Docket Number: EPA–HQ–OPP–2009–0167 www.regulations.gov

United States Prevent ion, Pesticides March 2010 Environmental Protection and Toxic Substances Agency (7510P)



# Bromine Final Registration Review Decision

Case 4015Docket Number: EPA–HQ–OPP–2009–0167 www.regulations.gov



### TABLE OF CONTENTS

Bromine Registration Re view 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 Ecol ogical 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................................................... 15Docket Number: EPA–HQ–OPP–2009–0167 www.regulations.gov

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 determina tion whether a pesticide meets, or does not meet, the standard for registration in the Fe deral 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

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FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated a registration review program. All pe sticides 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 h ealth or the environment when used as directed on product labeling. Th e registration review program is intended to make sure that, as the ability to assess risk evolve s and as policies and practices change, all registered pesticides continue to meet th e statutory standard of no unreasonable adverse
effects to human health or the environmen t. Changes in science, public policy, and pesticide use practices will occur over time . Through the registration review program, the Agency periodically reevaluates pesticid es to make sure that as change occurs, products in the marketplace can be used safel y. Information on this program is provided

at: http://www.epa.gov/oppsrrd1/ registration_review/

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In 2006, the Agency implemented the Registration Review program pursuant to FIFRA Section 3(g) and will review each regist ered pesticide every 15 years to determine
whether it continues to meet the FI FRA 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 rece ived 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 a nd 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 Pl an (PWP) for bromine indi cated 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. Beca use 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 r eceived, 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 PW P, continue to support this pesticide registration as summarized herei n. The status of these and ot her registration review cases
is available on http//www.epa.gov/oppsrrd1/registration review/review

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Bromine was first registered as an antimic robial pesticide in the United States in May of 1976. The bromine registration review case consists of one active ingredient (PC code 008701). Since the publica tion of the bromine PWP, two new products containing bromine as an active ingredient have been re gistered with the EPA. However, these two new products, which involved no new uses or changes to applicati on rates or methods, do not affect the data needs, work plan and tim eline 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 mildewsta t/mildewcide, bactericide, fungistat, fungicide, virucide, and insecticide. Bromine is regist ered for use to contro l bacteria and fungi on surfaces of agricultural, commercial, institu tional, industrial, re sidential, and public access premises and equipment. It is also re gistered for use to treat/disinfect potable water (examples of potable water system treatme nt sites include, but ar e not restricted to, aboard ships and on oil and gas drilling/production platforms).

Bromine (Br 2 ) is a naturally occurr ing 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 rapi dly 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 Toleran ce 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 i on in aqueous environments (e.g., swimming pools) and in the presence of sunlight, oxidi zing 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 asse ssments 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 th at may generate bromate ion. However, registered bromine products are not expected to generate brom ate 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 po table 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 duri ng drinking water ozonation). Therefore, because it is unlikely that its currently-register ed 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, risk s of concern resulting from the use of bromine products are not anticipated. For furt her information regard ing the toxicity of
bromine and the dissociation of bromine and bromine releasing chemicals please refer to
the document titled “Bromine. Human Hea lth 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

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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 Br 2 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 chem istry 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 ma y 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 Br 2 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. Th e pH of a solution of
deionized water and several bromine
concentrations is shown in Table below:

Mg/L Br 2 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/Me lting 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:

Br 2 + 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, Br 2 , 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, gaso line, 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 Decom position 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 Eligibilit y Decision (RED) for bromine was issued in 1993, and a Tolerance Reassessment Eligibility Deci sion (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 ha s determined that no additional exposure
assessments or data are needed. Based on th e low toxicity of bromine and its principal degradation products (bromide and hypobromite ), no additional toxicity and exposure data are needed for this registration re view. In addition, no additional or new occupational and residential exposure assessmen ts are needed to ensure that the bromine registration review case meet s the safety standards estab lished 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 Revi ew Decision. PC Code: 008701,” dated March 16, 2010.

1. Toxicology

The Agency has reviewed all toxic ity studies submitted for bromine and has determined that the toxicological database is sufficient and that addi tional toxicity studies for registration review are not needed. The toxicological data base for bromine, which is largely based on sodium bromide, is curre ntly comprised of published and unpublished studies either submitted to the Agency or obtained directly from published open literature. As previously mentioned, ba sed on bromine’s currently-registered use patterns, bromine products will not generate bromate ion as long as treated water is not exposed to stronger oxidizi ng 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 categorie s for bromine. Data from the existing bromine TRED indicate that, in technical form, sodium brom ide has low acute toxicity (Toxicity Category III) via the or al (rat) and dermal (rabbit) ro utes. 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 (Br 2 ) 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 endpo ints were not selected, exposures were not estimated, and risks have not been quantifie d for bromine and its degradation products
and are not needed in associa tion with this registration re view. 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 identifie d 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 li kely to result from registered bromine uses. No adverse systemic effects have been associated with either bromine (Br 2 ) or its principal degradation products, bromide (Br - ) or hypobromite ion (BrO - ) except at doses about 5,000X that likely from registered us es. 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 developmenta l study (MRID 55794601). The primary effect consisted of decreased body weight ga in and a NOAEL of 100 mg/kg/day was
established. The rats were administer ed 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 toxi city at the highest dose of 1,000 mg/kg/day. Other effects seen at the 1,000 mg/kg/day dos e level included unsteady gait, weakness, and loss of coordination, redu ced 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/da y for 4 weeks. Signs of toxicity were limited to the 200 mg/kg/day dose level. Sa livation was reported along with “noisy respiration.” Other signs of t oxicity included decreased food in take during the last week. Hematological parameters were altered such as significant elevati on of platelet and RBC count and hemoglobin levels. Clinical chemistry effects were also observed such as increases in aspartate aminotransferase, crea tinine, albumin, total pr otein and cholesterol levels. Additionally, urinary volume was increased and proteinuria was observed. Finally, histopathological hyperkeratosis a nd 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 toxic ity 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 beha vior. 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 th at 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 huma n carcinogen and its current use patterns are

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not expected to generate bromate ion, whic h 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 dete rmine whether certain substances (including pesticide active and other ingred ients) may have an effect in humans or wildlife similar to an effect produced by a “natur ally occurring estrogen, or othe r such endocrine effects as the Administrator may designate.” The ED SP 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 substa nce 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 inte ract with E, A, or T hormonal systems will proceed to the next stage of the EDSP wher e EPA will determine which, if any, of the Tier 2 tests are necessary based on the avai lable data. Tier 2 te sting is designed to identify any adverse endocrine related eff ects 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 c ontains 58 pesticide ac tive ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and wa ter, residential activity, and certain postapplication agricultural s cenarios. This list should not be construed as a list of known or likely endocrine disruptors.

Bromine is not among the group of 58 pest icide 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 fo r 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, Resident ial 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 dietar y (food) exposure to bromine residues may
occur as a result of its use in livestock premises, restau rants, 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 anticipate d. The following tolerance exemptions have

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been established for use on food contact surfac es: (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 brom ide (KBr) at use concentrations of ≤ 200 ppm available halogen on food processing equi pment 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 us e of bromine to treat potable water will not
result in the formation of br omate ion provided that the trea ted 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. Ho wever, based on the cu rrently-registered use patterns, if oxidation were to occur, the am ount 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 br omate ion sources (e.g., naturally occurring bromide ion during drinking water ozonation). Therefore, because it is unlikely that its currently-registered uses (including the potab le 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 drinki ng water exposure or to aggregate human exposure to bromate ion, risks of concern resu lting from the use of bromine products are not anticipated.

A tolerance of 1 ppm (the treatment concen tration) 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 Cont aminant Level (MCL) for residual bromate ion, the only bromine residue currently of hu man health concern, in drinking water at 10 μg/L (0.01 ppm). This MCL represents all so urces of residual bromate ion in drinking water whether they are naturally-occu rring/background sources or anthropogenic (including pesticidal). Howeve r, as previously mentioned th e currently-registered uses of
bromine will not result in the formation of br omate 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 cont ribute measurably to the aggregate human exposure to bromate ion in drin king water. Therefore the use of bromine to treat potable water does not trigger the need for a drinki ng 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 Br omine TRED. Based on an evaluation of the hazard database by the Agency in 2005, no adverse systemic effects have been associated with either bromine (Br 2 ) or its principal degradation products, bromide (Br - ) or hypobromite ion (BrO - ). Therefore, toxicity endpoint s 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 acu te irritation effects are mitig ated by the use of personal protective equipment (PPE) require ments included on product labels.

An occupational and/or residential expos ure assessment is needed for an active ingredient if (1) certain toxi cological criteria are triggere d and (2) there is potential exposure to handlers (mixers, loaders, applicat ors, etc.) during use or to persons entering treated sites after application is complete. For bromine, these toxi cological 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 pesticid e residues in food and drinking water, as well as non-occupational pesticide exposures. No adverse systemic effects have been associated with either bromine (Br 2 ) 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 as sessment 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 antimic robial pesticide for indoor use only. Therefore, the only possible routes of e nvironmental 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 le vels 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. Th erefore, no environmental fate or ecological
data are needed.

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For a detailed discussion of the environm ental fate and ecological risk assessment status for bromine please refer to the document titled “Summary of Product Chemistry, Environmental Fate, and Ecotoxi city Data for the Bromine Registration Review Decision Document,” dated September 10, 2009.

2. Endangered Species

EPA has made a “No Effect” determina tion 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 threaten ed terrestrial or aquatic species, or their designated critical habitats, as listed by the U.S. Fish a nd Wildlife Service (USFWS) and the National Oceanic and Atmospheric Administration (NOAA) National Marine Fishereries Service (NMFS).

E. Incidents

Federal law requires registrants of pestic ides 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 involve d 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 ope ning of a docket and the issuance of a Preliminary Work Plan (PWP) for public co mment. 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 Pl an 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 just ice - the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income - in the development, implementation, and enforcemen t 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 disproportiona te 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 envi ronmental justice issues, please visit
EPA’s website at: http://www.epa.gov/compliance/en vironmentaljustice/index.html

.

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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 recei ve any comments on water quality issues.

I. Trade Irritants

Through the registration review proce ss, 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 comme nts regarding the existence of any trade
irritant issues associated with bromine.

III. REGISTRATION REVIEW FINAL DECISION

The Agency has determined that no additi onal 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 factor s 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 contai ning bromine when currently required label instructions are followed. In addition, EP A has made a “No Effect” determination for endangered species for bromine and further e nvironmental 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 b een 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 availa bility of the Final Registration Review
Decision for bromine.

14Docket Number: EPA–HQ–OPP–2009–0167 www.regulations.gov

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

LC 50 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.

LD 50 Median Lethal Dose. A statistically deri ved 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 Identifi cation (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 Q 1 * 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 (Registrati ons 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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