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 2010Docket 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



### 2Docket Number; EPA

- HQ

- OPP

- 2010

- 0241 www.regulations.gov

3 

### 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

................................ ................................ .................. 10Docket Number; EPA

- HQ

- OPP

- 2010

- 0241 www.regulations.gov

4 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 CounselDocket Number; EPA

- HQ

- OPP

- 2010

- 0241 www.regulations.gov

5 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 (HP MTS) can be found in EPA’s public docket (EPA

- HQ

- OPP

2010

- 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 r egistration 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 t he 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 th is registration review case is 2

- h ydroxypropyl 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 c ase is Busan 74, henceforth this case will be referred to by its chemical name, 2

- h ydroxypropyl methanethiolsulfonate (HPMTS).

Pursuant to 40 CFR Sec. 155.50, the Agency formally initiated registration review for HPMTS with the following timeline:

**•** June 2 010 : 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 Pr oposed 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

re view 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 informa tion 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 AgencyDocket Number; EPA

- HQ

- OPP

- 2010

- 0241 www.regulations.gov

6 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 registere d end

- use products for HPMTS. T here 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, o r 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 Revie w,” dated May 26, 2010.

Tolerances

There are no tolerances or e x e m ptions 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 need ed for HPMTS because there are no registered products that will result in

exposure

. Aggregate and Cumulative Exposure and RiskDocket Number; EPA

- HQ

- OPP

- 2010

- 0241 www.regulations.gov

7 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”

conce rning 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 register ed 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 t here is no environmental exposure anticipated . T he Agency has determined the registration of the manuf acturing 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 (N MFS ). U nless public comments provide new

information or da ta 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 be en 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 Ma y 19, 2010.

D. Incidents

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

- HQ

- OPP

- 2010

- 0241 www.regulations.gov

8 E. Public Comments

Pursuant to 40 CFR Sec. 155.50, the Agency formally in itiated 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 bee n 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 comm ents or information were received during the public comment period concerning these issues.

The public will be invited to comment on th is 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 env ironmental 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 soug ht 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 i ssues 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 www.regulations.gov

9 III. REGIST RATION 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 ad versely 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 propose d 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. NE XT STEPS AND TIMELINE

Pursuant to 40 CFR Section 155.58, the Agency is issuing this p roposed Registration Review Final Decision document and placing it in the HPMTS docket (EPA

HQ

- OPP

- 20 10

- 0241 ). The Final Work Plan is also included in this document. A Federal Register Notice will announce the availability of th is 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 submitte d 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 decisio n will be issued in Fiscal Year 2011.Docket Number; EPA

- HQ

- OPP

- 2010

- 0241 www.regulations.gov

10 V. GLOSSARY of TERMS & ABBR EVIATIONS

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 Leve l 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/k g or ppm.
LD 50 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

w eight 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 R ecord 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 DoseDocket Number; EPA

- HQ

- OPP

- 2010

- 0241 www.regulations.gov

11 PAIRA Pure Active Ingredient Radiolabelled

PCA Percent Crop Area

PDP U SDA 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 (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