Docket Number: EPA–HQ–OPP–2009–0167 

www.regulations.gov 

 

United States Prevention, Pesticides March 2010 

Environmental Protection and Toxic Substances 

Agency (7510P)

Bromine Final Registration Review Decision 

Case 4015

Docket Number: EPA–HQ–OPP–2009–0167 

www.regulations.gov 

TABLE OF CONTENTS

Bromine Registration Review Team Members.......................................... 1 

I. Introduction.................................................................................... 2 

II. Scientific Assessment....................................................................... 4 

A. Chemical Identification.......................................................... 4 

B. Product Chemistry................................................................ 4 

C. Human Health Risk Assessment Status....................................... 8 

D. Environmental Fate and Ecological Effects Exposure and Risk 

Assessment Status................................................................. 12 

E. Incidents............................................................................. 13 

F. Public Comments.................................................................. 13 

G. Environmental Justice............................................................ 13 

H. Water Quality..................................................................... 14 

I. Trade Irritants..................................................................... 14 

III. Registration Review Final Decision.................................................... 14 

IV. Next Steps and Timeline.................................................................. 14 

V. Glossary of Terms of Abbreviations................................................... 15 
Docket Number: EPA–HQ–OPP–2009–0167 

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Bromine Registration Review Team

Human Health & Environmental Effects 

Jonathan Chen 

Srinivas Gowda 

William Hazel 

Risk Management

K. Avivah Jakob 

Lance Wormell 

Office of General Counsel

Philip Ross 

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I. Introduction

This document is EPA’s Final Registration Review Decision for bromine (Case 

4015) and is being issued pursuant to 40 CFR Sections 155.57 and 155.58. A registration 

review decision is the Agency’s determination whether a pesticide meets, or does not 

meet, the standard for registration in the Federal Insecticide, Fungicide and Rodenticide 

Act (FIFRA). For additional information on bromine, additional documents can be found 

in EPA’s public docket (EPA-HQ-OPP-2009-0167) at www.regulations.gov. 

 FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, 

mandated a registration review program. All pesticides distributed or sold in the United 

States must generally be registered by EPA, 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://www.epa.gov/oppsrrd1/registration_review/. 

 In 2006, the Agency implemented the Registration Review program pursuant to 

FIFRA Section 3(g) and will review each registered pesticide every 15 years to determine 

whether it continues to meet the FIFRA standard for registration. 

 

Pursuant to 40 CFR Sec. 155.50, the Agency formally initiated registration review 

for bromine with the following timeline: 

• March 2009: Publication of a Preliminary Work Plan (PWP) in the docket for 

bromine (EPA-HQ-OPP-2009-0167). The Agency received no comments during 

the 90 day public comment period which closed on June 16, 2009. 

• September 2009: Issuance of a Final Work Plan and Proposed Registration 

Review Final Decision for bromine. This document states that the most recent 

exposure and risk assessments for bromine continue to support the registration of 

pesticide products containing bromine and meet the requirements of registration 

review under 40 CFR Sec.155.50. During the 60 day comment period that closed 

on November 23, 2009, the Agency received no comments from the public.1

 

No comments were received on either the Preliminary Work Plan issued in March 

2009, or the combined Final Work Plan and Proposed Registration Review Final 

Decision, issued in September 2009. Therefore, the Agency is making its final decision 

 

1 The projected timeline in the Preliminary Work Plan (PWP) for bromine indicated that the Agency 

anticipated publishing a Final Work Plan (FWP) in September of 2009 and a Proposed Registration Review 

Final Decision document in December of 2009. Because no comments were received on the bromine PWP, 

the Agency combined the FWP and Proposed Registration Review Final Decision into one document. 

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on bromine based on no comments having been received, the low toxicity of bromine and 

no further risk assessments are required. In addition, the data and information evaluated 

to bromine, case 4015, as published in the PWP, continue to support this pesticide 

registration as summarized herein. The status of these and other registration review cases 

is available on http//www.epa.gov/oppsrrd1/registration review/review. 

Bromine was first registered as an antimicrobial pesticide in the United States in 

May of 1976. The bromine registration review case consists of one active ingredient (PC 

code 008701). Since the publication of the bromine PWP, two new products containing 

bromine as an active ingredient have been registered with the EPA. However, these two 

new products, which involved no new uses or changes to application rates or methods, do 

not affect the data needs, work plan and timeline described in the PWP, which remain as 

they were initially presented in the PWP. Currently, there are 5 registered products 

containing bromine as an active ingredient. Bromine is a bromide releasing antimicrobial 

pesticide that is registered as a mildewstat/mildewcide, bactericide, fungistat, fungicide, 

virucide, and insecticide. Bromine is registered for use to control bacteria and fungi on 

surfaces of agricultural, commercial, institutional, industrial, residential, and public 

access premises and equipment. It is also registered for use to treat/disinfect potable 

water (examples of potable water system treatment sites include, but are not restricted to, 

aboard ships and on oil and gas drilling/production platforms). 

 Bromine (Br2) is a naturally occurring element that is normally found as bromide 

ion (Br-

) in living organisms and the environment. Elemental bromine is very reactive 

and in the presence of water it is rapidly converted to form bromide ion (Br-) and 

hypobromite ion (BrO-). Therefore, any human exposure resulting from the use of 

bromine products will be to bromide ion and hypobromite ion, not to elemental bromine. 

In the 2005 Bromine Tolerance Reassessment Eligibility Decision (TRED) it was 

determined that bromine and its principal degradation products (bromide ion and 

hypobromite ion) do not induce adverse systemic effects and as a result endpoints were 

not selected. This determination is still considered to be accurate by the Agency. 

Bromate

 Bromide oxidizes to form bromate ion in aqueous environments (e.g., swimming 

pools) and in the presence of sunlight, oxidizing agents and/or alkaline conditions. 

Unlike other bromine residues, bromate ion is considered to be of toxicological concern 

and has been classified by the Agency as a probable human carcinogen (U.S. EPA, 

Guidelines for Carcinogen Risk Assessment, 1986). The EPA anticipates that an 

aggregate assessment and quantitative assessments of human exposure and possible 

cancer risks will be needed to assess possible exposures to bromate ion resulting from the 

use of all bromine releasing chemicals that may generate bromate ion. However, 

registered bromine products are not expected to generate bromate ion and therefore, 

the use of bromine products will not need to be considered in the exposure risk 

assessments for bromate ion. 

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 Based on bromine’s currently-registered use patterns, bromine products will not 

generate bromate ion as long as treated water is not exposed to stronger oxidizing agents 

such as ozone, HClO or UV light (for the potable water treatment use). The potential for 

oxidization during water treatment is very small. However, based on the currentlyregistered use patterns, if oxidation were to occur, the amount of bromate ion forming 

from the use of bromine to treat potable water systems would be insignificant and 

indistinguishable from background levels of naturally occurring bromate ion sources 

(e.g., naturally occurring bromide ion during drinking water ozonation). Therefore, 

because it is unlikely that its currently-registered uses (including the potable water system 

use) will result in the formation of bromate ion and because the use of bromine to treat 

potable water systems will not measurably contribute to drinking water exposure or to 

aggregate human exposure to bromate ion, risks of concern resulting from the use of 

bromine products are not anticipated. For further information regarding the toxicity of 

bromine and the dissociation of bromine and bromine releasing chemicals please refer to 

the document titled “Bromine. Human Health Effects Scoping Document for the 

Registration Review Decision. PC Code: 008701,” dated March 16, 2010. 

II. SCIENTIFIC ASSESSMENT

A. Chemical Identification 

Table 1 provides information on the chemical identity of bromine. 

Table 1. Chemical Identity 

Common Name Bromine 

Chemical Name Bromine 

Molecular Weight 159.81 g/mole 

PC Code 8701 

CAS Registry Number 7726-95-6 

Molecular Formula Br2

Chemical Family Halogen 

Molecular Structure Br-Br 

B. Product Chemistry 

 Table 2 provides information on the physical and chemical properties of bromine. 

All product chemistry data requirements have been fulfilled for the active ingredient 

bromine. Therefore, no additional product chemistry data for bromine are needed at this 

time. 

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Table 2. Product Chemistry Data Summary for Bromine (TGAI: 98-100%)

Guideline 

No. 

Physical and Chemical Properties Value 

830.1550 Product identity and composition Refer to Table 2 

830.1600 Description of materials used to produce 

the product 

Confidential Business information (CBI) 

830.1620 Description of production process CBI 

830.1650 Description of formulation process CBI 

830.1670 Discussion of formation of impurities CBI 

830.1700 Preliminary analysis CBI 

830.1750 Certified limits CBI 

830.1800 Enforcement analytical method The Colorimetric Method 

830.1900 Submittal of samples Not Applicable 

830.6302 Color Dark red-brown liquid at ordinary temperatures 

and pressures. 

The Vapor is amber in color. 

The solid is almost black. 

830.6303 Physical State Liquid at ordinary temperatures and pressures. 

Crystal Structure: Orthothrombic 

830.6304 Odor Suffocating odor. 

Sharp, penetrating halogen-like odor. 

830.6313 Stability to sunlight, normal and elevated 

temperature, metals/metal ions 

Dry (less than 30 ppm water) bromine may be 

stored and transported in mild steel containers, if 

trace ion contamination (up to 500 ppm) will not 

present a problem in an application. Wet bromine 

is very corrosive to most metals. Bromine is a 

strong oxidizing agent. The heat released during 

the oxidation reaction may raise the temperature 

of combustible materials to the ignition point. 

Dry bromine reacts violently with the metals 

aluminum, titanium, mercury and potassium. 

Neutralization of bromine with an alkali will 

produce bromite, which, when dry, is extremely 

flammable and shock sensitive. 

830.6314 Oxidation/Reduction: Chemical 

Incompatibility 

Not required for TGAI. 

The normal redox potential for elemental bromine 

is 1.07v. Bromine is a strong oxidizing agent. For 

comparison, elemental chlorine has a normal 

redox potential of 1.4v. 

Incompatibilities with Other Materials: Bromine 

is a strong oxidizer and can react violently with 

many oxidizable materials. 

830.6315 Flammability Not required for TGAI 

Not Applicable 

Bromine is not combustible. Therefore, a 

flashpoint determination is not required. 

830.6316 Explodability Not required for TGAI 

Bromine does not contain an explosive ingredient. 

830.6317 Storage Stability Not required for TGAI 

830.6319 Miscibility Not required (TGAI) 

The miscibility of Bromine is not required 

because it is not an emulsifiable liquid and not for 

dilution with petroleum solvents. 

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Guideline 

No. 

Physical and Chemical Properties Value 

830.6320 Corrosion Characteristic Not required for TGAI. 

Dry bromine (less than 30 ppm moisture) is 

relatively non-corrosive. 

830.6321 Dielectric breakdown voltage Not required for TGAI. 

830.7000 pH pH of a tap water solution after addition of 

Bromine 

Mg/L Br2 pH 

0 7.2 

2.5 7.2 

16.3 7.2 

29.2 7.3 

When added to deionized water, bromine reduces 

the pH since hypobromous acid, a weak acid is 

formed. Deionized water, has no buffer capacity, 

and the pH decreases. The pH of a solution of 

deionized water and several bromine 

concentrations is shown in Table below: 

Mg/L Br2 pH 

0 5.6 

1.0 5.3 

11.0 4.1 

19.4 3.8 

50.0 3.4 

830.7050 UV/Visible absorption 

830.7100 Viscosity Not required for TGAI 

Viscosities of Bromine: 

0.314 centistokes @ 20°C 

0.288 centistokes @ 30°C 

0.264 centistokes @ 40°C 

0.245 centistokes @ 50°C 

830.7200 Freezing/Melting Point -7.25 °C (19.04F) 

-7.27 °C 

830.7220 Boiling point 59.7°C 

58.8°C 

830.7300 Density/Bulk Density/Specific Gravity 

Specific Gravity (H2O=1) 

3.1023 g/ml at 25°C 

3.1396 g/cm3 at 15°C 

3.1226 g/cm3 at 20°C 

3.1055 g/cm3 at 25°C 

3.0879 g/cm3 at 30°C 

3.12 at 68°F 

830.7370 Dissociation Constants in water Not required (TGAI) 

In water, bromine rapidly hydrolyses to form 

hypobromous acid, HOBr: 

Br2 + H2O Æ HOBr + H+ + Br ̄

The hydrolysis constant for the reaction is: 

5.8 x 10-9 at 25C 

In pure aqueous solutions, the species present are 

molecular bromine, Br2, hypobromous acid, and 

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Guideline 

No. 

Physical and Chemical Properties Value 

the hypobromite ion resulting from the 

dissociation of hypobromous acid. The 

dissociation constant for the hydrolysis reaction is 

2 x 10-9 at 25oC

HOBr = OBr ̄ + H+ 

830.7520 Particle size Not Required 

830.7550 Octanol/water partition coefficient Required for non-polar organic active ingredient. 

Since bromine is an inorganic element, the 

octanol/water partition coefficient is not required. 

830.7840 Solubility in water 3.6 g/100 ml at 25°C 

3.50 g/100g @ 10°C 

3.38 g/100g @ 20°C 

3.12 g/100g @ 30°C 

2.88 g/100g @ 40°C 

2.62 g/100g @ 50°C 

42 g/l at 0°C (MSDS) 

830-xxxx Solubility in organic solvents in g/100 g Carbon Tetrachloride – Infinite 

Chloroform – Infinite 

Methylene chloride – Infinite 

Carbon Disulfide - Infinite 

Alkyl Bromides – Infinite 

Ether – Infinite 

Methanol – Infinite 

48% Hydrobromic acid – 900 

Concentrated HCl – Soluble 

Aqueous Metallic Halides - Soluble 

Soluble in benzene, gasoline, ethanol, ether and 

hydrogen sulphide (MSDS) 

830.7950 Vapor pressure 173 mm Hg @ 20°C 

226 mm Hg @ 77°F 

220 hPa at 20°C; 340 hPa at 30°C; 740 hPa at 50 

°C (MSDS) 

Hazardous Decomposition Products: Emits fumes of bromine and bromides upon 

thermal decomposition. 

Hazardous Polymerization: Will not occur. 

Other Physical/Chemical Properties 

Classification of a.i. Inorganic 

Halogen 

Non-metallic 

Log Kow 1.03 (EPI Suite) 

Henry's Law Constant at 25°C 2.45E-002 atm-m3/mole 

Koc 14.3 (EPI Suite) 

Log BCF 0.092 (BCF= 1.236) 

Ready Biodegradability Prediction Not Readily Degradable (EPI Suite) 

TASCA Listed on the TSCA 8(b) inventory 1

TGAI=Technical Grade Active Ingredient; CBI= Confidential business Information 

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C. Human Health Risk Assessment Status 

 A Reregistration Eligibility Decision (RED) for bromine was issued in 1993, and 

a Tolerance Reassessment Eligibility Decision (TRED) for bromine was issued in 

September of 2005. These documents can be located at: 

http://www.epa.gov/pesticides/reregistration/status.htm

 The Agency has reviewed all available information and data, including the hazard 

and exposure databases for bromine, and has determined that no additional exposure 

assessments or data are needed. Based on the low toxicity of bromine and its principal 

degradation products (bromide and hypobromite), no additional toxicity and exposure 

data are needed for this registration review. In addition, no additional or new 

occupational and residential exposure assessments are needed to ensure that the bromine 

registration review case meets the safety standards established by FIFRA and FFDCA, as 

amended by FQPA. For a detailed discussion of the human health exposure and risk 

assessment status, please refer to the “Bromine. Human Health Effects Scoping 

Document for the Registration Review Decision. PC Code: 008701,” dated 

March 16, 2010. 

1. Toxicology 

 The Agency has reviewed all toxicity studies submitted for bromine and has 

determined that the toxicological database is sufficient and that additional toxicity studies 

for registration review are not needed. The toxicological database for bromine, which is 

largely based on sodium bromide, is currently comprised of published and unpublished 

studies either submitted to the Agency or obtained directly from published open 

literature. As previously mentioned, based on bromine’s currently-registered use 

patterns, bromine products will not generate bromate ion as long as treated water is not 

exposed to stronger oxidizing agents (for the potable water treatment use). 

Acute Toxicity 

Acute toxicity data specific to bromine are not available. However, bromine 

readily converts to bromide ion in mammals and therefore, the Agency relied on the 

bromide acute toxicity values and categories for bromine. Data from the existing 

bromine TRED indicate that, in technical form, sodium bromide has low acute toxicity 

(Toxicity Category III) via the oral (rat) and dermal (rabbit) routes. It is a mild skin and 

eye irritant (Toxicity Category IV) and it is not a skin sensitizer. The acute inhalation 

studies for sodium bromide were waived in the 1993 RED. No adverse systemic effects 

have been associated with either bromine (Br2) or its principal degradation products, 

bromide (Br-) and hypobromite (BrO-), based on an evaluation of the hazard database by 

the Agency in 2005. Therefore, toxicity endpoints were not selected, exposures were not 

estimated, and risks have not been quantified for bromine and its degradation products 

and are not needed in association with this registration review. Being strong oxidizing 

agents, however, bromine and its degradation products are corrosive and irritating. These 

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acute irritation effects are currently mitigated by the use of personal protective equipment 

(PPE) requirements on product labels. 

a. Sub-chronic and Chronic Toxicity 

Although adverse effects have been identified in rats at high oral doses of for

sodium bromide or ethanolammonium perbromide for 10-28 days, the Agency did not 

select toxicity endpoints and does not believe the use of bromine products will result in 

adverse effects to humans at exposure levels likely to result from registered bromine uses. 

No adverse systemic effects have been associated with either bromine (Br2) or its 

principal degradation products, bromide (Br-) or hypobromite ion (BrO-) except at doses 

about 5,000X that likely from registered uses. Therefore, risks of concern are not 

anticipated. 

 Maternal effects were observed at the LOAEL of 300 mg/kg/day in a subchronic oral toxicity rat developmental study (MRID 55794601). The primary effect 

consisted of decreased body weight gain and a NOAEL of 100 mg/kg/day was 

established. The rats were administered 99.84% sodium bromide by gavage from 

gestation days 6 to 15 at dose levels of 0, 100, 300, and 1,000 mg/kg/day. Fetal effects 

were seen with significant maternal toxicity at the highest dose of 1,000 mg/kg/day. 

Other effects seen at the 1,000 mg/kg/day dose level included unsteady gait, weakness, 

and loss of coordination, reduced body tone and hair loss.

In another sub-chronic oral toxicity study (MRID 41833601), 

ethanolammonium perbromide was administered by daily oral gavage to Charles River 

rats at dose levels of 0, 2, 20, and 200 mg/kg/day for 4 weeks. Signs of toxicity were 

limited to the 200 mg/kg/day dose level. Salivation was reported along with “noisy 

respiration.” Other signs of toxicity included decreased food intake during the last week. 

Hematological parameters were altered such as significant elevation of platelet and RBC 

count and hemoglobin levels. Clinical chemistry effects were also observed such as 

increases in aspartate aminotransferase, creatinine, albumin, total protein and cholesterol 

levels. Additionally, urinary volume was increased and proteinuria was observed. 

Finally, histopathological hyperkeratosis and acanthosis of the stomach were also 

observed. 

In addition to the submitted studies, data were available from scientific literature. 

However, these data were not converted into mg/kg/day. In 1989, the Food and 

Agricultural Organization of the United Nations and the World Health Organization 

(FAO/WHO) summarized available animal toxicity studies. In rats administered sodium 

bromide in food, high dose levels (19, 200 ppm) caused rats to demonstrate lack of motor 

skills in their hind legs and poor grooming behavior. Concentrations of sodium bromide 

were high enough to displace 50% of the chloride in the plasma, brain, kidneys, and liver. 

A recent developmental study in rats indicates that pre- and post-natal exposure to high 

levels (250 mg) of sodium bromide affects postnatal growth and brain development. 

Bromine has not been identified as a human carcinogen and its current use patterns are 

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not expected to generate bromate ion, which has been identified as the only bromine 

residue of toxicological concern. 

 b. Endocrine Effects 

As required under FFDCA section 408(p), EPA has developed the Endocrine 

Disruptor Screening Program (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 

quantitative relationship between the dose and the E, A, or T effect. 

Between October 2009 and February 2010, EPA is issuing test orders/data call-ins 

for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 

inert ingredients. This list of chemicals was selected based on the potential for human 

exposure through pathways such as food and water, residential activity, and certain postapplication agricultural scenarios. This list should not be construed as a list of known or 

likely endocrine disruptors. 

Bromine is not among the group of 58 pesticide active ingredients on the initial 

list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen 

all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data 

call-ins for all Registration Review cases, including those for which EPA has already 

opened a Registration Review docket for a pesticide active ingredient. 

For further information on the status of the EDSP, the policies and procedures, the 

list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our 

website: http://www.epa.gov/endo/. 

2. Dietary, Drinking Water, Residential and Occupational Exposure 

a. Dietary and Drinking Water Exposure

 A dietary risk assessment, including a drinking water assessment, is not needed 

for bromine. Although low levels of dietary (food) exposure to bromine residues may 

occur as a result of its use in livestock premises, restaurants, schools and homes, risks of 

concern are not anticipated because bromine has very low toxicity and therefore, is not a 

residue of human health concern. Based on bromine’s low toxicity dietary and drinking 

water exposures of concern are not anticipated. The following tolerance exemptions have 

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been established for use on food contact surfaces: (1) potassium bromide (KBr) at a use 

concentration of ≤46 ppm available halogen in public eating places, dairy processing 

equipment, and food processing equipment and utensils [40 CFR 180.940 (a)]; and (2) 

sodium bromide (NaBr) or potassium bromide (KBr) at use concentrations of ≤200 ppm 

available halogen on food processing equipment and utensils [40 CFR 180.940 (c)]. 

 As previously mentioned, bromine’s currently-registered use patterns will not 

generate bromate ion as long as treated water is not exposed to stronger oxidizing agents 

(for the potable water treatment use). The use of bromine to treat potable water will not 

result in the formation of bromate ion provided that the treated water is not exposed to a 

stronger oxidizing agent such as ozone, HClO or UV light. The potential for oxidization 

during water treatment is very small. However, based on the currently-registered use 

patterns, if oxidation were to occur, the amount of bromate ion forming from the use of 

bromine to treat potable water systems would be insignificant and indistinguishable from 

background levels of naturally occurring bromate ion sources (e.g., naturally occurring 

bromide ion during drinking water ozonation). Therefore, because it is unlikely that its 

currently-registered uses (including the potable water system use) will result in the 

formation of bromate ion and because the use of bromine to treat potable water systems 

will not measurably contribute to drinking water exposure or to aggregate human 

exposure to bromate ion, risks of concern resulting from the use of bromine products are 

not anticipated. 

A tolerance of 1 ppm (the treatment concentration) for residual bromine has been 

established in drinking water aboard ships reflecting disinfection treatment of potable 

water with polybrominated ion-exchange resin (40 CFR §180.519). The EPA’s Office of 

Water (OW) has established a Maximum Contaminant Level (MCL) for residual bromate 

ion, the only bromine residue currently of human health concern, in drinking water at 10 

μg/L (0.01 ppm). This MCL represents all sources of residual bromate ion in drinking 

water whether they are naturally-occurring/background sources or anthropogenic 

(including pesticidal). However, as previously mentioned the currently-registered uses of 

bromine will not result in the formation of bromate ion provided that for the treated water 

use, the treated water is not exposed to a stronger oxidizing agent. In addition, although 

unexpected, if bromate ion were to form as a result of oxidation of bromine during 

potable water treatment, it would not contribute measurably to the aggregate human 

exposure to bromate ion in drinking water. Therefore the use of bromine to treat potable 

water does not trigger the need for a drinking water assessment nor does it need to be 

included in the aggregate assessment for bromate exposure. 

b. Residential and Occupational Exposure

The Agency reviewed all available data associated with bromine including the 

Bromine RED, Inorganic Halides RED and Bromine TRED. Based on an evaluation of 

the hazard database by the Agency in 2005, no adverse systemic effects have been 

associated with either bromine (Br2) or its principal degradation products, bromide (Br-

) 

or hypobromite ion (BrO-

). Therefore, toxicity endpoints were not selected, exposures 

were not estimated, and risks have not been quantified for these chemical species of 

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bromine and are not needed in association with this registration review. Bromine and its 

principal degradation products are strong oxidizing agents, which are corrosive and 

irritating. However, these acute irritation effects are mitigated by the use of personal 

protective equipment (PPE) requirements included on product labels. 

 An occupational and/or residential exposure assessment is needed for an active 

ingredient if (1) certain toxicological criteria are triggered and (2) there is potential 

exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons entering 

treated sites after application is complete. For bromine, these toxicological criteria are 

not triggered. Therefore, the Agency does not need new occupational and residential risk 

assessments for this registration review case. 

c. Aggregate and Cumulative Exposure 

 In examining aggregate exposure, EPA takes into account available and reliable 

information concerning exposures to pesticide residues in food and drinking water, as 

well as non-occupational pesticide exposures. No adverse systemic effects have been 

associated with either bromine (Br2) or its principal degradation products, bromide (Br-

) 

or hypobromite ion (BrO-) and it is not a residue of human health concern. Therefore, an 

aggregate exposure assessment is not needed for bromine in support of this registration 

review. 

 EPA has not yet determined whether bromine has a common mechanism with 

other compounds; consequently a cumulative assessment will not be performed at this 

time. 

D. Environmental Fate and Ecological Effects Risk Assessment Status 

1. Environmental Fate and Ecological Effects 

 Bromine is registered as an antimicrobial pesticide for indoor use only. 

Therefore, the only possible routes of environmental exposure resulting from the 

antimicrobial uses of bromine would be from antimicrobial products (containing 

bromine) washing down the drain. However, antimicrobial bromine products would be 

highly diluted under these circumstances and, given the low toxicity of bromine, it is 

exceedingly unlikely to result in levels in the environment that could cause any effect to 

any taxa of listed species. 

 

 Environmental fate and ecological risk assessments have not been conducted for 

bromine. Based on the strictly indoor use patterns, low use concentration (i.e., 0.04%), 

and the negligible environmental exposure levels of bromine, environmental fate and 

ecological risk assessments are not needed for the bromine registration review. All 

environmental fate data requirements have been waived and there are no outstanding ecotoxicity data requirements for bromine. Therefore, no environmental fate or ecological 

data are needed. 

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 For a detailed discussion of the environmental fate and ecological risk assessment 

status for bromine please refer to the document titled “Summary of Product Chemistry, 

Environmental Fate, and Ecotoxicity Data for the Bromine Registration Review Decision 

Document,” dated September 10, 2009. 

2. Endangered Species 

 EPA has made a “No Effect” determination for endangered species for bromine 

and further environmental risk assessments will not be conducted. Based on the strictly 

indoor use patterns the Agency has determined that the registered uses of bromine will 

have “no effect” (NE) on endangered or threatened terrestrial or aquatic species, or their 

designated critical habitats, as listed by the U.S. Fish and Wildlife Service (USFWS) and 

the National Oceanic and Atmospheric Administration (NOAA) National Marine 

Fishereries Service (NMFS).

E. Incidents 

Federal law requires registrants of pesticides to inform EPA about any harmful 

effects of their products. Two incidents related to the use of bromine have been reported 

in the OPP Incident Data System (IDS). Both incidents involved leaking of storage 

tanks/drums and no human and/or animal injuries were involved in either of the incidents. 

F. Public Comments 

Pursuant to 40 CFR Sec. 155.50, the Agency formally initiated registration review 

for bromine in March 2009 with the opening of a docket and the issuance of a 

Preliminary Work Plan (PWP) for public comment. The Agency received no comments 

concerning the PWP for bromine during the 90-day public comment period. The public 

was invited to comment on the Final Work Plan and Proposed Registration Review Final 

Decision for bromine issued in September 2009. The Agency received no comments 

concerning the Final Work Plan and Proposed Registration Review Final Decision during 

the 60 day comment period. 

G. Environmental Justice 

 EPA seeks to achieve environmental justice - the fair treatment and meaningful 

involvement of all people, regardless of race, color, national origin, or income - in the 

development, implementation, and enforcement of environmental laws, regulations, and 

policies. At this time EPA does not believe that use of pesticide products containing 

bromine will cause harm or a disproportionate impact on at-risk communities. In the 

Preliminary Work Plan dated March 17, 2009, the Agency sought comment on 

environmental justice issues regarding bromine. As previously mentioned, no comments 

were received. 

For additional information regarding environmental justice issues, please visit 

EPA’s website at: http://www.epa.gov/compliance/environmentaljustice/index.html. 

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Docket Number: EPA–HQ–OPP–2009–0167 

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H. Water Quality 

Bromine is not identified as a cause of impairment for any water-bodies listed as 

impaired under section 303(d) of the Clean Water Act, based on information provided at: 

http://oaspub.epa.gov/tmdl/waters_list.impairments?p_impid=3. The Agency sought 

submission of water quality data for bromine when the Preliminary Work Plan was issued 

for comment. The Agency did not receive any comments on water quality issues. 

I. Trade Irritants 

 Through the registration review process, the Agency intends to solicit information 

on trade irritants and, to the extent feasible, take steps toward facilitating irritant 

resolution. Growers and other stakeholders were asked to comment on any trade irritant 

issues resulting from lack of Maximum Residue Levels (MRLs) or disparities in key 

export markets, providing as much specificity as possible regarding the nature of the 

concern. The Agency did not receive any comments regarding the existence of any trade 

irritant issues associated with bromine. 

III. REGISTRATION REVIEW FINAL DECISION

 The Agency has determined that no additional data are required at this time to 

support the registration of bromine. The Agency has considered bromine in light of the 

standard for registration and safety factors in FIFRA and FFDCA as amended by FQPA. 

EPA has found that there are not likely to be any unreasonable adverse effects to the U.S. 

population in general, and to infants and children in particular, or to non-target 

organisms, from the use of products containing bromine when currently required label 

instructions are followed. In addition, EPA has made a “No Effect” determination for 

endangered species for bromine and further environmental risk assessments will not be 

conducted. The Agency has found that it is not necessary to conduct a new risk 

assessment for this case and is therefore issuing a final decision pursuant to 40 CFR 

155.58. 

 As per 40 CFR Sections 155.57 and 155.58, the Agency has determined that the 

standards for Registration Review have been met and that the registrations of the 

aforesaid bromine products may be maintained. 

IV. NEXT STEPS AND TIMELINE

Pursuant to 40 CFR Section 155.58, this Final Registration Review Decision 

document is being entered into the bromine docket (EPA-HQ-OPP-2009-0167). A 

Federal Register Notice will announce the availability of the Final Registration Review 

Decision for bromine. 

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Docket Number: EPA–HQ–OPP–2009–0167 

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V. GLOSSARY of TERMS & ABBREVIATIONS

ai Active Ingredient 

AR Anticipated Residue 

ASTM American Society for Testing and Materials 

AWPA American Wood Preserver’s Association 

CFR Code of Federal Regulations 

cPAD Chronic Population Adjusted Dose 

CSF Confidential Statement of Formula 

CSFII USDA Continuing Surveys for Food Intake by Individuals 

DCI Data Call-In 

DEEM Dietary Exposure Evaluation Model 

DFR Dislodgeable Foliar Residue 

DNT Developmental Neurotoxicity 

DWLOC Drinking Water Level of Comparison 

EC Emulsifiable Concentrate Formulation 

EDWC Estimated Drinking Water Concentration 

EEC Estimated Environmental Concentration 

EPA Environmental Protection Agency 

EUP End-Use Product 

FDA Food and Drug Administration 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FFDCA Federal Food, Drug, and Cosmetic Act 

FQPA Food Quality Protection Act 

FOB Functional Observation Battery 

GENEEC Tier I Surface Water Computer Model 

GRAS Generally Recognized as Safe 

IR Index Reservoir 

LC50 Median Lethal Concentration. A statistically derived concentration of a 

substance that can be expected to cause death in 50% of test animals. It is 

usually expressed as the weight of substance per weight or volume of water, air 

or feed, e.g., mg/l, mg/kg or ppm. 

LD50 Median Lethal Dose. A statistically derived single dose that can be expected to 

cause death in 50% of the test animals when administered by the route indicated 

(oral, dermal, inhalation). It is expressed as a weight of substance per unit 

weight of animal, e.g., mg/kg. 

LOC Level of Concern 

LOAEL Lowest Observed Adverse Effect Level 

μg/g Micrograms Per Gram 

μg/L Micrograms Per Liter 

mg/kg/day Milligram Per Kilogram Per Day 

mg/L Milligrams Per Liter 

MOE Margin of Exposure 

MRID Master Record Identification (number). EPA's system of recording and tracking 

submitted studies. 

MUP Manufacturing-Use Product 

NA Not Applicable 

NAWQA USGS National Ambient Water Quality Assessment 

NPDES National Pollutant Discharge Elimination System 

NR Not Required 

NOAEL No Observed Adverse Effect Level 

OPP EPA Office of Pesticide Programs 

OPPTS EPA Office of Prevention, Pesticides and Toxic Substances 

PAD Population Adjusted Dose 

PAIRA Pure Active Ingredient Radiolabelled 

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PCA Percent Crop Area 

PDP USDA Pesticide Data Program 

PHED Pesticide Handler's Exposure Data 

PHI Preharvest Interval 

ppb Parts Per Billion 

PPE Personal Protective Equipment 

ppm Parts Per Million 

PRZM/EXAMS Tier II Surface Water Computer Model 

Q1* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer 

Risk Model 

RAC Raw Agriculture Commodity 

RED Reregistration Eligibility Decision 

REI Restricted Entry Interval 

RfD Reference Dose 

RQ Risk Quotient 

SCI-GROW Tier I Ground Water Computer Model 

SAP Science Advisory Panel 

SF Safety Factor 

SLN Special Local Need (Registrations Under Section 24©) of FIFRA) 

TGAI Technical Grade Active Ingredient 

TEP Typical End-Use Product 

USDA United States Department of Agriculture 

UF Uncertainty Factor 

WPS Worker Protection Standard

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