United States Chemical Safety December 2011

Environmental Protection and Pollution Prevention

Agency (7510P)

Bis (trichloromethyl) sulfone

Summary Document:

Registration Review: Initial Docket

December 2011
Docket Number: EPA-HQ-OPP-2011-0614 

www.reguiations.gov 

Bis (trichloromethyl) sulfone 

Summary Document 

Registration Review: Initial Docket 

December 2011 

Case # 2055 

20f21 
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TABLE OF CONTENTS

Bis (trichloromethyl) sulfone Registration Review Team...................................................4

I. Preliminary Work Plan .....................................................................................................5

II. Fact Sheet ......................................................................................................................13

III. Summary of Anticipated Data Requirements ..............................................................18

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 Effects 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-HQ-OPP-2011-0614 located on the internet at

www.regulations.gov.
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Bis (trichloromethyl) sulfone Registration Review Team

Human Health & Environmental Effects

William Hazel

Srinivas Gowda

Risk Management

Seiichi Murasaki

Lance Wormell

Office of General Counsel

Philip Ross
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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 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. 

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 registered 

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 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 Bis (trichloromethyl) sulfone Case.

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 products

registered with EPA. Products containing the 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 oilrecovery 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. 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) for 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-HQ-OPP-2011-0614. Below is a summary of the issues 

relevant to this registration review case.
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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

(trichloromethyl) 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 designated 

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 in the registration review of bis (trichloromethyl) sulfone.

850.1010 – Freshwater invertebrate acute toxicity, Daphnia magna1

850.1035 – Estuarine/marine invertebrate acute toxicity1

850.1055 – Embryo larvae study using Mercenaria mercenaria 2

850.1075 – Freshwater fish acute toxicity3

850.1300 – Aquatic invertebrate life-cycle, freshwater Daphnia magna1

850.1350 – Aquatic invertebrate life-cycle, saltwater Americamysis bahia2

850.1400 – Fish early-life stage toxicity test, freshwater species 4

850.4225 – Seedling emergence (Tier II) with rice2

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 – Activated sludge respiration inhibition test2

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 with 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, Navicula 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.
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• 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 Isotherm6

835.3110 – Ready Biodegradability6

835.3220 – Porous Pot Test6

835.3240 – Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units6

835.3280 – Simulation Tests to Assess the Biodegradability of Chemicals Discharged 

to Wastewater6

• For 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 (trichloromethyl) 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 exposure

875.1200 – Dermal indoor exposure

875.1300 – Inhalation outdoo r expos ure (HSRB 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 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. Results for studies conducted with both the TGAI 

and the major degradate, pentachlorodimethylsulfone, must be submitted to satisfy this requirement.
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875.2900 – Data reporting and calculations

Special Study – Migration Studies7

• For 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 registration review case at this time.

• For 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 evaluates acute tests and 

chronic studies that assess growth, de velopmental and reproductive effects in different 

taxonomic groups. As part of its reregistration decision for bis (trichloromethyl) sulfone, 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), bis 

(trichloromethyl) sulfone is subject to the endocrine screening part of the Endocrine Disruptor 

Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect.

 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.
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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 ingredients. 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 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/.

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 2017

Open Public Comment Period for Preliminary Risk Assessments December 2018

Close Public Comment Period for Preliminary Risk Assessments January 2019

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision June 2019

Close Public Comment Period for Proposed Reg. Review Decision August 2019

Final Decision and Begin Post-Decision Follow-up 2019

Total (years) 8

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 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 of 
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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 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 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 red 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, 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 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-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 physical, chemical, and biological properties. 
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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 generated under 

Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence 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 exhibit 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 with progressively 

more data requirements.

If stakeholders believe that submission of predicted data can fulfill one of the data needs for the 

bis (trichloromethyl) sulfone case, 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 the Agency. Presubmission 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 species-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 application interval

6. State or local use restrictions
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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 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 bis

(trichloromethyl) sulfone case. 
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II. Fact Sheet

Background Information:

• Active Ingredient: Bis (trichloromethyl) sulfone

• Case 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.

• Antimicrobials 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 the 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 oilrecovery 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:

• The 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) sulfone (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.
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• 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 Category 

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 bacteria 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 coatings, 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 paper 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 possible 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 facilities into drinking water or migrate into residential 

groundwater wells as a result of its current use patterns. Therefore, the need for a 
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drinking water assessment will be revisited upon submission and review of the 

environmental fate data anticipated to be 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-occupational 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 through 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 estimating exposures associated with 

residential paint use.

Aggregate:

• 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 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 residues 

of BTS may reach drinking water will be determined upon review of the anticipated 

environmental fate data. 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 clothing 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 loading 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 use in determining more 

realistic estimates of occupational exposure.
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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 this 

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.

Incidents:

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 

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.

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 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 – Bis (trichloromethyl) sulfone

Registration # 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. 20
Docket Number: EPA-HQ-OPP-2011-0614

www.regulations.gov

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 3.33
Docket Number: EPA-HQ-OPP-2011-0614

www.regulations.gov

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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 Review 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

Major degradate, 

pentachlorodimethylsulfone 24

850.1075 Freshwater fish acute toxicity8 TGAI and the major degradate, 

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 species9

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 respiration 

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 requirement.

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 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-HQ-OPP-2011-0614

www.regulations.gov

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835.1110 Activated Sludge Sorption 

Isotherm11

TGAI and the major degradate, 

pentachlorodimethylsulfone 24

835.3110 Ready Biodegradability11 TGAI and the major degradate, 

pentachlorodimethylsulfone 24

835.3220 Porous Pot Test11 TGAI and the major degradate, 

pentachlorodimethylsulfone 24

835.3240

Simulation Test – Aerobic Sewage 

Treatment: A. Activated Sludge 

Units11

TGAI and the major degradate, 

pentachlorodimethylsulfone 24

835.3280

Simulation Tests to Assess the 

Biodegradability of Chemicals 

Discharged to Wastewater11

TGAI and the major degradate, 

pentachlorodimethylsulfone 24

870.3465 90-day inhalation toxicity (rat) TGAI 24

870.3800 Reproduction and fertility effects 

(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 

(HSRB 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) determine 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

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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 study.
Docket Number: EPA-HQ-OPP-2011-0614

www.regulations.gov

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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. Subsequent 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. Sunsequent 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 pulp 

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, Industrial (Nonfood contact)

Adhesives 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