special Review, studies from the above categories could be required to make a risk-benefit determination, or other information, such as those in the examples below, could be requested.

For product reregistration, DCIs are issued for acute toxicity studies and product chemistry. EPA has also issued DCIs for specific exposure scenarios that include large numbers of chemicals. Some examples of these are:

Whenever possible, EPA uses existing data and works with registrants to obtain data or other information as an alternative to issuing DCIs. This allows the Agency to obtain the necessary information more quickly and to prevent companies from undertaking costly and time-consuming studies unnecessarily. For example, EPA will conduct literature searches to see what is available publicly, and may accept existing reports from academia or other institutions as alternatives to requiring new studies. Registrants, too, may conduct literature searches or submit existing information as alternatives to fulfilling DCI guidelines, as long as the information is reliable and pertinent.

Often, registrants will conduct studies to refine a pesticide's risk without any requirement to do so by EPA. For example, many registrants have chosen to conduct dermal absorption studies as a means to refine the exposure of a given pesticide. Some registrants also gather monitoring data or survey data as a means of refining a pesticide's exposure and risk.

With the enactment of the Food Quality Protection Act (FQPA), EPA is required to reassess all existing tolerances (allowable pesticide residues in food). EPA has stated that it intends to reassess organophosphate tolerances as one of the first classes of chemicals under FQPA. EPA is currently deciding whether it will require more data on this group prior to reassessment. Two examples of data that could possibly be required are neurotoxicity and exposure data to refine drinking water risks. If EPA decides to issue DCIs for these data, EPA typically gives a timeframe of 12 months for acute neurotoxicity studies, and 24 months for developmental neurotoxicity studies. Preparation of the DCIs is a lengthy process that would add time to the information gathering exercise. Obtaining water exposure information could take several years. Once studies are received, time is required for EPA to review them. If EPA takes the traditional approach of issuing DCIs and waiting for the information to be submitted, then these timeframe issues will affect the Agency's ability to reassess the organophosphate tolerances by the year 2000. In addition, any new data requirements would need to be applied, as appropriate, to the evaluation of new pesticides as well as to existing pesticides.

EPA's goal is to take a rational and creative approach to obtain the necessary information in a timely and cost-effective manner. Prior to the issuance of any DCIs for the FQPA assessments, EPA will seek the cooperation of registrants, other Federal and state agencies, and any other interested parties to determine if useful and reliable data already exist.


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updated May 17, 1998