New Data will Help Ensure Protection of Children

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Current as of: August 2, 1999

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Action
Rationale for this Action
How EPA is Implementing this Action
To Get More Information

Action

In an effort to further increase protections for infants and children, EPA is requiring registrants of pesticides thought to have neurotoxic effects to conduct acute, subchronic, and developmental neurotoxicity studies and submit the results to EPA. These studies are designed to show the effects on the nervous system of a chemical after a one-time or very short-term exposure (acute), an exposure over an extended period of time (sub-chronic or intermediate), and an exposure before or shortly after birth (developmental).

This program to call in data will apply to approximately140 pesticides and will be completed in phases over the next several months. EPA expects to receive the first studies within two years. This data call-in program was developed after seeking advice from the Children’s Health Advisory Committee and the FIFRA Scientific Advisory Panel.

Rationale for this Action

Many currently-registered conventional food use pesticides have been observed to affect the nervous system in humans and/or laboratory animals. There are outstanding questions about these neurotoxic effects such as:

Do these chemicals harm the nervous system following exposure during critical stages of its development, both before birth in the fetus, and after birth in infants and young children?

Are the effects in the young different from those observed in an adult?

If similar effects were to occur in both the young and adults, would the young be more or less sensitive than the adult to these effects?

The data developed in response to this data call-in will help determine whether or not differences occur because of age or stage of nervous system development. The differences could be measurable (or quantitative) or descriptive (qualitative). EPA will use these data in making decisions in the implementation of certain aspects of the Food Quality Protection Act’s tolerance-setting process, specifically in making the "reasonable certainty of no harm" finding and addressing the requirement that "In the case of threshold effects....an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of data with respect to exposure and toxicity to infants and children. Notwithstanding such a requirement for an additional margin of safety, the Administrator may use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children." (Section 402 (b)(2)(C)).

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How EPA is Implementing this Action

EPA is mailing letters to the affected pesticide registrants. These letters provide details about the methods to be used in conducting the studies, as well as the schedule for submittal of progress reports and results of the studies.

Registrants must notify EPA within 90 days of receipt of the data call-in notice as to how they intend to respond to the data requirements. Instructions about waivers from this data call-in are provided for registrants who have been required to submit these studies to EPA in the past, or who have voluntarily submitted these studies to the Agency.

EPA is implementing the data call-in in phases to ensure that data from the highest priority neurotoxic pesticides are called in first and that the laboratory capacity available to registrants is adequate to perform the studies within the required timeframes. The cholinesterase-inhibiting organophosphates (e.g., azinphos-methyl, chlorpyrifos, and diazinon) has been selected to be the first chemical class to be called in, based on their known neurotoxicity concerns. Additional classes of chemicals identified for later phases of the data call-in are:

Cholinesterase-inhibiting carbamates. Examples include aldicarb, carbaryl, and carbofuran.
Thio- and dithiocarbamates. Examples include mancozeb, maneb, and triallate.
Pyrethrin and synthetic pyrethroids. Examples include deltamethrin, fenvalerate, and permethrin.
Persistent organochlorines. Examples include dicofol, endosulfan, and lindane.
Formamidines: Examples include amitraz, tridimefon, and tridimenol.
"Mectins". Examples include abamectin and emamectin.
Phosphides (i.e., phosphine generators). Examples include aluminum phosphide, magnesium phosphide, and zinc phosphide.
Organotins. Examples include cyhexatin, fenbutatin oxide, and fentin hydroxide (TPTH).
Organoarsenicals. Examples include disodium methanearsonate and cacodylic acid.
Dipyridyl compounds. Examples include diquat chloride, mepiquat chloride, paraquat bismethyl sulfate/dichloride.
Other neurotoxic pesticides. Examples include carbon disulfide, imidachloprid, and nicotine.

To Get More Information

EPA plans to publish a notice in the Federal Register in the near future announcing the availability of this data call-in. Please see the EPA Office of Pesticide Programs’ home page, for further information on EPA’s pesticide regulatory program. To reach OPP’s Communication Services Branch, call 703-305-5017. Information on pesticides and their toxicity is available from the National Pesticide Information Center at 1-800-858-7378 or through their website .