Document ID: EPA-HQ-OPP-2009-0264-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-12-04T05:00Z

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.:  0278.10

1(b).	Short Characterization/Abstract

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 March 31, 2010.  The information collection
activity notifies the Environmental Protection Agency (EPA) of a
supplemental registration of distributors of pesticide products.  EPA is
responsible for the regulation of pesticides as mandated by the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended.  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).  Additionally,
this statute allows the second company to distribute a registered
pesticide product under its own name.  Such distribution and sale is
termed “supplemental distribution” and the product is termed a
“distributor product.”  The 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).  

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
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

In proposing to renew this ICR, EPA is publishing a Federal Register
Notice that provides a 60-day public notice and comment period.

3(c).	Consultations

During the development of this renewal ICR, EPA contacted the following
representatives of a cross-section of pesticide registrants seeking
feedback on their assessment of the regulatory burden estimates
expressed by the Agency in this ICR:

L. Perrigo Company (Brian Anson; 269-673-1223)

Bonide Products, Inc. (Rebecca Horton; 540-375-8827)

Brulin & Company (Berma L. Johnson; 317-923-3211, ext 3391)

As of the submission date of this ICR on September 29, 2009, two out of
the above three, Brian Anson of L. Perrigo and Berma L. Johnson of
Brulin & Company, responded.  Among other feedback, they confirmed that
the estimated burden hours are accurate.  The consultation questions and
the responses received by the Agency have been included as an attachment
in the docket under attachments D and E, respectively.  

3(d).	Effects of Less Frequent Collection

This activity is only conducted once per "event" (one notification is
submitted per product), therefore, there is no way that the EPA can
reduce the frequency of the collection.  The EPA must maintain the
current frequency of this collection in order to avoid violating FIFRA
section 3(e).

3(e).	General Guidelines

The only PRA-imposed guideline in 5 CFR 1320.6 that may be exceeded in
this collection is the record-keeping retention period. We would expect
the registrant and the distributor 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
Reregistration 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.

 

This collection of information does not involve the use of automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses).  Additionally, is not practicable for the
Agency to implement electronic reporting at this time.

OPP is not yet able to make electronic reporting available for this
information collection.  Based on the Agency’s needs, and on the
Office of Management and Budget’s (OMB) GPEA guidance (as updated by
OMB’s policy on E-Authentication), EPA would likely require that any
electronically submitted forms be signed with an e-signature technology
such as public key infrastructure (PKI).  As this information collection
request indicates, both the basic product registrant and the distributor
must sign the required notification.  EPA is currently unaware of how an
e-signature technology that offers both the Agency and the signatories
the level of document integrity and signature security such as that
offered by PKI can be successfully applied to a document that requires
multiple signatures.

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

Any pesticide registrant may participate in this program by submitting a
completed EPA Form 8570-5, Notice of Supplemental Distribution of a
Registered Pesticide Product, to the Agency.  The registrant must
furnish the following information:

 •	EPA registration number of the product to be distributed;

 •	EPA-assigned distributor company number; 

 •	name and address of the basic product registrant;

 •	name of the registered product to be distributed;

 •	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 a
completed Form 8570-5, signed by both the basic product registrant and
the distributor, to EPA. Responsibility for regulatory compliance rests
primarily with the basic product registrant. However, both the basic
product registrant and the distributor may be held liable for any
violation of FIFRA.  A participant must undertake the following
activities in order to provide the requisite information to the EPA:



Read 	

Read form and instructions; and 

Compile	

review information for accuracy and appropriateness.

Submit	

Submit EPA Form 8570-5 to the Agency; and

Store	

file or maintain the information.

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. Subsequent processing steps
include:

Verify	

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

Assign	

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

Acknowledge receipt	

Provide a receipt of the notice by mailing a copy to the distributor
company.

Process	

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

File and maintain information 	

The original form is filed in the regulatory file of the parent Section
3 registration and kept in 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 15 minutes per response.  The Agency’s respondent
burden estimate on the per-response basis has not changed over the last
several years. However, there has been a decrease in the number of
notices submitted to EPA over the last several years.  Whereas EPA had
expected to receive about 2,500 notice submissions annually over the
past 3 years, based on the actual number of submissions received
annually over that period (1,972 in FY2006, 2,117 in FY2007, and 1,596
in FY2008), the Agency now expects to receive only 1,895 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 454.8
hours.

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.

	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 2007, 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   HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm" 
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   HYPERLINK "http://www.bls.gov/oes/current/oes_stru.htm" 
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   HYPERLINK
"http://www.bls.gov/news.release/ecec.t01.htm" 
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 fully loaded rates and overhead costs for this renewal are
listed in Attachment F.

Table 1.	Respondent Burden/Cost: Applicant Cost Estimate per
Supplemental Distribution Application 

REGISTRANT	

HOURS, RATES	

TOTAL

Collection Activities

	

Mgmt

$104.41/hr	

Tech

$57.88/hr.

	

Cler

$34.95/hr.

	

Hours	

Costs

Read any Instructions	

0.08	

0.00	

0.00	

0.08	

$8.35

Process, compile, review information for accuracy and appropriateness.	

0.05	

0.00	

0.00	

0.05	

$5.22

Complete and submit EPA Form 8570-5	

0.03	

0.00	

0.00	

0.03	

$3.13

Store, file, or maintain information.	

0.00	

0.00	

0.08	

0.08	

$2.80

Total	

0.16	

0.00	

0.08	

0.24	

$19.50

Data Source:  U.S. Department of Labor, Bureau of Labor Statistics, May,
2007.

NAICS 325300 - Pesticide, Fertilizer, and Other Agricultural Chemical
Manufacturing	

Notes: Fringe benefits/wage per hour is the average for non farm, non
federal civilian workers.	

Totals may not sum due to rounding.

ANNUAL BURDEN: 0.24 Total Hours x 1,895 Respondents = 454.8 Hours

ANNUAL COSTS: $19.50 Total Costs x 1,895 Respondents = $36,952.5

6(c).	Estimating Agency Burden and Cost

The Agency devotes 0.33 hours, or 20 minutes, to process each of the
1,895 supplemental distribution submissions. Processing of supplemental
distribution submissions is conducted by clerical staff (SOC of office
and administrative support occupations).

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). For clerical occupations, the fully loaded mean wage rate is
$41 (See Worksheet for NAICS 999100 EPA and Federal Government in
Attachment G).

T	he total annual Agency burden associated with the notice of
supplemental distribution of a registered pesticide product is 625.35
hours.  This estimate assumes the Agency devotes 0.33 hours to each of
the 1,895 respondents.  The Agency cost associated with this program is
$25,904.65 annually

ANNUAL BURDEN: 0.33 Total Hours x 1,895 Responses = 625.35

ANNUAL COSTS: $13.67 Total Costs x 1,895 Responses = $25,904.65

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	

	454.8	

$36,952.5

Annual Agency Burden/Cost  Estimates	

	625.35	

$25,904.65

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 454.8
hours, a decrease of 140.2 hours over the 595 hours estimated in the ICR
from 2006.  This decrease is an adjustment.  The average number of
supplemental registrations received by the EPA over the last three years
is approximately 1,895 responses per year (1,972 in FY2006, 2,117 in
FY2007, and 1,596 in FY2008).  Based on these numbers, the Agency
estimates that it will receive an average of 1,895 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 454.8 hours.   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 H).

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2009-0264, which is available for online viewing at  
HYPERLINK "http://www.regulations.gov"  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.  

	Comments may be submitted to EPA electronically through
http://www.regulations.gov or by mail addressed to Director, Collection
Strategies Division, U.S. Environmental Protection Agency (2822T), 1200
Pennsylvania Ave., NW, Washington, D.C. 20460.  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.  Include docket ID No.
EPA-HQ-OPP-2009-0264 and OMB control number 2070-0044 in any
correspondence but do not submit information under this collection to
these addresses.

Attachments List

All of the attachments listed below can be found in the docket for this
ICR (unless otherwise noted), accessible electronically through  
HYPERLINK "http://www.regulations.gov/"  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-2009-0264,
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	FIFRA Section 3 (7 U.S.C 136a)

FIFRA Section 3 (see page 16):   HYPERLINK
"http://agriculture.senate.gov/Legislation/Compilations/Fifra/FIFRA.pdf"
 http://agriculture.senate.gov/Legislation/Compilations/Fifra/FIFRA.pdf 

7 U.S.C. 136a: 

  HYPERLINK
"http://www4.law.cornell.edu/uscode/7/usc_sec_07_00000136---a000-.html" 
http://www4.law.cornell.edu/uscode/7/usc_sec_07_00000136---a000-.html 

Attachment B	EPA Form 8570-5

Notice of Supplemental Distribution of a Registered Pesticide Product:

  HYPERLINK "http://www.epa.gov/opprd001/forms/8570-5.pdf" 
http://www.epa.gov/opprd001/forms/8570-5.pdf  

Attachment C	40 CFR part 152.132

  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=4a068ea9e8a458
c82e7ca38e646d8bf5&rgn=div8&view=text&node=40:23.0.1.1.3.7.1.4&idno=40" 
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=4a068ea9e8a458c
82e7ca38e646d8bf5&rgn=div8&view=text&node=40:23.0.1.1.3.7.1.4&idno=40  

Attachment D	List of Standard Questions

Attachment E		Consultation Process:  Responses

Attachment F		Work Sheets used to Calculate Registrant Labor Costs  

Attachment G	Work Sheets used to Calculate EPA and Federal Government
Labor Costs  

Attachment H	OMB Control Numbers for EPA’s Regulations in Title 40 of
the CFR

List of OMB Control numbers related to 40 CFR 9.1:   HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=7598aa9097cc06
166e78fabfecb78a1e&rgn=div5&view=text&node=40:1.0.1.1.9&idno=40" 
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=7598aa9097cc061
66e78fabfecb78a1e&rgn=div5&view=text&node=40:1.0.1.1.9&idno=40  

September 30, 2009

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