United States Prevention, Pesticides Environmental Protection and Toxic Substances May 2009 Agency (7508P)


# Amended Reregistration Eligibility Decision (RED) for the Methyldithiocarbamate Salts (Metam

sodium, Metam-potassium) and Methyl Isothiocyanate (MITC)Glossary of Terms and Abbreviations

1,3- D 1,3-dichloropropene AGDC I Agricultural Data Call-In

a i Active Ingredient aPA D Acute Population Adjusted Dose AR S Agricultural Research Service BC F Bioconcentration Factor BEA D Biological and Econom ic Analysis Division CF R Code of Federal Regulations cPA D Chronic Population Adjusted Dose CS F Confidential Statement of Formulation CSFI I USDA Continuing Surveys for Food Intake by Individuals DC I Data Call-In DEE M Dietary Exposure Evaluation Model DF R Dislodgeable Foliar Residue DN T Developmental Neurotoxicity E C Emulsifiable Concentrate Formulation EDW C Estimated Drinking Water Concentration EE C Estimated Environmental Concentration EP A Environmental Protection Agency EU P End-Use Product FD A Food and Drug Administration FDM S Federal Docket Management System FIFR A Federal Insecticide, Fungicide, and Rodenticide Act FFDC A Federal Food, Drug, and Cosmetic Act FM P Fumigant Management Plan FQP A Food Quality Protection Act GA P Good Agricultural Practice GLN Guideline Number h a Hectare H C Human Concentration I R Index Reservoir ISCST 3 Industrial Source Complex Short Term (model) K dDissociation Constant LC 5 0 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 5 0 Median Lethal Dose. A statisticallyderived single dose that can be expected to cause death in 50% of th e test animals when administered by the route indicated (oral, dermal, inhalation). It is expr essed as a weight of substance per unit weight of animal, e.g., mg/kg. LO C Level of Concern

3LOAE L Lowest Observed Adverse Effect Level MAT C Maximum Acceptable Toxicant Concentration μg/ g Micrograms Per Gram μg/ L Micrograms Per Liter MA T Maximum Air Temperature MBA O Methyl Bromide Alternatives Outreach MIT C Methyl Isothiocyanate mg/kg/day Milligram Per Kilogram Per Day mg/ L Milligram Per Liter MS T Maximum Soil Temperature MO A Mode of Action MO E Margin of Exposure mp h Miles Per Hour MRI D Master Record Identification Number. EPA’s system for recording and tracking studies submitted. MSD S Material Safety Data Sheet MU P Manufacturing-Use Product NOAE L No Observed Adverse Effect Level OECD OP P EPA Office of Pesticide Programs OPPT S EPA Office of Prevention, Pe sticides, and Toxic Substances PA D Population Adjusted Dose PC A Percent Crop Area PDC I Product-Specific Data Call-in PD P USDA Pesticide Data Program PERFU M P robabilistic E xposure and R isk Model for Fum igants P F Protection Factor PHE D Pesticide Handler’s Exposure Data PH I Pre-harvest Interval pp b Parts Per Billion PP E Personal Protective Equipment pp m Parts Per Million PRZM/EXAM S Pesticide Root Zone Model/E xposure Analysis Modeling System (Tier II Surface Water Computer Model) RA C Raw Agriculture Commodity RE D Reregistration Eligibility Decision RE I Restricted Entry Interval Rf D Reference Dose R Q Risk Quotient SCI-GRO W Tier I Ground Water Computer Model SA P Science Advisory Panel S F Safety Factor SL C Single Layer Clothing TGA I Technical Grade Active Ingredient USD A United States Department of Agriculture

4USGS United States Geological Survey UF Uncertainty Factor UV Ultraviolet WPS Worker Protection Standard

5Table of Contents
Methyldithiocarbamate Salts and Methyl Isothiocyanate Team

.............................................. 8 Abstract

............................................................................................................................... ........... 9 I. Introduction

............................................................................................................................. 1 0 II. Chemical Overview

................................................................................................................ 1 5 A. Chemical Identity

............................................................................................................... 1 5 B. Use Profiles

.......................................................................................................................... 1 6 C. Regulatory History

............................................................................................................. 1 8 III. Metam-sodium and Metam-pot assium Risk Assessments

................................................ 1 9 A. General Overview of Soil Fumigants

............................................................................... 1 9 1. Human Health Risk

........................................................................................................ 1 9 2. Environmental Fate, Ecological Effects and Risks

...................................................... 2 3 3. Benefits

............................................................................................................................. 2 5 4. 2008 RED Mitigation Impacts

....................................................................................... 2 9 B. Overview of Sewer Use Risk

.............................................................................................. 3 1 C. Overview of Antimicrobial Risk

....................................................................................... 3 2 IV. Risk Management and Rereg istration Eligibility Decision

.............................................. 3 3 A. Determination of Reregistration Eligibility

..................................................................... 3 3 B. Public Comments and Responses

..................................................................................... 3 6 C. Regulatory Position

............................................................................................................ 3 7 1. Regulatory Rationale

...................................................................................................... 3 7 a. Soil Fumigant Uses of Metam-sodium and Metam-potassium

............................... 3 7 1. Use Sites Eligible for Reregistration

................................................................. 3 8 aa. Bystander Risk Mitigation

....................................................................................... 4 3 1. Buffer Zones

........................................................................................................ 4 4 2. Restriction for Schools and Oth er Difficult To Evacuate Sites

...................... 7 4 3. Posting

.................................................................................................................. 7 5 bb. Occupational Risk Mitigation for Soil Uses

........................................................... 7 8 1. Handler Definition

.............................................................................................. 7 8 2. Handler Requirements

....................................................................................... 7 9 3. Dermal Protection for Handlers

........................................................................ 8 0 4. Respiratory Protection for Handlers

................................................................ 8 4 5. Tarp perforation and removal

........................................................................... 9 2 6. Entry Prohibitions

.............................................................................................. 9 5 cc. Other Risk Mitigation

............................................................................................. 10 1 1. Restricted Use Pesticide (RUP) Classification

................................................ 10 1 2. Good Agricultural Practices (GAPs)

............................................................... 10 2 3. Fumigant Management Plans (FMPs)

............................................................ 11 2 4. Site Specific Response and Management

........................................................ 11 9 5. Notice to State Lead Agencies

.......................................................................... 12 5 6. Training for Applicators and Trai ning Information for Other Handlers

... 12 6 7. Community Outreach and Education Program

............................................. 13 1 8. Ambient Air Monitoring Program

.................................................................. 13 6

6b. Sewer Root Control Use

........................................................................................... 13 8 c. Antimicrobial Uses

.................................................................................................... 14 5 2. Endocrine Disruptor Effects

........................................................................................ 14 9 3. Endangered Species Considerations

........................................................................... 14 9 D. Conclusion

......................................................................................................................... 14 9 V. What Registrants Need to Do

.............................................................................................. 14 9 A. Manufacturing Use Products

.......................................................................................... 15 0 1. Additional Generic Data Requirements

...................................................................... 15 0 2. Labeling for Manufacturing-Use Products

................................................................ 15 8 B. End-Use Products

............................................................................................................. 15 8 1. Additional Product-Specific Data Requirements

....................................................... 15 8 2. Labeling for End-Use Products

................................................................................... 15 8 Appendix A : Uses Eligible for Reregistration

........................................................................ 15 9 Appendix B : Studies Used to Ma ke the Reregistration Decision

......................................... 17 1 Appendix C : Technical Support Documents

.......................................................................... 17 2 Appendix D : FMP Template-MeBr Example

........................................................................ 17 5

7Methyldithiocarbamate Salts a nd Methyl Isothiocyanate Team

Health Effects Risk Assessment Office of General Council Ruth Allen Andrea Medici Judy Facey Anna Lowit Jessica Ryman Office of Enforcement and Charles Smith Compliance Shalu Shelat, Risk Assessor David Stangel
Biological and Economic Analysis Assessment Risk Management Jonathan Becker Dirk Helder Angel Chiri Veronique LaCapra Bill Chism John Leahy Colwell Cook Nikhil Mallampalli David Donaldson Cathryn OConnell John Faulkner Karen Santora Monisha Kaul Andrew Lee Nikhil Mallampalli Registration Support William Phillips, II Tamue Gibson Sunil Ratnayake Mary Waller Elisa Rim Stephen Smearman TJ Wyatt Leonard Yourman Nicole Zinn

Environmental Fate and Effects Risk Assessment James Felkel Faruque Khan Gabriel Rothman
Risk Management – Antimicrobial Uses Timothy Dole Heather Garvie Diane Isbell Timothy Leighton Tim McMahon Kathryn Montague Rick Petrie Cassi Walls

8Abstract
This document presents EPA’s amended decisi on regarding the rere gistration eligibility of the currently registered soil, sewer root cont rol, and antimicrobial uses of metam-sodium, the soil and antimicrobial uses of metam-potassi um, and the antimicrobi al uses of methyl isothiocyanate (MITC). This follows the 105-day public comment period on the Reregistration Eligibility Decision provided for stakeholders to have the oppor tunity to review and provide comments on issues related to the implementation of the risk mitigation measures. The Agency’s risk conclusions for metam-sodium and metam-potassium 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 Agen cy has determined that certain modifications in how and when some measures will be implemente d are appropriate. Pr oducts containing metamsodium and metam-potassium for these 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) labels are amende d to implement these measures.
Generally, registered metam-sodium and me tam-potassium application/fumigation uses fall into four basic categories that include: (1) use as an agricultural soil fumigant for all food, feed, and fiber crops; (2) use on gol f course turf and for applicati on to small areas of turf and soil; (3) use as a root-control agent in drai ns and sewers; and (4) use for a number of antimicrobial and industrial uses, including tr eatments for sugar (raw beets and cane sugar) processing facilities; leather; sewage, sludge, and animal wast e; cooling water facilities; industrial water purification facilities; paints and coatings ; petroleum operations; and remedial wood treatment. MITC is registered as an active ingredient for only one use, as an antimicrobial agent for remedial wood treatment.

Concurrent to EPA’s review of the soil fu migant uses of metam-sodium and metampotassium, EPA assessed the risks and developed ri sk management decisions for four other soil fumigant pesticides, including: chloropicrin, dazomet, methyl bromide, and a new active ingredient, iodomethane. Risks of a fifth soil fumigant, 1,3-dichloroprop ene (1,3-D), were also analyzed along with the other soil fumigants for comparative purposes; its risk management decision was completed in 1998. The Agency eval uated these soil fumigants concurrently to ensure that human health risk assessment approaches are consistent and that risk tradeoffs and economic outcomes were considered appropriately in reaching risk management decisions. This review is part of EPA’s program to ensure thatall pesticides meet current health and safety standards.
EPA has identified potential human health risks of concern associated with the registered soil fumigant uses of metam-sodium and metam-potassium from acute inhalation exposure to handlers, bystanders, and re-entry workers. To reduce these exposures and to address subsequent risks of concern, EPA is requiring a number of mitigation measures, such as classifying some metam-sodium and metam-potassium products as re stricted use, use-site restrictions, buffer zones, posting, emergency preparedness and res ponse, monitoring and respiratory protection, restrictions on the timing of tarp perfora tion and removal operations, entry prohibitions,

9mandatory good agricultural practices (GAPs), fu migant management plans (FMPs), and training and outreach programs. Please note that only metam-sodium and metam-potassium soil and sewer use products and the MITC use for remedial treatment of wood poles and timbers will be classified as restricted use pesticides.
The Agency has identified slight exceedance of the cancer level of concern to applicators associated with the registered sewer root cont rol use of metam-sodium. The Agency also has identified concerns due to potentially ha rmful downstream effect s of metam-sodium on denitrifying bacteria and the asso ciated disruption to downstream se wage treatment facilities. To reduce applicator exposures, the Agency is requ iring additional personal protective equipment (PPE), including chemical-resistant gloves, doub le layer clothing, and a 90% protection factor respirator approved for MITC. To reduce the po tentially harmful effects of metam-sodium on denitrifying bacteria at downstream sewage tr eatment facilities, the Agency will be requiring additional label language requiring notification of downstream wast ewater facilities before a metam application takes place.
The Agency also has identifie d potential human hea lth risks of concern associated with the registered antimicrobial uses of metam- sodium, metam-potassium, and MITC. To reduce these exposures, the Agency is requiring a numbe r of mitigation measures, such as additional labeling language for remedial wood treatment and amended labeling for the cooling tower and sewage sludge/animal waste uses. In addition, th e Agency will be calling in air concentration monitoring data for all enclosed facilities that use metam-s odium and metam-potassium.
The Agency is issuing this amended decision document for metam-sodium, metampotassium, and MITC, as announced in a No tice of Availability published in the Federal Register

.
I. Introduction
This amends and supersedes the document, “Reregistration Eligibility Decision for Methyldithiocarbamate Salts (Metam-sodium, Me tam-potassium) and Methyl Isothiocyanate (MITC),” 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 AmericanForest 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

1 0reduce 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 metam-sodium and metam-potassium (EPA-HQ-OPP-2005-0125) at www.regulations.gov . EPA has determined that the modifications described herein will achieve the same protection goals for persons potenti ally exposed to metam-sodium and metampotassium and MITC but with a greater likelihoo d of compliance, fewer impacts on the benefits of metam-sodium and metam-potassium and MITC use, and with less uncertainty regarding the protectiveness of the required measures. Please see table 1 for modification from the 2008 RED to the 2009 amended soil fumigant REDs.

Note: Washington State University has submitted studies to quantify the flux rate for metamsodium and metam-potassium from shank inj ection applications and from center pivot applications using a drizzle boom in the Pacifi c Northwest. These studies were submitted in April, 2009, and are currently in re view. If these studies indicate that the buffer zones for these types of applications should be modified, the Agency will update the buffer tables prior to implementation of new labeling related to buffers for metam sodium in 2011. The results of these studies have not been includ ed in this amended document.

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

Buffer Zones Buffer zones based on New chloropicrin data support smaller available data buffers and increased confidence in safety New dazomet data support larger buffers Buffer Credits Credits allowed based on New data support additional credits and an available data; capped at increase in the cap to 80% for chloropicrin 50% and methyl bromide, metam-sodium and metam-potassium, and 40% for dazomet Structures within Monitor with devices Monitor for sensory irritation before Buffer Zones before reentry reentry Rights of Way Permission from local Permission from local authorities is only authorities must be granted required when a sidewalk or permanent if buffers extend onto walkway is present rights of way Buffer Overlap Buffers may not overlap Bu ffers may overlap; separate applications by 12 hours and increase emergency preparedness and response measures Restriction for 1/4 mile restriction around Maintain 1/4 mile restriction but allow a Difficult to Evacuate hard to evacuate areas reduced restricted area of 1/8 mile for Sites including day care centers, applications with smaller buffers (300 feet nursing homes, schools; or less); is to be in effect during the was to be in effect for the application for 36 hours following the duration of the buffer zone application period Posting Posting required at buffer The posting requirement is retained but no zones points of entry, longer requires areas between the entry

1 1Mitigation 2008 REDs 2009 Amended REDs
where people are likely to areas to be posted

Handler Protection

Respiratory Protection

Tarp perforation and removal
Entry Prohibitions

Restricted Use Classification

Good Agricultural Practices (GAPs) Fumigant Management Plans (FMPs)

Emergency Response and Preparedness approach, and areas between these locations Described tasks that may only be performed by handlers and situations when 2 handlers were required to be present while in the buffer zone Required monitoring devices to trigger additional measures

Perforating tarps restricted to mechanical means only
Entry for non-handlers is prohibited for the duration of the entry restricted period, until tarps have been removed, or if 14 days has passed The soil fumigant uses of metam-sodium and metam potassium, and MITC use for remedial treatment of wood poles and timbers are required to be classified as restricted use Certain GAPs required for all fumigant applications
FMPs required to be completed before fumigant application begins and post-application summary report required following the application If neighbors are near buffers they must be provided with information or buffer zones must be

12 Information required on the signs has been simplified to encourage reuse of signs Tasks that may only be performed by handlers have been updated and clarified The situations have been clarified requiring 2 handlers to be present based on the chemical properties of the different soil fumigants, and current label statements Allow sensory irritation properties to trigger additional measures for MITC and chloropicrin Monitoring with devices required to remove respirators Monitoring with devices required for methyl bromide formulations with <20% chloropicrin Perforating tarps by hand is allowed for areas less than 1 acre in size and for flood prevention activities No major changes

No change

Some clarifications and refinements have been made based on stakeholder comments
No major changes. Based on comments an example of an FMP has been included to illustrate how the required information may be presented effectively

Same basic measures Monitoring required only during peak emission times of the day; irritation detection acceptable for MITC andMitigation 2008 REDs 2009 Amended REDs
monitored every 1-2 hours chloropicrin in lieu of devices; methyl over 48 hours with bromide requires devices monitoring devices Notice to SLAs Applicators required to States may determine if they wish to provide notice to the receive this information appropriate state/tribal lead All states required to include strategies for agency before fumigating compliance assistance and assurance for to facilitate compliance soil fumigation in their cooperative assistance and assurance agreements Applicator Training Certified applicators Certified applicators required to receive required to receive registrant soil-fumigant training every registrant soil-fumigant three years training every year Community Outreach Registrants required to Same basic requirement and Education develop and implement The Agency is providing information on community outreach & where registrants are required to focus education programs along these efforts with information for first responder in high fumigant

use areas With regard to implementation timing, EPA has determined that most measures can be efficiently implemented via revi sed product labels by the 2010 use season for the antimicrobial uses and the soil fumigant uses. Other measures, in particular those related to buffer zones, will present greater compliance challe nges and will require additional time for EPA to conduct the necessary outreach, and communication activities with states, trib es, other regulatory partners, fumigant users, and other stakeholders to facili tate transition. EPA has determined that these measures will be implemented via revised product labels by the 2011 use season. As a result, all measures described in this amended RED that ar e necessary for reregistration eligibility will appear on product labels by 2011. The table below s hows 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 (for soil uses of metam-sodium and metam-potassium, and MITC use for remedial treatment of wood poles and timbers only) ● ● New Good Agricultural Practices ● ● Rate reductions ● ● Use site limitations ● ● New handler protections ● ● Tarp cutting and removal restrictions ● ● Extended worker reentry restrictions ● ●

1 3Risk Mitigation Measure Currently 2010 2011 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 database 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 and environmental effects; and to determine whether or not the pesticide meets the “no unreasonable adverse effects” criteria of FIFRA.
This document presents the Agency’s amende d reregistration eligibility decision for all the registered uses of metam-sodium, metam- potassium, and methyl is othiocyanate. Metampotassium and metam-sodium are non-selectiv e fumigants with fungi cidal, herbicidal, insecticidal, and nematicidal properties. Metam-sodium and metam-potassium are converted to MITC in the environment, particularly in the presence of moisture (such as in soil after application). It is MITC that performs th e fumigating activity. Metam-sodium and metampotassium have soil fumigant and antimicrobial uses, metam-sodi um is also used as a root control agent in sewers and drains , and MITC is registered as anantimicrobial agent for treating wood poles and pilings. Separate risk assessmen ts and analyses were developed for the soil fumigant, sewer root control, and antimicrobial uses of metam-sodium, metam-potassium, and MITC. To clearly present EPA’s decision regarding these uses, each use will be discussed in separate sections of this reregistration eligibility decision (RED).
As a result of this review, the Agency has determined that certain uses of (1) metamsodium (including use as a pre-plant soil fumigant in certain crops, specified later in this document, and as a root control agent in sewers and drains, and as an antimicrobial agent to treat wood poles and timbers and sewage sludge and an imal waste); (2) metam-potassium (including use as a pre-plant soil fumigant in certain crops, specified later in this document, and as an

1 4antimicrobial agent for treatment of pulp and paper, tanning drum leather applications, recirculating cooling water systems, and industr ial water purification systems); and (3) MITC (for use as an antimicrobial agent to treat wood poles and pilings) are elig ible for reregistration (see Appendix A), provided the risk mitigation m easures outlined in this document are adopted, label amendments are made to reflect these meas ures (see the label table in Section V of this document), and data are developed to assess interm ediate- and long-term ri sk to bystanders.

This document consists of five sections. S ection I contains the re gulatory framework for reregistration and a synopsis 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 the metam-sodium, metam-potassium, and MITC risk assessments as well as benefit and impact assessments. Section IV presents th e Agency’s reregistration eligibility and risk management decisions. Section V summarizes la bel changes necessary to implement the risk mitigation measures outlined in Section IV. Un less otherwise noted, all Agency references in this document are available for review in the metam-sodium and metam-potassium docket (EPAHQ-OPP-2005-0125) at www.regulations.gov

.
II. Chemical Overview

A. Chemical Identity
Both metam-sodium and metam-potassium are the active ingredients that make up reregistration case 2390 for the methyldithiocarb amate salts. The primary degradate of both metam-sodium and potassium is methyl isothycy anate (MITC), which is the active ingredient that makes up reregistration case 2405.
Table 3. Methyldithiocarbamate Salts & Methyl Isothiocyanate Nomenclature Chemical Structure:

H 3 C N H S

S Na + H 3 C N H S

S K + H 3 C N C S

Empirical Formula: C 2 H 4 NS 2 NaC 2 H 4 NS 2 K C 2 H 3 NS Common Name: Metam-sodium Metam-potassium Methyl isothiocyanate CAS Registry Number: 137-42-8 137-41-7 556-61-6 OPP Chemical Code: 039003 039002 068103 Case Number: 2390 2390 2405 Technical or Manufacturing-Use Registrants Douglas Products and Packing Company; IBC Manufacturing Co.; Buckman Laboratories Inc.; AMVAC Chemical Corporation; Drexel Buckman Laboratories Inc.; Athea Laboratories Inc.; Taminco Inc.; Tessenderlo Kerley, Inc. MLP International (Landis International, Inc.); Osmose Utilities Services, Inc.

1 5Chemical Co.; Loveland Products, Inc.; Taminco Inc.; BASF Sparks LLC; Tessenderlo Kerley, Inc.; Sewer Sciences, Inc.; Osmose Utilities Services, Inc.

B. Use Profiles
Pesticide Type: Metam-sodium and metam- potassium are broad-spectrum fumigants with fungicidal, bactericidal, algi cidal, herbicidal, insecticidal, nematicidal, and antimicrobial properties. They are dithiocarbamate salts that break down quickly in th e environment to the primary toxic degradate, methyl isothiocyanate. MITC is highly volatile and is responsible for the fumigant prope rties of metam-sodium and metampotassium.

1. Soil Use Target pests: Metam-sodium and metam-pot assium are used on a wide range of pests including fungi, plants, insects, and nematodes. Use patterns: Metam-sodium and metam- potassium are registered: (1) as an agricultural soil fumigant for use on all food, feed, and fiber crops and (2) for use on golf course turf and for application to small areas of turf and soil. Formulations: Three formulation classes—li quid, soluble concentr ate, and ready-touse—are registered for metam-sodi um and metam-potassium. Most metam-sodium products are registered for general use. Only the metam-sodium products registered specifically for use on golf courses and for use on small areas of turf and soil are classified as “restricted use.” The “restricted use” classifica tion restricts a product, or its uses, to use by certified pesticide appl icators or those working under the direct supervision of a certified applicator. No metam-sodium products are intended for use by homeowners. Methods of Application: In agricultural se ttings, metam-sodium and metam-potassium are applied through chemigation or w ith tractor-drawn equipment. Chemigation methods include sprinkle r irrigation (which accounts for 90% of irrigation applications), dr ip irrigation, flood irrigation, and furrow irrigation. Tractor-drawn ap plications are car ried out with various types of shank soil injection, rotary tiller, and spray blade injection equipment. Drip/trick le irrigation and tractor-drawn applications can be either tarped or untarped. Applications to smaller areas can be made with handheld equipment, including sprinkler cans,

1 6Application Rates:

Annual Usage in the U.S.:

2

. Sewer Use Target pests:
Use patterns:

Formulations:

Methods of Application:
Application Rates:

3

. Antimicrobial Use Target pests:

Use patterns: hose proportioners (hose-end spraye rs), or power sprayers (handgun sprayers). Metam-sodium/potassiumapplications to potting soil may be made by adding the chemical to soil in a cement mixer or by spraying it onto a soil stream as soil is ejected from a shredder The maximum applicatio n rate listed on most product labels for application to ornamentals; turf; and food, feed, and fiber crops is 320 pounds of active ingredient per acre (lbs ai/A). Tobacco plant beds have a maximum application rate of 387 lbs ai/A on most product labels, but at least one product lists a rate as high as 412 lbs ai/A. For small areas of ornamentals, food and fiber crops, seed beds, plant beds, and lawns, the maximum app lication rate is 12 lbs ai/1000 square feet. Approximately 51-55 million pounds of metam-sodium and 1-2 million pounds of metam-potassium used in the U.S. in 2002.

Metam-sodium is used as a root control agent for use in sewers and drains. Metam-sodium is classified as a restricted use product as a rootcontrol agent in drains and sewers. Three formulation classes— liquid, soluble con centrate, ready-touse—are registered for metam-sodium. All metam-sodium products for sewer use are classified as restri cted use pesticides. The “restricted use” classification restricts a product , or its uses, to use by certified pesticide applicators or those work ing under the direct supervision of a certified applicator. In sewer use applica tions, metam-sodium is applied using a foam applicator. For sewers and drains , the maximum application rate is 0.212 lbs ai/gallon of solution.

The antimicrobial uses of metam-sodium, metam-potassium, and MITC are used to control a num ber of microbiological pests, including bacteria and fungi.

• Metam-sodium is registered as an antimicrobial agent for: (1) wood poles/timbers, (2) leathe r processing (e.g., brine-cured hides and skins), (3) raw can e and beet sugar processing facilities, and (4) sewage sludge/animal wastes.

• Metam-potassium is registered as an antimicrobial agent for: (1) pulp and paper production, (2 ) leather processing, (3) raw cane and beet sugar processi ng facilities, (4) coatings (protective colloids, emulsi on resins, and water-thinned paints), (5) metalworking cu tting fluids and oils, (6)

1 7petroleum operations, (7) water cooling tower systems, and (8) industrial water purification systems.

• MITC is registered as an an timicrobial agent for wood poles and pilings. Formulations : Two formulation classes—so luble concentrate and ready-to-use—are registered for metam-sodium and metam-potassium. MITC is formulated as a solidified-melt, where it is a solid at ambient conditions and melts and vaporizes at elevated temperatures found within the pole being treated. Methods of Application : The antimicrobial uses of metam-sodium, metam-potassium, and MITC have a number of application methods, including open pour and manual application of pre-filled tubes of solidified-melt product for treatment of wood poles and pilings; metering pump for pulp and paper, leather, cooling water towers , and industrial water purification; and metered injection for animal wa ste and sewage sludge treatment.

C. Regulatory History
Metam-sodium (PC Code 039003) and metam-potassium (PC code 039002) are included in pesticide reregistration case number 2390. Currently, there are 39 registered products containing metam-sodium and 16 registered products containing metam-potassium. Metamsodium and metam-potassium are broad-spectr um fumigants with f ungicidal, herbicidal, insecticidal, bactericidal, algicidal, and nematicidal properties.
Metam-potassium was first registered in the United States in 1973 as a fungicide, a bacteriostat, and a microbicide ina variety of commercial and i ndustrial applications, such as pulp and paper mills, cooling tower waters, metalw orking cutting fluids, and adhesives. In 1994, the use of metam-potassium expanded to include food and feed uses when used as a soil fumigant.
Metam-sodium was first registered in the Un ited States in 1975. Metam-sodium is one of the most widely used agricultural pesticides in the United States and is presently registered on a wide variety of food and feed crops. Metam-s odium is also registered for a variety of antimicrobial and industrial uses.
Metam-sodium and metam-potassium are c onverted to MITC in the environment, particularly in the presence of moisture. It is MI TC that performs the fumi gating activity. It is the volatility of metam-sodium in the environment and the results of metabolism studies in plants that allow the Agency to conclude that there is no reasonable expectation of finite residues to be incurred in/on any raw agricu ltural commodity when these pr oducts are applied according to label directions. Therefore, this fumigant does not require the establishm ent of food tolerances.
A Phase IV data call-in (DCI) was issued for metam-sodium and metam-potassium in September 1991 and included data requirements fo r ecotoxicity, toxicology, environment fate,

1 8and residue chemistry. Metam-sodium also was included in the October 1995 agricultural reentry DCI.
Since metam-sodium and metam-potassium are converted to MITC in the environment, this RED will also include MITC. MITC (PC code 068103) is in case number 2405. Products containing MITC were first regi stered in 1984 as a soil fumigant with food and non-food uses.
A Phase IV DCI was issued for MITC in July 1991 and included data requirements for ecotoxicity, toxicology, environment fate, and residue chemistry. In response to this DCI, the registrants canceled all remain ing food uses in 1992. Currentl y, the only two remaining products containing MITC are for use on wood pilings, utilitypoles, and timbers for control of wood rot and decay due to fungal activity. Both produc ts are classified as restricted use.

III. Metam-sodium and Metam-pot assium 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
The main risk of concern for handlers, worker s, and bystanders associ ated with the soil uses of metam-sodium and metam-potassium is from acute inhalation exposure as a result of fumigant off-gassing. Metam-sodiumand metam-potassium handlers al so are at risk from direct fumigant exposure during a pplications. The term handler refers to persons involved in the application. For soil ap plications, handlers also include pe rsons involved in perforating and removing 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 completed, such as planting. The term bystander refers to any person who lives or works in the vicinity of a fumigation site.

In addition to the soil use of metam-sodium and metam-potassium, there are other uses that the Agency has assessed and included in this RED: (1) metam-sodium as a root control agent in sewers and drains and as an antimicrobial ag ent to treat wooden poles, timbers, sewage sludge, and animal waste; (2) metam-potassium as an antimicrobial agent for treatment of pulp and paper, leather tanning drum, recirculating cooling water systems, and industrial water purification systems; and (3) MITC as an antimicrobial agent to treat wood poles and pilings.
When metam-sodium and metam-potassium ar e applied and mixed with moist soil or water, they are quickly broken dow n into several strong irritant products. One of these products

1 9is MITC, which accounts for most of the fumigant activity. Based on mon itoring data, it is clear that bystander exposures to con centrations of MITC in the air after a metam-sodium/potassium application are possible. Therefore, the focus in assessing inhalation bystander and occupational exposures resulting from metam-sodium/potassium a pplications is on concentrations of MITC.
Estimating exposure to fumigants is differe nt from non-fumigant pesticides due to fumigants’ volatility and thus, 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 dr oplets), 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 rate of emissions from treated fields after the application of soil fumigants. Factors suchas the application me thod, soil moisture, soil temperature, organic matter levels, water treatments , the use of tarps, biol ogical activity in the soil, soil texture, weather conditions, soil co mpaction, and others influence the amount of fumigant that comes off the field and is available to move off s ite to areas where bystanders may be located.

The human health risk assessment indicates th at acute inhalation e xposures to MITC of 22 ppb or greater for a 1 to 8 hour time period fo r non-occupational (residential) bystanders and occupational handlers could potentia lly 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 lowe st observable adverse effect level (LOAEL) was 800 ppb, and the human concentration (HC) based on the No Obse rvable 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 submitted by the group Toxicology Excellence in Risk Assessment (TERA) on behalf of the metam-sodi um and metam-potassium registrants. The benchmark concentration analysis thus supports the Agency’s toxic ity endpoint. Since the study is a human exposure study for acute eye exposur e to MITC, the standard 10X for animal to human extrapolation is not needed. However, a 10X human variability uncertainty factor for MITC was included, which when applied to the HC, results 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, and a few have effects without eye irritation. Compared to eye irritation, the systemic and respiratory effects are more adverse in nature. Unfortunately, the available toxicity data in animals or humans do not allow a

2 0quantitative comparison of the dose response curves of the eye, systemic, and respiratory effects to determine the exact doses at which those eff ects occur. However, the Agency believes eye irritation provides a surrogate fo r other toxic effects and thus makes this the appropriate endpoint to regulate. To ensure that th is endpoint is protective of any effects from repeated and longerterm exposures, EPA is requiring data to evalua te developmental, reproductive, chronic, and cancer hazards and has encouraged the registrants to pursue additional studies to characterize the dose response curves of diffe rent target organs.
The Agency has not revised the 10X human variability 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 Alliance, Agency scientists have evaluated the registrant's scientific position [see www.regulations.gov , docket number: EPA-HQ-OPP-2005­ 0125]. While Agency scientists acknowledge thatdata 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 sc ientifically plausible 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 existi ng guidance, that the uncertainty factor can be reduced. If, in the future, additional data are provided, the Agency will re-evaluate the scientific basis for MITC's human variability uncertainty factor.
In assessing risks from metam-sodium and metam-potassium, the Agency considered multiple lines of evidence, using the best av ailable information from monitoring studies, modeling tools, and incident data.

• Monitoring: For the human health risk a ssessments completed for metam-sodium and metam-potassium and the other soil fumigant s within the group, several field-scale monitoring studies were considered, as we ll as monitoring of workers and handlers involved in various tasks. These studies quantify metam-sodium and metam-potassium concentrations in and around fields at va rious times and distances during and after applications. Many of these data indicate th at there can be risks of concern associated with metam-sodium and metam-potassium use ata broad range of distances 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 evaluate potential risks at distances around treated fields. PERFUM incorporates actual weathe r data and flux distri bution estimates, then accounts for changes and altering conditions. Analyses based on a variety of model outputs were used to compare the potential risks at a range of distances. The PERFUM

2 1model and users manual are public domain and can be downloaded at http://www.exponent.com/perfum/

.

• Bystander, Handler, and Worker Incident Reports: Exposure incidents for the soil fumigants generally occur at a low frequenc y relative to the total number of fumigant applications performed annually. However, when fumigant incidents occur, there are often many people involved. In cidents involving workers tend to occur more often than incidents with bystanders.
Reconstructing incidents to examine the exact factors that led to the incident can be difficult, especially when bystanders are involved , since all the factors th at contributed to the incident may not have been documented. Some of the factors that have been linked to incidents in the past have included equipment failure, handl er accidents, applicator failure to adhere to label recommendations and/or requirements, and temperature inversi ons. Incidents have occurred to bystanders close to fields and up to two miles away from the fumigated field.
Based on these lines of evidence, and as descri bed in more detail in the risk assessments, EPA has determined that metam-sodium and metam-potassium risks to handlers, workers, and bystanders are of concern given current labels and use practices. The human health risk assessments indicate that inhalation exposures to bystanders who live and work n ear agricultural fields and greenhouses where metam-sodium and metam-potassium soil fumigations occur have the potential to exceed the Agency’s level of c oncern without additional mitigation measures. There are also risks of concern for occupationa l handlers involved in metam-sodium and metampotassium applications and tarp perforation/removal activities and for workers who may re-enter the treated area shortly after fumigation or tarp perforation has been completed.
For more information about the specific inform ation in the Agency’s human health risk analyses, the documents listed below are relevantand available in the metam-potassium docket (EPA-HQ-OPP-2005-0125) at www.regulations.gov

.

• Methyl Bromide, 1,3-Dichloropropen e, Chloropicrin, Dazomet, Metam Sodium/Potassium, MITC: Health Effects Division (HED) Component of Agency Response To Comments On 2008 Reregist ration Eligibility Documents. May 14, 2009.

• EPA-HQ-OPP-2005-0125-0269, Metam-sodium: Final Revised Chapter of the Registration Eligibility Decision Docu ment (RED); DP Barcode: D293354, Metamsodium PC Code: 039003, Metam-potassi um PC Code: 039002, MITC PC Code 068103. June 24, 2008.

• EPA-HQ-OPP-2005-0125-0261, Mode of Acti on, Eye Irritation, and the IntraSpecies Factor: Comparison of Chloropicrin and MITC. (Lowit, A. and Reaves, E.). May 27, 2008.

• EPA-HQ-OPP-2005-0125-0074 , Review of Fumigants Group Incident Reports

• EPA-HQ-OPP-2005-0125-0075 , Summa ry Fumigants Group Incident Reports

2 2• EPA-HQ-OPP-2005-0125-0103 , Summary of Fumi gants Group Incident and Other Data

• EPA-HQ-OPP-2005-0125-0005 , Metam-sodium By stander Risk Assessment Report

• EPA-HQ-OPP-2004-0159-0106, Revised Metam-sodium: Occupational an d Residential Exposure Assessment for th e Reregistration Eligibility Decisio n Document. (PC Codes 039003 and 068103; DP Barcode D293328 )

2. Environmental Fate, Ecological Effects and Risks
The Agency’s environmental fate and ecological effects risk assessments indicate that there may be some concerns for non-target organisms that may be exposed to metam-sodium and potassium.
Metam-sodium and potassium degrade rapidl y in soil to generate MITC, the volatile biocidal active product. Once MITC volatilizes in to the atmosphere, it degrades rapidly due to direct photolysis. The primary concern for metam-sodium is the potentia l for acute exposure of terrestrial and aquatic organisms to MITC. Exposure to terrestrial organism such as birds and mammals to MITC would likely occur by the inha lation route. Potential exposure to aquatic organisms may occur from surface runoff/l eaching and drift (wind) of MITC.

Hazard
Metam-sodium is considered moderately t oxic on an acute oral basis to birds (LD 50 = 211 mg/kg). MITC is considered highly toxi c on an acute oral basis to mammals (LD 50 = 55 mg/kg), and moderately toxic via the inhalation route. Ac ute inhalation toxicity data with MITC are not available 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
Exposure of MITC to terrestrial animals was evaluated using the Industrial Source Complex Short Term (ISCST3) model together w ith information about MITC emissions from a treated field, taking into accountthe range of MITC concentra tions which might be found under different conditions of applicati on rate, weather, source size and shape (e.g., field size in acres) and distance from the treated field.
Aquatic
For MITC exposure to fish and aquatic invert ebrates, EPA consider s surface water only, since most aquatic organisms are not found in ground water. The aquatic exposure assessment

2 3for MITC relied on Tier II aquatic models. Th e Pesticide Root Zone Model (PRZM version 3.1.2 beta) simulates fate and transport on th e agricultural field, while the water body is simulated with Exposure Analysis Modeling Sy stem (EXAMS version 2.98.04). Simulations are run for multiple (usually 30) years and the repo rted estimated environmental concentrations (EECs) represent the values that are expected once every ten years based on the thirty years of daily values generated during the s imulation for selected scenarios.
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 f actors associated with the scenario. The crop/location scenario in a spec ific state is intended to represent a high-end vulnerable 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, and sediment. The estimated concentrations of chemicals like MITC in surface water bodies may be upper bound.
To simulate field application of metam-sodium, multiple scenarios were selected representing metam usage area s based on geography and weather. PRZM and EXAMS models are relevant scenarios were used to estim ate MITC EECs in surface water based on label information for metam-sodium application to oni ons, turf, tomatoes, and potatoes at the highest application rate.

Risk

Terrestrial Risk
A refined analysis using ma mmal inhalation data and both monitoring and modeling data for air concentrations of MITC do not indicate an acute risk of concern for wild mammals. Avian acute toxicity data via th e inhalation route are needed to evaluate risk to birds.

Risk to Plants
There is some uncertainty associated with ri sk of MITC to non-target plants, given the data gaps for guideline terrestrial plant toxicity data and an in complete aquatic plant toxicity database. However based on the labeled phytotox icity of MITC and some incidents, it is expected that at lease some non-target terrestrial plants off site may be at risk from off-gassed MITC.
Aquatic Risk
Acute aquatic levels of concern (LOCs) are slightly exceeded for MITC for both aquatic invertebrates [risk quotients (RQs) range from 0.15 to 0.64] and fish (RQs range 0.16 to 0.69). However, chronic exposure to MITC is expected to be low because of its high potential to volatilize from surface water bodies.

2 4Due to the current data gaps for MITC, the Agency is requiring additional eco-toxicity studies for both terrestrial and aquatic organisms.
For more information on the Agency’s envir onmental fate and ecological effects risk analysis, refer to the document listed below:

• EPA-HQ-OPP-2004-0159-0118, Revised Environmen tal Fate and Ecological Effects Risk Assessment for Metam-sodium and Metam-potassium. (PC Codes 039003 and 039002; DP Barcode D293339).

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 effici ently controlled. Benefits to crop production from metam-sodium/potassium use accrue either from superior pest control (e.g., tomatoes) or lower production costs (e.g., carrots , onions, peanuts), or both (e .g., cucurbits, peppers, potatoes), as compared to the next best alternative. Comm ercially feasible alternatives frequently include other soil fumigants such as chloropicrin and 1,3-dichloropropene (or mixtures of both). However, feasibility of using 1,3-dichloropropene as an alternative is li mited in California, a major usage region for metam-sodium/potassium, due to local township caps on annual amounts permitted for use across all crops. Alternatives that may become commercially viable in the longer term include dimethyl disulfide (DMDS) and iodomethane, both in combination with chloropicrin. However, in the context of high me tam-use sites, these materials are relevant only to cucurbits, peppers, and tomatoes, since thes e are the only metam-using crops for which registration of either chemical has been a pproved or is currently under consideration.
The table below (Table 4) summarizes some aspects of the importance of metam-sodium and metam-potassium to crop production in all crops for which benefits assessments were conducted by the Agency and these have not changed from the assessments included as part of the July 2008 RED. For further de tails, the reader is referred to the impact assessments, carried out by the Biological and Economic Assessment Di vision (BEAD), which are available in the metam-sodium and metam-potassiumdocket (EPA-HQ-OPP-2005-0125) at www.regulations.gov

. The economic benefits provided by metam-sodi um and metam-potassium use in many of the crops are estimated to be substantial. For example, in potatoes, without metam, growers would likely switch to fumigation with 1,3-dich loropropene and chloro picrin, which is less effective at controlling key soil pests and more costly. BEAD estimates that net operating revenue, the difference between gross revenue and operating costs, w ould drop about 20% in California and by about 85% in th e Pacific Northwest. Net operating revenue is a rough measure of grower income; it does not account for fixe d costs of production. The annual regional

2 5economic value of metam-sodium and metam-pota ssium fumigation is estimated to be about $8 million per year in California and about $48 m illion per year in the Pacific Northwest.
Taken together, benefits anal yses indicate that metam-sodi um and metam-potassium use is generally important in a variety of crops, and that if these fumigants could not be used, there would likely be significant ne gative economic impacts.
Table 4. Summary of benefits to crop production from metam-sodium & metam

potassium

Carrot s 1,3-D (with and without chloropicrin), plus various herbicides and fungicides to a much lower extent.

Cucurbit s 1,3-D (with and without chloropicrin), plus various herbicides and fungicides

Eggplant 1,3-D (with and without chloropicrin)

Grapes – 1,3-D (with and vineyard replan t without chloropicrin),

Nursery stock (fruit seedlings and roses)

Onion s 1,3-D (with and without chloropicrin), plus various herbicides and fungicides Crop Likely Alternatives to Metam Predicted impacts of loss of Me tam-sodium/Metam-potassium use

BEAD estimates the benefit of me tam-sodium in California carrot production to be about $3.5 million annually resulting from reduced production costs compared to fumigation with 1,3-dichloropropene and applications of other herbicides and fungicides. However, 1,3­ dichloropropene is subject to regulator y restrictions in California that may limit its availability for use by carrot growers. If 1,3-dichloropropene were not available to California growers, the benefits of metam-sodium could be as much as $140 million. In California, net operating revenue (NOR) could drop by 17 % if the likely alternative replaces metam-sodium. In Washington, the drop in NOR is estimated at 26%. Use of metam-sodium to control fungi and nematodes leads to improved yields over fumigation with 1,3-dichloropropene and chloropicrin and substantially reduces production costs, which makes cucurbit productionviable in infested areas. The total benefit of fumigating with metamsodium is about $100 million annually in gross production. NOR for California growers drops by as much as 177% if metam is replaced with the likely alternatives. The benefits of metam-sodium include higher yields and lower costs compared to fumigation with 1,3-dichloropropene and chloropicrin.Benefits range from $290-1,080/acre. The total contribution of metamsodium to California eggplant production is between $72,500 and $270,000 annually. Metam-sodium appears to be the preferred fumigant for vineyards in Washington and Oregon, saving growers $25-50/acre over fumigation with 1,3-dichloropropene and chloropicrin. For the region, savings range from $16,500-33,000 annually. Metam-sodium may also benefit producers through improved yields over 1,3-dichloropropene alone. Metam-sodium is used in nursery stock production throughout the U.S., however, few data are available to permit reliable estimates of area treated or quantity of fumigant used. Soil fumigation in nursery production controls diseases, nematodes and weeds and results in higher yields, higher quality plant production, and lower costs of production. Because of the great diversity of plants and production conditions and a general lack of data, BEAD has not been able to quantify the benefits, but they extend beyond producers to include consumers of nursery products and multiply considerably throughout the various production chains. Metam-sodium is about $34/acre less expensive than 1,3-dichloropropene and chloropicrin in the production of storage onions in Washington and Oregon, providing costs savings for the region ranging from $393,000 to $537,000 annually.

2 6Crop Likely Alternatives to Metam Predicted impacts of loss of Me tam-sodium/Metam-potassium use

Ornamentals Methyl bromide + (floriculture chloropicrin, 1,3-D only) (with and without chloropicrin), plus various herbicides and fungicides Peanuts 1,3-D (with and without chloropicrin), aldicarb Peppers 1,3-D (with and without chloropicrin), plus various herbicides and fungicides

Pome fruit 1,3-D (with and (apples and without pears) – orchard chloropicrin), replant

Potatoes 1,3-D (+ chloropicrin). Approx. 13 % yield loss expected with 1,3-D+Chloropricrin his alternative

Stone fruit 1,3-D (with and (apricot, cherry, without nectarine, chloropicrin), peach, plum probably to a lesser and prune) extent methyl bromide + chloropicrin Sweet potatoes 1,3-D (with and without chloropicrin), plus various herbicides and fungicides Tomatoes 1,3-D (with and without chloropicrin), plus various herbicides and fungicides; methyl bromide + chloropicrin (fresh tomatoes only) There is ample evidence of that fumigant use increases yield and quality and lowers production costs. Variations in pests and conditions suggest that yield and quality differences would be significant and that metam-sodium plays a critical role. This is especiallysignificant for the propagative sector because changes in the supply of s eedling stock would result in magnified changes to future supplies of mature plants and their products. The benefits of metam-sodium in peanut production are largely seen in the North Carolina and Virginia areas. NOR for these growers drops by 7% if 1,3D+Chloropicrin replaces metam; NOR drops by about 60% if aldicarb is the replacement. Metam-Sodium, and to a lesser extent metam-potassium, improves yields and saves on production costs co mpared to fumigation with 1,3­ dichloropropene and chloropicrin. Use of metam-sodium makes pepper production viable on much of the 1,500 acres in pepper production in California. Total benefits range from $0.5-33.1 million annually. NOR for California growers drops by 15 to 51% if metam is replaced with the likely alternatives. Orchards are fumigated at replanting to decrease mortality of young trees, improve growth and speed maturation, and increase yields throughout the lifespan of orchards. While 1,3-dichloropropene and chloropicrin are used more often, on appropriate soils, metam-sodium is often less expensive. In the absence of chloropicrin, metam-sodium would result in improved yields, valued at $92.8 million/year, over use of 1,3-dichloropropene alone. Some portion of the estimated benefits is passed along to consumers. The benefits of metam-sodium include yield increases and lower production costs. Overall, the annual benefits of metam-sodium are estimated to be about $800 per acre in California, and about $250 per acre in the PNW, which translates to benefits of about $8 million per year in California, and about $48 million per year in the Pacific Northwest. At the farm level, in California, NOR would drop by 20% and in the PNW, by 85% if metam is replaced by the likely alternatives. As with pome fruit, orchards are fumigated prior to replanting to better establish new trees, increase survival rates, improve growth and enhance maturity, and increase yiel ds throughout the lifespan of the orchard. On appropriate soils, metam-sodium provides cost savings of about $60/acre over 1,3-dichloropropene and chloropicrin.

Without metam-sodium, production of sweet potato would not be viable on nearly 10% of California fields. The benefits of metam-sodium amount to about $5.9 million in sweet potato production annually

Metam-sodium provides more complete control of pests than does 1,3­ dichloropropene and chloropicrin, which results in improved yields and increased revenue of nearly $130/acre. This repres ents an annual value for metam-sodium of about $7.3 milli on in California. Major use is in processed tomato production in California. NOR for these growers drops by about 13% if likely alternatives replace metam-sodium.

2 7Note: As part of the response to public comments received on the REDs, the Agency reviewed the need for metam registration in the context of certain specialized situ ations (such as cover crops), and for specific minor crops (such as seed crops) and concluded th at benefits of metam use there were important enough to warrant re-registration. This revi ew is available in the BEAD memo titled “Response to comments on use site re strictions included in the Reregistration Eligibility Decision (RED) fo r Metam-Sodium and Metam-Potassium (DP # 363544)”. This topic is also discussed earlier in this documen t in the section titled “Rate reduction and Use Sites”.

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, Dazomet) 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 a nd 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 Brom ide 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

• EPA-HQ-OPP-2005-0123-0331, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Me tam-sodium In Strawberry Production

• EPA-HQ-OPP-2005-0123-0332, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, Metam-sodi um, 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

2 8• 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 Be nefits of Soil Fumigation with Methyl Bromide in Crop Production

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

• Analysis of Soil Fumigant Risk Mana gement Requirements using Geographic Information Systems: Case Studies base d on a Forest Seedling Nursery (DP# 363546)

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 application 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, roads, 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

2 9with 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 other contributing factor s are the prohibition on buffers overlapping in space and time and the duration 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 less flexible than expected for certain scenarios, and the asso ciated field topography, field in frastructure, and need for a consistent orientation in the application of a fumigant, constr ain 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 s ubstantial delays in completing fumigations and multiple trips to a field with fumigation equipmen t 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 control ling emissions. Some grow ers will face numerous scheduling conflicts if they rely 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 blocks will increase costs, a further incentive for growers to conduct their own fumigations.
The Agency does agree that compliance with bu ffer 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 fromincidents involving fumigants continues to support a conclusion that metam-sodium and metam-potassium off-gasses and moves away from treated fields at concentr ations that have the pot ential to cause adverse effects. Therefore, the Agency still believes that buffer zones that exclude bystanders are a critical aspect of mitigating risks fr om metam-sodium and metam-potassium.
In addition to these impacts, if emergency preparedness and response requirements were triggered due to proximity of neighbors, for example, the requirement in the July 2008 RED to monitor the buffer zone for its duration was estimated 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 the 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 notification may not be an attractive optio n due to the potential for neighbors to attempt to impede or block fumigant applications.
Finally, the Agency concludes that the de velopment and implementation of workable fumigation strategies, considering buffer and ot her requirements, will require substantial new information and management skills on the part of growers and applicators. While the Agency’s

3 0risk 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, buffer zones distances for some scenarios have been refined. Although many aspects of the RED mitigation will appear on labels in 2010, the Agency will not require buffers until the 2011 growing season.

B. Overview of Sewer Use Risk
Because metam-sodium degrades rather quickly to MITC, short-term, intermediate-term, and chronic inhalation exposures to metam-sodium by workers are expected to be negligible when compared with MITC exposures. To a ddress the short- and intermediate-term MITC inhalation risks from MITC, in the July 2008 me tam-sodium metam-potassium RED, the Agency required that any person(s) engaged in any activitie s that are likely to invo lve direct contact with metam-sodium (including, but not limited to, mi xing, loading, and/or applying metam-sodium; equipment calibration; cleaning and repair of appl ication equipment; entering into treated areas; sampling cleanup spills; and rinsate disposal) we ar a half-face respirator with organic vapor cartridge approved for MITC.
While there is insufficient toxicological data to characterize the inha lation cancer risk of MITC, due to limitations in the rat and mouse MITC oral carcinogenicitystudies, the Agency anticipates that these new respiratory requirement s will adequately address this risk. However, the Agency is requiring additional study data for MITC.
The Agency revised the non-cancer, short- and intermediate-term occupational handler dermal exposure assessments based on the additional usage and occupational exposure information provided by the metam-sodium sewer us e registrants. The results of the revised noncancer, short-term occupational handler dermal exposure assessments for the sewer use of metam-sodium indicate that the MOEs for the derm al risk to handlers with engineering controls (e.g., closed mixing and loading systems) were above or just below the target MOE of 100, and the MOEs for the dermal risk to handlers withfull dermal PPE (i.e., ch emical resistant gloves and double layer clothing) were above 49, even at the highest daily rates of amount of product handled. In the case of the intermediate-term expos ures with full dermal PPE, MOEs were below the target MOE of 100, even with engineer ing controls. Although not all short- and intermediate-term dermal exposure MOEs reached the target MOE of 100 with the required dermal protection and engineering controls , the occupational handl er dermal exposure assessments are considered to be very conservative.

3 1EPA revised its occupational handler dermal cancer assessment for handlers engaged in sewer applications of metam-sodium to control roots in sewer systems based on the additional usage and occupational exposure informati on provided by the metam-sodium sewer use registrants during the post-RED comment period. The results of the revi sed cancer occupational handler dermal exposure assessment for the sewe r use of metam-sodium indicate that cancer risks for workers in full dermal PPE requireme nts (i.e., chemical resi stant gloves and double layer clothing) and/or those us ing engineering contro l technologies (i.e., closed mixing and loading systems) are below the targ et cancer risk level of between 1x10 -4 to 1x10 -6 for exposed handlers.

Based on the short- and intermediate-term de rmal exposure risks to workers, coupled with the worker risks associated with MITC inha lation exposures, the Agency is requiring that any person(s) engaged in any activities that are likely to involve dire ct contact with metamsodium, including but not limited to mixing, load ing, and/or applying metam-sodium; equipment calibration; cleaning and repair of application equipment; enteri ng into treated areas; sampling cleanup of spills; and rinsate disposal, to wear double-layer clothing, chemical resistant gloves, and a 90% protection factor respirator approved for MITC. To help mitigate these risks, the Agency is also adding a requirement that closed engineering systems for all mixing and loading activities be used.
For more information on the Agency’s sewer use risk analysis, refer to the documents listed below (all are available in the metam-sodium docket at www.regulations.gov ):

• “Metam Sodium: Third Revision of the HE D Human Health Risk Assessment;” May 2009; Charles Smith; Health Effects Division, U.S. EPA.

C. Overview of Antimicrobial Risk
Due to the short loading and/or applicati on durations (i.e., minutes), handlers (i.e., mixers/loaders) are not expected to be expos ed to the metam-sodium degradate, MITC. However, the Agency has concerns for potential post-application inhalation exposures to MITC after metam-sodium applications in the leathe r and/or sugar processi ng industries and also workers in the vicinity of sewage sludge treatm ents. The Agency also has concerns for potential post-application inhalation exposures to MITC fo r workers in the vicinity of metam-potassium applications in the leather, pulp/ paper, and sugar processing industr ies as well as in coatings and metal working fluid manufacturing, oil-field ope rations, cooling water towers, and industrial water purification facilities because MITC is a highly volatile organic chemical (vapor pressure = 150 mmHg). Furthermore, since metam-sodium and metam-potassium convert to MITC in aqueous media, the Agency also has concerns for the potential MITC inhalation exposures for the machinist who works with metal-working fluids that were preserved with metam-potassium.
For more information on the Agency’s antimicro bial use and industrial risk analysis, refer to the documents listed below (all are av ailable in the metam-sodium docket at www.regulations.gov ):

3 2• EPA-HQ-OPP-2005-0125-0264, Revised Occupational and Residential/Bystander Assessment of the Antimicrobial Use (Remedial Wood Treatment ) of Chloropicrin for the Reregistration Eligibility Decision (RED) Document (Pha se 3 Comment Period). PC Code 081501, DP Barcode D314399. February 14, 2008.

• EPA-HQ-OPP-2005-0125-0076, Occupational and Residential/Bystander Assessment of the Antimicrobial Use (Remedial Wood Treatment) of Methyl Isothiocyanate (MITC) for the Reregistration Eligibility Decision (RED) Document

• EPA-HQ-OPP-2005-0125-0077, Metam-potassium: Dietar y Risk Assessment of Antimicrobial Uses in Sugar Processing for the Rere gistration EligibilityDecision Document

• EPA-HQ-OPP-2005-0125-0078 , Metam-potassium: O ccupational and Residential Exposure Assessment of Antimicrobial Uses for the Re registration Eligibility Decision Document

• EPA-HQ-OPP-2004-0159-0119, Metam-sodium: Revi sed Occupational and Residential Exposure Assessment of Antimicrobial Uses fo r the Reregistration E ligibility Decision Document. (PC Codes 039003 and 068103)

• EPA-HQ-OPP-2004-0159-0006, Ecological Ri sk from Antimicrobial Uses of Metam-sodium to be Considered in the RED

• EPA-HQ-OPP-2004-0159-0017 , Metam-sodi um: Dietary Risk Assess ment of Antimicrobial Uses for the RED

IV. Risk Management and Reregis tration Eligibility Decision

A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of the Federal Insectic ide, Fungicide and R odenticide Act (FIFRA) calls for the Agency to determine, after subm ission of relevant dataconcerning an active ingredient, whether pesticides cont aining the active ingredient are eligible for reregistration. The Agency has previously identified and require d the submission of th e generic (i.e., active ingredient specific) data to support reregistration of products containing metam-sodium, metampotassium, and MITC.
In Phase 5, the Agency published a risk mitigation options paper. 1 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;

1 EPA-HQ-OPP-2005- 0128-0031, Risk Mitigation Options to Addre ss Bystander and Occupational Exposures from Soil Fumigant Applications

3 3• 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 metam-s odium, metam-potassium, and MITC databases and public comments on the Agency’s assessments for these active ingredients, the Agency has sufficient info rmation on the human health and ecological effects of metam-sodium, metam-potassium, a nd MITC to make decisions as part of the reregistration process under FIFRA. Further, based on the volatility of metamsodium, metam-potassium, and MITC and metabolism studies in plants, EPA has concluded that there is a r easonable expectation that no re sidue on food or feed items will occur with the use of these fumigant s. Therefore, no tolerances have been established.
As a result of this review, the Agency has determined that certain uses of (1) metamsodium (including use as a pre-plant soil fumigant in certain crops, as a root control agent in sewers and drains, and as an an timicrobial agent to treat wood poles and timbers and sewage sludge and animal waste); (2) metam-potassium (i ncluding use as a pre-plant soil fumigant in certain crops and as an antimicrobial agent for tr eatment of pulp and paper, tanning drum leather applications, recirculating cooli ng water systems, and industrial water purification systems); and (3) MITC (for use as an antimicrobial agent to treat wood poles and pilings) are eligible for reregistration, provided that the risk mitigation measures outlined in this document are adopted, label amendments are made to reflect these meas ures (as outlines in Section V), and data are developed to assess intermediate- and long-term risk to bystanders. Appendix A summarizes the uses of metam-sodium, metam-potassium, and MITC that are eligible for reregistration.
The Agency’s decision takes into account th e best available information on the potential risks and benefits of metam use. In reachi ng its reregistration decision and developing the metam mitigation proposal, EPA considered a range of factors, including: characteristics of bystander and other populations exposed to meta m; hazard characteristics of metam-sodium, metam-potassium, and MITC; available information on levels of exposure, feasibility, cost, and effectiveness of various risk mitigation options; incident information; public comments; potential impacts of mitigation on growers ability to produ ce crops; availability of efficacious alternatives; comparative risks of alternative control me thods; and the uncertainties and assumptions underlying the risk and benefit assessments.

3 4Some uncertainty remains associated with in termediate- and long-term exposure and risk to bystanders. To address these uncertainties, EPA is requiring additiona l data related to both toxicity and exposure. Notwithstanding these unc ertainties, the Agency has decided to proceed with its reregistration decision and implementation of mitigation at this time because mitigation implemented to address acute bystander risk will also serve to addre ss intermediate- and longterm bystander risk.
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. To ensure that data are developed and reviewed expeditiously, EPA plans to move the soil fumigants forward in registration revi ew, 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 risk s as EPA believes it will, and to include other soil fumigants which are not partof the current review.
Voluntary Cancellation of Antimicrobial Uses
On May 15, 2008, the Agency received le tters voluntarily cancelling several antimicrobial uses for metam-sodium and metam- potassium. The antimicrobial uses of metamsodium that were cancelled included: (1) treatm ent of process waters during the production of sugar (i.e., raw cane and beet sugars) and (2) tr eatment of brine-cured hides and skins (i.e., leather) during processing, and (3) treatment of sewage sludge and animal waste. The antimicrobial uses of metam-potassium that we re cancelled included: (1) the sugar beet and sugar cane use; (2) all leather uses, with the ex ception of the tanning drum leather use; (3) all paint uses (including the preserva tion of protective colloids and emulsion resins); (4) all waterbased drilling, completion, and packer fluid uses ; (5) all petroleum sec ondary recovery operation uses; (6) all once-throug h cooling water applications, and (7 ) all cutting fluids (metalworking fluids) uses. As a result of these cancellations, th ese uses have not been evaluated in the RED.
The Agency has determined that the remaini ng registered antimicrobial uses for metamsodium (i.e., remedial treatment of wooden poles and timbers and treatment of sewage sludge and animal waste), metam-potassium (i.e., us e in tanning drum leather, pulp and paper, recirculating cooling water systems, and industr ial water purification systems), and MITC (i.e., remedial treatment of wooden poles and timbers ) will not pose unreasonable risks or adverse effects to humans or the environment, provide d that the risk mitigation measures and label changes outlined in this RED are implemente d and, therefore, products containing metamsodium, metam-potassium, and MITC for these uses are eligible for reregistration.
Based on its evaluation of metam-sodium, metam-potassium, and MITC, the Agency has determined that products containing these chemicals, unless labeled and used as specified in this document, would present risks inco nsistent with FIFRA. Accordin gly, should a registrant fail to implement any of the risk mitigation measures id entified in this document, the Agency may take regulatory action to address the ri sk concerns from the use of these chemicals. If all changes

3 5outlined in this document are incorporated into the product labels, then current risks for metamsodium, metam-potassium, and MITC will be adequately mitigated for the purposes of this determination under FIFRA. Once a compre hensive endangered species assessment is completed, further changes to these registrations may be necessary.

B. Public Comments and Responses
The Phase 3 public comment period on the pr eliminary risk assessments and related documents lasted from July 13 through Oct ober 12, 2005. The Agency responses to Phase 3 public comments related to metam-sodium and metam-potassium soil uses, metam-sodium sewer use, and antimicrobial uses for metam-sodium, metam-potassium, and MITC can be found in the metam-sodium docket (EPA-HQ-OPP-2005-0125) at www.regulations.gov

. EPA revised its risk assessments and developed benefits and risk mitigation options during Phase 4. The Phase 5 public comment pe riod, for revised risk assessments, benefits analysis, and risk management options, lasted from May 2 to November 3, 2007. The Agency responses to Phase 5 public comments related to metam-sodium and metam-potassium soil uses, metam-sodium sewer use, and antimicrobial uses for metam-sodium, metam-potassium, and MITC can be found in the following documents, available in the metam-sodium docket (EPAHQ-OPP-2005-0125) at www.regulations.gov

.

• 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).

• 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 Metam-Sodium and Metam-Potassium RED on July16, 2008. The Agency received requests to

3 6extend 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 for an additional 45 days. The comment period closed on October 30, 2008. The Agency has reviewed these public comments as well as new scientific data and other inform ation 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 following do cuments include EPA’s responses to comments on the July 2008 RED which may be found in th e metam-sodium and metam-potassium 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

1. Regulatory Rationale
The Agency has determined that products containing metam-sodium, metam-potassium, and MITC are eligible for reregistration provided the risk mitigation measures outlined in this document are 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 potential exposted to metam-sodium and metam-potassium but with a greater likeliho od of compliance, fewer inpacts on the benefits of metam use, and with less uncer tainty regarding the protectiven ess of the required measures. The following is a description of the rationale for managing risks associated with the use of these fumigants. Where labeling revisi ons are warranted, spec ific language is set forth in the label table in Section V of this document.

a. Soil Fumigant Uses of Metam-sodium and Metam-potassium

i. Rate Reduction and Use Sites

While most current labels for metam-sodium and metam-potassium state that 320 lb ai/A is the maximum allowed rate, there are some labe ls which suggest that calculated rates may be

3 7higher than 320 lb ai/A. To consis tently clarify the maximum app lication rates fo r pre-plant soil fumigation, label language will be re quired to specifically state 320 lb ai/A as the upper limit for all application methods. No othe r rate changes for soil fumigati on uses are required in this decision.

1. Use Sites Eligible for Reregistration
In the July 2008 Metam-Sodium and Metam-Po tassium RED, the Agency determined the following uses to be eligible for reregistrati on: asparagus (nursery production only), artichokes, broccoli, brussels sprouts, cabba ge, carrot, cauliflower, celery, cu curbits (cucumber, cantaloupe, honeydew, pumpkin, squash, and watermelon), eggplant, forest seedli ngs, grape (vineyard replant only), lettuce, mint, nursery stock (fruit seedlings and rose bus hes only), oranges, onion, pome fruit (apples and pears; orchard replant onl y), stone fruit (apricot, cherry, nectarine, peach, plum and prune; orchard replant only), ornament als (floriculture only), peanut, pepper, potato, spinach, strawberries, sweet potato, tobacco, toma toes, and turf (inclu ding golf courses).
This list of crops was based on one or more of the following criteria: (1) the crop showed significant usage of metam-sodium and metam- potassium, as indicated by BEAD usage data,and/or (2) stakeholders for the crop submitted compelling benefits information for metamsodium and metam-potassium use during the Ph ase 5 comment period, and/or (3) removal of metam-sodium and metam-potassium use appeared likely to increase use of methyl bromide, which is being phased out under the Montréal Pr otocol. “Significant usage” was defined as a crop that has more than 5% cr op treated annually or more than1,000,000 lb of metam sodium or metam potassium applied annually.
All other pre-plant uses were to be dele ted, unless additional information to support a compelling case for the economic benefits of metam-sodium and metam-potassium was provided. This decision was based on potentially high risk to bys tanders from metam-sodium and metam-potassium, coupled with a lack of indi cation of high economic benefits for crops not included in the group described above.
During the post-RED comment period, the Ag ency received comments from various stakeholders asking that the Agency consider the eligibility of additional use sites. Key considerations identified during the po st-RED comment period included:

• Crops that are typically included as part of a rotational schedule or cover crop regimen. The Agency agrees that limiting the use metam-s odium and metam-potassium may have some unintended consequences. These include prev enting good soil erosion management (with cover crops), and magnifying the negative econo mic impact on growers who have to alter their crop rotation scheme unexpectedly due to, for example, changes in weather conditions or economic considerations, such as contractual agreements with processors. As a result, the following crops, which have been reported to be part of typical rotational schedules for metam users, will be added as eligible use sites: alfalfa, barley, rye, sugar beets, corn, and wheat. In addition, the Agency will add “cover crops,” i.e., crops planted between periods of

3 8regular crop production to prevent soil erosion, c ontrol weeds, and improve soil quality that are incorporated into the soil before the next crop is planted and may not be harvested for food or feed, to the list of eligible use sites for metam-sodium and metam-potassium.

• Use of metam-sodium and metam-potassium as a potential alternative to methyl bromide for orchard replant of tree nuts, be rry crops, ginger, and pineapple . The Agency analyzed the use of soil fumigants for orchard replant of tree nut crops, berry crops (i.e ., blueberry, blackberry, raspberry, etc.), ginger, and pineapple and determ ined that restriction of these uses of metamsodium and metam-potassium are likely to lead to an increased reliance on methyl bromide. As a result, orchard replant of tree nuts, berry crops, ginger, and pineapple have been added as eligible use sites for metam-sodium and metam-potassium.

• Metam-sodium and metam-potassium use on minor crops. The Agency received comments from stakeholders asking that several minor uses (e.g., arugula, wild rocket, and parsley; grapefruit) of metam-sodium and metam-potassium be considered eligib le. While such minor crop uses might not reach the threshold of “significant usage,” in cases where the crops mentioned were likely to be similar to others th at were retained for re registration, in terms of the pest management needs and crop production be nefits, the Agency made sure to evaluate those uses for eligibility in the RED addendum . Specifically, the Agency is including several of the EPA crop group listings as eligible use sites to provide growers additional flexibility with regard to use site eligibility [for a de scription of these crop groups, see “Pesticide Tolerances; Revision of Crop Groups, Final Ru le, Federal Register Notice, May 17, 1995 (Volume 60, Number 95); http://www.epa.gov/fedrgstr/E PA-PEST/1995/May/Day-17/pr266.html ]. As an example, by including “ EPA Crop Group 4, Leafy Vegetables” as an eligible use site, arugula, wild rocket , parsley and a number of other potential minor uses, which are similar to lettuce and spinach in terms of the pest management needs and crop production benefits, become eligible use sites. Further, the Agency is adding “crops grown solely for seed” to the list of eligible us e sites, because information from growers and extension agents indicates that, while a minor use, use of soil fu migants on seed crops is important for control of weeds and disease.

• California Department of Pesticide Regulation usage data. In responding to the post-RED comments, the Agency examined the California Department of Pesticides (CDPR) pesticide usage data for recent years (2003-2006), since the state generally is a significant user of metam-sodium and metam-potassium products and is a major producer of a diverse array of crops that may rely on soil fumigation, to ensure that it did not miss any important uses of metam. Based on these data, it appears that th ere are few crops not already deemed eligible for reregistration that do not meet the criteri on of 5% or more of th e crop acreage treated annually. Only seven additional crops, includ ing sweet basil, Chinese greens (often a synonym for bok choy), celeriac (a member of the celery family), collard, dill, leeks, and Swiss chard, were identified as having 5% or mo re of the crop treated in at least one year during the time period studied. Based on this analysis, the Agency is adding these seven additional to the list of eligible use site s for metam-sodium and metam-potassium.

3 9Based on the original criteria for determining eligible use sites (see above) as well as the comments and additional information received during the post-RED comment period, the EPA has determined that the followi ng expanded list of metam-sodium and metam-potassium use sites are eligible for reregistration. A ll other pre-plant uses are to be deleted, and product labels must be amended to reflect use only on the crops specified as eligible for reregistration.

• Alfalfa,

• Asparagus (nursery production only),

• Artichokes,

• Barley,

• Basil,

• Beet,

• Berries, [includes all EPA Crop Group 13, Berries Group, i.e., blackberry (Rubus eubatus ); bingleberry; black satin berry; boysenberry; Cherokee blackberry; chesterberry; Cheyenne blackberry; coryberry; darrowberry; dewberry; Di rksen thornless berry; Himalayaberry; hullberry; lavacaberry; lowberry; lucretiaberry; mammoth blac kberry; marionberry; nectarberry; olallieberry; Oregon evergreen berry; phenomenalberry; rangebe rry; ravenberry; rossberry; Shawnee blackberry; youngberry, and varieties and/or hybrids of these; blueberry ( Vaccinium spp. ); currant (Ribes spp. ); elderberry ( Sambucus spp. ); gooseberry ( Ribes spp. ); huckleberry ( Gaylussacia spp. ); loganberry (Rubus loganobaccus ); raspberry-black and red (Rubus occidentalis , Rubus strigosus , Rubus idaeus )],

• Broccoli,

• Brussels sprouts,

• Cabbage,

• Carrot,

• Cauliflower,

• Celeriac,

• Chineese greens or bok choy,

• Cilantro,

• Citrus (orchard replant only), [includes all of EPA Crop Group 10, Citrus Fruits, i.e., calamondin ( Citrus mitis X Citrofortunella mitis ); citrus citron ( Citrus medica ); citrus hybrids ( Citrus spp. ) (includes: chironja, tangelo, tangor); grapefruit ( Citrus paradisi ); kumquat ( Fortunella spp. ); lemon ( Citrus jambhiri , Citrus limon ); lime ( Citrus aurantiifolia ); mandarin (tangerine) ( Citrus reticulata ); orange, sour ( Citrus aurantium ); orange, sweet ( Citrus sinensis ); pummelo ( Citrus grandis , Citrus maxima ); satsuma mandarin ( Citrus unshiu )],

• Collard,

• Corn,

• Cover crops (i.e., crops planted between periods of regular crop production to prevent soil erosion, control weeds, and improve soil quality that are inco rporated into the soil before the next crop is planted and may not be harvested for food or feed),

• Crops grown solely for seed,

• Cucurbits [includes all of EPA Crop Group 9, Cucurbit Vegetables Group, i.e., chayote (fruit) ( Sechium edule ); Chinese waxgourd (Chinese preserving melon) ( Benincasa hispida ); citron melon ( Citrullus lanatus var. citroides); cucumber ( Cucumis sativus ); gherkin ( Cucumis anguria ); gourd, edible ( Lagenaria spp. ) [includes: hyotan, cucuzza ( Luffa acutangula , L. cylindrical; includes hechima, Chinese okra)]; Momordica spp. (includes balsam apple, balsam pear, bitter melon, Chinese cucumber); muskmelon [hybrids and/or cultivars of Cucumis melo (includes true cantaloupe, cantaloupe, casaba, crenshaw melon, golden pe rshaw melon, honeydew melon, honey balls, mango

4 0melon, Persian melon, pineapple melon, Sant a Claus melon, and snake melon)]; pumpkin ( Cucurbita spp. ); squash, summer ( Cucurbita pepo var. melopepo) (includes: crookneck squash, scallop squash, straightneck squash, vegetable marro w, and zucchini); squash, winter ( Cucurbita maxima ; C. moschata ) (includes: butternut squash, calabaza, hubbard squash) and ( C. mixta ; C. pepo ) (includes acorn squash, spaghetti squash); and watermel on (includes hybrids and/or varieties of Citrullus lanatus )],

• Dill,

• Eggplant,

• Forest seedlings,

• Ginger,

• Grape (vineyard replant only),

• Kale,

• Kohlrabi,

• Leafy greens [includes all of EPA Crop Group 4, Le afy Vegetables (Except Brassica Vegetables), i.e., amaranth (leafy amaranth, Chinese spinach, tampala) ( Amaranthus spp. ); arugula (roquette) ( Eruca sativa ); cardoon (Cynara cardunculus); celery ( Apium graveolens var. dulce); celery, Chinese ( Apium graveolens var. secalinum); celtuce ( Lactuca sativa var. angustana); chervil ( Anthriscus cerefolium ); chrysanthemum, edible-leaved ( Chrysanthemum coronarium var. coronarium); chrysanthemum; garland ( Chrysanthemum coronarium var. spatiosum); corn salad ( Valerianella locusta ); cress, garden ( Lepidium sativum ); cress, upland (yellow rocket, winter cress) (Barbarea vulgaris ); dandelion ( Taraxacum officinale ); dock (sorrel) (Rumex spp. ); endive (escarole) ( Cichorium endivia ); fennel, Florence (finochio) ( Foeniculum vulgare Azoricum Group); lettuce, head and leaf (Lactuca sativa ); orach ( Atriplex hortensis ); parsley ( Petroselinum crispum ); purslane, garden ( Portulaca oleracea ); purslane, winter (Montia perfoliata ); radicchio (red chicory) ( Cichorium intybus ); rhubarb ( Rheum rhab arbarum ); spinach ( Spinacia oleracea ); spinach, New Zealand ( Tetragonia tetragonioides , T. expansa ); spinach, vine (Malabar spinach, Indian spinach) ( Basella alba ); and swiss chard ( Beta vulgaris var. cicla)],

• Leek,

• Mint,

• Mustard,

• Nursery stock (fruit seedlings and rose bushes only),

• Onion,

• Ornamentals (floriculture only),

• Pome fruit (orchard replant only), [includes a ll of EPA Crop Group 11, Pome Fruits Group — Commodities, i.e., apple (Malus domestica ); crabapple (Malus spp. ); loquat ( Eriobotrya japonica ); mayhaw ( Crataegus aestivalis , C. opaca , and C. rufula ); pear ( Pyrus communis ); pear, oriental ( Pyrus pyrifolia ); and quince ( Cydonia oblonga )],

• Peanut,

• Pepper,

• Potato,

• Radish,

• Rye,

• Sugar beet,

• Soybean,

• Stone fruit (orchard replant only), [includes a ll of EPA Crop Group 12, Stone Fruits Group— Commodities, i.e., apricot ( Prunus armeniaca ); cherry, sweet ( Prunus avium ); cherry, tart ( Prunus

cerasus ); nectarine ( Prunus persica ); peach ( Prunus persica ); plum ( Prunus domestica , Prunus spp. );

4 1plum, Chickasaw ( Prunus angustifolia ); plum, Damson ( Prunus domestica spp. insititia ); plum, Japanese ( Prunus salicina ); plumcot ( Prunus. armeniaca X P. domestica ); prune (fresh) ( Prunus domestica, Prunus spp. )],

• Strawberries,

• Sugar beet,

• Sweet potato,

• Swiss Chard,

• Tobacco,

• Tomatoes,

• Tree nuts (orchard replant only), [includes all of EPA Crop Group 14, Tree Nuts Group (i.e., almond ( Prunus dulcis ); beech nut ( Fagus spp. ); Brazil nut ( Bertholletia excelsa ); butternut ( Juglans cinerea ); cashew ( Anacardium occidentale ); chestnut ( Castanea spp. ); chinquapin ( Castanea pumila ); filbert (hazelnut) ( Corylus spp. ); hickory nut ( Carya spp. ); macadamia nut (bush nut) (Macadamia spp. ); pecan ( Carya illinoensis ); and walnut, black and English (Persian) ( Juglans spp. ) as well as pistachio],

• Turnip,

• Turf (including golf courses), and

• Wheat

ii. Human Health Risk Management

For details on the metam-sodium and metam- potassium human health risk assessment, please refer to the human health risk assessmen ts and addenda. These documents are also available in the public docket EPA-HQ-OPP-2005-0125, located on- line in the Federal Docket Management System (FDMS) at www.regulations.gov

. Dietary Risk
Based on the currently registered use patter ns for metam-sodium and metam-potassium, dietary exposure, including exposur e from drinking water, is no t expected and no dietary risk mitigation is warranted for metam-sodium and metam-potassium at this time.
Bystanders, Workers, and Handlers

The human health risk assessments indicat e that inhalation expos ures to bystanders, handlers, and workers who live and work near agricultural fields and greenhouses where metamsodium/potassium fumigations occur have the potential to exceed the Agency’s level of concern without additional mitigation measures. To re duce the potential for metam-sodium and metampotassium exposure to bystanders , handlers, and workers and to address associated risks of concern, EPA is requiring a number of mitigation measures which include:

• Clarifying maximum application rates

• Clarifying use sites;

• Buffer zones;

• Dermal protection for handlers;

4 2• Respiratory protection and ai r monitoring 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 training and community outreach programs, will help reduce risk. Additionally, EPA is interested in working with registrants to identify additional measures that could be impl emented as part of product stewardship. These additional measures 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 margins of exposure (MOEs), others, such as emergency preparedne ss and response and community education, will contribute to bystander safety, but are difficult to express in terms of changes to quantitative risk estimates such as MOEs. However, EPA has de termined that these measures, working together, will prevent unreasonable adverse effects on 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 access 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 dietary exposure in that people consuming foods or

4 3drinking 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 information needed to take appropriate steps to mitigate the effects of the exposure. Thus, EPA’s mitigation includes elements for emergency preparedness and response, notice to state lead agencies, training, and community outreach as well as labeling changes.
The mitigation measures for bystander risks resulting from soil fumigation are described further in the following sections.

1. Buffer Zones

The human health risk assessments indicat e bystanders may be exposed to MITC air concentrations following metam-sodium and metam-potassium applications that exceed the Agency’s level of concern based on current labe l requirements. In general, the risk from inhalation exposures decreases as the distance from the field where bystanders are located increases. Because of this relationship, the Agen cy has determined that a buffer zone must beestablished around the perimeter of each application block where metam-sodium and metampotassium is applied. The Agency acknowledges that buffer zones alone will not mitigate all risks or eliminate incidents caused by equipm ent failure, human error, adverse weather (e.g., temperature inversions), or ot her events. The Agency however does believe that buffer zones along with other mitigation measures required by th is decision and described below will mitigate risks so that bystanders will not experience unreasonable adverse effects.
The Agency considered various buffer zone schemes ranging from fixed buffer zones for every application to site-specific buffer zones. During the Phase 5 comment period, the Agency received input in favor of a flexible buffer approach that would allow fumigant users to determine the buffer zone distance based on site c onditions and application practices. While the Agency believes that site-specific buffer zones w ould provide the most flexibility for users, the EPA currently does not have sufficient data to s upport this scheme. As a result, the Agency has developed a scalable buffer zone system that doe s provide flexibility by setting buffer zones for different application methods at various acreages and application rates.

Version 2.1.4 of the P robabilistic E xposure and R isk model for Fum igants (also called the PERFUM model) combined with monitoring data and incident data were used to characterize the risk for specific buffer zone distances corr esponding to the range of application scenarios anticipated. Additional information on the PERF UM inputs and outputs can be found in Agency

4 4risk assessment, (EPA-HQ-OPP-2005-0123-0285), in a June 2006 a peer-reviewed article describing the model ( http://www.sciencedirect.com/science/journal/13522310 ), and/or the PERFUM user’s guide which can be download from the internet ( http://www.exponent.com/perfum/ ). A CD containing all of th e PERFUM input/output files and files with the PERFUM MOE/air co ncentration analysis that were considered for this decision are available upon request at the OPP Docket Office.
(a) Buffer Zone Requirements
General Requirements in the July 2008 RED
The 2008 metam-sodium and metam-potassium RED described general buffer zone requirements for metam-sodium and metam-potassium and other soil fumigants. This included the definition of a buffer zone, the requirement to exclude non-handlers from the buffer zone during the buffer-zone period, and the de finition of the application block.

The RED also did not allow buffer zones to overlap and fumigations were prohibited within 1⁄4 mile of difficult to evacuate sites su ch as schools, state li censed 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

4 5Pacific 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 workable, 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 adjacentapplication 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 comments also asked for clarifica tion on various aspects of the buffer zone requirements, and some asked that EPA provide additional increments for acreages and application rates for buffer zone tables. In addition, many comments stated that buffer zone credits should be greater for the use of tarps and for certain environmental conditions. A number of comments indicated that obtaining written permission from local authorities for buffers to extend over roads and rights-of-way would be ex tremely difficult, and that neighbors may not provide permission. EPA also received additional field emi ssions (flux) data for some fumigants, as well as additional information rega rding 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 buffer zone requirements are appropriate. EPA believes these amendments will maintain the im portant 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 metam-sodium and metam-potassium off-gasses and moves away from tr eated fields at concentrations that have the potential to cause adverse effect s. Therefore, the Agency still believes that buffer zones that exclude bystanders are a critical aspect of mitig ating risks from the use of metam-sodium and metam-potassium. The Agency believes the modi fications to the buffer requirements, specified below, will increase compliance feasibility and encourage further adoption of emission reduction application techniques, while still protect ing human health and the environment.
Amended RED Requirements
EPA has determined that no changes to several 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, pedestrians, and other bystanders from the buffer zone during the buffer zone period (except for transit);

- the definition of the application block;

4 6- the minimum buffer of 25 feet and maximum buffer of 1⁄2 mile

.

- the requirement limiting entry into buffer z ones to handlers who have been properl y trained and equipped according to EPA’s Worker Protection Standard;

- the exemption for transit through buffer zones;

- 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 residential 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 atthe 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 and adjacent application blocks may overlap one another provided atleast 12 hours have elapsed fr om the end of one application until the start of the next applic ation. By separating the application times by at least 12 hours the

4 7fumigant emission peaks are less likely to occur at the same time which would sufficiently reduce potential exposure outside buffer zones and 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.
To 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.
Metam only: Applications of metam-sodium and metam-potassium can take place on large fields, typically greater th an 80 acres, and may require seve ral days to complete (e.g., via center pivot or lateral move irri gation systems). In situations where such large field sizes are treated the offsite movement of emissions may be proportionately less, on an acre basis, than smaller fields because the fetch (i.e., area over wh ich emissions are diluted) for certain areas of such fields would be either cont ained totally within the boundaries of the field or it would allow for significant dilution as the emissions move fr om the application block offsite into the buffer zone. As a result of the time requirements invol ved in treating such large areas and the reduced per acre contributions to overall emissions on large fields, EPA believes there is less potential for peak emissions from multiple large appli cations blocks to coincide and result in concentrations of concern outside adjacent buffers within localized areas th an would be expected if the situation varied by larger numbers of sm aller fields being treate d that would more likely result in coincidental peak emissions (e.g., fields th at take no more than one day to treat and that are smaller in acreage).
Although current modeling supports a conclusion that as application block size increases, the emissions into the buffer areas are reduced on a per acre basi s, the data to support a robust analysis of this relationship is very limited at this time. Based on comments provided, EPA also recognizes that compliance with the prohibition on buffer overlap in areas such as the Pacific Northwest with large-scale production systems ba sed on center pivot applications would be extremely challenging for metam users. EPA al so understands that, due to the length of time needed to complete these applications, separati ng applications by 12 hours is also impractical. EPA also wishes to encourage adoption of improve d application techniques such as low release center pivot systems because it believes that thei r use will reduce the potential for exposures of concern because they reduce dropl et drift potential for those inproximity to fields and may reduce application rates as we ll because of more effective water delivery. Based on these considerations, the Agency has determined that buffer zones may overlap for center-pivot application blocks only if each bl ock is treated using low release center pivot systems which will increase the feasibility of compliance with buffe r zone requirements and will not demonstratively alter the protection provided to bystanders.

4 8The Agency is maintaining the requirem ent for buffer zones around each application block to be in effect for 48 hours and that on ly properly trained and equipped handlers are allowed to enter into buffers zones.
To 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.
Metam Only: For Low Release Center Pivot Applications only:

• A buffer zone may NOT overlap buffer z ones from other application blocks which are already in effect UNLESS both application blocks are treated using low release center pivot systems. The 12 hour waiting period does not apply in this instance.
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 labels 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. In addition, certifie d applicators must obtai n permission from other landowners when buffers extend onto other lands which provides an additional mechanism to ensure handlers are aware when they are work ing in a buffer zone and that they have the necessary information regardi ng health effects, warning pr operties, 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

4 9path 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 dissipated. Therefore, monitoring of buildings and 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 agreement 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 obtain writt en permission will be an enforceable measure that will meet the goal of protecting worker s and bystanders on adjacent 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 and entry by non-handlers is prohi bited during the buffer zone period. Written permission from the appropriate st ate and/or local authorities 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 Agencybelieves that if a townor 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

5 0best positioned to make a determination about the practicality of preventing non-handlers from entering the buffer zone. EPA acknowledges that laws 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.
(b) PERFUM Model Inputs
The major input parameters for the modeling are: 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 uncertainty factors). The following summarizes the key points for each of these input parameters.
Application Rates
The Agency modeled up to 320 lb ai/acre for all metam applications, the maximum application rate permitted on the metam product labe ls. However, typical application rates vary by crop and geographic region. According to EPA proprietary data for 2004-2005, approximately 94% of metam-sodium was applied at a rate of 225 lb a i/acre or less. OPP’s Biological and Economic Analysis Division (BEAD) completed a seri es of benefits assessments by crop and region that included a more detailed analysis of use rates and are available for review in the metam-sodium docket (EPA-HQ-OPP-2005-0125) at www.regulations.gov

. Rates for bedded or strip applications (lb ai per treated area) were converted to broadcast equivalent application rates to determine the mi nimum buffer 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-shaded area is the area of the field that is untreated. As an example, assume that both fields are 10 acres, and only 50% of field in Figure 2 is fumigated, and the rate per treated acre is 400 lbs ai/A for both Figure 1 and 2. In this case, 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 under the application instructions but they must id entify buffer zone distances base d on the broadcast or effective broadcast equivalent rates. [Not e: In the risk assessment, a 60% value for proportion of field treated was used in the calculations.]

5 1Figure 1. Broadcast Application Figure 2. Bedded Application
Application Block Sizes
For all application methods, the Agency modeled up to 120 acres, which is the limit of the PERFUM model. However, typical applic ation block sizes vary by crop and geographic region. In the Pacific Northwest, crops are typica lly grown in fields aver aging 120-acres in size, while crops in California, the uppe r Midwest, and the Southeast te nd to be smaller, typically 10­ 60 acres, 30-50 acres, and 10-40 acr es respectively. OPP’s Biol ogical and Economic Analysis Division (BEAD) completed a seri es of benefits assessments by crop and geographic region that included a more detailed analys is of typical application block sizes, which are available for review in the metam-sodium docket (EPA-HQ-OPP-2005-0125) at www.regulations.gov

. The 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.

Emission Studies
The Agency’s risk assessment for the July2008 RED included modeling of four pre-plant soil application methods : (1) sprinkler irri gation (with standard 2 and intermediate 3 water seals), (2) shank injection (with standard 1 and intermediate 2 water seals, compaction, and standard

2 A standard water seal consisted of either a 1⁄2 inch of water added immediately after an application and another 1⁄2­ inch of water applied within 24 hours of the application (chemigation study) or a 1⁄2 inch of water applied within 24 hours of the application (shank injection study). 3 An intermediate water seal consisted of a 1⁄4 inch of wa ter applied immediately after application, two additional 1⁄4­ inch water seals applied the same day as the application, as well as three additional 1⁄4-inch water seals applied the day following application.

5 2polyethylene tarps), (3) drip irri gation (with and without standard polyethylene tarps), and (4) flood irrigation. The modeling performed by EPA was based on 14 field volatility studies. The majority of these studies were conducted in Ca lifornia (11), with several also conducted in Florida (2) and Washington (1).
While the Agency considered the modeling data from all 14 emissions studies available, it used a subset of the most representative emissi ons studies to serve as the basis for developing the buffer zone distances. These studies include d: (1) the Bakersfield, CA, sprinkler irrigation study with intermittent water se al (USDA CSREES Pr oject #74; 09/02); (2) the Bakersfield, CA, shank injection study with intermittent water s eal (USDA CSREES Project #74; 09/02); (3) the Citra, FL, drip irrigation study with tarps (USDA CSREES Pr oject #74; 02/03); and (4) the Brawley, CA, flood irrigation study (MRID 473143- 01). For application methods where the Agency does not currently have emissions study data available, these emissions study profiles also served as surrogate data. The buffer zone distances for all chemigat ion and the low-release height and low-drift center pivot applications were derived from th e sprinkler irrigation emission study profile with intermittent wate r seal. It should be noted th at the Agency does not believe that the sprinkler irrigation study emissions data are representati ve of the high-release height center pivot application method (w hich includes use of end guns). However, the Agency has selected buffer zone distances for this appl ication method that it believes are sufficiently protective of bystander risk. Washington State Un iversity has submitted studies to quantify the flux rate for metam-sodium and metam-potassium from shank injection a pplications and from center pivot applications using a drizzle boom in the Pacific Northwest. These studies were submitted in April, 2009, and are currently in revi ew. If these studies indicate that the buffer zones for these types of applications should be modified, the Agency will update the buffer tables prior to implementation of new labeling re lated to buffers for metam sodium in 2011. The results of these studies have not been included in this amended document and the buffer tables below. EPA is requiring the registrants to s ubmit studies to quantify the flux rate for metamsodium and metam-potassium from center pivot applications using low-, medium- and highrelease equipment, both with and without the use of endguns. The Agency will include the results of this research in its fina l labeling decisions, if possible.
Based on the site characteristics (i.e., maximum air temperature, maximum soil temperature, field capacity) of th e field volatility studies that se rved as the basis for the buffer zone distances, the profiles modeled for both th e sprinkler irrigation (with intermediate water seals) and shank injection (with intermediate water seals) scenarios, were assumed to represent high-end but not necessarily the worst case for me tam applications in the U.S. The profiles modeled for both the drip and flood irrigation scenar ios, which served as the basis for the buffer zone distances, were assumed to represent more “typical” site characteristics. The Agency believes that several required GAPs, including mandatory soil temperature and soil moisture requirements, will greatly reduce the likelihood that worst case scenarios will occur.

Weather

5 3The largest use of metam-sodium and metam- potassium for soil fumigation in the U.S. occurs in the Pacific Northwest and Calif ornia, followed by the upper Midwest and the Southeast. Based on these high-us e areas, six weather station datasets were modeled (Ventura, CA; Bakersfield, CA; Bradenton, FL; Tallahassee, FL; Flint, MI; and Yakima, WA). Each modeling run used five years of weather data (e.g., 1,825 potential application days) for each location. Generally, Ventura, and Bradenton we ather data result in the largest buffer zone distances, followed by Bakersfield and Tallahassee. Flint data result in significantly smaller buffers.
Target Air Concentrations

As described in the Human Health Risks s ection of Section 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 human variability uncertainty factor for intraspecies extrapolation. The lowest observable adverse effect level (LOAEL) is 800 ppb, and the human concentration (HC) based on the no ob servable adverse effect level (NOAEL) from this study is 220 ppb.
The Agency focused on achieving an MOE of 10 at upper percentiles of each of the distributions from the PERFUM modeling outputs. However, th e buffer zone distances required to achieve this MOE would have been prohibitivel y large and likely would have been impossible for most growers to implement. The Agency believes that the buffer zone distances being required, in addition to the other mitigation requi rements described herein (i.e., restricted use pesticide classification, posti ng and emergency preparedness pr ocedures for buffer zones, mandatory good agricultural practices, required fumigant management plans, soil fumigant training requirements for appli cators and handlers, and ambient air monitoring programs in highuse areas), adequately address th e risk of acute fumigant exposure to bystanders and will greatly reduce the magnitude and freque ncy of exposure incidents.
(c) 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 margins of exposure (MOEs) can be estimated. 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, and the whole field distribution, as described, differs because it includes all points around the perimeter for the same period. It also should be noted that another way to consider this is that maximum buffer results are a subset of the whole field results and that maximum distances allow for more resolution at the upper percentiles of this distribution. Vers ion 2.1.4 of PERFUM also allows for direct consideration of air conc entrations at various distances around treated fields. These values were also considered in the decision-making process.

5 4An analysis based on a variety of PERFUM outputs was used in the buffer distance determinations. This involved consideration of the typical maximum and whole-field results, which are predictions of the distances at which a target concentration of concern (i.e., the human equivalent concentration adjusted by applicable uncertainty factors) 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., margins of exposure) 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 viewof 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 metamsodium and metam-potassium use when coupled with other mitigation measures.

Buffer Zone Distances
The Agency has developed required buffer zone distances based on application method, application rate, and applicati on block size (rounding up to neares t whole units for application rate and block size). These distances ar e summarized in Tables 5 to 11 below.
For each of the outdoor pre-plant soil emission profiles, distances were first chosen for the rates identified in the ri sk assessment as the 10%, 25%, 50%, 75% and 100% of the maximum rates (i.e., 32, 80, 160, 240, and 320 lb ai/A for all metam applications), each paired with application block sizes of 5, 10, 20, 30, 40, 50, 60, 80, 100, and 120 acres. Distances for the other rates in the buffer zone tables were scaled by assuming a lin ear relationship between the 10%, 25%, 50%, 75% and 100% maximum la bel rates [e.g., distance at 37.5% rate = (distance at 25% rate + distance at 50% rate)/2]. This scalin g was necessary to provide an incremental spread of rates

. It should be noted that the distan ces in the lookup tables are not model outputs, although the model outputs were a tool used for their development. A description of how the model outputs were used to char acterize the buffer zone distances is provided immediately after the buffer zone look-up tables (Tables 5 to 11).

 Minimum and Maximum Distances
A minimum buffer zone of 25 feet will be requi red regardless of site-specific application parameters. In some instances, the PERFUM model predicts that the risks reach the target at the edge of the field, but the Agency believes th at a 25-foot minimum bu ffer 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 ov er a field and other factors not accounted for in the modeling. Conversely, application scenarios requi ring buffers zone distances of more than 1⁄2 mile (2,640 feet) are prohibited. EPA believes that for areas where metam-sodium and metampotassium are used, buffers greater than 1⁄2 mile are not practical and difficult to enforce.

5 5The 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 that included cons ideration of the hazard profile of metam-sodium and metam-potassium, information from incide nt reports, monitoring data, and stakeholder comments along with comprehensive analysis of results from PERFUM modeling and consideration of results usi ng other models (e.g., Industria l Source Complex Model). The analysis of PERFUM results considered distances at various percentiles of the whole field and maximum distance distributions as well as and pr edicted MOEs for various distances. The risk assessment characterizes additional types of an alysis that were performed. The following characterizes the risks associated with the buffer zone distances summarized in Tables 5 to 11.

The buffer zone distances at the 90 thpercentile maximum distri bution is equivalent to saying a person at the locati on on the perimeter of the bu ffer 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 woul d have at least a 90% chance of exposure below the level of concern. The buffer zone distances at the 90 thpercentile whole field distribution is equivalent to saying a person somewhere on the perimeter of the buffer zone during the worst case 24-hour period following the fumigation of a specific field during a 5-year period w ould have at least a 90% chance of exposure below the level of conc ern. The risk assessment, available in the metam-sodium/potassium docke t (EPA-HQ-OPP-2005-00125) at www.regulations.gov , characterizes additional types of analysis that were performed.

Note: Washington State University has submitted studies to quantify the flux rate for metamsodium and metam-potassium from shank inj ection applications and from center pivot applications using a drizzle boom in the Pacifi c Northwest. These studies were submitted in April, 2009, and are currently in re view. If these studies indicate that the buffer zones for these types of applications should be modified, the Agency will update the buffer tables prior to implementation of new labeling related to buffers for metam sodium in 2011. The results of these studies have not been included in this amended document and the buffer tables below.

5 6Table 5. 2008 Center Pivot Irrigation Application (High Release Height*) Buffer Zone Distance in Feet Application Rate (lb ai/A) Block Size (A) 32 56 80 100 120 140 160 180 200 220 240 260 280 300 320

1 50 80 125 160 185 205 220 235 250 262 275 288 300 312 325 5 50 100 150 188 225 263 300 313 325 338 350 363 375 389 400 10 50 100 150 200 250 300 350 375 400 425 450 488 525 563 600 20 75 138 200 250 300 350 400 450 500 550 600 650 700 750 800 30 75 138 200 269 338 407 475 557 638 719 800 850 900 950 1000 40 100 200 300 363 425 488 550 638 725 813 900 975 1050 1125 1200 50 100 200 300 382 463 544 625 719 813 907 1000 1100 1200 1300 1400 60 200 300 400 475 550 625 700 825 950 1075 1200 1300 1400 1500 1600 70 200 300 400 488 575 663 750 888 1025 1163 1300 1400 1500 1600 1700 80 200 300 400 500 600 700 800 950 1100 1250 1400 1500 1600 1700 1800 90 250 350 450 550 650 750 850 1000 1150 1300 1450 1563 1675 1788 1900 100 300 400 500 600 700 800 900 1050 1200 1350 1500 1625 1750 1875 2000 110 350 450 550 650 750 850 950 1100 1250 1400 1550 1688 1825 1963 2100 120 400 500 600 700 800 900 1000 1150 1300 1450 1600 1750 1900 2050 2200 140 600 700 800 900 1000 1100 1200 1350 1500 1650 1800 1950 2100 2250 2400 160 800 900 1000 1100 1200 1300 1400 1550 1700 1850 2000 2150 2300 2450 2600 * This buffer zone distance table is for center pivot irrigation equipment in which the: 1) release height greater than 8 feet, and 2) there is > 30 lbs psi at the sprinkler head.

5 7Table 6. 2008 Center Pivot Irrigation Application (Medium Release Height**) Buffer Zone Distance in Feet Application Rate (lb ai/A) Block Size (A) 32 56 80 100 120 140 160 180 200 220 240 260 280 300 320

1 25 25 25 37 50 62 75 87 100 112 125 138 150 162 175 5 25 38 50 63 75 88 100 113 125 138 150 263 175 188 200 10 25 50 75 94 113 132 150 175 200 225 250 288 325 363 400 20 25 50 75 107 138 169 200 250 300 350 400 450 500 550 600 30 25 50 75 125 175 225 275 357 438 519 600 650 700 750 800 40 50 75 100 163 225 288 350 438 525 613 700 775 850 925 1000 50 50 75 100 182 263 344 425 519 613 707 800 900 1000 1100 1200 60 75 138 200 275 350 425 500 625 750 875 1000 1100 1200 1300 1400 70 75 138 200 288 375 463 550 688 825 963 1100 1200 1300 1400 1500 80 75 138 200 300 400 500 600 750 900 1050 1200 1300 1400 1500 1600 90 88 169 250 350 450 550 650 800 950 1100 1250 1363 1475 1588 1700 100 100 200 300 400 500 600 700 850 1000 1150 1300 1425 1550 1675 1800 110 150 250 350 450 550 650 750 900 1050 1200 1350 1488 1625 1763 1900 120 200 300 400 500 600 700 800 950 1100 1250 1400 1550 1700 1850 2000 ** This buffer zone distance table is for center pivot irrigation equipment in whic h the: 1) release height AND spray height is less than 8 feet, AND 2) 29lbs. or less PSI at the sprinkler head, AND 3) there are no end guns.

5 8Table 7. 2008 Center Pivot Irrigation Application (Low Release Height***) Buffer Zone Distance in Feet Application Rate (lb ai/A) Block Size (A) 32 56 80 100 120 140 160 180 200 220 240 260 280 300 320

1 25 25 25 30 35 40 50 60 70 85 105 125 145 165 185 5 25 25 25 35 50 63 75 94 113 132 150 163 175 188 200 10 25 38 50 63 75 88 100 125 150 175 200 225 250 275 300 20 25 38 50 70 89 107 125 157 188 438 250 288 325 363 400 30 25 38 50 75 100 125 150 188 225 263 300 350 400 450 500 40 25 50 75 107 138 169 200 238 275 313 350 413 475 538 600 50 25 50 75 119 163 207 250 294 338 382 425 494 563 632 700 60 50 75 100 150 200 250 300 363 425 488 550 613 675 738 800 70 63 100 138 192 244 297 350 419 488 557 625 694 763 832 900 80 75 125 175 232 288 344 400 475 550 625 700 775 850 925 1000 90 88 138 188 254 319 385 450 532 613 694 775 857 938 1019 1100 100 100 150 200 275 350 425 500 588 675 763 850 938 1025 1113 1200 110 125 188 250 325 400 475 550 644 738 832 925 1019 1113 1207 1300 120 150 225 300 375 450 525 600 700 800 900 1000 1100 1200 1300 1400 *** This buffer zone distance table is for center pivot irrigation equipment in which the: 1) release height AND spray height is less than 4 feet, AND 2) 29lbs. or less PSI at the sprinkler head, AND 3) solid stream nozzle (e.g. drizzle boom, Smart Drop, etc.), AND 4) there are no end guns.

5 9Table 8. 2008 All Chemigation Except Center Pivot and Flood Applications Buffer Zone Distance In Feet Application Rate (lb ai/A) Block Size (A) 32 56 80 100 120 140 160 180 200 220 240 260 280 300 320

1 25 38 50 55 62 68 75 80 87 93 100 115 125 137 150 2 25 38 50 57 65 73 81 88 97 104 113 152 138 150 163 3 25 38 50 58 67 78 88 97 106 116 125 189 150 163 175 4 25 38 50 60 70 83 94 105 116 127 138 226 163 175 188 5 25 38 50 63 75 88 100 113 125 138 150 263 175 188 200 6 25 40 55 69 83 97 110 125 131 155 170 268 205 223 240 7 25 43 60 75 90 106 120 138 140 173 190 273 235 258 280 8 25 45 65 81 98 114 130 150 146 190 210 278 265 293 320 9 25 48 70 87 105 123 140 163 155 208 230 283 295 328 360 10 25 50 75 94 113 132 150 175 200 225 250 288 325 363 400 20 25 50 75 107 138 169 200 250 300 350 400 450 500 550 600 30 25 50 75 125 175 225 275 357 438 519 600 650 700 750 800 40 50 75 100 163 225 288 350 438 525 613 700 775 850 925 1000 50 50 75 100 182 263 344 425 519 613 707 800 900 1000 1100 1200 60 75 138 200 275 350 425 500 625 750 875 1000 1100 1200 1300 1400 70 75 138 200 288 375 463 550 688 825 963 1100 1200 1300 1400 1500 80 75 138 200 300 400 500 600 750 900 1050 1200 1300 1400 1500 1600 90 88 169 250 350 450 550 650 800 950 1100 1100 1363 1475 1588 1700 100 100 200 300 400 500 600 700 850 1000 1150 1300 1425 1550 1675 1800 110 150 250 350 450 550 650 750 900 1050 1200 1350 1488 1625 1763 1900 120 200 300 400 500 600 700 800 950 1100 1250 1400 1550 1700 1850 2000

6 0Table 9. 2008 Shank Injection Applications-Tarped and Untarped Buffer Zone Distance In Feet Application Rate (lb ai/A) Block Size (A) 32 44 56 68 80 100 120 140 160 180 200 220 240 260 280 300 320

1 25 25 25 25 25 25 25 25 25 32 38 44 50 56 63 69 75 2 25 25 25 25 25 25 25 25 25 32 38 44 50 58 66 74 81 3 25 25 25 25 25 25 25 25 25 32 38 44 50 60 69 79 88 4 25 25 25 25 25 25 25 25 25 32 38 44 50 61 72 83 94 5 25 25 25 25 25 25 25 25 25 32 38 44 50 63 75 88 100 6 25 25 25 25 25 26 28 29 30 38 45 53 60 75 90 105 120 7 25 25 25 25 25 28 30 33 35 44 53 62 70 88 105 123 140 8 25 25 25 25 25 29 33 36 40 51 60 70 80 100 120 140 160 9 25 25 25 25 25 31 35 40 45 57 68 79 90 113 135 158 180 10 25 25 25 25 25 32 38 44 50 63 75 88 100 125 150 175 200 20 25 25 25 25 25 32 38 44 50 69 88 132 175 207 238 269 300 30 25 32 38 44 50 57 63 69 75 113 150 188 225 257 288 319 350 40 25 32 38 44 50 57 63 69 75 119 163 207 250 288 325 363 400 50 25 38 50 63 75 82 88 94 100 150 200 250 300 350 400 450 500 60 25 38 50 63 75 82 88 94 100 163 225 288 350 413 475 538 600 70 38 51 63 76 88 104 119 135 150 207 263 319 375 444 513 582 650 80 50 63 75 88 100 125 150 175 200 250 300 350 400 475 550 625 700 90 63 76 88 100 113 138 163 188 213 266 319 372 425 500 575 650 725 100 75 88 100 113 125 150 175 200 225 282 338 394 450 525 600 675 750 110 75 91 107 123 138 163 188 213 238 298 357 416 475 550 625 700 775 120 75 94 113 132 150 175 200 225 250 313 375 438 500 575 650 725 800

6 1Table 10. 2008 Rotary Tiller and Spray Blade Applications Buffer Zone Distance In Feet Application Rate (lb ai/A) Block Size (A) 32 56 80 100 120 140 160 180 200 220 240 260 280 300 320

1 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 5 25 25 25 25 25 25 25 25 25 25 25 25 25 25 25 6 25 25 25 25 25 25 25 25 25 25 25 27 29 30 32 7 25 25 25 25 25 25 25 25 25 25 25 29 32 36 39 8 25 25 25 25 25 25 25 25 25 25 25 30 36 41 46 9 25 25 25 25 25 25 25 25 25 25 25 32 39 47 53 10 25 25 25 25 25 25 25 25 25 25 25 34 43 52 60 20 25 25 25 25 25 25 25 25 25 25 25 49 73 97 120 30 25 25 25 25 25 25 25 25 25 25 25 64 103 142 180 40 25 25 25 25 25 25 25 25 25 25 25 75 125 275 225 50 25 25 25 25 25 25 25 42 58 74 90 135 180 225 270 60 25 25 25 25 25 25 25 57 88 119 150 188 225 263 300 70 25 25 25 25 25 25 25 64 103 142 180 218 255 293 330 80 25 25 25 25 25 25 25 72 118 164 210 248 285 323 360

6 2Table 11. 2008 Drip Irrigation Applications-Tarped and Untarped Buffer Zone Distance in Feet Application Rate (lb ai/A) Block Size (A) 32 56 80 100 120 140 160 180 200 220 240 260 280 300 320

1 25 25 25 25 25 25 25 25 25 25 25 32 38 44 50 2 25 25 25 25 25 25 25 27 28 30 31 37 41 46 50 3 25 25 25 25 25 25 25 29 32 35 38 41 44 47 50 4 25 25 25 25 25 25 25 30 35 39 44 46 47 49 50 5 25 25 25 25 25 25 25 32 38 44 50 50 50 50 50 6 25 25 25 26 28 29 30 37 43 49 55 56 58 59 60 7 25 25 25 28 30 33 35 42 48 54 60 63 65 68 70 8 25 25 25 29 33 36 40 47 53 59 65 69 73 76 80 9 25 25 25 31 35 40 45 52 58 64 70 76 80 85 90 10 25 25 25 32 38 44 50 57 63 69 75 82 88 94 100 20 25 38 50 57 63 69 75 82 88 94 100 125 150 175 200 30 25 38 50 57 63 69 75 94 113 132 150 188 225 263 300 40 25 50 75 82 88 94 100 113 125 138 150 200 250 300 350 50 25 50 75 82 88 94 100 125 150 175 200 250 300 350 400 60 25 63 100 113 125 138 150 175 200 225 250 300 350 400 450 70 25 76 125 140 150 163 175 207 250 269 300 350 400 450 500 80 25 88 150 163 175 188 200 238 275 313 350 400 450 500 550
For all pre-plant soil applications for metam- sodium/potassium, the buffer zone distances necessary to achieve the targetMOE (an MOE of 10), for all weather station data modeled, are prohibitively large and would likel y be impossible for most growers to implement. The Agency worked to balance the need to develop buffer zone distances that are sufficiently protective with the benefits that accrue from the use of meta m-sodium/metam-potassium. The Agency believes that the buffer zone distances it has selected, combined with the other mitigation measures described herein (e.g., requiring GAPs and FMPs; posting and emergency preparedness requirements; soil fumigant tr aining requirements for applicator s and handlers; clarifying use sites and ambient air monitoring programs in high- use areas) will adequately address the risk of acute exposure to bystanders and will greatly reduce the magnitude and frequency of exposure incidents.
The Agency selected the buffer zone distan ces for metam-sodium/metam-potassium, such that the resulting MOEs are ≥ 3 for all application methods and all weather stations data. While this does not meet the target air concentration fo r the buffer zone distances, even at the lowest MOE (MOE of 3), the predicted air concentration at the edge of the buffer would be 12 times lower than the lowest observable adverse effect level (LOAEL), which is the level at which eye irritation effects begin in humans.

6 3The table below (Table 12) shows the buffer di stances and risk characterization for some key use scenarios, based on crop, region, typical application rate, and typica l application block size. It also shows the percentile for the whol e field and max distribution for each distance, as well as the MOE at the 95 thpercentile air concentration of PERFUM.

• As noted previously, the target MOE for me tam-sodium/potassium is 10, and the MOEs for these key metam use scenar ios range from 3 up to 26.

• For the key metam use scenarios presented belo w, all of the whole fi eld percentiles range from 60 to 99.9 percent, and the max percentiles range from <5 to 99 percent.

• The use of GAPs, FMPs, and other mitigati on measures required by this decision will contribute to an additional de crease in risk (see GAPs and FMPs sections below, pages 102 and 112 respectively).
Example
Consider the use scenario listed below (in Table 12) for potatoes grown in the Pacific Northwest using a center pivot with medium releas e height (i.e., maximum spray height less than 8 feet off the ground and no use of end guns). Here, with an application rate of 140 lb ai/acre and an application block size of 120 acres, the buffe r zone distance (without emissions credits) would be 700 feet. Note that:

• The MOE at the 95 thair concentration from the PERF UM modeling data at this buffer distance is 4.

• The risk level corresponding to th is buffer zone distance at the 95 thpercentile whole field distribution is equivalent to saying a person at any location onthe perimeter of the buffer zone during the worst 24-hour period following the fumigation of a specific field during a 5­ year period would have at le ast a 75% chance of having of exposure below the level of concern (i.e., MOE ≥ 10).

• The risk level corresponding to th e buffer zone distances at the 95 thpercentile maximum distribution is equivalent to saying a person at the location on the perimeter of the buffer zone where the maximum concentration o ccurs during the wors t case 24-hour period following the fumigation of a specific field during a 5-year period woul d have a 15% chance of exposure below the level of concern (i.e., MOE ≥ 10 for these typical use scenarios).

6 4Table 12. Buffer Zone Distances and Risk Char acterization for Key Metam Use Scenarios

Crop Region Application Method Typical Application Rates (lb ai/A) Typical Application Block Size (A) Buffer Zone Distances

(ft) w/o Credits Whole Field and Max Distance

Percentiles MOEs at the 95 th Air Concentration from PERFUM2 Whole Field Max

Potatoes

PNW Center Pivot – high release height 140 120-160 900-1300 n/a n/a n/a
Center Pivot – medium release height without end gun 140 120 700 75 15 4 Center Pivot – low release height without end gun 140 120 525 60 15 3 Upper Midwest Chemigation 150 30 200 65 <5 3 50 304 65 <5 3

PNW Shank Injection 140 80 175 60 <5 4 120 225 60 <5 3 Carrots

CA Shank (Broadcast) 170 80 225 65 <5 3 Chemigation 170 40 319 75 15 3 60 463 75 15 3

Flood 170 40 319 65 <5 3 60 463 65 <5 3 Drip 170 40 107 70 10 4 60 163 65 <5 4

WA Center Pivot – high release height 140 160 1300 n/a n/a n/a
Center Pivot –medium release height without end gun 140 120 700 75 15 4 Center Pivot – low release height without end gun 140 120 525 60 15 4
Cucurbits AZ & CA Shank (Strip, Tarped) 210 10 82 65 <5 3 40 185 60 <5 3

Southeast Shank (Strip, Tarped) 320 10 200 75 <5 3 40 400 70 <5 3 Tomatoes (Processed ) CA Shank (Strip, Tarped) 40 10 25 97 80 15 60 40 38 65 <5 9 Drip (Tarped) 40 10 25 99.9 99 26 60 40 38 97 80 11 Tomatoes (Fresh) Southeast Shank (Strip, Tarped) 320 10 200 75 <5 3 40 400 70 <5 3 Onions OR & WA Shank Strip 210 30 169 60 <5 3 40 185 60 <5 3

CA Shank Strip 110 30 60 65 <5 5 150 40 72 60 <5 3 Peppers CA Chemigation (Strip) 240 10 250 70 <5 3 40 700 80 10 3 Drip (Tarped) 240 10 75 75 10 5 40 150 65 <5 3

Southeast Shank (Strip, Tarped) 320 10 200 75 <5 3 40 400 70 <5 3

6 5Table 12. Buffer Zone Distances and Risk Char acterization for Key Metam Use Scenarios

Whole Field and

Max Distance

Percentiles Peanuts NC & VA Chisel Strip (Shaped Beds) 35 50 25 85 35 12 100 75 75 10 11 Sweet Potato CA Shank (Strip, Tarped) 300 10 175 65 <5 3 40 363 65 <5 3 Tobacco SC & VA Shank (Strip Tarped) 90 10 25 85 40 7 252 40 269 65 <5 3 Eggplant CA Shank (Strip Tarped) 160 10 50 65 <5 4 40 75 60 <5 3

Southeast Shank (Strip Tarped) 320 10 200 75 <5 3 40 400 70 <5 3 The Agency believes that the buffer zone dist ances described above, combined with other risk mitigation described herein, will provide pr otection against unreasonable adverse effects.
Amended General Buffer Zone Requirements
The following describes the general buffer z one requirements, as amended, for metam sodium:

• “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, nearbyresidents, pedestrians, and other bystanders, must be excluded from the buffer zone during the 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 “B uffer zone proximity” section below.
Buffer zone proximity-Exception to Allow Buffer Zone Overlap

• To reduce the potential for off-site movement from multiple fumigated fields, buffer zones from multiple metam-sodium and metam-pota ssium application blocks may not overlap UNLESS:

o 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.

For Metam-Sodium and Metam-Potassium Low Release Center Pivot Applications only:

6 6o A buffer zone may NOT overlap buffer z ones from other application blocks which are already in effect UNLESS both application blocks are treated using low release center pivot systems. The 12 hour waiting period does not apply in this instance.

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.
Exemptions 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 notshare a common wall with anoccupied structure.

6 7• 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 experience d

• 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 prohib ited during the buffer zone period. 3

. Applicators must comply withall 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 during the buffer zone period, 2

. Entry by non-handlers is prohibited during the buffer zone period, and 3

. Written permission to include the public area 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 withall 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 above 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.

6 8(d) Buffer Zone Reduction Credits
Requirements in the July 2008 RED
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,” 4 in the metam-sodium and metam-potassium docket. The Agency also coordinated and led a discussion on this issue at the 2006 and 2007 Methyl Bromide Alternatives Outreach (MBAO) Conferences with leading researchers and other stakeholders. A general description of the MBAO sessions can be found at http://mbao.org

. Based on the Agency’s analysis of the current data, the Agency developed metamsodium and metam-potassium buffer zone reduction credits for: high-barrier tarps (10%), soils with high organic matter (10%), soils with high clay content (10%), and low-temperature soils (10%). The July 2008 RED stated that the buffer zone credits were additive, but that the total credit could not exceed 40 percent. 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 buffer zone credits that apply in the Fumigant Mana gement Plan (FMP).
Comments on the July 2008 RED
Data were submitted since the July 2008 RED was issued that show greater reductions in emissions from the use of tarps and environmenta l conditions than what was determined in the July 2008 RED. In addition, the information submitted during the comment period indicated an additive effect in reducing emissions when multip le factors were combined. As a result, EPA has updated the buffer reduction credits and determined that the 40% credit cap should be increased to 80%. The new credits for individual factors and the cap on credits are detailed below. For details on the Agency’s analysis please see the May 14, 2009 memo; “Methyl Bromide (PC Code 053201), Chloropicrin (PC Code 081501), Dazo met (PC Code 035602), Metam Sodium and Potassium (PC Codes 039003 & 039002), MITC (PC Code 068103), DP Barcode D362369, Updated Health Effects Division Recommendati ons For Good Agricultural Practices and Associated Buffer Credits”, in the metam docket.

Soil Conditions

Soil 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

4 Factors Which Impact Soil Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Factor Approach, June 9, 2008, DP Barcode: 306857

6 9essentially beyond a grower’s ability to change. 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 5. 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 6 . See the Agency’s factors analysis for further details about the CHAIN_2D model 7

.
Based on the review of available 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 generallya high correlation between the organic matter content of the soils and th e dissociation constant (K d ) value. Increasing K dvalue by 10 or 25 percent generally reduced emissions by 10 or 20 percent. Decreasing the K dvalue 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).
Since 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,

5 Cryer, S.A. (2007) Air/Soil Boundary Conditions For Coupling Soil Physics and Air Dispersion Modeling

. Unpublished report of Dow AgroSciences LLC (Report # DN241493 ) 6 Wang, D; Yates, S.R.; Jury, W.A. (1998) Temperature Ef fect on Methyl Bromide Volatilization: Permeability o f Plastic Cover Films. J. Environ. Qual. 27, 821-827

. 7 Factors Which Impact Soil Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Facto r Approach, June 9, 2008, DP Barcode: 30685 7

7 0soils 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%.
Soil Temperature
In the July 2008 RED, the Agency provided a 10% buffer zone credit for all chemigation, center pivot, and/or tractor drawn (i.e., shank injection, spray blade, and rotary tiller) application in soils with temperatures of 70°F or less whenmeasured at a soil depth of 3 inches for all chemigation, center pivot, spray blad e, and rotary tiller applications and at the injection depth for shank injection applications. The Agency’s analysis of available data indicated increased soil temperature corresponds to increased fumigant emissions rates. Gi ven that lower soil temperatures lead to lower fumigant emissi on rates, a credit was provided for application scenarios with lower soil temperatures. Because the emissions studies from which the buffer zones were developed for chemigation, center pivot , and tractor drawn app lications all occurred at high air and soil temperatures, with maximum air temperatures (MATs) between 90-106°F and/or maximum soil temperatures (MSTs) betw een 90-93°F (where reported), a credit was given. Because the emissions studies used to develop buffer distances for the remaining application methods (i.e., drip and flood irrigation) occurred at lower temperatures, with MATs between 70-73°F and a MSTs of 70°F (where re ported), an emission credit was not provided to reduce the buffers for these application methods.
During the post-RED comment period, the Agencyreviewed all of th e currently available data on the effects of soil temperature on fumigant emissions. Based on this analysis, the Agency is providing an additional soil temperat ure credits as described below.
Chemigation, Center Pivot, and/ or Tractor Drawn Application
The emissions studies used to currently develop buffer distances for metam sodium applications performed using chemigation, center pivot, and/or tractor drawn equipment occurred at high temperatures. The average day/night ai r temperature in these studies ranged from 80­ 90°F and the maximum soil temperatures range d from 90-93°F (where reported). A 10% emission credit is being provided to reduce the buffers for these types of applications in soils with temperatures ranging from 50-70°F when meas ured at a soil depth of 3 inches. In addition a 20% emission credit is being prov ided to reduce the buffers for these types of applications in soils with temperatures of 50°F or less wh en measured at a soil depth of 3 inches.
Drip and Flood Application
The emissions studies used to currently develop buffer distances for metam sodium applications performed using drip and flood irrigation equipment occurred at reasonable temperatures. The average day/night air temper ature in these studies was approximately 60°F and the maximum soil temperatures around 70°F (whe re reported). A 10% emission credit is

7 1being provided to reduce the buffers for these type s of applications in soils with temperatures of 50°F or less when measured at a soil depth of 3 inches.
Note: Stakeholders and the registrants have pr oposed a laboratory so il column study examining the effect of soil temperature and soil moisture on MITC emissions. This study may provide more information around the effect on MITC em issions and the emissions for metam-sodium and metam-potassium may be revisited if n ecessary after review of these data.
High-Barrier Tarps
In the July 2008 RED, a 10% buffer credit was given when one of the following highbarrier tarps is used: Bromost op® (1.38 mil), IPM Clear VIF ( 1.38 mil), Eval/Mitsui (1.38 mil), Hytiblock 7 Black (0.00125”), XL Black Blockade (0.00125”), or Hytibar (1.5 mil) for either a shank injection or drip metam-sodium and metam-potassium application. Because current study data do not demonstrate significan t reductions in MITC emissions using standard polyethelyne tarps, no credit was provided for “standard” tarped metam applications. The credit was based on a study (Papiernik 2004) that s hows significant reductions in MI TC emissions when using a Hytibar (a high-barrier) tarp when compared to a standard polyethylene ta rp in drip irrigation experiments in both sand mesocosm and field expe riments. Given that study data (Wang et al., 2006) have shown that MITC and chloropicrin pa ss through standard tarps at similar rates, the Agency decided to allow emissions credits for the Hytibar tarp as well as the other high-barrier tarps that were given an emissi ons reduction credit for chloropicr in applications. The Agency believed that the actual reduction for tarps could be higher for certain conditions but that a 10% credit was appropriate based on uncerta inties in the available data.
Since the July 2008 RED was published, the Agen cy has looked at all of the available tarp data, in total. There is very limited data currently available that examines the ability of highbarrier tarps to reduce MITC emissions. One literature study (Papiernik et. al., 2004) showed significant reductions in MITC emissions when using a Hytibar (a high-barrier) tarp when compared to a standard polyethylene tarp in drip irrigation experiment s. Also, another study (Wang et. al., 2006) showed that MITC and chlor opicrin pass through standard tarps at similar rates (same order of magnitude).
As a result, the Agency has decided to allow emissions credits for all high-barrier tarps that are being given an emissions reduction cred it for chloropicrin. The Agency has selected more conservative credits for MITC based on uncertainties in the available data.

• A 15% buffer credit is appropriate for the following high-barrier tarps: Canslit Heatstrip Silver and Canslit Metalized.

• A 30% buffer credit is appropr iate for the following high-barrier tarps: Olefinas Embossed VIF, Klerks VIF, Pliant Blockade, Bromostop® (1.38 mil), Eval/Mitsui TIF (1.38 mil), Hytiblock 7 Black (0.00125”), XL Black Blockade (0.00125”), Hytibar (1.5 mil), and IPM Clear VIF (1.38 mil).

7 2Credit Cap
The Agency determined, in the July 2008 RED, that the buffer zone credits were additive. This meant, for example, that a 10% cr edit for a high barrier tarp could be added to a 10 % credit for organic matter to ac hieve a total credit of 20%. The Agency placed a limit, or “credit cap,” of 40% on the total size of the credit allowed fo r metam. During the comment period, the Agency received new data concerning a number of factors that impact fumigant emissions as well as a number of comments indicating that there should not be a cap on credits or that the cap should be raised. Some suggestedthat the 40% cap woul d be a disincentive to growers considering whether to adopt emission-reducing application methods.
Upon review of the new data and public comme nts, the Agency has decided to raise the credits cap to 80%. The Agency has reviewed the new studies to evaluate the extent to which the various factors that reduce emissions act independ ently, and has reconsidered the earlier studies. As a result of this evaluation, the Agency conclu des that credits be additive up to a cap of 80% for all fumigants. This revised credit cap is based on studies that show a greater-than-40% reduction in emissions when two or more factors are combined. Further, EPA believes that increasing the credit cap to 80% will encourage a doption of emission reducti on techniques, result in lower off-site fumigant concentrations, and wi ll allow for reduced application rates for various tarps.
Credit Example
If an application block is 10 acres and the applicator is pl anning to make a shank tarped application of 320 lbs of metam per acre, the buffe r distance from the look up tables is 200 feet. If the applicator decides to us e the Hytibar (1.5 mil) high barrier tarp, then the buffer zone may be reduced by 30 percent. By calculating 30 perc ent of 200 feet (200 feet x 30% = 60 feet buffer credit) and then subtracting the original buffe r distance by the credit ( 200 feet – 60 feet = 140 feet) the final buffer distan ce required is 140 feet.

Other Buffer Zone Credits Considered

Other factors such as soil moisture cont ent, field preparation, water sealing, and application injection depth could not be quantified as to how e ffectively they reduce emissions and were not used to establish buffer credits at this time. However, EPA has established mandatory good agricultural practices (GAPs) for th ese conditions. If a dditional tarps or other emission factor data become available to showthe emissions from metam-sodium and metampotassium applications are decreased, the Agency will consider adding those to the metamsodium and metam-potassium label. More information on the type of data the Agency is looking for can be found in the Health Effects Division Recommendations for Fumigant Data Requirements (J. Dawson, C. Smith, dated June 2008).
EPA (through OPP’s Environmental Stewards hip Branch) has proposed to co-fund a grant with USDA-ARS for several flux studies in the southeastern U.S. These studies would

7 3provide (1) field data on the emission reducti on potential of certain low permeability barrier films to support possible, additional, buffer reducti on 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 describe possible resear ch and study designs to reduce uncertainties in understand ing emission factors in the contex t of different films and seals, agricultural practices, and environmental conditions. 8 These studies were completed in the spring of 2009 and data from these studies will be submitted to the Agency for review in the near future.

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 has 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 Oth er 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 take 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 Agencyhas retained this mitigation measure to ensure the protection goals are still achieved and encourage lo wer-emission application methods. The mitigation measures have been refined such that compliance is more effective in achieving the protection goal. Modifications to this requi rement include: shorteni ng the duration of the restriction so weekends may be used to fumigate near schools and day car es; clarifying the types of schools that are covered by this requirement; removing the term “elder care facilities” from the list since many of the same facilities are incl uded in the terms, “ assisted living facilities, nursing homes, and in-patient clinic s;” and reducing the restricted ar ea from 1/4 mile to 1/8 mile for application blocks with less than 300 foot buffers. The 1/8 m ile (660 feet) distance is more than twice the required buffer di stance 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 proximityto 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

8 Health Effects Division Recommendations for Fumigant Data Requirements. June 2008. DP Barcode 353724

7 4blocks 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.

• 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 recognized as an effective mean s of informing workers and bystanders about areas where certain hazards and restrictions exist. Current soil fumigantlabels require treated areas to be posted and handlers ar e required to wear spec ific PPE when they are 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 buffers 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 themeasier to understand and implement. Based on EPA’s review and consideration of these comm ents, EPA has slightlyrevised 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.

7 5In 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. Many 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 configuration 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.
Comments 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 contiguous 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 prevent s 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 approachare 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:

7 6o 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.
Exception: 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 signs may remain posted until 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 fo r fumigants) must state the following : -- Skull and crossbones symbo l

-- "DANGER/PELIGRO, " -- "Area under fumigation, DO NO T ENTER/NO ENTRE, "

-- "Metam-sodium [or metam-potassium ] Fumigant in USE, " -- the date and time of fumigation , -- the date and time entry prohibition is lifte d -- Name of this product, an d -- name, address, and telephone number of th e certified applicator in charge of the fumigation

. The buffer zone sign must include th e following : -- Do not walk sig n

-- "DO NOT ENTER/NO ENTRE, " -- "Metam-sodium [or metam-potassium ] [Name of product] Fumigant BUFFE R ZONE, ” -- contact information for the certifie d applicator in charge of the fumigatio n

7 7bb. Occupational Risk Mitigation for Soil Uses
The Agency has concerns for handlers invol ved in metam-sodium and metam-potassium applications for both dermal and inhalation e xposure. In many cases with maximum personal protective equipment (PPE), exposur e still exceeds the Agency’s le vel of concern for short-term and long-term exposures. Based on stake holder comments, there appears to be a misunderstanding as to what EPA considers to be handler activities.

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 WPS and on fumigant labels. During the post-RED comment period the Agency received some comments from stakehol ders who were concerne d that the Agency was redefining handlers . It was not the Agency’s intention to change the current definition. As a result, the Agency has slightly changed the langu age from July 2008 RED so it is clear that the Agency is just clarifying the ex isting definition and not writing a new one. Below is the revised language.
“The following activities are prohibited from being performed in the fumigant application block or surrounding buffer zone during the buffe r zone period by anyone other than persons who have been appropriately trained and e quipped as handlers in accordance with the requirements in the Worker Protection Standard (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 supervis ors, loaders, drivers, tractor co-pilots, shovelers, cross ditchers, or as other direct application participants (note: the application starts when the fumigant is first in troduced 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

7 8o 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.

o In addition, to the above, persons outside th e perimeter of the buffer zone who visually monitor application equipment to ensure proper functioning and m onitor fumigant air concentrations must also be trained and equipped as handlers in accordance with the requirements in the WPS (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 in fumigant handling tasks during the monito ring period, and (3) the certified applicator supervising metam-sodium and metam-potassium applications could perform all tasks without anyone supervising them.
The July 2008 Metam-Sodium and Metam-Po tassium RED included exceptions for the on-site applicator supervision requirements in cases when the certified applicator typically leaves the site during an application. Requirements in the RED label table specified that for overhead, flood, or furrow irrigation and chemigation applica tions, the certified app licator supervising the fumigant application must be on site at the start of applicatio n but may leave and return for periodic monitoring of the fumigation site as long as he/she monitors the site at least once every four hours if the site is 20 acres or less; once every three hours if the site is greater than 20 acres, but less than 80 acres; an d once every two hours if the site is 80 acres or more. The Agency believes that consistent monitoring of wate r-run applications (e.g., drip, overhead, flood, or furrow irrigation and chemigation) is needed to he lp reduce potential risks during an application.
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 whenhandlers 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.

7 9During the post-RED comment period the Agen cy received many comments that stressed the difficulty implementing a requirement that mandates certified applicators to maintain visual contact with handlers. The commenters also indicated that for longe r applications this requirement would be a huge burden. Other stakehol ders stated that the Ag ency 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 applicat ors, which would eliminate the need for direct handler supervision.
The Agency has considered the comments and has revised the certif ied applicator and WPS-trained handler requirements for different application methods. EPA believes that these revisions accomplish the same goal as the July2008 RED mitigation while reducing the burden

on users.

• For all applications, except water run, (e.g., shan k, rotary tiller, etc.) from the start of the application until the fumigant has stopped bein g delivered/dispensed into the soil, i.e., after the soil is sealed, the certified applicat or must be at the fumigation site and must directly supervise all persons pe rforming handling activities.

• For water-run applications (e.g., chemigati on, center pivot, lateral move, drip, overhead, flood, furrow irrigation, etc.), th e certified applicator must be at the fumigation site to start the application in cluding set-up, calibration, and initiation of the application. The certified applicator may leave the site but must return at least every two hours to visually inspect the equipment to ensure proper f unctioning and monitor the air around the buffer zone and must supervise all WPS-trained handlers on-site until the fumigation has stopped being delivered/dispersed into the so il. WPS-trained handl ers may perform the monitoring functions in place of the certified applicator but must be under the supervision of the certified applicator and able to comm unicate with the certifie d applicator at all times during monitoring activities via cell phone or other means. The results of monitoring activities must be captured in the FMP.

• For fumigant handling activities that take place after the fumigant has been delivered/dispensed into the soil until the entry restricted period expires, the certified applicator does not have to be on-site, but must have communicated in writing to the site owner/operator and handlers the information necessary to comply with the label and procedures described in the FMP (e.g., em ergency response plans and procedures).
The July 2008 RED also required that certifie d applicators supervising the application completed a metam-sodium and metam-potassiumregistrant training program within the preceding 12 months before they applied a metam-sodium and metam-potassium product. The Agency is still requiring certified applicators co mplete the registrant training; however, the Agency is now requiring the certified applicator s successfully complete the training every three years. Please see the Soil Fumigation Training for Applicators and Other Handlers section for further.

3. Dermal Protection for Handlers

8 0The Agency’s human health risk assessmen t for metam-sodium and metam-potassium identifies dermal risks for many handler tasks that exceed the Agency’s level of concern for short-term, and intermediate-term exposures to the parent metam-sodium and metam-potassium. To address these dermal risk concerns, in the July 2008 Metam-Sodium and Metam-Potassium RED, the Agency required handlers engaged invarious tasks (e.g., tr ansferring or loading liquids; operating motorized gr ound application equipment withopen cabs; and cleaning up spills) to wear dermal protect ion (e.g., double layer clothing, chem ical resistant footwear plus socks) to protect against dermal exposure.
During the post-RED comment period, th e Agency received a comment from the Northwest Horticultural Council indicating that the primary a pplication method for orchard replant using metam sodium in the Pacific Northw est, a row/strip treatment of metam sodium to a future tree row using a weed sprayer while irrigation sprinklers are running, was not specifically addressed in the Agency’s RED decision. Based on additional information provided by a representative for the Council in a 3/13/08 e- mail to the Agency (a copy of this e-mail has been posted to the metam sodium docket atEPA-HQ-OPP-2005-0125), EPA is including this application method, provided that handlers wear the following derm al PPE to protect them from both the product and sprinkler irrigation: long-s leeved shirt and long pants; a full waterproof, chemical-resistant suit; chemical-resistant gloves; chemical-resistant footwear plus socks; and protective eyewear. Generally, the Agency does not like to require the use of full waterproof, chemical-resistant suits for handlers, given concerns regarding heat stress for handlers, especially for handheld applications. However, based on the comments submitted by the Council indicating that this PPE is currently a st andard practice and these applications are likely occurring in a cooler weather climate, the Agency is requiring such PPE in this instance.
The majority of comments relating to derm al handler protection for metam-sodium and metam-potassium that the Agency received duri ng the post-RED comment period involved the need for additional clarification of key dermal handler mitigation and risk concerns. Specifically, clarification of the “b aseline work clothes” requirement was requested. The Agency has more clearly defined this term in the dermal requ irements section below to avoid any potential confusion.
Additionally, during th e post-RED comment period, the Ag ency received comments from various stakeholders indicating th at the Agency had not fully characterized the dermal risks from metam-sodium and metam-potassium, specificallyshort-term and intermediate-term non-cancer and cancer dermal risks in the July 2008 Metam- Sodium and Metam-Potassium RED. To address these concerns, the Agency is providing addi tional characterization of these risks below.
Metam-Sodium and Metam-Potassium Non-Cancer Occupational Dermal Risks: Short-Term and Intermediate-Term
The results of the non-cancer, short-term and intermediate-term handler dermal exposure assessments indicate that the MOEs for the derm al risk to handlers with both full PPE (i.e., gloves and double-layer clothing) and/or engineering controls (i .e., closed mixing and loading

8 1systems and use of enclosed cabs) are above th e Agency’s level of concern (LOC) (i.e., MOE < 100) for many of the agricultural scenarios. The estimated exposures and risks are summarized in Tables 1-4 in Appendix J of the th ird revision of the Agency’s huma n health risk assessment. To view, please see, “Metam Sodium: Third Revision of the HED Human Health Risk Assessment, DP# 293354 located in the metam sodium docket at: EPA-HQ-OPP-2005-0125.
For short-term hander exposure scenarios, the margins of exposure (MOEs) for handlers loading metam products at higher application rates fo r large acreage appli cations exceed the Agency’s level of concern even with the a ddition of maximum persona l protective equipment (PPE). This is also true fo r applicators who are applying metam products at higher application rates for large acreage applications. However, for many of th e short-term handler exposure scenarios, when loading metam products for mo re typical acreage applications at typical application rates, MOEs are below the Agency’s level of concern when additional PPE and/or engineering controls are incorpor ated. For applicators, when tr eating typical acreage at more typical application rates, MOEs are below the Ag ency’s level of concern with additional PPE or when using a closed cab thatprovides dermal protection.
For intermediate-term exposures, the MOEs fo r handlers for the dermal risk to handlers with both full PPE (e.g., gloves and double-layer clothing) and/or engi neering controls (e.g., closed mixing and loading systems) exceed the Agency’s LOC (i.e., MOE < 100) for the majority of the agricultural scenarios.
Short- and intermediate-term dermal expos ure MOEs for many handler scenarios are below an MOE of 100 with the required dermal protection and/or engineering controls. The occupational dermal risk assessments are based on data from the Pesticide Handler Exposure Database (PHED) and Outdoor Residential Expo sure Task Force (ORETF). PHED and ORETF were designed to be used to assess nonvolatile pesticides. In the case of metam-sodium and metam-potassium, these data were used because th ere are no chemical-specific data available to the Agency. Since metam-sodium and metam-pota ssium degrades quickly to MITC, the dermal short- and intermediate-term risk assessment for metam generated by the Agency using data from PHED and ORETF can be consid ered to be conservative.
For the intermediate-term dermal exposures, another source of conservatism comes from the assumption that workers are exposed throughout an 8-hour workday for a 1- 6 month period. However, the Agency believes that many handlers, particularly private applicators of metam sodium, typically apply metam-sodium and metam- potassium for much shorter periods of time. In a 2004 survey of growers and applicators that use metam sodium conducted by the Metam Sodium Alliance and reviewed by the Agency, av erage number of days per year that growers reported potential metam exposure was 15 days, while custom applicators had an average of 50 days per year.

To address the short- and intermediate-t erm dermal risks from metam-sodium and metam-potassium, consistent with the mitigation required in the July 2008 RED, the Agency is requiring handlers engaged in various tasks to wear dermal protection to protect against dermal

8 2exposure. Given the conservative nature of the non-cancer short- and intermediate-term dermal exposure assessment, coupled with the Agency ’s dermal PPE requirements and engineering control requirements, which are detailed below in the dermal requirements section, the Agency believes that these measures are protective of pos sible short-term and intermediate-term dermal risks for metam-sodium and metam-potassium.

Metam-Sodium and Metam-Potassium Cancer Occupational Risks: Dermal Exposures
The Agency’s metam-sodium and metam-pota ssium cancer occupational handler dermal exposure assessment indicates that cancer risks for both noncommercial and commercial handlers are above the Agency’s LOC (ranging from 1x10 -4 to 1x10 -6 ) for the majority of agricultural scenarios wi th maximum PPE in place. This assessment should be considered conservative for a number of reasons. (1) The as sessments were based on data from PHED and ORETF, which are generally meant to assess non-volatile pe sticides. Using this data to assess dermal exposure to metam sodium should be cons idered very conservative due to the volatile nature of metam sodium. (2) Closed systems are used to mix and load metam-sodium and metam-potassium, which will greatly reduce an y potential exposure to metam-sodium and metam-potassium itself. (3) Much of the equipm ent typically used to apply metam-sodium and metam-potassium also greatly reduces any pot ential exposure to metam-sodium and metampotassium itself. Tractor appl ications of metam sodium eith er immediately incorporate or directly inject metam sodium into the ground, an d handlers are typically not in the field during chemigation applications.
Dermal Requirements
The Agency is requiring the mitigation measures specified below to reduce dermal exposures for handlers. Where indi cated, “baseline work clothes” refers to long-sleeved shirt, long pants, and socks and shoes.

• Transferring Liquids

o To reduce risk to handlers who transf er liquids from any container into application equipment or delivery eq uipment, the following is required:

 Double-layer clothing (i.e., baseline work clothes and coveralls), chemical-resistant gloves, chemical-resistant apron, chemical-resistant footwear plus socks, and protective eyewear.

o To reduce risk to handlers who transf er liquids from any container into application equipment or delivery equipm ent using a closed-connect system that reduces leakage to less than 2 ml of liquid per disconnect, the following is required:

 Baseline work clothes, chemical resistant gloves, chemical resistant apron, protective eyewear, and a closed-connect system.

• Driving Ground Rigs:

8 3o To reduce risk to handlers driving ground rig with a closed cab that provides dermal protection, the fo llowing is required :

 Baseline work clothes

. o To reduce risk to handlers driving a ground rig that does not provide dermal protection, the followi ng is required:

 Double-layer clothing (i.e., baseline work clothes and coveralls) and chemical-resistant footwear plus socks.

• Set-up, Calibration, and Start Up of Chemigation Equipment:

o To reduce risk to handlers who set-up and calibrate chemigation and irrigation equipment and either start the application from inside the buffer zone or remotely start the application from outside the buffer zone, the following is required:

 Baseline work clothes.

• Row/Strip Treatment Application of Metam Sodium via Weed Sprayer while Irrigation Sprinklers are Running:

o To reduce risk to handlers who apply metam-sodium and metam-potassium via weed sprayer while irrigati on sprinklers are running fo r row/strip treatment for orchard replant, the fo llowing is required:

 Long-sleeved shirt and long pants; chemical-resistant gloves; a full waterproof, chemical-resistant suit an d chemical-resistant footwear plus socks; and protective eyewear.

• Early Entry or Monitoring PPE:

o To reduce risk to handlers (1) entering a treated area during the application or (2) entering the treated field up to 120 hours af ter the application has ended for any reason (including, but not limited to, e quipment repair, cleaning up spills, equipment monitoring, scouting), or (3) entering the buffer zone for up to 48 hours after the application, the following is required:

 Baseline work clothes. If the handler will to be exposed to liquid or liquid spray from the application equipment, they must wear chemical-resistant coveralls, chemical-resistant gloves, chemical- resistant apron, chemical resistant footwear plus so cks, and protective eyewear.

4. Respiratory Protection for Handlers
The Agency’s human health risk assessment fo r metam indicates that inhalation risks for many handler tasks exceed the Agency’s LOC for the acute exposure to the parent (metam) and MITC. In the 2008 Metam-Sodium and Metam-Po tassium RED, the Agency required handlers potentially exposed to MITC vapors from metam- sodium and metam-potassium applications to either wear at least a half-f ace respirator during the handling activity, or follow the monitoring program detailed below. In addition, the Ag ency required that for some handling tasks, respirators were required to be worn at all ti mes due to the short duration of the task and the potentially high concentration of MITC exposur e. The certified applic ator supervising the

8 4fumigant application must ensure that any handl er who enters the buffer zone (including tractor drivers, loaders, irrigators, tarp cutters, removers, etc.) is either wearing respiratory protection or is following the handler monitoring requirements, with respirators immediately available 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 metam-sodium and metam-potassium handlers if concentrations of MITC reach a certain level; however, EPA is revising the required procedures for determining when respirators must be used due to technologi cal limitations of current ly available monitoring devices that are appropriate for fi eld use. EPA believes that while colorimetric tubes are likely to be reliable at higher concentrations and whenused in more static conditions (e.g., a warehouse or laboratory), under the dynamic conditions charact eristic of outdoor field fumigation, currently available devices provide somewh at 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 oncommenters’ 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 notreliable 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. Inaddition, 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: Case St udies based on a Forest Seedling Nursery , dated May 13, 2009, located in the metam 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 incertain 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

8 5required to help enable handlers to determine if concentrations have decr eased and whether it is safe 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 that level was base d on the lowest detection limit of the currently available MITC monitoring tubes. Due to the reliability issue discussed above, instead, the Agency is using an action level of 600 ppb which corresponds to early signs of exposure and effects are non-severe a nd reversible at this level. The Agency believes that this level is effective as a warning for handlers of when concentrations are reaching the point where steps are needed to protect fumigant handlers from inhalation exposures.
Respiratory Requirements
The following procedures must be followed for all agricultural pre-plant soil applications of metam-sodium and metam-potassium. In addi tion to the respiratory protection requirements, the Agency believes that GAPs, FMPs, and ot her mitigation measures will reduce inhalation risks from MITC to levels belo w the EPA’s level of concern.

• If at any time any handler experiences sens ory irritation (tearing, burning 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 collected 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.

8 6• 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 600 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.

8 7Figure 3. P rovides an illustration of the requi rements 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.

8 8Figure 4. Provides an illustration of the requireme nts 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 b egins.

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

8 9Respiratory Protection Equipment
In the July 2008 RED, the Agency required handlers 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 necessary; 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 irritation 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 docum ent located in the metam-sodium and metampotassium docket: Methyl Bromide, 1,3-Dichloropropene , Chloropicrin, Dazomet, Metam Sodium/Potassium, MITC: Health Effects Divisi on (HED) Component of Agency Response To Comments On 2008 Reregistrati on Eligibility Documents (Dated May 14, 2009). The Agency would like to clarify issues re garding the respiratory protection cartridges and respirators. Comments suggested that the Agen cy require organic-vapor cartri dges. This was the Agency’s intention in the July 2008 RED. Others co mmented on the use of full-face respirators and goggles. The Agency is still recommending the us e of organic-vapor cartr idges 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

9 0details of this requirement, for example who conducts the fit-testing and medical exam and what the medical exam entails.
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 withthis 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 any handler that uses a respirator is:

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

• Trained using a program that confirms to OSHA’s requirements (see 29 CFR 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. It does not need to be repeated unless the health status or respirator use 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 handler 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 are 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

9 1sensitive 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 th ere is a risk concern for handlers during the perforation (cutting, poking, punching, or slicing) and removal of tarps, and notes potential for increased risk when high barrier tarps are us ed. To address 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 atleast 48 hours had passed since fumigation completion, 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 particular the Agency received comments on the adequacy of the 5 day requirement for high barr ier tarps to protect workers; the difficulty implementing the 24 hour wait peri od between tarp perforatio n and removal; and concerns regarding the weather condition exceptions, mechanical perforation, 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 Bromid e (PC Code 053201), Chloropicrin (PC Code 081501), Dazomet (PC Code 035602), Metam Sodium and Potassium (PC Codes 039003 & 039002), MITC (PC Code 068103), Updated HealthEffects Division Recommendations for Good Agricultural Practices and Associated Buffer Credits). While this reduction decreases the risk to bystanders, it could increase the risk to handlers perforating or removing tarps because more fumigant could be trapped between the soil surface and the tarp—currently California

9 2Department of Pesticide Regula tion (CDPR) prohibits the use of methyl bromide with certain high barrier 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 amount of days before high barrier tarps can be perforated.
During earlier comment periods EPA heard from various stake holders that windy conditions sometimes caused tarps to blow off fields and create other 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 minimum 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 cut they are prone to blowing off when windy conditions occur. To decrease th e potential of broad cast tarps blowing off commenters also suggested that the Agency add flexibility to the 24 hour requirement by giving tarp removers the option to remove tarps 2 hours after tarp perforation if monitoring 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 Handlers); 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 panel to offgas before the tarp is removed. If each pane l 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

9 3determined 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 respir atory section of this document; th erefore 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 handlers 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 and 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 sect ion 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 minimum 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 Broa dcast Applications Only and Early Tarp Perforation with Seepage Irrig ation sections below.

• If tarps will be removed afte r planting, tarp removal must not begin until at least 2 hours after tarp perforation is complete.

• If tarps will not be removed before planti ng, planting or transpla nting must not begin until at least 48 hours after the tarp perforation is complete.

• If tarps are left intact for a minimum of 14 days 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 followin g situations :

9 4o 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 early tarp removal in fields with seepage irrigation if rainfall necessitates draining fields

• 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 with Seepage Irrigation

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.

o Subsequent tarp perforations must not occur until the original 5 days have elapsed.

o The events must be documented in the post fumigation summary section of the FMP.”

o 6. Entry Prohibitions
Most of the current metam-sodium and metam-potassium labels allow reentry to the treated field by workers 48 hours after application. The risk a ssessment indicates that risks exceed EPA’s level of concern for workers enteri ng fields after 48 hours. However, the risk assessment indicates that extending this period d ecreases this risk. Inaddition, stakeholder comments prior to the July 2008 RED indicated that non-handler en try to perform postapplication (i.e., non-handler) tasks is generally not needed for at least 7 to 14 days following the completion of the application and could reduce the effectiveness of the fumigation by disturbing the soil thus allowing the fumigate to escape th e soil before it effectively controls pests.

Due to the volatile nature of metam-sodium and metam-potassium and the potential for worker exposure, in the July 2008 RED the Agencyrestricted entry into the treated area by

9 5anyone other than a protected handler. This restriction differs from a restricted entry interval (REI), that is currently required for most conven tional pesticides, which contains exceptions for workers doing certain tasks before the REI has expired (e.g., scouting). Workers permitted entry under the REI are prohibited for soil fumigants. Under the Worker 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 lim ited; however for fumigants wh ere inhalation exposure is the primary risk concern, entry to a tr eated area is further restricted.
During the post-RED comment period, the Agen cy received comments that indicated the opposite of the comments received in phase 5. The post-RED comments stressed that the restriction would prohibit certain activities from taking place and th at the restrictions were not warranted. Based on discussions with stakeholders and the risks identified, EPA does not believe that the entry restricted period will have a substantial impact on agricultural operations, and the Agency is not making any changes to the July 2008 RED mitigation listed below.

EPA believes that risks will not exceed the Agency’s level of concern, provided entry (including early entry that would otherwise be permitted under the WPS) by any person—other than a correctly trained and PPE-equipped handler who is performi ng a handling task—is prohibited from the start of the application until:

• 5 days (120 hours) after application has ended for unt arped applications, or

• After tarps are perforated and removed if tarp removal is complete d less than 14 days after application, or

• 48 hours after tarps are perforat ed if they will not be re moved prior to planting, or

• 5 days (120 hours) after applica tion is complete if tarps are not perforated and removed 14 days after the application is complete.
Figures 5, 6, 7, and 8 provide illustrations of tarp perforation/removal and entry prohibition mitigation required for various metam- sodium and metam-potassium applications. The intervals depicted are the minimum that must be followed.

9 6Figure 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

9 7Figure 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 Ends Tarp Removal Begins Application Begins

2 hours 48 hours 5 days (120 hours)

9 899 Figure 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)Figure 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 5 days (120 hours)

48 hours

14 days Tarp Perforation & Planting

10 0cc. Other Risk Mitigation

1. Restricted Use Pesticide (RUP) Classification
All soil fumigant products containing met hyl bromide, 1,3-dichloropropene (Telone ® ), iodomethane, and chloropicrin are currently cl assified as RUPs. Soil fumigant products containing metam-sodium and metam-potassium ar e currently unclassified as such. However, MITC, the byproduct of metam-sodium and metam- potassium, has characteristics that meet the criteria for restricted use for both human hazard criteria (as specified in 40 CFR 152.170(b)) and from other evidence (as specified in 40 CFR 152.170(d)) including us e history 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 metam-sodium and metam-potassium (mostly toxi city categories III and IV). While the product toxicity of metam-sodium and metam-potassium do not meet the hazard criteria for classification as re stricted use, the degradate produ ct of MITC, which both handlers and bystanders 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 cause significant adverse effects. There is a history of incidents involving metam-sodium in which mu ltiple bystanders experienced illness/injury despite being several hundred to several thousand feet from the tr eated area. The application of soil fumigants can pose hazards for several hours fr om the time of appli cation to several days after application. Depending on the situation, wo rker and/or area air monitoring may be required to ensure that exposure limits are not exceeded. Special equipment is often needed to apply soil fumigant safely and accurately (e.g., compacti on rig, tarp equipment, self-contained breathing apparatus). To apply soil fu migants safely and ensure bysta nders and applicators are not adversely affected, handlers also need specialized skills and training.
In sum, metam-sodium and metam-potassium meet the standard for restricted use because:

• The application of these fu migants involves complex opera tions 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 may result in discernibl e adverse effects, of both direct and indirect nature, on non-target organisms.
Therefore, the Agency has determined that all metam-sodium and metam-potassium soil fumigant products must be classified as restricted use. Label requirements will include the following details, which are also cont ained in the attached label table.

10 1Requirement 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.”

In order to ensure that a certified applicator is at the application site, the label will also state, “the certified applicator supervising the application must be atthe fumigant application site and able to maintain visual contact with every hand ler participating in the application starting when the fumigant is first introduced into the so il and ending after the fu migant has stopped being delivered/dispensed to the soil and the soil is sealed.”

2. Good Agricultural Practices (GAPs)
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 required for soil applications of metam-sodium and metampotassium. 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 Reviewand Reregistration Division’s response to comments document. Ba sed on the comments, the Agency has revised some of the GAPs, and will continue to review GAPs as the Agency finalizes the soil fumigant labels.

The GAPs outlined in the RED and this RED amendment has been shown to reduce emissions and bystander exposures and will continue to be mandatory label requirements. Buffer

10 2zone 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, removing 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 lengthof time that the soil would be exposed to potentially erosive weather conditions.
Note: The Agency plans to work with the regist rants and other stakeholders to refine the GAPa for metam-sodium and metam-potassium pr ior to the 2010 and 2011 growing season.

Weather Conditions
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 conditions” 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 occur.
Stakeholders also questioned where the i nversion conditions must exist and to what extent the temperature inversion must exist that would prevent anapplication. 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

10 32008 RED since they provide additional clarity that will enhance users’ ability to practically comply with the requirements. The revised statements are stated below.
The following are mandatory GAPs that must be followed during all applications, as specified below. All measurements and othe r documentation planned to ensure that the mandatory GAPs are achieved must be recorded inthe FMP and/or the po st application summary report.
Registrants may also include optional GAPs that reduce emission on product labels. Some of the optional GAPs may qualify for buffer zone credits (e.g., reduced soil temperature, use of high barrier tarps, increa sed soil organic matter, and soils with increased clay content). All measurements and other documentation planned to ensure that the optional GAPs are achieved must be recorded in the FMP and/ or the post application summary report.
GAPS for Ground-rig Applications (Sha nk, Spray Blade, Rotary Tiller, etc.)
Wind Speed

• Wind speed at the application site must be a minimum of 2 mph at the start of the application or forecasted to reach at leas t 5 mph during the application.

Weather conditions

• Prior 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.

• 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.
Identifying 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 and 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.
Soil Conditions, Injection Depth and Soil Sealing

10 4• Soil must be in good tilth and free of large cl ods at the surface. If subsurface soil compaction layers (hardpans) are present wi thin the intended fumigation treatment zone, a deep tillage to fracture these layers must occur prior to the soil fumigant application.

• Field residue and stubble must be worked into the soil with li ttle or no crop residue present on the soil surface. Crop residue that is present must not in terfere with the soil seal. Removing the crop residue prior to fu migation 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 so il quickly and escape into the atmosphere. This may create potentially harmful conditions for workers and bystanders and will limit the efficacy of the fumigant. However, crop residue on the field serves to prevent soil erosion from both wind and water and is an important consideration. To accommodate erosion control, fumigant efficacy, and human health protection, clear fields of crop residue 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.

• For shank injection applications: The inje ction point for bedded and broadcast shank injection applications shall be a minimum of 3 inches from the post-application soil surface. Chisel traces must be eliminated following an application and the soil surface must be compacted immediately with a cult i-packer, ring roller, coil packer, soilcrumbler basket, bed-shaper, or other similar equipment.

• For spray blade and rotary ti ller applications: Spray or dr ip the product mixture on the soil immediately ahead of the bed-shaping equi pment or tiller. The soil surface must be compacted immediately after application usin g a culti-packer, ring roller, soil-crumbler basket, bed-shaper, or other similar equipment.
Soil temperature

• For all ground-rig applications, the maximum soil temperature measured throughout the treatment area at a three-inch soil de pth must be between 90-40 degrees F.

Soil Moisture

• Soil moisture, at the start of an application, must be at 60-80% field capacity two to six inches below the soil surface.

• To achieve soil moisture at 60-80% field capac ity, water treatments before or during the application, or tillage before or dur ing the application may be necessary.

• To conserve soil moisture, pretreatment water or tillage should be done as close to the time of application as possible.

• The soil shall contain at the time of application enough moisture two to six inches below the surface to meet the Feel Method test as appropriate for the soil texture. .

10 5coarse textured soils (fine sand and loamy fine sand) there must be enough moisture (50 to 75 percent available soil water moisture) so the soil is moist, forms a weak ball with loose and clustered sand grains on fingers, darkened color, moderate water staining on fingers, will not ribbon.
moderately coarse textured soils (sandy loam and fine sandy loam) there must be enough moisture (50 to 75 percent available so il water moisture) so the soil is moist, forms a ball with defined finger marks, very light soil/water staining on fingers, darkened color will not stick.

medium textured soils ( sandy clay loam, loam, and silt loam) there must be enough moisture (50 to 75 percent available soil water moisture) so the soil is moist, forms a ball, very light staining on fingers, darkened colo r, pliable, and forms a weak ribbon between the thumb and forefinger.

fine textured soils (clay, clay loam, and siltyclay loam) there must be enough moisture (50 to 75 percent available soil water moisture) so the soil is moist, forms a smooth ball with defined finger marks, light soil/wat er staining on fingers, ribbons between thumb and forefinger.

For fields with more than one soil texture , soil moisture content in the lightest textured (most sandy) areas must comply with this soil mo isture requirement. Whenever possible, the field should be divided into areas of similar soil texture and the so il moisture of each area should be adjusted as needed. Coarser textured soil s can be fumigated under conditions of higher soil moisture than finer textured soil s; however, if the soil moisture is too high, fumigant movement will be retarded and effectiveness of the treatment will be reduced. Previous and/or local experience with the soil to be tr eated or the crop to be plante d can often serve as a guide to conditions that will be acceptable. If there is un certainty in determining the soil moisture content of the area to be treated, a loca l extension service or soil conservation service specialist or pest control advisor (agriculture consultant ) should be consulted for assistance.
Prevention of Spillage

• Do not apply or allow fumigant to drain onto the soil surface.
Application and Equipment Considerations

• Injectors must be placed below the so il surface before product flow begins.

• Clear lines before lifting injectors from the soil.

• Each injection line must have a check valve located as close as possible to the final injection point.

• Use only tanks, hoses and fittings approved for metam.

10 6• Dry connect fittings (closed transfer system) must be installed on all tanks and transfer hoses.

• All systems must be equipped with an indivi dual tank monitoring system to detect flow problems in each individual tank.

• Each nozzle must be equipped with a flow m onitor, e.g. mechanical, electronic, or Redball type monitor.

• Prior to applications, the applicator must ensure that:

• Application equipment is in good working order,

• All tanks, hoses, fittings, valves and c onnections are tighten ed, sealed and not leaking,

• Tank monitoring equipment, flow monito ring equipment and check valves are functioning properly,

• There is no damage to hoses or piping,

• Sight gauges and pressure gauges are working,

• Nozzles and metering devices are of corre ct size and are sealed and unobstructed,

• All shields are in place.

Tarps

• When tarps are used in tractor applications, the tarps must be installed immediately after application.

• Only approved tarps identified in this doc ument, in the section titled “Buffer Zone Reduction Credits”, may be used for credits towards reducing the buffer.

• A written tarp plan must be developed a nd included in the FMP that includes:

o Schedule and procedures for checking tarpaulins for damage, tears, and other problems,

o Plans for determining when and how repairs to tarp will be made, and by whom,

o Minimum time following injection that tarp will be repaired,

o Minimum size of damage that will be repaired,

o Other factors used to determine when tarp repair will be conducted,

o Schedule, equipment and methods used to cut tarp,

o Aeration plans and procedures following cutting and /or slitting prio r to tarp removal or planting, and

o Schedule, equipment, and procedures for tarp removal.
GAPS for Sprinkler and Chemigation Applications
Wind Speed

10 7• For mid-release, high-release and end-gun sp rinkler or chemigati on applications as defined by U.S. EPA, wind speed at the application site must be a minimum of 2 mph at the start of the application or forecasted to reach 5 mph during the application and the maximum wind speed is 8 mph.

• For low-release sprinkler or chemigation a pplications as defined by U.S. EPA, wind speed at the application site mu st be a minimum of 2 mph at th e start of the application or forecasted to reach 5 mph during the applicat ion and the maximum wind speed is 25 mph.
Wind Speed

• Wind speed at the application site must be a minimum of 2 mph at the start of the application or forecasted to reach at leas t 5 mph during the application.

Weather conditions

• Prior 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.

• 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.
Identifying 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 and 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.

Soil Conditions

• Soil must be in good tilth and free of large cl ods at the surface. If subsurface soil compaction layers (hardpans) are present wi thin the intended fumigation treatment zone, a deep tillage to fracture these layers must occur prior to the soil fumigant application.

• Field residue and stubble must be worked into the soil with li ttle or no crop residue present on the soil surface. Crop residue that is present must not in terfere with the soil seal. Removing the crop residue prior to fu migation is important to limit the natural

10 8“chimneys” that will occur in the soil when crop residue is present. These “chimneys” allow the soil fumigants to move through the so il quickly and escape into the atmosphere. This may create potentially harmful conditions for workers and bystanders and will limit the efficacy of the fumigant. However, crop residue on the field serves to prevent soil erosion from both wind and water and is an important consideration. To accommodate erosion control, fumigant efficacy, and human health protection, clear fields of crop residue 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.
Air Temperature

• The maximum air temperature is 90 degrees F.
Soil temperature

• The maximum soil temperature, measured at a three-inch soil depth, is 90 degrees F.

Soil Moisture

• Apply sufficient water before or during the app lication to ensure soil moisture at 60-80% field capacity at a minimum of two to six inch es below the soil surfac e at the start of the application.
Flushing Irrigation Lines

• Do not allow fumigant to remain in the irrigation system after the application is complete. After application of the fumigant , flush the injection and irrigation system with untreated water. The flush time must be adequate to purge the fumigant from the injection and irrigation system, but should be less than the amount that could oversaturate the beds. If common lines are used for both the fumi gant application and a water treatment/seal (if applied), these lines must be adequately flushed before starting the water treatment/seal.
Set-up, Repair and Maintenance of Equipment

• Anti-siphon and back-flow prevention devices mu st be installed and in working order.

• Storage tanks must be inspected, in good condi tion, and not past thei r life expectancy to ensure product does not spill or leak.

• Storage tanks must have proper pesticide labels on them.

• Install a shut-off valve on the tank outlet to secure the bulk storage tank when not in use.

- Use only tanks constructed with materials approved for handling metamsodium/metam-potassium.

- Inter-connect the pump power supply and injec tion pump so that, if the center pivo t or linear move stops, the in jection pump shuts off

.

10 9GAPs for Drip Application
Wind Speed

• Wind speed at the application site must be a minimum of 2 mph at the start of the application or forecasted to reach at leas t 5 mph during the application.

Weather conditions

• Prior 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.

• 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.
Identifying 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 and 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.

Soil Conditions

• Soil must be in good tilth and free of large cl ods at the surface. If subsurface soil compaction layers (hardpans) are present wi thin the intended fumigation treatment zone, a deep tillage to fracture these layers must occur prior to the soil fumigant application.

• Field residue and stubble must be worked into the soil with li ttle or no crop residue present on the soil surface. Crop residue that is present must not in terfere with the soil seal. Removing the crop residue prior to fu migation 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 so il quickly and escape into the atmosphere. This may create potentially harmful conditions for workers and bystanders and will limit the efficacy of the fumigant. However, crop residue on the field serves to prevent soil erosion from both wind and water and is an important consideration. To accommodate erosion control, fumigant efficacy, and human health protection, clear fields of crop

11 0residue 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.
Soil Temperature

• The maximum soil temperature is 90 degrees F, measured at three inches in depth.
Set-up, Repair and Maintenance of Equipment

• Properly label metam-sodium storage tanks.

• Install a shut-off valve to secure the bulk storage tank when not in use.

• Use only tanks constructed with materials approved for handling metam products.

• The drip irrigation system (main lines, headers, drip tape) must be thoroughly checked for leaks before the start of the application. An adequate run-time and pressure are needed to detect leaks. Look for puddling along major pipes (holes on pipe s or leaky joints), at the top and ends of rows (leaky connections, open drip tape), in the furrows and on the bed surface (damaged drip tape, malfunctioning emitters).

• To inject fumigant, use a metering system, effectively designed and constructed of materials that are compatible with the fumigant and capable of being fitted with system interlocking controls.

• The system must contain a functional back -flow/check valve and low-pressure drain appropriately located on the i rrigation pipeline to prevent water source contamination and backflow.

• The fumigant injection system must contai n a functional, automatic, quick-closing check valve to prevent the flow of fumigant back toward the fumigant container.

• The fumigant injection system must contain a functional, normally closed valve located on the intake side of the inje ction point and connected to th e system interlock to prevent fumigant from being withdrawn from the suppl y tank when the irrigation system is either automatically or manually shut down.

• The system must contain functional interlocki ng controls to automatically shut off the fumigant injection when the irrigation water flow stops or decreases to the point where fumigant distribution is adversely affected.

Tarps

• When tarps are used in drip irrigation th e tarps must be installed immediately after application.

11 1• Only tarps mentioned previously in this doc ument (in the subsection titled “Buffer Zone Reduction Credits”, may be used for credits towards reducing the buffer.

• A written tarp plan must be developed and included in the FMP that that includes:

o Schedule and procedures for checking tarpaulins for damage, tears, and other problems,

o Plans for determining when and how repairs to tarp will be made, and by whom,

o Minimum time following injection that tarp will be repaired,

o Minimum size of damage that will be repaired,

o Other factors used to determine when tarp repair will be conducted,

o Schedule, equipment and methods used to cut tarp,

o Aeration plans and procedures following cutting and /or slitting prio r to tarp removal or planting, and

o Schedule, equipment, and procedures for tarp removal.
Flushing Drip Irrigation Lines

• After application of the fumigant, flush the in jection and irrigation sy stem with untreated water. Do not allow fumigant to remain in the irrigation system after the application is complete. The total volume of water must be adequate to completely remove the fumigant from the irrigation system. If common lines are used for both the fumigant application and a water treatment/seal (if applied), these lines must be adequately flushed before starting the water treatment/seal.

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 Association 9 (i.e., through “Administrative” and “Workpl ace” controls). The Centers for Disease Control provides guidance for developing health and safety plans in agricultural settings. 10 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

9 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) 10 Karsky (2002) Developing a Safety and Health Program 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

11 2Flexibility 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. 11

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 withlabel 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 applicators complete a post fumi gation summary that described any deviations from the FMP, measurements take n to comply with GAPs, and information about any 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 r eceived several comments regarding FMPs. Stakeholders noted that much of the informati on required for the site-specific FMP is already being documented by users and most industry stakeholders supported mandatory FMPs provided they are not too restrictive or complex. Several comments from industry and user stakeholders expressed concern that FMP re quirements would increase pape rwork burden without providing

11 United States Department of Labor, Occupational Safety and Health Administration (2008) Lookback Reviews available at http://www.osha.gov/dea/lookback.html

11 3significant risk reduction, though others supporte d FMPs provided they did not result in an excessive administrative burden. A number of co mments suggested that the level of detail EPA had required was too great and could result in voluminous, resource-intens ive plans. Some of these comments suggested that a checklist fo rmat would be more efficient and far less burdensome. Some comments expressed reserva tions about the ability of FMPs to enhance compliance with label requirements. Some commen ters were concerned about the feasibility of providing a copy of the FMP to on-site handlers or enforcement personnel, though others said that copies of the FMP should be provided to wo rkers in areas 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/r eregistration/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 metam-sodium and metam-potassium.
The Agency estimates that, if a certified appl icator decides not to use the FMP template and decides to prepare a narrative FMP, a caref ully designed FMP could take several hours 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.
Amended 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 applicato r), 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

11 4was 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 inadjacent 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 labels.
Each site-specific FMP must contain the following elements:

 Applicator information (name, phone number , license number, employer name, employer address, date of completing registrant methyl bromide training program)  General site information 3⁄4 Application block location, address, or gl obal positioning system (GPS) coordinates 3⁄4 Name, address, and, phone number of ow ner/operator of the application block 3⁄4 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 (preschool to grade 12), state licensed day care centers, nursing homes, assisted living faciliti es, hospitals, in-patient clinic s and prisons) 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) 3⁄4 Brand name, lot number, thickness 3⁄4 Name and phone number of person responsible for repairing tarps 3⁄4 Schedule for checking tarps for dama ge, tears, and other problems 3⁄4 Maximum time following notificatio n of damage that the pers on(s) responsible for tarp repair will respond 3⁄4 Minimum time following application that tarp will be repaired 3⁄4 Minimum size of damage that will be repaired 3⁄4 Other factors used to determine when tarp repair will be conducted 3⁄4 Name and phone number of person responsible fo r cutting and/or removing tarps (if other than certified applicator) 3⁄4 Equipment/methods used to cut tarps 3⁄4 Schedule and target dates for cutting tarps 3⁄4 Schedule and target dates for removing tarps  Soil conditions (description of soil texture in application bl ock, method used to determine soil moisture

11 5 Weather conditions (summary of forecasted condi tions for the day of th e application and the 48-hour period following the fumigant application) 3⁄4 Wind speed 3⁄4 Inversion conditions (e.g., shallow, compre ssed (low-level) temperature inversion) 3⁄4 Air stagnation advisory  Buffer zones 3⁄4 Application method 3⁄4 Application rate from lookup table on label (lb ai/A) 3⁄4 Application block size from lookup table on label (acres) 3⁄4 Credits applied 3⁄4 Buffer zone distance 3⁄4 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, locations of telephones, contact information for first responders, local/state/federal contacts, key personnel and emergency procedures/responsibilities in case of an incident, equipment/tarp/seal failure, odor complaints or elevated air concentration le vels outside buffer zone suggesting potential problems, or other emergencies).  Posting procedures (name, address, and phone number of person(s) who will post signs, location of posting signs, procedur es for posting and sign removal)  Site-specific response and management (if applicable) 3⁄4 Fumigant site monitoring

 Description of who, when, where, and procedures for monitoring buffer zone perimeter 3⁄4 Response information for neighbor s

 List of residences, businesses, and neighboring property owners informe d

 Name, address, and phone number of person doing notificatio n

 Method of sharing informatio n  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). 3⁄4 Name and phone number of persons contacted 3⁄4 Date contacted  Authorized on-site personnel 3⁄4 Names, addresses and phone numbers of all handlers 3⁄4 Employer name, addresses, and phone numbers for all handlers 3⁄4 Tasks that each handler is auth orized and trained to perform 3⁄4 Date of PPE training for each handler 3⁄4 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.

11 6 Air monitoring 3⁄4 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 3⁄4 For handlers with respiratory protection :

 Representative handler tasks to be monitore d

 Monitoring equipment to be us ed and timing of monitorin g  Good Agricultural Practices (GAPs) 3⁄4 Description of applicable mandatory GAPs (re gistrants may also include optional GAPs) 3⁄4 Measurements and other documentation planned to ensure GAPs are achieved (e.g., measurement of soil and other site conditions, tarp repair/perforating/removal plans)  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/operator of the applicat ion block that he/she (as well as the certified applicator) must keep a si gned 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 have changed need to be updated in the site-specific FM P provided the following:

• 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 requestthe 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 deviations 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. The summary must include the actual date of the application, a pplication rate, and size of application block fumigated.

11 7Specifically, 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) 3⁄4 Location and size of tarp damage 3⁄4 Description of tarp/tarp s eal/tarp equipment failure 3⁄4 Date and time of tarp repair  Tarp removal details (if applicable) 3⁄4 Description of tarp removal (i f different than in the FMP) 3⁄4 Date tarps were cut 3⁄4 Date tarps were removed  Complaint details (if applicable) 3⁄4 Person filing complaint (e.g., on-site handler, person off-site) 3⁄4 If off-site person, name, address, and phone number of person filing complaint 3⁄4 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) 3⁄4 Location of elevated air concentration levels 3⁄4 Description of control measures or emergency procedures followed 3⁄4 Air monitoring results

 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 commercially available software with certain

11 8elements listed above in check-lis t and/or fill in the blank fo rmat. Below are examples of other FMP templates available on the internet for structural fumigations that may be useful to users when developing FMPs fo r metam-sodium and metam-potassium soil applications:

• http://www.cardinalproproducts .com/Misc/FMP%20Version%203.pdf

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

• http://www.agr.state.ne.us/divi sion/bpi/pes/fum igation_plan.pdf

• http://www.agr.state.ne.us/divi sion/bpi/pes/fum igation_plan2.pdf

• http://nmdaweb.nmsu.edu/pesticides/Management%20Plans%20R equired%20for%20Fu migations.html
The Agency has provided a template locat ed 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.
Although 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 inthe 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 programs 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 and 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

11 9appropriately. 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 bromide applications to be an extension of the buffer zone. In areas where a large number of people would need to be notified about a planned methyl bromide application, 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/atcp029.pdf ). The requirements in Florida do not apply to agricultural chemical applications. Wisconsin also requires fumigators applying metamsodium and metam-potassium products through ch emigation to provide written notice to the

12 0county public health agency and to every indi vidual or household within 1⁄4 miles of the chemigation application site (see http://www.legis.state.wi.us/rsb/code/atcp/atcp030.pdf ). EPA agrees that information about how to recognize and address expos ures 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
To 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 requirement is not dependent on people actual ly being present in th e nearby buildings and homes. In this respect it differs from the quart er/eighth mile buffer zone restriction on certain types of occupied structures. Rather, this measure is intended to ensure protection in places people may be found present. Whether measures are required depends on the size of the buffer zone and how close land (e.g., resi dential properties and businesses) 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 RED ., 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 treated 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) determine the applicable distance 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 po ssible the EPA has included an exception for

12 1application blocks so fields with the smallest re quired buffers (25 feet) would not be subject to this requirement, since they are most likely usin g lower application rate s, applying to smaller areas, and/or using better app lication methods. Based on changes 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 colorimetr ic tubes were of concern. Stakeholders felt the inherent warning properties of chloropicrin and MITC (i .e., eye irritation) were better indicators of exposure than available devices. Se veral of these comments noted concerns with the reliability of such devices at low concentratio ns. Additionally, several stakeholders indicated that monitoring is most appropriate and effectiv e at dawn and dusk, the times of day when offsite movement of concentrations is most lik ely. Based on these comments, the Agency has revised the requirement so monitoring is requ ired during those periods when risk of high concentrations 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 reliable 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.
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. However, 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 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. In the interim, buffer monitoring for chloropicrin and the MITC genera ting chemicals will rely on sensory indicators (e.g., eye and/or nose irritation) to trigger a response instead of using tubes. Monitoring tubes are still required for measuri ng products that contain more than 80 % methyl bromide.
Finally some comments provided suggestions on how to increase fl exibility in how a grower may comply with these measures as well as the effectiveness of the option to provide

12 2information to neighbors. EPA agrees with the importance of users 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 pr ovide 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
When 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

Theneither 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 day 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 once during the night and during the day, to ensure concentrations do not exceed the action level which will be specified on product labels.
Specific requirements include:

12 3• 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.

• 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 1 week prior to the fumigant appli cation in a specified field. If after 4 weeks, the fumigation has not yet taken place, the in formation 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:

12 4• 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 (they must monitor where the black dot is) and the buffer zone or reside nts of the dotted house(?) [people within 100 feet of the buffer zone] must be provided emergency response information.

• So the dotted houses would need to be informed, butthe location of the cross-hatched house would not prompt any action.
Figure 9. Example Site Map for Informing Neighbors.

Treated 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 compliance. However, the Agency also received comments from states that were concerned about the notification requirement largely due to resource constraints. Some states also indicate d that they are already well-informed about when

12 5and 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, fumigators could enter application information into a registrant-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 withinformation 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:

o Applicator and property owner/operator contact information (name, telephone number, and applicator license number)

o Location of the appl ication block(s)

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

o Time period in which fumigation may occur
For states already requiring such inform ation through an existing state process, applicators will not be required to comply with this requirement. For example, the California Department of Pesticide Regulation already obtain s this information as part of their permitting process for fumigant applications.
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 fumigant applications, modification of their cooperative agreements must include the methods these agencies will use to survey fumigation application periods and locations.

6. Training for Applicators and Traini ng Information for Other Handlers

12 6Soil 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 resultof misapplications, failure to follow label requirements and other safety precautions, and other er rors on the part of fumigant applicators. Although states have certification programs, so me of which include a specific category or subcategory for soil fumigation, there currently is not a consistent standard across states and regions where soil fumigation is done. Additiona lly, the federal certification 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 to establish a national baseline for safe fumigant use, developed and implemented by registrants, will help enhance fumigators’ ability to adequate ly manage the complexities of soil fumigation and failure to comply 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 and 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 certification 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 fromthe state certification process and will be developed and administered byregistrants. Individual state regulatory

12 7agencies 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.
As 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 available 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 byregistrants in coordination with EPA. EPA will, however, work with state organizations and 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 metam 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. This training would be requi red as a condition of use by product labeling. During the public comment period on the proposed mitigation measures and the post-RED

12 8comment period, stakeholders were broadly 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 representatives and pesticide applicator trai ning organizations, such as the Association of American Pesticid e Control Operators, Association of American Pesticide Safety Educators, and Certification & Training A ssessment Group, expressi ng concern over EPA’s decision to implement the training via labeling an d raising questions over compliance and state enforcement of such a requirement and the pot ential for conflict or redundancy with state certification and training programs. Various stakeholders recommende d that, rather than a labelmandated training requirement, the Agency, instea d, should require regist rants to develop and implement training for soil fumigant app licators as a conditio n 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, above and beyond that available currently, wi ll be needed. The states thatcurrently have certification programs that include soil fumigation categories will not have requirements pertaining to the new mitigation and their program s will need to be modified. EPA agrees that making the required training programs a condition of registration is an important means of ensuring that such training is ultimately develope d and implemented. However, it would not ensure that all individuals in charge of soil fumi gant applications avail themselves of the training. The Agency believes that making successful completion of the training a condition of use is also important to achieve this goal. Therefore, EPA has decided that development and delivery of training will be a required in the DCI that accompanies this amended RED and successful 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 best practices for soil fumigants. Registrants will be required to submit proposals for these programs as data requirements that will accompany this RED. EPA will review each program and dete rmine whether it adequately addresses the requirements specified in the DCI. The proposal must address, among other elements, both the content and the format for deli vering training. The Agency ac knowledges the value of hands-on training in the field, 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 evaluation of the registrant traini ng 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 adding a seventh training element—training progr ams must also include information on how to

12 9develop 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, th is 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 isclarifying that applicator training requirements are active ingredient-specific rather than productspecific. That is, applicators w ho apply more than one of the soil fumigant active ingredients (i.e., methyl bromide, chloropicrin, metam-s odium, metam-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 jointly 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 approach, it will be the registrants’ choice as to how they will comply with the requirement to develop and implement training programs.
Training Materials for Handlers

13 0EPA 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 Agencyis 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 mitig ate 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 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 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 fumigant safe handling information to each handler involved in the application in a manner thatthey can understand pr ior to performing any fumigant handling task or confirm that each handle r participating in the a pplication has received fumigant safe handling 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 Program
EPA 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

13 1and 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 and 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 community 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 registrants 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 mitigation 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 community, 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 below 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 community outreach programs required by the RED.

13 2In the absence of acceptable alternative proposals, registrants, will be required to provide information to the 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 fumigant use. For the purposes of the RED addendum, high-use areas are considered atthe county level. To identify these areas, the Agency is proposing the process for identifying high-use areas 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 thatfirst 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., me tam-sodium and metam-potassium) as well as the active compound generated (e.g., MITC). Few details on how the educ ation programs would be implemented were provided in the RED. Rather, during the post-RED comment period, the Agency sought feedback from the registrants an d other stakeholders on how best to design and target programs to first responders in high-use areas. The Agency encouraged the registrants to work with state and local emerge ncy response coordinators to id entify needs and opportunities to supplement any information already included in stat e and local training for first responders 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

13 3responder 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 metam-sodium or metam-potassium fumigant exposure, (2) how to treat metam-sodium or me tam-potassium fumigant exposures, and (3) how (“x” chemical) fumigant exposures differ from othe r pesticide exposures as well as (4) copies of material safety data sheet(s) for the fumigant applied as well as for the active compound generated, if applicable. Training materials can take a number of forms, including: brochures, fact sheets, CDs, videos, web- based training materials, etc ., as long as these materials incorporate, at a minimum, the inform ation requirements identified above.
The Agency is requiring registrants to targettheir 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).
Process for Identifying High-Use Fumigant Areas:
Identifying high-use areas for metam-sodium and metam-potassium is a two-step process because reliable fumigant use data is not availa ble at the county level from either publicly available data sources or EPA pr oprietary data sources. First, th e states with high use of metamsodium and metam-potassium have been identif ied by the Agency using EPA proprietary data. [Although state-level data are avai lable from USDA’s National Agri cultural Statistics Service (NASS), EPA proprietary data are more r obust.] Second, the high-use counties for metamsodium and metam-potassium within those states must be identified. The second step, identifying high-use counties, will be the registrant’s resp onsibility, using the process defined below.

13 4• Step 1: Identifying States with High Use of Metam-Soidum and Metam-Potassium : The Agency is defining states with high usage of metam-sodium and metam-potassium as those states where, on average, more th an 100,000 lbs of metam-sodium and metampotassium are applied annually. To determine th ose states where, on average, more than 100,000 lbs of metam-sodium and metam-pota ssium has been applied annually, the Agency obtained data on the average numb er of pounds of metam-sodium and metampotassium applied in all states across a ten–year period (1999-2008) using EPA proprietary data. To view the Agency’s analys is of this data, pleas e see the Biological and Economic Analysis 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 metam-sodium and metam-potassi um docket at EPA-HQ-OPP-2005-0128.

• Step 2: Identifying Counties with High Use of Metam-Sodium and Metam-Potassium: 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 metam-sodium and metam-potassium may be high. Because county-level fumigant usag e data is not publicly available and EPA proprietary data are not reliab le, crop acreage should be used as a surrogate indicator for fumigant usage. Crop acreage can be obtaine d for major use sites of metam-sodium and metam-potassium from the publicly available 2007 USDA Census of Agriculture. Crop acreages for each of the major use sites for metam-sodium and metam-potassium should be obtained for each the major use sites fo r metam-sodium and metam-potassium and then summed by county. All counties making up at least the top 90% of acreage in a state are considered high-use areas. Registrants wi ll be required to target each of these highuse counties for community outreach programs.
For the purposes of this analysis, the Agency defines a “major use site” as any crop that has more than 5% crop treated annually or more than 1,000,000 lb of metam-sodium and metam-potassium applied annually.
Example Identifying High-Use Fumigant Areas for Metam Sodium and Metam-Potassium in California:
To help explain the process for identifyi ng high-use fumigant areas for metam-sodium and metam-potassium the Agency is providing th e following example, which identifies the highuse counties for the soil fumiga nt, metam-sodium and metam-pota ssium, usage in California.

• Step 1: Identify States with High Use of M etam-Sodium and Metam-Potassium :
o Based on its analysis of pr oprietary data, the Agency has identified the following high-use states for metam: California, Washington, Idaho, Oregon, Wisconsin, Michigan, Florida, Minnesota, North Carolina, Virginia, Arizona, Nevada, Georgia, Colorado, and North Dakota. This example will focus only on identifying the counties in California with high use of metam. The same process would be applied to other high-use states.

• Step 2: Identify the Counties in Californi a with High Use of Metam-Sodium and MetamPotassium:

13 5o EPA has identified the following as the major use sites of metam-soidum and metam-potassium: artichokes, cabbage, can taloupes, carrots, onions, peanuts, peppers, potatoes, spinach, squash, tomatoes, and watermelons.

o Using the 2007 USDA Census of Agriculture, registrants wi ll need to obtain harvested crop acreage data for each of the 12 major use sites for metam 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 which is located in the metam-sodium and metam-potassium docket at EPA-HQ-OPP-2005-0125.

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” date d May 14, 2009 which is located in the metam-sodium and metam-potassi um docket at EP A-HQ-OPP-2005-0125.]
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.

8. Ambient Air Monitoring Program
In the July 2008 Metam-Sodium and Metam- Potassium RED, the Agency required the registrants to develop an air monitoring program in high-use areas to ev aluate whether ambient air concentrations exceed EPA’s le vel of concern and help the Agency to determine whether the RED mitigation measures are adequately protecti ve of bystanders and decide whether additional risk management measures are warranted.
During the post-RED comment period, the Ag ency received 2008 ambient air monitoring data for MITC in Southern Fr anklin County, Washington, from th e Washington State University (WSU) Food and Environmental Quality Lab (F EQL) [“2008 MITC Residential Community Air Assessment: Franklin County, Washington” (LePage and Goss 2008); MRID 47732802]. Agency analysis of ambient ai r data collected by WSU-FEQL in Southern Franklin County, Washington in 2005, 2007, and 2008 show exceedances of the Agency’s level of concern for MITC (MOE < 10) at two monitoring stations in the fall of 2008. Agency analysis of ambient air data for MITC in California from 1997-2001 de veloped by the California Air Resources Board (CARB) identified exceedances of the Agency’s s hort- and intermediate-term levels of concern (MOE < 30) at three sample locations (indoor and outdoor) in Bakersfield, California, in the summer of 1997. In addition, the Agency is awar e of a number of on-going ambient monitoring efforts going on in certain parts of the country including California and th e Pacific Northwest. (For additional information on the Agency’s analysis of both the WSU-FEQL and CARB ambient air monitoring data, please see “Metam Sodium: Third Revision of the HED Human

13 6Health Risk Assessment, DP# 293354 located in the metam–sodium and metam-potassium docket at: EPA-HQ-OPP-2005-0125.) The Agency is also concerned about chronic exposures and is seeking additional toxicity data on the long-term effects from inhalation exposure to MITC. However, none of the available ambient air studies conducted so far adequately reflects potential long-term concentrations of MITC.
As part of the RED, the Agency is implementing a number of mitigation measures designed to reduce air concentra tions of MITC. To help the Agency to determine if these mitigation measures are adequately protective of bystanders and to decide whether additional risk management measures are warranted, the Agen cy is requiring registrants to conduct ambient air monitoring programs in six counties in the United States with the highest usage of metamsodium and metam-potassium, as identified in EPA’s analysis to identify high-use areas for implementing their community outreach and first responder training programs (see the Community Outreach Program and First Responder Education sections for deta ils). Registrants are required to develop air monitoring programs that will enable the Agency to evaluate both: (1) potential maximum peak air concentrations in areas of high seasona l use and (2) potential community-level chronic air concentrations in areas of high metam-sodium and metampotassium use. The air monitoring should be gin in 2010 and continue thru the 2011 and 2012 application seasons. This data will allow the Agency to evaluate whether the package of mitigation measures, including buffer zones, have effectively reduced ambient air concentrations and will be included in the reevaluation for metam-sodium and metam-potassium in registration review. EPA encourages the registrants to work with existing air monitori ng programs such as in CA and WA or the registrants may develop their own program. The registrant’s proposal for developing and implementing an air monitoring progr am will be required as a data requirement in the data call-in. Proposal s should identify the six high use counties where ambient air monitoring will take place. EP A will review these proposals to determine whether they adequately address the requireme nts specified in the DCI.
Environmental Risk Management
In the July 2008 RED, EPA addressed the c oncerns about both aqua tic and terrestrial risks which are discussed in Section III.C. Th e July 2008 RED also stated that EPA believed that mitigation measures detailed in the Human Health Risk Mitigation Section would also reduce ecological risks. The Agency stated that although buffer zones and GAPs do not directly reduce the potential risk to ecological organi sms, these mitigation measures do provide an incentive to reduce fumigant application rates and individual treatment areas which in turn will contribute to lower exposure and ri sks for non-target organisms.
The July 2008 RED discussed exposure to te rrestrial organisms, such as birds and mammals, which could occur via inhalation of MITC. Potential exposure to aquatic invertebrates and fish may occur from surface runoff/leaching and drift (wind) of MITC.
A species-specific analysis for the Califor nia Red-Legged Frog case has been conducted for metam-sodium and metam-potassium and it major degradate, MITC. The Agency determined that MITC “May-Affect“ this species. The Agency’s assessment is currently with the Services (i.e., the U.S. Fish and Wildlife Se rvice and the National Mari ne Fisheries Service).

13 7After the final determination has been made, the Agency may require other mitigation.
The July 2008 RED also discussed uncertainty as sociated with potential risk to non-target plants, given that there are no data available. Additional plant toxicity data for MITC is being required.
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 metam-sodium and metam-potassium’s most important route of dissipation, EPA required the following language in the July 2008 RED taking these factors into consideration: “While metam-sodium, metam-postass ium, and their major degradate MITC have certain properties and characterist ics in common with chemicals that have been detected in groundwater (MITC is highly solubl e in water and has low adsorption to soil), volatilization is this chemical'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 pack age. The new language will state, “Metamsodium, metam-potassium and their major de gradate MITC have certain properties and characteristics in common with chemicals that have been detected in groundwater (MITC is highly soluble in water and ha s low adsorption to soil).”
The July 2008 RED also included language required for both tarped and non-tarped metam-sodium and metam-potassium applications to minimize potential for leaching. During the post-RED comment period commenters stated th at the following language was not clear or enforceable: “For untarped applications of metam-sodium and metam-potassium, potential leaching into groundwater and runoff into surface water can be reduced by avoiding 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 12

.
Please see section V of this document for the revised ground water label statements.

b. Sewer Root Control Use

12 Zhang, Y. and Wang, D .2007. Emission, di stribution, and leac hing of methyl isothiocyanate and chloropicrin under different surface containments. Chemosphere, 2007 Jun; 68(3): 445-454.

13 8During the post-RED comment period, the Agency received additional usage and occupational exposure information from the two metam-sodium sewer use registrants, Sewer Sciences, Inc. and Douglas Pr oducts and Packaging Company, which allowed the Agency to refine the metam-sodium non-cancer (i.e., short- term and intermediate-term) and cancer sewer use risk estimates. (To view the revised metam- sodium human health risk assessment, which incorporates the revised sewer use risk estimates, please see: Metam Sodium: Third Revision of the HED Human Health Risk Assessment, 04/ 30/09, D357118 in the metam-sodium docket at EPA-HQ-OPP-2005-0125.) The comments specifically focused on the i nputs of application rate, the amount of product handled per day, the amount of time applicators may be exposed during a work day, and the typical number of days per year that metam-sodium is used. A short summary of the information provided and an explanation of how it was used by the Agency in revising it risk assessment is summarized below.

• Application Rate : The Agency revised the application rate used in the 2008 RED calculations (0.212 lb ai/A) based on typical application rate data submitted by Douglas Products and Packaging (0.111 lb ai/A) for Sanafoam Vaporooter II (EPA Registration No. 1015-70) and the application rate information listed on Sewer Science Inc.’s product, Rout, label (EPA Registration No. 64898-4) (0.127 lb ai/A). Both application rates were considered in the revised hu man health risk assessment.

• Amount of Metam-Sodium Handled Daily : Sewer Sciences Inc. reported that their applicators treat between 4,500 and a maxi mum of 10,000 feet of sewer pipe (8” diameter) in a day, which corresponds to between 600 and 1,333 gallons of metamsodium handled per day. Douglas Products and Packaging reported th at their applicators treat between 2000 and 4000 linear feet of sewer pipe (8” diameter) daily, which corresponds to between 250 and 500 gallons of metam-sodium handled per day. The Agency utilized both exposure estimates in its revised human health risk assessment.

• Exposure – Number of Days Wo rkers Treat Sewers Each Year : Based on an analysis of its sales data, Douglas Products reported thatworkers apply metam-sodium to sewers a maximum of 160 days per year. Sewer Scien ces reports that app licators apply their products approximately 220 days per year. Bothexposure scenarios were considered in the revised human health risk assessment.

• Exposure – Number of Hours Expos ed to Metam-Sodium Each Day : Sewer Sciences Inc. has reported that commercial applicators work with metam-sodium 8 hours each day and, therefore, metam-sodium worker exposures should be estimated at 8 hours daily. The comments submitted by Douglas Products and Pa ckaging reported that the time per day that metam-sodium exposure can occur is limited to the amount of time actually spent loading the chemical and the time when the applicator hose is removed from the sewer manhole. Most of the application time cons ists of the hose being unrolled into the manhole cover and then rolled out of the manhol e cover. Therefore, there is no potential for exposure to metam-sodium during most of the application time. Based on the usage and exposure information submitted by Douglas Products and Packaging, the Agency believes that it is appropriat e to assume two hours of exposure to metam-sodium in its cancer assessments, since the duration of exposure to metam-sodium is limited.
During the public comment period, the Agency also received information from Douglas Products indicating that closed engineering systems are empl oyed for all mixing and loading

13 9activities. As a result, EPA is requiring closedmixing loading systems for all metam-sodium sewer use applications to lim it exposures to handlers.
In a February 2009 letter received from a repr esentative on behalf of the registrant, Sewer Sciences Inc., the company provided data identifyi ng the sewer use of metam-sodium as a source of N-nitrosodiumethylamine (NDMA) in wastewat er and asked the Agency to consider this information in its assessment of the use of metam-sodium in sewers. In the Agency’s “Revised Environmental Fate and Ecologi cal Effects Risk Assessment for Metam-sodium and Metampotassium” (PC Codes 039003 and 039002; DP Barcode D293339) (see the metam-sodium docket at: EPA-HQ-OPP-2004-0159-0118), the Agency acknowledged NDMA, for which there is a National Recommended Water Quality Criteria of 0.00069 μ g/L (current/potential drinking water) and 3.0 μ g/L (no potential for drinking water), as a reported contaminant in metamsodium sewer use products. To further evaluate metam-sodium sewer use as a potential source for NDMA in wastewater, the Agency will require the registrants, in response to the productspecific data call-in (pDCI) that will accompany this RED addendum, to report to the Agency any concentration of NDMA intheir product(s), pursuant to FIFRA Section 158.350(a)(4).
Based on comments received during the pos t-RED comment period the Agency is providing additional characterization or the dermal risks from metam-sodium and the inhalation risks from both metam-sodium and MITC. Additionally, comments received from Sewer Sciences, Inc. identified errors that had been made in July 2008 RED which included noncommercial handler cancer risks, representing five days of exposure, rather than the commercial handler cancer risks, which were represented by 220 days of exposure and presenting cancer risk from dermal exposures to metam-sodium when an OV respirator is worn. In their comments, Sewer Sciences Inc. correctly noted that if the cancer risks are derived from dermal exposure, a respirator would not be aneffective means of mitigating these risks.

Rationale
Metam Sodium Non-Cancer Occupational Risk Concerns – Acute & Short-term Inhalation Risks from MITC Exposure
Because metam-sodium degrades rather quickly to MITC, short-term, intermediate-term, and chronic inhalation exposures to metam-sodium by workers are expected to be negligible when compared with MITC exposures. To asse ss acute and short-term inhalation risks to applicators, EPA utilized two studies, conducte d in Australia, which measured MITC air concentration levels during app lication of a metam-sodium produc t to sewers. These studies represent the best available acute- and short- term MITC inhalation exposure data. Table 12 below summarizes the acute and short-term MO E estimates for MITC inhalation exposure to handlers based on exposure levels from these studie s. Estimates represent baseline conditions as well as the use of dermal or respir atory protection, as indicated.

Table 12. Handler MOEs for MITC Inhalation Exposure from Sewer Use Application of Metam-Sodium Study Sample MITC Conc. (ppm) Baseline MOEs PF 10 Respirator MOEs Acute ST Acute ST

14 0MOE 1 MOE 2 MOE 1 MOE 2 Sheers R (1994) Melbourne Water - Sanafoam Vaporooter Trial, 7

November 1994 Operator breathing zone exposure 0.27 1 1 10 10 At point of application 22 <1 na 9-10 na Two manholes downstream (approx. 300 m) 0.017 36 na 360 na At point of application - 24 hours post-application 0.023 26 na 260 na Sheers R (1995) Melbourne Water - Sanafoam Vaporooter Trial,

13-14 February 1995, ICI Australia

Operations Pty Ltd. Operator breathing zone exposure < 0.017 13 10 130 100 Operator breathing zone exposure < 0.027 8 7 80 70 Operator breathing zone exposure 0.057 4 3 40 30 At point of application - 30 mins post application 2.6 <1 na3 9-10 na 3 At point of application - 90 mins post application 1.3 <1 na3 9-10 na 3 At point of application - 180 mins post application 6.8 <1 na3 9-10 na 3 At point of application - 270 mins post application 4.4 <1 na3 9-10 na 3 At point of application - 360 mins post application 0.87 1 na 3 10 na 3 At point of application - 24 hours post-application < 0.010 60 na3 600 na 3

1 Acute MOEs for breathing zones samples based on NOAEL of 0.22 ppm. For other samples (less than 15 minutes ) acute MOEs based on 0.60 ppm. Acute target MOE = 10

. 2 MOEs were not estimated for static measure measurements. Short-term target MOE = 30

. 3 na = not availabl e These estimates indicate that for samples take n in the breathing zone of the applicator, the target MITC concentrations ranged from 0.27 ppm to < 0.017 ppm, with acute MOEs ranging from 1 to 13 and short-term MOEs ranging from 1 to 10. While these MOEs are below both the target MOE of 10 for acute inhalation exposures to MITC and the targ et MOE of 30 for shortterm exposures to MITC, as noted previously, th ese estimates do not take into account the use of respiratory protection. Samples taken at the point of application (i.e., directly over a manhole where a metam-sodium application had taken place, both immediately after an application and at regular intervals in time after an application ha d taken place), were largely below an MOE of 1. To address the short- and intermediate-term MITC inhalation risks from MITC, in the July 2008 metam-sodium metam-potassium RED, the Agency required that any person(s) engaged in any activities that are likely to invol ve direct contact with metam- sodium (including, but not limited to, mixing, loading, and/or applying metam-sodium ; equipment calibration; cleaning and repair of application equipment; ente ring into treated areas; samp ling cleanup spills; and rinsate disposal) wear a half-face resp irator with organic vapor cartridge approved for MITC.
While there is insufficient toxicological data to characterize the inha lation cancer risk of MITC, due to limitations in the rat and mouse MITC oral carcinogenicitystudies, the Agency anticipates that these new respiratory requirement s will adequately address this risk. However, the Agency is requiring additional study data (see Section V), including: (1) an inhalation development toxicity rat study (GLN 870.3550), (2 ) a two-generation inhalation reproduction study in rat (GLN 870.3800), and (3 ) carcinogenicity studies (i.e ., rat and mouse) for MITC (GLN 870.4200). In addition, to understand the ra tio of the conversion of metam-sodium to MITC, the Agency is adding a requirement for monitoring data in the breathing zone of the mixer/loader/applicator for sewer use metam-sodium applicators (GLN 875.1300) This study should measure dermal exposure to metam-s odium and inhalation exposure to MITC to determine what handlers are being exposed to an d in what quantities. This MITC monitoring data, in addition to the data be ing requested to characterize the inhalation cancer risk of MITC, will enable the Agency to further characterize the toxicity profile of this chemical and to confirm

14 1whether the mitigation measures being required are adequate or if additional measures are warranted. These data will be required as a part of the data call-in that will accompany this RED.
Metam-Sodium Non-Cancer Occupational RiskConcerns – Short- and Intermediate-Term Dermal Risks from Me tam-Sodium Exposure
The Agency revised the non-cancer, short- and intermediate-term occupational handler dermal exposure assessments based on the additional usage and occupational exposure information provided by the metam-sodium sewer us e registrants. The results of the revised noncancer, short-term occupational handler dermal exposure assessments for the sewer use of metam-sodium indicate that the MOEs for the derm al risk to handlers with engineering controls (e.g., closed mixing and loading systems) were above or just below the target MOE of 100, and the MOEs for the dermal risk to handlers withfull dermal PPE (i.e., ch emical resistant gloves and double layer clothing) were above 49, even at the highest daily rates of amount of product handled. In the case of the intermediate-term expos ures with full dermal PPE, MOEs were below the target MOE of 100, even with engineering controls. Revised risk estimates are given in Table 13 below.

Table 13: Metam-Sodium Non-cancer D ermal Sewer Handler Risk Estimates
Application Rate (lbs ai/gal) Amount Handled Daily (gals) Baseline MOE PPE-G 1 MOE G 1 ,DL 2 MOE Eng Cont MOE 6PPEShort-term Margins of Exposure 3

0.111 500 5 0.73 93 130 250 1125 5 0.33 41 56 110

0.127 500 5 0.64 81 110 220 1125 5 0.29 36 49 96

Intermediate-term Margins of Exposure 4

0.111 500 5 0.017 2.2 3 5.9 1125 5 0.0077 0.97 1.3 2.6

0.127 500 5 0.015 1.9 2.6 5.1 1125 5 0.0068 0.85 1.2 2.3
1 G = gloves

. 2 DL = double layer of clothing

. 3 Short-term margins of exposure are calculated using a NOAEL of 4.22 mg/kg/day from a developmental ra t toxicity study. Short-term target MOE = 100

. 4 Intermediate-term margins of exposure are calculated using a NOAEL of 0.1 mg/kg/day from a chronic do g toxicity study. Intermediate-term target MOE = 100

. 5 500 and 1125 gallons handled per day equals treating 4,000 and 9,000 linear sewer feet per day

. 6 Engineering controls = mixing and loading activities, but not applications

. Although not all short- and intermediate-term dermal exposure MOEs reached the target MOE of 100 with the required dermal protec tion and engineering controls, the occupational handler dermal exposure assessments are considered to be very conservative. Coupled with the Agency’s dermal PPE requirements (i.e., chemi cal resistant gloves and double layer clothing) and engineering control require ments (i.e., closed mixing and loading systems), the Agency believes that it is being protective of possible metam-sodium short-term and intermediate-term dermal risks. The occupational dermal risk a ssessments are based on data from the Pesticide Handler Exposure Database (PHED). PHED was de signed to be used only to assess nonvolatile

14 2pesticides. In the case of metam-sodium sewer us e, PHED was used because there is no data available to the Agency to assess exposure to metam-sodium itself. Since metam-sodium degrades rather quickly to MITC, the dermal s hort- and intermediate-term sewer risk assessment for metam generated by the Agency using data from PHED can be considered very conservative. In addition, the mixer-loader open-pour exposure in formation from PHED used to estimate risk for sewer use handlers of metam-sodium mixing, loading, and applying is not necessarily a good representation of the actual sewer application activities. The PH ED scenario assumes that the handler is directly mixing and pouring the chemi cal into the applicati on tank, while application information provided by the registrants descri bes a lower-exposure practice in which the applicator unrolls a hose into the manhole cover and then rolls the hose out of the manhole cover as the chemical is being applied.

Another source of conservatism comes from the fact that both the short- and intermediate-term dermal exposure assessments assume that workers are exposed throughout an 8-hour workday. However, the Agency believes th at the amount of time workers are exposed tometam-sodium each day is limited to the amount of time spent loading and applying metamsodium, which the Agency has estimated at 2 hours per day, based upon information submitted by the registrant, Douglas Produc ts and Packaging Company.

To address the short- and intermediate-term dermal risks from metam-sodium, consistent with the mitigation required inthe July 2008 metam-sodium/potassium RED, the Agency is requiring that any person(s) engaged in any activities that are likely to involve directcontact with metam-sodium (including, but not limited to, mi xing, loading, and/or applying metam-sodium; equipment calibration; cleaning and repair of appl ication equipment; entering into treated areas; sampling cleanup spills; and rinsate disposal) be required to wear double-layer clothing and chemical-resistant gloves.
In addition to the worker PPE requirement s, the Agency will also require closed engineering systems for all mixing and loading of metam-sodium for sewer use. In addition, all systems must be capable of removing the pestic ide from the shipping co ntainer and transferring it into mixing tanks and/or appli cation equipment. At any disconn ect point, the system must be equipped with a dry disconnect or dry coupl e shut-off device that is warranted by the manufacturer to minimize drippa ge. Finally, handlers will also be required to position a clean water rinse hose to continually rinse off the appl ication hose as it is extracted from the sewer pipe. All of these mitigation measures are designed to further protect handlers from exposures. These additional requirements are a result of information that the Agency received from Douglas Products and Packaging Company during the post -RED comment period regarding typical usage scenarios, which included such practices.
To better evaluate the dermal exposure to mixer/loader/applicators of metam sewer use applications and to confirm whether the mitigatio n measures included in this RED are adequate and/or determine whether additional mitigation meas ures are warranted, the Agency also will be requiring the registrants to submit outdoor dermal exposure data (GLN 875.1100) and product use information (875.1700) as a part of the da ta call-in that will accompany this RED.
Metam-Sodium Cancer Occupational Risk Concerns

14 3EPA revised its occupational handler dermal cancer assessment for handlers engaged in sewer applications of metam-sodium to control roots in sewer systems based on the additional usage and occupational exposure informati on provided by the metam-sodium sewer use registrants during the post-RED comment period. The results of the revi sed cancer occupational handler dermal exposure assessment for the sewe r use of metam-sodium indicate that cancer risks for workers in full dermal PPE requireme nts (i.e., chemical resi stant gloves and double layer clothing) and/or those us ing engineering contro l technologies (i.e., closed mixing and loading systems) are below the targ et cancer risk level of between 1x10 -4 to 1x10 -6 for exposed handlers. Revised risk estimates are given in Table 14 below.

Table 14: Metam-Sodium Cancer Sewer Risk Estimates

Application Rate (lbs ai/gal)

0.111 Amount Handled

Daily (gals)

500 3 Hours per Day Exposed

2 of Days Treating per Year 160 Number
Baseline Cancer Risk

2.5E-04 PPE-G 1 Cancer Risk

2.0E-06 PPE-G 1 ,DL 2 Cancer Risk

1.4E-06 Eng Cont Cancer Risk

7.3E-07 220 1.8E-04 1.4E-06 1.1E-06 5.3E-07

0.127 160 2.8E-04 2.3E-06 1.7E-06 8.4E-07 220 2.1E-04 1.6E-06 1.2E-06 6.1E-07
1 G = gloves

. 2 DL = double layer of clothing

. 3 500 gallons handled per day equals treating 4,000 linear sewer feet per day

. Potential Impacts of Metam-Sodium on Nitrifying Bacteria at Downstream Water Treatment Facilities
During the Phase 5 and post-RED comment periods, the Agency received comments from various stakeholders, including Sewer Sc iences Inc. and wastewater treatment plant personnel, indicating that metam-sodium imp acted downstream wastewater treatment plant operations as a result of bacterial upset. Some wastewater treatment plant personnel provided anecdotal information that the use of metam-sodium led to upsets in the microorganisms at their facilities, but specific details regarding the ci rcumstances that led to these upsets were not provided. During this period, the Agency also received comments from Douglas Products and Packaging and other wastewater treatment plant pe rsonnel, indicating that they have observed no evidence that metam-sodium has led to imp acts on downstream wastewater treatment plant operations as a result of bacterial upset.
The Agency evaluated the availa ble literature to determine wh ether there is the potential concern for impacts to wastewater treatment plant microorganisms following application of pesticide products containing metam-sodium. Based on this analysis, the Agency has determined that “it appears as though there is a reasonable body of evidence to indicate that there may be circumstances in which application of pesticid e products containing metam-sodium to control intrusion of roots into sewage collection pipes and storm drains could adversely affect activated sludge microorganisms in wastewater treatment pl ants downstream of sites where such products have been applied.” For full details on th e Agency’s analysis, please see the 4-16-09 Antimicrobial Division memo, “ Evaluation of Potential Impacts to Wastewater Treatment Plan

14 4Microorganisms Following Application of Pe sticide Products Containing Metam Sodium (sodium methyldithiocarbamate) as an Active Ingredient to Cont rol Intrusions of Roots into Sewage Collection Pipes and Storm Drains , located in the metam-sodium and metam-potassium docket at EPA-HQ-OPP-2005-0125].
To mitigate the Agency’s concern over potentially harmful effects of metam-sodium on denitrifying bacteria and the asso ciated disruption to downstream se wage treatment facilities, the Agency is requiring applicators to notify downstream wastewater fac ilities prior to the start of metam-sodium applications so that they may mo nitor the operations of the wastewater treatment plant. The applicators are requi red to report how much product th ey are applying to the sewer system to operators of downstream water treatment plants and to inform these operators that high concentrations of these chemicals in wastewat er may adversely affectthe biological sewage breakdown process in wastewater treatment plants.

Conclusion for Sewer Root Control Use

EPA has evaluated the need for control of invasive roots in sewer systems and the available chemical, mechanical, and non-chemical alternatives to metam- sodium, concluding that each type of control has a place ineffective sewer maintenance ( see Revised Alternatives Assessment on Root Control Use of Metam-Sodi um in Sewer Lines (DP # 358321) and Response to Public Comments Received dated May 8, 2009 which is ava ilable in the metam-sodium and metam-potassium docket at EPA-HQ-OPP-2005-0125.

Based on the short- and intermediate-term de rmal exposure risks to workers, coupled with the worker risks associated with MITC inha lation exposures, the Agency is requiring that any person(s) engaged in any activities that are likely to involve dire ct contact with metamsodium, including but not limited to mixing, load ing, and/or applying metam-sodium; equipment calibration; cleaning and repair of application equipment; enteri ng into treated areas; sampling cleanup of spills; and rinsate disposal, to wear double-layer clothing, chemical resistant gloves, and a 90% protection factor respirator approved for MITC. To help mitigate these risks, the Agency is also adding a requirement that closed engineering systems for all mixing and loading activities be used.
To mitigate potentially harmfu l effects of metam-sodium on denitrifying bacteria and the associated disruption to downstream sewage tr eatment facilities, the Agency is requiring applicators to notify downstream waste water f acilities prior to the st art of metam-sodium applications so that they may monitor the ope rations of the wastewater treatment plant.
Based on the revised occupational risk assessments, coupled with the conservative nature of the short- and intermediate-term non-cancer data , the Agency finds that these measures will be adequate to address the risks associated with the sewer use of metam-sodium.

c. Antimicrobial Uses
For details on the metam-sodium, metam- potassium, and MITC human health risk assessments, please refer to the Human HealthRisk Assessments and addenda for these chemicals. The following docum ents are recent additions:

14 5• EPA-HQ-OPP-2005-0125-0267, Updated Label Language for the Antimicrobial Uses of Methyl Isothiocyanate (MITC) (PC Code 068103) for the Reregi stration Eligibility Decision Document. May 13, 2008.

• EPA-HQ-OPP-2005-0125-0266, Risk Mi tigation Measures, Vol untary Cancellations and Updated Label Language for the Antimicrobi al Uses of Metam Potassium (PC Code 039002) for the Reregistration Eligibili ty Decision Document. May 15, 2008.

• EPA-HQ-OPP-2005-0125-0265, Risk Mi tigation Measures, Vol untary Cancellations and Updated Label Language for the Antimicrobial Uses of Metam Sodium (PC Code 039003) for the Reregistration Eligibili ty Decision Document. May 15, 2008.

These documents are also available in the public docket EPA-HQ-OPP-2005-00125, located on-line in the Federal Docket Management System (FDMS) at www.regulations.gov

. During the post-RED comment period, the Agency received a comment from Sewer Sciences, Inc., which identified errors on page s 86 and 88 of the RED, wherein the Agency inadvertently included a combined cancer risk value of metam sodium and metam potassium. The risk information presented in the risk assessments for the antimicrobial uses of metam sodium and metam potassium correctly state the cancer risk for antimicrobial uses of both metam sodium and metam potassium. This error has been corrected below.

MITC
The results from the occupational and potenti al bystander assessment indicated that the occupational and potential bystander risks to the remedial wood treatment uses of MITC (i.e., treatment of utility po les, pilings, bridge timbers, and laminated wood products located outdoors) are expected to be negligible, based on the product formulation, product packaging, method of application, and required use of PPE during the application activity.
Mitigation for Wood Pole/Piling Use:
The Agency is requiring the following label re quirements, which are also contained in the label table, in Section V.

1

. “Plug the pre-drilled holes imme diately after applications,” 2

. “Do not treat structures/beams indoors,” and 3

. “Do not drill an application hole through seas oning checks to apply pr oduct. If the hole intersects a check, plug the hol e and drill another. If more than two treatment holes intersect an internal void or rot pocket, redr ill the holes farther up the pole into relatively solid wood.”

Metam-sodium
The results of the occupational assessment fo r most antimicrobial uses of metam-sodium (i.e., treatment of poles and pilings, leather processing, and treatment of sewage sludge) indicated that the non-can cer dermal and inhalation risks to handlers were not of concern (i.e., all MOEs are greater than the target of 100). The can cer risks for the rest of the metam-sodium uses

14 6were in the range of 1.1e-4 to 6.8e-6, where the ta rget cancer risk level is between 1e-4 to 1e-6 for occupationally exposed workers.
Because of the short loading and/or application durations (i.e., minutes), handlers (i.e., mixers/loaders) are not expected to be expos ed to the metam-sodium degradate, MITC. Occupational post-application and po tential bystander (i.e., residents) exposure to MITC after the pole treatment is considered negligible. Any migration of MITC through the wooden cap into the ambient air conditions is considered neglig ible. However, the Agency has concerns for potential post-application inhalation exposures to MITC after metam-sodium applications in the leather and/or sugar processing i ndustries and also for workers in the vicinity of sewage sludge treatments. However, no data are available to es timate the air concentrations at these types of processing facilities.
The following uses have been voluntarily can celled for metam-sodium: (1) the sugar beet/sugar cane use and (2) all leather and hide processing uses. One registrant has voluntarily cancelled the organic sludge fumi gation use; however, this use is still being maintained by another registrant. Therefore, the antimicrobial uses of metam- sodium that remain include: (1) the remedial treatment of wooden poles and ti mbers and (2) treatment of sewage sludge and animal waste.
Mitigation for Wood Pole/Piling Use:
The Agency is requiring the following label re quirements, which are included in the label table, in Section V.

1

. “Plug the pre-drilled holes imme diately after applications,” 2

. “Do not treat structures/beams indoors,” and 3

. “Do not drill an application hole through seas oning checks to apply pr oduct. If the hole intersects a check, plug the hol e and drill another. If more than two treatment holes intersect an internal void or rot pocket, re-dri ll the holes farther up the pole into relatively solid wood.”
Mitigation for Use to Treat Se wage Sludge and Animal Waste:
The Agency is requiring the new label langua ge be developed, wh ich states that the treated material is placed in a protected storag e area for 21 days. The current label language reads that the treated material needs to be paced in a protected storage area for 14-21 days or until a phytotoxicity test is completed. This new label language is contained in the Label Table, in Section V.
Metam-potassium
The results of the occupational assessmentfor most antimicrobial uses of metampotassium (i.e., pulp and paper, leather, sugars, and emulsions and cutting fluids) indicated that the non-cancer dermal and inhalation risks to handlers were not of concern (i.e., all MOEs are greater than the target of 100). However, the occupational assessment results of metampotassium used in water cooling systems exceeded the Agency’s level of concern (i.e., MOEs

14 7were less than the target of 100) for dermal and inhalation exposures of handlers during openpouring activities. Similarly, th e cancer risk for the handlers of liquid open-pour products in water cooling facili ties was also of concern, and is 2.9e-3. The cancer risks for the rest of the metam-sodium and metam-potassium handlers were in the range of 1.1e-4 to 1.6e-8, where the target cancer risk level is between 1e-4 to 1e-6 for occupationally exposed workers.
Because of the short loading and/or application durations (i.e., minutes), handlers (i.e., mixers/loaders) are not expected to be exposedto the metam-potassium degradate, MITC. However, the Agency has concerns for potential post-application inhalation exposures to MITC for workers in the vicinity of metam-potassium a pplications in the leathe r, pulp/paper, and sugar processing industries, as well as in coatings and metal working fluid manufacturing, oil-field operations, cooling water towers, and industrial wa ter purification facilities because MITC is a highly volatile organic chemical (vapor pressure = 150 mm Hg). Furthermore, since metamsodium and metam-potassium convert to MITC in aqueous media, the Agency also has concerns for the potential MITC inhalation exposures for the machinist who works with metal-working fluids that were preserved with metam-potassium.

While industrial workers are not expected to be exposedto MITC while mixing or loading paint products containing metam-potassium, bystanders in th e vicinity of freshly painted areas and occupational/professional workers and re sidential (do-it-yourself) applicators could have potential inhalation exposur e to MITC. (It is assumed that all metam-potassium used in paint products converts to MITC.) All of the pr ofessional painter MOEs for all time durations exceeded the Agency's level of concern (target MOE of 10). At the maximum application rate, the residential painter MOEs for the 8-hour and 28 -day durations also exceed the Agency’s level of concern. Furthermore, at the maximum app lication rate, the post-ap plication bystander MOE for all durations also exceeds the Agency’s level of concern.
The technical registrants have chosen to voluntarily cancel the fo llowing uses of metampotassium: (1) the sugar beet/sugar cane use; (2 ) all leather uses, withthe exception of the tanning drum leather applications; (3) all paint us es (inclusive of the preservation of protective colloids and emulsion resins); (4 ) all water-based dril ling, completion, and packer fluid uses; (5) all petroleum secondary rec overy operations uses; (6) all once-through cooling water applications; and (7) all cutting fluids (metalwork ing fluids) uses. Those antimicrobial uses of metam-potassium that remain include: (1) the tann ing drum leather use, (2) pulp and paper, (3) recirculating cooling water systems, and (4) industrial water purif ication systems.
Mitigation for Cooling Water Tower Use:

Both the dermal and inhalation risk and th e cancer risk to occ upational workers during open-pour activities for the recirculating cooling water tower use are mitigated by requiring the use of a metering pump system for the recirculating cooling tower use. Label requirements will include the following, which is also contai ned in the label table, in Section V.

• “This antimicrobial product may only be used in recirculating cooli ng water facilities.”

• “This antimicrobial product can only be appl ied to recirculating cooling water systems via a metering pump system.”

14 8• Update PPE to be inclusive of long sleeves, long pants, chemical resistant gloves, and goggles or face shield.

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 developed and vetted, metam-sodium, metam-pot assium, and MITC may be subjected to additional screening and/or testi ng to better characterize effects related to endocrine disruption.

3. Endangered Species Considerations
The Agency has not conducted a risk assessment that supports a complete endangered species determination. The ecological risk assessment planned during registration review will allow the Agency to determine wh ether metam-sodium, metam-potassium and MITC use has “no effect” or “may aff ect” federally listed threatened or endangered species (listed species) or their designated critic al habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Ag ency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

D. Conclusion
The Agency has determined that products containing metam-sodium, metam-potassium and MITC are eligible for reregistration provided the risk mitigation measures outlines above are adopted and label amendments are made to reflec t these measures. Where labeling revisions are warranted, specific language is set forth in th e label. Table in Sec tion V of the document.

V. What Registrants Need to Do
EPA recognizes that the extent of the mitig ation needed for metam-sodium and metampotassium 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 expeditiously, and that bystander and worker pr otection measures are implemen ted 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

14 9considering stakeholder comments largely focu sed on the challenges of implementing many ne w measures simultaneously, EPA has de veloped the following schedule :
July 2008 Metam-sodium/potassium REDs 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 o f 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, 200 9 EPA reviews/approve s new labeling for 2010 use season. During 2009-1 0 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, 201 0 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 metam-sodium and metam-potassium 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 Agencyanticipates that labeling appr oved late in 2009 would begin to appear on products used for the 2010 fumigation season.
The Agency has determined that, with the mitigation measures identified in this document, some metam-sodium, metam-potassium, and MITC us es are eligible for reregistration; however, additional data are required to confirm this deci sion. In the near future, the Agency intends to issue data call-in (DCI) notices requiring product-speci fic data and generic (technical grade) confirmatory data. Generally, registrants will have 90 days from receipt of a DCI to complete and submit response forms or request time extensi on and/or waiver requests with a full written justification.

A. Manufacturing Use Products

1. Additional Generic Data Requirements

15 0The generic data base supporting the reregist ration of metam-sodium, metam-potassium, and MITC has been reviewed, and data gaps exis t. The data listed below are necessary to confirm the reregistration eligibility decision doc umented in this RED and determine whether the mitigation measures outlined in this RED are ade quate or if additional measures are warranted.
The Agency is requiring th e following toxicity studies.

OPPTS Guideline Number Data Requirement Study type

870.6200 Neurotoxicity Screening Battery - Inhalation TOX 870.3550 Developmental Toxicity Screening Test - Inhalation TOX

870.3800 Reproduction and Fertility Effects - Inhalation TOX 870.5550 Unscheduled DNA Synthesis in Mammalian Cells in Culture TOX

870.4200 Chronic/Carcinogenicity Rats - Inhalation TOX 870.4200 Chronic/Carcinogenicity Mice - Inhalation TOX
870.6200 - Neurotoxicity Screening Battery
An acute neurotoxicity study in rat via the i nhalation route with pathological evaluation of the complete respiratory tract is being reque sted. The Agency is currently using single day, acute exposures in its consideration of buffer zones following app lications of metam-sodium and metam-potassium. The toxicology data available to inform this decision are limited to an eye irritation study in human subjec ts and an acute inhalation stu dy. The purpose of the acute study was to determine the LC50, not for use in hazard id entification for human health risk assessment. The Agency cannot evaluate the dose response relationship of irritation and systemic effects to the nose and lungs using these studies. This inform ation on the respiratory tr act is critical for the risk assessment as the relative sensitivity of ey e irritation and more serious health outcomes is unknown. The Agency is open to discussing MI TC-specific changes to the standard neurotoxicity screening battery to ensure that the appropriate targetorgans are evaluated and that relevant dose-response data would be generated.
870.3550 - Developmental toxicity screening test - Inhalation
This inhalation developmental toxicity study 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 areas where the gene ral public lives, works, and plays. 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 rat via inhalation with pathological evaluation of the complete respiratory tract in offspring is needed. This inhalation reproductive toxicity study is being requested to further ch aracterize the toxicity profile of this compound via the inhalation

15 1route. MITC has been shown to travel off fields to areas where the general public lives, works, and plays. As such, it is appropriate to evaluate the effects of MITC on reproductive performance and to pups directly exposed to MITC via the inhalation route. Note: the Agency would be open to discussing withthe registrant the potential for performing the new enhanced one-generation reproductive study instead of the standard two-generation study.
870.5550 - Unscheduled DNA Synthesis in Mammalian Cells in Culture
This study is required to complete th e genetic toxicity testing battery.
870.4200 - Chronic/Carcinogenicity Rats and Mice
Carcinogenicity studies for MITC per se are insufficient to characterize cancer risk; therefore, the carcinogenic potentia l of MITC cannot be determined at this time. Although there are not expected to be exposures of six months or longer in duration in a given year, since the same fields are often treated ev ery year, there is potential fo r exposure to occur annually for many years. Moreover, metaplasia of the resp iratory epithelium, a lesion often associated cancer, was observed after only 28 days of exposur e in the subchronic inha lation study in rats with MITC. As such EPA is requiring inhalati on carcinogenicity studies w ith MITC in rats and mice.
Additional data requirements for metam- sodium and metam-potassium soil uses

OPPTS Guideline Number Data Requirement Study type

835.8100 Field Volatility from soil ORE 875.1100 Dermal exposure - outdoor ORE 875.1300 Inhalation exposure - outdoor ORE Special Avian acute inhalation, MITC 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 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
Data Requirements:

152The Agency is requiring the following volat ility and human exposure studies which will be used to confirm if bystander and worker risks are below the Agency’s level of concern. They will also be used to determine if additional mitigation measures are warranted:

• GLN 835.8100 - Field volatility from soil (cente r pivot, spray blade, and rotary tiller)

• GLN 875.1100 - Dermal exposure - outdoor

• GLN875.1300 - Inhalation exposure - outdoor
835.8100 - Field volatility from soil
Volatility studies are required for metam- sodium and metam-potassium soil uses to determine flux for modeling purposes of the br eakdown products of metam-sodium and metampotassium, including formaldehyde. Center pivot, spray blade, and rotarytiller application methods should be included.
For center pivot applications the Agency is requiring field volatility studies for all application methods including high release, me dium release and low release application methods. In addition, the field volatility study for low release applications should evaluate the cumulative flux from 2 adjacent applications that are occurring at the same time.
875.1100 - Dermal exposure – outdoor and 875.1300 - Inhalation exposure - outdoor
These studies will be used to confirm if bystander and worker risks are below the Agency’s level of concern. They will also be us ed to determine if additional mitigation measures are warranted.
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.

850.1075 - Acute Marine/Est uarine Fish, MITC
The aquatic risk assessment of metam-sodi um and metam-potassium use is based on exposure to MITC. Given the use patterns evalua ted, marine/estuarine sp ecies could also be exposed. This study will enable a risk asse ssment for marine/estuarine species exposure.
850.1025 - Acute Marine/Estuarine Mollusk, MITC
The aquatic risk assessment of metam-sodi um and metam-potassium use is based on exposure to MITC. Given the use patterns evalua ted, marine/estuarine sp ecies could also be exposed. This study will enable a risk assessment for marine/estuarine species exposure. It will also improve certainty with the endangered species risk assessment, as this test species may be more representative of endangered fre shwater mussels than the freshwater Daphnia

. 850.1035 - Acute Marine/Estuarine Shrimp, MITC

15 3The aquatic risk assessment of metam-sodi um and metam-potassium use is based on exposure to MITC. Given the use patterns evalua ted, marine/estuarine sp ecies could also be exposed. This study will enable a risk asse ssment for marine/estuarine species exposure.
850.4225 - Seedling Emergence – Tier II, MITC
Metam-sodium and metam-potassium are 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.
850.4250 - Vegetative Vigor – Tier II, MITC
Metam-sodium and metam-potassium are 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.
850.4400 - Aquatic Plant Growth – Tier II, MITC
Only one of four tests currently available (o n duckweed) is considered to be acceptable (Core) (MRID #45919422). The submission of datafor remaining test species under this guideline will reduce uncertainty and improve the assessment of risk to aquatic plants. For example, 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 metam-sodium and metam-potassium indicating that it is relatively non-toxic to honey be es, there is a concern that MITC could be more toxic to bees. Therefore, honeybee acute contact data is required for MITC.
Special Study - Community Outreach and Education Program
The Agency is requiring registrants to de velop and implement community outreach and education programs, including programs for first responders, to address these needs. Community outreach and education programs mu st include the following elements, at minimum: (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 m itigate exposures, (5) what to do in case of an emergency, and (6) how to report an incident. EPA expects registrants’ proposals for the first responder programs described in Section IV will also be designed to integrate with existing local first-response and emergency preparedness networks.
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 failure to comply with fumigant product labeling. Additionally, EPA believes that providing safety information to other fumigant handlers will

15 4help them understand and adhere to practices th at will help handlers protect themselves from risks of 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 that 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 successfullycompleted the program within the preceding 12 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) make 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 reque st, documentation that verifies 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 the 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) appropriate 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 36 months. The label will also require that the training information be provided in a

15 5manner 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

Registrants must capture all of the information 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.
Additional data requirements for metam-sodium sewer uses
Because chemical-specific exposure data were not available to assess the sewer use of metam-sodium, surrogate data for mixers and loaders from the Pest icide Handlers Exposure Database (PHED) were used in the risk assessmen t. To better evaluate exposure and characterize risk and to confirm that the mitigation measur es included in this RED are adequate and/or determine whether additional measures are warr anted, the following data will be required for metam-sodium:

• GLN 875.1100 – Dermal exposure – outdoor

• GLN 875.1700 – Product use information

15 6Because metam-sodium degrades into MITC, the Agency also needs MITC monitoring data in the breathing zone of the mixer/lo ader/applicator. The following data will be required for MITC:

• GLN 875.1300 – Inhalation exposure - outdoor
Given the specialized nature of these sewer-u se studies, the Agency would like to discuss the study design with the registra nts before the studies are begun.
Additional data requirements for metam-sodi um and metam-potassium antimicrobial uses
Because chemical-specific exposure data were not available to assess the antimicrobial uses of metam-potassium, surrogate data from both the Pesticide Handlers Exposure Database and the Chemical Manufacturers Association (CMA) were used to generate screening-level risk assessments. Therefore, the following data ar e needed to confirm the mitigation measures included in this RED are adequate, or if additional measures are warranted.

• GLN 875.1200 - Dermal exposure - indoor

• GLN 875.1400 - Inhalation exposure - indoor

• GLN 875.1600 - Applicator exposur e monitoring data reporting

• GLN 875.1700 - Product use information
Because metam-sodium degrades into MITC, the Agency needs MITC air concentration monitoring data for all enclosed facilities that utilize metam-s odium. For metam-sodium this only includes sewage sludge and animal waste treatment facilities as the leather use and sugar cane and beet uses are being voluntarily cance lled. 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 data reporting and calculations
Residue data are needed to support the metam-potassium antimicrobial use in pulp and paper manufacturing. The purpose of this confirmatory study is to demonstrate that the paper manufacturing processes remove any residual metam-potassium and MITC.

• GLN 860.1520
Because metam-potassium degrades into MITC, the Agency needs MITC air concentration monitoring data for all enclosed facilities that utili ze metam-potassium. For metam-potassium this includes pulp and paper faci lities, recirculating co oling water facilities, leather processing facilities, and industrial water purif ication facilities. The guideline numbers are as follows:

• GLN 875.2500 - Inhalation exposure study

• GLN 875.2700 - Product use information

15 7• GLN 875.2800 - Description of human activity

• GLN 875.2900 - Post-application data reporting and calculations.

2. Labeling for Manufacturing-Use Products
In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV.

B. End-Use Products

1. 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 ensu re that they meet current EPA acceptance criteria and, if not, commit to conduct new studies. If a registrant believes that previously submitted data meet current testing standa rds, then the study master record identification numbers (MRIDs) must be cited according to the in structions in the Requirement Status and Registrants Response Form provided for each product. The Agency inte nds to issue a separate product-specific data call-in (PDCI), outlining specific data requirements. For questions regarding the PDCI, contact Karen Jones from OPP/SRRD’s Product Reregistration Branch at (703) 308-8047 or by e-mail at Jones.Karen@epa.gov.

2. Labeling for End-Use Products
In order to be eligible for reregistration, am end all product labels to incorporate the risk mitigation measures outlined in Section IV.

15 8Appendix A: Uses Eligible for ReregistrationMetam Sodium (PC Code 039003) and Metam Potassium (PC Code039002) Soil Fumigant Uses Eligible For ReregistrationUse SiteSoil Pre-PlantAlfalfa,Asparagus (nursery production only),Artichokes,Barley,Basil,Beet,Berries, [includes all EPA Crop Group 13, Berries Group, i.e., blackberry (Rubuseubatus); bingleberry; black satin berry; boysenberry; Cherokee blackberry;chesterberry; Cheyenne blackberry; coryberry; darrowberry; dewberry; Dirksenthornless berry; Himalayaberry; hullberry; lavacaberry; lowberry; lucretiaberry;mammoth blackberry; marionberry; nectarberry; olallieberry; Oregon evergreenberry; phenomenalberry; rangeberry; ravenberry; rossberry; Shawnee blackberry;youngberry, and varieties and/or hybrids ofthese; blueberry (Vaccinium spp.);currant (Ribes spp.); elderberry (Sambucus spp.); gooseberry (Ribes spp.);huckleberry (Gaylussacia spp.); loganberry(Rubus loganobaccus); raspberry-blackand red (Rubus occidentalis, Rubus strigosus, Rubus idaeus)],Broccoli,Brussels sprouts,Cabbage,Carrot,Cauliflower,Celeriac,Chineese greens or bok choy,Cilantro,Citrus (orchard replant only), [includesall of EPA Crop Group 10, Citrus Fruits, i.e.,AnnualUseFormulationApplicationLimitationsRateLiquid,320 lbs.SeeSolublea.i./AcreTheConcentrateLabelTableForSpecificUseLimitations.159Use Sitecalamondin (Citrus mitis X Citrofortunella mitis); citrus citron (Citrus medica);citrus hybrids (Citrus spp.) (includes: chironja, tangelo, tangor); grapefruit (Citrusparadisi); kumquat (Fortunella spp.); lemon (Citrus jambhiri, Citrus limon); lime(Citrus aurantiifolia); mandarin (tangerine)(Citrus reticulata); orange, sour (Citrusaurantium); orange, sweet (Citrus sinensis); pummelo (Citrus grandis, Citrusmaxima); satsuma mandarin (Citrus unshiu)],Collard,Corn,Cover crops (i.e., crops planted betweenperiods of regular crop production toprevent soil erosion, controlweeds, and improve soil quality that are incorporatedinto the soil before the next crop is planted and may not be harvested for food orfeed),Crops grown solely for seed,Cucurbits [includes all of EPA Crop Group 9, Cucurbit Vegetables Group, i.e.,chayote (fruit) (Sechium edule); Chinese waxgourd (Chinese preserving melon)(Benincasa hispida); citron melon (Citrullus lanatus var. citroides); cucumber(Cucumis sativus); gherkin (Cucumis anguria); gourd, edible (Lagenaria spp.)[includes: hyotan, cucuzza (Luffa acutangula, L. cylindrical; includes hechima,Chinese okra)]; Momordica spp. (includes balsam apple, balsam pear, bitter melon,Chinese cucumber); muskmelon [hybrids and/or cultivars of Cucumis melo(includes true cantaloupe, cantaloupe, casaba, crenshaw melon, golden pershawmelon, honeydew melon, honey balls, mango melon, Persian melon, pineapplemelon, Santa Claus melon, and snake melon)]; pumpkin (Cucurbita spp.); squash,summer (Cucurbita pepo var. melopepo)(includes: crookneck squash, scallopsquash,straightneck squash, vegetable marrow, and zucchini);squash, winter (Cucurbita maxima; C.moschata) (includes: butternut squash,calabaza, hubbard squash) and (C. mixta;C. pepo) (includes acorn squash, spaghettisquash); and watermelon (includes hybrids and/or varieties of Citrullus lanatus)],Dill,Eggplant,Forest seedlings,AnnualUseFormulationApplicationLimitationsRate160AnnualUseUse SiteFormulationApplicationLimitationsRateGinger,Grape (vineyard replant only),Kale,Kohlrabi,Leafy greens [includes all of EPA Crop Group 4, Leafy Vegetables (Except BrassicaVegetables), i.e., amaranth (leafy amaranth, Chinese spinach, tampala) (Amaranthusspp.); arugula (roquette) (Eruca sativa); cardoon (Cynara cardunculus); celery(Apium graveolens var. dulce); celery, Chinese (Apium graveolens var. secalinum);celtuce (Lactuca sativa var. angustana);chervil (Anthriscus cerefolium);chrysanthemum, edible-leaved (Chrysanthemum coronarium var. coronarium);chrysanthemum; garland (Chrysanthemum coronarium var. spatiosum); corn salad(Valerianella locusta); cress, garden (Lepidium sativum); cress, upland (yellowrocket, winter cress) (Barbarea vulgaris); dandelion (Taraxacum officinale); dock(sorrel) (Rumex spp.); endive (escarole) (Cichorium endivia); fennel, Florence(finochio) (Foeniculum vulgare AzoricumGroup); lettuce, head and leaf (Lactucasativa); orach (Atriplex hortensis); parsley(Petroselinum crispum); purslane, garden(Portulaca oleracea); purslane,winter (Montia perfoliata); radicchio (red chicory)(Cichorium intybus); rhubarb (Rheum rhabarbarum); spinach (Spinacia oleracea);spinach, New Zealand (Tetragonia tetragonioides, T. expansa); spinach, vine(Malabar spinach, Indian spinach) (Basella alba); and swiss chard (Beta vulgaris var.cicla)],Leek,Mint,Mustard,Nursery stock (fruit seedlings and rose bushes only),Onion,Ornamentals (floriculture only),Pome fruit (orchard replant only), [includes all of EPA Crop Group 11, Pome FruitsGroup —Commodities, i.e., apple (Malusdomestica); crabapple (Malus spp.);loquat (Eriobotrya japonica); mayhaw (Crataegus aestivalis, C. opaca, and C.rufula); pear (Pyrus communis); pear,oriental (Pyrus pyrifolia); and quince161AnnualUseUse SiteFormulationApplicationLimitationsRate(Cydonia oblonga)],Peanut,Pepper,Potato,Radish,Rye,Sugar beet,Soybean,Stone fruit (orchard replant only), [includes all of EPA Crop Group 12, Stone FruitsGroup—Commodities, i.e., apricot (Prunusarmeniaca); cherry, sweet (Prunusavium); cherry, tart (Prunus cerasus); nectarine (Prunus persica); peach (Prunuspersica); plum (Prunus domestica,Prunus spp.); plum, Chickasaw (Prunusangustifolia); plum, Damson (Prunus domestica spp. insititia); plum, Japanese(Prunus salicina); plumcot (Prunus. armeniaca X P. domestica); prune (fresh)(Prunus domestica, Prunus spp.)],Strawberries,Sugar beet,Sweet potato,Swiss Chard,Tobacco,Tomatoes,Tree nuts (orchard replant only), [includes all of EPA Crop Group 14, Tree NutsGroup (i.e., almond (Prunus dulcis); beech nut(Fagus spp.); Brazil nut (Bertholletiaexcelsa); butternut (Juglans cinerea); cashew (Anacardium occidentale); chestnut(Castanea spp.); chinquapin (Castanea pumila); filbert (hazelnut) (Corylus spp.);hickory nut (Carya spp.); macadamia nut (bush nut) (Macadamia spp.); pecan (Caryaillinoensis); and walnut, black and English (Persian) (Juglans spp.) as well aspistachio],Turnip,Turf (including golf courses), andWheat162Metam Sodium(PC Code 039003) Uses Eligible For ReregistrationUse SiteFormulationSewer UseRoot Control in Sewerliquid,Linessolubleconcentrate(SC),ready-to-use(RTU)Agricultural Premises & EquipmentSewage Sludge & AnimalSewageWaste TreatmentSludge &AnimalWasteTreatmentWood PreservativesMethod ofApplicationFoamapplicationequipmentSewage Sludge& AnimalWasteTreatmentApplication Rate/ No. ofapplicationsFor sewers and drains, themaximum application rateis 0.212 lbs ai/gallon ofsolution.Sewage Sludge & AnimalWaste TreatmentUse LimitationsDo not discharge effluent containing thisproduct to sewer systems without previouslynotifying the local sewage treatment plantauthority. For guidance, contact your StateWater Board or Regional Office of the EPA.Sewage Sludge & Animal Waste Treatment163Timbers and WoodPoles/PilingsReady toUse LiquidFumigant ispoured intoholes that havebeen drilled intoWood Poles: Drill holes ata 45 degree angle to alength of approximately 21⁄2 times the radius of thesection of poleswhere decay isdetectedwood. The first holeshould be at the groundlineand succeeding holesapproximately 6-8 incheshigher and 90 degreesrotated from the next lowerhole. The amount offumigant to be used perpole is based on the polecircumference at thegroundline.Plug holes with treatedwood plugs.None Listed164Metam Potassium (PC Code 039002) Uses Eligible For ReregistrationUse Site FormulationIndustrial Processes and Water SystemsRecirculating CoolingTower WaterReady to UseMethod ofApplicationChemicalmeteringpumpsApplication Rate/ No. ofapplicationsInitial Slug: 5.1 to 10.2fluids ounces of productper 1000 gallons of water.Use LimitationsSubsequent Dose: 1.7 to10.2 fluid ounces per 1000gallons of water every 1 to5 days or as needed; orInitial Dose: 6.9 to 13.9 fl.Oz. of product per 1000gallons of system water(56-115 ppm).Subsequent Dosage: 2.3 to9.8 fl. Oz per 1000 gallonsof water (20-115 ppm); orInitial Dose: 1.5 to 3.0 fl.Oz. of product per 1000gallons of system water(15-30 ppm).Subsequent Dosage: 0.5 to3.0 fl. Oz per 1000 gallonsof water (5-30 ppm); orInitial Dose: 3.3 to 6.6 fl.Oz. of product per 1000gallons of system water165Use Site Formulation Method ofApplication Rate/ No. ofUse LimitationsApplicationapplications(30-60 ppm).Subsequent Dosage: 1.1 to6.6fl. Oz per 1000 gallonsof water (10-60 ppm).166Use SiteIndustrial WaterPurification systems(including reverse osmosissystems, filters, clarifiersand ion exchangeequipment)FormulationReady to UseMethod ofApplicationChemicalmeteringpumpsApplication Rate/ No. ofapplications24.5 to 49.0 fl. Oz per 1000gallons of water (200-400ppm) for 4 to 6 hours.Online Maintenancetreatment: 4.9 to 9.8 fl. Oz.of product per 1000 gallonsof water (40 to 80 ppm) for6 – 12 hours, once a weekUse LimitationsNot intended for use in potable water.or as needed; or5.0 to 10.0 fl. Oz per 1000gallons of water (50-100ppm) for 4 to 8 hours.Online Maintenancetreatment: 1.0 to 2.0 fl. Oz.of product per 1000 gallonsof water (10 to 20 ppm) for6 – 12 hours, once a weekor as needed.167Use Site Formulation Method ofApplication Rate/ No. ofUse LimitationsApplicationapplicationsPulp & Paper MillsReady to UseChemical0.25 to 1lb.of product perNone Listedmeteringshort ton; orpumps0.8-5.0 lbs of product perton for six hours; or0.2 to 0.4 lb of product perton.Materials PreservativesPaper makingReady to UseChemical75 to 400 ppm dependingNone Listed(preservation)meteringon PH level.pumpsTanning Drum LeatherReady to UseOpen pourTo preserve tannery glueNone Listedsolutions, add to glue atrates of 100-250 ppm,based on the total weight ofthe glue solution168MITC (068103) Uses Eligible For ReregistrationUse SiteWood preservativesReg. no./FormulationMethod ofApplicationRemedial Treatment:Utility poles, piling,bridge timbers, andlaminated wood products(located outdoors).Ready to UseManuallyinsert tube intopre-drilled holeApplication Rate/ No. ofapplicationsUse LimitationsDosage Rate: 1 tube (30grams) per drill hole;Pole Circumference ininches/No. of TubesInstalled:Do not contaminate water, food or feed bystorage or disposal.Do not use, pour, spill or store near an openflame.35” or less- 3 holesbeginning at ground linespaced 120 degrees apartand 6”to 8” higher than theprevious hole.36” to 49” -4 holesbeginning at the groundline spaced 90 degreesapart and 6” to 8” higherthan the previous hole.50” to 59”-5 holesbeginning at the groundline spaced 70 degreesapart and 6”to 8” higherthan the previous pole.60” to 70” –6 holesbeginning at ground linespaced 60 degrees apartand 4” to 6” higher than169Use SiteReg. no./ Method ofFormulationApplicationApplication Rate/ No. ofUse Limitationsapplicationsthe previous hole.70” to 80”-7 holes. Thefirst 2 at ground line 160degrees apart and theremaining 5 spaced 60degrees apart and 4” to 6”higher than the previoushole.80” to 90”- 8 holes. Thefirst 2 at ground line 180degrees apart and theremaining 6 spaced 50degrees apart and 4” to 6”higher than the previoushole.Over 90”–9 holes. Thefirst 2 at ground line 180degrees apart and theremaining 7 spaced 45degrees apart and 4” to 6”higher than the previoushole.170Appendix B: Studies Used to Make the Reregistration DecisionThis section not currently available.171Appendix C: Technical Support Documents
Additional support of this RED is maintained in the OPP docket at: http://www.regulations.govat EPA-HQ-OPP-2005-0125. This docket may be accessed in the OPP docket room located at S4900, One Potomac Yard 2777 S. Crystal Drive, Arlington, VA. It is open Monday through Friday, excluding federal holidays, from 8:30-4:00 pm. All documents may be view in the OPP docket room or downloaded or viewed via the internet.
Health Effects Support Documents

• “Metam Sodium: Third Revision of the HE D Human Health Risk Assessment;” May 2009; Charles Smith; Health Effects Division, U.S. EPA.

• Methyl Bromide, 1,3-Dichloropropen e, Chloropicrin, Dazomet, Metam Sodium/Potassium, MITC: Health Effects Division (HED) Component of Agency Response To Comments On 2008 Reregistrati on Eligibility Docume nts (Date May 14, 2009).

• “Methyl Bromide, 1,3-Dichloropropen e, Chloropicrin, Dazomet, Metam Sodium/Potassium, MITC; PC Codes 053201, 029001, 081501, 035602, 039003, 039002, 068103; Health Effects Division (HED) Component of Agency Response To Comments On 2008 Reregistration Eligibili ty Documents;” May 2009; Charles Smith and Jeff Dawson; Health Eff ects Division; U.S. EPA.

• EPA-HQ-OPP-2007-0350-0172, MOA Mode of Ac tion, Eye Irritation, and the IntraSpecies Factor: Comparison of Chloropicr in and MITC. June 25, 2008. DP Barcode 293356.

• “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 Divisi on Recommendations for Good Agricultural Practices and Associated Buffer Credits;” May 2009; Charles Smith and Jeff Dawson; Health Effects Division; U.S. EPA.

• EPA-HQ-OPP-2007-0350-0173, Factors Which Im pact Soil Fumigant Emissions - Evaluation For Use In Soil Fumigant Buffer Zone Credit Factor Approach. June 9, 2008. (DP Barcode 306857).
Biological and Economical A nalysis Support Documents

• Evaluation of Potential Impacts to Wastewat er Treatment Plant Microorganisms...”; PC Code: 039003; DP Barcode: 364230; April 2009; Pat Jennings; Antimicrobials Division; U.S. EPA.

• Response to comments on use site restrictions included in the Rere gistration Eligibility Decision (RED) for Metam-Sodium and Metam-Potassium (DP Barcode: 363544); May 2009; Nikhil Mallampalli, Chism, Becker; Biol ogical and Economic Analysis Division; U.S. EPA.

• Revised Alternatives Assessment on Root Control Use of Metam-Sodium in Sewer Lines (DP # 358321) and Response to Public Comme nts Received (EPA Docket No. EPA-HQOPP-2005-0125);” May 2009; Sunil Ratnayak e and Tara Chandgoyal; Biological and Economic Analysis Division; U.S. EPA.

• Identification of High-Use Fumigation Areas at State and County Levels (DP#364647);” May 2009; Monisha Kaul and Jenna Carter; Bi ological and Economic Analysis Division; U.S. EPA.

17 2• Response to BEAD Related Public Comments Received on the Reregistration Eligibility Decision for Chloropicrin, Dazomet, Metam 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.

• Process for Defining High-Us e Fumigation Areas at the State and County Levels (DP#364647) May 14, 2009.

• EPA-HQ-OPP-2007-0350-0168, Review of Stake holder 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. June 25, 2008. DP Barcode 353940.

• EPA-HQ-OPP-2007-0350-0169, Response to Phase 5 BEAD Related Public Comments Received on the Reregistration of Chlor opicrin, Dazomet, Metam Potassium, Metam Sodium, and Methyl Bromide. June 25, 2008. DP Barcode 353940.

• EPA-HQ-OPP-2007-0350-0018, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Metam Sodium in Cucurbit Production.

• EPA-HQ-OPP-2007-0350-0019, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Metam Sodium in Eggplant Production.

• EPA-HQ-OPP-2007-0350-0020, Assessment of the Benefits Soil Fumigants (Methyl Bromide, Chloropicrin, Metam-Sodium, Dazomet) Used by Forest Tree Seedling Nurseries.

• EPA-HQ-OPP-2007-0350-0021, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin, Dazomet, and Metam Sodium for Use in Raspberry Nurseries, Fruit and Nut Deciduous Tree Nurseries, and Rose Bush Nurseries in California.

• EPA-HQ-OPP-2007-0350-0022, Assessment of the Benefits of Soil Fumigation with Chloropicrin and Metam-sodium in Onion Production.

• EPA-HQ-OPP-2007-0350-0023, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin, and Metam Sodium in Grape Production.

• EPA-HQ-OPP-2007-0350-0024, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin and Metam Sodium in Tree Nut Production.

• EPA-HQ-OPP-2007-0350-0025, Assessment of the Benefits of Soil Fumigation with Chloropicrin and Metam Sodium in Pome Fruits Production.

• EPA-HQ-OPP-2007-0350-0026, Assessment of the Benefits of Soil Fumigation with Methyl Bromide, Chloropicrin, and Me tam Sodium in Stone Fruit Production.

• EPA-HQ-OPP-2007-0350-0027, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Me tam Sodium in Bell Pepper Production.

• EPA-HQ-OPP-2007-0350-0028, Assessment of the Benefits of Soil Fumigation with Metam Sodium in Potato Production.

• EPA-HQ-OPP-2007-0350-0029, Assessment of Soil Fumigation with Chloropicrin, Methyl Bromide and Metam-sodi um in Strawberry Production.

• EPA-HQ-OPP-2007-0350-0030, Assessment of the Benefits of Chloropicrin, Methyl Bromide, Metam-sodium and Dazomet Use In Strawberry Nursery Runner Production.

• EPA-HQ-OPP-2007-0350-0031, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Me tam-sodium on Sweet Potato Production.

• EPA-HQ-OPP-2007-0350-0032, Assessment of the Benefits of Soil Fumigation with Chloropicrin in Tobacco Production.

• EPA-HQ-OPP-2007-0350-0033, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, and Metam Sodium in Tomato Production.

17 3• EPA-HQ-OPP-2007-0350-0034, Assessment of the Benefits of Soil Fumigation with Metam-Sodium in Carrot Production.

• EPA-HQ-OPP-2007-0350-0035, Assessment of the Benefits of Soil Fumigation with Metam Sodium in Peanut Production.

• EPA-HQ-OPP-2007-0350-0036, Assessment of the Benefits of Soil Fumigation with Chloropicrin, Methyl Bromide, Metam Sodi um and Dazomet in Ornamental Production.

• EPA-HQ-OPP-2007-0350-0037, BEAD's Planned Impact Assessments on Agricultural Sites with Significant Use of Soil Fumigants (Chloropicrin, Dazomet, Methyl Bromide, Metam Potassium, and Metam Sodium.
Environmental Fate and Ecologi cal Effects Support Documents

• EPA-HQ-OPP-2004-0159-0117 – Transmittal Memo fo r the Revised Environmental Fate and Ecological Effects Risk Assessment for Metam Sodium and Metam Potassium.

• E PA-HQ-OPP-2004-0159-0118 Revised Environmental Fate and Ecological Effects Risk Assessment for Metam Sodium and Metam Potassium.
Antimicrobial Assessment Support Documents

• EPA-HQ-OPP-2007-0350-1066, Phase 6 Response to Substantive Public Comments on Antimicrobials Division’s Occupational and Residential Assessments for the Reregistration Eligibility Decision (RED) Documents for the following chemicals: Methylisothiocyanate (MITC), Metam Sodium, Dazomet, and Chloropicrin.
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.

• EPA-HQ-OPP-2007-0350-1073, Factors Which Im pact Soil Fumigant Emissions - Evaluation for Use in Soil Fumigant Buffer Zone Credit Factor Approach. Dawson, J. and Smith, C.; D306857; June 9, 2008.

• EPA-HQ-OPP-2007-0350-1078, Health Effects Di vision Recommendations for Fumigant Data to Refine Exposure Assessments. DP Barcode 353724.
Risk Management Support Documents

• EPA-HQ-OPP-2007-0350-1077, SRRD’s Response to Phase 5 Public Comments for the Soil Fumigants. Rice, M. and McNally, R.; July 2008.

• EPA-HQ-OPP-2007-0350-0003, Risk Mi tigation Options to Address Bystander and Occupational Exposures from Soil Fumigant Applications.

17 4Appendix D: FMP Template-MeBr Example

Note: The Agency plans to work with the registrants and other stakeholders to develop a metam-sodium and metampotassium specific FMP that will serve as a template for growers and the States to use for the most common application methods prior to the 2010 and 2011 growing season.

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 Target application date/window: Brand name of fumigant: EPA Registration Number:

Tarps (check here if section is not applicable ) Brand name: 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 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 contact person responsible for 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 and moisture in application block: Description of method used to determine soil moisture level:

17 5Weather 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 Rate from lookup table on label (lb ai/A): Block size from lookup table on label (acres): Credits applied: high barrier film _____________ % organic content _____________ % clay content _____________ % other: _____________ % Total credits _____________ % 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).

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

17 6If 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 If your state and/or tribal lead agency requires notice, list contacts that were notified: 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:

Comments/notes:

17 7Site Map

Location of application block: _______________________________________________________________________________

B

IPC Map Legend
Application block
Bus stop WB

Inpatient clinic P Buffer zone
Water body

Prison Property lines DC Daycare facility

Well Sch

NH Roads

School

Nursing home Right-of-way NAB Nearby application block

ALF Assisted living facility Walkway, sidewalk, path

17 8Handler InformationHandler Name, Address, and PhoneNumberEmployer Name, Address, and PhoneNumberTasks They are Trained andAuthorized to PerformDate of PPETrainingDate ofMedicalQualification toWear aRespiratorDate of FitTesting forRespirator179Air 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.

If intend to cease operations - Name, address, and phone number of handler to perform monitoring activities prior to operations resuming: Monitoring equipment:

For Handlers with Respiratory Protection: (check here if section is not applicable ) Representative Handler Tasks to be Monitored Monitoring Equipment Timing

Air 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:

18 0Area 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

18 1Methyl 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 zo nes, property lines, roads, bus stops, water bodies, wells, rights-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 sizeor 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 decomposition prior to fumigation, little or no crop residue is present on the soil su rface, and crop residue that is present does not interfere with 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 s ealed 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).

18 2Application 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. 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 the 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 they, 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 stapplication 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 maintained 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 summary 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

183_ ______________________________________________ ___________________________________ fumigation.

Signature of certified applicator supervising the fumigation Date

18 4Post-Application Summary

General Application Information Application date and time: Application rate: 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 cut: 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:

Description of Incidents (check here if section is not applicable ) Description of incident, equipment failure, or other emergency: Date and time:

Description of emergency procedures followed:

18 5Additional 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:

18 6Air 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

18 7_ ______________________________________________ ___________________________________ I have verified that this post application 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

18 8