### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C

. 20460



### MEMORANDUM

Date: 03111 / 2016 OFFICE OF
C HEMI CA L SAF ETY AND

P OLLUTION PR EVEN TIO N



### SUBJECT: Pentachloronitrobenzene 

### (PCNB). Human Health Assessment Scoping

Document in Suppo rt of Registration Review.

PC Code: 056502

Deci s ion No.: 51041 1

Petition No.: N I A DP Barcode: 0429798 Regi stra tion No.: N I A

Re g ulator y Action: Registration Review Scoping Document

Case No.: 0128 Ri sk Assessment T y pe: N I A

TXR No.: N I A CAS No.: 82-68-8

MRID No.: N I A



### FROM: 40 CFR: § 180.291



### Shalu Shelat, Enviromnenta l Health Scientist

Julie 

### L. Van A l stine

, Env i ronmental H ealth Scientist

Evisabe l Craig, Ph.D.

, D ABT

, Toxicologist

Risk Assessment Branch V T (RABV I )

Health Effects Division (HED

, 7509P)



### THROUGH: Donna S

. D avis

, Branch Ch i ef

RABVl/H E D (7509P)



### TO: Veronica Dutch

, C h emical Review Manager

Jill Bloom, Team Lead

Linda An-ington, Branch Chief

Pesticide Re-Evaluation Di v i sion (PRO) (7508P)

Attached i s HED's human health risk assessme nt scoping document for pentach l oronjtrobenzene (PCNB) to suppo rt Registration Review.

Page I of 55Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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### Table of Contents

Executive Summary

................................ ................................ ................................ ........................ 3
1.0 Introduction

................................ ................................ ................................ ............................. 4
2.0 Hazard Characterization/Assessment

................................ ................................ ....................... 5 3.0 Residue Chemistry

................................ ................................ ................................ ................... 6 4.0 Dietary Exposure

................................ ................................ ................................ ..................... 7 5.0 Residential Exposure

................................ ................................ ................................ ............... 8
6.0 Non

- occupational and Bystander Exposure

................................ ................................ .............. 8 7.0 Aggregate Risk Assessment

................................ ................................ ................................ ..... 9 8.0 Occupational Exposure

................................ ................................ ................................ ............ 9 9.0 Public Health and Pesticide Epidemiology Data

................................ ................................ ... 10
10.0 Tolerance Assessment and International Harmonization

................................ .................... 11
11.0 Environmental Justice

................................ ................................ ................................ .......... 11
12.0 Cumulative

................................ ................................ ................................ ........................... 11
13.0 Human Studies

................................ ................................ ................................ ..................... 12 14.0 Risk Assessment Updates and Data Deficiencies

................................ ................................ 12
15.0 References

................................ ................................ ................................ ............................ 14 Attachment 1: Chemical Identity Tables.

................................ ................................ .................... 16 Attachment 2: PCNB Acute, Subchronic, and Chronic Toxicity Profile.

................................ ... 28 Attachment 3: Summary of Toxicological Doses and Endpoints for PCNB (from 2005 Risk Assessment).

................................ ................................ ................................ ................................ . 32 Attachment 4: Summary of Residues of Concern for PCNB.

................................ ..................... 34
Attachment 5: PCNB International Residue Limit Status Sheet.

................................ ................ 35 Attachment 6: Summary of Registered Uses for PCNB

................................ .............................. 36
Attachment 7: PCNB DFR Waiver Criteria

................................ ................................ ................. 46 Attachment 8. Residue Chemistry Data Needs for Registration Rev iew of PCNB

..................... 48Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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### Executive Summary

HED has prepared a scoping document to support Registration Review of the fungicide pentachloronitrobenzene (PCNB) (1,2,3,4,5

- pentachloro

- 6

- nitrobenzone). PCNB is an organochlorine contact fungicide for soil and limited foliar treatment around vegetables, field crops, turf (sod farms and golf courses), and ornamentals as well as residential turf. PCNB is
formulated as liquid and granular formulations.

The most recent human health risk assessment for PCNB was performed in 2005 entitled the 2 nd 

### Revised HED Chapter of the Reregistration Eligibility Document (RED) (D. Locke, D312691, 2/3/2005). In 2011, 2012, and 2013 HED performed three separate Occupational Exposure and
Risk Assessments for only the impurit ies resulting from the PCNB manufacturing process (S. Shelat, D393194, 11/22/11; S. Shelat, D404118, 6/25/12; S. Shelat, D401422, 2/28/13). The impurity assessmen ts resulted in risk mitigation, which has been implemented by the Registration Division on the current PCNB labels.

HED has evaluated the status of the human health assessments for PCNB to determine whether sufficient data are available, and whether any updates are needed to support Registration Review. HED has considered all available data and human health risk assessments for PCNB with respect to its toxicity, exposure, and usage databases, and the most updated Agency science policy and
risk assessment methodologies to determine the scope of work necessary to support Registration
Review.

Based on the 2007 revised 40 CFR Toxicology Data Requirements, the to xicity database for
PCNB is in complete. The need for a subchronic inhalation study (guideline # 87 0.3465) 

### for
PCNB was recently confirmed by the HASPOC. Also, a special comparative thyroid assay (CTA) is required for PCNB because of the concern that points of departure (PODs) from adult animal studies may not be protective of potential thyroid toxicit y in the young. As part of registration review, the endpoints, doses, and uncertainty/safety factors used in the most recent
risk assessment will be re

- evaluated according to current HED policy.

The residue chemistry database is not complete. T he following studies are outstanding and should be submitted as part of Registration Review: an additional plant metabolism study on potato es or cabbage (860.1300) ; new ruminant and poultry metabolism studies (860.1300) ; a livestock tolerance enforcement method (860.1340) ; storage stability data to support the cottonseed, peanut, potato, and tomato processing studies ( 860.1380 ) ; additional field trials on potatoes, garlic, broccoli, dry beans, lima beans, snap beans, soybeans, bell peppers, non

- bell

pepper s, tomatoes, cottonseed, cotton gin byproducts, and peanuts (860.1500) ; livestock feeding
studies (860.1480) ; and field accumulation studies on rotated crops (860.1900) . There are no
Codex or Canadian MRLs established for residues of PCNB and its metaboli tes; therefore, harmonization is not an issue at this time. The tolerance expressions in 40 CFR§180.291 have not been updated to reflect current HED policies and will need to be revised during Registration
Review.

The most recent chronic dietary (food and drinking water) risk estimates were below HED’s level of concern for the general U.S. population and all population subgroups examined. An acute assessment was not required. Additionally, for the purpose of risk characterization, it was
recommended t hat the Reference Dose approach be used for quantification of human cancer risks. As part of Registration Review, an updated chronic dietary exposure and risk assessment

may be required if updated percent crop treated (PCT) data, monitoring data, and/or e stimatedPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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### drinking water concentrations (EDWCs) result in significantly higher exposure and risk
estimates . This assessment should incorporate updated PCT data, monitoring data, updated EDWCs, the most recent dietary exposure assessment model, and any revi sed toxicological
PODs.

PCNB is currently registered for use s including golf courses and college and professional athletic
fields. Although the technical registrant and most formulators have deleted residential turf uses for PCNB, two labels (EPA Reg. No. 10404

- 37 and 19713

- 312) currently exist which allow for use on residential turf, including lawns

. For the residential turf uses , an adult residential handler dermal and inhalation assessment as well as adult dermal and children (1 to <2 years old) der mal and incidental oral assessments are anticipated during Registration Review. Based on the registration of PCNB on golf courses, this use also results in the potential for dermal post

application exposure to adults and children (6 to < 11 years old and 1 1 to < 16 years old) who come into contact with treated golf course turf and will be considered during Registration
Review. Updated residential handler dermal and inhalation assessments and post

- application
dermal and incidental oral assessments will be c onducted to reflect all currently registered uses and maximum application rates, using current residential exposure policies and updated toxicological PODs.

Based on the registered PCNB application methods, a spray drift asses sment will be conducted
dur ing Registration Re view. The need for a volatilization risk assessment for PCNB will be examined during Registration Review.

The occupational exposure database is not adequate to support the Registration Review process
for PCNB. A chemical

- specific DFR study will be needed to conduct the occupational post

application foliar potato and magnolia tree assessment for PCNB. The ris k estimates provided in
the most recent 2005 PCNB o ccupational handler and post

- application exposure assessments are
not reflective of the mitigation establis hed in the impurity assessment and current exposure policies

. 

### During Registration Review, updated occupational handler dermal and inhalation assessments and post

- application dermal assessments may be conducted to reflect all currently registered uses and maximum application rates, using current occupational exposure policies and updated dermal and inh alation toxicolo gical PODs , if needed

.

Additionally, as part of Registration Review, HED may also consider the impurities of PCNB in any dietary (food and water), residential, occupational, and/or aggregate exposure and risk assessments that are complet ed

.

1.0 Introduction

PCNB is an organochlorine fungicide that is effective in retarding germination and colony growth and suppressing sporulation. PCNB is formulated as a liquid formulation and granular formulation, and is currently registered for use on a variety of crops such as ornamentals ; a variety of container grown crops ; and agricultural c ro ps including cole crops, beans, garlic, pepper, tomato, peanut, potato, and cotton, as well as sod farms, golf courses, college and professional athletic fields, and in residential turf settings. The most recent human health risk assessments were performed as part of the Reregistration Eligibility Decision document in 2005 (D. Locke et al. , D291281, 7/27/2004). Three subsequent occupational assessments were compl eted to address the exposure and risk estimates from the PCNB impurity only (S. Shelat, D393194, 11/22/11; S. Shelat, D404118, 6/25/12; S. Shelat, D401422, 2/28/13). The impurity assessments resulted in risk mitigation, which have been implemented by the RegistrationPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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### Division on the current PCNB labels.

2.0 Hazard Characterization/Assessment

The toxicology database for PCNB is incomplete. The current 40 CFR Part 158 Toxicology Data Requirements state that subchronic inhalation, immunotoxicity, metabolism, and neurotoxicity (acute and subchronic) studies are required for PCNB. The Hazard and S cience Policy Council (HASPOC) recently confirmed the need for a subchronic inhalation study (TXR# 0057268, 2016 ). However, based on a weight

- of

- evidence (WOE) approach, the HASPOC
determined that immunotoxicity, metabolism, and neurotoxicity (acute and s ubchronic) studies are not required at this time to support the registered uses of PCNB (TXR# 0057268, 2016 ) . The HASPOC further concluded that, in agreement with the previous risk assessment, a comparative thyroid assay (CTA) is also required because of the concern that PODs from adult animal studies may not be protective of potential thyroid toxicity in the young (TXR# 0057268, 2016 ) . The TOXLINE (National Library of Medicine) database literature search did not identify any new toxicological information not already considered.

Subchronic and chronic studies in multiple species indicate that the thyroid and liver are target organs for PCNB. Effects include increases in thyroid weights, thyroid

- stimulating hormone (TSH), aspartate transaminase (AST) and alanine aminotransferase (ALT) as well as hypertrophy of the thyroid and liver. No findings of significant toxicological concern were identified in the submitted developmental or reproductive toxicity data. No neurobehavioral alterations nor
evidence of ne uropathological effects were observed in the available data. There was no indication of increased susceptibility in these studies.

P CNB is not mutagenic in bacteria or in cultured mammalian cells. There is suggestive in vitro evidence showing that PCNB i s clastogenic in the absence of S9 activation and equivocal in the presence of S9 activation. However, in a more definitive erythrocyte mouse mic ronucleus assay

, PCNB was not shown to be clastogenic. PCNB was also negative for the induction of sister
chrom atid exchanges ( SCEs ) in vitro. In 1992, the Cancer Peer Review Committee (CPRC) classified PCNB as a Group C

- possible human carcinogen based on the presence of thyroid
follicular cell adenomas and carcinomas in rats. CPRC recommended that for the purpose of risk characterization, the Reference Dose ( RfD ) approach should be used to quantif y human risk.

Data from a series of limited single

- and repeated

- dose Rhesus monkey studies suggest that PCNB bioaccumulates in mammals. In this same series, it was note d that both the biliary

- fecal
and renal

- urinary routes were utilized for the excretion of PCNB and its metabolites, with a slight preference for the fecal route. The limited data in rats, monkeys, and dogs suggest that the
metabolites accumulated within ti ssues to a greater extent than parent PCNB. The available data in rats, monkeys, and dogs are considered sufficient for risk assessment purposes based on the profile of the chemical and the target organs.

Generally, PCNB has low acute toxicity via oral, dermal, or inhalation route (Toxicity Categories III or IV). It is a slight eye or skin irritant. Several studies indicate that PCNB is a sensitizer while others show negative results. The conflict in the outcome of these studies might be related
to diffe rences in impurities associated with variations in production batches and manufacturing sites, and/or differences in testing methodology.

There is no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses
after in utero exposure (relative to structural abnormalities and developmental delays), or afterPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 6 of 55 

### pre

- or postnatal exposure to rats in multigeneration reproduction studies. Acceptable developmental toxicity studies in rats and rabbits, and reproductive toxicity studies are available and adequate for FQPA considerations. The previous risk assessment retained the FQPA safety factor of 10X because of the lack of a comparative thyroid and acceptable metabolism study. T he HASPOC recently determined that a comparative thyroid study is required for PCNB. Therefore, upon the receipt of the required data, the need for the FQPA safety factor will be re

- evaluated during Registration R eview. PCNB is on List 1 for which EPA has received all of the required Tier 1 assay data. The Age ncy has reviewed all of the assay data received for the appropriate List
1 chemicals and the conclusions of those reviews are available in the chemical

- specific public dockets (see Docket # OPP

- 2009

- 0634 )

.

Conclusions for Hazard Identification/Toxicology The toxicology database for PCNB is incomplete . A subchronic inhalation study and a CTA study are needed to support R egistration R eview

. Upon receipt of the se data, a s part of Registration R eview, the endpoints, doses, and uncertainty/safety factors used in the most recent
risk assessment will be re

- evaluated according to current HED policy

.

3.0 Residue Chemistry

At the time of the RED, there were two technical registrants for PCNB, Uniroyal and Amvac. After examination of the toxicology and chemistry data submitted by Uniroyal and Amvac, the Hazard Identification Assessment Review Committee (HIARC, 1992) conclude d that the PCNB technical materials from both of these registrants were so dissimilar they needed to be considered as separate and distinct chemicals based on differences in impurities and contaminants associated with the different manufacturing processes of the two registrants. As these registrants could not share information, separate data were required from both registrants to fulfill the residue chemistry data requirements. Currently, there is only one technical registrant for PCNB, Amvac. As such, o nly the Amvac residue chemistry database has been reviewed during the scoping

process.

A total of 84 polychlorinated phenyl metabolites of PCNB have been identified in livestock and plant metabolism and environmental degradate data. For identification and structures of each metabolite, see Table A.1.3 in Attachment 1. The limited data that are available suggest that generally, the metabolites of PCNB accumulate within plant and livestock tissues to a greater extent than the parent PCNB itself. The Me tabolism Assessment Review Committee (MARC) concluded that the residues of concern for tolerance enforcement for plant and livestock commodities are PCNB and the metabolites pentachloraniline (PCA) and pentachlorothioisole (PCTA). Since all of the metabol ites of PCNB are polychlorinated phenyl compounds and thus of toxicological concern, the MARC concluded that PCNB and all of its metabolites (including minor metabolites) are of concern in plant and livestock commodities for risk assessment. Due
to the la ck of monitoring and field trial data on every metabolite of PCNB in plants and livestock, for PCNB dietary risk assessments, the MARC recommended using plant and
livestock metabolism studies to derive a ratio of all residues of concern to those residues i n the tolerance expression (PCNB, PCA, PCTA), and using that ratio to estimate the concentration of residues of concern from field trial or monitoring data. A summary of the residues of concern
for risk assessment and tolerance enforcement can be found in Attachment 4.

Several residue chemistry data deficiencies were previously identified for PCNB , and remain as
deficiencies at this time . The available Amvac residue chemistry database is not complete and the following studies should be submitted as part of Registration Review: an additional plantPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 7 of 55 

### metabolism study on potato es or cabbage ; new ruminant and poultry metabolism studies; a livestock tolerance enforcement method; storage stability data to support the cottonseed, peanut, potato, and tomato proces sing studies; additional field trials on potatoes, garlic, broccoli, dry beans, lima beans, snap beans, soybeans, bell peppers, non

- bell peppers, tomatoes, cottonseed, cotton gin byproducts, and peanuts; livestock feeding studies; and field accumulation st udies on rotated crops. Additional details regarding the outstanding studies can be found in Attachment 8. A detailed discussion of the available Amvac PCNB residue chemistry database is available in the 2004 document (S. Kinard, D291280, 12/14/2004). T he need for tolerances for residues in livestock will be examined during Registration Review.

Conclusions: The Amvac residue chemistry database is not complete. The following studies are recommended to be requir ed as part of Registration Review: an a dditional plant metabolism study; new ruminant and poultry metabolism studies; a livestock tolerance enforcement method; storage stability data to support the cottonseed, peanut, potato, and tomato processing studies; additional field trials on potatoes, g arlic, broccoli, dry beans, lima beans, snap beans, soybeans, bell peppers, non

- bell peppers, tomatoes, cottonseed, cotton gin byproducts, and peanuts; livestock feeding studies; and field accumulation studies on rotated crops. The need for
livestock tole rances will be examined during Registration Review. Additionally, HED will review all impurities of PCNB as part of Registration Review.

4.0 Dietary Exposure

The most recent chronic dietary assessment was conducted in 2005 to support HED’s RED ( S.
Kinard

, D 322231

, 10/20 /2005 ). The residues of concern for dietary risk assessment include
PCNB and its 84 polychlorinated phenyl metabolites . An acute dietary assessment was not conducted for PCNB because an endpoint of concern attributable to a single d ose was not identified. Additionally, HED’s Carcinogenicity Peer Review Committee (CARC) classified PCNB as a Group C

- possible human carcinogen and recommended that for the purpose of risk characterization, the RfD approach should be used for quantifica tion of the human cancer risk.

The most recent chronic dietary (food and drinking water) assessment was refined and incorporated USDA Pesticide Data Program (PDP) monitoring data, anticipated residues, empirical processing data, and PCT data. The avail able m onitoring data did not analyze all PCNB metabolites of concern; therefore, the assessment used total radioactive residue ( TRR )
ratios based on the available metabolism studies to account for all metabolite s of concern. EDWC values were provided by t he Environmental Fate and Effects Division (EFED) and were directly incorporated into the assessments. The assessments were performed using Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM

FCID  , Version 2.03), whic h uses food consumption data from the US Department of Agriculture ’s (USDA’s) Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994

- 1996 and 1998.

The chronic dietary (food and drinking water) risk estimates do not exceed HED’s level of

co ncern (< 100% of the chronic population

- adjusted dose (cPAD)). For registered commodities, the chronic dietary (food and drinking water) risk estimates were 32% of the cPAD for the general U.S. population and 77% of the cPAD for all infants less than 1 ye ar old, the most highly

- exposed population subgroup.

Conclusions: The most recent chronic dietary (food and drinking water) risk estimates were below HED’s level of concern for the general U.S. population and all population subgroupsPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 8 of 55 

### examined. An acute assessment was not required. Additionally, for the purpose of risk characterization, it was recommended that the RfD approach be used for quantifica tion of human
cancer risks. As part of Registration Review, an updated chronic dietary exposure a nd risk

assessment may be required if updated PCT data, monitoring data, and/or EDWCs result in significantly highe r exposure and risk estimates . This assessment should incorporate updated
PCT data, monitoring data, updated EDWCs from EFED, the most recen t dietary exposure
assessment model , and any revised toxicological PODs. Additionally, as part of Registration Review, HED will consider the impurities of PCNB.

5.0 Residential Exposure

In the 2005 risk assessment for PCNB, a residential handler asse ssment was conducted for use on residential lawns as well as post

- application exposures to individuals entering treated lawns and golf courses. Some short

- term risk estimates were of concern for residential handlers as well as
post

- application exposures o n the day of treatment (i.e., Day 0) (i.e., dermal, incidental oral, and inhalation MOEs < 1000). In order to allow a safety finding under FQPA, Amvac requested the voluntary termination of lawn and related use sites from its PCNB registrations , as well as the use of PCNB on golf course roughs . Most other registrants followed suit. T wo labels (EPA Reg.
No. 10404

- 37 and 19713

- 312) still allow for use on residential turf, including lawns

. A
chemical

- specific turf transferable residue study (MRID 44687 1

- 01) is available for PCNB.

For the residential turf uses, an adult residential handler dermal and inhalation assessment as well as adult dermal and children (1 to <2 years old) dermal and incidental oral assessments are anticipated during Registration Review. Based on the registration of PCNB on golf courses, this use also results in the potential for dermal post

- application exposure to adults and children (6 to < 11 years old and 11 to < 16 years old) who come into contact with treated golf course tur f

, and these exposures will be considered during Registration Review.

Conclusions : The residential exposure database is adequate to support the Registration Review process for PCNB. The most recent residential handler and post

- application exposure

asse ssments are not reflective of current exposure patterns, policies and data. During Registration Review, updated residential dermal and inhalation handler assessments as well as dermal and incidental oral post

- application assessments will be conducted to re flect all currently registered uses and maximum application rates, current ORE policies and/or updated toxicological PODs.

6.0 Non

- occupational and Bystander Exposure

Residential bystander exposures resulting from off

- site transport (e.g., spray drif t or volatilization) may occur as a result of applications of PCNB. The potential for spray drift will be quantitatively evaluated for each pesticide during the Registration Review process that ensures that all uses for that pesticide will be considered c oncurrently. The approach is outlined in the revised (2012) Standard Operating Procedures for Residential Risk Assessment (SOPs)

– Residential Exposure Assessment Standard Operating Procedures Addenda 1: Consideration of Spray Drift. This document outli nes the quantification of indirect non

- occupational exposure to
drift.

In terms of volatilization, PCNB has been included as part of the Pesticide Action Network Pesticide Drift Monitoring in Minnesota report and these data will be assessed as part of

R egistration Review. In addition, the agency has developed a Volatilization Screening Tool and a subsequent Volatilization Screening AnalysisPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 9 of 55 

### ( http://www.regulations.gov/#!docketDetail;D=EPA

- HQ

- OPP

- 2014

- 0219 ). During Registration Review, the agency will utilize this analysis to determine if data (i.e., flux studies, route

- specific inhalation toxicological studies) or further analyses are required for specific chemicals.

Conclusions: The need for spray drift an d volatilization risk assessment for PCNB will be examined during Registration Review.

7 .0 Aggregate Risk Assessment

The most recent aggregate risk assessment for PCNB was performed in conjunction with the 2005 HED human health risk assessment (D. Locke, D312691, 2/3/2005). The Agency conducts aggregate exposure assessments by summing dietary (food and water) and reside ntial exposures.
An acute aggregate assessment was not conducted for PCNB because an endpoint of concern attributable to a single dose was not identified. The chronic aggregate risk assessment is equal to the chronic dietary estimates (food and water onl y)

. T he short

- term aggregate

- risk ass essment performed in 2005 included the short

- term residential exposures and the chronic dietary

exposures and resulted in risks of concern.

Conclusions: A new aggregate risk assessment will be required due to update s to the residential
scenarios as well as potential updates to the dietary exposure assessment.

8 .0 Occupational Exposure

PCNB is registered for use on a variety of crops, ornamentals, sod farms, and golf courses turf (tees, greens, and fairways) . Attachment 6 provides a summary of the occupational use pattern.

Based on the registered use patterns, there is a potential for dermal and inhalation exposure to PCNB in occupational scenarios from handling PCNB products during the application proc ess (i.e., mixer/loaders, applicators, and mixer/loader/applicators). In addition, there is a potential for post

- application worker exposure from entering into areas previously treated with PCNB.

Occupational Handlers : In the 2005 risk assessment for PCNB, an occupational handler assessment was conducted for a variety of application methods and rates. There were non

- cancer risk estimates of concern identified at that time. The assessment recommended either additional PPE or engineering controls be re quired for the affected scenarios . Based on the impurity assessments conducted in 2011, 2012, and 2013, the risk management division (RD) implemented additional mitigation for the PCNB labels.

The 2005 risk assessment does not reflect the most up

- to

- da te exposure data or inputs for occupational handlers, nor do they reflect the maximum application rates registered for this chemical. An updated occupational handler dermal and inhalation assessment may be conducted to reflect the maximum application rate s and use parameters registered for PCNB using current ORE policies and updated toxicological PODs.

Occupational Post Application : In the 2005 risk assessment for PCNB, an occupational post

application assessment was conducted only for the golf course an d sod farm application
scenarios. Since PCNB used on most other use sites is applied to soil directly and is soil incorporated before the plants mature, the assessment did not require a post

- application assessment for the agricultural uses of PCNB. S hort

- term risk estimates were not of concern (i.e., MOEs ≥100) on the day of treatment (i.e., Day 0) for all post

- application exposure activitiesPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 10 of 55 

### for the golf course and sod farm application scenarios.

A turf transferable residue (TTR) study (MRID 446871

- 01 ) is available for PCNB. The study was used in the 2005 assessment as well as characterization in the 2011 golf course assessment and 2013 sod and athletic field assessment for the impurity. Although PCNB is applied to soil directly and is soil incorporat ed before the plants mature for most uses, current review of the labels have shown that there are two agricultural uses with the potential for foliar residue. The foliar chemigation use for potato and the registered use on magnolia trees both have the pot ential to result in dermal post

- application exposure.

There is currently no chemical

- specific dislodgeable foliar residue (DFR) study available for PCNB. Since the highest estimated occupational post

- application exposure using default DFR
values for PCNB is not minimal in comparison to the level of concern (i.e., the calculated MOE is not greater than 2 times higher than the level of concern, MOE = 17 compared to the LOC of 100); EPA is requiring the 40CFR DFR data. Therefore, EPA is requiring the 40CFR DFR data requirement to facilitate any necessary exposure assessments refinements and to further EPA’s general understanding of the availability of dislodgeable foliar pesticide residues. See Attachment 7 for additional information regarding the DFR waiver criteria.

The most recent occupational post

- application exposure assessment is not reflective of current exposure policies and data, nor does it cover the highest application rate for some crops and the highest post

- application activities. Therefore

, a quantitative dermal post

- application assessment may be required for PCNB during Registration Review.

Based on the Agency's current practices, a quantitative occupational post

- application inhalation exposure assessment was not performed for PCNB at t hat t ime. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post

- application inhalation exposure assessment for PCNB.

Conclusions : The occupational exposure database is not adequate to support the Regi stration Review process for PCNB due to the lack of a chemical

- specific DFR study. The most recent
2005 occupational handler and post

- application exposure assessments are not reflective of current exposure policies and data, an d did identify risks of concern. During Registration Review, updated occupational handler dermal and inhalation assessments and post

- application
dermal assessments may be conducted to reflect all currently registered uses and maximum application rates, cu rrent ORE policies and/or updated toxicological PODs.

9 .0 Public Health and Pesticide Epidemiology Data

For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk

- Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient PCNB. The purpose of the database search is to identify potential pat terns in the frequency and severity of the health effects attributed to PCNB exposure. PCNB is not included in the Agricultural Health Study and therefore this study does not provide information for this report.

For the Main IDS, from January 1, 2010 to September 22, 2015, there were no incidents reported for the single chemical PCNB only in the database. Aggregate IDS, from January 1, 2010 to September 22, 2015, there were two incidents reported involving PCNB. These incidents werePentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 11 of 55 

### classified as minor severity. Overall, there are few incidents reported to IDS involving PCNB. A query of SENSOR

- Pesticides from 1998

- 2011 identifies 18 cases involving PCNB; four of which involve a single ai. All four single ai case s are classified as low in severity and all four
cases are work

- related. Two cases, from two separate events, occurred at pesticide manufacturing facilities during the chemical manufacturing process. No further details were provided for these two cases. The remaining two cases occurred from the same event where one individual reported gastrointestinal symptoms and the other sought medical care.

Based on the low frequency and severity of incident cases reported for PCNB in both IDS and
SENSOR

- Pesticides there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.

10 .0 T olerance Assessment and International Harmonization

Tolerances for residues of PCNB and its metabolites PCA and PCTA are established for beans,

Brassica head and stem subgroup 5A, cotton undelinted seed, garlic, peanut, potato, soybean (forage, hay, and s eed), and fruiting vegetable crop group 8. Additionally, there are tolerances established based on regional registrations for collards, kale, and mustard greens. As part of Registration Review, the need for tolerances for residues in livestock commoditie s will be
determined. There are no Codex or Canadian MRLs established for residues of PCNB and its metabolites; therefore, harmonization is not an issue at this time. The PCNB International
Residue Limit Status Sheet is available in Attachment 5. The to lerance expressions in 40 CFR§180.291 have not been updated to reflect current HED policies and will need to be revised during Registration Review.

11 .0 Environmental Justice

Potential areas of environmental justice concerns, to the extent possible, were considered in the

most recent PCNB human

- health risk assessment, in accordance with U.S. Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Po pulations and Low

Income Populations a 

### .” The OPP typically considers the highest potential exposures from the legal use of a pesticide when conducting human health risk assessments, including, but not limited to, people who obtain drinking water from sourc es near agricultural areas, the variabilit y of diets within the U.S., and people who may be exposed when harvesting crops. Should these highest exposures indicate potential risks of concern, OPP further refines the risk assessments to
ensure that the risk estimates are based on the best available information.

12 .0 Cumulative

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for
PC NB and any other substances; and PCNB does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that PCNB does not have a common mechanism of toxicity with other subst ances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning c ommon mechanism determinations

a http://www.epa.gov/compliance/environmentaljustice/resources/policy/exec_order_12898.pdfPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 12 of 55 

### and procedures for cumulating effects from substances found to have a common mechanism on
EPA’s website at http://www.epa.gov/pesticide

- science

- and

- assessing

- pesticide

risks/cumulative

- assessment

- risk

- pesticides

.

1 3

. 0 Human Studies

Past PCNB risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pe sticide 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
Handler Exposure Task Force (AHETF) Database, and the Agricultural Reentry Task Force (ARTF) 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 of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on these studies.

1 4 .0 Risk Assessment Updates and Data Deficiencies

As part of Registration Review, HED will also review all impurities of PCNB. Amvac is encouraged to provide an analysis of the testing materials for any new studies submitted during Registration Review that addresses all impurities of concern. All new st udies should be conducted with test material that has an impurity profile that is similar to the PCNB products that are currently in production. EPA notes the following risk assessment updates and data deficiencies will need to be completed and addressed during Registration Review:

o Toxicology:

o A subchronic inhalation study is recommended to be required

o A CTA study is recommended to be required

o Residue Chemistry/Dietary Exposure:

o Label changes are recommended for EPA Reg. Nos. 5481

- 8992, 5481

- 8988, and 100

- 823. The recommended changes can be found in Attachment 8.

o T he following studies are outstanding and are recommended to be required as part of Registration Review: an additional plant metabolism study on potatoes or cabbage (860.1300); new ruminant a nd poultry metabolism studies (860.1300); a livestock tolerance enforcement method (860.1340); storage stability data to support the cottonseed, peanut, potato, and tomato processing studies (860.1380); livestock feeding studies (860.1480); and field accum ulation studies on rotated crops (860.1900). Additional information about each data requirement can be found in
Attachment 8.

o T he following field trial data (860.1500) are recomme nded to be required as part of Registration Review. Additional information about each data requirement can be
found in Attachment 8.

 Potatoes: An additional 35 field trials are required for potatoes using 10% G and 2 lb/gal EC formulations. Two sets of trials are required for each formulation, one set of pre

- plant incorporated ( PPI) field trials (9 trials per formulation) and one set of in

- furrow application field trials (9 trials for the 10% G formulation and 8 trials for the 2 lb/gal EC formulation)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 13 of 55 

###  Garlic: Field trial data on garlic should be submitted by Amvac as part of Reg istration Review in accordance with 860.1500.

 Broccoli: An additional 7 field trials are required for broccoli: 1) using a 75% WP formulation at 30 lb ai/A as a broadcast PPI application (1 field trial) and as a banded application (1 field trial); 2) us ing a 75% WP formulation at 4.5 lb ai/100 gal. in soil drench application with a PHI > 72 days (3 field trials); and 3) using a 10% G formulation at 30 lb ai/A in broadcast PPI application at transplant with a PHI > 72 days (1 field trial)
and as a banded application with a PHI > 72 days (1 field trial).

 Dry beans: An additional 8 field trials are required for dry beans with 2 lb/gal EC (4 field trials) and 75% WP formulations (4 field trials) to match previously submitted data.

 Lima beans: An addition al 6 field trials are required for lima beans with 2 lb/gal EC (3 field trials) and 75% WP formulations (3 field trials) to match previously submitted data.

 Snap beans: An additional 12 field trials (6 per formulation; 75% WP and 2 lb/gal EC) are requir ed for snap beans.

 HED notes that granular data are not available for dry, lima, and snap beans and should be submitted as part of Registration Review. Alternatively, EPA Reg. Nos. 100

- 823 and 5481

- 8988 could be revised to remove applications to beans.

 Soybeans: Field trial data are required reflecting the use of PCNB on soybeans at the maximum application rate. Alternatively, the labels could be revised to prohibit the direct application of PCNB to soybeans, and field trials would not be required.

 Bell peppers: An additional 6 bell pepper field trials (3 per application method) using each application type (in

- furrow and soil drench) are
needed.

 Non

- bell peppers: Two non

- bell pepper field trials are needed for each application type (in

- furrow an d soil drench) for a total of 4 additional field
trials.

 HED notes that granular data are not available for bell and non

- bell peppers and should be submitted as part of Registration Review. Alternatively, EPA Reg. No. 5481

- 8988 can be revised to remove

ap plications to peppers.

 Tomatoes: An additional 14 tomato field trials are needed. 7 field trials should be completed using the soil drench application method and 7 field trials should be completed using the in

- furrow application method.

 HED notes tha t granular data are not available for tomatoes and should be submitted as part of Registration Review. Alternatively, EPA Reg. No.
5481

- 8988 can be revised to remove applications to tomatoes.

 Cottonseed: An additional 12 field trials (4 per formulation /application type) should be conducted with the following formulation and application types: 10% G in in

- furrow application, 10% G in banded application, and
EC formulation in in

- furrow application.

 Cotton gin byproducts: At least 12 field trials (6 per formulation type) for cotton gin byproducts data are required. At least three field trials for each type of harvesting (stripper and picker) are needed, for a total of six field trials per applicatio n formulation/type. Current labels include flowable and granular formulations with in

- furrow applications.Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 14 of 55 

###  Peanuts: A total of 30 additional field trials are needed for peanut. 9 field trials are needed with the 10% G formulation, 10 field trials are needed with the 75% WP formulation, and 11 field trials are needed with the 75%
EC.

o The need for livestock tolerances will be examined during Registration Review.

o An updated chronic dietary exposure and risk assessment may be completed that incorporates u pdated PCT data, monitoring data, updated EDWCs, the most recent
version of DEEM

- FCID, and any revised toxicological PODs.

o Updated tolerance expressions in 40 CFR§180.291 to reflect current HED policies.

o Occupational/Residential Exposure:

o Updated residential and occupational handler and post

- application assessments may be conducted to reflect all currently registered uses and maximum application rates, current ORE policies and/or updated inhalation toxicological
PODs.

o The need for spray drift and v olatilization risk assessments for PCNB will be examined during Registration Review.

o A Dislodgeable Foliar Residue study is recommended to be required for Registration Review.

1 5 .0 References

Memoranda Relevant to Registration Review.

Author Barcode Date Title

D. Locke et al. D312691 2/3/2005 PENTACHLORONITROBENZENE (PCNB): 2nd Revised HED Chapter of the Reregistration Eligibility Decision Document (RED). PC Code: 056502. Case#0128 List A. DP
Barcode D312691.

S. Shelat et al. D393194 11/22/2011 Occupational Exposure and Risk Assessment for Dioxin from Tier I Uses of PCNB: Golf Courses (tees, greens, and fairways), Cole Crops, Cotton, Potato, and Ornamentals
Bulb and Cut Flowers Soak

S. Shelat et al. D401418 6/25/12 Occupational Exposure and Risk Assessment for Dioxin from PCNB Foliar Use on Potatoes in the States of Idaho, Washington, Oregon, and Nevada

S. Shelat et al. D401422 2/28/13 Occupational Exposure and Risk Assessment for Dioxin
from Various Tier II Uses of PCNB

M. Sahafeyan et al. TXR

NO.
0051921 5/27/2003 Pentachloronitrobenzene (PCNB) . (List A, Case No.0128)
The Outcome of the HED Metabolism Assessment Review Committee Held on April 16 th , 2003 to discuss residues of concern in risk assessment and tolerance expression of Pentachloronitrobenzene (PCNB). Chemical 056502.

M. Sahafeyan et al. D291353 4/8/2003 Pentachloronitrobenzene (PCNB) . (List A, Case No.0128) Briefing Memorandum to M etabolism Assessment Review
Committee to discuss PCNB residues of concern for inclusion in dietary risk assessment. Chemical 056502. DP
Barcode: D291353.

S. Kinard D291280 12/14/2004 Pentachloronitrobenzene (PCNB). Revised Reregistration Eligibility D ecision Document (RED): Product and Residue Chemistry Considerations

.

S. Kinard D322231 10/20/2005 Pentachloronitrobenzene (PCNB) . Chronic Dietary Exposure Assessments for the Reregistration Eligibility Decision (RED).

S. Ga llagher TXR No.

0057268 3/10 / 2016 PCNB: Summary of Hazard and Science Policy Council (HASPOC) Meeting of October 15, 2015: RecommendationPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

_____________________________________________________________________________________________________________________________ _____________________________________________________________________________________________________________________________ ______ _____________________________________________________________________________________________________________________________ _____________________________________________________________________________________________________________________________ ______ _____________________________________________________________________________________________________________________________ _____________________________________________________________________________________________________________________________ ______ _____________________________________________________________________________________________________________________________ __________________________

Page 1 5 of 55 Memoranda Relevant to Registration Review.

Author Barcode Date Title on the Requirement for Acute Neurotoxicity, Subchronic Neurotoxicity, Immunotoxicity, Inhalation, Metabolism, and Comparative Thyroid studie s.

E. Evans et al

. D 431876 3/2 / 2016 PCNB : Tier I (Scoping) Review of Human Incidents and Epidemiology



### Attachments: Attachment 1: Chemical Identity Tables. Attachment 2: PCNB Acute, Subchronic, and Chronic Toxicity Profile. Attachment 3: Summary of Toxicological Doses and Endpoints for PCNB. Attachment 4: Summary of Residues of Concern for PCNB.
Attachment 5: PCNB International Residue Limit Status Sheet. Attachment 6: Summary of Registered Uses for PCNB.
Attachment 7: PCNB DFR Waiver Criteria.
Attachment 8: Residue Chemistry Data Needs for Registration Review of PCNB.Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 16 of 55 

### Attachment 1: Chemical Identity Table s

.

Table A.1.1. Test Compound Nomenclature.

Chemical structure

Common name Pentachloronitrobenzene, PCNB Empirical formula C 6 Cl 5 NO 2 IUPAC name pentachloronitrobenzene

CAS name 1,2,3,4,5

- pentachloro

- 6

- nitrobenzene

CAS number 82

- 68

- 8

PC Code 056502

End

- use products (EP) Food/Feed Uses EPA Reg. Nos.: 5481

- 8992 (Flowable); 5481

- 8988 (Granular);
100

- 823 (Granular)

Non

- food Uses EPA Reg. Nos.: 5481

- 585 (Liquid); 19713

- 312 (Liquid); 9198

- 183 (Granular); 9198

- 227 (Granular); 10404

- 37 (Granular); 34704

- 1087 (Granular)

Table A.1.2. Physicochemical Properties of the Technical Grade Test Compound.

Parameter Value Reference Molecular weight 295.3

Memo, D. Locke, 07

- JAN

- 2005; D311394 Specific gravity 1.718 Boiling point 328  C Melting point/melting range 142

- 145  C Water solubility 440 ppb Vapor pressure 1.13 x 10

- 4 mmHg



### Table A.1.3 lists all the compounds that are associated with PCNB from its metabolism in plants, livestock, toxicity studies, and water Memo, M. Sahafeyan et al. , April 8, 2003; D291353).

Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

# Matrices (MRID in

parentheses) Chemical Name (other names in parenthesis) Structure

1 Potato (45307303) peanut (45307302) peanut roots (41562902) whole potato, callus, and peel (41562903) cabbage leaves (41562904) chicken fat (41692801) Rotational crops: lettuce, wheat forage, wheat straw (44577501) pentachloronitrobenzene (PCNB)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 17 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

2 Potato (45307303) peanut (45307302)
whole potato and peel (41562903) goat liver (41692805) goat kidney (41692805) goat omental fat (41692805) goat renal fat (41692805) goat milk (41692805) chicken fat (41692801) egg yolk (41692801) Rotational crops: turnip top, turnip root, lettuce, wheat forage, wheat straw (44577501) pentachloroaniline (PCA)

3 Potato (45307303) whole potato and peel (41562903) cabbage leaves (41562904) chicken thigh (41692801) egg yolk (41692801) Rotational crops: turnip root, lettuce, wheat forage, wheat straw (44577501) pentachlorothioanisole (PCTA)

or,

(methyl pentachlorophenyl sulfide, MPCPS)

4 Potato (45307303) peanut (45307302) Rotational crops: lettuce (44577501) S

- (pentachlorophenyl) malonylcysteine (PCP

- MalCys)

(C5MaCy)

5 Potato (45307303) peanut (45307302) Rotational crops: wheat forage, wheat straw (44577501) aminotetrachlorobenzene sulfonic acid (AM TCB sulfonic acid)

(C4SANH)

(tetrachlorosulfanilic acid)

6 Potato (45307303) pentachloroanisole (PCAN)

7 Potato (45307303) egg yolks (41692801) Rotational crops: lettuce, wheat forage, wheat straw (44577501) pentachlorobenzene (PCB)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 18 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

8 Potato (45307303) peanut root (41562902) whole potato, callus, and peel (41562903) cabbage leaves (41562904) goat liver (41692805) goat urine (41692805) chicken kidney (41692801) N

- hydroxypentachloroaniline (NOHPCA)

9 Potato (45307303) potato callus and peel (41562903) S

- (pentachlorophenyl)

- γ

- glutamyl cysteine (PCP

- GluCys)

10 Potato (45307303) Rotational crops: wheat forage (44577501) S

- (pentachlorophenyl) glutathione (PCP

- GSH)

11 Potato (45307303) peanut roots (41562902) whole potato callus, and peel (41592903) chicken excreta (41692801) S

- (pentachlorophenyl) malonylcysteine monomethyl ester (PCP

- MalCys ester)

12 Potato (45307303) chicken fat (41692801) goat kidney (41692805) tetrachloroaniline methyl sulfoxide (TCA sulfoxide isomers)

13 Potato (45307303) tetrachloro

- methylthio

- aniline sulfamate (TC

- MET

- A sulfamate)

14 Potato (45307303) potato peel (41562903) tetrachloronitrobenzene (TCNB isomers)

15 Potato (45307303) tetrachloronitrobenzene sulfonic acid (TCNB sulfonic acid isomers)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 19 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

16 Potato (45307303) tetrachloronitrothioanisole (TCNTA isomers)

17 Potato (45307303) tetrachlorophenol methyl sulfoxide (TCP sulfoxide)

18 Potato (45307303) tetrachlorothiophenol methyl sulfoxide (TCTP sulfoxide)

19 Potato (45307303) tetrachlorothiophenol sulfonic acid (TCTP sulfonic acid)

20 Potato (45307303) aminotetrachloroaniline (AM TCA isomers)

21 Potato (45307303) aminotetrachloroaniline sulfamate (AM TCA sulfamate)

22 Potato (45307303) hydroxytetrachloroaniline (OH TCA)

23 Potato (45307303) N

- hydroxyamino

- tetrachloroaniline (NOHAM TCA)

24 Potato (45307303) N

- hydroxyamino

- tetrachlorophenol (NOHAM TCP)

25 Potato (45307303) N

- hydroxyamino

tetrachlorothioanisole (NOHAM TCTA isomers)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 20 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

26 Potato (45307303) S

- (tetrachloro

- methyl sulfoxy

phenyl) glutathione (TC

- MES

- P

GSH)

27 Potato (45307303) S

- (tetrachloro

- methyl sulfoxy

phenyl) malonylcysteine (TC

- MES

P

- MalCys)

28 Potato (45307303) peanut (45307302) S

- (tetrachloronitrophenyl) glutathione (TCNP

- GSH)

29 Potato (45307303) Peanut (45307302) S

- (tetrachloronitrophenyl) malonylcysteine (TCNP

- MalCys)

30 Potato (45307303) S,Sʹ

- (tetrachlorophenyl) diglutathione (TCP

- diGSH)

31 Potato (45307303) S,Sʹ

- (tetrachlorophenyl) dithioacetate (TCP

- dithioacetate)

32 Potato (45307303) S,Sʹ

- (tetrachlorophenyl)

- γ

- glutamyl cysteine

- cysteine (TCP

- GluCys

- Cys)

33 Potato (45307303) acetyl S,Sʹ

- (tetrachlorophenyl) cysteine

- cysteinyl α

- hydroxyglutarate (AC TCP

- Cys

- CysHOG)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 21 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

34 Potato (45307303) trichloronitroaniline methyl sulfoxide (RCNA sulfoxide)

35 Potato (45307303) N

- hydroxy

- trichloro

- dimethylthio

aniline (NOH RC

- diMET

- A)

36 Potato (45307303) N

- hydroxyamino

- trichloro

- methoxy

aniline (NOHAM RC

- OME

- A)

37 Potato (45307303) S,Sʹ

- (trichloroanilino)

- γ

glutamylcysteine

- cysteine (RCA

GluCys

- Cys)

38 peanut (45307302) N

- malonyl

- S

- (tetrachloroaminophenyl)

- cysteine

39 Potato (45307303) S,Sʹ

- (trichloronitrophenyl) malonyl cysteine

- thioacetate (RCNP

- MalCys

thioacetate)

40 Potato (45307303) S,Sʹ

- (trichlorothioanisole)

- γ

- glutamyl cysteine

- cysteine (RCTA

- GluCys

Cys)

41 Potato (45307303) diacetyl S,Sʹ

- (trichloro

- anisole) glutathione

- cysteine (diAC RCAN

GSH

- Cys)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 22 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

42 Potato (45307303) diacetyl S,Sʹ

- (trichloro

- thioanisole) diglutathione (diAC RCTA

diGluCys)

43 Potato peel (41562903) Tetrachloronitrophenol (TCNP)

44 potato peel (41562903) Tetrachlorophenol (TCP)

45 peanut roots (41562902) Tetrachloroaniline (TCA)

46 goat urine (41692805) Pentachloroaniline sulfamate

47 Rotational crops: turnip top, turnip root, lettuce, wheat forage, wheat straw (44577501) C5SA pentachlorobenzenesulfonic acid

48 goat liver (41692805) goat kidney (41692805) chicken excreta (41692801) chicken liver (41692801) egg yolk (41692801) Pentachlorothiophenol (PCTP)

49 cabbage leaves (41562904) chicken liver (41692801) Rotational crops: turnip top, turnip root, wheat forage, wheat straw (44577501) Pentachlorothioanisole sulfoxide (PCTA sulfoxide) (PCTASO) (C5MX)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 23 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

50 goat kidney (41692805) chicken fat (41692801) Tetrachlorothioanisole (TCTA)

51 cabbage leaves (41562904) Rotational crops: wheat straw (44577501) Tetrachlorophenyl methyl sulfoxide (TCPM sulfoxide) (C4MX)

52 cabbage leaves (41562904) chicken kidney (41692801) chicken thigh (41692801) Rotational Crops: turnip top, turnip root, lettuce (44577501) Tetrachlorophenyl methyl sulfone (TCPM sulfone) (TCTASOO) (C4MS) (TCP methyl sulfone)

53 cabbage (41562904) Rotational crops: turnip top, turnip root, lettuce, wheat forage, wheat straw (44577501) Trichlorophenyl methyl sulfone (RCPM sulfone) (C3MS)

54 cabbage leaves (41562904) Trichlorophenol methyl sulfone (RCHM sulfone)

55 goat liver (41692805) goat kidney (41692805) goat urine (41692805) Tetrachloro (methylthio) thiophenol (TCTP S

- Met)

56 goat liver (41692805) Pentachlorothiophenol dimer (PCTP dimer)

57 potato callus and peel (41562903) goat urine (41692805) Pentachlorothiophenyl conjugate (PCTP

- X)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 24 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

58 chicken excreta (41692801) chicken kidney (41692801) chicken liver (41692801) chicken thigh (41692801) S

- (pentachlorophenyl) thioacetate

59 chicken excreta (41692801) S

- (pentachlorophenyl) thiopyruvate

60 whole potato, callus, and peel (41562903) chicken kidney (41692801) S

- (pentachlorophenyl) cysteine (PCP

- Cys)

61 peanut roots (41562902) S

- [(methylthio)tetrachlorophenyl]

- 2

- thioacetic acid (MTCP

- TAA)

62 potato callus and peel (41562903) Pentachlorothiophenyl glycoside (PCTP

- Gly)

63 potato callus and peel (41562903) Pentachlorophenol glycoside (PCP

Gly)

64 goat liver (41692805) goat kidney (41692805) N

- (pentachloroaniline) glucuronide (PCA

- Gluc)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 25 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

65 Rotational Crops: turnip top, turnip root (44577501)

Pentachlorophenol (PCP)

66 Rotational crops: turnip top, turnip root, lettuce, wheat forage, wheat straw (44577501) tetrachlorobenzenesulfonic acid

(C4SA)

67 Rotational crops: turnip top, turnip root, wheat forage, wheat straw (44577501) C3SA
trichlorobenzenesulfonic acid

68 Rotational crops: turnip top, turnip root, wheat forage (44577501) C2SA

dichlorobenzenesulfonic acid

69 Rotational crops: wheat forage, wheat straw (44577501) C4MXSA

tetrachlorosulfophenyl methyl
sulfoxide

(tetrachlorothioanisole sulfoxide, sulfonic acid)

70 Rotational crops: wheat straw (44577501) C3MXSA

trichlorosulfophenyl methyl sulfoxide

(trichlorothioanisole sulfoxide, sulfonic acid)

71 Rotational crops: wheat straw (44577501) C4MSSA

tetrachlorosulfophenyl methyl
sulfone

(tetrachlorothioanisole sulfone, sulfonic acid)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 26 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

72 Rotational crops: turnip top, turnip root, wheat forage, wheat straw (44577501) C3MSSA

trichlorosulfophenyl methyl sulfone

(trichlorothioanisole sulfone, sulfonic acid)

73 Rotational crops: wheat straw (44577501) C2MSSA

dichlorosulfophenyl methyl sulfone

(dichlorothioanisole, sulfonic acid)

74 Rotational crops: wheat forage, wheat straw (44577501) C3SANH

trichlorosulfanilic acid

75 Rotational crops: wheat forage (44577501) C3SAOH

hydroxy

- trichlorobenzene sulfonic
acid

(trichloro

- hydroxybenzene sulfonic acid)

76 Rotational crops: lettuce, wheat forage, wheat straw (44577501) C4MeAcCy

N

- {1

- methyl

- 2[(tetrachlorophenyl)

- thio]ethyl}acetamide

(tetrachlorophenyl methyl cysteine)

77 Rotational crops: lettuce, wheat forage (44577501) C4MaCyFCy

S

- (tetrachlorophenyl)

- N

malonylcysteine

- S’

- formylcysteine

78 Rotational crops: wheat forage (44577501) C5SAHx b

pentachlorobenzenesulfonic acid
hexose esterPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 27 of 55 Table A.1.3. A compiled list of all metabolites of PCNB found in plant metabolism, animal metabolism, rotational crops, water, and rat (toxic ity ) studies. 1

79 Rotational crops: wheat forage (44577501) C4CyCy

S,S’

- tetrachlorophenyl dicysteine

80 Rotational crops: lettuce (44577501) C4CyFCy

S

- (tetrachlorophenyl)

- cysteine

- S’

- formylcysteine

81 Rotational crops: turnip root, lettuce (44577501) C3MSMaCy

N

- malonyl

- S

- trichloro

- (methylsulfonophenyl)

- L

- cysteine

S

- (trichlorophenyl methyl sulfone)

- malonyl cysteine

82 Rotational crops: turnip top, turnip root (44577501) C2MSMaCy

N

- malonyl

- S

- dichloro

- (methylsulfonophenyl)

- L

- cysteine

S

- (dichlorophenyl methyl sulfone)

- malonyl cysteine

83 Goat liver (41692805) glucuronide of NOHPCA (NOHPCA

- Gluc)

84 Water (minor degradate) pentachlorothioanisole sulfone (PCTASO2)

1 Memo, M. Sahafeyan et al. , April 8, 2003; D291353.Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 28 of 55 

### Attachment 2: PCNB A cute, Subchronic, and Chronic Toxicity Profile

.

Table A. 2

. 1 . Acute Toxicity for PCNB (Amvac)

Guideline No. Study Type MRIDs # Results Toxicity Category

870.1100 Acute Oral 41443101 LD 50 

### = >5050 mg/kg IV

870.1200 Acute Dermal 41443102 LD 50 

### = >2020 mg/kg III

870.1300 Acute Inhalation 41443103 LC 50 

### = > 6.49 mg/L III

870.2400 Primary Eye Irritation 41443104 Slight irritant III

870.2500 Primary Skin Irritation 41443105 Non irritant IV

870.2600 Dermal Sensitization 45236401
40734001 Sensitizer

Non

- sensitizer

Table A.2. 2 PCNB Subchronic, Chronic and Other Toxicity Profile Guideline No./ Study Type MRID No. (year)/

Classification
/Doses Results

870.3100
90

- Day Oral Toxicity in

Rats 42630801 (1993 ) Supplementary 0, 20, 60 00 ppm in diet [equivalent to 0, 1, 333 mg/kg/d (males only)] NOAEL = not determined LOAEL = 1 mg/kg/day based on liver and thyroid hypertrophy.

870.3100
90

- Day Oral Toxicity in

Rats 42630801 (1992 ) Acceptable/ non

guideline 0, 5, 10, 100 or 1000 mg/kg/d via gavage NOAEL = 100 mg/kg/day LOAEL = 1000 mg/kg/day based on increased relative liver weight and histopathological changes in the liver
and th yroid.

870.3150
90

- Day Oral Toxicity in
mice 45609101 (1987) Acceptable/guideline 1250ppm (males), 2500,
5000 10000 and 20000 ppm (males and females)

M: 225, 450, 900, 1800 and 3600 mg/kg/day F: 488, 975, 1950 and 3900 mg/kg/day NOAEL = 1250ppm (225 mg/kg/day) for males and 2500 ppm (488 mg/kg/day) for females

LOAEL = 2500ppm (450 mg/kg/day) for males and 5000ppm (975 mg/kg/day) for females based on increased absolute and relative liver weights

870.3200
21/28

- Day Dermal Toxicity

- rat 42416002 (1992) Acceptable/non

guideline 0, 100, 300 and 1000 mg/kg/day NOAEL = 300 mg/kg/day LOAEL = 1000 mg/kg/day based on the increased incidences of dilation of the thyroid follicles and hypertrophy of the thyroid follicular epithelium in males. No reported treatment

- related effects in females.Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 29 of 55 

### Table A.2. 2 PCNB Subchronic, Chronic and Other Toxicity Profile Guideline No./ Study Type MRID No. (year)/

Classification
/Doses Results

870.3250
90

- Day Dermal Toxicity

rabbits 42413901 (1992)
Core minimum 0, 30, 300 and 1000 mg/kg/day NOAEL = 1000 mg/kg/day (HDT)
LOAEL = Not determined

870.3465
90

- Day Inhalation Toxicity Not available

870.3700a

Pr enatal developmental in

rats 40588601 (1988)
Guideline 0, 30, 600 and 1200 mg/kg/day via gavage Maternal NOAEL = 1200 mg/kg/day (HDT)
Maternal LOA EL = not determined

Developmental NOAEL = 1200 mg/kg/day (HDT) Developmental LOA EL = not determined

870.3700b

Prena tal developmental in
rabbits 40717102 (1988)
Core minimum 0, 6.25, 12.5, 125 and 250 mg/kg/day via

gavage Maternal NOAEL = 12.5 mg/kg/day
Maternal LOA EL = 125 mg/kg/day based on decreased maternal body weight

Developmenta l NOAEL = 125 mg/k g/day Developmental LOA EL = 250 mg/kg/day based on decreased fetal body weight

870.3700b

Prena tal developmental in
rabbits 41361301 (1989) Supplementary 0, 100, 300 and 900 mg/kg/day via gavage Maternal NOAEL = 300 mg/kg/day
Maternal LOA EL = 900 mg/kg/day based on clinical signs of toxicity, decreased food consumption, abortions and premature delivery

Developmenta l NOAEL = 900 mg/kg/day (HDT) Developmental LOA EL = not determined

870.3800 Reproduction and Fertility
Effects

- 2

- generation rat 41918701 (1991)
Core minimum 0, 1.2, 169 and 344 mg/kg/day in males and 0, 1.5, 218 and 455 in
females Parental/Systemic NOAEL = 1.2 mg/kg/day
LOAEL = 169 mg/kg/day based on decreased body weight

Reproductive / Offspring NOAEL = 1.2 mg/kg/day
LOAEL = 169 m g/kg/day based on decreased mean pup weights

870.3800 Reproduction and Fertility
Effects

- 2

- generation rat 43469301
43469302 43469303 (1994) Acceptable 0, 10, 100 and 1000 mg/kg/day Parental/Systemic NOAEL = 10 mg/kg/day for males
and 100 mg/kg/day for females Parental/Systemic LOAEL = 100 mg/kg/day for males
and 1000 mg/kg/day for females based on increases in hepatocellular hypertrophy and thyroid follicular cell hypertrophy/hyperplasia

Reproductive / Offspring NOAEL = 1000 mg/kg/day Reproductive / Offspring LOAEL = not determined

870.4100a Chronic Toxicity

- 2yr rat See combined chronic toxicity/carcinogenicity study below

870.4100b Chronic toxicity ( 1yr

- dog) 41718600 and 41718601 (1993) Acceptable/guideline 0, 15, 150 and 1500 ppm (equivalent to 0, 0.375,
3.75 and 37.5 mg/kg/day) NOAEL = 3.75 mg/kg/day LOAEL = 37.5 mg/k g/day based on increased serum ALP and cholesterol, increased liver weight and hepatocellular hypertrophy.Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 30 of 55 

### Table A.2. 2 PCNB Subchronic, Chronic and Other Toxicity Profile Guideline No./ Study Type MRID No. (year)/

Classification
/Doses Results

870.4200a Carcinogenicity

- 2yr rat See combined chronic toxicity/carcinogenicity study below

870.4200b Carcinogenicity (mouse) 45609101 (1987) 0, 400 and 1000 mg/kg/day for males and 0, 600 and 1400 mg/kg/day for females NOAEL = 1400 mg/kg/day
LOAEL = not determined
No evidence of carcinogenicity

. De creased survival
due to infection was noted.

870.4300
Combined Chronic Toxicity/Carcinogenicity

2yr rat 41987301 (1991) Acceptable/Guideline 0, 1, 150, 300 mg/kg/day
in the diet NOAEL = 1 mg/kg/day
LOA EL = 150 mg/kg/day based on an increase in hepatocellular hypertrophy, hepatocellular hyperplasia, thyroid hypertrophy & hyperplasia, increase in thyroid
follicular cell adenomas & carcinomas.

870.4300
Combined Chronic Toxicity/Carcinogenicity

2yr rat 43015801 (199 3 ) Acceptable/Guideline 0, 3.6, 36, 357 and 714 mg/kg/day via gavage NOAEL = 3.6 mg/kg/day for males and 36 mg/kg/day
for females
LOA EL = 36 mg/kg/day for males and 357 mg/kg/day
for females based on hepatocellular hypertrophy & the thyroid follicular cell h ypertrophy/hyperplasia. Negative for neoplasia.

870. 5265
Gene mutation

- Ames assay 45609101 (1987) Acceptable/guideline 0, 100, 333, 1000, 3333, 6667 μg/plate (±S9) Non

- mutagenic when tested up to 6667 ug/plate, in presence and absence of activation, in S. typhimurium strains TA98, TA100, TA1535 and TA1537.

870.5300
Mammalian cell mutation

assay 45609101 (1987) Acceptable/guideline 0, 1.25, 2.50, 5.0, 7.5

and 10.00  g/mL (±S9) Non

- mutagenic at the TK locus in L5178Y mouse lymphoma cell s in presence and absence of S

- 9
activation.

870.5375 Mammalian Cytogenetics Assay (CHO

- K1 Cells) 45609101 (1987) Acceptable/guideline 2.4, 7.5, 24 and 75

 g/mL Did not induce structural chromosome aberration in
CHO

- K1 cell cultures in the presence and absence of
activatio n

.

870.6200a Acute Neurotoxicity Screening Battery Not available.

870.6200b Subchronic Neurotoxicity Screening Battery Not available.

870.6300 Developmental Neurotoxicity Not available.

870.7485
Metabolism and
Pharmacokinetics

- rats 248286 (1981) Unacceptable Single oral dose of 5mg/kg The majority of the dose was excreted in feces (81% feces and 5% urine after 3 days). Females excreted higher proportion of dose in urine than males.

870.7485
Metabolism and
Pharmacokinetics

- monkeys 114233 (1979)
248286 Unacceptable Single oral dose of 2 mg/kg to 6 males and 2
females Half

- life was approximately 1.5 to 1.7 days. After 14 days, 85% of dose was accounted for in urine and feces.Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 31 of 55 

### Table A.2. 2 PCNB Subchronic, Chronic and Other Toxicity Profile Guideline No./ Study Type MRID No. (year)/

Classification
/Doses Results

870.7600 Dermal penetration 156046 (1986) Unacceptable

Dermal pads were placed on workers (2

- 3 per scenario) using
TERRACLOR for seed planting, vegetable transplanting or turf spraying. Total exposure to workers wearing long sleeves and gloves was between 0.03 and 8.46 mg/kg/day

870.7800 Immunotoxicity Not available.Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 32 of 55 

### Attachment 3: Summary of Toxicological Doses and Endpoints for PCNB (from 20 0 5 Risk Assessment)

.

Table A.3.1 Summary of Toxicological Do ses and Endpoints for PCNB for Use in Dietary and Non

- Occupational
Human Health Risk Assessments

Exposure/
Scenario Point of

Departure (mg/kg/day) Uncertainty/

FQPA Safety
Factors RfD, PAD, Level of

Concern for Risk
Assessment Study and Toxicological Effects

Acute Dietary No appropriate endpoint attributed to a single dose was identified. Therefore, an acute RfD was not

established.

Chronic Dietary NOAEL =
1.0 UF A = 10 x

UF H = 10 x FQPA SF= 10 x Chronic RfD = 0.01

mg/kg/day
cPAD 1 = 0.001 mg/kg/day Combined chronic toxicity/carcinogenicity study in rats
MRID# 41987301
Systemic toxicity LOAEL = 150 mg/kg/day, based on hepatocellular hypertrophy, hepatocellular hyperplasia (females) and thyroid hypertrophy and hyperplasia.

Incidental Oral, Short (1

- 30 days)

- Term NOAEL=

1.0 UF A = 10 x

UF H = 10 x FQPA SF= 10 x LOC for residential

MOE = 1000 Nonguideline 90

- day subchronic oral toxicity study in male rats
MRID# 42630801
Based on thyroid follicular epithelial hypertrophy observed at 333 (LOAEL) after 14 & 30 days.

Incidental Oral, Intermediate (1

- 6 months)

- term NOAEL= <

1.0 UF A = 10 x

UF H = 10 x FQPA SF= 10 x LOC for residential

MOE = 1000 Nonguideline 90

- day subchronic oral toxicity study in male rats
MRID# 42630801
LOAEL is 1.0 mg/kg/day based on liver & thyroid hypertrophy at 90

days.

Dermal, Short (1

- 30 days)

- & Intermediate (1

- 6 months)

- Term NOAEL =

300 UF A = 10 x

UF H = 10 x FQPA SF= 10 x LOC for residential

MOE = 1000

LOC for occupational
MOE = 100 21

- Day dermal toxicity study in male
and female rats
MRID# 42416002
LOAEL is 1000 mg/kg/day based on hypertrophy of the thyroid follicular epithelium and dilation of the thyroid follicles in males only.

Dermal, Long

Term (6 months to
life

- time)

Absorption factor
33% used for
conversion from
oral to dermal

route NOAEL =

1.0 UF A = 10 x

UF H = 10 x FQPA SF= 10 x LOC for residential

MOE = 1000

LOC for occupational
MOE = 100 Chronic toxicity/carcinogenicity study in rats
MRID# 41987301
Systemic toxicity LOAEL = 150 mg/kg/day, based on hepatocellular hypertrophy, hepatocellular hyperplasia (females) and thyroid hypertrophy and hyperplasia.

Inhalation, Short (1

- 30 days)

- Term NOAEL=
1.0 UF A = 10 x

UF H = 10 x FQPA SF= 10 x LOC for residential

MOE = 1000 LOC for occupational
MOE = 100 Nonguideline 90

- day subchronic oral toxicity study in male rats
MRID# 42630801Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 33 of 55 Table A.3.1 Summary of Toxicological Do ses and Endpoints for PCNB for Use in Dietary and Non

- Occupational
Human Health Risk Assessments

Exposure/
Scenario Point of

Departure (mg/kg/day) Uncertainty/

FQPA Safety
Factors RfD, PAD, Level of

Concern for Risk
Assessment Study and Toxicological Effects

Based on thyroid follicular epithelial hypertrophy observed at 333 (LOAEL) after 14 & 30 days.

Inhalation, Intermediate (1

- 6 months)

- Term NOAEL= <
1.0 UF A = 10 x

UF H = 10 x FQPA SF= 10 x LOC for residential

MOE = 1000 LOC for occupational
MOE = 100 Nonguideline 90

- day subchronic oral toxicity study in male rats
MRID# 42630801
LOAEL is 1.0 mg/kg/day based on liver & thyroid hypertrophy at 90

days.

Inhalation, Long

Term (6 months to
life

- time) NOAEL =

1.0 UF A = 10 x

UF H = 10 x FQPA SF= 10 x LOC for residential

MOE = 1000 LOC for occupational
MOE = 100 Chronic toxicity/carcinogenicity study in rats
MRID# 41987301
Systemic toxicity LOAEL = 150 mg/kg/day, based on hepatocellular hypertrophy, hepatocellular hyperplasia (females) and thyroid hypertrophy and hyperplasia.

Cancer Group C

- Possible human carcinogen. Combined incidence of thyroid follicular cell adenomas &

carcinomas significantly increased in male but not female rats, with a significant trend in both sexes.

Q 1 * not calculated (not required)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 34 of 55 

### Attachment 4: Summary of Residues of Concern for PCNB

.

Table A.4. Summary of Residues of Concern for PCNB 1

Chemical: PCNB (pentachloronitrobenzene)

Date: 16

- April

- 2003
Residues of Concern 2

Matrix For Risk Assessment For Tolerance Expression

Plants

- Primary crops Parent plus all identified
metabolites Parent, PCA, PCTA

Plants

- Rotational crops Parent plus all identified
metabolites Parent, PCA, PCTA

Livestock

- Ruminant Parent plus all identified
metabolites Parent, PCA, PCTA

Livestock

- Poultry Parent plus all identified
metabolites Parent, PCA, PCTA

Water Parent, PCA, and PCP N/A

1 Table from Memo, M. Sahafeyan et al. , May 27, 2003; TXR NO. 0051921.

2 PCA = pentachloraniline; PCTA = pentachlorothioisole or methyl pentachlorophenyl sulfide; PCP = pentachlorophenol.Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 35 of 55 

### Attachment 5 : PCNB International Residue Limit Status Sheet.

Pentachloronitrobenzene (PC Code 056502) Summary of US and International Tolerances and Maximum Residue Limits. Residue Definition :
US Canada Mexico 1 Codex 40 CFR §180. 291 (a) Primary Crops: the combined residues of the fungicide pentachloronitrobenzene (PCNB) and its metabolites pentachloroaniline (PCA), and pentachlorothioanisole (PCTA) None None

Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico 1 Codex

Bean 0.1

Brassica , head and stem, subgroup
5A 0.1

Cotton, undelinted seed 0.1 Garlic, bulb 0.1

Peanut 1

Potato 0.1 Soybean, forage 0.02 Soybean, hay 0.02 Soybean, seed 0.02 Vegetable, fruiting, group 8 0.1 Completed: M. Negussie; 01/19/16

1 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.



### (c) Tolerances with regional registrations. Tolerances with regional registrations, as defined in §180.1(l), are established for the combined residues of the fungicide pentachloronitrobenzene (PCNB) and its metabolites pentachloroaniline (PCA), and pentac hlorothioanisole (PCTA), in or on the following food commodities:

Commodity Parts per million
Collards 0.2
Kale 0.2 Mustard, greens 0.2Page 36 of 55 

### Attachment 6 : Summary of Registered Uses for PCNB

Table A.6.1 . Proposed Use Patterns and Formulations Assessed

Formulation Use Sites Application Equipment PCNB Max

Application Rates (lbs ai/A) Max rate per

crop season (lb ai/A) REI Application directions 2

Flowable
5481

- 8992 Golf Courses groundboom 32.67 66 N/A At first sign of disease (foliar application) Do not mix/load more than 150 gallons of product per day

Athletic fields groundboom 32.67 66 N/A Applications are limited to Fall and Winter months for pink and grey snow mold, no more than 3 applications per season (Oct

Mar) with 14 day application intervals; treated area must be irrigated with 1⁄4 inch of water and left idle for at least 2 days after application. For all Non

- Residential Turf use applications, Mix ers and Loaders cannot handle more than 150 gallons product per day (equivalent to 600 lbs. A.I. /day).

Sod Farms groundboom 32.67 66 N/A For Sod farm applications, applicators cannot handle more than 425 gallons of product per day (equivalent to 1,700 lbs. A.I. /day).

Woody plants Groundboom,

chemigation, manually

pressurized handwand, backpack sprayer, mechanically

pressurized handgun

sprayer 40.8

(0.00375 lbs ai/gallon) N/S 12 Soil drench, bed, bench, container, and field

grown plants. Use of any hand

- held application equipment is prohibited except for greenhouse use. 

### Groundboom applicators cannot handle more than 425 gallons of product per day (equivalent to 1,700 lbs. A.I. /day). Groundboom and chemigation applications: mixers/loaders cannot
hand le more than 190 gallons of product per day (equivalent to 760 lbs. A.I. /day).

Groundboom 114 Broadcast incorporatedPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 37 of 55 Table A.6.1 . Proposed Use Patterns and Formulations Assessed

Formulation Use Sites Application Equipment PCNB Max

Application Rates (lbs ai/A) Max rate per

crop season (lb ai/A) REI Application directions 2

Bulb soak (gladiolus, hyacinth, iris, narcissus, tulip) Mixer/Loader Liquids 0.468 Lbs ai/gallon N/S 12 Soak bulbs for 5 minutes Use of any hand

- held application equipment is prohibited except for greenhouse use.

Bulb soak (lilies) Mixer/Loader Liquids 0.045 Lbs ai/gallon N/S 12 Soak bulbs for 5 to 15 minutes Use of any hand

- held application equipment is prohibited except for greenhouse use.

Southern magnolia

trees Airblast, chemigation,

manually

- pressurized handwand, backpack sprayer, mechanically

pressurized handgun

sprayer 32.67 N/S

12 Foliar spray application; Apply 4 sprays are
2 week intervals 

### Airblast application may be used on Southern Magnolia Trees, applicators cannot handle more than 4.5 gallons of product per day (18 lbs. A.I. /day). Groundboom applicators cannot handle more than 425 gallons of product per day (equivalent to 1,700 lbs. A.I. /day). Groundboom, airb last, and chemigation applications: mixers/loaders cannot handle more than 190 gallons of product per day (equivalent to 760 lbs. A.I. /day). Soil drench mixer/loader/applicators cannot handle more than 0.42 gallons product per day (equivalent to 1.68 lbs. A.I. /day).

Southern Pine
seed or seedlings Groundboom,

chemigation 43.56 N/S Broadcast prior to planting 

### Groundboom applicators cannot handle more than 425 gallons of product per day (equivalent to 1,700 lbs. A.I. /day). Groundboom, airblast, and chemigation applications: mixers/loaders cannot handle more than 190 gallons of product per day (equivalent to 760 lbs. A.I. /day).Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 38 of 55 Table A.6.1 . Proposed Use Patterns and Formulations Assessed

Formulation Use Sites Application Equipment PCNB Max

Application Rates (lbs ai/A) Max rate per

crop season (lb ai/A) REI Application directions 2

Vegetable bedding plants
Container grown (cole

crops,
peppers, tomatoes) Groundboom,

chemigation, manually

pressurized han dwand, backpack sprayer, mechanically

pressurized handgun

sprayer 20.4 20.4

12 Soil drench applications in the nursery or greenhouse to seedlings grown in containers or beds prior to transplanting into the field; do not exceed 22.5 lbs ai/A in any one season Use of any hand

- held application equipment is prohibited except for greenhouse use. For 

### Groundboom applicators cannot handle more than 425 gallons of product per day (equivalent to 1,700 lbs. A.I. /day). Groundboom, airblast, and chemigation applications: mixers/loaders cannot handle more than 190 gallons of product per day (equivalent to 760 lbs. A.I. /day). For Vegetable Bedding Plants, applicators cannot handle more than 1 pint product per 1000 square feet (equivalent to 20.4 lbs. A.I. /Acr e) per

season. Soil drench mixer/loader/applicators cannot handle more than 0.42 gallons product per day (equivalent to 1.68 lbs. A.I. /day). Cole Crops (Broccoli*,
Brussels Sprouts*, Cabbage*,
Chinese Broccoli*, groundboom 22.5 22.5 Pre

- plant, soil

- directed For Cole Crop applications, Mixers and Loaders cannot handle more than 150 gallons product per day (equivalent to 600 lbs. A.I. /day). Applicato rs cannot apply more than 337 gallons of product per day (1,350 lbs. A.I. /day)Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 39 of 55 Table A.6.1 . Proposed Use Patterns and Formulations Assessed

Formulation Use Sites Application Equipment PCNB Max

Application Rates (lbs ai/A) Max rate per

crop season (lb ai/A) REI Application directions 2

Cauliflower*,
Chinese Cabbage* (tightheaded
varieties only), Collards*, Kale*,
Mustard Greens*) Groundboom,

manually

- pressurized handwand, backpack sprayer, mechanically

pressurized handgun

sprayer 1.5

0.015 lbs ai./gallon Transplant Solution: Use a maximum of 0.75 pints of solution per plant; do not exceed 22.5 lbs ai/A in any one season Use of any hand

- held application equipment is prohibited except for greenhouse use.

Beans (Dry,

snap, or succulent) Groundboom 1.5 10 Band row treatment; do not exceed 10 lbs ai/A in any one season

Beans (Dry or snap) Groundboom 2 10 Band row treatment; ; do not exceed 10 lbs ai/A in any one season

Garlic Groundboom 20 20 In furrow; ; do not exceed 20 lbs ai/A in any

one season For Garlic and Peanut applications,
mixers/loaders cannot handle more than 190 gallons of product per day (equivalent to 760 lbs. A.I. /day).

Pepper/

Tomato Groundboom;

manually

- pressurized handwand, backpack sprayer, mechanically

pressurized handgun

sprayer 0.0375 lbs ai/gallon

7.5 12 Transplanting; do not exceed 7.5 lbs ai/A in

any one season 

### For Peppers and Tomatoes, mixers/loaders/applicators cannot handle more than 0.42 gallons product per day (equivalent to 1.68 lbs. A.I. /day).

Groundboom 7.5 In

- furrow; do not exceed 7.5 lbs ai/A in any

one seasonPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 40 of 55 Table A.6.1 . Proposed Use Patterns and Formulations Assessed

Formulation Use Sites Application Equipment PCNB Max

Application Rates (lbs ai/A) Max rate per

crop season (lb ai/A) REI Application directions 2

Peanut Groundboom 2

10 Pre

- plant soil mix; application can be made simultaneously with planting; do not exceed 10 lbs ai/A in any one season For Garlic and Peanut applications,
mixers/loaders cannot handle more than 190 gallons of product per day (equivalent to 760 lbs. A.I. /day).

Groundboom 10 At pegging bands; do not exceed 10 lbs ai/A in any one season

Groundboom 3.25 At cultivation; do not exceed 20 lbs ai/A in

any one season

Potato Groundboom 5

5 Band application; do not exceed 5 lbs ai/A in

any one season

Chemigation 2.5 Foliar use through chemigation; do not exceed 5 lbs ai/A per year. For Chemigation applications to potatoes,
Mixers and Loaders cannot handle more than 150 gallons of product per day (equivalent to 600 lbs. A.I. /day).

Cotton Groundboom 2 2 In

- furrow; do not exceed 2 lbs ai/A in any

one season Liquid (EPA Reg
No. 5481

- 585) Golf Courses Groundboom 16.43 43.56 N/A Mixers and Loaders cannot handle more than 150 gallons of product per day (equivalent to 601 lbs. AI of PCNB/day). Use of any hand

held application equipment is prohibited.

Liquid (EPA Reg
No. 19713

- 312) Lawns and

Ornamental
Turf Ground and handheld

equipment 21.7

N/S N/A Apply with sprinkler can, hand sprayer, or

any other convenient method of obtaining even coverage. Then, lightly water the
treated area to insure movement of the chemical through the grass to the soil level.
Retreat the area 3

- 4 weeks later if it has been subjected to unusually heavy rainfall, or
is flooded, or if the disease is severe or

reappears. Ornamentals (Azaleas and Camellias) Soil Drench 217.7Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 41 of 55 Table A.6.1 . Proposed Use Patterns and Formulations Assessed

Formulation Use Sites Application Equipment PCNB Max

Application Rates (lbs ai/A) Max rate per

crop season (lb ai/A) REI Application directions 2

GRANULAR

Granules (10% ai)
5481

- 8988 Sod Farms spreader 43.56 87.12 For Sod farm applications, Mixers/loaders cannot handle more than 23,000 Ibs. of product per day (equivalent to 2,300 Ibs. A.I. /day), Applicators cannot handle more than 26,000 Ibs. of product per day (equivalent to 2,600 Ibs. A.I. /day).

Golf Courses spreader 43.56 87.12 Apply on application in the spring or at sign
of first disease; immediately irrigate with 1⁄4
inch water

College and professional
athletic fields spreader 32.67 66 Make application prior to first snowfall or in the absence of snow cover; apply at 4 to 6 week intervals; treated areas much be irrigated with 1⁄4 inch of water on day of application

Woody
Ornamentals Spreader

handheld equipment (only for growing media mix) 65.34

12
hours For Woody Ornamentals: Mixers/loaders cannot handle more than 23,000 Ibs. of product per day (equivalent to 2,300 Ibs. A .I. /day), Granular spreader applicators cannot handle more than 26,000 Ibs. of product per day (equivalent to 2,600 Ibs. A.I. /day), Backpack applicators cannot handle more than 1,300 Ibs. of product per day (equivalent to 130 Ibs. A.I. /day)
GROWING MED IA MIX: Mix 1 to 1.5 Ibs. of product per cubic yard of media. To prevent agglomeration, ensure that ingredients are dry and free of large bumps. Blend thoroughly to ensure uniform distribution throughout the mixture. Use the
lower rate for mixtures used at the time of seeding or transplanting of young seedlings or plugs. Use the higher rate for older plants or nursery stock. Do not mix more than 1 0 cubic yards of media mix /day. 87.12

0.15 (lbs ai/cubic yard media) N/SPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 42 of 55 Table A.6.1 . Proposed Use Patterns and Formulations Assessed

Formulation Use Sites Application Equipment PCNB Max

Application Rates (lbs ai/A) Max rate per

crop season (lb ai/A) REI Application directions 2

Vegetable bedding plants
Container grown (beans. cole crops,

peppers, tomatoes) Spreader 0.15 (lbs ai/cubic yard media) N/S Mixers and Loaders cannot handle more than 23,000 Ibs. of product/day (equivalent to 2,300 Ibs. A.I. /day). Applicators using granular spreader equip ment for broadcast and band applications cannot handle more than 26,000 Ibs. of product/day (equivalent to 2,600 Ibs. A.I. /day). Backpack applicators cannot handle more than 1,300 Ibs. of product per day (equivalent to 130 Ibs. A.I. /day)
GROWING MEDIA MI X: Mix 1 to 1.5 Ibs. of product per cubic yard of media. To prevent agglomeration, ensure that ingredients are dry and free of large bumps. Blend thoroughly to ensure uniform distribution throughout the mixture. Use the
lower rate for mixtures used at the time of seeding or transplanting of young seedlings or plugs. Use the higher rate for older plants or nursery stock. Do not mix more than 1 0 cubic yards of media mix /day.

Cole crops (cabbage, cauliflower,
Brussels
sprouts, broccoli, collards, kale, mustard) Tractor drawn spreader 22.5 Pre

- plant transplant row treatment; apply in a
12

- 15 inch band
BROADCAST TREATMENT: Broadcast application to soil surface prior to planting; including Band Row Treatment for
cauliflower BAND TREATMENT: Apply in an 8

- i nch wide band centered on the row immediately before planting. Mix granules into soil before planting to a depth of 2 inches. 22.5

Peppers Tractor drawn spreader 4.4 In furrow application at time of planting; apply to the soil around the seed and to the covering soil as it fills the furrowPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 43 of 55 Table A.6.1 . Proposed Use Patterns and Formulations Assessed

Formulation Use Sites Application Equipment PCNB Max

Application Rates (lbs ai/A) Max rate per

crop season (lb ai/A) REI Application directions 2

Potato Tractor drawn spreader 2.54 IN

- FURROW BAND TREATMENT: Apply
in a 8.5

- inch band with 34" row spacing. Direct the product into the furrow over the seed and cover as part of the hilling operation during planting. It is best to apply when the soil is slightly moist. Do not harvest within 45 days of application.

Beans (Bush beans) Tractor drawn spreader 4.36 APPLY AS AN IN

- FURROW SOIL BAND TREATMENT. Apply in a 12 to 15

- inch band. Apply over the seed at planting time in the furrow and immediately cover with soil utilizing appropriate application equipment.
Do not feed treated vines to livestock. Beans (Pole beans) Tractor drawn spreader 8.71

Peanuts Tractor drawn spreader 9.98

Do not
exceed 10 Ibs. A.I. /A per

season regardless of
the application
methods used. IN

- FURROW: Apply in a 12 to 15

- inch band. Apply in furrow at planting using suitable equipment.

4.36 AS A SOIL MIX DURING CULTIVATION

- Turfcide 10% Granular may be applied in two applications with the first application made at pegging (approximately 60 days after planting) and the second made approximately 30 days later. Apply at the rate of 14 Ibs. / 12,400 linear feet of row in a
12

- inch band. Do not apply more than 28 Ibs.

o f product per 12,400 feet of row in one year. Apply by attaching two delivery tubes per row (or bed if two rows per bed) and adjust
so as to treat a total band of 12

- inches wide centered on the row. Lightly incorporate to move the product into the soil. D o not pile untreated soil on crown of plant.Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 44 of 55 Table A.6.1 . Proposed Use Patterns and Formulations Assessed

Formulation Use Sites Application Equipment PCNB Max

Application Rates (lbs ai/A) Max rate per

crop season (lb ai/A) REI Application directions 2

Cotton Tractor drawn spreader 2 N/S IN

- FURROW SOIL TREATMENT: Apply
in a 12 to 15

- inch band with 40" row spacing. Apply over the seed and immediately cover with soil at planting time.
Do not allow livestock to graze or feed on cotton foliage in treated fields.

Granular (EPA Reg
No. 100

- 823) Beans

Ground application Aerial not prohibited handheld not prohibted 3.3 N/S

48
hours Cotton 1 N/S

Peanuts 5 7.5 Do not apply more than 75 Ibs. of :Ridomil Gold PC GR per 14,520 linear ft. of row per season. (3) Do not apply within 75 days of
harvest.

Granular (EPA Reg
No. 9198

- 183) Golf Course Tractor drawn equipment only 43.5 87 12 N/A Apply one application in the spring or at first
indication of disease If disease is severe or reappears retreat 3 to 4 weeks later After application immediately irrigate with' 1/4 inch water Mowing may not occur in treated area until one day after application

Granular (EPA Reg
No. 9198

- 227) Golf Course Tractor drawn equipm ent only 21.8 87.12 N/A Do not make more than one application at the HIGH rate (291 Ibs. product/acre) per season except for golf course greens and tees. Repeat applications at the HIGH rate on greens and tees must not be made sooner than 14 days. Repeat applications at the LOW rate (145 Ibs. product/acre) per season must not be made sooner than 7 days. *Single applications must not exceed 43.56 Ibs. ai/A, and total seasonal applications
must not exceed 87.12 Ibs. ai/A.

Granular (EPA Reg
No. 10404

- 37) Tur f Ground application Aerial not prohibited handheld not prohibted 32.67 N/S N/A NOT FOR USE on turf being grown for sale or other commercial use as sod, or for commercial seed production or for research

purposes. Chemigation prohibitedPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 45 of 55 Table A.6.1 . Proposed Use Patterns and Formulations Assessed

Formulation Use Sites Application Equipment PCNB Max

Application Rates (lbs ai/A) Max rate per

crop season (lb ai/A) REI Application directions 2

Granular (EPA Reg
No. 34704

- 1087) Golf courses Tractor drawn equipment only 43.5 87 12 N/A Apply one application in the spring or at first
indication of disease If disease is severe or reappears retreat 3 to 4 weeks later After application immediately irrigate with' 1/4
in ch water Mowing may not occur in treated area until one day after applicationPage 46 of 55



### Attachment 7 : PCNB DFR Waiver Criteria

In accordance with 40CFR158, DFR data are required for all occupational (e.g., crop, nursery, greenhouse use sites) or residential (e.g., ornamental and vegetable gardens, pick your own farms, retail tree farms) uses that could result in post

- application exposure to foliage. In the
absence of chemical

- sp ecific DFR data, EPA uses default values. The 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment includes an analysis of a number of DFR studies, which resulted in the selection of a revised default values for the fraction of the application rate available for transfer after a foliar application (F AR 

### ). This value is based on an analysis of 19 DFR studies. Since that time, the Agricultural Re

- entry Task Force has submitted information (MRID 49299201) that corrects an applica tion rate error made in the original
submission of “ARF039

– Determination of Dermal and Inhalation Exposure to Reentry Workers During Chrysanthemum Pinching in a Greenhouse” (EPA MRID 45344501). As a result of this submission, the default value of 25% wa s not changed as it still reflects a high

- end, conservative value. However, it is important to note that the range of F AR 

### values was revised from 2%

- 89%
to 2%

- 47%. In the data, a large range of transferability is observed and this variability can
pot entially be attributable to many factors such as active ingredient; formulation; field conditions in the studies; weather conditions (e.g., humidity); or many other difficult to quantify factors. Although witnessed across multiple chemicals, this range in F AR 

### values is not expected when considering DFR data for a single chemical. Because DFR data are not available for PCNB, EPA is using the default value of 25%. Although there may be a small degree of uncertainty in
the use of the default DFR value for P CNB (i.e., there is a small chance that the F AR 

### value may exceed the applicable default value ), it is likely that the health

- protective aspects of EPA’s occupational post

- application assessment methodology will more than compensate for this potential uncer tainty. For example, when assessing residential and occupational post

application exposure to gardens and ornamentals, EPA assumes the following: exposures occur

to zero

- day (i.e., day of application ) residues every day of the assessed exposure duration (i.e., EPA assumes that no dissipation or degradation occurs, it doesn’t rain, etc); individuals perform
the same post

- application activities performed in the transfer coefficient study day after day (e.g., weeding, harvesting, pruning, etc.); and individuals engage in these post

- application activities for a high

- end amount of time every day (represented by data reflecting time spent gardening based on survey data).

Given the conservatisms discussed above and the potential compounding nature of th ese conservatisms, EPA is able to rely upon the calculated exposure estimates with confidence that exposure is not being underestimated.

Since the highest estimated occupational post

- application exposure using default DFR values for
PCNB is not minimal i n comparison to the level of concern (i.e., the calculated MOE is not greater than 2 times higher than the level of concern, MOE = 17 compared to the LOC of 100);
HED recommends that the 40CFR DFR data be required

. Submission of these data will facilitatePentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 47 of 55 

### any necessary exposure assessments refinements and further EPA’s general understanding of the availability of dislodgeable foliar pesticide residues.

Attachment Table 7.1 Post

- application Exposure and Risk Estimates to Support the DFR Waiver Criteria

Cr op Application

Rate (lb ai/acre) Activity Transfer
Coefficient (cm 2 /hr) MOE

Nursery Crop/Ornamentals 32.67 Hand Harvesting, Hand Pruning, Scouting, Container moving, Hand Weeding, Transplanting, Grafting, Propagating, Pinching, Tying/Training 230 140

Irrigation (hand set) 1900 17

Potatoes 2.5 Hand Weeding 70 6100 Scouting 210 2000 Irrigation (hand set) 1900 230Page 48 of 55 

### Attachment 8. Residue Chemistry Data Needs for Registration Review of PCNB

Table A.8.1 Residue Chemistry Data Needs for Registration Review of PCNB 1

.

GLN: Data Requirements 40 CFR
Tolerance (ppm) RED Data Requirements Scoping Data Requirements

Were
Additional
Data Requested in
the RED? References

MRID Are

Additional
Data
Need ed? Comments

860.1200: Directions for

Use N/A Yes N/A Yes EPA Reg. No. 100

- 823 includes an extensive list of crops that can be rotated
within 12 months of field treatments. The label should be revised to indicate that only registered crops can be rotated. If the Registrant wis hes to include additional crops for rotation on the label, these crops should be identified and the corresponding rotational field trial data will be need ed.

EPA Reg. Nos. 5481

- 8992 and 5481

- 8988 include the following statement, “Do not plant root crops in PCNB treated fields within 12 months of the last application of PCNB unless PCNB is registered for use on those crops.” The planting of unregistered crops i n treated fields within 12 months is not limited to root crops. The labels should be revised to indicate the following, “Do not plant crops in PCNB treated fields within 12 months of the last application of PCNB unless PCNB is registered for use on those crops.”

EPA Reg. Nos. 5481

- 8992, 5481

- 8988, and 100

- 823 restrict the feeding or grazing of cotton foliage by livestock. This language is not enforceable and should be removed from the labels. Cotton gin byproduct field trial data are need ed

.

HED no tes that granular field trial data are not available for dry, lima, and snap beans and should be submitted as part of Registration Review. Alternatively, EPA Reg. Nos. 100

- 823 and 5481

- 8988 could be revised to remove applications to
beans.

HED notes th at granular field trial data are not available for bell pepper, non

- bell peppers, and tomatoes and should be submitted as part of Registration Review. Alternatively, EPA Reg. No. 5481

- 8988 can be revised to remove applications to peppers and tomatoes.

HED notes that field trial data are not available for soybean. These data should be submitted as part of Registration Review. Alternatively, the labels could bePentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

_____________________________________________________________________________________________________________________________ _____________________________________________________________________________________________________________________________ ______ _____________________________________________________________________________________________________________________________ _____________________________________________________________________________________________________________________________ ______ _____________________________________________________________________________________________________________________________ _____________________________________________________________________________________________________________________________ ______ _____________________________________________________________________________________________________________________________ __________________________

Page 49 of 55 Table A.8.1 Residue Chemistry Data Needs for Registration Review of PCNB 1

.

GLN: Data Requirements 40 CFR
Tolerance (ppm) RED Data Requirements Scoping Data Requirements

Were
Additional
Data Requested in
the RED? References

MRID Are

Additional
Data
Need ed? Comments

revised to prohibit the direct application of PCNB to soybeans, and field trials
would not be required.

860.1300: Plant
Metabolism N/A Yes 42222101
42482701
42482702 Yes The nature of the residue in plants is not adequately understood. Additional data are required to upgrade Amvac’s existing plant metabolism studies on peanuts, cabbage, and potatoes. In considering all three of Amvacs’ previously submitted plant metaboli sm studies, the Agency (D184350 and D181195, J. Abbotts, 4/16/96) noted that the early metabolites in peanut, potato, and cabbage are similar, and the HPLC profiles of polar metabolites are also similar for these crops. Provided a new acceptable metabolis m study is completed on potato or cabbage, including identification of the Unknown metabolites D and H, the Agency would be willing to conclude that the nature of the residue in plants was adequately understood. These studies should be submitted as part o f Registration
Review.

860.1300: Livestock
Metabolism N/A Yes 41303101
41303301
41823601
41839701 Yes The nature of the residues in livestock is not adequately understood. The Agency
concluded that additional data and information are need ed to upgrade the available ruminant and poultry metabolism studies submitted by Amvac. However, after considering the age of the samples from Amvac’s ruminant and poultry metabolism studies, HED (J. Abbotts, 4/16/96) recommended that Amvac should
submit new li vestock metabolism studies. Ruminant and poultry metabolism studies should be submitted as part of Registration Review.
860.1340: Residue Analytical Methods

- Plant commodities N/A No 41870204 No No additional data are need ed at this time. Adequate analytical methods are available to determine residues of PCNB, PCA, PCTA, PCB, HCB, and TCNB in plant commodities.

860.1340: Residue Analytical Methods

- Livestock commodities N/A Yes

-- Yes As part of Registration Review, the need for tolerances for residues in livestock commodities will be considered. If tolerances are recommended, a tolerance enforcement method will be needed to analyze for the residues of concern in
livestock commodities. It is the recommendation of the Agency that since all the identified metabolites of PCNB are of concern, a radiovalidated common moiety method should be developed by the registrant, if needed. The registrant should also make sure that any future submiss ion clearly states the levels of Total Radioactive Residue (TRR) for PCNB, PCA, and PCTA.
860.1360: Multiresidue
Methods N/A No

-- No No additional data are required at this time. The Agency has determined that PCNB, PCA, MPCPS, PCB, and HCB are compl etely recovered through PAMPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 50 of 55 Table A.8.1 Residue Chemistry Data Needs for Registration Review of PCNB 1

.

GLN: Data Requirements 40 CFR
Tolerance (ppm) RED Data Requirements Scoping Data Requirements

Were
Additional
Data Requested in
the RED? References

MRID Are

Additional
Data
Need ed? Comments

Vol. I, Methods 302, 303, and 304. No additional data are required (D. Edwards, 8/1/86).

860.1650: Analytical
Reference Standards NA Yes

-- No Analytical standards are currently available in EPA’s National Pesticide Standards Repository (NPSR) for PCNB (expires 4/30/2022), PCA (expires 9/1/2021), and PCTA (expires 4/30/2020) (email communication between G. Verdin and J. Van Alstine, 12/7/2015).

860.1380: Storage Stability Data N/A Yes 41870204 Yes Storage stability data should be submitted as part of Registration Review to support Amvac’s cottonseed, peanut, potato, and tomato processing studies. Additionally, any field trial or processing st udies submitted as part of Registration Review should be supported by adequate storage stability data. 860.1500: Crop Field Trials

Potato 0.1 Yes 41870208 Yes An additional 35 field trials are required for potatoes and should be submitted as part of Registration Review. These trials should be conducted with 10% G and 2 lb/gal EC formulations to match previously submitted data. Two sets of trials are required f or each formulation, one set of pre

- plant incorporated (PPI) field trials (9 trials per formulation) and one set of in

- furrow application field trials (9 trials for the 10% G formulation and 8 trials for the 2 lb/gal EC formulation). The field
trials for each formulation and application method should be conducted in NAFTA Growing Zones 1 (1 field trial), 2 (1 field trial), 5 (2 field trials), 9 (1 field trials), and 11 (4* field trials). *For the in

- furrow 2 lb/gal EC formulation, 3 trials are required in NAFTA Growing Zone 11.

Garlic 0.1 Yes

-- Yes Amvac has not submitted field trial data on garlic. The original garlic data were submitted by the Olin Chemical Company. Field trial data on garlic should be submitted by Amvac as part of Registration Review in accordance with 860.1500.

Broccoli 0.1 Yes16 41870201 Yes An additional 7 field trials are required for broccoli and should be submitted as part of Registration Review. These trials should all be conducted in NAFTA Growing Zone 10, as follows: 1) using a 75% WP formulation at 30 lb ai/A as a broadcast PPI application (1 field trial) and as a banded application (1 field trial); 2) using a 75% WP formulation at 4.5 lb ai/100 gal. in soil drench application with a PHI > 72 days (3 field trials); and 3) using a 10% G formulation at 30 lb ai/A in broadcast PPI application at transplant with a PHI > 72 days (1 field trial) and as a banded application with a PHI > 72 days (1 field trial).Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 51 of 55 Table A.8.1 Residue Chemistry Data Needs for Registration Review of PCNB 1

.

GLN: Data Requirements 40 CFR
Tolerance (ppm) RED Data Requirements Scoping Data Requirements

Were
Additional
Data Requested in
the RED? References

MRID Are

Additional
Data
Need ed? Comments

Cabbage 0.1 No 41870202 No No additional data are required at this time.
Collards 0.2 No 00158795 No No additional data are required at this time.

Kale 0.2 No 00158795 No No additional data are required at this time.

Mustard Greens 0.2 No 00158795 No No additional data are required at this time.

Beans 0.1 Yes 41870204
41870205
41870209 Yes Dry Beans: An additional 8 field trials are required for dry beans and should be submitted as part of Registration Review. These trials should be conducted with 2 lb/gal EC (4 field trials) and 75% WP formulations (4 field trials) to match previously sub mitted data. The field trials for each formulation should be conducted in NAFTA Growing Zones 5 (2 field trials), 7 (1 field trial), and 8 (1 field trial).

Lima Beans: An additional 6 field trials are required for lima beans and should be submitted as part of Registration Review. These trials should be conducted with 2 lb/gal EC (3 field trials) and 75% WP formulations (3 field trials) to match previously submitted da ta. The field trials for each formulation should be conducted in NAFTA Growing Zones 2 (2 field trials) and 11 (1 field trial).

Snap Beans: An additional 12 field trials (6 per formulation ; 75% WP and 2 lb/gal
EC ) are required for snap beans and should be submitted as part of Registration Review. The available Amvac snap bean field trial data are not adequate. No tests were conducted in EPA Region 5. In addition, different post

- treatment intervals (7, 10, 14, or 20 days) were utilized at each test si te, resulting in
substantial differences in the residue values. The additional field trials should be conducted in the NAFTA growing regions specified in OSCPP 860.1500.

HED notes that granular data are not available for dry, lima, and snap beans and should be submitted as part of Registration Review. Alternatively, EPA Reg. Nos.
100

- 823 and 5481

- 8988 could be revised to remove applications to beans.

Soybeans (seed, forage, and hay) 0.02 Yes None Yes HED notes that the soybean commodity tolerances appear to be established based on seed treatment data. Seed treatment uses of PCNB are no longer registered. Field trial data are required reflecting the use of PCNB on soybeans at the maximum application r ate. Alternatively, the labels could be revised to prohibitPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 52 of 55 Table A.8.1 Residue Chemistry Data Needs for Registration Review of PCNB 1

.

GLN: Data Requirements 40 CFR
Tolerance (ppm) RED Data Requirements Scoping Data Requirements

Were
Additional
Data Requested in
the RED? References

MRID Are

Additional
Data
Need ed? Comments

the direct application of PCNB to soybeans, and field trials would not be required. The need for this tolerance should be considered as part of Registration Review.

Peppers 0.1 Yes 41870207 Y es The Amvac pepper field trial data are not adequate based on the geographic representation of the field trials. An additional 6 bell pepper field trials (3 per application method) and 4 non

- bell pepper field trials (2 per application method)
should be submitted as part of Registration Review. The bell pepper field trials should be conducted in NAFTA Growing Zones 5 (1 trial) and 10 (2 trials) using each application type (in

- furrow and soil drench) for a total of 6 field trials. Additionally, 2 field t rials must also be conducted on non

- bell peppers using each application type (in

- furrow and soil drench) for a total of 4 additional field trials.

HED notes that granular data are not available for bell and non

- bell peppers and should be submitted as part of Registration Review. Alternatively, EPA Reg. No.
5481

- 8988 can be revised to remove applications to peppers.

Tomatoes 0.1 Yes 41870210 Yes The Amvac tomato field trial data are not adequate based on the number and geographic representation of the s ubmitted field trials. An additional 14 tomato field trials are required and should be submitted as part of Registration Review. 7 field trials should be completed using the soil drench application method and 7 field trials should be completed using the in

- furrow application method. The field trials for each application method should be conducted in NAFTA Growing Zones 1 (1 field trial), 3 (1 field trial), and 10 (5 field trials).

HED notes that granular data are not available for tomatoes and should be submitted as part of Registration Review. Alternatively, EPA Reg. No. 5481

- 8988 can be revised to remove applications to tomatoes.

Cottonseed 0.1 Yes 41870203 Yes The Amvac cotton field trial data are not adequate based on the number of crop
field trials and geographic representation. An additional 12 field trials (4 per formulation/application type) should be submitted as part of Registration Review. The field trials should be conducted in NAFTA Zones 2 (1 trial) and 8 (3 trials)
with each formul ation

- application scenario (10% G in in

- furrow application, 10% G in banded application, and EC formulation in in

- furrow application).Pentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 53 of 55 Table A.8.1 Residue Chemistry Data Needs for Registration Review of PCNB 1

.

GLN: Data Requirements 40 CFR
Tolerance (ppm) RED Data Requirements Scoping Data Requirements

Were
Additional
Data Requested in
the RED? References

MRID Are

Additional
Data
Need ed? Comments

Additionally, the feeding or grazing restriction for cotton foliage by livestock is
not enforceable and should be remove d from the labels. At least 12 field trials (6 per formulation type) for cotton gin byproducts data are required and should be submitted as part of Registration Review. The cotton must be harvested by commercial equipment (stripper and mechanical picker) to provide an adequate representation of plant residue for the ginning process. At least three field trials for each type of harvesting (stripper and picker) are needed, for a total of six field trials per application formulation/type. Current labels inc lude flowable and granular formulations with in

- furrow applications. The submitted data should reflect the use pattern for each formulation type.

Peanuts 1.0 Yes 41870206 2

42718601 Yes Amvac’s peanut field trial data are not adequate based on the number of crop field trials and geographic representation. A total of 30 additional field trials are needed for Registration Review. An additional 9 field trials should be conducted
with the 1 0% G formulation in NAFTA Zones 2 (7 field trials), 3 (1 field trial), and 8 (1 field trial). An additional 10 field trials should be conducted with the 75% WP formulation in NAFTA Zones 2 (7 field trials), 3 (1 field trial), 6 (1 field trial), and 8 (1 f

ield trial). An additional 11 field trials should be conducted with the 75% EC formulation in NAFTA Zones 2 (8 trials), 3 (1 field trial), 6 (1 field trial), and 8 (1 field trial).

Crops with Seed

Treatment Uses None Yes 41758201
41871301 No HED notes that the HED Revised RED Chemistry Chapter (Memo, S. Kinard, 12/14/2004, D291280 ) i ndicated that data were required depicting residues of PCNB, PCA, MPCPS, PCB, and HCB in/on RACs of barley, corn, oats, peas, rice, safflower, sorghum, sugar beets, and whea t grown from seed treated with PCNB at the maximum labeled rate. Since seed treatment uses are no longer registered,
these data are not need ed at this time.

Ginseng None Yes

-- No HED notes that the HED Revised RED Chemistry Chapter (Memo, S. Kinard, 12/14/2004, D291280 ) indicated that PCNB residues were detected in samples of ginseng taken by FDA for monitoring purposes. The HED Revised RED Chemistry Chapter (Memo, S. Kinard, 12/14/2004, D291280 ) included a data requirement that residue data for gins eng should be generated in the representative countries and tolerance should be proposed. Currently there are no ginseng uses
on the labels , so these data are not needed at this time.
860.1520: Processed Food/FeedPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 54 of 55 Table A.8.1 Residue Chemistry Data Needs for Registration Review of PCNB 1

.

GLN: Data Requirements 40 CFR
Tolerance (ppm) RED Data Requirements Scoping Data Requirements

Were
Additional
Data Requested in
the RED? References

MRID Are

Additional
Data
Need ed? Comments

Beans, cannery waste None No 41975804 No Bean cannery waste is no longer a regulated commodity.

Cottonseed None Yes 41975801 Yes To upgrade Amvac’s cottonseed processing study, data are need ed depicting the frozen storage stability of residues (PCNB, PCA, MPCPS, PCB and HCB) in processed cottonseed fractions. Cottonseed processed fractions were stored frozen
for 29

- 232 days prior to analysis. These data should be submitted as part of Regist ration Review.

Peanut None Yes 41975802 Yes To upgrade Amvac’s peanut processing study, data are neede d depicting the frozen storage stability of residues (PCNB, PCA, MPCPS, PCB and HCB) in processed peanut fractions. Peanut processed fractions were stored frozen for 9

- 204 days prior to analysis. These data should be submitted as part of Registration

Rev iew.

Potato None Yes 41975803 Yes To upgrade Amvac’s potato processing study, data are need ed depicting the frozen storage stability of residues (PCNB, PCA, MPCPS, PCB and HCB) in processed potato fractions. Potato processed fractions were stored frozen for 8

- 218 days prior to analysis. These data should be submitted as part of Registration Re view.

Soybean None Yes

-- Yes A soybean processing study is need ed. Alternatively, the registrant could prohibit direct applications to soybeans, in which case a soybean processing study would not be required. These data should be submitted as part of Registration Review if applications to soybeans are not prohibited.

Tomato None Yes 41975805 Yes To upgrade Amvac’s tomato processing study, data are need ed depicting the frozen storage stability of residues (PCNB, PCA, MPCPS, PCB and HCB) in processed tomato fractions. Tomato processed fractions were stored frozen for 63

- 227 days prior to analysis. These data should be submitted as part of Registration

R eview.

860.1480: Meat, Milk, Poultry, and Eggs None Yes

-- Yes As part of Registration Review, the need for tolerances for residues in livestock commodities will be considered. Amvac has not submitted ruminant and poultry feeding studies and these dat a may be required as part of Registration Review.
860.1400: Water, Fish, and Irrigated Crops NA NA

-- NA NA

860.1460: Food Handling NA NA

-- NA NAPentachloronitrobenzene Registration Review Human Health Assessment Scoping Document

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Page 55 of 55 Table A.8.1 Residue Chemistry Data Needs for Registration Review of PCNB 1

.

GLN: Data Requirements 40 CFR
Tolerance (ppm) RED Data Requirements Scoping Data Requirements

Were
Additional
Data Requested in
the RED? References

MRID Are

Additional
Data
Need ed? Comments

860.1850: Confined Rotational Crops NA No 42599201 No Amvac has not submitted adequate confined rotational crop data ; however, the ChemSAC determined that based on all available data, PCNB

- treated crops should only be rotated to labeled crops (6/18/03 Minutes). Additional confined rotational crop data are not required at this time.

860.1900: Field Rotational Crops None Yes

-- Yes The ChemSAC determined that based on all available data, PCNB

- treated crops should only be rotated to labeled crops (6/18/03 Minutes). Field accumulation studies on rotational crops are need ed during Registration Review.

1 Data requirements were initially identified in Table B2 of Memo, S. Kinard, 14

- DEC

- 2004; D291280.

2 As all nutmeat samples from Amvac’s field trials reported in MRID 41870206 were ground with the shells before analysis, the r esidue data from these samples are considered

invalid and were not reviewed.