Document ID: EPA-HQ-OPP-2012-0544-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-11-21T05:00Z

SUPPORTING STATEMENT FOR 
                       AN INFORMATION COLLECTION REQUEST

1. 	IDENTIFICATION OF THE INFORMATION COLLECTION
                                                                        
      1(a)	Title of the Information Collection:  

      TITLE:  Notice of Supplemental Distribution of a Registered Pesticide Product

      OMB No.:  2070-0044		EPA No.:  0278.11
                                                                  
      1(b)	Short Characterization/Abstract
      This information collection activity notifies the Environmental Protection Agency (EPA) of supplemental distribution of registered pesticide products.  As mandated by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended, EPA is responsible for the regulation of pesticides.  Section 3 (e) of FIFRA (7 U.S.C. 136a (e)) allows pesticide registrants to distribute or sell registered pesticide products under a different name or in addition to the registered name (see Attachment A).  According to 40 CFR 152.132, registrants may distribute or sell their registered product under another company's name and address instead of (or in addition to) their own.  Such distribution and sale is termed "supplemental distribution" and the product is termed a "distributor product."  EPA requires pesticide registrants who enter into supplemental distribution agreements with other companies to submit Form 8570-5, Notice of Supplemental Distribution of a Registered Pesticide Product (see Attachment B).  This information collection request (ICR) is a proposed renewal of an existing ICR currently approved by Office of Management and Budget (OMB) and is due to expire on July 31, 2013.  

2. 	NEED FOR AND USE OF THE COLLECTION

      2(a)	Need/Authority for the Collection 

      This information is required to be submitted pursuant to Section 3 (e) of FIFRA, as amended.  Regulations pertaining to supplemental distribution of pesticide products are contained in Title 40 CFR Part 152.132 (see Attachment C).

      2(b)	Practical Utility/Users of the Data

      Section 3 (e) of FIFRA requires pesticide registrants to notify the Agency when the registrant has entered into an agreement with a second company to distribute the registrant's product under the second company's name and product name.  The distributor is considered an agent of the registrant for all intents and purposes under the Act, and both the registrant and the distributor may be held liable for violations pertaining to the distributor product.  EPA's Office of Pesticide Programs is responsible for maintaining information about supplemental distribution agreements.
3.	NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

      3(a) 	Non duplication

      This is the only information collection activity of its kind, and the information collected under this program is collected only once per receipt of a notice of distributor registration. Therefore, the possibility of duplication does not exist.

      3(b)	Public Notice Required Prior to ICR submission to OMB

      Pursuant to 5 CFR 1320.8(d), in proposing to renew this ICR, EPA is publishing a Federal Register Notice that provides a 60-day public notice and comment period.  The materials related to the proposed renewal of this ICR, as well as any comments submitted during the public comment period may be accessed as described in section 6(f) of this supporting statement.
      
      3(c)	Consultations

      Under 5 CFR 1320.8(d)(1), agencies are required to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an original or renewal ICR to OMB for review and approval.  During the development of this renewal ICR, EPA staff will contact appropriate stakeholders and ask them for their assessment of the regulatory burden estimates expressed by the Agency in this ICR.  A summary of these consultations will be provided as part of the supporting statement during the second comment period (Attachment D).
      
      3(d)	Effects of Less Frequent Collection

      This activity is only conducted once per "event" (one notification is submitted per product); it is not possible to reduce the frequency of the collection.  EPA must maintain the current frequency of this collection in order to avoid violating FIFRA Section 3 (e).

      3(e)	General Guidelines

      Long-term recordkeeping:  The only PRA-imposed guideline in 5 CFR 1320.6 that may be exceeded in this collection is the record-keeping retention period. The registrant and the distributor are expected to maintain copies of their distribution agreement (EPA Form 8570-5) as long as the registration is valid or until the parties notify EPA that they have voluntarily dissolved the distribution agreement.  Registrations are valid unless they are voluntarily canceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration as a result of the Registration Review Program or an adverse finding by the Agency.  
      
      Since the average period of marketability of a pesticide ranges from 15 to 30 years, the PRA-imposed guideline indicating that data, other than health, medical, or tax records need not be retained for more than 3 years generally will be exceeded in this program.
       
      Electronic submissions:  OMB regulations require agencies to provide a statement indicating whether the proposed collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and an explanation of the decision (5 CFR 1320.5(a)(iii)(E)).  At this time, OPP is not offering a fully electronic submission option.  As this information collection request indicates, both the basic product registrant and the distributor must sign the required notification.  While EPA Form 8570-5 is available and fillable online, the form currently needs to be printed out to be signed and mailed.  
      
      The Agency is actively working to extend full electronic submission options in keeping with the June 22, 2012 OMB memo on "Reducing Reporting and Paperwork Burdens" and other related policy and guidance.  In the future, the Agency hopes to offer a fully electronic version of this form, including electronic signature and submission, through the Agency's Central Data Exchange (CDX).  Electronic submission should reduce the time needed to complete the form and the activities described in Sections 4 and 5 of this ICR while improving the overall quality of submissions.

      3(f)	Confidentiality

      Product distributorship data submitted by basic product registrants under FIFRA Section 3(e) are considered by the Office of Pesticide Programs (OPP) to contain no confidential business information (CBI). 

      3(g)	Sensitive Questions

      No information of a sensitive or private nature is requested in conjunction with this information collection activity. Further, this information collection activity complies with provisions of the Privacy Act of 1974 and OMB Circular A-108.

4. 	THE RESPONDENTS AND THE INFORMATION REQUESTED

      4(a)	Respondents/NAICS Codes

      The North American Industrial Classification System (NAICS) code for businesses participating in this program is 325320 (Pesticide and other Agricultural Chemical Manufacturing).

      4(b)	Information Requested

         (i)	Data Items, Including Record Keeping Requirements

      Pursuant to 40 CFR 152.132, supplemental distribution of a registered pesticide is permitted if the registrant meets all of the conditions and submits a completed and signed EPA Form 8570-5, Notice of Supplemental Distribution of a Registered Pesticide Product.  Sub-section 152.132 (a) requires the registrant to furnish the following information:

 EPA registration number of the product to be distributed;
 EPA-assigned distributor company number; 
 Name of the registered product to be distributed;
 Name and address of the basic product registrant;
 Name to be used on the distributed product;
 Name and address of the distributor;
 Signature and title of the distributor and date signed; and 
 Signature and title of the basic product registrant and date signed.

      (ii)	Respondent Activities

      For each distributor product, the basic product registrant must send to EPA a completed Form 8570-5, signed by both the basic product registrant and the distributor (Attachment E provides detailed information on EPA's requirements).  Responsibility for regulatory compliance rests primarily with the basic product registrant. However, both the registrant and the distributor may be held liable for any violation of FIFRA.  
      
      A registrant wishing to distribute a registered product under a different name or through a different company must provide the following information to EPA:
      

Read 

Read form and instructions.

Request
If necessary, obtain an EPA company number for the supplemental distributor.

Compile

Review information for accuracy and appropriateness.

Submit

Submit EPA Form 8570-5 to the Agency.

Store

File or otherwise maintain the information.

      EPA Form 8570-5 requires the distributor to have an EPA-assigned company number.  If the distributor company is different from the registrant of the product and has not previously obtained an EPA company number, one needs to be assigned to them before the form can be completed for submission (see Attachment F for instructions on how to obtain an EPA company number).   
      
      The Agency estimates conservatively that one-third of the responses submitted to EPA on Form 8570-5 are completed using newly-assigned company numbers.  The one-third estimate is considered conservative because the number of entities submitting requests to EPA for company number assignment during a reporting period is often far fewer than the total number of forms that use newly-assigned distributor company numbers.  This is because companies often enter into distribution agreements for multiple products, either with the same or with different registrants, and notifications for all of those products get submitted around the same time period. 

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

      5(a)	Agency Activities

      Notices of Supplemental Distribution of a Registered Pesticide Product are pin-punched with the date of receipt.  The forms are copied, screened for completeness, and included with a letter acknowledging receipt of each notification that is sent to the registrant, along with, if relevant, a checklist of items to be corrected.  Consistent with 40 CFR 152.132(d)(1), starting in 2010, a product team reviews the product information submitted on the form and follows up with the registrant through the OPP division where the original product is registered.  Subsequent processing steps are the electronic entry and filing of distributor information under the original registration of the product, and maintenance of electronic records.

Assign
If necessary, assign an EPA company number to the supplemental distributor.

Verify

Verify the regulatory status of the primary registration to be supplementally distributed;

Acknowledge receipt

Provide a receipt of the notice by mailing a copy to the distributor company;
Product information review
Check product information; make decisions; if necessary, follow-up with registrant;

Process information

Enter information from the form into the computerized "Distributor File," a part of the Office of Pesticide Programs Integrated Network (OPPIN); and

File and maintain information 

The original form is electronically filed in the regulatory file of the parent Section 3 registration which is maintained by the Office of Pesticide Programs' Information Services Center.

      5(b)	Collection Methodology and Management

      Registrants voluntarily enter into agreements with distributors.  They are required, under FIFRA, to notify the Agency of these agreements.  EPA maintains the original notifications in the regulatory file of the parent Section 3 registration at the Office of Pesticide Programs Information Services Center.

      5(c)	Small Entity Flexibility

      Most of the companies participating in this program would qualify as small entities.  The Agency closely examined potential burdens to small entities and instituted changes to this program in 1984.  At that time, OMB approved the changes.  The Agency also re-evaluated the general burden categories in 1986.  The Agency believes that the burden imposed by this activity has been minimized to what is believed to be the minimal level at which this program can effectively function under the requirements specified in the FIFRA and the regulations for the enforcement of FIFRA.

      5(d)	Collection Schedule

      Not applicable.  This activity is conducted only once per "event" when the registrant submits a Notice of Supplemental Distribution of a Registered Pesticide Product, to the Agency.  Therefore, there is no set schedule for collection of this information.
 

6. 	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

      6(a)	Estimating Respondent Burden
            
      The burden associated with this collection of information is estimated to be approximately 19 minutes per response.  The respondent burden estimate on the per-response basis has changed slightly from previous years due to a previously unaccounted-for activity which is conservatively estimated to apply to one-third of the responses submitted.  To complete Form 8570-5, a distributor's EPA-assigned company number must be included.  Distributors without an EPA company number must send a formal request letter on company letter-head to the Agency to get one assigned (Attachment F).  EPA estimates that one-third of the responses submitted to EPA on Form 8570-5 are completed using newly-assigned company numbers.  This is a conservative estimate because companies often enter into distributor agreements to distribute two or more registered products.  The number of entities submitting requests to EPA for company number assignment during the reporting period is far fewer than the total number of forms that use newly-assigned distributor company numbers.  The exact number of company number requests that are submitted specifically for the purposes of becoming a distributor cannot be determined at this time, and EPA has used the larger estimate of one-third.  The additional step is estimated to add 4.8 minutes to the previously approved total per-response burden of approximately 14.5 minutes.   Therefore, the total respondent burden is estimated to be 19 minutes per response.
      
      However, due to an overall decrease in the number of supplemental distribution notifications received by the Agency over the last several years, the total burden hours have also decreased.  Whereas EPA had expected to receive about 1,895 notice submissions annually over the past 3 years, based on the actual number of submissions received annually over that period (1,764 in FY2009, 1,365 in FY2010, and 1,224 in FY2011), the Agency now expects to receive only 1,451 notice submissions annually over the next 3 years.  Given this change, EPA estimates the total annual burden associated with the notice of supplemental distribution of a registered pesticide product to be 387 hours.
      
      6(b)	Estimating Respondent Costs
      
      Consistent with recent ICR renewals, OPP is using labor cost estimates from Agency economists with respect to 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.
      
Labor Cost Approach
Description
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).  Fully loaded wage rates are used to calculate respondent costs.  This renewal uses data from 2011, which is the most recent.
Unloaded Wage Rate:
Wages are estimated for occupations (management, technical, and clerical) within applicable sectors. The Agency uses average 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.  
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).  
Loaded Wage Rate:
Benefits represent 43% 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 Rate:
The loaded wage rate is multiplied by 50% (EPA guidelines 20-70%) to get overhead costs.
	  
      A copy of the formula work sheets used to estimate the labor rates and to derive the registrants' fully loaded rates and overhead costs for this renewal are listed in Attachment G.

Table 1.  Estimated Respondent Burden/Cost per Supplemental Distribution Application 
                                  REGISTRANT
                                 HOURS, RATES
                                     TOTAL
Collection Activities
                                  Mgmt, $/hr
                                Technical, $/hr
                                Clerical, $/hr
                                     Hours
                                     Costs

                                                                     $   124.10
                                                                      $   61.21
                                                                       $  36.79

Read instructions
                                     0.08
                                       -
                                       -
                                     0.08
                                                                         $9.93 
Process, compile, review information for accuracy and appropriateness
                                     0.05
                                       -
                                       -
                                     0.05
                                                                         $6.21 
If necessary, obtain an EPA company number for the supplemental distributor
                                       -
                                       -
                                     0.08
                                     0.08
                                                                         $2.94 
Complete and submit EPA Form 8570-5
                                     0.03
                                       -
                                       -
                                     0.03
                                                                         $3.72 
Store, file, or maintain information
                                       -
                                       -
                                     0.08
                                     0.08
                                                                         $2.94 
Total
                                     0.16
                                     0.00
                                     0.16
                                     0.32
                                                                        $23.78 

ANNUAL BURDEN: 387 Hours
ANNUAL COSTS: $34,505  

      6(c)	Estimating Agency Burden and Cost

      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). 
      
      Table 2 summarizes the Agency process in reviewing the supplemental distribution applications, with associated hours and costs for each task.  A copy of the formula work sheets used to estimate the labor rates and to derive the Agency's fully loaded rates and overhead costs for this renewal are listed in Attachment H.
      

Table 2.  Estimated Agency Burden/Cost per Supplemental Distribution Application.  
REGISTRANT
HOURS, RATES
TOTAL
Collection Activities
Mgmt, $/hr
Technical, $/hr
Clerical, $/hr
                                     Hours
                                     Costs

 $ 120.32 
 $ 77.85 
 $ 44.05 

If necessary, assign an EPA company number to the supplemental distributor.
                                       -
                                       -
                                     0.08
                                     0.08
$3.52 
Verify, acknowledge receipt1  
                                       -
                                       -
                                     0.03
                                     0.03
$1.51 
 Initial product screening2
                                       -
                                     0.36
                                       -
                                     0.36
$27.90 
 Product review meeting2
                                     0.63
                                       -
                                       -
                                     0.63
$75.46 
 Process disapproved product distribution information2
                                       -
                                     0.42
                                       -
                                     0.42
$32.42 
Process: Enter form information into electronic file in OPPIN
                                       -
                                     0.50
                                       -
                                     0.50
$38.93 
File and maintain information
                                       -
                                     0.02
                                       -
                                     0.02
$1.30 
Total
                                     0.63
                                     1.29
                                     0.03
                                     1.95
$52.78 
 Source:  U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/naics4_999100.htm May, 2011.
 1  Approximately 90% of forms received by EPA are appropriately completed and undergo standard processing, requiring only clerical and technical labor types. 
 2  The rest of the forms (approximately 10%) require review by the Agency's product review team, requiring all three types of labor.

      The total annual Agency burden associated with the notice of supplemental distribution of a registered pesticide product is 970 hours.  This represents an increase over the Agency burden estimated for the 2009 ICR (625 hours) due to a review process that was implemented in 2010.  The tasks marked by the superscript 2 represent the new review process in which some of the product information must be reviewed by the Agency to determine that supplemental distributed product names are consistent with 40 CFR 152.132(d)(1) and are not "misleading."  The annual total Agency cost is $76,589, increased from $25,905 of the 2009 ICR.

      6(d)	Bottom Line Burden Hours and Cost Tables

	Total Annual Respondent and Agency Burden and Costs

                                     Total

                                     Hours
                                     Costs
Annual Respondent Burden/Cost Estimates
                                      387
                                   $34,505  
Annual Agency Burden/Cost  Estimates
                                      970
                                    $76,589

      6(e)	Reasons for Change in Burden

      The total annual respondent burden associated with the notice of supplemental distribution of a registered pesticide product is 387 hours, a 68 hour decrease from 455 hours estimated in the ICR from 2009.  This decrease is an adjustment.  The average number of supplemental registrations received by the EPA over the last three years is approximately 1,451 responses per year (1,764 in FY2009, 1,365 in FY2010, and 1,224 in FY2011).  Based on these numbers, the Agency estimates that it will receive an average of 1,451 supplemental registrations annually for the next three years. 

      6(f)	Burden Statement

      The total estimated annual respondent paperwork burden to comply with this information collection activity is 387 hours, or about 19 minutes per response, adjusted up from 15 minutes per response from the last renewal.  The per-response increase is due to the inclusion of a required step in the notification process that was not previously considered as part of this ICR but is estimated to apply to a third of the responses.  This estimate includes the time needed to review instructions; 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 respond to a collection of information; search existing data sources; complete and review the collection of information; and transmit or otherwise disclose the 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 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 (see Attachment I).

      The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2012-0544, which is available for online viewing at www.regulations.gov, or in person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA.  This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.  The docket telephone number is (703) 305-5805.  You may submit comments regarding 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.  
      
	Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2012-0544 and OMB Control No. 2070-0044, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Public Information and Records Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.
                               Attachments List
                                       
All of the attachments listed below can be found in the docket for this ICR (unless otherwise noted), accessible electronically through www.Regulations.gov . On the main page, select Advanced Search from the menu bar at the top and select Docket Search. Enter the Docket ID Number, EPA-HQ-OPP-2012-0544, in the Docket ID field. Click on the Submit button. From the results page, you will be able to link to the docket view or directly open select documents found in the docket.

Attachment A
7 U.S.C. 136a  -  Section 3 of FIFRA. Also available at online at the US House of Representatives' US Code website.
Attachment B
EPA Form 8570-5 - Notice of Supplemental Distribution of a Registered Pesticide Product 
Also online at http://www.epa.gov/opprd001/forms/8570-5.pdf
Attachment C
40 CFR Part 152.132 - Obligations and Rights of Registrants - Supplemental Distribution.  Also available online at the National Archives and Records Administration's Electronic CFR Website.
Attachment D
(Reserved)
Attachment E
Requirements for Approval of Supplemental Distribution 
Also available at: http://www.epa.gov/opprd001/registrationmanual/chapter9.html
Attachment F
How to Obtain an EPA Company Number 
http://www.epa.gov/pesticides/registrationkit/company-num_addr-chg.pdf
Attachment G
Work Sheets used to Calculate Registrant Labor Costs
Attachment H
Work Sheets used to Calculate EPA & Federal Government Labor Costs  
Attachment I
Display Related to OMB Control #2070-0044  -  Listings of Related Regulations in 40 CFR 9.1. Also available online at the National Archives and Records Administration's Electronic CFR Website.