
Stephen L. Johnson, Administrator
Dear Administrator Johnson:
We Local Presidents of
EPA Unions representing scientists, risk managers, and related staff, are
writing to express our concern that EPA could betray the public trust by
violating the intention of the Food Quality Protection Act (FQPA) to protect
the Nation’s infants, children, and susceptible subpopulations, unless the
Agency adheres to principles of scientific integrity and sound science in the
pesticide tolerance reassessments it is undertaking.
There are more than 20
neurotoxic organophosphate (OP) and carbamate pesticides scheduled for final
tolerance decisions by EPA no later than
Those actions were consistent with the
overarching precautionary intent of FQPA which requires that, in the absence of
reliable data on toxicity or exposure, the Agency must ensure an adequate
margin of safety for the health of the nation’s infants, children, and
susceptible subpopulations through the use of uncertainty factors in relevant
analysis.
Accordingly, as EPA
approaches the August 2006 statutory deadline for the determination of final
tolerances for the remaining OP and carbamate pesticides, we urge the Agency to
adhere to its principles of scientific integrity and employ the precautionary
approach intended by the FQPA in assessing the cumulative and aggregate
exposure and risk from the uses of these neurotoxicants. This approach – compliance with the FQPA and
our principles of scientific integrity - is the only way to remain faithful to
the public trust and ensure that our children will not be exposed to pesticides
that may permanently damage their brains and nervous systems.
The
partial cancellation agreements of the 1990's mostly addressed residential
exposures, but did not adequately consider continued exposure through foods
eaten. As risk assessors, we continue to
be troubled by the Agency’s failure to adequately consider exposure to
neurotoxic pesticides by infants and children who commonly enter fields treated
with these pesticides while accompanying their parents employed to perform
post-application tasks. The children of
farmworkers, living near treated fields, are also repeatedly exposed through
pesticide drift onto outdoor play areas and through exposure to pesticide
residues on their parents’ hair, skin, and clothing.
Additionally,
we are concerned that unborn fetuses may also be exposed to these
neurotoxicants when pregnant women are employed to handle (mix, load, apply)
these pesticides or are employed to enter treated areas to perform hand labor
tasks following pesticide applications.
The
Agency’s own Scientific Advisory Panel (SAP) has expressed concern that the
Pesticide Program’s current approaches may not be sufficiently conservative,
may underestimate the risks to infants and children, and do not adequately
identify individuals that may be inherently sensitive to neurotoxicants. (May 25, 1999 SAP meeting)
We
are confident that you share our sense of urgency about taking the necessary
actions to protect the health of our Nation’s children. As you are aware, in August 1999, EPA
informed the public that it was issuing data call-in notices to pesticide
registrants of cholinesterase-inhibiting OP pesticides and requiring submission
of data on developmental neurotoxicity.
We
are concerned that the Agency has not, consistent with its principles of
scientific integrity and sound science, adequately summarized or drawn
conclusions about the developmental neurotoxicity data received from pesticide
registrants. Our colleagues within the
Agency, including EPA’s Inspector General (EPA IG), believe that it would be
premature to conclude that there is a complete and reliable database on
developmental neurotoxicity of pesticides (see Attachment) upon which to base
any final tolerance reassessment decisions as required by the FQPA. Consequently, EPA’s risk assessments cannot
state with confidence the degree to which any exposure of a fetus, infant or
child to a pesticide will or will not adversely affect their neurological
development.
As
you also know, in the absence of a robust body of data, FQPA requires EPA to
use an additional 10-fold safety factor in its risk assessments when setting
pesticide tolerances. Thus both
statutory language and sound science require that the Agency continue to retain
the 10-fold safety factor as a precaution when reassessing the tolerances for
the remaining OP and carbamate pesticides given the existing uncertainty about
developmental neurotoxicity.
Many influential proponents of
agriculture have repeatedly expressed their concerns to EPA about properly
coordinating with agricultural stakeholders, the U.S. Department of Agriculture
(USDA), and producers when implementing FQPA.
It appears that the Agency has inadvertently taken this to mean that the
concerns of agriculture and the pesticide industry come before our
responsibility to protect the health of our Nation's citizens. We are concerned that the Agency has lost
sight of its regulatory responsibilities in trying to reach consensus with
those that it regulates, and the result is that the integrity of the science
upon which Agency decisions are based has been compromised.
Our
colleagues in the Pesticide Program feel besieged by political pressure exerted
by Agency officials perceived to be too closely aligned with the pesticide
industry and former EPA officials now representing the pesticide and
agricultural community; and by the USDA through their Office of Pest Management
Policy. Equally alarming is the belief among
managers in the Pesticide and Toxics Programs that regulatory decisions should
only be made after reaching full consensus with the regulated pesticide and
chemicals industry.
In
the rush to meet the August 2006 FQPA statutory deadline, many steps in the
risk assessment and risk management process are being abbreviated or eliminated
in violation of the principles of scientific integrity and objectivity by which
we as public servants are bound.
Congress specifically asked EPA to take reasonable action to reduce the
risk of pesticides for infants and children where existing uses posed a
concern. We should honor the charge from
Congress to protect the public health, unencumbered by political influences; therefore,
at this time, we do not believe that the Agency should make any final tolerance
reassessment decisions.
We
therefore request the following:
1. Where data are insufficient for
decision-making, that you make decisions based on the Precautionary Principle
and add appropriate uncertainty factors to protect human health in conformity
with the FQPA and our principles of scientific integrity.
2. Where developmental neurotoxicity
studies are absent, it is imperative that the Agency continue to retain the
10-fold safety factor - if not increase it - as a precaution, when making final
reregistration decisions for OP and carbamate pesticides.
3. That EPA issue an interim
reregistration decision mandating that maximum protections - engineering
controls for handlers and longer re-entry intervals for postapplication labor-
be put into place for agricultural uses of these pesticides; where this is not
feasible, cancel these registrations, as EPA promised before. EPA issued PR Notice 2000-9 in 2000 to this
effect (Worker Risk Mitigation for Organophosphate Pesticides: http://www.epa.gov/PR_Notices/pr2000-9.pdf
),
but then never carried through on
this: (http://www.epa.gov/pesticides/factsheets/opworkers.htm
)
In
its response to comments on this PR notice, EPA stated that the Agency will
seek cancellation of uses if available risk mitigation measures, such as engineering
controls and extended REI's, do not provide an adequate margin of safety and
the risks outweigh the benefits:
(http://www.epa.gov/PR_Notices/draftprworker-response.htm
)
Six years is an unacceptably long
wait. It is time to act now, and act
responsibly.
4. That you take steps to ensure that the
Agency consider non-pesticide chemicals - industrial and commercial - in the
same manner as pesticides with regard to their potential impact on the health
of our nation’s children.
Administrator Johnson, we ask that you
adhere to your pledge to protect the public health of our nation’s infants and
children, ensure that final tolerance reassessment decisions are unbiased by
outside political influences, and that any decisions be based on a transparent
and complete database in conformity with the law, sound science, and our
principles of scientific integrity.
Until EPA can state with scientific confidence that these pesticides
will not harm the neurological development of our nation’s born and unborn
children, there is no justification to continue to approve the use of the
remaining OP and carbamate pesticides.
The
undersigned take our civil service oath very seriously. We believe that it
would be a perversion of the constitutional process and betrayal of the public
trust for the agency to fail to adhere to the mandates of the FQPA. We
recognize that under the Constitution our role is only to provide the above
advice to you, while your role is to faithfully execute the laws entrusted to
your administration. We believe that by providing this advice in the strongest
possible terms we are fulfilling our duty and helping you to fulfill yours.
Very sincerely yours,
/S/
Dwight A. Welch, President,
NTEU Chapter 280,
/S/
Dave Christenson, President
AFGE Local 3607,
/S/
Larry Penley, President
NTEU Chapter 279,
/S/
Patrick Chan, President
NTEU Chapter 295,
/S/
Paul Scoggins, President
AFGE Local 1003, Dallas
/S/
Steve Shapiro, President
AFGE Local 3331,
/S/
Mark Coryell, President
AFGE Local 3907,
/S/
Wendell Smith, President
ESC EPA – Unit San Francisco
/S/
John O’Grady, President
AFGE Local 704,
Attachment 1
Examples of support for the conclusion
that EPA cannot yet ensure that fetuses, infants and children will not suffer
developmental neurotoxicity from exposure to neurotoxic pesticides:
(1)
The January 10, 2006 Office of Inspector General Report, “Opportunities
to Improve Data Quality and Children’s Health through the Food Quality
Protection Act” (see http://www.epa.gov/oigearth/reports/2006/20060110-2006-P-00009.pdf
). It
states that:
EPA’s required pesticide testing
does not include sufficient evaluation of behavior, learning or memory in
developing animals.
EPA has no standard evaluation
procedure for interpreting results from DNT tests.
EPA has not yet summarized or
drawn conclusions about DNT which it has collected for pesticides.
(2)
Not all scientists are in agreement with EPA that developmental effects
of the OP pesticide chlorpyrifos occur only at doses above those which cause
cholinesterase inhibition, or even that
they occur exclusively through
the mechanism of cholinesterase inhibition. (see for example: Cholinergic
systems in brain development and disruption by neurotoxicants: nicotine,
environmental tobacco smoke,
organophosphates, Toxicol. Pharmacol.198: 132-151 (2004;
Guidelines for developmental neurotoxicity and their impact on organophosphate
pesticides: a personal view from an academic perspective,
Neurotoxicology 25(4): 631-640 (2004).
(3) EPA has data demonstrating that the immature
are more sensitive to the OP pesticide malathion than adults (see for example
Developmental Neurotoxicity Study in Rats,
(4) EPA has also received, but has not released
for review by the SAP or external parties, data suggestive of direct effects of
malathion on brain structure concurrent with cholinesterase inhibition
and changes in behavior (personal
communication, Dr. Brian Dementi; see
also paragraphs #8, 9,11,12,13, and 17 of the June 20, 2005 letter to you from
Dr. Dementi in which he advised you of these concerns).
(5) More data are accumulating indicating
differential sensitivity to other OP pesticides greater than the 10-fold safety
factor required by FQPA (see for example Paraoxonase polymorphisms,
haplotypes and enzyme activity in
Latino mothers and newborns, Pharmacogenetics
and Genomics 16: 183-190 (2006).