United States Chemical Safety September 2012 Environmental Protection and Pollution Prevention Agency (7510P)



# Ammonia & Ammonium Sulfate Summary Document Registration Review : Initial Docket September 2012Docket Number: EPA

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### 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:

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### T ABLE 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 th e 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 Sco ping Document

. September 1 4 , 2012

Additional supporting documents for the Ammonia and Ammonium Sulfate Case s may be found in the registration review docket EPA

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.Docket Number : EPA

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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 Co unsel Philip RossDocket Number : EPA

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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 regis tered 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. Cha nges 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. In formation 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 In secticide, 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 a re 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 C ase s

. 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 # 507 3) 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 a re 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, non

fish containing decorative fountains and ponds used for cooling purposes, sewage and wastewater systems. All a mmonia 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 C ases in terms of ammonium sulfate.Docket Number : EPA

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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 monochlora mine solution is the active biocide in the pulp, papermill and other industrial water systems. According to product labeling, a mmonium 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 regi stered 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 f or 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.regulat ions.gov in docket EPA

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. Documents associated with the registration review of ammonium bromide can be viewed at regulations.gov in docket EPA

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- 0683. Below is a summary of the issues relevant to th e registration review of ammon ia 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 anticipat e 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 rec ent ecological risk assessment was completed in 2011 , in supp ort of the initial registration of ammonium sulfate for use in pulp and papermills. The AgencyDocket Number : EPA

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7 of 20 determined that

, based on the use pattern, the re was a low likelihood of exposure and

, therefore, acute or chronic risk to the aquatic environment was not expec ted

.

• 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, t he Agency anticipates co nducting 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 ass essment that supports a complete endangered species determination for registered ammonia and ammonium sulfate products. The ecological risk assessment planned during registration review will allow th e Agency to determine whether the registered pesticide p roducts 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 gener ated during use in once

- through industrial water systems

.
850.1400

-- Fish early

- life stage toxicity test (freshwater and estuarine/marine ) 850.1300

-- D aphnid chronic toxicity test 850.1350

-- Mysid chronic tox

- aquatic invert ebrate life

- cycle (saltwater) 850.4225

-- Seedling emergence, Tier II 850.45 00

-- Aquatic plant growth (algal) Tier II: marine diatom, freshwater diatom 850. 4550

-- Aquatic plant growth (a lgal) 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

• F or more information

, pleas e 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

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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 determ ined that the only potentially toxic compound resulting from ammonium sulfate use in the water system is

mono chloramine

. Any mono chloramine not consumed in the water system is expected to degrade under the high temperature conditions of the paper drying p rocess (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, t he Agency does not anticipate the need to conduct a human health risk assessment or require additional human health data for th is registration review at this time.

• F or more information

, please refer to Ammonia and Ammonium Sulfate: Human Health Registration Review Scoping Document

, located in t he docket

. Product Chemistry :

• The Agency does not anticipate the need to require additional product chemistry data for th is registration review at this time.

• F or more information

, please refer to Product Chemistry, Environmental Fate, and Ecological Effec ts 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 expos ure 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 assessm ents, 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 ammo nium 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 requiredDocket Number : EPA

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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 t hat 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 dat a. 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 sul fate

. 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 crea ted the following estimated timeline for the completion of the a mmonia 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 Sept ember 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 Se ptember 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. R eview Decision May 2017 Final Decision and Begin Post

- Decision Follow

- up 2017 Total (years) 5Docket Number : EPA

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10 of 20 Guidance for Commenters :
The public is invited to comment on EPA’s P reliminary W ork P lan and rationale. The Agency will carefully consider all comments as w ell as any additional information or data provided in a timely manner prior to issuing a final work plan for the a mmonia and ammonium sulfate registration review case s

.
Trade Irritants :
Through the registration review process, the Agency intends to solici t 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 dispa rities 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 impair ed 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

, 201 2 ) 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 , 201 2 ) 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. N o 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 , 201 2 ) 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 con form 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 s eeks 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=PESTICIDESDocket Number : EPA

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11 of 20 atypical, unusually high exposure to ammoni a 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 info rmation 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 conduct ed 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

- makin g 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 avai lable. 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 prop erty.
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 dat a, 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

- the

evidence 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 C ase s , 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 o f 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

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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 poten tial 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, amphibia n 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 W ork Plan for the Ammonia and Ammonium Sulfa te Cases

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13 of 20 II. Fact Sheet

Background Information Ammonia :

• Active Ingredient : A mmonia

• C ase number : 7440

• PC Code : 005302

• CAS number: 7664

- 41

- 7

• R egistrant: 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 C ases 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 Ingredient s: Ammonium Sulfate

• C ase number s: 5073

• PC Code : 005601

• CAS number: 7783

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- 2

• Registrants: Nalco Company ; Kemira Chemicals, Inc.

• First approved for use in a registered product : 1987

• Resid ues 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, seawat er 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

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14 of 20 • All products are required by the product labels to be administered via a clos ed 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 rec ent ecological risk assessment was completed in 2011 in support of the initial registration of ammonium sulfate for use in pulp and papermills. Environmental

e xposure is no t expected due to reactivity in the system and retention of dis c harge 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, t he Agency determi ned 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 rece nt human health risk assessments for a mmonia 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 f rom ammonium sulfate

use in the water system is mono chloramine

. Any mono chloramine 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

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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 drinkin g 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 exposu re 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

- occupation al pesticide exposures. An aggregate risk assessment ha s 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 mono chloramine 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 system s

.
Cumulative:

• EPA does not have , at this time, available data to deter mine whether ammonium sulfate ha s a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assess ment. For the purposes of this registration r eview, EPA has assumed th at ammonium sulfate do es 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 productDocket Number : EPA

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16 of 20 that contained ammoni um sulfate as an inert , two incidents involve d foreign products that are not registered in the U.S.

, and six incidents involve d a currently registered antimicrobial product.

Tolerances and International Harmo nization :

• 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) websi te 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. A ctive 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

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17 of 20 III. Summary of Anticipated Data Requirements

The table below summarizes anticipated data needs for the Ammonia and Ammonium Sulfate Case s in Sectio n 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 Revi ew 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 Require ments

– 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 (freshw ater 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

850.4 100 Seedling emergence, Tier II Monochloramine 12

850

. 45 00 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 12IV. Appendix A: Use Patterns

– Ammonia & Ammonium Sulfate

Table 4. Use Patterns

– Ammonia Registrations (PC C ode 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, non

fish 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 injectio n 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 solutionDocket 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 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 0.6 oz/1.0 oz Na ClO (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 Food

Pulp and Paper Mill water systems Metered injection 1 ppm avai lable 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