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



# Bis (trichloromethyl) sulfone Summary Document: Registration Review : Initial Docket December 2011Docket Number: EPA-HQ-OPP-2011-0614 www.reguiations.gov



## Bis (trichloromethyl) sulfone Summary Document Registration Review: Initial Docket December 2011

Case # 

## 2055

20f21Docket Number: EPA

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3 of 21 

### TABLE OF CONTENTS
Bis (trichloromethyl) sulfone Registration Review Team

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

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

................................ ................................ ................................ ...................... 1 3 III. Summary of Anticipated Data Requirements

................................ .............................. 1 8 IV. Appendix A

................................ ................................ ................................ .................. 21

________________________________________ Please Note This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's current position based on the following doc uments:
1. Product Chemistry, Environmental Fate, and Ecological Effec ts Scoping Document in support of Registration Review of Bis (trichloromethyl) sulfone (BTS)

. December 15 , 2011
2. Bis(trichloromethyl)sulfone: Human Health Effects Scoping Document for the Registration Review Decision

. October 13, 2011 Additional supporting documents for the Bis (trichloromethyl) sulfone Case may be found in the registration review docket EPA

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.Docket Number: EPA

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4 of 21 Bis (trichloromethyl) s ulfone Registration Review Team

Human Health & Environmental Effects William Hazel Srinivas Gowda Risk Management Seiichi Murasaki Lance Wormell
Office of General Counsel Philip RossDocket Number: EPA

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5 of 21 I. Preliminary Work Plan

-- Bis (trichloromethyl) sulfone
Introduction: The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program

. All pesticides distributed or sold in the United States generally must be registered by the U.S. Environmental Protection Agency (USEPA, EPA, or the Agency ) based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling

. The registration review program is intended to make sure that, as the ability to assess risk evolve s 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

. Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/

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

. The Agency will consider benefits information and da ta 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 needed to make a registration review decision

. After reviewing and respond ing 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 Bis (trichloromethyl) sulfone C ase. The first product containing bis (trichloromethyl) sulfone ( BTS ) (PC Code 035601 ) as an active ingredient was registered in the United States in 1967

. Currently , there are nine product s registered with EPA. Products containing the organo
- sulfur compound BTS are registered for use to control algae, slime

- forming b acteria, and fungi in industrial process water systems such as pulp and papermill process water systems, recirculating cooling towers, and secondary oil

recovery injection water systems. Additionally, products containing BTS are registered for use as a mat erial preservative in household and construction materials including paints, coatings, and fuels. There are no tolerances, exemptions from tolerances, or tolerance petitions for BTS. BTS is approved by FDA as an indirect food additive at 21 CFR 176.300 for use as a paper slimicide, at 21 CFR 175.105 to preserve food

- packaging adhesives, and at 21 CFR 176.180 to preserve coatings to be used on paper and paperboard in contact with dry foods. The Agency completed a Reregistration Eligibility Decision (RED) fo r bis (trichloromethyl) sulfone in 1995

.

Documents associated with the registration review of bis (trichloromethyl) sulfone can be viewed at www.regulations.gov in docket EPA

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

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6 of 21 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 bis (trichloromethyl) sulfone

. The Agency anticipates the need to conduct a human health risk assessment. The Agency anticipates needing additional data for use in conducting the registration review for bis (trichloromethyl) sulfone

. Ecological Risk:

**•** The Agency has not conducted a risk assessment that supports a complete endangered species determination for bis (trichloromethyl) sulfone

. The ecological risk assessment planned during registration review will allow the Agency to determine whether bis (trichl oromethyl) sulfone ’s use has 'no effect' or 'may affect' federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use 'may affect' a listed species or its desi gnated critical 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 the following additional ecological data for use i n the registration review of bis (trichloromethyl) sulfone

. 850.1010

– Freshwater invertebrate acute toxicity, Daphnia magna 1 850.1035

– Estuarine/marine invertebrate acute toxicity 1 850.1055

– Embryo larvae study using Mercenaria mercenaria 2 850.1075

– Freshwater fish acute toxicity 3 850.1300

– Aquatic invertebrate life

- cycle , freshwater Daphnia magna 1 850.13 5 0

– Aquatic invertebrate life

- cycle, salt water Americamysis bahia 2 850.1400

– Fish early

- life stage toxicity test , freshwater species 4 850.4225

– Seedling emergence (Tier II) with rice 2 850 .4400

– Aquatic plant toxicity test using Lemna spp. 1 850.5400

– Algal Toxicity ( Tier II ) 5

1 Results for studies conducted with both the TGAI and the major degradate, pentachlorodimethylsulfone, must be submitted to satisfy this requirement. 850.6800 or OECD 209

– A ctivated sludge respiration inhibition test 2

2 Results for study conducted with the major degradate , pentachlorodimethylsulfone , must be submitted to satisfy this requirement. 3 Results for studies conducted with the TGAI for both (i) coldwater and (ii) warmwater species, as well as results for a study with the major degradate, pentachlorodimethylsulfone, and (iii) the most TGAI

- sensitive species, must be submitted to satisfy this requirement. 4 Results for studies conducted using the most TGAI

- sensitive species w ith both the TGAI and the major degradate, pentachlorodimethylsulfone, must be submitted to satisfy this requirement. 5 Results for studies conducted with the TGAI for (i) the freshwater green alga, Selenastrum capricornutum , (ii) the freshwater diatom, Na vicula pelliculosa , (iii) the marine diatom, Skeletonema costatum , and (iv) the cyanobacteria species Anabaena flos

- aquae as well as results for a study with the major degradate, pentachlorodimethylsulfone, and (v) the most TGAI

- sensitive species, must be submitted to satisfy this requirement.Docket Number: EPA

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7 of 21 **•** The Agency anticipates the need to require the following additional environmental fate data for use in the registration review of bis (trichloromethyl) sulfone

. 835.1110

– Activated Sludge Sorption Isotherm 6 835.3110

– Ready Biodegradability 6 835.3220

– Po rous Pot Test 6 835.3240

– Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units 6 835.3280

– Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 6

**•** F or more information , please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in support of Registration Review of Bis (trichloromethyl) sulfone (BTS) , located in the docket

. Human Health Risk:

**•** The most recent human health risk assessments for bis (trich loromethyl) sulfone were completed in 1995, in support of the RED

.

**•** The Agency anticipates the need to require the following additional human health data for use in the registration review of bis (trichloromethyl) sulfone

. 870.3465

– 90

- day inhalation toxicity (rat) 870.3800

– Reproduction and fertility effects (multigeneration)

- rat 870.4100

– Chronic oral toxicity

- rat 870.4200

– Carcinogenicity (rat and mouse, preferred) 870.7485

– Rat Metabolism Study 875.1100

– Dermal outdoor e xposure 875.1200

– Dermal indoor exposure 875.1300

– Inhalation outdoo r expos ure (H S R B costs not included) 875.1400

– Inhalation indoo r expos ure 875.1600

– Application exposure data reporting and calculations 875.1700

– Product use information 875.2300

– Indoor surface residue dissipation 875.2500

– Inhalation exposure 875.2700

– Product use information 875.2800

– Description of human activity

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

– Aerobic Sewage Treatment: A. Activated Sludge Units or (iii) the Porous Pot Test would be anticipated to be required. If the ASRI test EC 50 is greater than 20 mg/L, t hen 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 biodegradability study, then no further testing would be expected to be required. If, however, the antimicrobial fails the ready biodegradability study, then the (i) Biodegradation in Activated Sludge or (ii) Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units,
or (iii) the Porous Pot study would be expected to be required. Results for studies conducted with both the TGAI and the major degradate, pentachlorodimethylsulfone, must be submitted to satisfy this requirement.Docket Number: EPA

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8 of 21 875.2900

– Data reporting and calculations Special Study

– Migration Studies 7

**•** F or more information , please refer to Bis (trichloromethyl) sulfone : Human Health Effects Scoping Document for the Registration Review Decision , located in the docket

. Product Chemistry:

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

**•** F or more information , please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in support of Registration Review of Bis (trichloromethyl) sulfone (BTS) , located in the docket

. Endocrine Disruptor Screening Prog ram As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from expos ure to chemicals

. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring

. For ecological hazard assessments, EPA evaluate s acute tests and chronic studies that assess growth, de velopmental and reproductive effects in different taxonomic groups. As part of its reregistration decision for b is (trichloromethyl) sulfone , EPA reviewed these data and selected the most sensitive en dpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), b is (trichloromethyl) sulfone is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP)

. E

PA 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 chemical substance to interact with the estrog en, 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, i f 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 effec t.

7 Migration of BTS from paper packaging to the food contents is likely to occur; therefore, registrants would be expected to be required to conduct a food migration study. Registrants will be expected to be required to submit a protocol for EPA review prior to initiating the study.Docket Number: EPA

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9 of 21 Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingr edients. bis (trichloromethyl) sulfone 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 issue future EDSP orders/data call

- ins, requiring the submission of EDSP screening assays for bis (trichloromethyl) sulfone

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

. Timeline EPA has created the following estimated timeline for the completion of the bis (trichloromethyl) sulfone 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 201 7 Open Public Comment Period for Preliminary Risk Assessments December 201 8 Close Public Comment Period for Preliminary Risk Assessments January 201 9 Phase 3: Registration Review Decision Open Public Comment Period for Proposed Reg. Review Decision June 201 9 Close Public Comment Period for Proposed Reg. Review Decision August 201 9 Final Decision and Begin Post

- Decision Follow

- up 201 9 Total (years) 8

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 bis (trichloromethyl) sulfone 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 ofDocket Number: EPA

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10 of 21 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: Bis (trichloromethyl) sulfone is not identified as a cause 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 Maximum Daily Loads (TMDL) have been developed for bis (trichloromethyl) sulfone , based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_po llutant_group_id =885&p_pollutant_group_name=PESTICIDES. More information on impaired water bodies and TMDLs can be found at http://www. epa.gov/owow/tmdl/

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

. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Oth er 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 o rder 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, na tional origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to bis (trichloromethyl) sulfone compa re d to the general population. Please comment if you are aware of any sub

- pop ulations 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 the results of such testing (measured data) is a logical, scient ifically rigorous process that identifies the physical, chemical, and environmental fate properties of the pesticide, as well as the dose and endpoints at which an adverse effect can occur in various animal species. Today, there is significant interest in alternative techniques, i.e., techniques other than data generation that could signi ficantly inform the Agency’s decision

- making process

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

- mak ing 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 physical, chemical, and biolo gical properties

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11 of 21 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, generated using validated models, is considered along with information from open literature and studies specifically generate d under Part 161 requirements

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

- of

- the

evidence evaluation

. At this time, EPA believes that for certain endpoints, especially physical/chemical and fate properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements for many antimicrobial pesticide chemicals

. When considering biological properties, at this time, EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of chemicals that e xhibit lower toxicity for human health and/or ecotoxicity parameters

. This is appropriate because the risk assessment for lower toxicity chemicals can be stream

- lined, i.e., a screening

- level assessment procedure rather than multiple tiers of assessments w ith progressively more data requirements. If stakeholders believe that submission of predicted data can fulfill one of the data needs for the bis (trichloromethyl) sulfone 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 validity of the information

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

. Pre

submission consultation with the Agency is encouraged.

Additional Information: Stakeholders are also specifically asked to provide available information and data that will assist the Agency in refining its risk assessments , including any spec ies

- specific ecological effects determinations. The Agency is interested in receiving the following information:
1. Confirmation on the following label information:
a. Sites of application b. For mulations
c. Application methods and equipment d. Maximum application rates
e. Frequency of application, application intervals and maximum number of app lications f. Geographic limitations on use 2. Use or po tential use distribution 3. Use history 4. Usage/use information for non

- agricultural uses (e.g., materials preservation) 5. Typical applicatio n interval 6. State or local use restrictionsDocket Number: EPA

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12 of 21 7. Ecological incidents (non

- target plant damage 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 close s 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 bis (trichloromethyl) sulfone c ase
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13 of 21 II. Fact Sheet Background Information:

**•** Active Ingredient: Bis (trichlorometh yl) sulfone

**•** C ase number: 2055

**•** PC Code: 035601

**•** CAS number : 3064

- 70

- 8

**•** Technical registrant: Verichem, Inc.

**•** First approved for use in a registered product: 1967

**•** There are no tolerances, exemptions from tolerances, or tolerance petitions for BTS. BTS is approved by FDA as an indirect food additive at 21 CFR 176.300 for use as a paper slimicide, at 21 CFR 175.105 to preserve food

- packaging adhesives, and at 21 CFR 176.180 to preserve coatings to be used on paper and paperboard in contact with dry foods.

**•** An timicrobials Division Chemical Review Manager (CRM): Seiichi Murasaki , murasaki.seiichi@epa.gov

**•** Antimicrobials Division Product Manager (PM): Jacqueline Campbell

- McFarlane , campbell

- mcfarlane.jacqueline@epa.gov

**•** Chemical Structure: Use & Usage Information:

**•** Products containing t he organo

- sulfur compound BTS are registered for use to control algae, slime

- forming bacteria, and fungi in industrial process water systems such as pulp and papermill process water systems, recirculating cooling towers, and secondary oil

recovery injection water systems. Additionally, products containing BTS are registered for use as a material preservative in household and construction materials including paints, coatings, and fuels. Recent/Pending Regulatory Actions:

**•** Th e end

- use product 67869

- 32 was registered on April 21, 2011. Ecological Risk Assessment Status:
Please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in support of Registration Review of Bis (trichloromethyl) sulfon e (BTS) , located in the docket, for a detailed discussion of the ecological risk assessments.

**•** Toxicity studies indicate BTS is practically non

- toxic to birds, slightly toxic to small mammals, very highly toxic to freshwater fish, highly toxic to freshwater invertebrates, very highly toxic to marine invertebrates, and highly toxic to marine fish. No algal toxicity data have been submitted.Docket Number: EPA

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14 of 21 **•** Ecological and environmental fate risk assessments were not conducted on the currently registered use patterns. Material preservatives may potentially pass through waste water treatment plants (WWTPs) and be discharged into terrestrial and aquatic environments. The Agency will conduct ecological and environmental fate risk assessments for material preservative uses because of the potential for environmental exposure. To support the planned risk assessments during registration review, the Agency anticipates requiring additional environmental fate and toxicity data.
Human Health Risk Assessment Status: The following are key findings of the recent human health risk assessments for bis (trichloromethyl) sulfone . Please refer to Bis (trichloromethyl) sulfone : Human Health Effects Scoping Document for the Registration Review Decision , located in the docket, for a detailed discussion of the human health risk assessment. Hazard Characterization:

**•** BTS is corrosive to the eyes and strongly irritating to the skin and the lungs (all are Toxicity Category I). Acute oral (Toxicity Category III) and dermal (Toxicity Ca tegory IV) toxicities are low to moderate. BTS was determined not to be a dermal sensitizer.

**•** A carcinogenicity study is expected to be needed due to chronic human exposure to BTS via food and drinking water sources, due to a number of positive mutagenicity studies, and the potential for degradation of BTS to chloroform, a probable human carcinogen. Dietary (Food and Water):

**•** Dietary (food) exposure to BTS could potentially occur since products containing BTS are registered for use to inhibit slime

- forming ba cteria and fungi in paper process water systems when producing paper and paperboard that may be used for food contact. Also, products containing BTS are registered for use to preserve a number of paper

- making chemicals as well as paper and paperboard coati ngs, adhesives, dispersed pigments, etc. The FDA regulates BTS as an indirect food additive at 21 CFR 176.300 for use as a paper slimicide, at 21 CFR 175.105 to preserve food

- packaging adhesives, and at 21 CFR 176.180 to preserve coatings to be used on pap er and paperboard in contact with dry foods. Migration of BTS from paper packaging to the food contents is likely to occur. Therefore, a migration study is expected to be needed as is a dietary (food source) risk assessment.

**•** Drinking water exposure is poss ible since the registered uses of BTS may result in contamination of surface water and possibly ground water as a result of discharges of treated water from industries using this antimicrobial in their water systems or as a material preservative. The need for a dietary drinking water exposure assessment for BTS will be determined upon review of environmental fate data the Agency anticipates requiring. These environmental fate data will be used to determine if BTS can pass through wastewater treatment facili ties into drinking water or migrate into residential groundwater wells as a result of its current use patterns. Therefore, the need for aDocket Number: EPA

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15 of 21 drinking water assessment will be revisited upon submission and review of the environmental fate data anticipated to b e needed.
Residential:

**•** Products containing BTS are registered for use to preserve a number of construction and household materials for use in the home and/or in commercial, institutional, and industrial settings resulting in residential and other non

- occup ational expos ures. O f the preserved materials, paints are expected to result in the highest residential exposure. Both dermal and inhalation expos ures of homeowner handlers and bystanders (including children) are expected. Children may be exposed to BTS th rough post

- app lication exposure as well as incidental oral exposure from playing with toys made of treated plastic. Data are anticipated to be needed for use in estimat ing exposures associated with residential paint use. Aggregate:

**•** In examining aggregate e xposure, EPA takes into account the available and reliable information concerning exposures to pesticide residues in food and drinking water, as well as non

- occupational pesticide exposures. Dietary expos ure may occur based on the registered uses of BTS as a paper chemical preservative and use as a slimicide during the manufacture of paper and paperboard that may contact food. The extent to which r esidues of BTS may reach drinking water will be determined upon review of the anticipated environmental fate da ta. Additionally, exposure of adults and children to BTS in residential and other nonoccupational settings is likely to occur from the use of preserved materials to be represented by preserved paint. Thus, the Agency intends to assess potential aggregate risk from exposures via food, in the home, and possibly via drinking water. Occupational:

**•** The product labels instruct the handler to wear protective eyewear (goggles, face shield, or safety glasses), rubber gloves, and protective clothi ng when BTS products are added to pulp and paper water systems, other industrial water systems, and different materials during the manufacturing process. However, open

- pour loading is permissible in most cases since labels do not indicate the type of loadi ng and mixing equipment to be used (Note: The only exception is Verichem's 20% EP (EPA Reg. No. 67869

- 32), which requires a meter

- pump system or a closed loading/application system be used to load and apply the product to oil recovery drilling muds/packer fluids, commercial/industrial water cooling systems, evaporative condenser water systems, and heat exchanger systems). During open

- pour activities, dermal and inhalation exposure of workers to BTS is expected. Worker inhalation exposure is likely to result from bot h gaseous and aerosolized parent compound due to the relatively high vapor pressure of BTS (1.1 x 10

- 3 mmHg). Detailed product use and human activity information as well as dermal and inhalation exposure studies are anticipated to be needed for us e in determin ing more realistic estimates of occupational exposure.Docket Number: EPA

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16 of 21 Cumulative:

**•** EPA does not have, at this time, available data to determine whether bis (trichloromethyl) sulfone has a common mechanism of toxicity with other substances or how to include th is pesticide in a cumulative risk assessment. For the purposes of this Registration Review, EPA has assumed that bis (trichloromethyl) sulfone does not have a common mechanism of toxicity with other substances when used as an antimicrobial as registered.
I ncidents: Ecological:

**•** No bis (trichloromethyl) sulfone ecological incidents have been repor ted in the Agency’s Ecological Incide nt Infor mation System (EISS)

. Human Health:

**•** No bis (trichloromethyl) sulfone human poisoning incidents have been reported in OPP’s Incident Data System (IDS).
Tolerances and International Harmonization:

**•** There are no tolerances, exemptions from tolerances, or tolerance petitions for BTS. BTS is approved by FDA as an indirect food additive at 21 CFR 176.300 for use as a paper sli micide, at 21 CFR 175.105 to preserve food

- packaging adhesives, and at 21 CFR 176.180 to preserve coatings to be used on paper and paperboard in contact with dry foods.
Data Call

- In Status:

**•** There are no outstanding data call

- in (DCI) requirements for bis ( trichloromethyl) sulfone

. 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 regist ration labels may be obtained from the Pesticide Product Label System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home

. Table 1
. Registered Products

– Bis (trichloromethyl) sulfone Registrat ion # Registration Name Company Name Formulation Type % A.I. 67869

- 14 N

- 1386 Technical Verichem, Inc. Technical Chemical 98
67869

- 15 N

- 1386 Hexylene Glycol Verichem, Inc. Formulation Intermediate 35 67869

- 16 N

- 1386 Naptha Han Verichem, Inc. Ready

- to

- Use Solution 39.2
67869

- 32 N

- 1386 PEG

- EU 20 Verichem, Inc. Emulsifiable Conc. 20Docket Number: EPA

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17 of 21 74655

- 3 Spectrum RX

- 36 Hercules Incorporated Ready

- to

- Use Solution 20
74655

- 6 Spectrum RX

- 38 Hercules Incorporated Ready

- to

- Use Solution 17
74655

- 10 Spectrum RX

- 65 Hercules Incorporated Ready

- to

- Use Solution 18
74655

- 15 Spectrum RX

- 10 Hercules Incorporated Ready

- to

- Use Solution 5.3 1706

- 177 Nalcon® 7642 Nalco Company Ready

- to

- Use Solution 3.33Docket Number: EPA

- HQ

- OPP

- 2011

- 0614 www.regulations.gov

18 of 21 III. Summary of Anticipated Data Requirements

– Bis (trichloromethyl) sulfone

The table below summarizes anticipated data needs for the Bis (trichloromethyl) sulfone Case in Section I of this document (Preliminary Work Plan), Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in support of Registration R eview of Bis (trichloromethyl) sulfone (BTS) , and Bis (trichloromethyl) sulfone : Human Health Effects Scoping Document for the Registration Review Decision

. Table 2. Summary of Anticipated Data Requirements

– Bis (trichloromethyl) sulfone

Guideline Number Anticipated Data Requirement Test Material Es timated Timeframe (Measured in months

from DCI Receipt)

850.1010 Freshwater invertebrate acute toxicity, Daphnia magna TGAI and the major degradate, pentachlorodimethylsulfone 24

850.1035 Estuarine/marine invertebrate acute toxicity TGAI and the major degradate, pentachlorodimethylsulfone 24

850.1055 Embryo larvae study using Mercenaria mercenaria M ajor degradate, pentachlorodimethylsulfone 24

850.1075 Freshwater fish acute toxicity 8 TGAI and the major de gradate, pentachlorodimethylsulfone 24

850.1300 Aquatic invertebrate life

- cycle, freshwater Daphnia magna TGAI and the major degradate, pentachlorodimethylsulfone 24

850.1350 Aquatic invertebrate life

- cycle, saltwater Americamysis bahia Major degradate, pentachlorodimethylsulfone 24

850.1400 Fish early

- life stage toxicity test, freshwater species 9 TGAI and the major degradate, pentachlorodimethylsulfone 24

850.4225 Seedling emergence (Tier II) with rice Major degradate, pentachlorodimethylsulfone 24

850.4400 Aquatic plant toxicity test using Lemna spp. TGAI and the major degradate, pentachlorodimethylsulfone 24

850.5400 Algal Toxicity (Tier II) 10 TGAI and the major degradate, pentachlorodimethylsulfone 24

850.6800 or OECD 209 Activated sludge respira tion inhibition test TGAI and the major degradate, pentachlorodimethylsulfone 24

8 Results for studies conducted with the TGAI for both (i) coldwater and (ii) warmwater species, as well as results for a study with the major degradate, pentachlorodimethylsulfone, and (iii) the most TGAI

- sensitive species, must be submitted to satisfy this requirement. 9 Results for studies conducted using the most TGAI

- sensitive species with both the TGAI and the major degradate, pentachlorodimethylsulfone, must be submitted to satisfy this requirem ent. 10 Results for studies conducted with the TGAI for (i) the freshwater green alga, Selenastrum capricornutum , (ii) the freshwater diatom, Navicula pelliculosa , (iii) the marine diatom, Skeletonema costatum , and (iv) the cyanobacteria species Anabaena fl os
- aquae as well as results for a study with the major degradate, pentachlorodimethylsulfone, and (v) the most TGAI

- sensitive species, must be submitted to satisfy this requirement.Docket Number: EPA

- HQ

- OPP

- 2011

- 0614 www.regulations.gov

19 of 21 835.1110 Activated Sludge Sorption Isotherm 11 TGAI and the major degradate, pentachlorodimethylsulfone 24

835.3110 Ready Biodegradability 11 TGAI and the major degradate, pentachlorodimethylsulfone 24

835.3220 Porous Pot Test 11 TGAI and the major degradate, pentachlorodimethylsulfone 24

835.3240 Simulation Test

– Aerobic Sewage Treatment: A. Activated Sludge Units 11 TGAI and the major degradate, pentachlorodimethylsulfone 24

835.3280 Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 11 TGAI and the major degradate, pentachlorodimethylsulfone 24

870.3465 90

- day inhalation toxicity (rat) TGAI 24

870.3800 Reproduction and fertility effect s (multigeneration)

– rat TGAI 48

870.4100 Chronic oral toxicity

– rat TGAI 48

870.4200 Carcinogenicity (rat and mouse, preferred) TGAI 48

870.7485 Rat Metabolis m Study TGAI 24
875.1100 Dermal outdoor exposure TGAI 24
875.1200 Dermal indoor exposure TGAI 24

875.1300 Inhalation outdoor exposure (H S R B costs not included) TGAI 24

875.1400 Inhalation indoor exposure TGAI 24

875.1600 Application exposure data reporting and calculations TGAI 12

875.1700 Product use information TGAI 12
875.2300 Indoor surface residue dissipation TGAI 24
875.2500 Inhalation exposure TGAI 24
875.2700 Product use information TGAI 12

11 The results of the Activated Sludge Respiration Inhibition Test (ASRI) d etermine which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC50 is less than or equal to 20 mg/L, then either the (i) Biodegradation in Activated Sludge Study or (ii) Simulation Test

– Aerobic Sewage Treatment : A. Activated Sludge Units or (iii) the Porous Pot Test would be anticipated to be required. If the ASRI test EC50 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 Pot Test. If the antimicrobial passes the ready biodegradability study, then no further testing would be expected to be required. If, however, the antimicrobial fails the ready biodegradability study, then the (i) Biodegradation in Activated Sludge or (ii) Simulation Test

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

- HQ

- OPP

- 2011

- 0614 www.regulations.gov

20 of 21 875.2800 Description of human activity TGAI 12
875.2900 Data reporting and calculations TGAI 12 Special Study Migration Studies 12 TGAI 24

12 Migration of BTS from paper packaging to the food contents is likely to occur; therefore, registrants would be expected to be required to conduct a food migration study. Registrants will be expected to be required to submit a protocol for EPA review prior to initiating the stud y.Docket Number: EPA

- HQ

- OPP

- 2011

- 0614 www.regulations.gov

21 of 21 IV. Appendix A : Use Patterns

– Bis (trichloromethyl) sulfone

Treatment Site EPA Reg. no. Method of Application Application Rate/ No. of applications / Use Limitations Industrial Processes and Water Systems: Commercial / Industrial Cooling Water (Recirculating) Water 67869

- 14 Water 67869

- 15 Water 67869

- 16 Industrial Processes and Water Systems: Gas / Oil Recovery Injection Water Systems Water 67869

- 14 Water 67869

- 15 Water 67869

- 16 Industrial Processes and Water Systems: Pulp / Paper Mill Water Systems Water 1706

- 177 Feed 0:25

- 1.5 lbs per ton of total paper (dry basis) production. Water 67869

- 14 Water 67869

- 15 Water 67869

- 16

Water 74655

- 10 Feed INTERMITTENT OR SLUG METHOD: Initial dose

- 0.2

- 3.0 lbs per ton of pulp or paper produced. Subsequent dose

- 0.1

- 2.0 lbs per ton of pulp or paper produced. CONTINUOUS FEED METHOD: Initial dose

- 0.2

- 3.0 LBS per ton of pulp or paper produced. Subseque nt dose

- Maintain continuous feed at rate of 0.2

- 0.75 lbs per ton of pulp or paper produced.

Water 74655

- 15 Feed INTERMITTENT OR SLUG METHOD: Initial dose

- 1.0

- 3.0 lbs per ton of pulp or paper produced. Subsequent dose

- 0.75

- 2.5 lbs per ton of pulp or paper produced. CONTINUOUS FEED METHOD: Initial dose

- 0.75

- 2.5 LBS per ton of pulp or paper produced. Subsequent dose

- Maintain continuous feed at rate of 0.5

- 2.0 lbs per ton of pulp or paper produced.

Water 74655

- 3 Feed INTERMITTENT OR SLUG METHOD: Initial dose

- .2

- 1.0 lbs per ton of pulp or paper produced. Subsequent dose

- 0.1

- 0.75 lbs per ton of pulp or paper produced. CONTINUOUS FEED METHOD: Initial dose

- 0.2

- 1.0 LBS per ton of pulp or paper produced. Sunseque nt dose

- Maintain continuous feed at rate of 0.2

- 0.75 lbs per ton of pulp or paper produced.

Water 74655

- 6 Feed INTERMITTENT OR SLUG METHOD: Initial dose

- 0.1

- 0.5 lbs per ton of pulp or paper produced. Subsequent dose

- 0.1

- 0.3 lbs per ton of p ulp or paper produced. CONTINUOUS FEED METHOD: Initial dose

- 0.2

- 0.75 LBS per ton of pulp or paper produced. Subsequent dose

- Maintain continuous feed at rate of 0.1

- 0.3 lbs per ton of pulp or paper produced. Material Preservatives: Adhesives, Indu strial (Nonfood contact) A dhesives 74655

- 3 Pour Additions should be 200

- 300 ppm Adhesives 67869

- 14 Adhesives 67869

- 15 Adhesives & Latexes 67869

- 16 Material Preservatives: Papermaking (Nonfood contact) pulp, paper mill and the additive system, end (or the preservation of pulp, pigment slurries, 74655

- 3 Pour Additions should be 200

- 300 ppm / Add to the material to be preserved prior to manufacture
Material Preservatives: Specialty Products emulsions, defoamers, polymers 74655

- 3 Pour Additions should be 200

- 300 ppm