Docket Number; EPA–HQ–OPP–2010-0241

www.regulations.gov

United States Chemical Safety December 2010

Environmental Protection and Pollution Prevention

Agency (7510P)

Busan 74 (HPMTS) Final Work Plan & 

Proposed Registration Review Decision

December 2010
Docket Number; EPA-HQ-OPP-20IO-0241 

www.regulations.gov 

Docket Number: EPA-HQ-OPP-2010-0241 

Busan 74 (HPMTS) Final Work Plan & 

Proposed Final Decision 

Registration Review 

Case # 3033 

Approved By: 

an Harrigan- arrell 

irector, Antimicrobials Division 

Date: 

/1130 /201 (j 

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Docket Number; EPA-HQ-OPP-2010-0241

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Table of Contents

Busan 74 (HPMTS) Registration Review Team......................................................................................... 4

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

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

III. REGISTRATION REVIEW PROPOSED FINAL DECISION ........................................................ 9

IV. NEXT STEPS AND TIMELINE .......................................................................................................... 9

V. GLOSSARY of TERMS & ABBREVIATIONS ..................................................................................10
Docket Number; EPA-HQ-OPP-2010-0241

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Busan 74 (HPTMS) Registration Review Team

Timothy Dole

Human Health & Environmental Effects 

Srinivas Gowda

Rebecca von dem Hagen

Risk Management

Lance Wormell

Philip Ross

Office of General Counsel
Docket Number; EPA-HQ-OPP-2010-0241

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I. INTRODUCTION

This document is EPA’s Final Work Plan and Proposed Registration Review 

Final Decision for Busan 74 (HPMTS) and is being issued pursuant to 40 CFR Sections 

155.57 and 155.58. A registration review decision is the Agency’s determination 

whether a pesticide meets, or does not meet, the standard for registration in the Federal 

Insecticide, Fungicide and Rodenticide Act (FIFRA). Additional information and 

documents on Busan 74 (HPMTS) can be found in EPA’s public docket (EPA-HQ-OPP2010-0241) at www.regulations.gov. 

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 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, henceforth this case will 

be referred to by its chemical name, 2-hydroxypropyl methanethiolsulfonate (HPMTS).

Pursuant to 40 CFR Sec. 155.50, the Agency formally initiated registration review 

for HPMTS with the following timeline:

• June 2010: Publication of a Preliminary Work Plan (PWP) in the docket for 

HPMTS (EPA-HQ-OPP-2010-0241). The Agency received one comment during 

the 90 day public comment period which closed on August 23, 2010. 

• December 2010: Issuance of a Final Work Plan and Proposed Registration 

Review Final Decision for HPMTS. This document states that the most recent 

exposure and risk assessments for HPMTS continue to support the registration of 

pesticide products containing HPMTS and meet the requirements of registration 

review under 40 CFR Sec.155.50. This document will be issued for a 60-day 

public comment period.

EPA received one comment during the public comment period on the initial 

docket, described below. In the PWP, EPA also solicited comments on three specific 

topics: environmental justice; water body impairment; and trade irritants. No comments 

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

Comment: The Physicians Committee for Responsible Medicine (PCRM)

encourages the registrant to utilize the labeling approach suggested by the Agency 
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in order to avoid performing the acute inhalation toxicity study. If the registrant 

does not choose to utilize the labeling approach, PCRM recommends the 

registrant submit a waiver request for this study because the known dermal 

corrosivity of HPMTS would have severe implications for animal welfare. 

Response: The Agency has received and approved the amended label stating 

“This product may not be sold, distributed, or used.” As stated in the PWP, 

because this statement has been added to the label, the Agency no longer 

anticipates requiring the acute inhalation toxicity study.

HPMTS was first registered in the United States in 1968 and a Reregistration 

Eligibility Decision (RED) for Busan 74 (HPMTS) was issued in 1995. There are 

currently no registered end-use products for HPMTS. There is one registered 

manufacturing use product (MUP) (EPA Reg. No.1448-31) that contains HPMTS as the 

active ingredient (ai). The MUP for formulating use only and the labeling prohibits the 

product’s sale, distribution, or use. 

II. SCIENTIFIC ASSESSMENT

A. Human Health Risk Assessment Status

 

There are no registered end-uses or end-use products for HPMTS. The one 

registered manufacturing use product prohibits sale, distribution, or use; therefore, human 

exposure is not expected to occur and a human health risk assessment was not necessary 

to ensure that this registration review case meets the FIFRA and FFDCA standards. If in 

the future a registrant were to apply for a new HPMTS product registration, the necessary

data would be required prior to registration and the necessary risk assessments would be 

conducted by the Agency at that time to assess possible exposure and risk resulting from 

the product’s proposed new use(s).

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 exemptions from tolerance for HPMTS.

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. An aggregate risk assessment is 

not needed for HPMTS because there are no registered products that will result in 

exposure. 

Aggregate and Cumulative Exposure and Risk
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Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to 

establish, modify, or revoke a tolerance, the Agency consider “available information” 

concerning the cumulative effects of a particular 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 needed in support of this registration review. 

B. Environmental Fate and Ecological Effects Risk Assessment Status

1. Environmental Fate and Ecological Effects

There are no registered end-uses or end-use products for HPMTS. The registered 

manufacturing use product is for formulating use only, bears the label restrictions barring 

sale, distribution, and use, and hence 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 at this time to ensure 

that this registration review case meets the FIFRA and FFDCA standards. For further 

information see “Summary of Product Chemistry, Environmental Fate, and Ecotoxicity 

Data for the HPMTS Registration Review Decision Document,” dated May 19, 2010.

2. Endangered Species

 There are currently no registered end-use products for HPMTS; the only 

registration is for the manufacturing use product which bears the label restrictions barring 

sale, distribution, and use, and hence there is no environmental exposure anticipated. The 

Agency has determined the registration of the manufacturing use product will have "no 

effect" (NE) on endangered or threatened terrestrial or aquatic species, or their designated 

critical habitats, as listed by the U.S. Fish and Wildlife Service (USFWS) and the 

National Marine Fisheries Service (NMFS). Unless public comments provide new 

information or data that warrant such assessment, no additional environmental risk 

assessment is needed in support of this registration review. 

C. Product Chemistry

 All product chemistry data requirements have been fulfilled for the active 

ingredient HPMTS. Further product chemistry information is available in the document 

titled, “Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the 

HPMTS Registration Review Decision Document,” dated May 19, 2010.

D. Incidents

No HPMTS incidents have been reported in the OPP Incident Data System (IDS). 
Docket Number; EPA-HQ-OPP-2010-0241

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E. Public Comments

Pursuant to 40 CFR Sec. 155.50, the Agency formally initiated registration review 

for HPMTS on June 23, 2010 with the opening of a docket and the issuance of a PWP for 

public comment. EPA received one comment during the public comment period on the 

initial docket, described earlier in this document. The comment received addressed a 

label amendment that has been submitted and approved and a data need that is no longer 

required as a result of the approved label amendment. In the PWP, EPA also solicited 

comments on three specific topics: environmental justice; water body impairment; and 

trade irritants. No comments or information were received during the public comment 

period concerning these issues. 

The public will be invited to comment on this combined Final Work Plan and

Proposed Registration Review Final Decision for 60 days following the issuance of this

document.

F. 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. At this time EPA does not believe that use of pesticide products containing 

HPMTS will cause harm or a disproportionate impact on at-risk communities. In the 

December 2009 Preliminary Work Plan, the Agency sought comment on environmental 

justice issues regarding HPMTS. As previously mentioned, no comments were received. 

For additional information regarding environmental justice issues, please visit 

EPA’s website at: http://www.epa.gov/compliance/environmentaljustice/index.html.

G. Water Quality

HPMTS 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://oaspub.epa.gov/tmdl/waters_list.impairments?p_impid=3. The Agency sought 

submission of water quality data for HPMTS when the Preliminary Work Plan was issued 

for comment. The Agency did not receive any comments on water quality issues.

H. Trade Irritants

 Through the registration review process, the Agency solicited information on trade 

irritants and, to the extent feasible, took steps toward facilitating irritant resolution. 

Growers and other stakeholders were asked to comment on any trade irritant issues 

resulting from lack of Maximum Residue Levels (MRLs) or disparities in key export 

markets, providing as much specificity as possible regarding the nature of the concern. 

The Agency did not receive any comments on trade irritant issues. 
Docket Number; EPA-HQ-OPP-2010-0241

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III. REGISTRATION REVIEW PROPOSED FINAL DECISION

The Agency has determined that no additional data are required at this time to 

support the registration of HPMTS. The Agency has considered HPMTS in light of the 

standard for registration and safety factors in FIFRA and FFDCA as amended by FQPA. 

EPA has found that there are not likely to be any unreasonable adverse effects to the U.S. 

population in general, and to infants and children in particular, or to non-target 

organisms, from the single manufacturing use only product containing HPMTS when 

currently required label restrictions and instructions are followed. Further, the Agency 

has determined that HPMTS will have “no effect” on any federally listed threatened or 

endangered species nor will such use destroy or adversely modify any designated critical 

habitat of such species. The Agency has found that it is not necessary to conduct a new 

risk assessment for this case and is therefore issuing a proposed final decision pursuant to 

40 CFR 155.53 (c)(2) and 40 CFR 155.58.

As per 40 CFR Sections 155.57 and 155.58, the Agency’s proposed registration 

review final decision is that the standards for Registration Review have been met and that 

the registration of the one registered HPMTS product may be maintained. 

IV. NEXT STEPS AND TIMELINE

 Pursuant to 40 CFR Section 155.58, the Agency is issuing this proposed 

Registration Review Final Decision document and placing it in the HPMTS docket (EPAHQ-OPP-2010-0241). The Final Work Plan is also included in this document. A Federal 

Register Notice will announce the availability of this combined Final Work Plan and

Proposed Registration Review Final Decision and allow a 60 day comment period. If 

there are no significant comments or additional information submitted to the docket 

during that period that lead the Agency to change its proposed decision, EPA will issue a 

final decision for HPMTS Case Number 3033. The Agency anticipates the final decision 

will be issued in Fiscal Year 2011.
Docket Number; EPA-HQ-OPP-2010-0241

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V. GLOSSARY of TERMS & 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

LC50 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.

LD50 Median Lethal Dose. A statistically derived 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 Identification (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
Docket Number; EPA-HQ-OPP-2010-0241

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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 

Q1* 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 (Registrations 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