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



# Tetrakis(Hydroxymethyl) Phosphonium Sulfate (THPS) Summary Document: Registration ReviewDocket Number: EPA-HQ-OPP-2011-0067 www.regulations.gov


### TABLE OF CONTENTS

Tetrakis(Hydroxymethyl)Phosphonium Sulfate (THPS) Registration Review Team .........4 I. Preliminary Work Plan .....................................................................................................5 II. Fact Sheet ......................................................................................................................12 III. Summary of Anticipated Data Requirements ..............................................................17 IV. Appendix A ..................................................................................................................19

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Please Note

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

1. Scoping Document: Product Chemistry/Environm ental Fate/Ecotoxicity of Tetrakis (hydroxymethyl) Phosphonium Sulfate.

2. Summary of Human Health Effects Data for the THPS Registration Review Decision Document.

Additional supporting documents for the Tetrak is(Hydroxymethyl)Phosphonium Sulfate (THPS) Case may be found in the registration review docket EPA-HQ-OPP-2011-0067 located on the internet at www.regulations.gov

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Tetrakis(Hydroxymethyl)Phosphonium Sulfa te (THPS) Registration Review Team

Human Health & Environmental Effects Nathan Mottl Najm Shamim

Risk Management Eliza Blair Lance Wormell

Office of General Counsel Philip Ross

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I. Preliminary Work Plan -- Tetrakis(Hyd roxymethyl) Phosphonium Sulfate (THPS)

Introduction:

The Food Quality Protection Act (F QPA) of 1996 mandated a regist ration review program. All pesticides distributed or sold in the United St ates generally must be registered by the U.S. Environmental Protection Agency (USEPA, EPA, or the Agency ) based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The regist ration 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 th e statutory standard of no unreas onable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/

. The Agency is implementing the registration 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. 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 whatit knows about the pesticide and what additional risk analyses and data or information it belie ves are needed to make a registration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will de velop and commit to a final work plan and schedule for the Tetrakis(Hydroxymethyl )Phosphonium Sulfate (THPS) Case.

The first product containing Tetrakis(hydroxym ethyl) phosphonium sulfate (THPS or THPS) (PC Code 129058) as an active ingredient was regist ered in the United States in 1995. Currently there are 15 products containing te trakis(hydroxymethyl)phosphonium sulfate (THPS) registered with EPA. The products are registered for use as a materials preserva tive in paperboard manufacturing, coatings, pigments, emulsions an d solutions, and fire protection systems. The products are also registered for antifoulant us e in recirculating indus trial process and water systems and oilfield recovery operations (drilling muds, packer fluids, pipeline pigging and scraping, and hydrotesting, among othe r applications). There are no pesticide tolerances or exemptions from the requirement of a tolerance for this chemical.

A Reregistration Eligibility Decision (RED) was not issued for THPS, because it was first registered after November 1, 1984.

Documents associated with the registration review of Tetrakis(hydroxymethyl)phosphonium sulfate (THPS) can be viewed at www.regulations.gov in docket EPA-HQ-OPP-2011-0067. Below is a summary of the issues releva nt to the registra tion review case.

The Agency believes that THPS may be a form aldehyde releaser because it contains a hydroxymethyl group, which is essential to the production of formaldehyde; additionally, the

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degradation products observed in an aquati c medium are trihydroxymethyl phosphine (THP) molecules, which are formed by releasi ng two formaldehyde (HCHO) molecules.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species risk assessment, for all uses of THPS. The Agency anticipates the need to conduct a human hea lth risk assessment as well. The Agency anticipates needing additional data to conduct the registration review for THPS.

Ecological Risk:

• No recent ecological risk assessment has b een performed for THPS. The most recent ecological risk assessment was performed in 1995 in support the initial registration of a product containing THPS.

• The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for THPS. The eco logical risk assessment planned during registration review will allow the Agency to determine whether THPS’s use has 'no effect' or 'may affect' federall y listed threatened or endange red species (listed species) or their designated critical hab itats. When an assessment concludes that a pesticide’s use 'may affect' a listed species or its designated cr itical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

• The Agency anticipates the need to require th e following additional ecological data for the registration review of THPS.

850.1010 -- Aquatic invertebrate acute toxicity, freshwater daphnids 850.1300 -- Daphnid chronic toxicity test 850.1350 -- Mysid chronic tox - aquatic inve rtebrate life-cycle (saltwater) 850.4400 -- Aquatic plant toxicology test using Lemna spp., Tier I 850.1400 -- Fish early-life stage to xicity test (freshwater) 850.5400 -- Algal Toxicity Tier I and Tier II

• The Agency anticipates the need to require the following additional environmental fate data for the registra tion review of THPS.

835.2240 -- Photodegradation in water 835.1230 -- Sediment and soil adsorption/desorption 835.1240 -- Leaching and adsorption/desorption 835.4300 -- Aerobic aquatic metabolism 835.4400 -- Anaerobic aquatic metabolism 835.3110 -- Ready Biodegradability

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• For more information, please refer to Scoping Document: Product Chemistry/Environmental Fate /Ecotoxicity of Tetrakis (hydroxymethyl) Phosphonium Sulfate , located in the docket.

Human Health Risk:

• No recent human health risk assessment has been performed for THPS. The most recent human health risk assessment was performed in 1995 in support the in itial registration of a product containing THPS.

• The Agency anticipates the need to require the following additional human health data for the registration review of THPS.

870.3465 -- 90-day inhalati on toxicity (rat) 875.1100 -- Dermal outdoor exposure 875.1200 -- Dermal indoor exposure 875.1300 -- Inhalation outdoor exposure (HRSB costs not included) 875.1400 -- Inhalation indoor exposure 875.1600 -- Application exposure data reporting and calculations 875.1700 -- Product use information

• Because the use of THPS in paints and coa tings may result in inhalation exposure to users, the Agency will also need air monitoring data and would expect to require the following data to examine THPS and formal dehyde inhalation exposure. The studies anticipated as needed would be:

875.2500 -- Inhalation exposure 875.2700 -- Product use information 875.2900 -- Data reporti ng and calculations

• For more information, please refer to Summary of Human Health Effects Data for the THPS Registration Review Decision Document , located in the docket.

Product Chemistry:

• The Agency anticipates the need to require the following additional product chemistry data for the registra tion review of THPS.

830.7840 -- Solubility in organi c solvents in g/100 ml

• For more information, please refer to Scoping Document: Product Chemistry/Environmental Fate /Ecotoxicity of Tetrakis (hydroxymethyl) Phosphonium Sulfate , located in the docket.

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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 endpoints which may be susceptible to endocrine influence

, including effects on endocrine 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. As part of its most recent registration decision

, EPA reviewed these data and selected the most sensitive endpoi nts for relevant risk assessment scenarios from the existing hazard database. However, as required by FFD CA section 408(p), THPS is subject to the endocrine screening part of the Endocrine Disruptor Screenin g 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. THPS is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issu e future EDSP orders/data callins, requiring the submission of EDSP screening assays for THPS. 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/

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Timeline

EPA has created the following estimated timeline for the completion of the Tetrakis(hydroxymethyl)phosphonium sulf ate (THPS) registration review:

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Anticipated Schedule Activities Estimated Month/Year Phase 1: Opening the docket Open Public Comment Period for Docket March 2011 Close Public Comment Period for Docket May 2011 Phase 2: Case Development Develop Final Work Plan (FWP) September 2011 Issue DCI June 2012 Data Submission June 2014 Open Public Comment Period for Prelim inary Risk Assessments December 2015
Close Public Comment Period for Prelim inary Risk Assessments February 2016 Phase 3: Registration Review Decision Open Public Comment Period for Pro posed Reg. Review Decision June 2016 Close Public Comment Period for Proposed Reg. Review Decision September 2016 Final Decision and Begin Post-Decision Follow-up 2016 Total (years) 5.5

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency will carefully consider all comments as well as any additional information or data provided in a timely manner prior to issuing a final work plan for the Tetrakis(hydroxymethyl)phosphonium sulfate (THPS) registration review case.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. Growers and other stakeholders are asked to comment on any tr ade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the na ture of the concern.

Water Quality:

THPS is not identified as a cause of impairme nt for any water bodies listed as impaired under section 303(d) of the Clean Water Ac t, 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 Maximum Daily Loads (TMDL) have been developed for THPS, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?p_pollutant_group_id =885&p_pollutant_group_name=PESTICIDES.

More information on impaired wate r bodies and TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this

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pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclus ion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Revi ew Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ), in order to ensure the data can be used quantitatively or qual itatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to THPS compar ed to the general popul ation. 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 qual ity and reliability for each decision made by the Agency. In the Office of Pesticide Program s (OPP), the evaluation process for a pesticide chemical traditionally begins with the applicant’ s submission of a set of studies conducted with the specific pesticide chemical of interest. The use of the results of such testing (measured data) is a logical, scientifically rigorous proce ss that identifies the physical, chemical, and environmental fate properties of the pesticide, as well as the dose and endpoints at which an adverse effect can occur in various animal species.

Today, there is significant interest in alternat ive techniques, i.e., tech niques other than data generation that could significantly inform th e Agency’s decision-making process. Recently, OPP has made increasing use of structure activity relationship (S AR) as part of its regulatory decision-making process. In the SAR process, a chemical's molecular structure is compared to that of other chemicals for which data are available. These structural similarities are then used to make predictive judgments about a chemical’s p hysical, chemical, and bi ological properties. Thus, the chemical’s physical, chemical, and biol ogical properties are a f unction 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 da ta on a single physical, chemical, or biological property is used to derive a model (an equatio n) to predict the valu e of that property.

Since SAR assessments and QSAR modeling are anothe r set of tools that are available to Agency scientists, OPP has begun a proce ss shift that envisions shifting from the current study-by-study approach to an approach in which the use of pr edicted data, generated us ing validated models, is considered along with information from open litera ture and studies specifically generated under Part 161 requirements. All relevant information w ould be considered as pa rt of a weight-of-theevidence evaluation.

At this time, EPA believes that for certain e ndpoints, especially physi cal/chemical and fate properties, that SAR and QSAR might be effect ively utilized to fulfill these data requirements

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for many antimicrobial pesticide chemicals. Wh en considering biologica l properties, at this time, EPA believes that SAR and QSAR can be mo st effectively utilized in the evaluation of chemicals that exhibit lower toxicity for human h ealth and/or ecotoxicity parameters. This is appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a screening-level assessment procedure rather than multiple tiers of assessments with progressively more data requirements.

If stakeholders believe that submission of predic ted data can fulfill one of the data needs for the Tetrakis(Hydroxymethyl)Phosphonium Sulfate (T HPS) case , then the Agency invites submission of this information. The submitte r would be expected to supply a rationale describing the utility of the information and provide documentation on the scientific validity of the information. The determination that the predicted data fulfills the data requirement would be at the sole discretion of the Agency. Pre- submission consultation with the Agency is encouraged.

Additional Information:

Stakeholders are also specifically asked to provid e available information a nd data that will assist the Agency in refining its risk assessments, including any species-spec ific ecological effects determinations. The Agency is interested in receiving the following information:

1. Confirmation on the following label information:

a. Sites of application b. Formulations

c. Application methods and equipment d. Maximum application rates

e. Frequency of application, applicatio n intervals and maximum number of applications f. Geographic limitations on use 2. Use or potential use distribution 3. Use history 4. Usage/use information for non-agricultura l uses (e.g., materials preservation) 5. Typical application interval 6. State or local use restrictions 7. Ecological incidents (non-target plant dama ge and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency 8. Monitoring data

Next Steps:

After the 60-day comment period closes in Ma y 2011, the Agency will review and respond to any comments received in a timely manner, and then issue a Final Work Plan for the Tetrakis(Hydroxymethyl)Phosphonium Sulfate (THPS) case.

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II. Fact Sheet

Background Information:

• Active Ingredient: Tetrakis(hydroxy methyl) phosphonium sulfate (THPS)

• Case number: 5034

• PC Code: 129058

• CAS number: 55566-30-8

• Technical registrants: Dow Chemical Co, Rhodia Inc

• First approved for use in a registered product: 1995

• There are no registered tolerances or exemp tions from the requirement of a tolerance for this chemical. The Agency did not identify any FDA clearances for this chemical.

• Antimicrobials Division Chemical Revi ew Manager (CRM): Eliza Blair, blair.eliza@epa.gov

• Antimicrobials Division Product Ma nager (PM): Marshall Swindell, swindell.marshall@epa.gov

Use & Usage Information:

• The first product containing tetrakis(hydroxymethyl) phosphonium sulfate (THPS) as an active ingredient was registered in the Un ited States in 1995. Currently 15 products containing tetrakis(hydroxy methyl)phosphonium sulfate (THPS) are registered. The chemical is registered for use as a materi als preservative in paperboard manufacturing, coatings, pigments, emulsions and solutions, and fire protection systems. The products are also registered for antifoulant use in recirculating industrial process and water systems and oilfield recovery operations (dri lling muds, packer fl uids, pipeline pigging and scraping, and hydrotesting, among other applications). There are no pesticide tolerances or exemptions from the requirement of a tolerance for this chemical.

Recent/Pending Regulatory Actions:

• There are no recent or pending regula tory actions for this chemical.

Ecological Risk Assessment Status:

Please refer to Scoping Document: Product Chemistry/En vironmental Fate/E cotoxicity of Tetrakis (hydroxymethyl) Phosphonium Sulfate , located in the docket, fo r a detailed discussion of the ecological risk assessments.

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• The most recent ecological risk assessment was performed in 1995 in support the initial registration of a produc t containing THPS.

• THPS appears to be stable and persistent unde r abiotic conditions at pHs 5, and 7 with half lives greater than 30 days. However, at pHs above 8 (basic conditions), it degrades within 7 days. The degradation products ha ve been identified as trishydroxymethyl phosphine (THP) and subsequently trishydr oxymethyl phosphine oxide (THPO). An open literature study also shows that THPS degrades in artificial seawater (ph 7.9) with a half life of 6 days. EPA’s EPI Suite model indicat es that THPS is easily biodegradable (fast biodegradability); ultimate biode gradability is fast as well . Primary biodegradation half life is estimated at hours/days.

• Its estimated Log Kow varies from -4.42 to - 20.39; it is not likely to bioaccumulate in aquatic organisms. It does not appear to be persistent in air as its estimated half life (measured against hydroxyl radical ) is less than 5 hours. The majo r uses of this pesticides are outdoor, and because it is hydrolytically stable, a number of environmental fate studies are triggered as the exposure from these uses will be in soils and water. Leaching and adsorption/desorption studies will clearly show if the chem ical easily migrates into the soils and sediments and Kd values determined from adsorption/desorption studies will show if the binding with soils is st rong or weak. Metabolism studies and biodegradability will show if the pesticide degrades in actual environmental medium.

• THPS has been determined to show moderate acute toxicity to estuarine/marine organisms like Mysid Shrimp as well as to bivalves. THPS shows slight to moderate acute toxicity to Bluegill Sunfish and Rai nbow Trout while it is only slightly toxic to Sheephead Minnow. For Avian Toxicity Testin g, it shows moderate oral toxicity to Mallard Duck while only slight dietary acute toxicity is obse rved with Mallard Duck and Bobwhite Quail.

Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for Tetrakis(hydroxymethyl)phosphonium su lfate (THPS). Please refer to Summary of Human Health Effects Data for the THPS Registration Review Decision Document , located in the docket, for a detailed discussion of the human health risk assessment.

Hazard Characterization:

• The most recent human health risk asse ssment was performed in 1995 in support the initial registration of a product containing THPS.

• The Agency believes that THPS may be a fo rmaldehyde releaser, because it contains a hydroxymethyl group, which is essential for the production of formaldehyde; additionally, the degradation products observed in an aquatic medium are trihydroxymethyl phosphine (THP) molecule s, which are formed by releasing two formaldehyde (HCHO) molecules.

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• The Agency does not have the emissions (e .g. air chamber) data to estimate potential concentrations of formaldehyde released in to air under various c onditions. The Agency will likely need further data to determine the extent of the THPS degradation in air to form formaldehyde and THP. If EPA identif ies that THPS is in fact a formaldehyde releaser, EPA may also need to develop addi tional inhalation risk assessments to assess the contribution of formaldehyde to the overall aggregate risk from all sources.

Dietary (Food and Water):

• THPS is most often used as a microbiocide/sl imicide that is used to control bacteria, fungi, and algae in the manufacture of paper and paperboard products and adhesives that do not contact food. However, some end use pro ducts can also be used on emulsions that are applied to food-contact paper and paperboa rd. Therefore, indirect dietary exposure to food could be expected based on the use. Although likely to be infrequent, dietary exposures via drinking water may occur and assessments will be needed based on release to surface water from recirculating cooling towers. Upon receipt and review of the environmental fate data the Agency anticipat es requiring, the Agency will determine the need for a down-the-drain drinking water assessment.

Residential:

• Residential handler exposure (dermal and inhalation) can oc cur through the application of THPS preservative coatings via paintbrush/r oller or sprayer app lication for painting. Because these exposures are likely to be brie f, the Agency expects to conduct residential handler risk assessments for these scenario s of only short-term duration (1-30 days).

• There also may be residential post-applica tion inhalation exposure to the degradate formaldehyde for these brush/roller a nd airless sprayer application methods.

Aggregate:

• In examining aggregate exposure, EPA take s into account the available and reliable information concerning exposures to pesticid e residues in food and drinking water, as well as non-occupational pesticide exposures . The Agency expects to conduct an aggregate risk assessment that will include residential, dietary and drinking water
exposures.
Occupational:

• Assessments of occupational risk are planne d for registration revi ew because potential exposure is expected through dermal and i nhalation routes during open pour/pump liquid applications for the uses in industrial pro cesses and water systems uses and material preservative uses. Some products’ use in pi gments and coatings strongly implies that THPS may be used in paints; thus, the Ag ency will need to assess this use.

• Both occupational and reside ntial application techniques typically associated with painting exposures (pump/pour liquids, brush/ro ller, and airless spra yer) will be assessed

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using the labeled rates typically used to pres erve the water based coatings, pigments, and slurries. EPAwill assess residential handler exposure to paints assessing applications to brush/roller and airless sprayer for both s hort-term and intermediate-term durations.

• There also may be occupational inhalation e xposure to the degradate formaldehyde for these brush/roller and airless sprayer a pplication methods. Other post-application inhalation exposures to THPS or from formal dehyde for uses such as oil drilling are expected to be minimal. Dermal post-appli cation exposures for wate r-treatment and other material preservation uses such as paper ma nufacturing or oil drilling are likely to be minimal for THPS or formaldehyde.

Cumulative:

• EPA does not have, at this time, available data to determine whether THPS has a common mechanism of toxicity with other substa nces or how to includ e this pesticide in a cumulative risk assessment. For the purpos es of this Registration Review, EPA has assumed that THPS does not have a comm on mechanism of toxicity with other substances.

Incidents:

Ecological:

• No THPS ecological incidents have been report ed in the OPP Incident Database System (IDS).

Human Health:

• There has been one reported human incident in the OPP Incident Database System (IDS) that has been associated with exposure to TH PS and appears to be a result of a misuse. No further information was available on this incident.

Tolerances and International Harmonization:

• There are no tolerances or exemptions from tolerances for this chemical.

Data Call-In Status:

• No Data Call-In (DCI) has been issued for this chemical.

Labels:

Registered active products, includi ng 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 labe ls may be obtained from the Pesticide Product Label System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home

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Table 1. Registered Active Products – THPS

EPA Reg. Number Product Name Formulation Type % Active Ingredient Registrant

464-8129 CYPHOS B1 PHOSPHONIUM SALT Formulation Intermediate 77.6 Dow Chemical Co.

464-8127 AQUA THPS 75FW Ready-to-Use Solution 76.6 Dow Chemical Co. 464-8126 AQUATHPS 75 Ready-to-Use Solution 76.5 Dow Chemical Co. 33677-3 TOLCIDE PS75 Formulation Intermediate 75 Rhodia UK, Ltd

33677-7 TOLCIDE PS75LT Ready-To-Use Solution 75 Rhodia UK, Ltd

4564-20 TOLCIDE PS70A Soluble Co ncentrate 70 Rhodia, Inc. 4564-19 TOLCIDE PS70FA Flowable Concentrate/ Formulation Intermediate 70 Rhodia, Inc

4564-RA TOLCIDE PS355A Soluble Concentrate 35 Rhodia UK, Ltd 10707-57 MAGNACIDE 575S Water-Soluble Packaging 50 Baker Petrolite Corp 4564-17 TOLCIDE PS50A Soluble Concentrate 50 Rhodia Inc. 33677-5 TOLCIDE PS352C Ready-To-Use Solution 35 Rhodia UK Ltd

4564-18 TOLCIDE PS20A Soluble Concentrate 20 Rhodia Inc. 4564-15 TOLCIDE PS200 Ready-to-Use Solution 20 Rhodia Inc.

82932-1 ALL CLEAR Soluble Concentrate 3 KIDDE Fire Fighting 86130-2 FLOWCHEM FCAF001 Flowable Concentrate 20 Flowchem Technologies

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III. Summary of Anticipated Data Requirements – Tetrakis(Hydroxymethyl)Phosphonium Sulfate (THPS)

The table below summarizes anticipated data needs for the Tetrakis(Hydroxymethyl)Phosphonium Sulfate (TH PS) Case in Section I of this document (Preliminary Work Plan), Scoping Document: Product Chemistry/Environmental Fate/Ecotoxicity of Tetrakis (hydroxymethyl) Phosphonium Sulfate , and Summary of Human Health Effects Data for the THPS Registration Review Decision Document

. Table 2. Summary of Anticipated Data Requirements – THPS

Guideline Number Anticipated Data Requirement Test Material Est. Timeframe (months) (Measured from DCI Receipt)

870.3465 90-day inhalation toxicity (rat) TGAI, MP 24

875.1100 Dermal outdoor exposure TGAI, MP 12-24

875.1200 Dermal indoor exposure TGAI, MP 12-24

875.1300 Inhalation outdoor exposure TGAI, MP 12-24

875.1400 Inhalation indoor exposure TGAI, MP 24

875.1600 Application exposure data reporting and calculations TGAI, MP 12

875.1700 Product use information TGAI, MP 12

875.2500 Inhalation exposure TGAI, MP 24

875.2700 Product use information TGAI, MP 12

875.2900 Data reporting and calculations TGAI, MP 24

835.2240 Photodegradation in water TGAI, MP 12

835.1230 Sediment and soil adsorption/desorption TGAI, MP 12

835.1240 Leaching and adsorption/desorption TGAI, MP 12

835.4300 Aerobic aquatic metabolism TGAI, MP 24

835.4400 Anaerobic aquatic metabolism TGAI, MP 24

835.3110 Ready Biodegradability TGAI, MP 24

850.1010 Aquatic invertebrate acute toxicity, freshwater daphnids TGAI, MP 24

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18 850.1300 Daphnid chronic toxicity TGAI, MP 12

850.1350 Mysid chronic tox - aquatic invertebrate life-cycle (saltwater) TGAI, MP 12

850.4400 Aquatic plant toxicology test using Lemna spp., Tier I TGAI, MP 12

850.1400 Fish early-life stage toxicity test (freshwater) TGAI, MP 12

850.5400 Algal Toxicity Tier I and Tier II TGAI, MP 12