Atrazine Updates

Current as of January 2013

One of the most widely used agricultural pesticides in the
U.S., atrazine may be applied before and after planting to
control broadleaf and grassy weeds. It is used primarily on
corn, sorghum, and sugarcane, and is applied most heavily in
the Midwest. Atrazine is used to a lesser extent on residential
lawns, particularly in Florida and the Southeast.

Atrazine Evaluation Process
Atrazine SAP Meetings
June 12-15 SAP
Meeting EPA-HQ-OPP-
2012-0230
July 26-29, 2011 SAP
Meeting EPA-HQ-OPP-
2011-0399
September 14-17, 2010 SAP
Meeting EPA-HQ-OPP-
2010-0481
April 26-29, 2010 SAP
Meeting EPA-HQ-OPP-
2010-0125
February 2-4, 2010 SAP
Meeting EPA-HQ-OPP-
2009-0851
November 3, 2009 SAP
Meeting EPA-HQ-OPP-
2009-0759
Atrazine Evaluation
EPA Press Release,
October 7, 2009
Atrazine Science Evaluation:
Potential Health Impacts
Since we concluded our last evaluation of atrazine in 2003,
we have evaluated close to 150 published studies
investigating a wide array of effects potentially relevant to
human health risk assessment. Given this significant new
body of scientific information as well as the documented
presence of atrazine in both drinking water sources and other
bodies of water, we determined it appropriate to review the
state of the science in light of the new research and to ensure
that the agencys regulatory decisions continue to protect
public health and the environment.
This review is based on transparency and sound science,
including independent scientific peer review. Since 2003 our
oversight of atrazine has always been dynamic, not static, to
ensure continued safety.
Scientific Peer ReviewHuman Health
To be certain that the best available science is used to inform
its atrazine risk assessments, and to ensure transparency, we
have sought advice on key aspects of the science evaluation
from the independent FIFRA Scientific Advisory Panel (SAP).
SAP meetings are open to the public, and we encourage all
interested parties to participate in these meetings. From
2010-2011, we presented information to the SAP on four
occasions to invite independent scientific peer review on over
150 new studies concerning atrazine and its potential impact
on human health. During the July 2011 FIFRA SAP meeting,
the Panel commented that while there are still areas of
uncertainty the agencys scientific bases for its regulation of
atrazine are robust and ensure prevention of exposure levels
that could lead to reproductive effects in humans.
Reproductive effects are the most sensitive effects
observed in atrazine toxicity tests and, as such, our efforts to
regulate the pesticide to protect against these effects through
drinking water exposure will protect against all other effects
that occur at higher levels. We plan to take the
recommendations from the SAPs report on the July 26-29,
2011 meeting as well as all previous SAPs into account as we
update the state of the science on the health effects of
atrazine. The scientific information will be thoroughly
considered in registration review of atrazine, scheduled to
begin in 2013.
Scientific Peer ReviewEcological Assessment
On June 12-15, 2012, we held a FIFRA SAP meeting to review
the agencys problem formulation for the environmental fate
and ecological risk assessment for atrazine. During this SAP,
we presented a refined methodology for determining the
magnitude and frequency of atrazine exposures below which
significant changes in aquatic plant community structure,
function and productivity are not expected. We also presented
our review of atrazine studies with amphibians published in
the open literature since 2007. In general, during the June
2012 FIFRA SAP meeting, the Panel recommended that EPA
further analyze existing data and proposed that additional
studies be conducted to further refine the environmental fate
and ecological risk assessment for atrazine. The Panel also
recommended some refinements and alternative approaches
for us to consider when interpreting uncertainty in atrazine
water monitoring data. We plan to take the recommendations
from this SAP as well as previous SAPs into account as we
update the state of the science for the atrazine registration
review beginning in 2013. All documents for the June 2012
SAP meeting, including the FIFRA SAP Meeting Report &
Transcript, background documents and public comments, are
available at www.regulations.gov in docket EPA-HQ-OPP-
2012-0230.


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Registration Review to Begin in 2013
Atrazine will begin registration review, EPAs periodic re-
evaluation program for existing pesticides, in mid-2013. The
registration review preliminary work plan will be available in
the public docket for a 60-day comment period and will
include a summary of what is known about atrazine as well as
a list of anticipated data needs. For more information on
registration review please visit EPAs website
http://www.epa.gov/oppsrrd1/registration_review/index.htm.
If at any time atrazine data raise new risk concerns, we
will modify our regulation of atrazine as appropriate.
Triazine Cumulative Risk Assessment
EPAs triazine cumulative risk assessment considered the
combined effects of atrazine and simazine, two closely related
triazine herbicides. In 2006, we concluded that cumulative
exposures to these pesticides through food and drinking water
are safe and meet the rigorous human health standards set
forth in the Food Quality Protection Act (FQPA). This
assessment showed that the levels of atrazine and simazine
that Americans are exposed to in their food and drinking
water, combined, are below the level that would potentially
cause health effects.
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Atrazine Post-RED Results
Quick Resources
Atrazine Reregistration Eligibility Decision (RED)(PDF) (323
pp, 187M, about PDF)
Atrazine Reregistration Docket EPA-HQ-OPP-2003-0367
This section provides results to date from the programs,
activities, and studies required by EPAs Atrazine
Reregistration Eligibility Decision (RED) (PDF) (323 pp, 187M,
about PDF) of 2003, including:
Office of Pesticide Programs Monitoring in Community Water
Systems
Ecological Watershed Monitoring Program
Cancer
Amphibians
Pesticide Programs' Monitoring in Community
Water Systems
Status Update
Atrazine Monitoring Data
Currently, an intensive monitoring program to look for
atrazine residues in drinking water from approximately 30
community water systems (CWS) is ongoing. These systems,
located primarily in the Midwest, are among the most
vulnerable to atrazine exposure. Through our review of
data from this program, we have confirmed that none of the
systems have exceeded our level of concern, a 90-day
average of 37.5 parts per billion (ppb) of atrazine and its
degradates. The program is dynamic in nature; because CWS
enter and exit the program on an ongoing basis, the number
of systems that have taken part in this program varies from
year to year. The agency may release CWS from the program
when those systems have had no exceedances of the level of
concern after five consecutive years of monitoring.
Conversely, we add CWS into the program based on data
gathered under the Safe Drinking Water Act (SDWA) that
suggest those particular systems may approach levels of
concern.
The data available for this program are the following:
A summary of data submitted by the registrant from 2003
2007
The complete raw data from the program are available in
two locations:
OPPs public docket EPA-HQ-OPP-2003-0367
In the data files listed below
The following data complement the summary listed above.
These spreadsheets present atrazine drinking water
monitoring data that are required under the 2003 Atrazine
Reregistration Eligibility Decision (RED) and subsequent
Memorandum of Agreement (MOA) with the atrazine
registrants. These Atrazine Monitoring Program (AMP) data
files contain the results of the required sampling, by year, for
all CWS that have been monitored over a 9-year period from
2003 to 2011.
2003 Atrazine Monitoring Program (AMP) Drinking Water
Data
2004 Atrazine Monitoring Program (AMP) Drinking Water
Data
2005 Atrazine Monitoring Program (AMP) Drinking Water
Data
2006 Atrazine Monitoring Program (AMP) & Simazine
Monitoring Program (SMP) Drinking Water Data
2007 Atrazine Monitoring Program (AMP), Simazine
Monitoring Program (SMP) & Simazine Confirmatory
Monitoring Program (SCMP) Drinking Water Data
2008 Atrazine Monitoring Program (AMP) Drinking Water
Data
2008 Simazine Monitoring Program (SMP) Drinking Water
Data (includes atrazine data)
2009 Atrazine Monitoring Program (AMP) Drinking Water
Data
2009 Simazine Monitoring Program (SMP) Drinking Water
Data
2010 Atrazine Monitoring Program (AMP) Drinking Water
Data
2010 Simazine Monitoring Program (SMP) Drinking Water
Data (includes atrazine data)
2011 Atrazine Monitoring Program (AMP) Drinking Water
Data
2011 Simazine Monitoring Program (SMP) Drinking Water
Data
Each data file includes a ReadMe worksheet that explains
the data contained in the file. AMP data for 2003 and 2004 do
not contain simazine data. AMP data from the latter half of
2005 onward contain data for all triazine residues, including
simazine.
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Interpreting the Atrazine Drinking Water Monitoring
Data
An EPA level of concern is specific to a particular issue
(human health, for example) and an exposure period. For
example, a long-term (or chronic) level of exposure would be
associated with an exposure over many months or years,
while an intermediate level of exposure would be looking at
potential health effects over a three-month period. Through
the atrazine monitoring programs in place, we can evaluate
all these potential exposures.
Atrazine potential risk and how it is evaluated
Change in hormone levels is the most sensitive health effect
observed in an extensive battery of atrazine toxicity tests. In
other words, if our standard is protective of hormonal effects,
it will protect against all other effects that occur at higher
levels. Our 2003 risk assessment supporting the re-
registration of atrazine incorporates standard safety factors to
ensure protection of public health, as well as an additional
safety factor to ensure further protection for children. As a
result, our risk assessment includes a 300-fold margin of
safety to help ensure that an exposure will not affect hormone
levels, and a 1000-fold margin of safety to help protect
against long-term or chronic effects. In other words, the
exposure that the agency allows is at least 300 to 1000 times
more protective than the level where the agency saw no
adverse effects in the most sensitive animal species tested.
EPA applies these additional safety factors as a precaution to
protect the public health of all consumers in the United
States. Based on this risk analysis, we determined that
concentrations of atrazine and its degradates in raw water
below an average of 37.5 ppb over a 90-day period ensures
protection of pregnant women and all others, and
concentrations of atrazine in finished water that do not
exceed 3 ppb as an annual average protect consumers from
longer term chronic effects. The following paragraphs
describe the short-, intermediate-, and long-term exposure
levels that we have evaluated and found to be protective of
human health.
Short-term exposure - Based on the screening-level
assessment conducted for the Atrazine Interim Reregistration
Eligibility Decision (IRED) from 2003, one-day concentrations
less than the Drinking Water Level of Concern (DWLOC) of
298 ppb do not exceed our level of concern for acute effects.
In other words, occasional readings of atrazine that are below
298 ppb in water treated by municipalities do not pose a risk
to human health.
Intermediate-term exposure - Our level of concern for
drinking water is an intermediate level of exposure where the
level is exceeded if, in a 90-day rolling average, the
concentration exceeds 37.5 ppb for atrazine and its
degradates in raw water. After seven years of monitoring,
although some amount of atrazine may be detected in
community water systems, none of the CWS in the monitoring
program have exceeded the 37.5 ppb level of concern as a
90-day rolling average in raw water. This suggests that the
more stringent restrictions and use practices required by the
agency in 2003 are working to reduce the amount of atrazine
reaching water bodies, thereby protecting public health. If any
CWS were to exceed this level twice within a five-year period,
we would prohibit atrazine use in the watershed associated
with the CWS.
Long-term exposure - Under the Safe Drinking Water Act
(SDWA), the atrazine Maximum Contaminant Level (MCL) is
intended to prevent longer-term, or chronic, health concerns
from occurring even after years of exposure and is calculated
against a running average from four quarterly samples. An
occasional peak concentration above 3 ppb is, therefore, not
cause for concern. Rather, a long-term, consistent value
above a yearly average of 3 ppb would be of concern. The
MCL is designed to protect all population subgroups.
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Background on CWS Monitoring Program
The January 2003 Atrazine Interim Reregistration Eligibility
Decision (IRED) (323 pp, 1.87 MB) about PDF) and
subsequent Memorandum of Agreement (MOA) (36 pp, 132k,
about PDF) between EPA and the atrazine registrants initiated
a monitoring program to focus on the most significant human
health exposures associated with agricultural and residential
uses -- exposures through drinking water. Through the CWS
monitoring program, we are ensuring that exposures to
atrazine in drinking water do not reach levels that pose a risk
to public health. Our regulatory program for atrazine ensures
drinking water concentrations are below a level that could
potentially cause changes in hormone levels, which is the
most sensitive health effect observed in an extensive battery
of toxicity tests. Our level of concern ensures protection of
children and adults, including women of child-bearing age.
How CWS were Chosen - Of the approximately 50,000 CWS
in the United States, 40,000 are served by ground water and
10,000 are served by surface water. Because atrazine levels
in surface water tend to be higher than those in ground
water, surface water is EPA's focus for this monitoring
program. In 2003, we identified 3,600 systems where
atrazine was used and monitoring information was available.
OPP used Safe Drinking Water Act (SDWA) data to screen
CWS nationwide to see which systems might be more likely to
have higher seasonal atrazine contamination. An initial group
of CWS was identified for more intensive monitoring based
upon our review of data submitted voluntarily by the
registrant. Under conditions of the Atrazine RED and MOA, we
required an intensive drinking water monitoring program in
these CWS. This monitoring program began in 2003.
Information developed by EPA's Office of Water under the
SDWA is continually reviewed to determine whether additional
CWS should be monitored more intensively through OPPs
required atrazine monitoring program. Since 2003, a number
of CWS have been added to OPPs monitoring program based
on SDWA monitoring data as detections approached or
exceeded the Office of Water's Maximum Contaminant Level
(MCL) for atrazine as an average of four quarterly samples.
CWS Monitoring - Since 2003, raw and finished water at
approximately 150 CWS has been monitored under the
atrazine MOA to ensure that levels of atrazine and its
chlorinated degradates do not reach the level of concern of
37.5 ppb. Because CWS enter and exit the program on an
ongoing basis, the number of systems that have taken part in
this program varies from year to year. These CWS have been
monitored on a weekly basis during the peak atrazine use
season and biweekly during the rest of the year. Under the
MOA, monitoring is conducted for at least five years. Two
exceedances in raw water at a CWS in different years over a
five-year period will result in prohibition of further atrazine
use in the associated watershed. If a CWS does not have
exceedances during five consecutive years of monitoring, it
may be released from this monitoring program. To date, 119
systems have been released from the program, and no
system has had two exceedances. Over 30 CWS have been
added to program. EPA will continue to review monitoring
data under the SDWA. If any CWS in the future have
detections approaching the MCL, then the intensive
monitoring requirements and regulatory oversight of the
Pesticide Program will be invoked.
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Ecological Watershed Monitoring Program
Background
During atrazines reregistration in 2003, EPA established a
framework for developing an aquatic ecosystem level of
concern (LOC) that ensures atrazine concentrations in
watersheds will not cause significant changes in aquatic plant
community structure, function and productivity, the most
sensitive effect of concern. Concentrations of atrazine that
affect aquatic plant community structure, function and
productivity typically occur at levels lower than those that
directly affect fish and aquatic invertebrates. By focusing on
aquatic plant community structural and productivity changes,
the EPA intends to protect invertebrates, fish, and amphibians
from the direct effects of atrazine as well as the effects that
atrazine could have on the habitat and food sources of aquatic
animals. To that end, in its October 2003 Atrazine Interim
Reregistration Eligibility Decision (IRED) (323 pp, 1.87 MB,
about PDF), EPA required atrazine registrants to implement
an innovative, intensive ecological watershed monitoring
program, as well as a risk mitigation process if atrazine water
concentrations exceed the agency's levels of concern for
aquatic ecosystems.
Aquatic Ecosystem Level of Concern
Level of Concern Development
When atrazine is applied during the growing season, water
bodies receive episodic and highly variable amounts of
atrazine runoff from agricultural fields. Since 2003, EPA has
been working to develop a level of concern (LOC) that is
based on the numerous studies (microcosm and mesocosm
studies, which are studies designed to mimic conditions in
natural communities and ecosystems) where effects on
aquatic plants have been measured at constant atrazine
concentrations. This analysis allows the agency to better
understand and evaluate the varied concentrations and
durations of exposures monitored in natural systems. To
address this fundamental challenge of applying experimental
toxicity information to natural systems, the EPA developed a
tool called the Plant Assemblage Toxicity Index (PATI) to
estimate the LOC. The PATI methodology uses single-species
plant toxicity data and microcosm/mesocosm studies to
discern what atrazine exposure patterns and concentrations
can cause adverse effects on aquatic plant communities. We
use these data to develop a level of concern, which together
with monitoring data can be used to identify watersheds
where atrazine levels are too high and need to be mitigated
consistent with 2003 IRED and Memorandum of Agreement
(MOA) (36 pp, 132 KB, about PDF)signed by the agency and
Syngenta.
In public peer review meetings in 2007 and 2009, EPA
consulted with the FIFRA Scientific Advisory Panel (SAP) on its
general approach and the specific methodologies that could
be used in developing the LOC. As a body of independent
scientific experts, the SAP provides advice and
recommendations to the agency on important scientific
issues. EPA first presented the PATI methodology at the 2009
SAP meeting and has since incorporated many of the Panels
recommendations concerning this methodology, including
additional evaluations of the PATI index, further development
of the microcosm/mesocosm dataset, and development of a
new method for determining LOCPATI (see Update and Next
Steps). The 2007 SAP report can be found in docket EPA-HQ-
OPP-2007-0934 and the 2009 SAP's final report can be found
in docket EPA-HQ-OPP-2009-0104.

The Current Aquatic Ecosystem Level of Concern
The EPA is currently estimating the aquatic ecosystem level of
concern as approximately 10 parts per billion (ppb) for
atrazine over a 60-day period. This estimate was developed
using the PATI model described in EPAs issue paper that we
presented to the 2009 SAP, available at www.regulations.gov
in docket number EPA-HQ-OPP-2009-0104-0006. If a
watershed shows levels of atrazine above this level of concern
in any two years of monitoring, atrazine registrants must
initiate watershed-based management activities in concert
with state or local watershed programs to reduce atrazine
exposure. These remedies will be consistent with the
approaches used in the EPA Office of Water's Total Maximum
Daily Load (TMDL) program but are enforceable under FIFRA
through the 2003 Atrazine IRED and Memorandum of
Agreement.
Monitoring Results in Areas of Corn, Sorghum, and
Sugarcane Production
With regard to corn and sorghum producing areas, the
ecological watershed monitoring program was designed to
focus initially on flowing water bodies in the most vulnerable
watersheds in the Midwest. Monitoring occurred over a three-
year period (2004 through 2006), and certain sites have had
additional monitoring conducted from 2007-2011. During the
sampling timeframe, 40 watersheds (PDF) (2 pp, 125k, about
PDF) were monitored for at least two years. These initial 40
were selected to be representative of watersheds potentially
vulnerable to atrazine runoff. The results of this survey
informed the agencys decision to sample an additional 25
sites (1 pp, 73k, about PDF) across the Midwest in 2010 and
2011. These sites appear to have characteristics similar to the
most vulnerable of the original 40 sites and thus were
expected to be prone to atrazine runoff resulting in water
concentrations that exceed the agency's levels of concern.
The 2010 and 2011 monitoring results for these new sites, as
well as the existing sites, are available at public docket
number EPA-HQ-OPP-2003-0367-0206. 17 of these 25 sites
will continue to be monitored. A pilot atrazine monitoring
program in water bodies associated with sugarcane crop
production was initiated in 2005. Monitoring began in
Louisiana in March 2005 and Florida in December 2005.
However, the monitoring effort in Louisiana was delayed in
the latter half of 2005 because of Hurricane Katrina.
In May 2012, we released monitoring data collected in 2011
from Midwestern streams and sugarcane-growing areas that
are part of EPAs atrazine ecological watershed monitoring
program. These data are available in public docket EPA-HQ-
OPP-2003-0367.

Monitoring Sites that Exceed the Level of Concern
Two Missouri ecological watershed monitoring sites and one
Nebraska site have exceeded the agencys level of concern
based on the draft methodology presented to the 2009 FIFRA
SAP. The two Missouri sites are in the South Fabius River and
Youngs Creek watersheds. The Nebraska site is in the Big
Blue River (Upper Gage). The atrazine registrant,
Syngenta, has collected detailed soil, slope and cropping
maps, rainfall measurements, crop rotation patterns, and
other information about the sites, and continues monitoring in
these watersheds. Syngenta is also conducting watershed
stewardship and outreach activities with growers and other
stakeholders.
These sites remain a high priority for mitigation, as they have
repeatedly exceeded EPAs level of concern:
Youngs Creek site exceeded in four out of seven years of
monitoring
The South Fabius River site exceeded in five out of seven
years of monitoring
The Big Blue River (Upper Gage) site exceeded in five out of
six years of monitoring
As a result, the agency has been working with atrazine
registrants to ensure additional mitigation steps are taken
consistent with requirements of the 2003 IRED (323 pp, 1.87
MB, about PDF) and Memorandum of Agreement (36 pp, 132
KB, about PDF). One Louisiana monitoring site has
exceeded the agencys level of concern based on the draft
methodology presented to the 2009 FIFRA SAP. Advice from
that SAP meeting is helping us interpret these data to
determine whether additional monitoring and/or mitigation is
needed.
Status Update and Next Steps
In June 2012, the EPA presented to the FIFRA SAP the refined
methodology that updates the current aquatic ecosystem level
of concern. The EPA describes this methodology in more detail
in its problem formulation for the ecological risk assessment
for atrazine, which is available in SAP docket EPA-HQ-OPP-
2012-0230. This docket also contains the software that can be
used to evaluate and apply the methodology. Additionally, the
EPAs reviews for the microcosm and mesocosm studies
considered in the methodological framework are available in
public docket EPA-HQ-OPP-2003-0367. EPA believes that
establishing a level of concern with a fixed atrazine
concentration and exposure duration will be more useful for
state officials and the general public. Therefore, the EPA has
used the software posted in the docket to examine data from
several intensive watershed monitoring programs (including
those conducted by Heidelberg University, states, the U.S.
Department of Agriculture and atrazine registrants) to
establish a concentration-equivalent level of concern that
effectively discriminates between exposures that exceed
LOC
pati
and those that do not. EPA presented the derivation of
this concentration-equivalent level of concern to the 2012
SAP. EPA plans to take the recommendations from this
SAP as well as previous SAPs into account as it updates the
state of the science for the atrazine registration review
beginning in 2013. The 2012 SAP Report is located in docket
EPA-HQ-OPP-2012-0230.

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Cancer
Status Update
Based on the review of available scientific studies, EPA
determined in 2000 that atrazine is not likely to cause cancer
in humans. This determination was the result of a transparent
process that invited public participation, solicited development
and submission of the best available scientific data, and
allowed preeminent independent scientists to ensure that the
agency was using the highest quality data in its regulatory
decision-making process. This determination was based on
results from the full spectrum of animal test data that the
agency requires, as well as numerous research studies on
atrazines mechanism of action.
Since the mid-1990s, EPA has been co-sponsoring
epidemiological studies through the National Cancer Institute
(NCI) to evaluate the potential for any association between
atrazine exposure, as well as other pesticides, to people and
cancer, even though rigorously conducted animal studies
show that this result is unlikely. In 2011, updated Agricultural
Heath Study (AHS) analyses were published that will inform
our risk assessment process.
Background
The EPA identified several epidemiological cancer studies for
atrazine. Specifically, the agency received and reviewed the
following studies noted by the 2003 FIFRA Scientific Advisory
Panel (SAP) as particularly important to this question:
a report from the National Cancer Institute analyzing
previous epidemiological studies of atrazine and non-
Hodgkin's lymphoma;
an epidemiological study of all cancers among atrazine
agricultural workers from NCI's Agricultural Health Study
(2004), entitled Cancer Incidence Among Pesticide
Applicators Exposed to Atrazine in the Agricultural Health
Study (PDF) (8 pp, 116k, about PDF); and
a study conducted for Syngenta of the incidence of prostate
cancer in workers at an atrazine manufacturing plant in
St. Gabriel, Louisiana.
The EPA also received and reviewed an updated
epidemiological study comparing specific cancer types
between atrazine-exposed and atrazine non-exposed pesticide
applicators from the NCIs AHS. At EPAs request, the July 26-
29, 2011 SAP provided advice about the tools, approaches
and endpoints EPA might use in its assessment of potential
cancer and non-cancer human health risks of exposure to
atrazine. The EPA values the SAPs assessment of the
atrazine cancer epidemiology studies published 1985 through
2011. Even though the panel agreed with EPA that the
epidemiologic evidence does not strongly suggest a link
between atrazine and cancer, the panel did not agree that a
lack of strong evidence justifies a conclusion that atrazine is
not likely to be a human carcinogen. The panel noted some
suggestive epidemiologic findings for specific tumors that
warrant additional analyses prior to the EPA's full weight-of-
evidence review of the cancer classification for atrazine.
Following the EPA's Cancer Assessment Guidelines, the
agency will weigh and integrate all of the lines of scientific
evidence (e.g., toxicology, metabolism, epidemiology, mode-
of-action studies). EPA plans to take the recommendations
from this SAP report as well as all previous SAPs into account
as it updates the state of the science on the health effects of
atrazine. The scientific information will be thoroughly
considered in registration review of atrazine, scheduled to
begin in 2013.
The Panel commented that while there are still areas of
uncertainty, the agencys regulatory decisions to-date are
based on the most sensitive endpoint currently available --
reproductive effects -- and thus are protective of public
health. We expect that regulating for these effects in drinking
water will protect against all other effects that could occur at
higher levels of atrazine exposure.
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Amphibians
Status Update
The EPA concluded in 2007 that atrazine does not adversely
affect amphibian gonadal development based on a review of
laboratory and field studies, including studies submitted by
the registrant and studies published in the scientific literature.
On June 12-15, 2012, EPA held a FIFRA Scientific Advisory
Panel (SAP) meeting that included a review of atrazine studies
with amphibians published in the open literature since 2007.
The SAP was asked to comment on whether EPAs analysis
appropriately captures all relevant studies and whether
uncertainties are adequately characterized. EPA plans to take
the recommendations from this SAP as well as previous SAPs
into account as it updates the state of the science for the
atrazine registration review beginning in 2013. The 2012 SAP
Report is located in docket EPA-HQ-OPP-2012-0230.
Background
In June 2003, after evaluating the available literature on the
potential effects of atrazine on amphibian gonadal
development, EPA concluded that there was sufficient
information to formulate a hypothesis that atrazine exposure
can affect amphibian gonadal development; however, there
was insufficient information to refute or confirm that
hypothesis, mainly because of the limitations of the study
designs and uncertainties in the data. The agencys 2003
White Paper (PDF) (8 pp, 62k, about PDF) carefully evaluated
the data from 17 laboratory and field studies, discussed
remaining uncertainties in evaluating the potential effects of
atrazine on amphibian development, and outlined future
studies that could address these uncertainties. The FIFRA SAP
reviewed EPAs White Paper and concluded that the agencys
review was thorough, the conclusions were valid, and the
approaches and criteria for new studies were appropriate. The
SAP also agreed that additional studies were warranted and
that a tiered testing approach was appropriate. In
response to a November 2004 Data Call-In (DCI) Notice from
EPA, Syngenta, the principal atrazine registrant, developed a
testing protocol for determining the effects of atrazine on
amphibian gonadal development, and conducted two studies
consistent with the first tier of testing described in the 2003
White Paper and the SAP review. In June 2007, Syngenta
submitted to EPA its final report regarding the potential
effects of atrazine on gonadal development of
amphibians. To ensure the quality and transparency of its
assessment of atrazines potential to affect amphibian gonadal
development, EPA solicited advice from the SAP at a second
public peer review meeting on October 9 - 11, 2007. During
this meeting, EPA presented its assessment of 19 laboratory
and field studies, including the registrant-submitted studies
and additional studies available in the public literature since
the 2003 SAP. Of the 19 studies, only the two DCI studies
submitted by the registrant incorporated all of the design
elements recommended by the agency and the 2003 SAP to
address uncertainties identified in the 2003 White
Paper. The 2007 SAP agreed with the agency that,
although both DCI studies contained some limitations, the
overall design and conduct of the studies reflected a high
degree of quality control that allowed them to be used to
evaluate whether or not atrazine exposure affects amphibian
gonadal development. The 2007 SAP also agreed with the
agency that other laboratory and field studies reviewed by the
agency did not fully account for experimental and
environmental conditions that could influence relevant
endpoints. The SAP Panel concluded at that time that
atrazine does not produce consistent, reproducible effects on
the gonadal development of amphibians; however, the Panel
recommended that EPA continue to be apprised of ongoing
research and review any new data. The 2007 SAP's final
report and recommendations are available in public docket
EPA-HQ-OPP-2007-0498. Based on the agencys thorough
examination of the 19 studies and the 2007 SAPs subsequent
concurrence with the agencys assessment of those studies,
EPA concluded that atrazine does not adversely affect
amphibian gonadal development. EPA is not currently
requiring additional testing of atrazine on amphibians. EPA
has conducted a comprehensive reevaluation of atrazines
ecological effects, including data on potential effects on
amphibians published in the public literature since 2007. EPA
presented this evaluation to the FIFRA SAP during its June 12-
15, 2012 meeting. EPA plans to take the recommendations
from this SAP as well as previous SAPs into account as it
updates the state of the science for the atrazine registration
review beginning in 2013. The 2012 SAP Report is located in
docket EPA-HQ-OPP-2012-0230.