Document ID: EPA-HQ-OPP-2011-1036-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-07-05T04:00Z

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
      
      1(b).	Short Characterization/Abstract 

      EPA completed Reregistration Eligibility Decisions (REDs) for a group of soil fumigant chemicals in May 2008 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.  The Agency has determined that certain uses of these soil fumigants are eligible for reregistration, provided that the risk mitigation measures outlined in the REDs are adopted.  The required mitigation measures may result in a burden, applicable under the Paperwork Reduction Act (PRA), to those participating in soil fumigant applications, those enforcing soil fumigant label requirements, and registrants of soil fumigant products.  These measures are designed to decrease the likelihood of exposures to these chemicals while maintaining their important benefits to U.S. agriculture.  
      
      Without the complete suite of measures, these chemicals do not meet the requirements to be eligible for reregistration under 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) or section 3(c)(5) 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

      EPA's Office of Pesticide Programs (OPP), under the Office of Chemical Safety and Pollution Prevention, uses the information collected under this ICR to ensure that risk mitigation for certain soil fumigant chemicals necessary for reregistration eligibility are adequately implemented.  The programs and activities represented in this new 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.  
      
      Sections 3(a) and12(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 United States.  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:

 Its composition is such as to warrant the proposed claims for it.
 Its labeling and other material required to be submitted comply with the 	requirements of this Act.
             It will perform its intended function without unreasonable adverse effects on the environment.
             When used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.
 
      FIFRA section 2(bb) 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 re-assess 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 the FIFRAcalls for EPA to determine, after submission of relevant data concerning an active ingredient, whether pesticides containing the active ingredient are eligible for reregistration.  EPA completed REDs for a group of soil fumigant chemicals in May 2008 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.  
       
       The chemicals included in this review are metam sodium/potassium, dazomet, chloropicrin, and methyl bromide.  The Agency completed a RED for another soil fumigant, 1,3-dichloropropene (Telone (R)), in 1998.  Additional soil fumigants, iodomethane and dimethyl disulfide (DMDS) were registered in October 2007 and July 2010 respectively.  The EPA considered these soil fumigants as a group in order to ensure that similar risk assessment tools and methods were used for all, and risk management approaches were consistent.  Documents to support the reregistration or registration actions for this group of chemicals can be found in the public docket at www.regulations.gov under the following docket numbers: EPA-HQ-OPP-2005-0123 (methyl bromide), EPA-HQ-OPP-2005-0124 (1,3-dichloropropene), EPA-HQ-OPP-2005-0125 (metam sodium/potassium), EPA-HQ-OPP-2005-0128 (dazomet), EPA-HQ-OPP-2007-0350 (chloropicrin), EPA-HQ-OPP-2005-0252 (iodomethane), EPA-HQ-OPP-2007-0092 (DMDS).  Attachment C lists these chemicals and the docket numbers.

      The Agency has determined that certain uses of these soil fumigants are eligible for reregistration, provided that the risk mitigation measures outlined in the REDs are adopted.  EPA is requiring a suite of complementary mitigation measures to protect handlers, reentry workers, and bystanders from risks resulting from exposure to the soil fumigant pesticides. While these measures are designed to work together to address all risks, the new mitigation measures have a specific focus on the acute human inhalation risks that have been identified in the revised risk assessments for these fumigants.  This ICR accounts for the additional risk mitigation activities outlined in the REDs that are applicable under the PRA, and documents the respondent burden and costs for these activities.
      
      In addition, when new soil fumigants iodomethane and DMDS were registered, the conditions of the registration required products containing these active ingredients to include similar risk mitigation measures to those that were required in the REDs for the other chemicals.  Similarly, these measures are required to ensure handlers, reentry workers, and bystanders that may be exposed to soil fumigants are protected.  
      
      Without the complete suite of measures, these chemicals do not meet the requirements to be eligible for reregistration under FIFRA.  EPA may determine products containing these chemicals do not meet the 3(c)(5) standard for registration under FIFRA.  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(b).	Practical Utility/Uses of the Data

      Background on Soil Fumigants

      Soil fumigants are 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 highly 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 indicate that fumigant use is important in a variety of crops, and that if these fumigants could not be used, there would likely be significant negative economic impacts.

      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. 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.
      
      Bystanders, who are not involved in the fumigant application but who live, work, go to school, or are otherwise located in nearby areas, may be exposed to airborne fumigants that move off the application site. Bystanders include agricultural workers in nearby fields who are not involved with the fumigant application. 

      Incidents of bystander exposure demonstrate that fumigants have the potential to move off site at concentrations that produce adverse health effects in humans, over periods of several hours to days after application. These health effects may range from mild and reversible eye irritation to more severe and irreversible effects, depending on the fumigant and the level of exposure.

	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, those enforcing soil fumigant label requirements, and registrants of soil fumigant products.  These measures are designed to decrease the likelihood of exposures to these chemicals while maintaining their important benefits to U.S. agriculture.  
      
      For example, measures such as Fumigant Management Plans (FMPs) are designed to reduce workplace injuries and accidents by prescribing a series of operational requirements and criteria.  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 done.  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.  

More information on the soil fumigants in general can be found through this website, including links to all of the public comments received during the reregistration process for this group of chemicals (http://www.epa.gov/pesticides/reregistration/soil_fumigants/index.htm).

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

		3(a). 	Non-duplication

      Respondents will not be asked to provide information that has been or is currently being collected by EPA, other federal or state agencies or proprietary sources.  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 will publish a Federal Register (FR) Notice announcing this proposed information collection activity and provide a 60-day public comment period.  Any public comment received for this action will be posted at http://www.regulations.gov using the docket identifier EPA-HQ-OPP-2011-1036.	

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

      In addition to the public notice that EPA will publish 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 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.  EPA's fumigant webpage contains a number of implementation resources as well as background information on these decisions and can be found at this location:  http://www.epa.gov/pesticides/reregistration/soil_fumigants/index.htm.

      In addition, before sending this ICR to OMB for review and approval, EPA staff will contact 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. Their responses to EPA's consultation efforts will be summarized and made publicly available.

      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.  

	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 will not be required to retain records for this program for more than 2 years. 
      
      3(f).	Confidentiality

      No 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); state and tribal lead agencies (NAICS 999200  -  State Government); and the U.S. EPA (999100  -  Federal Executive Branch).

      The users of soil fumigants containing the following active ingredients are subject to the collection activities specified in this ICR:

Table 1:  Active Ingredients Subject to this ICR
Active Ingredient
PC Code
1, 3-dichloropropene
029001
Chloropicrin
081501
Dazomet
035602
DMDS
000011
Iodomethane
029088
Metam sodium
039003
Metam potassium
039002
Methyl bromide
053201
Methyl isothiocyanate
068103

      4(b).	 Information CollectedThese users will need to engage in the following activities to assure compliance with new fumigant label requirements:

Table 2: User (applicators or handlers) Activities
                                     Burden
                                  Description
Read the label 

(applicator's responsibility)
Read and understand revised product label(s) bearing new label language.
Posting:
Fill-in application information on signs and post buffer zones 

(applicator or handler's responsibility)
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.
State Lead Agencies (SLAs):
Check EPA website to determine if notice is required and provide notice of applications to applicable SLAs

(applicator's responsibility)
Applicators must check the EPA fumigant website for a list of states that require notification.
Provide to the SLA that require notification, the following:  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.
Fumigant Management Plan (FMP):
Prepare a FMP and a post-application summary 

(applicator's responsibility)
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 post-application summary. 

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.  
Applicator Training:
Applicators must take registrant developed and EPA approved fumigant training

(applicator's responsibility)
Applicators must attend a soil fumigant training program designed specifically to 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.  
Handler Information:
Handlers must receive fumigant specific information 

(applicator and handler's responsibilities)
Applicators are responsible to disseminate fumigant specific information prior to each fumigation to every handler participating in the application.  

      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 has not been duplicated here.  The burden and activities listed below fall outside of the scope of the DCI ICR.

Table 3:  Registrant Activities
                                    Burden
                                  Description
Training:
Develop 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 electronic, paper, or in person)

Handler Information:
Develop 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 electronic or paper)

Community Outreach:
Develop 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.

First Responder Training:
Develop 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.  

Table 4: State Activities
                                    Burden
                                  Description
Notice to States
State Lead Agencies (SLAs) have the option to either receive notice prior to fumigant applications or to update their state cooperative agreements in order to structure their compliance and enforcement activities around fumigation times.  SLAs will not be responsible for both these measures, but will have the choice. Since those states that chose to incorporate fumigant compliance and enforcement activities with their typical work will not be faced with an additional burden, the additional burden in the following tables assumes all states chose to receive notice prior to a fumigant application.  

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

      5(a).	Agency Activities

      This ICR involves activities conducted by third parties. EPA does not collect any information under this ICR. Participating States are responsible for conducting voluntary training verification programs, such as state-specific fumigant applicator training, if desired.  EPA implements the soil fumigant mitigation measures.

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

      Not applicable.  This ICR involves activities conducted by third parties.  EPA does not conduct any activities under this ICR.  Participating States are responsible for implementing voluntary training verification programs, such as state-specific fumigant applicator training, if desired.
       
      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.  To diminish the cost to individual registrants, there are six task forces that will be developing and disseminating the required materials.

      5(d).	Collection Schedule

      This ICR involves activities conducted by third parties. EPA does not conduct any activities or collect any information under this ICR. Participating States are responsible for implementing voluntary training verification programs, such as state-specific fumigant applicator training, if desired.  EPA periodically checks the fumigant 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 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.  
      
      Certified applicators and pesticide handlers have paperwork burden associated with fumigant application activities, such as reading the label, posting treatment areas and the development of a fumigant management plan.  It is estimated that the burden associated with the first application will be highest, mostly due to the time necessary to develop the fumigant management plan (12 hours).  Each of the other paperwork related activities is estimated to take no more than an hour.  Total burden for the first application is estimated to be nearly 14 hours, while each subsequent application is estimated to take less than 3 hours.  The Agency estimates that more than 12,000 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, 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 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.  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 rule and the agricultural Worker Protection Standard. There are an estimated 4,458 certified applicators applying soil fumigants and 13,374 pesticide handlers of soil fumigants subject to these training requirements.

      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 12 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.  There are six task forces that will be developing and disseminating the required materials.
      
      States are responsible for enforcement and compliance of the fumigant-related application requirements.  It is estimated that states will spend an average of 15 minutes per application on enforcement and compliance activities.  Given the more than 12,000 fumigant applications made per year, state activities amount to more than 3,000 hours per year.

      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).

	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 is 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.  The wage rate for certified applicators is based on the scientist/technician labor category, while the pesticide handler wage is based on an average of the wage for the scientist/technician and agriculture worker labor categories, reflecting a higher skilled worker.
	
		(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 that more than 12,000 applications are made per year by certified applicators and pesticide handlers based on historical pesticide usage data for the soil fumigants.  

Table 6.  Certified Applicator and Pesticide Handler Burden and Cost for User Application Activities per Application, By Activity
Category
Activity
Frequency
Certified Applicator
Hours
Cost
(@$33.24/hr)[1]
Pesticide Handler
Hours
Cost
(@$23.32/hr)[1]
Total
Hours
Cost[2]
Read the label
Learn 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 Signs
Per Application
0
$0
0.50
$11.66
0.50
$11.66
Notice to SLA
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
Fumigant Management
Plan
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 Application[3]

Initial Application
13.90
$462.04
0.50
$11.66
14.40
$473.70

Subsequent Application
2.90
$96.40
0.50
$11.66
3.40
$108.06
Numbers may not add due to rounding.
1 - Cost is equal to the hours times the wage rate ($/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
Year
Certified Applicator
Hours
Cost[1]
Pesticide Handler
Hours
Cost[1]
Total
Hours
Cost[2]
Year 1
175,849
$5,845,217
6,326
$147,511
182,174
$5,992,728
Year 2
175,849
$5,845,217
6,326
$147,511
182,174
$5,992,728
Year 3
106,268
$3,532,362
6,326
$147,511
112,594
$3,679,872
3 Year Annual Average
152,655
$5,074,265
6,326
$147,511
158,981
$5,221,776
3 Year Total
457,966
$15,222,796
18,977
$442,532
476,943
$15,665,328
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 12,374 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
Cost[2]
Applicator Fumigant Training
Mandatory Training
Once Every 3 Years
8.00
$265.92
0
$0
8.00
$265.92

Retain Training Documentation
Once Every 3 Years
0.05
$1.66
0
$0
0.05
$1.66
Handler Safety Information
Annual Handler Safety Training
Annual
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. 

Table 9.  Total Annual Certified Applicator and Pesticide Handler Burden and Cost for Training Activities
Year
Certified Applicator
Hours and Cost[1]
Pesticide Handler
Hours and Cost[1]
Total
Hours and Cost[2]
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 is 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
Cost[2]
Fumigant
Training
Develop
Training
Materials
One Time
80.00
$9,622.40
160.00
$9,736.00
80.00
$2,968.80
320.00
$22,327

Distribute
Training
Materials
Annually
0
$0
0
$0
12.00
$445.32
12.00
$445
Handler Safety Information
Prepare
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 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 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 
Year
Managerial
Hours and Cost[1]
Technical
Hours and Cost[1]
Clerical
Hours and Cost[1]
Total
Hours and Cost[2]
Year 1
1,920
$230.938
2,400
$146,640
2,784
$104,177
7,104
$480,292
Year 2
240
$28,867
240
$14,604
1,104
$40,969
1,584
$84,441
Year 3
240
$28,867
240
$14,604
1,104
$40,969
1,584
$84,441
3 Year Annual Average
800
$96,224
960
$58,416
1,664
$61,751
3,424
$216,391
3 Year Total
2,400
$288,672
2,880
$175,248
4,992
$185,253
10,272
$649,173
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).  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 use, 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.    Costs are measured on a per application basis.  Annual burden, assuming more than 12,000 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 Cost[2]
State Compliance and Enforcement
Paperwork for Compliance and Enforcement in High Use Areas
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 Cost[1]
Total
Hours and Cost[2]
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 Cost[2]
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/Cost[1]
Technical
Hours/Cost[1]
Total
Hours/Cost[2]
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
      Tables 16 and 17 summarize the total annual respondent and Agency burden, respectively.  

Table 16.  Annual Respondent Burden and Cost
Year
Total Hours[1]
Total Cost[1]
Year 1
242,059
$8,113,617
Year 2
200,652
$6,524,885
Year 3
131,071
$4,212,029
3 Year Annual Average
191,261
$6,283,510
3 Year Total
573,782
$18,850,531
1  -  Total hours and cost are a sum of total hours and cost for each respondent.  See Tables 2, 4, 6, and 8.

Table 17.  Annual Agency Burden and Cost
Year
Total Hours[1]
Total Cost[1]
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 10.

      6(e).	Reasons for Change in Burden

      This is a new ICR.

      6(f).	Burden Statement

      The total estimated average annual respondent paperwork burden to comply with this information collection activity is 191,261 hours.  This estimate includes the time needed for certified applicators, pesticide handlers, registrants and states to conduct fumigant application related paperwork activities (see section 6(a) and 6 (d)).  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 online viewing at http://www.regulations.gov.  Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

	Comments may be submitted to EPA electronically (our preferred method) through http://www.regulations.gov, or by mail addressed to OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), Mail Code:  28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.  To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm. 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 No. 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). Available online at the House of Representatives' US Code Website
 
 
 Attachment B:	7 U.S.C. 136a - FIFRA Section 3(c)(5). Available online at the House of Representatives' US Code Website
 
 
 Attachment C:	Fumigant Reregistration Eligibility Decisions and Supporting Documents, available at www.regulations.gov.
 
 Attachment D:	Placeholder for 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