SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

Pesticide Establishment Application, Notification of Registration and Pesticide Production 

Report for Pesticide-Producing and Device-Producing Establishments (40 CFR Part 167) 

(Renewal)

1. Identification of the Information Collection

1(a) Title of the Information Collection

Application for Registration of Pesticide-Producing and Device-Producing

Establishments (EPA Form 3540-8); Notification of Registration of Pesticide-Producing and 

Device-Producing Establishments and Pesticide Report for Pesticide-Producing and DeviceProducing Establishments (EPA Form 3540-16). EPA ICR Number: 0160.10 (Renewal).

1(b) Short Characterization/Abstract

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7(a) requires 

that any person who produces pesticides or active ingredients subject to the Act must register 

with the Administrator of EPA the establishment in which the pesticide is produced. This 

Section further requires that the application for registration of any establishment shall include the 

name and address of the establishment and of the producer who operates such an establishment. 

EPA Form 3540-8, Application for Registration of Pesticide-Producing and Device-Producing 

Establishments, is used to collect the establishment registration information required by this 

Section.

FIFRA Section 7(c) requires that any producer operating an establishment registered 

under Section 7 report to the Administrator within 30 days after it is registered, and annually

thereafter by March 1st for certain pesticide/device production and sales/distribution information. 

The producers must report which types and amounts of pesticides, active ingredients, or devices 

are currently being produced, were produced during the past year, sold or distributed in the past 

year. The supporting regulations at 40 CFR Part 167 provides the requirements and time 

schedules for submitting production information. EPA Form 3540-16, Pesticide Reports for 

Pesticide-Producing and Device-Producing Establishments, is used to collect the pesticide 

production information required by Section 7(c) of FIFRA.

Establishment registration information, collected on EPA Form 3540-8, is a one-time 

requirement for all pesticide-producing and device-producing establishments. Pesticide and 

device production information, reported on EPA Form 3540-16, is required to be submitted 

within 30 days of receipt of the Notification of Registration of Pesticide-Producing and DeviceProducing Establishments, and annually thereafter on or before March 1. 

Attached are copies of: (1) Forms 3540-8 and 3540-16; (2) instructions for their 

completion; (3) Section 7 of FIFRA; and (4) 40 CFR Part 167 (1998), to further explain the 

establishment registration and reporting requirements.
2

2. Need for and Use of the Collection

2(a) Need/Authority for the Collection

FIFRA Section 7 states that required pesticide production information be reported 

annually as required under regulations (40 CFR 167) as the Administrator may prescribe.

2(b) Practical Utility/Users of the Data

The purpose of this reporting requirement is to obtain pesticide production information. 

The EPA requires this information in order to maintain current and complete records of the 

locations of all pesticide-producing and device-producing establishments. This information 

provides an overview of establishments engaged in pesticide activities and allows the Agency to 

target establishments for inspections with optimal utilization of limited inspection resources. 

Such production information permits EPA to trace ineffective, contaminated or otherwise 

violative products to their source, and minimizes any adverse environmental impact that might 

arise from the production or distribution of violative products. If this information were not 

collected, the Agency would be unable to meet the statutory requirements of FIFRA.

The Office of Compliance (OC) in the Office of Enforcement and Compliance Assurance 

(OECA) collects the establishment and pesticide production information for compliance purposes 

and risk assessment. This information is used by EPA Regional pesticide enforcement and 

compliance staffs, the OC, the Office of Civil Enforcement (OCE), and the Office of Pesticide 

Programs (OPP) within the Office of Chemical Safety & Pollution Prevention (OCSPP), as well 

as the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), other 

Federal agencies, States under Cooperative Enforcement Agreements, and the public.

EPA Headquarters, Regions and the States use the data for targeting inspection activities, 

compliance and outreach, and enforcement actions. Establishment registration and production 

data are used to: identify where specific pesticides are made; target inspections in response to tips 

or complaints of producer violations; determine where violative products found in the 

marketplace were produced, thus facilitating recalls of problem products; facilitate the issuance of 

Stop Sale, Use, or Removal Orders for violative products; help locate production sites of canceled 

or suspended products; and assist in notifying producers of regulatory actions or requirements. 

3. Non-duplication, Consultations and Other Collection Criteria

3(a) Non-duplication

No agency besides EPA, nor any other program within EPA, requests this information. 

The Agency, under Section 29 of FIFRA, does collect a subset of production data for 

conditionally registered pesticides only. However, this production data for conditionally

registered pesticides does not fulfill the requirements of Section 7 of FIFRA. Therefore, no 

duplication exists.

3(b) Public Notice Required Prior to ICR Submission to OMB
3

The Federal Register notice required by 5 CFR 1320.8(d) was published November 29, 

2011 at 76 FR 73620-73622.

3(c) Consultations

One comment was received in response to the Federal Register Notice. However, EPA 

was unable to respond promptly to the commenter since the representative did not provide any

contact information. The comment was submitted by a regulatory compliance consulting

company affected by this ICR. This comment is addressed below.

The private consulting company, Lighthouse Product Services (LPS), submitted a 

comment directed toward the application process for requesting and receiving an EPA 

establishment registration number. LPS stated that filing an initial report 30 days after the 

assignment of the establishment registration number is an unnecessary burden of time, when 

production reports must be filed yearly by March 1st. This concern is directly answered in 

Sections’ 1(b), 2, 3(a) and (d) of this Supporting Statement that details the need and use of the 

data collected under this ICR.

3(d) Effects of Less Frequent Collection

EPA Form 3540-8 is a one-time requirement for information used to register pesticideproducing and device-producing establishments. EPA Form 3540-16 must be submitted by all 

establishments subject to Section 7 of FIFRA, 30 days after notification of the initial assignment 

of an establishment registration number, and thereafter on an annual basis. The statute dictates 

the time schedule in which reporting must occur. Therefore, EPA could not carry out the 

requirements of the statute if EPA collected such data on a less frequent reporting schedule.

Additionally, if the information were not submitted, the EPA would be unable to fulfill its 

statutory responsibilities relative to the review and registration of pesticides and the protection of 

human health and the environment.

3(e) General Guidelines

None of the reporting or record keeping requirements contained in 40 CFR 167 or 

otherwise pertinent to this request violate any of the regulations established by OMB in 5 CFR 

1320.6.
4

3(f) Confidentiality

The information collected on EPA Form 3540-8 does not involve any confidentiality

concerns or sensitive questions. However, pesticide and device producers must report certain 

confidential business information (CBI) on EPA Form 3540-16, including the amounts of 

pesticides/devices produced, sold, and distributed, under FIFRA Section 7 requirements. EPA 

safeguards trade secrets in accordance with FIFRA Sections 7(d) and 10. The Agency’s copies of 

individual firms’ reports are stored in secure file cabinets within CBI security areas. Confidential 

business information pertaining to specific data on any one firm cannot be released to the public.

3(g) Sensitive questions

This information collection activity does not involve any questions of a sensitive nature.

4. The Respondents and the Information Requested

4(a) Respondents NAICS Codes

Establishments producing pesticide products, pesticide chemical ingredients, and devices 

are subject to FIFRA. The six-digit sector/sub-sector United States North American Industry

Classification System (NAICS) Codes assigned to the businesses and other institutions 

participating in this program include primarily Manufacturing, Sectors 31-33; and Agricultural, 

Forestry, Fishing & Hunting, Sector 11. 

4(b) Information Requested

(i) Data Items

All data in this ICR that is recorded is required by Section 7 of FIFRA and the supporting 

regulations at 40 CFR 167. Under this requirement producers of pesticides and devices must 

report to the Agency annually the amounts of pesticides and devices produced, repackaged, 

relabeled; the amount sold or distributed in U.S. markets; the amount sold or distributed in 

Foreign markets; and the amount anticipated to be produced in the following year.

(ii) Respondent Activities

- Read instructions (provided with each EPA Form)

- Plan the reporting activity

- Gather information

- Plan and review information for accuracy

- Store, file and maintain the information
5

During the course of normal business operations, a producer would plan and maintain the 

information required to comply with this information collection activity, arrange for the 

collection, review the information for accuracy, and arrange to maintain or store the information. 

The information required to be reported is information that the producer would generally maintain 

as prudent business practices. The Agency does not specify in the regulation how the data to be 

gathered must be organized; however, the Agency does supply a reporting form, which provides 

for the reporting of the required information in a consistent manner.

5. The Information Collected: Agency Activities, Collection Methodology, and Information 

Management

5(a) Agency Activities

In this collection the Agency will: 1) answer companies’ and producers’ questions; 2) will 

review the data collected; 3) provide appropriate protection of confidential business information; 

and 4) store collected data both electronically and in paper file system.

5(b) Collection Methodology and Management

Producers determine how to best comply with the requirements for record keeping under 

FIFRA Section 7. They may collect and store the required data electronically or by paper copy.

The Agency in turn annually provides forms for pesticide-producing and device-producing

establishments to report their collected and stored information. 

5(c) Small Entity Flexibility

The information collected under this ICR does not significantly impact small businesses, 

since the information being reported is that which their records would be considered as 

“customary and usual business activities.” To the extent that larger businesses can use economies 

of scale to reduce their burden, the overall burden will be reduced. However, even though the 

record keeping and reporting requirements are the same for small and large businesses, the 

Agency considers these requirements the minimum needed to ensure compliance and, therefore, 

cannot reduce them further for small businesses.

5(d) Collection Schedule

The collection schedule established in the regulations at 40 CFR 167.85(d) requires that each 

producer report pesticide and device production information within 30 days of receipt of the 

notification of assignment of their establishment number from the Agency; thereafter, each 

producer is required to report their pesticide production information by March 1st annually. The 

Agency will mail out notifications each December reminding producers of the March 1 reporting 

deadline and providing them with the link where they can obtain the forms online. The 

notification will also include a phone number for producers to call to request the Agency to mail 

them the forms, but it is expected that the majority of producers will print out the required forms 

from the website.
6

6. Estimating the Burden and Cost of the Collection

6(a) Estimating Respondent Burden

The estimates for EPA Form 3540-8 are based on discussions with the industry. The onetime submission of information is of such a nature as to demand no research of company records 

or calculations; it is easily completed by clerical personnel; and reviewed and signed by a 

company officer. The completion of the application rarely exceeds the estimated hourly rate. See 

Table 1 for respondent burden estimates.

Burden estimates for EPA Form 3540-16 are based on the results of interviews with a 

cross-section of industry respondents. We asked six industry representatives of the respondent 

universe -- small businesses, firms with multiple establishments, and repackagers -- to estimate 

the amount of time they typically spent gathering, compiling and filling out information for the 

report.

From these interviews we learned that, generally, the information is already assembled 

and compiled so filling out the form involves little burden. See Table 2 for the respondent burden 

estimates for EPA Form 3540-16.

6(b) Estimating Respondent Costs

(i) Estimating Labor Costs

Since the regulation and associated information collection has a minor economic impact 

on respondents, a regulatory impact analysis was not conducted. This ICR uses estimates of labor 

rates and associated costs based on Department of Commerce Bureau of Labor Statistics 

estimates. Specifically this ICR uses the May 2010 National Industry-Specific Occupational 

Employment and Wage Estimates for the industry NAICS code 325300 (Pesticide, Fertilizer and 

other Agricultural Chemical Manufacturing), which is presumed to dominate this sector. The 

mean hourly wage rates for NAICS code 325300 were: management, $55.84; technical 

(engineering), $38.78; and clerical (administrative), $17.23. A factor of 1.14 was added to adjust 

for benefit costs, resulting in respective total wage costs of $119.50, $82.99, and $36.87.

Application for Registration of Pesticide-Producing and Device-Producing Establishments (EPA 

Form 3540-8):

Public reporting burden for this collection of information is estimated to average 0.30 

hours (18 minutes) per response, including time for reviewing instructions, searching existing 

data sources, gathering and maintaining the data needed and completing the review and collection 

of information. 

Pesticide Report for Pesticide-Producing Establishments (EPA Form 3540-16)

Public reporting burden for this collection of information is estimated to average 1.43 hour 

(1 hour and 26 minutes) per response, including time for reviewing instructions, searching 
7

existing data sources, gathering and maintaining the data needed, and completing the review and 

collection of information.

See Tables 1 and 2 for the respondent cost estimates for EPA Forms 3540-8 and 3540-16, 

respectively. 

(ii) Estimating Capital and Operations and Maintenance Costs

The only type of industry costs associated with the ICR activity in the standards is labor 

costs.

(iii) Capitol/Start-up vs. Operating and Maintenance (O&M) Costs

This is not applicable as there are no capital/start-up costs.

6(c) Estimate of Agency Burden and Costs

The cost to the Government for the Application for Registration of Pesticide-Producing 

and Device-Producing Establishments (EPA Form 3540-8) is based on one work-year to review 

and process applications. Other direct costs are limited to printing costs for instructions and 

reporting forms, review of the data, mailing costs, etc. The number of respondents (700) are 

estimated based on the average annual number of applicants registering establishments over past 

three year periods. See Table 3 for Agency burden and cost estimates.

The cost to the Government for the Pesticide Report for Pesticide-Producing and DeviceProducing Establishments (EPA Form 3540-16) is based on one work-year to review and process 

production reports. Other direct costs are limited to printing costs for instructions and reporting 

forms. The number of respondents is the number of active pesticide-producing and deviceproducing establishments registered with EPA (13,830) See Table 4 for Agency burden and cost 

estimates.

This ICR consolidated all government labor costs to that of a GS-12 step 1, as the bulk of 

the work is performed at this level. The minor shares of burden carried by management and 

clerical staff have been judged approximately equal and thus balance out if the entire burden is 

estimated at the GS-12/1 level.

The estimates for Agency costs for EPA Forms 3540-8 and 3540-16 are shown in Tables 3 

and 4, respectively.
8

6(d) Estimating the Respondents Universe and Total Burden and Costs

As of November 2011, there were 13,830 active pesticide-producing and deviceproducing establishments registered with EPA. While the actual number of registered 

establishments fluctuates somewhat, the average over the past three year period has appeared to 

stabilize approximately at the present level. For purposes of this ICR, EPA assumes that the 

number of newly registered establishments in any period of time will approximately equal the 

number of currently registered establishments going out of business. The total annual labor costs 

are $16,395 + $1,528,709 = $1,545,104. Details upon which this estimate is based appear in 

Tables 1 & 2: Respondent Burden.
9

6(e) Bottom Line Burden Hours and Cost Tables

Table 1

Respondent Burden Hours and Costs for 

Application for Registration of Pesticide-Producing Establishments

(EPA Form 3540-8)

ACTIVITIES ANNUAL BURDEN HOURS TOTAL

HOURS

TOTAL

COST

Management $ Technical Clerical

$119.50 $82.99 $38.87

a. Read or Hear 

Any Instructions

14 21 0 35 $3,415.79

b. Plan Activities 0 0 0 0 $0

c. Create 

Information

0 0 0 0 $0

d. Gather 

Information

0 0 0 0 $0

e. Process, Compile, 

and Review the 

Information

0 35 0 35 $2,904.65

f. Complete Form(s) 0 70 0 70 $5,809.3

g. Record, Disclose, 

Display, or Report 

the Information

0 35 0 35 $2,904.65

h. Store, File, or 

Maintain the 

Information

0 0 35 35 $1,360.45

TOTAL 14 161 35 210 $16,394.84

Annual Burden Hour total = 210*

Annual Cost total = $16,395* 

* assumes 700 responses annually

***NOTE: Numbers in the Tables (1-4) may vary slightly because of a rounding factor.
10

Table 2

Respondent Burden Hours and Costs for

Pesticide Report for Pesticide-Producing Establishments

(EPA Form 3540-16)

ACTIVITIES ANNUAL BURDEN HOURS TOTAL

HOURS

TOTAL

COST

Management Technical Clerical $

$119.50 $82.99 $38.87

a. Read or Hear Any 

Instructions

1383 2074.5 0 3457.5 $337,431.26

b. Plan Activities 1383 2074.5 0 3457.5 $337,431.26

c. Create Information 0 0 0 0 $0

d. Gather Information 0 2212.8 0 2212.8 $183,640.27

e. Process, Compile, and 

Review the Information

0 2351.1 0 2351.1 $195,117.79

f. Complete Written 

Form(s)

0 3457.5 0 3457.5 $286,937.93

g.Photocopying Form(s) 0 0 1383 1383 $53,757.21

h. Record, Disclose, 

Display, or Report the 

Information

0 0 2351.1 2351.1 $91,387.26

i. Store, File, or 

Maintain the Information

0 0 1106.4 1106.4 $43,005.77

TOTAL 2766 12170.4 4840.5 19,776.9 $1,528,708.75

Annual Burden Hour total = 19,776.9*

Annual Cost total = $1,528,709*

* assumes 13,830 responses annually

***NOTE: Numbers in the Tables (1-4) may vary slightly because of a rounding factor.
11

Table 3

Annual Agency Burden/Cost Estimates for

Application and Notification for Pesticide-Producing Establishments

(EPA Form 3540-8)

ACTIVITIES ANNUAL 

BURDEN 

HOURS 

TOTAL

COSTS

$

a. Respond to Inquiries 1120 $69,440

b. Review Information for Accuracy 520 $32,240

c. Record Form Submission and Assign Establishment Number 185 $11,470

d. Store and Maintain Data 140 $8,680

e. Prepare Notification 195 $12,090

TOTAL 2160 $133,920

Other Annual Agency Costs associated with Table 3:

1. Postal Mailing Costs. . . . . . . . . . . . . . .$ 590

Other Annual Total Costs . . . . . ...... . $ 590

Burden Cost + Other costs are: $133,920+ $590 = $134,510

***NOTE: Numbers in the Tables (1-4) may vary slightly because of a rounding factor.
12

Table 4

Annual Agency Burden Cost Estimates for

Pesticide Report for Pesticide-Producing Establishments

(EPA Form 3540-16)

ACTIVITIES ANNUAL 

BURDEN 

HOURS

ANNUAL

COST

a. Preparation of Notification 90 $5,580

b. Respond to Inquiries 1375 $85,250

c. Review Information for Accuracy 1050 $65,100

d. Record and Enter Data into Electronic Database 1060 $65,720

e. Store and Maintain Data 430 $26,660

f. Prepare Annual Solicitation/Mailings 80 $4,960

TOTAL 4085 $253,270

Other Annual Agency Costs associated with Table 4:

1. Printing of Notification . . . . . . $ 4,250

2. Postage Mailing Costs . . . . . . . $ 4,438

 Other Annual Agency Costs . . . . . . $ 8,688

Burden Cost + Other Costs are: $253,270 + $8,688 = $261,958

$134,510 (Table #3) + $261,958 (Table #4) = $396,468

COMBINED AGENCY BURDEN COSTS FOR THIS ICR = $396,468

***NOTE: Numbers in the Tables (1-4) may vary slightly because of a rounding 

factor.
13

6(f) Program Changes and Adjustments

No program changes occurred affecting the burden estimates of this ICR. Adjustments to 

the burden estimates per response resulted from (1) adjustments in the salary computation for 

industry to reflect current wage scales, (2) adjustments in the salary computation for Agency

personnel to reflect current wage scales, (3) adjustments for inflation, and (4) adjustment to the 

number of respondents.

6(g) Burden Statement

The annual public reporting and recordkeeping burden for this collection of information 

is estimated to average 1.45 hours per response. Burden means the total time, effort, or financial 

resources expended by persons to generate, maintain, retain, 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 

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 are listed in 40 CFR Part 9 and 48 CFR Chapter 15. 

To comment on the Agency's need for this information, the accuracy of the provided 

burden estimates, and any suggested methods for minimizing respondent burden, including the 

use of automated collection techniques, EPA has established a public docket for this ICR under 

Docket ID Number EPA-HQ-OECA-2011-0824, which is available for online viewing at 

www.regulations.gov, or in person viewing at the Enforcement and Compliance Docket in the 

EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, 

Washington, D.C. 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 (202) 566-1744, and the telephone number for the Enforcement and Compliance Docket 

is (202) 566-1752. An electronic version of the public docket is available at 

www.regulations.gov. This site can be used to submit or view public comments, access the 

index listing of the contents of the public docket, and to access those documents in the public 

docket that are available electronically. When in the system, select “search,” then key in the 

Docket ID Number identified above. Also, you can send comments to the Office of Information 

and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, 

D.C. 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPAHQ-OECA-2011-0824 and OMB Control Number 2070-0078 in any correspondence.

Part B of the Supporting Statement

This part is not applicable to this collection.