United States Chemical Safety December 2011 Environmental Protection and Pollution Prevention Agency (7510P)



# Tri

- N Butyl Tetradecyl Phosphonium Chloride (TTPC) Summary Document: Registration Review : Initial Docket December 2011Docket Number: EPA

- HQ

- OPP

- 2011

- 0952 www.regulations.gov

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## Tri

- N Butyl Tetradecyl Phosphonium Chloride (TTPC) Summary Document Registration Review: Initial Docket December 2011

Case # 5111

Approved By:

Joan Harrigan

- Farrelly Director, Antimicrobials Division

Date:Docket Number: EPA

- HQ

- OPP

- 2011

- 0952 www.regulations.gov

3 of 17 

### TABLE OF CONTENTS

Tri

- N Butyl Tetradecyl Phosphonium Chloride Registration Review Team

....................... 4 I. Preliminary Work Plan

................................ ................................ ................................ ........ 5 II. Fact Sheet

................................ ................................ ................................ .......................... 12 III. Summary of Anticipated Data Requirements

................................ ................................ 16 IV. Appendix A

................................ ................................ ................................ ...................... 18

________________________________________
Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's current position based on the following documents:

1. Product Chemistry, Envir onmental Fate, and Ecological Effects Scoping Document in Support of the Registration Review of Tri

- n

- butyl tetradecyl phosphonium chloride

. December 6 , 2011

2. Tributyl Tertradecyl Phosphonium Chloride (TTPC): Human Health Risk Assessment Scoping Document in Support of Registration Review

. October 31, 2011

Additional supporting documents for the Tri

- N Butyl Tetradecyl Phosphonium Chloride Case may be found in the registration review docket located on the internet at www.regulations.gov

.Docket Number: EPA

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- OPP

- 2011

- 0952 www.regulations.gov

4 of 17 Tri

- N Butyl Tetradecyl Phosphonium Chloride Registration Review Team

Nathan Mottl Human Health & Environmental Effects

Srinivas Gowda

Eliza Blair Risk Management

Lance Wormell

Philip Ross Office of General CounselDocket Number: EPA

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- OPP

- 2011

- 0952 www.regulations.gov

5 of 17 I. Preliminary Work Plan

-- Tri

- N Butyl Tetradecyl Phosphonium Chloride

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 registere d 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 pro gram is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment

. Changes in science, public policy, and pesticide use practices will occur over time

. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely

. Inform ation on this program is provided at Introduction:

http://www.epa.gov/oppsrrd1/registration_review/

. The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecti cide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration

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

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

. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are ne eded 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 Tri

- N Butyl Tetradecyl Phosphonium Chloride C ase.

Tri

- n butyl tetradecyl phosponium chloride (TTPC) was initially registered as a pesticide in the United States in 1987 for use as a disinfectant ; it was later withdrawn , and no registered products containing TTPC existed until its reactivation in 2006 for use as an algicide, fungicide and bacteriocide. Currently there are three registered products containing TTPC

. Products containing TTPC are registered for use in indust rial processes and water systems such as commercial and industrial cooling towers, evaporative condensers, heat exchange water systems, evaporative coolers, dairy sweetwater systems, industrial process water systems, brewery pasteurizers, can warmers, hydr ostatic sterilizers and retorts, air washing systems equipped with a mist eliminator, and industrial air scrubbing systems as well as enhanced oil recovery s ystems. There are no pesticide tolerances or exemptions from the requirement of tolerance for TTPC

.

No RED was developed for this chemical because products containing t he active ingredient

w ere first registered after November 1, 1984.

Documents associated with the registration review of Tri

- n butyl tetradecyl phosphonium chloride can be viewed at www.regulations.gov in docket EPA

- HQ

- OPP

- 2011

- 0952

. Below is a summary of the issues relevant to th is registration review case.Docket Number: EPA

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- 0952 www.regulations.gov

6 of 17 The Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species risk assessment, for all uses of TTPC. The Agency does not anticipate the need to conduct a human health risk assessment. The Agency anti cipates needing additional data for use in conducting the registration review for TTPC. Anticipated Risk Assessment and Data Needs:

Ecological Risk:

**•** An ecological risk assessment was performed for TTPC as part of the 2006 registration action

. TTPC uses that have potential for environmental exposure are industrial slimicides used in recirculating water cooling towers and pulp and paper mill discharges. The Agency needs to conduct environmental fate and ecological risk assessments for industrial sli micides used in recirc ulating water cooling towers, pulp and paper mills , and oilfield drilling and maintenance fluids that potentially pass through waste water treatment plants (WWTPs) and may be discharged into terrestrial and aquatic environments.

**•** The A gency has not conducted a risk assessment that supports a complete endangered species determination for TTPC

. The ecological risk assessment planned during registration review will allow the Agency to determine whether TTPC ’s use has 'no effect' or 'may af fect' 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 wi th the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

**•** The Agency anticipates the need to require the following additional environmental fate data for use in the registration review of TTPC.

o 835.4300 Aerobic aquatic metabolism

o 835.4400 Anaerobic aquatic metabolism

o 835.1240 Adsorption/Desorption

o 850.6800 Modified Activated Sludge Respiration Inhibition

o 835.1110 Activated Sludge Sorption Isotherm

o 835.3110 Ready biodegradability

o 835.3220 Porous Pot Test 1

o 835.3280 Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 1

o 835.3240 Simulation Test

– Aerobic Sewage Treat ment: A. Activated Sludge Units 1

1

1 The results of the Activated Sludge Respiration Inhibition Test (ASRI) that is expected to be required would determine which of these three biodegradation tests are required. If the ASRI test EC 50 is less than or equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test

– Aerobic Sewage Tr eatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test EC 50 is greater than 20 mg/L, then the applicant would choose to conduct either: (i) Ready Biodegradability or (ii) Biodegradation in Activated Sludge or Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous PotDocket Number: EPA

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7 of 17 o 830.7550

- Octanol/water partition coefficient determination for TTPC by the S hake Flask Method modified to use measured TTPC ion pair and cation concentrations at equilibrium

**•** The Agency anticipates the need to require the following additional e c otoxicity data for use in the registration review of TTPC.

o 850.1400

- Fish early

- life stage toxicity test, freshwater species (most acutely sensitive Blue gill sunfish, Lepomis macrochirus )

o 850.1300

- Aquatic invertebrate life

- cycle, freshwater species

o 850.4400

- Aquatic plant toxicity test, vascular species

o 850.5400

- Aquatic plant toxicit y test, non

- vascular (4 species : a freshwater green alga, a freshwater diatom, a cyanobacterium, and a marine diatom )

o Special Study

- Sediment chronic toxicity test, freshwater invertebrate Hyallela
azteca 2

o 850.1075

- Fish acute toxicity, es tuarine/marin e species

o 850.1035

- Mysid acute toxicity test

o 850.1025 or 850.1055

- Mollusc acute toxicity

o 850.1350

- Mysid life

- cycle toxicity test

o 850.4100

- Seedling emergence and growth test for rice ( Oryza sativa )

o Special Study

- Sediment chronic toxicity test, fr eshwater invertebrate Chironomous dilutus

**•** F or more information

, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of the Registration Review of Tri

- n

butyl tetradecyl phosphonium chloride , located in the docket

.

Human Health Risk:

**•** A human health risk assessment was performed for TTPC as part of the 2006 r egistration action.

**•** The Agency does not anticipate the need to require additional human health data for th is registration review case at this tim e.

**•** F or more information

, please refer to Tributyl Tertradecyl Phosphonium Chloride (TTPC): Human Health Risk Assessment Scoping Document in Support of Registration Review

, located in the docket

.

Test. If the antimicrobial passes the ready biodegradability study, then no further testing would be expected to be required. If, however, the antimicrobia l fails the ready biodegradability study, then the Biodegradation in Activated Sludge or Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required. 2 The sediment toxicity tests that are anticipated to be required could be waived if acceptable environmental fate data are provided to demonstrate that the half

- life of the pesticide in the sediment is greater than 10 days and if at least one of the following conditions is met: 1) Kd < 50, 2) Koc <1000, and/or 3) Kow <3.Docket Number: EPA

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8 of 17 Product Chemistry:

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

**•** F or more information

, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of the Registration Review of Tri

- n

butyl tetradecyl phosphonium chloride

, located in the docket

.

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals

. Collectively, these stud ies 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, inc luding effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring

. For ecological hazard assessments, EPA evaluates acute tests and chroni c studies that assess growth, developmental and reproductive effects in different taxonomic groups

. As part of its most recent registration decision for TTPC , 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), TTPC is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). Endocrine Disruptor Screening Program

EPA has developed the EDSP to determine whether certain substan ces (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

- ti ered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems

. Chemic als 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 availabl e 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 pest icide 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. TTPC is not among the group of 58 pesticide active in gredients 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 TTPC

. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.Docket Number: EPA

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9 of 17 Timeline

EPA has created the following estimated timeline for the co mpletion of the Tri

- n butyl tetradecyl phosphonium chloride registration review:

Anticipated Schedule Activities Estimated Month/Year Phase 1: Opening the docket Open Public Comment Period for Docket December 2011 Close Public Comment Period for Docket February 2012 Phase 2: Case Development Develop Final Work Plan (FWP) June 2012 Issue DCI June 2013 Data Submission June 2014 Open Public Comment Period for Preliminary Risk Assessments December 2015 Close Public Comment Period for Preliminary Risk Assessments January 2016 Phase 3: Registration Review Decision Open Public Comment Period for Proposed Reg. Review Decision June 2016 Close Public Comment Period for Proposed Reg. Review Decision August 2016 Final Decision and Begin Post

- Decision Follow

- up 2016 Total (years) 5

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 well as any additional information or data provided in a timely manner prior to issuing a final work plan for the Tri

- n butyl tetradecyl phosphonium chloride registration review case.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution

. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern.

Water Quality:

TTPC is not identified as a c ause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88 5. In addition, no Total Max imum Daily Loads (TMDL) have been developed for TTPC , based on information provided atDocket Number: EPA

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10 of 17 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id =885&p_pollutant_group_name=PESTICIDES.

More information on impaired water b odies and TMDLs can be found at http://www.epa.gov/owow/tmdl/

. The Agency invites submission of water quality data for this pesticide

. To the extent possible, data should conform to the quality standards in Appen dix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm ), in order to ensure the data can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental j ustice 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 atypical, unusually high exposure to TTPC compare d to the general population. Please comment if you are aware of any sub

- populations that may have atypical, unusually high exposure compared to the general population.

Structure Activity Relationships:

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

. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide chemical traditionally begins with the applicant’s submission of a set of studies conducted with the specific pesticide chemical of interest

. The use of t he 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 v arious animal species.

Today, there is significant interest in alternative techniques, i.e., techniques other than data generation that could significantly inform the Agency’s decision

- making process

. Recently, OPP has made increasing use of structure act ivity relationship (SAR) as part of its regulatory decision

- making process

. In the SAR process, a chemical's molecular structure is compared to that of other chemicals for which data are available

. These structural similarities are then used to make predic tive judgments about a chemical’s physical, chemical, and biological properties

. Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly related to) the chemical’s molecular structure

. Quantitative SAR is referred to as QSAR

. To develop a QSAR, a selected set of measured data on a single physical, chemical, or biological property is used to derive a model (an equation) to predict the value of that property

. Since SAR assessments and QSAR modeling are another set of tools that are available to Agency scientists, OPP has begun a process shift that envisions shifting from the current study

- by

- study approach to an approach in which the use of predicted data, gene rated using validated models, is considered along with information from open literature and studies specifically generated underDocket Number: EPA

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11 of 17 Part 161 requirements

. All relevant information would be considered as part of a weight

- of

- the

evidence evaluation

.

At this ti me, 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 proper ties, 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 toxicit y 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 f or the Tri

- N Butyl Tetradecyl Phosphonium Chloride c ase, 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 val idity of the information

. The determination that the predicted data fulfills the data requirement would be at the sole discretion of the Agency

. Pre

- submission consultation with the Agency is encouraged.

Additional Information:

Stakeholders are also specif ically 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. Confirma tion 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 p otential 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, amph ibian and mammalian mortalities) not already reported to the Agency 8. Monitoring data

Next Steps:

After the 60

- day comment period closes in February 2012 , the Agency will review and respond to any comments received in a timely manner, and then issue a Final Work Plan for the Tri

- N Butyl Tetradecyl Phosphonium Chloride c ase

.Docket Number: EPA

- HQ

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- 0952 www.regulations.gov

12 of 17 II. Fact Sheet

Background Information:

**•** Active Ingredient: Tri

- n butyl tetradecyl phosponium chloride (TTPC)

**•** C ase number: 5111

**•** PC Code: 128824

**•** CAS number : 81741

- 28

- 8

**•** Technical registrant: BWA Water Additives LLC

**•** First approved for use in a registered product: 1987 (withdrawn /inactive 1988, re

activated 2006)

**•** There are no pesticide tolerances or exemptions from the requirement of tolerance for TTPC

.

**•** Antimicrobials Division Chemical Review Manager (CRM): Eliza Blair

, blair.eliza@epa.gov

**•** Antimicrobials Division Product Manager (PM): Velma Noble

, noble.velma@epa.gov

**•** Chemical Structure:

Use & Usage Information:

**•** TTPC is a quaternary phosphonium liquid biocide registered for use as an end

- use product for control of algae, slime

- forming bacteria, sulfate

- reducing bacteria and fungi in industrial process water treatments (Use Site Category VIII). TTPC is delivered to industrial process waters using closed metered delivery s ystems; open pouring is prohibited. Examples of registered TTPC uses include water treatment in recirculating cooling water and process waters, heat exchange water systems, air washing systems, evaporative coolers, brewery pasteurizers, can warmers, hydro static sterilizers and retorts, pulp/paper/paperboard systems (non

- food contact paper and paperboard manufacture of brown paper, sheet for corrugated board, Kraft paper, newsprint and similar paper), enhanced oil recovery systems (non

- marine/non

- estuarine use), oil and gas production transmission pipelines and systems, gas storage wells and systems, hydro

testing of pipelines and tanks, pipeline pigging and scraping operations and oil and gas well drilling and maintenance fluids.

Recent/Pending Regulatory Actions :

**•** A n applica tion for amendment for a new product use to control microbial growth in waters and on pipe surfaces in fire protection systems was submitted to the Agency on July 12, 2011. If approved, this requested new use will not change the data needs or risk assessments for this registration review.Docket Number: EPA

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13 of 17 Ecological Risk Assessment Status:

Please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of the Registration Review of Tri

- n

- butyl tetradecyl phosp honium chloride

, located in the docket, for a detailed discussion of the ecological risk assessments.

**•** TTPC is highly to very highly acutely toxic to freshwater fish and invertebrates. TTPC is slightly to moderately toxic to birds.

**•** The environmental fat e and ecological risk assessment for TTPC performed at the time of registration did not address all current uses and environmental exposures . The Agency needs to conduct environmental fate and ecological risk assessments for industrial slimicides used in recirculating water cooling towers and paper mills that potentially pass through waste water treatment plants (WWTPs) and may be discharged into terrestrial and aquatic environments.

Human Health Risk Assessment Status:

The following are key findings of th e recent human health risk assessments for Tri

- n butyl tetradecyl phosphonium chloride . Please refer to Tributyl Tertradecyl Phosphonium Chloride (TTPC): Human Health Risk Assessment Scoping Document in Support of Registration Review

, located in the docket , for a detailed discussion of the human health risk assessment.

Hazard Characterization:

**•** TTPC exhibits low acute oral and dermal toxicity ( T oxicity C ategory III) and is corrosive to the eye (Toxicity Category I). An acute inhalation toxicity study for TT PC was waived and Toxicity Category I assigned for inhalation. A formulated manufacturing

- use product/end

- use product (BELLACIDE 350, 50% TGAI) shows low acute oral toxicity (Toxicity Category III); however, it is acutely toxic via the dermal route (Toxic ity Category I) and is highly irritating and corrosive to the eyes and skin ( Toxicity Category I).

Dietary (Food and Water):

**•** A dietary risk assessment has not been conducted for TTPC.

**•** C urrent labels restrict product use to nonfood applications and no tolerances or exemptions from tolerances exist for indirect food contact use of TTPC ; therefore

, food exposure is expected to be negligible and no dietary assessment is anticipated to be needed.

**•** D ietary exposures via drinking water may occur in the event of a down

- the

- drain discharge. The contaminated water could pass through wastewater treatment facilities into the drinking water or may be discharged directly to surface water which is later
treate d. However, at this time there are no available environmental fate data to determine whether TTPC can pass through wastewater treatment facilities into drinking water orDocket Number: EPA

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14 of 17 migrate into residential groundwater wells as a result of its current use patterns. Up on receipt and review of the environmental fate data the Agency anticipates requiring, the Agency will determine the need for a down

- the

- drain drinking water assessment.

Residential:

**•** A residential risk assessment has not been performed for TTPC.

**•** The labels for TTPC are for industrial applications a nd TTPC is not used to treat products registered for household/residential use. Therefore, no residential exposure is expected and no residential assessments will be needed for this registration review

. Aggregate:

**•** An aggregate assessment has not been conducted for TTPC. In examining aggregate exposure, EPA takes into account the available and reliable information concerning exposures to pesticide residues in food and drinking water, as well as non

- occupational pest icide exposures. An aggregate risk assessment ha s not been deemed necessary for TTPC because non

- occupational exposure other than potential exposure to drinking water (see above) is not expected to occur

. Occupational:

**•** An occupational exposure assessment f or TTPC was completed in 2007.

**•** An occupational risk assessment was conducted at the time of initial registration . TTPC products are required to be metered into water via a fully closed system. Labeling also requires PPE such as coveralls worn over long

- sleeved shirt, goggles, face shield, chemical resistant gloves and footwear in case of leaks or breaks in the closed delivery system.

**•** As a result of the closed mixing/loading, PPE for protection against leaks/malfunctions, and low volatility, additio nal occupational handler assessments are not anticipated as needed for registration review. Dermal and inhalation post

- application risks for water

treatment uses are likely to be minimal based on dilution, limited exposure contact, and low volatility.

Cum ulative:

**•** A cumulative risk assessment has not been performed for TTPC. The Agency does not have, at this time, available data to determine whether TTPC has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulativ e risk
assessment. For the purposes of this Registration Review, EPA has assumed that TTPC does not have a common mechanism of toxicity with other substances when used as an antimicrobial as registered.Docket Number: EPA

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15 of 17 Incidents:

Ecological:

**•** There are no reported inciden ts in the Agency's Ecological Incident Information System (EIIS) regarding TTPC.

Human Health:

**•** No TTPC human poisoning incidents have been reported in the OPP incident database.

Tolerances and International Harmonization:

**•** There are no pesticide tolerances or exemptions from the requirement of tolerance for TTPC

.
Data Call

- In Status:

**•** No Data Call

- In has been issued for TTPC.

Labels:

Registered products, including EPA registration numbers are provided in Table 1 below

. For future reference, during registration review a list of product registration numbers will be included in the docket. Product registration labels may be obtained from the Pesticide Product Label System (PPLS) website at: http:/ /oaspub.epa.gov/pestlabl/ppls.home

.

Table 1

. Registered Products

– TTPC

Registration No. Registration Name Company Name Formulation Type % of Active Ingredient

83451

- 15 Bellacide 350 BWA Water Additives US LLC Soluble Concentrate MU P/ E P 50

83451

- 16 Bellacide 355 BWA Water Additives US LLC Soluble Concentrate E P 5

83451

- 20 Bellacide 303 BWA Water Additives US LLC Flowable Concentrate E P 15Docket Number: EPA

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16 of 17 III. Summary of Anticipated Data Requirements

– Tri

- N Butyl Tetradecyl Phosphonium Chloride

The table below summarizes anticipated data needs for the Tri

- N Butyl Tetradecyl Phosphonium Chloride Case in Section I of this document (Preliminary Work Plan), Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of t he Registration Review of Tri

- n

- butyl tetradecyl phosphonium chloride , and Tributyl Tertradecyl Phosphonium Chloride (TTPC): Human Health Risk Assessment Scoping Document in Support of Registration Review

.
Table 2. Summary of Anticipated Data Requirements

– T TPC

Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured in months from DCI Receipt)

835.4300 Aerobic aquatic metabolism TGAI 24

835.4400 Anaerobic aquatic metabolism TGAI 24

835.1240 Adsorption/Desorption TGAI 24

850.6800 Modified Activated Sludge Respiration Inhibition TGAI 24

835.1110 Activated Sludge Sorption Isotherm TGAI 24

835.3110 Ready biodegradability 3 TGAI 12

835.3220 Porous Pot Test TGAI 3 12

835.3280 Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater TGAI

3 12

835.3240 Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units TGAI
3 12

850.1400 Fish early

- life stage toxicity test, freshwater species (most acutely sensitive Blue gill sunfish, Lepomis macrochirus ) TGAI

24

3 The results of the Activated Sludge Respiration Inhibition Test (ASRI) that is expected to be required would determine which of these three biodegradation tests are required. If the ASRI test EC 50 is less than or equ al to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test EC 50 is greater than 20 mg/L, the n the applicant would choose to conduct either: (i) Ready Biodegradability or (ii) Biodegradation in Activated Sludge or Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test. If the antimicrobial passes the ready bi odegradability study, then no further testing would be expected to be required. If, however, the antimicrobial fails the ready biodegradability study, then the Biodegradation in Activated Sludge or Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.Docket Number: EPA

- HQ

- OPP

- 2011

- 0952 www.regulations.gov

17 of 17 850.1300 Aquatic invertebrate life

- cycle, freshwater species TGAI 24

850.4400 Aquatic plant toxicity test, vascular species TGAI 24

850.5400 Aquatic plant toxicity test, non

- vascular (4 species : a freshwater green alga, a freshwater diatom, a cyanobacterium, and a marine diatom ) TGAI

12

830.7550 Octanol/water partition coefficient determination for TTPC by the Shake Flask Method modified to use measured TTPC ion pair and cation concentrations at equilibrium TGAI

12

850.4100 Seedling emergence and growth test for rice ( Oryza sativa ) TGAI 12

850.1350 Mysid life

- cycle toxicity test TGAI 12

850.1025 or 850.1055 Mollusc acute toxicity TGAI 12

850.1035 Mysid acute toxicity test TGAI 12

850.1075 Fish acute toxicity, estuarine/marine species TGAI 12

Special Study Sediment chronic toxicity test, freshwater invertebrate Chironomous dilutus TGAI 24

Special Study Sediment chronic toxicity test, freshwater invertebrate TGAI 24Appendix A: Tri-n butyl tetradecyl phosphonium chloride (TTPC)EPA Reg # Formulation % A. I. Use Site Treatment Site/Surfaces Application Method Min App Rate Max App RateMax App RateConverted Units Use Limitations83451-15SolubleConcentrate 50Industrialprocesses andwater systemscommercial and industrial cooling towers,evaporative condensers, heat exchangewater systems, evaporative coolers, dairysweetwater systems, industrial processwater systems, brewery pasteurizers, canwarmers, hydrostatic sterilizers and retorts,air washing systems equipped with a misteliminator, and industrial air scrubbingsystems. Metered1.3-2.6 oz per 1000gallons3.8-7.7 oz per 1000gallons oz per galdairy sweetwater systems, brewerypasteurizers, can warmers, hydrostaticsterilizers and retorts, air washingsystems equipped with a mist eliminator,and industrial air scrubbing system usesare not registered for use in CA.83451-15SolubleConcentrate 50Industrialprocesses andwater systemspulp, paper, and paperboard mill processwater systems Metered0.3-0.5 lbs per tonof pulp or paper (drybasis)2.0-3.0 lbs per tonof pulp or paper(dry basis) LBS per TONOnly for Paperboard not intended forfood contact uses.83451-15SolubleConcentrate 50MaterialpreservativeWater based coatings, starches, pigmentsand filler slurries. Metered 200ppm 1000ppmOnly for Paperboard and adhesives notintended for food contact uses.83451-15SolubleConcentrate 50Industrialprocesses andwater systems Enhanced Oil Recovery Systems Metered4.2 gallons per 1000barrels42 gallons per 1000barrelsGallons perBarrel83451-15SolubleConcentrate 50Industrialprocesses andwater systems Gas Storage Wells and Systems Metered 100ppm 1000ppmGallons perBarrel83451-15SolubleConcentrate 50Industrialprocesses andwater systems Hydrotesting Metered 100ppm 1000ppmGallons perBarrel83451-15SolubleConcentrate 50Industrialprocesses andwater systems Pipeline pigging and scraping Metered 100ppm 1000ppmGallons perBarrel83451-15SolubleConcentrate 50Industrialprocesses andwater systemsDrilling, packer, completion, workover andfracturing fluids Metered 100ppm 1000ppmGallons perBarrel83451-16SolubleConcentrate 5Industrialprocesses andwater systemscommercial and industrial cooling towers,evaporative condensers, heat exchangewater systems, evaporative coolers, dairysweetwater systems, industrial processwater systems, brewery pasteurizers, canwarmers, hydrostatic sterilizers and retorts,air washing systems equipped with a misteliminator, and industrial air scrubbingsystems. Metered13-26 oz per 1000gallons38-77 oz per 1000gallons oz per galdairy sweetwater systems, brewerypasteurizers, can warmers, hydrostaticsterilizers and retorts, air washingsystems equipped with a mist eliminator,and industrial air scrubbing system usesare not registered for use in CA.83451-16SolubleConcentrate 5Industrialprocesses andwater systemspulp, paper, and paperboard mill processwater systems Metered3.0-5.0 lbs per tonof pulp or paper (drybasis)20-30 lbs per ton ofpulp or paper (drybasis) LBS per TONOnly for Paperboard not intended forfood contact uses.83451-16SolubleConcentrate 5MaterialpreservativeWater based coatings, starches, pigmentsand filler slurries. Metered 200ppm 1000ppmOnly for Paperboard and adhesives notintended for food contact uses.83451-16SolubleConcentrate 5Industrialprocesses andwater systems Enhanced Oil Recovery Systems Metered42 gallons per 1000barrels420 gallons per1000 barrelsGallons perBarrel83451-16SolubleConcentrate 5Industrialprocesses andwater systems Gas Storage Wells and Systems Metered 1000ppm 10000ppmGallons perBarrelAppendix A: Tri-n butyl tetradecyl phosphonium chloride (TTPC)EPA Reg # Formulation % A. I. Use Site Treatment Site/Surfaces Application Method Min App Rate Max App RateMax App RateConverted Units Use Limitations83451-16SolubleConcentrate 5Industrialprocesses andwater systems Hydrotesting Metered 1000ppm 10000ppmGallons perBarrel83451-16SolubleConcentrate 5Industrialprocesses andwater systems Pipeline pigging and scraping Metered 1000ppm 10000ppmGallons perBarrel83451-16SolubleConcentrate 5Industrialprocesses andwater systemsDrilling, packer, completion, workover andfracturing fluids Metered 1000ppm 10000ppmGallons perBarrel83451-20FlowableConcentrate 15Industrialprocesses andwater systemscommercial and industrial cooling towers,evaporative condensers, evaporativecoolers, closed loop heating and· coolingsystems and industrial process watersystems. Metered1.9-6.4oz per 1000gallons9.6-19.2 oz per1000 gallons oz per gal83451-20FlowableConcentrate 15Industrialprocesses andwater systemsair washing systems equipped with a misteliminator and industrial air scrubbingsystems. Metered1.9-6.4oz per 1000gallons9.6-19.2 oz per1000 gallons oz per gal83451-20FlowableConcentrate 15Industrialprocesses andwater systemsbrewery pasteurizers, bottle and canwarmers and hydrostatic sterilizers andretorts. Metered1.9-6.4oz per 1000gallons9.6-19.2 oz per1000 gallons oz per gal83451-20FlowableConcentrate 15Industrialprocesses andwater systemspulp, paper, and paperboard millprocess water systems including white watersystems Metered0.3-0.5 lbs per tonof pulp or paper (drybasis)2.0-3.0 lbs per tonof pulp or paper(dry basis) LBS per TONOnly for Paperboard not intended forfood contact uses.83451-20FlowableConcentrate 15Industrialprocesses andwater systems Enhanced Oil Recovery Systems Metered4.2 gallons per 1000barrels63 gallons per 1000barrelsGallons perBarrel83451-20FlowableConcentrate 15Industrialprocesses andwater systems Gas Storage Wells and Systems Metered 100ppm 1500ppmGallons perBarrel83451-20FlowableConcentrate 15Industrialprocesses andwater systems Hydrotesting Metered 100ppm 1500ppmGallons perBarrel83451-20FlowableConcentrate 15Industrialprocesses andwater systems Pipeline pigging and scraping Metered 100ppm 1500ppmGallons perBarrel83451-20FlowableConcentrate 15Industrialprocesses andwater systemsDrilling, packer, completion, workover andfracturing fluids Metered 100ppm 1500ppmGallons perBarrel