United States Chemical Safety January 2013 

Environmental Protection and Pollution Prevention 

Agency (7510P) 

 

Ammonium Bromide 

Registration Review: 

Final Work Plan 

January 2013 

 

Docket Number: EPA-HQ-OPP-2012-0683 

www.regulations.gov

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Ammonium Bromide Registration Review Team

Human Health & Environmental Effects

Timothy Dole 

Jenny Tao 

William Hazel 

Srinivas Gowda 

Najm Shamim 

William Erickson 

Risk Management

Rebecca von dem Hagen 

Lance Wormell 

Office of General Counsel

Philip Ross 

________________________________________ 

Supporting documents for the Ammonium Bromide Case may be found in the registration review 

docket EPA-HQ-OPP-2012-0683 located on the internet at www.regulations.gov. 
Docket Number: EPA-HQ-OPP-2012-0683 

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Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the 

Agency”) for the registration review of ammonium bromide (Case 5002). The work plan 

includes the expected registration review timeline. The work plan also addresses public 

comments received concerning the Preliminary Work Plan (PWP) in the Summary Document 

which was posted in the ammonium bromide registration review docket, and any other comments 

concerning the initial docket postings. The Summary Document provided information on what 

EPA knows about the pesticide and what additional risk analyses and data or information the 

Agency believes are needed to make a registration review decision. 

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. Changes in science, public policy and pesticide use practices will occur over time. 

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 that 

statutory standard. The public phase of registration review begins when the initial docket is 

opened for each case. Information on this program is provided at: 

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

The first product containing ammonium bromide (PC Code 000352, Case #5002) as an active 

ingredient was registered in the United States in 1999 for use in recirculating cooling water 

systems and pulp and papermills. Currently, there are five products containing ammonium 

bromide as the active ingredient registered with the EPA. Ammonium bromide is an algicide, 

bactericide, microbicide and slimicide registered for use in industrial process and water systems 

such as recirculating cooling towers, pulp and papermills and wastewater treatment systems. 

Paper and paperboard treated with ammonium bromide are approved for food contact use. The 

registered ammonium bromide products may be mixed on-site with a substance such as sodium 

hypochlorite or chlorine gas to form a monochloramine solution. The monochloramine solution 

is the active biocide in the pulp, papermill and other industrial water systems. Ammonium 

bromide is not registered for use in drinking water systems. Products registered as ammonia (PC 

Code 005302, Case #7440) and ammonium sulfate (PC Code 005601, Case # 5073) are also used 

in conjuction with an oxidizing agent to form a monochloromine solution; however, the Agency 

is evaluating ammonia and ammonium sulfate under separate registration review cases because 

the chemical reaction of ammonium bromide when mixed on-site as noted above results in the 

formation of hypobromous acid in addition to monochloramine. 

EPA did not complete a reregistration eligibility decision (RED) for ammonium bromide because 

the first pesticide product containing ammonium bromide was registered after November 1, 

1984. 

The Ammonium Bromide Preliminary Work Plan (PWP) (PC Code 000352) was published on 

September 26, 2012 and the 60-day comment period ended on November 26, 2012. Documents 

associated with the registration review of ammonium bromide can be viewed at 

www.regulations.gov in docket EPA-HQ-OPP-2012-0683. Documents associated with the 

registration review of the Ammonia and Ammonium Sulfate Cases can be viewed at 
Docket Number: EPA-HQ-OPP-2012-0683 

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www.regulations.gov in docket EPA-HQ-OPP-2012-0684. Below is a summary of the issues 

relevant to this registration review case. 

Comments Received on the Preliminary Work Plan

The Agency received one comment during the public comment period on the initial docket, 

described below. In the PWP, the Agency solicited comments on specific topics: environmental 

justice, water body impairment, trade irritants, and structure activity relationships. No comments 

or information were received during the public comment period concerning these issues. 

Comment: In the Ammonium Bromide: Human Health Registration Review Scoping 

Document. the Agency classified the 90-day subchronic oral study as unacceptable, but 

upgradable. ICL-IP American Inc., the sole registrant of ammonium bromide 

manufacturing and end-use products, brought to the attention of the Agency that the 

information on the neurotoxicity screening assessment portion of the 90-day subchronic 

oral study necessary to upgrade the study was submitted to EPA in June 2001 under 

MRID 5450401. The registrant also provided information on a hydrolysis study. 

Response: The Agency has reviewed MRID 5450401 and based on the information 

provided, has reclassified the 90-day subchronic oral (diet) study as acceptable. The 

Agency encourages the registrant to submit the hydrolysis study for consideration in the 

registration review risk assessment. 

The comment received during the initial public comment period did not affect the data needs, 

including the required 90-day inhalation toxicity study, work plan, and timeline described in the 

PWP and they remain as they were presented initially in the PWP. Further, this document makes 

final the work plan for the ammonium bromide registration review process. 

Risk Assessments and Anticipated Data Needs

The Agency does not anticipate the need to conduct an ecological risk assessment. The Agency 

anticipates the need to conduct a human health risk assessment. The Agency anticipates needing 

additional data for use in conducting the registration review for ammonium bromide. 

Ecological Risk: 

A quantiative ecological risk assessment has not been performed for ammonium bromide due to 

the low likelihood of exposure. Pulp and paper use is a closed system, with waste water initially 

held in holding ponds. Based on the physical/chemical characteristics of monochloramine (e.g., 

short hydrolytic half-life, readily biodegradable), pond water released into the aquatic 

environment is unlikely to contain monochloromine. Similarly, waste water released from 

recirculating cooling towers is not likely to contain monochloramine, and minimal exposure is 

expected in the aquatic environment. 

 The Agency does not anticipate the need to require additional ecological or 

environmental fate data for this registration review case at this time. 
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 For more information, please refer to Product Chemistry, Environmental Fate, and 

Ecological Effects Scoping Document in Support of Registration Review of Ammonium 

Bromide, located in the docket. 

Human Health Risk: 

 A human health risk assessment has not been performed for ammonium bromide. 

 The Agency anticipates the need to conduct an occupational exposure risk assessment for 

the registration review of ammonium bromide’s liquid and granular formulations. 

 If labels were amended to require that a closed system and chemical reistant gloves be 

used for the mixing of the liquid formulation of ammonium bromide, then the Agency 

anticipates that a risk assessment for the liquid formulation will no longer be needed 

because human exposure will be minimal*. 

 If particle size data is provided showing the granulars are not inhalable, then registrant 

may request a waiver for the 90-day inhalation toxicty and inhlation exposure studies*. 

 The Agency anticipates the need to require the following additional human health data 

for use in the registration review of ammonium bromide. 

875.3465 – 90-day inhalation toxicity (see above*) 

875.1400 -- Inhalation indoor exposure (see above*) 

 For more information, please refer to Ammonium Bromide: Human Health Registration 

Review Scoping Document, located in the docket. 

Product Chemistry: 

 The Agency anticipates the need to require the following additional product chemistry 

data for use in the registration review of ammonium bromide end-use products (EUP) 

that are formulated as a solid. 

 830.7520 – Particle size (see above*) 

 For more information, please refer to Product Chemistry, Environmental Fate, and 

Ecological Effects Scoping Document in Support of Registration Review of Ammonium 

Bromide and Ammonium Bromide: Human Health Registration Review Scoping 

Document, located in the docket. 

Incidents:

Ecological: 
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 No ammonium bromide ecological incidents have been reported in the OPP incident 

database. 

Human Health: 

 No ammonium bromide human poisoning incidents have been reported in the OPP 

incident database. 

 
Docket Number: EPA-HQ-OPP-2012-0683 

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Endangered Species

Based on the low likelihood of exposure, the Agency intends to conclude that the registered uses 

of ammonium bromide 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's (NOAA) 

National Marine Fisheries Service (NMFS). EPA anticipates conducting no further analysis of 

potential risks to endangered or threatened species unless public comment provides data or 

information that would otherwise inform the Agency's determination. 

Endocrine Disruptor Screening Program

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. A human health risk assessment identifying the most sensitive endpoints has 

not been conducted for ammonium bromide. However, as required by FFDCA section 408(p), 

ammonium bromide is 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, 

which contains 58 pesticide active ingredients and 9 inert ingredients. Ammonium bromide is not 

among the group of 58 pesticide active ingredients on the initial list to be screened under the 

EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data callins, requiring the submission of EDSP screening assays for Ammonium bromide. For further 

information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, 

future lists, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/. 
Docket Number: EPA-HQ-OPP-2012-0683 

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Timeline

EPA has created the following estimated timeline for the completion of the ammonium bromide 

registration review: 

Anticipated Schedule

Activities Estimated Month/Year

Phase 1: Opening the docket 

Open Docket and 60-Day Public Comment Period for PWP September 2012 – 

Complete 

Close Public Comment Period for Docket November 2012 – 

Complete 

Phase 2: Case Development 

Develop Final Work Plan (FWP) January 2013 – Complete

Issue DCI March 2014 

Data Submission March 2015 

Open 30-Day Public Comment Period for Preliminary Risk 

Assessments 

September 2016 

Close Public Comment Period for Preliminary Risk Assessments October 2016 

Phase 3: Registration Review Decision 

Open 60-Day Public Comment Period for Proposed Reg. Review 

Decision 

March 2017 

Close Public Comment Period for Proposed Reg. Review Decision May 2017 

Final Decision and Begin Post-Decision Follow-up 2017 

Total (years) 5 

Next Steps

A DCI will be developed regarding the data needs listed under the “Risk Assessments and 

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

March 2014. 

 
Docket Number: EPA-HQ-OPP-2012-0683 

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Summary of Anticipated Data Requirements – Ammonium Bromide 

The table below summarizes anticipated data needs for the Ammonium Bromide Case in this 

Final Work Plan, Product Chemistry, Environmental Fate, and Ecological Effects Scoping 

Document in Support of Registration Review of Ammonium Bromide, and Ammonium Bromide: 

Human Health Registration Review Scoping Document. 

Summary of Anticipated Data Requirements – Ammonium Bromide 

Guideline 

Number Anticipated Data Requirement Test Material

Estimated Timeframe 

(Measured in months 

from DCI Receipt) 

870.3465 90-day inhalation toxicity1 TGAI 12 

875.1400 Inhalation indoor exposure1 TGAI/MUP 12 

830.7520 Particle size1 EUP 12 

 

1

 Data for requirements 870.3465, 875.1400, and 830.7520 may be waived if labels are amended and particle size 

data is provided. See Risk Assessments and Anticipated Data Needs section above for further details.