2451 01_Fumigants ICR_Revised_2016-03-13

March 13, 2016

SUPPORTING STATEMENT

FOR AN INFORMATION COLLECTION REQUEST (ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a). Title of the Information Collection

Soil Fumigant Risk Mitigation

OMB Control No.: 2070-NEW

EPA No.: 2451.01

Docket ID No.: EPA-HQ-OPP-2011-1036

1(b). Short Characterization/Abstract

This information collection request (ICR) accounts for the existing collection of information without an OMB control number that was established in 2010 for certain soil fumigant chemicals, risk mitigation measures necessary for reregistration eligibility are adequately implemented. In May 2008, the Environmental Protection Agency (“EPA” or “the Agency”) completed Reregistration Eligibility Decisions (REDs) for a group of soil fumigant chemicals after an extensive review and public participation process. The Agency’s decision takes into account the best available information on the potential risks and benefits of soil fumigant use. EPA published the final decision documents for public comment, and issued final REDs in June 2009. Implemented on a case-by-case basis between 2010 and 2012, these measures work together to establish a baseline for safe use of the soil fumigants throughout the United States, reducing fumigant exposures and significantly improving safety.

Pursuant to section 4(g) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EPA reviewed data concerning the risks and benefits of certain soil fumigant chemicals and determined that certain uses of these soil fumigants are eligible for reregistration only if certain additional risk mitigation measures were included as terms and conditions of those products’ registrations. The registrants agreed to amend their registrations to include those terms and conditions. One of those terms and conditions is that the registrants must develop and implement training for fumigators in charge of fumigations, develop and disseminate safety information for handlers, develop and implement community outreach and education programs, and develop and implement first responder training.

Another of those terms and conditions is that the registrants must include in the labeling of their soil fumigant products certain additional directions for use. These new directions for use include requirements that users post information concerning soil fumigant applications on signs around the use site, provide notice of fumigant applications to applicable states, prepare a Fumigant Management Plan (FMP) and Post-Application Summary (PAS), participate in an EPA-approved fumigant training program, and disseminate fumigant safe handling information to handlers.

The required mitigation measures may result in a burden, applicable under the Paperwork Reduction Act (PRA), on those participating in soil fumigant applications, on those enforcing soil fumigant label requirements, and on the registrants of soil fumigant products. These measures are designed to decrease the likelihood of exposures to these chemicals while maintaining important benefits to United States (U.S.) agriculture. To ensure that risk mitigation measures are adequately implemented, the respondents identified below must complete the following activities:

• Users – Users of soil fumigants include both certified applicators and pesticide handlers. Applicators must understand the new requirements, complete application information on posting signs, provide notice of fumigant applications to applicable states, prepare a Fumigant Management Plan (FMP) and Post-Application Summary (PAS), participate in an EPA-approved fumigant training program, and disseminate fumigant safe handling information to handlers. Handlers may help in the posting of buffer zone signs, and must also complete a fumigant training program.

• Registrants – Registrants of soil fumigant products must develop and implement training for fumigators in charge of fumigations, develop and disseminate safety information for handlers, develop and implement community outreach and education programs, and develop and implement first responder training.

• States – States are involved in the enforcement of soil fumigant label requirements, and would receive notification of fumigations in their state if they have selected this option.

Without the complete suite of measures, these chemicals do not meet the requirements to be eligible for reregistration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The programs and activities represented in this ICR are the result of the Agency exercising the authority of section 3(c)(2)(B) (Attachment A) or section 3(c)(5) (Attachment B) of FIFRA, which authorizes EPA to require pesticide registrants to generate and submit data to the Agency, when such data are needed to maintain an existing registration of a pesticide. Due to the high benefits to agriculture from these chemicals, there could be significant economic impact if soil fumigant products are no longer available to American farmers.

2. NEED FOR AND USE OF THE COLLECTION

2(a). Need/Authority for the Collection

In general, authorizing legislation is contained in Section 3 of FIFRA, with implementing regulations in 40 CFR parts 152 (registration standards and general requirements), 156 (labeling), 158 (data requirements) and part 171 (certified applicators of restricted use products). Application of the requirements applied to the registration of soil fumigants is discussed in EPA’s Fumigant Reregistration Eligibility Decisions and Supporting Documents, which can be accessed using the docket numbers provided in attachment C. See also the EPA website dedicated to soil fumigants (http://www.epa.gov/soil-fumigants).

Overview of Mandates Applicable to Registered Pesticides

Sections 3(a) and 12(a)(1) of FIFRA require a person to register a pesticide product with the EPA before the pesticide product may be lawfully sold or distributed in the U.S. A pesticide registration is a license that allows a pesticide product to be sold and distributed for specific uses under specified terms and conditions such as use instructions and precautions. The proponent of initial or continued registration always bears the burden of demonstrating that a pesticide product meets the statutory standard for registration. A pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in section 3(c)(5) of FIFRA, which is as follows:

1. Its composition is such as to warrant the proposed claims for it.

2. Its labeling and other material required to be submitted comply with the requirements of this Act.

3. It will perform its intended function without unreasonable adverse effects on the environment.

4. When used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.

Section 2(bb) of FIFRA defines “unreasonable adverse effects on the environment'' as (1) “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food Drug and Cosmetic Act.''

Section 4 of FIFRA requires EPA to reassess the health and safety data for all pesticide active ingredients registered before November 1, 1984, to determine whether these “older” pesticides meet the criteria for registration that would be expected of a pesticide being registered today for the first time. Section 4 directs EPA to use section 3(c)(2)(B) authority to obtain the required data. Section 4(g)(2)(A) of FIFRA calls for EPA to determine, after submission of relevant data concerning an active ingredient, whether pesticides containing the active ingredient are eligible for reregistration.

Failure of a registrant to comply with the terms and conditions of registration would lead to cancellation of its soil fumigant products pursuant to FIFRA section 6(b) for failure to meet the section 3(c)(5) criteria for registration. Users must comply with pesticide labeling or face civil and criminal penalties pursuant to FIFRA sections 12(a)(2)(G) and 14, and certified applicators may also be sanctioned by suspension or revocation of certification (40 CFR 171.7(b)(iii)(A)).

Overview of Mandates Specific for Soil Fumigants

In completing its review of several soil fumigants pursuant to FIFRA section 4(g), EPA determined that certain uses of these soil fumigants are eligible for reregistration only if specific risk mitigation measures as outlined in the REDs are adopted and implemented by the registrants.

EPA completed the REDs for a group of soil fumigant chemicals in 2009,after an extensive review and public participation process. The Agency’s decision takes into account the best available information on the potential risks and benefits of soil fumigant use. EPA considered these soil fumigants as a group in order to ensure that similar risk assessment tools and methods were used for all soil fumigants and that risk management approaches were consistent. The chemicals included in the 2009 review are metam sodium/potassium, dazomet, chloropicrin, and methyl bromide. The Agency had also completed a RED for another soil fumigant in 1998, 1,3-dichloropropene (Telone ®), and registered the soil fumigant dimethyl disulfide (DMDS) in 2010.

Documents to support the reregistration or registration actions for this group of chemicals can be found in the public docket at http://www.regulations.gov under the docket numbers provided in Attachment C.

As described in the REDs, these soil fumigants are eligible for reregistration if certain risk mitigation measures are adopted. This ICR accounts for the risk mitigation activities outlined in the REDs that are applicable under the PRA as information collection activities (as listed in section 4 of this ICR), and estimates the respondent burden and costs for these activities (estimates are presented in section 6 of this ICR).

2(b). Practical Utility/Uses of the Data

The information collection activities covered by this ICR will provide the risk mitigation measures identified by the EPA's Office of Pesticide Programs (OPP) in the Office of Chemical Safety and Pollution Prevention (OCSPP) as necessary for certain soil fumigant chemicals to be eligible for reregistration under FIFRA. Without these measures, EPA may determine that products containing these chemicals do not meet the standard for registration under FIFRA section 3(c)(5). Due to the high benefits to agriculture, there could be significant economic impact if soil fumigant products are no longer available.

Background on Soil Fumigants

Soil fumigants are restricted use pesticides that, when applied to soil, form a gas to control pests that live in the soil and can disrupt plant growth and crop production. The fumigants are either volatile chemicals that become gases at relatively low temperatures, around 40 degrees Fahrenheit, or they are chemicals that react to produce such a gas (e.g., dazomet and metam sodium converting to methyl isothiocyanate, or MITC). Soil fumigants are used on many high value crops, including vegetables, fruits, nuts, forest seedlings, ornamentals, and nursery crops, to control a wide range of pests including nematodes, fungi, bacteria, insects, and weeds. Benefits analyses have indicated that fumigant use is important in a variety of crops. If these fumigants could not be used, there would likely be significant negative economic impacts. (These analyses are included in the Fumigant Reregistration Eligibility Decisions and Supporting Documents, which can be accessed using the docket numbers provided in attachment C.)

Because of the broad range of pests controlled, soil fumigants are used as part of the production of a wide variety of crops and provide high benefits for many growers. As gases, however, fumigants move from the soil to the air at the application site and may pose risks to handlers, re-entry workers, and bystanders as delineated in the Fumigant Reregistration Eligibility Decisions and Supporting Documents, including sensory irritation (stinging in eyes, nose, throat), nausea, vomiting, dizziness, headache, weakness, and collapse, and at the extreme, death. To reduce these exposures and address risks of concern, the Agency has required a number of mitigation measures designed to work together to address all risks, but focus on the acute human inhalation risks that have been identified in the revised risk assessments for these fumigants. Since the exposure pathway of concern is inhalation, the population of concern is anyone who might be exposed through this pathway, which includes applicators and handlers involved in the fumigant application, and bystanders (anyone nearby the treated field).

The Agency is requiring a number of mitigation measures (as described in Section 4 of this document) that may result in a burden to those participating in soil fumigant applications, to those enforcing soil fumigant label requirements, and to those who register soil fumigant products. These measures are designed to decrease the likelihood of exposures for the population of concern to these chemicals while maintaining their benefits to U.S. agriculture. For example, measures such as FMPs are designed to reduce workplace injuries and accidents by prescribing a series of operational requirements and criteria. Also, training is required to ensure applicators across the country receive the same basic level of information prior to making an application. Although there are some areas of the country where training is currently available from states or registrants, there is currently no consistent training standard across states and regions where soil fumigation is conducted. For the most part, people living and working near areas where fumigation is taking place do not have much knowledge about these types of applications. In several incidents, even emergency first responders who have responded to incidents involving soil fumigants do not understand the unique chemical properties of these chemicals and have in some cases increased the exposure of bystanders to these chemicals following an incident.¹

In general, more information on the soil fumigants, including links to all of the public comments received during the reregistration process for this group of chemicals, can be found athttp://www.epa.gov/soil-fumigants.

3. NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a). Non-duplication

Respondents will not be asked to collect or provide information that has been or is currently being collected by EPA, other federal or state agencies or proprietary sources, or is available elsewhere. The information collected is unique and is not duplicative of previous information collection requests.

3(b). Public Notice

Pursuant to 5 CFR 1320.8(d), EPA published a Federal Register (FR) Notice (77 FR 39699, July 5, 2012) announcing this proposed information collection activity and provided a 60-day public comment period. The Agency established a public docket for this proposal, which can be accessed at http://www.regulations.gov using the docket identifier EPA-HQ-OPP-2011-1036. The Agency did not receive any comments during the public comment period.

3(c). Consultation Required Prior to ICR Submission to OMB

In addition to the public notice published in the Federal Register concerning the development of this ICR, the Agency has and will continue to consult with stakeholders and respondents who actively interact with the Agency. For example, in developing the REDs the Agency used a thorough, multi-step, comprehensive process to elicit public comment, provide responses, and revise the decisions as appropriate. Starting in 2004, EPA held a series of public meetings to discuss the proposed risk assessment methods which the Agency then used to develop draft risk assessments. In 2005, EPA incorporated new modeling tools developed by industry and reviewed by the Scientific Advisory Panel (SAP) into the risk assessments, presented the preliminary risk assessments at another public meeting, and opened the first public comment period soliciting comments on the Agency’s assessment. In 2007, EPA issued responses to public comments on the revised risk and benefits assessments, and issued risk mitigation proposals for public comment. EPA then held a series of public meetings around the country to get input on the risk mitigation proposals. Then in 2008, EPA published REDs for public comment. The REDs showed label statements that would be used to mitigate risks and how the new measures would be implemented. In 2009, EPA published amended REDs that were revised based on public comments on the 2008 REDs. EPA continues to work closely with stakeholders to help ensure new label changes are implemented in a timely manner, and that users and enforcement personnel are prepared when these changes take effect. For more information, EPA’s fumigant webpage² contains a number of implementation resources as well as background information on these decisions.

Before sending this ICR to OMB for review and approval, EPA staff contacted five representatives from a cross-section of respondents to seek feedback on the burden estimates in the ICR, the clarity of instructions provided, and other questions pertaining to the requirements of the program. Based on the comments received during the consultation process, EPA has made changes to the original burden estimates in section 6 of this supporting statement. EPA has summarized those comments and describes how EPA has changed its original estimates below. For representatives’ contact information and their complete responses to the consultation questions, please see Attachment D.

First, in the original supporting statement, EPA did not specify additional capital or operation and maintenance costs. Several of the representatives commented that EPA should consider the costs associated with creating buffer zone signs. Additionally, several commenters also suggested that there are costs associated with purchasing air monitoring equipment that EPA did not address. EPA agrees that these are additional costs, and has accounted for them in section 6(b)(1)(a) of the supporting statement. None of the representatives provided estimates for costs associated with these items, so EPA has provided an estimate for each of these based off of current market prices for the materials and equipment.

Second, in the original supporting statement, EPA had indicated that it would take approximately 30 minutes to post buffer zone signs (see Table 6). Several commenters suggested that this was too short of a time to post signs for buffer zones. These commenters suggested that it could take anywhere from 1 to 2 hours to post the necessary signs. EPA has changed its estimate from 30 minutes to 1 hour based on these recommendations, accounting for the time it takes to both post and remove these signs after the buffer zone time period has expired.

Third, one commenter stated that EPA did not assign a cost to the distribution of training materials listed in Table 10. However, EPA did include the distribution of materials as a “clerical task” in all cases, so the time associated with this activity is listed in the “clerical” column. In reviewing the initial supporting statement and representative comments pertaining to this particular, EPA has decided to include 10 hours under the “technical” category for that activity in addition to the time accounted for in the “clerical” category. EPA has also changed the name of that activity from “Distribute Training Materials” to “Maintain/Distribute Training Materials.” EPA felt that in addition the distribution of training materials at the clerical staff level, technical staff will also be needed to ensure that the fumigant training materials for certified applicators is up to date.

EPA also received two comments regarding EPA’s estimate that it takes 30 minutes to read a soil fumigant label (see Table 6). The representatives suggested that it could take 2-3 hours to read a soil fumigant label. EPA has changed the activity name to “Understanding requirements,” but it has not changed the burden estimate. Reading the label is the law for all pesticide products, but the Agency did want to capture the additional time it may take to understand the suite of fumigant risk mitigation measures. These measures are included on fumigant product labels, but could also be learned in REDs or on EPA’s fumigant webpage. Additionally, 30 minutes is an average for all soil fumigant applications. Certified applicators will likely make multiple fumigant applications, oftentimes with the same soil fumigant. The initial application will take more time to understand the requirements as suggested by the representatives, but EPA believes that subsequent applications will require less time as the certified applicator will already be familiar with the requirements. Therefore, EPA has decided not to change this estimate.

For the representatives’ complete responses to the consultation questions, as well as EPA’s responses to those comments, please see Attachment D of this supporting statement.

3(d). Effects of Less Frequent Collection

The Agency is not requiring regular reporting on the status of these tasks back to the Agency which will significantly reduce the burden on the respondents. Information is reported only when needed, and cannot be collected less frequently and still maintain necessary risk mitigation. For example, certified applicators must only give FMPs to state enforcement officials when requested.

3(e). General Guidelines

The information collection activities discussed in this ICR comply with all regulatory guidelines under 5 CFR 1320.5(d)(2). Respondents are required to retain records, but respondents will not be required to retain records for more than 2 years.

3(f). Confidentiality

None of the information collected by EPA under this ICR comprises confidential business information.

3(g) Sensitive Questions

The information collection activities discussed in this document do not involve any sensitive questions.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a). Respondents/NAICS Codes

Respondents affected by the collection activities under this ICR are soil fumigant users, specifically certified applicators and agriculture pesticide handlers (NAICS 111000 – Agriculture, Forestry, Fishing and Hunting); soil fumigant registrants (NAICS 325300 - Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing); and state and tribal lead agencies (NAICS 999200 – State Government).

Soil fumigant users subject to the ICR are considered “applicators” and “handlers”. Soil fumigants are only allowed to be applied by, or under direct supervision of, specially trained and certified applicators. Certification programs are conducted by states, territories, and tribes in accordance with national standards. Fumigant handlers are identified as workers working in a fumigant application block or buffer zone that performs certain kinds of tasks as specified on fumigant labels.

Users of soil fumigants containing the active ingredients listed in Table 1 are subject to the collection activities specified in this ICR.

Table 1: Active Ingredients Subject to this ICR

Active Ingredient	Pesticide Chemical (PC) Code
1, 3-dichloropropene	029001
Chloropicrin	081501
Dazomet	035602
DMDS	000011
Metam sodium	039003
Metam potassium	039002
Methyl bromide	053201
Methyl isothiocyanate	068103

4(b). Information Collected

In order to be eligible for continued registration under FIFRA section 4(g), EPA determined that certain additional risk mitigation measures were necessary as terms and conditions of those registrations. The registrants agreed, and have amended their registrations to address the specific terms and conditions that are now being applied to all soil fumigant registrations. Information about EPA’s soil fumigant program is available at http://www.epa.gov/soil-fumigants. The activities are grouped according to the applicable respondent group.

Users of soil fumigants will need to engage in the activities identified in Table 2 to assure compliance with new fumigant label requirements. Note that compliance with the label-required training is a condition of product use. Because soil fumigants are Restricted Use Products, only certified applicators or handlers under their supervision may purchase or use them. Users must comply with pesticide labeling or face civil and criminal penalties pursuant to FIFRA sections 12(a)(2)(G) and 14, and certified applicators may also be sanctioned by suspension or revocation of certification (40 CFR 171.7(b)(iii)(A)).

Table 2: User (applicators and/or handlers) Activities

Burden	Description
Understand the requirements (applicator’s responsibility)	Learn/refresh understanding of fumigant requirements applicable to users that are provided on the fumigant product labels, and additional information on these requirements available at http://www.epa.gov/soil-fumigants/what-are-soil-fumigants.
Posting (applicator or handler’s responsibility)	As specified on the product label, obtain signs from product dealers (provided to dealers by registrants); fill in (1) product name, and (2) contact information for the fumigator; place signs at usual points of entry and along likely routes of approach unless a physical barrier (fence, wall) prevents access to the buffer; remove signs after buffer zone time period has ended. Information on buffer zone posting can be found at http://www.epa.gov/soil-fumigants/buffer-zone-fact-sheets.
Notify State Lead Agencies (SLAs) (applicator’s responsibility)	Applicators must check the EPA fumigant website for a list of states that require notification. If applicable, provide the following to the SLA: contact information for the fumigator and owner/operator; location of the field to be treated; product name and registration number; and when the fumigation is expected to occur. Information on notification to SLAs can be found at http://www.epa.gov/soil-fumigants/complying-required-state-and-tribal-notification-soil-fumigation
Fumigant Management Plan (FMP) and a post-application summary (PAS) (applicator’s responsibility)	As specified on the product label, prepare a written FMP for each fumigation to include the following: information on the site, fumigator, and owner/operator; fumigation procedures; buffer determinations; information on worker protection; procedures for air monitoring, posting, communication among key parties; and record keeping; emergency response plans and procedures for addressing accidental fumigant releases. Results of air monitoring for handlers, air monitoring results between buffers and bystanders, as well as any deviations from the FMP must be recorded in a PAS. Both documents must be filed and retained by both the certified applicator and the property owner for at least 2 years, and available to disclose to enforcement personnel or handlers participating in the application if requested. Information on FMPs can be found at http://www.epa.gov/soil-fumigants/introduction-soil-fumigant-management-plan
Applicator Training (applicator’s responsibility)	Applicators must attend a soil fumigant training program designed by the registrant and approved by EPA to specifically cover the following topics: how to correctly apply the fumigant, how to protect handlers and bystanders, how to determine buffer zone distances, how to develop an FMP and post-fumigation summary report, how to determine when unfavorable conditions exist, and how to comply with the required GAPs. The applicators participation in the training must be documented in the FMP. Information on applicator training can be found at http://www.epa.gov/soil-fumigants/soil-fumigant-training-certified-applicator
Disclosure to Handlers (applicator and handler’s responsibilities)	Applicators are responsible for disseminating fumigant specific information prior to each fumigation to every handler participating in the application. Information on handler information can be found at http://www.epa.gov/soil-fumigants/safety-information-fumigant-handler

Registrants of soil fumigants will need to engage in the activities identified in Table 3 in order for their product to remain eligible for registration under FIFRA section 3. Failure of a registrant to comply with the terms and conditions of registration would lead to cancellation of its soil fumigant products pursuant to FIFRA section 6(b) for failure to meet the section 3(c)(5) standard for registration.

Please note that EPA has included certain aspects of these requirements in the Data Call-In (DCI) notices that are being sent to the fumigant registrants. The DCI is requiring registrants to submit proposals on how they are planning to address each of the reregistration requirements listed below. The registrant’s burden covered in the DCI ICR (OMB Control No. 2070-0174) has not been duplicated here. The burden and activities listed below deal with development and implementation of requirements and therefore fall outside of the scope of the DCI ICR.

Table 3: Registrant Activities

Burden	Description
Training: Develop/update and implement training for fumigators in charge of fumigations	Prepare training materials, develop channels for training fumigators, and design and implement mechanisms for tracking fumigators who successfully complete training. Update training materials periodically. Disseminate training materials (either electronically, by paper, or in person). This may be done by registrants individually, or collaboratively through a soil fumigant registrant task force or group. As discussed in Table 2, information on applicator training, including already approved courses that are available, can be found at http://www.epa.gov/soil-fumigants/soil-fumigant-training-certified-applicator
Handler Information: Develop/update and disseminate safety information for handlers	Prepare safety training materials for handlers and make them available to fumigators to provide to fumigant handlers under their supervision. Update safety information periodically. Disseminate training materials (either electronically or by paper) As discussed in table 2, information on handler information can be found at http://www.epa.gov/soil-fumigants/safety-information-fumigant-handler.
Community Outreach: Develop/update and implement community outreach and education programs	Design and implement outreach programs to provide communities with information about soil fumigants, buffer zones, early signs of exposure, and what to do in case of an exposure, emergency, or incident; Update community outreach program periodically. Information on community outreach can be found at http://www.epa.gov/soil-fumigants/community-outreach-and-education-soil-fumigant
First Responder Training: Develop/update and implement first responder training	Identify communities in which fumigants are used which do not already have information or training on appropriate response to soil fumigant incidents, and develop and incorporate training for first responders into existing programs; Update first responder training periodically. Information on first responder training can be found at http://www.epa.gov/soil-fumigants/community-outreach-and-education-soil-fumigant

State Lead Agencies (SLAs) may engage in the activities identified in Table 4. Although not required, pesticide SLAs may also provide applicators EPA-approved alternatives to registrant-sponsored training.

Table 4: State Activities

Burden	Description
Receive Notice to States	State Lead Agencies (SLAs) have the option to receive notice prior to fumigant applications. As discussed in table 2, information on notification to SLAs can be found at http://www.epa.gov/soil-fumigants/complying-required-state-and-tribal-notification-soil-fumigations

5. THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

5(a). Agency Activities

This ICR primarily involves activities conducted for the purpose of submitting or providing information to third parties. EPA, however, does receive and review training and safety information materials developed or updated by registrants prior to their distribution to third parties. EPA implements the soil fumigant mitigation measures as part of the reregistration program.

Table 5: Agency Activities

Burden	Description
EPA Review, Coordination, and Implementation Responsibilities	EPA has the responsibility to implement the soil fumigant mitigation measures, review and approve materials that are submitted, and coordinate reviews among experienced professionals.

5(b). Collection Methodology and Management

This ICR primarily involves activities conducted for the purpose of submitting or providing information to third parties. For the information that EPA may collect in the future under this ICR (i.e., training and safety information materials), registrants will submit the materials as needed and EPA will track, review and approve any new or updated materials consistent with current Agency processes and procedures for the submission of pesticide information to the Agency.

5(c). Small Entity Flexibility

The reregistration eligibility of the soil fumigants depend upon applicators receiving the various information and training required in the soil fumigant labels. These cannot be reduced for small establishments without seriously compromising the protections offered to applicators and bystanders. As such, small entities are required to follow the same requirements as larger establishments.

5(d). Collection Schedule

This ICR primarily involves activities conducted for the purpose of submitting or providing information to third parties. For registrants who must submit training and safety information materials to the Agency for review, there is no set collection schedule as registrants submit materials only when developed or updated. Since training is required by the label, training materials should be completed before labels requiring the training are approved. EPA periodically checks the fumigant risk mitigation measures as a part of the registration review program.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a). Estimating Respondent Burden

The burden associated with this collection of information is described in detail in the following sections. The respondents include certified applicators, pesticide handlers, fumigant registrants and states. To estimate the respondent burden, the Agency used current information and statistics from a variety of sources as explained in this chapter, on the number of fumigant applications made annually, the number of certified applicators and pesticide handlers that apply or handle soil fumigants, and the number of fumigant registrants. This information comes from a variety of sources including state reports, previous EPA analyses, and other EPA databases.

Certified applicators and pesticide handlers have paperwork burden associated with fumigant application activities, such as understanding the requirements, posting treatment areas and developing a FMP. For pesticide handlers, burden is estimated per application, where an application is the delivery of a pesticide to a field or application block. It is estimated that the burden associated with the first application after the labels have been updated with the new mitigation measures will be highest, mostly due to the time necessary to develop the FMP (12 hours). Each of the other paperwork related activities is estimated to take no more than an hour. Total burden for the first application following the changes to the label is estimated to be nearly 15 hours, while each subsequent application using the updated labels is estimated to take less than 4 hours. The Agency estimates 12,651 soil fumigant applications are made in the U.S. each year.

Requirements currently exist to ensure that certified applicators and agricultural handlers possess general pesticide use and safety information. Applicators must be determined to be competent to become certified, and to maintain their certification they must either receive training or be recertified by exam on a schedule determined by the state (Certification of Pesticide Applicators, 40 CFR 171). That schedule ranges, depending on the state, from 1 to 5 years. Under the agricultural Worker Protection Standard (40 CFR 170), agricultural handlers are required to receive general pesticide safety training at least once every 5 years. Burdens from those requirements are included in currently-approved ICRs for those two rules (Certification of Pesticide Applicators (OMB Control No. 2070-0029) and Worker Protection Standard Training and Notification (OMB Control No. 2070-0148)), and are not included here.

The soil fumigant label revisions establish training requirements specific to soil fumigation for certified applicators and handlers on the safe and appropriate use of these products. Soil fumigant applicators are required by the product labels approved in accordance with 3(c)(5) to receive this fumigant-specific training every 3 years; handlers involved in soil fumigant application must be provided with the specific safe handling information annually in accordance with fumigant product labels approved under EPA’s authority under 3(c)(5). Burdens from these fumigant-specific requirements are included in this ICR and are separate and distinct from the requirements cited above under the Certification of Pesticide Applicators ICR (OMB Control No. 2070-0029) and the agricultural Worker Protection Standard ICR (OMB Control No. 2070-0148). There are an estimated 4,458 certified applicators applying soil fumigants and 13,374 pesticide handlers of soil fumigants subject to these training requirements as specified by product labels approved in accordance with 3(c)(5).

Registrant burden is associated with the development and dissemination of fumigant application, handler safety and first responder training materials. They must also develop and implement a community outreach program. The majority of the burden associated with these activities is in the one-time development of the materials. An estimated 320 hours will be spent by each registrant developing the fumigant training materials; 120 hours will be spent developing the handler safety materials; and 240 hours will be spent developing the first responder training and developing the community outreach program. The annual dissemination of fumigant training and handler safety materials is estimated to take 22 hours per registrant for each activity, while the implementation of the community outreach program is estimated to take 120 hours per registrant annually, and the dissemination of first responder training is estimated to take 120 hours per registrant annually. Registrants have the option of forming task forces if it is their interest, and may provide data submissions through this collective group. There are currently six task forces that were established by the registrants, and at the discretion of the registrants, prior to the activities associated with the label mitigation measures identified in this data collection request. These same task forces will be developing and disseminating the required materials.

States are responsible for enforcement and compliance of the fumigant application-related requirements. It is estimated that states will spend an average of 15 minutes per application on enforcement and compliance activities. Given the EPA’s estimate of 12,651 fumigant applications made per year, state activities amount to more than 3,000 hours per year. Estimates and methodology are addressed in Table 13.

The detailed burden estimates and calculations are presented below for each respondent group, along with costs. The burden for certified applicators and pesticide handlers is shown in Tables 6, 7, 8, and 9; burden for registrants of soil fumigant products in Tables 10 and 11; and burden for states in Tables 12 and 13.

6(b). Methodology for Estimating Respondent Cost

Respondent cost is based on the burden as described above and summarized below, and wages, benefits and overhead for all labor categories for affected industries, state government, and EPA employees. This approach uses a transparent and consistent methodology and current publicly-available data to provide more accurate estimates and allow easy replication of the estimates of wages, benefits and overhead.

Methodology: The methodology uses data on each sector and labor type for an unloaded wage rate (hourly wage rate), and calculates the loaded wage rate (unloaded wage rate + benefits), and the fully loaded wage rate (loaded wage rate + overhead). Costs are indexed to 2010 dollars.

Wage Rates: Wages are estimated for occupations (management, technical, and clerical) within applicable sectors. The Agency uses average unloaded wage data for the relevant sectors available in the National Industry-Specific Occupational Employment and Wage Estimates from the Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm. For loaded wage rates, benefits represent 44% of unloaded wage rates, based on benefits for all civilian non-farm workers, from http://www.bls.gov/news.release/ecec.t01.htm. Fully loaded wage rates include an additional 50% on top of the loaded wage rate to capture overhead costs (EPA guidelines 20-70%). The data and calculations for wage rates used in this document are presented in Attachment E.

Sectors: The specific North American Industry Classification System (NAICS) code and website for each sector is included in that sector’s wage rate table. Within each sector, the wage data are provided by Standard Occupational Classification (SOC). The SOC system is used by Federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data (see http://www.bls.gov/oes/current/oes_stru.htm ).

There are three categories of respondents: certified applicators and handlers, registrants and states. The cost associated with each is described in this section.

1. Certified Applicators and Pesticide Handlers

The estimated costs of paperwork activities for certified applicators and pesticide handlers are shown in Tables 6, 7, 8, and 9, along with burden. Tables 6 and 7 list the estimated costs associated with paperwork for user application activities, while Tables 8 and 9 list the costs associated with training activities. Wage rates are based on NAICS code 111000 - Agriculture, Fishing, Forestry and Hunting. They are loaded to account for some benefits paid by the employer, but do not account for overhead. The loaded wage rate for certified applicators ($33.24) is based on the scientist/technician labor category, while the pesticide handler wage is based on an average of the loaded wage rate for the scientist/technician and agriculture worker labor categories (($33.24+$13.40)/2 = $23.32), reflecting a higher skilled worker (see Attachment E).

(1a) User Application Activities

Table 6 summarizes the burden and cost for paperwork activities per soil fumigant application for certified applicators and pesticide handlers. Table 7 summarizes the burden and cost per year. The annual burden and cost is based on the number of applications made per year. EPA estimates 12,651 applications are made per year by certified applicators and pesticide handlers based on historical pesticide usage data for the soil fumigants.

In addition to the hourly burden and cost of compliance with the product labels as approved in accordance with FIFRA section 3(c)(5), applicators are required to purchase signs for the posting requirement and tubes and pumps for the air monitoring requirement. The sign cost is $0.09 per sheet³ and assuming 4 sheets per application (posting at 2 points of entry to the treated field and 2 postings along routes of approach to the treated field on average), the cost per application is $0.36. The total annual material cost for posting, assuming 12,651 applications per year, is $4,554. With 37,953 applications over 3 years, the total estimated 3 year cost is $13,663.

Monitoring devices must be used during methyl bromide applications and if sensory irritation occurs while applying other fumigants. Each application requires a pump to be on-site, and a new tube is necessary for every measurement. The cost of a Draeger tube for monitoring the air at an application site is $16 on average⁴ and the cost of a Draeger pump is $405⁵. Assuming one tube per application, the total annual cost of the tubes is $202,416 ($16 per tube per application multiplied by 12,651 applications). Over 3 years, the total cost of the tubes is $607,248. Assuming each certified applicator (there are an estimated 4,458 certified applicators) purchases one new pump every 3 years, the total 3 year cost for the pumps is $1,805,490, for an average of $601,830 per year.

Table 6. Certified Applicator and Pesticide Handler Burden and Cost for User Application Activities per Application, By Activity (4,458 certified applicators and 12,374 handers)

Category	Activity	Frequency	Certified Applicator Hours Cost (@$33.24/hr)1	Pesticide Handler Hours Cost (@$23.32/hr)1	Total Hours Cost2
Understanding requirements	Learn/refresh understanding of fumigant requirements	Annual	0.50 $16.62	0 $0	0.50 $16.62
Posting	Fill in Information	Per Application	0.13 $4.32	0 $0	0.13 $4.32
	Post/Remove Signs	Per Application	0 $0	1.0 $23.32	1.0 $23.32
Check EPA website to determine if notice is required and provide notice of applications to applicable SLAs	Prepare information in Notice	Per Application	0.17 $5.65	0 $0	0.17 $5.65
	Send Notice	Per Application	0.05 $1.66	0 $0	0.05 $1.66
Prepare a Fumigant Management Plan (FMP) and a post-application summary (PAS)	Prepare Initial Plan	Per Initial Application	12.00 $398.88	0 $0	12.00 $398.88
	Prepare Subsequent Plan	Per Subsequent Application	1.00 $33.24	0 $0	1.00 $33.24
	Create Post Fumigation Report	Per Application	1.00 $33.24	0 $0	1.00 $33.24
	File and Disclose Plan	Per Application	0.05 $1.66	0 $0	0.05 $1.66
Total Burden and Cost Per Initial and Subsequent Application3
		Initial Application	13.90 $462.04	1.0 $23.32	14.90 $485.36
		Subsequent Application	2.90 $96.40	1.0 $23.32	3.90 $119.72

Numbers may not add due to rounding.

1 - Cost is equal to the hours times the wage rate ($/hr).

2 - Total hours and cost are the sum of certified applicator and pesticide handler hours and cost.

3 – Initial Application is equal to the sum of each activity less prepare subsequent plan. Subsequent application hours and cost is equal to the sum of each activity less prepare initial application.

Table 7. Total Annual Certified Applicator and Pesticide Handler Burden and Cost for User Application Activities (4,458 certified applicators and 12,374 handers)

Year	Certified Applicator Hours Cost1	Pesticide Handler Hours Cost1	Total Hours Cost2
Year 1	175,849 $5,845,217	12,651 $295,021	188,500 $6,140,239
Year 2	175,849 $5,845,217	12,651 $295,021	188,500 $6,140,239
Year 3	106,268 $3,532,362	12,651 $295,021	118,919 $3,827,383
3 Year Annual Average	152,655 $5,074,265	12,651 $295,021	165,306 $5,369,287
3 Year Total	457,966 $15,222,796	37,953 $885,064	495,919 $16,107,860

Numbers may not add due to rounding.

1 - Cost is equal to the total hours and cost for the initial and subsequent application as listed in rows 11 and 12 of Table 6 multiplied times the number of applications. EPA assumes that fumigations occur once every two years, and that 100% of fumigations in year 1 and 2 are first time fumigation, and 50% of fumigations are first time fumigations starting in year 3. The estimated number of applications per year is as follows:

Initial Applications Subsequent Applications

Year 1 12,651 0

Year 2 12,651 0

Year 3 6,326 6,326

3 Year Average 10,543 2,109

3 Year Total 31,628 6,326

For Example: For certified applicators in Year 3 the hours are equal to following:

Certified applicator: (13.90 hours/application x 6,326 applications) + (2.90 hours/application x 6,326 applications)

2 - Total hours and cost are the sum of certified applicator and pesticide handler hours and cost.

(1b) Training Activities

Table 8 summarizes the burden and cost for certified applicators and pesticide handlers for training activities per trainee, while Table 9 summarizes the burden and cost per year of training activities. The annual burden and cost is based on the number of certified applicators and pesticide handlers involved with soil fumigant applications. EPA estimates that there are 4,458 applicable certified applicators and 13,374 handlers. This is based on data submitted to EPA on the number of certified applicators and the assumption of three pesticide handlers per certified applicator.

Table 8. Certified Applicator and Pesticide Handler Burden and Cost for Training Activities per Applicator, By Activity

Category	Activity	Frequency	Certified Applicator Hours and Cost (@$33.24/hr)1	Pesticide Handler Hours and Cost (@$23.32/hr)1	Total Hours and Cost2
Applicators must take registrant developed and EPA approved fumigant training	Training as required by product labels approved in accordance with 3(c)(5)	Once Every 3 Years	8.00 $265.92	0 $0	8.00 $265.92
	Retain training documentation as required by product labels approved in accordance with 3(c)(5)	Once Every 3 Years	0.05 $1.66	0 $0	0.05 $1.66
Handlers must receive fumigant specific information	Fumigant specific safety information as required by product labels approved in accordance with 3(c)(5)	Annual3	0.08 $2.66	1.00 $23.32	1.08 $25.98

Numbers may not add due to rounding.

1 - Cost is equal to the hours times the wage rate ($/hr).

2 - Total hours and cost are the sum of certified applicator and pesticide handler hours and cost.

3 – Information is disseminated to pesticide handlers on a per application basis. Estimates presented here are the total estimated annual burden of all applications conducted by a certified applicator or pesticide handler in a given year.

Table 9. Total Annual Certified Applicator and Pesticide Handler Burden and Cost for Training Activities (4,458 certified applicators and 12,374 handers)

Year	Certified Applicator Hours and Cost1	Pesticide Handler Hours and Cost1	Total Hours and Cost2
Year 1	36,244 $1,204,735	13,374 $311,882	49,618 $1,516,617
Year 2	357 $11,855	13,374 $311,882	13,731 $323,736
Year 3	357 $11,855	13,374 $311,882	13,731 $323,736
3 Year Annual Average	12,319 $409,482	13,374 $311,882	25,693 $721,363
3 Year Total	36,957 $1,228,445	40,122 $935,645	77,079 $2,164,090

Numbers may not add due to rounding.

1 - Cost is equal to the total hours and costs as listed Table 8 times the number of certified applicators and pesticide handlers that apply or handle soil fumigants. EPA estimates an applicable 4,458 certified applicators and 13,374 pesticide handlers.

For Example: For certified applicators in Year 1 the hours are equal to following:

Certified applicator: (8.00 hours/applicator + 0.05 hours/applicators + 0.08 hours/applicator) x (4,458 applicators)

2 - Total hours and cost are the sum of certified applicator and pesticide handler hours and cost.

2. Registrants of Soil Fumigant Products

The estimated paperwork costs for soil fumigant registrants are shown in Tables 10 and 11. Wage rates are for NAICS 325300 - Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing and are fully loaded to account for benefits and overhead. EPA estimates that there are 6 registrant task forces that will develop and distribute the required materials based on correspondence with these task forces. Table 10 shows the estimates of burden and cost per registrant task force to develop and distribute training materials; prepare and distribute safety information; design and implement community outreach; and develop and distribute first responder training materials. Table 11 shows the annual cost across all registrants of the activities taking into account the frequency of the activity.

Table 10. Soil Fumigant Registrant Burden and Cost, By Activity

Category	Activities	Frequency	Management Hours and Cost (@$120.28/ hr)1	Technical Hours and Cost (@$60.85/ hr)1	Clerical Hours and Cost (@$37.11/ hr)1	Total Hours and Cost2
Applicators must take registrant developed and EPA approved fumigant training	Develop/Update Training Materials	One Time	80.00 $9,622.40	160.00 $9,736.00	80.00 $2,968.80	320.00 $22,327
	Maintain / Distribute Training Materials	Annually	0 $0	10 $608.50	12.00 $445.32	22.00 $1,054
Handlers must receive fumigant specific information	Prepare/Update Information	One Time	40.00 $4,811.20	40.00 $2,434.00	40.00 $1,484.40	120.00 $8,730
	Distribute Training Materials	Annually	0 $0	0 $0	12.00 $445.32	12.00 $445
Community Outreach Program	Design/Update Program	One Time	80.00 $9,622.40	80.00 $4,868.00	80.00 $2,968.80	240.00 $17,459
	Implement Program in High Use Areas	Annually	40.00 $4,811.20	40.00 $2,434.00	40.00 $1,484.40	120.00 $8,730
First Responder Training	Develop/Update Training Materials	One Time	80.00 $9,622.40	80.00 $4,868.00	80.00 $2,968.80	240.00 $17,459
	Distribute Material in High Use Areas	Annually	0 $0	0 $0	120.00 $4,453.20	120.00 $4,453

Numbers may not add due to rounding.

1 - Cost is equal to the hours times the wage rate ($/hr).

2 - Total hours and cost are the sum of managerial, technical and clerical hours and cost.

Table 11. Total Annual Registrant Burden and Cost (4,458 certified applicators and 12,374 handers)

Year	Managerial Hours and Cost1	Technical Hours and Cost1	Clerical Hours and Cost1	Total Hours and Cost2
Year 1	1,920 $230,938	2,460 $149,691	2,784 $103,314	7,164 $483,943
Year 2	240 $28,867	300 $18,255	1,104 $40,969	1,644 $88,092
Year 3	240 $28,867	300 $18,255	1,104 $40,969	1,644 $88,092
3 Year Annual Average	800 $96,224	1,020 $62,067	1,664 $61,751	3,484 $220,042
3 Year Total	2,400 $288,672	3,060 $186,201,201	4,992 $185,253	10,452 $660,126

Numbers may not add due to rounding.

1 - Cost is equal to the total hours and cost in Table 10 multiplied times the estimated number of registrant task forces (6). There are 14 registrants represented by the 6 registrant task forces. For Example: The Year 1 number of managerial hours is equal to the hours per registrant for each of the activities times 6: (80 hours/registrant+0 hours/registrant+40 hours/registrant+0 hours/registrant+80 hours/registrant+40 hours/registrant+80 hours/registrant+0 hours/registrant) x (6 registrants)

2 - Total hours and cost are the sum of managerial, technical and clerical hours and cost.

3. States

The burden for states per application for compliance and enforcement activities is shown in Table 12. Wage rates are for NAICS 999200 – State Government and are fully loaded to account for benefits and overhead. EPA’s requirements are for only those states with high fumigant use⁶, and currently, EPA estimates that there are 15 states that account for the majority of fumigant use and are considered high use: California, Washington, Idaho, Oregon, Wisconsin, Michigan, Florida, Minnesota, North Carolina, Virginia, Arizona, Nevada, Georgia, Colorado, and North Dakota. This is based on an EPA analysis of fumigant pesticide usage and U.S. crop acreage grown which showed that a majority of soil fumigant usage occurred in 15 states.⁷ Costs are measured on a per application basis. Annual burden, assuming more than 12,651 fumigant applications per year, is shown in Table 13. The Agency estimates that all of the paperwork burden for responding to this ICR will be conducted by clerical (or administrative) staff.

Table 12. State Burden and Cost per Application

Category	Activities	Frequency	Clerical Hours and Cost (@$39.20/hr)1	Total Hours and Cost2
State Compliance and Enforcement	Paperwork for Compliance and Enforcement	Annually	0.25 $9.80	0.25 $9.80

Numbers may not add due to rounding. State management and technical staff are not estimated to be impacted by this ICR.

1 - Cost is equal to the hours times the wage rate ($/hr).

2 - Total hours and cost are the sum of managerial, technical and clerical hours and cost. Since only clerical staff is impacted, the total hours and cost are equal to the clerical hours and cost.

Table 13. Total Annual State Burden and Cost

Year	Clerical Hours and Cost1	Total Hours and Cost2
Year 1	3,163 $123,980	3,163 $123,980
Year 2	3,163 $123,980	3,163 $123,980
Year 3	3,163 $123,980	3,163 $123,980
3 Year Annual Average	3,163 $123,980	3,163 $123,980
3 Year Total	9,488 $371,939	9,488 $371,939

Numbers may not add due to rounding. State management and technical staff are not estimated to be impacted by this ICR.

1 - Cost is equal to the total hours and cost per application as listed in Table 7 multiplied times the number of applications. EPA assumes that fumigations occur once every two years, and that 100% of fumigations in year 1 and 2 are first time fumigation, and 50% of fumigations are first time fumigations starting in year 3. The estimated number of applications per year as follows:

Initial Applications Subsequent Applications

Year 1 12,651 0

Year 2 12,651 0

Year 3 6,326 6,326

3 Year Average 10,543 2,109

3 Year Total 31,628 6,326

For Example: For states in Year 1, the hours are equal to the following: (0.25 hours/application x 12,651 applications)

2 - Total hours and cost are the sum of managerial, technical and clerical hours and cost. Since only clerical staff is impacted, the total hours and cost are equal to the clerical hours and cost.

6(c). Estimating Agency Burden and Cost

Agency burden is shown in Tables 14 and 15. To determine Agency costs, the Agency used the Bureau of Labor Statistics estimates of labor rates for the North American Industry Classification System code for the Federal Executive Branch (NAICS 999100). Wage rates are fully loaded to account for benefits and overhead. Table 14 shows the burden and cost per activity for the Agency, while Table 15 is the annual burden and cost across all activities. Agency costs are based on managerial and technical hours spent on compliance and enforcement activities.

Table 14. Agency Burden and Cost

Category	Activities	Frequency	Management Hours and Cost (@$119.85/hr)1	Technical Hours and Cost (@$71.58/hr)1	Total Hours and Cost2
Federal Compliance and Enforcement	Review Registrant Training Materials	One Time	80.00 $9,588.00	1,092.00 $78,165.36	1,172 $87,753
	Develop User Tools and Templates	One Time	40.00 $4,794.00	1,092.00 $78,165.36	1,132 $82,959
	Review Labels and Materials	One Time	40.00 $4,794.00	2,184.00 $156,330.72	2,224 $161,125
	Compliance Training and Stakeholder Engagement	Annually	104.00 $12,464.40	1,092.00 $78,165.36	1,196 $90,630

Numbers may not add due to rounding. Agency clerical staff are not impacted by this ICR.

1 - Cost is equal to the hours times the wage rate ($/hr).

2 - Total hours and cost are the sum of managerial, technical hours and cost.

Table 15. Total Annual Agency Burden and Cost

Year	Managerial Hours/Cost1	Technical Hours/Cost1	Total Hours/Cost2
Year 1	264 $31,640	5,460 $390,827	5,724 $422,467
Year 2	104 $12,464	1,092 $78,165	1,196 $90,630
Year 3	104 $12,464	1,092 $78,165	1,196 $90,630
3 Year Annual Average	157 $18,856	2,548 $182,386	2,705 $201,242
3 Year Total	472 $56,569	7,644 $547,158	8,116 $603,727

Numbers may not add due to rounding.

1 - Cost is equal to the total hours and cost across activities based on frequency from Table 14. For example: The Year 1 number of managerial hours is equal to the sum of the hours for each activity: 80 hours + 40 hours + 40 hours + 104 hours. Years 2 and 3 only include the activities incurred annually (104 hours).

2 - Total hours and cost are the sum of managerial and technical hours and cost.

6(d). Bottom Line Burden Hours and Cost

Tables 16 and 17 summarize the total annual respondent and Agency burden, respectively. Including the cost to applicators for the materials required for compliance with the posting and air monitoring requirements ($2,426,401), the total 3 year respondent cost is $21,730,417.

Table 16. Annual Respondent Burden and Cost

Information Collection	Respondent	No. of Responses	Burden Hours	Costs
Fumigant User Application Activities (Table 7)	Certified Applicators	12,651	152,655	$5,883,0651
	Pesticide Handlers	12,651	12,651	$295,021
Fumigant Training Activities (Table 9)	Certified Applicators	4,458	12,319	$409,482
	Pesticide Handlers	13,374	13,374	$311,882
Development and Distribution of Training & Informational Materials (Table 11)	Registrants	6	3,484	$220,042
Paperwork for Compliance and Enforcement in High Use States (Table 13)	State Agencies	12,651	3,163	$123,980
Total Annual Average		55,791	197,646	$7,243,472

1- Costs for certified applicators include the capital costs of $808,800 for purchasing buffer zone signs and air monitoring equipment (pumps and tubes). See section 6(b)(1a) and Table 7.

Table 17. Annual Agency Burden and Cost

Year	Total Hours1	Total Cost1
Year 1	5,724	$422,467
Year 2	1,196	$90,630
Year 3	1,196	$90,630
3 Year Annual Average	2,705	$201,242
3 Year Total	8,116	$603,727

1 – Total hours and cost are a sum of total hours and cost for the Agency. See Table 15.

6(e). Reasons for Change in Burden

The increase in burden are related to the implementation of statutory responsibilities associated with the reregistration of pesticides. Certain uses of soil fumigants are eligible for reregistration, provided that the risk mitigation measures outlined in Reregistration Eligibility Decisions are adopted. The activities covered by this new ICR will be used to ensure that the soil fumigant risk mitigation measures are adequately implemented, and accounts for the burden on respondents to adopt those risk mitigation measures. The annual respondent burden for this ICR is estimated to be 197,646 burden hours.

6(f). Burden Statement

The total estimated annual respondent paperwork burden to comply with this information collection activity is 197,646 hours. This estimate includes the time needed for certified applicators (164,974 hours), pesticide handlers (26,025 hours), registrants (3,484 hours), and states (3,163 hours) to conduct fumigant application related paperwork activities (see section 6(b) and 6 (d)). For certified applicators, the burden for this collection is estimated to be 2.9 to 13.9 hours per soil fumigant application, and 0.08 to 8.13 hours per certified applicator per year for training. For pesticide handlers, the burden for this collection is estimated to average 1 hour per soil fumigant application, and 1 hour per pesticide handler per year for safety training. The burden for registrant task forces to develop, distribute, and implement fumigant training and informational materials is estimated to be 274 to 1,194 hours per task force per year. For states, the burden for this collection is estimated to average 0.25 hours per application.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR Part 9, and included on the related collection instrument or form, if applicable.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under docket ID No. EPA‑HQ‑OPP‑2011-1036, which is available for public viewing at the OPP Docket in the EPA Docket Center, EPA West, Rm. 3334, 1200 Pennsylvania Ave, NW, Washington, DC 20460-0001. This docket facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The OPP Docket telephone number is (703) 305-5805. An electronic version of the public docket is available through Federal eRulemaking Portal, http://www.regulations.gov. Follow the online instructions for viewing documents and submitting comments. You can also send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the docket ID No. EPA‑HQ‑OPP‑2011-1036 and OMB control number 2070-NEW in any correspondence.

Attachments to the Supporting Statement

Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPP-2011-1036. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in section 6(f) of the supporting statement.

Attachment A: 7 U.S.C. 136a - FIFRA section 3(c)(2)(B). This is also available online at the House of Representatives’ US Code Website

Attachment B: 7 U.S.C. 136a - FIFRA Section 3(c)(5). This is also available online at the House of Representatives’ US Code Website

Attachment C: Docket Numbers for Fumigant Reregistration Eligibility Decisions and Supporting Documents

Attachment D: Record of Consultations Between the U.S. Environmental Protection Agency and Respondents to the Information Collection Request: “Soil Fumigant Risk Mitigation”

Attachment E: Worksheet for Estimating OPP ICR Wage Rates for Industry, State and EPA Labor Costs

Attachment F: Fumigant Management Plans (FMP) Information and Templates: http://www.epa.gov/pesticides/reregistration/soil_fumigants/soil-fum-mgmt-plans-templates.html

Attachment G: Identifying Fumigant High-Use Areas Using Metam-Sodium as an Example

1 Summary Fumigants Group Incident Report. R. Allen. 4/17/07. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2005-0125-0075

2 http://www.epa.gov/pesticides/reregistration/soil_fumigants/index.htm

3

4 Draeger tubes are sold in packages of 10 for as much as $160 per package. Source: AFC International, Inc., 2012.

5 Source: AFC International, Inc., 2012.

6 For additional information on determining high-use areas, see Attachment G, “Identifying Fumigant High-Use Areas Using Metam-Sodium as an Example”

7 The EPA document can be found at http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2005-0125-0516.

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