United States Chemical Safety January 2013 Environmental Protection and Pollution Prevention Agency (7510P)



# Ammonium Bromide Registration Review: Final Work Plan January 2013Docket Number: EPA-HQ-OPP-2012-0683 www.regulations.gov

3 of 10 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 Ca se 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 www.regulations.gov

4 of 10 Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the Agency”) for the registration review of am monium bromide (Case 5002). The work plan includes the expected registration review time line. The work plan also addresses public comments received concerning the Preliminary Wo rk Plan (PWP) in the Summary Document which was posted in the ammonium bromide regi stration review docket, and any other comments concerning the initial docket postings. The Su mmary 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 ma ke a registration review decision.

The Agency is implementing the registration revi ew 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 th e FIFRA standard for registration. Changes in science, public policy an d pesticide use practices will occur over time. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and practi ces change, all registered pestic ides continue to meet that statutory standard. The public pha se 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 brom ide (PC Code 000352, Case #5002) as an active ingredient was registered in the United States in 1999 for use in reci rculating 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 br omide are approved for food contact use. The registered ammonium bromide products may be mi xed on-site with a substance such as sodium hypochlorite or chlorine gas to form a monochl oramine solution. The monochloramine solution is the active biocide in the pulp, papermill and other industria l water systems. Ammonium bromide is not registered for use in drinking wate r 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 unde r separate registrati on review cases because the chemical reaction of ammoni um 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 eligibil ity decision (RED) for ammonium bromide because the first pesticide product cont aining ammonium bromide was re gistered 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 pe riod 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-2 012-0683. Documents associated with the registration review of the Ammonia and Ammonium Sulfate Cases can be viewed atDocket Number: EPA-HQ-OPP-2012-0683 www.regulations.gov

5 of 10 www.regulations.gov in docket EP A-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 p ublic comment period on the initial docket, described below. In the PWP, the Agency soli cited comments on specific topics: environmental justice, water body impairment, trade irritants, an d structure activity relati onships. No comments or information were received during the public comment period con cerning these issues.

Comment: In the Ammonium Bromide: Human Health Registration Review Scoping Document. the Agency classified the 90-day subc hronic 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 a ssessment 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 provi ded information on a hydrolysis study.

Response: The Agency has reviewed MRID 5450401 and based on the information provided, has reclassified the 90-day subchr onic 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 co mment period did not affect the data needs, including the required 90-day i nhalation toxicity study, work pla n, and timeline described in the PWP and they remain as they were presented init ially 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 condu ct 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 regi stration 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/che mical characteristics of monochloramine (e.g., short hydrolytic half-life, readily biodegra dable), pond water releas ed into the aquatic environment is unlikely to contain monochlorom ine. 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.Docket Number: EPA-HQ-OPP-2012-0683 www.regulations.gov

6 of 10  For more information, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Suppor t 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 a mmonium bromide’s liquid and granular formulations.

 If labels were amended to require that a cl osed system and chemical reistant gloves be used for the mixing of the liquid formulati on 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 inhala ble, then registrant may request a waiver for the 90-day inhalati on toxicty and inhlati on exposure studies*.

 The Agency anticipates the need to require the following additional human health data for use in the registration re view of ammonium bromide.

875.3465 – 90-day inhalation t oxicity (see above*) 875.1400 -- Inhalation indoor e xposure (see above*)

 For more information, please refer to Ammonium Bromide: Hum an 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 Suppor t of Registration Review of Ammonium Bromide and Ammonium Bromide: Human Hea lth Registration Review Scoping Document , located in the docket.

Incidents:

Ecological:Docket Number: EPA-HQ-OPP-2012-0683 www.regulations.gov

7 of 10  No ammonium bromide ecological incidents ha ve 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 www.regulations.gov

8 of 10 Endangered Species

Based on the low likelihood of exposur e, the Agency intends to conclu de that the registered uses of ammonium bromide will have 'no effect' (NE) on endangered or threatened terrestrial or aquatic species, or their designa ted critical habitats, as listed by the U.S. Fish and Wildlife Service (USFWS) and the National Oceanic and Atmospheric Administration's (NOAA) National Marine Fisherie s 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 in form the Agency's determination.

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive 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 whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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 scre en all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/dat a call-ins for the firs t group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredie nts. 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 revi ew, 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 polic ies 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 www.regulations.gov

9 of 10 Timeline

EPA has created the following estimated timelin e 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 Prelim inary 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 Pro posed 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 www.regulations.gov

10 of 10 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 Fa te, and Ecological Effects Scoping Document in Support of Registratio n Review of Ammonium Bromide , and Ammonium Bromide: Human Health Registrati on 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 toxicity 1 TGAI 12
875.1400 Inhalation indoor exposure 1 TGAI/MUP 12

830.7520 Particle size 1 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.