NRDC Consent Decree - 4th Annual Report
Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.
September 26, 2005: EPA Actions Implementing Regulatory Determinations Required under Certain Provisions of the NRDC Consent Decree
In September 2001, the Federal Court for the Northern District of California entered a Consent Decree to conclude litigation in the case, Natural Resources Defense Council v. Whitman. Under the Consent Decree, among other things, EPA is required to issue an annual report providing information on the steps that the Agency has taken to implement certain regulatory determinations that it is required to make by the Consent Decree. Specifically, the Consent Decree directs EPA, beginning one year after the entry of the Consent Decree and annually for several years thereafter, to issue a report addressing the risks identified in certain previously issued Reregistration Eligibility Decisions (REDs) and Interim Reregistration Eligibility Decisions (IREDs).
With respect to each covered RED and IRED, in previous annual reports, EPA identified any risks from pesticide use and/or any pesticide tolerances that the Agency determined did not meet applicable statutory standards and described its plans for addressing the risk or tolerance. In this annual report, EPA describes steps toward completing its plan for addressing unreasonable risks associated with:
- Benomyl (risk mitigation completed)
In addition, with respect to certain groups of pesticides which EPA has determined share common mechanisms of toxicity, the Consent Decree required the first annual report to include schedules for issuing preliminary and revised cumulative risk assessments. Like the second and third annual reports, this fourth annual report provides an update on EPA's steps toward meeting its schedule for completing preliminary and revised cumulative risk assessments for the triazines, and discusses the Agency's cumulative determination for the thiocarbamate and dithiocarbamate pesticides.
Finally, the Consent Decree requires EPA to post each annual report on its website. The four annual reports are available on the Agency's website from the pesticides progress and status reports Web page.
Implementing REDs and IREDs
A number of steps must take place in order to translate risk mitigation determinations contained in RED or IRED documents into label language on pesticide products in the marketplace. Typically, EPA signs a RED or IRED document and then sends it, along with its attachments and appendices, to affected registrants for follow-up actions. Unless all products containing the pesticide active ingredient are being voluntarily canceled, a product-specific Data Call-In (DCI) is sent to the affected end-use product registrants in conjunction with the RED or IRED so that EPA can obtain product chemistry, acute toxicity, and other data that are required for product reregistration. If the RED or IRED includes additional confirmatory data requirements, EPA also issues a generic DCI to the affected technical or manufacturing use product registrants. Typically, EPA transmits the DCI to registrants of the pesticide along with the RED or IRED. The RED or IRED contains instructions to the registrants about when and how to submit applications for amended registration reflecting the risk mitigation measures contained in the RED or IRED. Following receipt of the applications, EPA reviews and, if appropriate, approves the amendments by sending a stamped copy of the new labeling to the registrant. Either the approval of the amendment or the RED or IRED will establish a time frame for the registrant to implement the new labeling.
Because of its concerns about the pesticides included in this report, EPA has expedited the process of implementing risk mitigation measures for several of them. Using Memoranda of Agreement, shorter deadlines for submission of applications, and other changes to our typical procedures, EPA has sought to achieve implementation of the risk mitigation measures for these pesticides more quickly than usual.
REDs and IREDs as well as many supporting documents for the pesticides discussed in the NRDC annual report are available from the pesticide reregistration status Web page. Many related support documents also are available from Regulations.gov.
I. Updates on REDs and IREDs Covered in the Consent Decree
- The January 2003 Atrazine IRED and MOA will substantially mitigate atrazine human health risks by reducing the most significant exposures associated with agricultural and residential uses - exposures through drinking water. Among other requirements, the atrazine MOA includes a performance standard for community water systems (CWSs), targeted monitoring of untreated drinking water entering certain community water systems in areas of atrazine use, and, if atrazine is detected in water at levels above Agency safety standards, prohibition of use in that watershed area.
- The January 2003 Atrazine IRED called for ecological monitoring
of watersheds due to the potential for community-level and population-level
risk to aquatic ecosystems from atrazine use. To assess and manage
potential ecological risks, the Agency and atrazine registrants have
developed a program under which the registrants are monitoring for
atrazine concentrations and will mitigate environmental exposures
if EPA determines that mitigation is necessary. This monitoring program
and mitigation plan is detailed in the October 2003 IRED.
- The program focuses on watershed impacts of atrazine use. The monitoring
protocol is initially focused on flowing water bodies (i.e., streams)
associated with corn and sorghum production. However, a program is
also being conducted to monitor atrazine levels in sugarcane producing
areas, and programs are being developed for estuaries and static water
- The purpose of the monitoring program is to determine whether water bodies with the greatest potential vulnerability to atrazine exposure (primarily based on atrazine use and runoff potential) are exceeding the level of concern set forth in the atrazine ecological risk assessment. The goal of the monitoring is to ensure that atrazine concentrations in watersheds will not cause significant changes in aquatic plant community structure. This is the most sensitive endpoint in the aquatic ecosystem, used by both EPA's Office of Pesticide Programs and Office of Water, and will ensure that all aquatic organisms - including fish, amphibians and aquatic invertebrates, not just plants - are protected.
- Based on scientific studies available to the Agency, EPA believes
that atrazine is not likely to cause cancer in humans.
- EPA's January 2003 Atrazine IRED did not include a quantitative risk assessment for cancer due to the Agency's determination, consistent with June 2000 conclusions by the FIFRA Scientific Advisory Panel (SAP), that it is unlikely that atrazine's cancer mode of action in the rat is operative in humans. Considering the animal data and human epidemiological data, EPA concluded that atrazine is "not likely to be carcinogenic to humans." Results of recent epidemiological studies regarding atrazine's potential link to cancer taken to the SAP in July 2003 did not alter that conclusion. Accordingly, the Agency concluded in the revised IRED that atrazine is not likely to be a human carcinogen.
- EPA is concerned about the potential for atrazine to cause developmental
damage to amphibians. After a very careful assessment, EPA's current
view is that the available scientific studies do not substantiate
or refute the possibility that atrazine causes such effects. The FIFRA
Scientific Advisory Panel (SAP) convened in June 2003 supported this
- At the time of the January 2003 IRED, EPA did not have reliable evidence to state that atrazine caused endocrine effects in the environment. The Agency concluded that atrazine should be subject to more definitive testing once the appropriate testing protocols have been established. In the October 2003 revised IRED, the Agency determined that because of the inconsistency and lack of reproducibility across studies and an absence of a dose-response relationship in data available at the time, more definitive testing is needed.
- EPA also must consider the cumulative effects of the triazine pesticides
atrazine, propazine, simazine, and their common chlorinated degradates,
which share a common mechanism of toxicity. The Agency expects to
complete a cumulative assessment of the triazines in 2006. Final tolerance
reassessment decisions for atrazine and the other triazines will be
issued at that time, and the Agency may need to pursue further risk
mitigation for atrazine to address any risks identified in the triazine
- For additional information about EPA's cumulative assessment of the triazines, see II. Common Mechanism Determinations later in this report, and see the Agency's Assessing Pesticide Cumulative Risks Web page.
- Product Labeling - EPA issued generic and product-specific
DCIs for the January 2003 Atrazine IRED in March 2004. In addition,
all the atrazine technical registrants signed an Atrazine MOA in the
spring of 2004, which put them on a fast track to implement label changes.
EPA received and reviewed amended atrazine product labels, which appeared
on atrazine products in the marketplace by the 2005 growing season.
- Atrazine Monitoring Programs - Both the drinking water monitoring
program and the ecological monitoring of flowing water bodies associated
with corn, sorghum, and sugarcane are being implemented and monitoring
- Drinking Water Monitoring in CWSs - For the current Community Water
Systems (CWSs) in the drinking water monitoring program, monitoring
will be conducted for at least five years. EPA has received and reviewed
monitoring data from 2003 and 2004 for these CWSs. Total chloro triazine
levels of the untreated and treated water, as well as 90-day rolling
averages of the untreated water samples, were measured and reported
for each CWS involved in the program on a weekly basis during the peak
atrazine use season and biweekly during the rest of the year. No exceedances
of the 90-day rolling average of 37.5 ppb, the Drinking Water Level
of Concern (DWLOC), were reported.
As agreed upon in the MOA, additional CWSs are added to the monitoring program if Maximum Contaminant Level (MCL) compliance data collected through the Office of Water for the previous year indicates levels of atrazine above a certain threshold. After the monitoring program began in 2003, a total of six new CWSs were added as a result of MCL monitoring data collected in 2003 and 2004. Each of these new CWSs also will be monitored for five years.
- Ecological Watershed Monitoring Program
Corn and Sorghum - For the monitoring program in flowing water bodies associated with corn and sorghum, during 2004 through 2006, atrazine registrants will monitor 40 indicator watersheds, each for a period of two years, to determine whether the atrazine level of concern is exceeded. Watersheds exceeding this level will be subject to watershed management program remedies consistent with EPA's Total Maximum Daily Load (TMDL) program requirements.
The 40 watersheds, located in 10 states, are representative of the 1,172 watersheds defined as most vulnerable to atrazine surface water loading from use on corn and sorghum. After 2006, results from monitoring of the 40 watersheds will be used to determine if further monitoring or remedial efforts are needed. A list of the 40 watersheds included in the ecological monitoring program is available from the atrazine Web page .
The ecological monitoring program of flowing water bodies associated with corn and sorghum is being implemented and monitoring is underway. EPA has received preliminary monitoring results for 2004 and is reviewing the data to determine whether levels of concern have been exceeded. Two years of data are needed before any final analysis can be done. However, no threshold has been exceeded in the initial year which would require the registrant to initiate best management practices immediately in order to decrease concentrations found in watersheds.
Sugarcane - Sites have been selected in Louisiana and Florida for the monitoring program in flowing water bodies associated with sugarcane crop production. Monitoring began in Louisiana in March 2005, and will begin in Florida in October 2005.
Estuaries and Static Water Bodies - EPA is currently developing a plan for the monitoring program in estuaries and static water bodies.
- Cancer - EPA expects to receive and review five new epidemiological
cancer studies for atrazine.
- A report from the National Cancer Institute (NCI) on non-Hodgkin's
lymphoma, an epidemiological study of all cancers related to atrazine
exposure from NCI's Agricultural Health Study, and a nested, case-control
study conducted for Syngenta of workers at an atrazine manufacturing
plant in St. Gabriel, Louisiana have been received and are in review.
- EPA expects to receive two additional epidemiological studies
and analyses concerning atrazine and cancer from NCI's Agricultural
Health Study in 2005 and 2006.
EPA plans to convene another SAP meeting in 2006. EPA then will examine all available data about the potential carcingenicity of atrazine - both epidemiology studies and laboratory animal studies - and see whether the totality of the data would suggest that the Agency should revise its determination that atrazine is not likely to cause cancer in humans.
- A report from the National Cancer Institute (NCI) on non-Hodgkin's lymphoma, an epidemiological study of all cancers related to atrazine exposure from NCI's Agricultural Health Study, and a nested, case-control study conducted for Syngenta of workers at an atrazine manufacturing plant in St. Gabriel, Louisiana have been received and are in review.
- Amphibians - EPA is committed to fully understanding whether
atrazine has the potential to harm amphibians. To resolve these questions,
the Agency has required new research, is monitoring the progress of
ongoing research, and will analyze all of these data as they become
available. If data show that atrazine harms wildlife, EPA will initiate
a comprehensive risk/benefit analysis to determine appropriate additional
risk mitigation measures.
- The SAP concluded in 2003 that additional amphibian studies should be conducted and that the Agency's proposed conceptual model for future studies was appropriate. Since the August 2003 SAP report, the atrazine registrant has developed protocols and initiated studies in August/September 2005 to address the uncertainties regarding the potential for atrazine to affect gonadal development. An initial study is expected to be completed in late spring 2006.
- Azinphos-methyl products in the marketplace during the 2005 use season
had new labeling that implements all of the significant worker and ecological
risk reduction measures outlined in the May 2002 MOA.
- EPA worked with USDA and stakeholders to develop clear, enforceable
labeling to inform users and address potential risks associated with
pesticide spray drifting from target application sites. The approved
labels include spray drift language that differs from the language in
the IRED and that was developed to address azinphos-methyl-specific
risk concerns. The language used for azinphos-methyl is not intended
to serve as a model for mitigating spray drift risks of other pesticides.
The label language retains the existing generic statement and also requires
management practices to mitigate risks from drift associated with azinphos-methyl
use that were outlined in the IRED.
- EPA published a FIFRA section 6(f) notice in the Federal Register
on September 30, 2002, announcing the Agency's receipt of requests for
amendments to delete 23 Group 1 uses from products containing azinphos-methyl.
These uses have been removed from currently approved product labeling
and are therefore no longer approved uses. A follow-up cancellation
order will be issued in October 2005.
- EPA published a FIFRA section 6(f) notice in the Federal Register
on February 28, 2005, announcing the Agency's receipt of requests for
amendments to delete 7 Group 2 uses (caneberries, cotton, cranberries,
nectarines, peaches, potatoes, and Southern pine seed orchards) from
manufacturing-use products containing azinphos-methyl. The cancellation
order for these uses on manufacturing-use product labeling was issued
on August 17, 2005.
- EPA published a FIFRA section 6(f) notice in the Federal Register
on August 17, 2005, announcing the Agency's receipt of requests for
amendments to delete 7 uses (caneberries, cotton, cranberries, nectarines,
peaches, potatoes, and Southern pine seed orchards) from end-use products
containing azinphos-methyl. The comment period for this notice closes
on September 16, 2005. In the absence of substantive comments meriting
further consideration of this matter, a cancellation order for these
uses will be issued after the close of the comment period.
- Data on worker exposure, biomonitoring, ground water monitoring, and eco toxicity have been submitted in compliance with the April 23, 2002, DCI. These data are being evaluated in connection with EPA's review of the AZM registrants' applications to amend their registrations to retain the remaining uses of azinphos-methyl (almonds, apples and crab apples, blueberries, Brussels sprouts, cherries, nursery stock for control of black vine weevil, parsley, pears, pistachios, and walnuts). The Agency plans to issue the revised assessments for comment, propose a decision on the remaining uses for comment, and issue a final decision next year.
- EPA issued a formal cancellation order for the liquid broadcast use
on residential turf on March 9, 2005. Shortly before the IRED was completed
in June, 2003, the carbaryl technical registrants agreed not to produce
new technical ingredient labeled for residential lawn broadcast application
of carbaryl liquid formulations until EPA could consider data being
submitted to refine the Agency's risk assessment for post-application
exposures to toddlers. BayerCrop Science submitted new pharmacokinetic
data and a method for using the data to refine risk estimates to the
Agency in the summer of 2004. EPA presented this information to the
FIFRA SAP on December 2, 2004, for an independent scientific review.
The SAP report was finalized January 26, 2005. After reviewing the SAP's
recommendations, the Agency determined that the Bayer data were not
sufficient to address EPA's risk concerns and the formal cancellation
order was issued shortly thereafter.
- EPA published a notice of availability of the Carbaryl IRED for public
comment in the Federal Register on October 27, 2004. All comments are
being reviewed by the Agency to determine appropriate followup actions;
see EDocket OPP-2004-0377.
- EPA issued Generic and Product Specific DCIs for carbaryl in March
2005. As a result of these DCIs, the Agency has received a number of
requests for voluntary cancellation of carbaryl products. One of the
two technical registrants, Burlington Scientific, has requested cancellation
of their carbaryl technical registration. Revised labels for all carbaryl
products are due to EPA in November 2005. These revised labels will
effectuate all the risk mitigation measures specified in the IRED when
the labels are approved and the individual products complete product
reregistration. All pet uses except pet collars are being cancelled.
- On August 3, 2005, EPA revoked 4 carbaryl tolerances on flax straw, bean forage and bean hay, and pineapple bran. A notice of this tolerance revocation was published in the Federal Register.
- On January 10, 2005, EPA received a petition from NRDC to revoke all carbaryl tolerances and cancel all uses. The Agency published a Notice of Filing for this petition in the Federal Register on March 30, 2005, and accepted public comments on this notice in EDocket OPP-2005-0077. All comments are undergoing internal Agency review to determine appropriate followup actions.
- Pre-Construction Termiticide Use - The chlorpyrifos MOA specified
that formulation of products for the pre-construction termiticide use
was allowed only through December 31, 2004, and use of these products
would be permitted through December 31, 2005, unless acceptable data
were submitted to support continued formulation and use.
Dow AgroSciences submitted a CARES (Cumulative and Aggregate Risk Evaluation System) probabilistic assessment in support of continued use. EPA's evaluation of the CARES assessment indicates that it is scientifically sound and reproducible, although incomplete. The CARES analysis did not include an aggregate dietary and residential risk assessment that would be needed to make a safety finding. Also, the exposure (air monitoring) data inputs to the analysis were based on existing post-construction monitoring, not monitoring specific to the pre-construction use.
EPA, therefore, has allowed the prohibition on formulation of new products labeled for the pre-construction termite use to go into effect. Dow AgroSciences LLC, Cheminova Inc., Makhteshim-Agan, and Gharda USA Inc. have indicated that they will not pursue extension of either the pre-construction termiticide use or the stop use and sale date of December 31, 2005.
EPA informed the registrants that no further formulation of chlorpyrifos end-use products labeled for pre-construction use was permitted after December 31, 2004. Existing stocks of end-use products already labeled for the pre-construction termite treatment can continue to be sold, distributed, and used until December 31, 2005.
- MOA Implementation. Labeling reflecting the mitigation measures
set forth in the June 2000 MOA, specifically directed at reducing exposure
to children, has been submitted, reviewed, approved, and is currently
reflected on the approximately 300 chlorpyrifos products remaining in
the marketplace. The MOA canceled and phased out nearly all indoor and
outdoor residential uses, thus reducing exposure to children. This reduction
represented approximately 50% of the use of chlorpyrifos or about 10
million pounds a year. All home lawn, indoor crack and crevice treatments,
and whole house post construction termiticide treatments were canceled.
Also, indoor and outdoor area uses, where children could be exposed
(such as schools and parks), were canceled. Due to low exposure, the
ant and roach bait in child resistant packaging is the only chlorpyrifos
residential use remaining.
- IRED Implementation. The Chlorpyrifos IRED, which included
generic and product-specific DCI notices, was issued to all registrants
of products containing chlorpyrifos in March 2003. Full implementation
of the additional risk mitigation measures specified in the IRED was
accomplished by a second round of label amendments as current registrants
submitted their responses to the IRED. EPA first focused on the approximately
three dozen agricultural use products for which additional measures
to mitigate worker risk were recommended. The Agency completed its review
of the agricultural use product labels early in 2004 and approved new
labels incorporating worker risk mitigation. A re-review of non-agricultural
use product labels submitted in response to the IRED and the PDCI started
in 2004. Registrants have already amended labels to reflect additional
PPE and protective measures for some uses.
- Consent Decree and Worker Risk Mitigation. In April 2004, EPA satisfied the requirement in paragraph 9(c) of the Consent Decree to address "those worker risks determined to be an unreasonable adverse effect on the environment as identified in the IRED." Through a letter to NRDC issued on April 26, 2004, posted on EPA's website at http://www.epa.gov/oppsrrd1/op/chlorpyrifos.htm, the Agency explained that it had satisfied this obligation through amendments to the terms and conditions of all affected registrations and through label changes for chlorpyrifos. Once these terms and conditions are implemented, EPA does not expect any of the unacceptable worker risks identified in the IRED to remain.
- All indoor residential use product registrations were canceled and
retail sale of these products ended as of December 31, 2002.
- All outdoor residential use product registrations were canceled
and retail sale of these products ended as of December 31, 2004. A
buy-back program in early 2005 helped remove remaining outdoor diazinon
residential use products from the market and prevented further sale.
- During fall 2004, EPA issued a notice to hardware and home and garden retailers, reminding them of the approaching December 31, 2004, stop sale date for all outdoor diazinon home, lawn and garden products, and explaining the buy-back program. By anticipating the deadline, selling inventories of diazinon home lawn and garden products, and understanding product recovery and disposal options for any products not sold after the deadline, retailers played an important part in responsible stewardship for diazinon.
- The Diazinon IRED was issued with a 60-day public comment period
through a Federal Register notice published on September 25, 2002.
An addendum to the Diazinon IRED addressed minor mitigation changes
based on public comments received. This addendum and a Response to
Comments Memorandum are available in Docket OPP-2002-0251.
- EPA issued the generic and product-specific DCIs for diazinon in
June 2004. In early 2005, the Agency received and began reviewing
amended product labels reflecting the agricultural/worker and ecological
risk mitigation measures recommended in the Diazinon IRED. All the
registrants signed a written agreement in conjunction with the IRED
in which they agreed to these mitigation measures and committed to
submit appropriate amended product labels.
- In April 2004, EPA satisfied the requirement in paragraph 9(c) of the Consent Decree to address "those worker risks determined to be an unreasonable adverse effect on the environment as identified in the IRED." Through a letter to NRDC issued on April 19, 2004, posted on EPA's website, the Agency explained that it had satisfied this obligation through requiring the submission of amendments to the terms and conditions of all affected diazinon registrations. Once these terms and conditions are implemented, EPA does not expect any of the unacceptable worker risks that were determined to be an unreasonable adverse effect on the environment in the IRED to remain.
- EPA published a Federal Register notice on November 6, 2002, announcing
the availability of the Endosulfan RED and opening a 60-day public
comment period that closed on January 6, 2003.
- EPA is requiring numerous additional generic studies for endosulfan,
listed in the RED, to confirm its regulatory assessments and conclusions.
The generic and product-specific DCIs for endosulfan were approved
by OMB and the Agency issued those DCIs in 2004.
- Within 8 months of the mail-out of the August 2004 Endosulfan RED
and DCI (by mid-2005), the Agency received and began reviewing amended
endosulfan product labels reflecting the risk mitigation measures
recommended in the RED. Additional mitigation measures may be developed
through stakeholder involvement to address risks to aquatic organisms
and environmental loading issues.
- Use on the 5 deleted crops (succulent beans, succulent peas, spinach,
grapes, and pecans) will be eliminated over the next several years,
consistent with EPA's existing stocks provisions. EPA has received
and is processing requests from the registrants for these use deletions.
- EPA's Office of Pesticide Programs (OPP) will work with the Endosulfan
Task Force, interested federal and state agencies, and other stakeholders
to finalize and implement a targeted monitoring protocol to resolve
the uncertainty related to endosulfan use near vulnerable aquatic
areas that may pose a risk to non-target aquatic animals. EPA conducted
site visits in the fall of 2004 to better assess these vulnerable
areas, and met with Florida stakeholders including state and local
government officials and growers.
- EPA has participated in international discussions during 2004 and 2005 designed to better evaluate and address issues associated with long range transport of endosulfan. EPA will continue to participate in these meetings over the next few years to see what additional steps, if any, may be needed to better address this issue.
- EPA requested public comments on the Lindane RED during a 60-day
public comment period, as announced in a Federal Register Notice published
September 25, 2002. At the appropriate time, the Agency will prepare
a response to comments document that addresses comments received during
the comment period for the RED.
- The generic and product-specific DCIs for lindane were issued in
February 2004. In response, 17 of the 29 currently registered products
were cancelled either through voluntary cancellation (see 70 FR 11634,
March 9, 2005) or non-payment of maintenance fees on October 15, 2004
(see 69 FR 62666, October 27, 2004).
- An additional generic DCI for lindane was issued in September 2004
requiring an occupational exposure (seed treating) study as confirmatory
data. No cancellation requests were received in response to this latter
- EPA expedited its review of the remaining revised end-use product
labels that were submitted in response to the February 2004 DCI. By
January 2005, all mitigation measures specified in the Lindane RED
were reflected on all end-use product labels.
- Since September 2004, EPA has received and initiated its review
of the following outstanding data: the occupational exposure study
required from the September 2004 DCI, the seed leaching study required
under the February 2004 DCI, and a crop (wheat) metabolism study required
from an older DCI.
- EPA published a Federal Register Notice on April 15, 2005, that
proposed revoking all existing lindane tolerances, except five existing
livestock fat tolerances. It is possible that livestock feed may be
derived from grain grown from lindane-treated seed and residues of
lindane in livestock would be expected. Consequently, the Agency believes
that the existing livestock fat tolerances for lindane per se must
be maintained until and unless the grain seed treatment uses are no
longer registered. The Agency received no comments in favor of keeping
the tolerances proposed for revocation. EPA published a final notice
revoking these tolerances on September 21, 2005.
- EPA intends to consider establishing tolerances for the seed treatment uses of lindane. To establish all required tolerances for residues of lindane on food, the Agency will review the existing risk assessments and relevant new information in order to make a decision as to whether or not new tolerances can be established that meet the safety standard in FFDCA. At that time, the Agency may find it appropriate to revise portions of the existing risk assessments. If EPA decides to establish the new tolerances, the Agency will publish that decision in the Federal Register and provide an opportunity for public comment.
- EPA received a petition dated March 31, 2005, from the Washington
Toxics Coalition (WTC), the Pesticides Action Network North America
(PANNA), and the Alaskan Community Action on Toxics (ACAT), asking for
the revocation of all lindane tolerances. The Agency published a Notice
of Filing for this petition in the Federal Register on April 15, 2005,
and accepted public comments on this petition in docket OPP-2004-0246
in conjunction with the proposed Agency rule to cancel all non-fat tolerances
(see earlier bullet).
- EPA and FDA are participating with Mexico and Canada in the development of a North American Regional Action Plan (NARAP) for lindane. The goal of the NARAP is to eliminate unnecessary uses of lindane, reassess risk, and encourage the use of safer substitutes. The NARAP is expected to be completed in June 2006.
- The 60-day comment period for the Phosmet IRED closed on January
28, 2002. Approximately 70 comments were received, resulting in changes
in REIs or PHIs for the following crops: sweet potatoes, low bush
blueberries, highbush blueberries, and grapes. For citrus, the Agency
agreed to retain the use if additional residue data were submitted
by the registrant. EPA allowed these changes because either they did
not increase risk or data are required to confirm that there is no
increase in risk.
- EPA agreed to allow a FIFRA section 24(c) special local needs registration
for apple maggot control in Washington state. This use allows PCOs
to apply phosmet to residential trees, provided that written warning
is given to residents to prevent them from entering treated home orchards.
These applications are occasionally needed to control a potentially
serious threat to commercial apple production in Washington.
- Based on comments received, EPA is requiring a 14-day REI for harvesting
crops at pick-your-own establishments. This issue had not been addressed
in the IRED.
- An addendum to the IRED and response to comments document will be issued by the end of 2006 that will include these revisions and the reevaluation of the 9 time-limited crop uses.
- The generic and product-specific DCIs were issued on April 9, 2003.
The generic DCI required the registrant to submit data on biomonitoring
of workers and use and usage, among other things. The worker biomonitoring
study was conducted in May 2005 and is due to the Agency in October
- Federal Register Notices were published on October 16, 2002, March
19, 2003, and June 19, 2003, announcing EPA's receipt of requests
for voluntary cancellation of various phosmet home and garden and
veterinary products. The cancellation order for these uses will be
published in 2005.
- The most widely used phosmet labels have been approved including mitigation recommended in the IRED, and remaining labels should be approved in 2005.
- EPA issued the DCI and PDCI for propargite on January 6, 2003, and
the registrants responded on April 8, 2003. The studies submitted are
in review and some protocols are being developed.
- EPA issued a Federal Register notice on August 4, 2004, proposing
all the tolerance actions recommended in the Propargite RED, including
revoking, raising, lowering, revising, and creating new propargite tolerances.
The public comment period closed on October 4, 2004. The Agency plans
to issue a final rule effecting the propargite tolerance changes in
- EPA has ruled on the registrant's requests for REI exceptions and runoff spray drift revisions, and by September 30, will finalize the propargite reregistration eligibility decision resulting in revised labeling on propargite products.
The January 31, 2003 Atrazine IRED and Memorandum of Agreement (MOA) with the principal registrant initiated an innovative and effective program to protect community drinking water systems from contamination by this widely used triazine herbicide. The Revised Atrazine IRED, completed October 31, 2003, initiated an ecological monitoring program to protect potentially vulnerable watersheds and aquatic ecosystems. It also addressed the potential association between atrazine exposure and the incidence of prostate cancer and other cancers in humans, and potential effects of atrazine on amphibian endocrinology and development.
Estimated to be the most heavily used herbicide in the U.S., atrazine is applied in agriculture, primarily to corn, sorghum, and sugarcane crops; on golf course turf; and on residential lawns. Because of its volume of use and tendency to persist and move with water, atrazine is also the most commonly detected pesticide in surface water.
Although atrazine does not pose risks of concern through food, the Agency's drinking water, residential, occupational, and ecological risk assessments for atrazine indicated risks of concern. EPA has found that atrazine is not likely to be carcinogenic to humans, but will revisit this issue further with the FIFRA Scientific Advisory Panel (SAP) in the future, when additional data are received and reviewed. Atrazine has been associated with sub-lethal effects in aquatic organisms and amphibians in research presented in open, peer-reviewed literature. These include potential effects on endocrine-mediated processes in frogs and in largemouth bass, as well as olfactory effects in salmon.
To mitigate the identified risks, additional monitoring for atrazine levels and certain changes in atrazine use are necessary, as described fully in the Atrazine IRED. These changes are being implemented through atrazine product label amendments. To further address atrazine areas of concern, EPA and the technical registrants of atrazine developed the Memorandum of Agreement (MOA), that sets forth additional requirements designed to reduce the most significant atrazine exposures.
Drinking Water Monitoring in Community Water Systems
Ecological Watershed Monitoring Program
EPA's risk mitigation plan, set forth in the Azinphos-methyl IRED and May 2002 Memorandum of Agreement (MOA), includes measures to delete, phase out, or continue under time-limited registrations the crop uses of this organophosphate insecticide, to improve worker safety and lessen ecological risk. During the phase-out and time-limited registration periods, a variety of new, more stringent use restrictions are included to protect agricultural workers, including longer REIs and PHIs, reductions in the amount of pesticide applied and number of applications, and prohibitions on most aerial applications. The registrants were also required to conduct studies and provide data on the effectiveness and feasibility of certain PPE, and conduct ground water monitoring and worker biomonitoring studies. In addition to the measures to improve worker safety, other mitigation measures to reduce ecological risks include adding buffer zones to protect surface water, improved directions to reduce off-site exposure from airblast applications, and enforceable label language to address risks from spray drift.
EPA has completed its reregistration eligibility decision for the fungicide benomyl. Although benomyl was scheduled for a RED in 2002, the registrants requested voluntary cancellation in 2001 and 2002. After considering public comment, EPA granted the voluntary cancellation requests.
At present, all benomyl product registrations are canceled; the sale and distribution of benomyl products ended on December 31, 2002. All benomyl tolerances are revoked, with expiration dates ranging from January 1, 2006, to January 1, 2009. Any treated fresh commodity or processed food should have ample time to clear channels of trade.
EPA has assessed the risks of carbaryl and, on June 30, 2003, reached an Interim Reregistration Eligibility Decision (IRED) for this N-methyl carbamate pesticide. Although some uses may pose unreasonable risks to human health and the environment, these effects can be mitigated by the measures identified in the Carbaryl IRED. Provided that these risk mitigation measures are adopted, aggregate risks for carbaryl alone will be within acceptable levels and the pesticide may be eligible for reregistration once EPA considers the cumulative risks of the N-methyl carbamate pesticides.
Carbaryl is one of the most widely used broad-spectrum insecticides in agriculture, professional turf management and ornamental production, and residential pet, lawn, and garden markets. Although dietary (food and drinking water) exposures are not of concern, carbaryl does pose risks of concern from uses in and around the home. With mitigation measures discussed in the IRED document, carbaryl will fit into its own "risk cup" and will not pose significant aggregate risk concerns. Carbaryl also poses risks of concern to occupational handlers who mix, load, and apply the pesticide in agricultural sites, and to workers who may be exposed upon re-entering treated agricultural areas. Carbaryl poses ecological risks, particularly to honey bees and aquatic invertebrates. With mitigation measures, these occupational and ecological risks also will not be of concern for reregistration.
EPA must consider the cumulative effects of the N-methyl carbamate pesticides, which share a common mechanism of toxicity. The Agency presented the preliminary cumulative risk assessment for the N-methyl carbamates to the FIFRA Science Advisory Panel (SAP) on August 23-26, 2005. The public had an opportunity to comment on the preliminary assessment at the SAP meeting. When the Agency completes its cumulative assessment of these pesticides, final tolerance reassessment decisions for carbaryl and other N-methyl carbamates will be issued. At that time, EPA may need to pursue further risk mitigation for carbaryl to address any risks identified in the cumulative assessment. For additional information on the N-methyl carbamate cumulative risk assessment, see EPA's Assessing Pesticide Cumulative Risk Web page.
EPA's plan to reduce worker and ecological risks, as set forth in the September 2001 Chlorpyrifos IRED, included additional PPE and engineering controls, reductions in application rates, increasing retreatment intervals, reducing seasonal maximum amounts applied, and no-spray setback zones around water bodies. In June 2000, EPA entered into a Memorandum of Agreement (MOA) with the technical registrants of chlorpyrifos to eliminate virtually all homeowner uses, except ant and roach baits in child resistant packaging. All post-construction termite use was canceled as of December 31, 2002, and pre-construction termiticide use was permitted to continue at a reduced rate only until December 31, 2005, unless exposure data were developed and showed that residential risks from this use are not of concern.
As a result of implementation of the MOA and the issuance of the IRED, the number of products containing chlorpyrifos has dramatically decreased, from approximately 850 products before the June 2000 MOA to a current total of approximately 300 products. The chlorpyrifos IRED transmittal letter advised registrants that if they failed to implement any of the risk mitigation measures in the IRED document, EPA would continue to have concerns about the risks posed by chlorpyrifos and would initiate regulatory actions to address its concerns. To date, chlorpyrifos registrants have complied fully with the MOA requirements and IRED conclusions.
EPA completed the Diazinon IRED on July 31, 2002. Without mitigation, diazinon poses unreasonable risks to agricultural workers and to birds and other wildlife species. To increase protection for workers, birds, and the environment, the Agency's decision includes provisions to phase out and cancel certain agricultural crop uses, the granular formulation, and aerial applications; reduce the amount and frequency of use; and employ engineering controls and other protective measures. Even with the recommended mitigation measures in the IRED, diazinon's worker and ecological risks continue to be above levels of concern, but these risks are offset by strong benefits of diazinon use in fruit and vegetable production. These changes in diazinon use were developed through discussions with the technical registrants and were based on extensive stakeholder input.
An organophosphate, diazinon has been one of the most widely used insecticides in the U.S. for household as well as agricultural pest control. Under a December 2000 Memorandum of Agreement (MOA) with the technical registrants, all indoor and outdoor residential uses of diazinon were canceled over a period of several years in order to reduce risks to children and others. Prior to residential mitigation, diazinon was used outdoors on household lawns and gardens to control insects, grubs, and nematodes in turf; indoors for fly control through crack and crevice treatments; and for veterinary use to control fleas and ticks through pet collars. Diazinon remains registered for use in agriculture to control foliage and soil insects and pests of many fruit, nut, and vegetable crops, and is used in cattle eartags.
Residential Risk Mitigation
To reduce risks to children and others, the December 2000 MOA phased out and canceled all residential uses of diazinon.
Agricultural and Ecological Risk Mitigation
To mitigate risks to agricultural workers as well as to birds and other wildlife, a number of mitigation measures are recommended by the Diazinon IRED, including cancellation of certain crop uses, cancellation of most uses of the granular formulation, deletion of aerial application, deletion of foliar applications on most vegetable crops, use rate reductions, cancellation of seed treatment uses, adoption of engineering controls including water soluble bags and closed cabs, reducing the number of applications per growing season, and other measures.
On July 31, 2002, EPA completed a RED for endosulfan, a chlorinated cyclodiene insecticide and acaricide registered for use on a wide variety of vegetables, fruits, cereal grains, and cotton, as well as on ornamental shrubs, trees, vines, and ornamental herbaceous plants in commercial agricultural settings. In the Endosulfan RED, EPA concluded that endosulfan exceeds its own "risk cup," and poses occupational and ecological risks that constitute unreasonable adverse effects on human health and the environment. However, if certain food uses are deleted and mitigation measures to prevent contamination of surface waters are implemented, the Agency believes that endosulfan will "fit" within its risk cup. EPA found that the 80 endosulfan tolerances meet FQPA safety standards, provided the risk mitigation measures outlined in the RED are fully implemented. EPA also believes that endosulfan's occupational and ecological risks can likely be acceptably mitigated through changes to pesticide labeling and formulations. Accordingly, the Agency determined that endosulfan is eligible for reregistration provided that: (1) additional required data will confirm this decision for occupational exposures associated with the application of dip treatment to roots or whole plants and ecological risks; and (2) the risk mitigation measures outlined in the RED are adopted, and label amendments are made to reflect these measures. If vulnerable areas in specific geographic areas are identified as a result of a stakeholder process explained in the RED, additional ecological risk mitigation measures may be necessary.
To mitigate dietary, worker, and ecological risks of concern for endosulfan, mitigation measures set forth in the RED included deleting use on several crops including succulent beans, succulent peas, spinach, grapes, and pecans; reducing maximum seasonal application rates for many crops; spray buffer and vegetative buffer strip requirements to protect bodies of water; Restricted Use Pesticide classification; engineering controls such as use of water soluble bags, closed mixing/loading systems, and closed cabs; cancellation of wettable powders on many crops; cancellation of aerial applications using wettable powders on many crops; and increased REIs for many crops.
Given the toxicity and persistence of endosulfan and potential risks to aquatic organisms, EPA developed a number of mitigation measures to reduce the risks to aquatic organisms, outlined in the RED. The Agency believes that these measures will reduce the potential for exposures to aquatic organisms and reduce the overall environmental loading of endosulfan. However, in specific geographic areas where conditions exist that make aquatic organisms especially vulnerable (e.g., shallow, leaky aquifers, highly erodible lands, the presence of especially sensitive organisms, and high use of endosulfan), additional measures may be identified. In order to more fully evaluate the risks in these vulnerable areas; the risk management strategies that may be in place or could potentially be implemented in such areas to reduce exposure; and the benefits of the use of endosulfan in those areas, the Agency plans to work with stakeholders to accomplish this objective. Additional mitigation measures may be needed following the completion of this process.
On July 31, 2002, EPA completed a Reregistration Eligibility Decision (RED) for the organochlorine lindane and identified risk mitigation measures necessary to address the human health and environmental risks associated with its use. The lindane food/feed uses supported for reregistration are pre-plant seed treatment on barley, corn, oats, rye, sorghum, and wheat; a new use on canola seed also has been proposed. EPA determined that currently registered lindane seed treatment products could be eligible for reregistration if the registrants make the changes to the registration terms and conditions specified in the RED document and provide the required data, and if EPA is able to establish all required tolerances for residues of lindane in food.
As part of the RED, EPA determined that all existing tolerances for lindane should be revoked. These tolerances were deemed no longer necessary because all lindane products for which the tolerances were originally established had been canceled. The Agency identified additional data needed to characterize lindane metabolites in order to complete its assessment of potential dietary risks related to remaining seed treatments. Finally, EPA has determined that the use of lindane for seed treatment is likely to result in residues in raw agricultural commodities derived from plants grown from seeds treated with lindane. Therefore, new tolerances are required before the currently registered lindane products may be reregistered. EPA also determined that a number of changes to the terms and conditions of registration of the seed treatment products are necessary to prevent unreasonable adverse effects on the environment.
EPA is considering whether the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the Agency to include in its aggregate exposure and safety assessment those exposures resulting from use of lindane in pharmaceutical products. Lindane is approved by the Food and Drug Administration (FDA) for use in pharmaceutical products to control head lice and scabies. Although information for assessing exposure and risks is limited, EPA's assessment indicated that while use of lindane as a shampoo for head lice control does not pose risks of concern, use as a lotion for treatment of scabies may cause some adverse effects in some portion of the patient population. EPA solicited additional information and views that may help it determine how best to approach the public policy and statutory interpretation issues associated with the pharmaceutical uses of lindane.
EPA's Agricultural Pesticide Products
To mitigate human health and ecological risks of concern associated with lindane's registered pesticide uses as part of the RED, EPA recommended that revised labels be submitted to implement mitigation measures including prohibiting on-farm treatment of wheat, barley, oats, and rye seeds with the lindane dust formulation; reducing the maximum application rate for corn; requiring workers to wear double layer clothing, chemical-resistant gloves, and a dust/mist respirator for on-farm treatment of corn and sorghum seeds only with the dust formulation; a 24-hour REI for all seed treatment uses; and end-use product labels must specify a 30-day plantback interval for leafy vegetables and a 12-month plantback interval for all other unregistered crops. The registrant may conduct a confined accumulation of rotational crops study to show that these plantback intervals can be reduced. Since then, the following actions have been taken:
FDA's Pharmaceutical Products
To reduce over-use and increase the safe use of lindane pharmaceutical (i.e., head lice and scabies control) products, FDA is implementing several measures, discussed on its lindane Web page.
The October 2001 Phosmet IRED indicated that risk mitigation measures were necessary to eliminate phosmet exposure in residential settings, improve worker safety, and lessen ecological risks. An OP insecticide, phosmet is widely used in agriculture and provides important pest control benefits, but also poses worker and ecological risks. To address phosmet's risks, 3 uses were to be canceled (use on domestic pets, household ornamentals, and household fruit trees). Nine crop uses were reregistered on a time-limited basis for 5 years. The continued registration of these uses was contingent on additional risk reduction measures and the submission of data to better characterize risk to workers. These 9 crop uses with the time-limited registrations (apples, crabapples, apricots, high-bush blueberries, nectarines, peaches, pears, plums/prunes, and grapes) will be reevaluated in 2006. In addition, 33 uses would continue with additional mitigation. To protect agricultural workers during the time-limited registration period, new precautions were needed including increased REIs, closed transfer systems, and enclosed cabs or maximum PPE for applicators. To reduce ecological risks, recommendations included label language regarding spray drift, inward spraying of outside rows of orchards, limiting application amounts, and prohibiting application during bloom period. Additional generic data have been required including worker biomonitoring and other studies.
Changes to the IRED
The September 2001 Propargite RED recommended mitigation measures to address worker and ecological risks. To reduce risks to agricultural workers, the recommended measures included closed mixing/loading systems for corn and cotton applications, enclosed cockpits for all aerial applications, water soluble packaging for all wettable powder formulations, enclosed cabs for all airblast spray applications, PPE, longer REIs for most crops, and Restricted Use Pesticide classification. To reduce ecological risks, mitigation measures included decreasing seasonal maximum application rates for several crops, adding spray intervals of 21 days for most food crops (28 days for citrus), decreasing the number of cotton applications annually from 3 to 2, adding no-treatment buffer zones around aquatic areas, adding label language to minimize spray drift, and requiring testing to better characterize risks to birds. Other generic studies were required. EPA was to propose several tolerance revocations.
The discussion below provides EPA's current thinking and plans for addressing the cumulative risks of certain groups of chemicals identified by the NRDC Consent Decree.
The cascade of biological events triggered by atrazine exposure leading to mammary gland tumors in female SD rats is not expected to occur in humans given the species difference in reproductive aging. However, the potential for disruption of the hypothalamic pituitary axis and consequent attenuation of the LH surge leading to other health consequences not associated with reproductive aging (e.g., delay in pubertal development) can not be dismissed. Thus, EPA has determined that the triazine pesticides (with a common mechanism group of atrazine, propazine, simazine, and their chlorometabolites) have a common mechanism of suppression of LH surge and consequent reproductive and developmental effects. EPA expects to complete a preliminary cumulative risk assessment in early 2006; this is contingent on completion of the IREDs for the individual chemicals. The revised Atrazine IRED was completed on October 31, 2003, while the IRED for simazine and the work on propazine is slated for completion in 2006. EPA expects to complete the revised cumulative risk assessment for the triazines in summer 2006.
The thiocarbamate pesticides (EPTC, molinate, pebulate, and cycloate) were determined not to share a common mechanism of toxicity. See "Thiocarbamates: A Determination of the Existence of a Common Mechanism of Toxicity and A Screening Level Cumulative Food Risk Assessment," December 19, 2001 (51 pp, 480k, About PDF).
The dithiocarbamate pesticides (mancozeb, maneb, metiram, Na-dimethyldithiocarbmate, ziram, thiram, ferbam, and metam sodium) were determined not to share a common mechanism of toxicity based on neuropathy. See "The Determination of Whether Dithiocarbamate Pesticides Share a Common Mechanism of Toxicity," December 19, 2001 (46 pp, 348k, About PDF).
A subset of the dithiocarbamate pesticides (mancozeb, maneb, and metiram) was determined to induce a common effect (thyroid cancer) by the formation of the common metabolite, ETU. The Agency determined that these three chemicals should be grouped, as in the past, when conducting a risk assessment. Thus the mancozeb, maneb, and metiram REDs, to be completed in September 2005, all consider aggregate risks from ETU.
Another subset (ziram and metam sodium) was determined to share a common mechanism based on the inhibition of cholinesterase. However, the data available do not support cholinesterase inhibition as being a common effect of the entire group of dithiocarbamates. Further, a cumulative assessment is not needed for ziram and metam sodium because EPA is regulating these two pesticides on more sensitive endpoints than cholinesterase inhibition, which will be more protective in terms of any potential cumulative risk.