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Page 2 of 22 Homopolymer Registration Review Team

Human Health & Environmental Effects Siroos Mostaghimi Jim Breithaupt David Bays Jonathan Chen Nate Mottl Katelynn King

Risk Management Donna Kamarei Elizabeth Watkins Rose Kyprianou

Office of General Counsel Philip RossDocket Number EPA

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Page 3 of 22 TERMS, ABBREVIATIONS AND SYMBOLS

AD Antimicrobials Division A.I. or a.i. active ingredient ASRI a ctivated sludge r espiration i nhibition CAS Chemical Abstracts Service CFR Code of Federal Regulations CMA Chemical Manufacturers Association COC c oncentration

- of

- c oncern EC 50 m edian (or 50 percent) e ffect c oncentration ECOTOX ECOTOXicology EDSP E ndocrine Disruptor Screening Program E

- FAST Exposure a nd Fate Assessment Screening Tool EPA Environmental Protection Agency FDA Food and Drug Administration FFDCA Feder al Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPA Food Quality Protection Act HPV h igh production v olume IDS Incident Data System Kow o ctanol

- water partition coefficient LC 50 m edian (or 50 percent) l ethal c oncentration LD 50 m edian (or 50 percent) l ethal d ose Log K ow l ogarithm of the octanol

- water partition coefficient
μg m icrogram mg/kg m illigram p er k ilogram mg/L m illigram p er l iter mm Hg m illimeter of mercury MRID Master Record Identification Number MRL m aximum r esidue l imit N/A n ot a pplicable

nm n anometers NOAEC no

- observed

- adverse

- effect

- c oncentration OCSPP Office of Ch emical Safety and Pollution Prevention OPP Office of Pesticide Programs % p ercent PC Code Pesticide Chemical Code pKa p ower of the acid dissociation constant or negative base

- 10 logarithm of the acid dissociation constant of a solution ppb p arts p er b illion
ppm p arts p er m illion PWP Preliminary Work Plan RED Rere gistration Eligibility Decision SSTS Section Seven Tracking System TGAI t echnical grade active i ngredient TMDL total maximum daily l oads UV/VIS ultraviolet/v isible light a bsorption WWTPs w astewater treatment plantsDocket Number EPA

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Page 4 of 22 

### Table of Contents
1 Introduction

................................ ................................ ................................ ............................. 6 1.1 Statutory and Regulatory Authority

................................ ................................ ................. 6 1.2 Case Overview

................................ ................................ ................................ ................. 7 1.3 Chemical Identification and Properties

................................ ................................ ............ 7 1.4 Use/Usage Description

................................ ................................ ................................ ..... 9 1.4.1 Registrations

................................ ................................ ................................ ............. 9 1.4.2 Summ ary of Registered Uses

................................ ................................ .................... 9 1.4.3 Usage Information

................................ ................................ ................................ .... 9 1.5 Regulatory History

................................ ................................ ................................ ........... 9 1.5.1 Recent/Pending Regulatory Actions

................................ ................................ ....... 10 1.5.2 Tolerance Information

................................ ................................ ............................ 10 1.6 Incidents

................................ ................................ ................................ ......................... 10 1.6.1 Human Health

................................ ................................ ................................ ......... 10 1.6.2 Ecological

................................ ................................ ................................ ............... 10 2 Anticipated Data Needs

................................ ................................ ................................ ........ 10 3 Hu man Health Risk Assessment

................................ ................................ ........................... 10 3.1 Existing Toxicological Endpoints

................................ ................................ .................. 10 3.2 Dietary Exposure

................................ ................................ ................................ ............ 11 3.2.1 Food and Drinking Water

................................ ................................ ....................... 11 3.3 Occupational and Residential Exposures

................................ ................................ ....... 11 3.4 Aggregate and Cumulative Exposure

................................ ................................ ............. 11 3.4.1 Aggregate Exposures

................................ ................................ .............................. 11 3.4.2 Cumulative Exposures

................................ ................................ ............................ 11 4 Environmental Risk Assessment

................................ ................................ ........................... 12 4.1 Threatened and Endangered Species

................................ ................................ .............. 12 4.2 Environmental Fate Assessment

................................ ................................ .................... 13 4.2.1 Water Quality

................................ ................................ ................................ .......... 13 4.3 Conc eptual Models for Environmental Exposure Pathways

................................ .......... 13 4.4 Ecological Effects Assessment

................................ ................................ ....................... 13 4.4.1 Measures of Effect (Ecotoxicology Endpoints)

................................ ...................... 13 4.5 Exposure Analysis Plan

................................ ................................ ................................ .. 14 4. 5.1 Aquatic and Terrestrial Wildlife Exposure Estimates

................................ ............ 14 4.5.2 Screening Level Down

- the

- Drain Analysis

................................ ............................ 14 5 Endocrine Disruptor Screening Program (EDSP)

................................ ................................ . 14 6 Optional Label Changes

................................ ................................ ................................ ........ 15 7 Co mbined Preliminary Work Plan and Proposed Interim Registration Review Decision

... 15 8 Next Steps

................................ ................................ ................................ ............................. 15 9 References

................................ ................................ ................................ ............................. 16

Appendix A T oxicology Profile

................................ ................................ ............................... 17 Appendix B Environmental Fate

................................ ................................ ............................. 20 Appendix C Ecotoxicology Profile

................................ ................................ .......................... 21Docket Number EPA

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Page 5 of 22 List of Tables Table 1

– Summary of Anticipated Risk Assessments and Data Needs for Registration Review: Homopolymer

................................ ................................ ................................ ................................ . 7 Table 2

– Anticipated Registration Review Schedule

................................ ................................ .... 7 Table 3

– Chemical Identification of Homopolymer

................................ ................................ ...... 8 Table 4

– Physical

- Chemical and Environmental Fate Properties for Homopolymer

.................... 8 Table 5

– Homopolymer Registered Use

................................ ................................ ........................ 9 Table 6

– Acute Toxicity Studies for Homopolymer

................................ ................................ .... 17 Table 7

– Freshwater Fish and Amphibian Toxicity Data

................................ ............................ 21 Table 8

– Freshwater Invertebrate Toxicity Data

................................ ................................ ......... 21Docket Number EPA

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## 1 Introduction

This document is the Environmental Protection Agency’s (EPA or “ the a gency ” ) combined Preliminary Work Plan (PWP) and Proposed Interim Registration Review Decision for 2

- Propen

- 1

- aminium, N,N

- dimethyl

- N

- 2

- propenyl

- , chloride, homopolymer herein referred to as homopolymer

, and is being issued pursuant to 40 CFR Sections 155.50, 155.5 6 and 155.58. This document explains what EPA’s Office of Pesticide Programs knows about homopolymer , noting that no additional data nor further ass essments are required, and provides an anticipated timeline for completing homopolymer’s review. It also includes the agency’s Proposed Interim Registration Review Decision for homopolymer

. A registration review decision is the a gency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The agency may issue, when it determines it to be appropriate, a proposed interim registration review decision be fore completing a registration review. Among other things, the proposed interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review,

a nd include schedules for submitting the required data, conducting the new risk assessment and completing the registration review.



## 1.1 Statutory and Regulatory Authority
The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. Al l pesticides distributed or sold in the United States generally must be registered by the USEPA 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 r egistration 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 th e environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the a gency 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://www2.epa.gov/pesticide

- reevaluation

.
The a gency is implementing the registration review program pursuant to Section 3(g) of FIFRA

a nd will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing registration review begin at 40 CFR 155.40. The a gency will consider benefits information and d ata as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the a gency ’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or inform ation it believes are needed to make a registration review decision.Docket Number EPA

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## 1.2 Case Overview

The docket for homopolymer (case # 5024) has been established at http://www.regulations.gov in docket number EPA

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. Documents associated with this registration review can be viewed in this docket. Tables 1

- 2 b elow summar ize the issues relevant to this registration review case and the anticipated registration review schedule

.

Table 1

– Summary o f Anticipated Risk Assessments and Data Needs for Registration Review : Homopolymer

Risk Assessment Assessment Necessary to

Support Registration Review Date of Most Recent Assessment Type of Assessment

Required (New/Updated) Data Anticipated as Needed

Dietary (food / drinking
water ) No N/A None None

Occupational & Residential Handler /Post Application No N/A None None

Aggregate No N/A None None

Cumulative No N/A None None

Tolerance Review No N/A None None Ecological No N/A None None

N/A = Not applicable

Table 2

– Anticipated Registration Review Schedule

Anticipated Activity Target Date * Completion Date Combined Preliminary Work Plan and Interim Registration Review Decision and Implementation Open 60

- Day Public Comment Period for Combined Preliminary Work Plan and Proposed Interim Decisio n 2015

- 06 2015

- 06

Close Public Comment Period 2015

- 08 Issue Interim Decision 201 5

- 12 Begin Post

- Decision Followup 201 6 Total (years) 1

* The anticipated schedule will be revised as necessary ( e.g ., need arising under the Endocrine Disruptor Screening Program with respect to the active ingredients in this case).



## 1.3 Chemical Identification and Properties

Table 3 presents the active ingredient to be assessed in c ase 5024 : homopolymer (PC Code 1 28727 )

. The active ingredient ha s one registered product with the active ingredient composing 19.8 % (w/w).Docket Number EPA

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Page 8 of 22 Table 3

– Chemical Identification of Homopolymer

Chemical Name Homopolymer Reference (MRID unless specified) Comments Chemical Classification Polymeric quaternary ammonium PAN 1

PC Code 128727 None

CAS Number 26062

- 79

- 3 (polymer) 7398

- 69

- 8 (monomer) PAN

Molecular Formula Polymer : Not applicable Monomer : C 8 H 16 CN None

Molecular Weight (grams/mole) 200,000 (average

, polymer ) 161.68 (monomer) Sigma Aldrich (polymer) Epi

- Web 4.1 (monomer)

Molecular Structure Hess et al., 2003

The homopolymer p hysical chemistry information is summarized in Table 4. T he details of the environmental fate information are discussed in Appendix B

.

Table 4

– Physical

- Chemical and Environmental Fate Properties for Homopolymer

Guideline No. Parameter H omopolymer (EPA Reg. No. 1706

- 226 ): Poly (dimethyldially) ammonium chloride Reference (MRID unless specified)

830.7050 UV/Visible Absorption Stable to sunlight (no conjugation in structure) Lyman et al., 199 0

830.7370 Dissociation constant (pKa) Not applicable No ionizable functional groups

830.7550 Octanol

- water partition coefficient at 25 o C (Log K ow ) Not applicable (substance is miscible in water) 42618401

830.7840 Solubility in water Miscible (10 ,000 mg/l used in calculations) 42618401

830.7950 Vapor pressure (mmHg) Polymer : None (up to 230 o C) Monomer: 15 mm Hg 42618401

None Henry ’ s law constant at 25 o C (atm

- m 3 /mol) CALCULATED Polymer : Not applicable ( polymer has wide range of molecular weights) Monomer : 3.2 x 10

- 4 None

atm

- m 3 /mol = atmosphere cubic meter per mole; o C = degrees Celsius; mg/L = milligrams per liter ; mmHg = millimeters of mercury.

1 http://www.pesticideinfo.org/Detail_Chemical.jsp?Rec_Id=PC35969Docket Number EPA

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Page 9 of 22 

## 1.4 Use/Usage Description

1.4.1 Registrations

There is one E PA

- registered product contain ing homopolymer as an active ingredient (a.i.)

. 2 It contains 19.8 percent homopolymer in a liquid soluble concentrate formulation.



### 1.4.2 Summary of Registered Uses

Table 5 presents the registered use of homopolymer as mollusk control (e.g. Zebra musse ls) in potable water supplies. The product is added to water systems as a concentrated liquid using metered pumps. The label state s that applications should occur at a point sufficiently inside the intake pipe to prevent any release of product into the int ake source (5

- 10 feet). Feed exits must be equipped with a pressure check valve at the feed line exit to seal the feed li ne when the intake flow stops. Feed pumps must be designed to shu t down when intake pumps stop. Planned shutdowns require feed pumps to be stopped half an hour prior to shut down

.

Table 5

– Homopolymer Registered Use

Use Application Method Application Rate (ppm a.i.)
Industrial Process and Water Systems
Water supplies Meter ed Pump 25

- 50



### 1.4.3 Usage Information

In addition to its use as a pesticide, homopolymer is used as a flocculant in drinking water
treatment. Based on information provided by the registrant, the pesticidal use of homopolymer is minor when compared to the non

- pesticidal use. According to the 20 04 high production volume test p lan , homopolymer has been manufactured for at least 40 years in the United Sta tes with three current manufacturing facilities

. The monomer is used almos t exclusively in the manufacturing of cationic, water

- soluble polymers which are used in such industries as water treatment plants, pape r mills, and textile printing. Using B est Available Technology (BAT) to achieve maximum efficacy, the maximum free monomer content of the polymeric produc ts is about 1 percent

. 3



## 1.5 Regulatory Histor y

The first product containing homopolymer was registered on October 6, 1995 for the use in industrial process and water systems

. A Reregistration Eligibility Decision (RED) was not completed for homopolymer becau se it was registered after November 1, 1984.

2 Veligon TL

- M, EPA Reg. No. 1706

- 226

3 Regnet Environmental Services,Docket Number EPA

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### 1.5.1 Recent/Pending Regulatory Actions

There are no recent regulatory actions for homopolymer.



### 1.5.2 Tolerance Information

There are no EPA

- established tolerances in raw agricultural commodities or processed food and feed products for homopolymer under the Federal Food, Drug and Cosmetic Act (FFDCA) Sections 408. Additionally, the Federal Food and Drug Administration (FDA) has not established any clearances under FFDCA 409. However, Food Contact Not ifications (FCNs) have been established for homopolymer as part of various polymers. Since these uses are not FIFRA

registered, no dietary exposure assessment is required.



## 1.6 Incidents

1.6.1 Human Health

No homopolymer related incidents have been reported in the a gency ’s Incident Data System (IDS) for the time period from 1992 to present , based on a search conducted on March 2015

. IDS contains reports of incidents from various sources, including registrants, other federal and state health and environmental agencies and individual consumers, submitted to OPP since 1992.



### 1.6.2 Ecological

No h omopolymer incide nts have been reported in the a gency’s Ecological Incident Information System (EISS) for the time period spanning 2000 to 2015 based on a search conducted on April 15, 2 015.


## 2 A nticipated Data Needs

The agency does not anticipate requiring any additional d ata to support this registration review.


## 3 Human Health Risk Assessment

With the existing toxicology databas e, homopolymer appears to have low toxicity (Appendix A). T he use of homopolymer as a water treatment for control of mollusks in water supplies is not expected to pose a hazard to food or drinking water based on the lack of exposure. The application system is closed and there is no expected occupational exposure. The agency does not anticipate the need to conduct a human health risk assessment for homopolymer.



## 3.1 Existing Toxicological Endpoints

No toxicological endpoints have been selected for homopolymer

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## 3.2 Dietary Exposure

The agency does not anticipate the need to conduct a dietary exposure assessment to support this registration review.



### 3.2.1 Food and Drinking Water A dietary (food and drinking water) exposure assessment is not anticipated to be required for homopolymer at thi s time. The only FIFRA

- registered use of homopolymer is as a water treatment for the control of mollusks in water supplies . There is only one label use for this product

, and this use is not expected to result in direct or ind irect dietary (food) exposure. T he use of homopolymer as a water treatment for the contro l of mollusks in water supplies is not expected to result in exposure from groundwater or surface waters; therefore, a drinking water assessment is not required at this time.



## 3.3 Occupational and Reside ntial Exposures
In April of 2015, the registrant amended its label to r estrict application to closed metered delivery systems; open pouring is prohibited for water treatment. Occupational handler exposures are not expected due to c losed mixing/loading. Dermal and inhalation post

- application exposures for the water treatment uses are expected to result in limited exposure contact. No additional occupational exposure data or occupational risk assessments are anticipated to be required

. No residential exposure is expected since applications are only performed in occupational settings.



## 3.4 Aggregate and Cumulative Exposure

3.4.1 Aggregate Exposures

An aggregate exposure risk assessment will not be conducted for this chemical because of a lack of residential exposure due to its use pattern of only being applied in industrial pipes with restrictions for controlling backflow into surface water

.


### 3.4.2 Cumulative Exposures With respect to cumulative exposure, unlike other pesticides for which EPA has follow ed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to homopolymer and any other substances

, and homopolymer does not appear to produce a toxic metabolite produced by other subst ances. For the purposes of this registration review, therefor e, EPA has not assumed that homopolymer has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of t oxicity and to evaluate the cumulative effects of such chemicals, see http://www.epa.gov/pesticides/cumulative/

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## 4 Environmental Risk Assessment

The a gency has not previously conducted a risk assessme nt that supports a complete endangered species determination for homopolymer. The label state s that application to intake water should be made 5

- 10 feet away from the source water intake source to prevent contamination. Based on the use in potable water su pply systems, the potential pathways of exposure to aquatic organisms include transport from in

- service use to surface water by way of wastewater treatment plants (WWTPs) and any backflow from treated intake water. However, l abel restrictions prevent backf low into surface water, and the environmental fate data indicate strong sorption to sediment. Additionally, the pesticidal use of homopolymer is minor when compared to the non

pesticidal use.

Based on the chemical, physical, and environmental fate properties, homopolymer is miscible in water, non

- volatile, and stable to hydrolysis and photodegradation. E nvironmental fate data are not anticipated to be required (Table 4 and Appendix B). The acce ptable ASRI study (MRID 49437513) demonstrated an IC50 of 127 mg/L (>20 mg/L) indicating negligible effects on WWTP organisms

. 4 While data on sorption to soil and sediment (835.1230) have not been submitted, the agency considers drinking water exposure to be negligible because, as a quaternary ammonium polymer, homopolymer will attach to suspended sediments and organic matter and will be removed by flocculation and coagulation of suspe nded particles in source
water. Flocculants work by reducing or neutraliz ing negative charges on suspended particles, allowing them to associate and settle in the treatment process. 5 If any particles with sorbed homopolymer are redeposited into surface water, homopolymer is not expected to desorb and enter the water column. The agency does not intend to conduct an environmental risk assessment because label restrictions prevent backflow into surface water.



## 4.1 Threatened and Endangered Species

There is no reasonable expectation for the registered use of homopolymer to cause direct or indirect adverse effects to threatened and endangered species. No adverse modification of any designated critical habitat for such species is expected from the use of homopolymer. Exposure of terrestrial species is unlikely, because label restrictions p revent backflow into surface water, and the environmental fate data indicate strong sorption to sediment. Additionally, the pesticidal use of homopolymer is minor when compared to the no n

- pesti c idal use. EPA has made a “no effect” determination under the Endangered Species Act (ESA) for all listed species and designated critical habitat for such species and has therefore concluded that consultation with the Fish and Wildlife Service and the National Marine Fisheries Service under ESA section 7(a)(2) is not required.

4 Breithaupt, James; D427116, Reviewed and accepted on May 5, 2015

5 CIBA, http://www.siltstop.com/pdf/flocculation

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## 4.2 Environmental Fate Assessment
Based on the chemical, physical, and environmental fate properties, homopolymer is miscible in water, non

- volatile, and stable to hydrolysis and photodegradation (Table 4 and Appendix B). Additional environmental f ate data are not anticipated to be required because backflow into surface water is not expected to occur based on the use directions specified on the label

.


### 4.2.1 Water Quality Homopolymer is not identified as a cause of impairment for any water bodies list ed as impaired under section 303(d) of the Clean Water Act

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

. 7 More information on impaired water bodies and TMDLs can be found at EPA’s website

. 8



## 4.3 Conceptual Model s for Environmental Exposure Pathways

The only environmental exposure pathway for the pesticidal use of homopolymer is one of potential backflow into the surfa ce water used as source water. As a mitigation measure, the labels state that application to intake wat er should be made 5

- 10 feet away from the source water intake source to prevent contamination. As a result, the agency does not assume that environmental exposure will occur and therefore is not including conceptual models for
exposure.



## 4.4 Ecological Effects Assessment

A n ecological effects risk assessment will not be c onducte d for this chemical because of a lack of exposure to non

- target organisms due to its restricted use pattern of only being applied in industrial pipes with restrictions for controlling ba ckflow into su rface water

.


### 4.4.1 Measures of Effect (Ecotoxicology Endpoints)

Ecotoxicity endpoint data are used as measures of effects to aquatic and terrestrial organisms. Selected endpoints will not be necessary for this chemical because an environme ntal risk
assessment is not anticipated to be necessary

. There we re six ecotox icity studies submitted to the

a gency as a condition of registration for two chemicals containing homopo lymer as an active ingredient. The se studies are outlined in A ppendix C.

6 http://iaspub.epa.gov/tmdl_waters10/attains_na tion_cy.cause_detail_303d?p_cause_group_id=885

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

8 http://www.epa.gov/owow/tmdl/Docket Number EPA

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## 4.5 Exposure Analysis Plan

4.5.1 Aquatic and Terrestrial Wildlife Exposure Estimates

The agency does not anticipate the need to conduct an ecological risk assessment, because of negligible environmental exposure based on the label language to prevent backflow from i ntake pipes and the strong tendency of ho mopolymer to sorb to negatively

- charged particles in intake
water.



### 4.5.2 Screening Level Down

- the

- Drain Analysis

The Down

- the

- Drain (DtD) module of E

- FAST (Exposure and Fate Assessm ent Screening Tool) was not used to ass ess homopolymer since the compound is a strong floculant which would be removed prior to a wastewater treatment plant.


## 5 Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse

ou tcomes 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 end points 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 ecologic al hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision

, for homopolymer , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), homopolymer is subject to the endocrine screening part of the Endocr ine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chem ical 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 pe sticide active ingredients and 9 inert ingredients. A second list of chemicalsDocket Number EPA

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Page 15 of 22 identified for EDSP screening was published on June 14, 2013 9 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists should be construed as a list of known or likely endocrine disruptors. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 10



## 6 Optional Label Changes

The agency invites comment on any label amendments that could be considered to improve label clarity.


## 7 Combined Preliminary Work Plan and Pr oposed Interim Registration Review Decision

In accordance with 40 CFR Sections 1550.50, 155.5 6 and 155.58, the a gency is issuing this combined Preliminary Work Plan and Proposed Interim Registration Review Decision. Based on the assumption of no exposure to humans and non

- target organisms, no additional data are anticipated to be needed and no risk assessments are planned. The agency has made a “no effect” finding based on lack of potential exposure for endangered spe cies (see Section 4). Except for the EDSP component of the homopolymer registration review case, t he a gency has made the proposed decision that n o additional data and no further risk assessments are required

. 

## 8 Next Steps

A Federal Register N otice will anno unce the availability of this combined Preliminary Work Plan and Proposed Interim R egistration R eview D ecision for homopolymer and allow a 60

- day comment period

. If there are no significant comments or additional information submitted to the docket during the comment period that leads the a gency to change its proposed decision, EPA may issue an interim decision. The final decision on the r egistration r eview for homopolymer (case 5024) will occur after an EDSP FFDCA section 408(p) determination is made. See the estimated timeline for the completion of homopolymer registration review in Table 2.

9 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.

10 http://www.epa.gov/endo/Docket Number EPA

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## 9 References

Breithaupt, James. May 5, 2015. Review of Modified Activated Sludge Respiration Inhibition Study (OCSPP 850.3300) for Homopolymer. MRID 49437513, D427116

Ciba (year unknown). Flocculation Theory and Application. http://www.siltstop.com/pdf/flocculation

- theory_application.pdf

Hess, C.E., Naik, K.N., Paquin, T.J., and Rose, S.J

. February 27, 2003 . Topcoat compositions, substrates containing a topcoat derived therefrom, and methods of preparing the same. Publication Number: WO2003016045 A1, Application Number: PCT/US2002/026136. http://www.google.com/patents/WO2003016045A1?cl=en

MRID 42618401. Oslosky, S. (1992) Product Chemistry: Poly (N,N

- dimethyl diallyl ammonium chloride): Lab Project Number: DMDAAC. Unpublished study prepared by Calgon Corporati on. 8 p.

Park, S.H. April, 2008. E ffect of Amine

- Based Water Treatment Polymers on the Formation of N

- Nitrosodimethylamine (NDMA) Disinfection By

- Product. Georgia Institute of Technology. https://smartech.gatech.edu/bitstream/handle/1853/22549/park_sanghyuck_200805_phd. pdf?sequence=1

Pesticide Action Network (PAN) . 2014. Diallyl dimethyl ammonium chloride polymers. http://www.pesticideinfo.org/Detail_Chemical.jsp?Rec_Id=PC35969

Regnet Environmental Services. April 29, 2004. Test Plan for D iallyldimethylammonium Chloride (DADMAC): CAS No. 7398

- 69

- 8. EPA 201

- 15208A. http://www.epa.gov/chemrtk/pubs/summaries/dialdime/c15208tp.pdf

Sigma Aldrich Online Catalog. 2014. http://www.sigmaaldrich.com/life

- science/life

- science

catalog.html

U.S. Environmental Protection Agency (EPA). 2002. ECOTOX User Guide: ECOTOXicology Database Syst em. Version 3.0. Available: http://www.epa.gov/ecotox/

U.S. Environmental Protection Agency (EPA). 2012. EPI

- Suite 4.11. http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm

U.S. Environmental Protection Agency. High Production Volume Information System (HPVIS). http://www.epa.gov/hpvis/Docket Number EPA

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# Appendix A T oxicology Profile

Acute Toxicity for Product Labeling

As listed in Table 6
, homopolymer is a moderate dermal irritant (Category I II ) and is in Category III for acute oral toxicity and Category IV for acute dermal toxicity based on guideline studies. It is likely a moderate eye irritant (Category III) . However, guideline acute studies are not available for acute inhalation acute eye irritation and dermal sensitization.

Table 6

– Acute Toxicity Studies for Homopolymer
Guideline No./ Study Typ e MRID No. Results Toxicity Category
870.1100/ Acute oral toxicity 42534004 LD50 = 4,100 mg/kg for male and female r at III

870.1200/ Acute dermal toxicity 42534005 LD50 ≥ 20,000 mg/kg for male and female rabbit I V

870.1300/ Acute inhalation toxicity NA No acceptable Guideline study. T his study is considered as a data gap

. Unknown

870.2400/ Acute eye irritation 42534006 Eye irritation at 24 hours after treatment and clearing in 7 days. III

870.2500/ Acute dermal irritation 42534007 Moderate irritation at 72 hours on New Zealand Albino Rabbits I II

Note: N/A=Not available 

## Subchronic Toxicity

For subchronic oral toxicity, the database includes four studies :

• Roper, J.M. (2009) A 90

- day oral (drinking water) toxicity study of 2

- Methyl

- 1,2

- benzisothiazolin

- 3

- one Technical in rats. WIL Research Laboratories, LLC, Ashland, OH, USA.WIL

- 91057, November 9, 2009. MRID 48251534. Unpublished

.

• Trautwein and Drommer. (1976). 13 Weeks Oral Toxicity Feed ing Study with Monomer in Rats. In ternational Bio

- Research, Inc. Unpublished.

• Trautwein and Drommer. (1976). 13 Weeks Oral Toxicity Feeding Study with Cat Floc

T in Rats. In ternational Bio

- Research, Inc . Unpublished.

• Tegeris, A.S. (1976). DADM

– Ninet y

- Day Feeding Study to Dogs. Pharmacopathics Research Laboratories, Inc. Laurel, MD. 20810. Sponsored Re port No. 76

- 57. July 2, 1976. Unpublished.Docket Number EPA

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## Developmental Toxicity

• Adamik, E. R. (1979). Rabbit Teratology Study with Cat

- Floe T. Wil Research La boratories, Inc. Cincinnati, OH 45241. November 29, 1979. MRID 42534016. Unpublished.

• Irvine, L.F.H. and Palmer, K. (1990). Poly(Dimethyl Diallyl Ammonium Chloride) (PDADMAC) Oral (Gavage) Rat Teratology Study. Toxicol Laboratories Limited. Herefordshi re, England HR8 lLH . Laboratory Project ID CMA/5/91. November 9, 1991. MRID 48437511. Unpublished. 

## Reproductive Toxicity

• Adamik, E. R. (1979). Multigeneration Study in Rats with Cat

- Floe T. Wil Research Laboratories, Inc. Cincinnati, OH 45241. Laborato ry Project ID WIL

- 1140

- 77. November 29, 1979. MRID 49437512. Unpublished. 

## Chronic Toxicity There is currently no existing chronic toxicity study for homopolymer

. Since there is no chronic exposure concern, this is not considered as a data gap.


## Carcinogenicity There is currently no existing cancer study for homopolymer. Since there are existing mutagenicity studies indicating homop ol ymer is not mutagenic, the absence of a cancer study is not considered as a data gap.


## Neurotoxicity There is no neurotoxicity study in the database for homopolymer.


## Mutagenicity

1. Sun, R.H.C. and Shelton, J.B. (1990). Selmonella/Mammalian

- Microsome Plate Incorporation Mutagenicity Assay (Amen Test)

- Poly (dtaiiyldimethyl ammonium chloride) . Microbio logical Associates, Inc., Rockville, MD 20850. June 21, 1990

. MRID 42534013. Unpublished.

2. Putman, D.L. (1990). Micronucleus Cytogenetic Assay in Mice

- Poly (dtaiiyldimethyl ammonium chloride). Microbiological Associates, Inc., Rockville, MD 208 50. June 21, 1990. MRID 42534014 . Unpublished

3. Putman, D.L. (1991). Micronucleus Cytogenctic Assay in Mice . Microbiological Associates. Inc. Bethesda, MD 20816. Laboratory Project ID T9143.122. March 27, 1991 . MRID 49437510. Unpublished.Docket Number EPA

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## Dermal Absorption/Penetra tion

There is no dermal abs orption study in the database. However, since homopolymer is applied through closed system

, there is no occupational exposure.


## Immuntoxicity There is currently no existing immunot oxicity study for homopolymer. However, since there is
no exposure concern , immunotoxicity study is not considered as a data gap.



## Metabolism
There is no metabolism stud y available. However, since there is no exposure concern, the absence of a metabolism study is not considered as a data gap.Docket Number EPA

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# Appendix B Environmental Fate

Environmental Fate and Transport Properties of H omopolymer

This environmental fate assessment addresses the persistence and mobility of the parent compound homopolymer

. Based on the chemical, physical, and environmental fate properties, homopolymer is miscible in water, non

- volatile, and stable to hydrolysis and photodegradat ion, see Table 4. As a flocculant, homopolymer sorbs to organic material, soils and sediment. Additional environmental fate data for homopolymer are not anticipated t o be required because

, based on the label language, the agency assumes that backflow into surface water will not occur.

Appendix B References

Breithaupt, James. May 5, 2015. Review of Modified Activated Sludge Respiration Inhibition Study (OCSPP 850.3300 ) for Homopolymer. MRID 49437513, D427116

Ciba (year unknown). Flocculation Theory and Application. http://www.siltstop.com/pdf/flocculation

- theory_application.pdf

Lyman, W.J., W.F. Reehl, and D.H. Rosenblatt. 1990. Handbook of Chemical Property Estimation Methods. American Chemical Society. ISBN O

- 8412

- 1761

- 0

Mostaghimi, Siroos. November 12, 1998. Hydrolysis Waiver Request for CAT

- FLOC CL. D236082.

MRID 49437 513. Licata

- Messama, L. March 21, 1995. Test to Evaluate the Inhibition of Respiration in Activated Sludge (Test Substance: FL 45 CLV). Unpublished study performed by Societe d’Ecotoicologie et de Physico

- Chimied, Sarcey, France, and submitted by the SN F, Inc. Study No. S.E.P.C. Report No. F065.Docket Number EPA

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# Appendix C Ecotoxicology Profile

Toxicity to Aquatic Receptors

Freshwater Fish

Table 7

– Freshwater Fish and Amphibian Toxicity Data

Species Test Material (% a.i.) Toxicity Endpoint B Value Toxicity Category MRID/ Study Classification/ Comments

Rainbow trout ( Oncorhynchus mykiss ) VeliGon L

- M ( 1 9. 8 %) 96

- h LC 50 = 0 .0 77 ppm a i 95% CI = 0.59

- 0.11 ppm a i Probit slope = NA NOAEC = Not determined Very high ly toxic 44 148402 / Acceptable

Fathead minnow ( Pimephales promelas) VeliGon L

- M ( 1 9 .8 %) 96

- h LC 50 = 0

. 26 ppm a i 95% CI=0.17

- 0.48 ppm ai Probit slope = NA NOAEC = Not determined High ly toxic 44148401/ Acceptable

Rainbow trout ( Oncorhynchus mykiss ) VeliGon CL

- M (39.8%) 96

- h LC 50 =0.066 ppm ai 95% CI=0.043

- 0.12 ppm ai Probit slope=NA NOEAC=0.043 ppm ai Very highly toxic 44148405/ Acceptable

Fathead minnow ( Pimephales promelas ) VeliGon CL

- M (39.8%) 96

- h LC 50 =0.22 ppm ai 95% CI=0.19

- 0.26 ppm ai Probit slope =5.4 NOAEC=0.11 ppm ai Highly toxic 44148404/ Acceptable

Freshwater Invertebrates

Table 8

– Freshwater Invertebrate Toxicity Data

Species Test Material (% a.i.) Toxicity Endpoint B Value Toxicity Category MRID/ Study Classification/ Comments

Waterflea ( Daphnia magna ) VeliGon L

- M ( 19.8% ) 48

- h EC 50 = 0

. 075 ppm a i 95% CI = 0 .059

– 0

. 11 ppm a i Probit slope= NA NOAEC= not determined Very high ly toxic 44148403/ Acceptable

Waterflea ( Daphnia magna ) VeliGon ( 39.8% ) 48

- h EC 50 = 2. 1 ppm ai 95% CI = 1 .8

– 2

. 6 ppm a i Probit slope=NA NOAEC = 0. 50 ppm a i Moderately toxic 156044/ SupplementalDocket Number EPA

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## References:

Ward, T.J., J.P. Magazu and R.L. Boeri. 1996. Acute Toxicity of VeliGon L

- M to the Fathead Minnow, Pimephales promelas . T.R. Wilbury L aboratories, Inc

. , Marblehead, MA. Lab. Report ID: 965

- CA. MRID#: 44148401

, Unpublished.

Ward, T.J., J.P. Magazu and R.L. Boeri. 1996. Acute Toxic i ty of VeliGon L

- M to the Rainbow Trout, Oncorhy n chus mykiss

. T .R. Wilbury Laboratories, Inc., Marblehead, MA. Lab. Repo rt ID: 964

- CA. MRID#: 44148402

, Unpublished.

Ward, T.R., J.P. Magazu and R.L. Boeri. 1996. Acute Toxicity of VeliGon L

- M to the Daphnid, Daphnis magna

. T.R. Wilbury Laboratories, Inc., Marblehead, MA. Lab. Report ID: 963

- CA. MRID#: 44148403

, Unpublished

. Ward, T.J., P. Kowalski and R.L. Boeri, 1996. Acute Toxicity of VeliGon CL

- M to the Fathead Minnow, Pimephales promelas

. T.R. Wilbury laboratories, Inc., Marblehead, MA. Lab. Report ID: 962

- CA. MRID#: 44148404

, Unpublished.

Ward , T.J., P.L. Kow a lski and R.L. Boeri. 1996. Acute Toxicity of V eli G on CL

- M to the Rainbow trout, Oncorhynchus mykiss . T.R. Wilbury Laboratories, Inc., Marblehead, Ma. Lab. Report ID: 961

- CA. MRID#: 44148405, Unpublished.

Ward, T.J., P.L. Kowalshi and R.L. Boeri. 1996. A cut e Toxicity of VeliGon CL

- M to the Daphnid, Daphnia magna . TR. Wilbury Laboratories, Inc., Marblehead, MA. Lab. Report ID: 960

- CA. MRID#: 44148406

, Unpublished.