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N-bromosulfamate salts and mixtures Registration Review Team

Human Health & Environmental Effects

Tim McMahon

Nate Mottl

Julie VanAlstine

Siroos Mostaghimi

Bill Erickson

James Breithaupt

Risk Management

SanYvette Williams

Stacey Grigsby/Jacqueline Hardy

Rose Kyprianou

Office of General Counsel

Philip Ross
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TERMS, ABBREVIATIONS AND SYMBOLS

AD Antimicrobials Division

A.I. or a.i. active ingredient

aPAD acute population adjusted dose 

ASRI activated sludge respiration inhibition

atm-m3

/mole atmospheric pressure-cubic meter per mole

BCF bioconcentration factor 

°C degrees Celsius

CAS Chemical Abstracts Service 

CFR Code of Federal Regulations 

CHO Chinese hamster ovary

CMA Chemical Manufacturers Association

CO2 carbon dioxide

COC concentration-of-concern

cPAD chronic population adjusted dose 

DCI data call-in

EC50 median (or 50 percent) effect concentration

EC05 5 percent effect concentration

ECOTOX ECOTOXicology

EDI estimated daily intake

EDSP Endocrine 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 Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act 

FWP Final Work Plan

g/mol grams per mole

GLN guideline number

HPV high production volume

IDS Incident Data System 

Koc organic carbon normalized soil-water partition coefficient

Kd soil-water partition coefficient

Kow octanol-water partition coefficient

LC50 median (or 50 percent) lethal concentration

LD50 median (or 50 percent) lethal dose

LOAEC lowest-observed-adverse-effect-concentration 

LOEC lowest-observed-effect-concentration

LOAEL lowest-observed-adverse-effect-level

Log Kow logarithm of the octanol-water partition coefficient

μg microgram

ml/g milliliter per gram

mg/kg milligram per kilogram

mg/kg/day milligram per kilogram per day 

mg/L milligram per liter

mm Hg millimeter of mercury

MOE margin of exposure 
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MRID Master Record Identification Number

MRL maximum residue limit 

N/A not applicable 

nm nanometers

NBS and M n-bromosulfamate salts and mixtures

NOAEC no-observed-adverse-effect-concentration

NOAEL no-observed-adverse-effect-level

OCSPP Office of Chemical Safety and Pollution Prevention

OECD Organization for Economic Co-operation and Development

OPP Office of Pesticide Programs

PAD population adjusted dose

PAI pure active ingredient

PDM Probabilistic Dilution Model

% percent

PC Code Pesticide Chemical Code

PCF pounds per cubic foot

pH power of hydrogen or power of the concentration of the hydrogen ion

PHED Pesticide Handler’s Exposure Data

PIS primary irritation score

pKa power of the acid dissociation constant or negative base-10 logarithm of the acid 

dissociation constant of a solution

ppb parts per billion 

ppm parts per million

PWP Preliminary Work Plan

QSAR quantitative structure-activity relationship

RED Reregistration Eligibility Decision

SAR structure activity relationship

SF safety factor

SSTS Section Seven Tracking System

TEP typical end-use product

TGAI technical grade active ingredient

TMDL total maximum daily loads

UF uncertainty factor

UV/VIS ultraviolet/visible light absorption

% w/w percent weight per weight.

WP wettable powder

WWTPs wastewater treatment plants
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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 Regulatory 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 Exposure............................................................................. 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 (Ecotoxicology 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 Endocrine 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 .................................................................................................. 31
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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 – Ecological Effects Endpoints ................................................................ 23
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1 Introduction

This document is the United States Environmental Protection Agency’s (USEPA, EPA or “the 

Agency”) Final Work Plan (FWP) for N-bromosulfamate salts and mixtures. The FWP document 

explains 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 the 

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 Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States generally must be registered by the USEPA 

based on scientific data showing that they will not cause unreasonable risks to human health or 

the environment when used as directed on product labeling. The registration review program is 

intended to make sure that, as the ability to assess risk evolves and as policies and practices 

change, all registered pesticides continue to meet the statutory standard of no unreasonable 

adverse effects to human health or the environment. Changes in science, public policy, and 

pesticide use practices will occur over time. Through the registration review program, the agency

periodically reevaluates pesticides to make sure that as change occurs, products in the 

marketplace can be used safely. Information on this program is provided 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 it continues to meet the FIFRA standard for 

registration. The regulations governing registration review begin at 40 CFR 155.40. The agency

will consider benefits information and data as required by FIFRA. The public phase of 

registration review begins when the initial docket is opened for each case. The docket is the 

Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses 

and data or information it believes are needed to make a registration review decision.

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.

• Updated Section 1.7 Incidents - Recent search dates of February 3, 2016 are noted.
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• 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 

needed only for the once-through cooling tower use.

• Updated 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 indicated in Appendix F, the 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-bromosulfamate 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 docket. Tables 1 and 2 below summarize 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-bromosulfamate 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 details)

Dietary (food) Yes N/A New

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

Developmental 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 Exposure

Product Use

Occupational PostApplication No N/A None None
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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 details)

Residential Handler No N/A None None 

Residential Post 

Application - Incidental 

Oral and Dermal 

No N/A None None 

Residential Post 

Application - Inhalation No N/A None None

Aggregate No 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. 

Table 2 – Anticipated Registration Review Schedule

Anticipated Activity Target Date* Completion Date

Phase 1: Opening the Docket 

Open Docket and 60-Day Comment Period for Preliminary Work Plan 2015-09 2015-10-02

Close Public Comment Period 2015-11 2015-12-01

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 Proposed Decision 2021-03

Close Public Comment Period 2021-05

Issue Final Decision 2021-09

Begin Post-Decision Follow-up 2021
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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 Identification 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 these PC codes, the active ingredients 

include the N-bromosulfamate and N-chlorosulfamate 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 bromine.

Table 3 – Chemical Identification of N-bromosulfamate salts and mixtures

Chemical Name Sodium Nbromosulfamate 

Sodium Nchlorosulfamate Potassium Nbromosulfamate Potassium Nchlorosulfamate 

Chemical

Classification Bromosulfamate 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]) CLNS(=O)(=O)(O[Na]) BrNS(=O)(=O)(O[K]) ClNS(=O)(=O)(O[K])

Molecular Formula H1Br1N1O3S1Na1 H1Cl1N1O3S1Na1 H1Br1N1O3S1K1 H1Cl1N1O3S1K1

Molecular Weight 

(grams/mole) 197.97 153.52 214.07 169.62

Molecular 

Structure

Product 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. Further details of the 

product chemistry data are discussed in Appendix E. 

Br NH

S

O

O

O

Na

Cl NH

S

O

O

O

Na
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Table 4 – Estimated Physical and Chemical Properties for N-bromosulfamate salts and 

mixtures from EPI-WEB 4.11 

Guideline 

No. Parameter3 Sodium Nbromosulfamate 

Sodium Nchlorosulfamate Potassium Nbromosulfamate Potassium Nchlorosulfamate 

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 acid 

(Adam, 1992)2 with a typical wavelength range of 290-380 nm. 

830.7370 Dissociation 

constant (pKa)

Not available

830.7550

Octanol-water 

partition 

coefficient at 25 

o

C (Log Kow)

-5.45

830.7840 Solubility in water 

(mg/L) at 25 o

C

1 x 106

830.7950 Vapor pressure 

(mmHg) at 25 oC 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 oC 

(atm-m3/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. 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

atm-m3/mol = atmosphere cubic meter per mole; oC = degrees Celsius; mg/L = milligrams per liter; mmHg = millimeters of mercury. 

Table 5 – Estimated Physical and 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 S1O3N1

None Molecular Weight (grams/mole) 97.09

830.7050 UV/Visible Absorption1

No UV/Visible sorption based on lack of double bonds.

830.7370 Dissociation constant (pKa)

Not available

830.7550 Octanol-water partition coefficient at 25 o

C 

(Log Kow)

0.1

830.7840 Solubility in water (mg/L) at 25 oC

1.5 x 105

830.7950 Vapor pressure (mmHg) at 25 oC 8.5 x 10-21

 
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Guideline No. Parameter Sulfamic Acid

None Henry's law constant at 25 oC (atmm3

/mol)2 2 x 10-21

None

Molecular structure

1 Lyman, 1990. 2 atm-m3

/mol = atmosphere cubic meter per mole; oC = 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 Nos 8622-81, 3377-55, 3377-78 and 

3377-79) that contain sodium bromosulfamate salts and mixtures. The four products 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 fungicides, algaecides, slimicides, and microbiocides 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 mills, 

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 total 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-bromosulfamate salts and mixtures Registered Uses*

Use Application 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 Systems Liquid Pump 10 ppm

Liquid Pour 10 ppm
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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

Liquid Pour 10 ppm Liquid Pump

Ornamental Ponds Liquid Pour 10 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 and Paper Liquid Pour 10 ppm Liquid Pump

* Only maximum application rates in bromine were reported on the label.

1.6 Regulatory History

The first product containing N-bromosulfamate salts and mixtures was registered in 1987. At the 

time, the active ingredient 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 

registration 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 products 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-bromosulfamate 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 

review 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 that 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 active 

ingredients that will require assessment under this registration review case. 
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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 tolerances 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 Nbromosulfamate salts and mixtures under FFDCA Section 408. FDA has not established 

clearances for sodium N-bromosulfamate, sodium N-chlorosulfamate, potassium Nbromosulfamate, 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. FCN 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 acid has been identified as generally recognized as safe 

(GRAS) by the US FDA as an indirect 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 CFR §186.1093). In accordance with 21CFR 186.1(b)(1), sulfamic acid is used 

as an indirect food ingredient with no limitations other than current good manufacturing practice. 

1.7 Incidents

1.7.1 Human Health 

There are no human health incidents in OPP’s Incident Data System (IDS) from June 28, 2006 to

February 3, 2016.

1.7.2 Ecological

There are no ecological incidents in OPP’s IDS from June 28, 2006 to February 3 2016.

2 Anticipated Data Needs

There was no Reregistration Eligibility Decision (RED) for N-bromosulfamate salts 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 available as full study reports, 
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these would be useful to the agency in addressing the anticipated data requirements 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 

TGAI1 12 Environmental exposure

All Ecological

835.2240 Photodegradation in water One 

TGAI1 12 Environmental exposure

All Ecological

835.4300 Aerobic aquatic metabolism

One 

TGAI1

and 

sulfamic 

acid

24 Environmental 

exposure 

All Ecological

835.1230 Leaching/adsorption/desorption (batch 

equilibrium)

One 

TGAI1

and 

sulfamic 

acid

12 Environmental 

exposure

All Ecological

835.4100 Aerobic soil metabolism

One 

TGAI1

and 

sulfamic 

acid

24 Environmental 

exposure

All Ecological

835.31103

835.32203

835.32403

835.32803

Biodegradability in WWTP

One 

TGAI1

and 

sulfamic 

acid

12 Environmental 

exposure 

All Ecological 

850.33003Activated Sludge Respiration Inhibition 

(ASRI)

One 

TGAI1

and 

sulfamic 

acid

12 Environmental 

exposure

All Ecological

850.2100 Avian acute oral One 

TGAI1 12 Terrestrial organisms

All Ecological

850.4500 Algal toxicity, green algae One 

TGAI1 12 Aquatic organisms All Ecological

850.1010 Freshwater invertebrate, acute toxicity One 

TGAI1 12 Aquatic organisms All Ecological

850.1075 Freshwater fish, acute toxicity One 

TGAI1 12 Aquatic 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 Ecological
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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 Sulfamic 

acid2 24 Human Health All All

870.3465 90-Day Inhalation Toxicity Sulfamic 

acid2 24 Human Health All Occupational handler

870.3700 Developmental Toxicity in Rats Sulfamic 

acid2 24 Human Health All All

870.3700 Developmental Toxicity in Rabbits Sulfamic 

acid2 24 Human Health All All

870.3800 Reproduction and Fertility Effects Sulfamic 

acid2 24 Human Health All All

870.4300 Combined Chronic 

Toxicity/Carcinogenicity

Sulfamic 

acid5 24 Human Health Once-through cooling tower

Dietary 

(drinking 

water) 

870.5100 Reverse Mutation Assay Sulfamic 

acid2 12 Human Health All All

870.5300 

or 5375 In vitro mammalian gene mutation Sulfamic acid2 12 Human Health All All

870.5385 

or 5395 In vivo cytogenetics Sulfamic acid2 12 Human Health All All

870.7800 Immunotoxicity Sulfamic 

acid2 12 Human Health All All

870.6200 Neurotoxicity screening battery4 Sulfamic 

acid2 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 Liquid 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 in 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 anticipated 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 Biodegradability or (ii) a) 

Biodegradation in Activated Sludge or b) Simulation Test - Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot 

Test. 

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

antimicrobial fails the Ready Biodegradability 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) and 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. Data for sulfamic acid are anticipated 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 conducted and

the chronic toxicity/carcinogenicity study will not be needed.
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3 Human Health Risk Assessment

The agency anticipates the need to conduct a human health risk assessment for Nbromosulfamate salts and mixtures including a risk assessment for the primary degradate, 

sulfamic acid. Additional data as noted in Table 7 are anticipated to be required for use in 

conducting 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 may not be needed for 

sulfamic acid.

3.1 Existing Toxicological Endpoints

For N-bromosulfamate salts and mixtures, there are no existing toxicological endpoints.

Endpoints 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 assessments as part of 

registration 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, livestock, 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 indicates 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 Nchlorosulfamate, potassium N-bromosulfamate, and potassium N-chlorosulfamate. The 

registrant has indicated an interest in retaining these uses and obtaining 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 data, 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 analysis of the pulp and paper use, chronic toxicity and carcinogenicity data are 

not anticipated to be required. If FFDCA clearances are not obtained for sodium 

bromosulfamate, sodium chlorosulfamate, potassium bromosulfamate, and/or potassium 

chlorosulfamate, then the labels (EPA Reg. Nos. 3377-55; 3377-79; 3377-78) should be revised 
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to indicate 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 ingredients. 

3.2.2 Drinking Water

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. Breakdown 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 

treatment 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 environmental fate data which are 

anticipated to be required for registration review show that sulfamic acid degrades rapidly, the 

agency would not expect a drinking water assessment to be necessary. If no drinking water 

assessment is needed, the Combined Chronic Toxicity/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 not previously conducted for Nbromosulfamate 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 Handler Exposure

The agency has identified the potential for liquid pour occupational exposures. The latest 

registered labels do not prohibit liquid pour applications. Therefore, the agency will need to 

conduct an occupational assessment for liquid pour applications 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, the agency would not anticipate the need to conduct a handler risk 

assessment.

Table 8 – Occupational 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 minimal. The post-application workers would not be 
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expected to regularly contact treated N-bromosulfamate salts and mixtures and any infrequent 

exposure would be limited to a diluted solution which is not volatile.

3.3.3 Residential Handler Exposures

The N-bromosulfamate 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 Residential 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 postapplication assessments or data are expected to be required.

3.4 Aggregate and Cumulative Exposure

3.4.1 Aggregate Exposures 

An 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 common mechanism of toxicity, EPA has not made a 

common mechanism of toxicity finding for the N-bromosulfamate salts and mixtures. Nbromosulfamate salts and mixtures do not appear to produce a toxic metabolite produced by 

other substances. For the purposes 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 mechanism 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 mixtures were initially 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 result of registered uses of Nbromosulfamate 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 oil recovery well 
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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 exposed 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 listed 

threatened or endangered species (listed species) or their designated critical habitats. When an 

assessment concludes that a pesticide’s use 'may affect' a listed species or its designated critical 

habitat, the agency will consult with the U.S. Fish and Wildlife Service and/or National Marine 

Fisheries 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 potassium as cations. Guideline data on environmental 

fate on the active ingredients and carrier molecule (sulfamic acid) have not been submitted but 

are anticipated to be required (Table 7). However, based on the chemical structure, Nbromosulfamate 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 residues 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 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, 835.3240, and 835.3280) and toxicity (850.3300) 

have not been 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=885
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NBSD and its degradates.

3 More information on impaired water bodies and TMDLs can be 

found at EPA’s website.

4

4.2 Conceptual Models for Environmental Exposure Pathways

N-bromosulfamate salts and mixtures can be used as a fungicide, algaecide, slimicide, and 

microbiocide 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 mills, wastewater systems, oilfield applications (oil 

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 properties 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 Environmental Exposure Pathways of Antimicrobial Pesticides” (EPA-HQ-OPP2014-0638-0002), found at www.regulations.gov in docket EPA-HQ-OPP-2014-0638.

5

 For 

cooling and water process systems, heat transfer systems, air washers, and industrial oncethrough 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 fluids, 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 nontarget 

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 environment, 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 

TGAI and bridged to the others.

 3

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_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-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals.
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The available chlorine ecotoxicity endpoints are provided in Table 9. Additionally, open 

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 

Material1 Scenario Toxicity Endpoint

(μg/L) Reference

Freshwater fish

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 --

TRC1 Acute 17 EPA 1985

Chronic 3.7 EPA 1985

Sulfamic acid Chronic No data --

Estuarine/marine 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 chlorine) and CPO (chlorine-produced oxidants) are used to denote chlorinebased 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 determine 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 exposure 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)

is 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-products. Because of the lack of 
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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 toxicity to activated sludge microorganisms and biodegradation of Nbromosulfamate 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 ECOTOX database will be searched during the risk assessment phase of Nbromosulfamate 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 

satisfy an existing data gap(s) will be used during the risk assessment phase of Nbromosulfamate 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 

Environmental 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, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. However, as required by FFDCA section 408(p), N-bromosulfamate salts 

and mixtures are subject to the endocrine screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the agency must screen all pesticide chemicals. Between October 

2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, 
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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 should 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 reliance 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 

obtained for sodium bromosulfamate, sodium chlorosulfamate, potassium bromosulfamate, 

and/or potassium chlorosulfamate, then the labels (EPA Reg. Nos. 3377-55; 3377-79; 3377-78) 

must be revised to indicate that N-bromosulfamate salts and mixtures cannot be used in 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 assessment.

7 Next Steps

After the FWP for the N-bromosulfamate salts and mixtures case is posted to the docket at EPAHQ-OPP-2015-0265, a DCI will be developed regarding the data needs listed under the 

“Anticipated Data Needs” section of this document. The Agency expects to issue the DCI by 

March 2017.

 6 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of 

chemicals. 

7 http://www.epa.gov/endo/.
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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/DISS97d74cbc-1047-09ab-e044-00144f67d031/DISS-97d74cbc-1047-09ab-e044-

00144f67d031_DISS-97d74cbc-1047-09abe044-00144f67d031.html.

Envirotech. TECHNICAL BULLETIN: UV Exposure and BromMax. 

http://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.astro.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. ECOTOX 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.
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Appendix A Toxicology Profile

Acute Toxicity for Product Labeling 

Acute 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 label 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 LD50 = 2491 mg/kg (males and females) III

870.1200/ 

Acute dermal toxicity 44792106 LD50 > 2000 mg/kg (males and females) III

870.1300/ 

Acute inhalation toxicity 44792107 LC50 > 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 Nonsensitizer

N/A=Not available 

Subchronic Toxicity 

The agency’s records indicate subchronic toxicity studies were previously submitted for sulfamic 

acid, but the studies are not adequate. The agency has no data on subchronic toxicity of the Nbromosulfamates and mixtures. The agency further has no information on whether the Nbromosulfamates and mixtures are equivalent to sulfamic acid in terms 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 subchronic inhalation toxicity study using OCSPP 870.3465 

guideline is also anticipated to be required, as specified in Table 7. Currently, there 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-e044-00144f67d031_DISS-97d74cbc-1047-

09abe044-00144f67d031.html). This website indicates studies that are anticipated to be required

for sulfamic acid.
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Developmental Toxicity 

There are no developmental toxicity studies for N-bromosulfamate salts 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 sulfamic 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 the OCSPP 870.3700 guideline are anticipated to be required for 

the N-bromosulfamate salts 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, there 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-e044-00144f67d031_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 salts and mixtures

or sulfamic acid. The agency has no adequate data on reproductive toxicity of the Nbromosulfamates 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 fertility effects toxicity study by the oral route 

conducted according to the OCSPP 870.3800 guideline is required for the N-bromosulfamate

salts and mixtures, as specified in Table 7 of this registration review. Based on the lack of 

reproductive toxicity information 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 concentrations). 

Currently, there are only summary data available on sulfamic acid through the European 

Chemical Agency website (http://apps.echa.europa.eu/registered/data/dossiers/DISS-97d74cbc1047-09ab-e044-

00144f67d031/DISS-97d74cbc-1047-09ab-e044-00144f67d031_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 salts and

mixtures or sulfamic acid. The agency further has no information on whether the Nbromosulfamates 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 salts and mixtures, as specified in Table 7 of 

this workplan. Human health toxicity data are not anticipated to be required on N-
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bromosulfamate salts and mixtures since the potential residue in drinking 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/DISS97d74cbc-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 assess the hazard from the drinking water exposure in oncethrough cooling towers.

Carcinogenicity 

No carcinogenicity data are available for N-bromosulfamate salts and mixtures or sulfamic acid. 

Carcinogenicity 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, human health toxicity data are not anticipated to be required on N-bromosulfamate 

salts and mixtures since the potential residue in drinking water is expected to be sulfamic acid.

Mutagenicity 

No mutagenicity data are available in the agency’s records for N-bromosulfamate salts and 

mixtures or sulfamic acid. Mutagenicity studies conducted according to the appropriate OCSPP 

guideline (as specified in Table 7 of this preliminary work plan) are anticipated to be required for 

the N-bromosulfamate salts and mixtures. Based on the lack of mutagenicity information for 

either the N-bromosulfamate salts and mixtures and sulfamic acid, mutagenicity 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 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). These data indicate studies that are to be planned 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 

screening 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 salts and mixtures have 

other toxicological effects, based on the lack mammalian toxicity data. If data become available
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on other effects other than those discussed in this section, the toxicity will be characterized as 

part of the toxicology database. 
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Appendix B Environmental Fate

Environmental Fate and Transport Properties of N-bromosulfamate 

salts and mixtures chemicals 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. Guideline data on environmental 

fate have not been submitted but are 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 residues of Nbromosulfamate 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-bromosulfamate salts and mixtures compounds 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 

(Lyman, 1990).

Aqueous Photolysis

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 the concentration increases. 

Octanol-Water Partition Coefficient and Bioconcentration in Fish

Based on the estimated log Kow values and high water solubility values for N-bromosulfamate 

salts and mixtures compounds in Table 4 and for sulfamic acid in Table 5, bioconcentration in 

fish and other aquatic organisms is not expected to occur. 

 8 Envirotech, http://www.stabilizedbromine.com/pdf/BromMax-UV%20Tech%20Bulletin.pdf.
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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 compound and the degradate sulfamic acid.

Anaerobic 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 Nbromosulfamate 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 degradate sulfamic acid.

Anaerobic Soil Metabolism

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

salts and mixtures compounds and the sulfamic acid degradate 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 salts 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, Antimicrobial Environmental Fate Data Requirements Table).

Activated Sludge Biodegradation

Data on activated sludge biodegradation are expected to be required for one of the Nbromosulfamate salts and mixtures compounds and the degradate sulfamic acid because of 

chemical 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.
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Activated Sludge Respiration Inhibition

ASRI data are anticipated to be required for one of the N-bromosulfamate salts and mixtures

compounds and for the degradate sulfamic acid. 
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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 studies anticipated to be required.
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Appendix D Screening Level Downthe-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 downstream 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 highend 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 wastewater treatment plants based on the 10th percentile 

stream dilution factor (SDF); the average scenario uses surface water concentrations based on the 

50th 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 LC50 values (or EC50 values, if 

appropriate) from acute toxicity tests on aquatic vertebrates and invertebrates by 2. COCs for 

listed endangered and threatened aquatic organisms were determined by dividing LC50 values 

from acute toxicity tests on aquatic vertebrates and invertebrates by 20. COCs for chronic effects 

for non-listed and listed species were based on NOAEC values from tests on aquatic vertebrates 

and invertebrates. COCs for non-listed and listed aquatic plant species were determined by using 

the IC50 and NOAEC, respectively, from aquatic plant tests.
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Appendix E Product Chemistry

N-bromosulfamate 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 Mixtures Products by PC 

Code

PC Code

Active Ingredient

Sodium Nbromosulfamate Sodium Nchlorosulfamate Potassium NbromosulfamatePotassium Nchlorosulfamate

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 Nbromosulfamate Sodium N-chlorosulfamate Potassium Nbromosulfamate Potassium Nchlorosulfamate 

Chemical

Classification Bromosulfamate salt Chlorosulfamate salt Bromosulfamate salt Chlorosulfamate salt

PC Code of 

active 

ingredient

028960, 028961, and 

028964

028961, 028964, and 

028960 028963 028962

PC Codes 

with active 

registrations 

containing 

this chemical

028960, 028961, and 

028964 028961 and 028964 028964 028964

CAS Number 134509-56-1 13637-90-6 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 H1Br1N1O3S1Na1 H1Cl1N1O3S1Na1 H1Br1N1O3S1K1 H1Cl1N1O3S1K1

Molecular 

Weight 

(grams/mole)

197.97 153.52 214.07 169.62

Molecular 

Structure

Br NH

S

O

O

O

Na

Cl NH

S

O

O

O

Na
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Guideline data on product chemistry were not submitted for any 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. Parameter3 Sodium Nbromosulfamate 

Sodium Nchlorosulfamate Potassium Nbromosulfamate Potassium Nchlorosulfamate Source (EPI-WEB 

4.11 unless stated)

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 acid (Adam, 1992)2 with a typical 

wavelength range of 290-380 nm. 

Ingham, 1998

Adam, 1992

830.7370

Dissociation 

constant 

(pKa)

Not available

EPI-WEB 4.11

830.7550

Octanolwater 

partition 

coefficient at 

25 oC (Log 

Kow)

-5.45

830.7840

Solubility in 

water (mg/L) 

at 25 oC

1 x 106

830.7950

Vapor 

pressure 

(mmHg) at 

25 oC

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 (atmm3

/mol)

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. 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-m3/mol = atmosphere cubic meter per mole; oC = degrees Celsius; mg/L = milligrams per liter; mmHg = 

millimeters of mercury.

 
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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 Number 5329-14-6 None

None Smiles code O=S(=O)(O)N None

None Molecular Formula S1O3N1 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 Dissociation constant 

(pKa)

Not available

EPI-WEB 4.11

830.7550

Octanol-water partition 

coefficient at 25 oC (Log 

Kow)

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 oC 8.5 x 10-21

None Henry's law constant at 

25 oC (atm-m3/mol) 2 x 10-21

None

Molecular structure

atm-m3/mol = atmosphere cubic meter per mole; oC = degrees Celsius; mg/L = milligrams per liter; mmHg = 

millimeters of mercury.
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Appendix F Public Comments 

Received on the Preliminary Work 

Plan

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

period.