Document ID: EPA-HQ-OECA-2007-0558-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-12-05T05:00Z

SF-83 SUPPORTING STATEMENT 

ENVIRONMENTAL PROTECTION AGENCY 

RECORDKEEPING REQUIREMENTS FOR PRODUCERS OF PESTICIDES 

40 CFR PART 169

1. Identification of the Information Collection 

1(a) Title of the Information Collection 

Recordkeeping Requirements for Producers of Pesticides under section 8
of the Federal Insecticide, Fungicide, and Rodenticide Act as amended
(FIFRA). ICR Number 0143.10 

1(b) Short Characterization/Abstract 

FIFRA section 8 states that the Administrator of the Environmental
Protection Agency may prescribe regulations requiring pesticide
producers, registrants and applicants for registration to maintain such
records with respect to their operations and the effective enforcement
of this Act and to make such records available for inspection and
copying as specified in the statute. The regulations at 40 CFR Part 169
(Books and Records of Pesticide Production and Distribution) specify the
following records that producers must keep and the disposition of those
records. 

Producers must maintain records on production data for pesticides,
devices, or active ingredients (including pesticides produced pursuant
to an experimental use permit); receipt by the producer of pesticides,
devices, or active ingredients used in producing pesticides; delivery,
moving, or holding of pesticides; inventory; domestic advertising for
restricted use pesticides; guarantees; exports; disposal; human testing;
and tolerance petitions. Additionally, section 8 gives the Agency
inspectional authority to monitor the validity of research data
(including raw data), developed in accordance with Good Laboratory
Practice Standards, and used to support pesticide registration. These
records generally consist of the material produced during the course of
ordinary business activity, and are maintained in the location, manner,
and duration as is generally prudent for such records in the course of
ordinary business activity. 

Respondents are required to maintain records of receipt, production,
shipping, and inventory for two years. Records regarding testing of
registered pesticides must be maintained for the life of the pesticide
registration, as such data are necessary to support the regulatory
decision. 

Approximately 13,400 respondents are currently subject to this
requirement, and it is estimated that no additional respondents per year
will become subject to this requirement in the next three years. The
cost of this ICR to the respondents is estimated to be $1,107,524.00.
The estimate of number of respondents is based on the number of
pesticide producers who have responded to the latest mandatory annual
reporting response under FIFRA section 7, which defines the entire
universe of legal producers of pesticides for sale or distribution in
the United States. The estimated change is based on extrapolation from
trends in the number of reported producers over the last three years.
The estimated cost per producer has been estimated to consist entirely
of the cost of preparing records for inspection, as the recordkeeping
itself consists of activities that are considered to be customary
business practices. 

2. Need for and Use of the Collection 

2(a) Need/Authority for the Collection 

FIFRA section 8(a) states that the Administrator may prescribe
regulations requiring producers, registrants, and applicants for
registration to maintain such records with respect to their operations
and the pesticides and devices produced as the Administrator determines
are necessary for the effective enforcement of  FIFRA and to make such
records available for inspection and copying. 

FIFRA section 1 2(a)(2)(B)(i) provides that it is unlawful for any
person to refuse to prepare, maintain, or submit any records required by
or under section 8 of the Act. 

2(b) PRACTICAL UTILITY/USERS OF THE DATA 

EPA must be able to examine and copy records at pesticide producers
demonstrating the identity, production, receipt, shipment, inventory,
advertisement, and guarantees with respect to all domestically sold or
distributed pesticides. This is necessary to determine that such
products are in compliance with FIFRA and to support enforcement action
against the products producers if they are not. EPA must be able to
examine and copy records with respect to exported pesticides in order to
determine that products that have been exported are in compliance with
labeling and foreign purchaser specification and acknowledgment
requirements, and to take support enforcement action against exporters
who do not comply with FIFRA requirements. EPA must be able to examine
records of pesticide disposal in order to protect public health and the
environment should it be necessary to locate such disposal sites. EPA
must be able to access records regarding testing on humans to protect
the health and safety of such testing subjects should potential adverse
effects become known. EPA must be able to access records regarding
testing of registered pesticides to determine the integrity of such
information, and the subsequent validity of regulatory decisions based
on such information that allow the continued sale and distribution of
specific pesticide products. 

These data may be used by enforcement and compliance officers at the
federal and state level, and by regulatory officials at the federal and
state level. 

3. Nonduplication, Consultations, and Other Collection Criteria 

3(a) Nonduplication 

The records required to be maintained are normal business records and as
such are only created upon the occurrence of a discrete activity. These
records may be reproduced at the time of an inspection but EPA does not
require a producer to submit these records to the Agency. Since it
applies to the original records, no duplication exists. 

3(b) Public Notice Required Prior to ICR Submission to 0MB 

An announcement of a public comment period for the renewal of this ICR
was published in the Federal Register on August 20, 2007, Volume 72 page
46462. 

3(c) Consultations 

EPA received one comment which addressed the length of time the records
should be kept, suggesting records should be kept for 30 years.  This
ICR addresses requirements established in regulations (at 40 CFR Part
169) and cannot change those requirements.  When EPA established the
current regulations, it considered appropriate duration of recordkeeping
depending on the nature of the activities for which records were being
kept.  As a result, disposal records and records of tests involving
human subjects must be kept for 20 years, and data records in support of
registrations must be kept for the life of the registration.   

3(d) Effects of Less Frequent Collection 

Each record required relates to a separate, discrete business activity.
Each record is generated only once in the course of each activity. It
would not be possible to reduce the collection frequency without
removing certain activities from compliance altogether. 

3(e) General Guidelines 

None of the reporting or recordkeeping requirements contained in 40 CFR
Part 169 or otherwise pertinent to this request violate any of the
regulations established by 0MB in 5 CFR 1320.6. 

3(f) Confidentiality 

The required information consists of emissions data and other
information that have been 

determined not to be private. However, any information submitted to the
agency for which a 

claim of confidentiality is made will be safeguarded according to the
Agency policies set forth in 

Title 40, Chapter 1, Part 2, Subpart B - Confidentiality of Business
Information (see 40 CFR 2; 

41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8,
1978; 43 FR 42251, 

September 20, 1978; 44 FR 17674, March 23, 1979). 

3(g) Sensitive Questions 

None of the reporting or recordkeeping requirements contained in 40 CFR
Part 169 or otherwise pertinent to this request contain sensitive
questions. 

4. The Respondents and the Information Requested 

4(a) Respondents/SIC Codes 

The three-digit Standard Industrial Classification codes assigned to
pesticide producers are 286 and 287. 

4(b) INFORMATION REQUESTED

 

(i) Data Items 

All data in this ICR that is recorded is required by 40 CFR Part 169.
Under this requirement producers of pesticides must maintain: 

In a current status: 

 Inventory records with respect to types and amounts of pesticides and
active ingredients or quantities of devices in stock. These records may
be discarded when updated with more current records. (169.2(e)) 

For one (1) year: 

 copies of all guarantees given pursuant to section 1 2(a)(2)(C) of the
Act. (169.2(g)) 

 For two (2) years: 

Records showing the product name, EPA registration number, experimental
use permit number, amounts per batch and batch identification numbers of
pesticides produced. 

 

Records showing the brand names and quantities of pesticides produced.
(169.2(b)) 

Records showing the following information regarding receipt by the
producer of pesticides, devices, and active ingredients: brand name of
pesticide or device or common/chemical name of active ingredient; name
and address of shipper; name of delivering carrier; date received; and
quantities received. (169.2(c)) 

Records showing the following information regarding shipment by the
producer of pesticides, devices, and active ingredients: brand name of
pesticide or device or common/chemical name of active ingredient; name
and address of consignee; in the case of pesticides produced pursuant to
sections 5, 18, or 24 of the Act, the information required under these
sections and any regulations promulgated thereto regarding the
distribution of such pesticides; name of originating carrier; date
shipped or delivered for shipment; and quantities shipped or delivered
for shipment. (169.2(d)) 

Copies of all domestic advertising of the restricted uses of any
restricted use pesticide that the producer caused to have prepared.
(169.2(f)) 

 In the case of pesticides, devices, and active ingredients used in
producing pesticides intended solely for export: copies of
specifications or directions of the foreign purchaser for production of
such pesticides, devices, and active ingredients; copies of labels or
labeling required to comply with section 1 7(a)( 1) of the Act; and for
any pesticide not registered under section 3 or sold under section 6(a)(
1) of the Act, a copy of the statement from the foreign purchaser
acknowledging that the foreign purchaser is aware that the product is
not registered in the United States and cannot be sold for use in the
United States. (169.2(h)) 

(D) For twenty (20) years, or forwarded after three (3) years to EPA for
maintenance: 

-

Records of the method of disposal, data or dates of disposal, location
of disposal sites, and types and amounts of pesticides or pesticide
active ingredients disposed of by the producer or contractor, deviations
from normal practice, and records on disposal of pesticides, active
ingredients, or containers specified pursuant to section 19 of the Act
or regulations promulgated thereto. (169.2(i)) 

Records of any tests conducted on human beings whether conducted by or
paid for by the producer, including: the names and addresses of subjects
tested, dates and types of tests; written consent of subjects to test;
instructions to subjects regarding purpose, nature, foreseeable health
consequences of the tests; and any records of adverse effects either
before or after the tests. (169.2(j)) 

For as long as a registration is valid and the producer is in business: 

Records containing research data relating to registered pesticides
including data submitted to the EPA in support of a registration or
tolerance petition, and all underlying raw data. (169.2(k))

This period of retention is necessary to allow the agency to evaluate
the validity of data used to support pesticide registrations at any time
during the period that the product is registered. Without these data the
Agency would not be able to support its regulatory decision allowing the
product to be registered. 

(ii) Respondent Activities 

Read instructions- 40 CFR Part 169 regulations. 

Plan activities- CBP 

Gather information- CBP 

Plan and review information for accuracy- CBP

 Store, file, and maintain the information- CBP

 

CBP- “Customary and Usual Business Practice” 

During the course of normal and prudent business operations, a producer
would plan his and his staffs information collection activities, arrange
for the collection, review himself or have staff review the information
for accuracy, and arrange to maintain or store the information detailed
under 3(b). The information required to be kept is generally information
that prudent businesses would maintain. The Agency does not specify in
the regulation how the data to be gathered must be organized. Therefore,
producers can continue to gather the required data in a manner
consistent with their customary and usual business practices. 

5. The Information Collected -- Agency Activities, Collection
Methodology, and Information Management 

5(a) Agency Activities 

        In this collection the Agency will: 1) answer producers’
questions; 2) may audit or review data collected; 3) provide appropriate
protection of confidential business information; and 4) store long-term
data, if requested.

 

5(b) Collection Methodology and Management 

Producers determine how best to comply with the requirements for
recordkeeping under FIFRA section 8. They may collect and store the
required data electronically. The Agency, through State, headquarters or
EPA Regional inspectors, may periodically audit or review the data at
sites chosen by individual producers. Other than review during periodic
inspections, those records will generally not be submitted to the Agency
unless the Agency requests them for a specific reason, such as a need to
review research data supporting a registration or in the preparation of
an enforcement case. 

Those records pertaining to disposal of pesticide and human testing,
which are required to be retained for 20 years, may be turned over to
the Agency for storage after 3 years. The Agency then stores those
records in the form in which they are submitted. If a producer submits
section 8 records to the Agency, that portion of the records which are
not classified as Confidential Business Information (CBI) could be
accessed by the public through the Freedom of Information Act. 

5(c) Small Entity Flexibility

The information collected under ICR # 0143 does not negatively impact
small businesses, since the records required to be maintained are those
which qualify as “customary and usual business activity.” 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
recordkeeping and reporting requirements are the same for small and
larger 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 

There is no specified collection schedule. Production of records for
Agency review occurs at the time of routine inspection, which occurs
approximately every two to three years, or when a specific need arises
to evaluate the compliance of a producer. For the purposes of
estimation, this is assumed to be annual, which overstates the actual
collection burden. 

6. Estimating the Burden and Cost of the Collection 

The records that must be maintained for purposes of FIFRA section 8 are
generally those that a responsible company would maintain as good
business practice. It is estimated that the burden for a producer to
prepare for the possibility of an on- site EPA inspection of those
records, is two hours per year. The burden is due, therefore, less to
the actual recordkeeping requirement itself than to the burden placed
upon the record keeper in locating and presenting these records to an
inspector. While the actual burden that falls upon a company undergoing
an inspection may be greater than the estimated two hours, a given
company will undergo an inspection no more often than once every two to
three years, if that frequently. EPA estimates that approximately one
hour is spent by management employees in the planning and reviewing of
the records for presentation to an EPA inspector and one hour by a
clerical employee in the planning, gathering, and maintenance of the
information. 

Table 2 documents the computation of individual burdens for each of the
recordkeeping and reporting requirements applicable to the industry. The
individual burdens are expressed under standardized headings believed to
be consistent with the concept of burden under the Paperwork Reduction
Act. Where appropriate, specific tasks and major assumptions have been
identified. 

Responses to this information collection are mandatory, as required at
FIFRA sections 8 and 12(a)(2)(B). The 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 0MB control number. 

6(a) Estimating Respondent Burden 

The average annual burden to industry over the next three years from
these recordkeeping and reporting requirements is estimated at two (2)
person-hours. These hours are based on Agency knowledge and experience
with the pesticides program, the previously approved ICR, and any
comments received about time to prepare reports. 

6(b) Estimating Respondent Costs 

(i) Estimating Labor Costs 

This ICR uses labor rates of Executive, Administrative, and Managerial
($62.52, based on $29.77 per hour + 110% overhead) and Clerical ($29.11,
based on $13.86 per hour + 110% overhead). These rates were from the
United States Department of Commerce Bureau of Labor Statistics, May
2005, Table 2: Employment Costs for Civilian Workers by Occupational and
Industry Group.  Costs are determined to be equally divided between
managerial and clerical.

(ii) Estimating Capital and Operations and Maintenance Costs

 

The only type of industry costs associated with the information
collection activity in the standards are labor costs.

 

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

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

6(c) Estimating Agency Burden and Cost 

As part of an existing and ongoing program, the developmental costs for
this information collection activity are minimal, and includes only the
preparation of a written justification, narrative, and description for
the clearance request, and the preparation of and description for the
clearance request, and the preparation of the SF 83. The EPA estimates
such costs at a GS-13 (step 1) salary level for two work weeks. Since
these activities occur only in the three-year clearance period, their
cost on a pro-rated annual basis is one-third of the total one-time
cost. The estimated cost is $2191.20 (hourly rate of $38.04, with an
additional benefits multiplication factor of 1.16, multiplied by 80
hours, and that number divided by 3). As a recordkeeping requirement,
rather than a reporting requirement, there are no additional Federal
costs directly associated with this information collection activity.
Details upon which this estimate is based appear in Table 1: Agency
Burden. 

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

The number of existing respondents subject to 40 CFR Part 169 is 13,400.
The number of new respondents subject to 40 CFR Part 169 from the
previous ICR is 447, which is an adjustment reflecting fluctuations in
the numbers of respondents. The total annual labor costs are
$1,227,976.00 and total annual capital and O&M costs to the regulated
entity are $0 dollars. Details upon which this estimate is based appear
in Table 2: Industry Burden

 

6(e) Bottom Line Burden Hours And Cost Tables

TABLE 1. AVERAGE ANNUAL EPA RESOURCE REQUIREMENT 

FOR PESTICIDE PRODUCERS, 40 CFR PART 169 

Activity 	(A) 

EPA hr/ 

Occurrence 	(B) 

Occurrences 	(C) 

EPA hr/yr 	 

(D)

EPA Cost 

($) 

Preparation of ICR 	80 	0.333 

26.666 	$2,191 

TOTAL ANNUAL HOURS 

26.666 	$2,191

	Salary: (1 person x 26.666 hrs/year x $82.17/hr) = $2191/year

Total Annual Cost to EPA = $2,191

Assume and hourly wage of $38.04 plus 116 percent to account for
benefits and overhead which equals $82.17.  This amount was multiplied
by the hours per year in column C

TABLE 2. ANNUAL BURDEN OF REPORTING AND RECORDKEEPING 

REQUIREMENTS FOR PESTICIDE PRODUCERS, 40 CFR PART 169

Recordkeeping requirements 	(A) 

Occurences /hours per occurence 	(B) 

Hours! 

respondent 

/year 	(C=AXB) 

Respondent 

/year 	(D) 

Respondents per year 	(E=CXD) 

Hours per year 	(F) Cost/ 

year, $ 

A. Read Instructions 	1 	0.5 	0.5 	13,400 	6,700 	$306,994 

B. Plan Activities 	1 	0.5 	0.5 	13,400 	6,700 	$306,994 

C. Implement Activities 	1 	1.0 	1.0 	13,400 	13,400 	$613,988 

D. Develop Record System 	- 	- 

N/A 

E. Time to Enter Information 	- 	- 

N/A 

F. Audits 	- 	- 

N/A 

TOTAL ANNUAL BURDEN 	- 	- 

	26,800 	$1,227,976 

For Column F, assume an hourly wage of $21.82 plus 110 percent overhead
costs, which equals $45.82. This amount was multiplied by the hours per
year in Column E

For lines D and E, assume this is in accordance with customary business
practices with no additional burden to the respondent.

For line F, burden for audits is included in activities A-C

6(f) Reasons for Change in Burden

The increase in burden of 893 hours annually is an adjustment due to a
change in the number of respondents since the last ICR.. 

6(g) Burden Statement 

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 col1ection of
information unless it displays a currently valid 0MB control number. The
0MB 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, EPA has established a public docket for this ICR
under Docket ID No. EPA-HQ-OECA-2007-0558, which is available for online
viewing at   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov , or in person viewing at the Enforcement and
Compliance Docket and Information Center (ECDIC), Environmental
Protection Agency, EPA Docket Center, EPA West, Room 3334, 1301
Constitution Avenue, NW., Washington, DC.  The EPA Docket Center 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 ECDIC  is (202) 566-1752.

Use   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
 to view public comments, access the index listing of the contents of
the 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 in this document.