2 

### Atrazine Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 4

Chemical Facts 4

Use and Usage Information 7

Recent Actions 9

Anticipated Risk Assessments for Registration Review 9

Timeline 11

Next Steps 12

Appendix – Additional Areas Considered in the Atrazine Registration Review 13

References: This Preliminary Work Plan summarizes the En vironmental Protection Agency's current position based on the following documents:

1. Addendum to the Problem Formulation for the Ecological Risk Assessment to be Conducted for the Registration Review of Atrazine

. A. Blankinship. F. Farruggia. James Hetrick, PhD. May 14, 2013. Combined in the docket with Meeting of the FIFRA Scientific Advisory Panel on the Problem Fo rmulation for the Environmental Fate and Ecological Risk Assessment for Atrazine. June 12-15, 2012.

2. Atrazine, Propazine, and Simazine. Human He alth Risk Scoping Document in Support of Registration Review . W. Donovan. S. Tadayon. J. Liccione. June 4, 2013.

3. Atrazine, Propazine and Simazine: Review of Human Incidents . S. Recore. January 22,

2013

4. Use Characterization for Atrazine. S. Haddad. B. Phillips. March 22, 2012.

5. Atrazine Screening Level Usage Analysis . November 15, 2011.

6. PRD Label Data Report: Food/Feed & N on-Food/Non-Feed Uses Considered in Registration Review Work Planning . February 17, 2012.

These and other supporting documents for the atrazi ne registration review case may be found in the docket EPA-HQ-OPP-2013-0266 at http://www.regulations.gov

.3 OVERVIEW

The docket for atrazine is now open, initiati ng the first public comment period for this registration review (docket num ber EPA-HQ-OPP-2013-0266). Atrazine is a triazine herbicide registered for use on various agricultural cr ops with the largest us e on corn, sorghum, and sugarcane. Additionally, it is registered for use on wheat, guava, macadamia nuts, and range grasses and for several non-agricu ltural use sites such as orname ntals, Christmas trees, and sod. There are also registered resident ial and recreational uses on turf such as on parks, golf courses, schools, or home lawns and for some commercial a nd industrial use sites. For human health risk assessment, atrazine is part of the tri azine common mechanism group based on a common toxicity end-point and known m echanism of toxicity. The tr iazine common mechanism group consists of the pesticide active ingredients at razine, simazine, propazine, and the metabolites desethyl-s-atrazine (DEA), desi sopropyl-s-atrazine (DIA), and diaminochlorotriazine (DACT). 1
This Preliminary Work Plan (PWP) document expl ains what EPA's Office of Pesticide Programs knows about atrazine, highlighting anticipated data and assessment needs, identifying the types of information that would be especially usef ul to the Agency in conducting the review, and providing an anticipated timeline for comple ting the registration review for atrazine.

The registration review process was designed to include a publi c participation component to solicit input from interested stake holders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows about atrazine and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on atrazine. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional inform ation that will help the Agency’s decisionmaking process for atrazine. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP and Appendix about which the Agency specifically seeks comments and information. Interested stakeholde rs could include: environmental non-profit or interest groups; pe sticide manufacturers; agricultural labor or commodity groups; commercial, institutional, reside ntial, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by discussing that there are no anti cipated data needs for atrazine. Next, it discusses the statutory and regu latory authority for Registration Review. Then the document provides chemical facts, use and us age information, recent actions, anticipated risk assessments, and projected registration review timeline for atrazine. Finally, the Appendix

includes identification and discussion of some areas that are generally considered in Registration Review along with some additional chemical case-specific information.

1 There are other triazine pesticides, such as ametryn, prometryn, and prometon, but they are excluded from the

triazine common mechanis m group because they do not share the same toxicity profile. ( Triazine Cumulative
Risk Assessment . J. Morales. March 28, 2006.)4 ANTICIPATED DATA NEEDS

An extensive amount of atrazine toxicity and effects data have been submitted to and reviewed by the Agency. There are no remaining data gaps anticipated for the registration review of

atrazine. For further discussion of existing atrazine data, see the Addendum to the Problem Formulation for the Ecological Risk Assessment to be Conducted for the Registration Review of
Atrazine and Atrazine, Propazine, and Simazine. Hum an Health Risk Scoping Document in Support of Registration Review.

STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonabl e adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided on EPA’s website. 2

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The regulations governing regi stration review begin at 40 CFR 155.40. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses
and data or information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docke t during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of atrazine.

CHEMICAL FACTS

Table 1 provides a summary of the chemical facts for atrazine.

Table 1: Chemical Facts for Atrazine

PC code 080803

Case Number 0062

CAS Number 1912-24-9 Year first registered 1958

2 http://www.epa.gov/oppsrrd1/registration_review/5 Table 1: Chemical Facts for Atrazine

Pesticide Type Selective herbicide

Chemical class Triazine Reregistration Eligibility Decision (RED) January 2003 and October 2003 Inte rim REDs; RED finalized April 6, 2006 upon completion of triazine cumulative risk assessment.

Tolerance Reassessment Eligibility Decision (TRED) Not applicable because tolerances were reassessed as part of the

RED.

Cumulative group Triazine. The most r ecent human health cumulative risk assessment was completed in March 2006. ( Triazine Cumulative
Risk Assessment . J. Morales. March 28, 2006.) 40 CFR Citation Tolerances for atrazine are established in 40 CFR § 180.220. Dual-use Atrazine is regi stered for conventional pes ticidal uses only and has no registered antimicrobial or biopesticidal uses. Non-pesticidal uses There are no identi fied non-pesticidal uses of atrazine.

Pesticide Re-evaluation Division, Chemical Review Manager Monica Wait, wait.monica@epa.gov, (703)347-8019

Registration Division, Product Manager Kable Davis, davis.ka ble@epa.gov, (703)306-0415

Table 2 below provides references to atrazine public dockets a nd FIFRA Science Advisory Panel (SAP) meetings that have occurred in recent years and may be of interest to some stakeholders. Meeting summaries, supporting documents, appendi ces, public comments, and technical papers about atrazine-specific scientific is sues may be found in these dockets.

Table 2: Atrazine Existing Pub lic Dockets and Recent SAP Meetings

Docket # at regulations.gov Docket Title and/or SAP Title Notes

EPA-HQ-OPP-2003-

0367 Atrazine Interim Reregistration Eligibility Decision (IRED) Includes January and October 2003 Atrazine IREDs, support documents, data evaluation records (DERs), atrazine water monitoring data submitted by the registrants from 2003 to 2012, and more.

See document EPA-HQOPP-2003-0367-0207 for a bibliography of the aquatic plant community microcosm and mesocosm study DERs

contained in this docket.6 Table 2: Atrazine Existing Pub lic Dockets and Recent SAP Meetings

Docket # at regulations.gov Docket Title and/or SAP Title Notes

EPA-HQ-OPP-2004-
0319 Atrazine Special Review Includes documents related to EPA’s Special Review process for atrazine, initiated
in 1994. EPA-HQ-OPP-2005-

0481 Triazine Cumulative Risk Assessment Includes March 2006 human
health cumulative risk assessment and supporting

documents. EPA-HQ-OPP-2007-
0498 Potential for Atrazine to Affect Amphibian Gonadal Development SAP meeting held from

10/9/07 to 10/12/07 EPA-HQ-OPP-2007-
0934 Interpretation of the Ecological Significance of Atrazine Stream-WaterConcentrations Using a StatisticallyDesigned Monitoring Program SAP meeting held from

12/4/07 to 12/7/07

EPA-HQ-OPP-2009-

0104 Ecological Significance of Atrazine Effects on Primary Producers in
Surface Water Streams in the Corn and Sorghum Growing Region of the
United States SAP meeting held from
5/12/09 to 5/15/09

EPA-HQ-OPP-2009-
0759 Presentation of the Atrazine
Reevaluation Plan SAP meeting held 11/3/09

EPA-HQ-OPP-2009-

0851 Draft Framework and Case Studies on Atrazine, Human Incidents, and the Agricultural Health Study: Incorporation of Epidemiology and

Human Incident Data into Human

Health Risk Assessment SAP meeting held from

2/2/10 to 2/5/10

EPA-HQ-OPP-2010-

0125 Re-Evaluation of Human Health
Effects of Atrazine: Review of Experimental Animal and In Vitro Studies and Drinking Water Monitoring Frequency SAP meeting held from

4/26/10 to 4/29/10

EPA-HQ-OPP-2010-

0481 Re-Evaluation of Human Health
Effects of Atrazine: Review of NonCancer Effects and Drinking Water Monitoring Frequency SAP meeting held from

9/14/10 to 9/17/10

EPA-HQ-OPP-2011-
0399 Re-Evaluation of Human Health
Effects of Atrazine: Review of NonCancer Effects, Drinking Water Monitoring Frequency, and Cancer Epidemiology SAP meeting held from

7/26/11 to 7/29/11

EPA-HQ-OPP-2011-

0586 Petition Requesting Ban on Use and

Production of Atrazine Petition submitted in May 2011 by Save the Frogs7 Table 2: Atrazine Existing Pub lic Dockets and Recent SAP Meetings

Docket # at regulations.gov Docket Title and/or SAP Title Notes

EPA-HQ-OPP-2012-

0230 Problem Formulation for Reassessment of Ecological Risks from Use of

Atrazine SAP meeting held from

6/12/12 to 6/15/12

EPA-HQ-OPP-2013-

0266 Atrazine Registration Review Docket opened June 2013

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for atrazine. Please see Use Characterization for Atrazine in the registration review docket for more details.

Table 3: Atrazine Use and Usage Information

Summary of Use Atrazine is a triazine herbicide register ed for use against broadleafand some grassy weeds in a variety of agricultural and nonagricultural use sites. Use Sites Agricultural : Registered for use on corn, sweet corn, sorghum, sugarcane, wheat (wheat stubble on fallow land), macadamia nuts, guava, and range grasses. 3

Non-agricultural : Registered for use in conifer forests, Christmas tree farms, sod farms, ornamental grasses, ornamental plants, ornamental turf, outdoor residential lawn (this use is primarily in Florida and the Southeast), schools, parks, playgrounds, and athletic

fields. Atrazine is al so registered for use on roadsides, rights-ofway, airfields, vacant lots, lumber yards, agricultural buildings, industrial sites, and storage sites. Summary of Usage Agricultural usage : Based on survey data from 2000 to 2010, annual usage averaged approximately 72 million pounds of active ingredient (a.i.) for 71 million acr es. For the time period from 2006 to 2010, usage averaged approximately 66 million pounds a.i. for 67 million acres. From 2006 to 2010, the primary crops in terms of average annual pounds of a.i. applied were corn (88%), sorghum (8%), and sugarcane (2%).

Non-agricultural usage : Available non-agricultural usage data is limited to certain types of applications and does not include usage information for all non-agricultural use sites. In 2006, 1.2 million pounds a.i. was applied by profession al applicators to golf courses,

3 The March 22, 2012 Use Characterization for Atrazine erroneously includes oats as a registered use site. Atrazine

is not registered for use on oats. Additionally, that document lists soybeans as a use site. Soybeans is registered as a Special Local Needs (Section 24c) use site in Kansas on ly. There are no Section 3 registrations for use of atrazine on soybeans.8 Table 3: Atrazine Use and Usage Information

institutional turf, landscape, lawns, turf farms, and in nurseries or greenhouses. For the consumer market, approximately 400,000 pounds a.i. were applied in 2005 as a lawn herbicide. Formulation Type(s) Granular, wettable powder, water dispersible granules, emulsifiable concentrate, flowable concentrate, soluble concentrate, ready-touse, and water soluble packs.

Some products are co-formulated with other herbicides and/or

fertilizers. Application Method(s) Groundboom sprayer, airc raft, tractor-drawn spreader, rights-ofway sprayer, low pressure handwand, backpack sprayer, lawn handgun, push-type spreader, and hand-crank spreader. Technical Registrant(s) Syngenta Crop Protec tion, Agan Chem Mfg Ltd, Drexel Chemical Company, Oxon Italia SPA Registrations Approximately 160 Section 3 registrations 4 and 30 Section 24(c) (special local needs) registrations Restricted Use Products containing > 4% atrazine (75% of registrations) are
classified as restricted use wh ich must be applied by certified applicators only. Products containing ≤ 4% atrazine are not
classified as restricted use and ar e registered for lawn applications.

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of part icular interest to EPA, are described below.

 Confirmation of the following label information for all agricultural and non-agricultural uses: sites of application; formulations ; application methods and equipment; maximum application rates; total seasonal/calendar year maximum rates; frequency of application, application intervals, and maximum number of applications per season or calendar year; and geographic limitations a nd/or prohibitions on use.

 Use distribution ( e.g. , acreage and geographical distri bution of relevant use sites).

 Median and 90 th percentile reported use rates (lbs a i/A) from usage data – national, state, and county.

 Typical application timing (date of first appl ication) – national, state, and county (e.g. prior to planting, at planting, preem ergence, postemergence, fall).

 Typical application interval (days).

 State or local use restrictions.

 Foreign technical registrants not listed above who supply tech nical atrazine to the US
market.

4 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website

(http://oaspub.epa.gov/pestlabl/ppls.home).9 RECENT ACTIONS

As noted earlier in Table 2, there have been several SAPs in the past few years for atrazine as the
state of the science has continued to evolve a nd new data have become available. The SAPs have addressed issues concerning human health, su ch as incident and epidemiology data, cancer effects, and drinking water monitoring, as we ll as ecological issues such as effects on amphibians, aquatic ecosystems, and monitoring of atrazine in streams. For the list of recent SAPs and their associated docket numbers, see Table 2. Additional details and supporting
documents can be found in the individual SAP dockets.

The January and October 2003 Atrazine IRED s, May 2004 Memorandum of Agreement (MOA) with the atrazine registrants 5 , and reregistration data call-ins (GDCI-080803-20871 and GDCI080803-25114) involve requirements fo r submission of annual water monitoring data for raw and finished drinking water sources under provisions of the Atrazine M onitoring Program (AMP) and ecological water monitoring data for smalle r streams and watersheds under the Atrazine Ecological Exposure Monitoring Program (AEEMP 6 ). The raw monitoring data files are publicly available in the atrazine IRED docket (see Table 2) and on EP A’s Atrazine Updates webpage. 7 As new data become available, EPA conducts reviews of the registrant submitted water monitoring data and other water monito ring programs looking for atrazine, such as USGS’s National Water Quality Assessment Program (NAWQA) and state monitoring

programs.

The Agency is currently evaluating a toleran ce petition for simazine (2F8006, 77 FR 50686) to establish crop group tolerances for stone fruit, pome fruit, citrus fruit, and tree nuts; to remove
individual tolerances which w ould be replaced by the new crop groups; and for several other related actions. EPA is in the pr ocess of reviewing this request which will likely necessitate an updated assessment for the triazine cumulative group.

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for the single active ingredient atrazine was completed on April 16, 2002 in prepar ation for the IRED. The most recent human
health triazine cumulative risk assessment wa s completed on March 28, 2006. The most recent comprehensive ecological and environmental fate risk assessment was completed on April 22, 2002 for the IRED. Findings and conclusions from these risk assessments are summarized in the Addendum to the Problem Formulation for the Ec ological Risk Assessment to be Conducted for the Registration Review of Atrazine and Atrazine, Propazine, and Sima zine. Human Health Risk Scoping Document in Support of Registration Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of atrazine. For human health, EPA anticipates the need to co nduct revised dietary, residential, occupational, and cumulative risk assessments during registrati on review. If toxicologi cal endpoints or points

5 http://www.epa.gov/oppsrrd1/reregi stration/atrazine/AtrazineMOA.pdf

6 This program is also referred to as the Atrazine Ec ological Monitoring Program (AEMP) in some documents.

7 http://www.epa.gov/oppsrrd1/reregistration/atrazine/atrazine_update.htm10 of departure are revised based on additional data available in the open literature, they will be considered in the new assessments, as well as an y changes to the standard operating procedures or default exposure assumptions.

Table 4 below summarizes the anticipated regi stration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document.

Table 4: Anticipated Risk Assessments for the Atrazine Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y The parent atrazine will be considered the stressor of concern because it is expect ed to be protective for any non-target organisms that may be exposed to the parent and any of its degradates.

Incidents Will check for updates A search of the ecological in cident databases will be conducted and analyzed for the upcoming registration review risk assessment. See page 93 of the June 2012

Problem Formulation for additional details.

Human Health Dietary

Food Y Drinking water Y The drinking water assessment will incorporate atrazine water monitoring data. Occupational Handlers (mixers, loaders, applicators) Y As discussed further in the Scoping Document, the durations of exposure are e xpected to be short- and intermediate-term. Long-term exposures are not anticipated. Post-application Y

Residential

Handlers Y As discussed furthe r in the Scoping Document, the duration of exposure is exp ected to be short-term only. Intermediate- and long-term exposures are not anticipated based on the resi dential use patterns of

atrazine. Post-application Y

Other Aggregate Y Evaluates the combined risk from dietary and residential exposures. Cumulative Y An assessment of the triazine cumulative group is expected as part of registration review. Tolerances Y Tolerances for atrazine will be assessed and revised, as needed, during registration review.

Incidents Will check for updates For a discussion of reported human incidents for atrazine, see the Atrazine, Propazine, and Simazine: Review of Human Incidents

.11 Guidance for Commenters: Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.

 The May 14, 2013 Problem Formulation Addend um has several “Stakeholder Input Requests” for additional information:

o Page 8 – EPA is interested in any information regarding what may constitute ‘normal development’ for different amphibian species under different
environmental conditions. This information can be used to evaluate if
environmental conditions described in the open literature studie s were appropriate for proper development of different species.

o Page 11 – EPA is interested in receiv ing feedback from stakeholders on our proposed approach for evaluating the amphi bian toxicity data and is soliciting alternative scientifically s ound approaches for evaluating the large set of toxicity data available for amphibians.

o Page 13 – EPA is interested in receiv ing information related to potential differences in sensitivities with regard to biological and/or physiological factors
between Xenopus laevis and native North American (e.g., Rana pipiens ) species of frogs. EPA is interested in understanding if there are fundamental toxicodynamics and/or toxico kinetic differences between X. laevis and other native species of frogs such that it is expected to resu lt in a markedly different response to a chemical such as atrazine.

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not alr eady reported to the Agency.

 Water quality monitoring data (s ee Appendix for further details).

TIMELINE

EPA has created the following estimated timeline for the completion of th e atrazine registration
review in Table 5 below.

Table 5: Projected Atrazine Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2013 – June Close Public Comment 2013 – August Case Development

Final Work Plan 2013 – November 60-day Public Comment Period for Draft Risk Assessments 8,9 2015 – April - June Registration Review Decision

8 The registration review schedule for most conventional pesticides includes a 6 month period after the Final Work

Plan to issue a data call-in and then an appropriate time period for the required data to be submitted to EPA. However, because there are no anticip ated human health or environmental fate and effects data needs for the atrazine registration review, the schedule has been modified as appropriate.

9 The regulations governing Registration Review generally require the Agency to provide a public comment period

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the Agency plans to provide a 60 calendar day public comment period for draft risk assessments.12 Table 5: Projected Atrazine Registration Review Timeline

Activities Estimated Date 60-day Public Comment Period fo r Proposed Registration Review

Decision 2015 – Oct. - Dec.

Registration Review Decision and Begin Post-Decision Follow-up 2016 Total (years) 3

NEXT STEPS

After the 60-day public comment period closes , the Agency will review and respond to any comments received in a timely manner and then i ssue a Final Work Plan for the registration
review of atrazine.13 

### Appendix – Additional Areas Considered in the Atrazine Registration Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submi ssions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. The Agency will work to harmonize tolerances and international maximum residue limits (MRLs) and may modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, provi ding as much specificity as possible regarding

the nature of the concern.

Water Quality:

As discussed on page 20 of the June 2012 Problem Fo rmulation, atrazine is mobile and persistent
in the environment. The main routes of di ssipation are microbial degradation under aerobic conditions, runoff, and leaching. Because of its pe rsistence and mobility, atra zine will move into surface and groundwater, which has been confirmed by the widespr ead detections in monitoring
data. Additional information about the environmen tal fate of atrazine can be found in the June 2012 Problem Formulation. As was discussed pr eviously in this PWP, EPA is actively collecting, analyzing, and staying ab reast of water quality monitori ng data for atrazine collected through the AMP and AEEMP programs and other monitoring programs looking for atrazine, such as NAWQA and state monitoring programs.

Atrazine is identified as a cause of impairment, as defined under sec tion 303(d) of the Clean Water Act, for 173 water bodies in Iowa, Illinois, Kansas, Missouri, Nebr aska, and Ohio, based on information provided at EPA’s website. 10 In addition, Total Maximum Daily Loads (TMDL) have been developed for atrazine in 68 impaired water bodies in Alabama, Iowa, Illinois, Kansas, Missouri, Nebraska, Ohio, and Texas, base d on information provided at the website. 11 More information on impaired water bodies and TMDLs can be found at EPA’s website. 12

The Agency invites submission of water quality data for atrazine. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Im paired Water Body and Other Water Quality Data in OPP’s Registration Review Risk A ssessment and Management Process 13 in order to ensure that it can be used quantitatively or qualitativel y in pesticide risk assessments.

10 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

11 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl _pollutant_detail?p_pollutant_group_id=885&p_pollutant _group_name=PESTICIDES

12 http://www.epa.gov/owow/tmdl/

13 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm14 Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to atrazi ne compared to the general population. Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure compared to the general population.

ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been conducted for atrazine. The ecological risk as sessment planned during registration review will allow the Agency to determine whether use of atr azine has “no effect” or “may affect” federally listed threatened or endangered species (listed sp ecies) or their designate d critical habitats. When an assessment concludes that a pesticid e’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service
and/or National Marine Fisheries Service (the Se rvices), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM:

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological h azard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of the re registration decision for atrazine, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), atrazine is subject to the endocrine screening part of the Endocri ne Disruptor Screen ing Program (EDSP).

EPA has developed the EDSP to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 215 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must scre en all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Atrazine was included on

that list and has been issued an order to conduct the Tier 1 testing. Once all required Tier 1 and Tier 2 data have been received and reviewed, the endpoints and safety factors used for risk assessment purposes will be examined and a new risk assessment performed if necessary. For further information on the status of the EDSP, the policies and procedur es, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening ba ttery, please visit our
website. 14

HUMAN STUDIES:

Occupational and Residential

Past atrazine risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to de termine their dermal and inhalation exposure. Many such studies, involving exposur e to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handl ers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database, and th e Outdoor Residential Exposure Task Force (ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases, and has found no clear and c onvincing evidence that the conduct of any of them was either fundamentally unethical or si gnificantly deficient relative to the ethical standards prevailing at the time the research wa s conducted. All applicab le requirements of EPA’s Rule for the Protection of Human Subject s of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barri er to continued reliance on these studies.

AGRICULTURAL HEALTH STUDY:

Atrazine is among several agricultural chemi cals included in the Agricultural Health Study (AHS). The AHS began in 1993 and is a collaboration of the National Institute of Environmental Health Sciences (NIEHS), the Nati onal Cancer Institute (NCI), the EPA, and the National Institute for Occupational Safety and H ealth (NIOSH). Designe d as a large long-term epidemiological study, the AHS collects and analyzes data on the health and work practices of nearly 90,000 farmers and their families in Iowa and North Carolina who enrolled in the study before any disease developed. The study focu ses particularly on fa rmers' exposure to 50 chemicals including many of the most widely used pesticides. As data are collected over a period of years, scientists can compare overall he alth outcomes for people who differ in whether they have had exposure to various chemicals. While these comparisons cannot conclusively demonstrate how exposure affects health, they ca n show some statistical associations. More information on the AHS can be found at: http:/ /aghealth.nci.nih.gov. EPA is monitoring the results of the AHS and will consider this study in the registration review of atrazine as appropriate.

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