Docket Number EPA

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Page 2 of 39Docket Number EPA

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Page 3 of 39 N

- bromosulfamate salts and mixtures Registration Review Team

Human Health & Environmental Effects Tim McMahon Nate Mottl Julie VanAlstine Siroos Mostaghimi Bill Erickson J ames Breithaupt

Risk Management SanYvette Williams Stacey Grigsby /Jacqueline H ardy Rose Kyprianou

Office of General Counsel Philip RossDocket Number EPA

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Page 4 of 39 TERMS, ABBREVIATIONS AND SYMBOLS

AD Antimicrobials Division A.I. or a.i. active ingredient aPAD a cute p opulation a djusted d ose ASRI a ctivated sludge r espiration i nhibition
atm

- m 3 /mole a tmosp heric pressure

- cubic meter per mole BCF b ioconcentration f actor °C d egrees Celsius CAS Chemical Abstracts Service CFR Code of Federal Regulations CHO Chinese h amster o vary CMA Chemical Manufacturers Association CO 2 c arbon dioxide COC c oncentra tion

- of

- c oncern cPAD c hronic p opulation a djusted d ose DCI data call

- in EC 50 m edian (or 50 percent) e ffect c oncentration EC 05 5 p ercent e ffect c oncentration ECOTOX ECOTOXicology EDI e stimated daily i ntake EDSP E ndocrine Disruptor Screening Program E

- FAST Exposure and Fate Assessment Screening Tool EPI Suite Estimation Program Interface Suite EPA Environmental Protection Agency FDA Food and Drug Administration FFDCA Feder al Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, an d Rodenticide Act FQPA Food Quality Protection Act FWP Final Work Plan g/mol g rams per mole GLN guideline number HPV h igh production v olume IDS Incident Data System Koc o rganic carbon normalized soil

- water partition coefficient Kd s oil

- water pa rtition coefficient Kow o ctanol

- water partition coefficient LC 50 m edian (or 50 percent) l ethal c oncentration LD 50 m edian (or 50 percent) l ethal d ose LOAEC l owest

- o bserved

- a dverse

- e ffect

- c oncentration LOEC l owest

- o bserved

- e ffect

- c oncentration LOAEL lowe st

- observed

- adverse

- e ffect

- l evel Log K ow l ogarithm of the octanol

- water partition coefficient μg m icrogram ml/g m illiliter p er g ram mg/kg m illigram p er k ilogram mg/kg/day m illigram p er k ilogram p er d ay mg/L m illigram p er l iter mm Hg m illimeter of mer cury MOE m argin of e xposureDocket Number EPA

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Page 5 of 39 MRID Master Record Identification Number MRL m aximum r esidue l imit N/A n ot a pplicable

nm n anometers NBS and M n

- bromosulfamate salts and mixtures NOAEC no

- observed

- adverse

- effect

- c oncentration NOAEL n o

- o bserved

- a dverse

- e f fect

- l evel OCSPP Office of Chemical Safety and Pollution Prevention OECD Organization for Economic Co

- operation and Development OPP Office of Pesticide Programs PAD p opulation a djusted d ose PAI p ure active i ngredient PDM Probabilistic Dilution Model % p ercent PC Code Pesticide Chemical Code PCF p ounds p er c ubic foot pH power of h ydrogen or power of the con centration of the hydrogen ion PHED Pesticide Handler’s Exposure Data PIS primary i rritation s core pKa p ower of the acid dissociation constant or negative base

- 10 logarithm of the acid dissociation constant of a solution ppb p arts p er b illion ppm p arts p er m illion PWP Preliminary Work Plan QSAR q uantitative s tructure

- a ctivity r elationship RED Rere gistration Eligibility Decision SAR s truct ure a ctivity r elationship SF s afety f actor SSTS Section Seven Tracking System TEP t ypical e nd

- u se p roduct TGAI t echnical grade active i ngredient TMDL total maximum daily l oads UF uncertainty factor UV/VIS ultraviolet/v isible light a bsorption % w / w p ercent weight per weight. WP w ettable powder WWTPs w astewater treatment plantsDocket Number EPA

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Page 6 of 39 

### Table of Contents 1 Introduction

................................ ................................ ................................ ............................. 8 1.1 Statutory and Regulatory Authority

................................ ................................ ................. 8 1.2 Updates to the Work Plan

................................ ................................ ................................ . 8 1.3 Case Overview

................................ ................................ ................................ ................. 9 1.4 Chemical Identification and Properties

................................ ................................ .......... 11 1.5 Use/Usage Description

................................ ................................ ................................ ... 13 1.5.1 Registrations

................................ ................................ ................................ ........... 13 1.5.2 Summary of Registered Uses

................................ ................................ .................. 13 1.6 Regulatory History

................................ ................................ ................................ ......... 14 1.6.1 Recent/Pending Reg ulatory Actions

................................ ................................ ....... 15 1.6.2 Tolerance Information

................................ ................................ ............................ 15 1.7 Incidents

................................ ................................ ................................ ......................... 15 1.7.1 Human Health

................................ ................................ ................................ ......... 15 1.7.2 Ecological

................................ ................................ ................................ ............... 15 2 Anticipated Data Needs

................................ ................................ ................................ ........ 15 3 Human Health Risk Assessment

................................ ................................ ........................... 18 3.1 Existing Toxicological Endpoints

................................ ................................ .................. 18 3.2 Dietary Exposure

................................ ................................ ................................ ............ 18 3.2.1 Food

................................ ................................ ................................ ........................ 18 3.2.2 Drinking Water

................................ ................................ ................................ ....... 19 3.3 Occupational and Residential Exposures

................................ ................................ ....... 19 3.3.1 Occupational Handler Exposure

................................ ................................ ............. 19 3.3.2 Occupational Post

- application Exposure

................................ ................................ 19 3.3.3 Residential Handler Exposures

................................ ................................ ............... 20 3.3.4 Residential Post

- Application Exposures

................................ ................................ . 20 3.4 Aggregate and Cumulative Exposu re

................................ ................................ ............. 20 3.4.1 Aggregate Exposures

................................ ................................ .............................. 20 3.4.2 Cumulative Exposures

................................ ................................ ............................ 20 4 Environmental Risk Assessment

................................ ................................ ........................... 20 4.1 Environmental Fate Assessment

................................ ................................ .................... 21 4.1.1 WWTP

................................ ................................ ................................ .................... 21 4.1.2 Water Quality

................................ ................................ ................................ .......... 21 4.2 Conceptual Models for Environmental Exposure Pathways

................................ .......... 22 4.2.1 Ecological Effects (Eco toxicology Endpoints)

................................ ....................... 22 4.3 Exposure Analysis Plan

................................ ................................ ................................ .. 23 4.3.1 Aquatic and Terrestrial Wildlife Exposure Estimates

................................ ............ 23 4.3.2 Screening Level Down

- the

- Drain Analysis

................................ ............................ 23 4.4 Effects Analysis Plan

................................ ................................ ................................ ..... 24 5 E ndocrine Disruptor Screening Program (EDSP)

................................ ................................ . 24 6 Optional Label Changes

................................ ................................ ................................ ........ 25 7 Next Steps

................................ ................................ ................................ ............................. 25 8 References

................................ ................................ ................................ ............................. 26

Appendix A Toxicology Profile

................................ ................................ ................................ . 27 Appendix B Environmental Fate

................................ ................................ ................................ .. 31Docket Number EPA

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Page 7 of 39 Appendix C Ecotoxicology Profile

................................ ................................ ............................... 34 Appendix D Screening Level Down

- the

- Drain Analysis

................................ ............................. 35 Appendix E Product Chemistry

................................ ................................ ................................ . 36 Appendix F Public Comments Received on the Preliminary Work Plan

................................ ..... 39

List of Tables Table 1

– Summary of Anticipated Risk Assessments and Data Needs for Registration Review: N

- bromosulfamate salts and mixtures and degradates

................................ ................................ .... 9 Table 2

– Anticipated Registration Review Schedule

................................ ................................ .. 10 Table 3

– Chemical Identification of N

- bromosulfamate salts and mixtures

............................... 11 Table 4

– Estimated Physical and Chemical Properties for N

- bromosulfamate salts and mixtures from EPI

- WEB 4.11

................................ ................................ ................................ ...................... 12 Table 5

– Estimated Physical and Chemical Properties for the Degradate Sulfamic Acid from EPI

- WEB 4.11

................................ ................................ ................................ .............................. 12 Table 6

– Summary of N

- bromosulfamate salts and mixtures Registered Uses*

......................... 13 Table 7

– Studies Anticipated as Needed for the Registration Review of N

- bromosulfamate salts and mixtures

................................ ................................ ................................ ................................ .. 16 Table 8

– Occupational Handler Exposure Scenarios for N

- bromosulfamate salts and mixtures

. ................................................................................................... 19
Table 9

– Eco logical Effects Endpoints

. . .............................................................. 2 3Docket Number EPA

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Page 8 of 39 

## 1 Introduction

This document is the United States Environmental Protection Agency ’s ( USEPA, EPA or “the Agency ”) Final Work Plan ( FW P ) for N

- bromosulfa ma te salts and mixtures

. The F WP docum ent explain s what EPA's Office of Pesticide Programs (OPP) knows about N

- bromosulfamate salts and mixtures , highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the agency in conducting the review , and providing an anticipated timeline for completing this review.
The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends, by sharing this information in t he docket, to inform the public of what it knows about N

- bromosulfamate salts and mixtures and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on N

- bromosulfamate salts and mixtures

. 

## 1.1 Stat utory and Regulatory Authority
The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United States generally must be registered by the USEPA based on scientific data showing that th ey will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, al l registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review prog ram, the agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at http://www2.epa.gov /pesticide

- reevaluation

.
The agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether i t continues to meet the FIFRA standard for registration. The regulations governing registration review begin at 40 CF R 155.40. The agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency ’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review decision.



## 1.2 Updates to the Work Plan
Since publication of the N

- bromosulfamate salts and mixtures Preliminary Work Plan (PWP)
, the agency has made the following updates:

• Updated Table 2

– Anticipated Registration Review Schedule.

• Updated PC code information in Table 3.

• Update d Section 1. 7 Incidents

- Recent search dates o f February 3, 2016 are noted

.Docket Number EPA

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Page 9 of 39 • Updated Tables 1 and 7 and Section 3

– removed anticipated requirement for chronic toxicity / carcinogenicity study (guideline 870.4300) for dietary (food) use ; these data are neede d only for the once

- through cooling tower use

.
• Upd ated language in Section 3.2.1 on anticipated dietary (food) exposure.

• Deleted Section 7 “ Guidance for Commenters ” language

.
• Updated Section 8 (now is Section 7) “ Next Steps

. ”

• Appendix A Toxicology Profile

- deleted “pulp and paper use” from the Chronic Toxicity and Carcinogenicity sections.

• Added “ Appendix F Public Comments Received on the Preliminary Work Plan

. ”

• Corrected formatting and typographical errors and made other minor editorial changes.

As indic ated in Appendix F, t he Agency received no submissions during the public comment period on the initial docket. This document makes final the work plan for the N

- bromosulfamate salts and mixtures registration review process.



## 1.3 Case Overview

The docket for N

- b romosulfamate salts and mixtures ( case 5069 ) has been established at http://www.regulations.gov in docket number EPA

- HQ

- OPP

- 2015

- 0265

. Documents associated with this registration review can be viewed in this docke t. Tables 1 and 2 b elow summar ize the issues relevant to this registration review case and the anticipated registration review schedule

.
Table 1

– Summary of Anticipated Risk Assessments and Data Needs for Registration Review : N

- bro mosulfamate salts and mixtures and degradates

Risk Assessment Assessment Necessary to

Support Registration Review Date of Most Recent Assessment Type of Assessment

Required (New/Updated) Data Anticipated as Needed (See Table 7 for detail s)

Dietary (food) Yes N/A N ew Subchronic Oral Toxicity Developmental Toxicity (2 species) Reproduction and Fertility Effects Mutagenicity testing battery Immunotoxicity Neurotoxicity screening battery

Dietary (drinking water) Yes N/A New Subchronic Oral Toxicity Deve lopmental Toxicity (2 species) Reproduction and Fertility Effects Chronic toxicity/Carcinogenicity Mutagenicity testing battery Immunotoxicity Neurotoxicity screening battery

Occupational Handler Yes N/A New Indoor Inhalation Exposure Indoor Dermal Expo sure Product Use Occupational Post

A pplication No N/A None NoneDocket Number EPA

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Page 10 of 39 Risk Assessment Assessment Necessary to

Support Registration Review Date of Most Recent Assessment Type of Assessment

Required (New/Updated) Data Anticipated as Needed (See Table 7 for detail s)

Residential Handler No N/A None None
Resident i al Post Application

- Incidental Oral and Dermal No N/A None None

Resident i al Post Application

- Inhalation No N/A None None

Aggregate N o N/A None None
Cumulative No N/A None None
Tolerance Review No N/A None None

Ecological Yes N/A New Hydrolysis, photodegradation in water, aerobic soil, aerobic aquatic metabolism, leaching

- adsorption

- desorption, biodegradation in WWTPs, ASRI
, avian acute oral, algal toxicity, freshwater invertebrate, freshwater fish acute, fish

- early life stage, aquatic invertebrate N/A = Not applicable * Table 1 is a summary of the anticipated risk assessments and data needs for Registration Review.

Ta ble 2

– Anticipated Registration Review Schedule
Anticipated Activity Target Date * Completion Date Phase 1: Opening the Docket

Open Docket and 60

- Day Comment Period for Preli minary Work Plan 2015

- 09 2015

- 10

- 02

Close Public Comment Period 2015

- 11 2015

- 12

- 0 1 Phase 2: Case Development

Issue Final Work Plan 2016

- 03 2016

- 03

Issue Data Call

- In (DCI) 2017

- 03

Receive Data to be Considered in Risk Assessment 2019

- 03

Open 30

- Day Public Comment Period for Preliminary Risk Assessment(s) 2020

- 09

Close Public Comment Period 2020

- 10 Phase 3: Registration Review Decision and Implementation Open 60

- Day Public Comment Period for Pro posed Decision 2021

- 03

Close Public Comment Period 2021

- 05

Issue Final Decision 2021

- 09 Begin Post

- Decision Follow

- up 2021Docket Number EPA

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Page 11 of 39 Total (years) 6

* The anticipated schedule will be revised as necessary ( e.g ., need arising under the Endocrine Disruptor Screening Program with respect to the active ingredients in this case).


## 1.4 Chemical Identificati on and Properties

N

- bromosulfamate salts and mixtures products with active labels are included in Table 3 for active ingredient (s) to be assessed in case 5069

. In case 5069, the only PC codes with active labels include 028960, 028961, and 028964. Within t hese PC codes , the active ingredients include the N

- b romosulfa ma te and N

- chlorosulfa ma te salts of sodium and potassium at 17

- 25 %

. Application rates are based on the total bromine content released since these active ingredients are stabilized forms of bro mine.

Table 3

– Chemical Identification of N

- bromosulfamate s alts and m ixtures

Chemical Name Sodium N

bromosulfamate Sodium N

chlorosulfamate Potassium N

bromosulfamate Potassium N

chlorosulfamate Chemical Classification Bro mosulfamate salt Chlorosulfamate salt Bromosulfamate salt Chlorosulfamate salt

Present in PC Codes 028960, 028961, 028964 028961, 028964 028964 028964

CAS Number 134509

- 56

- 1 13637

- 90

- 6 1192047

- 27

- 0 1192047

- 23

- 6 Smiles code BrNS(=O)(=O)(O[Na]) CLN S(=O)(=O)(O[Na]) BrNS(=O)(=O)(O[K]) ClNS(=O)(=O)(O[K]) Molecular Formula H 1 Br 1 N 1 O 3 S 1 Na 1 H 1 Cl 1 N 1 O 3 S 1 Na 1 H 1 Br 1 N 1 O 3 S 1 K 1 H 1 Cl 1 N 1 O 3 S 1 K 1 Molecular Weight (grams/mole) 197.97 153.52 214.07 169.62

Molecular Structure

P roduct chemistry data for the N

- bromosulfamate salts and mixtures product chemistry information from EPI

- WEB 4.11 that is relevant to risk assessment is summarized in Table 4 for the active ingredients and in Table 5 for the degradate sulfamic acid. F urther details of the product che mistry data are discussed in Appendix E

. 

## B

r N H S O
O O N a



# C l N H S O
O O N aDocket Number EPA

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Page 12 of 39 Table 4

– Estimated Physical and Chemical Properties for N

- bromosulfama te s alts and

m ixtures from EPI

- WEB 4.11

Guideline No. Parameter 3 Sodium N

bromosulfamate Sodium N

chlorosulfamate Potassium N

bromosulfamate Potassium N

chlorosulfamate

830.7050 UV/Visible Absorption These active ingredients form hypobromous acid and hypochlorous acid, and UV/Visible absorption similar for both hypobromous acid (Ingham, 1998) 1 and hypochlorous aci d (Adam, 1992) 2 with a typical wavelength range of 290

- 380 nm

.

830.7370 Dissociation constant (pKa) No t available

830.7550 Octanol

- water partition coefficient at 25

o C (Log K ow ) - 5.45

830.7840 Solubility in water (mg/L) at 25 o C 1 x 10 6

830.79 50 Vapor pressure (mmHg) at 25 o C 8.5 x 10

- 21 3.1 x 10

- 20 8.5 x 10

- 21 3.1 x 10

- 20

None Henry's law constant at 25 o C (atm

- m 3 /mol) 3 2.2 x 10

- 27 6.2 x 10

- 27 2.4 x 10

- 27 6.8 x 10

- 27

1 Ingham, T., Bauer, D., Landgraf, J., and Crowley, J.N. 1998. Ultraviole t/visible absorption cross sections of gaseous HOBr, J. Phys. Chem., 102: 3293

- 3298. Spectrum located at http://vpl.astro.washington.edu/spectra/hobringhamfig1.jpg.
2 Adam, L.C., Fabian, I., Suzuki, K. and Gordon, G. “Hypochlorous Acid Decomposition in th e pH 5

- 8 Region”, Inorganic Chemistry, 1992, vol. 31, pp. 3534

- 3541.
3 atm

- m 3 /mol = atmosphere cubic meter per mole; o C = degrees Celsius; mg/L = milligrams per liter; mmHg = millimeters of mercury

.
Table 5

– Estimated Physical an d Chemical Properties for the Degradate Sulfamic Acid from EPI

- WEB 4.11

Guideline No. Parameter Sulfamic Acid None CAS Number 5329

- 14

- 6 None Smiles code O=S(=O)(O)N None Molecular Formula S 1 O 3 N 1 None Molecular Weight (grams/mole) 97.09

830.7050 UV/Vis ible Absorption 1 No UV/Visible sorption based on lack of double bonds.

830.7370 Dissociation constant (pKa) No t available

830.7550 Octanol

- water partition coefficient at 25 o C (Log K ow ) 0.1

830.7840 Solubility in water (mg/L) at 25 o C 1.5 x 10 5

830.7950 Vapor pressure (mmHg) at 25 o C 8.5 x 10

- 21Docket Number EPA

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Page 13 of 39 Guideline No. Parameter Sulfamic Acid None Henry's law constant at 25 o C (atm

m 3 /mol) 2 2 x 10

- 21

None

Molecular structure

1 Lyman
, 1990

. 2 atm

- m 3 /mol = atmosphere cubic meter per mole; o C = degrees Celsius; mg/L = milligrams per liter ; mmHg = millimeters of mercury

. 

## 1.5 Use/Usage Description

1.5.1 Registrations There are four registered pesticide products (EPA Reg No s 8622

- 81, 3377

- 55, 3377

- 78 and 3377

- 79 ) that contain sodium bromosulfamate s alts and m ixtures. The four product s range from 17

- 25 % a.i content

. 

### 1.5.2 Summary of Registered Uses

Table 6 presents a summary of the registered uses of N

- bromosulfamate salts and mixtures that will be assessed in this registration review

. N

- bromosulfamate salts and mixtures are registered for use as fungicide s , algaecide s , slimicide s , and microbiocide s in cooling and process water systems, heat transfer systems, air washers, industrial scrubbing systems, containerized ponds and decorative fountains, industrial once

- through cooling water systems, pulp, and paper m ills, wastewater systems, water lines for livestock, and oilfield applications (oil recovery well fluids, fracturing fluids, secondary oil recovery well fluids, pumps, pipeworks, heat exchangers, and filters). The maximum application rate (expressed as tot al bromine) is 10 mg/L , and the labels state that chlorine levels can be multiplied by 2.25 (based on molecular weight) to be expressed as bromine.

Table 6

– Summary of N

- bromosulfama te s alts and m ixtures Registered Uses*

Use Appli cation Method Application Rate (total bromine) Industrial Processes and Water Systems

Air Washer Systems Liquid Pour 10 ppm Liquid Pump

Heat Exchanger Water Systems Liquid Pump 10 ppm

Wastewater Systems Liquid Pump 10 ppm

Industrial Scrubbing Syste ms Liquid Pump 10 ppm Liquid Pour 10 ppmDocket Number EPA

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Page 14 of 39 Cooling Water (Recirculating/Once Through) Liquid Pump

Oil Field Applications Liquid Pour 10 ppm Liquid Pump

Circulate in Place (CIP) Liquid Pour 10 ppm Liquid Pump Aquatic Areas

Decorative Fountains L iquid Pour 10 ppm Liquid Pump

Ornamental Ponds Liquid Pour 1 0 ppm Liquid Pump Agricultural Premises and Equipment

Livestock Water Line Liquid Pour 10 ppm Liquid Pump
Material Preservatives

Oil Wells Liquid Pour 10 ppm Liquid Pump

Pulp a nd Paper Liquid Pour 10 ppm Liquid Pump * Only maximum application rates in bromine were reported on the label.


## 1.6 Regulatory Histor y The first product containing N

- bromosulfamate salts and mixtures was registered in 1987. At the time, the active ingredie nt was presented as bromine chloride. A RED for bromine chloride was not issued because the chemical was registered after October 1984 . The N

- bromosulfamate salts and mixtures were included in the Preliminary and Final Work Plan for the Bromine chloride

re gistration review case, published in 2009 under EPA docket number EPA

- HQ

- OPP

- 2009

- 0025. The work plan noted that with respect to the N

- bromosulfamate salts and mixtures, “It is very likely that the actual halogen

- bearing active ingredients in these product s are bromosulfamate and/or chlorosulfamate salts.” Subsequent to publication of the FWP, the registrant petitioned the agency to change the active ingredient on their labels from bromine chloride to bromosulfamate and chlorosulfamate salts (i.e.
, N

- bromo sulfamate salts and mixtures). The labels were changed in 2009 to reflect the active ingredient as sodium bromosulfamate, sodium chlorosulfamate, potassium bromosulfamate, and/or potassium chlorosulfamate. Therefore, the creation of this registration revie w case for N

- bromosulfamate salts and mixtures is being done pursuant to 40CFR §155.42(b)(2) which states that “The agency may...split a registration review case into two or more registration review cases. For example, new data or information may suggest tha t active ingredients in a registration review case are not as similar as previously believed and that they belong in two or more separate registration review cases.”

Thus, the N

- bromosulfamates (collectively, N

- bromosulfamate salts and mixtures) are activ e ingredients that will require assessment under this registration review case.Docket Number EPA

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Page 15 of 39 

### 1.6.1 Recent/Pending Regulatory Actions There are no recent or pending regulatory actions for N

- bromosulfamate salts and mixtures

. 

### 1.6.2 Tolerance Information

EPA has not established to lerances for residues of N

- bromosulfamate salts and mixtures in or on raw agricultural commodities or processed food and feed products under the Federal Food, Drug
, and Cosmetic Act (FFDCA) Section 408 . There are no tolerance exemptions for residues of N

bromosulfamate salts and mixtures under FFDCA Section 408. F DA has not established clearances for sodium N

- bromosulfamate, sodium N

- chlorosulfamate, potassium N

bromosulfamate, and potassium N

- chlorosulfamate. Bromine chloride is listed as a food contact substance by the US Food and Drug Administration (US FDA) and a Food Contact Notification (FCN) ( No. 567 ) has been granted to Albemarle Corporation for the use of bromine chloride as a slimicide in the manufacture of food

- contact paper and paperboard . FC N No. 567 was effective

on April 28
, 2006 at a maximum level of 10 ppm in the process water and is only effective for the manufacturer or supplier identified in the notification (see section 3.2.1 for more discussion of this FCN)

. Additionally, sulfamic a cid has been identified as generally recognized as safe (GRAS) by the US FDA as an i ndirect human food ingredient based upon the current good manufacturing practice of using this ingredient in the manufacture of paper and paperboard that contact food ( 21 C FR § 186.1093 )

. In accordance with 21CFR 186.1(b)(1) , sulfamic acid is used as an indirect food ingredient with no limitations other than curre nt good manufacturing practice.



## 1.7 Incidents

1.7.1 Human Health

There are no human health incidents in OPP’s Incident D ata System (IDS) from June 28, 2006 to February 3, 2016

. 

### 1.7.2 Ecological
There are no ecological incidents in OPP’s IDS from Ju ne 28, 2006 to February 3 2016

. 

## 2 A nticipated Data Needs

There was no Reregistration Eligibility Decision ( RED ) for N

- bromosulfamate sal ts and mixtures so no data were called in. The agency notes that the European Chemical Agency (ECHA) has a list of mammalian toxicology and ecotoxicology studies either apparently conducted with sulfamic acid or planned to be conducted. This is listed at: http://apps.echa.europa.eu/registered/data/dossiers/DISS

- 97d74cbc

- 1047

- 09ab

- e044

- 00144f67d031/DISS

- 97d74cbc

- 1047

- 09ab

- e044

- 00144f67d031_DISS

- 97d74cbc

- 1047

- 09abe044

- 00144f67d031.html . The agency has no further information on these data. For the uses listed on the N

- bromosulfamate salts and mixtures labels, Table 7 lists the anticipated studies needed as part of this case. If the studies listed in the ECHA document are availabl e as full study reports,Docket Number EPA

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Page 16 of 39 these would be useful to the agenc y in addressing the ant icipated data require ments for human health and ecological hazard assessment for N

- bromosulfamate salts and mixtures

.

Table 7

– Studies Anticipated as Needed for the Registration Review of N

- bromosulfamate salts and mixtures

GLN Study Name Test Substance Time Frame (Measured in months from DCI Receipt) Risk Assessment(s)

Data Will Support Use Site(s) Triggering Anticipated Data Requirement Applicable Exposure Scenario

835.2120 Hydrolysis One TGAI 1 12 Environmental exposure All E cological

835.2240 Photodegradation in water One TGAI 1 12 Environmental exposure All Ecological

835.4300 Aerobic aquatic metabolism One TGAI 1 and sulfamic acid 24 Environmental exposure All Ecological

835.1230 Leaching/adsorption/desorption (batch eq uilibrium) One TGAI 1 and sulfamic acid 12 Environmental exposure All Ecological

835.4100 Aerobic soil metabolism One TGAI 1 and sulfamic acid 24 Environmental exposure All Ecological

835.3110 3 835.3220 3 835.3240 3 835.3280 3 Biodegradability in WWTP One T GAI 1 and sulfamic acid 12 Environmental exposure All Ecological

850.3300 3 Activated Sludge Respiration Inhibition (ASRI) One TGAI 1 and sulfamic acid 12 Environmental exposure All Ecological

850.2100 Avian acute oral One TGAI 1 12 Terrestrial organism s All Ecological

850.4500 Algal toxicity, green algae One TGAI 1 12 Aquatic organisms All Ecological

850.1010 Freshwater invertebrate, acute toxicity One TGAI 1 12 Aquatic organisms All Ecological

850.1075 Freshwater fish, acute toxicity One TGAI 1 12 Aqua tic organisms All Ecological

850.1400 Fish, early life stage Sulfamic acid 24 Aquatic organisms All Ecological

850.1300 Aquatic invertebrate, life cycle Sulfamic acid 24 Aquatic organisms All EcologicalDocket Number EPA

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Page 17 of 39 GLN Study Name Test Substance Time Frame (Measured in months from DCI Receipt) Risk Assessment(s)

Data Will Support Use Site(s) Triggering Anticipated Data Requirement Applicable Exposure Scenario

870.3100 90

- Day Oral Toxicity in Rats S ulfamic aci d 2 24 Human Health All All

870.3465 90

- Day Inhalation Toxicity Sulfamic acid 2 24 Human Health All Occupational handler

870.3700 Developmental Toxicity in Rats S ulfamic acid 2 24 Human Health All All

870.3700 Developmental Toxicity in Rabbits S ulfamic

ac id 2 24 Human Health All All

870.3800 Reproduction and Fertility Effects S ulfamic acid 2 24 Human Health All All

870.4300 Combined Chronic Toxicity/ Carcinogenicity Sulfamic acid 5 24 Human Health Once

- through cooling tower Dietary (drinking water)

870. 5100 Reverse Mutation Assay Sulfamic acid 2 12 Human Health All All

870.5300 or 5375 In vitro mammalian gene mutation Sulfamic acid 2 12 Human Health All All

870.5385 or 5395 In vivo cytogenetics Sulfamic acid 2 12 Human Health All All

870.7800 Immunotoxic ity Sulfamic acid 2 12 Human Health All All

870.6200 Neurotoxicity screening battery 4 Sulfamic acid 2 24 Human Health All All

875.1200 Dermal Exposure EP 24 Occupational Handler All Liquid Pour

875.1400 Inhalation Exposure EP 24 Occupational Handler All L iquid Pour

875.1700 Product Use EP 12 Occupational Handler All Liquid Pour

1. Any of the four active ingredients may be used as test material

. 2. No human health toxicity data are anticipated to be required on the halogenated TGAI since the potential residue i n paper, paperboard, and drinking water is expected to be sulfamic acid. 3. For one TGAI and the degradate sulfamic acid, the results of the Activated Sludge Respiration Inhibition Test (ASRI) will determine which of these four biodegradation tests is/are ant icipated to be required.

• If the ASRI test EC50 is less than or equal to 20 mg/L, then either the (i) Biodegradation in Activated Sludge Study or (ii) Simulation Test

-

Aerobic Sewage Treatment: A. Activated Sludge Units or (iii) the Porous Pot Test would be anticipated to be required. If the ASRI test EC50 is greater than 20 mg/L, then the registrant would be anticipated to be required to conduct either: (i) Ready Biodegrada bility or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test

- Aerobi c Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test.

• If the Ready Biodegradability study is conducted and passes, then no further testing would be anticipated to be required. If, however, the

antimicrobial fails the Ready Biodegradabil ity study, then the a) Biodegradation in Activated Sludge or b) Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units, or c) the Porous Pot study would be anticipated to be required

. 4. Acute (study due 12 months after receipt of DCI) a nd subchronic (study due 24 months after receipt of DCI) neurotoxicity studies are anticipated to be required. A protocol should be submitted to the agency for review prior to conducting the neurotoxicity studies. 5. D ata for sulfamic acid are antici pated to be required based on the once through cooling tower use and potential for persistence and long

- term exposure. If the environmental fate (835 series) data show that sulfamic acid degrades quickly, a drinking water analysis will not be c onducted and th e chronic toxicity/carcinogenicity study will not be needed.Docket Number EPA

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Page 18 of 39 

## 3 Human Health Risk Assessment

T he a gency anticipates the need to conduct a human health risk assessment for N

bromosulfamate salts and mixtures including a risk assessment for the primary degr adate, sulfamic acid

. Additional data as noted in T able 7 are anticipated to be required for use in conduct ing this assessment for registration review. However, if the GRAS determination for sulfamic acid previously made by the Food and Drug Administration (21 CFR 186.1093) can be verified as due to lack of toxicity of sulfamic acid, then certain data m ay not be needed for sulfamic acid.



## 3.1 Existing Toxicological Endpoints

For N

- bromosulfamate salts and mixtures, th ere are no existing toxicological endpoints

. End points will need to be selected following submission and review of the mammalian toxicology studies that are anticipated to be required

. 

## 3.2 Dietary Exposure

The agency anticipates the need to conduct food and drinking water assessment s as part of registra tion review.



### 3.2.1 Food

Based on the current N

- bromosulfamate salts and mixtures labels, there are two use patterns that could potentially result in dietary (food) exposures: 1) clean

- in

- place uses in piping and tubing associated with water lines in animal, l ivestock, and poultry housing facilities (EPA Reg. No. 3377

- 55); and 2) uses in pulp and paper mills that produce paper products that may contact food (EPA Reg. Nos. 3377

- 55
, 3377

- 79 , and 3377

- 78). The clean

- in

- place label (EPA Reg. No. 3377

- 55) clearly i ndicates that prior to use, the animals, livestock, and birds should be removed from the premises and therefore an assessment of human dietary exposures due to consumption of treated livestock are not anticipated to be required at this time

. Even though a FCN is available for bromine chloride and sulfamic acid is classified as GRAS in the manufacture of paper and paperboard , FFDCA clearances are required for the active ingredients listed on the labels if there is the potential for residues in/on food due to contact with treated items. FFDCA clearances are not available for sodium N

- bromosulfamate, sodium N

chlorosulfamate, potassium N

- bromosulfamate, and potassium N

- chlorosulfamate . The registrant has indicated an interest in retaining these uses and obt aining the appropriate FDA clearances for these active ingredients; therefore, EPA anticipates the need to conduct a dietary (food) assessment as part of registration review for these uses. This assessment will reflect any updated policies, consumption da ta, and any changes to the toxicity points of departure. Additionally, since these uses are expected to result in residues less than 200 ppb based on a screening

- level analy sis of the pulp and paper use , chronic toxicity and carcinogenicity data are not a nticipated to be required. If FFDCA clearances are not obtained for sodium bromosulfamate, sodium chlorosulfamate, potassium bromosulfamate, and/or potassium chlorosulfamate , then t he labels (EPA Reg. Nos. 3377

- 55; 3377

- 79; 3377

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Page 19 of 39 to in dicate that N

- bromosulfamate salts and mixtures cannot be used in the manufacture of pulp and paper products that contact food. The registrant has indicated an interest in retaining these uses and obtaining the appropriate FDA clearances for these active i ngredients.



### 3.2.2 Drinking Wate r A drinking water assessment is anticipated to be required based on the use of N

- bromosulfamate salts and mixtures in once

- through cooling water systems which is the use predicted to result in surface water residues. Brea kdown of the bromosulfamate parent is expected to be faster at high pHs, but dehalogenation is expected at all environmental pHs. The amount of time required from release from the cooling water system to the drinking water intake and further through the
tr eatment facility to the tap is expected to be long enough for complete dehalogenation. Therefore, the primary residue that is expected to reach drinking water is sulfamic acid
, and chronic toxicity data are anticipated to be required

. If the environmenta l fate data which are anticipa ted to be required for registration review show that sulfamic acid degrades rapidly, the agency would not expect a drinking wat er assessment to be necessary. If no drinking water assessment is needed, the Combined Chronic Toxi city/Carcinogenicity study which is anticipated to be needed for chronic dietary (drinking water) assessment will not be necessary.



## 3.3 Occupational and Residential Exposures
The agency anticipates the need to conduct a new occupational handler assessment and request new exposure data since an occupational assessment was n ot previously conducted for N

bromosulfamate salts and mixtures . Use of N

- bromosulfamate salts and mixtures may result in occupational handler exposures as presented in Table 8

. 

### 3.3.1 Occupational H andler Exposure The agency has identified the potential for liquid pour o ccupational exposure s. The latest registered labels do not pr ohibit liquid pour applications. Therefore, the agency w ill need to conduct an occupational assessment for liquid pour app lications via the dermal and inhalation exposure route and anticipates calling in data to support this assessment . If all N

- bromosulfamate salts and mixtures labels are revised to prohibit liquid pour applications for N

- bromosulfamate salts and mixtures , t he agency would not anticipate the need to conduct a handler risk
assessment.

Table 8

– O ccupational Handler Exposure Scenarios for N

- bromosulfamate salts and mixtures
Occupational Exposures Exposure Route(s) Duration
Applying N

- bromosulfamate salts and mixtures biocide using liquid pour Dermal Inhalation Short and Intermediate Term 

### 3.3.2 Occupational Post

- application Exposure The agency does not anticipate the need to conduct an occupational post

- application risk assessment since exposure potential is mi nimal. The post

- application workers would not beDocket Number EPA

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Page 20 of 39 expected to regularly contact treated N

- bromosulfamate salts and mixtures and any infrequent exposure would be limited to a dilu ted solution which is not volatile.



### 3.3.3 Residential Handler Exposures
The N

- bromos ulfamate salts and mixtures products are not used in residential settings. Therefore, homeowners are not expected to handle N

- bromosulfamate salts and mixtures products

. No additional residential handler assessments or data are expected to be required.



### 3.3.4 Re sidential Post

- Application Exposures

Residential post

- application exposure concerns are not expected since N

- bromosulfamate salts and mixtures products are not used in residential settings. No additional residential post

application assessments or data are expected to be required.



## 3.4 Aggregate and Cumulative Exposure

3.4.1 Aggregate Exposures

A n aggregate exposure assessment is anticipated for N

- bromosulfamate salts and mixtures , based on the dietary and drinking water exposures to the chemical , from pulp and paper uses as well as use in once

- through cooling towers . There are no residential uses for these chemicals

. 

### 3.4.2 Cumulative Exposures

With respect to cumulative exposure, unlike other pesticides for which EPA has followed a cumulative risk approach based on a co mmon mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for the N

- bromosulfamate salts and mixtures

. N

bromosulfamate salts and mixtures do not appear to produce a toxic metabolite produced by other substances. For the purpose s of this registration review, therefore, EPA has not assumed that the N

- bromosulfamate salts and mixtures have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechani sm of toxicity and to evaluate the cumulative effects of such chemicals, see http://www.epa.gov/pesticides/cumulative/

. 

## 4 Environmental Risk Assessment

N

- bromosulfamate salt and mixture s were initiall y included in the Bromine chloride registration review case and subsequently switched to their own case pursuant to 40CFR 155.42(b)(2). Since no ecological risk assessment was previously performed on these ingredients, the agency has determined that all uses may have the potential to lead to environmental exposure. Specifically, the potential for ecological exposures as a r esult of registered uses of N

bromosulfamate salts and mixtures (i.e., cooling and process water systems, heat transfer systems, air washers, industrial scrubbing systems, containerized ponds and decorative fountains, industrial once

- through cooling water systems, pulp, and paper mills, wastewater systems, oilfield applications [ oil recovery well fluids, fracturing fluids, secondary oi l recovery wellDocket Number EPA

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Page 21 of 39 fluids, pumps, pipeworks, heat exchangers, and filters ] ) cannot be ruled out, and the potential for exposure and risk must be evaluated and data is anticipated to be called in

. The agency has not previously conducted a risk assessment that supports a complete endangered species determination for N

- bromosulfamate salts and mixtures . The ecological risk assessment planned during registration review will allow the agency to determine potential acute and chronic risks to aquatic organisms expose d to N

- bromosulfamate salts and mixtures or transformation products transported from treatment sites into the aquatic environment. The risk assessment also will allow the agency to determine whether each use has 'no effect' or 'may affect' federally liste d threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use 'may affect' a listed species or its designated critical habitat, the agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.



## 4.1 Environmental Fate Assessment

N

- bromosulfamate salts and mixtures products are mixtures of chlorinated or brominated sulfamic acid salts with either sodium or potass ium as cations. G uideline data on environmental fate on the active ingredients and carrier molecule (sulfamic acid) have not be en submitted but

are anticipated to be required (T able 7 ). However, based on the chemical structure, N

bromosulfamate salts and mixtures are expected to degrade by disassociation in water to remove cations and by hydrolysis to release halogens and form the sulfamic acid degradate. As with other halogenated compounds, hydrolysis is expected to occur faster at higher pH values. Re lease of chlorine and bromine atoms will form hypochlorous and hypobromous acid, both of which are highly

- reactive and non

- persistent. All residues of N

- bromosulfamate salts and mixtures (including sulfamic acid) are highly water soluble, not likely to so rb to soil, sediment, or sludge, and not likely to volatilize or bioconcentrate based on the chemical and physical properties in Table 4 and Table 5

. 

### 4.1.1 WWTP Data on degradation (835.3110, 835.3220, 83 5.3240, and 835.3280) and toxicity (850.3300) have not be en submitted for a parent N

- bromosulfamate salts and mixtures compound and the degradate sulfamic acid . Sorption to sludge (835.1110) is expected to be minimal for all residues and data are not required.



### 4.1.2 Water Quality

N

- bromosulfamate salts and mixtures and the degradate sulfamic acid are not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 2 In addition, no Total Maximum Daily Loads (TMDL) have been developed for

2 http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d?p_cause_group_id=885Docket Number EPA

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Page 22 of 39 NBSD and its degrada tes

. 3 More information on impaired water bodies and TMDLs can be found at EPA’s website

. 4



## 4.2 Conceptual Model s for Environmental Exposure Pathways

N

- bromosulfamate salts and mixtures can be used as a fungicide, algaecide, slimicide, and microbiocide in cooli ng and process water systems, heat transfer systems, air washers, industrial scrubbing systems, containerized ponds and decorative fountains, industrial once

- through cooling water systems, pulp, and paper mills, wastewater systems, oilfield applications (o il recovery well fluids, fracturing fluids, secondary oil recovery well fluids, pumps, pipeworks, heat exchangers, and filters).
Based on the summary of registered uses of N

- bromosulfamate salts and mixtures presented in Table 6 and physical/chemical prop erties presented in Table 4 , the agency has developed conceptual model diagrams for exposure of ecological organisms to N

- bromosulfamate salts and mixtures and its degradate sulfamic acid. These conceptual models are located at “Conceptual Models for Envi ronmental Exposure Pathways of Antimicrobial Pesticides” (EPA

- HQ

- OPP

2014

- 0638

- 0002), found at www.regulations.gov in docket EPA

- HQ

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- 2014

- 0638

. 5 For cooling and water process systems, heat transfer systems, ai r washers, and industrial once

through cooling water systems, refer to slides 13 and 14. For pulp and paper mills, refer to slide 26. For containerized ponds and decorative fountains, refer to slides 27 and 28. For oil recovery drilling muds/packer fluid s, and secondary oil recovery injection water, refer to slides 19 and 20. The screening

- level risk assessment that will be conducted as part of this registration review will evaluate potential risks to ecological organisms from exposure to parent compound and the degradate sulfamic acid.



### 4.2.1 Ecological Effects (Ecotoxicology Endpoints) Acute and chronic toxicity data from registrant

- submitted studies (850 OCSPP Harmonized Test Guidelines) are used to evaluate the potential effects to aquatic and terrestrial n ontarget organisms

. Because these compounds release chlorine or bromine in water, exposure of aquatic organisms is expected to be to chlorine byproducts and sulfamic acid. No data are available for any TGAI. Chlorine data is available from EPA’s Ambient Water Quality Criteria for Chlorine

– 1984 (AWQC, EPA 1985) and will be used to assess risks to aquatic organisms exposed to chlorine. No data are available for sulfamic acid. Because sulfamic acid might persist longer than chlorine in the aquatic envir onment, chronic studies are needed for fish and aquatic invertebrates. Four acute studies (bird, fish, aquatic invertebrate, green algae) are also needed to support the basic ecotoxicity data requirements for a TGAI. Those data can be generated on one TGA I and bridged to the others.

3 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_po llutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES
4 http://www.epa.gov/owow/tmdl/
5 See http ://www.regulations.gov/#!documentDetail;D=EPA

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Page 23 of 39 The available chlorine ecotoxicity endpoints are provided in Table 9

. Additionally, o pen literature studies will be identified through EPA’s ECOTOXicology (ECOTOX) database , which will be searched when the risk assessment is prepared. Any acute or chronic endpoints more sensitive than what is currently available may be used in the risk assessment.

Table 9

– Ecological Effects Endpoints

Receptor

Group Test Material 1 Scenario Toxicity Endpoint (μg/L) Reference

Freshwater f ish TGAI Acute No data

--

TRC Acute 40 EPA 1985
Chronic 11.2 EPA 1985
Sulfamic acid Chronic No data

--

Freshwater invertebrates TGAI Acute No data

--

TRC 1 Acute 17 EPA 1985
Chronic 3.7 EPA 1985
Sulfamic acid Chronic No data

--

Estuarine/ma rine fish CPO Acute 32 EPA 1985
Chronic 46.4 EPA 1985
Estuarine/marine

invertebrates CPO Acute 26 EPA 1985

Aquatic plants TGAI EC50 and NOAEC No data

--

Birds TGAI Acute No data

--

1 In accordance with the AWQC (EPA 1985), TRC (total residual chlorin e) and CPO (chlorine

- produced oxidants) are used to denote chlorine

based toxicity values in freshwater and estuarine water, respectively

.


## 4.3 Exposure Analysis Plan

4.3.1 Aquatic and Terrestrial Wildlife Exposure Estimates

Available models will be used to determin e the estimated environmental concentration (EECs) in the aquatic environment including direct (end of pipe) exposure from uses such as oil recovery and wastewater systems as well as down

- the

- drain exposures for waters treated in a WWTP

. Resulting exposu re estimates will be compared to the toxicity endpoints to determine if levels of concern are exceeded for each receptor group.



### 4.3.2 Screening Level Down

- the

- Drain Analysis

The Down

- the

- Drain (DtD) module of E

- FAST (Exposure and Fate Assessment Screening Tool) i s used to determine the potential for aquatic organisms downstream of domestic wastewater treatment plants that receive discharges from end

- use of N

- bromosulfamate salts and mixtures to be exposed to N

- bromosulfamate salts and mixtures and its by

- product s

. Because of the lack ofDocket Number EPA

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Page 24 of 39 ecological toxicology data, it is not possible to run the DtD model for bromosulfamates at the present time.

The agency anticipates needing data (Table 7 ) on N

- bromosulfamate salts and mixtures to fulfill data gaps regarding toxi city to activated sludge microorganisms and biodegradation of N

bromosulfamate salts and mixtures during wastewater treatment

. 

## 4.4 Effects Analysis Plan
Additional open literature studies will be identified through EPA’s ECOTOXicology (ECOTOX) database. The E COTOX database will be searched during the risk assessment phase of N

bromosulfamate salts and mixtures and the data reviewed following the agency’s policy for reviewing public literature to be more sensitive than those currently in Table 9 and or which

sa tisfy an existing data gap(s) will be used during the risk assessment phase of N

bromosulfamate salts and mixtures to update Table 9

. ECOTOX was created and is maintained by the USEPA, Office of Research and Development, and the National Health and Enviro nmental Effects Research Laboratory’s Mid

- Continent Ecology Division.


## 5 Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, t hese studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influ ence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests a nd chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups

. However, as required by FFDCA section 408(p), N

- bromosulfamate salts and mixtures are subject to the endocrine screening part of the Endocrine Dis ruptor Screening Program (EDSP).
EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estroge n, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical su bstance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDS P where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and establish a dose

- response relationship betwee n the dose and the E, A, or T effect.
Under FFDCA section 408(p), the agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals,Docket Number EPA

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Page 25 of 39 which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 6 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists shoul d be construed as a list of known or likely endocrine disruptors.
For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website

. 7


## 6 Optional Label Changes

The agency invites any label amendments that could be considered to eliminate the anticipated need for EPA to require certain data, reduce the possibility that EPA’s planned risk assessments overestimate risk due to relia nce on conservative assumptions, and/or improve label clarity.

Since FCNs are chemical

- specific, as indicated in section 3.2.1 the Albemarle bromine chloride FCN no longer applies to N

- bromosulfamate salts and mixtures. If FFDCA clearances are not obtaine d for sodium bromosulfamate, sodium chlorosulfamate, potassium bromosulfamate, and/or potassium chlorosulfamate , then t he labels (EPA Reg. Nos. 3377

- 55; 3377

- 79; 3377

- 78)
must be revised to indicate that N

- bromosulfamate salts and mixtures cannot be used i n the manufacture of pulp and paper products that contact food.

Also, as indicated in section 3. 3.1 , if labels are revised to prohibit liquid pour, the agency would not anticipate the need to call in exposure data and conduct an occupational handler asses sment.


## 7 Next Steps

After the F WP for the N

- bromosulfamate salts and mixtures case is posted to the docket at EPA

HQ

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- 026 5 , a DCI will be developed regarding the data needs listed under the “Anticipated Data Needs” section of this document. The Agenc y expects to issue the DCI by March 201 7

.

6 See http://www.regulations.gov/#!documentDetail;D=E PA

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- 0074 for the final second list of chemicals.
7 http://www.epa.gov/endo/.Docket Number EPA

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Page 26 of 39 

## 8 References

Adam, L.C., Fabian, I., Suzuki, K. and Gordon, G. “Hypochlorous Acid Decomposition in the pH 5

- 8 Region”, Inorganic Chemistry, 1992, vol. 31, pp. 3534

- 3541.

European Chemicals Agency: http://apps.echa.europa.eu/registered/data/dossiers/DISS

97d74cbc

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- 00144f67d031.html

. Envirotech. TECHNICAL BULLETIN: UV Exposure and BromMax. ht tp://www.stabilizedbromine.com/pdf/BromMax

- UV%20Tech%20Bulletin.pdf

. Gowda, S. September 19, 2007. Environmental Fate Assessment of Sodium Hypochlorite (12.5%) for the Proposed Use in Oilfield Water Systems (New Use Registration). D338622.

Ingham, T., Bauer, D., Landgraf, J., and Crowley, J.N. 1998. Ultraviolet/visible absorption cross sections of gaseous HOBr, J. Phys. Chem., 102: 3293

- 3298. Spectrum located at http://vpl.a stro.washington.edu/spectra/hobringhamfig1.jpg

. Lyman, W.J., W.F. Reehl, and D.H. Rosenblatt. 1990. Handbook of Chemical Property Estimation Methods. American Chemical Society. ISBN O

- 8412

- 1761

- 0.

U.S. Environmental Protection Agency (EPA). 2002. ECOTO X User Guide: ECOTOXicology Database System. Version 3.0. Available: http://www.epa.gov/ecotox/

. U.S. Environmental Protection Agency. High Production Volume Information System (HPVIS). http://www.epa.gov/hpvis/

. U.S. Environmental Protection Agency. Ambient Water Quality Criteria for Chlorine

– 1984. EPA 440/5

- 84

- 030, January, 1985.Docket Number EPA

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# Appendix A T oxicology Profile

Acute Toxicity for Product Labeling

A cute toxicity studies are available for the Albemarle® S909 Biocide label (EPA Reg# 3377

- 55 ; 18% sodium bromosulfamate and sodium chlorosulfamate ). Acute toxicity studies were not located for the other three current labels for N

- bromosulfamates. The summary of the acute toxicity data for the Albemarle® S909 la bel is shown below in Table A1

.
Table A1

– Acute Toxicity Studies for Albemarle S909 Biocide
Guideline No./ Study Type MRID No. Results Toxicity Category 870.1100/ Acute oral toxicity 44792105 LD 50 = 2 491 mg/kg ( males and females ) III

870.1200/ Acu te dermal toxicity 44792106 LD 50 > 2000 mg/kg (males and females) III

870.1300/ Acute inhalation toxicity 44792107 LC 50 > 2.09 mg/L IV

870.2400/ Acute eye irritation N/A Category I label language assigned I

870.2500/ Acute dermal irritation N/A Category I label language assigned I

870.2600/ Skin sensitization 44792109 no evidence of sensitization Non

sensit i zer N/A=Not available 

## Subchronic Toxicity

The agency’s records indicate subchronic toxicity studies were previously submitted for s ulfamic acid, but the studies are not adequate

. The agency has no data on subchronic toxicity of the N

bromosulfamates and mixtures. The agency further has no information on whether the N

bromosulfamates and mixtures are equivalent to sulfamic acid in term s of subchronic toxicity. A subchronic toxicity study by the oral route conducted using the OCSPP 870.3100 guideline is anticipated to be required for the N

- bromosulfamate salts and mixtures , as specified in Table 7 of this preliminary workplan

. A subchron ic inhalation toxicity study using OCSPP 870.3465 guideline is also anticipated to be required, as specified in Table 7

. Currently, t here are only summary data available on sulfamic acid through the European Chemical Agency website (http://apps.echa.europ a.eu/regist ered/data/dossiers/DISS

- 97d74cbc

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.Docket Number EPA

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## Deve lopmental Toxicity

There are no developmental toxicity studies for N

- bromosulfamate s alts and mixtures or the sulfamic acid degradate in the agency’s records. The agency has no data on developmental toxicity of the N

- bromosulfamates and mixtures or sulfam ic acid. The agency further has no information on whether the N

- bromosulfamates and mixtures are equivalent to sulfamic acid in terms of developmental toxicity. Developmental toxicity studies by the oral route in the rat and rabbit conducted according to t he OCSPP 870.3700 guideline are anticipated to be required for the N

- bromosulfamate s alts and mixtures , as specified in Table 7 of this preliminary workplan

. Based on the lack of developmental toxicity information for either the N

- bromosulfamate salts and mixtures and sulfamic acid , developmental toxicity studies using both are anticipated, unless they can be shown to be toxicologically equivalent (i.e. produce similar effects at similar doses or concentrations). Currently, t here are only summary data avai lable on sulfamic acid through the European Chemical Agency website (http://apps.echa.europa.eu/registered/data/dossiers/DISS

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- 09ab

- e044

- 00144f67d031_DISS

- 97d74cbc

- 1047

- 09abe044

- 00144f67d031.html). 

## Reproductive Toxicity

The agency’s records indicate reproductive toxicity data were submitted, but these data do not provide adequate information on reproductive toxicity of N

- bromosulfamate s alts and mixtures or sulfamic acid. The agency has no adequate d ata on reproductive toxicity of the N

bromosulfamates and mixtures or sulfamic acid. The agency further has no information on whether the N

- bromosulfamates and mixtures are equivalent to sulfamic acid in terms of reproductive toxicity. A reproductive and f ertility effects toxicity study by the oral route conducted according to the OCSPP 870.3800 guideline is required for the N

- bromosulfamate

s alts and mixtures , as specified in Table 7 of this registration review. Based on the lack of reproductive toxicity i nformation for either the N

- bromosulfamate salts and mixtures and sulfamic acid , reproductive toxicity studies using both are anticipated, unless they can be shown to be toxicologically equivalent (i.e. produce similar effects at similar doses or concentra tions). Currently, t here are only summary data available on sulfamic acid through the European Chemical Agency website (http://apps.echa.europa.eu/registered/data/dossiers/DISS

- 97d74cbc

1047

- 09ab

- e044

- 00144f67d031/DISS

- 97d74cbc

- 1047

- 09ab

- e044

- 00144f67d03 1_DISS

- 97d74cbc

- 1047

- 09abe044

- 00144f67d031.html). These data indicate studies that are to be planned for sulfamic acid, and are summary data only. 

## Chronic Toxicity

There are no chronic toxicity data in the agency’s records for N

- bromosulfamate s alts and mixtures or sulfamic acid. The agency further has no information on whether the N

bromosulfamates and mixtures are equivalent to sulfamic acid in terms of chronic toxicity. A chronic toxicity study by the oral route is anticipated to be required to assess hazard from drinking water exposure to the N

- bromosulfamate s alts and mixtures , as specified in Table 7 of this workplan

. H uman health toxicity data are not anticipated to be required on N

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Page 29 of 39 bromosulfamate salts and mixtures since the potential residue in d rinking water is expected to be sulfamic acid

. There are currently only summary data available on sulfamic acid through the European Chemical Agency website ( http://apps.echa.europa.eu/registered/data/dossiers/DISS

97d74cbc

- 1047

- 09ab

- e044

- 00144f67d031/DISS

- 97d74cbc

- 1047

- 09ab

- e044

- 00144f67d031_DISS

- 97d74cbc

- 1047

- 09abe044

- 00144f67d031.html). There is no indication in this reference that a chronic toxicity study is available or is being planned for sulfamic acid. This study is anticipated to be required to ass ess the hazard from the drinking water exposure in once

through cooling towers

. 

## Carcinogenicity

No carcinogenicity data are available for N

- bromosulfamate s alts and mixtures or sulfamic acid. C arcinogenicity data are anticipated as required for the once

- through cooling tower use on sulfamic acid for purposes of registration review. Similar to the chronic toxicity data requirement, h uman health toxicity data are not anticipated to be required on N

- bromosulfamate salts and mixtures since the potential resi due in drinking water is expected to be sulfamic acid

. 

## Mutagenicity

No mutagenicity data are available in the a gency’s records for N

- bromosulfamate salts and mixtures or sulfamic acid. Mutagenicity studies conducted according to the appropriate OCSPP guid eline (as specified in Table 7 of this preliminary work plan) are anticipated to be required for the N

- bromosulfamate s alts and mixtures

. Based on the lack of mutagenicity information for either the N

- bromosulfamate salts and mixtures and sulfamic acid , mu tagenicity studies using both are anticipated, unless they can be shown to be toxicologically equivalent (i.e. produce similar effects at similar doses or concentrations). There are currently only summary data available on sulfamic acid through the Europe an Chemical Agency website (http://apps.echa.europa.eu/registered/data/dossiers/DISS

- 97d74cbc

- 1047

- 09ab

- e044

- 00144f67d031/DISS

- 97d74cbc

- 1047

- 09ab

- e044

- 00144f67d031_DISS

- 97d74cbc

- 1047

- 09abe044

- 00144f67d031.html). These data indicate studies that are to be p lanned for sulfamic acid, and are summary data only. 

## Neurotoxicity

The database for neurotoxicity for N

- bromosulfamate salts and mixtures is considered incomplete. There are no neurotoxicity studies in the agency’s hazard database. A neurotoxicity

sc reening battery is anticipated to be required for registration review risk assessment, based on the indirect food use. However, if no evidence of neurotoxicity is observed in the 90

- day oral toxicity study, then the neurotoxicity screening battery may not be anticipated to be required.



## Other Toxicological Effects

It is not currently possible to characterize whether the N

- bromosulfamate s alts and mixtures have other toxicological effects, based on the lack mammalian toxicity data

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Page 30 of 39 on other effects other than those discussed in this section, the toxicity will be characterized as part of the toxicology database.Docket Number EPA

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Page 31 of 39 

# Appendix B Environmental Fate

Environmental Fate and Transport Properties of N

- bromosulfamate salts and mixtures chemi cals and the Sulfamic Acid Degradate

N

- bromosulfamate salts and mixtures products are mixtures of chlorinated or brominated sulfamic acid salts with either sodium or potassium as cations

. G uideline data on environmental fate have not been submitted but ar e anticipated to be required (see Table 7 ). However, based on the chemical structure, N

- bromosulfamate salts and mixtures are expected to degrade by disassociation in water to remove cations and by hydrolysis to release halogens and form the sulfamic acid degradate. As with other halogenated compounds, hydrolysis is expected to occur faster at higher pH values. Release of chlorine and bromine atoms will form hypochlorous and hypobromous acid, both of which are highly

- reactive and non

- persistent. All res idues of N

bromosulfamate salts and mixtures (including sulfamic acid) are highly water soluble, not likely to sorb to soil, sediment, or sludge, and not likely to not likely to volatilize or bioconcentrate based on the chemical and physical properties in Table 4 and Table 5

.
Water and Sediment
Hydrolysis
Data have not been submitted for hydrolysis and are anticipated to be required to address the formation and decline rate of hypobromous or hypochlorous acid because the primary degradation products of N

- br omosulfamate salts and mixtures compound s are hypochlorous and hypobromous acid (active ingredients) . The carrier molecule, sulfamic acid
, does not have any hydrolyzable function groups and therefore is not expected to degrade by the presence of water (Ly man, 1990).
Aqu eous Photoly s is

Data on photodegradation in water have not been submitted and are anticipated to be required. According to Envirotech
, 8 the N

- bromosulfamate salts and mixtures compounds are very sensitive to UV light and degrade faster as t he concentration increases.

Octanol

- Water Partition Coefficient and Bioconcentration in Fish
Based on the estimated log Kow values and high water solubilit y values for N

- bromosulfamate salts and mixtures compounds in Table 4 and for sulfamic acid in Tabl e 5, bioconcentration in fish and other aquatic organisms is not expected to occur.

8 Envirotech, http://www.stabilizedbromine.com/pdf/BromMax

- UV%20Tech%20Bul letin.pdf

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Page 32 of 39 Aerobic Aquatic Metabolism

Data on aerobic aquatic metabolism have not been submitted and are anticipated to be required for one N

- bromosulfamate salts and mixtures comp ound and the degradate sulfamic acid.

A n a erobic Aquatic Metabolism

Data on anaerobic aquatic metabolism have not been submitted but are not anticipated to be required because of the limited sorption associated with high water solubility for both N

bromosu lfamate salts and mixtures (Table 4) compounds and the sulfamic acid degradate (Table 5)

.
Soil
Soil Leaching/Adsorption/Desorption Batch Equilibrium

Data on leaching

- adsorption

- desorption have not been submitted and are anticipated to be required for one N

- bromosulfamate salts and mixtures compound and the degradate sulfamic acid.

Aerobic Soil Metabolism

Data on aerobic soil metabolism have not been submitted and are anticipated to be required for

one N

- bromosulfamate salts and mixtures compound and the de gradate sulfamic acid.

A n a erobic Soil Metabolism

Data on anaerobic soil metabolism are not anticipated to be required because N

- bromosulfamate salts and mixtures compounds and the sulfamic acid deg radate are expected to degrade under aerobic conditions and not reach lower soil depths.
Fate and Transport in WWTP
Activated Sludge Sorption Isotherm
Data on activated sludge sorption isotherm (ASSI) were not submitted but are not anticipated to be required because the log Kow values of all N

- bromosulfamate sa lts and mixtures compounds is

- 5.45 (Table 4) and the log Kow for the degradate sulfamic acid is 0.1 (Table 5) , both of which are less than three. According to the Final 158W Rule, ASSI data are not required if the log Kow is <3 (Footnote 19
, Antimicrobia l Environmental Fate Data Requirements Table ).
Activated Sludge Biodegradation
Data on activated sludge biodegradation are expected to be required for one of the N

bromosulfamate salts and mixtures compounds and the degradate sulfamic acid because of chem ical similarity between the active ingredients and sulfamic acid because it is the primary residue after the disassociation of chlorine and bromine from the parent compound molecules.Docket Number EPA

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Page 33 of 39 Activated Sludge Respiration Inhibition

ASRI data are anticipated to be required for one of the N

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# Appendix C Ecotoxicology Profile

There is no ecotoxicity data for the N

- bromosulfamate salts and mixtures products

. See section 4.2.1 for stud ies anticipated to be required

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Page 35 of 39 

# Appendix D Screening Level Down

the

- Drain Analysis

The Down

- the

- Drain (DtD) module of E

- FAST (Exposure and Fate Assessment Screening Tool), [version 2] will be used to screen for the potential for aquatic organisms downs tream of domestic wastewater treatment plants to be exposed to N

- bromosulfamate salts and mixtures and its degradates . The Down

- the

- Drain module uses daily per capita release of household wastewaters, stream dilution factors, and wastewater treatment plant removal efficiency to provide both high

end and median (average) time

- averaged surface water concentrations of chemicals discharged by domestic wastewater treatment plants. The high

- end scenario uses surface water concentrations downstream of domestic was tewater treatment plants based on the 10 th percentile stream dilution factor (SDF); the average scenario uses surface water concentrations based on the 50 th percentile SDF. SDF is defined as the ratio of the stream flow downstream of a wastewater
treatment plant to the wastewater treatment plant flow. Inputs used to run the DtD module included concentrations of concern (COCs) for aquatic organisms, percent removal during wastewater treatment, and hypothetical wastewater treatment plant influent volumes. The results of the DtD module are expressed as number of days of exceedance of COCs for aquatic organisms. COCs for acute effects were determined by dividing LC 50 values (or EC 50 values, if appropriate) from acute toxicity tests on aquatic vertebrates and inv ertebrates by 2. COCs for listed endangered and threatened aquatic organisms were determined by dividing LC 50 values from acute toxicity tests on aquatic vertebrates and invertebrates by 20

. COCs for chronic effects for non

- listed and listed species were b ased on NOAEC values fr om tests on aquatic vertebrates and invertebrates

. COCs for non

- listed and listed aquatic plant species were determined by using the IC 50 and NOAEC, respectively, from aquatic plant tests

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# Appendix E Product Chemistry

N

- brom osulfamate salts and mixtures products with active labels are included in Table E1 which presents the active ingredient (s) to be assessed in case 5069. In Case 5069, the only PC Codes with active labels include 028960, 028961, and 028964. Within these PC Codes, the active ingredients include the N

- bromosulfamate and N

- chlorosulfamate salts of sodium and potassium. Table E1 below includes the PC Codes and the active ingredients.

Table E1 . Active Ingredients in N

- bromosulfamate Salts and M ixtures Produc ts by PC Code

PC Code Active Ingredient Sodium N

bromosulfamate Sodium N

chlorosulfamate Potassium N

bromosulfamate Potassium N

chlorosulfamate 028960 028961 028964 028960, 028961, 028964 028961, 028964 028964 028964

Table E2 below includes the chemical identification of the active ingredients and Table E3 includes the chemical and physical properties.

Table E2

– Chemical Identification of N

- bromosulfamate salts and mixtures Products Chemical Name Sodium N

bromosulfamate Sodium N

- chlorosulfamate Potassium N

bromosulfamate Potassium N

chlorosulfamate Chemical Classification Bromosulfamate salt Chlorosulfamate salt Bromosulfamate salt Chlorosulfamate salt

PC Code of active ingredient 028960, 028961, and 028964 028961, 028964, and 0 28960 02896 3 028962

PC Codes with active registrations containing this chemical 028960, 028961, and 028964 028961 and 028964 02896 4 02896 4

CAS Number 134509

- 56

- 1 1 363 7

- 90

- 6 1192047

- 27

- 0 1192047

- 23

- 6 Smiles code BrNS(=O)(=O)(O[Na]) CLNS(=O)(=O)(O[Na]) BrNS(=O)(= O)(O[K]) ClNS(=O)(=O)(O[K]) Molecular Formula H 1 Br 1 N 1 O 3 S 1 Na 1 H 1 Cl 1 N 1 O 3 S 1 Na 1 H 1 Br 1 N 1 O 3 S 1 K 1 H 1 Cl 1 N 1 O 3 S 1 K 1
Molecular Weight (grams/mole) 197.97 153.52 214.07 169.62

Molecular Structure


### B r N H S O
O O N

a



### C l N H S O
O O N

aDocket Number EPA

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Page 37 of 39 Guideline data on product chemistry were not submitted for an y of the N

- bromosulfamate salts and mixtures compounds. However, the EPI

- WEB 4.11 model provides adequate product chemistry data, and as a result, the N

- bromosulfamate salts and mixtures product chemistry information from EPI

- WEB 4.11 that is relevant to risk assessment is summarized in Table E3 for the active ingredients and in Table E4 for the degradate sulfamic acid.

Table E3

– Estimated Physical and Chemical Properties for N

- bromosulfamate salts and mixtures

Guideline No. Parameter 3 Sodium N

bromos ulfamate Sodium N

chlorosulfamate Potassium N

bromosulfamate Potassium N

chlorosulfamate Source (EPI

- WEB 4.11 unless stated)

830.7050 UV/Visible Absorption These active ingredients form hypobromous acid and hypochlorous acid, and UV/Visible absorptio n similar for both hypobromous acid (Ingham, 1998) 1 and hypochlorous acid (Adam, 1992) 2 with a typical wavelength range of 290

- 380 nm. Ingham, 1998 Adam, 1992

830.7370 Dissociation
constant (pKa) No t available

EPI

- WEB 4.11 830.7550 Octanol

wate r partition coefficient at 25 o C (Log K ow ) - 5.45

830.7840 Solubility in water (mg/L) at 25 o C 1 x 10 6

830.7950 Vapor pressure (mmHg) at 25 o C 8.5 x 10

- 21 3.1 x 10

- 20 8.5 x 10

- 21 3.1 x 10

- 20

None Henry's law
constant at 25 o C (atm

m 3 /mol) 2.2 x 1 0

- 27 6.2 x 10

- 27 2.4 x 10

- 27 6.8 x 10

- 27

1 Ingham, T., Bauer, D., Landgraf, J., and Crowley, J.N. 1998. Ultraviolet/visible absorption cross sections of gaseous HOBr, J. Phys. Chem., 102: 3293

- 3298. Spectrum located at http://vpl.astro.washington.edu/ spectra/hobringhamfig1.jpg.
2 Adam, L.C., Fabian, I., Suzuki, K. and Gordon, G. “Hypochlorous Acid Decomposition in the pH 5

- 8 Region”, Inorganic Chemistry, 1992, vol. 31, pp. 3534

- 3541.
3 am

- m 3 /mol = atmosphere cubic meter per mole; o C = degrees Celsius; m g/L = milligrams per liter; mmHg = millimeters of mercury.Docket Number EPA

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Page 38 of 39 Table E4

- Estimated Physical and Chemical Properties for Degradate Sulfamic Acid Based on EPI

- WEB 4.11

Guideline No. Parameter Sulfamic Acid Source (EPI

- WEB 4.11 unless stated) None CAS Numb er 5329

- 14

- 6 None None Smiles code O=S(=O)(O)N None None Molecular Formula S 1 O 3 N 1 None

None Molecular Weight (grams/mole) 97.09 EPI

- WEB 4.11

830.7050 UV/Visible Absorption No UV/Visible sorption based on lack of double bonds. Lyman, 1990

830.7370 D issociation constant (pKa) No t available

EPI

- WEB 4.11 830.7550 Octanol

- water partition coefficient at 25 o C (Log K ow ) 0.1

830.7840 Solubility in water (mg/L) at 25 o C 1.5 x 10

- 5

830.7950 Vapor pressure (mmHg) at 25 o C 8.5 x 10

- 21

None Henry's law constant at 25 o C (atm

- m 3 /mol) 2 x 10

- 21

None

Molecular structure

atm

- m 3 /mol = atmosphere cubic meter per mole; o C = degrees Celsius; mg/L = milligrams per liter; mmHg = millimeters of mercury

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# Appendix F Public Comments Received on the Prel iminary Work Plan

There were no public comments submitted to the docket during the comment period.