Docket Number EPA-HQ-OPP-2015-0348 www.regulations.gov



# Pentachloronitrobenzene Preliminary Work Plan Registration Review: Initial Docket Case Number 0128

Approved by:

Date: 

# March 2016

Yu- Tin Guilaran, Director Pesticide Re-evaluation Division

### Pentachloronitrobenzene (PCNB) Preliminary Work Plan- Table of Contents

OVERVIEW
. .. . ......... . . . . . ... . ................... . ...... .. . ....... . .............. . .. . . . ............ . . . . . . . . .... . ......................... . . 4 ANTICIPATED DATA NEEDS
........... . ....... . . .. . .. . ...... .. ... . .. . ........... . . ... . .......................... . . ........ .. . .. 5 STATUTORY AND REGULATORY AUTHORITY
... . .................. . ... . . . . . ... . ...... . ......... . .... .......... . 7 CHEMICAL FACTS
.......................... . .... . ....... . . .. . ................. . .... . . . . ................... . ... .. . . .................... . 8 USE AND USAGE INFORMATION
................................................ . .. ...... ... . . . ...... . ....... . . .. . .... .. . ... 9 RECENT ACTIONS
..... ............... ........................... . .............. . ........ ............ . . ............. . . .. . . .. ....... . . .. 10 ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW
.... . . .... . .... ......... . .. . .. 10 TIME LINE
....... . ...... ...... . . . ..... ... . .................................... . .................. . . . . .......... .. . . . . . ............ . .. . . .... ... 12 NEXT STEPS
.. . .... . . ................ . . . ...... . . ...... . .. . .... . .. . .... . .... . ......... . .... . . ... . ............... . . ........... ..... . ......... 13 Appendix

- Additional Areas Considered in the PCNB Registration Review
........ . .. . ....... . ..... 14

Refe rences: This Preliminary Work Plan summarizes the Environmental Protection Agency's current position based on the following documents: 1. Registration Review : Preliminary Problem Formulationfor Environmental Fate Ecological Risk , Endangered Species, and Human Health Drinking Water Exposure Assessments for Pentachloronitrobenzene (PCNB). Jim Carleton, Ph.D. , and Thomas Steeger, Ph.D
. March 6 , 2016
. 2. Pentachloronitrobenzene (PCNB). Human Health Assessment Scoping Document in Support of Registration Review
. Shalu Shelat, Julie L. Van Alstine , and Evisabel Craig. March 11 , 2016
. 3. Pentachloronitrobenzene ( PCNB) : Tier I (Scoping) Review of Human Incidents
. Elizabeth Evans and Sharma Recore. March 2, 2016
.

24. BEAD Chemical Profile (BCP)for Registration Review of PCNB (Pentachloronitrobenzene) , Chemical Code 056502. Leonard Yourman , Rafael A. Prieto , and Andrew Lee. December 24,2015
. 5
. PCNB (056502) Screening Level Usage Analysis (SLUA). June 26 , 2015. 6. Label Data Report Spreadsheet: PC Code: 056502. July 23 , 2015
. 7. Health Effects Division Master Label Report Spreadsheet: PC Code 056502
. July 23, 2015. These and other supporting documents for the PCNB registration review case may be found in the docket EPA-HQ-OPP-2015-0348 at http: //www.regulations.gov.

3

### OVERVIEW The docket for pentachloronitrobenzene (PCNB) is now open, initiating the first public comment period for this registration review (docket number EPA-HQ-OPP-20 15-0348). Pentachlorobenzene (PCNB) is an organochlorine contact fungicide registered for the control of fungal diseases on agricultural crops such as beans , broccoli , Brussels sprouts , cabbage, cauliflower, collards , cotton , garlic, kale, mustard , peanuts , pepper, potato , and tomato. PCNB is also registered for non-agricultural uses such as golf courses, ornamental plants, bulbs , turf and professional and college athletic fields. In addition , over 80 metabolites/degradates of PCNB have been identified. Three are considered to be " major degradates"-- pentachloroanaline (PCA) , pentachlorothioanisole (PCTA) and pentachlorobenzene (PCB)
. These compounds also are ofpotential concern from an ecotoxicological perspective. Of the three , PCA is of the greatest significance due to its stability and mobility, and its relatively high concentration in fate studies for PCNB (up to 86.6% of applied radioactivity). PCTA is less mobile , and PCP appeared in only one fate study. The Agency intends to require several fate and ecotoxicity studies on the PCA degradate only, to address its environmental fate characteristics and relative abundance in the fate studies
. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about PCNB , highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing the registration review for PCNB. The registration review process was designed to include a public participation component to solicit input from interested stakeholders
. The Agency intends, by sharing this information in the docket, to inform the public of what it knows about PCNB and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on PCNB. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional information that will help the Agency ' s decision-making process for this chemical. 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 stakeholders could include: environmental nonprofit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial , institutional , residential , and other users of pesticides; or the public at large. The Preliminary Work Plan begins by listing the anticipated data needs for PCNB. Next, it discusses the statutory and regulatory authority for registration review
. Then the document provides chemical facts , use and usage information, recent actions, the anticipated risk assessments , and a projected registration review timeline for PCNB. Finally , the Appendix to this document includes identification and discussion of some areas that are considered generally in registration review along with some additional chemical case-specific information.

4ANTIC IPATED DATA NEEDS Table 1 below summarizes anticipated data needs for PCNB. For additional discussion of the anticipated data needs , see the Registration Review : Preliminary Problem Formulationfor Environmental Fate, Ecological Risk , Endangered Species, and Human Health Drinking Water Exposure Assessments for Pentachlorobenzene (PCNB) and Pentachloronitrobenze ne (PCNB). Human Health Assessment Scoping Document in Support of Registration Rev iew
. Table 1: Anticipated D ata Needs for the PCNB Registration Review Estimated Guideline Timeframe Number1 Study Title Test Material (Months from receipt ofDCI) Anticipated Data Needs fo r the Parent PCNB 835.2240 Photodegradation in Water TGAI 12 835. 237 0 Photodegradation in Air TGAI 12 835.4100 Aerobic Soil Metabolism TGAI 24 835.4200 Anaerobic Soil Metabolism TGAI 24 835.4300 Aerobic Aquatic Metabolism TGA I 24 835.4400 Anaerobic Aquatic Metabolism TGA I 12 850 .135 0 Aquatic invertebrate life cycle (saltwater) TGAI 12 850. 1400 Fish earl y-life stage toxicity (saltwater) TGAI 12 850 .15 00 Fish life cyc l e (freshwater) 2 TGAI 24 850 .15 00 Fish life cyc l e (estuarine/marine) TGAI 24 850.1735 Who l e sediment: ac ute freshwater invertebrates TGAI 12 (3 benthic species) 850 .174 0 Whole sediment: acute marine invertebrates (3 TGAI 12 benthic species) 850.1850 Aq uati c food chain transfer TGAI 12 850.2100 Avian oral toxicity (passerine spec i es) TGAI 12 850 .3040 Field testing for pollinators (Tier Hl )3 TEP 24 850 .4 100 Seedling emergence (T ier I /Tier II) TEP 12 850 .415 0 Vegetative vigor (Tier 1 /Tier II ) TEP 12 850 .4550 Cyanobacteria (Anabaena flos-aqua e) Toxicity TGAI 12 850 .44 00 Aquatic plant growth (Lemna minor) Toxicity TGAI 12 850.5400 Aquatic plant growth (Algal) Toxicity TGAI 12

1 On June 27,2012, EPA announced certain revisions in harmonized guideli ne series 850

- Ecological Effects Tests -inc luding renumbering and other designations or changes for some guideline studies. See "Final Test Guide line s; OCSPP 850 Series ; Notice of Availability" 77 FR 38282, June 27, 2012. http :/ /www.regulations.gov/# !documentDetai i; D=EPA-HQ-OPPT-2009-0 154-0028 2 The anticipated requirement may be waived if acceptable medaka extended one-generation data (OCSPP Guideline 890.2200) are s ubmitted
. 3 For all Tier II and Tier III pollinator studies: the Agency anticipates requiring these studies pending the outcome of lower tier pollinator studies with larval and adult bees
. 5Table 1: A nticipated Data Needs fo r th e P CNB Registrati on Review Estimated Guideline Study Title Timeframe Number1 Test Material (Months from receipt ofDCI) 850.6100 Environmental chemistry method s & independent TGAI 12 laboratory validation (soil & sediment) 850.6200 Environmental chemistry methods & independent TGAI 12 laboratory validation for water Non- Whole sed iment ; chronic4 TGAI 12 g uide line Non- Acute oral toxicity test with adult honey bees TGAI 12 guideline (OECD 213)tTier I) Non- Acute honey bee larvae toxicity test (OECD 237) TGAI 12 guideline (Tier I) Non- 1 0-day adult honey bee chronic toxicity test (draft TGAI 12 guideline OECD test guideline) (Tier I) Non- 21-day larval honey bee chronic toxicity test TGAI 12 guideline (draft OECD guidance document) (Tier I) Non- Field trial of residues in pollen and**necta~** (Tier TEP 12 guideline II) Non- Semi-field whole colony test (OECD 75) 3 (Tier TEP 24 guideline II)

860.1200 Directions for use 5 TGAI 12 860 .13 00 Nature ofresidue-plants 6
, livestock 7 TGAI 24 860 .1340 Residue analytical methods-livestock TGAI 24 commodities 8 860 .1 380 Storage stability data9 TEP 24 860 .1 480 Magnitude of the residue: meat/milk/poultry/eggs TGAI 24 860 .1 500 Magnitude of the residue: crop field trials 10 TEP 24

4 A tiered testing strategy may be considered for the data recommended to be required for sediment toxicity. Under this strategy, I0-day sediment toxicity testing is first conducted with H yalella azteca, Chironomus dilutus, and Leptoche irus plumulosus under OSCPP Guidelines 850.1735 and 850
. 1740
. After submission and review of data from the se studies (i ncluding a comparison of estimated environmental concentrations in sediment and pore water with toxicity results from the I0-day studies) , the Agency will advise the registrant on the need for one or more chronic sediment toxicity studies. 5 Labeling pertaining to rotational crops and feeding/grazing restrictions for some registrations is not supported with data; the Agency intends to require the relevant data (listed in this table). Alternatively, the registrant may elect to revise labels accordingly. Details on the labeling and supporting data may be found in Table A.8.1 in the scoping document. 6 Potatoes or cabbage 7 Ruminant and poultry 8 Data are needed on levels of Total Radioactive Residue (TRR) for PCNB , PCA , and PCTA
. 9 Data are needed to support Amvac's cottonseed, peanut , potato , and tomato processin g studies
. Storage stability data are also needed to support any new field trial and processing studies submitted for the registration review of PCNB. Details may be found in Table A.8.1 in the scoping document. 10 Potato , garlic, broccoli , beans, soybean (seed, forage and hay) , peppers , tomatoes , cottonseed , and peanuts
. 

### 6Table 1 : A nticipated Data N eeds for the PC N B Regi stration R ev iew Estimated Guideline Study Title Timeframe Number1 Test Material (Months from receipt ofDCI) 860.1520 Magnitude of the resid ue : processed food/feed 11 TEP 24 860
. 1900 Magnitude of the resid u e: field rotational crop s TEP 24 870. 3 465 90-day Inhalation

- rat TGAI 24

N o n- Comparative thy roid assay TGAI guid e line 12 875. 2 100 Dislodgeab1e foliar residue and turf transferab le TEP 24 residues 1 2 N o n- Foliar Dissipation 1 3 (Guideline 835.6100 SS) TEP guid e line 12 Anticipated Data Needs for the Metabolite PCA 835 .2 240 Photodegradation in Water DEGR 12 835.2370 Photodegradation in Air DEGR 12 850 .1 010 Acute toxicity fres hwater invertebrate DEGR 12 850 .1 025 850 .1 035 Acute toxicity estuarine and marine organisms DEGR 12 850. 1045 (mysid) 850 .1 055 850. 1075 Acute toxicity (saltwater fish) DEGR 12 850
. 1075 Acute toxicity freshwater fish bluegill sunfish DEGR 12 and rainbow trout 850
. 1300 Aquatic invertebrate life cyc le (fres hwater) DEG R 12 850.1400 Fish early

- life stage tox icity (freshwater) DEGR 12 TGAI = techmcal grade active mgred1ent ; TEP = typical end-use product ; DEGR = degradate (PCA) STATUTORY AND REGULATO RY AUTHORITY The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United States (U
. S
.) generally must be registered by the Environmental Protection Agency (EPA or the Agency), based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to asse s s risk evolves and as policies and practices change , all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy , and pesticide use practices will occur over time
. 11 A soybean proce ssing study is needed
. Alternatively, the regi strant may elect to prohibit application s to soybean
. 12 Di s lodgeable foliar residue data only are anticipated to be required
. 13 Foliar dissipation half-life data are needed to estimate residues on forage items for terrestrial wildlife. Residues and dis sipation rates for the three major degradates (PCA , PCTA and PCB) and the minor degradates/contaminants (PCP and HCB ) mu st be quantified. The Agency has used a default half-life value for foliar dissipation value for PCNB in its past ass essments
. The study should include re levant environmental chemistry methods (ECM ) for soil , water, and sediment with independent laboratory validation (IL V)
. 7Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided on EPA's website. 14 The Agency is implementing the registration review 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 the FIFRA standard for registration. The regulation s governing registration review begin at 40 CFR 15 5.40. 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 Agenc y' s opportunity to state what it knows about the pesticide and what additional risk analy ses 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 docket during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of PCNB. CHEMICAL FACTS Table 2 provides a summary of the chemical facts for PCNB. Table 2: Chemical Facts for PCNB. PC code 056502 Case Number 0128 CAS Number 82-68-8 Year first registered June 30, 1964 Pesticide Type Fungicide Chemical clas s Benzene; organochlorine Reregistration Eligibility RED was issued June 2006. Decision (RED) Tolerance Reassessment Not applicable
. Tolerance reassessment was addressed in the Eligibilit y Decision RED. (TRED ) Cumulative group Not applicable
. PCNB has not been identified as a member of a cumulative group that shares a common mechanism of toxicity
. 40 CFR Citation Tolerances for PCNB are established in 40 CFR§180.291. Dual- use PCNB is registered for conventional pesticide uses only and has no registered antimicrobial or biopesticidal uses. Non-pesticidal uses There are no identified non-pesticidal uses of PCNB
. Pesticide Re-evaluation Veronica Dutch , dutch.veronica @ epa . gov , (703)-308-8585 Division , Chemical Review Manager Regis tration Division , Hope Johnson , johnson.hope @ epa.go v, (703)-305-5410 Product Manager

14http ://ww w2 .epa .gov/pe sticide-reevaluation


### 8USE AND USAGE INFORMATION Table 3 summarizes the use and usage information for PCNB. Please see the BEAD Chemical Profile ( BCP)for Registration Review of PC N

B ( Pentachloronitrobenzene), Chemical Cod e 056502 in the registration review docket for more details
. Table 3: PCNB Use and Usage Information Summary of Use PCNB is a contact fungicide that is registered for preventative and residual protection against soil-borne fungal diseases on vegetables , field crops , turf , and ornamentals. PCNB ' s mode of action has not been definitively characterized but is proposed to be through lipid peroxidation, causing cell damage 15

. PCNB has commonly been used in combination with insecticides and other fungicides
. Use Sites Use sites for PCNB are beans , broccoli, Brussels sprouts , cabbage , cauliflower, collards , cotton , potato , garlic , kale , mustard, peanuts, pepper, and tomato, golf course turf grass such as tees, greens and fairways , and ornamental bulbs
. Summary ofUsage Average agricultural usage (1998-2013) was approximately 360,000 pounds of active ingredient applied annually on approximatel y 440,000 acres, for an overall average of 0.82 pounds a.i ./acre. Average usage for 2011 indicated that golf courses were the main non-agricultural use for PCNB at 250 ,000- 500,000 lbs/year. Formulation Type(s) PCNB is formulated as a granular, flowable concentrate , emulsifiable concentrate , and dry flowable
. Applic ation Method(s) Products can be applied as a foliar broadcast, soil band, soil drench , bulb dip, soil broadcast, in-furrow , and through chemigation
. Technical Registrant(s) Amvac Chemical Company No
. of Registrations 9 Section 3 products 16 Restricted Use No Guidance for Commenters: Additional areas of use and usage related information requested for this registration review , and of particular interest to EPA , are described below
.
• If any label use parameters are missing , EPA expects to use conservative assumptions to approximate these parameters in order to conduct a quantitative risk assessment. However, the Agency will work with registrants to clarify information on PCNB product labels , especially the maximum annual application rates for nonagricultural uses including golf courses, turf , and ornamental lawns. • The Agency seeks information on seed treatment usage for PCNB.

15 http ://www .frac
. info/home 16 Section 3 product labels can be obtained from the Pe sticide Product Label System (PPLS) website (http :/ /oaspub
.epa .gov/pestlab V ppls.home). 

### 9• The Agency seeks usage data for non-agricultural uses ofPCNB , including bulb dips and ornamental soil drenches. RE CENT and PENDING ACTIONS A new end-use product containing PCNB was registered August 28, 2015, for use on golf course turf-greens , tees , and fairways only
. Removal of conditions on technical AMVAC product Registration #5481-197 was approved on September 26 , 2014
. Amvac is no longer required to submit to the Agency documentation ofthe impurity profiles in each finished lot of the product; however, such documentation must be submitted to the Agency upon request. Amvac had been required to submit this information to resolve concerns about previously unreported toxic contaminants in the technical product, and had been doing so in accordance with the conditions of registration. The impurity profiles that were submitted have been consistent with prescribed limits for the impurities , and the Agency believes that information obtained on an as-needed basis will be sufficient in the future. Additionally , EPA is currently discussing with the registrants an issue regarding two PCNB products that do not conform to labeling on the technical product that prohibits the use of PCNB on residential lawns and related sites , and set limits for the use of PCNB on athletic fields. The registrants are expected to submit requests for label amendments consistent with the technical product labeling. When the amendments are approved and implemented , the use of any PCNB product will be prohibited on residential lawns and related sites , so an assessment of residential handler and post-application risks will not be needed
. ANTI CIPATED RI SK ASSESS MENT S FOR RE GISTRATION RE VIEW The most recent human health risk assessment in conjunction with the most recent aggregate risk assessment for PCNB was performed in 2005 for the RED. The most recent ecological and environmental fate risk assessment was completed 2005 for the same reason . Findings and conclu sions from these risk assessments are summarized in Registration Review: Preliminar y Problem Formulationfor Environmental Fate, Ecological Risk , Endangered Species, and Human Health Drinking Water Exposure Assessments for Pentachloronitrobenzene (PC N

B) and Pentachloronitrobenzene (PC N

B) and Human Health Assessment Scoping Document in Support of Registration Review
. Table 4 below summarizes the anticipated registration review risk assessments based on the EFED Problem Formulation and HED Scoping Document.

10Table 4: Anticipated Risk Assessments for the PCNB Registration Review
Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including

Food

Drinking water
Handlers (mixers , loaders , applicators)

Post-application

Post-application Bystanders Conduct? y



### y

y
y

y

N

y The Agency will conduct a comprehensive ecological assessment, including an endangered species assessment.
For a discussion of reported ecological incidents for 29 of the Problem Formulation.

Data anticipated to be required for the registration review of PCNB could result in changes to the point of departure (POD), necessitating a new dietary assessment. Likewise , if updated percent crop treated data, monitoring data, the most recent dietary exposure assessment model , and/or revised estimated drinking water concentrations result in significantly higher exposure and risk estimates, the Agency will revisit the assessment. 

### An updated drinking water exposure assessment is

anned for re · review. Updated occupational handler dermal and inhalation assessments may be conducted to reflect all currently registered uses and maximum application rates, current occupational and residential exposure assessment policies , and/or updated toxicological PODs, and data anticipated to be required for the re review ofPCNB. Occupational post-application dermal assessments may be conducted to reflect all currently registered uses and maximum application rates , current occupational residential exposure assessment (ORE) policies , and/or updated toxicological PODs, and data to be · for re · stration review. Pending amendment of non-conforming end-use product labels, residential handler and post-

. tions risk assessments will not be needed. The need for spray drift and volatilization risk assessment for PCNB will be examined during stration review.



### 11Aggregate 

### y A new aggregate risk assessment will be required due to updates to residential scenarios as well as potential updates to the dietary exposure assessment, toxicological endpoints, and/or the POD. Cumulative N The Agency has not made a common mechanism of toxicity finding for PCNB and other substances , and PCNB does not appear to produce a toxic metabolite produced by other substances. Tolerance s 

### y The Agency will revisit the tolerances during registration review
. Incidents Will check for For a discussion of reported human incidents for updates PCNB , see page 11 of the Scoping Document and Pentachloronitrobenzene (PC N

B) : Tier 1 ( Scoping Review of Human Incidents and Epidemiology
. Guidance for Commenters: Additional ecological information requested for this registration review , and of particular interest to EPA , is described below.

• Ecological and crop damage incidents not already reported to the Agency. Guidance for Commenters: Additional human health information requested for this regi stration review , and ofparticular interest to EPA, is described below
.
• Human health incidents not previously reported to the Agency. TIMELINE EPA has created the following estimated time line for the completion of the PCNB registration review in Table 5 below
.

12

### Table 5: Projected PCNB Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period March-2016 Close Public Comment May-2016 Case Development Final Work Plan September 2016 Issue DCI October-December 2016 Data Submission October- December 20 18 60-day Public Comment Period for Draft Risk April-June 2020 Assessments 17 Registration Review Decision 60-day Public Comment Period for Proposed January-March 2021 Registration Review Decision Registration Review Decision and Begin Post-Decision 2021 Follow-up Total (years) 5 

### 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 issue a Final Work Plan for the registration review of PCNB.

17 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 generally for draft risk assessments
. 13

### Appendix - Additional Areas Considered in the PCNB Registration Rev iew PUBLIC COMMENTS AND FEEDB ACK: Guidance for Comm enters: The areas below highlight topics of special interest to the Agency where your comments, data submissions , or reference to sources of additional information could be of particular use. Trade Irritants : Through the registration review process , the Agency intends to solicit information on trade irritants and , to the extent feasible, take steps toward facilitating irritant resolution
. The Agenc y 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 as ked to co mm ent on any trade irritant issues resulting from lack ofMRLs or disparities between U .S
. tolerances and MRLs in key export markets , providing as much specificity as possible regarding the nature of the concern . W

ater Quality : PCNB is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 18 In addition , no Total Maximum Daily Loads (TMDL) have been developed for PCNB. 19 More information on impaired water bodies and TMDLs can be found at the Agenc y' s website. 20 Th e Age ncy invites submiss ion of water quality data f or this pesticide. To the extent possible , data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Bod y and Other Water Quality Data in OPP 's Registration Review Risk Assessment and Management Process 21 in order to ensure they can be used quantitati ve l y or qualitatively in pesticide risk assessments. Environmental Justice: EPA seeks to achieve environmental justice , the fair treatment and meaningful involvement of all people , regardless of race , color, national origin , or income , in the development, implementation , and enforcement of environmental laws , regulations, and policies. To help address potential environmental justice issues , the Agency seeks information on any groups or segments of the popula tion who , as a result of their location , cultural practices , or other factors , may have atypical, unusuall y high exposure to PCNB compared to the general population
. Please comm ent if you are aw are of any sub-populations that may have atypical, unu sually high expo sure compared to the general population .

18 http ://ias pub
.epa . gov/tmdl waters I 0/attains nation cy .cau s e detail 30 3 d ?p cau se group id= 885 19http ://ias pub
.epa . gov/tmdl waters I 0/attains nation
.tmdl pollutant detail ?p pollutant group id= 885&p pollutant

group name= PESTICID ES 20 http ://w ww .epa.gov/owow/tmd l/ 2 1 http ://w ww2
.epa . gov/pesticide-reevaluation/opp-guidan ce- s ubmi s sion- state-and-tribal

- water-guality-monitoringdata 14ENDANGERED SPECIES: A risk assessment that supports a complete endangered species determination has not been conducted for PCNB. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of PCNB 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 and/or National Marine Fisheries Service (the Services), as appropriate
. ENDOCRINE DISRUPTOR SCREENING PROGRAM: As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity , including assessments of carcinogenicity , neurotoxicity, developmental, reproductive , and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility , pregnancy rates , reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of (its reregistration decision for PCNB, 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), PCNB is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). EPA has developed the EDSP to determine whether 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 other such endocrine effects as the Administrator may designate." The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identif y the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A , or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact withE, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine-related effects 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 screen 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. 22 A second list of chemicals identified for EDSP screening was published on June 14 , 2013 23 and includes some pesticides scheduled for registration review and chemicals found in water
. Neither of these lists should be construed as a list of known or likely endocrine disruptors.

22 See http ://www.regulations.gov/# !documentDetail;D= EPA-HQ-OPPT-2004 -0109-0080 for the final initial list of chemicals. 23 See http: //www.regulations.gov/#! documentDetaii;D =EPA -HQ-OPPT- 2009-0477-0074 for the final second list of

chemicals. 15PCNB, as "quintozene," was included in the first group of 67 chemicals issued an order to conduct Tier 1 EDSP testing, for which EPA has received all of the required Tier 1 assay data. The Agency has reviewed all of the assay data received for the List 1 chemicals and conclusions are available in the chemical-specific public dockets. 24 The Agency has determined that there is no evidence ofpotential interaction of PCNB with the estrogen pathway in the mammals
. However, PCNB may potentially interact with the estrogen pathway in wildlife based on the complementarity effects observed within the fish short-term reproduction assay and the results of the Tier 1 steroidogenesis assay. For the androgen pathway, there is no convincing evidence of potential interaction ofPCNB with mammals or wildlife. Additionally, there is no evidence of potential interaction of PCNB with the thyroid pathway in amphibians. There is evidence of potential interaction of PCNB with the thyroid pathway in mammals, although it is noted that the observed thyroid effects were consistently associated with alterations in the liver. In the EDSP Tier 1 assays and OSRI, there is evidence for potential interaction with the thyroid pathway in studies conducted with adult animals , but no such data exists for its effects in the young animals
. For registration review , the Agency intends to require data to compare thyroid effects in adults and young . For further information on the status of the EDSP , the policies and procedures , the lists of chemicals , future lists, the test guidelines, and the Tier 1 screening battery , please visit our website. 25 HUMAN STUDIES: Past PCNB risk assessments rely 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 , involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED) , the Agricultural Reentry Task Force (ARTF) Database, and the 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 convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the research was conducted. All applicable requirements of EPA ' s Rule for the Protection ofHuman Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on these studies.

24 http ://www2
.epa . gov/sites/production/files/20 15-06/documents/pcnb-056502 2015-06-29 txr0057138
.pdf 25 http ://www .epa.gov/endo/ 16