                      Information Collection Request for
             Diesel Emissions Reduction Act (DERA) Rebate Program

           OMB Control No. 2060-0686 (Renewal), EPA ICR No. 2461.04

                 United States Environmental Protection Agency
                          Office of Air and Radiation
                         1200 Pennsylvania Avenue, NW
                             Washington, DC 20460

Contents
1. Identification of the Information Collection	3
1(a) Title of the Information Collection	3
1(b) Short Characterization/Abstract	3
2. Need for and Use of the Collection	4
2(a) Need/Authority for the Collection	4
2(b) Practical Utility/Users of the Data	4
3. Non-duplication, Consultations, and Other Collection Criteria	5
3(a) Non-duplication	5
3(b) Public Notice Required Prior to ICR Submissions to OMB	5
3(c) Consultations	5
3(d) Effects of Less Frequent Collection	7
3(e) General Guidelines	7
3(f) Confidentiality	7
3(g) Sensitive Questions	7
4. The Respondents and the Information Requested	8
4(a) Respondents/Standard Industrial Classification (SIC) Codes	8
4(b) Information Requested	9
4(b)(i) Data Items	9
4(b)(ii) Respondent Activities	11
5(a) Agency Activities	11
5(b) Collection Methodology and Management	12
5(c) Small Entity Flexibility	12
5(d) Collection Schedule	12
6. Estimating the Burden and Cost of the Collection	13
6(a) Estimating Respondent Burden	13
6(b) Estimating Respondent Costs	13
6(b)(i) Estimating Labor Costs	13
6(b)(ii) Operating and Maintenance (O&M) Costs	13
6(b)(iii) Capital/Start-up Costs	13
6(c) Estimating Agency Burden and Cost	14
6(d) Estimating the Respondent Universe and Total Burden and Costs	14
6(e) Bottom Line Burden Hours and Cost Tables	14
6(e)(i) Respondent Tally	14
6(e)(ii) The Agency Tally	14
6(f) Reasons for Change in Burden	15
6(g) Burden Statement	15

Appendices
 Respondents and Agency Activities Table

Tables
Table 6.1 Respondent tally	14
Table 6.2 Agency tally	15

1. Identification of the Information Collection
1(a) Title of the Information Collection
Title: Diesel Emissions Reduction Act (DERA) Rebate Program
OMB Control Number: 2060-0686
EPA ICR Number: 2461.04
1(b) Short Characterization/Abstract
This is an extension of the Information Collection Request (ICR) for the Diesel Emission Reduction Act program (DERA) authorized by Title VII, Subtitle G (Sections 791 to 797) of the Energy Policy Act of 2005 (Public Law 109-58), as amended by the Diesel Emissions Reduction Act of 2010 (Public Law 111-364) and Division S (Section 101) of the Consolidated Appropriations Act, 2021 (Public Law 116-260), codified at 42 U.S.C. 16131 et seq. DERA provides the Environmental Protection Agency (EPA) with the authority to award grants, rebates or low-cost revolving loans on a competitive basis to eligible entities to fund the costs of a retrofit technology that significantly reduces diesel emissions from mobile sources through implementation of a certified engine configuration, verified technology, or emerging technology. Eligible mobile sources include buses (including school buses), medium heavy-duty or heavy heavy-duty diesel trucks, marine engines, locomotives, or nonroad engines or diesel vehicles or equipment used in construction, handling of cargo (including at port or airport), agriculture, mining, or energy production. In addition, eligible entities may also use funds awarded for programs or projects to reduce long-duration idling using verified technology involving a vehicle or equipment described above. The objective of the assistance under this program is to achieve significant reductions in diesel emissions in terms of tons of pollution produced and reductions in diesel emissions exposure, particularly from fleets operating in areas designated by the Administrator as poor air quality areas.

EPA uses approved procedures and forms to collect necessary information to operate a grant program, and has been providing grants under DERA since Fiscal Year 2008 and rebates since Fiscal Year 2012. EPA is requesting an extension to the existing approved ICR for forms needed to collect necessary information to operate a rebate program as authorized by Congress under the DERA program.

EPA will collect information from applicants who wish to apply for a rebate under the DERA Rebate Program. Information collected from applicants will ensure that they are eligible to receive funds under DERA, that funds are provided for eligible activities, and to calculate estimated and actual emissions benefits that result from activities funded with rebates as required in DERA's authorizing legislation.
2. Need for and Use of the Collection
2(a) Need/Authority for the Collection
This ICR is necessary to ensure that only eligible entities will receive funds under this program, and that funds are only provided for eligible activities per the DERA legislation (42 U.S.C. 16131 et seq.).  The information requested on the Rebate Application and the Payment Request form is also needed to ensure the activities are completed in accordance with program guidance.  In addition, the information is necessary to ensure fiscal control and accountability for EPA funds and to deter waste, fraud, and abuse.

Congress requires EPA to calculate and report on the estimated and actual air quality and diesel fuel conservation benefits resulting from DERA funding, as well as cost-effectiveness and cost-benefits of the grant, rebate and loan programs. To accurately provide this required information to Congress, EPA must collect specific information about the vehicles and technologies funded through the DERA program.
2(b) Practical Utility/Users of the Data
The rebate process requires applicants to submit up to two forms. All applicants fill out an application to reserve funds (Rebate Application) that asks for information about the applicant including DUNS number, EIN, contact information for representatives, address, and number of vehicles to be retrofitted or replaced. This information is required to ensure the applicant is eligible, and to have contact information on file. All applicants will also provide information on the current vehicle to be replaced or retrofitted and attach scans of the title and registration for that vehicle to demonstrate ownership. Information requested includes the fleet type, vehicle identification number, engine model year, gross vehicle weight rating, engine manufacturer, engine family name, engine tier, average annual vehicle miles traveled or usage rate, annual fuel consumption, annual idling hours, and horsepower (for nonroad engines only).  This information is collected to ensure the vehicle or equipment being replaced or retrofitted is eligible under the DERA rebate program guidelines. In addition, the information will be used to calculate the estimated emissions reductions that will be achieved by the rebate funding, and to meet the statutory requirements to report to Congress the estimated air quality and diesel fuel conservation benefits, cost-effectiveness, and cost-benefits of that activity prior to the activity occurring.

EPA will make random selections from the pool of eligible applicants but may give priority consideration to those applicants for projects located in areas of poor air quality. EPA may also ensure that each region or state is represented in the group of selectees. Upon notification from EPA, the selectee may purchase the vehicle or equipment specified in the rebate program guidance. After purchase and installation of the new vehicle or equipment, the selectee will request payment from EPA by submitting the Payment Request Form. The selectee will also submit a copy of all invoices for the purchase and installation of the new vehicle or equipment as well as written confirmation and photographs documenting that the replaced equipment was scrapped. This information is necessary to meet the statutory requirements to report to Congress the actual air quality and diesel fuel conservation benefits and cost-effectiveness of the funded rebate project. In addition, the information collected will ensure fiscal control and accountability for EPA funds and to deter waste, fraud, and abuse.

3. Non-duplication, Consultations, and Other Collection Criteria
3(a) Non-duplication
Information requested from respondents under this ICR is not available from other sources. There are no existing rebate programs at EPA where this information may have been previously collected. Some rebate applicants may have applied for and received grants from EPA; however, information currently held in EPA's Integrated Grants Management System that could pertain to the rebate program would likely only consist of applicant names, addresses, and other identifying information that would not be burdensome for a rebate applicant to reproduce. Other information related to the specific vehicle(s) targeted for rebates would not be readily available from other sources.
3(b) Public Notice Required Prior to ICR Submissions to OMB
In compliance with the 1995 Paperwork Reduction Act (PRA), any agency developing a non-rule-related ICR must solicit public comments for a 60-day period before submitting the ICR to OMB. These comments, which are used partly to determine realistic burden estimates for respondents, must be considered when completing the Supporting Statement that is submitted to OMB.
3(c) Consultations
EPA staff responsible for DERA program oversight and implementation were contacted to provide information, data, and review for this ICR renewal.

During the initial setup of the Rebate Program, EPA solicited information on rebate program structure, management, and information collection from other federal, state and local rebate programs, including:

 USDOT CARS Program ("Cash for Clunkers")
      Contact: Terry Anderson, National Highway Traffic Safety Administration
<PHONE_NUMBER>

 California Air Resources Board (CARB) Hybrid Truck and Bus Voucher Incentive Project
      Contact: Joe Calavita, CARB
<PHONE_NUMBER>

 Pittsburgh Healthy School Bus Initiative
      Contact: Brooke Suter, Clean Air Task Force
<PHONE_NUMBER>

Additionally, EPA consulted with representatives from industries potentially affected by a rebate program to determine availability of the information we are requesting on the rebate forms and the typical process and time required to procure a new vehicle or retrofit an existing vehicle.

For this renewal, EPA contacted nine applicants that have received rebates from previous rebate funding opportunities and requested feedback about how long the rebate process took to complete. EPA requested that applicants provide estimates of how much time was required to review instructions, gather information about existing vehicles, fill out necessary forms, and to complete submission to EPA. The burden hours from responses are recorded in Table A8 in Appendix A. The first four applicants listed below responded to this request, while the remaining five applicants did not:

 Stephens County Board of Education
      Contact: Dale Meeks
<PHONE_NUMBER>
<EMAIL_ADDRESS>
 Kobussen Buses LTD
      Contact: Scott Kobussen
<PHONE_NUMBER>
<EMAIL_ADDRESS>
 Unified School District 234
      Contact: Gina Shelton
<PHONE_NUMBER>
<EMAIL_ADDRESS>
 Culpeper County Public Schools Division
      Contact: Dr. Stacey L. Timmons
<PHONE_NUMBER>
<EMAIL_ADDRESS>
 South Carolina Department of Education (for Lexington School District 2)
      Contact: Bill Tindal
<PHONE_NUMBER>
<EMAIL_ADDRESS>
 St. Clair County Board of Education
      Contact: Jerry Fuller
<PHONE_NUMBER>
<EMAIL_ADDRESS>
 Haley Transportation of St. Charles Inc.
      Contact: Sally Haley
<PHONE_NUMBER>
<EMAIL_ADDRESS>
 Kottkes' Bus Service, Inc.
      Contact: Michael Pipenhagen
<PHONE_NUMBER>
<EMAIL_ADDRESS>
 Bell County Board of Education
      Contact: Steven Silcox
<PHONE_NUMBER>
<EMAIL_ADDRESS>3(d) Effects of Less Frequent Collection
EPA recognizes the importance of balancing the need for data collection efforts against respondent burden and costs. The information needed for EPA to assess whether a rebate applicant is eligible to receive a rebate is expected to be submitted one time for each rebate funding opportunity. Individual applicants may apply for multiple rebates at one time (the maximum number will be announced by EPA at the start of a new rebate funding opportunity). The Rebate Application and the Payment Request Form can accommodate information related to several vehicles and/or retrofit technologies. EPA needs current information about the vehicle(s) to be replaced or retrofitted and the proposed replacement vehicle(s) or retrofit technology(s) to properly evaluate rebate eligibility and to calculate the emissions reductions that will be achieved through the rebate. The burden described in this ICR identifies the burden that EPA has determined as necessary. EPA strives to minimize burden. EPA has determined that the information currently required is the minimum that is necessary to adequately evaluate applicant eligibility and to calculate the emissions reductions that will be achieved through the rebate.
3(e) General Guidelines
This information collection is consistent with OMB guidelines contained in 5 CFR 1320.5(d)(2). Requests for supplemental information for the purposes of emergency response or enforcement activities are exempt from the Paperwork Reduction Act requirements.
3(f) Confidentiality
Applicants will not be required to submit confidential business information. If an applicant feels that any information requested would be confidential business information, the applicant may request that such information be treated as confidential. All confidential data will be handled in accordance with 40 CFR 122.7, 40 CFR Part 2, and EPA's Security Manual Part III, Chapter 9, dated August 9, 1976. Any claim of confidentiality must be asserted at the time of submission.
3(g) Sensitive Questions
Sensitive questions are defined in EPA's ICR Handbook, Guide to Writing Information Collection Requests Under the Paperwork Reduction Act of 1995 as "questions concerning sexual behavior or attitudes, religious beliefs, or other matters usually considered private." The requirements addressed in this ICR do not include sensitive questions.
4. The Respondents and the Information Requested
4(a) Respondents/Standard Industrial Classification (SIC) Codes

The primary recipients of EPA rebates are State and local governments, Indian Tribes, educational institutions, and certain private organizations.  The information requested is used to determine rebate eligibility, pay recipients, and collect information on how Federal funds are being spent.

Standard Industrial Classification Codes for respondents include:

1629		 -  Heavy Construction, Not Elsewhere Classified
4011 		 -  Railroads, Line-Haul Operating
4013		 -  Railroad Switching and Terminal Establishments
4111		 -  Local and Suburban Transit
4212		 -  Local Trucking Without Storage
4213		 -  Trucking, Except Local
4151		 -  School Buses
4449		 -  Water Transportation of Freight, Not Elsewhere Classified
4489		 -  Water Transportation of Passengers, Not Elsewhere Classified
4491		 -  Marine Cargo Handling
4492		 -  Towing and Tugboat Services
8211 		 -  Elementary and Secondary Schools
8221 		 -  Colleges, Universities, and Professional Schools
8399		 -  Social Services, Not Elsewhere Classified
9199		 -  General Government, Not Elsewhere Classified

The corresponding North American Industry Classification System (NAICS) Codes for respondents include:

23		 -  Construction
482 		 -  Rail Transportation
483 		 -  Water Transportation
484		 -  Truck Transportation
485		 -  Transit and Ground Passenger Transportation
4854		 -  School and Employee Bus Transportation
48831		 -  Port and Harbor Operations
61111 		 -  Elementary and Secondary Schools
61131 		 -  Colleges, Universities, and Professional Schools
9211 		 -  Executive, Legislative, and Other Government Support
9221		 -  Justice, Public Order, and Safety Activities

4(b) Information Requested
This section presents the data items, including recordkeeping requirements, and required respondent activities involved in preparing and submitting those data items.
4(b)(i) Data Items

For this ICR renewal EPA is making minor changes to the data items collected in the Rebate Application and will have a negligible effect on the time required for applicant responses.

On the Rebate Application, these changes include collecting:
 The new sam.gov unique entity identifier
 For rebates impacting school buses, the number and percentage of students receiving free or reduced-price school lunches in the schools or school districts served by the buses
 The estimated remaining life of the equipment being replaced
 Confirmation that that the applicant understands and agrees to follow the program requirements
 Whether the equipment operates in a nonattainment, maintenance, or other area of poor air quality as defined in the program guidance
 Whether the equipment operates in an environmental justice area as defined in the program guidance
 The type of organization applying for the rebate

On the Payment Request Form, these changes include collecting:
 For electrification projects, information on the type of charging equipment, costs of that equipment, and costs for installation
 Confirmation that that the applicant understands and agrees to follow the program requirements

The following data items are expected to be collected as part of a rebate application and payment request process:

 Applicant name, address, and other identifying information, such as Employer Identification Number, Dun and Bradstreet Number, sam.gov unique entity identifier, type of organization, and whether the applicant identifies as a federally recognized tribe
 Primary and alternate applicant contact information, such as name, title, phone number, and email address
 If a private applicant, name and address of the eligible entity for which the applicant operates under a contract, license, or lease, per requirements in the DERA authorization language
 For rebates impacting school buses, the number and percentage of students receiving free or reduced-price school lunches in the schools or school districts served by the buses
 Fleet size  -  total number of vehicles or equipment in regular operation
 If the applicant's vehicles operate under an idle reduction policy
 Confirmation that the organization understands and agrees to follow the program requirements
 Information on the original vehicle(s) for which the rebate(s) is requested, including:
 Vehicle identification number (VIN)
 Engine manufacturer, model year, tier level, and engine family name
 Estimated remaining life
 Whether the equipment operates in a nonattainment, maintenance, or other area of poor air quality
 Whether the equipment operates in an environmental justice area
 Gross vehicle weight rating
 Average annual miles driven (or usage rate for non-road equipment)
 Annual fuel consumption
 Annual hours idling
 Horsepower (for non-road equipment)
 Emissions control strategy (retrofit/replacement)
 Information on the replacement vehicle(s) or retrofit technology(ies), to ensure that DERA program objectives will be met, including:
 For vehicle/equipment replacement rebates:
 VIN
 New engine manufacturer, model year, tier level and family name
 Gross vehicle weight rating
 New vehicle fuel type
 New vehicle cost
 For electrification projects:
 Charging equipment type
 Charging equipment cost
 Installation cost for charging equipment
 For retrofit rebates:
 Retrofit technology type, manufacturer, and model
 Retrofit technology cost
 Installation cost
 For engine repower rebates:
 New engine manufacturer, model year, tier level and family name
 Engine serial number
 Horsepower (for nonroad engines)
 New engine fuel type
 Repower cost (engine and installation)
4(b)(ii) Respondent Activities

DERA Rebate Program applicants must perform the following:

 Submit a completed Rebate Application signed by an Authorized Representative, within the open application period
 Subject to lottery selection from the pool of eligible applicants to participate, selectee will submit proof of purchase (such as a copy of a Purchase Order or other equivalent documentation) showing that a new vehicle or retrofit technology has been ordered, within a designated period of times specified in the program guidance
 Selectee will submit a Payment Request Form signed by an Authorized Representative along with evidence of completion of the rebate-eligible activity (e.g., for vehicle replacements, written verification and photographs demonstrating scrappage of the old vehicle along with an invoice and proof of delivery of the new vehicle) to obtain a rebate payment, within a designated period of time specified in the program guidance
 Retain all records related to the rebate application and payment for a period of 3 years

5. The Information Collected -- Agency Activities, Collection Methodology, and Information Management
5(a) Agency Activities
This ICR includes all the application and reimbursement forms related to EPA's Diesel Emissions Reduction Act Rebate Program. EPA will continue to accept, evaluate, and identify selectees from the pool of eligible applicants for eligible rebate activities. EPA will subsequently review each selectee's payment request form and associated invoices to determine if payment is warranted. EPA will enter information on all eligible applicants, selectees, vehicles, and rebate payments into a database to manage the rebate program.

Agency activities associated with the review and approval of a rebate consist of the following:

 Identify selectees randomly from the pool of applicants
 Review and determine eligibility of selectee submissions
 Notify selectees and non-selectees within 90 days of the closing date for the application submission period
 Create a wait-list of eligible applicants that were not selected in the initial random selection
 Reserve (obligate) funds for selectees
 Review Payment Request Form, proof of purchase of new vehicles, and proof of scrappage of old vehicles submitted by selectees
 Determine and notify the selectee, within 30 days of rebate request submission, whether submission is complete and rebate can be issued
 Issue rebate payment to selectees
5(b) Collection Methodology and Management
EPA will continue to collect data from applicants and selectees, such as identification information, vehicle specifications, and payment information. EPA will store the information in a database to manage the rebate program. Data supplied by rebate applicants and selectees on paper or electronic forms (via email) will be entered into the database by EPA or a contractor to EPA. EPA will ensure the accuracy and completeness of collected information by reviewing applications and information entered in the database. EPA will use data collected on processed rebate requests to estimate the emission reductions and cost-effectiveness of the rebate program for its required biennial report to Congress.
5(c) Small Entity Flexibility
For many reasons, EPA believes the reporting requirements discussed in this ICR do not place an unreasonable burden on small businesses. The Rebate Application and the Payment Request Form collect minimal information needed to identify an applicant or selectee, verify eligibility, and evaluate the proposed action for rebate eligibility. The Rebate Application is submitted once for all eligible vehicles and equipment. If that applicant is selected to participate in the rebate program via random selection, a Payment Request Form is submitted after all program requirements have been met to receive payment. The burden represented by the Rebate Application and the Payment Request Form cannot be further reduced for small businesses. EPA needs certain basic information to make decisions regarding rebate payments. This basic information is not dependent on an operator's size.

Minimizing the burden on small entities also comes in the form of guidance materials.  For example, to assist applicants of all sizes, but potentially most useful for small entities, EPA will develop guidance on applying for a rebate.
5(d) Collection Schedule
Applying for a rebate is a voluntary activity. Information collection will begin once EPA announces the availability of a funding opportunity and makes the program guidance available on the internet (www.epa.gov/dera/rebates). Applicants may apply for rebate funds during a designated open time window (e.g. within 30 days of the program announcement) by submitting a Rebate Application. At the end of the open time window, EPA will make random selections from the pool of eligible applicants. EPA may also ensure that each region or state is represented in the group of selectees. All eligible applicants not selected will be placed on a waitlist, in the event that additional funds become available. Selectees will then have a designated period of time, as specified in the program guidance, to submit evidence to EPA that an order has been placed for a new vehicle or retrofit (proof of purchase), such as a copy of a purchase order. Finally, selectees will have a designated period of time from proof of purchase submittal, as specified in the program guidance, to submit a Payment Request Form with required supporting documentation to obtain a rebate. The designated period of time for selectees to submit the proof of purchase and submit the Payment Request Form with supporting documentation will be dependent on the specific rebate funding opportunity, based on the target fleet and emissions control strategy applied.
6. Estimating the Burden and Cost of the Collection
6(a) Estimating Respondent Burden
 This section presents the estimated respondent burden for each information request. Data are tabulated in the "Respondents and Agency Activities Table" provided as Appendix A. That table presents all assumptions, calculations, and results discussed in this ICR. The breakdown of cost and burden by labor category is provided in Section 6(b).
6(b) Estimating Respondent Costs
With burden hour estimates in place from Section 6(a), the next step is to estimate the labor cost per respondent and the capital costs required to complete each activity. The total cost for each respondent activity is composed of the following:
Labor Cost;
Operating and Maintenance (O&M) Cost; and
Capital/Start-up Cost.

The results of the respondents' costs analysis are presented in the Respondents and Agency Activities Table in Appendix A. Note that there are no O&M or capital costs associated with the DERA Rebate Program.
6(b)(i) Estimating Labor Costs
To estimate the potential costs, EPA identified labor categories associated with performing each activity.  Labor categories include managerial, technical, and clerical.  Mean hourly wage data was obtained from the Bureau of Labor Statistics (BLS) news release, Employer Costs for Employee Compensation (March 2021).  This dataset can be found at http://www.bls.gov/news.release/ecec.t03.htm and https://www.bls.gov/news.release/ecec.t04.htm. Table A1 in Appendix A shows the wage rates used to determine the cost of labor for various types of applicants.

The previously approved ICR renewal used wage rates from the Bureau of Labor Statistics (BLS) news release, Employer Costs for Employee Compensation (March 2018).
6(b)(ii) Operating and Maintenance (O&M) Costs
This ICR accounts for labor costs only. The DERA rebate program does not require respondents to perform activities outside the normal operation practices.
6(b)(iii) Capital/Start-up Costs
This ICR accounts for labor costs only. The DERA rebate program does not require respondents to perform activities outside the normal operation practices.
6(c) Estimating Agency Burden and Cost
EPA's estimate of its burden and costs are from the activities described in Section 5(a). When calculating the Agency cost, EPA makes the following assumption:

EPA determined the hourly employment cost of federal employees using methodology established in previous ICRs. According to the U.S. Office of Personnel Management, 2021 General Schedule (2021-GS), the average annual salary of a government employee at the GS-13, Step 10 level is $103,309. Step 10 is assumed to account for overhead costs.  At 2,086 hours per year, the hourly wage, including overhead, is $49.50

Burden and costs incurred by EPA are presented in Table A7 in Appendix A.
6(d) Estimating the Respondent Universe and Total Burden and Costs
Detailed information describing the universe and basis for burden and costs is provided in Section 6(a). Results are presented in Tables A2 through A6 in Appendix A. Those tables provide the respondent universe and the source of information for all respondent categories used throughout this ICR.
6(e) Bottom Line Burden Hours and Cost Tables
6(e)(i) Respondent Tally
The bottom line burden hours and costs for rebate applicants are the average annual hours and costs collectively incurred for all activities over a 7-year period covered by this ICR between 2012 and 2019. These figures do not include rebates offered in 2013 because the 2013 rebate program was a small pilot targeting a different vehicle sector that included only 3 rebate recipients. Including 2013 rebates in the data would skew the average annual responses significantly, which would result in an underestimation of the annual burden. Table 6.1 provides a summary of the average annual number of applicants, burden hours, and costs. A more detailed summary is provided in Tables A2 through A6 in Appendix A.

                          Table 6.1 Respondent tally
Respondents (number)
                                                                            564
Responses (number)
                                                                            656
Burden (hours)
                                                                           2903
Costs (labor)
                                                                    $121,421.59
Costs (capital)
                                                                             $0
Costs (O&M)
                                                                             $0
Total costs
                                                                    $121,421.59
Average annual burden per respondent
                                                                        $215.29
6(e)(ii) The Agency Tally
The bottom line burden hours and costs for the Agency are the total annual hours and costs collectively incurred for all activities during the period covered by this ICR. Table 6.2 provides a summary of the average annual Agency burden hours and costs. A more detailed summary is provided in Table A7 in Appendix A.

                            Table 6.2 Agency tally
Responses (number)
                                                                            656
Burden (hours)
                                                                            702
Costs (labor)
                                                                     $34,749.00
Costs (capital)
                                                                             $0
Costs (O&M)
                                                                             $0
Total costs
                                                                     $34,749.00

6(f) Reasons for Change in Burden
There is a decrease of 42 hours in the annual estimated respondent burden compared with the approved ICR. The revised burden of 2,903 hours reflects a 1.4% decrease in burden compared to the previous 2018 estimate of 2,945 hours. This decrease is the result of a reduction in annual responses in the program in 2018 and 2019 which offset a small increase in hours per response resulting from new estimates provided in the respondent consultation.
6(g) Burden Statement
The annual public reporting and recordkeeping burden for this collection of information is estimated to average 4.4 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, or disclose or provide information to or for a federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose information. 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 are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

To comment on EPA'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, the Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OAR-2012-0103, which is available for public viewing at the Air and Radiation Docket in the EPA Docket Center (EPA/DC), 1200 Pennsylvania Avenue NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Air Docket is<PHONE_NUMBER>.  An electronic version of the public docket is available through www.regulations.gov. Use www.regulations.gov to submit or view public comments, to access the index listing of the contents of the public docket, and to access documents in the public docket that are available electronically. Once in the system, key in the docket ID number identified above. 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 EPA Docket ID No. EPA-HQ-OAR-2012-0103 and OMB Control No. 2060-0686 in any correspondence.


[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Notices]
[Pages 63964-63966]
[FR Doc No: 2011-26535]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65522; File No. SR-ISE-2011-56]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fees and Rebates for Certain Orders Executed on the
Exchange

October 7, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on September 23, 2011, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission (the ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend transaction fees and rebates for
certain orders executed on the Exchange. The text of the proposed rule
change is available on the Exchange's Web site (http://www.ise.com), at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange currently assesses a per contract transaction charge
to market participants that add or remove liquidity from the Exchange
(``maker/taker fees'') in 103 options classes (the ``Select
Symbols'').\3\ For removing liquidity in the Select Symbols, the
Exchange currently charges a take fee of: (i) $0.25 per contract for
Market Maker and Market Maker Plus orders.\4\ The Exchange now proposes
to change the take fees for Market Maker and Market Maker Plus orders
in the Select Symbols from $0.25 per contract to $0.26 per contract.
---------------------------------------------------------------------------

    \3\ Options classes subject to maker/taker fees are identified
by their ticker symbol on the Exchange's Schedule of Fees. See
Securities Exchange Act Release Nos. 61869 (April 7, 2010), 75 FR
19449 (April 14, 2010) (SR-ISE-2010-25), 62048 (May 6, 2010), 75 FR
26830 (May 12, 2010) (SR-ISE-2010-43), 62282 (June 11, 2010), 75 FR
34499 (June 17, 2010) (SR-ISE-2010-54), 62319 (June 17, 2010), 75 FR
36134 (June 24, 2010) (SR-ISE-2010-57), 62508 (July 15, 2010), 75 FR
42809 (July 22, 2010) (SR-ISE-2010-65), 62507 (July 15, 2010), 75 FR
42802 (July 22, 2010) (SR-ISE-2010-68), 62665 (August 9, 2010), 75
FR 50015 (August 16, 2010) (SR-ISE-2010-82), 62805 (August 31,
2010), 75 FR 54682 (September 8, 2010) (SR-ISE-2010-90), 63283
(November 9, 2010), 75 FR 70059 (November 16, 2010) (SR-ISE-2010-
106), 63534 (December 13, 2010), 75 FR 79433 (December 20, 2010)
(SR-ISE-2010-114); 63664 (January 6, 2011), 76 FR 2170 (January 12,
2011) (SR-ISE-2010-120); 64303 (April 15, 2011), 76 FR 22425 (April
21, 2011) (SR-ISE-2011-18); 64992 (July 29, 2011), 76 FR 47279
(August 4, 2011) (SR-ISE-2011-43); 65021 (August 3, 2011), 76 FR
48933 (August 9, 2011) (SR-ISE-2011-45); 65087 (August 10, 2011), 76
FR 50783 (August 16, 2011) (SR-ISE-2011-47); 65327 (September 13,
2011), 76 FR 58068 (September 19, 2011) (SR-ISE-2011-48); 65084
(August 10, 2011), 76 FR 50805 (September August 16, 2011) (SR-ISE-
2011-49); and 65297 (September 8, 2011), 76 FR 56844 (September 14,
2011) (SR-ISE-2011-54).
    \4\ A Market Maker Plus is a market maker who is on the National
Best Bid or National Best Offer 80% of the time for series trading
between $0.03 and $5.00 (for options whose underlying stock's
previous trading day's last sale price was less than or equal to
$100) and between $0.10 and $5.00 (for options whose underlying
stock's previous trading day's last sale price was greater than
$100) in premium in each of the front two expiration months and 80%
of the time for series trading between $0.03 and $5.00 (for options
whose underlying stock's previous trading day's last sale price was
less than or equal to $100) and between $0.10 and $5.00 (for options
whose underlying stock's previous trading day's last sale price was
greater than $100) in premium across all expiration months in order
to receive the rebate. The Exchange determines whether a market
maker qualifies as a Market Maker Plus at the end of each month by
looking back at each market maker's quoting statistics during that
month. If at the end of the month, a market maker meets the
Exchange's stated criteria, the Exchange rebates $0.10 per contract
for transactions executed by that market maker during that month.
The Exchange provides market makers a report on a daily basis with
quoting statistics so that market makers can determine whether or
not they are meeting the Exchange's stated criteria.
---------------------------------------------------------------------------

    As an incentive for members to direct customer order flow to the
Exchange, Priority Customer complex orders in a select number of
options classes (``Designated Symbols''),\5\ currently receive a rebate
of $0.26 per contract on

all legs when these orders trade with non-customer orders in the
Exchange's complex order book. The Exchange proposes to increase this
rebate to $0.27 per contract. The Exchange believes it is necessary to
increase the rebate for Priority Customer complex orders in the
Designated Symbols in order to continue to attract Priority Customer
complex order flow to the Exchange as NASDAQ OMX PHLX, Inc. (``PHLX'')
recently increased a similar rebate from $0.26 to $0.27 per
contract.\6\
---------------------------------------------------------------------------

    \5\ The Designated Symbols are AAPL, BAC, C, F, GLD, INTC, IWM,
JPM, QQQ, SLV, SPY and XLF.
    \6\ See Securities and Exchange Act Release No. 65312 (September
9, 2011) (SR-PHLX-2011-126).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the Securities and Exchange Act
of 1934 (the ``Act'') \7\ in general, and furthers the objectives of
Section 6(b)(4) of the Act \8\ in particular, in that it is an
equitable allocation of reasonable dues, fees and other charges among
Exchange members and other persons using its facilities. The impact of
the proposal upon the net fees paid by a particular market participant
will depend on a number of variables, most important of which will be
its propensity to add or remove liquidity in options overlying the
Select Symbols and Designated Symbols, as applicable.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rebate for options
overlying the Designated Symbols remain competitive with fees charged
by other exchanges and are therefore reasonable and equitably allocated
to those members that opt to direct orders to the Exchange rather than
to a competing exchange. The Exchange believes that its proposal to
assess a $0.26 per contract take fee for Market Maker and Market Maker
Plus orders in the Select Symbols is reasonable and equitably allocated
because the fee is within the range of fees assessed by other exchanges
employing similar pricing schemes and the proposed nominal increase
will bring this fee closer to the fee the Exchange currently charges to
other market participants that employ a similar trading strategy. The
Exchange further notes that with this proposed increase, the fee
charged to Market Maker and Market Maker Plus orders will remain lower
than the fee currently charged by the Exchange to other market
participants. The Exchange believes that the price differentiation
between the various market participants is justified because market
makers have obligations to the market that the other market
participants do not. The Exchange believes that it is equitable to
assess a nominally higher fee to market participants that do not have
the quoting requirements that Exchange market makers do.
    The Exchange also believes that it is reasonable and equitable to
provide a rebate for Priority Customer complex orders in the Designated
Symbols because paying a rebate would continue to attract additional
order flow to the Exchange and thereby create liquidity in the
Designated Symbols that ultimately will benefit all market participants
who trade on the Exchange. The proposed increased rebate of $0.27 per
contract for Priority Customer complex orders in the Designated Symbols
is identical to a proposal recently submitted by PHLX.\9\
---------------------------------------------------------------------------

    \9\ See supra note 6.
---------------------------------------------------------------------------

    Moreover, the Exchange believes that the proposed fees are fair,
equitable and not unfairly discriminatory because the proposed fees are
consistent with price differentiation that exists today at other
options exchanges. Additionally, the Exchange believes it remains an
attractive venue for market participants to trade complex orders
despite its proposed fee change as its fees remain competitive with
those charged by other exchanges for similar trading strategies. The
Exchange operates in a highly competitive market in which market
participants can readily direct order flow to another exchange if they
deem fee levels at a particular exchange to be excessive. For the
reasons noted above, the Exchange believes that the proposed fees are
fair, equitable and not unfairly discriminatory.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\10\ At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2011-56 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2011-56. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the

Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-ISE-
2011-56 and should be submitted on or before November 4, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-26535 Filed 10-13-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Rules and Regulations]
[Pages 32146-32152]
[FR Doc No: 2013-12461]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0780; FRL-9387-1]

Triforine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of
triforine in or on blueberry and tomato. Summit Agro North America
Holding Corporation requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 29, 2013. Objections and
requests for hearings must be received on or before July 29, 2013, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0780, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Heather Garvie, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 308-0034; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0780 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 29, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your

objection or hearing request, identified by docket ID number EPA-HQ-
OPP-2001-0780, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of November 9, 2011 (76 FR 69690) (FRL-
9325-1), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1E7911) by Summit Agro North America Holding Corporation, 600 Third
Avenue, New York, NY 10016-2001. The petition requested that 40 CFR 180
be amended by establishing tolerances for residues of the fungicide
triforine, piperazine-1,4-diylbis(2,2,2-trichloroethane-1,1-
diyl)diformamide [also more commonly known as triforine, (N,N[acute]-
[1,2-piperazinediylbis(2,2,2-trichloroethylidene)]bis[formamide])], in
or on blueberry and tomato at 0.02 and 0.5 parts per million (PPM),
respectively. That document referenced a summary of the petition
prepared by Landis International, Inc. on behalf of Summit Agro North
America Holding Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. A comment was received on the
notice of filing. EPA's response to this comment is discussed in Unit
IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the tolerance for blueberry from 0.02 ppm to 1.0 ppm. The
reasons for this change are explained in Unit IV.D.
    There are no registered food uses for triforine in the United
States. These tolerances were requested in connection with use of
triforine on tomatoes and blueberries grown overseas. These tolerances
will allow blueberries and tomatoes containing triforine residues to be
imported into the United States.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for triforine including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with triforine follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The principal toxic effects of triforine are changes in the
liver and hematopoietic system following repeated oral dosing, and the
dog is the most sensitive species for the hematopoietic effects. Liver
effects include increased liver weights, cholesterol and alkaline
phosphatase levels. Toxicity was not observed in a rat 21-day dermal
toxicity study at dose levels greater than the limit dose. Triforine is
not acutely toxic via the oral, dermal, and inhalation routes. No
developmental or reproductive toxicity was observed at doses below the
limit dose. Triforine does not demonstrate neurotoxic or immunotoxic
potential. Although the mouse study showed that triforine was
associated with common tumors in the mouse, the EPA has determined that
quantification of risk using a non-linear approach; i.e., reference
dose (RfD), for triforine will adequately account for all chronic
toxicity, including carcinogenicity, that could result from exposure to
triforine. That conclusion is based on the following considerations:
(1) No carcinogenic response was seen in either sex in an acceptable
rat cancer study; (2) the tumors found in the mouse are commonly seen
in the mouse; (3) both tumors types were found only at the high dose,
which was above the limit dose (males 1204, females 1507 milligrams/
kilogram (mg/kg/day)); (4) triforine is not mutagenic; (5) each tumor
type was observed in one sex only; i.e., liver tumors in male mice and
lung tumors in female mice.
    Specific information on the studies received and the nature of the
adverse effects caused by triforine as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Triforine. Human Health Risk Assessment
to Support Petition for the Establishment of Permanent Tolerances
without U.S. Registration for Blueberries and Tomatoes on pages 8
through 13 in docket ID number EPA-HQ-OPP-2011-0780.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level generally referred to as a
population adjusted dose (PAD) or an RfD, and a safe margin of exposure
(MOE). For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
expected in a

lifetime. For more information on the general principles EPA uses in
risk characterization and a complete description of the risk assessment
process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for triforine used for
human risk assessment is shown in the following Table.

    Table--Summary of Toxicological Doses and Endpoints for Triforine for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)..  No hazard or appropriate acute endpoint was identified in the database.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 22 mg/kg/day.  Chronic RfD = 0.22   Subchronic/Chronic oral toxicity
                                   UFA = 10x...........   mg/kg/day.           (dog)
                                   UFH = 10x...........  cPAD = 0.22 mg/kg/   LOAEL = 120 mg/kg/day, based on
                                   FQPA SF = 1x........   day.                 decreased RBC, hematocrit,
                                                                               hemoglobin values and siderosis
                                                                               in the liver, spleen, and bone
                                                                               marrow.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL= 22 mg/kg/day.  LOC for MOE = <100.  Subchronic/chronic oral toxicity
 30 days).                         UFA = 10x...........                        (dog)
                                   UFH = 10x...........                       LOAEL = 120 mg/kg, based on
                                   FQPA SF = 1x........                        decreased RBC, hematocrit, and
                                                                               hemoglobin values, increased
                                                                               spleen weight, and siderosis in
                                                                               the liver, spleen, and bone
                                                                               marrow.
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term  NOAEL= 22 mg/kg/day.  LOC for MOE = <100.  Subchronic/chronic oral toxicity
 (1 to 6 months).                  UFA = 10x...........                        (dog)
                                   UFH = 10x...........                       LOAEL = 120 mg/kg, based on
                                   FQPA SF = 1x........                        decreased RBC, hematocrit, and
                                                                               hemoglobin values, increased
                                                                               spleen weight, and siderosis in
                                                                               the liver, spleen, and bone
                                                                               marrow.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (all durations)  No potential hazard via the dermal route based on the lack of systemic
                                    effects following repeat dermal exposure of rats at dose levels up to 1100
                                    mg/kg/day which is greater than the limit dose. The endpoints of concern
                                    were all assessed in this study, and there is no developmental or
                                    reproductive concern at dose levels below the limit dose.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = <100.  Subchronic/chronic oral toxicity
 days).                             study.                                     (dog)
                                   NOAEL= 22 mg/kg/day.                       LOAEL = 120 mg/kg, based on
                                   UFA = 10x...........                        decreased RBC, hematocrit, and
                                   UFH = 10x...........                        hemoglobin values, increased
                                   FQPA SF = 1x........                        spleen weight, and siderosis in
                                                                               the liver, spleen, and bone
                                                                               marrow.
----------------------------------------------------------------------------------------------------------------
Inhalation intermediate-term (1    Inhalation (or oral)  LOC for MOE = <100.  Subchronic/chronic oral toxicity
 to 6 months).                      study.                                     (dog)
                                   NOAEL = 22 mg/kg/day                       LOAEL = 120 mg/kg, based on
                                    (inhalation                                decreased RBC, hematocrit, and
                                    absorption rate =                          hemoglobin values, increased
                                    100%).                                     spleen weight, and siderosis in
                                   UFA = 10x...........                        the liver, spleen, and bone
                                   UFH = 10x...........                        marrow.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  EPA has determined that quantification of risk using a non-linear approach
                                    (i.e., RfD) will adequately account for all chronic toxicity, including
                                    carcinogenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to triforine, EPA considered exposure under the petitioned-for
tolerances. EPA assessed dietary exposures from triforine in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for triforine; therefore, a
quantitative acute dietary exposure assessment was unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption
data from the U.S. Department of Agriculture's (USDA's) National Health
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA). As to residues levels in food, EPA assumed tolerance level
residues in the chronic

dietary assessment for these raw agricultural commodities (RACs). A
processing study for tomatoes was submitted that showed no
concentration of triforine residues in tomato paste and puree;
therefore the RAC tolerance was used and the concentration factor were
set to a value of ``1'' for all processed tomato products, with the
exception of dried tomatoes. Empirical data are not available for this
processed commodity, so the DEEM 7.81 default processing factor for
dried tomatoes of 14.3 was included in the dietary risk assessment. In
addition, the dietary assessment assumes that 100% of the blueberry,
tomato, and tomato processed commodities consumed in the U.S. are
imported, and further that all of the imports have been treated with
triforine, effectively assuming 100 percent crop treated (PCT) for the
two crops that are included in the dietary risk assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
determined that although the mouse study showed that triforine was
associated with common tumors in the mouse, quantification of risk
using a non-linear approach for triforine would adequately account for
all chronic effects, including potential carcinogenicity that could
result from exposure to triforine.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for triforine. Tolerance level residues and/or 100 PCT were assumed for
all food commodities.
    2. Dietary exposure from drinking water. Since this petition
requests tolerances without U.S. registration, establishing the
requested tolerances will have no impact on domestic drinking water.
However, for the purpose of this risk assessment, the most recent
drinking water assessment dated March 5, 2008, which estimated residues
resulting from the residential uses of triforine, was consulted. Along
with the other risk assessments supporting this action, the drinking
water assessment (DP 339605; K. Moore, 3/5/08) can be found in the
triforine docket, EPA-HQ-OPP-2011-0780. Modeled estimated drinking
water concentrations from those uses are included in this risk
assessment. Surface water estimated drinking water concentrations
(EDWCs) are based on first index reservoir screening tool (FIRST)
modeling and represent untreated surface water concentrations. For
surface water, the modeled EDWC for annual average exposure was 0.84
parts per billion (PPB). The one-in-10-year annual average
concentration is used for chronic exposure assessments. Groundwater
EDWCs are based on Screening Concentration in Ground Water (SCIGROW)
modeling and represent the concentration that might be expected in
shallow unconfined aquifers under sandy soils. For groundwater, the
average exposure estimate is 0.43 ppb. The drinking water models and
their descriptions are available at the EPA Internet site:  http://www.epa.gov/oppefed1/models/water/. The highest annual average EDWC
from the surface water model of 0.84 ppb was included in the chronic
dietary risk assessment.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Triforine is
currently registered for the following uses that could result in
residential exposures: ornamentals including roses, trees, herbaceous
plants, and woody shrubs and vines. There are no new residential uses
with this petition; however, in order to complete the aggregate risk
assessment, the Agency updated the residential exposure assessment.
Because triforine does not pose a hazard by the dermal route of
exposure, the residential handler assessment includes only inhalation
exposure. The residential handler exposure assessment does not identify
any residential handler risk concerns, in spite of representing worst
case inhalation exposures. For post-application exposures, although a
quantitative residential post-application exposure assessment was not
performed, the Agency concluded that there is no concern for post-
application exposures to triforine for the following reasons:
    i. Since no dermal endpoints of concern were identified, there is
also no concern for post-application dermal exposures.
    ii. While the mouthing behaviors of children are also commonly
addressed in post-application assessments, the Agency does not expect,
based on the primary use pattern of triforine to control diseases on
roses and other ornamental plants, children to routinely contact
treated plants and engage in mouthing behaviors.
    iii. Triforine is relatively non-volatile which, coupled with the
dilution expected outdoors and the small amounts of active ingredient
used diminish the possibility of post-application inhalation exposure.
Moreover, the residential handler inhalation exposure assessment, which
represents worst case inhalation exposures, and is considered
protective of most post-application inhalation exposure scenarios.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found triforine to share a common mechanism of toxicity
with any other substances, and triforine does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that triforine does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility following in utero exposure to triforine in
either the rat or rabbit developmental toxicity study at dose levels up
to the limit dose, and there is no evidence of increased susceptibility
following in utero and/or pre-/post-natal exposure in the 2-generation
reproduction study in rats at any dose levels, even those greater than
the limit dose.

    Triforine has been evaluated for potential developmental effects in
the rat and rabbit (gavage administration). Maternal toxicity included
decreased body weight and food consumption in rabbits at the limit
dose, and maternal toxicity was not observed in rats at dose levels up
to the limit dose. Decreased fetal body weight was observed in the
rabbit at the limit dose, whereas there were no developmental effects
in the rat at the limit dose (actual 840 mg/kg/day). Decreased
fertility index and decreased testes weight was observed in F1 males in
the 2-generation reproduction study only at a dose level greater than
the limit dose.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for triforine is complete.
    ii. There is no indication that triforine is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. As indicated in Unit III.D.2., there is no evidence that
triforine results in increased susceptibility in in utero rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to triforine in drinking water. No risk is expected
from the dermal route of exposure for children's postapplication
exposure. Because of the use pattern, no incidental oral exposure is
expected for children and no quantitative exposure assessment was
conducted. These assessments will not underestimate the exposure and
risks posed by triforine.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-term, intermediate-term, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
triforine is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
triforine from food and water will utilize <1% of the cPAD for the
general U.S. population and all population subgroups. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of triforine is not expected;
therefore the chronic aggregate risk includes food and drinking water
only.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Triforine is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to triforine. The Agency conducted
short-term aggregate risk assessments only for adult males and adult
females since there are no short-term residential exposures for
children. There are no oral residential exposures for adults and
triforine does not pose a dermal hazard, so only residential inhalation
exposure is included in the aggregate assessment. Using the exposure
assumptions described in this unit for short-term exposures, EPA has
concluded the combined short-term food, water, and residential
inhalation exposures result in aggregate MOEs of 46,000. Because EPA's
level of concern for triforine is a MOE of 100 or below, these MOEs are
not of concern.
    4. Intermediate-term risk. Residential intermediate-term exposure
is not anticipated; therefore an intermediate-term aggregate risk
assessment is not necessary.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA has determined that quantification of risk using a non-
linear approach for triforine will be protective of all chronic effects
including potential carcinogenicity. There are no chronic aggregate
risks of concern and, therefore, there are no cancer aggregate risks of
concern.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to triforine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron
capture detection) is available to enforce the tolerance expression.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has
established MRLs for triforine in or on blueberry and tomato at 1.0 and
0.5 ppm, respectively. These MRLs are the same as the tolerances being
established for triforine in the United States.

C. Response to Comments

    One comment was received in response to the notice filing. The
commenter asked the Agency to deny the petition stating that * * *
``toxic effects to red blood cells and iron deposition in the wrong
places is enough reason to deny this product.'' The comment also
requested that all studies be verified by an independent lab. The
Agency responds to this comment by stating that all toxicity studies
required in accordance with new 40 CFR part 158 data requirements have
been submitted. The studies available for consideration of triforine
toxicity provide a comprehensive and complete database. The Agency has
conducted a human health risk assessment with this database and has
concluded that there are no risks of concern to human health from the
requested use of triforine as demonstrated by the risk assessment. Only
dietary exposure is expected for

the establishment of a tolerance on imported blueberries and tomatoes
and adequate studies are available for consideration of this potential
exposure scenario. All studies conducted on pesticide products to
support applications for research or marketing should follow the Good
Laboratory Practice (GLP) standards as stipulated in 40 CFR part 160
under FIFRA. When a registrant utilizes the service of a laboratory to
conduct a study, they must notify the laboratory that the study should
be conducted in accordance with this part (Sec.  160.10). Every study
that is submitted to the Agency must include a statement that the study
was conducted in accordance with this part (Sec.  160.12). Submission
of a false statement may for the basis for cancellations, suspension,
etc. EPA may refuse to consider reliable any data from a study which
was not conducted in accordance with this part (Sec.  160.17). The
Agency's Office of Enforcement and Compliance (OECA) conducts
inspections of laboratory facilities for the purpose of compliance
review to determine that the GLP regulations of FIFRA are being
observed. This compliance review includes inspection of all raw data
records, specimens and other entities as needed as stipulated in this
part (Sec.  160.15). The toxicity studies used to assess the potential
risks associated with exposure to triforine were conducted in
compliance with 40 CR part 160, and included submission of all raw data
as well as required GLP compliance statements. Further, Agency
scientists conducted a thorough and independent review of these data
during the registration process. The Agency has no objection to the
establishment of tolerances without U.S. registrations for residues of
triforine in or on blueberry and tomato.

D. Revisions to Petitioned-for Tolerances

    The tolerance level for blueberry being established by the EPA
differs from that proposed in the tolerance petition submitted by
Summit Agro North America Holding Corporation. The Agency determined
that the tolerance level of 1.0 ppm instead of 0.02 ppm for blueberry
is needed so as to harmonize with the established Codex Maximum Residue
Limits (MRL). This tolerance level will allow for full harmonization of
both the residue definition and the tolerance level between the United
States and Codex.

 V. Conclusion

    Therefore, tolerances are established for residues of triforine,
(N,N'-[1,2-piperazinediylbis(2,2,2-
trichloroethylidene)]bis[formamide]), including its metabolites and
degradates, in or on tomato and blueberry at 0.5 and 1.0 ppm,
respectively.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: May 20, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1321 to read as follows:

Sec.  180.1321  Triforine; tolerances for residues.

    (a) General. Tolerances are established for residues of triforine,
including its metabolites and degradates. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only triforine (N,N'-[1,2-piperazinediylbis(2,2,2-
trichloroehylidene)]bis[formamide]), in or on the following
commodities.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Blueberry \1\...........................................             1.0
Tomato \1\..............................................             0.5
------------------------------------------------------------------------
\1\ There are no U.S. registrations for blueberry and tomato.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2013-12461 Filed 5-28-13; 8:45 am]
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