United States Chemical Safety June 2012 

Environmental Protection and Pollution Prevention 

Agency (7510P) 

 

Bis (trichloromethyl) sulfone 

Registration Review: 

Final Work Plan 

June 2012 

 

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

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 

________________________________________ 

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

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Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the 

Agency”) for the registration review of Bis (trichloromethyl) sulfone (Case 2055). The work plan 

includes the expected registration review timeline. The work plan also addresses public 

comments received concerning the Preliminary Work Plan (PWP) in the Summary Document 

which was posted in the Bis (trichloromethyl) sulfone registration review docket, and any other 

comments concerning the initial docket postings. The Summary Document provided information 

on what EPA knows about the pesticide and what additional risk analyses and data or 

information the Agency believes are needed to make a registration review decision. 

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

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 that 

statutory standard. The public phase of registration review begins when the initial docket is 

opened for each case. Information on this program is provided at: 

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

The Bis (trichloromethyl) sulfone Preliminary Work Plan (PWP) (PC Code 035601) was 

published on December 21, 2011 and the 60-day comment period ended on February 21, 2012. 

The Preliminary Work Plan document is available on www.regulations.gov docket number EPAHQ-OPP-2011-0614. 

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 

containing BTS as an active ingredient registered with EPA. Products containing the organosulfur 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. 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. 

Comments Received on the Preliminary Work Plan

The Agency received one comment during the public comment period on the initial docket, 

described below. In the PWP, the Agency solicited comments on specific topics: environmental 
Docket Number: EPA-HQ-OPP-2011-0614 

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justice, water body impairment, trade irritants, and structure activity relationships. No comments 

or information were received during the public comment period concerning these issues. 

Comment: We wish to comment on the multigeneration reproduction and fertility effects 

requirement (870.3800). PCRM found a study that analyzed the effects of BTS and its 

reversibility in male rats. 

Xu Y et al. 1998. Studies on the antifertility effect of bis-trichloromethyl sulfone 

and its reversibility in male rats. Yao Xue Xue Bao 33(1):1-4. 

While we recognize that this study is sex specific we urge the Agency to review this 

study. If it provides no additional information to aid in the risk assessment process then 

we suggest the registrant use the [Organisation for Economic Cooperation and 

Development (OECD) Technical Guidance] 443 Extended One-Generation Reproductive 

Toxicity Study (EOGRTS) instead of the EPA guideline. This will allow the registrants to 

conduct one extended study saving many animals lives while gaining the same results. 

The TG is currently available on the OCED web site. 

Response: The Agency encourages the registrants to submit relevant studies and 

applicable waivers in response to the data call-in associated with this registration review. 

At that time, the Agency will review the information to determine if the reproductive 

toxicity data requirement is adequately met or can be waived. 

The Agency agrees with PCRM that an extended one-generation reproductive and 

fertility effects study will provide the Agency with sufficient information to support the 

human health risk assessment planned for the BTS registration review. The Agency will 

accept a multigeneration or an extended one-generation reproductive and fertility effects 

study. 

The comment received during the initial public comment period did not affect the data needs, 

work plan and timeline described in the PWP and they remain as they were presented initially in 

the PWP. Further, this document makes final the work plan for the Bis (trichloromethyl) sulfone 

registration review process. 

Risk Assessments and Anticipated Data Needs

The Agency will conduct a comprehensive ecological risk assessment, including an endangered 

species risk assessment, for all uses of bis (trichloromethyl) sulfone. The Agency will conduct a 

human health risk assessment. The Agency expects to require additional data for use in 

conducting the registration review for bis (trichloromethyl) sulfone. 

Ecological Risk Assessment Status and Anticipated Data Needs 

• The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for bis (trichloromethyl) sulfone. 

• The Agency anticipates the need to require the following additional ecological data for use in 

conducting the registration review of bis (trichloromethyl) sulfone. 
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850.1010 – Freshwater invertebrate acute toxicity, Daphnia magna1

850.1035 – Estuarine/marine invertebrate acute toxicity1

850.1055 – Embryo larvae study using Mercenaria mercenaria2

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 species4

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

850.6800 or OECD 209 – Activated sludge respiration inhibition test2

• The Agency anticipates the need to require the following additional environmental fate data 

for use in conducting 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. 

 

1

 Results for studies conducted with both the TGAI and the major degradate, pentachlorodimethylsulfone, must be 

submitted to satisfy this requirement. 

2

 Results for a 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. 

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

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Human Health Risk Assessment Status and Anticipated Data Needs 

• The most recent human health risk assessments for bis (trichloromethyl) sulfone were 

completed in 1995, in support of the RED. 

Dietary Assessment

• 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. 

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. 

Occupational and Residential Assessment and Risk

• 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 both 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. 

• 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 exposures. Of the preserved 

materials, paints are expected to result in the highest residential exposure. Both dermal and 

inhalation exposures of homeowner handlers and bystanders (including children) are 
Docket Number: EPA-HQ-OPP-2011-0614 

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expected. Children may be exposed to BTS through post-application 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 and Cumulative Exposure and Risk

• 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 exposure 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. 

• 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. 

Human Health Anticipated Data Needs

• The Agency anticipates the need to require the following additional human health data for 

use in conducting 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 outdoor exposure (HSRB costs not included) 

875.1400 – Inhalation indoor exposure 

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 

875.2900 – Data reporting and calculations 
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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 Anticipated Data Needs

• The Agency does not anticipate the need to require additional product chemistry data for the 

registration review 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. 

Incidents:

Ecological: 

• No bis (trichloromethyl) sulfone ecological incidents have been reported in the Agency’s 

Ecological Incident Information System (EISS). 

Human Health: 

• No bis (trichloromethyl) sulfone human poisoning incidents have been reported in OPP’s 

Incident Data System (IDS). 

Endangered Species 

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. 

Endocrine Disruptor Screening Program 

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

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

 

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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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, developmental 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. 

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 Completed 

December 2011

Close Public Comment Period for Docket Completed 

February 2012 

Phase 2: Case Development 

Develop Final Work Plan (FWP) Completed 

June 2012 
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Issue DCI June 2013 

Data Submission June 2015 

Open Public Comment Period for Preliminary Risk Assessments December 2016 

Close Public Comment Period for Preliminary Risk Assessments January 2017 

Phase 3: Registration Review Decision 

Open Public Comment Period for Proposed Reg. Review Decision June 2017 

Close Public Comment Period for Proposed Reg. Review Decision August 2017 

Final Decision and Begin Post-Decision Follow-up December 2017 

Total (years) 6 

Next Steps

A DCI will be developed regarding the data needs listed under the “Risk Assessments and 

Anticipated Data Needs” section of this document. The Agency expects to issue the DCI in June 

2013. Human health and environmental fate and ecological hazard assessments will be 

conducted for all uses. 

 
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Summary of Anticipated Data Requirements – bis (trichloromethyl) sulfone 

The table below summarizes anticipated data needs for the Bis (trichloromethyl) sulfone Case in 

this document (Final Work Plan), Product Chemistry, Environmental Fate, and Ecological 

Effects Scoping Document in support of Registration Review of Bis(trichloromethyl)sulfone, and

Bis(trichloromethyl)sulfone: Human Health Effects Scoping Document for the Registration 

Review Decision.

Guideline 

Number Anticipated Data Requirement Test Material 

Estimated 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 

835.1110 Activated Sludge Sorption TGAI and the major degradate, 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. 
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Isotherm11 pentachlorodimethylsulfone 

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 Metabolism 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. 
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875.2800 Description of human activity TGAI 12 

875.2900 Data reporting and calculations TGAI 12 

Special 

Study Migration Studies12 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.