United States Chemical Safety September 2012

Environmental Protection and Pollution Prevention

Agency (7510P)

Ammonia & Ammonium Sulfate

Summary Document

Registration Review: Initial Docket

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

www.regulations.gov 

Ammonia & Ammonium Sulfate 

Summary Document 

Registration Review: Initial Docket 

September 20 12 

Case #s 7 440 & 5073 

Approved By: 

oan Harrigan-Farrelly 

Director, Antimicrobials Division 

Date: 

2 of20 
Docket Number: EPA-HQ-OPP-2012-0684

www.regulations.gov

3 of 20

TABLE OF CONTENTS

Ammonia & Ammonium Sulfate Registration Review Team........................................................ 4

I. Preliminary Work Plan -- Ammonia & Ammonium Sulfate....................................................... 5

II. Fact Sheet ................................................................................................................................. 13

III. Summary of Anticipated Data Requirements......................................................................... 17

IV. Appendix A: Use Patterns – Ammonia and Ammonium Sulfate.......................................... 18

________________________________________

Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents: 

1. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in 

Support of Registration Review of Ammonia and Ammonium Sulfate. September 24, 

2012

2. Ammonia and Ammonium Sulfate: Human Health Registration Review Scoping 

Document. September 14, 2012

Additional supporting documents for the Ammonia and 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

www.regulations.gov

4 of 20

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

www.regulations.gov

5 of 20

I. Preliminary Work Plan -- Ammonia & Ammonium Sulfate

Introduction: 

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States generally must be registered by the U.S. 

Environmental Protection Agency (USEPA, EPA, or the Agency) 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/.

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. The Agency will consider benefits information and data as required by FIFRA. The 

public phase of registration review begins when the initial docket is opened for each case. The 

docket is the Agency’s opportunity to state what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the Ammonia & Ammonium Sulfate Cases.

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

www.regulations.gov

6 of 20

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). 

Documents associated with the registration review of the Ammonia and Ammonium Sulfate 

Cases can be viewed at www.regulations.gov in docket EPA-HQ-OPP-2012-0684. Documents 

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

in docket EPA-HQ-OPP-2012-0683. Below is a summary of the issues relevant to the

registration review of ammonia and ammonium sulfate.

Anticipated Risk Assessment and 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 
Docket Number: EPA-HQ-OPP-2012-0684

www.regulations.gov

7 of 20

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 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.

• 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)

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

www.regulations.gov

8 of 20

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.

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

www.regulations.gov

9 of 20

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/.

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

Close Public Comment Period for Docket November 2012

Phase 2: Case Development

Develop Final Work Plan (FWP) March 2013

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

www.regulations.gov

10 of 20

Guidance for Commenters: 

The public is invited to comment on EPA’s Preliminary Work Plan and rationale. The Agency 

will carefully consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a final work plan for the ammonia and ammonium sulfate 

registration review cases.

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 are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key 

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

Water Quality: 

Ammonium Sulfate 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 the 

Agency’s National Pesticides Cause of Impairment of Waters website (searched September 6, 

2012)

1

. In addition, no Total Maximum Daily Loads (TMDL) have been developed for

ammonium sulfate, based on information provided at the Agency’s National Pesticide TMDL 

web site (searched September 6, 2012)

2

. However, ammonia was identified as a cause of 

impairment for 584 water bodies (unionized (167), total ammonia (158), ammonia (66), and 

ammonia nitrogen (3)) under section 303(d) of the Clean Water Act. No Total Maximum Daily 

Loads (TMDL) have been developed for ammonia, based on information provided at the 

Agency’s National Pesticide TMDL web site (searched September 6, 2012)

2

.

More information on impaired water bodies and TMDLs can be found at http: 

//www.epa.gov/owow/tmdl/. The Agency invites submission of water quality data for this 

pesticide. To the extent possible, data should conform to the quality standards in Appendix A of 

the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water 

Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: 

http: //www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm), in order to ensure the 

data can be used quantitatively or qualitatively in pesticide risk assessments.

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. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

 1 . http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 2

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES
Docket Number: EPA-HQ-OPP-2012-0684

www.regulations.gov

11 of 20

atypical, unusually high exposure to ammonia or ammonium sulfate compared to the general 

population. Please comment if you are aware of any sub-populations that may have atypical, 

unusually high exposure compared to the general population.

Structure Activity Relationships: 

EPA must rely upon information of appropriate quality and reliability for each decision made by 

the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide 

chemical traditionally begins with the applicant’s submission of a set of studies conducted with 

the specific pesticide chemical of interest. The use of the results of such testing (measured data) 

is a logical, scientifically rigorous process that identifies the physical, chemical, and 

environmental fate properties of the pesticide, as well as the dose and endpoints at which an 

adverse effect can occur in various animal species. 

Today, there is significant interest in alternative techniques, i.e., techniques other than data 

generation that could significantly inform the Agency’s decision-making process. Recently, OPP 

has made increasing use of structure activity relationship (SAR) as part of its regulatory 

decision-making process. In the SAR process, a chemical's molecular structure is compared to 

that of other chemicals for which data are available. These structural similarities are then used to 

make predictive judgments about a chemical’s physical, chemical, and biological properties.

Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly 

related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To 

develop a QSAR, a selected set of measured data on a single physical, chemical, or biological 

property is used to derive a model (an equation) to predict the value of that property.

Since SAR assessments and QSAR modeling are another set of tools that are available to Agency 

scientists, OPP has begun a process shift that envisions shifting from the current study-by-study 

approach to an approach in which the use of predicted data, generated using validated models, is 

considered along with information from open literature and studies specifically generated under 

Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence evaluation.

At this time, EPA believes that for certain endpoints, especially physical/chemical and fate 

properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements 

for many antimicrobial pesticide chemicals. When considering biological properties, at this time, 

EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of 

chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is 

appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a 

screening-level assessment procedure rather than multiple tiers of assessments with progressively 

more data requirements.

If stakeholders believe that submission of predicted data can fulfill one of the data needs for the 

Ammonia and Ammonium Sulfate Cases, then the Agency invites submission of this 

information. The submitter would be expected to supply a rationale describing the utility of the 

information and provide documentation on the scientific validity of the information. The 

determination that the predicted data fulfills the data requirement would be at the sole discretion 

of the Agency. Pre-submission consultation with the Agency is encouraged.
Docket Number: EPA-HQ-OPP-2012-0684

www.regulations.gov

12 of 20

Additional Information: 

Stakeholders are also specifically asked to provide available information and data that will assist 

the Agency in refining its risk assessments, including any species-specific ecological effects 

determinations. The Agency is interested in receiving the following information: 

1. Confirmation on the following label information: 

a. Sites of application

b. Formulations

c. Application methods and equipment

d. Maximum application rates

e. Frequency of application, application intervals and maximum number of 

applications

f. Geographic limitations on use

2. Use or potential use distribution

3. Use history

4. Usage/use information for non-agricultural uses (e.g., materials preservation)

5. Typical application interval

6. State or local use restrictions

7. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian 

and mammalian mortalities) not already reported to the Agency

8. Monitoring data

Next Steps: 

After the 60-day comment period closes in November 2012, the Agency will review and respond 

to any comments received in a timely manner, and then issue a Final Work Plan for the 

Ammonia and Ammonium Sulfate Cases.
Docket Number: EPA-HQ-OPP-2012-0684

www.regulations.gov

13 of 20

II. Fact Sheet

Background Information Ammonia: 

• Active Ingredient: Ammonia

• Case number: 7440

• PC Code: 005302

• CAS number: 7664-41-7

• Registrant: Buckman Laboratories Inc.

• First approved for use in a registered product: 1971

• All ammonia and ammonium sulfate products can be expressed in terms of percent active 

ingredient ammonium sulfate; 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.

• Antimicrobials Division Chemical Review Manager (CRM): Rebecca von dem Hagen, 

vondem-hagen.rebecca@epa.gov

• Antimicrobials Division Product Manager (PM): Velma Noble, noble.velma@epa.gov

Background Information Ammonium Sulfate: 

• Active Ingredients: Ammonium Sulfate

• Case numbers: 5073

• PC Code: 005601

• CAS number: 7783-20-2

• Registrants: Nalco Company; Kemira Chemicals, Inc.

• First approved for use in a registered product: 1987

• 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).

• Antimicrobials Division Chemical Review Manager (CRM): Rebecca von dem Hagen, 

vondem-hagen.rebecca@epa.gov

• Antimicrobials Division Product Manager (PM): Velma Noble, noble.velma@epa.gov

Use & Usage Information: 

• Ammonia and ammonium sulfate products are registered for use in pulp and papermill 

industrial water systems. Paper and paperboard manufactured with ammonium sulfate 

are approved for food contact use. 

• 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, 

non-fish containing decorative fountains and ponds used for cooling purposes, sewage 

and wastewater systems.
Docket Number: EPA-HQ-OPP-2012-0684

www.regulations.gov

14 of 20

• All products are required by the product labels to be administered via a closed system by 

authorized, trained personnel.

Ecological Risk Assessment Status: 

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, for a detailed discussion of the ecological risk assessments.

• 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. Environmental 

exposure is not expected due to reactivity in the system and retention of discharge water 

in holding ponds. Monochloramine is expected to react with organic matter prior to any 

release of the holding pond water into an aquatic environment. Therefore, the Agency 

determined that acute or chronic risk for non-target species was not expected. 

• A qualitative risk assessment on the use of the registered ammonia products in industrial 

water systems was conducted in 2008. The qualitative assessment concluded that listed 

and nonlisted aquatic organisms may be at risk from exposure to monochloramine 

released from once-through cooling towers. Additional data were needed to refine the 

assessment; however, these data were not received. The Agency anticipates the need to 

require the data identified in the 2008 risk assessment for use in conducting a quantitative 

risk assessment, including an endangered species assessment, for this registration review.

Human Health Risk Assessment Status: 

The following are key findings of the recent human health risk assessments for ammonia and 

ammonium sulfate. Please refer to Ammonia and Ammonium Sulfate: Human Health 

Registration Review Scoping Document, located in the docket, for a detailed discussion of the 

human health risk assessment.

Hazard Characterization: 

• Ammonium sulfate is of low acute toxicity (i.e. toxicity category III or IV) by all routes 

of administration and is not a dermal sensitizer. 

Dietary (Food and Water): 

• A qualitative dietary (food) assessment was conducted in 2011 for the initial registration 

of the ammonium sulfate product used in pulp and papermills. This assessment was 

triggered by the use of the product 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. 
Docket Number: EPA-HQ-OPP-2012-0684

www.regulations.gov

15 of 20

• A drinking water assessment has not been conducted due to the low likelihood of 

exposure. EPA’s Office of Water has established a maximum residual disinfectant level 

(MRDL) of 4.0 ppm and water utilities are required to maintain total chloramines at or 

below this MRDL. Given this limit, the fact that the maximum application rate is 10 ppm 

(for paper mills), and the fact that most of the monochloramine will be consumed during 

the treatment process, the Agency does not anticipate drinking water exposures to 

monochloramine. Ammonia and ammonium sulfate are not registered for use in drinking 

water systems.

Residential: 

• A residential assessment has not been conducted for the ammonia and ammonium sulfate 

products because residential exposure is not expected from the registered use patterns.

Aggregate: 

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

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

well as non-occupational pesticide exposures. An aggregate risk assessment has not been 

deemed necessary for ammonia due to the lack of residential and dietary exposure.

Occupational: 

• The most recent qualitative assessment on occupational exposure to ammonium sulfate 

and monochloramine was conducted in 2011. The Agency determined that exposures 

were not anticipated to result in any risks of concern because ammonium sulfate is of low 

toxicity and it is only registered for use in closed systems. 

Cumulative: 

• EPA does not have, at this time, available data to determine whether ammonium sulfate 

has a common mechanism of toxicity with other substances or how to include this 

pesticide in a cumulative risk assessment. For the purposes of this registration review, 

EPA has assumed that ammonium sulfate does not have a common mechanism of 

toxicity with other substances when used as an antimicrobial as registered.

Incidents: 

Ecological: 

• No ammonia or ammonium sulfate ecological incidents have been reported in the OPP 

incident database.

Human Health: 

• There are nine human exposure incidents in the OPP incident database that are associated 

with ammonia or ammonium sulfate. All of these incidents are classified as minor. One 

incident involved exposure to the hand of an individual using a spray adjuvant product
Docket Number: EPA-HQ-OPP-2012-0684

www.regulations.gov

16 of 20

that contained ammonium sulfate as an inert, two incidents involved foreign products that 

are not registered in the U.S., and six incidents involved a currently registered 

antimicrobial product. 

Tolerances and International Harmonization: 

• 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).

Data Call-In Status: 

• No data call-ins have been issued for the registered ammonia and ammonium sulfate

products.

Labels: 

Registered products, including EPA registration numbers are provided in Table 2 below. For 

future reference, during registration review a list of product registration numbers will be included 

in the docket. Product registration labels may be obtained from the Pesticide Product Label 

System (PPLS) website at: http: //oaspub.epa.gov/pestlabl/ppls.home.

Table 2. 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%
Docket Number: EPA-HQ-OPP-2012-0684

www.regulations.gov

17 of 20

III. Summary of Anticipated Data Requirements 

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

Cases in Section I of this document (Preliminary Work Plan), 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 oncethrough 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
IV. Appendix A: Use Patterns – Ammonia & Ammonium Sulfate

Table 4. Use Patterns – Ammonia Registrations (PC Code 005302)

EPA 

Reg 

# Formulation

% 

A. 

I. Use Site Treatment Site/Surfaces

Application 

Method

Min 

App 

Rate

Max 

App 

Rate

Max 

App 

Rate 

Units

Max App 

Rate 

Converted Units

Use 

Limitations

1448-

432

Intermediate 

Formulation 7.59

FORMULATING USE 

ONLY into EPA

registered antimicrobials 

for the following uses: 

Industrial processess and 

water systems - Pulp and 

Paper Mills, Recirculating 

Cooling Water Systems, 

Evaporative Condensers, 

Brewery and Food 

Pasteurizers, Seawater 

Desalination and Reverse 

Osmosis systems, Sewage 

and Wastewater Systems, 

Non-Fish containing 

Decorative fountains and 

Pond, Seawater and 

Freshwater Influent 

Systems, Paint Spray 

Booth Sumps, and Air 

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

www.regulations.gov

19 of 20

1448-

433

Soluble 

Concentrate 7.59

Industrial 

Processes 

and water 

systems

Industrial cooling towers, 

Recirculating cooling 

water systems, evaporative 

condensers, influent water 

systems, brewery and food 

pasteurizers, industrial 

fresh water systems, 

airwashers, seawater 

desalination and reverse 

osmosis systems, paint 

spray booth sumps, nonfish containing decorative 

fountains and ponds used 

for cooling purposes, 

sewage and wastewater 

systems

Metered 

injection

1 ppm 

in 

excess 

of the 

system 

oxidant 

demand

5 ppm 

in 

excess 

of the 

system 

oxidant 

demand PPM

5ppm 

available 

chlorine

0.5 oz/1.0 oz 

NaClO 

(12.5%)

product is 

applied in 

conjunction 

with sodium 

hypochlorite--

App rates are 

for made up 

solution

1448-

433

Soluble 

Concentrate 7.59

Industrial 

Processes 

and water 

systems

Indoor Food-Pulp and 

Paper Mill water systems

Metered 

injection

1 ppm 

in 

excess 

of the 

system 

oxidant 

demand

5 ppm 

in 

excess 

of the 

system 

oxidant 

demand PPM

5ppm 

available 

chlorine

0.5 oz/1.0 oz 

NaClO 

(12.5%)

product is 

applied in 

conjunction 

with sodium 

hypochlorite--

App rates are 

for made up 

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

www.regulations.gov

20 of 20

Table 5. Use Patterns – Ammonium Sulfate Registrations (PC Code 005601)

EPA 

Reg # Formulation

% A. 

I. Use Site

Treatment 

Site/Surfaces

Application 

Method

Min App 

Rate

Max App 

Rate

Max 

App 

Rate 

Units

Max App 

Rate 

Converted Units Use Limitations

9386-

49

Soluble 

Concentrate 7.59

Industrial 

Processes 

and water 

systems

Indoor FoodPulp and Paper 

Mill water 

systems

Metered 

injection

1 ppm in 

excess of 

the system 

oxidant 

demand

5 ppm in 

excess of 

the system 

oxidant 

demand PPM

5ppm 

available 

chlorine

0.6 oz/1.0 oz 

NaClO (12.5%)

product is applied 

in conjunction 

with sodium 

hypochlorite--

App rates are for 

made up solution

1706-

240

Soluble 

Concentrate 20.00

Industrial 

Processes 

and water 

systems

Indoor FoodPulp and Paper 

Mill water 

systems

Metered 

injection

1 ppm 

available 

chlorine

10 ppm 

available 

chlorine PPM

10ppm 

available 

chlorine

1.5 gal/1.0 gal 

NaClO (12.5%)

product is applied 

in conjunction 

with sodium 

hypochlorite--

App rates are for 

made up solution