Docket Number: EPA–HQ–OPP–2010–0241 www.regulations.gov

United States Chemical Safety and June 2010

Environmental Protection Pollution Prevention Agency (7510P)



## Busan 74 Summary Document: Registration ReviewDocket Number: EPA–HQ–OPP–2010–0241 www.regulations.gov



### TABLE OF CONTENTS

Busan 74 Registration Review Team Members........................................... 1 I. Preliminary Work Plan..................................................................... 2

II. Fact Sheet.................................................................................... 10 III. Glossary of Terms and Abbreviations................................................ 13 IV. Appendix A................................................................................. 15Docket Number: EPA–HQ–OPP–2010–0004 www.regulations.gov

Busan 74 Registration Review Team

Human Health & Environmental Effects Timothy Dole

Srinivas Gowda

Risk Management

K. Avivah Jakob Rebecca von dem Hagen

Lance Wormell

Office of General Counsel Philip Ross

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I. PRELIM INARY WORK PLAN – 

### Busan 74

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a re gistration review program. All pesticides distributed or sold in the United States generally must be registered by the U.S. Environmental Protec tion 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 di rected on product labe ling. 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 pestic ide use practices will occur over time. Through the registration review program, the Agency periodically r eevaluates 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/oppsrr d1/registration_review/

.

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and R odenticide Act (FIFRA) and will review each registered pesticide every 15 years to determ ine whether it continues to meet the FIFRA standard for registration. The Agency will c onsider benefits information and data as required by FIFRA. The public phase of regi stration 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 registrati on review decision. After reviewing and responding to comments and data received in the docket during th is initial comment period, the Agency will develop and commit to a final work plan and schedule for the registration review of Busan 74.

The chemical name for the active ingredient in this registration review case is 2- hydroxypropyl methanethiolsulfonate (HPMTS). Busan 74 is a trade name that refers to a product, which is no longer registered, that contained HPMTS as an active ingredient. Although the name for this registration review case is Busan 74, hence forward this case will be referred to by its chemical na me, 2-hydroxypropyl- methanethiolsulfonate (HPMTS).

HPMTS was first registered in the Unite d States in 1968. There are currently no registered end-use products for HPMTS. There is one registered product (EPA Reg. No.1448-31) that contains HPMTS as the activ e ingredient (ai). This product is a manufacturing use product (MP) for formula ting use only. A Reregistration Eligibility Decision (RED) for HPMTS was issued in 1995. The RED can be located at: http://www.epa.gov/pesticides/reregistration/status.htm . At the time the HPMTS Reregistration Eligibility Decision (RED) was written, there was one registrant and nine registered products. The end-use products (EP) existing at the time of the RED were registered for use as materials preservatives (industrial coatings, paints, emulsions, wet2Docket Number: EPA–HQ–OPP–2010–0241 www.regulations.gov

end additives) and for treatm ent of industr ial cooling water systems and pulp and paper mill water systems. Although these uses were found to be eligible for reregistration, all of the end-use products were voluntarily cancell ed after the RED was issued. As a result of these product cancellations, there are no remaining registered end-uses or end-use products containing HPMTS.

Risk Assessment Status & Anticipa ted Risk Assessmen t and Data Needs

Human Health Risk Assessment Status

There are no registered end-us es or end-use products for HPMTS. The one registered manufacturing use product does not contain any information on application rates or use directions. Human exposures th at occur during the formulati on of a pesticide product are regulated by the Occupational Safety and Health Administration (OSHA) and are not under the jurisdiction of the EPA. Therefor e, because the EPA does not asses exposures that may occur during the form ulation of a pesticide product and there are no registered HPMTS end-uses or end-use products that would result in human exposure, human exposure assessments are not anticipated as bei ng needed to ensure th at this registration

review case meets the FIFRA and FFDCA st andards. For further information see “Summary of Human Health Effects Data for the HPMTS Registration Review,” dated May 26, 2010.

Tolerances

There are no tolerances or exceptions from the need to establish tolerances for

HPMTS.

Aggregate and Cumulative Exposure and Risk

In examining aggregate exposure, EPA take s into account the available and reliable information concerning exposures to pesticid e residues in food and drinking water, as well as non-occupational pesticide exposures. An aggregate risk assessment is not needed for HPMTS because there are no register ed end-uses or end-use products that will result in residential exposure.

Section 408(b)(2)(D)(v) of FFDCA require s that, when considering whether to establish, modify, or revoke a tolerance, th e Agency consider “available information” concerning the cumulative effects of a part icular pesticide's residues and “other

substances that have a common mechanism of toxicity.” EPA has not yet determined

whether HPMTS has a common mechanism with other compounds; consequently, a cumulative assessment is not anticipated at this time.

Anticipated Human Health Data Needs

As previously mentioned, there are no re gistered end-uses and end-use products for HPMTS and the registered manufacturing use product is for formulating use only. Because there are no registered end-uses th at would result in dietary, drinking water,

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residential or occupational exposure to HP MTS, hum an exposure and risk assessments are not needed in support of this registration review.

However, the Agency anticipates that an acute inhalation toxicity study (GLN 870.1300) will be needed to fulfill standard acute toxicology data requirements as outlined in 40 CFR 161.340. Based upon 40 CFR 161.340 Toxicology Data Requirements, a standard battery of acute toxi city and mutagenicity tests are required for all antimicrobial pesticides regardless of use pattern. The requirement for an acute inhalation toxicity study wa s waived in support of the HPMTS RED because it was

believed that the uses that existed at that time would not result in the generation of respirable particles. However, this rationale is no longer considered to be valid because non-respirable particles and aerosols can have portal of entr y and respiratory tract effects. This is particularly true fo r HPMTS, which caused corrosive effects in the 14- and 90-day

dermal studies.

The Agency anticipates that the following t oxicity data will be needed to support the HPMTS manufacturing use product registration.

Anticipated Toxicity Data Needs

 (GLN 870.1300) Acute Inhalation Toxicity

It should be noted that the Agency likel y would not anticipate needing an acute inhalation toxicity study at this time if the registration were amended to add the following label restriction to the manufacturing use product registration label for EPA Reg. No. 1448-31: “This product may not be sold, distribute d, or used.” If this language is added to the label the product may not be sold, dist ributed, or used until (1) the label for this product is amended to add specific use patterns , (2) an end-use regist ration application is submitted for each use pattern listed on the manufacturing use label, (3) all data necessary to support the application are s ubmitted, reviewed and found acceptable and (4) the end-use product is registered for th e proposed uses. Should the registrant voluntarily amend its product registration a nd label with this language and then subsequently submit a registration amendment to remove that language from the label, an acute inhalation study and any other data that the Agency determined were necessary to support the product registration at th at time would be needed.

If in the future a registrant were to apply for a new HPMTS product registration, the necessary risk assessments would be conducted by the Agency at that time to assess possible exposure and risk resul ting from the proposed new use(s).

Anticipated Physical/Chemical Property Data Needs

All product chemistry data requirements have been fulfilled for HPMTS. Therefore, it is anticipated that additiona l product chemistry data will not be needed for HPMTS.

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Environmental Fate an d Ecologi cal Risk Assessment Status

There are no registered end- uses or end-use products for HPMTS. The registered manufacturing use product is for form ulating use only and will not result in environmental exposure. Because there are no registered uses that would result in environmental exposure to HPMTS, environmen tal fate and ecological risk assessments

are not needed at this time to ensure that this registration review case meets the FIFRA

and FFDCA standards. For further inform ation see “Summary of Product Chemistry, Environmental Fate, and Ecot oxicity Data for the HPMTS Registration Review Decision Document,” dated May 19, 2010.

Anticipated Environmental Fate and Ecological Data Needs

As previously mentioned, there are no regi stered end-uses or end-use products for HPMTS. The registered manufacturing use product is for formulating use only and will not result in environmental exposure. Because there are no registered uses that would result in environmental exposure to HPMTS, environmental fate and ecological risk

assessments are not needed in s upport of this regi stration review.

Endangered Species

Labels may be categorized into two types: labels for manufacturing uses and label for end-use products. Manufacturing use products are not used directly in the environment, but instead, are used to make formulated or end-use products. End-use products are used to control a pest and carry label instructions that indicate how the product may legally be used. There are currently no registered end-use products for HPMTS; the only registration is for the manufact uring use product. There is no environmental exposure anticipated and the Agency has determined the registration of the manufacturing use product will have "no effect" (NE) on endangere d or threatened terr estrial or aquatic species, or their designated critical habitats , as listed by the U. S. Fish and Wildlife Service (USFWS) and the National Oceanic and Atmospheric Admi nistration (NOAA). Therefore, no additional environmental risk a ssessment is anticipated to be undertaken. However, the EPA will review any comments made by the public on this document and will conduct an environmental risk assessment, if new information warrants such action. If such a decision is made, the environmental risk assessment will conclude that the registered pesticide's use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or thei r 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 Service (the Services), as appropriate.

Incidents

Federal law requires registrants of pesticides to inform EPA about any harmful effects of their products. No HPMTS incidents have been reported in the OPP Incident Data System (IDS).

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Timeline

The EPA has created the following estimated timeline for the completion of the HPMTS registration review case. The Agency anticipates requiring additional data for this registration review case.

Anticipated Schedule
Registration Review for HPMTS Projected Registration Review Timeline

Activities Time Opening Docket Open Public Comment Period for HPMTS Docket June 2010

Close Public Comment Period August 2010 Case Development Develop Final Work Plan (FWP) December 2010

Issue Final DCI December 2011

Data Submission December 2012 Registration Review Decision Open Public Comment Period for Proposed RR Decision May 2013

Close Public Comment Period August 2013

Final Decision 2013 Total (years) 4 years

Guidance for Commenters

The public is invited to comment on the Ag ency’s preliminary registration review work plan and rationale. The Agency will consider all comments as well as any

additional information or data provided in a timely manner pr ior to issuing a final work plan (FWP) for the HPMTS case.

Trade Irritants

Through the registration review process, th e 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 Maximum Residue Li mits (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.

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Water Quality

HPMTS is not identified as a cause of im pair ment 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/attain s_nation_cy.cause_detail_303d? p_cause_grou p_id=885 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for HPMTS, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tm dl_pollutant _detail?p_pollutant_gr oup_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 Im paired Water Body and Other Water Quality Data in OPP’s Registration Review Risk A ssessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice

The EPA seeks to achieve environmental just ice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcemen t 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 factor s, may have atypical, unusually high exposure to HPMTS, compared to the general populati on. Please comment if you are aware of any sub-populations that may have atypical, unusua lly high exposure compared to the general population.

Structure Activity Relationships

EPA m ust rely upon information of appropr iate 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 appli cant’s submission of a

set of studies conducted with th e 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 environmen tal 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 altern ative techniques, i.e., techniques other than data generation that could significantly info rm the Agency’s decision-making process. Recently, OPP has made increasing use of struct ure activity relationshi p (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 ma ke predictive judgments about a chemical’s

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physical, chem ical, and biological properties. 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 re ferred to as QSAR. To develop a QSAR, a selected set of measured data on a single phys ical, chemical, or bi ological property is used to derive a model (an equation) to predict the value of that property.

Since SAR assessments and QSAR modeli ng 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 appro ach to an approach in which the use of predicted data, generated using validated models, is cons idered along with information from open literature and studies specifi cally generated under Part 161 requirements. All relevant information would be considered as part of a weight-of-the-evidence evaluation.

At this time, EPA believes that for cert ain 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 c onsidering biological properties, at this time, EPA believes that SAR and QSAR can be most effectively

utilized in the evaluation of ch emicals that exhibit lower toxi city 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 screen ing-level assessment pr ocedure rather than multiple tiers of assessments with pr ogressively more data requirements.

If stakeholders believe that submission of da ta may affect this registration review case for HPMTS, then the Agency invites submission of this information. The submitter would be expected to supply a rationale desc ribing the utility of the information and provide documentation on the scie ntific validity of the info rmation. The determination that the predicted data fulfills a data require ment would be at the sole discretion of the Agency. Pre-submission consultation with the Agency is encouraged.

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 quantitative relationship between the dose and the E, A, or T effect.

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Between October 2009 and February 2010, EPA i ssued test orders/data call-ins for the first group of 67 chem icals, which contains 58 pesticide active i ngredients 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.

HPMTS is not among the group of 58 pesticide active ingredients on th e initial list to

be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen allpesticide chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data callins for all Registration Review cases, includ ing those for which EPA has already opened a Registration Review docket for a pesticide active ingredient.

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

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

.

Additional Information

Stakeholders are also specifically asked to provide available information and data in the following areas:

1. Confirmation on the following label information:

a. Sites of application

b. Formulations

c. Application methods and equipment

d. Maximum application rates

e. Frequency of application, app lication intervals and maximum number of applications

f. Geographic limitations on use

2. Use or potential use distribution

3. Use history

4. Usage/use information for non-agricultural uses (e.g., materials preservation)

5. Typical application interval

6. State or local use restrictions

7. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mo rtalities) not already reported to the Agency

8. Monitoring data

9. Structure Activity Relationships

Next Steps

After the 60-day comment period closes in August 2010, the Agency will review and respond to any comments received in a timely manner and then issue a Final Work Plan (FWP) for HPMTS.

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II. FACT S HEET

Background Information

 Active Ingredient: 2-Hydroxypropyl methanethiolsulfonate (HPMTS)

 Case Number: 3033

 PC Code: 035604

 CAS Registry Number: 30388-01-3

 Technical Registrant: Buckman Laboratories

 First approved for use in a registered product: 1968

 Antimicrobials Division Chemical Revi ew Manager (CRM): Rebecca von dem Hagen, VonDem-Hagen.Rebecca@epa.gov

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

Chemical Identity/Structure

 Empirical Formula: C 4 H 11 S 2 0 3

Use & Usage Information

 There is one registered HPMTS manufact uring use product; it is registered for formulating use only.

 There are no registered end-use products.

 There are no FDA approvals for HPMTS.

Earlier Regulatory Actions

 Hydroxypropyl methanethiosulfonate Rere gistration Eligibility Decision (RED) Document, 1995 http://www.epa.gov/pesticides/reregistration/status.htm

Human Health Risk Assessment Status

There are no registered end- uses or end-use products for HPMTS. The one registered manufacturing use product does not contain any information on application rates or use

directions. The manufact uring use product is for fo rmulating use only. Human exposures that may occur during the formula tion of a pesticide pr oduct are regulated by the Occupational Safety and Health Admi nistration (OSHA) a nd are not under the jurisdiction of the EPA. Th erefore, because the EPA does not asses exposures that may occur during the formulation of a pesticide product and there are no registered HPMTS end-uses or end-use products that woul d result in human exposure, human exposure assessments are not anticipated as being needed. It is anticipated that an acute inhalation toxicity study (GLN 870.1300) will be needed to satisfy the standard battery of acute toxicology data requirements as described in 40 CFR 161.340. These data are anticipated as being needed to support the continued registration of the sole HPMTS manufacturing

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use product. Further inform ation and a detailed justification for the da ta that are expected to be required are available in the documen t titled “Summary of Human Health Effects Data for the HPMTS Registra tion Review,” dated May 26, 2010.

Product Chemistry Database Status

The Agency has reviewed the product chemis try database for the HPMTS registration review case and anticipates th at no additional product chemistr y data will be needed for registration review. Further information is available in the “Summary of Product Chemistry, Environmental Fate, and Ecotoxi city Data for the HPMTS Registration Review Decision Document,” dated May 19, 2010.

Ecological Risk Assessment Status

There are no registered end- use products for HPMTS. Th erefore, environmental fate and ecological risk assessments are not anticipated as being needed and environmental fate and ecological data are not anticipated as being needed in support of the HPMTS registration review. Further information is available in the “Summary of Product Chemistry, Environmental Fate and Ecotoxi city Data for the HPMTS Registration Review Decision Document,” dated May 19, 2010.

Labels may be categorized into two types: labels for manufacturing uses and label for end-use products. Manufacturing use products are not used directly in the environment, but instead, are used to make formulated or end-use products. End-use products are used to control a pest and carry label instructions that indicate how the product may legally be used. There are currently no registered end-use products for HPMTS; the only registration is for the manufact uring use product. There is no environmental exposure anticipated and the Agency has determined the registration of the manufacturing use product will have "no effect" (NE) on endangere d or threatened terr estrial or aquatic species, or their designated critical habitats , as listed by the U. S. Fish and Wildlife Service (USFWS) and the National Oceanic and Atmospheric Admi nistration (NOAA). Therefore, no additional environmental risk a ssessment is anticipated to be undertaken. However, the EPA will review any comments made by the public on this document and will conduct an environmental risk assessment, if new information warrants such action. If such a decision is made, the environmental risk assessment will conclude that the registered pesticide's use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or thei r 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 Service (the Services), as appropriate.

Tolerances

There are no tolerances or exemptions from tolerances for HPMTS as an active ingredient and there are no registered food uses.

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12 Data Call-In Status

 In September of 1992, EPA issued a GDCI (generic data call-in) for product chemistry data, ecological toxicity data and human toxicity data. The data requirements for this GDCI have been satisfied.

 In September of 1993, EPA issued a GDCI for product chemistry data, ecological toxicity data, environmental fate data and human toxicity data. The data requirements for this GDCI have been satisfied.

 In February of 1996, EPA issued a PDCI (product specific data call-in) for product chemistry data and human toxicity data. The data requirements for this

PDCI have been satisfied.

Labels

There is one registered ma nufacturing use product that is a part of the HPMTS registration review case. Th e product registration number is listed below. The product registration label may be obtained from th e Pesticide Product Label System (PPLS)

website at: http://oaspub.epa.gov/pestlabl/ppls.home

.

Table #1. Registered Active Products of HPMTS

Registration Number Product Name Company Name

1448-31 HPMTS Buckman Laboratories Inc.Docket Number: EPA–HQ–OPP–2010–0004 www.regulations.gov

III. GLOSSARY of T ERMS & ABBREVIATIONS

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

AWPA American Wood Preserver’s Association

CBI Confidential Business Information

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

EP End use Product 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

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14 PAIRA Pure Active Ingredient Radiolabelled PCA Percent Crop Area PDP USDA Pesticide Data Program PHED Pesticide Handler's Exposure Data

PHI Preharvest Interval phr Pounds Per Hundred 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 RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose RQ Risk Quotient RTU Ready to Use 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 StandardDocket Number: EPA–HQ–OPP–2010–0004www.regulations.govAppendix A: Use and Usage Information 2-Hydroxypropyl methanethiolsulfonate (HPMTS)Use SiteFormulationMethod ofApplicationApplication Rate/No. of applicationsUse LimitationsNo registered use sites.For formulating use only.N/AN/A“For formulating use only.”“Note: Formulators are responsible for providing data to supportregistration of products formulated from this active ingredient.Formulators are also responsiblefor obtaining their own licensesfor any uses or formulations of this material covered by patents.This label is not to be taken asa license to operate under, orrecommendation to infringe, any patent.”15