Docket Number: EPA-HQ-OPP-2009-0725 www.regulations.gov

United States Chemical Safety June 2010

Environmental Protection and Pollution Prevention Agency (7510P)



# 2-Mercaptobenzothiazole Final Work Plan Registration Review

June 2010Docket Number: EPA-HQ-OPP-2009-0725 www.regulations.gov



### TABLE OF CONTENTS

2-Mercaptobenzothiazole Registration Review Team ................................................... 4

I. INTRODUCTION ..................................................................................................... 5

II. SUMMARY OF COMMENTS RECE IVED ON PRELIMINARY WORK

PLAN .......................................................................................................................... 5

III. RISK ASSESSMENT AND DATA NEEDS ........................................................... 6

IV. TIMELINE .............................................................................................................. 10

V. GLOSSARY of TERMS & ABBREVIATIONS .................................................. 11Docket Number: EPA-HQ-OPP-2009-0725 www.regulations.gov

2-Mercaptobenzothiazole Registration Review Team

Human Health & Environmental Effects

William Hazel

Srinivas Gowda

Risk Management
Eliza Blair
Lance Wormell

Office of General Counsel Philip Ross

1Docket Number: EPA-HQ-OPP-2009-0725 www.regulations.gov

I. INTRODUCTION

This is the Environmental Protection Agency’s (EPA or “the Agency”) Final Work Plan (FWP) for the registration review of 2-Mercaptobenzothiazole (Case 2380). The FWP includes the expected registration review timelin e. The work plan also addresses public comments received con cerning the Preliminary Work Plan in the Summary Document which was posted in th e 2-Mercaptobenzothi azole registration review docket, and any other comments c oncerning the initial docket postings. The Summary Document provided information on what EPA knows about the pesticide and what additional risk analyses and data or in formation 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 year s 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 registrati on 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 th at 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 2-Mercaptobenzothiazole Preliminary Work Plan was entered into the docket for this registration review on December 16, 2009. The 90-day comment period ended on March 16, 2010. The Preliminary Work Plan document is available on www.regulations.gov , docket number EPA-HQ-OPP-2009-0725.

II. SUMMARY OF COMMENTS RE CEIVED ON PRELIMINARY WORK

PLAN

The Agency received one comment fro m R.T. Vanderbilt, Inc. during the comment period on the initial docket as desc ribed below. In addition, the Agency received one comment from the FIFRA Endangered Species Task Force (FESTF). The anticipated data needs, work plan and timeline described in the Preliminary Work Plan remain as they were presented initially. Th is document makes final the work plan for the 2-Mercaptobenzothiazole regi stration review process.

In the Preliminary Work Plan, the Agen cy solicited comments on three specific topics: environmental justice, water body impairment, and trade irritants. No comments or information were received during the comment period concerning these issues.

Comment : The FIFRA Endangered Species Task Force (FESTF) submitted a comment noting that it has data that will assist the Agency in conducting an endangered species risk assessment for 2-Mercaptobenzothiazole, an d requesting that any technical registrant for 2-Mercaptobenzothiazole who is not a member of the FESTF (or a company having met its data compensation obligations) be as ked to provide a formal offer-to-pay to

FESTF for reliance on their data.

2Docket Number: EPA-HQ-OPP-2009-0725 www.regulations.gov

Response : The Agency thanks FESTF for its comment and will consider this information as it conducts the registrati on review and makes its regi stration review decisions.

Comment : R.T. Vanderbilt submitted a document responding to the Guidance for Commenters section of the 2-Mercaptobenzothiazole Preliminary Work Plan (“2- Mercaptobenzothiazole Summary Documen t: Registration Review”, December 2009).

The document confirmed available informati on for each section, including application information, use sites, and trade irritants.

Response: The Agency thanks R.T. Vanderbil t for its comment and will use this information as it conducts the registration review and makes its registration review

decisions.

III. RISK ASSESSMEN T AND DATA NEEDS

2-Mercaptobenzothiazole shares its si ngle product, Vancide 51, with another active ingredient, sodium dimethyldith iocarbamate. Vancide 51 contains 2- Mercaptobenzothiazole at a c oncentration of 2.4%, and sodi um dimethyldithiocarbamate at a concentration of 27.6%. In respon se to the Dimethyldithiocarbamate Salts Reregistration Eligibility Decision (RED) in June 2009, the registrant submitted requests to voluntarily cancel several uses of Va ncide 51. Effective November 12, 2009, upon publication of the final cancellation order fo r this product in the Federal Register, the wood veneer, textile fabric, and alginate past e preservation uses were removed from the Vancide 51 registration. The remaining regi stered uses (materials preservation of metalworking fluids, paper/paperboard products , and starch/casein pa stes and solutions) will be assessed in this registration review.

A pesticide product containing 2-Mercapto benzothiazole was first registered in 1949. A RED was issued for 2-Mercaptobenz othiazole in September 1994. The Agency anticipates needing additional data to complete a risk assessment for Registration

Review.

Human Health Risk

Toxicity

2-Mercaptobenzothiazole is registered for use as a preservative of metalworking fluids, starch/casein pastes and solutions , and paper and paperboard sheet surface treatment. In the 1994 RED, dermal risks we re well below the Agency’s level of concern for occupational handlers. However, a 90-da y inhalation toxicity study is needed to elucidate potential systemic a dverse effects that may result from this route of exposure due to aerosolization from metalworking flui ds and open-pour addition of preservatives in a manufacturing setting.

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Dietary and Drinking Water Exposure

All registered use sites for 2-Mercap tobenzothiazole are indoors. Dietary exposure via drinking water is possible in th e event a discharge of contaminated waste water occurs from a facility manufacturing starch or casein suspensions or pastes or from metalworking facilities. In such cases , 2-Mercaptobenzothiazole may pass through

wastewater treatment facilities and into drinki ng water. The potential for this to occur and the extent needs to be assessed and will be based on physicochemical properties and

environmental fate studies now available or an ticipated to be needed in association with the subject Registration Review.

The currently-registered use of the 2.4% SC /L as a surface treatment of paper and paperboard sheeting is not expected to re sult in dietary exposure because the label prohibits use for food packaging purposes.

Occupational and Residential Exposure

2-Mercaptobenzothiazole is registered fo r use as a preservative of metalworking fluids, starch/casein pastes and solutions , and paper and paperboard sheet surface treatment. An occupational handler risk assessment was conducted in 1994 for the 2- Mercaptobenzothiazole RED. Application methods such as open pouring of the liquid concentrate and open pouring of the powder into adhesives, paints, and other industrial products present the potential for dermal and inhalation exposure to applicators. While a dermal toxicity study was performed for the RED, and inhalation toxicity study has not been performed. A 90-day inhalation toxicity study is anticipated as being needed to elucidate potential systemic adverse effects that may result from the inhalation occupational route of exposure due to aeros olization from metalworking fluids and openpour addition of preservatives in a manufacturing setting.

It is also anticipated that exposure studies to measure inhalation and dermal exposures to occupational handlers will be requir ed that address: (i) metalworkers using treated metalworking fluids; (ii) open-pouring into starch and casein pastes and solutions in the factory; and (iii) paper and paperboa rd sheet surface treatmen t. Each of these

scenarios will need to be assessed to estimate the concomitant risks to workers.

Anticipated Human Health Data Needs

Human Health Toxicity:

o (GLN 870.3465) 90-Day Inha lation Toxicity (Rat)

Occupational and Residential Exposure:

o ((GLN 875.2700) Product Use Information – Indoor

o (GLN 875.2800) Descriptions of Human Activity

o (GLN 875.1200) Indoor Dermal Exposure

o (GLN 875.1400) Indoor I nhalation Exposure

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o (GLN 875.1600) Applicator Exposure Monitoring Data Reporting for

Dermal and Inhalation Data

o (GLN 875.2900) Data Reporti ng and Calculations

Further information is available in “Summary of Human Health Effects Data for the 2-Mercaptobenzothiazole Registration Re view Decision Document,” dated December 7, 2009.

Anticipated Physical/ Chemic al Property Data Needs

All product chemistry data requirements have been fulfilled for the active ingredient 2-Mercaptobenzothi azole. Therefore, the Agency does not anticipate needing additional product chemistry data at this time.

Further information is available in “Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data fo r the 2-Mercaptobenzothiazole Registration Review Summary Document”, dated December 7, 2009.

Environmental Fate

No studies have been submitted regarding the environmental fate of 2- mercaptobenzothiazole, and none have been reviewed. The Agency has not conducted an environmental fate assessment for 2-mercaptobe nzothiazole use patterns described in this document. The Agency needs to conduct an environmental fate assessment for material preservatives that potentially pass through waste water treatment plants (WWTPs) and may be discharged into terrestrial and aqua tic environments. For this assessment, the Agency anticipates needing those data outlined below.

Ecological Risk

No risk assessment was performed for 2-me rcaptobenzothiazole. The Agency has since reviewed four ecotoxicology studies for 2-mercaptobenzothiazole. The four studies submitted on the 98.22 - 100% active ingredient were all found to be acceptable for use in a hazard assessment. An ecological assessment will be needed for materials preservatives uses and paper mill discharges that potentially pass through waste water treatment plants (WWTPs) and may be discharged into terrestrial and aquatic environments. One additional ecotoxicity st udy is needed to conduc t this assessment.

Anticipated Environmental Fate and Ecological Data Needs for 2- mercaptobenzothiazole

The Agency anticipates needing the followi ng data in order to conduct a complete environmental fate and ecotoxicity asse ssment, including an endangered species

assessment for all uses:

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Environmental Fate Risk Assessment Data Needs :

o (GLN 835.2120) Hydrolysis

o (GLN 835.2240) Photodeg radation in Water

o (GLN 850.6800) Modified Activated Sludge Respiration Inhibition

o (GLN 835.1110) Activated Sludge Sorption Isotherm

o (GLN 835.3110) Ready Biodegradability

Ecological Risk Assessment Data Needs :

o (GLN 850.5400) Algal Toxicity (Tier II) using freshwater green alga, Selenastrum capricornutum.

Further information is available in “Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data fo r the 2-Mercaptobenzothiazole Registration Review Summary Document”, dated December 7, 2009.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p) , EPA has developed the Endocrine Disruptor Screening Program (EDSP) to dete rmine whether certain substances (including pesticide active and other ingred ients) may have an effect in humans or wildlife similar to an effect produced by a “natur ally occurring estrogen, or othe r such endocrine effects as the Administrator may designate.” The ED SP 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 substa nce 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 inte ract with E, A, or T hormonal systems will proceed to the next stage of the EDSP wher e EPA will determine which, if any, of the Tier 2 tests are necessary based on the avai lable data. Tier 2 te sting is designed to identify any adverse endocrine related eff ects caused by the substance, and establish a dose-response relationship between th e dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which c ontains 58 pesticide ac tive ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and wa ter, residential activity, and certain postapplication agricultural s cenarios. This list should not be construed as a list of known or likely endocrine disruptors.

2-Mercaptobenzothiazole is not amo ng the group of 58 pesticide active ingredients on the initi al list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemi cals. Accordingly, EPA anticipates issuing

future EDSP test orders/data call-ins for all pesticide active ingredients.

6Docket Number: EPA-HQ-OPP-2009-0725 www.regulations.gov

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our

website: http://www.epa.gov/endo/

.

IV. TIMELINE

EPA has created the following estimated timeline for the completion of the 2- Mercaptobenzothiazole registration review.



### Registration Review for 2-Mercaptobenzothiazole Projected Registration Review Timeline

Activities Time

Opening Docket
Open Docket Completed December 2009

Close Public Comment Period Completed March 2010
Case Development

Final Work Plan Completed June 2010

Issue DCI June 2011

Data Submission June 2012
Preliminary Risk Assessment June 2014

Close Public Comment Period September 2014

Registration Review Decision
Proposed Registration Review Decision December 2014

Public Comment Period March 2015 Final Registration Review Decision & Begin Post-Decision Follow-up 2015 Total (years) 5

Next Steps:

A Data Call-In (DCI) will be developed regarding the data gaps listed under the

“Risk Assessment and Data Needs” section. Also, human health and ecological risk

assessments will be conducted for all uses.

7Docket Number: EPA-HQ-OPP-2009-0725 www.regulations.gov

V. GLOSSARY of TERMS & ABBREVIATIONS

ai Active Ingredient AR Anticipated Residue ASTM American Society for Testing and Materials

AWPA American Wood Preserver’s Association

CFR Code of Federal Regulations cPAD Chronic Population Adjusted Dose

CSF Confidential Statement of Formula CSFII USDA Continuing Surveys for Food Intake by Individuals

DCI Data Call-In DEEM Dietary Exposure Evaluation Model DFR Dislodgeable Foliar Residue DNT Developmental Neurotoxicity DWLOC Drinking Water Level of Comparison

EC Emulsifiable Concentrate Formulation EDWC Estimated Drinking Water Concentration

EEC Estimated Environmental Concentration EPA Environmental Protection Agency

EUP End-Use Product FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug, and Cosmetic Act FQPA Food Quality Protection Act FOB Functional Observation Battery GENEEC Tier I Surface Water Computer Model

IR Index Reservoir

LC 50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD 50 Median Lethal Dose. A statistically deri ved single dose that can be expected to

cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.

LOC Level of Concern

LOAEL Lowest Observed Adverse Effect Level μg/g Micrograms Per Gram μg/L Micrograms Per Liter mg/kg/day Milligram Per Kilogram Per Day mg/L Milligrams Per Liter MOE Margin of Exposure

MRID Master Record Identifi cation (number). EPA's system of recording and tracking

submitted studies. MUP Manufacturing-Use Product

NA Not Applicable NAWQA USGS National Ambient Water Quality Assessment NPDES National Pollutant Discharge Elimination System

NR Not Required

NOAEL No Observed Adverse Effect Level

OPP EPA Office of Pesticide Programs OPPTS EPA Office of Prevention, Pesticides and Toxic Substances PAD Population Adjusted Dose PAIRA Pure Active Ingredient Radiolabelled PCA Percent Crop Area

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9 PDP USDA Pesticide Data Program PHED Pesticide Handler's Exposure Data

PHI Preharvest Interval ppb Parts Per Billion

PPE Personal Protective Equipment

ppm Parts Per Million PRZM/EXAMS Tier II Surface Water Computer Model Q 1 * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer

Risk Model RAC Raw Agriculture Commodity RASSB Risk Assessment and Science Support Branch RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose RQ Risk Quotient SCI-GROW Tier I Ground Water Computer Model

SAP Science Advisory Panel SF Safety Factor

SLN Special Local Need (Registrati ons Under Section 24©) of FIFRA) TGAI Technical Grade Active Ingredient

TEP Typical End-Use Product USDA United States Department of Agriculture UF Uncertainty Factor

WPS Worker Protection Standard