SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

  SEQ CHAPTER \h \r 1 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 Device-Producing 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
Device-Producing 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.  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   SEQ CHAPTER \h \r 1
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

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.  SEQ CHAPTER \h \r 1   This comment is addressed below.

The private consulting company,   SEQ CHAPTER \h \r 1 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   SEQ CHAPTER \h \r 1 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 pesticide-producing 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.

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

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.  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.    SEQ CHAPTER \h \r 1 The one-time 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 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 Device-Producing 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 device-producing 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.

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

As of November 2011, there were 13,830 active pesticide-producing and
device-producing 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.

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.

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

	$

	

  SEQ CHAPTER \h \r 1 Management	

  SEQ CHAPTER \h \r 1 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.

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.

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.

	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  
HYPERLINK "http://www.regulations.gov"  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
EPA-HQ-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.

( PAGE  13 (

