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



# Ammonia & Ammonium Sulfate Registration Review: Final Work Plan January 2013Docket Number: EPA-HQ-OPP-2012-0684 www.regulations.gov

3 of 10 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 & Ammoni um 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 10 Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the Agency”) for the registration review of A mmonia (Case 7440) and Ammonium Sulfate (Case 5073). The work plan includes the expected registration review timeline. The work plan also addresses public comments received concerni ng 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 conc erning the initial docke t postings. The Summary Document provided information on what EPA k nows about the pesticide and what additional risk analyses and data or information the Agen cy believes are needed to make a registration review decision.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. Changes in science, public policy an d pesticide use practices will occur over time. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and practi ces change, all registered pestic ides continue to meet that statutory standard. The public pha se of registration review begins when the initial docket is opened for each case. Information on this program is provided at: http://www.epa.gov/oppsrrd1/ registration_review/.

The Ammonia and Ammonium Sulfate Prelim inary 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 availa ble 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 fo r 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 re gistered products with ammonia as the active ingredient and two EPA registered pr oducts with ammonium sulfate as the active ingredient. Ammonia and ammonium sulfate ar e registered for use in pulp and papermill industrial water systems. Ammonia products are al so registered for use in other industrial water systems including recirculating cooling water syst ems, evaporative condensers, influent water systems (freshwater and seawater), brewery and f ood pasteurizers, industrial fresh water systems, air washers, seawater desalination and revers e osmosis systems, paint spray booth sumps, nonfish containing decorative fountains and ponds used for cooling purposes, sewage and wastewater systems. All ammoni a and ammonium sulfate products can be expressed in terms of percent active ingredient ammonium sulfate as pr esented in Table 1; therefore, for the purposes of this registration review, EPA intends to a ssess exposure and risk to all products in the Ammonia and Ammonium Sulfate Case s in terms of ammonium sulfate.Docket Number: EPA-HQ-OPP-2012-0684 www.regulations.gov

5 of 10 Table 1. Registered Products Co ntaining 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 Sulf ate – 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, traine d personnel in a clos ed system with sodium hypochlorite to form a monochloramine solution. The monochloramine solution is the active biocide in the pulp, papermill and other in dustrial water systems. According to product labeling, ammonium bromide (PC Code 000352) ma y also be used in conjuction with a substance such as sodium hypochlorite or chlo rine gas to form a monochloromine solution; however, the Agency is evaluating this active ingredient under a se parate registrati on 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 contai ning ammonium sulfate was regist ered after November 1, 1984. Although the first pesticide produc t containing ammonia was regi stered before November 1, 1984, EPA did not undertake a reregi stration eligibility decision (R ED) for ammonia because the last product containing ammonia as an active i ngredient 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 ag ricultural practices as inert (or occasionally active) ingredients in pesticide formulations a pplied 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 p ublic comment period on the initial docket, described below. In the PWP, the Agency soli cited comments on specific topics: environmental justice, water body impairment, trade irritants, an d structure activity relati onships. No comments or information were received during the public comment period con cerning these issues.

Comment: 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 tec hnical 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 www.regulations.gov

6 of 10 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 co mment period did not affect the data needs, work plan and timeline described in the PWP and th ey 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 assessmen t, for monochloramine. The Agency does not anticipate the need to conduct a human health risk assessmen t. The Agency anticipates needing additional data for use in conducting the registration review risk assessment.

Ecological Risk:

 The most recent ecological risk assessmen t was completed in 2011, in support of the initial registration of ammonium sulfate fo r use in pulp and papermills. The Agency determined that, based on the use patter n, there was a low likelihood of exposure and, therefore, acute or chroni c risk to the aquatic environment was not expected.

 A qualitative ecological risk assessment of us e in once-through industrial water systems was conducted in 2008. Additional data are e xpected to be needed to refine the
assessment.

 For the purpose of this registration review, the Agency anticipates conducting a quantitative risk assessment on the monochloramin e 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 soluti on resulting from the use of ammonium sulfate in pulp and papermills due to the rapid hydrolysis and biodegradation of monochloramine in industrial water system s, including their waste systems, and, therefore, the low lik elihood 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 te st (freshwater and estuarine/marine) 850.1300 -- Daphnid chronic toxicity test 850.1350 -- Mysid chronic tox - aquatic inve rtebrate life-cycle (saltwater) 850.4225 -- Seedling emergence, Tier II 850.4500 -- Aquatic plant growth (algal) Tier II: mari ne diatom, freshwater diatom 850.4550 -- Aquatic plant growth (algal) Tier II: cyanobact eria (blue-green algae)Docket Number: EPA-HQ-OPP-2012-0684 www.regulations.gov

7 of 10  The Agency anticipates the need to require the following additional environmental fate data for monochloramine generated during use in once-through industr ial water systems.

835.6200 -- Aquatic field dissipation

 For more information, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Suppor t 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 Agen cy determined that the only potentially toxic compound resulting from ammonium sulfate use in the water system is monochloramine. Any monochloramine not consum ed 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 afte r use, the Agency doe s not anticipate the need to conduct a human health risk assessm ent 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 Suppor t of Registration Review of Ammonia and Ammonium Sulfate , located in the docket.

Endangered Species

The Agency has not conducted a risk assessmen t that supports a complete endangered species determination for registered ammonia and ammo nium sulfate products. The ecological risk assessment planned during registration review w ill allow the Agency to determine whether the registered pesticide products ha ve “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their desi gnated 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 W ildlife Service and/or Nati onal Marine Fisheries Service (the Services ), as appropriate.Docket Number: EPA-HQ-OPP-2012-0684 www.regulations.gov

8 of 10 Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. A human health risk assessment identifying the most sensitive endpoints has not been conducted for 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 whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must 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 pest icide active ingredients and 9 inert ingredients. Ammonia and ammonium sulfate are not among the group of 58 pest icide 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, requiri ng the submission of EDSP scr eening assays for ammonia and ammonium sulfate.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening ba ttery, please visit our website: http://www.epa.gov/endo/.Docket Number: EPA-HQ-OPP-2012-0684 www.regulations.gov

9 of 10 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 Prelim inary Risk Assessments October 2016 Phase 3: Registration Review Decision Open 60-Day Public Comment Period for Proposed Reg. Review Decision March 2017

Close Public Comment Period for Pro posed Reg. Review Decision May 2017 Final Decision and Begin Post-Decision Follow-up 2017 Total (years) 5

Next Steps

A DCI will be developed regarding the data needs listed under the “Risk Assessments and Anticipated Data Needs” section of this docum ent. The Agency expects to issue the DCI in March 2014.Docket Number: EPA-HQ-OPP-2012-0684 www.regulations.gov

10 of 10 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 Revi ew 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 ad ditional ecological and en vironmental 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: cyanobacter ia (blue-green algae) Monochloramine 12