United States Prevention, Pesticides

Environmental Protection and Toxic Substances May 2009 Agency (7508P)



# Amended Reregistration Eligibility

Decision for DazometGlossary of Terms and Abbreviations

AGDCI Agricultural Data Call-In

ai Active Ingredient

aPAD Acute Population Adjusted Dose

BCF Bioconcentration Factor

CFR Code of Federal Regulations

cPAD Chronic Population Adjusted Dose

CSF Confidential Statement of Formulation

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

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

GLN Guideline Number

IR Index Reservoir

LC 50 Median Lethal Concentration. A sta tistically 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 a 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 derived single dose that can be expected to cause death in 50% of th e test animals when administered by the route indicated (oral, dermal, inhala tion). It is expr essed as a weight of substance per unit weight of animal, e.g., mg/kg.

LOC Level of Concern

LOAEL Lowest Observed Adverse Effect Level

MATC Maximum Acceptable Toxicant Concentration μg/g Micrograms Per Gram μg/L Micrograms Per Liter mg/kg/day Milligram Per Kilogram Per Day mg/L Milligram Per Liter

MOA Mode of Action

MOE Margin of Exposure

MRID Master Record Identification Number. EPA’s system for recording and tracking studies submitted.

3MUP Manufacturing-Use Product

NOAEL No Observed Adverse Effect Level

OPP EPA Office of Pesticide Programs OPPTS EPA Office of Prevention, Pe sticides, and Toxic Substances PAD Population Adjusted Dose

PCA Percent Crop Area

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

PHI Pre-harvest Interval ppb Parts Per Billion

PPE Personal Protective Equipment ppm Parts Per Million PRZM/EXAMS Tier II Surface Water Computer Model

RAC Raw Agriculture Commodity

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

SLC Single Layer Clothing

TGAI Technical Grade Active Ingredient USDA United States Department of Agriculture USGS United States Geological Survey UF Uncertainty Factor

UV Ultraviolet

WPS Worker Protection Standard

4Table of Contents

Abstract

.......................................................................................................................................... 9

I. Introduction

............................................................................................................................ 10

II. Chemical Overview

................................................................................................................ 14

A. Chemical Identity

.......................................................................................................... ...... 14

B. Use and Usage Profile

......................................................................................................... 15

C. Regulatory History

.............................................................................................................. 17

III. Dazomet Risk Assessments

................................................................................................. 17

A. General Overview of Soil Fumigants

.................................................................................. 17

1. Human Health Risk

........................................................................................................ 17

2. Environmental Fate, Ecol ogical Effects and Risks

........................................................ 20

3. Benefits

........................................................................................................................... 23

4. 2008 RED Mitigation Impacts

....................................................................................... 24

B. Antimicrobial Risk

............................................................................................................... 26

IV. Risk Management and Reregistration Decision

................................................................ 27

A. Determination of Reregistration Eligibility

......................................................................... 27

B. Public Comments and Responses

........................................................................................ 28

C. Regulatory Position

............................................................................................................. 29

1. Regulatory Rationale

...................................................................................................... 30

a. Dazomet Soil Uses

....................................................................................................... 30

i. Rate Reduction and Use Sites

................................................................................... 30

ii. Human Health Risk Management

............................................................................. 30 aa. Bystander Risk Mitigation

............................................................................................ 32

1. Buffer Zones

................................................................................................................. 32

2. Restriction for Schools and Other Difficult to Evacuate Sites

.................................... 53

3. Posting

........................................................................................................................... 54 bb. Occupational Risk Mitigation

...................................................................................... 56

1. Handler Definition

........................................................................................................ 56

2. Handler Requirements

................................................................................................. 57

3. Dermal Protection for Handlers

................................................................................... 59

4. Respiratory Protection for Handlers

............................................................................ 59

5. Tarp perforation and removal

...................................................................................... 67

6. Entry Prohibitions

........................................................................................................ 70 cc. Other Risk Mitigation

................................................................................................... 75

1. Restricted Use Classification

....................................................................................... 75

2. Good Agricultural Practices

......................................................................................... 77

3. Fumigant Management Plans (FMPs)

......................................................................... 80

4. Site Specific Response and Management

.................................................................... 87

5. Notice to State Lead Agencies

..................................................................................... 94

6. Soil Fumigation Training for Applicators and Training Information for Other Handlers

... ............................................................................................................................ ............ 95

7. Community Outreach and Education Programs

........................................................ 100

iii. Environmental Risk Management

......................................................................... 105

2. Endocrine Disruptor Effects

......................................................................................... 108

3. Endangered Species Considerations

............................................................................. 109

5D. Conclusion

........................................................................................................................ 109

V. What Registrants Need to Do

............................................................................................. 109

A. Manufacturing Use Products

............................................................................................. 110

1. Additional Generic Data Requirements

....................................................................... 110

2. Labeling for Manufacturing-Use Products

................................................................... 116

B. End-Use Products

.......................................................................................................... ... 116

1. Additional Product-Specific Data Requirements

........................................................ 117

2. Labeling for End-Use Products

................................................................................... 117 Appendix A(1). Dazomet (PC Code 035602) Soil Fu migant Uses Eligible for Reregistration

.... ........................................................................................................................... ...................... 118 Appendix A(2). Dazomet (PC Co de 035602) Antimicrobial Uses Eligible for Reregistration

Appendix B. Table of Generic Data Requi rements and Studies Used to Make the .... ........................................................................................................................... ...................... 119

Reregistration Decision

............................................................................................................ 128 Appendix C. Technical Support Documents

......................................................................... 129 Appendix D. Bibliography

...................................................................................................... . 132 Appendix E. FMP Template

................................................................................................... 133

6Dazomet Reregistration Eligibility Decision Team

Office of Pesticide Programs: Office of General Council:

Andrea Medici

Health Effects Risk Assessment Charles Smith, Risk Assessor Office of Enforcement and Compliance: Anna Lowit, Toxicology David Stangel Sherri Kinard, Residue Chemistry Ruth Allen, Epidemiology Judy Facey, Toxicol ogy Shalu Shelat, Risk Assessor

Biological and Economic Analysis Assessment TJ Wyatt, Senior Agricultural Economist Jonathan Becker, Senior Science Advisor Bill Chism, Senior Agronomist David Donaldson, Agricultural Economist, Team Leader Colwell Cook, Entomologist Nicole Zinn, Biologist Stephen Smearman, Economist Leonard Yourman, Plant Pathologist John Faulkner, Ec onomist Nikhil Mallampalli, Entomologist Sunil Ratnayake, Botanist

Environmental Fate and Effects Risk Assessment Mah Shamim, Branch Chief Faruque Khan, Senior Fate Scientist James Felkel, Wildlife Biologist Gabriel Rothman, Environmental Scientist

Registration Support Mary Waller, Product Manager Tamue Gibson, Product Reviewer Kathy Monk, Senior Advisor

Antimicrobial Risk Assessment Team Heather Garvie, Chemical Review Manager Diane Isbell, Reregistration Team Leader Cassi Walls, Ph.D., Chemist Timothy Dole, Industrial Hygienist Rick Petrie, Senior Agronomist, Team Leader

7Risk Management Andrea Carone, Chemical Review Manager Steven Weiss, Industrial H ygienist, Chemical Review Manager Susan Bartow, Chemical Review Manager Dirk Helder, Chemical Review Manager Karen Santora, Chemical Review Manager Dana Friedman, Chemical Review Manager Cathryn O’Connell, Team Leader Eric Olson, Team Leader John Leahy, Senior Advisor

8Abstract

This document presents the Environmental Prot ection Agency’s (hereafter referred to as EPA or the Agency) amended decision regarding th e reregistration eligibility of the registered

soil and antimicrobial uses of dazomet. This follows the 105-day public comment period on the Reregistration Eligibility Decision provided for st akeholders to have th e opportunity to review and provide comments on issues related to the im plementation of the risk mitigation measures. The Agency’s risk conclusions for dazomet have not changed. In addition, all measures established in the July 2008 RED to reduce risks to bystanders and workers will still be required. However, the Agency has determined that certai n modifications in how and when some measures will be implemented are appropriate. Products containing dazomet uses are eligible for reregistration provided that: (1) current data gaps are addressed; (2) the risk mitigation measures identified in the document are adopted; and (3) la bels are amended to implement these measures.

Generally, registered dazomet uses fall into two basic categories , soil fumigation or antimicrobial use. Soil fumigation includes us e on golf greens and tees , nonbearing crops, turf sites, ornamental sites, fiel d nurseries, compost piles, potti ng soils, and strawberries and tomatoes in California only. Antimicrobial uses include: 1) as a treat ment during the production of pulp and paper; 2) as a material preserva tive treatment paper coatings, non-food adhesives, epoxy flooring compounds, slurries, and high viscous suspensions; 3) as a biocide treatment used during petroleum operations; 4) as a biocide treatment to recirc ulating cooling water systems; and 5) as a remedial wood treatment to utility poles.

Concurrent to EPA’s review of the soil fumiga nt uses of dazomet, EPA assessed the risks and developed risk management decisions for four other soil fumigant pesticides, including: chloropicrin, metam sodium/potassium, met hyl bromide, and a new active ingredient, iodomethane. Risks of a fifth soil fumigant, 1,3 -dichloropropene (1,3-D), were also analyzed along with the other soil fumigants for comparat ive purposes; its risk management decision was completed in 1998. The Agency evaluated these soil fumigants concurrently to ensure that human health risk assessment approaches are co nsistent, and that risk tradeoffs and potential economic impacts were considered appropriately in reaching risk management decisions. This review is part of EPA’s program to ensure that all pesticides meet cu rrent health and safety

standards.

EPA has identified potential human health risks of concern associated with the registered soil fumigant uses of dazomet from acute in halation exposure to ha ndlers, bystanders, and workers. To reduce these exposures and to addr ess risks of concern, EP A is requiring a number of mitigation measures, such as buffer zones, posting, handler protection, restrictions on the timing of tarp perforation and removal operations, extending the entry prohibitions, restricted use classification (for soil uses only), mandatory goo d agricultural practices (GAPs), site-specific fumigant management plans (FMP s), emergency preparedness and response, notice to state and tribal lead agencies, training for applicators and handlers, and require d community outreach and education programs. In addition the registrants have agreed to reduce the maximum rate from

530 lbs ai/A to 425 lbs ai/A for in corporated applications except golf course greens/tees and turf

9Mitigation renovation (which will remain at 530 lbs ai/A) which will directly reduce the potential risks to both humans and non-target organism s. The ecological risk assessm ent identified potential acute

risks of concern for birds and mammals that could be exposed to unincorporated dazomet granules.

The Agency also has identified potential human health risks of concern associated with the registered antimicrobial uses of dazomet. To reduce these exposures, th e Agency is requiring a number of mitigation measures, including ad ditional PPE for handlers engaged in these applications: pulp and paper use, cooling tower use, and metering pumps. For the epoxy flooring uses, the labels must be amended to reduce the amount of dazomet formulated in end use products.

I. Introduction

This amends and supersedes the document, “Reregistration Eligibility Decision for Dazomet,” published by the U.S. Environmental Pr otection Agency (hereafter, EPA) on July 16, 2008. That day EPA opened a 60-day public comme nt period on the implementation aspects of the risk mitigation measures that were required as conditions of reregi stration eligibility under FIFRA. EPA received requests to extend the comment period from the Methyl Bromide Industry Panel (MBIP), California Specialty Crops Council, the Chloropicrin Manuf acturers' Task Force (CMTF), the National Association of Manufact urers (NAM), the American Nursery and Landscape Association (ANLA), the California Strawberry Nurserymen's Association, the Agricultural Retailers Association, the American Forest and Paper Association, and McDermott, Will, and Emery LLP, on behalf of the Minor Crop Farmer Alliance (MCFA). In response to these requests, on August 29, 2008, EPA published a not ice in the Federal Register extending the comment period for an additional 45 days. Th e comment period closed on October 30, 2008. EPA has completed its review of public comments as well as new scie ntific data and other information provided and determined that all measures established in the July 2008 RED to reduce risks to bystanders and workers will still be required. The Agency has determined that

certain modifications in how and when some measures will be implemented are appropriate. The public comments and EPA’s responses, as well as other supporting docume nts, may be found in the public docket for dazomet at EPA- HQ-2005-0128. EPA has determined that the

modifications described herein will achieve th e same protection goals for persons potentially exposed to dazomet but with a greater likelihood of compliance, fewer imp acts on the benefits of dazomet use, and with less uncer tainty regarding the protectiven ess of the required measures.

Please see table 1 for modifications from the 2008 RED to the 2009 amended soil fumigant

REDs.

Table 1. Modifications from 2008 to 2009 Amended Soil Fumigant REDs

2008 REDs 2009 Amended REDs

Buffer Zones Buffer zones based on

available data New chloropicrin data support smaller buffers and increased confidence in safety New dazomet data support larger buffers

10Mitigation 2008 REDs 2009 Amended REDs

Buffer Credits Credits allowed based on available data; capped at

50% New data support additional credits and an increase in the cap to 80% for chloropicrin and methyl bromide, 80% for metam sodium and metam potassium, and 40%

for dazomet.

Structures within

Buffer Zones Monitor with devices before reentry Monitor for sensory irritation before

reentry Rights of Way Permission from local authorities must be granted

if buffers extend onto rights of way Permission from local authorities is only required when a sidewalk or permanent walkway is present

Buffer Overlap Buffers may not overlap Bu ffers may overlap; separate applications by 12 hours and increase emergency preparedness and response measures

Restriction for

Difficult to Evacuate

Sites 1/4 mile restriction around

hard to evacuate areas including day care centers, nursing homes, schools;

was to be in effect for the

duration of the buffer zone period Maintain 1/4 mile restriction but allow a

reduced restricted area of 1/8 mile for applications with smaller buffers (300 feet or less); is to be in effect during the application for 36 hours following the application

Posting Posting required at buffer zones points of entry, where people are likely to approach, and areas

between these locations The posting requirement is retained but no longer requires areas between the entry areas to be posted Information required on the signs has been simplified to encourage reuse of signs

Handler Protection Described tasks that may only be performed by

handlers and situations

when 2 handlers were required to be present

while in the buffer zone Tasks that may only be performed by handlers have been updated and clarified

The situations have been clarified requiring one handler supervised by a certified applicator to be present based on the chemical properties of the different soil fumigants, and current label statements Respiratory

Protection Required monitoring devices to trigger

additional measures Allow sensory irritation properties to trigger additional measures for MITC and chloropicrin Monitoring with devices is still required to remove respirators Monitoring with devices required for methyl bromide formulations with <20% chloropicrin Tarp perforation and

removal Perforating tarps restricted to mechanical means only Perforating tarps by hand is allowed for

areas less than 1 acre in size and for flood prevention activities Entry Prohibitions Entry for non-handlers is prohibited for the duration No major changes

11Mitigation 2008 REDs 2009 Amended REDs

of the entry restricted period, until tarps have been removed, or if 14 days has passed

Restricted Use The soil fumigant uses of No change

Classification dazomet, metam-sodium and metam potassium, and
MITC use for remedial treatment of wood poles

and timbers are required

to be classified as restricted

use Good Agricultural

Practices (GAPs) Certain GAPs required for all fumigant applications Some clarifications and refinements have

been made based on stakeholder comments

Fumigant Management Plans (FMPs) FMPs required to be completed before fumigant application begins and post-application summary report required following the application No major changes. Based on comments an example of an FMP has been included to illustrate how the required information may be presented effectively

Emergency Response If neighbors are near Same basic measures and Preparedness buffers they must be provided with information

or buffer zones must be monitored every 1-2 hours

over 48 hours with monitoring devices Monitoring required only during peak emission times of the day; irritation detection acceptable for MITC and chloropicrin in lieu of devices; methyl bromide requires devices

Notice to SLAs Applicators required to provide notice to the appropriate state/tribal lead agency before fumigating to facilitate compliance

assistance and assurance States may determine if they wish to

receive this information All states required to include strategies for compliance assistance and assurance for soil fumigation in their cooperative

agreements

Applicator Training Certified applicators required to receive registrant soil-fumigant training every year Certified applicators required to receive registrant soil-fumigant training every three years

Community Outreach Registrants required to Same basic requirement

and Education develop and implement community outreach & education programs along

with information for first responder in high fumigant

use areas The Agency is providing information on where registrants are required to focus

these efforts

12With regard to implementation timing, EPA has determined that most measures can be efficiently implemented via revi sed product labels by the 2010 use season. Other measures, in particular those related to buffer zones, will present greater compliance challenges and will require additional time for EPA to conduct the necessary outreach, and communication activities with states, tribes, other regulatory partners, fumiga nt users, and other stak eholders to facilitate

transition. EPA has determined that these meas ures will be implement ed via revised product labels by the 2011 use season. As a result, all meas ures described in this amended RED that are necessary for reregistration elig ibility will appear on product labels by 2011. The table below

shows the measures that will be implemented in 2010 and the additional measures that will be implemented in 2011.

Table 2. Implementation Schedule for So il Fumigant Risk Mitigation Measures

Risk Mitigation Measure Currently 2010 2011

Restricted Use ● ● New Good Agricultural Practices ● ●

Rate reductions ● ●

Use site limitations ● ● New handler protections ● ● Tarp cutting and removal restrictions ● ● Extended worker reentry restrictions ● ● Training information for workers ● ● Fumigant Management Plans ○ ● First responder and community outreach ○ ● Applicator training ○ ● Compliance assistance and assurance measures ○ ● Restrictions on applications near sensitive areas ● Buffer zones around all occupied sites ● Buffer credits for best practices ● Buffer posting ● Buffer overlap prohibitions ● Emergency preparedness measures ●

○ = under development

● = adopt completely

The Federal Insecticide, Fungicide, and R odenticide Act (FIFRA) was amended in 1988 to accelerate the reregistration of products with active ingredient s registered prior to November 1, 1984. The amended Act calls for the developm ent and submission of data to support the reregistration of an active ingredient, as well as EPA’s review of all submitted data. Reregistration involves a thorough re view of the scientific data base underlying a pesticide's registration. The purpose of the Ag ency's review is to reassess the potential risks arising from the currently registered uses of the pesticide; to determine the need for additional data on health

13and environmental effects; and to determine whether or not the pe sticide meets the "no

unreasonable adverse effects" criteria of FIFRA.

Dazomet is used as a non-se lective soil fumigant with fungicidal, herbicidal, and nematicidal properties. It is also used as an algaecide, bacteriostat, fungicide, microbiocide,

mildewcide in a number of antimicrobial use site s. When dazomet is applied, it is quickly broken down into several degradates; the major de gradate being methyl is othiocyanate (MITC). The Agency made its reregistration eligibility determination based on the required data, the current guidelines for conducting acceptable st udies to generate such data, and published scientific literature. The Agency has found that cu rrently registered uses of dazomet are eligible for reregistration provided the mitigation and labeling outlined in this amended RED are implemented.

This document presents the Agency’s reregist ration eligibility deci sion for the supported

soil and antimicrobial uses of dazomet. The doc ument consists of five sections. Section I contains the regulatory framework for reregistration and a synops is of modifications from the July 2008 RED. Section II provides a profile of the use and usage of the chemical. Section III provides a general fumigant overview and also su mmarizes dazomet’s risk assessments as well as benefit and impact assessments. Section IV presents the Agency’s reregistration eligibility and risk management decisions. Section V summ arizes label changes necessary to implement the risk mitigation measures outlined in Sect ion IV. Unless otherwise noted, all Agency

references in this document are available fo r review in the dazomet docket (EPA-HQ-OPP-2005­ 0128) at www.Regulations.gov

.

II. Chemical Overview

A. Chemical Identity

When dazomet is applied to soil, either to the surface or incorporated, it quickly breaks down. The major degradate is MITC, but formaldehyde, monomethylamine, hydrogen sulfide and (in acid soils) carbon disulfide, are also formed. All of these degradates are gases or volatile liquids which diffuse through the spaces in the soil, killing living organisms with which they come in contact. This reregist ration eligibility deci sion considers risks of exposure of dazomet and the major degradate, MITC, as a result of dazomet applications. Table 3 provides a summary of the dazomet and MITC nomenclature.

14Table 3: Dazomet and MITC Nomenclature

Properties Dazomet MITC

Chemical Structure 

### N S N S 

## H 3 

## C N
C S

Chemical Group Dithiocarbamate Isothiocyanate

Common Name Dazomet Methyl isothiocyanate

Molecular formula C 5 H 10 N 2 S 2 C 2 H 3 NS

Molecular Weight 162.28 73.12

CAS No. 533-74-4 556-61-6

PC Code 035602 068103

Case Number 2135 N ot Applicable

B. Use and Usage Profile

Soil Uses

Pesticide Type: Broad spectrum soil fumiga nt with herbicidal , nematicidal, and fungicidal properties

Target pests: Weeds, nematodes and various soil-borne pathogens

Use patterns: Golf greens/tees, nonbear ing crops (such as orchard crops, berries, and flower bulbs), turf sites (establishi ng or renovating), ornamental sites (establishing or renovating), field nurseries (establishing or renovating), greenhouses, compost piles, potting soils, and strawberries a nd tomatoes in California only

Formulations: Granular

Methods of Application: Tractor drawn spreaders and handheld equipment such as belly grinders and push-type spreaders

Application Rates: Maximum application rate for incorporated applications is 530 lbs ai/acre and for surface appl ications is 265 lbs ai/acre

15Technical registrant: Certis USA, LLC

Annual Usage: Approximately 15,000 pounds of dazomet are used annually 1 as a soil fumigant.

Antimicrobial Uses

Pesticide Type: Algaecide, bacteriostat, fungicide, microbiocide, mildewcide

Target pests: Fungi, bacteria, mildew, algae

Use patterns: Dazomet may be used in a variety of ways including: 1) as a treatment during the production of pulp and paper; 2) as a material preservative treatm ent for paper coatings, non-food adhesives, epoxy flooring co mpounds, slurries, and high viscous suspensions; 3) as a biocide treatment used during petroleum operations; 4) as a biocide treatment to recirculating cooling water systems; and 5) as a remedial wood treatment to utility poles.

Formulations: Pelleted/tableted, liqui d (soluble concentrate and flowable concentrate) solutions, water soluble packaged solids, ready to

use solutions

Methods of Application: Open pour (for both solid and liquid formulations), metering pump, and water-soluble packaged solid mixing

Application Rates: Rates vary by applic ation use site and method. Maximum rates are included in Table 4.1 of the Revised Occupational and Residential Antimicrobial Exposure Assessment (Walls, C. 2/14/08)

Technical registrant: BASF

1 USDA Agricultural Chemical Usage 2003 Nursery and Floriculture Summary, September 2004, http://usda.mannlib.cornell.edu/MannUsda /viewDocumentInfo.do?documentID=1001

.

16C. Regulatory History

Dazomet, (PC code 035602) and the sodi um salt, tetrahydro-3,5-dimethyl-2H-1,3,5­ thiadiazine-2-thione (PC Code 035607) are included in pesticid e reregistration case number 2135. Currently, there are 22 products registered containing dazomet and there are no active products registered containi ng the sodium salt.

Dazomet has both agricultural and antimicrobial uses. Dazomet was first registered in the United States in 1967 as an algaecide, a ba cteriostat, and a microbi ocide in a variety of commercial and industrial applications such as pulp and paper mills, cooling tower waters, and

non-food adhesives.

In the late 1980s pre-plant soil uses of dazo met were registered. Dazomet is registered for use on non-bearing orchard crops, ornamental s, and turf to control plant pathogens, nematodes, and weeds. Unlike other soil fumigants, dazomet is applied as a dry granule and incorporated into the soil or applied to the soil surface and watered into the soil to activate it.

A Phase IV data call-in (DCI) was issued for dazomet in January 1991 and included data requirements for ecotoxicity, toxicology, and envi ronment fate. A follow-up DCI was issued in May of 1992 that included data requirements for neurotoxicity and the nature of residue in plants. Dazomet was also included in the October 1995 agricultural r eentry data call-in.

III. Dazomet Risk Assessments

A. General Overview of Soil Fumigants

Soil fumigants are pesticides that form gasses wh en applied to soil. Once in the soil, the fumigants work by controlling pest s that can disrupt plant grow th and crop production. Soil fumigants play a very important ro le in agriculture, but they also have the potential to pose risk concerns to people involved in application of the chemicals (h andlers), workers who re-enter fumigated fields (workers), and people who may be near the treated area (bystanders).

1. Human Health Risk

When dazomet is applied and mixes with moist soil, it is quickly broken down into several products. One of these pr oducts is MITC that accounts for most of the fumigant activity. The main risk of concern for handlers, workers, and bystanders associated with the soil uses of dazomet is from acute inhalation exposure to MITC as a result of fumigant off-gassing.

Dazomet handlers also are at risk from direct fumigant exposure during applications. The term

handler refers to persons involved in the application of dazomet. For soil applications, handlers also include persons involv ed in perforating and rem oving of tarps. The term worker in this document refers to persons performing non-handler tasks within the application block, after the fumigation process has been comple ted, such as planting. The term bystander refers to any person who lives or works in the vicinity of a fumigation site.

17In addition to soil use, dazomet is also used as an antimicrobial pesticide in the following ways: 1) as a treatment during the production of pulp and paper; 2) as a material preservative treatment for coatings, adhesives, epoxy flooring compounds, slurries, and high viscous suspensions; 3) as a biocide treatment used during petroleum operations; 4) as a biocide treatment to recirculating cooling water systems; and 5) as a remedial wood treatment to utility poles.

Estimating exposure to fumigants is differe nt from non-fumigant pesticides due to fumigants’ volatility, and thus, th is increased ability to move off site during and after application. For example, pesticide spray drift is the physical movement of pesticide particulate or droplets from the target site during the a pplication and soon thereafter. In the case of soil fumigants, the pesticide moves as a gas (not as particulate or droplets) and movement off-site can occur for an extended period after app lication. Importantly, fumigants ha ve a well-documented history of causing large-scale human exposure incidents up to several thousand feet from treated fields. Assessing fumigant exposure takes into account the size of the fumigated field, the amount of fumigant applied, and the rate at which th e fumigant escapes from the treated field.

The term “flux rate” or “emission rate” define s the rate at which a fumigant off-gasses from a treated field. Many factors influence the ra te of emissions from treated fields. Factors such as the application method, soil moisture, soil temperature, organic matter levels, water treatments, the use of tarps, biological activity in the soil, soil texture, weather conditions, soil compaction, and others influence th e amount of fumigant that comes off the field and is available

to move off-site to areas wh ere bystanders may be located.

The human health risk assessment indicates that acute inhalation exposures to MITC concentrations of 22 ppb or greater for a 1 to 8 hour time period for non-occupational (residential) bystanders and occupational handl ers could pose risks of concern. The 22 ppb concentration is based on a reversible endpoint from a human eye irritation and odor threshold study for acute exposures to MITC. The lowest observable adverse effect level (LOAEL) was 800 ppb, and the human concentration (HC) based on the no observable adverse effect level (NOAEL) from this study is 220 ppb. The NOAEL of 220 ppb being used by EPA is similar to a benchmark concentration level of 200 ppb s ubmitted by the group Toxicology Excellence in Risk Assessment (TERA) on behalf of the metam sodium registrants. The benchmark concentration analysis thus suppor ts the Agency’s toxicity endpoi nt. Since the study is a human exposure study for acute eye exposures to MI TC, the standard 10X for animal to human extrapolation is not needed. A 10X uncertainty factor for intraspecies variability was included, which when applied to the HC, re sults in the target concentration for acute inhalation exposures of 22 ppb.

California Pesticide Illness Surveillance Pr ogram data from 1992-2003 confirm that eye effects from MITC exposure as seen in this human study provide a sensitive endpoint for regulating acute inhalation exposures. In many inci dent cases, people complain of eye effects. However, many reported cases also report systemic or respiratory effects without eye irritation. Compared to eye irritation, the systemic and resp iratory effects are more serious in nature. Unfortunately, the available toxicity data in animals or humans do not allow a quantitative

18comparison of the dose response curves of the eye, systemic, and respiratory effects to determine

at the exact doses of which those effects occur. However, the Agency believes eye irritation provides a surrogate for other t oxic effects and thus makes this the appropriate endpoint to regulate. To ensure that this endpoint is protective of any effects from repeated and longer term exposures, EPA is requiring data to evaluate de velopmental, reproductive , chronic, and cancer hazards and has encouraged the registrants to purse additional studies to characterize the dose response curves of different target organs.

The Agency has not revised the 10X human va riability uncertainty factor for MITC and the MITC-generating compounds. Agency scientists have carefully reviewed comments provided by the Metam Alliance and TERA that cl aim a mode of action (MOA) evaluation for MITC and the relative sensitivities of the eyes and lungs to MITC, support an uncertainty factor less than 10X. Upon request by the Metam Allia nce, Agency scientists have evaluated the registrant's scientific positi on [see regulations.gov , docket nu mber: EPA-HQ-OPP-2005-0125]. While Agency scientists acknowle dge that data are available to formulate a hypothesis for a MOA, currently available data are insufficient to support the key events of the proposed MOA and also to refute other scientifically plausibl e hypotheses (a step critical in a MOA framework analysis). Moreover, there remains uncertainty with respect to the dose response relationship for sensitive measures of respiratory effects. Thus , given gaps in the existing data for MITC, the Agency is unable to determine, according to exis ting guidance, that the uncertainty factor can be reduced. If, in the future, additional data are pr ovided, the Agency will re-evaluate the scientific

basis for MITC's human vari ability uncertainty factor.

In assessing risks from dazomet, the Agency considered multiple lines of evidence, using the best available information from monitoring st udies, modeling tools, and from incidents.

 Monitoring: For the human health risk asse ssments completed for dazomet and the other soil fumigants within the group, several field- scale monitoring studies were considered. These studies quantify dazomet concentrations in and around fi elds at various times and distances during and after appl ications. Many of these data indicate that there can be

risks of concern associated with dazomet use at a broad range of di stances from treated fields. However, these data are limited in their utility because they provide results only for the specific conditions unde r which the study was conducted.

 Modeling: Models enable the use of da ta from monitoring studies to estimate concentrations and potential ri sks under a wide range of c onditions and use patterns.

EPA used the Version 2.1.4 of the P robabilistic E xposure and R isk model for Fum igants (also called the PERFUM model) to evalua te potential risks at distances around treated fields. PERFUM incorporates actual weathe r data and flux distri bution estimates, and then accounts for changes and altering conditi ons. Analyses based on a variety of model outputs were used to compare the potential risks at a range of distances. The PERFUM model and users manual are public domain and can be downloaded at http://www.exponent.com/perfum/

.

19 Bystander, handler, and worker incident reports: Incide nts for the soil fumigants generally occur at a low freque ncy relative to the total numbe r of fumigant applications performed annually. However, when incidents occur, there are often many people

involved. Incidents involvi ng handlers and workers tend to occur more often than incidents with bystanders.

Reconstructing incidents to examine the exact factors which led to the incident can be difficult, especially when bysta nders are involved since all th e factors that contributed to the incident may not have been documented. Some of the factors that have been linked to incidents in the past have included equipmen t failure, handler accidents, applicator failure

to adhere to label recommendations and/or requirements, and temperature inversions. Bystander incidents have occu rred both close to fumigate d fields and up to two miles away from the fumigated field, although these types of incidents have not been reported specifically for dazomet.

Based on these lines of evidence and as describe d in more detail in the risk assessments,

EPA has determined that dazomet risks to handl ers, workers, and bystanders are of concern given current labels and use practices. The hum an health risk assessments indicate that inhalation exposures to bystanders who live and work near agri cultural fields where dazomet fumigations occur have the potential to exceed the Agency’s LOC without additional mitigation

measures. There are also risks of concern for occupational handlers involved in dazomet applications and for workers who may re-enter treated area shortly after fumigation or tarp perforation has been completed.

For more information about the specific informati on in the Agency’s human health risk analysis for dazomet, refer to the documents listed belo w, all of which can be found in the dazomet docket # EPA-HQ-OPP-2005-0128 at http://www.regulations.gov:

 Dazomet: Updated Final Revised HED C hapter of the Reregistration Eligibility Decision Document (RED). ( Shelat, S. et al., Dated April 30, 2009)

 Methyl Bromide (PC Code 053201), Chloropicrin (PC Code 081501), Dazomet (PC Code 035602), Metam Sodium and Potassium (PC Codes 039003 & 039002), MITC (PC Code 068103), DP Barcode 362369, Updated Health Effects Division Recomme ndations for Good Agricultural

Practices and Associ ated Buffer Credits (Dated May 14, 2009)

 MITC 10X placeholder

 Dazomet: Updated Final Revised HED Chapt er of the Reregistration Eligibility Decision Document (RED). (Smith, C. et al., Dated June 2008)

 Mode of Action, Eye Irritation, and the Intra-Species Factor: Comparison of Chloropicrin and MITC. (Lowit, A. and Reaves, E., Dated June 25, 2008)

2. Environmental Fate, Ecological Effects and Risks

20The Agency’s environmental fate and ecological effects risk assessments indicate that there are some concerns for non-target organisms that may be exposed to fumigants. Exposure to terrestrial organism such as birds and mammals could occur tw o ways, as either oral exposure to dazomet granules or by the inhalation rout e of exposure to the breakdown product MITC. Potential exposure to aquatic organisms may occur from surface runoff/leaching and/or volatilization and deposition of MITC in water bodies.

Hazard

Dazomet is considered moderately toxic on an acute oral basis to both birds (LD 50 = 424 mg/kg) and mammals (LD 50 = 415 mg/kg). MITC is considered highly toxic on an acute oral basis to mammals (LD 50 = 55 mg/kg), and moderately toxic vi a the inhalation route. Acute oral and inhalation toxicity data with MITC are needed for birds.

MITC is considered very highl y toxic to both fish (lowest LC 50 = 51.2 ppb) and aquatic invertebrates (lowest LC 50 = 55 ppb).

Exposure

Terrestrial (Dazomet and MITC)

Direct exposure of mammals and birds to dazomet granules was estimated using the model T-REX, Version 1.2.3 (T-REX, 2005). T-REX was run for tomato and strawberry crops (also applicable to turf, ornamental and other pr e-plant incorporated uses ) for a single application of dazomet applied at the maximum rate of 530 lb a.i./A. In addition, exposure of terrestrial animals to the volatile degradation product MITC was evaluated using a preliminary LD 50 /square foot risk screening method. The Industrial Source Complex Short Term (ISCST3) model together with information about MITC emissions from a treated field was used to evaluate the range of MITC concentrations which might be found under different conditions of application rate, weather, source size and shap e (e.g., field size in acres) and dist ance from the treated field.

Aquatic (MITC)

For exposure to fish and aquatic invertebra tes, EPA considers surface water only, since most aquatic organisms are not found in ground water. The aquatic exposure assessment for MITC relied on Tier II aquatic models. Th e Pesticide Root Zone Model (PRZM version 3.1.2 beta) simulates fate and transport on the agricultu ral field, while the water body is simulated with Exposure Analysis Modeling System (EXAMS version 2.98.04). Simulations are run for multiple (usually 30) years and the reported EECs represent the values that are expected once every ten years based on the thirty years of daily values generated during the simulation.

PRZM/EXAMS simulates a 10 hectare (ha) field immediately adjacent to a 1 ha pond, 2 meters deep with no outlet. The location of the fi eld is specific to the cr op being simulated using site specific information on the soils, weather, cropping, and management factors associated with the scenario. The crop/location scenario in a spec ific state is intended to represent a high-end

21vulnerable site on which the crop is normally grown. Based on hist orical rainfall patterns, the pond receives multiple runoff events during the years simulated. PRZM has limited capabilities in capturing the amount of a volat ile chemical in air, water an d sediment. The estimated concentrations of chemicals like MITC in surface water bodies may be upper bound.

To simulate field application of dazomet, multiple scenarios were selected representing proposed dazomet usage areas based on geography and weather. PRZM and EXAMS models and

relevant scenarios were used to estimate MITC estimated exposure conc entrations (EECs) in

surface water based on label information for dazome t application to tomatoes, strawberries, turf and ornamental trees at the highest application rate. Th e scenario with the highest concentration of MITC from dazomet applications was the California strawberry scenario.

Risk

Terrestrial Risk (Dazomet and MITC)

Available dazomet toxicity studies allow the assessment of acute oral exposure of birds and mammals. Inhalation toxicity studies for MI TC are only available fo r mammals. There are currently no studies available to esti mate chronic terrest rial risks.

The Agency’s levels of concern are exceeded for acute oral consumption of dazomet granular product for both mammal and bird specie s that are not Federally- listed as endangered or threatened as well as for ‘listed’ species. Ho wever, for mammal inhalation exposure to MITC all of the estimated risks are below the Agency’s LOC for both listed and no n-listed species. The inhalation effects observed at levels higher than would be expected under normal use and

assessed in mammals included both metaplasia of respiratory epithelium and lethality. There

were no data available to assess i nhalation risk to birds, and additional data is required. At the present time there are no registrant-submitted toxi city studies, or studies published in the open literature, that evaluate the toxicity of dazomet or MITC to terrestrial plants.

Aquatic Risk (MITC)

None of the estimated acute fish or aquatic invertebrate risks were above the Agency’s LOC for freshwater non-listed or listed species . However, no MITC studies are available for marine/estuarine organisms. For chronic risk from MITC the only data available to evaluate chronic effects on aquatic organisms are for freshw ater invertebrates, which predict risks below the Agency’s LOC. However, no MITC data ar e available to evaluate the chronic effects on freshwater and estuarine/marine fish, or estuarin e/marine invertebrates. All of the estimated risks for aquatic plants were below the Agency’s levels of concern.

Due to the current data gaps for dazomet a nd MITC, the Agency is requiring additional eco-toxicity studies for both te rrestrial and aquatic organisms. For more information on the Agency’s environmental fate and eco logical effects risk analysis:

22 Revised Environmental Fate and Ecol ogical Risk Assessment For Dazomet. (Khan. F. and Felkel, J., Dated April 8, 2008)

3. Benefits

Soil fumigation can provide benefits to both food consumers and growers. Forconsumers it means more fresh fruits and vegetables can be cheaply produced domestically yearround because severe pest problems can be efficien tly controlled. Growers benefit because crops grown in fumigated soil produce fewer blemished pr oducts, which translates into an increase in marketable yields. Fumigation can also provi de benefits to grow ers by increasing crop management flexibility. This includes shorter crop rotational intervals (i.e., less time when fields are left fallow), improved ability to meet qua rantine requirements (which are imposed when states or other jurisdictions require a pest-free harvested product), and consistent efficacy against critical pests. The magnitude of benefits depe nds on pest pressure, whic h varies over space and time, and the availability and costs asso ciated with the use of alternatives.

There are a number of benefits assessments th at have been completed by the Agency to

estimate the value of these chemicals to vari ous industries, which are listed below.

 EPA-HQ-OPP-2005-0123-0321 , Assessment of the Benefits of Soil Fumigation with Chloropicrin, Metam-Sodium, and Methyl Bromide in Eggplant Production

 EPA-HQ-OPP-2005-0123-0322, Assessment of the Benefits Soil Fumigants (Methyl Bromide, Chloropicrin, Metam-Sodium, Da zomet) Used by Forest Tree Seedling

Nurseries

 EPA-HQ-OPP-2005-0123-0323, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin, Dazomet, Metam Potassium and Metam Sodium for Use in Raspberry Nurseries, Fruit and Nut Deciduous Tree Nurseries, and Rose Bush Nurseries in California

 EPA-HQ-OPP-2005-0123-0324, Assessment of the Benefits of Soil Fumigation with Chloropicrin and Metam-sodium In Onion Production

 EPA-HQ-OPP-2005-0123-0325, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin and Metam-sodium In Grape Production

 EPA-HQ-OPP-2005-0123-0326, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin and Metam-sodium In Tree Nut Production

 EPA-HQ-OPP-2005-0123-0327, Assessment of the Benefits of Soil Fumigation with Chloropicrin, and Methyl Bromide In Pome Fruit Production

 EPA-HQ-OPP-2005-0123-0328, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin, and Me tam Sodium In Stone Fruit Production

 EPA-HQ-OPP-2005-0123-0329, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Me tam-Sodium in Bell Pepper Production

 EPA-HQ-OPP-2005-0123-0330, Assessment of the Benefits of Soil Fumigation with

Metam-sodium in Potato Production

23 EPA-HQ-OPP-2005-0123-0331, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Meta m-sodium In Strawberry Production

 EPA-HQ-OPP-2005-0123-0332, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, Metam-s odium, and Dazomet In Strawberry Nursery

Runner Production

 EPA-HQ-OPP-2005-0123-0333, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide and Metam-sodium In Sweet Potato Production

 EPA-HQ-OPP-2005-0123-0334, Assessment of the Benefits of Soil Fumigation with Chloropicrin In Tobacco Production

 EPA-HQ-OPP-2005-0123-0335, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Metam-sodium in Tomato Production

 EPA-HQ-OPP-2005-0123-0336, Assessment of the Benefits of Soil Fumigation with

Metam Sodium in Carrot Production

 EPA-HQ-OPP-2005-0123-0337, Assessment of the Benefits of Soil Fumigation with

Metam Sodium in Peanut Production

 EPA-HQ-OPP-2005-0123-0338, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, Metam Sodi um and Dazomet in Ornamental Production

 EPA-HQ-OPP-2005-0123-0339, Summary of the Benefits of Soil Fumigation with Methyl Bromide in Crop Production

 EPA-HQ-OPP-2005-0123-0340, BEAD's Planned Impact Assessments on Agricultural Sites with Significant Use of Soil Fumigants

4. 2008 RED Mitigation Impacts

Requirements in the July 2008 RED

The July 2008 RED acknowledged that even w ith the use of credits, there could be significant economic impacts to some growers who may not be able to accommodate large

buffers based on their current a pplication practices. However, the Agency believed that the options provided in the scalable buffer approach in the fumi gant REDs would allow growers the flexibility to modify their practices to achieve smaller buffers; for example, by treating smaller application blocks, switching to a lower emission application method, or by switching to an alternative fumigant that would require smaller buffers. Therefore, the Agency concluded that growers would be able to alter their fumigation applications, give n the flexibility designed into the system, in a manner that would enable gr owers to minimize the impact on production. The Agency noted, however, that the buffers would significantly impact some growers by delays in planting due to longer fumigation operations, additio nal planning, and more trips to the field for planting and other operations if fu migating in smaller blocks result ed in staggered operations. It

was determined that some of these costs could be substantial in some production scenarios.

Comments on the July 2008 RED

The July 2008 RED requested commenters to submit a description of fumigation practices and provide maps of th eir property illustrating locations of fields, offices, residences,

24roads, and property lines so that the Agency c ould better understand the impacts of the mitigation plan. In response, various stakeholders, incl uding several forest seedling nursery operations, submitted detailed information. From an analysis of the information submitted, including an analysis of a nursery and options they would ha ve for compliance, the Agency concludes that it had overestimated the ease with which many grower s and fumigators would be able to comply with the buffer requirements as presented in the July 2008 RED, and that potential impacts would be much greater than previously anticipated for some types of production.

From the Agency’s analysis, the primary driver of the impacts is the size of the buffer zones, which will require many growers to divide their fields into smaller fumigation blocks to

achieve smaller buffer zone distances. Two ot her contributing factors are the prohibition on buffers overlapping in space and time and the dura tion of the buffer zone. As discussed above, the Agency has provided flexibility on overlapping buffers. Nevertheless, the analysis indicates that the buffer system identifie d in the July 2008 RED can be le ss flexible than expected for

certain scenarios and the associated field t opography, field infrastructure, and need for a

consistent orientation in the application of a fumigant, whic h constrain how a field may be divided. Together, these requirements could result in the loss of part of a grower’s field that can be effectively fumigated. Further, there may be substantial delays in co mpleting fumigations and multiple trips to a field with fu migation equipment may often be necessary. Not only could there be delays in production activities in these instances, but it may also be difficult to maintain proper soil moisture over the period that multiple blocks would be fumigated. Soil moisture has

been identified as a critical element in controllin g emissions. Some growers will face numerous scheduling conflicts if they re ly on commercial applicators, and the Agency estimates that growers would be more likely to conduct their ow n fumigations. In addition, repeated trips to the field to fumigate small bloc ks will increase costs, a furthe r incentive for growers to conduct their own fumigations.

The Agency does agree that compliance with buffer zone requirements as outlined in the July 2008 RED would be a significant challenge fo r applicators and growers. However, field flux studies, monitoring data, modeling analyses and information from incidents involving fumigants continues to support a conclusion th at dazomet off-gasses and moves away from

treated fields at concentrations that have the potential to cause adverse effects. Therefore, the Agency still believes that buffer zones that exclud e bystanders are a critical aspect of mitigating

risks from dazomet.

In addition to these impacts, if emergency preparedness and response requirements were triggered due to proximity of neighbors, for ex ample, the requirement in the July 2008 RED to

monitor the buffer zone for its duration was estima ted to impose the highest direct costs. The Agency estimates that the cost of sampli ng tubes alone could range from $1000 to over $3000 for a field or enterprise, not including th e cost of labor. These costs would fall disproportionately on growers with small acreage. As an alternative, growers could notify their neighbors of their intent to fu migate. However, the Agency understands and appreciates the many comments indicating that no tification may not be an attract ive option due to the potential for neighbors to attempt to impede or block fumigant applications.

25Finally, the Agency concludes that the de velopment and implementation of workable fumigation strategies, considering buffer and other requirements, will require substantial new information and management skills on the part of growers and applicators. While the Agency’s risk management approach provides flexibility to the grower, providing a reasonable period of time for growers to adapt would reduce impacts.

Based on this new information and EPA’s analyses, the Agency has identified modifications to the mitigation which will mainta in the important protections necessary for the health and safety of workers and bystanders, but will increase the ability of fumigant users to comply by reducing impacts associated with the mitigation. This includes allowing buffer zone overlap and changes in monitoring requirements. In addition, due to new data that have been submitted to the Agency and buffer zones distances for some scenarios have been refined. Although many aspects of the RED mitigation will a ppear on labels in 2010, the Agency will not require buffers until the 2011 growing season.

B. Antimicrobial Risk

In addition to the use of fumigants to sterilize soil before planting, there are a number of antimicrobial uses that the Agency has assessed in this RED. Dazomet may be used as an antimicrobial chemical in the following ways: 1) as a treatment duri ng the production of pulp and paper; 2) as a material preservative trea tment for paper coatings, non-food adhesives, epoxy flooring compounds, slurries, and high viscous suspensions; 3) as a biocide treatment used during petroleum operations; 4) as a biocide treatment to recirc ulating cooling water systems; and 5) as a remedial wood treatment to utility poles.

All of the occupational handler risks were below the Agency’s LOC except for some scenarios with the following uses: preservati on of epoxy flooring compounds, pulp and paper slimicide use, and microbe control in large water cooling systems.

For more information on these antimicrobial uses:

 Dazomet Antimicrobial Risk Mitigation Paper. (Garvie, H., Dated June 2008)

 Dazomet: Revised Occupational and Resident ial Exposure Assessment of Antimicrobial Uses for the Reregistration Eligib ility Decision (RED) Document. (Walls, C., Dated June 2008)

 Dazomet: Dietary Risk Assessment of An timicrobial Uses for the Reregistration Eligibility Decision (RED) Document. (Walls, C., Dated March 2007)

 Environmental Fate and Ecologi cal Risk Assessment for th e Reregistration of Dazomet (035602) and MITC (068103) – Antimicrobial Uses. (Petrie, R., Dated April 2007)

Please refer to the RED Appendix for the co mplete document citations, which are also

available in the dazomet docke t (OPP-2005-0128) at www.regulation.gov

.

26IV. Risk Management and Reregistration Decision

A. Determination of Reregistration Eligibility

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data concerning an active ingredient , whether or not products containing the active ingredient are eligible for reregi stration. The Agency has previ ously identified and required the submission of the generic (i.e., active ingredient-specific) data to support reregistration of products containing dazomet. The Agency has completed its assessment of the residential, occupational, and ecological risks associated w ith the use of pesticides containing the active ingredient dazomet.

In Phase 5, the Agency published a risk mitigation options paper. 2 This document detailed potential mitigation options and sought public comment on these options. The following is the list of mitigation options discussed in the Agency’s paper:

 Buffer zones;

 Sealing methods;

 Timing of applications;

 Application block size limitations;

 Respiratory protection;

 Tarp perforation/removal procedures;

 Entry-restricted period;

 Application method/practice restrictions;

 Fumigant management plans (FMPs);

 FMP certification;

 Responsible parties;

 Record keeping/reporting/tracking;

 Restricted Use Pesticide Classification;

 Notification and posting;

 Good agricultural practices;

 Fumigant manuals; and

 Stewardship programs.

Based on a review of the dazomet databa se and public comments on the Agency’s assessments for dazomet, the Agency had sufficient information on the human health and ecological effects of dazomet to make decisions as part of the reregistration process under FIFRA in July 2008. The Agency determined in the 2008 Dazomet RED that dazomet products are eligible for reregistration provided that (i) re quired product specific data are submitted, (ii) the risk mitigation measures outlined in this do cument are adopted, and (iii) label amendments

2 EPA-HQ-OPP-2005- 0128-0031, Risk Mitigation Options to Addre ss Bystander and Occupational Exposures from Soil Fumigant Applications
27are made to implement these mitigation measures, as outlined in Chapter V. Appendix A

summarizes the uses of dazomet that are eligible for reregistration.

The Agency’s decision takes into account th e best available information on the potential

risks and benefits of dazomet use. In reach ing its reregistration decision and developing the dazomet mitigation proposal, EPA considered a ra nge of factors, including: characteristics of bystander and other populations exposed to dazo met; hazard characteristics of dazomet and MITC; available information on levels of exposure, feasibility, cost, and ef fectiveness of various risk mitigation options; incident information; pub lic comments; potential impacts of mitigation on growers ability to produce crops; availability of efficacious alternatives; comparative risks of alternative control methods; a nd the uncertainties and assump tions underlying the risk and

benefit assessments.

A substantial amount of research is currently und erway or is expected to begin in the near term to (1) address current data gaps, and (2) refi ne understanding of factor s that affect fumigant emissions. Additionally, a num ber of new methods and technologies for fumigation are emerging. EPA plans to move the soil fumigant s forward in Registration Review, from 2017 to 2013, which will allow EPA to consider new data and information relatively soon, determine whether the mitigation included in this decision is effectively addressing the risks as EPA believes it will, and to include other soil fumigant s which are not part of the current review.

The Registration Review process for dazome t and the other soil fumigants will also include a comprehensive endangered species assessment. Once that endangered species assessment is completed, further changes to dazomet labels may be necessary.

B. Public Comments and Responses

The Phase 3 public comment period on the pr eliminary risk assessments and related documents for dazomet lasted from July 13 through October 12, 2005. EPA-HQ-OPP-2005­ 0128-0062 contains the Agency responses to Phase 3 public comments related to dazomet uses.

EPA revised its risk assessments and developed benefits and risk mitigation options during Phase 4. The Phase 5 public comment period on re vised risk assessments, benefits analysis, and risk management options took place from May 2 to November 3, 2007. Comments on issues which were significant to many stakeholders and directly in fluenced EPA's decisions are highlighted in this document as well as EPA's responses to those comments. The following documents include EPA’s responses to comments related to dazomet which may be found in the

dazomet docket.

 The Health Effects Division’s Resp onse to Comments on EPA’s Phase 5 Reregistration Eligibility Deci sion Document for Dazomet. (Smith, C., Dated June 2008)

 Response to Phase 5 Public Comments on the Phase 4 Dazomet Environmental Fate and Ecological Risk Assessment. (Khan, F., and Felkel, J., Dated April 2, 2008)

28 Response to Phase 5 BEAD Related Public Comments Received on the Reregistration of Chloropicrin, Dazo met, Metam Potassium, Metam Sodium, and Methyl Bromide. (Donaldson, D. et al., Dated June 2008)

 Review of Stakeholder Submitted Impac t Assessments of Proposed Fumigant Buffers, Comments on Initial Buffer Zone Proposal, and Case Studies of the Impact of a Flexible Buffer System for M anaging By-Stander Risks of Fumigants. (Wyatt, T., et al, Dated June 2008)

 Phase 6 Response to Substantive Public Comments on Antimicrobials Division’s Occupational and Residential Assessment s for the Reregistration Eligibility Decision (RED) Documents for the followi ng chemicals: Methylisothiocyanate (MITC), Metam Sodium, Dazomet, and Chloropicrin. (Walls, C., Dated February 14, 2008)

 SRRD’s Response to Phase 5 Public Comments for the Soil Fumigants. (Dated July

2008 )

The Agency also opened a 60-day public comment period following the publication of the dazomet RED on July 16, 2008. The Agency received requests to extend the comment period, so in response to these requests, on August 29, 2008, EPA published a notice in the Federal Register extending the comment period fo r an additional 45 days. The comment period closed on October 30, 2008. The Agency has re viewed these public comments as well as new

scientific data and other informa tion provided and determined that all measures established in the July 2008 RED to reduce risks to bystanders and wo rkers will still be required. The Agency has

determined that certain modifications in how a nd when some measures will be implemented are appropriate. The following documents include EPA’s responses to comments on the dazomet RED which may be found in the dazomet docket:

 Further Response to Public Comments on the 7/9/08 Completed Dazomet RED. (Dated March 3, 2009)

 Methyl Bromide, 1,3-Dichloropropene, Chloropicrin, Dazomet, Metam Sodium/Potassium, MITC: Health Effects Division (HED) Co mponent of Agency Response To Comments On 2008 Reregi stration Eligibility Documents (Dated May 14, 2009)

 Response to BEAD Related Public Co mments Received on the Reregistration Eligibility Decision for Ch loropicrin, Dazomet, Meta m Potassium, Metam Sodium, and Methyl Bromide (DP# 363545; Dated May 14., 2009)

 Analysis of Soil Fumigant Risk Ma nagement Requirements using Geographic Information Systems: Case Studies based on a Forest Seedling Nursery (DP# 363546; Dated May 13, 2009)

 SRRD’s Response to Post-RED Comments for the Soil Fumigants (Dated May 20, 2009)

C. Regulatory Position

291. Regulatory Rationale

The Agency has determined that dazomet is eligible for reregistration provided the risk mitigation measures outlined in this document ar e adopted and label amendments are made to

reflect these measures. EPA has determined that the modifications to the measures outlined in the July 2008 RED, described herein, will achieve the same protection goals for persons potentially exposed to dazomet but with a great er likelihood of compliance, fewer impacts on the benefits of dazomet use, and with less uncerta inty regarding the protec tiveness of the required measures. The following is a summary of the ra tionale for managing risks associated with the use of dazomet. Where labeling revisions are wa rranted, specific language is set forth in the summary table in Section V of this document.

a. Dazomet Soil Uses

i. Rate Reduction and Use Sites

Rate

The current maximum application rates for dazomet are 530 lbs ai/A for incorporated applications and 265 lbs ai/A for surface applications. Acco rding to the dazomet soil use registrant, Certis, USA LLC, the actual use rate of dazomet is usually much lower for most uses

of dazomet. The turf and ornamental use ra rely requires the maximum rate, except for golf course or turf renovation. For crop uses, the rate generally ranges from 200-300 lbs ai/A, although there are some cases where an application up to 400 lbs ai/A is needed. Therefore, the registrant has agreed to lower the maximum use ra te of dazomet to 425 lbs ai/A for all registered uses except for golf course/turf renovation. The maximum rate for golf course/turf renovation

will remain at 530 lbs ai/A.

Use Sites

Although current labels include instructions for dazomet’s use in greenhouses, the Agency was not aware of greenhouse use occu rring prior to the 2008 RED and prohibited all dazomet use in greenhouses. The Agency re ceived a comment citing dazomet’s use in greenhouses, and in light of this additional info rmation, use in greenhouses is being retained provided the risk mitigation measures outlined in this document are adopted and label

amendments are made to reflect these measur es. Please refer to Table 6 for information regarding greenhouse buffer zones.

ii. Human Health Risk Management

For details on the dazomet human health risk assessment for soil uses, please refer to the

Human Health Risk Assessments referenced in Section III of this document. These documents are also available in the public docket EP A-HQ-OPP-2005-00128, located on-line in the Federal Docket Management System (FDMS) at http://www.regulations.gov.

30Dietary Risk

Based on the currently register ed use patterns for dazomet, dietary exposure, including exposure from drinking water, is not expected and no dietary risk mitigation is warranted for

dazomet at this time.

Bystanders, Workers, and Handlers

The human health risk assessments indicate that inhalation exposure to bystanders who live and work near agricultural fields, nurseries , golf courses, and other areas where dazomet fumigations occur, and to handler s involved in the application of dazomet have the potential to exceed the Agency’s LOC without additional mitigation measures.

To reduce the potential for exposure to bysta nders, handlers, and workers and to address subsequent risks of concern, EP A is requiring a number of mitig ation measures which include:

 Reducing maximum application rates;

 Clarifying use sites;

 Buffer zones;

 Dermal protection for handlers;

 Respiratory protecti on for handlers;

 Restrictions on the timing of perf oration and removing of tarps;

 Posting;

 Good agricultural practices;

 Fumigant management plans;

 Site specific response and management; and

 Notice to state lead agencies.

The Agency also believes that registrant developed and implemented training and community outreach and education programs, will help reduce risk. Additionally, EPA will continue to work with registrants to identify a dditional measures that could be implemented as part of product stewardship. These additional meas ures should include efforts to assist users’ transition to the new label requirements.

Some of the required mitigation measures only address one group of potentially exposed individuals (i.e., bystanders, handlers, or workers) , while other measures will help reduce risk to more than one group. All mitigation measures are designed to work together to reduce exposures, enhance safety, and facilitate complian ce and enforcement. The Agency has based its risk mitigation decision on a flexible approach which EPA believes will be protective and allow users to make site-specific choices to reduce po tential impacts on benefits of the use. While some of these measures, buffer zones for example, can be used to estimate MOEs, others such as emergency preparedness and response and comm unity education will contribute to bystander safety, but are difficult to expre ss in terms of changes to quantit ative risk estimates such as

31MOEs. However, EPA has determined that these measures, working together, will prevent

unreasonable adverse effects to human health.

aa. Bystander Risk Mitigation

Bystanders are persons who live and/or work near fumigated fields and are potentially exposed to fumigant emissions th at travel off-site. In some cases the bystanders are workers performing agricultural tasks in nearby fields. If they are employed by the grower who has control of the fumigated field, they are more likel y to be aware that a fumigant application has

occurred.

Bystander risks for people that live near tr eated fields differ from other human health risks evaluated under FIFRA, fo r example residential and worker reentry risks. Unlike residential exposures resulting from use of pr oducts to control pests in and around the home, non-occupational bystanders receive no direct benefit from the pesticide which was applied elsewhere. These bystanders have not made a decision to purchase a pe st control product or service, and as a result they have little acces s to information about the product (e.g., hazards, safety information, first aid, etc.) or sympto ms of exposure. Additionally, non-occupational bystander exposures to fumigants are largely invo luntary and unanticipated. In this regard nonoccupational bystander exposure is similar to dietar y exposure in that people consuming foods or drinking water expect to be safe from possible adverse effects asso ciated with pesticide residues that could be present in their food and drinking water.

Unlike workers, non-occupational bystanders ty pically receive no safety information or training related to the pesticide to which they may be exposed. Whereas workers are generally expected to play an active role in protecting themselves from pe sticide risk, no such expectation exists for non-occupational bystanders. Work ers who experience symptoms of pesticide exposure are also more likely to link their sympto ms to the pesticide and take steps to receive appropriate treatment. Conversely, bystanders are much less likely to attribute adverse effects to pesticide exposures or to have access to informa tion needed to take appropriate steps to mitigate the effects of the exposure. Thus, EPA’s mitig ation includes elements for site specific response and management, notice to state lead agencies, training, and community out reach and education, as well as labeling changes.

1. Buffer Zones

The human health risk assessments indicat e bystanders may be exposed to MITC air concentrations, following dazomet applications, which exceed the Agency’s level of concern based on current label requirements. In general, the risk from inhalation exposures decreases as the distance from the field where bystanders are lo cated increases. Because of this relationship, the Agency has determined that a buffer zone mu st be established around the perimeter of each application block where dazomet is applied. The Agency acknowledges that buffer zones alone will not mitigate all risks or eliminate incide nts caused by equipment failure, human error, adverse weather (e.g., temperature inversions), or other events. The Agency however does

32believe that buffer zones along with other m itigation measures required by this decision described below will mitigate risks so that bys tanders will not experience unreasonable adverse

effects.

Buffer Zone Requirements

General Requirements in the July 2008 RED

The 2008 dazomet RED described general buffe r zone requirements for dazomet and other soil fumigants. This included the definiti on of a buffer zone, the requirement to exclude non-handlers from the buffer zone during the buffer-zone period, and the definition of the application block.

The RED also did not allow buffer zones to overlap and fumigations were prohibited

within 0.25 miles of difficult to evacuate sites such as schools, state licensed day care centers, nursing homes, and hospitals, if occupied during the buffer zone period. Exemptions for vehicular and bicycle traffic were allowed on ro adways through the buffer zone. However, bus stops or other locations where persons wait for p ublic transit were not permitted within the buffer

zone. Structures within the buffer zone were al so not allowed to be occupied during the buffer zone period and air samples were required before bystanders c ould enter the structure following expiration of the buffer-zone period. In addition, before a buffer zone could extend onto adjacent private or public property, the applicator needed to obtain written permission from the owner/operator or local authority to allow the buf fer zone to extend onto the property. This was

to ensure that non-handlers woul d not enter the buffer zone and th at buffer zones did not overlap.

Comments on the July 2008 RED

During the post-RED comment period, the Agency received many comments from stakeholders concerning the buffer zone require ments. Many comments stated that the large buffer zone distances would make fumigation infeasible and the mitigation options were not flexible enough to allow some fumigations to occur; however other co mments expressed concern that buffers EPA specified would not be large enough to protect bystanders.

The Agency also received numerous comment s that buffer zone duration will present severe hardship for growers. Many commenters expressed concern that the buffer zone overlap

restriction would have the uninten ded consequence of forcing some applications to occur during less-than-optimal weather and soil conditions, because the restriction could preclude nearby application blocks from being treated when w eather and soil conditions would be optimal for reducing emissions. Hence, subsequent fumigations in adjacent fields would have an increased chance of occurring when weather and soil cond itions are more conducive to off-gassing. Examples cited by commenters where this situ ation could occur include the Southeast and Pacific Northwest where optimal soil moisture conditions occur during a limited time period.

The commenters felt that while the buffer zone is in effect, properly trained and equipped handlers should be allowed to enter adjacent appl ication blocks to make applications. Several commenters felt that providing an exception to this prohibition woul d make buffers more

33workable, reduce delays, allow a more efficient use of equipment and labor, allow growers additional flexibility to achieve compliance with buffer requirements, and potentially reduce risk if applications could be made under more favor able soil and weather conditions. In addition, some comments suggested that allowing adjacent application blocks to be treated would not increase risk to bystanders since the Agency’s mitigation measures encourage users to split application blocks into smaller treatment areas which result in less fumigant being applied, less exposure, and less potential risk.

Some commenters also asked for clarification on various aspects of the buffer zone requirements, and some asked that EPA provi de additional increments for acreages and application rates for buffer zone tables. In addition, many commenters st ated that buffer zone credits should be greater for the use of tarps a nd for certain environmenta l conditions. A number

of comments indicated that obtai ning written permission from local authorities for buffers to extend over roads and rights-of-way would be extremely difficult, and that neighbors may not provide permission. EPA also re ceived additional field emi ssions (flux) data for some fumigants, as well as additional information regarding factors that affect fumigant emissions.

Based on EPA’s review of the comments, and new data and information, the Agency has

determined that certain amendments to the bu ffer zone requirements are appropriate. EPA

believes these amendments will maintain the important protections for bystanders but will increase the feasibility of compliance with buffe rs and will reduce potential impacts of buffers on the beneficial uses of soil fumigants. The Ag ency does agree that compliance with buffer zone requirements as outlined in the July 2008 RED would be a signifi cant challenge for applicators and growers. However, field flux studies, m onitoring data, modeling analyses, and information from incidents involving fumigants continue to support a conclusion that dazomet off-gasses and moves away from treated fields at concentrations that have the poten tial to cause adverse effects. Therefore, the Agency still believes that buffer zones that exclude bystanders are a critical aspect of mitigating risks from the use of dazomet. Th e Agency believes the modifications to the buffer requirements, specified below, will increase compliance feasibility and encourage further adoption of emission reduction ap plication techniques, while stil l protecting human health and

the environment.

Amended RED Requirements

EPA has determined that no changes to se veral aspects of the general buffer zone requirements from the 2008 RED are appropriate. This includes

- the definition and duration of a buffer zone;

- the requirement to exclude field workers, nearby residents, pe destrians, and other bystanders from the buffer zone during the buffer zone period (except for transit);

- the definition of the application block;

- the minimum buffer of 25 feet and maximum buffer of 1⁄2 mile.

- the requirement limiting entry into buffer zones to handlers who have been properly trained and equipped according to EPA’s Worker Protection Standard;

- the exemption for transit through buffer zones;

34- the prohibition on including in buffer z ones bus stops or other locations where persons wait for public transit;

- the prohibition against incl uding in buffer zones buildings under the control of the owner/operator of the application block us ed for storage such as sheds, barns, garages, etc., unless the st orage buildings are not occ upied during the buffer zone period, and the storage buildings do not share a common wall with an occupied

structure;

- the prohibition against incl uding in buffer zones residen tial areas that are not under the control of the owner/operator unless o ccupants agree in writing that they will voluntarily vacate the buffer zone until the buffer zone period expires;

- the prohibition against incl uding in buffer zones agricultu ral areas that are not under the control of the owner/ope rator unless the owner/operator of the other area provides written agreement that they, their employ ees, and other persons will not enter the buffer zone; and

- the prohibition against incl uding in buffer zones publicly owned and/or operated areas such as parks, sidewalks, walki ng paths, playgrounds, and athletic fields without first obtaining written perm ission from local authorities.

EPA has determined that certain other amendments to the July 2008 RED requirements are appropriate; these are discussed in great er detail below. The amended buffer zone requirements are summarized at the end of this section.

Buffer Zone Proximity - Exception to Allow Buffer Zone Overlap

The Agency is concerned that emissions from multiple fields located close to one another could be higher than air concentrations from i ndividually treated fields. As a result, bystanders outside of buffers for individual application bl ocks could be exposed to concentrations of concern particularly if peak concentrations from multiple application blocks in proximity to each

other coincide. To reduce the potential for off-site movement of fumigant emissions beyond buffer zones for multiple fumigated fields, the July 2008 RED prohibited buffer zones from multiple application blocks from overlapping, in cluding application blocks fumigated by other

property operators.

EPA has considered the comments submitted and has determined that allowing an exception to the buffer zone overlap prohibiti on, under the conditions specified below, is reasonable and will not demonstrably alter the prot ection goals provided to bystanders in the July

2008 RED. EPA has determined that buffer zone s from nearby application blocks may overlap one another provided at least 12 hours have elap sed from the end of one application until the start of the next application. By separati ng the application times by at least 12 hours the fumigant emission peaks are less likely to occu r at the same time, which would sufficiently reduce potential exposure outside buffer zones a nd meets the Agency’s protection goals.

The Agency is maintaining the requirem ent for buffer zones around each application

block to be in effect for 48 hour s, as well as the requirement that only proper ly trained and equipped handlers are allowed to enter into buffers zones.

35To clarify, below are conditions when buffer zones may or may not overlap:

 A buffer zone may NOT overlap buffer zone s from other application blocks that are already in effect UN LESS a minimum of 12 hours has elapsed from the time the first application ends until the second application begins.

EPA has determined that when fumigators exercise the exception to allow buffers to overlap, the emergency preparedness and response measures described later in this document must be implemented if there are homes, businesse s, or property not within the control of the fumigator within 300 feet of the buffer zone.

To ensure handlers are aware that they ar e working in an existing buffer from an overlapping buffer zone area, the la bels will require the certified applicator, before beginning the application, to determine whether the application block or its resu lting buffer will overlap with a buffer that is already in effect. If so, the certified app licator must inform handlers of this and the health effects, early signs of exposure, and respiratory protection and PPE requirements for products applied in both the application bloc k in which they are working and the other application block. The Agency is requiring that all treatment areas and buffers be clearly posted with proper signage to ensure ha ndlers entering a treatment area are aware of previous treatments

and the existence of buffers associated with that treatment. In addition, ce rtified applicators must obtain permission from other landowners when bu ffers extend onto other lands. This provides an additional mechanism to ensure handlers are aware when they are working in a buffer zone and that they have the necessary information re garding health effects, warning properties, and respiratory/PPE requirements for all products they may be exposed to.

Areas not under the control of owne r/operator of the application block

For areas not under the contro l of the owner/operator of the application block, the requirements remain unchanged except (1) air samples do not need to be taken to allow occupants to reenter buildings or homes after the buffer zone period ha s expired, and (2) buffer zones may include publicly owned and/or operated roads, including rights of ways, without first obtaining written permission from lo cal authorities; however, if a sidewalk or permanent walking path is associated with the road or right-of -way, written permission must be given by the appropriate state and/or local authorities.

In summary, areas of a buffer zone not unde r the control of the owner/operator of the application block, may not include residen tial areas (including employee housing, private property, buildings, commercial, industrial, and other areas that peopl e may occupy or outdoor residential areas, such as lawns, gardens, or play areas) unless the occupants provide written agreement that they will voluntarily vacate the buffe r zone during the entire buffer zone period. The Agency determined that the concentrations of the fumigants 48 hours after completion of the application were likely to be below the Agen cy’s level of concern, and that the warning properties of MITC would alert persons reenteri ng these sites if con centrations had not yet

36dissipated were of concern. Therefore, mon itoring of buildings a nd outdoor areas after termination of the buffer zone is not necessary and will no longer be required.

Buffer zones may still not include agricultural areas owned/operated by persons other than the owner/operator of the application bloc k unless the owner/operator of the application block can ensure that the buffer zone will not overlap with a buffer zone from any adjacent property owners, taking into account the ame nded requirements for overlapping buffers. In addition, the applicator must st ill receive written permission fr om the owner/operator of areas

that are not under the control of the applicator stating that the owner, their employees, and other persons other than handlers, consistent with buffe r overlap provisions, will stay out of the buffer zone during the entire buffer zone period. The goal of this agreemen t is to ensure that a property owner of an agricultural fi eld adjacent to an area that will be treated with a fumigant is aware when the fumigation will occur. This will allow the applicator to post on the adjacent property and take other required safety measures to en sure that persons on the property will not be exposed to a fumigant at levels above the Agency’s level of concern. Informing the property owner of the adjacent field will enable them to take any appropriate safety measure The Agency believes that requiring the applicator to obtain wr itten permission will be an enforceable measure that will meet the goal of protecting worker s and bystanders on adjacen t properties that fall

within a buffer zone.

In addition, buffer zones still may include publ icly owned and/or ope rated areas such as parks, sidewalks, walking paths, playgrounds, and athletic fields onl y if the area is not occupied during the buffer zone period a nd entry by non-handlers is prohi bited during the buffer zone period. Written permission from the appropriate st ate and/or local author ities to include those public areas in the buffer zone is also still required.

However, for roads and rights-of-ways, EPA ha s determined that these may be included in buffers, subject to local laws and regulati ons, as long as it is posted according to the requirements of this amended RED. If, as di scussed above, the road or right-of-way has an associated sidewalk or permanent walking path, then written permission would also be required to include the area in the buffer zone. The Agency believes that if a town or county has invested resources into building a sidewalk or establishing a walking path, it is reasonable to anticipate pedestrian traffic at that locati on. In such circumstances EPA be lieves a local authority would be best positioned to make a determination about the practicality of preventing non-handlers from entering the buffer zone. EPA acknowledges that la ws and regulations vary from jurisdiction to jurisdiction and that the requireme nt to post points of entry into buffer zones may necessitate additional steps on the part of fumigant applicator s before a road or right-of-way can be included

in a buffer.

Buffer zone distances

The Agency has received additional flux st udies from the California Department of Pesticide Regulation, and the dazomet buffer zones ha ve been revised to reflect this new data as well as other information received during Phas e 5 comment period. Buffer zones have increased for surface applications of between 132 lbs ai/A and 265 lbs ai/A only.

37PERFUM Model Inputs

The major input parameters for the modeling were: application rate s, application block sizes, application method emission profiles, weathe r conditions, and the targ et air concentration (based on acute inhalation endpoint and uncertain ty factors). The following summarizes the key points for each of these input parameters.

Rates

The maximum rates for soil applications of dazomet are 425 lbs ai/A for incorporated applications and 265 lbs ai/A for surface applications. Since there is limited use information on typical dazomet rates, a range of rates was modeled. The rates used in the model included the maximum, along with rates at 75%, 50%, and 25% of the maximum for both surface and incorporated applications.

Rates for bedded or strip applications (lb ai per treated area) were converted to broadcast equivalent application rate to determine the minimum buffe r zone distance. In Figures 1 and 2 (shown below), the dashed line re presents the perimeter of the field, the shaded area is the portion of the field that is treated, and the un-sh aded area is the untreated portion of the field. Assuming both fields are 10 acres, and only 50% of field in Figure 2 is fumigated, the rate per
treated acre is 400 lbs ai/A for both Figure 1 and 2. The broadcast rate for Figure 1 is 400 lb

ai/A but the effective broadcast equivalent rate for Figure 2 is 200 lbs ai/A. Labels may express rates as lbs per treated acre unde r the application instru ctions but they must identify buffer zone

distances based on the broadcast or e ffective broadcast equivalent rates.

Figure 1. Broadcast Application Figure 2. Bedded Application

Block Sizes

The Agency has limited information available on the size of application blocks treated in a given day but according to the registrants, dazome t is generally applied to a smaller number of acres than other fumigants, typically from 5 to 20 acres. The modeling did consider block sizes up to 40 acres per day for dazomet, and so based on the registrant comment the application block

size will be limited to 40 acres for dazomet.

38The application block size pertai ns to size of the field and no t the size of the area treated. The area inside the dashed lines in both Figures 1 and 2 is the application block. In this example the application block size for both figures is 10 acres. For both figures, 10 acres would be used

to determine the buffer zone distance.

During the post-RED comment period, the Ag ency received comments requesting buffer zone distances for additional acreage increments for small fields. In response, the Agency

determined buffer distances for smaller bloc k sizes (1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 acres). Although the Agency added addition al acreage and rate increments , not all increments may be captured by the tables presented. If the tables do not capture a specific acreage or rate, round up to the nearest acre or rate. For example, when applying to a 9.5 acre field, round up to 10 acres.

In the 2008 RED, the Agency had calculated all dazomet buffer zones based on a square application block. The Agency received comments regarding the buffer zone calculations for the use of dazomet on golf course fairways, as a rect angular applicator block is more representative of how fairways are treated. The Agency agr ees that fairways should be calculated using a rectangular application block because it is more representative of th e typical treatment for specific use-site. The Agency has thus calcula ted the buffer zones for golf course fairways taking into account this additional information, a nd more information on these buffers is located

in the section on buffer zone distances.

Emission Studies

The Agency’s risk assessment for the RED includes modeling of the two main ways that dazomet is applied, surface or soil-incorporated. Details of these emission studies can be found in Appendix D of the Dazomet: Final Revised HED Chapter of the Reregistration Eligibility Decision Document (RED dated April 2009)

.

Weather

It is estimated that the major use of dazome t is in California and Washington. Some use in Michigan and Florida (or elsewhere in those re gions) is also estimated. As a result, weather data for the following locations were included in this assessment: Bakers field, CA; Ventura, CA; Flint, MI; Tallahassee, FL; Bradenton, FL; and Ya kima, WA. Each modeling run used five years of weather (i.e., 1,825 potential application days) for each weather data set. Generally, Ventura, and Bradenton weather data result in the larges t buffer zone distances, Bakersfield, Tallahassee, and Yakima data fall in the middle, and Flint data resulted in the smallest buffers.

Target Air Concentration

As described in the Human Health Risks s ection of Chapter III, the 22 ppb target air

concentration is based on a reve rsible sensitive endpoint from a human eye irritation and odor threshold study for acute exposures to MITC, with a 10X uncertainty factor for intraspecies extrapolation. The lowest observable adverse effect level (LOAEL) was 800 ppb and the human

39concentration (HC) based on the no observable adverse effect leve l (NOAEL) from this study is 220 ppb.

PERFUM Model Outputs

The PERFUM model outputs are presented in percentiles for “whole field” and the

“maximum distance” distributions. The model al so provides outputs as distributions of air

concentrations from which MOEs can be estima ted. The following summarizes the key points

for each of these output parameters.

The maximum distance distribution is a compilation of the farthest predicted buffer distances (i.e., the farthest dow nwind points) over 5 years of weather. The whole field

distribution differs because it includes all points around the pe rimeter for the same period. Another way to consider the difference between the distributions is that maximum distance

results are a subset of the w hole field results and that maxi mum distances allow for more resolution at the upper percentiles of this distribution. Version 2.1.4 of PERFUM also allows for

direct consideration of air conc entrations at various distances around treated fields. These air

concentrations and MOEs were also cons idered in the decision making process.

An analysis based on a variety of PERFUM outputs was used in the buffer distance

determinations. This involved consideration of not only the typical maximum and whole-field results, which are predictions of the distances at which a target concentration of concern (i.e., the human concentration adjusted by applicable uncertainty fact ors) is achieved at varying percentiles of exposure. In addition, a comp lementary approach, which determined the percentiles of exposure for maximum and whole-fi eld buffers at predetermined buffer distances, was employed. Air concentration da ta were also used to calculate risk estimates (i.e., MOEs) at predefined buffer distances and varied percentiles of exposure.

This overall approach allowed the Agency to utilize more of the information available from PERFUM so that a more comprehensive view of the risks could be considered. Buffer distances indicated by this type of analysis along with informa tion from monitoring studies and incidents were valuable in determining buffer di stances to manage potential risks from dazomet use when coupled with other mitigation measures.

Buffer Zone Distances

The Agency has developed buffer zones di stances based on app lication rate and application block size (rounding up to nearest rate and block size). These distances are summarized in Tables 4, 5, 6, and 7.

For each of the soil emission studies, distances were first chosen for the rates identified in the risk assessment as the 100%, 75%, 50%, and 25% of the maximum rates for each application method, as shown by the bolded red font in the tabl e. For example, for surface applications the rates were 265 lbs ai/A, 200 lb s ai/A, 132 lbs ai/A, and 66 lbs ai/A; and for incorporated applications the rates were 530 lbs ai/A, 400 lbs ai/A, 265 lbs ai/A, and 132 lbs ai/A. For golf

40course fairways, buffers were calculated for recta ngular application blocks of 1 and 5 acres. For greenhouse applications, buffers were calcula ted for structures sizes between 5,000 and 50,000 square feet. For all other applications, applica tion block sizes of 5, 20, and 40 acres were used in

the buffer zone calculations. Distances for the ot her rates in the buffer zone tables were scaled by assuming a linear relationship between the 100%, 75%, 50%, and 25%, and maximum rates (e.g., distance at 37.5% rate = [distance at 25% rate + distance at 50% rate]/2 ) with some adjustments for whole numbers. This scaling was necessary to provide an incremental spread of

rates. It should be noted that the distances in the lookup tables are not model outputs, although the model outputs were used for their development.

Minimum and Maximum Buffer Zone Distances

For dazomet, the largest bu ffer distance is 1140 for appli cations of 265 lbs ai/A for greenhouses of 50,000 square feet. Applications to larger block sizes and higher rates will be prohibited for dazomet. Comments from the regi strants indicate that dazo met users do not apply to large areas at the very highest rates on current labels. A minimum buffer zone of 25 feet will be required regardless of site-specific applicati on parameters. In some instances the PERFUM model predicts that the risks reach the target at the edge of the field, but the Agency believes that a 25 foot minimum buffer is a good agricultural practice. While modeling may support no buffer in some cases, a minimum buffer is being required because of variability in emission rate over a

field and other factors not accounted for in the modeling.

Additional buffer tables for use of dazomet in greenhouses and for golf course use have

been added below since the 2008 RED.

41Table 4: Buffer zone distances (in feet) for all dazomet soil applications except golf course fairways and greenhousesApplication Rates for incorporated applications (lbs ai/acre)BlockSize(acres)42540039038037036035034033032031030029028027026526025024040864770750730710690670650630610590565545524505500490471452306926055885715545375205034874704544354174003833753683533382052044042641239838437035634333031730528827526025024523422315400343333323312302292281271261251242229219208200193182171102802472402332272202132072001931861791711641561501411301199256230222215210204198192186180173167159153146140130120109823221020419719318818217717116716015514714213613011910998720819018617917617216616215715314714213513112512011099896184170168161159156151147143139134129123119115110998978516015014714414113813513212812412011611210810410089786741501351301271231201171131091051019793898582726455314011711311010610299959187827875706664565043212010096928884807672686460565248444036321 or less110757269666360575451484542393633302525Application Rates for incorporated applications (lbs ai/acre)BlockSize(acres)230220210200190180170160150140132130120110100908070664043341439537535733932130328526725025021818615412290582530323308293281268255242229215202188188164141117947047252021220119018717917116315414513612512511095806550352515160149138133127.7122117111105999292827262524232251010897867976.3373.771686562585853484338332825999897668656361595654514945413834312825888786557555351494745444138353330282725427786854464443424139383735333130282726256675744383534333231313030292828272626255564534252525252525252525252525252525254473931252525252525252525252525252525253383229252525252525252525252525252525252282525252525252525252525252525252525251 or less25252525252525252525252525252525252525Table 5: Buffer zone distances (in feet) for all dazomet soil applications except golf course fairways and greenhousesApplication Rates for surface applications (lbs ai/acre)BlockSize(acres)265260250240230220210200190180170160150140132130120110100908070664067566966365765164563963057652246741436030625025021818615412290582530560546532518504490477465425385345305265225188188164141117947047252045042940838736634532330027525022520017515012512511095806550352515420400379359338318297274248222196170144118929281.677262524232251039037135033131029127124822119416714011386585853.3348433833282593603423213032822642452221971721471229772515147434136312725833031329227525423721919617214812410076524444413838332927257300284263247226210193170151132113947556383835343330282625627025523421919818316714412711093765942313130292927262625524022320618917215513812010692786450362525252525252525254176164152140128116104918273645546372525252525252525253112105989184777062575146403530252525252525252525247454241393836353332292827262525252525252525251 or less353434333231313129282727262625252525252525252543Table 6: Buffer zone distances (in feet) for dazomet greenhouse applicationsStructure Size265 lbs ai/A (100%)200 lbs ai/A (75%)132 lbs ai/A (50%)66 lbs ai/A (25%)5000 square feet2401801204510000 square feet3603002109015000 square feet45033027011020000 square feet54045033017025000 square feet63054039021030000 square feet72057045024035000 square feet81065058527040000 square feet85572054030045000 square feet90076060033050000 square feet1140810630360Table 7: Buffer zone distances (in feet) for dazomet golf course fairways applicationsApplication Rates for incorporated applications (lbs ai/acre)BlockSize(acres)5304003903803703603503403303203103002902802702652602502405252525252525252525252525252525252525254252525252525252525252525252525252525253252525252525252525252525252525252525252252525252525252525252525252525252525251 or less2525252525252525252525252525252525252544The buffer zone distances shown in Table 7 are based on PERFUM modeling runs that are representative of golf course fairways where the width of the application block is 15% of the length of the application block. This ratio was proposed by the d azomet registrants as a typical representation of golf course fairways. The Agen cy understands that golf course fairway width to length ratios can vary signifi cantly. Given these potential vari ations, the Agency believes that applicators can use the rectangular buffer zones shown in Table 6 if the width of the application block is less than or equal to 20% of the length of the applica tion block. Examples have been provided below:

For an application block 550 feet long by 110 feet wide: 110 feet / 550 feet = 0.20 x 100 = 20%, so the buffers in table 6 can be used

For an application block 700 feet long by 175 feet wide: 700 feet / 175 feet = .25 x 100 = 25%, so the buffers in table 6 cannot be used;

The buffers in table 4 must be used instead.

The buffer zone distances were not based on the selection of a sp ecific percentile or distribution from the PERFUM modeling results. Rather, EPA used a weight of evidence approach to set the buffers which included c onsideration of the hazard profile of MITC, information from incident reports, monito ring data, stakeholder comments along with comprehensive analysis of results from PERFUM modeling and considera tion of results using other models (e.g., the F umigant E missions M odeling S ystem or FEMS). Each model was reviewed by the FIFRA Scientific Adviso ry Panel (SAP) in 2004 during the August and September meetings ( http://www.epa.gov/oscpmon t/sap/meetings/2004/index.htm ). The analysis of PERFUM results considered distances at various percentiles of the whole field and maximum distance distributions, and predicted MOEs for various distances. The risk assessment characterizes additional types of analysis that we re performed. EPA’s goal for risk management

was to achieve buffer distances where associated risks were at or above target concentration levels at high percentiles of exposure. The fo llowing characterizes the risks associated with the

buffer zone distances summarized in Table 8:

• This table shows the various buffer distances fo r each rate and block size. It also shows the percentile for the whole and maximum distribution for each dist ance, as well as the MOE at the 95th percentile air concentration of PERFUM2.

• The target MOE for dazomet is 10, and the MO Es at these distances range from about 7 up to 20. Although the target air concentration is not below ou r LOC at all the distances, at the lowest MOE of 7, the predicted air co ncentration would be 28 times lower than the

lowest observable adverse effect level (LOAEL) that is the level where the eye irritation effects were first observed in the human study.

• Two registrant-submitted studies were used to calculate the buffers in the RED, and this data indicated little apparent difference in risk between the surface and incorporated application methods when sim ilar rates were compared.

• Flux data for surface applications was submitted by CDPR during the comment period, and the Agency has incorporated this new data in calculating the surface application

45buffer distances. The new surface application buf fer zone distances were calculated using the CDPR data because it is more conservative, and the buffer zones for the higher surface application rates have ch anged as a result. Since the Agency did not receive any new data for the incorporated application method, buffer zone distances for this method have not changed since the RED.

• The use of GAPs, FMPs, and other mitigati on measures required by this decision will

contribute to an addition al decrease in risk (see GAP and FMP sections).

Example

Table 8 shows the required buffer zone di stances and correspondi ng PERFUM modeling results for the soil uses of dazomet (excludi ng fairway and greenhouse applications) using both

the maximum distribution and the w hole field distribution to the ta rget concentration based on an MOE of 10, as well as the MOE fr om the air concentration out puts from PERFUM at the 95th percentile. The weather data selected here are from Ventura, CA, si nce only California has agricultural uses registered which typically invo lve larger application blocks than dazomet’s

other soil uses.

Focusing on the incorporated ap plication method in the top ro w, using a 265 lbs ai/A rate on a 40 Acre block size, the buffer zone required fo r that application is 500 feet. The blocks referenced in this example are shaded in gray in Table 8.

 At this distance using the PERFUM model to predict both the whole field and maximum

distributions the results indicate 91 st percentile for whole field and 57 th percentile for maximum, as shown in the next two columns in the table.

o The risk level corresponding to th is buffer zone distance at the 91 st percentile

whole field distribution is equivalent to saying a pers on at any location on the perimeter of the buffer zone during th e 24 hour period following the fumigation of a specific field during a 5-year period would have at least a 91 percent chance of having of an exposure below the LOC (i.e., MOE of ≥ 10).

o The risk level corresponding to th e buffer zone distances at the 57 th percentile

maximum distribution is e quivalent to saying a pers on at the location on the perimeter of the buffer zone where the maximum concentration occurs during the worst case 24 hour period following the fumigation of a specific field during a 5­ year period would have a 57 percent chan ce of having of an exposure below the LOC (i.e., MOE of ≥ 10) for these typical use scenarios.

 Using the PERFUM 2 model outputs of air co ncentrations to predict MOEs at the 95 th
percentile, at 500 feet for thes e application parameters, the MOE is about 9 which is not significantly below th e target MOE of 10.

46Table 8: Dazomet’s Buffers and Risk EstimatesIncorporated applications530 lbs ai/A (100%)Max incorporated rate400 lbs ai/A (75%)265 lbs ai/A (50%)132 lbs ai/A (25%)BlockSize(acres)BufferDistance(feet)PercentileusingPERFUM atMOE of 10MOE at95thpercentileofPERFUM 2BufferDistance(feet)PercentileusingPERFUM atMOE of 10MOE at95thpercentile ofPERFUM 2BufferDistance(feet)PercentileusingPERFUM atMOE of 10MOE at95thpercentileofPERFUM 2BufferDistance(feet)PercentileusingPERFUM atMOE of 10MOE at95thpercentileofPERFUM 2WholeMaxWholeMaxWholeMaxWholeMax401080934677709350750091579250967211206509343744093497250915381259873125200924471509274810096631125999819Surface applications265 lbs ai/A (100%)Max surface rate200 lbs ai/A (75%)132 lbs ai/A (50%)66 lbs ai/A (25%)BlockSize(acres)BufferDistance(feet)PercentileusingPERFUM atMOE of 10MOE at95thpercentileofPERFUM 2BufferDistance(feet)PercentileusingPERFUM atMOE of 10MOE at95thpercentile ofPERFUM 2BufferDistance(feet)PercentileusingPERFUM atMOE of 10MOE at95thpercentileofPERFUM 2BufferDistance(feet)PercentileusingPERFUM atMOE of 10MOE at95thpercentileofPERFUM 2WholeMaxWholeMaxWholeMaxWholeMax406759023763093457250893872590618204509025730090307125883372593721052409338712090307258737725999114Ventura Weather Data is used to calculate all the numbers in this table since it was one of the worst weather scenarios and forthe agricultural uses of dazometthere is more use in California than Florida.Shaded areas represent the numbersexplained in the example above.All values are approximate.47The Agency believes that the buffer zone dist ances described above, combined with other risk mitigations described herein, will provide protection against any unreasonable adverse

effects.

Amended General Buffer Zone Requirements

The following describes the general buffer zone requirements, as amended, for dazomet:

 “Buffer zone” is an area established around the perimeter of each application block or greenhouse where a soil fumigant is applied. The buffer zone must extend from the edge of the application block or greenhouse peri meter equally in all directions.

 All non-handlers including field workers, nearby residents, pedestrian s, and other bystanders, must be excluded from the buffer zone during th e buffer zone period except for transit (see exemptions section).

 The “buffer zone period” starts at the moment when any fumigant is delivered/dispensed to the soil within the applicati on block and lasts for a minimum of 48 hours after the fumigant has stopped being delivered/ dispensed to the soil.

 An “application block” is a fiel d or portion of a field treated with a fumigant in any 24-hour period. See exception provided in the “Bu ffer zone proximity” section below.

Buffer zone proximity

 To reduce the potential for off-site movement from multiple fumigated fields, buffer zones from multiple dazomet application blocks may not overlap UNLESS:

o A minimum of 12 hours have elapsed from th e time the earlier application(s) for which a buffer is in place end(s) un til the latter application begins, and

o Emergency preparedness and response meas ures specified later in this document have been implemented if there are any homes, businesses, or property not within the control of the fumigator within 300 feet of each buffer zone.

Buffer zone distances

 Buffer zone distances must be based on look-up tables on product labels. Twenty-five feet is the minimum buffer distance regardless of site-specific application parameters.

 For selective replant fumigation in an orch ard using hand held application methods (e.g., deep injection auger probes), the minimum bu ffer zone will be 25 feet measured from the center of each injection s ite (i.e., tree hole).

Authorized entry to buffer zones

 Only authorized handlers who have been prope rly trained and equippe d according to EPA’s Worker Protection Standard (WPS) and label re quirements may be in the buffer zone during the buffer zone period.

48Exemptions for transit through buffer zones

 Vehicular and bicycle traffic on public and pr ivate roadways through the buffer zone is permitted. "Roadway" means that portion of a street or highway improved, designed or ordinarily used for vehicular travel, exclusiv e of the sidewalk or shoulder even if such

sidewalk or shoulder is used by persons riding bicycles. In the event a highway includes two or more separated roadways, the term "roadway " shall refer to any such roadway separately. (This definition is based on the definition of ro adway in the Uniform Vehicle Code prepared by the National Committee on Uniform Traffic Laws and Ordinances. See http://www.ncutlo.org/ for more details)

 Bus stops or other locations where persons wait for public transit are not permitted within the

buffer zone.

 See the Posting Section of this document for additional requirements that may apply.

Structures under the control of owne r/operator of the application block

 Buffer zones may not include buildings used for storage such as sheds, barns, garages, etc., UNLESS,

1. The storage buildings are not occupied during the buffer zone period, and

2. The storage buildings do not share a common wall with an occupied structure.

 See the Posting Section of this document for additional requirements that may apply.

Areas not under the control of owne r/operator of the application block

 Buffer zones may not include residential areas (including employee housing, private property, buildings, commercial, industrial, and other areas that people may occupy or outdoor residential areas, such as lawns, gardens, or play areas) UNLESS,

1. The occupants provide written agreement that they will voluntarily vacate the buffer zone during the entire buffer zone period, and

2. Reentry by occupants and other non -handlers must not occur until,

 The buffer zone period has ended, and;

 Sensory irritation is not experienced

 Buffer zones may not include agricultural ar eas owned/operated by pe rsons other than the owner/operator of the application block, UNLESS,

1. The owner/operator of the application bloc k can ensure that the buffer zone will not overlap with a buffer zone from any adjacent property owners, except as provided for above, and

2. The owner/operator of the adjacent areas (i.e ., areas that are not unde r the control of the owner/operator of the application block) provide s written agreement to the applicator that they, their employees, and other persons will stay out of the buffer zone during the entire buffer zone period.

 Buffer zones must not include roads and rights of way UNLESS,

1. The area is not occupied dur ing the buffer zone period, and

2. Entry by non-handlers is prohibited during the buffer zone period.

493. Applicators must comply w ith all local laws and regulations.

 For all other publicly owned and/or operated areas such as parks, side walks, walking paths, playgrounds, and athletic fields, buffer zones must not include these areas UNLESS,

1. The area is not occupied dur ing the buffer zone period,

2. Entry by non-handlers is prohibited during the buffer zone period, and

3. Written permission to include the public ar ea in the buffer zone is granted by the appropriate state and/or local authorities responsible for management and operation of the

area. 4. Applicators must comply with all local laws and regulations..

Restriction for Schools and Other Difficult-to-Evacuate Sites

 “Difficult-to-evacuate” sites in clude schools (preschool to grade 12), state licensed day care centers, nursing homes, assisted liv ing facilities, hospitals, in-patient clinics, and prisons.

 No fumigant application with a buffer zone gr eater than 300 feet is permitted within 1⁄4 mile (1320 feet) of the sites listed a bove unless the site is not occ upied during the application and the 36-hour period followi ng the application.

 No fumigant application with a buffer zone of 300 feet or less is permitted within 1/8 mile (660 feet) of the sites listed above unless the si te is not occupied dur ing the application and the 36-hour period following the application.

Buffer Zone Reduction Credits

In preparing for the July 2008 RED, the Agen cy undertook a significant effort to evaluate available empirical data results, modeling, and sc ientific studies reporte d in the literature regarding the factors and control methods that may reduce emissions from soil fumigants. For details on the Agency’s analysis, please see the June 9, 2008 memo, “Factors Which Impact Soil Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Factor Approach,” 3 in the dazomet docket. The Agency also coordinated and led a discussion on this issue at the 2006 and 2007 Methyl Bromide Altern atives Outreach (MBAO) Conferences with leading researchers and other st akeholders. A general descrip tion of the MBAO sessions can be

found at http://mbao.org

.

Based on the Agency’s analysis of the current data, the Agency developed dazomet buffer zone reduction credits for: soils with high organic matter, and for soils with high clay content. The Agency believes that in addition to reducing bystander risk and the size of buffer zones, these credits have the potential to also decrease application rates. Applicators will be required to document any information about buffe r zone credits that apply in the Fumigant Management Plan (FMP).

Soil Conditions

3 Factors Which Impact Soil Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Factor Approach, June 9, 2008, DP Barcode: 306857
50Soil conditions like the amount of organic matter and type of soil do have an impact on fumigant emissions. However, soil conditions differ from other credits because they are essentially beyond a grower’s ability to cha nge. Although a grower may not be able to manipulate organic matter or soil type, the Ag ency’s factors document indicates that soil conditions can reduce fumigant emissions, and is offering credits for these conditions. EPA acknowledges that some variability in soil characteristics within a gi ven field is likely. If users are unsure whether the fields they intend to treat meet the criteria for a credit, they may consult with their local agriculture extension office or soil conservation distri ct for assistance in determining soil characteristics.

The Agency’s factors document not only revi ews available literature regarding soil conditions, but also describes modeling exercises that estimate th e impact of organic matter and soil type using Chain_2D. Chain_2D is a first pr inciples model that takes into consideration factors such as boundary layers or moisture that could impact fumigant emissions. The Agency used Chain_2D as modified by Dow AgroScienc es’ Steve Cryer and Ian van Wesenbeek in the sensitivity analysis 4. Cryer and van Wesenbeek modified the original source code to create a more usable graphical user interface; this included incorporating a new air/soil boundary condition proposed by Wang in 1998 5 . See the Agency’s factors analysis for further details about the CHAIN_2D model 6

.

Based on the review of availa ble literature and modeling with the CHAIN_2D model, EPA believes 10 percent buffer zone credits are appr opriate if the applicat ion block contains soil with organic matter of greater than 3 percent and/ or for clay content of at least 27 percent. CHAIN_2D that shows the impact of changes in organic content is not fumigant specific.

The Agency’s Chain_2D sensitivity analysis suggests that organic matter can have a small impact on emissions. There is generally a high correlation between the organic matter

content of the soils and th e dissociation constant (K d ) value. Increasing K d value by 10 or 25 percent generally reduced emissions by 10 or 20 percent. Decreasing the K d value by 10 or 25 percent increased emissions by 10 or 20 percent (s ee figures 147 to 154 of the factors analysis for further details).

Generally, clay loam and sandy clay loam soils tended to show significantly lower emissions than other soil types, sometimes s howing 50 percent lower reductions. Conversely, loamy sand and loam soils tended to show higher emissions than other soil types (see figures 167 to 174 of the factors analysis for further details).

4 Cryer, S.A. (2007) Air/Soil Boundary Conditions For Coupling Soil Physics and Air Dispersion Modeling. Unpublished report of Dow AgroSciences LLC (Report # DN241493)

5 Wang, D; Yates, S.R.; Jury, W.A. (1998) Temperature Ef fect on Methyl Bromide Volatilization: Permeability of Plastic Cover Films. J. Environ. Qual. 27, 821-827.

6 Factors Which Impact Soil Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Factor Approach, June 9, 2008, DP Barcode: 306857
51Since the 2008 RED, information from the Chloropicrin Task Force has been submitted and has allowed the Agency to reevaluate credits for soil organic matter. From these studies the Agency has determined that soils with between 1% and 2% organic matter will get a 10% credit, soils with between 2% and 3% organic matter will get a 20% credit, and greater than 3%, a 30% credit. No credit will be given for soils with le ss than 1% organic matter. The credit for clay content of greater than 27% will remain at 10%.

Dazomet buffer zone credits are additive and as since only the orga nic content and clay content credits apply for dazomet, buffer zone credits will not exceed 40 percent (e.g., 40 percent credit would apply for us ing > 3 percent organic content and >27 percent clay content).

For example, if an application block is 10 acres and the applicator is planning to make an incorporated application of 230 lbs of dazomet per acre, the buffer distance from the look up

tables is 108 feet. If after th e applicator tests the soil and determines the soil contains greater than 27 percent clay content, then the buffer zone may be reduced by 10 percent. By calculating 10 percent of 108 feet (108 feet x 10% = 10.8 feet bu ffer credit) and then s ubtracting the original buffer distance by the credit (108 feet – 10.8 feet = about 97 feet) the final buffer distance required is 97 feet.

Other Buffer Zone Credits Considered

Currently the dazomet label allows for use of tarps when making applications, but there is little information to suggest that growers are curr ently using tarps with dazomet. Since there is no information available about how dazomet reacts with tarps, and since other data for metam sodium suggests that standard tarps may not be very effective in trappi ng MITC vapors, there is no tarp credit for dazomet at this time. If add itional tarps or other emission factor data become

available to show the emissions from dazomet applications are decreased, the Agency will consider adding those to the dazomet label. More information on the type of data the Agency is looking for can be found in the Health Effects Division Recomme ndations for Fumigant Data Requirements (J. Dawson, C. Smith, dated June 2008).

EPA (through OPP’s Environmental Stewards hip Branch) has co-funded a grant with

USDA-ARS for several flux studies in the southe astern U.S. These studies would provide (1) field data on the emission reduction potential of certain low permeability barrier films to support possible, additional, buffer reduction credits as well as to (2) help develop an affordable and reliable hybrid field/lab test to evaluate the many barrier films available to growers. EPA has also prepared a document to desc ribe possible research and study designs to reduce uncertainties in understanding emission factors in the contex t of different films and seals, agricultural practices, and envir onmental conditions. 7 These studies are scheduled to be completed in 2009 and data from these studies will be submitted to the Agency for review.

Other factors such as soil moisture cont ent, field preparation, water sealing, and application depth could not be used to justify credits based on th e available data. However, EPA

7 Health Effects Division Recommendations for Fumigant Data Requirements. June 2008. DP Barcode 353724
52has established mandatory good agricultural practices (GAPs) for these conditions. See the GAP

section of this document for further discussion. If additional data on such emission reduction methods becomes available, EPA will consider developing further credits.

2. Restriction for Schools and Ot her Difficult to Evacuate Sites

Certain types of sites are diffi cult to evacuate should an incide nt occur. EPA determined that additional measures to reduce the potential need to evacuate these types of sites were necessary to reduce risk of exposure to occupant s and address potential challenges associated with an accident. There were many comments on th is measure including: requests to delete this requirement; suggestions to reduce the size of the restricted area; a proposal to use a scalable approach to calculate the distance; requests to define and refine th e places included on this list so

that facilities such as research universities were excluded; sugges tions to shorten the duration of the requirement so applicators may be able to ta ke advantage of weekends to fumigate; questions

about how to determine where these sites are located, and other suggestions to change the required measures.

Based on a review of the comments, the Agency has retained this mitigation measure to ensure the protection goals are still achieved and encourage lo wer-emission application methods. This mitigation measure has been refined such that compliance is more effective in achieving the protection goal. Modifications to this requ irement include: shortening the duration of the restriction so weekends may be used to fumigate near schools and day car e centers; clarifying the types of schools that are covered by this requi rement; removing the term “elder care facilities” from the list since many of the same facilities are included in the terms, “ assisted living facilities, nursing homes, and in-pa tient clinics;” and reducing the re stricted area from 1/4 mile to 1/8 mile for application blocks w ith less than 300 foot buffers. The 1/8 mile (660 feet) distance is more than twice the required buffer distan ce and remains protective of people who may be difficult to evacuate while reducing the potential challenges of complying with the restrictions for some users who may be fumigating in close proximity to these types of institutions. EPA has

determined that these modifications achieve the same protection goals as the 2008 RED but provide additional clarity and flexibility that will enhance users’ ability to practically and effectively comply with the requirements. EPA also believes that reducing the restricted area for blocks with buffers less than 300 feet will prov ide an incentive for some users to adopt loweremission application methods or practices. Th e revised measures are summarized below.

 “Difficult-to-evacuate” sites include schools (preschool to grade 12), state licensed day care centers, nursing homes, assisted living fa cilities, hospitals, in-patient clinics, and prisons.

 No fumigant application with a buffer zone greater than 300 feet is permitted within 1/4 mile (1320 feet) of the sites listed above unless the site is not occupied during the application and the 36-hour period fo llowing the start of application.

53 No fumigant application with a buffer zone of 300 feet or less is permitted within 1/8 mile (660 feet) of the sites listed above unl ess the site is not occupied during the application and the 36-hour period following the start of application.

3. Posting

Posting is an effective means of informi ng workers and bystanders about areas where

certain hazards and restrictions exist. Current so il fumigant labels requ ire treated areas to be posted and handlers are required to wear specific PPE when they ar e in a treated area. For buffer zones to be effective risk mitigation, bystanders , including agricultural workers in nearby areas, need to be informed of the location and timing of the buffer zone to ensure they do not enter designated areas.

In addition to alerting bystanders, posting a buffer zone will help handlers determine where and when they are required to use PPE. As described in the Handler Section, handlers working in treated areas or buffers during the buffer zone period must use label-specified PPE and meet other requirements under the Worker Pr otection Standard (WPS). Therefore, EPA has determined that to ensure the protectiveness of buffer zones for bystanders and handlers, the perimeter of the fumigant buffer zones must be posted.

Comments received in response to the Ju ly 2008 RED decisions recommended some changes to the posting requirements to make them easier to understand and implement. Based on

EPA’s review and consideration of these comm ents, EPA has slightly revised the posting requirements and provided additional clar ification as described below.

EPA had included two exceptions for the buffe r zone posting requirement. The first exception did not require posting in situations where the land 300 feet fr om the edge of the

buffer was under the control of th e property operator. Based on comments that this measure was too complicated and confusing this exception has b een removed. There were also comments that the examples provided in the description of a phy sical barrier may lead to misinterpretation of the requirement. EPA agrees and believes that a performance standard is a more effective means of communicating the requirement. Therefore, to reduce the potential for confusion, the examples have been removed.

In the 2008 RED, signs were required to be posted at usual points of entry and likely routes of approach to buffer zones. If there were no usual points of en try or likely routes of approach, then posting was required in the corners of buffer zones, and between the corners, so signs could be viewed from one another. Ma ny comments expressed concern over the burden and potential confusion with the number of signs that may need to be posted and how many signs may need to be posted depending on the configura tion of the field. EPA ag rees that signs posted

in areas where there is low likelihood of work ers or others approaching or accessing the buffer provide little risk reduction, but can add substantially to the cha llenges of compliance. As a result, the Agency has revised the criteria for lo cation of signs since the areas that are of most concern are those where people are mo st likely to enter (e.g., roads, f ootpaths, etc.), and at likely routes of approach such as the perimeter of a buffer that faces a housing development.

54Comments also indicated that the requiremen t to include certain application-specific information on the posted signs would make reuse of the signs more difficult and would also substantially increase the amount of time n eeded to prepare signs before posting. These comments stated that the primary purpose of signs is to communicate to bystanders the buffer zone locations. EPA generally agrees with these comments; therefor e certain applicationspecific details on the posted si gns, like the date and time of the fumigation and buffer zone restrictions, have also been reduced to a llow the signs to be reused more easily.

Comments also stated that the posting example included in the 2008 RED was confusing. Since the posting restrictions have been simplif ied by removing the distance criteria, the example

has been removed from this document. Ther e were no substantive comments suggesting a change to the exception for posting multiple con tiguous blocks and no changes have been made

in this Amendment.

The revised posting requirements are listed belo w and have been incl uded in the revised

label table.

Requirements

 Posting of a buffer zone is required unless there is a physical barrier that prevents bystander access to the buffer zone.

 Buffer zone posting signs must:

o Be placed at all usual points of entry and along likely routes of approach from areas where people not under the land operator’s c ontrol may approach the buffer zone.

o Some examples of points of entry incl ude, but are not limited to, roadways, sidewalks, paths, and bike trails.

o Some examples of likely routes of appro ach are the area between a buffer zone and a roadway, or the area between a buffer zone and a housing development.

 Buffer zone posted signs must meet the following criteria:

o The printed side of the sign must face away from the treated area toward areas from which people could approach.

o Signs must remain legible during entire posting period and must meet the general

standards outlined in the WPS for text size and legibility (see 40 CFR §170.120).

o Signs must be posted before the applicati on begins and remain posted until the buffer zone period has expired.

o Signs must be removed within 3 days af ter the end of the buffer zone period.

o Registrants must provide ge neric buffer zone posting signs which meet the criteria above at points of sale for applicators to use. The Agency is requiring registrants to submit proposals for these materials through the data call-ins that will accompany this

RED.

55Exception: If multiple contiguous blocks are fumigated within a 14-day period, the entire periphery of the contiguous bl ocks’ buffer zones may be posted. The signs must remain posted until the last buffer zone period expires and si gns may remain posted up to 3-days after the buffer zone period for the last block has expired.

Additional requirements for treated-area posting:

 The treated area posted signs must remain pos ted for no less than the duration of the entry restricted period after treatment.

 Treated area signs must be removed within 3 days after the end of the entry-restricted period.

 Signs must meet the general standards in the WPS for placement, text size, and location (40 CFR §170.120).

Contents of Signs

The treated area sign (currently required for fumigants) must state the following: -- Skull and crossbones symbol

-- "DANGER/PELIGRO," -- "Area under fumigation, DO NOT ENTER/NO ENTRE,"

-- "Dazomet fumigant in USE," -- the date and time of fumigation, -- the date and time entry prohibition is lifted -- Name of this product, and -- name, address, and telephone number of the certified applicator in charge of the fumigation. The buffer zone sign must include the following: -- Do not walk sign

-- "DO NOT ENTER/NO ENTRE," -- ”Dazomet OR [Name of product] Fumigant BUFFER ZONE,”

-- contact information for the certified applicator in charge of the fumigation

bb. Occupational Risk Mitigation

1. Handler Definition

Based on stakeholder comments provided durin g the Phase 5 comment period, the July 2008 RED clarified fumigation tasks th at meet EPA’s definition of handler activities, as currently defined in the Worker Protection Stan dard (WPS) and on fumigant labels. During the post-RED comment period the Agency received so me comments from stakeholders who were concerned that the Agency was redefining handlers . It was not the Agency’s intention to change

56the current definition. As a result, the Agency has slightly changed the language from the July 2008 RED so it is clear that the Agency is just clarifying the existing de finition and not writing a new definition. Below is the revised language.

The following activities are prohibited fr om being performed in the fumigant application block or surrounding buffer zone during the buffer zone period by anyone other than persons who have been appropria tely trained and equi pped as handlers in accordance with the requirements in the WPS (40 CFR Part 170), from the start of the application until the entry-restricted period e nds. Those activities include those persons:

 Participating in the application as supervisor s, loaders, drivers, co-pilots, shovelers, shovel ditchers, or as other direct applicati on participants (note: the application starts when the fumigant is first introduced into the soil and ends after the fumigant has stopped being delivered/dispensed to the soil);

 Using devices to take air samples to monitor fumigant air concentrations;

 Persons cleaning up fumigant spills (thi s does not include emergency personnel not associated with the fumigation application);

 Handling or disposing of fumigant containers;

 Cleaning, handling, adjusting, or repairing the parts of fu migation equipment that may contain fumigant residues;

 Installing, repairing, or operating irrigation eq uipment in the fumigant application block or surrounding buffer zone duri ng the buffer zone period;

 Entering the application site or surrounding buffer zone during the buffer zone period to perform scouting or crop advising tasks;

 Installing, perforating (cutting, punching, slicing, poking), removing, repairing, or monitoring tarps:

o until 14 days after application is complete if tarps are not perforated and removed during those 14 days, or

o until tarp removal is complete if tarps are both perforated and removed less than 14 days after application; or

o until 48 hours after tarp perforation is comp lete if they will not be removed within 14 days after application.

 In addition to the above, persons outside th e perimeter of the buffer zone who monitor fumigant air concentrations must also be trained and equipped as handlers in accordance with the requirements in the Worker Protection Standard (40 CFR Part 170)

.

2. Handler Requirements

Since many incidents are caused by human erro r and equipment failure, EPA believes the presence of on-site trained pers onnel would help to reduce these ri sks. To address these risks, the July 2008 RED required that (1) a certified applicator must supervise all fumigant handlers during the entire period that the pe rson is performing a fumigant ha ndling task within the treated field or within the buffer zone, (2) the person mo nitoring another handler could also be engaged

57in fumigant handling tasks during the monito ring period, and (3) the certified applicator supervising dazomet applications could perfor m all tasks without anyone supervising them.

In addition to certified applicator supervisi on, in the July 2008 RED, the Agency required

that a minimum of two WPS-trai ned handlers remain on site when handlers are fixing tarps, moving irrigation equipment, and/or performing other handler tasks as defined above. This mitigation measure was put in place to address the possibility that handlers could be overcome with the vapors and have difficulty leaving the area while they are performing these tasks. The Agency is removing this handler requirement for the MITC generating chemicals since the hazard profiles are not the same for all the soil fumigants. With MI TC-generating compounds, EPA believes eye or sensory irri tation would likely be felt in sufficient time for a handler to leave the area or put on a respirator, before more serious effects occur. With chloropicrin, in contrast, as indicated by precauti onary statements on current labels, a handler may be overcome more quickly, justifying the pr esence of another person to provide assistance if needed.

During the post-RED comment period the Agen cy received many comments that stressed the difficulty implementing a requirement that manda tes certified applicators to maintain visual

contact with handlers. The commenters also indicated that for longe r applications this requirement would be significant burden. Other stakeholders stated that the Agency needs to modify the requirement to ensure that the certified applicator is on site while others believe EPA should require that all handlers are certified applicators, which would eliminate the need for direct handler supervision.

The Agency has considered the comments and has revised the certified applicator requirement by specifying different requirements for different app lications. EPA believes that these revisions accomplish the same goal as the July 2008 RED mitigation while reducing the burden on users. The revised language is:

 For ground-rig applications (e.g., shank, rototiller, a nd spray blade), from the start of the application until the fumigant has stopped be ing delivered/dispensed into the soil (e.g., soil is sealed) the certified applicator must be at the fumigation site and must directly supervise all persons performing handling activities.

 For fumigant handling activities that ta ke place after the fumigant has been delivered/dispensed into the soil until the entry restricted period expires, the certified applicator must communicate in writing to the site owner/operator and other handlers information necessary to comply with the label and the FMP (e.g., emergency response plans and procedures).

The July 2008 RED also required that certifie d applicators supervising the application completed a registrant administered dazomet training program within the preceding 12 months before they applied a dazomet product. The Agen cy is still requiring certified applicators to complete the registrant training; however, the Agency is now requiring the certified applicators successfully complete the training ev ery three years. Please see the Soil Fumigation Training for Applicators and Other Handlers section for further.

583. Dermal Protection for Handlers

The dazomet dermal risk assessment indicated potential risks of c oncern for handlers for some scenarios. For handlers loading and appl ying dazomet for tractor drawn spreaders, there were potential risks for short term exposures assuming applications to 80 acres per day. According to information from the registrant in the phase 3 comments, dazomet is not typically applied to large acreages, but more typically applied to blocks 5-20 acres in size. The Agency is prohibiting applications to block sizes over 40 acres, so the short term concerns for dermal risk to handlers loading and applying with tractor drawn spreaders does not present unreasonable

adverse effects.

For intermediate term dermal risk, there are potential risk concerns for loaders and applicators, with MOEs below 100, the intermediate dermal LOC. MOEs for loaders range from 13 for handlers wearing baseline PPE, up to 650 for handlers using closed systems. For applicators, there is only data for handlers applying with closed cabs, and the MOE is 52 for a 40 acre field. Due to the amount of dazomet applied, and the small area it is typically applied to, it is not likely a single handler will be exposed to the amount assumed in the risk assessment over

the intermediate time frame of 1 to 6 months. Cu rrent dazomet labels require handlers to wear double layers (coveralls over short-sleeved shirt a nd short pants) and chemicals resistant gloves to protect from dermal exposures. The Agency doe s not calculate risks w ith this level of PPE

since there is no data to assess coveralls over shor t-sleeved shirt and short pants. However, since the current labels require this level of protecti on, the short-term risks were acceptable and the amount of dazomet exposure assumed in the interm ediate term assessment are higher than would be expected based on dazomet’s use patterns, th e Agency is requiring al l handlers to wear double layers consisting of coveralls ove r short-sleeved shirt and short pants with gloves. In addition, handlers will have an option to reduce the dermal protection if application equipment (i.e., enclosed cabs) that provides dermal protection is used.

For hand held applications there are potenti al dermal risks of concern when making applications with baseline PPE. The registrants ha ve indicated that they will not be continuing to support applications with hand held equipment, a nd labels will be amended to prohibit hand held equipment.

4. Respiratory Protection for Handlers

The Agency’s human health risk assessment for dazomet indicates that inhalation risks for many handler tasks exceed the Agency’s LOC fo r the acute exposure to the parent (dazomet) and MITC. In the 2008 Dazomet RED, the Agen cy required handlers potentially exposed to MITC vapors from dazomet applications to either wear at least a half-face respirator during the handling activity, or follow the monitoring progr am detailed below. In addition, the Agency required that for some handling task s, respirators were required to be worn at all times due to the

short duration of the task and th e potentially high concentration of MITC exposure. The certified applicator supervising the fumiga nt application must ensure th at any handler who enters the

59buffer zone (including tractor driver s, loaders, irrigators, tarp cu tters, removers, etc.) is either wearing respiratory protection or is followi ng the handler monitoring requirements, with respirators immediately avai lable to each handler.

During the post-RED comment period, the Agency received several comments on the Respiratory Protection for Handlers section. For MITC, comments focused on the feasibility of using colormetric tubes, due to the current sensitiv ity and accuracy of the tubes; the cost of the tubes; and the Agency’s trigge r level of 100 ppb, which some co mmenters questioned, given that the Agency’s level of concern for acute MI TC exposures is 22 ppb. Some comments also suggested that rather than wear respirators, fumigators should have the option of ceasing the application until air concentrations of MITC are less than the action level.

After reviewing the comments, the Agency has determined that resp iratory protection is still needed to mitigate risks to dazomet handlers if concentrations of MITC reach a certain level; however, EPA is revising the requ ired procedures for determining when respirators must be used due to technological limitations of currently avai lable monitoring devices that are appropriate for

field use. EPA believes that while colorimetr ic tubes are likely to be reliable at higher

concentrations and when used in more static conditions (e.g., a warehous e or laboratory), under the dynamic conditions characteristic of outdoor field fumigation, currently available devices provide somewhat less reliable information about concentrations relative to EPA’s action level,

which is below the levels for which the devices are rated.

The Agency is aware of several commerci al systems for monitoring MITC, including colormetric tubes from the following manufacturers: Sensidyne and Dragaer. While these tubes have detection limits of at least 100 ppb, based on commenters’ experience and the accuracy of the tubes (e.g., some tubes have a standard deviation plus or minus 20-30%), the Agency believes it is possible that handlers will experi ence sensory irritation before the monitoring device shows a level of concern. As such, the Agen cy does not believe that initial monitoring to trigger the use of respirators si gnificantly reduces handler risks. EPA is also concerned that monitoring with devices that are not reliable could cause handlers to believe that concentrations are below the action level despite other indications (eye irritation). As a result, the Agency is removing the initial monitoring requirement. In addition, EPA is aware that monitoring with these devices adds significant costs to fumi gations. For additional details please see the following document: Analysis of Soil Fumigant Risk Management Requirements using Geographic Information Systems: A Case Study for the Forest Seedling Industry, dated May 13, 2009, located in the dazomet docket..

EPA does believe, however, that monitoring de vices that are currently available will generally be reliable at higher concentrations of MITC and th at there is high value in air monitoring using currently available devices in certain situations. As a result, EPA is maintaining the requirement for colorimetric t ube monitoring once use of respirators has been triggered and respirators are being worn. This will enable handlers to dete ct concentrations that would exceed the upper working limit of the respirator. Additiona lly monitoring will still be required to help enable handlers to determine if concentrations have decr eased and whether it is

60safe to either remove respirators or to resume the application if the fumigator has opted to cease the application rather than wear respirators.

The Agency is modifying the procedures for respiratory protection because of technological limitations of current ly available devices. However, the Agency does believe that quantitative air monitoring would enhance worker safety if the appropriate technology were available. Some equipment manufacturers have indicated interest in developing devices that

would be more functional and reliable for field fumigation applic ations (e.g., badge-type monitors). EPA encourages such efforts and plans to stay abreast of developments and improvements in monitoring devices and will consider this issue again in registration review or

sooner should such monitors become available in the short term.

Since the Agency has removed the initial mon itoring requirement, regulating at an action level of 100 ppb is no longer approp riate since this level was base d on the detection limit of the currently available MITC monitoring tubes. Due to the reliability issue previously, instead, the Agency is using an action level of 600 ppb wh ich corresponds to early signs of exposure and effects are non-severe and reversible at this level. .The Agency believes that this level is effective as a warning for handlers of when conc entrations are reaching the point where steps are needed to protect fumigant handlers.

Respiratory Requirements

The following procedures must be followed for all agricultural pre-plant soil applications

of dazomet. In addition to th e respiratory protection requiremen ts, the Agency believes that GAPs, FMPs, and other mitigation measures will reduce inhalation risks from MITC to levels

below the EPA’s level of concern.

 If at any time any handler experiences sens ory irritation (tearing, bur ning of the eyes or nose) then either:

o An air-purifying respirator (APR) must be worn by all handlers who remain in the application block and surrounding buffer zone, or

o Operations must cease and handlers not w earing respiratory protection must leave the application block and surrounding buffer zone.

 Handlers can remove respirators or resume ope rations if two consecu tive breathing-zone samples taken at the handling site at least 15 minutes apart show that levels of MITC have decreased to less than 600 ppb, provided that handlers do not experience sensory irritation. Samples must be taken wher e the irritation is first experienced.

 When respirators are worn, then air monitoring samples must be collect ed at least every 2 hours in the breathing zone of a handler performing a representative handling task.

 If at any time: (1) a handler experiences any sensory irritation when wearing a respirator, or (2) an air sample is greater than or e qual to 6000 ppb, then all handler activities must cease and handlers must be removed from the application block and surrounding buffer zone. If operations cease the emergency plan detailed in the FMP must be implemented.

61 Handlers can resume work activities without respiratory protection if two consecutive breathing-zone samples taken at the handling site at least 15 minutes ap art show levels of

MITC have decreased to le ss than 6000 ppb, provided that handlers do not experience sensory irritation.

 During the collection of air samples an air- purifying respirator must be worn by the handler taking the air samples. Samples must be taken where the irritation is first experienced.

 Work activities may resume if the foll owing conditions exist provided that the appropriate respirator y protection is worn:

o Two consecutive breathing zone samples for MITC taken at the handling site at least 15 minutes apart must be less than 600 ppb,

o Handlers do not experience sensory irri tation while wearing the APR, and

o Cartridges have been changed.

o During the collection of air samples an ai r-purifying respirator must be worn by the handler taking the air samples. Sample s must be taken where the irritation is first experienced.

62Figure 3 provides an illustration of the re quirements when handlers cease operations.

Handler activity begins. Handlers are NOT wearing APRs.

Sensory Irritation

Certified applicator in charge decides to cease operations rather than continue with respirators.

Handlers must stop work and leave application block and buffer

zone.

If 2 samples taken at least 15 minutes apart (by a handler

wearing an APR) show

concentrations are less than 600 ppb and NO sensory irritation,

then

Resume operations.

63Figure 4 provides an illustration of the requirements when handlers put on a respirator.

Handler activity begins. Handlers are NOT wearing APRs.

Sensory Irritation

Certified applicator in charge decides to continue operations.

All handlers in the application block and buffer zone put on an APR. Air monitoring program begins.

Feel irritation through APR, OR monitoring indicates concentrations above 6000 ppb.

Handlers must stop work and leave application block and buffer

zone.

If, 2 consecutive samples taken at least 15 minutes apart, by a handler wearing an APR are above 600 ppb BUT below 6000 ppb, no sensory irritation is felt,

and the cartrid g e is chan g ed

, then

Resume operations wearing an APR. Air monitoring continues. Resume operations without an APR or remove respirator. If 2 consecutive samples taken at least 15 minutes apart, by a handler wearing an APR, are less

than 600 ppb and NO sensory irritation, then

64Respiratory Protection Equipment

In the July 2008 RED, the Agency required ha ndlers to wear an air purifying respirator approved for MITC with a protection factor ( PF) of 10. For additional clarity, even though currently there are no air-purifying respirator cartridges certified by the Mine Safety and Health

Administration-National Institut e for Occupational Safety and Health (MSHA-NIOSH) for protection against MITC, NIOSH/OSHA does r ecommend respirators with organic vapor cartridges for MITC use, and the Agency is requiring half-face resp irators with organiccartridges be used when a respirator is necessa ry; the Agency will consider other APR-cartridges combinations provided written certification of th eir efficacy against MITC is provided to the Agency. The EPA assumes that half-face respirators have a protection factor of 10, therefore, the respiratory protection will onl y be protective up to MITC concentrations of 6000 ppb, and if concentrations exceed 6000 ppb (or if eye irrita tion occurs), operations must cease. At air concentrations greater than 6000 ppb, the respirator is not designe d to protect handlers from inhaling more than 600 ppb of MITC. Therefore, the handler must continue to monitor once respirators are donned. If concentrations of MITC exceed 6000 ppb or if eye irritation occurs, then the operations must cease until levels of MITC are measured to be below 600 ppb from consecutive air samples.

The Agency did receive comments regard ing the cartridge recommendations, the recommended equipment, and the assumed respirat or protection factor. All of these comments are addressed in detail in the following document located in the dazomet docket: Methyl Bromide, 1,3-Dichloropropene, Chloropicri n, Dazomet, Metam Sodium/Potassium, MITC: Health Effects Division (HED) Component of Agency Response To Comments On 2008 Reregistration Eligibility Documents (Dated May 14, 2009). The Agency would like to clarify issues regarding the respiratory protection cartridges and respirat ors. Comments suggested that the Agency require organic-vapor cartridges. Th is was the Agency’s in tention in the July 2008

RED. Others commented on the use of full-face respirators and goggles. The Agency is still recommending the use of organic-vapor car tridges when protection is required.

Respirator fit testing, trai ning, and medical qualification

As detailed in the July 2008 RED, the respir ator protection factor described above in the Respiratory Protection Equipment section is based on the fo llowing assumptions: 1) the respirator is fit-tested, 2) prope r respirator training occurs, and 3) an annual medical evaluation and clearance is completed. Without these require ments, it is unclear whether the reduction in inhalation exposure that is assumed by the protection factor will be achieved. In order to ensure that the respiratory protection EPA is assumi ng is being achieved in the field, respiratory requirements will include fit testing, respirator training, and annual medical evaluation.

During the post-RED comment period, the Agency received a variety of comments ranging from full support of the requirement, to comments about the cost and time burden associated with the requirement. The Agency also received several comments regarding the details of this requirement, for example who conducts the fit-testing and medical exam and what the medical exam entails. Detailed responses to the general requirements are included in the

65following document: SRRD’s Response to Post-RED Co mments for the Soil Fumigants , dated May 20, 2009 located in the dazomet docket.

While EPA recognizes that there is a cost a ssociated with the f it-testing, training, and medical exam requirement the Agency still belie ves that respirator fi t-testing, training, and medical exams are a necessary part of the mitigation package. Since the Agency is now offering

a cease operations option where handlers can leave the application block and surrounding buffer zone in lieu of putting on an air-purifying resp irator, the Agency is onl y requiring that handlers who wear a respirator are fit-te sted, trained, and medically examin ed. The Agency believes that

this revision will reduce the cost associated with this requirement while still keeping the same level of protection for the handler s that wear respirators. The following language must be added to product labels:

“Employers must also ensure that an y handler who uses a respirator is:

 Fit-tested and fit-checked using a program that conforms to OSHA’s requirements (see 29CFR Part 1910.134)

 Trained using a program that confirms to OSHA’s requirements (see 29CFR Part 1910.134)

 Examined by a qualified medical practitioner to ensure physical ability to safely wear the style of respirator to be worn. A qualifie d medical practitioner is a physician or other licensed health care professional (PLHCP) who will evaluate the ability of a worker to wear a respirator. The initial evaluation consists of a questionnaire that asks about medical conditions (such as a heart condition) that w ould be problematic for respirator use. If concerns are identified, then additional evaluations, such as a physical exam, might be necessary. The initial evaluation must be done before respirator use begins. Handlers must be reexamined by a qualified medical practitioner at least annually or if their health status or respirator style or us e-conditions change.”

Respirator availability

The handler employer must confirm and docum ent in the FMP that enough air-purifying respirators and cartridges are available for each ha ndler that wears an ai r-purifying respirator. The Agency is requiring that at minimum two handlers have the appropr iate respirator and cartridges available and that these handlers ar e fit-tested, trained, and medically examined.

Tarp Repair

The July 2008 RED required handlers to w ear APRs if they perform tarp repair operations before the entry-restricted period ha s ended. The requirement s were different from other handling activities because th e duration of tarp repair activi ties was believed to be shorter than other handling tasks and th erefore tarp repair activities would not trigger the initial monitoring requirement. Upon consideration of comments the Agency received on this requirement, EPA has determined that respiratory protection for tarp repa ir activities should be handled consistently with other handler activities, i.e., handlers repairing tarps are not required to wear respirators unless sensory irritation is expe rienced. Additionally, the Agency believes that tarp repair like other handling ac tivities described above would benefit from the development of

66sensitive monitoring devices to reliably inform handlers if and when c oncentrations are above the action level for respiratory protection. EPA will reevaluate this measure during Registration

Review or sooner if such devices are available in the short term.

5. Tarp perforation and removal

The Agency’s risk assessment indicates that there is a risk concern for handlers during the perforation (cutting, poking, punchi ng, or slicing) and removal of tarps, and notes potential for increased risk when high ba rrier tarps are used. To addr ess these risks EPA required the following mitigation in the July 2008 RED:

 Tarps cannot be perforated until a minimum of 5 days (120 hours) after fumigation was complete.

 Tarps cannot be removed until 24 hours after tarp perforation is complete.

 If tarps are not removed after perforati on, planting cannot start until 48 hours after perforation is complete.

 If tarps are left intact for at least 14 days after the fumigation is complete then planting can take place as tarps are being perforated.

 Broadcast tarps could be removed before 5 days if adverse weather compromised the integrity of the tarp provided that at l east 48 hours had passed since the fumigation was completed, the buffer zone was extended until 24 hours after the tarp removal was complete, and untreated areas in the applicati on block are not treated for at least 24 hours after tarp removal is complete.

 Tarp perforation must be done using mechanical methods.

 Each broadcast tarp panel must be pe rforated using a lengthwise cut.

During the post-RED comment period the Agency received comments on the tarp perforation and removal requirements. In par ticular the Agency received comments on: the adequacy of the 5 day requirement for high barrier tarps to protect workers; the feasibility of leaving tarps down for 5 days in areas that use seepage irrigation; the difficulty implementing the 24 hour period between tarp perforation and re moval; and concerns regarding the weather condition exceptions, mechanical perforati on, and broadcast panel perforation.

There is some uncertainty regarding potenti al risks if high barrier tarps are perforated after 5 days. This is because worker exposure da ta used in the risk assessments are generally based on what has been the industry standard tarping technology, i.e ., low or high density polyethylene tarps, typically wi th higher application rates and no significant emphasis on using

the GAPs as defined in the RED. Data indicate th at high barrier tarps are effective measures to reduce fumigant emissions (see Methyl Bromide (PC Code 053201), Chloropicrin (PC Code 081501), Dazomet (PC Code 035602), Metam Sodium and Potassium (PC Codes 039003 & 039002), MITC (PC Code 068103), Updated Health Effects Division Recommendations for Good Agricultural Practices and Associated Buffer Credits located in the dazomet docket). While this reduction decreases the risk to bystand ers, it could increase the risk to handlers

67perforating or removing tarps be cause more fumigant could be tr apped between the soil surface and the tarp—currently California Department of Pesticide Regulation (CDPR) prohibits the use of methyl bromide with certain high barri er tarps due to worker concerns.

Based on CDPR’s prohibition and stakeholde r’s comments, EPA considered requiring a longer interval such as 10 days before allowing high barrier tarps to be perforated. However, EPA was concerned that adding such a requirement could discourage fumigators from using high barrier tarps which potentially allow for lowe r application rates a nd reduce bystander risk associated with offgassing. New studies currently underway which invol ve use of high barrier tarps may enable EPA to refine estimates of handler risk in the future. EPA will consider these data during Registration Revi ew, or sooner as the information becomes available.

Since the Agency has designed the mitigation measures to work together and believes

that measures to address handler risks are likely to protect thes e handlers when the reduced rates are considered in conjunction with other measures such as respiratory protection, GAPs, FMPs, and training, EPA is not increasing the number of days before high barrier tarps can be perforated.

In the comment period EPA learned from stake holders that leaving the tarps on for 5 days would pose problems for current flood prevention activities. According to the comment, for flood prevention fields must be pr operly drained. In order to ensu re proper drainage tarps must be manually cut, soil removed, and then tarps re tucked. The Agency understands that the 5 day requirement before tarps can be perforated and the restriction on manual tarp perforation would be difficult for this situation and the Agency ha s added language to addre ss this situation.

During earlier comment periods EPA heard from various stake holders that windy conditions sometimes caused tarps to blow off fields and create ot her hazards, e.g., to motorists on nearby roadways. As a result, in the July 2008 RED the Agency provided an exception toallow tarps to be removed after 48 hours under adverse weather conditions. During the postRED comment period EPA received comments that th is exception did not fully address the issue since the mitigation required waiting a minimu m of 48 hours after fumigation but tarps could

blow of fields sooner than that. Commenters al so said waiting 24 hours be tween tarp perforation and removal and the requirement to cut every broad cast tarp panel added to the potential for tarps

to blow off fields and create other hazards: once tarps are cu t they are prone to blowing off when windy conditions occur. To decrease the pot ential of tarps blowing off, commenters also suggested that the Agency add flexibility to th e 24 hour requirement by giving tarp removers the option to remove tarps 2 hours af ter tarp perforation if monito ring indicated levels below the Agency’s LOC. Commenters also suggested that every 1-3 tarp panels should be cut based on the professional judgment of the handler.

Upon review of the comments the Agency agre es that the mitigation should be revised somewhat to allow for tarp removal at any time if the tarp is no longer performing its intended function and it is creating other types of risk. Therefore, EPA is revising the exception outlined

in the RED to address these comments. EPA not es that handlers undertaking these tasks must follow the respiratory protection procedures deta iled in Section 4 (Respiratory Protection for

68Handlers); this change still provides handler protection while reducing the unintended consequences of tarps creating other hazards.

The Agency believes cutting every panel allows the fumigant trapped beneath each panelto off-gas before the tarp is removed. If each panel is not cut, it is not likely that necessary offgassing can take place to reduce risks to handlers removing tarps. The Agency understands that the main concern for not cutting every panel is du e to the potential for tarps to blow off and has

determined that this concern is best addre ssed by modifying the 24-hour wait period. Tarps may be removed 2 hours after tarp perforation is co mplete provided that ta rp removers follow the procedures set forth in the (cite respiratory protection section); ther efore the risk to handlers will

not increase as a result of this modification. EP A considered the suggestion to monitor before tarp removal begins; however, because of t echnical limitations with current technology the Agency did not include monitoring as part of the mitigation. As with the respiratory protection section, the Agency sees the valu e in a monitoring program if re liable and accurate devices are available and will consider monitoring during Re gistration Review or sooner if information

becomes available.

The Agency received comments supporting the requirement for mechanical tarp perforation, though other commenters stated that for some situati ons mechanical cutting is not feasible. Examples cited included at the start of a row when a mechanical device such as an ATV will be used to cut the tarps on the field, during flood prevention activities, and for small fields. Based on comments, EPA believes these ar e necessary short-durati on activities. Provided the respiratory protection procedures for ha ndlers are followed, thes e activities would not increase the risk to handlers. With regard to small fields where mechanical cutting is not feasible, the Agency considered the duration of the activity and the respiratory protection considerations and will permit manual perforation only for application blocks that are 1 acre or

less in size.

As a result of the Agency’s review a nd consideration of comments, the following summarizes the revised mitigation measures to a ddress inhalation risks from tarp perforation and

removal activities:

 As described in the Handler Definition secti on of this document, tarp perforators and removers are considered handlers for a specifi ed duration and every handler must adhere to the respiratory protection pr ocedures outlined in the Resp iratory Protection section of

this document.

 Tarps must not be perforated until a minimu m of 5 days (120 hours) have elapsed after the fumigant injection into the soil is comp lete (e.g., after injec tion of the fumigant product and tarps have been laid or after drip lines have been purged and tarps have been laid), unless a weather conditi on exists which necessitates th e need for early perforation

or removal See Early Tarp Removal for Broadcast Applications Only and Early Tarp Perforation for Flood Prevention Activities sections below.

 If tarps will be removed before planting, ta rp removal must not be gin until at least 2 hours after tarp perforation is complete.

69 If tarps will not be removed before planti ng, planting or transpla nting must not begin

until at least 48 hours after the ta rp perforation is complete.

 If tarps are left intact for a minimum of 14 da ys after fumigant injection into the soil is complete, planting or transplanting may take place while the tarps are being perforated.

 Each tarp panel used for broadcas t fumigation must be perforated.

 Tarps used for fumigations may be perforated manually ONLY for the following

situations:

o At the beginning of each row when a coulter blade (or other device which performs similarly) is used on a mo torized vehicle such as an ATV.

o In fields that are 1 acre or less.

o During flood prevention activities

 In all other instances tarps mu st be perforated (cut, punche d, poked, or sliced) only by

mechanical methods.

 Tarp perforation for broadcast fumigations must be completed before noon. (seepage irrigation exception)

 For broadcast fumigations tarps must not be pe rforated if rainfall is expected within 12

hours.

 Early Tarp Removal for Broadcast Applications Only:

o Tarps may be removed before the required 5 days (120 hours) if adverse weather conditions have compromised the integr ity of the tarp, provided that the compromised tarp poses a safety hazard. Adverse weather includes high wind, hail, or storms that blow tarps off the fi eld and create a hazard, e.g., tarps blowing into power lines and onto roads. A compromised tarp is a tarp that due to an adverse weather condition is no longer performing its intended function and is creating a hazard.

o If tarps are removed before the require d 5 days have elapsed due to adverse weather, the events must be documented in the post fumigation summary section

of the FMP.

 Early Tarp Perforation for Flood Prevention Activities

o Tarp perforation is allowed before the 5 days (120 hours) have elapsed if rain necessitates field drainage.

o Tarps must be immediately retucked and packed after soil removal.

6. Entry Prohibitions

Current dazomet labels allow reentry to the treated field by workers 24 hours after application. The risk assessment indicates th at risks could exceed EPA’s LOC for workers entering fields at this time period. In addition, stakeholder comments prior to the July 2008 RED indicated that non-handler entry to perform post- application (i.e., non-hand ler) tasks is generally not needed for at least 10 to 14 days fo llowing the completion of the application.

Due to the volatile nature of MITC and the potential for exposure to unprotected workers, in the July 2008 RED the Agency restricted entry in to the treated area by anyone other than a properly trained and protected hand ler. This restriction differs from Restricted Entry Intervals

70(REIs) that is currently require d for most conventiona l pesticides where dermal exposure is the primary pathway of exposure. Under the Work er Protection Standard (WPS), exceptions allow certain tasks to take place before the REI has expired as long as dermal contact with treated surfaces will be limited; however for fumigants where inhalation exposure is the primary risk concern, entry to a treated ar ea is further restricted.

During the post-RED comment period the Agency received some comments that expressed concern that extending the entry-restricted period for fumigants could prevent certain important activities from taki ng place, contrary to the comm ents received during earlier comment periods. Based on discussions with st akeholders, EPA’s review of public comments,

and the risks identified in EPA’s risk assessmen t, EPA does not believe any change to the entryrestricted period is warranted. EPA’s review of comments indicates that extending the entryrestricted period to protect workers will not have a substantial impact on agricultural operations. Therefore, the Agency is not making any changes to this section of the July 2008 RED. The mitigation is listed below.

EPA believes that risks will not exceed th e Agency’s LOC provided entry (including early entry that would otherwise be permitted under the WPS) by any person – other than a correctly trained and PPE-equippe d handler who is performing a handling task – is prohibited from the start of the application until:

 5 days (120 hours) after applic ation has ended for untarped a pplications (Figure 5), or

 After tarps are perforated and removed if ta rp removal is complete d less than 14 days after application (Figure 6), or

 48 hours after tarps are perforated if they will not be remove d prior to planting (Figure 7),

or

 5 days (120 hours) after applica tion is complete if tarps are not perforated and removed until14 days after the applicati on is complete (Figure 8).

Figures 5, 6, 7, and 8 provide illustrations of tarp perforation/remova l and entry prohibition mitigation required for various dazomet applicati ons. The intervals depicted are the minimum

that must be followed.

71Figure 5. Untarped Applications

48 hours

Buffer Zone

Period Begins

Entry

Restricted

Period Begins Application

Ends Buffer Zone

Period Ends

Entry

Restricted

Period Ends Application Begins 5 days (120 hours)

72Figure 6. Tarp Broadcast Applications (tarps removed before planting)

Tarp

Perforation Begins Buffer Zone

Period Begins

Entry

Restricted

Period Begins Application

Ends Buffer Zone

Period Ends

Tarp

Perforation

Ends Entry

Restricted

Period Ends

Tarp

Removal Begins Tarp

Removal

Ends Application Begins

2 hours 48 hours 5 days (120 hours)

73Figure 7. Tarp Bed Applications (T arps not removed before planting)

Application Begins

Buffer Zone

Period Begins

Entry

Restricted

Period Begins Application

Ends Buffer Zone

Period Ends

Tarp

Perforation Begins Tarp

Perforation

Ends

Planting Can Begin Entry

Restricted

Period Ends

48 hours 48 hours 5 days (120 hours)

74Figure 8. Tarp Bed/Broadcast Applications (T arps are not perforated until 14 days after application)

Application Begins

Buffer Zone

Period Begins

Entry

Restricted

Period Begins Application

Ends Buffer Zone

Period Ends

Entry

Restricted

Period Ends

Tarp

Perforation & Planting 5 days (120 hours)

48 hours

14 days

cc. Other Risk Mitigation

Below are requirements for FMPs, GAPs, em ergency preparedness and response, notice to state lead agencies, trai ning, and community outreach and education that the Agency concludes are needed to mitigate risks and th e likelihood of incidents caused by human error, equipment failure, and weather events such as temperature inversions.

1. Restricted Use Classification

All soil fumigant products containing met hyl bromide, 1,3-dichloropropene (1,3-D), iodomethane, and chloropicrin are currently cl assified as RUPs. Soil fumigant products containing dazomet and metam sodium/potassium are currently unclassif ied. However, MITC, the byproduct of dazomet and metam sodium/potassium , has characteristics that meet the criteria

for restricted use for both human hazard criteri a (as specified in 40 CFR 152.170(b)) and from

75other evidence (as specified in 40 CFR 152.170(d)) including the use histor y and incident data from exposure to MITC.

Human Hazard Criteria

The acute toxicity prof ile of MITC shows it is more acute ly toxic (toxicity categories are all I or II) than dazome t (mostly toxicity categories III a nd IV. While the product toxicity of

dazomet does not meet the hazard criteria for cla ssification as restricted use, the degradate product of MITC, that both handlers and bystander s can be exposed to, does meet the criteria.

Other Evidence

If any soil fumigant is not applied correctly, bystanders may be exposed to concentrations

that exceed levels of concern and that could caus e significant adverse eff ects. There is a history of incidents involving fumigants in which multiple bystanders experienced illness/injury despite being several hundred to several thousand feet from the treated area. The application of soil fumigants can pose risk for several hours from the time of application to several days after application. Depending on the situation, worker and/or area air monitoring may be required to ensure that exposure limits are not exceeded. Sp ecial equipment is often needed to apply soil fumigants safely and accurately (e.g., compac tion rig, tarp equipment, and self-contained breathing apparatus). To apply so il fumigants safely and ensure bystanders and applicators are not adversely affected, handlers also need specialized competencies.

In sum, dazomet meets the standard for restricted use because:

 The application of fumigants involves comp lex operations requiring specialized training and/or experience.

 Fumigant label directions call for specialized apparatus and protective equipment that is not available to the general public.

 A minor failure to follow label directions may result in severe adverse effects.

 Even if directions for use are followed, use ma y result in discernible adverse effects, of

both direct and indirect natu re, on non-target organisms.

Therefore, the Agency has determined that all da zomet soil fumigant products must be classified as restricted use. Label requirements will include the following, which is also contained in Table

9. This requirement has not changed from the July 2008 RED.

Requirement on Labels

“Restricted Use Pesticide Due to acute inhalation toxicity to humans.”

“For retail sale to and use by Certified Applicat ors or persons under their direct supervision and only for those uses covered by the Certif ied Applicator’s ce rtification.”

76In order to ensure that a certifi ed applicator is at the appli cation site, the label will also state, “the certified applicator s upervising the application must be at the fumigant application site

and able to maintain visual c ontact with every handler particip ating in the application starting when the fumigant is first introduced into the soil and ending after the fumigant has stopped being delivered/dispensed to the soil and the soil is sealed.”

2. Good Agricultural Practices

Since the application methods and work practices of fumiga tors have direct impacts on the amount of fumigant applied and emitted, the Agency determined that labeling should require proven practices that will reduce risks to handlers, bystanders, and the environment. Registrants, applicators, growers, and other stakeholders have consistently reported to the Agency that GAPs are a key mitigation measure to reduce the amount of fumigants applied and fumigant emissions.

The purpose of this section in the July 2008 RED was to specify good agricultural practices (GAPs) that were requi red for soil applications of dazo met. The practices specified contribute to reducing emissions and thereby are expected to reduce potential for worker and bystander exposures.

The Agency received comments regarding the GAPs outlined in the July 2008 RED. These comments addressed a range of topics:

 making the GAPs voluntary rather than mandatory label requirements,

 buffer zone credits associated with GAP implementation,

 wind speed requirements and the desc ription of inversion conditions,

 crop residue requirements,

 application equipment requirements,

 soil moisture and temperature requirements,

 flexibility in the event that new GAPs are developed,

 enforceability of GAPs,

 university research exemptions, and

These comments are addressed in detail in the Special Review and Reregistration Division’s response to comments document. Ba sed on the comments, the Agency has revised

some of the GAPs.

The GAPs outlined in the RED and this RED amendment have been shown to reduce emissions and bystander exposures and will continue to be mandatory label requirements. Buffer zone credits have been reanaly zed and additional credits have been calculated for various GAPs depending on the soil fumigant used (see buffer zone credit section).

The Agency has clarified the language regarding inversions and wind speed requirements. The Agency agrees that erosion co ntrol is an important co nsideration. However,

77removing the crop residue prior to fumigation is important to limit the natural “chimneys” that will occur in the soil when crop residue is present. These “chimneys” allow the soil fumigants to move through the soil quickly and escape into the atmosphere. This may create potentially harmful conditions for workers and bystanders and will limit the efficacy of the fumigant. To accommodate both of these important considera tions (erosion control and human health protection), the Agency encourages that the field be cleared of crop residu e as close to the timing of the fumigation as possible to limit the length of time that the soil would be exposed to potentially erosive weather conditions.

The following are mandatory GAPs that alrea dy appear on dazomet product labels. Some of the measures have been updated to clarify th e language and be consistent among the fumigant chemical product labels.

 Do not use dazomet when the soil temperature is extremely high (over 90  F at 2”deep).

 Do not apply dazomet if ambient air temperature exceeds 103  F.

 Do not apply within 3-4 feet of growing plants or closer than the drop line of trees and large shrubs. If slopes are treated with th is product, take precau tions to prevent the chemical from washing downward to growing plants.

 The area intended for treatment should be in s eedbed condition with a fine tilth, free of clods. Do not apply dazomet to dry or imprope rly tilled soil. Repeated cultivation before treating will improve control of perennial w eeds. Ditching around the site will prevent weed seeds, nematodes, and fungi from wash ing into the treated area and contaminating

it.

 For optimal effect, the soil to be fumigated must have sufficient moisture for good plant growth (at least 50% field capacity) for 5-14 days (depending on temperature) before the

treatment.

 After application, the soil must be kept uniform ly moist for 5-7 days. As soon as possible after incorporation, the soil must be sealed to retain th e concentration of gases in the soil which can be achieved by:

o Compacting the soil surface after incorpor ation with a roller attached behind the compacting implement.

o Moistening the surface after incorp oration so a crust forms.

o Lightly moistening the soil on the third and fourth days after treatment in case the

weather dries out the soil surf ace to avoid surface cracks.

o In difficult situations best results may be obtained by tarping the treated area.

 Do not store dazomet in an open spreader overnight.

 Do not apply dazomet when wind may cause granules to drift from target area.

 Do not apply dazomet through any type of irrigation equipment.

 Before using dazomet be aware that the thr ee most critical factors for a successful fumigation program are: soil preparation, soil temperature, a nd soil moisture.

Weather Conditions

78The Agency is concerned with off gassing occurring during temperat ure inversion. In many reported incidents, a temperature inversion is often given as a potential contributing factor. To address this concern in the 2008 RED, the Agen cy prohibited applicati ons during periods of temperature inversion, or when the wind speed is less than 2 mph, which can sometimes be an indication an inversion is occurring. In addi tion, the Agency provided additional information on the label as guidance to applicators in determining if an inversion exists.

The Agency received many comments related to the inversion label language including:

concern that some of the charac teristics of inversion conditions (like misty conditions or clear skies at night) do not always indi cate the presence of an inversi on: relying on a weather forecast to predict inversions is unreli able and not enforceable: and that prohibiting a pplication during

inversions does not address concerns of inversions during the off-gassing period.

Based on these comments the Agency has revi sed the “weather condi tions” section of the GAPs that relates to temperature in versions to clarify that parts of the weather conditions that are requirements and those that are included to help guide the applicator to identify temperature inversions. The measures have also been upda ted to prohibit applica tion only if temperature inversion conditions are forecasted to persist for more than 18 of the 48 hours after the start of the application since this will filter out condi tions when diurnal temperature inversions may occur, though even diurnal temperature inversio ns could contribute to exposures to fumigant concentrations outside buffers. As such, EPA be lieves that the measures described below in the emergency preparedness and response section of this document are important to address potential

risks associated with shorter-term diurnal i nversions. The Agency is also changing the wind speed requirement so winds may either be 2 mph at the start of application or be forecasted to reach 5 mph during the application. These change s are designed to prevent applications when inversion conditions are predicted to occur after the application ha s begun, since this is the time when the peak off-gassing is expected to o ccur. In summary, EPA has determined that applicators must (1) check the weather forecast and make a decision whether to proceed with a planned fumigation, based on conditi ons that are predicted, (2) only begin a fumigant application if wind speed is a minimum of 2 mp h at the start of the application or forecasted to reach at least 5 mph during the application, and (3 ) not fumigate if there will be a persistent low-level local inversion or an air stagnation ad visory is in effect. EPA be lieves advisory language providing more detailed information on how to identify inversions and adverse weather conditions will increase the likelihood that applicators will pr oceed with applications only when weather

conditions are or are forecast to be favorable for safe fumigations. See below and the label table

in Section V of this document for label statements.

Stakeholders also questioned where the i nversion conditions must exist and to what extent the temperature inversion must exist that would prevent an application. The Agency has provided additional temperature inversion details and has added a prohibition for application during an air-stagnation adviso ry. Air-stagnation advisories are issued through the National Weather Service and usually capture long periods of air stillness that may remain in an area from one to several days. EPA has determined that th ese modifications achieve the same goals as the 2008 RED since they provide additional clarity that will enhance users’ ability to practically comply with the requirements. The revised statements are stated below.

79Prior to fumigation the weather forecast for the day of the application and the 48-hour period following the fumigation must be checked to determine if unfavorable weather conditions exist or are predicted and wh ether fumigation should proceed.

Wind speed at the application site must be a mi nimum of 2 mph at the st art of the application

or forecasted to reach at leas t 5 mph during the application.

Do not apply if a shallow, compressed (low-level ) temperature inversion is forecast to persist

for more than 18 consecutive hours for the 48-hour period after the start of application, or if there is an air-stagnation advisory in effect for the area in which the fumigation is planned.

Detailed local forecasts for weather conditi ons, wind speed, and air stagnation advisories may be obtained on-line at: http://www.nws.noaa.gov . For further guidance, contact your local National Weather Service Forecasting Office.

Unfavorable Weather Conditions

Unfavorable weather conditions block upward m ovement of air, whic h results in trapping fumigant vapors near the ground. The resulting air mass can move off-site in unpredictable directions and cause injury to humans, animal s or property. These conditions typically exist prior to sunset and continue past sunrise a nd persist as late as noontime. Unfavorable conditions are common on nights with limited cl oud cover and light to no wind and their presence can be indicated by ground fog or smog and can also be identified by smoke from a ground source that flattens out below a ceiling la yer and moves laterally in a concentrated

cloud.

All measurements and other documentation plan ned to ensure that the mandatory label requirements are achieved must be recorded in the FMP and/or the pos t application summary

report.

3. Fumigant Management Plans (FMPs)

As noted elsewhere in this document, soil fumigation is a complex site-specific activity. Failure to adhere to label requirements and proced ures for safe use has le d to accidents affecting workers involved in fumigations as well as bysta nders. Information from various sources shows that health and safety plans, FMPs in this context, typically reduce workplace injuries and accidents by prescribing a series of operational requirements and crit eria. In fact plans like these are widely implemented in a vari ety of industries and are recommended as standard approaches for occupational health and safety management by groups such as American Industrial Hygiene

80Association 8 (i.e., through “Administrative” and “Workpl ace” controls). The Centers for Disease Control provides guidance for developing health and safety plans in agricultural settings. 9 The effectiveness of similar plans has also been ev aluated in the literature. Examples include “lookback” reviews conducted by th e Occupational Safety and H ealth Administration (OSHA) which essentially implemented standards in various industries then reviewed their effectiveness in this process as they are re quired to determine whether the standards should be maintained without change, rescinded or modified. OSHA is required by Section 610 of the Regulatory Flexibility Act (5 U.S.C. 610) and Executiv e Order 12866 to conduct the “lookback” reviews. These reviews are conducted to make the subj ect final standards more effective or less burdensome in achieving their objec tives, to bring them into bette r alignment with the objectives of Executive Order 12866, and to make them cons istent with the objectives of the Regulatory Flexibility Act. Two examples of “lookback” reviews that support the use of FMPs for soil fumigant health and safety management include: ethylene oxide use as a fumigant/sterilant, and grain handling facilities requirements. 10

In the July 2008 RED, EPA required FMPs to be completed before a fumigant application occurs. EPA concluded that FMPs will reduce potential risks to bystanders as well as handlers by requiring that applicat ors have carefully planned, in writing, each major element of the fumigation. In this context, an FMP is a set of performan ce criteria for each application, including how the fumigator intends to comply with label requirements. As added benefits, the Agency determined that FMPs would ensure di rections on the product la bels were followed and that the conditions under which fumigation occurre d were documented. EPA also concluded that FMPs would help ensure an appropriate response by the applicator or others involved in the application should an incident occur since a proper and prompt re sponse would reduce the potential risk to bystanders from potential high exposure situations (e.g., readily available first responder contact information could reduce respons e times to impacted bystanders and carefully thought out emergency response plans can help ensu re appropriate actions are taken in case of unforeseen events).

The July 2008 RED provided a list of each major element FMPs would need to address. These included general site and applicator information, applicati on procedures, and a description of how the fumigator planned to comply with label requirements for GAPs, buffer zones, monitoring, worker protection, post ing, and providing notif ication to the state or tribal lead agency. FMPs also were required to include plans for communication between the applicator

and others involved in the fumigation, documentation, and handling emergency situation. Additionally, EPA required that a pplicators complete a post fumi gation summary that described any deviations from the FMP, measurements take n to comply with GAPs, and information about

8 Ignacio and Bullock (2006) A Strategy For Assessing and Managing Occupational Exposures (Third Edition), American Industrial Hygiene Association, AIHA Press 2700 Prosperity Avenue, Suite 250 Fairfax VA 22031 (ISBN 1-931504-69-5)

9 Karsky (2002) Developing a Safety and Health Progra m to Reduce Injuries and Accident Losses, Centers For Disease Control National Ag Safety Database, av ailable at http://www.cdc.gov/nasd/docs/d001501­

d001600/d001571/d001571.html

10 United States Department of Labor, Occupational Safety and Health Administration (2008) Lookback Reviews available at http://www.osha.gov/dea/lookback.html
81any problems such as complaints or incidents that occurred as a result of the fumigation. The RED also specified requirements for record keeping and that FMPs must be provided, upon request, to enforcement officials and handlers involved in the fumigation.

According to stakeholder comm ents in earlier comment periods, much of the information required for the site-specific FMP was already being documented by users, and most industry stakeholders supported mandatory FMPs provided th ey are not too restrictive or complex and do

not result in an excessive administrative burden.

During the post-RED comment period, EPA recei ved several comments regarding FMPs. Several comments from industry and user stakeholders expressed concern that FMP requirements would increase paperwork burden w ithout providing significant risk reduction, though others supported FMPs provi ded they did not result in an excessive administrative

burden. A number of comments s uggested that the level of de tail EPA had required was too great and could result in volumi nous, resource-intensive plans. Some of these comments suggested that a checklist form at would be more efficient an d far less burdensome. Some comments expressed reservations about the ability of FMPs to enhance compliance with label requirements. Some commenters were concerned about the feasibility of providing a copy of the FMP to on-site handlers or enforcement personn el, though others said th at copies of the FMP should be provided to workers in area s adjacent to the application block.

Following EPA’s review of the post-RED comments, the Agency still believes that FMPs will reduce potential risks to bystanders as well as handlers and are a key component of the package of measures to reduce risks. EPA believes that FMPs will also enhance compliance by requiring that applicators veri fy and document compliance with the label requirements during and after application events are completed. In cases where errors may have occurred, a post-application summary may also prevent sim ilar problems from occurring during future applications. However, in response to comments, the Agency has somewhat modified the list of elements that must be addressed in the FMP (as described below) to make

it more streamlined and thus less burdensome to applicators and grower s. In addition, the Agency has developed a sample template in which many of the elements are covered in checklist format, which fumigators have the option of downloading and modifying to meet the needs of their specific fumigation situations. See [ http://www.epa.gov/pesticides/rereg istration/soil_fumigants /]. EPA will also continue to work with stakeholders to refine the FMP template and potentially develop others so it is a more useful tool for ensuring the safe application of dazomet.

The Agency estimates that, if a certified appl icator decides not to use the FMP template and decides to prepare a narrative FMP, a carefu lly designed FMP could take several days to develop the first time. Subsequent FMPs s hould require substantially less time to develop

because much of the information can be reused fr om the initial plan. In addition, an enterprise fumigating multiple application blocks as part of a larger fumigation may format their FMP in a manner whereby all of the information that is co mmon to all the application blocks is captured once, and any information unique to a particular application block or blocks is captured in subsequent, separate sections.

82Amended FMP Requirements

Consistent with the July 2008 RED, the Agency is not requiring FMPs to be submitted to state or local agencies. They must, however be maintained by the applicator and grower (if the grower is not the applicator) for a period of 2 years.

The Agency agrees with comments that having both the applicator and the owner/operator provide copies of the FMP to handlers is unnece ssarily duplica tive and that providing each worker with a hard copy of the FMP wastes paper. The Agency also agrees that it is not necessary for the FMP to be provided to the workers in areas adjacent to the application block. Workers in adjacent areas will be notified of the fumigation by buffer posting requirements and, in the case of neighbors whose land is part of a buffer zone, the adjoining neighbor has responsibility for workers in areas adjacent to the application for which permission was granted to use as part of a fumigation buffer. The Agency has revised the following requirement that was included in the 2008 RED, “Once the application begins, the certified applicator and owner/operator of the application block must provide a copy of the FMP to handlers involved in the fumigation, workers in adjacent areas to the application block, and federal/state/local enforcement personnel, upon request.” The RED Amendment requires the certified applicator to make a copy of the FMP available for viewing by handlers involved in the fumigation. The certified applicat or or the owner/operator of the application block must provide a copy of the FMP to any federal, state, tribal , or local enforcement personnel who request the FMP. In the case of an emergency, the FMP must be made available when requested by federal/state/local emergency re sponse and enforcement personnel.

The Agency agrees with comments that the term “etc.” complicates enforcement

activities and has removed that term from the label tables.

Each site-specific FMP must contain the following elements:

 Applicator information (name, phone number , license number, employer name, employer address, date of completing regi strant dazomet training program)
 General site information
 Application block location, address, or gl obal positioning system (GPS) coordinates
 Name, address, and, phone number of ow ner/operator of the application block
 Map, aerial photo, or detailed sketch showing field location, dimensions, buffer zones, property lines, roads, rights-o f-ways, sidewalks, permanen t walking paths, bus stops, water bodies, wells, nearby application blocks , surrounding structures (occupied and nonoccupied), locations of posted signs for buffers, and sites requiring 1⁄4 or 1⁄8 mile buffer zones (e.g., schools, state licensed day care centers, nursing homes, assisted living facilities, hospitals, in-patient clinics and pris ons) with distances from the application site

labeled
 General application information (target applic ation date/window, brand name of fumigant, EPA registration number)
 Tarp Information and procedures for repair, perforation and removal (if tarp is used)

83 Brand name, lot number, thickness
 Name and phone number of person responsible for repairing tarps
 Schedule for checking tarps for dama ge, tears, and other problems
 Maximum time following notificatio n of damage that the pers on(s) responsible for tarp repair will respond
 Minimum time following application that tarp will be repaired
 Minimum size of damage that will be repaired
 Other factors used to determine when tarp repair will be conducted
 Name and phone number of person responsible fo r cutting and/or removing tarps (if other than certified applicator)
 Equipment/methods used to cut tarps
 Schedule and target dates for cutting tarps
 Schedule and target dates for removing tarps
 Soil conditions (description of soil texture in application bl ock, method used to determine soil moisture)
 Weather conditions (summary of forecasted condi tions for the day of th e application and the 48-hour period following the fumigant application)
 Wind speed
 Inversion conditions (e.g., shallow, compre ssed (low-level) temperature inversion)
 Air stagnation advisory
 Buffer zones
 Application method
 Application rate from lookup table on label (lb ai/A)
 Application block size from lookup table on label (acres)
 Credits applied
 Buffer zone distance
 Description of areas in the buffer zone that are not under the control of the owner/operator of the application block
 Respirators and other persona l protective equipment (PPE) for handlers (handler task, protective clothing, respirator type , respirator cartridge type, re spirator cartridge replacement schedule, eye protecti on, gloves, other PPE)
 Emergency procedures (evacuation routes, loca tions of telephones, contact information for first responders, local/state/federal contacts, key personnel and emergency procedures/responsibilities in case of an incide nt, equipment/tarp/seal failure, complaints or

elevated air concentration leve ls outside buffer zone suggestin g potential problems, or other emergencies).
 Posting procedures (person(s) who will post signs, location of posting signs, procedures for sign removal)
 Site-specific response and ma nagement (if applicable)
 Fumigant site monitoring

 Description of who, when, where, and procedures for monitoring buffer zone perimeter
 Response information for neighbors

 List of residences, businesses, and neighboring property owners informed

 Name, address, and phone number of person doing notification

84 Method of sharing information
 State and tribal lead agency no tification (If state and/or tribal lead agency requires notice, provide a list of contacts that we re notified and date notified.)
 Plan describing how communication will take pl ace between applicator, land owner/operator, and other on-site handlers (e.g., ta rp cutters/removers, irrigato rs) for complying with label requirements (e.g., buffer zone location, buffer zone start/stop times, timing of tarp cutting and removal, PPE).
 Name and phone number of persons contacted
 Date contacted
 Authorized on-site personnel
 Names, addresses and phone numbers of all handlers
 Employer name, addresses, and phone numbers for all handlers
 Tasks that each handler is auth orized and trained to perform
 Date of PPE training for each handler
 For handlers designated to wear respirator s when respiratory protection is required (minimum of one handler), date of medical qua lification to wear a re spirator and date of fit testing for respirator.
 Air monitoring
 For buffer zone monitoring:

 Name, address, and phone number of handl er to perform monitoring activities

 Location and timing of monitoring for the buffer zone
 For handlers without re spiratory protection:

 If sensory irritation is experienced, indi cate whether operations will be ceased or operations will continue with respiratory protection

 If intend to cease operations when sensory i rritation is experienced, provide the name, address, and phone number of the handler that will perform monitoring activities prior to operations resuming
 For handlers with respiratory protection:

 Representative handler tasks to be monitored

 Monitoring equipment to be us ed and timing of monitoring
 Good Agricultural Practices (GAPs)
 Description of applicable mandatory GAPs (re gistrants may also include optional GAPs)
 Measurements and documentation to ensure GAPs are achieved (e.g., measurement of soil and other site conditions)
 Description of hazard communication. (The buf fer zone around the application block has been posted in accordance with the label. Pest icide product labels and material safety data sheets are on-site and readily available for employees to review.)
 Record keeping procedures (the owner/operato r of the application block as well as the certified applicator, must keep a signed copy of the site-specific FMP and the post application summary for 2 years fr om the date of application).

For situations where an initial FMP is deve loped and certain elements do not change for multiple fumigation sites (e.g., applicator inform ation, authorized on-site personnel, record keeping procedures, emergency pr ocedures) only elements that ha ve changed need to be updated in the site-specific FM P provided the following:

85 The certified applicator superv ising the application has verifi ed that those elements are current and applicable to the application bl ock before it is fumigated and has documented the verification in the site-specific FMP.

 Recordkeeping requirements are followed for the entire FMP (including elements that do not change)

Once the application begins, the certified applic ator must make a copy of the FMP available for viewing by handlers involved in the fumigation. Th e certified applicator or the owner/operator of the application block must provi de a copy of the FMP to any federal, state, tribal, or local enforcement personnel who request the FMP. In the case of an emergency, the FMP must be made available when requested by federal/state/local emergency response and enforcement personnel.

Within 30 days of completing the applicati on portion of the fumigation process, the certified applicator supervising the application must complete a post fumigation application summary that describes any devia tions from the FMP that have occurred, measurements taken to comply with GAPs as well as any complaints an d/or incidents that ha ve been reported to

him/her.

Specifically, the Post-Application Summary must contain the following elements:

 Actual date of the applicati on, application rate, and size of application block fumigated
 Summary of weather conditions on the day of the application and during the 48-hour period following the fumigant application
 Tarp damage and repair information (if applicable)
 Location and size of tarp damage
 Description of tarp/tarp s eal/tarp equipment failure
 Date and time of tarp repair
 Tarp removal details (if applicable)
 Description of tarp removal (i f different than in the FMP)
 Date tarps were cut
 Date tarps were removed
 Complaint details (if applicable)
 Person filing complaint (e.g., on-site handler, person off-site)
 If off-site person, name, address, and phone number of person filing complaint
 Description of control measures or emerge ncy procedures followed after complaint
 Description of incidents, equi pment failure, or other emergency and emergency procedures followed (if applicable)
 Details of elevated air concentratio ns monitored on-site (if applicable)
 Location of elevated air concentration levels
 Description of control measures or emergency procedures followed
 Air monitoring results

86 When sensory irritation experienced:

 Date and time of sensory irritation

 Handler task/activity

 Handler location where irritation was observed

 Resulting action (e.g., cease operations, c ontinue operations with respiratory protection)

 When using a direct read instrument:

 Sample date and time

 Handler task/activity

 Handler location

 Air concentration

 Sampling method
 Date of sign removal
 Any deviations from the FMP

In addition to recordkeeping requiremen ts from 7 CFR part 110 “Recordkeeping Requirements for Certified Applicators of Federa lly Restricted Use Pesticides”, this decision requires that both the applicator and owner/operator of the app lication block keep a signed copy of the site-specific FMPs and the post-applicatio n summary record for 2 years from the date of application.

Applicators and other stakeholde rs have the flexibility to use EPA’s templates, prepare their own FMPs templates, or use other commerci ally available software with certain elements

listed above in check-list and/or fill in the blank format. Below are examples of other FMP templates available on the internet for structural fumigations that may be useful to users when developing FMPs for dazomet soil applications:

 http://www.cardinalproproducts.c om/Misc/FMP%20Version%203.pdf

 http://www.pestcon.com/tech library/fum_m gmt_plan.doc

 http://www.agr.state.ne.us/divisi on/bpi/pes/fumig ation_plan.pdf

 http://www.agr.state.ne.us/divisi on/bpi/pes/fumig ation_plan2.pdf

 http://nmdaweb.nmsu.edu/pesticides/Management%20Plans%20R equired%20for%20Fu migations.html

The Agency has provided a template in loca ted in the appendix of this document.

4. Site Specific Response and Management

EPA believes measures for ensuring prepare dness for situations when accidents or emergencies occur are an important part of the su ite of measures necessary to address risks posed by fumigants. Therefore, EPA is requiring such measures at the community level in the form of educational materials for first responders, and measures for specific sites to ensure early detection and quick and appropriate res ponse to situations as they arise.

87Although EPA believes buffers and other mitigati on will prevent many future incidents, it is likely that some incidents w ill still occur due to accidents, e rrors, and/or unforeseen weather conditions such as diurnal inversions.. Early de tection and appropriate response to accidental

chemical releases is an effective means of reduc ing risk, as well as addressing the source of the release. Reducing risks associated with incidents that may occur in the future is a key part of EPA’s soil fumigant decisions. By combini ng buffers with GAPs, FMPs, and effective emergency response, EPA is able to reach a “no unreasonable adverse effects” finding under

FIFRA.

To ensure that appropriate response mechanis ms are in place in the event of a fumigant exposure incident, EPA is requiri ng that registrants provide trai ning information, in the context of their community outreach and education progra ms to first responders in high-fumigant use areas and areas with signifi cant interface between communities and fumigated fields. In addition, for situations in which people, homes, or other structures are in close proximity to buffer zones, applicators must either monitor bu ffer zone perimeters or, alternatively, provide emergency response information directly to neigh bors. Each element is discussed in more detail

below.

First Responder Education

EPA is requiring registrants through their community outreach and education programs (see the Community Outreach and Education Sectio n), to ensure that emergency responders have the training and information that they need to effectively identify a nd respond to fumigant exposure incidents. EPA believes this will help ensure, in the case of a fumigant accident or incident that first responders recognize th e exposure as fumigant related and respond appropriately. Additional details are include d in the Community Outreach and Education

Section of this document.

Emergency Preparedness and Respons e Considerations for the 2008 RED

Prior to the 2008 RED the EPA received comm ents from many stakeholders about the Agency’s emergency preparedness and response op tion. Users have commented that notification is burdensome and that it is unnecessary if buffer zones are also required. However, community groups have commented on the importance of bysta nders being informed when fumigations are occurring, since this group of pesticides, compared to other pesticides, ha s a greater potential to move off site and affect people not involved in the application. State regulators have different views on this requirement. Some support the sharing of information with neighbors, and some states have notification requirements for fumi gations with certain products or for certain application methods. In addition, some states require notification to chemically sensitive individuals in proximity to pe sticide applications. Others also had concerns about the enforceability of this type of measure and the possible burden on the states to enforce a notification requirement.

California currently requires no tification of persons within 3 00 feet of a methyl bromide buffer zone. California strawberry growers cons ider the 300 foot notification area for methyl

88bromide applications to be an extension of the buffer zone. In areas where a large number of people would need to be notified about a plan ned methyl bromide a pplication, strawberry growers indicated that they would rather not use methyl bromide because some communities could mobilize to prevent the fumigation from taki ng place. Some stakeholders also commented that it would be protective and less burdensome if EPA required the user to monitor fumigant air concentrations at the edge of the buffer for 24 hour s after the application to ensure the fumigant does not move beyond the buffer at concentrations that exceed EPA’s level of concern. If concentrations of concern were detected, the us er would be required to implement the emergency response measures specified in the fumigant management plan.

EPA has concluded that bystande rs could take steps to prot ect themselves if they had basic information about fumigati ons and the appropriate steps to take if they experienced symptoms of exposure. In a number of fumigant incidents that have occurred, the magnitude and severity of the incident could have been signi ficantly reduced if people had such information. Similarly, having on-site monitoring will enable si te managers to take remedial action (i.e., activate the control plan in the FMP) to lower emissions soone r, also resulting in fewer and less severe exposures. And, if necessary, site managers would activate the emergency response

elements of the FMP.

Providing communities with information about local chemical releases is an important part of emergency preparedness programs and is recognized as an effective means of addressing

risk at the local level. Some states, like Florida and Wisconsin, have requirements for providing information to chemically-sensitive individuals about chemicals used nearby so they can take steps to protect themselves from potentially harmful exposures (see http://edis.ifas.ufl.edu/pi004

and http://www.legis.state.wi.us/rsb/code/atcp/atc p029.pdf). The requirements in Florida do not apply to agricultural chemical a pplications. Wisconsin also requires fumigators applying metam sodium products through chemigation to provide written notice to the county public health agency and to every individual or household with in 1⁄4 miles of the chemigation application site (see http://www.legis.state.wi.us/rsb/code/atcp/atc p030.pdf). EPA agrees that information about how to recognize and address exposures can help citizens reduce potential risk.

EPA understands that difficult challenges exist when agricultural land borders urban or

suburban communities. While EPA’s decisions for the fumigants will not alleviate challenges that already exist, EPA is allowing options for ensuring emergency preparedness in an effort to lessen potential impact on growers, while main taining the Agency’s protection goals.

EPA is not requiring a specific method of pr oviding the information to neighbors, but rather that it be done in a way that effectively communicates, in a manner the recipients will understand. Some methods may not result in docume ntation that would be retained. To address concerns about enforcement, EP A is requiring that information on how and when the emergency response information was delivered, and to whom, be included in the FMP.

Emergency Preparedness and Response Revisions

89To reduce risks to people who may be near a buffer zone (e.g., at their home or working in a nearby field) in the July 2008 RED EPA requir ed applicators to eith er monitor buffer zone perimeters or, alternatively, provide emergency res ponse information directly to neighbors. This measure is intended to ensure protection in pl aces people may be found. Whether measures are required depends on the size of the buffer zone and how close land (e.g., residential properties and businesses) not within the control of the ow ner/operator of the application block may be to

the buffer zone.

The Agency received many comments about the Emergency Preparedness and Response requirements that suggested the requirements were too complex and confusing. To address these concerns, EPA has revised the structure and content of the requirements in the RED Amendment to improve clarity. As was outlined in the 2008 RE D, it is important to note that site-specific Emergency Preparedness and Response measures ar e only required if there are people, homes or businesses within a certain specified dist ance from the edge of the buffer zone.

Some comments were receive d that questioned the rationale behind scaling the Emergency Preparedness and Response measures. EPA believes that scaling the size of the Emergency Preparedness and Response area will be protective. Generally the larger the buffer distance the higher the app lication rate or the size of the trea ted area may be, which translates to a greater total amount of fumigant being applie d and potentially higher exposure in the area surrounding the application block. The buffe r distances for triggering the Emergency Preparedness and Response requirements are scaled to allow the amount of fumigant used (a surrogate for potential exposure) to determine the applicable di stance for implementing this requirement. When the area is scaled to the si ze of the buffer, small buffers which generally result from applications to small areas, at low application rates, a nd/or using low-emission application techniques, will have small or no areas to monitor or inform, while larger applications will have larger areas to monitor or inform. In addition, to create additional incentive to achieve the smallest buffer possibl e, EPA has included an exception for application blocks so fields with the smallest required bu ffer (25 feet) which would not be subject to this requirement, since they are most likely using lowe r application rates, applying to smaller areas, and/or using lower emission appl ication methods. Based on cha nges to the buffer zone section regarding overlapping buffer zones, any buffer zone that overlaps with another buffer zone must use the maximum distance in the Emergency Prep aredness and Response measures to determine if monitoring or providing information to neighbor s is needed. None of the other distances have changed.

Many stakeholders also expressed con cern over the potentia l burden the 2008 RED requirements may have on applicators and grower s. Specifically, the frequency and cost of monitoring using sampling devices such as colorime tric tubes were of concern. Several of these comments noted concerns with the reliability of such devices at low concentrations.

Stakeholders felt the inherent wa rning properties of chloropicrin and MITC (i.e., eye irritation) were better indicators of expos ure than available devices. Additionally, several stakeholders indicated that monitoring is most appropriate and effective at dawn and dusk, the times of day

when off-site movement of concentrations is most likely. Based on these comments, the Agency has revised the requirement so monitoring is re quired during those periods when risk of high

90concentrations of fumigant moving beyond buffers is greatest (i.e., at dawn and dusk). As a precaution, monitoring is also required once during the night and during the day.

Additionally, as noted above in the respiratory protection secti on of this document, due to limitations on currently available technology for monitoring, use of sampling devices such as colorimetric tubes will not be required at this ti me. EPA believes that currently available devices are likely to be more reliab le at fumigant concentrations which exceed EPA’s action level concentrations. In fact, some of these action levels are at or near the detection limits for the devices available for some fumigants. Additionally, colorimetric devices provide snapshot measurements. In conditions that are likely to be more static (e.g., monitoring an indoor fumigation such as a grain mill or warehouse) it is likely that minute to minute changes in conditions would not be as gr eat as those anticipated fo r the more dynamic conditions

characteristic of outdoor field fumigation where exposure concentr ations could shift because of weather changes or stratification in soil conditions across a single field.

While the Agency is modifying the procedures for monitoring buffer zones because of technological limitations of current ly available devices for MITC and chloropicrin that are not practical or reliable for field use, the Agency does believe that quantitative air monitoring would enhance safety if the appropriate technology were available as it is for methyl bromide. Some equipment manufacturers have indicated interest in developing devices that would be more functional and reliable for field fumigation ap plications (e.g., badge-type monitors). EPA encourages such efforts and plans to stay abreast of developments and improvements in monitoring devices and will consider this issue again in Registration Review or sooner should

such monitors become available in the short te rm. In the interim, buffer monitoring for the MITC generating chemicals and chloropicrin wi ll rely on sensory indicators (e.g., eye and/or nose irritation) to trigger a res ponse instead of using tubes. M onitoring tubes are still required for measuring products that contain more than 80% methyl bromide.

Finally some comments provided suggestions to increase flexibility in how a grower may comply with these measures as well as the eff ectiveness of the option to provide information to neighbors. EPA agrees with the importance of us ers being able to comply with these measures and has modified some aspects of the requirements for this option to reduce the number of notices an applicator may need to provide to a given neighbor. Also, to enhance the effectiveness of the information neighbors would r eceive, EPA is requiring that the information is provided close to when the application is planned to take place and early enough for neighbors

to make use of the information. EPA believes these modifications will enhance compliance and effectiveness of the information if the emerge ncy response criteria are met and applicators exercise this option.

Emergency Preparedness and Response Requirements

91When are Emergency Preparedness and Response Measures Needed?

If

the buffer zone is: AND There is land (e.g. residential properties and businesses) NOT in the control of the

property operator within this distance from the edge of the buffer zone:

25 feet < Buffer ≤ 100 feet 50 feet

100 feet < Buffer ≤ 200 feet 100 feet

200 feet < Buffer ≤ 300 feet 200 feet

Buffer > 300 feet or buffer zones 300 feet overlap

Then either monitoring of the buffer zone pe rimeter or providing emergency response information to neighbors is required.

If the buffer zone is 25 feet, the minimal buffer zone size, then the Emergency Preparedness and Response requirements are not a pplicable. Also, if a ll of the land within 300 feet of the edge of the buffer zone is under th e control of the property operator, then no site monitoring or informing neighbors would be require d regardless of the size of the buffer zone.

Fumigation Site Monitoring

EPA has determined that monitoring of the buffer zone perimeter for fumigants moving beyond buffers is an effective approach to prot ecting bystanders. Under this approach, if the person monitoring the buffer perimeter experiences eye or nasal irritation, an early sign of exposure to concentrations that exceed the Agency’s action leve l, then the emergency response plan specified in the FMP must be implemented. If other problems occur, such as a tarp coming loose, then the appropriate control plan must be activated. Because data indicate that peak

concentrations sometimes occur on the second da y following applications, and the greatest potential for concentrations out side buffers may be observed at dawn and dusk, EPA has decided that this monitoring must be done at least three times per day during the full buffer zone period at dawn, dusk, and once during the ni ght and during the day, to en sure concentrations do not

exceed the action level which will be specified on product labels.

Specific requirements include:

 Monitoring must take place beginning on the day the application begins until the buffer zone period expires.

 Monitoring must be conducted by a certified ap plicator or someone under his/her supervision.

 Monitoring for air concentrations above the ac tion level for the fumigant, as determined by sensory irritation, must take pl ace in areas between the buffer zone perimeter and residences or other occupied areas that trigger this requirement.

 The person monitoring for percep tible levels must start monitoring approximately 1 hour before sunset of the day the application begi ns and continue once during the night, once at 1 hour after sunrise, and once during the day until the end of the buffer zone period.

92 If at any time the person monitoring the air concentrations experien ces sensory irritation, then the emergency response plan stated in the FMP must be immediately implemented.

 If other problems occur, such as a tarp coming loose, then the appropria te control plan must

be activated.

 The location and any results of the air mon itoring must be recorded in the FMP.

While protective, this site monitoring might be burdensome for users fumigating in areas with few people. Therefore, EPA is allo wing users the alterna tive option of providing emergency response informati on directly to neighbors.

Response Information for Neighbors

As an alternative to on-site monitoring, the certified applicat or supervising the fumigation (or someone under his/her direct su pervision) would need to ensure that residences, businesses,

or other sites that meet the criteria outlined below have been provided the required information below at least one week prior to the fumigant applic ation in a specified field. If after four weeks, the fumigation has not yet taken place, the information must be delivered again.

 Information that must be provided includes:

o The general location of the application block,

o Fumigant(s) applied including the active ingredient, name of the fumigant products(s), and the EP A Registration number,

o Contact information for the applicat or and property owner/operator,

o Time period in which the fumigation is planned to take place (must not range more than 4 weeks),

o Early signs and symptoms of exposure to the fumigant(s) applied, what to do, and what emergency responder phone number to call who to call if you believe you are being exposed (911 in most cases), and.

o How to find additional inform ation about fumigants.

The method for distributing information to ne ighbors must be described in the FMP and may be accomplished through mail, telephone, door hangers, or through other methods that can be reasonably expected to effectively inform people at residences a nd businesses within the required distance from the edge of the buffer zone.

To clarify this measure, the following example is provided:

 IF the buffer zone is 125 feet , then these requirements apply to residences within 100 feet of the buffer zone. Either the applicator must monitor the area between the dotted house and the buffer zone

or residents of the dotted house must be provided emergency response information.

 The location of the cross-hatched house would not prompt any action.

Figure 9. Example Site Map for Informing Neighbors

93Treated field Buffer zone 45 ft

288 ft 125 ft 100 ft

If there are no residences or other occupied structures within 300 feet of the edge of the buffer zone, or if the buffer distance is the mi nimum of 25 feet, neithe r site monitoring nor providing information to neighbors is required.

5. Notice to State Lead Agencies

Ensuring fumigant users understand and comply with the new label requirements is an important component of the fumigant risk m itigation package since these requirements are designed to mitigate risks of concern for bystander s, handlers, and workers. Knowledge of the location and timing of fumigant applications allows enforcement officials to focus their compliance assistance and inspection effort s around periods when, and places where, fumigations are expected to occur. Therefore, in the July 2008 RE D, the Agency required written notification of the appropriate state or tribal l ead agency prior to fumigant applications.

Following publication of the July 2008 REDs, the Agency received feedback from some states that were interested in receiving the notice because it would e nhance their ability to provide technical assistance and assure complia nce. However, the Agency also received

comments from states that were concerned abou t the notification requirement largely due to

resource constraints. Some states also indicate d that they are already well-informed about when and where fumigations take place, and receiving specific notice of applications would create a paperwork burden rather than aid their compliance assistance and assurance programs. Some states recommended that, in lieu of receiving not ice of fumigations, states could modify their cooperative agreements with EPA to incorporate specific strategies for assuring compliance with the new fumigant labels. States also suggested that rather th an providing notice directly to states,

94fumigators could enter applica tion information into a regist rant-developed and maintained database. They suggested this would be an a ppropriate mechanism because it would standardize and streamline the process for applicators to pr ovide the required inform ation, and states could access and utilize information more quickly, with greater ease, and using fewer state resources.

Based on consideration of public comments, the Agency still believes that compliance

assistance and assurance is a cri tical component of the soil fumigant mitigation. EPA agrees that some states already have mechanis ms in place to provide them with information needed to assist and assure compliance with new fu migant requirements, but other st ates are in need of additional information to accomplish this objective. The Ag ency also believes that all states in which fumigants are used will need to modify thei r cooperative agreements, to some extent, to incorporate strategies for compliance assistance and assurance to aid the transition from current labels to labels that reflect the new mitigation.

While the Agency will continue to work with a ll state and tribal lead agencies on efficient ways to obtain the information needed to pl an and implement compliance assistance and assurance activities, the Agency is currently re taining the notification requirement only for state and tribal lead agencies that c hoose to be notified of fumigant applications. The Agency plans to provide a website listing these state and tribal lead agencies and how and when these agencies want applicators to provide to them the following information:

 Applicator and property owner/operator cont act information (name, telephone number, and applicator license number)

 Location of the appl ication block(s)

 Name of fumigant(s) produc ts(s) applied in cluding EPA Registration number

 Time period in which fumigation may occur

The Agency will work with all states to am end their cooperative agreements to include strategies for compliance assistance and assuran ce, which will be particul arly important over the next several years as the new mitigation measur es are implemented. For states that do not choose to be notified of fumiga nt applications, modification of their cooperative agreements must include the methods these agencies will use to survey fumigation application periods and

locations.

6. Soil Fumigation Training for Applicators a nd Training Information for Other Handlers

Soil fumigation is an inherently complex activity involving specia lized equipment and application techniques. Additionally, the mitigati on measures required as part of these decisions will introduce new requirements in the form of more detailed instructions and restrictions on soil fumigations. Failure to adequately manage fumi gant applications increases risks to handlers involved in the fumigation, nearby workers, and other bystanders. Incident data show that a number of fumigant incidents are the result of misapplications, failure to follow label requirements and other safety precautions, and other er rors on the part of fumigant applicators.

95Although states have certification programs, so me of which include a specific category or subcategory for soil fumigation, there currently is not a consistent sta ndard across states and regions where soil fumigation is done. Additiona lly, the federal certifica tion program currently has no category for soil fumigation, and while EPA is considering the development of a category for soil fumigation, the potential changes to the federa l certification program and worker safety regulations to include a soil fumigation category are not anti cipated in the near future.

EPA believes that training is an effectiv e way to increase applicators’ skill and knowledge so they are better prepared to e ffectively manage the complexities and risks associated with soil fumigation. Further, training is a means of ensuring fumigators are able to understand and comply with revised fumigant labeling. Therefore, EPA determined that training designed to establish a national baseline for safe fumigant us e, developed and implemented by registrants, will help enhance fumigators’ ability to adequately manage the complexities of soil fumigation and enhance compliance with fumigant product labeling. EPA also determined that providing additional safety information to other fumigant handlers will help them understand and adhere to practices that will help handlers protect themselves from risks of exposure.

Soil Fumigation Training Considerations

In comments on fumigant risk management options, stakeholders were broadly supportive of additional training for applicators and handlers. During the Phase 5 and post-RED comment periods, the majority of stakeholde rs, including growers, community groups, farm workers, states, and registrants expressed str ong support for increased tr aining for applicators

and other handlers. Several comm ents noted that fumigant inci dents affecting both fumigant workers and bystanders could have been prevented or mitigated if applicators had better training about correct practices and procedures.

The Agency agrees that additional training for fumigant applicators and handlers will help educate and inform these workers, thus decreasing the likelihood of both incidents and noncompliance. EPA believes fumigant-specific tr aining for applicators a nd additional training information for handlers also will help re duce the magnitude and frequency of exposure incidents and, coupled with the other mitigation m easures described in this decision, will address

risks of unreasonable adverse effect s from the use of soil fumigants.

It is important to note that training devel oped and provided by regi strants as required by this RED is separate and distinct from state cer tification programs. EPA encourages registrants, in developing their training proposals, to work with states where their products are used to identify opportunities to build on and compleme nt state programs. However, the training programs required as part of this decision are inte nded to be separate from the state certification process and will be developed and administered by registrants. Individual state regulatory agencies have the option of working with regist rants on these activities, but are not required to do so. It is important to note that some fu migant registrants have already developed soil fumigant training programs that will serve as a good basis for this expanded effort.

96As noted above, several states have high-qua lity certification programs for fumigators that include exams to test the competency of fu migators. EPA recognized that for applicators to become certified in those states, they must acqui re the knowledge and skill necessary to pass the

exam. But several stakeholders commented th at training opportunities are varied across the country, and the scope and detail of information provided in availa ble training is not consistent.

EPA is also concerned that information in ex isting programs will need to be substantially updated as a result of new requi rements associated with this decision and the label changes which will implement it. Although EPA is consider ing revisions to the federal certification and training program in the future to include a soil fumigation category/subcategory, EPA believes that registrants have access to resources and mate rials to best develop and deliver training in the

interim.

EPA stresses that registrant tr aining programs will be separate from the state certification process and will be developed and administered by registrants in coordination with EPA. EPA will, however, work with state organizations a nd training experts to explore opportunities for the registrant programs to supplement any existing state programs to provi de additional training resources for fumigators working in those states. EPA will also work with state lead agencies and extension programs to review training progr am proposals, the conten t for the programs and materials, and proposed vehicles for delivery.

During the post-RED comment period, the Ag ency received comments from several states asking that the applicator training re quirements be coordinated with existing state certification and training programs. The Agency agrees that for states that have existing soil fumigation certification program s that address the same training elements required of the registrant soil fumigant training programs, as outlined in this section of the RED addendum, applicators should be able to complete the stat e certification program in lieu of completing the registrant soil fumigation training. For the state soil fumigation certification program to qualify, both EPA and the state must agree that the progr am satisfies the appli cator training elements required in the RED.

Pesticide labels will state that the certified applicator supervising that application must have successfully completed, within the last 36 months, a dazomet training program made available by the registrant. The Fumigant Mana gement Plan must document when and where the training program was completed. This requirem ent for registrant-provi ded applicator training does not supersede or fulfill state requirements, unless the state has expressly acknowledged that the registrant training may substitute for state requirements.

Training for Applicators Supervising Fumigations

The July 2008 RED required registrants to develop and implement training programs for applicators in charge of soil fumigations on the proper use of and best management practices for soil fumigants. During the public comment period on the proposed mitigation measures and the post-RED comment period, stakeholders were br oadly supportive of additional training for fumigators, but concerns were raised with regard to implementa tion of the training. The Agency also received comments from state represen tatives and pesticide applicator training

97organizations, such as the Association of Amer ican Pesticide Control Operators, American Association of Pesticide Safety Educators, and Certification & Training Assessment Group, expressing concern over EPA’s decision to impl ement the training via labeling and raising questions over compliance and state enforcemen t of such a requirement and the potential for conflict or redundancy with stat e certification and training pr ograms. Various stakeholders recommended that, rather than a label-mandate d training requirement, the Agency, instead, should require registrants to de velop and implement training for soil fumigant applicators as a condition of registration.

The Agency’s goal in requiring soil fumigation tr aining for applicators is to ensure that all applicators in charge of so il fumigations understand the safe use of soil fumigants and in how to apply products in compliance with new pr oduct labeling, including pr ovision required by the RED. Given the unique properties of soil fumigant s and their application and safety procedures compared with other agricultural and non-agricu ltural pest control pr actices, the inherent complexities involved in soil fumigant applicat ions, and the additional complexities that will arise with the implementation of the REDs, the Agency feels that additional training, beyond that available currently, will be needed. The states that currently have cer tification programs that include soil fumigation categories will not have requirements pertaining to the new mitigation and their programs will need to be modified. EPA agrees that making the required training programs a condition of registration is an importa nt means of ensuring that such training is ultimately developed and implemented. However, it would not ensure that all individuals in charge of soil fumigant applicati ons avail themselves of the trai ning. The Agency believes that making successful completion of the training a conditi on of use is also important to achieve this goal. Therefore, EPA has decided that develo pment and delivery of training will be included in the DCI that accompanies this RED and successf ul completion of the training will remain a

condition of use.

Each registrant must develop and implement training programs for applicators in charge of soil fumigations on the proper use of and be st practices for soil fumigants. In addition, registrants will be required to submit proposals for these programs as data requirements that will accompany this RED. EPA will review each pr ogram and determine whether it adequately addresses the requirements specified in the DCI. The proposal must address, among other elements, both the content and the format for de livering training. The Agency acknowledges the value of hands-on training in the fi eld, but recognizes that may not be feasible in all instances. The Agency welcomes and is actively seeking participation from state lead agencies and extension programs in the evalua tion of the registrant training proposals and materials that are

submitted.

The training programs must a ddress, at a minimum, the following elements: (1) how to correctly apply the fumigant, including how to co mply with new label requirements; (2) how to protect handlers and bystanders; (3) how to determine buffer zone distances; (4) how to develop a FMP and complete the post-fumigation appli cation summary; (5) how to determine when weather and other site-specific factors are not favo rable for fumigant application; and (6) how to comply with required GAPs and how to document compliance with GAPs in the FMP. In addition, based on comments received during th e post-RED comment period, the Agency is

98adding a seventh training element—training progr ams must also include information on how to develop and implement emergency response plans—to ensure that applicator s are prepared in the event that a problem develops during or shortly after the fumigant application. EPA is also requiring registrants to incorporat e a mechanism for evaluating the effectiveness of their training programs at conveying the required information to participants and for determining whether participants have successfully completed the training program.

To assist states in enforcing these training re quirements, the registrants will be required to (1) develop a database to track which certified applicators have successfully completed the training, (2) make this database available to state and/or federal enforcement entities upon request, and (3) provide documentation (e.g., a card) to each training participant who successfully completes the training. This docum entation shall include the applicator’s name, address, license number, and the da te of completion. Applicators must provide to federal, state, or local enforcement personnel, upon request, this documentation that verifies successful completion of the appropriate training program(s).

In the July 2008 RED, the Agency require d applicators supervising fumigations to complete the training annually. During the post-RED public comment period, the Agency

received comments from various stakeholders indicating that the subs tance and content of training would not change signifi cantly from year to year, and that an annual training requirement for applicators would be excessi ve and burdensome to both applicators and registrants and was unnecessary. As a result of these comments, the Agency has decided to require applicators supervising fumigations to have successfully completed the program within the preceding 36 months and to document when and where the training program was completed in their FMPs. This may be accomplished, for example, by simply attaching a copy of the training documentation provided by the registrant to the FMP. The registrant also must be able to provide to federal, state, or local enforcem ent personnel, upon request, the names, addresses, and certified applicator license numbers of persons who successfully completed the training program, as well as the date of completion.

Based on questions received during the post-RED comment period, the Agency is clarifying that the applicator tr aining requirements are active i ngredient-specific rather than product-specific. That is, applic ators who apply more than one of the soil fumigant active ingredients (i.e., methyl bromide, chloropicri n, metam sodium/potassium, or dazomet) will be required to complete training for each soil fumigant active ingredient they apply, but not for each different product containing the same active ingr edient(s). Further, EPA encourages the soil fumigant registrants to join tly develop programs to reduce the redundancy of this training requirement. For example, a substantial portion of the required training is universal to all soil fumigants. Therefore modules addressing the in formation common to all could be generic and each fumigator would participate in those modul es, while separate modules addressing active ingredient-specific content could be provided to those fumigators supervising applications with those active ingredients only. Documentation pr ovided to trainees could indicate the active ingredient modules completed. While EPA sees effi ciencies in such an a pproach, it will be the registrants’ choice as to how they will comply with the requirement to develop and implement training programs.

99Training Materials for Handlers

EPA is requiring registrants to prepare and disseminate training information and materials for other fumigant handlers, i.e., thos e working under the supervision of the certified applicator in charge of fumigations. The Agency is requiring registrants to submit proposals for these materials through the data call-ins that wi ll accompany this RED. EPA will review these materials to determine whether they adequately address the requirements specified in the DCI. The Agency welcomes and is actively seeking participation from state lead agencies and extension programs in the evaluation of these handler training materials.

The training materials must address, at minimum, the following elements: (1) what fumigants are and how they work, (2) safe applic ation and handling of soil fumigants, (3) air monitoring and respiratory protec tion requirements for handlers, (4 ) early signs and symptoms of exposure, (5) appropriate steps to take to m itigate exposures, (6) what to do in case of an emergency, and (7) how to report incidents. Regi strants must provide th is training information through channels open to the public (e.g., via a we bsite). Pesticide labe ls will require that applicators supervising fumigati ons provide this training inform ation to handlers under their supervision before they perform any fumigant ha ndling task, or they must ensure that handlers have been provided the required information within the preceding 12 months. The label will also require that the training inform ation be provided in a manner th at the handler can understand. Applicators supervising fumigati ons must ensure the FMP incl udes how and when the required training information was provided to the handlers under their supervision.

“The certified applicator must provide fu migant safe handling information to each handler involved in the app lication in a manner that they can understand prior to performing any fumigant handli ng task or confirm that each handler participating in the application has received fumigant safe hand ling information in the past 12 months.”

During the post-RED comment period, no s ubstantive comments were received that resulted in changes to the RED requirements for tr aining materials for handlers, as a result, these requirements are identical to those published in the July 2008 RED. However, during the comment period, the Agency received comments i ndicating that there was some confusion about whether fumigant handlers working under the su pervision of the certifie d applicator would be required to be trained, i.e., participate in a training program developed by the soil fumigant registrant(s), or whether handler s would need only to be provided with training information and materials. The Agency wishes to clarify that handler participation in a registrant training program, per se, is not required. As noted above , applicators supervisi ng a soil fumigation will be required to provide the regi strant-developed, EPA-approved tr aining information to handlers in a manner that they can understand prior to performing any fumigant handling task, or applicators must ensure that th e handler has been provided the required information within the proceeding 12 months.

7. Community Outreach and Education Programs

100EPA understands from public comments, site visits, and stakeholder meetings, conducted as part of the soil fumigant review, that there is often a fundamental lack of information and communication about soil fumigants within communities where soil fumigation occurs, which has raised health and safety concerns among community members. This lack of information and communication has led to inappropriate responses in cases where fumigants have moved off site and into communities. This also has led, in some cases, to unwarranted concern and anxiety among communities about the risks associated with the use of fumigants. The Agency believes

that outreach and education to communities where soil fumigation occurs is an important component of the overall package of measures to address bystander ris k. Community outreach will address the risk of acute bystander expos ure by informing community members in high-use

areas about buffer zones and thei r characteristics a nd purpose, the meaning of posted warning signs, the importance of not ente ring buffer zones, how to rec ognize early signs of fumigant exposure, and how to respond appropri ately in case of an incident.

In the July 2008 RED, the Agency require d registrants to develop and implement community outreach and education programs to address these needs. At a minimum, these programs were to include the following elements : (1) what soil fumigants are and how they work, (2) what buffer zones are, (3) early signs and symptoms of exposure, (4) appropriate steps to take to mitigate exposures, (5) what to do in case of an emergency, and (6) how to report an incident as well as a plan for evaluating the e ffectiveness of these programs. Few details on how the programs would be implemented were provide d in the RED. Rather, during the post-RED comment period, the Agency sought feedback from the registrants and other stakeholders on how best to design and target programs to comm unity members in high-use areas. The Agency encouraged the registrants to work with exis ting community resources, such as community health networks, for disseminating information and implementing community outreach

programs.

During the post-RED comment period, the Agency received some comments from stakeholders that suggested that having regist rants develop and implement a community outreach and education program is unnecessary and likely to needlessly raise heath and safety concerns among community members, and such a requirement could draw scarce resources from other registrant stewardship efforts. As noted previ ously, the Agency believes that providing basic information about soil fumigants and buffer zones as well as information on what to do in the

event that an incident occurs to communities in high fumigant use areas is an important component of the overall package of risk mitiga tion measures to address bystander risk. EPA’s community outreach requirements do not preclude other voluntary stewardship programs or activities targeted to community members or th e applicator/grower comm unity, but rather are meant to help ensure that community members in high fumigant usage ar eas are informed about soil fumigant safety and better able to respond ap propriately if an incident were to occur.

Few recommendations and no specific proposals for these programs were received during the post-RED comment period. Therefore, the Ag ency is identifying minimum requirements that each registrant must fulfill when developing it s community outreach programs in response to a DCI that will be issued. The Agency remains open to considering additional registrant outreach program elements that address the same needs and goals as the program requirements described

101below in their response to the DCI. EPA notes that registrants have suggested that programs focusing on specific target audiences, such as sta ff and managers of migrant health care and day care facilities, prison officials, and school nurses and principals , may be more effective in providing useful information in a meaningf ul way than broadcast messages to entire communities. Registrants have indicated that th ey will provide proposals for such programs in late May 2009. EPA looks forward to these propos als and will consider the extent to which they contribute to meeting the goals of the comm unity outreach programs required by the RED.

In the absence of acceptable alternative proposal s, registrants will be required to provide

information to communities in the form of monthly public service announcements (PSAs)

distributed via local radio stations or news papers in high-use fumi gant areas during the fumigation season(s) in those area s. As per the requirements include d in the July 2008 RED, at a minimum, registrants must include the following information in their community outreach messages: (1) what soil fumigants are and how th ey work, (2) what buffer zones are, (3) early signs and symptoms of exposure to MITC, (4) appr opriate steps to take to mitigate exposures to MITC, (5) what to do in case of an emergency, a nd (6) how to report an incident as well as a plan for evaluating the effectiv eness of these programs. Based on comments, EPA has decided that information on the meaning of posted warning signs is also important to help ensure the signs convey the needed information about the importance of staying out of buffer zones and

treated areas.

The Agency is requiring registrants to im plement their outreach programs in communities located in areas where there is high soil fumiga nt use. For the purposes of the RED addendum, high-use areas are considered at the county level. To identify these areas, the Agency is proposing a process for identifying high-use area s in the subsection following the section on information for first responders. However, the Agency is willing to consider alternative proposals for identifying high so il fumigant-use areas, based on additional data sources and alternate approaches identified by the re gistrant(s) and other stakeholders.

Information for First Responders

In the July 2008 RED, the Agency required regi strants to ensure that first responders in areas with high fumigant usage ha ve the training and information th at they need to effectively identify and respond to fumigant exposure incide nts. Specifically, the re gistrants were required to provide information and/or training to first responders, wh ich at a minimum, included the following elements: (1) how to r ecognize the early signs and symp toms of fumigant exposure, (2) how to treat fumigant exposures, and (3) how fumigant exposure differs from other pesticide exposure. In addition, the registrant s were required to provide materi al safety data sheets to first responders for both the fumigant applied (e.g., dazomet) as well as the active compound generated (e.g., MITC). Few deta ils on how the education programs would be implemented were provided in the RED. Rather, during the post-RED comment peri od, the Agency sought feedback from the registrants and other st akeholders on how best to desi gn and target programs to first responders in high-use areas. The Agency encouraged the registrants to work with state and local emergency response coordinators to identif y needs and opportunities to supplement any

102information already included in state and local training for first responder s about soil fumigants specifically.

During the post-RED comment period, the Ag ency received comments from several registrants indicating that rather than requiri ng registrants to implem ent face-to-face training programs, the Agency should consider allowing the required first responde r training information to be conveyed via written materials to stat e and local emergency response agencies, which would provide these agencies th e ability to incorporate this information into their existing training programs. Other comments indicated that even if training progr ams were developed, it would be difficult to ensure participation of fi rst responders. The Agency’s goal for the first responder training program is to ensure that fi rst responders in high use fumigant areas have access to the information that they need to be able to quickly and effectively identify an exposure that is fumigant related and re spond appropriately. The Agency agr ees that this goal can be met by requiring the soil fumigant registrants to develop informational materials on the soil fumigants and distribute this information to firs t responders (i.e., police, fire, rescue, emergency medical services, and others who respond to “911 ” calls) in high soil fumigant-use areas. This would then provide the first res ponder entities the ability to in corporate this information into their existing first responder training programs as they best see fit. This recommendation has been incorporated into the RED am endments for the soil fumigants.

The Agency is willing to consider additional registrant proposals so long as they address the same needs and achieve the same goals as the program requirements described below. At a minimum, registrants will be required to de velop and disseminate chemical-specific soil fumigant training materials to first responders i.e., police, fire, rescue, emergency medical services, and others who respond to “911” calls) operating in high fu migant-use areas. As a data requirement in the DCIs that will accompany the REDs, registrants must submit proposals detailing how they will (1) identify the first responder entities in high so il fumigant-use areas to which they will disseminate the training materi als, and (2) provide materials to the first responders in these areas. Additionally registrant s must provide draft copies of the training materials for EPA review and approval. As per the requirements included in the July 2008 RED, at a minimum, the materials must convey the foll owing information to first responders: (1) how to recognize the early signs and symptoms of dazomet fumigant exposure, (2) how to treat dazomet fumigant exposures, and (3) how dazo met fumigant exposures differ from other pesticide exposures as well as (4) copies of materi al safety data sheet(s) for the fumigant applied as well as for the active compound generated, if applicable. Traini ng materials can take a number of forms, including: brochures, f act sheets, CDs, videos, web-base d training materials, etc., as long as these materials incorpor ate, at a minimum, the information requirements identified

above.

The Agency is requiring registrants to target their first responder training information to those communities located in high soil fumigant -use areas. For the purposes of the RED, highuse areas are considered at the county level. To identify these areas, the Agency is proposing the following process. However, the Agency is wil ling to consider altern ative proposals in the registrants’ response to the DCIs for identifying and targeting hi gh-use soil fumigant areas, based on additional data sources and alternate appr oaches identified by the registrant(s).

103Process for Identifying High-Use Fumigant Areas:

Identifying high-use areas for dazomet is a two-step process because reliable fumigant

use data is not available at th e county level from either publicly available data sources or EPA proprietary data sources. First, the states with high use of d azomet have been identified by the Agency using EPA proprietary data. Second, th e high-use counties for dazomet within those states must be identified. The second step, iden tifying high-use counties, will be the registrant’s responsibility, using the pro cess defined below.

 Step 1: Identifying States with High Use of Dazomet: The Agency is defining states with high usage of dazomet as those states wh ere, on average, more than 100,000 lbs of dazomet are applied annually. To determine those states where, on average, more than 100,000 lbs of dazomet has been applied annu ally, the Agency obtained data on the average number of pounds of dazomet applie d in all states across a ten–year period (1999-2008) using EPA proprietary data. To view the Agency’s analysis of this data, please see the Biological and Economic An alysis Division’s memo, “Process for Defining High-Use Fumigant Areas at State and County Levels” dated May 14, 2009 and supporting documentation located in the dazomet docket at EPA-HQ-OPP-2005-0128.

 Step 2: Identifying Counties with High Use of Dazomet: For each of the high-use states that the Agency identified in Step 1, the registrants will be required to identify the counties where use of dazomet may be high. Be cause county-level fumigant usage data is not publicly available and EPA proprietary da ta are not appropriate for this level of specificity, crop acreage should be used as a su rrogate indicator for fumigant usage. Crop acreage can be obtained for major use sites of dazomet from the publicly available 2007 USDA Census of Agriculture. Crop acreages fo r each of the major use sites for dazomet should be obtained for each the major use sites for dazomet and then summed by county. All counties making up at least the top 90% of acreage in a st ate are considered high-use areas. Registrants will be required to ta rget each of these high-use counties for community outreach programs.

For the purposes of this analysis, the Agency de fines a “major use site” as any crop that has more than 5% crop treated annually or more th an 100,000 lb of dazomet applied annually. Given the low usage rates of dazomet at this time, the requirement for community outreach and first responder training programs will not likely be triggered. However, the Agency could review this issue during registration review to determine of dazomet usage has changed, such that community outreach and first responder training programs are determined to be necessary.

Example Identifying High-Use Fumigant Areas for Metam Sodium in California:

To help explain the process for identify ing high-use fumigant areas for dazomet the Agency is providing the following example, which identifies the high-use counties for the soil fumigant, metam sodium, usage in California.

104 Step 1: Identify States wi th High Use of Metam Sodium:

o Based on its analysis of pr oprietary data, the Agency has identified the following high-use states for metam sodium: Ca lifornia, Washington, Idaho, Oregon, Wisconsin, Michigan, Florida, Minnesot a, North Carolina, Virginia, Arizona, Nevada, Georgia, Colorado, and North Da kota. This example will focus only on identifying the counties in California w ith high use of metam sodium. The same process would be applied to other high-use states.

 Step 2: Identify the Counties in Calif ornia with High Use of Metam Sodium:

o EPA has identified the following as the major use sites of metam sodium/potassium: artichokes, cabbage, cantaloupes, carrots, onions, peanuts, peppers, potatoes, spinach, squash, tomatoes, and watermelons.

o Using the 2007 USDA Census of Agricult ure, registrants wi ll need to obtain harvested crop acreage data for each of th e 12 major use sites for metam sodium identified above for each county in California. (An example of this analysis is provided as a supporting document to th e Biological and Economic Analysis Division’s memo “Process for Defining Hi gh-Use Fumigant Areas at State and County Levels” dated May 14, 2009 and supporting documentation located in the dazomet docket at EPA-HQ-OPP-2005-0128)

o Registrants will then need to sum the total number of combined crop acres for these major use sites for each county in Ca lifornia and then select all the counties that make up at least the top 90% of acr eage in the county. [An example of this analysis is also provided as a s upporting document to the Biological and Economic Analysis Division’s memo “P rocess for Defining High-Use Fumigant Areas at State and County Levels” dated May 14, 2009 and supporting documentation located in the dazomet docket at EPA-HQ-OPP-2005-0128)

As with the training for fumigant applicat ors and handlers and the community outreach program that the Agency is requ iring, the first responder training requirements are intended to be part of the registrants’ long-te rm product stewardship. The Agen cy encourages registrants to work with appropriate state emergency response entities in these areas to ensure that the appropriate first responder entiti es are being targeted and that the information being provided to first responders is both useful and presented appropriately.

iii. Environmental Risk Management

In the July 2008 RED, EPA addressed the c oncerns about both aqua tic and terrestrial risks are discussed in Section III.C. The July 2008 RED also stated that EPA believed that mitigation measures detailed in the Human Hea lth Risk Mitigation Section would also reduce ecological risks. The Agency stated that al though buffer zones and GAPs do not directly reduce the potential risk to ecological organisms, these mitigation measures do provide an incentive to reduce fumigant application rates an d individual treatment areas whic h in turn will contribute to lower exposure and risks for non-target organisms.

105The July 2008 RED discussed exposure to te rrestrial organisms such as birds and mammals, which could occur two ways, as either oral exposure to dazomet granules or by the inhalation route of exposure to the breakdown product MITC. Potential exposure to aquatic organisms may occur from surface runoff /leaching and drift (wind) of MITC.

The risk assessment also identified potent ial acute risks of concern for birds and mammals, since it is assumed they could be expos ed to unincorporated dazomet granules. There are uncertainties about the aquatic risks since there are no toxicity data available. Additional eco-toxicity data are required for both dazomet and MITC.

Since dazomet is applied as a granular and wate ring in is required in order to activate the product, the amount of dazomet gr anular left on the soil surface to which birds and mammals

could have access is not estimated in this assessmen t. It is likely the am ount of dazomet actually

available to birds and mammals is less than assume d in the risk assessment due to watering in.

In addition, the registrants will lower the ma ximum rate for dazomet from 530 to 425 lbs a.i./A for all use sites, except for golf-course re novation. This rate reduc tion will also reduce the potential for effects on non-target organisms. In addition, the structure of the buffer zones required in this decision encourag es growers to use the lowest ra te and block size feasible in

order to establish the sm allest possible buffer zone distance for an application. Although this mitigation measure does not directly reduce the pot ential risk to ecological organisms, it does provide an incentive to reduce fumigant applicati on rates and individual tr eatment areas which in turn will contribute to lower exposure and risks for non-target organisms.

The July 2008 RED noted that based on the fate parameters of MITC, it should not persist in terrestrial environments because of volatilization and degradation and the available non-targeted monitoring data does no t detect MITC in the ground-water samples within the U.S. However, MITC is highly soluble in water and has a low adsorption to soil which suggests that there is a potential of leaching to shallow groundwater under flooded and saturated conditions. Also, if intense rainfall or cont inuous irrigation occurs there is potential for MITC to move to surface water. Due to the importance of adequate soil moisture as described in the GAP section and the knowledge that volatilizat ion is dazomet’s most import ant route of dissipation, EPA required the following language in the July 2008 RE D taking these factors into consideration: “While dazomet and its major degradate MITC ha ve certain properties a nd characteristics in

common with chemicals that have been detect ed in groundwater (MITC is highly soluble in water and has low adsorption to so il), volatilization is this chemi cal's most important route of dissipation.”

While the Agency believes that volatilization is this chemical’s most important route of dissipation, it is being remove d from the groundwater statemen t because volatilization is addressed in other areas of the mitigation packag e. The new language will state, “Dazomet has certain properties and characteristics in common with chemicals that have been detected in groundwater (dazomet is highly soluble in water and has low adsorption to soil).”

106The July 2008 RED also included language required for both tarped and non-tarped dazomet applications to minimize potential for leaching or runoff. During the post-RED comment period commenters stated that the foll owing language was not clear or enforceable:

“For untarped applications of dazomet, potential le aching into groundwater and runoff into surface water can be reduced by avoi ding applications when heavy rainfall is forecasted to occur

within 24 hours.”

EPA would like to clarify that the stat ement was meant to be advisory and not mandatory. However in an effort to clarify th e requirement the Agency has revised the July 2008 RED language as follows, “For untarped app lications, leaching and runoff may occur if there is heavy rainfall after soil fumigation.” The revised statement is based on information presented in a 2007 article by Zhang and Wang 11

.

b. Dazomet Antimicrobial Uses

The Agency received comments on the RED fo r antimicrobial uses of dazomet. A summary of the risk mitigation measures for the antimicrobial uses of dazomet is presented below; for further information on the antimicrobi al risk assessment and mitigation, please see

these documents in the dazomet docket:

 Dazomet: Revised Occupational and Residential Exposure Assessment of Antimicrobial Uses for the Reregistration Eligibility Decision (RED) Document. (Walls, C., Dated June 4, 2008)

 Risk Mitigation Measures and Updated Label Language for the Antimicrobial Uses of Dazomet (PC Code 035602) for the Reregi stration Eligibility Decision Document. (Garvie, H., Dated June 2 2008)

All of the dazomet antimicrobial uses are for occupational applic ations. These uses include: 1) a treatment during the production of pulp and paper; 2) a materials preservative treatment for paper coatings, non-food adhesive s, epoxy flooring compou nds, slurries, and high viscous suspensions; 3) a bioc ide treatment used during petr oleum operations; 4) a biocide treatment used in recirculating cooling water syst ems; and 5) a remedial wood treatment to utility poles.

Risks of Concern

All of the occupational handler inhalation, de rmal and total MOEs we re above the target MOE of 100 (short-term and intermediate-term) except for the following scenarios:

11 Zhang, Y. and Wang, D .2007. Emi ssion, distribution, and leaching of meth yl isothiocyanate and chloropicrin under different surface containments. Chemosphere, 2007 Jun; 68(3): 445-454.
107 Intermediate-term dermal exposure resu lting from the preservation of epoxy flooring compounds via solid op en pour methods: MOE = 58

 Intermediate-term total e xposure resulting from the preservation of epoxy flooring compounds via solid open pour methods: MOE = 55

 Intermediate-term dermal exposure result ing from pulp and paper slimicide use via solid open pour methods: MOE = 79

 Intermediate-term total e xposure resulting from pulp and paper slimicide use via solid open pour methods: MOE = 74

 Intermediate-term inhalation exposure re sulting from the maintenance dose of microbe control in large water coolin g system via metering pump: MOE = 98

 Intermediate-term total e xposure resulting from the maintenance dose of microbe control in large water cooling syst em via metering pump: MOE = 55

Risk Mitigation Measures

 For epoxy flooring open pour scenario- labeli ng language must state that the product is not to exceed 3,500 ppm (maximum applica tion rate of .35%) by weight of material

treated.

 For the pulp and paper solid open pour scen ario – update PPE language to state that long sleeve coveralls will be required in addition to wear ing long sleeved shirt, long pants, shoes, socks, goggles or face sh ield and chemical resistant gloves.

 For the cooling tower use: update personal protective equipment (PPE) language to state that chemical resistant gloves are necessary, in addition to goggles or face

shield.

 For all scenarios that use metering pumps, chemical resistant gloves must be used.

 Additional label instru ctions for pole treatment use requi ring that pre-drilled holes are plugged immediately after application and instru ctions that holes ar e not to be drilled through seasoning checks.

The data requirements for dazomet’s antimicrobial use and label changes are found in Section V.

2. Endocrine Disruptor Effects

EPA is required under the FFDCA, as ame nded by FQPA, to develop a screening program to determine whether certain substanc es (including all pes ticide active and other ingredients) “may have an effect in humans that is sim ilar to an effect pro duced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of the program, androgen and thyroid hormone syst ems, in addition to the estrogen hormone system. EPA also adopted EDSTAC’s recommenda tion that the Program include evaluations of potential effects in wildlife. When the appropr iate screening and/or testing protocols being considered under the Agency’s Endocrine Disr upter Screening Program (EDSP) have been

108developed and vetted, dazomet may be subjected to additional screen ing and/or testing to better

characterize effects relate d to endocrine disruption.

3. Endangered Species Considerations

The Agency has not conducted a risk asse ssment that supports a complete endangered species determination. The ecological risk as sessment planned during registration review will allow the Agency to determine whether dazomet use has “no effect” or “may affect” federally listed threatened or endangered species (listed sp ecies) or their designate d critical habitats. When an assessment concludes that a pesticid e’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service

and/or National Marine Fi sheries Services (the Services), as appropriate.

D. Conclusion

The Agency has determined that produc ts containing dazomet are eligible for reregistration provided the risk mitigation m easures outlines above are adopted and label

amendments are made to reflect these measur es. Where labeling revisions are warranted, specific language is set forth in Section V of this document.

V. What Registrants Need to Do

EPA recognizes that the extent of the mitigat ion needed for dazomet and the other soil fumigants will require continued coordination among state regulatory agencies, EPA, registrants, growers and other stakeholders to ensure that all provisions of the RED are understood, that data are developed and evaluated expe ditiously, and that bystander a nd worker protection measures are implemented as soon as practicable.

When the soil fumigant REDs were issued in July, 2008, EPA specifically requested comment on the mechanisms and timing of impl ementing the provisions of the REDs. After considering stakeholder comments largely focu sed on the challenges of implementing many new measures simultaneously, EPA has de veloped the following schedule:

July 2008 Dazomet RED issued October 2008 Comment period closed May 2009 EPA responds to comments, amends RED as appropriate Mid 2009 EPA issues product and generic DCIs September 1, 2009 Registrants must submit revised labels to EPA , reflecting phase one of the mitigation measures as outlined in Ta ble 2: restricted use, GAPs, rate reductions, limitations on use sites, new handler protecti on measures, tarp cutting and removal restrictions, exte nded worker re-entry restrictions, training information for workers, an d relevant portions of the FMP requirements. December, 2009 EPA reviews/approve s new labeling for 2010 use season

109During 2009-10 EPA works with registrants, stat es and stakeholders to develop and begin implementation of first responder an d community outreach, applicator training, and compliance assistance and assurance measures. September 1, 2010 Registrants must submit revise d labels to EPA refl ecting all remaining mitigation measures outlined in Table 2 including: applicator training, restri ctions on applications near sensitive sites, buffer zones, buffer credits, buffer zone posting and buffer overlap prohibitions and exceptions, and the full FMP requirements. 2009-2012 Registrants develop data per DCIs

2013 EPA begins Registration Review for dazomet and other fumigants

Labeling

Registrants must submit labeling reflecting phase one mitigation measures by September 1, 2009. All measures will need to be reflected on labels submitted to EPA by September 1, 2010. Because of the relatively large amounts of product shipped under a single label, e.g., 50 gallon drums and railroad tank cars, changes to fumigant labeling can be adopted relatively quickly. Therefore, the Agency anticipates that labeling appr oved late in 2009 would begin to appear on products used for the 2010 fumigation season.

A. Manufacturing Use Products

1. Additional Generic Data Requirements

The generic data base supporting the reregistration of dazome t for the eligible uses has been reviewed and determined to be substantially complete. However, data to characterize the hazard of MITC, the degradate of dazomet, are not available and are ne cessary to confirm the reregistration eligibility decision documented in this RED.

Data requirements for all dazomet usesOPPTSGuidelineNumberDataRequirementStudy type

870.6200 Neurotoxicity Screening Battery – Inhalation (MITC) TOX

870.3550 Developmental Toxicity Screening Test – Inhalation (MITC) TOX

870.3800 Reproduction and Fertility Effects – Inhalation (MITC) TOX

870.5550 Unscheduled DNA Synthesis in Mammalian Cells in Culture (MITC) TOX

870.4200 Chronic/Carcinogenicity Rats – Inhalation TOX

110(MITC)

870.4200 Chronic/Carcinogenicity Mice – Inhalation (MITC) TOX

870.6200 - Neurotoxicity Screening Battery

Acute neurotoxicity study in rat via the inha lation route with pathol ogical evaluation of the complete respiratory tract. The Agency is using single day, acu te exposures in its

consideration of buffer zones follo wing applications of dazomet. The toxicology data available to inform this decision are limited to an eye irritation study in human subjects and an acute inhalation study in rats. The purpose of the acute study in rats was to determine the LC50, not

for use in hazard identification fo r human health risk assessment. The Agency can not evaluate the dose response relationship of irritation and syst emic effects to the nose and lungs using these studies. This information on the respiratory tract is critical for the risk assessment as the relative sensitivity of eye irritation and more serious health outcomes is unknown. The Agency is open to discussing MITC-specific changes to the standard neurotoxicity screen ing battery to ensure that the appropriate target orga ns are evaluated and that releva nt dose-response data would be generated.

870.3550 - Developmental Toxicity Screening Test - Inhalation

This inhalation developmental toxicity st udy in rat is being requested to further characterize the toxicity profile of this compound via the inhala tion route. MITC has been

shown to travel off fields to residential areas. As such, it is appropriate to evaluate the effects of MITC on pregnant females and their fetuses.

870.3800 - Reproduction and Fertility Effects

Two generation reproduction study in rats via inhalation with pathological evaluation of the complete respiratory tract in offspring is needed for MITC. This inhalation reproductive toxicity study is being requested to further characterize the toxi city profile of this compound via

the inhalation route. MITC has been shown to travel off fields to residential areas. As such, it is appropriate to evaluate the e ffects of MITC on reproductive pe rformance and to pups directly exposed to MITC via the inhalation route. The Agency is open to discussing with the registrant the potential for performing the new enhanced 1-generation reproductive study instead of the standard 2-generation study.

870.5550 - Unscheduled DNA Synthesis in Mammalian Cells in Culture

This study is required to complete the ge netic toxicity testi ng battery for MITC.

870.4200 - Chronic/Carcinogenicity in Rats and Mice

111Carcinogenicity studies for MITC per se are not available; therefore, the carcinogenic potential of MITC cannot be dete rmined at this time. Although there are not expected to be exposures of six months or longe r in duration in a given year, si nce the same fields are often treated every year, there is pot ential for exposure to occur annually for many years. Moreover, metaplasia of the respiratory epithelium, a le sion often associated can cer, was observed after only 28 days of exposure in the subchronic inhalati on study in rats with MITC. As such EPA is requiring inhalation carcinogenicity studies with MITC in rats and mice.

Data requirements for dazomet’s soil usesOPPTSGuidelineNumberDataRequirementStudy type

835.8100 Field Volatility from Soil ORE Special Avian Acute Inhalation, MITC ECO

850.2300 Avian Reproduction, Dazomet (bobwhite quail and mallard) ECO

850.1075 Acute Marine/Estuarine Fish, MITC ECO

850.1025 Acute Marine/Estuarine Mollusk, MITC ECO

850.1035 Acute Marine/Estuarine Shrimp, MITC ECO

850.4225 Seedling Emergence – Tier II, MITC. ECO

850.4250 Vegetative Vigor – Tier II, MITC ECO

850.4400 Aquatic Plant Growth – Tier II, MITC (3 remaining species) ECO

850.3020 Honeybee Acute Contact, MITC ECO Special Community Outreach an d Education Program Special

Special Training for Applicators Supervising Fumigations Special

Special Training Materials for Handlers Special Special Buffer Zone Posting Signs Special

835.8100 - Field Volatility from Soil

Volatility studies are required for dazomet’ s soil uses to determine flux for modeling purposes of the breakdown products of dazomet, including formaldehyde.

Special - Avian Acute Inhalation, MITC

The current estimate of avian risk is base d largely on the mammal assessment. This study will enable an inhalation risk assessment speci fic to birds. This is critical, since avian exposure to MITC is expected to be largely via inhalation.

850.2300 - Avian Reproduction (bobwhite quail and mallard duck), Dazomet

112These studies are needed to a ssess potential reproductive e ffects in birds from exposure to the parent dazomet in the granular formulati on. Neither of the exis ting studies is able to provide an overall NOAEL/LOAEL needed for risk assessment. There were problems with mixing of the diet in both studies and the ma llard study had unacceptably high embryo mortality in the controls between day 21 and hatch. The studies indicate the possibility of severe reproductive effects, particularly in the mallard study, which in cluded effects prior to those

identified in the controls.

850.1075 - Acute Marine/Est uarine Fish, MITC

The aquatic risk assessment of dazomet use is based on exposure to MITC. Given the use patterns evaluated, marine/est uarine species could also be e xposed. This study will enable a

risk assessment for marine/e stuarine species exposure.

850.1025 - Acute Marine/Estuarine Mollusk, MITC

The aquatic risk assessment of dazomet use is based on exposure to MITC. Given the use patterns evaluated, marine/est uarine species could also be e xposed. This study will enable a risk assessment for marine/estuarine species exposu re. It will also impr ove certainty with the endangered species risk assessment, as this test species may be more representative of endangered freshwater mussels than the freshwater Daphnia

.

850.1035 - Acute Marine/Estuarine Shrimp, MITC

The aquatic risk assessment of dazomet use is based on exposure to MITC. Given the use patterns evaluated, marine/est uarine species could also be e xposed. This study will enable a

risk assessment for marine/e stuarine species exposure.

850.4225 - Seedling Emergence – Tier II, MITC

Dazomet is used in part due to the phytotoxicity of MITC at the application site. This study will enable the assessment of risk to non-target terrestrial plants off-site. The protocol should be modified to test using air concentrations of MITC.

850.4250 - Vegetative Vigor – Tier II, MITC

Dazomet is used in part due to the phytotoxicity of MITC at the application site. This study will enable the assessment of risk to non-target terrestrial plants off-site. The protocol should be modified to test using air concentrations of MITC.

850.4400 - Aquatic Plant Growth – Tier II, MITC

Only one of five tests currently available ( on duckweed) is considered to be Acceptable (Core) (MRID #45919422). The submission of data for remaining test species under this guideline will reduce uncertainty and improve the assessment of risk to aquatic plants. For

113example, the blue-green alga an d green alga studies are 72-hour OECD studies that are only accepted as Tier I screening studies.

850.3020 – Honeybee Acute Contact, MITC

Although there is honeybee data for dazomet indicating that it is relatively non-toxic to honey bees, there is a concern th at MITC could be more toxic to bees. Therefore, honeybee acute contact data is required for MITC.

Special Study - Training for App licators Supervising Fumigations

EPA has determined that training, developed and implemented by registrants to foster product stewardship, will help reduce potential risk s associated with failure to adequately manage the complexities of fumigation, and ensure compliance with fumigant product labeling. Additionally, EPA believes that providing safety information to other fumigant handlers will help them understand and adhere to practices th at will help handlers protect themselves from fumigant exposure.

Registrants are required to de velop and implement training programs for applicators in charge of soil fumigations on the proper use of and GAPs for soil fumigants. EPA is requiring registrants to submit proposals for these program s. The training programs must address, at minimum, the following elements: how to correc tly apply the fumigant; how to protect handlers and bystanders; how to determine buffer zone di stances; how to develop a FMP and complete the post fumigation application summary; how to dete rmine when weather and other site-specific

factors are not favorable for fu migant application; how to comply with required GAPs and document compliance in the FMP. The training pr ogram must be made available to applicators at least annually. The registrant shall provide documentation, such as a card or certificate, to each applicator who successfully completes the training. This documentation shall include the applicator’s name, address, license nu mber, and the date of completion.

The registrant must be able to provide to fe deral, state, or loca l enforcement personnel, upon request, the names, addresses, and certified applicator license numbers of persons who successfully completed the training program, as well as the date of completion. Applicators supervising fumigations must have successfully completed the program within the preceding 36

months and must document when and where the training program was comp leted in the FMP. The registrants will be required to (1) develop a database to track which certified applicators have successfully completed the training and (2) ma ke this database available to state and/or federal enforcement entities upon request. In add ition, the applicator must provide to Federal, State, or local enforcement personnel, upon reques t, documentation that ve rifies completion of the appropriate training program(s).

Training programs must also include info rmation on how to develop and implement emergency response plans to ensure that applicat ors are prepared in the event that a problem develops during or shortly after the fumigant application. EPA is also requiring registrants to incorporate a mechanism for evaluating the effectiv eness of their training programs at conveying

114the required information to participants and for determining whether participants have successfully completed the training program.

Special Study - Training Materials for Handlers

EPA has determined that registrants must prepare and disseminate training information and materials for other fumigant handlers, i. e., those working under the supervision of the certified applicator in charge of fumigations. The training materi als must address, at minimum, the following elements: (1) what fumigants ar e and how they work, (2) safe application and handling of soil fumigants, (3) air monitori ng and respiratory prot ection requirements for handlers, (4) early signs and symp toms of exposure, (5) appropria te steps to take to mitigate exposures, (6) what to do in case of an emergenc y, and (7) how to report incidents. Registrants must provide this training info rmation through channels open to the public (e.g., via a website). Pesticide labels will require that applicator s supervising fumigations provide this training information to handlers under their supervision be fore they perform any fumigant handling task, or they must ensure that handlers have been provided the required information within the preceding 12 months. The label will also require that the training information be provided in a manner that the handler can understand. Applicat ors supervising fumigations must ensure the FMP includes how and when the required trai ning information was provided to the handlers under their supervision.

Special Study – Buffer Zone Posting Signs

EPA has determined that registrants must prepare and disseminate generic buffer zone posting signs which meet the following criteria: (1) signs must remain legible during the entire posting period (2) signs must m eet the general standards outlined in the WPS for text size and legibility (see 40 CFR §170.120). The requirements for the contents of the sign are as follows

The treated area sign (currently required for fumigants) must state the following: -- Skull and crossbones symbol

-- "DANGER/PELIGRO," -- "Area under fumigation, DO NOT ENTER/NO ENTRE,"

-- "Dazomet fumigant in USE," -- the date and time of fumigation, -- the date and time entry prohibition is lifted -- Name of this product, and -- name, address, and telephone number of the certified applicator in charge of the fumigation. The buffer zone sign must include the following: -- Do not walk sign

-- "DO NOT ENTER/NO ENTRE," -- “Dazomet OR [Name of product] Fumigant BUFFER ZONE,”

-- contact information for the certified applicator in charge of the fumigation

115Registrants must capture all of the informa tion above, excluding the contact information for the certified applicator in charge of fu migating. However, regi strants must provide appropriate space on the sign, and the sign must be made of material appr opriate for applicators

to write in this information on the buffer zone posting signs. Registra nts must provide buffer zone posting signs at the point of sale for applicators to use. EPA is requiring registrants to submit proposals that must address their strate gy for development and dissemination of the buffer zone posting signs.

Data requirements for dazomet’s antimicrobial uses

Chemical Manufactures Association (CMA ) unit exposure data to be called in:

 GLN 875.1200 – dermal indoor exposure

 GLN 875.1400 – inhalation indoor exposure

 GLN 875.1600 – applicator exposur e monitoring data reporting

 GLN 875.1700 – product use information

Because dazomet degrades into MITC, the Agen cy needs MITC air concentration monitoring

data for all enclosed facilities that utilize d azomet. The guideline numbers are as follows:

 GLN 875.2500 – inhalation exposure study

 GLN 875.2700 – product use information

 GLN 875.2800 – description of human activity

 GLN 875.2900 – post-application da ta reporting and calculations

Residue data are needed to support the dazo met antimicrobial use in pulp and paper manufacturing. The purpose of this confirmato ry study is to demons trate that the paper manufacturing processes remove any re sidual dazomet and MITC - GLN 860.1520

Avian acute oral LD 50 data using technical MITC to bobw hite quail or mallard duck – GLN

850.2100

Acute estuarine fish LC 50 data using technical MITC – GLN 850.1075

Acute mysid shrimp using technical MITC – GLN 850.1035

Acute bivalve embryo larvae using techni cal MITC to Eastern oyster – GLN 850.1055

2. Labeling for Manufacturing-Use Products

To ensure compliance with FIFRA, manufact uring use product (MUP) labeling must be revised to comply with all current EPA regulat ions, PR Notices, and applicable policies.

B. End-Use Products

1161. Additional Product-Specific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Ag ency to obtain any needed product-specific data regarding the pesticide after a determination of eligibility has been made. The Registrant must review previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct new studies. If a regi strant believes that previously submitted data meet current testing standards, then the study MRID numbers must be cited according to the instructions in the Requirement Status and Registrants Response Form provided for each product. The Agency intends to issue a separate product-specific data call-in (PDCI), outlining specific data requirements.

2. Labeling for End-Use Products

In order to be eligible for reregistration, registrants must amend all product labels to incorporate the risk mitigation m easures outlined in Section IV.

117Appendix AAppendix A(1). Dazomet (PC Code 035602) Soil Fumigant Uses Eligible for ReregistrationUse SiteFormulationMethod ofApplicationMaximum Application RateUse LimitationsSoilNonbearing crops (such asorchard crops, berries, andflower bulbs), ornamentalsites (establishing orrenovating), field nurseries(establishing or renovating),compost piles, potting soils,and strawberries andtomatoes in California onlyGranularTractor drawnspreader425 lbs ai/A for incorporatedapplications.265 lbs ai/A for surfaceapplications.Application with hand-held applications isprohibited.See the label table in Section V for additional userestrictions.Golf greens/tees, turf sites(establishing or renovating),GranularTractor drawnspreader530 lbs ai/A for incorporatedapplications.265 lbs ai/A for surfaceapplications.Application with hand-held applications isprohibited.See the label table in Section V for additional userestrictions.GreenhousesGranularTractordrawnspreader/mechanicalspreader265 lbs ai/A for surfaceapplications.Application with hand-held applications isprohibited.See the label table in Section V for additional userestrictions.118Appendix A(2). Dazomet (PC Code 035602) Antimicrobial Uses Eligible for ReregistrationUse SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsMaterials PreservativesSlurries and high viscositysuspensions (starches, nonfood use adhesives, clayslurries, glues, coatings forpaper and resin emulsions)Ready to usesolution1706-193Pump or GravityfeedAdd 0.03-0.50% by weightbased on the totalformulation. Actual uselevels should be determinedby a test of the system.SolublePump or GravityAdd 0.01-0.11% by weightconcentratefeedbased on the totalformulation. Actual use1448-104levels should be determined33753-25by a test of the system.FlowablePump or GravityAdd 0.5-2.5% by weight ofconcentratefeedthe suspension or dispersion.Actual use levels should be67869-25determined by a test of thesystem.Solubleconcentrate67869-46Pump or GravityfeedAdd at concentration of 250ppm to 5000 ppm to waterFormulationIntermediate1448-98Slurries and high viscositysuspensions (starches, nonfood use adhesives, clayslurries, and coatings forpaper)Ready to usesolution1448-1031448-3951706-1939386-3Pump or GravityfeedAdd 0.04-0.5 % by weightbased on the totalformulation. Actual uselevels should be determinedby a test of the system.119Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse Limitations9386-28Ready to usePump or GravityAdd 1.67-2.5 pounds persolutionfeed1000 gallons of material to bepreserved. Actual use levels74655-1should be determined by atest of the system.FormulationIntermediate1448-98Slurries and high viscositysuspensions (starches, nonfood use adhesives, clayslurries, coatings for paper,and glues)Solubleconcentrate1706-195Pump or GravityfeedAdd 0.04-0.1% by weightbased on the totalformulation. Actual uselevels should be determinedby a test of the system.Paper and pulp mill SlimecontrolReady to usesolution1448-1031448-3959386-39386-28Pump or GravityfeedIntermittent method: Add 12­20 oz per ton (dry basis) ofpulp or paper for two hoursevery 8 hours.Continuous method: Add 5­15 oz per ton (dry basis) ofpulp or paper on a continuousbasis.Badly fouled systems may require cleaning beforeinitial treatment.Ready to usePump or GravityAdd 5-36 oz per ton ofShock dosages are to be avoided. Badly fouledsolutionfeedfinished product on acontinuous basis. Actual usesystems may require cleaning before initialtreatment.1706-193levels should be determinedby a test of the system.120Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsReady to usePump or Gravityfeed0.083-0.415 lbs. per 1000gallons of treated water.1706-195Actual use levels should bedetermined by a test of thesystem.FlowablePump or GravityAdd 0.5-2.5% by weight ofBadly fouled systems may require cleaning beforeconcentratefeedthe suspension or dispersion.Actual use levels should beinitial treatment.67869-25determined by a test of thesystem.67869-46Pump or GravityfeedAdd concentrations of 250­4000 ppm into make up waterduring the grind during themanufacturing processReady to usePump or GravityIf system is noticeably fouled,Badly fouled systems may require cleaning beforesolutionfeedadd product at the rate of 0.5to 3.0 pounds per ton of pulpinitial treatment.74655-1or paper product. Additions toadditive system should bemade directly at the rate of0.2 to 4.0 pounds (24 to480ppm) per 1000 gallons.Add product at the rate of0.5-2.0 pounds per ton ofpulp or paper produced. Treatthe system as needed tomaintain control. Additionsto the additive system may bereduced to 0.2 to 2.0 pounds(24 to 240 ppm) per 1000gallons.121Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsConstruction Products:Caulking material, Concreteadditives, concrete andmasonry additivesSolubleconcentrate:67869-46IncorporationCan be fed at concentration of250 to 6000 ppm eitherdirectly to the finishedproduct or to one of the rawmaterialsCoatings for paperSolubleconcentrate:67869-46IncorporationAdd at concentration of 250to 4000 ppm into the makeupwater during the grind duringthe manufacturing processEpoxy Flooring CompoundsReady to usesolution1448-104Solid open pourWater-solublepackaged solids0.59% a.i. by weight (0.6%product by weight of materialtreated X 98% a.i. in product)FormulationIntermediate1448-98Industrial Processes and Water SystemsRecirculating cooling watersystemsReady to usesolution1448-1031448-3959386-39386-28Pump or GravityfeedAdd 3.25-6.5 ounces ofproduct to 1000 gallons ofwater to produce a 30-60ppmconcentration initially. Add0.5-3.25 ounces of product to1000 gallons of water toproduce a 5-30ppmconcentration to maintaincontrol.SolubleconcentratePump or GravityfeedAdd 16 ounces of product pereach 5,000-16,000 gallons of122Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse Limitations1448-104water in system initially toproduce a concentration of7.5-15ppm. Add 16 ouncesof product per each 15,000­96,000 gallons of water insystem to produce aconcentration of 1.25-7.5ppmto maintain control.Recirculating cooling watersystemsFormulationIntermediate1448-98123Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsOilfield water treatment andwater floodsReady to usesolution1448-1031448-3959386-39386-28Open PourAdd 2.1 pounds of product to1000 gallons of drilling fluidto produce a 2500ppmconcentration initially. Add0.30 pounds of product to1000 gallons of drilling fluidto produce a 350ppmconcentration to maintaincontrol.Solubleconcentrate33753-25Open PourAdd 1.67 pounds of productto 1000 gallons of drillingfluid to produce a 200ppmconcentration initially. Add1.25 pounds of product to1000 gallons of drilling fluid124Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse Limitationsto produce a 150ppmconcentration to maintaincontrol.SolubleAdd 5.22 pounds of productconcentrateto 1000 gallons of drilling1448-104fluid to produce a 625ppmconcentration initially. Add0.73 pounds of product to1000 gallons of drilling fluidto produce an 88ppmconcentration to maintaincontrol.For water soluble packaging:One pound per 191 gallonsinitially then one pound per1363 gallons to maintaincontrol.Oilfield Drilling Muds andwork over or completionfluidsSolubleconcentrate1448-1049386-1333753-25Open PourAdd 175-182 pounds ofproduct to 1000 barrels ofdrilling fluid to produce a500-520ppm concentration.For best results add productin a thin stream to the pitwhile drilling fluid iscirculating.Ready to useAdd 75 pounds of product tosolution1000 barrels of drilling fluidto produce a 2080-2500ppm1448-103concentration. For best9386-3results add product in a thinstream to the pit whiledrilling fluid is circulating.125Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsReadytouseAdd 75 pounds of product tosolution1000 barrels of drilling fluidto produce a 2080ppm1448-395concentration. For best9386-28results add product in a thinstream to the pit whiledrilling fluid is circulating.Wood PreservativesUtility Poles, pilings,timbers, solid and laminatedwood products.Pelleted solid7969-16271406-51448-104Applied intreatment holesdrilled into woodproduct to betreatedDrill three 7/8 in. diameter by14 in. long holes at a steepangle (45 deg or greater) in aspiral patter starting at groundline. Apply 70 grams of enduse product into each hole.Do not overfill treatmenthole. Add liquid accelerant ifdesired to treatment hole.Plug treatment hole with atight fitting treated woodendowel, removable plastic plugor other suitable cap.For wood in ground contact, the first hole shouldstart at or slightly below ground line and shouldbe arranged in a spiral pattern covering thetreatment zone with about 6” to 12” verticallybetween holes.An accelerant of a 1% solution of coppernapthenate in mineral spirits may be added totreatment holes after application of the productand is designed to speed up the decomposition andrelease of the active fumigant inside the woodproduct. Keep accelerant away from productexcept when in treatment holes, which should beplugged immediately after they combine.Not to be used indoors or underneath indoorstructures.Technical RegistrationsTechnicalN/AN/AFor use in the formulation of dazomet end-useChemical:registrations only.7969-161For use in the formulation of microbiocides andwood protectants only.126Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsTechnicalchemical:9386-10N/AN/AFor use in the formulation of dazomet end-useregistrations onlyTechnicalchemical:67869-18N/AN/AFor use in the formulation of dazomet end-useregistrations onlyFor use in the following Industrial Process WaterSystems: pulp and paper mill systems.For Material Preservations of slurries and highviscosity suspensions (starches, non-foodadhesives, clay slurries, glues, coatings for paper,and resin emulsions)127Appendix B. Table of Generic Data Requi rements and Studies Used to Make the Reregistration Decision

This section is currently not available.

128Appendix C. Technical Support Documents

Additional documentation in support of this RED is maintained in the OPP docket, located in room S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA 22202 . It is open Monday through Frida y, excluding legal holidays, from 8:30 am to 4 pm. All documents, in hard copy form , may be viewed in the OPP docket room or

downloaded or viewed via the Intern et at the following site: http:// www.regulations.gov

These documents include:

Health Effects Support Documents

 Methyl Bromide, 1,3-Dichloropropen e, Chloropicrin, Dazomet, Metam Sodium/Potassium, MITC: Health Effects Division (HED) Component of Agency Response To Comments On 2008 Reregistra tion Eligibility Documents, May 14, 2009

 Dazomet: Third Revision of the HED Human Health Risk Assessment. April 30, 2009

 Dazomet: Updated Final Revised HED Chapter of the Reregistration Eligibility Decision Document (RED). Smith, C. et al.; D354014; June 24, 2008.

 Mode of Action, Eye Irritation, and the Intra- Species Factor: Comparison of Chloropicrin and MITC. Lowit, A. and Reaves, E.; D293356; TXR 0054860; June 25, 2008.

 The Health Effects Division’s Response to Comments on EPA’s Phase 5 Reregistration Eligibility Decision Document for Dazo met. Smith, C.; D306858; June 18, 2008.

Environmental Fate and Ecologi cal Effects Support Documents

 Further Response to Public Comments on the 7/9/08 Completed Dazomet RED, Rothman, G. and Felkel, J. March 3, 2009

 Revised Environmental Fate and Ecological Risk Assessment For Dazomet. Khan. F. and Felkel, J.; D306855; April 8, 2008.

 Response to Phase 5 Public Comments on th e Phase 4 Dazomet Environmental Fate and Ecological Risk Assessment. Khan, F ., and Felkel, J.; D306854; April 2, 2008.

Biological and Economical A nalysis Support Documents

 Response to BEAD Related Public Comments Received on the Reregistration Eligibility Decision for Chloropicrin, Dazomet, Meta m Potassium, Metam Sodium, and Methyl

Bromide (DP# 363545) May 14, 2009.

 Analysis of Soil Fumigant Risk Mana gement Requirements using Geographic Information Systems: Case Studies base d on a Forest Seedling Nursery (DP#363546). May 13, 2009.

129 Process for Defining High-Us e Fumigation Areas at the State and County Levels (DP#364647) May 14, 2009.

 Assessment of the Benefits Soil Fumigant s (Methyl Bromide, Chloropicrin, MetamSodium, Dazomet) Used by Forest Tree Seedlin g Nurseries. (Chiri, D. and Donaldson, D. Dated April 19, 2007) EPA-HQ-OPP-2005-0125-0044

 Assessment of the Benefits of Soil Fumiga tion with Methyl Bromide, Chloropicrin, Dazomet, Metam Potassium and Metam Sodium for Use in Raspberry Nurseries, Fruit and Nut Deciduous Tree Nurseries, and Rose Bush Nurseries in Califor nia. (Faulkner, J., and Yourman, L., Dated April 20, 2007) EPA-HQ-OPP-2005-0125-0045

 Assessment of the Benefits of Soil Fumiga tion with Chloropicrin, Methyl Bromide, Metam-sodium, and Dazomet In Strawbe rry Nursery Runner Production. (Yourman, L., and Smearman, S., Dated April 19, 2007) EPA-HQ-OPP-2005-0125-0054

 Assessment of the Benefits of Soil Fumiga tion with Chloropicrin, Methyl Bromide,

Metam Sodium and Dazomet in Ornamental Production. (Chiri, A., a nd Wyatt., T., Dated April 18, 2007) EPA-HQ-OPP-2005-0128-0060

 Response to Phase 5 BEAD Related Public Co mments Received on the Reregistration of Chloropicrin, Dazomet, Metam Potassium, Metam Sodium, and Methyl Bromide. (Donaldson, D. et al., Dated June 2008)

 Review of Stakeholder Submitted Impact Assessments of Proposed Fumigant Buffers, Comments on Initial Buffer Zone Proposal, and Case Studies of the Impact of a Flexible Buffer System for Managing By-Stander Risks of Fumigants. (Wyatt. T., et al, Dated June 2008)

Antimicrobial Assessment Support Documents

 Dazomet Antimicrobial Risk Mitigation Paper. Garvie, H., Dated June 2, 2008.

 Dazomet: Revised Occupational and Resident ial Exposure Assessment of Antimicrobial Uses for the Reregistration Eligibility D ecision (RED) Document. Walls, C.; D Dated

June 2008.

 Dazomet: Dietary Risk Assessment of An timicrobial Uses for the Reregistration Eligibility Decision (RED) Document. (Walls, C., Dated March 2007)

 Environmental Fate and Ecologi cal Risk Assessment for th e Reregistration of Dazomet (035602) and MITC (068103) – Antimicrobial Uses. (Petrie, R., Dated April 2007)

 Phase 6 Response to Substantive Public Comments on Antimicrobials Division’s Occupational and Residential Assessments for the Reregist ration Eligibility Decision

130(RED) Documents for the following chemicals: Methylisothiocya nate (MITC), Metam Sodium, Dazomet, and Chloropicr in. Walls, C.; February 14, 2008.

Buffer Zone Credits Support Document

 Methyl Bromide (PC Code 053201), Chlor opicrin (PC Code 081501), Dazomet (PC Code 035602), Metam Sodium and Potassium (PC Codes 039003 &039002), MITC (PC Code 068103), DP Barcode 362369, Updated Hea lth Effects Division Recommendations for Good Agricultural Practices and A ssociated Buffer Credits. May 14, 2009

 Factors Which Impact Soil Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Factor Approach. Da wson, J. and Smith, C.; D306857; June 9, 2008.

Risk Management Support Documents

 SRRD’s Response to Post-RED Comments for the Soil Fumigants. Rice, M. and McNally, R; May 2009.

 SRRD’s Response to Phase 5 Public Comments for the Soil Fumigants. Rice, M. and McNally, R.; July 2008.

 Risk Mitigation Options to Address Bystander and Occupational Exposures from Soil Fumigant Applicati ons. EPA-HQ-OPP-2005-0128-0031.

131Appendix D. Bibliography

This section is not currently available.

132Appendix E. FMP Template (template uses MeBr soil applications as an example)

133Target application date/window: Brand name of fumigant:

Brand name:

Minimum time following application that tarp will be repaired:

Name and phone number of contact person responsible for cutting and/or removing tarps (if other than certified applicator):

Schedule and target dates for cutting tarps: Certified Applicator Sup ervising the Fumigation
Name and phone number: License number:

 Commercial applicator

 Private applicator

Employer name and address: Date of completing registrant training program:

General Site Information
Application block location, address, or global positioning system (GPS) coordinates:

Name, address, and phone number of owner/operator of application block:

General Application Information
EPA Registration Number:

Tarps (check here if section is not applicable  )

Lot #: Thickness:

Name and phone number of contact person responsible for repairing tarps:

Schedule for checking tarps for damage, tears, and other problems:

Maximum time following notification of damage that th e person(s) responsible for tarp repair will respond:

Minimum size of damage that will be repaired:

Other factors used to determine when tarp repair will be conducted:

Equipment/methods used to cut tarps:

Schedule and target dates for removing tarps:

134Description of soil texture and moisture in application block:

Rate from lookup table on label (lb ai/A): Credits applied:

 high barrier film ____ %

 organic content _____________ %

 clay content _____________ %

 other: _____________ % Total credits _____________ % Soil Conditions
Description of method used to determine soil moisture level:

Weather Conditions
Summary of the weather forecast for the day of the application and the 48-hour period following the fumigant application (may a ttach a copy of printed forecast to FMP):

Buffer Zones

Application method:

 Bedded

 Broadcast

 Hot gas - outdoor

 Hot gas - greenhouse

 Hand held probes Block size from lookup

table on label (acres): _________ Buffer zone

distance:

__________ ft

List and describe areas in the buffer zone that are not unde r the control of owner/operator of the application block:

Personal Protective Equipment for Handlers

Handler Task Clothing Respirator Type, Filter Cartridge Type and Change-out Schedule Eye

Protection Gloves Other

Emergency Response Plan
Description of evacuation routes:

Locations of telephones:

Contact information for first responders: Local/state/federal contacts: Other contact information for emergencies:

Emergency procedures/responsibilities in case of an incident, e quipment/tarp/seal failure, odor complaints or elevated air conc entration levels outside buffer zone suggesting potential problems, or other emergencies).

135If your state and/or tribal lead agency requires notice, list contacts that were notified: Posting Signs
Name and phone number of person that is doing posting:

Location of posting signs:

Procedures for posting and sign removal:

Site Specific Response and Management  Fumigation Site Monitoring or  Response Information for Neighbors

If Response Information for Neighbors has been selected, completed the following:

If buffer zone is 25-100 ft:  Neighbors within 50 ft of buffer zone  No neighbors within 50 ft of buffer zone

If buffer zone is 100-200 ft:  Neighbors within 100 ft of buffer zone  No neighbors within 100 ft of buffer zone

If buffer zone is 200-300 ft:  Neighbors within 200 ft of buffer zone  No neighbors within 200 ft of buffer zone

If buffer zone is > 300 ft:  Neighbors within 300 ft of buffer zone  No neighbors within 300 ft of buffer zone If buffer zones overlap  Neighbors within 300 ft of buffer zone  No neighbors within 300 ft of buffer zone
List of residences and businesses informed (neighboring property owners):

Name, address, and phone number of person providing information:

Method used to provide information:

Notice to State Lead Tribal Agencies

Date notified:

Communication Between Applicator, Land Ow ner/Operator, and Other On-site Handlers
Plan for communicating to the land owner/operator and all on-site handlers (e.g., tarp cutters/r emovers, irrigators) requiremen ts to comply with label including location and start/stop times of buffer zones; timing of tarp cutting/removal, and PPE:

Names and phone numbers of persons contacted: Date contacted:

136Comments/notes:

137Site Map

Location of application block: _______________________________________________________________________________

Map Legend

Application block Buffer zone Property lines Roads Right-of-way Walkway, sidewalk, path

Sch

NH NAB B WB DC Bus stop Water body Daycare facility School Nearby application block

IPC ALF P Inpatient clinic Prison Well Nursing home Assisted living facility

138Handler InformationHandler Name, Address, and PhoneNumberEmployer Name, Address, and PhoneNumberTasks They are Trained andAuthorized to PerformDate of PPETrainingDate ofMedicalQualification toWear aRespiratorDate of FitTesting forRespirator139If intend to cease operations - Name, address, and phone number of handler to perform monitoring activities prior to operations resuming: Air Monitoring Plan

For Buffer Zone Monitoring: (check here if section is not applicable  )

Name of handler performing monitoring

activities Handler address Handler phone

number Location of monitoring Timing

For Handlers without Respiratory Protection: (check here if section is not applicable  )

If sensory irritation is experienced:  Intend to cease operations  Intend to continue operations with respiratory protection If intend to continue operations with respiratory protection, complete section for Handlers with Respiratory Protection below.

Monitoring equipment:

For Handlers with Respiratory Protection: (check here if section is not applicable  )
Representative Handler Tasks to be Monitored Monitoring Equipment Timing

140Air Monitoring Plan for Methyl Bromide Formulation with < 20% Chloropicrin

For Buffer Zone Monitoring: (check here if section is not applicable  )
Name, address, and phone number of person(s) to perform sampling:

Area or Structure to be Monitored Before Reentry is Permitted Monitoring Equipment Timing

For Handlers with Respiratory Protection:
Representative Handler Tasks to be Monitored Monitoring Equipment Timing

141Methyl Bromide FMP Check List

General Site Information
A map, aerial photo, or detailed sketch is attached to this FM P that shows each of the following with distances from the applic ation site labeled: field location, application block dimensions, buffer zone s, property lines, roads, bus stops, water bodies, wells, rig hts-of-ways, nearby application blocks, surrounding structures, and sites requiring 1⁄8 and 1⁄4 mile buffer zones. 

Supervision of Handlers
An on site certified applicator will directly supervis e the handlers participating in the application starting when the fumigant is first introduced into the soil and ending after the fumigant has stopped being delivered/dispensed to the soil and the soil is sealed. 

After the application is complete, and before leaving the application block, the certified applicator has provided the owner/op erator and handlers with written information necessary to comply with the label and procedures outlined in the FMP. 

Fumigant safe handling information has been provided to each handler involved in the application or confirm that each handler participating in the application has received fumigant safe handling information in the past 12 months. 

For all fumigation handling tasks, at least 2 WPS-trained handlers must be present. 

Weather Conditions
Wind speed at the application site is a minimum of 2 mph at the start of the application or forecasted to reach at least 5 mph during the application. 

A shallow, compressed (low-level) temperature inversion is not forecast to persist for more than 18 consecutive hours during th e 48-hour period after the application. 

An air-stagnation advisory is not in effect for the area where the application site is located. 
If air temperatures have been above 100 degrees F in any of the 3 days prior to application, then soil temperature will be meas ured and recorded in the post application summary report. 

Soil Conditions
The soil has been properly prepared and the surface has been checked to ensure that it is free of clods that are golf ball size or larger. 
The area to be fumigated has been tilled to a depth of 5 to 8 inches. 
Field trash has been properly managed (e.g., residue from a previous crop has been worked into the soil to allow for decomposit ion prior to fumigation, little or no crop residue is present on the soil surface, and crop residue that is present does not interfere wi th the soil seal). 

The soil temperature at the depth of injection ≤ 90 degrees F at the beginning of the application. 

The soil moisture at 9 inches below the surface is sufficient (field capacity is 50 to 80 percent). 
Trash pulled by the shanks to the ends of the field will be cove red with tarp or soil before making the turn for the next pass. 

Shank Applications (check here if section is not applicable  )

For tarped-broadcast and -bedded applications, injection points wi ll be at least 8 inches from the nearest final soil/air inter face. 
For tarped-bedded applications, the injection depth will not be as deep as the lowest point of the tarp (i.e., the lowest point of the tuck). 
For untarped-bedded applications, the injection points will be at least 12 inches from the nearest final soil/air interface. 
For untarped-broadcast applications, the injection points will be at least 18 inches from the nearest final soil/air interface. 
For broadcast untarped applications, a disc or similar equipment will be used to uniformly mix the soil to at least a depth of 3 to 4 inches to eliminate the chisel or plow traces and will following elimination of the chisel trace, the soil surface will be compacted w ith a cultipacker, ring roller, and roller in combination with tillage equipment. 

For performed bed applications, the soil will be sealed by disr uption of the chisel trace using press sealers, bed shapers, cul tipackers, or by re-shaping (e.g., relisting, lifting, replacing) the beds immediately following injection. 

For beds formed at the time of application, the soil will be sealed by disrupting the chisel tr ace using press sealers, or bed shapers. 
For shanked bedded and broadcast applications, tarps will be inst alled immediately after fumigant is injected into the soil. 
Applicators have been trained and instructed not to apply or allow fumigant to drain onto the soil surface. 
For each injection line a check valve been located as close as possible to the final injection point, or applicators will drain /purge the line of any remaining fumigant prior to lifting injection shanks from the ground. 

Applicators have been trained and instructed not to lift injection shanks from the soil until the shut-off valve has been close d and the fumigant has been depressurized (passively drained) or pur ged (actively forced out via air compressor) from the system. 

Brass, carbon steel, or stainless steel fittings must be used throughout application rigs. 
Polyethylene tubing, polypropylene tubing, Teflon® tubing or Teflon® -lined steel braided tubing have been used for all low pre ssure lines, drain lines, and compressed gas or air pressure lines and is all other tubing Teflon® -lined steel braided. 

Application equipment been inspected to ensure that application rigs do not contain galvanized, PVC, nylon, or aluminum pipe fi ttings. 
All rigs include a filter to remove any particulates from the fumi gant, and a check valve to prevent backflow of the fumigant i nto the pressurizing cylinder or the compressed air system. 

All rigs include a flowmeter or a constant pressure system with orifice plates to insure the proper amount of fumigant is appli ed. 
Applicators have been trained and instructed to ensure that positive pressure is maintained in the cylinder at not less than 20 0 psi during the entire time it is connected to the application rig, if a compressed gas cylinder is used. (This is not required for a comp ressed air system that is part of the application rig because if the compressor system fails the application rig will not be operable). 

Application rigs are equipped with properly functioning check valv es between the compressed gas cylinder or compressed air syst em and the fumigant cylinder. 

Applicators have been trained and instructed to always pressurize the system with compressed gas or by use of a compressed air system before opening the fumigant cylinder valve. 

142_ ______________________________________________ ___________________________________ Before using a fumigation rig for the first time, or when prepari ng it for use after storage, applicators have been trained and instructed to:

 Check the filter, and clean or replace the filter element as required.

 Check all tubes and chisels to make sure they are free of debris and obstructions.

 Check and clean the orifice plates and screen checks, if installed.

 Pressurize the system with compressed gas or compressed air, and check all fittings, valves, and connections for leaks using so ap solution. 

Applicators have been trained and instructed to:

 Install the fumigant cylinder, and connect and secure all tubing. Slowly open the compressed gas or compressed air valve, and increase the pressure to the desired level. Slowly open the fumigant cylinder valve, always watching for leaks.

 When the application is complete, close the fumigant cylinder valv e and blow residual fumigant out of the fumigant lines into t he soil using compressed gas or compressed air. At the end of th e application, disconnect all fumigant cylinders from the applica tion rig. At the end of the season, seal all tubing opening s with tape to prevent the entry of insects and dirt.

 Calibrate all application equipment and ensure that all control systems must be working properly. 

Hot Gas Applications (check here if section is not applicable  )

Tarps have been installed prior to starting the application. 
All delivery tubes have been placed under the tarp in such a way that they do not move during the application of methyl bromide

. 
The fumigant will be introduced from outside of the greenhouse. 
All fittings, connections, and valves have been checked for leaks prior to fumigation and if cylinders are replaced during the fumigation process, the connections and valves were checked for leaks prior to continuing the job. 

Tree Replant (non-shank) Application (check here if section is not applicable  )

For each individual tree-site, the tree stump and primary root system have been removed and the tree hole has been backfilled w ith soil before application. 

The fumigant will be injected at a depth of at least 18 inches into the soil. 
The wand will be cleared using nitrogen or compressed air before removing it from the soil and after the wand is cleared and re moved from the soil, the injection hole will be covered with soil and tamp or the soil will be compacted over the injection hole. 

Buffer Zones

There are no difficult to evacuate sites within 1⁄4 (or 1⁄8 ) miles of the application block that will be occupied during the buffer zone period. 
There are no bus stops or other locations where pers ons wait for public transit within the buffer zone. 
There are no buildings used for storage such as sheds, barns, garages, within the buffer zone that are occupied or that share a common wall with an occupied structure. 

For areas in the buffer zone that are not under the control of owner/operator of the application block, written agreement has b een obtained from occupants that they will voluntarily vacate the buffer zone during the entire buffer zone period. 

For nearby agricultural areas that are in the buffer zone the owner/operator of that property provided written agreement that t hey, their employees, or other persons will stay out of the buffer zone during the entire buffer zone period. 

For publicly owned and/or operated areas (e.g., parks, rights of way, side walks, walking paths, playgrounds, athletic fields) written permission has been given to include the public area in the buffer zone from the appropriate local and/or state officials.

Buffer Zones Overlap (check here if section is not applicable  ) 

A minimum of 12 hours has elapsed from the time the 1 st application ends until the 2 nd application begins. 
If a structure exists within 300 feet of the buffer zone, appropr iate emergency preparedness and response procedures are follow ed. 
Certified applicator has informed handlers of the overlapping buffers and associated health protection requirements.  Personal Protective Equipment for Handlers
At least 1 air rescue device (e.g., SCBA) is on-site in case of an emergency. 

All of the handler’s PPE has been cleaned and maintain ed as required by the WPS for Agricultural Pesticides. 

Hazard Communication

The application area buffer zone has been posted in accordance with the label. 
Pesticide product labels and material safety data sheets are on-site and readily available for employees to review. 
Recordkeeping

The owner/operator of the application block has been informed that he/she as well as the certified applicator must keep a signe d copy of the site-specific FMPs and the post-application summar y record for 2 years from the date of application. 

I have verified that this site-specific FMP reflects current site conditions and product label directions before beginning the fumigation.

Signature of certified applicator supervising the fumigation Date

143Application date and time: Application rate:

Date tarps were cut: Post-Application Summary

General Application Information
Size of application block:

Weather Conditions
Summary of the weather on the day of the application:

Summary of the weather during the 48-hour period following the fumigant application:

Soil Conditions (check here if section is not applicable  )
Soil temperature if air temperatures were above 100 degrees F in any of the 3 days prior to the application:

Tarp Damage and Repair (check here if section is not applicable  )
Location and size of tarp damage:

Description of tarp/tarp seal/tarp equipment failure:

Date and time of tarp repair:

Additional comments or other deviations from FMP (if applicable):

Tarp Removal (check here if section is not applicable  )
Description of tarp removal (if different than in the FMP):

Date tarps were removed:

Odor Complaints (check here if section is not applicable  )
Person filing odor complaint:

 On-site handler

 Person off-site If off-site person, name, address, and phone number of person filing odor complaints:

Description of control measures or emergency procedures followed after odor complaint:

Additional comments:

144Description of incident, equipment failure, or other emergency: Description of Incidents (check here if section is not applicable  )

Date and time:

Description of emergency procedures followed:

Additional comments:

Elevated Air Concentration Levels (check here if section is not applicable  )

 On-site

 Outside buffer zone Location of elevated air concentration levels: Date and time:

Description of elevated air concentration levels: (provide air monitoring results on next page)

Description of control measures or emergency procedures followed:

Description of deviations from FMP (if applicable):

Posting Signs
Date of sign removal:

Description of deviations from FMP (if applicable):

Other

Additional comments/notes:

145_ ______________________________________________ ___________________________________ Air Monitoring Results

When Respiratory Protection is Not in Use – Sensory Irritation Experienced (check here if section is not applicable  )

Date and Time Handler Task/Activity Handler Location Where

Irritation Was Observed Resulting Action Comments

 Cease operations

 Respiratory protection

 Cease operations

 Respiratory protection

 Cease operations

 Respiratory protection

 Cease operations

 Respiratory protection

 Cease operations

 Respiratory protection
When Respiratory Protection is in Use – Direct Read Instrument Air Monitoring (check here if section is not applicable  )

Sample Type Sample

Number Sample

Date/Time Handler Task/Activity (not applicable for

structural monitoring) Handler

Location/

Structure

Location Air

Concentration Sampling

Method Comments (e.g., sensory irritation experienced while wearing respirator)

 Area

 Breathing Zone

 Structure

 Area

 Breathing Zone

 Structure

 Area

 Breathing Zone

 Structure

 Area

 Breathing Zone

 Structure

 Area

 Breathing Zone

 Structure

 Area

 Breathing Zone

 Structure

 Area

 Breathing Zone

 Structure

 Area

 Breathing Zone

 Structure

 Area

 Breathing Zone

 Structure

 Area

 Breathing Zone

 Structure

I have verified that this post applica tion summary reflects the actual site conditio ns during the fumigation and an accurate description of deviations from the FMP (if applicable).

Signature of certified applicator supervising the fumigation Date

146147