March 3 , 2016

Page 1 of 11 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.: 0278.1 2

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

Insecti cide, 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 products

with the same formulation

, label claims, and manufacturer as a regi stered pr oduct to be distributed under the same registration as the basic product (see Attachment A). Pesticide registrants may distribute or sell registered pesticides under a different product name in addition to the registered

name , or under a different entity ’s name and address

. 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 EPA Form 8570

- 5, Notice of Supplemental Distribution of a Registered Pesticide Product (see Attachment B). Supplemental registrations are only an extension of a currently federally registered pesticide product.

Distributor products must reflect any chan ges in formulation or labeling made to the basic registered product within the same timeframe imposed on that product. A distributor is considered an agent of the registrant; both the registrant and the distributor may be held liable for violations pertai ning to the distributed product. In addition to notifying the Agency, an individual or entity may become a distributor upon meeting the regulatory conditions. D istributor product s must be the same as the registered product, and may not be repackag ed ( must remain in the producer’s unopened container ) ; distributor product labels must bear qualifications such as “distributed by,” or “sold by ; ” the labeling must bear the same claims as the basic registered product

-- with the exception of deletion of speci fic claims. In addition, a lthough the distributed product’s name may be different from that of the registered product, it may not be misleading

. This information collection request (ICR) is a proposed renewal of an existing ICR currently approved by Offi ce of Management and Budget (OMB) that is due to expire on November 30 , 201 6

.

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, asMarch 3 , 2016

Page 2 of 11 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 they enter into an agreement with a second company to distribute the registrant's product under the second

company and product ’s name. The distributor is considered an agent o f 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 (OPP) is responsible for maintaining infor mation 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, performed only once per receipt

of a notice of distri butor 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), EPA is publishing a Federal Register (FR) notice soliciting comment on this information collection activity and announcing the Agency’s intent to renew the OMB approval of this ICR. The FR notice and the proposed renewal ICR a s well as any public comments are located in the docket for this action, which can be accessed at http://www.regulations.gov using the docket i dentifier EPA

- HQ

- OPP

- 2016

- 0108

.

3(c) Consultations

Under 5 CFR 1320. 8(d)(1)

, agencies are require d to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting a renewal ICR to OMB for review and approval. During preparation of this ICR renewal, EPA staff will contact respond ent representatives to seek feedback on the burden estimates in the ICR and the clarity of guidance provided. Their responses to EPA’s consultation efforts will be summarized and made publicly available with the final ICR renewal request

.

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 under FIFRA Section 3 (e).

3(e) General Guidelines

Long

- term recordkeeping: The only PRA

- imposed guideline in 5 CFR 1320.6 that mayMarch 3 , 2016

Page 3 of 11 be exceeded in this collection is the record

- keeping retention period. The registrant and the distributor are expected to maintain c opies 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

w ithdrawn 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 yea rs, 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 s tatement 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 respo nses, 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 but will soon be offering the option to submit via the Agency’s Central Data Exchange (CDX)

Portal . As this informa tion 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 . Once the 8570

- 5 form is signed by both parties, it may be mailed or submitted as a pdf via the CDX Portal

.

The CDX Portal is the Agency ’s way to extend full electronic submission options in keeping with the June 22, 2012 OMB memo on "Reducing Reporting and Paperwork B urdens" and other related policy and guidance. Electronic submission via the CDX Portal 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 Sec tion 3(e) are considered by OPP to contain no confidential business information (CBI).

3(g) Sensitive Questions

No information of a sensitive or priva te 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

Potential respondents are i ndividuals or firms engaged in registration and distribution of pesticide product s. The North American Industrial Classification System (NAICS) code forMarch 3 , 2016

Page 4 of 11 businesses participating in this program is 3 25320 (Pesticide and other Agricultural Chemical Manufacturing).

4(b) Information Requested

(i) Data Items, Including Record Keeping Requirements

P u rsuant to 40 CFR 152.132, supplemental distribution of a registered pesticide is permitted if the re gistrant 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 ( see Attachment E for

instructions and 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 goes through the process summarized below:

Summary of Steps to Notify EPA of Supplemental Distribution Agreement

Read Read form and instructions ;

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

Compile Assemble information; r eview for accuracy and completeness;

Submit Submit EPA Form 8570

- 5 to the Agency ;

Store File or otherwise maintain the information.

Before distribution and sale of EPA

- registered pesticides, a company must 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, the company needs to obtain

one before submitting the form to EPA (see Attachment F for instructions on how to obtain anMarch 3 , 2016

Page 5 of 11 EPA company number).

The Agency estimates that one

- third of the responses submitted to EPA on Form 8570

- 5 are completed using newly

- assigned company numbers. Th is is a conservative estimate because the number of entities submitting requests to EPA for company number assignment as part of the process for a supplemental distribution agreement is often very low compared to the total number of forms that use newly

- assigned distributor company numbers. The primary reason for such a discrepancy is that comp anies often establish multiple 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. The exact number of company number

req uests that are submitted specifically for the purposes of becoming a distributor cannot be determined at this time, and EPA has used a larger estimate of one

- third.

5. THE INFORMATION COLLECTED

- AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATIO N MANAGEMENT

5(a) Agency Activities

Upon receipt of Notices of Supplemental Distribution of a Registered Pesticide Product

, EPA Form 8570

- 5, the front

- end process involves the following activities:

• receive distribution n otices;

• pin

- punch forms with date of receipt ;

• make cop ies of the forms ;

• screen for ms for completeness of information ; contact the registrant when needed ;

• send letter s of receipt to the registrants, including copies of the pin

- punched forms ;

• if items need to be corrected, include a correction checklist with the letter ;

• send forms for review and follow up by product teams where the original product was registered ;

• enter information from reviewed forms in database under the basic registration file ; and

,

• scan original forms into an el ectronic filing system

.

Consistent with labeling regulation 40 CFR 15 6.10

, starting in 2010, a product team reviews the product information submit ted on the form

. The team verifies the registered product information and ensures that the distributor product name is in compliance with labeling as well as supplemental distribution regulations. If needed, EPA staff follows up with the registrant throu gh

the OPP division where the original product is registered. After product team review , the

information is ent ered in an electronic database under the original registration of the product . The pin

- punched forms are maintained in electronic records.

Summary of Steps for Reviewing and Recording Notification Information

Assign Assign an EPA company number to the supplemental distributor if the company does not already have one

.March 3 , 2016

Page 6 of 11 Verify Verify the regulatory status of the primary registration that is to be supplementally distributed;

Acknowledge receipt Provide receipt of the supplemental distribution notice by mailing a copy of it to the distributor company;

Product information

review Check distributor product information; if necessary, follow

- up with registrant ; make decisions

.

Process information Enter information from EPA Form 8570

- 5 (Notice of Supplemental Distribution of a Registered Pesticide Product) into an electronic "Distributor File," a part of the Office of Pesticide Programs Integr ated Network (OPPIN);

File and maintain

information E lectronically file date

- stamped form in the regulatory file of the parent Section 3 registration . This file is maintained by OPP at the 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 a t the OPP 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 w hich 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 Bur den

The burden associated with this collection of information is estimated to be approximately

19 minutes per response

. 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). EPAMarch 3 , 2016

Page 7 of 11 estimates that one

- third of the responses submitted to EPA on Form 8570

- 5 are completed using newly

- assigned company numbers. This is a conservativ e estimate ; the actual number may be

much lower 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 p eriod is far fewer than the total number of forms that use newly

assigned distributor company numbers.

Due to an overall in crease in the number of supplemental distribution notifications received by the Agency over the last several years, the total burde n hours ha s in creased. Whereas EPA had expected to receive about 1,451 notice submissions annually over the past 3 years, based on the actual number of submissions received annually over that period ( 1

, 904 in FY20 12

, 1

, 822

in FY201 3 , and 1

, 930 in FY201 4 ), the Agency now expects to receive about 1,885 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 603 hours , as shown below:

Total annual notification burden for forms

= number of ALL responses per year x time to complete notification

= 1,885 x 0. 32 hours

= 603.2 hours

Total annual respondent burden is estimated to be = 603 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

cons istent methodology and current publicly

- available data to provide more accurate estimates and allow easy replication of the estimates.

Table 1. Methodology Used to Calculate Labor Costs

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 201 4

, which is the most recent.

Unloaded Wage Rate: Wages are estimated for occupations (management, technical, and clerical) within applicable sectors. The A gency 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 SOCMarch 3 , 2016

Page 8 of 11 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 4 6.3 % 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 shee t s used to estimate the labor rates and to derive the registrants’ fully loaded rates and overhead costs for this renewal are listed in Attachmen t G

.

Table 2

. Estimated Respondent Burden/Cost per Supplemental Distribution Application

REGISTRANT HOURS, RATES TOTAL

Collection Activities Mgmt, $/hr Technical, $/hr Clerical, $/hr Hours Costs

$135.39 $69.33 $45.19

Read instructions 0.08

- - 0.08 $10.83

Process, compile, review information for accuracy and appropriateness 0.05

- - 0.05 $6.77

If necessary, obtain an EPA company number for the supplemental distributor - - 0.08 0.08 $3.62

Complete and submit EPA Form 8570

- 5 0.03

- - 0.03 $4.06

Store, file, or maintain information

- - 0.08 0.08 $3.62

Total 0.16 0 0.16 0.32 $28.89

ANNUAL BURDEN: 603 Hours (= 0.32hrs X 1,885 responses)

ANNUAL COSTS: $54,463 (=0.32hrs X $28.89 average hourly wage rate)

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 Ex ecutive Branch (NAICS 999100). Historical Submissions

Table 3 summarizes the A gency process in reviewing the supplemental distribution applications, with associated hours and costs for each task. A copy of the formula work sheet s used to estimate the labor rates and to derive the Agency’s fully loaded rates and overhead costs

for t his renewal are listed in Attachmen t H

.March 3 , 2016

Page 9 of 11 Table 3 . Estimated Agency Burden/Cost per Supplemental Distribution Application

AGENCY HOURS, RATES * TOTAL

Collection Activities Mgmt, $/hr Technical, $/hr Clerical, $/hr Hours Costs

$124.09 $81.53 $46.42

If necessary, assign an EPA company number to the supplemental distributor. 1 - - 0.08 0.08 $3.71 1

Verify, acknowledge receipt 2

- - 0.03 0.03 $1.39

• Initial product screening 3 - 0.36

- 0.36 $29.35

• Product review meeting 3 0.63

- - 0.63 $78.18

• Process disapproved product distribution information 3 - 0.42

- 0.42 $34.24

Process: Enter form information

into electronic file in OPPIN - 0.5

- 0.5 $40.77

File and maintain information

- 0.02

- 0.02 $1.63

Total 0.63 1. 3 0. 11 2.0 4 $59.20 4

4 $1.24 (footnote 1) + $ 1.39 + $14.18 (footnote 3) + $40.77 + $1.63 = $59.20

The total annual Agency burden associated with the notice of supplemental distribution of a registered pesticide product is 1

, 260 hours. The tasks marked by the superscript 2 represent the review process in which some of the product information must be rev iewed by the Agency to

determine that supplemental distributed product names are consistent with 40 CFR 15 6.10 (5) and are not “misleading.” The annual total Agency c ost is $ 111,592 an i ncrease from $76,589 of the

20 12 ICR due to the increase in the average amount of submissions (2011

- 1,451 to 2014

- 1,885)

, and the wage rate

. * U.S. Department of Labor, Bureau of Labor Statistics. (201 4 ) May 201 4 National Industry

- Specific Occupational
Employment and Wage Estimates; NAICS 999100

– Federal Executive Branch (OES Designation). Available from

BLS Web site at http://www.bls.gov/oes/current/naics4_999100.htm

1 This step is only necessary in a third of cases based on co nservative e stimates from historical data. In the calculations the maximum time was used, but the expected cost $1.24 (1/3 * $3.71) was used for total.

2 Approximately 90% of forms received by EPA are completed correctly and undergo standard processing,
requiring only clerical and technical labor t ypes.

3 The rest of the forms (approximately 10%) require review by the Agency's product review team, requiring
all three types of labor. In the calculations the maximum time was used, but the expected cost $14.18 [10% *
$141.77 (29.35+78.18+34.24)] was used for total.March 3 , 2016

Page 10 of 11 6(d) Bottom Line Burden Hours and Cost Tables

Total Annual R espondent and Agency Burden and Costs

Total

Hours Costs Annual Respondent Burden/Cost Estimates 603 $ 5 4

, 463 Annual Agency Burden/Cost Estimates 1260 $ 111 ,5 92

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 603 hours, a 216 hour in crease from 387 hours estimated in the

ICR from 20 12 . This in crease is an adjustment based on t he avera ge number of supplemental registrations received by the EPA over the last three years which was approximately 1,885

responses per year ( 1

, 904 in FY2012, 1

, 822 in FY2013, and 1

, 930 in FY2014) . Based on these numbers, the Agency estimates that it will recei ve an average of 1,885 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 603 hours, or about 19 minutes per r esponse. 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

ot herwise 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 titl e 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

- 2016

- 0108 , which is available for online viewing at http://www.regulations.gov , or in person viewing at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in EPA West, Room 3334, 1301 Constitution Ave, NW, Washington, DC 20460. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday thr ough 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 av ailable at http://www.epa.gov/dockets

.

Com m e nts regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden ma y be submi t ted to EPA e le c troni ca l l y thro u g hMarch 3 , 2016

Page 11 of 11 ht t p: / /ww w

. r e gulations. g ov or b y mail add re ssed to Di r ec t o r , Co l le c t i on S tr a te g ies Division, U. S

. Environ m e ntal P rot ec t i on A g e n c y (282 2 T ) , 1200 P e nn s y l v a nia A v e ., N W

, W a shin g t on, D.C.

20460. You c a n a lso s e nd c om m e nts t o the O f fi c e o f I n f o rm a t i on a n d Re g ulato r y A f f

a irs, of the

Office of M a n a g e ment a nd B u d g e t, 725 17 t h S tr ee t, N W

, W a shin g ton, DC 20503, Attention: D e sk

O f fi c e f or EPA. I n c lude d o c k e t ID No. EPA

- HQ

- OPP

- 2016

- 0108 a nd OMB n umber 2070

- 0044 in

a n y c o r r e spon d e n ce . Follow the online instructions for submitting comments online. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

ATTACHMENTS LIST All of the attachments listed below can be found in the docket for this ICR (unless otherwise noted), accessible electronically through http:// www.Regulations.gov On the main page, select

Advance d Search from the menu bar at the top and select Docket Search . Enter the Docket ID Number, EPA

- HQ

- OPP

- 2016

- 0108 , in the Docket ID field. Click on the Submit bu tton . 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 o nline 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 Adm inistration’s Electronic CFR Website

.

Attachment D Placeholder for future Consultation s : List of Standard Questions and Industry Responses

Attachment E Requirements for Approval of Supplemental Distribution

Also available at : http://www.epa.gov/opprd001/registrationmanual/chapter9.html

Attachment F How to Obtain a n EPA Company Number http://www.epa.gov/pesticides/registrationkit/company

- num _addr

- chg.pdf

Attachment G Work Sheets used to Calculate Registrant & EPA Wage Rates

Attachmen t H 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

.