EPA Scientists Cite Pressure In Pesticide Study

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EPA Scientists Cite Pressure In Pesticide Study: Union Files Letter

Blasting Agency Managers, Industry Over Tests on Toxics Family

By J. Fialka

Wall Street Journal

May 25, 2006; Page A4

http://online.wsj.com/article/SB114852646165862757.html

[Please visit the original website to view the whole article. - Mod.]

WASHINGTON -- Union leaders representing Environmental Protection

Agency scientists and other specialists assert that agency managers

and pesticide-industry officials are exerting " political pressure " to

allow continued use of a family of pesticides that might be harmful to

children, infants and fetuses.

In a letter to , EPA's administrator, the union leaders

said scientists are being pushed to skip steps in their testing, and

alleged that the " integrity of the science upon which agency decisions

are based has been compromised. "

The protest from unions representing some 9,000 EPA scientists and

other employees about a pending agency determination is unprecedented

and a professional rebuke to Mr. , himself a scientist and

former assistant administrator in charge of the agency's program to

test the harmful effects of pesticides.

EPA spokeswoman Wood said the agency " has been reviewing all

pesticides in question and applying new, stricter standards as

required under the Food Quality Protection Act, with a specific focus

on their effects on children's health. " The agency had no specific

response to the union leaders' assertions. Spokesmen for groups

representing the pesticide industry didn't immediately return phone

calls.

....

Sass, a toxicologist for the Natural Resources Defense

Council, another environmental group, said there is " a lot of

uncertainty " in scientific data about the pesticides and " newer,

cleaner alternatives " are available. " This is old style chemistry and

these [chemicals] should have been buried years ago. "

After World War II, scientists discovered that insects were more

sensitive to nerve gases than humans and it was felt that humans

wouldn't be harmed by relatively low applications of the chemicals.

According to a recent report by the EPA's Office of Inspector General,

however, later studies showed that some pesticides can easily enter

the brain of fetuses and young children and may destroy cells in the

developing nervous system.

Although the federal law gave the EPA 10 years to settle the issue,

the inspector general's report, issued in January, said the agency

still lacked a standard evaluation procedure for testing the toxicity

to developing nervous systems. The union leaders recommended that Mr.

tighten restrictions on use of the pesticides until the

questions are settled.

The letter was sent by leaders of nine local chapters of three unions:

the American Federation of Government Employees, National Treasury

Employees Union and Engineers and Scientists of California.

Write to J. Fialka at john.fialka@...

======================================================

May 24, 2006

L. , Administrator

U.S. Environmental Protection Agency

Ariel Rios Building

1200 Pennsylvania Avenue, N.W.

Washington, D.C. 20460

Dear Administrator :

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 August 3, 2006, as required by the FQPA. During the 1990s, the

Agency reached partial cancellation agreements with the registrants of

certain OP pesticides, such as chlorpyrifos, methyl parathion, and

diazinon, based on compelling information that these neurotoxic

pesticides damage the developing nervous system of fetuses, infants

and children (an effect known as " developmental neurotoxicity " ).

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 , 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, Washington, DC

/S/

Dave Christenson, President

AFGE Local 3607, Denver

/S/

Larry Penley, President

NTEU Chapter 279, Cincinnati

/S/

Chan, President

NTEU Chapter 295, San Francisco

/S/

Scoggins, President

AFGE Local 1003, Dallas

/S/

Steve Shapiro, President

AFGE Local 3331, Washington, DC

/S/

Mark Coryell, President

AFGE Local 3907, Ann Arbor

/S/

Wendell , President

ESC EPA – Unit San Francisco

/S/

O'Grady, President

AFGE Local 704, Chicago

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, August 22, 2002. Memorandum. MRID

45646401; and Special Study, Effects on Cholinesterase Inhibition in

Adult & Juvenile CD Rats, Companion Study to Developmental

Neurotoxicity Study 870.6300., Tox Review No. 0050550, MRID No.

45566201).

(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. 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).

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