New
Data will Help Ensure Protection of Children
August 2,
1999
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?
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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)).
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:
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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).
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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.
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