Docket Number EPA-HQ-OPP-2011-0840 www.regulations.gov



## Chlorothalonil Summary Document Registration Review: Initial Docket March 20123 TABLE OF CONTENTS

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 14

III. Summary of Data Gaps 21

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency’s current position based on the following documents:

1. Registration Review – Preliminary Problem Formulation for the Ecological Risk Assessment and Drinking Water Exposure A ssessment of Chloro thalonil. March 22, 2012.

2. Chlorothalonil. Human-Health Assessment Sc oping Document in Support of Registration Review. March 13, 2012.

3. BEAD Chemical Profile for Registration Review: Chlorothalonil (PC Code 081901). October 25, 2011.

4. Chlorothalonil (081901) Screening Leve l Usage Analysis (SLUA). May 7, 2011.

5. Chlorothalonil (081901) California DPR Usage Data. October 17, 2011.

6. PRD Appendix A: Food/Feed & Non-Food/Non- Feed Uses Considered in Registration Review Work Planning, Chlorothalonil (081901). September 14, 2011.

7. Summary of Registered Antim icrobial Uses of Chloro thalonil in S upport of the Registration Review Summary Document. March 12, 2012

Supporting documents for the registration review of chlorothalonil are lo cated in docket EPAHQ-OPP-2011-0840 at www. regulations.gov.4 I. PRELIMINARY WORK PLAN

Introduction

The Food Quality Protection Act (F QPA) of 1996 mandated a regist ration 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 at: http://www. epa.gov/oppsrrd1/registration_review/.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. 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 whatit knows about the pesticide and what additional risk analyses and data or information it belie ves are needed to make a registration review decision. After reviewing and responding to co mments and data received in the docket during this initial comment period, the Agency will de velop and commit to a final work plan and schedule for the registration review of chlorothalonil.

Chlorothalonil is a pesticide active ingredient that was first registered in the United States in 1966 for use as a fungicide on turfgrass. The fi rst food crop registration was in 1970 for potato use and the first antimicrobial use was registered in 1974 as a mildewcide in latex and solventbased paints. There are 134 registered products containing ch lorothalonil at this time, 103 conventional pesticide products and 31 antim icrobial pesticide product registrations. Chlorothalonil is registered for a variety of conventional uses, includ ing food and ornamentalcrops in both agricultural and residential sites. Additional conventional uses include nonresidential turf and forest nursery trees. Chloro thalonil is also registered as an antimicrobial pesticide for use as an industrial and consum er wood preservative, in the manufacture of fungicidal/mildewcidal/agalcidal pa ints, stains, and coatings, and in many industrial and building products such as caulks, sealants, adhesives, co atings, concrete blocks and surfaces, emulsions, grouts, plaster and stucco. The Reregistration El igibility Decision (RED) for chlorothalonil was issued in 1999, in which the Agency concluded that a variety of mitigation measures were necessary to continue th e registration of chlorothalonil pesticide products.

Anticipated Risk Assessment and Data Needs

The Agency anticipates requiring data for us e in conducting new ecol ogical (including an endangered species) and human health risk assessments for all regist ered uses of chlorothalonil.5 Below is a summary of the issues relevant to the registration re view of chloro thalonil and the data the Agency anticipates requiring.

Ecological Risk:

 The Agency anticipates the need to c onduct a new comprehensive ecological risk assessment for all uses of chloro thalonil for registration review.

 The registration review ecological risk assessm ent for chlorothalonil will consider effects to non-target organisms from chlorothalonil, degradates of concern, impurities, spray drift, atmospheric long-range transport and runoff. Additionally, the Agency intends to assess risk from down-the-drain exposure (m anufacturing of wood preservatives) and inuse/lifetime exposure (leaching from treate d wood) from the antimicrobial uses of chlorothalonil.

 In the registration review ecol ogical risk assessment, incident reports will be evaluated to determine if the reported incidents represent cu rrent patterns of use for chlorothalonil.

 The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for all uses of chlo rothalonil. The ecological risk assessment planned during registration review will a llow the Agency to determine whether chlorothalonil’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service (USFWS) and/or National Marine Fisherie s Service (NMFS) (the Services), as appropriate.

 On January 19, 2011, the Center for Biologi cal Diversity and the Pesticide Action Network North America filed a lawsuit in th e United States District Court for the Northern District of California, against th e Environmental Protection Agency (EPA) for allegedly failing to undergo consultation with the USFWS and NMFS regarding the effects of over 350 pesticides , including chlorothalonil, on over 200 endangered and threatened species throughout the United States ( Center for Biological Diversity, et al. v. EPA

, et al. , No. C 11-00293 (N.D.Cal.).

 Anticipated data needs exist in the environmental fate and ecological toxicity database for chlorothalonil. The Agency anticipates the n eed to require the following data for use in conducting a complete ecological risk asse ssment, including an endangered species assessment, for both conventional and an timicrobial uses of chlorothalonil:

Environmental Fate Data Needs

o Guideline No. 835.1230 Adsorption/desorption

o Guideline No. 835.1240 Soil column leaching

o Guideline No. 835. 2120 Hydrolysis

o Guideline No. 835.2240 Aqueous photolysis6 o Guideline No. 835.4200 Anaerobic soil metabolism

o Guideline No. 835.4300 Aerobic aquatic metabolism

o Guideline No. 835.4400 Anaerobic aquatic metabolism

Ecological Toxicity Data Needs

o Guideline No. 850.1075 Saltwater fish acute toxicity

o Guideline No. 850.1350 Saltwater invertebrates life cycle

o Guideline No. 850.1400 Saltwater fish early life stage

o Guideline No. 850.1735 Freshwater inve rtebrate acute whole sediment toxicity

o Guideline No. 850.1740 Saltwater invertebrate acute whole sediment toxicity

 The Agency anticipates the need to require the following data for use in conducting a complete ecological risk assessment, including an endangered species assessment, for conventional uses of chlorothalonil:

Environmental Fate Data Needs

o Guideline No. 835.4100 Aerobic soil metabolism

o Guideline No. 835.2370 Air photolysis

o Guideline No. 835.6100 Terrestrial field dissipation

o Guideline No. 835.8100 Field volatility

Ecological Toxicity Data Needs

o Guideline No. 850.2100 Avian acute oral toxicity, passerine

o Guideline No. 850.4100 Seedling emergence, Tier II

o Guideline No. 850.4150 Vegetative vigor, Tier II

o Non-guideline study Avian acute inhalation

 The Agency anticipates the need to require the following data for use in conducting a complete ecological risk assessment, including an endangered species assessment, for antimicrobial uses of chlorothalonil:

Data Needs for Assessing Activated Sludge Toxicity

o Guideline No. 850.6800 Modified activat ed sludge respiration inhibition

Environmental Fate Data Needs

o Guideline No. 835.1110 Activated sludge sorption isotherm

o Guideline No. 850.3110 Ready biodegradation 1

1 The results of the Activated Sludge Respiration Inhib ition Test (ASRI) expected to be required will determine which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC50 is less than or equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test EC50 is greater than 20 mg/L, then the applicant would choo se to conduct either: Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing would be expected to be required. If, however, the an timicrobial fails the Ready Biodegradability study, then the7 o Guideline No. 850.3220 Porous pot 1

o Guideline No. 850.3240 Simulation tests—aerobic sewage treatment: A activated sludge 1

o Guideline No. 850.3280 Simulation tests to assess the biodeg radability of chemicals discharged to wastewater 1

o Non-guideline study Wood leaching study

 Given that there are uncertainties in the e nvironmental fate profile for chlorothalonil regarding the potential for de gradates/transformation products, if additional information becomes available, then chlorothalonil and a ny transformation products deemed to be of toxicological concern will be ev aluated as part of registrati on review by incorporating the total toxic residue approach when derivi ng aquatic and terrestrial environmental concentrations.

 The Agency is also seeking additional in formation on wood preservative facility emissions to Wastewater Treatment Plants (W WTP). Facility information that would be useful for estimating aquatic exposures from emissions to WWTP from the industrial wood preservative process include the following:

o The number of facilities that pressure treat wood products with chlorothalonil

o How many of these facilities have on-site and/or off-site wastewater treatment

 Please refer to the March 22, 2012 Registration Review – Preliminary Problem Formulation for the Ecological Risk A ssessment and Drinking Water Exposure Assessment of Chlorothalonil, located in docket EPA-HQ-OPP-2011-0840 at www.regulations.gov, for a more detailed discu ssion of the anticipat ed ecological risk assessment and data needs for chlorothalonil.

Human Health Risk:

 An updated dietary risk assessment may be n eeded if there are ch anges to the endpoints as a result of new data, or if there are cha nges to estimated drinking water concentrations (EDWCs), which the Agency anticipa tes updating during registration review.

 The Agency anticipates conducting an updated re sidential exposure assessment to include both conventional and antimicrobial uses that were not previously assessed. The updated risk assessment may also incorporate any pot ential changes to the Standard Operation Procedures (SOPs) for residential risk a ssessments, as well as any changes to the endpoints as a result of new data.

 The Agency may conduct an aggregate (dietary food + drinking water + residential) risk assessment if there are changes to the toxicol ogical endpoints.

Biodegradation in Activated Sludge or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.8  The Agency anticipates conducting an updated occupational risk as sessment to include updated handler exposure surrogate data, as well as formulations and use sites not previously assessed. The Agency may also re consider the use of respirators for highpressure handwand uses and resi dential paint applications.

 The Agency anticipates that it may set the FQ PA safety factor at 3X for acute and 30X for repeated residential inhalation exposure scenarios for registration review due to uncertainty regarding inhalation toxicity. The Agency anticipates re-evaluating the FQPA Safety Factor based upon submission of anticip ated toxicity studies including inhalation, acute neurotoxicity, and immunotoxicity studies.

 The Agency anticipates the need to assess occupational handler e xposure from the open pouring of wettable powder in the manufacture of antimicr obial products as well as occupational exposure that may occur during the dip, spray and pressure treatment of wood.

 The Agency anticipates revising the tolera nce expression for chlorothalonil in 40 CFR §180.275(a)(1) and §180.275(a)(2) during registra tion review to ensure that it appropriately covers the metabolites and degrad ates of chlorothalonil and that it specifies the residues to be measured in each commodity.

 The Agency intends to modify tolerance levels as needed, and work to harmonize tolerances/maximum residue limits (MRLs) , where possible, in key export markets during registration review.

 The frequency and severity of human health incidents reported for chlorothalonil may warrant further analysis in the regist ration review of chlorothalonil.

 The Agency anticipates the need to recons ider chlorothalonil's dermal sensitization classification during registrati on review. In the 1999 RED, chlorothalonil was classified as not being a dermal sensitizer; however, a published literature study indicates that chlorothalonil may be an extremely potent contact allergen, induc ing sensitization.

 The Agency anticipates the need to require the following toxicity data for use in conducting a complete human health risk asse ssment for conventional and antimicrobial uses of chlorothalonil:

o Guideline No. 870.3465 90-day inhalation toxicity (rat)

 The Agency anticipates the need to require the following data for the conventional uses of chlorothalonil for use in conducting a complete human health risk assessment:

o Guideline No. 860.1360 Multiresidue method recovery data (degradate SDS- 3701)

o Guideline No. 870.6200 Acute neurotoxicity9 o Guideline No. 870.7800 Immunotoxicity

 The Agency anticipates the need to require the following human health data for the antimicrobial uses of chlorothalonil:

o Guideline No. 875.1400 Inhalation exposure, indoor 2

o Guideline No. 875.1600 Exposure monitoring data reporting

o Guideline No. 875.1700 Product Use Information

o Guideline No. 875.2300 Surface residue dissipation

 Chlorothalonil is among several agricultural chemicals included in the Agricultural Health Study (AHS). The AHS began in 1993 and is a collaborat ion of the National Institute of Environmental Health Sciences (N IEHS), the National Cancer Institute (NCI), the EPA, and the National Institute for O ccupational Safety and Health (NIOSH). Designed 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 fa milies in Iowa and North Carolina who enrolled in the study before any disease developed. The study focuses particularly on farmers' exposure to 50 chemicals including many of the most widely used pesticides. As data are collect ed over a period of years, scientists can compare overall health outcomes for peopl e who differ in whether they have had exposure to various chemicals. While these comparisons cannot conclusively demonstrate how exposure affects health, they can show some statis tical associations. More information on the AHS can be found at: http://aghealth.nc i.nih.gov. EPA is monitoring the results of the AHS and will cons ider this study in the registration review of chlorothalonil as appropriate.

 Please refer to the March 13, 2012 Chlorothalonil. Human-Health Assessment Scoping Document in Support of Registration Review , available in docket EPA-HQ-OPP-2011- 0840 at www.regulations.gov, for a detailed disc ussion of the anticipated human health risk assessment and data needs.

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 hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its 1999 reregistra tion decision for chlorothalonil, EPA reviewed

2 The Agency anticipates the need to require inhalation exposure studies for the follo wing scenarios: open-pour liquids during material preservation; open-pour wettable powders during material preservation; brush/roller application of treated paints; airless sprayer application of treated paints; and dip, spray, and pressure treatment of wood.10 these data and selected the most sensitive endpoint s for relevant risk assessment scenarios from the existing hazard database. However, as requir ed by FFDCA section 408(p), chlorothalonil is subject to the endocrine screeni ng part of the Endocrine Disrup tor Screening 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 2 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/dat a call-ins for the firs t group of 67 chemicals, which contains 58 pesticide ac tive ingredients and 9 inert ingredients. Chlorothalonil was included on that list and has been issued an orde r 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 ED SP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening ba ttery, please visit our website: http://www.epa.gov/endo/.

Timeline

The projected timeline for the completion of the chlorothalonil registration review is presented below in Table 1.

Table 1. Projected Chlorothalonil Registration Review Timeline Activity Estimated Date Opening the Docket Open Docket and Public Co mment Period 2012 – March Close Public Comment 2012 – May Case Development Final Work Plan 2012 – August Issue DCI 2013 – April – June Data Submission 2015 – April – June Open Public Comment Period for Draft Risk Assessments 2016 – Oct. – Dec. Close Public Comment Period 2017 – Jan. – March Registration Review Decision Open Public Comment Period for Proposed Registration Review Decision 2017 – April – June

Close Public Comment Period 2017 – July – Sept.11 Registration Review Decision and Begin Post-Decision Follow-up 2018 Total (years) 6

Guidance for Commenters

The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency will carefully consider all commen ts, as well as any additional information or data provided in a timely manner, prior to issuing a final work plan for the chlorothalonil case.

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. Growers and other stakeholders are asked to comment on any tr ade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the na ture of the concern.

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 exposur e to chlorothalonil compared to the general population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure, compared to the general population.

Water Quality

Organochlorine pesticides are identified as a cau se of impairment for two water bodies listed as impaired under section 303(d) of the Clean Wate r Act as of the water body report completed in 2010. 3 Although chlorothalonil is sometim es referred to as an orga nochlorine, it is unclear if chlorothalonil is one of the or ganochlorine pesticides contribu ting to the water body impairment. The two water bodies are in New York: Niagara River, upper, main stem and Niagara River, lower, main stem. Total Maximum Daily Loads (TMDL) 4 have not been developed for chlorothalonil or organochlorin e pesticides. More information on impaired water bodies and TMDLs can be found at the Agency’s website 5 . The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: In clusion of Impaired Water Body and Other Water Quality Data in OPP’s Registratio n Review Risk Assessment and Management

3 http://iaspub.epa.gov/tmdl_waters10/attains_nation.cause_detail_303d?p_cause_group_id=885&p_cycle=2010

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

5 http://www.epa.gov/owow/tmdl/12 Process 6 in order to ensure they can be used quant itatively or qualitativel y in pesticide risk

assessments.

Structure Activity Relationships

EPA must rely upon information of appropriate qual ity and reliability for each decision made by the Agency. In the Office of Pesticide Program s (OPP), the evaluation process for a pesticide chemical traditionally begins with the applicant’ s submission of a set of studies conducted with the specific pesticide chemical of interest. The us e of the results of such testing (measured data) is a logical, scientifically rigorous proce ss that identifies the physical, chemical, and environmental fate properties of the pesticide, as well as the dose and endpoints at which an adverse effect can occur in various animal species.

Today, there is significant interest in alternat ive techniques, i.e., tech niques other than data generation that could significantly inform the Agency’s decision-making process. Recently, OPP has made increasing use of stru cture activity relationship (SAR ) as part of its regulatory decision-making process. In the SAR process, a ch emical's molecular structure is compared to that of other chemicals for which data are availabl e. These structural similarities are then used to make predictive judgments about a chemical’s physical, chemical, and biological properties. Thus, the chemical’s physical, chemical, and biol ogical properties are a f unction of (or directly related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To develop a QSAR, a selected set of measured da ta on a single physical, chemical, or biological property is used to derive a model (an equatio n) to predict the valu e of that property.

Since SAR assessments and QSAR modeling are anothe r set of tools that are available to Agency scientists, OPP has begun a proce ss shift that envisions shifting from the current study-by-study approach to an approach in which the use of pr edicted data, generated us ing validated models, is considered along with information from open litera ture and studies specifically generated under Part 161 requirements. All relevant information w ould be considered as pa rt of a weight-of-theevidence evaluation.

At this time, EPA believes that for certain e ndpoints, especially physi cal/chemical and fate properties, that SAR and QSAR might be effect ively utilized to fulfill these data requirements for many antimicrobial pesticide chemicals. When considering biological prope rties, at this time, EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a screening-level assessment procedure rather than multiple tiers of assessments with progressively more data requirements.

If stakeholders believe that submission of predic ted data can fulfill one of the data needs for the Chlorothalonil Case, then the Agency invites submission of this information. The submitter would be expected to supply a ra tionale describing the utility of the information and provide documentation on the scientific va lidity of the information. The de termination that the predicted

6 http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm13 data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission consultation with the Agency is encouraged.

Other Information

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining risk assessments, includ ing any species-specific ecological effects determinations for chlorothalonil. The Agen cy is interested in receiving the following information:

1. confirmation on the following label information

a. frequency of application, applicati on intervals, and maximum number of applications per season b. geographic limitations on use 2. use or potential use distributi on (e.g., acreage and geographica l distribution of relevant crops) 3. use history 4. median and 90 th percentile reported use rates (lbs. a. i./acre) from usage data – national, state, and county 5. application timing (date of first application and application interval s) by crop – national, state, and county 6. sub-county crop location data 7. usage/use information for non-agricultural uses (e.g., forestry, reside ntial, rights-of-way) 8. directly acquired county-level usage da ta (not derived from state level data)

a. maximum reported use rate (lbs. a.i. /acre) from usage data – county b. percent crop treated – county

c. median and 90 th percentile number of applications – county d. total pounds per year – county

e. the year the pesticide was last us ed in the county/sub-county area f. the years in which the pesticide was applied in the county/sub-county area 9. typical application interval (days) 10. state or local use restrictions 11. ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not alr eady reported to the Agency 12. monitoring data, air or water 13. amount of impurities present in technical chlorothalonil

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 chlorothalonil.14 II. FACT SHEET

Background Information

 Registration Review Case Number: 0097

 Pesticide Chemical (PC) Code: 081901

 Chemical Abstracts Serv ice (CAS) Number: 1897-45-6

 Chlorothalonil was first registered in the Un ited States in 1966 for use as a fungicide on turfgrass. The first food crop registration was in 1970 for potato use and the first antimicrobial use was registered in 1974 as a mildewicide in latex and solvent-based paints.

 The Reregistration Eligibility Decision for chlorothalonil was completed in April 1999.

 Technical registrants (conven tional with antimicrobial uses ): GB Bioscience Corporation, Sipcam Agro USA, Inc., Vischim SRL & Celcius Property B.V.

 Technical registrants (conven tional pesticides only): Arys ta LifeScience & Orion ATO

 Technical registrants (antimicrobial onl y): IBC Manufacturing Corporation & GB Bioscience Corporation

 Active Section 3 registrations as of February 2012

o Conventional: 103

o Antimicrobial: 31

 U.S. tolerances for chlorothalonil: 40 CFR §180.275.

 Pesticide Re-evaluation Di vision Chemical Review Ma nager (CRM): Jose Gayoso, gayoso.jose@epa.gov

 Antimicrobials Division CRM: Rebecca von dem Hagen, vondemhagen.rebecca@epa.gov

 Registration Division Product Manager (PM): Tony Kish, kish.tony@epa.gov

 Antimicrobials Division PM: Marshall Sw indell, swindell.marshall@epa.gov

 Chemical Structure:

Use and Usage Information

For additional details, please refer to BEAD Chemical Profile for Registration Review: Chlorothalonil (PC Code 081901) , dated October 25, 2011; Chlorothalonil (081901) Screening Level Usage Analysis (SLUA) , dated May 7, 2011; Chlorothalonil (081901) California DPR Usage Data, dated October 17, 2011; PRD Appendix A: Food/Feed & Non-Food/Non-Feed Uses Considered in Registrati on Review Work Planning

. Chlorothalonil (081901) , dated September 14, 2011; and Summary of Registered Antimicrobial Us es of Chlorothalonil in Support of the Registration Review Summary Document, dated March 12, 2012, located in docket EPA-HQOPP-2011-0840 at www.regulations.gov.15  Chlorothalonil is registered for agricultura l use on many food crops, including almonds, apples, apricots, asparagus, barley, numer ous bean crops, cole crops, cucurbit/melon crops, mint, onions, okra, peanuts, peppers, ston e fruit crops, potatoes, tomatoes, walnuts, and wheat.

 Chlorothalonil is registered for a variety of non-agricultural uses. Resi dential uses include many ornamental plants (both foliar and bulbs) and home fr uit and vegetable gardens. Residential antimicrobial uses include paints , wood preservatives, caulks, and sealants.

 Other non-agricultural registered uses of chlorothalonil include numerous turf grass species (including, but not limited to, golf c ourses), forest nursery trees, as well as antimicrobial uses on various industrial a nd building products in cluding adhesives, coatings, concrete blocks and surfaces, em ulsions, grouts, irriga tion systems, lumber, paints, plaster, polishes, stai ns, stucco, construction timber, and wood building materials.

 Chlorothalonil products are formulated in soli d form as dust, water dispersible granules, pellets, tablets, impregnated material, and wettable powder; in liquid form as emulsifiable, flowable, or soluble concentrat es, as well as ready-to-use solutions. Some products are coformulated with other pesticide active ingredients.

 The annual total agricultural usage of chlorothalonil averaged approximately 9 million pounds active ingredient (lbs. a.i.) for the period 1998-2010. The crops with the most use in terms of lbs. a.i. applied are peanuts ( 37%), potatoes (26%), and tomatoes (8%). The crops with the greatest total area treate d are peanuts (42%), potatoes (31 %), and tomatoes (6%).

 On average, the states with the most agricultu ral usage in terms of lbs. a.i. applied are Georgia (25%), Florida (13%), California (9%), Michigan (8%), and Alabama (7%).

 Non-agricultural annual to tal conventional chlorothaloni l usage for the period 2000-2006 was reported to be approximately 4.3 million lbs. a.i. The highest use was reported on golf courses, with approxim ately 3 million lbs. a.i.

 Usage data are unavailable for antimicrobi al uses of chlorothalonil, including paints/adhesives/caulking/coating, commer cial/institutional/industrial buildings, composition board and concrete surfaces, and use as a wood preservative.

Recent and Pending Actions

 There are no recent or pending new use re gistration actions for chlorothalonil.

Ecological Risk Assessment Status

The following are key findings from the most rece nt ecological risk assessments regarding the environmental fate, ecological effects, and ri sks of chlorothalonil. Please refer to the Registration Review – Preliminary Problem Formul ation for the Ecological Risk Assessment and16 Drinking Water Exposure Assessment of Chlorothalonil , March 22, 2012, located in docket EPA-HQ-OPP-2011-0840 at www.regulations .gov, for a detailed discussion.

 The most recent ecological risk assessment fo r conventional uses of chlorothalonil was conducted in 2010 to assess risk from an IR-4 petition for use on bulb vegetables, bushberries, and low growing berries.

 The most recent comprehensive ecological risk assessment for all c onventional uses of chlorothalonil was conducted in support of the 1999 Reregistration Eligibility Decision (RED) for chlorothalonil.

 A quantitative ecological risk assessment for th e antimicrobial uses of chlorothalonil has not been conducted.

Ecological Effects:

 The 2010 assessment concluded that the levels of concern were exceeded for all size classes of birds and mammals, fish, aquati c invertebrates, and non-vascular aquatic plants. Endangered terrestrial invertebrates we re at risk from the proposed bulb vegetable

use.

 The 1999 RED concluded that levels of concern, especially for aquatic organisms, were exceeded for a number of crops, including peanut s and potatoes, as well as turf use. In addition, many chlorothalonil labels did not pr ovide specific maximu mapplication rate s. Marine/estuarine mollusks were particularly at risk. To mitigate ecological risks, the registrants agreed to reduce individual and seasonal maximum application rates for many use sites. In addition, the regi strants agreed that labels w ould require untreated buffers between estuarine/marine water bodies and agricultural crops treated with chlorothalonil– at least 150 feet for aerial and air-blast applicatio ns and 25 feet for ground applications.

Human Health Risk Assessment Status

The following are key findings from the most re cent human health risk assessments conducted for chlorothalonil registered uses. Please refer to Chlorothalonil. Human-Health Assessment Scoping Document in Support of Registration Review, March 13, 2012, located in docket EPAHQ-OPP-2011-0840 at www.regulations.gov, for a detail ed discussion of the human health risk

assessment status.

 The most recent human health risk assessm ent was conducted in 2010 to assess risk from an IR-4 petition for use on bulb vegetables , bushberries, and low growing berries. The Agency was not able to make a safety fi nding due to residential/non-occupational and occupational inhalation toxicity concerns and the petition was withdrawn. The most recent comprehensive human health risk assessment for chlorothalonil was conducted in support of the 1999 RED for chlorothalonil.17 Hazard Characterization:

 The oral and inhalation routes of exposure ar e of the most toxicological concern with chlorothalonil.

 Chlorothalonil is in acute Toxicity Category IV (the least toxic of f our categories) for the oral route of exposure, and in Toxicity Ca tegory II for the inhalation route. For acute dermal effects and acute skin irritation, chlorothalonil is in Toxicity Category IV. Chlorothalonil produces severe eye irritati on in rabbits (Toxicity Category I). The Agency has classified chlorothalonil as a likely human carcinogen (formerly Group B2). The mechanistic data, includi ng the negative findings of a ll genetic toxicology testing, supported a non-neoplastic patholog y as directly rela ted to the eventual neoplasia and a non-linear mode of action for tu mor production by chlorothalonil.

 SDS-3701, the major metabolite of chlorothalonil, is in acute Toxicity Category II for the oral route of exposure. There is no ev idence of carcinogenicity for the SDS-3701 metabolite.

 Hexachlorobenzene (HCB) is an impurity pres ent in chlorothalonil and other pesticide products. It is classifi ed as a B2 carcinogen.

 In the 1999 RED, the Agency decided to rem ove the 10X FQPA safety factor. However, for registration review, the Agency anticipat es updating the FQPA safety factors.

Summary of Risks:

Dietary

 The most recent non-cancer dietary assessm ent (food and water) conducted in 2010 was a screening level assessment and did not indicate risk estimates of concern from exposure to chlorothalonil and degradate SDS-3701. Th e dietary assessment in the RED also concluded that there were no di etary risks of concern from exposure to chlorothalonil and SDS-3701.

 The dietary assessment conducted for the RED found that cancer risks exceeded the level of concern for combined dietary exposure to HCBs found in chlorothalonil and several other pesticide active ingredients. To mitigat e this risk, the chlorothalonil registrants agreed to reduce the level of HCB in chlorothalonil tec hnical and manufacturing-use products to 40 ppm, which is the lowest leve l that has been shown to be technologically feasible for chlorothalonil.

Residential

 In the 2010 risk assessment, inhalation risk concerns for the shor t-/intermediate-term exposure durations were identified for re sidential handlers using treated paint. Additionally, risk concerns we re identified for post-application scenarios from inhaling vapors from treated paint, and for bysta nder volatilization i nhalation exposure.18  In the RED, residential handlers were es timated to be at risk from exposure to chlorothalonil from using certain equipment on turf. Additionally, post-application exposure risks were estimated for residents a nd children exposed to contact with treated lawns. To mitigate risk to residential handler s of pesticides containing chlorothalonil and children who are exposed to chlorothalonil afte r application to home lawns, the registrants agreed to prohibit home lawn use on chlorothalonil labels.

Aggregate

 An aggregate (dietary food + drinking water + residential exposure ) risk assessment was performed in support of the 2010 human hea lth risk assessment for chlorothalonil. Aggregate risk was determined to be equal to dietary food + drinking water risk because the toxicological endpoints for dietary e xposure (kidney effects) and residential inhalation exposure (respiratory irritation clinical signs) coul d not be combined.

Occupational

 In the latest risk assessment, inhalation ri sk concerns for occupational handlers were identified for both acute and shor t-/intermediate-term exposures.

 In the RED, occupational handlers were esti mated to be at risk from the following scenarios: (1) applications of wettable powder formulations , (2) granular applications with tractor-drawn spreaders to turf, (3) applications with specialty air-assisted equipment on golf courses, and (4) professi onal painters using sp rayers. Additionally, post-application exposure risk exceeded the level of concern for workers re-entering treated sodfarm areas to cut, roll, and ha rvest sod. The Agency determined that the restricted entry interval (REI) for agricult ural applications coul d be reduced from 48 hours to 12 hours, as long as additional measures were taken to protect the eyes for seven days after application. To mitigate the risks of concern in the RED, the registrants agreed to the following measures:

o wettable powder formulations must be pack aged in water-soluble bags or labeled for use only in closed mixing/loading systems

o MUPs must not be formulated into a product intended as a mildewcidal paint additive designed for direct sale to reta il customers, e.g., in a ‘pillow pack’ or other small volume or one-use package

o handlers of granular formul ations applied with tracto r-drawn spreaders to turf must wear dust masks

o applicators using specialty air-assisted application equipment on turf must wear chemical-resistant gloves

o painters using airless spraye rs should wear respirators

o workers who reenter treated areas after the restricted-entry interval, but within 7 days of treatment, must receive special notification about ey e irritation hazards and have access to on-site eye-flushing equipment19 o handlers of wettable powder, liquid flowable, and dry flowable formulations, and those using hand-held equipment (such as backpack sprayers ) must wear gloves

o handlers in enclosed spaces (gree nhouses) must wear respirators

o sod treated with chlorothalonil must be harvested, roll ed, and palletized mechanically.

Human Studies

 Past chlorothalonil risk assessments relied in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, invo lving exposure to many different pesticides, comprise generic pesticide exposure databa ses such as Pesticide Handlers Exposure Database (PHED), the Outdoor Residential E xposure Task Force (ORETF) Database, and the Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies supporting these multi-pesticide generic expos ure databases, and has found no clear and convincing evidence that the conduct of any of them was either f undamentally unethical or significantly deficient relative to the et hical standards prevailing at the time the research was conducted. All appl icable requirements of EPA’ s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to conti nued reliance on these studies.

Incidents

Ecological Incidents:

 The most recent review of the chlorothalonil ecological incident reports was conducted in November 2011. Between 1976 and 2003, there were 33 chlorothalonil incidents reported to the Ecological Incident Information Syst em (EIIS) and the Avian Incident Monitoring System (AIMS). In one of the incidents, chlorothalonil was unlikely the cause of the incident. Six of the incidents involved misuse s or spills. In the re maining 26 incidents, the legality of use was either a registered use (5) or undetermined (21) and the certainty index was possible (24) or hi ghly probable (2). Of these 26 incidents, 7 involved aquatic animals, 4 involved terrestrial anim als, and 15 involved plant damage.

 In addition to the incidents recorded in EIIS and AIMS, 409 aggregate incidents were reported to the Agency from 1995 to 2011 (404 involving plants and 5 involving animals).

Human Health Incidents:

 In the Aggregate OPP Incident Data System (IDS), which contains exposures classified as minor, unknown, or no effects outcomes, from January 1, 2006 to November 2, 2011, there were 117 reported exposures involving chlorothalonil resulting in low severity. There were relatively few details provided on the incidents in the Aggregate IDS module and these incidents were of low severity.20  In the Main IDS, from January 1, 2006 to November 2, 2011, there were 22 exposures reported for chlorothalonil only in the database (20 exposure classified as resulting in a moderate outcome and 2 classified as majo r) and 12 additional exposures that involved more than one chemical.

Tolerances and International Harmonization

 U.S. tolerances for chlorothalonil are located at 40 CFR §180.275.

 A table listing the differences between U. S. tolerances and Canadian, Mexican, and CODEX Maximum Residue Limits (MRLs) for chlorothalonil is included in the Chlorothalonil. Human-Health Assessment Scoping Document in Support of Registration Review, March 13, 2012, available in docket EPA-HQ-OPP-2011-0840 at www.regulations.gov.

Labels

 Active Section 3 labels for chlorothalonil can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

.21 III. SUMMARY OF ANTIC IPATED DATA NEEDS

A summary of the anticipated data needs for the ch lorothalonil registration review is presented in the tables below.

Table 2. Summary of Anticipated Data Need s for both Conventional and Antimicrobial Uses of Chlorothalonil

Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured in Months from DCI Receipt)

835.1230 Adsorption/desorption batch equilibrium TGAI 12

835.1240 Soil column leaching TGAI 12

835.2120 Hydrolysis TGAI 12

835.2240 Aqueous photolysis TGAI 12

835.4100 Aerobic soil metabolism TGAI 24

835.4200 Anaerobic soil metabolism TGAI 24

835.4300 Aerobic aquatic metabolism TGAI 24

835.4400 Anaerobic aquatic metabolism TGAI 24

850.1075 Saltwater fish acute toxicity TGAI 12

850.1350 Saltwater invertebrates life cycle TGAI 12

850.1400 Saltwater fish early life stage TGAI 12

850.1735 Freshwater invertebrate acute whole sediment toxicity TGAI 12

850.1740 Saltwater invertebrate acute whole sediment toxicity TGAI 12

870.3465 90-day inhalation toxicity (rat) TGAI 24

Table 3. Summary of Anticipated Data Needs for Only Conventional Uses of Chlorothalonil

Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured in Months from DCI Receipt)

835.2370 Air photolysis TGAI 12

835.6100 Terrestrial field dissipation TGAI 24

835.8100 Field volatility TGAI 12

850.4100 Seedling emergence, Tier II TGAI 12

850.4150 Vegetative Vigor, Tier II TGAI 1222 850.2100 Acute avian oral, passerine 1 TGAI 12

860.1360 Multiresidue method recovery data SDS-3701 12

870.6200 Acute neurotoxicity TGAI 12

870.7800 Immunotoxicity TGAI 12 Non-guideline study (Special Study) Avian acute inhalation 2 TGAI 12

Table 4. Summary of Anticipated Data Needs for Only Antimicrobial Uses of Chlorothalonil

Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured in Months from DCI Receipt)

835.1110 Activated sludge sorption isotherm TGAI 12

850.6800 Modified activated sludge respiration inhibition 3 TGAI 12

850.3110 Ready biodegradation 3 TGAI 12

850.3220 Porous pot 3 TGAI 12

850.3240 Simulation tests—aerobic sewage treatment: A. activated sludge 3 TGAI 12

850.3280 Simulation tests to assess the biodegradability of chemicals discharged to wastewater 3 TGAI 12

875.1400 Indoor inhalation exposure 4 TGAI/TEP 12

875.1600 Exposure monitoring data reporting TGAI/TEP 12

875.1700 Product Use Information TGAI/TEP 12

875.2300 Surface residue dissipation 5 TGAI/TEP 24

1 The anticipated DCI will provide that a protocol must be submitted for review and approval by the Agency prior to initiating this study.

2 The anticipated DCI will provide that a protocol must be submitted for review and approval by the Agency prior to initiating this study.

3 The results of the Activated Sludge Respiration Inhib ition Test (ASRI) expected to be required will determine which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC50 is less than or equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test EC50 is greater than 20 mg/L, then the applicant would choo se to conduct either: Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing would be expected to be required. If, however, the an timicrobial fails the Ready Biodegradability study, then the Biodegradation in Activated Sludge or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.

4 The Agency anticipates the need to require inhalation exposure studies for the follo wing scenarios: open-pour liquids during material preservation; open-pour wettable powders during material preservation; brush/roller application of treated paints; airless sprayer application of treated paints; and dip, spray, and pressure treatment of wood.

5 Anticipated to be required to assess residential exposu re to pressure-treated wood. The anticipated DCI will provide that a protocol must be submitted for review and approval by the Agency prior to initiating this study.23 Non-guideline study (Special Study) Wood leaching study 6 TEP 24

6 The anticipated DCI will provide that a protocol must be submitted for review and approval by the Agency prior to initiating this study.