United States Chemical Safety January 2013 

Environmental Protection and Pollution Prevention 

Agency (7510P) 

 

Ammonia & Ammonium Sulfate 

Registration Review: 

Final Work Plan 

January 2013 

 

Docket Number: EPA-HQ-OPP-2012-0684 

www.regulations.gov

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Ammonia & Ammonium Sulfate 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 Ammonia & Ammonium Sulfate Cases may be found in the 

registration review docket EPA-HQ-OPP-2012-0684 located on the internet at

www.regulations.gov. 
Docket Number: EPA-HQ-OPP-2012-0684 

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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 Ammonia (Case 7440) and Ammonium Sulfate (Case 

5073). 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 Ammonia and Ammonium Sulfate 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 Ammonia and Ammonium Sulfate Preliminary Work Plan (PWP) was published on 

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

Preliminary Work Plan document is available on www.regulations.gov docket number EPA-HQOPP-2012-0684. 

The first product containing ammonia (PC Code 005302, Case #7440) as an active ingredient 

was registered in the United States in 1971 for conventional pesticide uses. The first product 

containing ammonium sulfate (PC Code 005601, Case # 5073) was registered in 1987 for use as 

a wood preservative. Currently, there are two EPA registered products with ammonia as the 

active ingredient and two EPA registered products with ammonium sulfate as the active 

ingredient. Ammonia and ammonium sulfate are registered for use in pulp and papermill 

industrial water systems. Ammonia products are also registered for use in other industrial water 

systems including recirculating cooling water systems, evaporative condensers, influent water 

systems (freshwater and seawater), brewery and food pasteurizers, industrial fresh water systems, 

air washers, seawater desalination and reverse osmosis systems, paint spray booth sumps, nonfish containing decorative fountains and ponds used for cooling purposes, sewage and 

wastewater systems. All ammonia and ammonium sulfate products can be expressed in terms of 

percent active ingredient ammonium sulfate as presented in Table 1; therefore, for the purposes 

of this registration review, EPA intends to assess exposure and risk to all products in the 

Ammonia and Ammonium Sulfate Cases in terms of ammonium sulfate.
Docket Number: EPA-HQ-OPP-2012-0684 

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Table 1. Registered Products Containing Ammonium Sulfate 

EPA Reg. 

Number 

Product 

Name 

Company 

Name 

Active Ingredient Listed 

on Label – Percent A.I. 

Active Ingredient 

Expressed as Percent A.I. 

Ammonium Sulfate 

9386-49 Fennosurf 586 Kemira Ammonia (total) – 7.59% Ammonium Sulfate – 28% 

1706-240 Nalco 60620 Nalco Ammonium Sulfate – 20% Ammonium Sulfate – 20% 

1448-433 Busan 1215 Buckman Ammonia (total) – 7.59% Ammonium Sulfate – 28% 

1448-432 BCMW Buckman Ammonia (total) – 7.59% Ammonium Sulfate – 28% 

All registered products are mixed on-site by authorized, trained personnel in a closed system with 

sodium hypochlorite to form a monochloramine solution. The monochloramine solution is the 

active biocide in the pulp, papermill and other industrial water systems. According to product 

labeling, ammonium bromide (PC Code 000352) may also be used in conjuction with a 

substance such as sodium hypochlorite or chlorine gas to form a monochloromine solution; 

however, the Agency is evaluating this active ingredient under a separate registration review case 

(Case Number 5002) because the chemical reaction results in the formation of hypobromous acid 

in addition to monochloramine. 

EPA did not undertake a reregistration eligibility decision (RED) for ammonium sulfate because 

the first pesticide product containing ammonium sulfate was registered after November 1, 1984. 

Although the first pesticide product containing ammonia was registered before November 1, 

1984, EPA did not undertake a reregistration eligibility decision (RED) for ammonia because the 

last product containing ammonia as an active ingredient was cancelled in 1989, prior to the 

initiation of the reregistration process for this chemical. 

Residues of ammonium sulfate are exempted from the requirement of a tolerance when used as a 

solid diluent or carrier in accordance with good agricultural practices as inert (or occasionally 

active) ingredients in pesticide formulations applied to growing crops or to raw agricultural 

commodities after harvest (40 CFR 180.910). 

Comments Received on the Preliminary Work Plan

The Agency received two comments 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: The FIFRA Endangered Species Task Force (FESTF) submitted two 

comments, one on the Ammonia Case and one on the Ammonium Sulfate Case, 

requesting that the lead technical registrants for ammonia and ammonium sulfate who are 

not a members of the FESTF (or a company having met its data compensation 

obligations) provide a formal offer-to-pay to FESTF for reliance on their data or be 

required to develop substantially similar data on their own. 
Docket Number: EPA-HQ-OPP-2012-0684 

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Response: The Agency thanks FESTF for its comments and will consider this 

information as it conducts the registration review and makes its registration review 

decisions. 

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

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 ammonia and ammonium 

sulfate registration review process. 

Risk Assessments and Anticipated Data Needs

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, 

including an endangered species risk assessment, for monochloramine. The Agency does not 

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

additional data for use in conducting the registration review risk assessment. 

Ecological Risk: 

 The most recent ecological risk assessment was completed in 2011, in support of the 

initial registration of ammonium sulfate for use in pulp and papermills. The Agency 

determined that, based on the use pattern, there was a low likelihood of exposure and, 

therefore, acute or chronic risk to the aquatic environment was not expected. 

 A qualitative ecological risk assessment of use in once-through industrial water systems 

was conducted in 2008. Additional data are expected to be needed to refine the 

assessment. 

 For the purpose of this registration review, the Agency anticipates conducting a 

quantitative risk assessment on the monochloramine solution that is the active biocide in 

once-through industrial systems. The Agency does not anticipate the need to conduct a 

risk assessment on the monochloramine solution resulting from the use of ammonium 

sulfate in pulp and papermills due to the rapid hydrolysis and biodegradation of 

monochloramine in industrial water systems, including their waste systems, and, 

therefore, the low likelihood of exposure. 

 The Agency anticipates the need to require the following additional ecological data for 

monochloramine generated during use in once-through industrial water systems. 

850.1400 -- Fish early-life stage toxicity test (freshwater and estuarine/marine) 

850.1300 -- Daphnid chronic toxicity test 

850.1350 -- Mysid chronic tox - aquatic invertebrate life-cycle (saltwater) 

850.4225 -- Seedling emergence, Tier II 

850.4500 -- Aquatic plant growth (algal) Tier II: marine diatom, freshwater 

diatom 

850.4550 -- Aquatic plant growth (algal) Tier II: cyanobacteria (blue-green algae) 
Docket Number: EPA-HQ-OPP-2012-0684 

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 The Agency anticipates the need to require the following additional environmental fate 

data for monochloramine generated during use in once-through industrial water systems. 

835.6200 -- Aquatic field dissipation 

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

Ecological Effects Scoping Document in Support of Registration Review of Ammonia and 

Ammonium Sulfate, located in the docket. 

Human Health Risk: 

 A quanitative risk assessment has not been conducted on ammonium sulfate due to the 

low likelihood of exposure. The most recent qualitative assessment was completed in 

2011 in support of the registration of ammonium sulfate for use in pulp and papermills in 

food contact paper and paperboard. The Agency determined that the only potentially 

toxic compound resulting from ammonium sulfate use in the water system is 

monochloramine. Any monochloramine not consumed in the water system is expected to 

degrade under the high temperature conditions of the paper drying process (110 °C) and 

therefore, not remain in the paper to migrate to food. 

 Because all registered products are administered in a closed system and the Agency does 

not anticipate human exposure during or after use, the Agency does not anticipate the 

need to conduct a human health risk assessment or require additional human health data 

for this registration review at this time. 

 For more information, please refer to Ammonia and Ammonium Sulfate: Human Health 

Registration Review Scoping Document, located in the docket. 

Product Chemistry: 

 The Agency does not anticipate the need to require additional product chemistry data for 

this registration review at this time. 

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

Ecological Effects Scoping Document in Support of Registration Review of Ammonia and 

Ammonium Sulfate, located in the docket. 

Endangered Species

The Agency has not conducted a risk assessment that supports a complete endangered species 

determination for registered ammonia and ammonium sulfate products. The ecological risk 

assessment planned during registration review will allow the Agency to determine whether the 

registered pesticide products have “no effect” or “may affect” federally listed threatened or 

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

concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the 

Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries 

Service (the Services), as appropriate. 
Docket Number: EPA-HQ-OPP-2012-0684 

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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 ammonia or ammonium sulfate. However, as required by FFDCA 

section 408(p), ammonia and ammonium sulfate are subject to the endocrine screening part of 

the Endocrine Disruptor Screening Program (EDSP). 

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

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

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

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

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

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

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

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

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

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

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

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

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

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Ammonia and 

ammonium sulfate are 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 call-ins, requiring the submission of EDSP screening assays for ammonia and 

ammonium sulfate. 

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-2012-0684 

www.regulations.gov

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Timeline

EPA has created the following estimated timeline for the completion of the ammonia and 

ammonium sulfate 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-2012-0684 

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III. Summary of Anticipated Data Requirements 

The table below summarizes anticipated data needs for the Ammonia and Ammonium Sulfate 

Cases in this document, Product Chemistry, Environmental Fate, and Ecological Effects Scoping 

Document in Support of Registration Review of Ammonia and Ammonium Sulfate, and Ammonia 

and Ammonium Sulfate: Human Health Registration Review Scoping Document. The Agency 

anticipates the need to require the following additional ecological and environmental fate data 

for monochloramine generated during use in once-through industrial water systems.

Table 3. Summary of Anticipated Data Requirements – Ammonia Registrations 

Guideline 

Number Anticipated Data Requirement Test Material 

Estimated Timeframe 

(Measured in months from 

DCI Receipt) 

835.6200 Aquatic field dissipation Monochloramine 12 

850.1400 Fish early-life stage toxicity test 

(freshwater and estuarine/marine) Monochloramine 12 

850.1300 Daphnid chronic toxicity test Monochloramine 12 

850.1350 Mysid chronic tox - aquatic 

invertebrate life-cycle (saltwater) Monochloramine 12 

850.4100 Seedling emergence, Tier II Monochloramine 12 

850.4500 Aquatic plant growth (algal) Tier 

II: marine diatom, freshwater 

diatom 

Monochloramine 12 

850.4550 

Aquatic plant growth (algal) Tier 

II: cyanobacteria (blue-green 

algae) 

Monochloramine 12