Document ID: EPA-HQ-OPP-2008-0191-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-11-17T05:00Z

SUPPORTING STATEMENT

FOR AN INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title of the Information Collection

TITLE: Application for New and Amended Pesticide Registration 

OMB No. 2070-0060		EPA No. 0277.15

1(b)	Short Characterization/Abstract

This data collection program is designed to provide the Environmental
Protection Agency (EPA) with necessary data to evaluate an application
of a pesticide product as required under Section 3 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Federal Food,
Drug, and Cosmetic Act (FFDCA) as amended (see Attachment A). Under
FIFRA as amended, EPA must evaluate pesticides thoroughly before they
can be marketed and used in the United States to ensure that they will
not pose unreasonable adverse effects to human health and the
environment. Pesticides that meet this test are granted a license or
"registration" which permits their distribution, sale and use according
to requirements set by EPA to protect human health and the environment.

Registration of a pesticide is a scientific, legal and administrative
process through which EPA examines the ingredients of the pesticide; the
particular site or crop on which it is to be used; the amount, frequency
and timing of its use; and storage and disposal practices. In evaluating
a pesticide registration application, EPA assesses a wide variety of
potential human health and environmental effects associated with use of
the product. The producer of the pesticide must provide data from tests
done according to EPA guidelines. These tests must determine whether a
pesticide has the potential to cause adverse effects on humans,
wildlife, fish and plants, including endangered species and non-target
organisms, as well as possible contamination of surface water or
groundwater from leaching, runoff and spray drift. Potential human risks
include short-term toxicity and long-term effects such as cancer and
reproductive system disorders. EPA also must approve the language that
appears on each pesticide label. A pesticide product can only be used
according to the directions on the labeling accompanying it at the time
of sale, through its use and disposal. Following labeling instructions
carefully and precisely is necessary to ensure safe use.

An individual or entity wanting to obtain a registration for a pesticide
product must submit an application package consisting of information
relating to the identity and composition of the product, proposed
labeling, and supporting data (or compensation for others’ data) for
the product as outlined in 40 CFR part 158. The EPA bases registration
decisions for pesticides on its evaluation of a battery of test data
provided primarily by applicants for registration. Required studies
include testing to show whether a pesticide has the potential to cause
unreasonable adverse human health or environmental effects. The Agency
currently collects data on physical chemistry, toxicology, environmental
fate, ecological effects, worker exposure, residue chemistry,
environmental chemistry, and product performance.  If EPA’s evaluation
of the data shows that the statutory requirements of FIFRA are met, then
a registration is approved. 

Registrants of EPA-registered pesticide products at times become subject
to regulations or guidance that includes labeling revisions. The revised
labeling is submitted as an amendment to the Agency along with the
completed application form (EPA Form 8570-1 and other forms as needed,
see Attachment B). Normally, data are not required or reviewed for
revised labeling regulations or guidance; however, EPA must review and
approve the revised labeling. This review is most often accomplished by
a Product Manager (PM), or Team Leader (TL), in one of the three
regulatory divisions within EPA’s Office of Pesticide Programs (OPP)
responsible for pesticide registration: the Registration Division, the
Antimicrobial Division, and the Biopesticides and Pollution Prevention
Division who ensure that revisions comply with the applicable labeling
requirement or guidance.

The Agency has added to its basic registration information collection
additional information from registrants. This allows the implementation
of the Reduced-Risk Initiative (PR Notice 97-3, “Guidelines for
Expedited Review of Conventional Pesticides under Reduced-Risk
Initiative and for Biological Pesticides;” see Attachment C). The
guidance in this notice is intended to give scheduling priority in
registration consideration to those pesticide products that can be
expected to accomplish one or more of the following:

(1)	Reduce the risks of pesticides to human health.

(2)	Reduce the risks of pesticides to nontarget organisms.

(3)	Reduce the potential for contamination of groundwater, surface
water, or other valued environmental resources.

(4)	Broaden the adoption of integrated pest management strategies, or
make such strategies more available or more effective.

Applicants for the registration of such products are invited to provide
an explanation (rationale) accompanied by any supporting information on
their application with any associated tolerance petitions for special
consideration based on these factors. Products that are successfully
classified as presenting the potential to reduce risk will receive
priority treatment in the scheduling of scientific reviews with
resulting potential benefit of earlier registration and consequent
earlier marketability.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

Authorizing legislation is contained in section 3 of FIFRA as amended.
Governing regulations and guidelines are contained in 40 CFR parts 152,
156, 158 (attachments D, E, and F, respectively), and in PR Notice (PRN)
97-3. Label amendments, 40 CFR 156, may be required to maintain
continued registration following a regulatory review (e.g.,
reregistration). Labeling amendments pertaining to groups of products
may be implemented through Pesticide Registration (PR) or Federal
Register (FR) notices.

2(b)	Practical Utility/Users of the Data

	For conventional pesticides, the application is reviewed by the
Information Technology and Resources Management Division (ITRMD), the
Registration Division (RD), the Health Effects Division (HED), and the
Environmental Fate and Effects Division (EFED), and Biological and
Economic Analysis Division (BEAD).  For biological/biopesticide
pesticides, the application is reviewed by the Biopesticides and
Pollution Prevention Division (BPPD). Applications for antimicrobial
pesticide products are reviewed within the Antimicrobial Division (AD).
The degree and level of the review will depend on the complexity of the
product, and whether it is identical or substantially similar to other
products already registered. Products containing active ingredients
present in currently registered products and proposed for uses currently
registered (“me-too”) may require only a minimal review for
completeness of the application, the adequacy of the labeling, and the
satisfaction of data compensation requirements. However, a product
containing a new active ingredient may require multiple data reviews
related to physical chemistry, toxicology, environmental fate,
ecological effects, worker exposure, residue chemistry, environmental
chemistry, and product performance prior to approval.  Therefore, other
OPP Divisions such as the Heath and Effects Division (HED), the
Biological and Economic Analysis Division (BEAD), Special Review and
Reregistration Division (SRRD), and the Environmental Fate and Effects
Division (EFED) are actively involved in the data analysis and agency
determination of OPP registration actions.

An application that is incomplete or that is found to be deficient in
data or labeling is rejected, and the applicant is permitted to correct
the deficiencies and resubmit the application. When all data reviews are
completed satisfactorily, the labeling is determined to be adequate, and
the product is determined to meet the statutory standards of FIFRA, then
registration is issued to the applicant.

Once issued, a registration also may be amended in various ways, such as
adding or deleting uses, modifying the labeling, or altering the product
composition in minor ways. To request these changes, the registrant is
required to submit an application for amended registration on EPA Form
8570-1, along with all appropriate additional forms, labeling and
supporting data..

Registrants submitting registration applications for pesticide products
that may fall within the scope of the Reduced-Risk Initiative may
provide a written rationale with any supporting information on why their
pesticide may qualify for special consideration because it presents the
opportunity for risk reduction. This rationale with supporting
information will be reviewed and evaluated and, if the pesticide
demonstrates the opportunity for risk reduction, the EPA uses this
finding as a factor in determining application review priority. This
policy specifies the standard format for registrants to use when
providing justification for a reduced-risk pesticide to allow efficient
processing within OPP.

3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a)	Non-duplication

Duplication will not occur in this program, as each applicant must
submit information unique to the particular product being offered for
registration. If the product is not unique, existing data may be
referenced by the applicant as described in item 5(c) below. On amended
applications, the applicant also is able to refer to any appropriate
information previously submitted, thereby satisfying data requirements,
if any data is needed, without the burden of providing duplicate
information or additional data development.

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

Pursuant to 5 CFR 1320.8(d), ICR, EPA published a Federal Register (FR)
Notice (73 FR 17973; April 2, 2008).  The Agency did not receive any
public comments. 

	3(c)	Consultations

Consultation and/or dialogue between the respondent and EPA occurs on an
informal, ongoing "as needed" basis, primarily during the submission and
review of the application for an experimental use permit. Historically,
when technical, administrative, or other problems arise, the respondent
has ample opportunity to inform the agency and vice versa.  It has been
the Agency’s experience that registrants do not hesitate to inform OPP
staff when problems or questions arise, and we welcome those contacts,
as well as suggestions for improvement in the process.  This
communication between both parties may take place either in a telephone
conversation or in a meeting setting, but not necessarily by a
prescribed schedule.

During the preparation of this ICR renewal, EPA staff contacted several
representatives of pesticide registrants by e-mail to seek feedback on
the information reporting requirements and process.  A sample copy of
the ICR questionnaire provided to industry representatives is in
Attachment J.  The Agency received no comments from the representatives
listed below during the consultation period. 

Amy Roberts,

Regulatory Consultant

Technology Science Group, Inc.

  HYPERLINK "mailto:aroberts@tsgusa.com"  aroberts@tsgusa.com 

	Dr. Ray S. McAllister

Director Regulatory Affairs

CropLife  

  HYPERLINK "mailto:rmcallister@croplifeamerica.org" 
rmcallister@croplifeamerica.org 

Mr. Eric Maurer 

Valent Corporation

Eric.Maurer@valent.com

	

Robin G. Todd PhD BCE

Director

ICR, Inc.

1330 Dillon Heights Avenue

Baltimore, MD 21228-1199

3(d)	Effects of Less Frequent Collection

Not applicable. This information collection activity is initiated by
applicants for registration. Information is submitted in conjunction
with the application. There is no set means by which the EPA can reduce
the frequency. If the information were not submitted, EPA would be
unable to fulfill its statutory responsibilities relative to the review
and registration of pesticides and protection of human health, wildlife,
and the environment, including endangered species.

3(e)	General Guidelines

In accordance with a determination made by the Office of Management and
Budget (OMB) in 1995, the third party disclosure requirement involving
the registrant’s disclosure of product specific information to
potential users and the general public through the pesticide label, is
not a collection of information because the information that must be
included as the product labeling has been approved and provided to the
registrant by EPA as part of the original registration (5 CFR
1320.3(c)(2)). As such, this ICR does not include any third party burden
or cost estimates specifically associated with the labeling activities
that are a part of the original registration. Please note, however, that
EPA must seek OMB concurrence whenever any general labeling changes
initiated by the Agency result in an estimated burden of more than 5,000
burden hours. In such cases, EPA must provide OMB with a brief
description of the general labeling change, along with the estimated
burden and costs. OMB has agreed to notify EPA of any comments or
questions within 10 days of receiving the information, after which EPA
may proceed with the labeling change.

The recordkeeping activities briefly described in this ICR exceed
OMB’s guideline that agencies not require that records be retained for
more than 3 years (5 CFR 1 320.5(d)(2)(iv)). As authorized under FIFRA
section 8, EPA regulations require that registrants retain records
containing research data relating to registered pesticides (including
all data submitted to EPA in support of a registration - see 40 CFR
169.2(k)) for as long as the registration is valid and the producer is
in business. However, the burden related to the recordkeeping
requirements is covered under another ICR (see OMB Control No.
2070-0028, Recordkeeping Requirements for Producers of Pesticides under
Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA)).

Also, OMB ’s regulations require agencies to provide a statement
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 responses, 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. Additionally, OPP is not yet
prepared to accept the electronic submission of any forms listed in this
ICR. Forms-based submissions likely would be transmitted via the World
Wide Web and neither OPP nor the Agency’s Office of Environmental
Information have developed the information technology approaches that
would adequately protect FIFRA Confidential Business Information
submitted in this way. Therefore, the public should note that the
electronic submission option currently applies only to the submission of
studies and supplemental files.

Ordinarily, registrants would be required to submit 3 paper copies of
study data to EPA. However, as a option registrants need only submit 2
two paper copies if they submit the required study data in Adobe Acrobat
Portable Document Format (PDF) on a compact disc.  Extensive guidance
regarding the electronic submission option is available to registrants
via the OPP Internet site at   HYPERLINK
"http://www.epa.gov/oppfead1/eds/esr_guidance.htm" 
http://www.epa.gov/oppfead1/eds/esr_guidance.htm .

3(f)	Confidentiality

Although the EPA urges the submitter to minimize the amount of claimed
Confidential Business Information (CBI), all data and/or information
brought to the Agency in conjunction with this rule that may be claimed
as trade secret, commercial or financial information will be protected
from disclosure by EPA under FIFRA section 10 and the associated
regulation as contained in 40 CFR Part 2, Subpart B.

	3(g)	Sensitive Questions

Not applicable. No information of a sensitive or private nature is
requested in conjunction with this collection activity. In addition,
this information collection activity complies with the provisions of the
Privacy Act of 1974 and OMB circular A-108.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents - NAICS Codes

Respondents affected by the collection activities under this ICR are
individuals or entities engaged in activities related to the
registration of pesticide products. The North American Industrial
Classification System (NAICS) assigned to the parties responding to this
information are as follows:

Category	NAICS codes	

Examples of potentially affected

entities

Pesticide and other agricultural

chemical manufacturing	32532	

Individuals or entities engaged in

activities related to the registration of

a pesticide product.

4(b)	Information Requested

		(i)	Data items, including recordkeeping requirements

There are two main categories of applicants for registration: those
requiring submission of a full complement of supporting data (e.g., new
active ingredients); and those requiring submission of little or no data
(e.g., “me-too” products) for currently registered chemicals and use
patterns. Applicants for “me-too” products (i.e., pesticide products
claimed to be identical or substantially similar in composition and use
to a product currently registered by the EPA) may be required only to
use the forms listed below to certify that the applicant intends to rely
on data previously submitted to the EPA by another producer, the
applicant has contacted the appropriate company (owning the data that
the applicant is referencing) and the applicant has offered to pay
reasonable compensation for the use of the data.

Applicants for new active ingredients will be required to submit a full
complement of chemistry, toxicology, environmental fate, ecological
effects, worker exposure, residue chemistry, environmental chemistry,
product performance, and perhaps efficacy data as identified in 40 CFR
158.

In addition to the annual reporting and record keeping burden associated
with a Section 3 registration, the Agency may promulgate guidance that
encourages registrants to submit amended labeling for their pesticide
products. The combined burden for such labeling guidance may be
considered representative of the additional labeling burden placed on
registrants by the Agency, and may enable EPA to create a “generic”
new labeling burden.

The completion and submission of the following forms, see Attachment B,
are necessary in order to register a pesticide product:

	EPA Form 8570-1, Application for Pesticide Registration, Amendment,
Other;

	EPA Form 8570-4, Confidential Statement of Formula (CSF)

	EPA Form 8570-27, Formulator’s Exemption Statement

	EPA Form 8570-34, Certification With Respect to Citation of Data

	EPA Form 8570-35, Data Matrix

	EPA Form 8570-36, Summary of the Physical/chemical Properties

	EPA Form 8570-37, Self-certification Statement for the
Physical/Chemical Properties

(ii) 	Respondent Activities

Respondent Paperwork Activity	Description

1. Read instructions	Read germane FIFRA legislation, 40 CFR regulations,
application form instructions, the Reduced-Risk policy, applicable
guidance and correspondence, and germane labeling PR and FR notices;

 

2. Plan activities	Decide whether pesticide being registered is a
“me-too” pesticide, as this will determine succeeding activities;

3. Create information	Arrange for testing of any physical chemistry,
toxicological, environmental fate, ecological effects, worker exposure,
residue chemistry, environmental chemistry, product performance, and
efficacy data that appear to be required by germane regulations to
support registration.

4. Gather information	Canvass/contact other chemical firms holding EPA
registrations, if any, to determine whether it would be appropriate to
share or rely on testing data already submitted by another company;

5. Compile and review	Assemble data, evaluate for accuracy,
appropriateness, and completeness;

6. Complete paperwork	Complete all appropriate application documents;

7. Store/maintain data	File and maintain copies of all registration data
submitted to the Agency.

Response Type

	Description/Example

Type A	Description: “Type A” activities support the registration of
new active ingredients and new uses. "Type A" activities involve a
registrant or applicant assembling and submitting an application for
registration of a new active ingredient or a new use for a currently
registered active ingredient. The items required to be submitted in this
application include generic data, product specific data, administrative
forms, product labeling, and a CSF. The generic and product specific
data specified in 40 CFR 158 must be generated by the registrants,
formatted properly, and submitted with the correct number of copies.
Administrative forms usually include the application for registration,
data compensation form, a data matrix, and a CSF. Five copies of the
complete labeling must be submitted as well.

	Example: An example of a "Type A" activity would be an application for
registration of a new active ingredient (a.i.). Typically, for new
a.i.'s, applications must be submitted for at least two new products --
the manufacturing use product (either imported or made in the U.S. that
may be formulated into end-use products) and at least one end-use
product (that bears directions for the intended end uses). An applicant
would need to determine generic and product specific data required by 40
CFR 158 for the new a.i. (taking into account the use patterns sought),
generate those data, and submit them with the application. For a new
a.i., the generic data consists of certain acute, sub-chronic, and
chronic toxicology; environmental fate; ecological effects (birds, fish,
invertebrates); and product chemistry. When the data are completed, the
applicant would format and submit the studies along with the other items
required for an application, as described above.

Type B	Description: "Type B" activities involve a registrant or
applicant assembling and submitting an application for registration of a
new or amended product that contains a currently registered active
ingredient. Generally, "Type B" activities involve far less data and
complexity than "Type A" activities. The items that must be submitted or
cited in this application include product specific data, administrative
forms, product labeling, and a CSF. The product specific data specified
in 40 CFR 158 must be generated by the registrant/applicant or cited
from an identical or substantially similar product. If submitted, the
data must be formatted properly and with the correct number of copies.
Administrative forms usually include the application for registration,
data compensation form, a data matrix, and a CSF. Five copies of the
complete labeling must be submitted as well.

	Example: An applicant might seek registration of a new product
containing an active ingredient that is already registered. Often, the
formulation of this product is identical or substantially similar to
that of a currently registered end-use product. This is called a
"me-too" registration. In this case, the applicant only needs to cite
data from another product (selective method) or from all products
containing that a.i. (cite-all method) to support the new product. The
applicant also submits the labeling and other administrative forms
without submitting any data. If a product is not substantially similar
to another product, the applicant must submit product specific data
(acute toxicity and product chemistry) for that product. Nevertheless,
this kind of application is far less complicated than a "Type A"
application.

Type C	Description: “Type C" activities involve registration of new
conventional active ingredients or uses that may qualify as "reduced
risk" chemicals and/or OP replacements that are given expedited
processing. An applicant must prepare an application that includes
specific information as described in PR notice 97-3 and/or 98-7 to
explain why the new conventional a.i. or use has inherently lower risk
than currently registered products.

	Example: A new a.i. may have a lower toxicity, exposure and risk
profile than a currently registered a.i. for the same conventional
commodity. If the applicant can document and explain why the new a.i. or
new use should be a reduced risk or OP replacement, the Agency will
accept the application as "reduced risk” and/or OP replacement and
will process it expeditiously, presuming that all required data have
been submitted. This kind of application is less complex than the "Type
A" activity, but more complex than "Type B."

5.	THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT.

5(a)	Agency Activities

The pesticide registration application package, complete with the
required forms, necessary data, and labels, is mailed to OPP, where it
is received by the Front-End Processing Unit in the Information
Technology and Resources Management Division (ITRMD).  After screening
the application for administrative completeness, ITRMD then refers both
complete application and any accompanying data to the appropriate
regulatory division.  ITRMD is responsible for entering the registration
action into the appropriate database for tracking purposes.

If the application form is accompanied by data to support the
registration application (e.g., new active ingredients and new uses),
ITRMD will forward the registration data package to a contractor for
microfilming and for inputting into the tracking database. After this is
completed, the data package is routed to the PM or TL for processing.

If the registration application is clearly for a “me-too” pesticide
product or use, then the product may be registered on an expedited basis
by the PM or TL. If its similarity to a pesticide currently registered
by the EPA is questionable, it may be sent for a short interdisciplinary
review. The PM or TL ensures that the database is updated by identifying
where it is sent for review.

If the registration action is clearly not for a “me-too” pesticide
product or use, then the PM or TL logs in and routes the data to the
appropriate scientific evaluation group for full data reviews. Each
scientific discipline reviews the data and may develop a Data Evaluation
Report (DER) and appropriate risk assessments that summarize the data
review. The PM or TL examines all of the scientific reviews and proposed
labeling and determines whether the product may be registered. If the
product contains an active ingredient not currently registered by EPA,
the review summary is included as part of a decision package and
referred to the Director of OPP for the final decision to register a
pesticide.

If the registration action is for revised labeling in response to a PR
Notice, the revised labeling submitted along with appropriate EPA forms
will be reviewed by a PM or TL for compliance with the applicable Notice
and, following the registration decision, entered into the tracking
database.

Rationales with supporting information that propose to present a
reduced-risk product for registration are reviewed by senior OPP
scientists and risk managers who determine whether the product does
indeed warrant the priority treatment accorded to reduced-risk pesticide
applications. Pesticide applications with any associated tolerance
petitions for pesticides successfully classified as offering
opportunities for risk reduction will receive priority treatment in the
scheduling of scientific reviews.

The Agency sometimes allows registration to be altered in some way via
notification or “minor” amendment. Notifications are registration
modifications without need of extensive data review (e.g., product
chemistry and labeling) that require the registrant to inform the EPA
but do not require the Agency’s approval. Notifications for
conventional pesticides are screened in the RD Registration Support
Branch to ensure they are not beyond the scope of the notification
process. Biological/biopesticide notifications are reviewed by the BPPD;
antimicrobial notifications are reviewed by AD.

Agency Activity	Description

1. Receive Application	In the case of new registration applications, the
Front-End Processing Unit reviews the application for administrative
completeness and routes complete applications to the appropriate
regulatory division;

2. Plan activities	Registration actions accompanied by data to support
registration are routed to a contractor for loading into the tracking
database. The action then is routed to the appropriate PM/TL.
Registration actions not accompanied by data are loaded into the
tracking database by ITRMD. Following that, actions are routed to the
PM/TL who routes them for review. In the case of revised labeling
amendments such as those submitted in support of requirements under the
Worker Protection Standard (WPS), ITRMD will screen the application for
completeness and submit it to the appropriate regulatory division for
examination.

3. Create information	In the case of new active ingredient or new use
applications, the Agency scientists (or contractors) review all
submitted data and forward DERs and risk assessments to the PM/TL that
summarize the results of their reviews and presents their evaluation;

4. Gather information	The DERs and risk assessments from the scientific
disciplines are routed to a PM or TL;

5. Compile and review	The PM or TL reviews the data summaries and risk
assessments For new active ingredients and new uses, decision packages
are prepared and routed to the Director of OPP for the final decision.
For all other actions, the PM/TL makes a determination whether to
register a new or amended product.

6. Complete paperwork	Complete and send a Notice of Registration to the
applicant informing the applicant that the product has been registered
and specifying any conditions of registration. For labeling amendments,
a letter is sent to the applicant stating approval/disapproval with
comments.

7. Store/maintain data	Store, file, and maintain copies of any
registration notices and labeling information.

5(b)	Collection Methodology and Management

All registration actions are entered into the database to track progress
toward registration. Registration actions accompanied by data (e.g.,
products containing new active ingredients or new uses) also are entered
into OPP’s database to track progress toward registration. Once a
product has been registered, pertinent status information regarding the
product is revised in the tracking database. The system contains the
following types of information: new or amended product registrations,
suspensions, cancellations, product active ingredients, product uses,
and use deletions. ITRMD maintains official registration file jackets,
in which copies of the application, EPA’s reviews, registration
approvals, correspondence, the CSF and other related information are all
retained

5(c)	Small Entity Flexibility

EPA Form 8570-27 (“Formulator’s Exemption Statement”) reduces the
data submission burden on an applicant for registration of a product
that uses an EPA-registered pesticide product as the source of its
active ingredient. This form exempts the applicant from furnishing the
generic data that already were submitted by the company registering the
source product.

The Agency also has cataloged and computerized its pesticide data base
so that one can easily determine whether a particular study has been
submitted, and by whom it was submitted. This identifies, by chemical
and site(s), each item of data in the EPA’s files. As a result,
applicants encounter little difficulty in identifying available data
needed to support an application for registration.

5(d)	Collection Schedule

Not applicable. The activity is conducted only as a registration
application is received for consideration. There is no set schedule for
the collection of this information.

6.	ESTIMATING BURDEN AND COST OF THE COLLECTION

6(a)	Estimating Respondent Burden

The reporting and recordkeeping burden associated with Section 3
registration of pesticides may be thought of in terms of three general
categories of burden (including most registration actions except those
pertaining to setting tolerances and inert ingredients). Total aggregate
burden for all respondent registration activities is estimated to be
76,180 hours.

The annual burden for all respondents completing “Type A” activities
is estimated to be 27,160 hours, based on 140 responses at 194 hours per
response.

The annual burden for all respondents completing “Type B” activities
is estimated to be 42,560 hours, based on 3,040 responses at 14 hours
per response.

The annual burden for all respondents completing “Type C” activities
is estimated to be 6,460 hours, based on roughly 10 responses at 646
hours per response.

6(b)	Estimating Respondent Costs

There are currently an estimated 1,725 pesticide registrants holding at
least one pesticide registration. The number of pesticide registrants
has decreased since the last ICR renewal from 2,100 to 1,725, a
difference of 375.  For purposes of determining the appropriate number
of responses for each activity, EPA averaged respondent data for
registration activities submitted to EPA from 2005-2007; EPA has
averaged almost 3,200 annual responses.  Thus, average number of
responses annually has also changed from the last ICR renewal from 7,021
to 3,190, a reduction of over 50%.

The annual costs associated with these activities are estimated to be
approximately $5,528,542 per year.

“Type A” activities are estimated to cost about $1,768,193 per year.

“Type B” activities are estimated to cost about $3,339,318 per year.

“Type C” activities are estimated to cost $421,030 per year.

	Agency economists revised the estimated wages, benefits and overhead
for all labor categories for affected industries, state government, and
EPA employees based on publicly available data from the US Bureau of
Labor Statistics. The formulas used to estimate the labor rates and
formulas used to derive the fully loaded rates and overhead costs for
this ICR renewal are listed in Attachment G

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 2006 data.

Unloaded Wage Rate	Wages are estimated for labor types (management,
technical, and clerical) within applicable sectors. The Agency uses
average wage data for the relevant sectors available in the National
Industry-Specific Occupational Employment and Wage Estimates from the
Bureau of Labor Statistics (BLS) at   HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm" 
http://www.bls.gov/oes/current/oes_nat.htm .  

Sectors	The specific North American Industry Classification System
(NAICS) code and website for each sector is included in that sector’s
wage rate table (see Attachment G).  Within each sector, the wage data
are provided by Standard Occupational Classification (SOC).  The SOC
system is used by Federal statistical agencies to classify workers into
occupational categories for the purpose of collecting, calculating, or
disseminating data (see   HYPERLINK
"http://www.bls.gov/oes/current/oes_stru.htm" 
http://www.bls.gov/oes/current/oes_stru.htm ).

Loaded Wage Rate	Unless stated otherwise, all benefits represent 43% of
unloaded wage rates, based on benefits for all civilian non-farm
workers, from   HYPERLINK "http://www.bls.gov/news.release/ecec.t01.htm"
 http://www.bls.gov/news.release/ecec.t01.htm . However, if other
sectors are listed for which 43% is not applicable, the applicable
percentage will be stated.

Fully Loaded Wage Rate	We multiply the loaded wage rate by 50% (EPA
guidelines 20-70%) to get overhead costs.

The following tables present the estimated registration annual burden
and cost estimates:

Table 1-A: Est. Burden/Cost per “Type A” Antimicrobial Registration
Application (AD) 

Collection Activities	Burden Hours	Total

	Mgmt.

$103.62/hr	Tech.

$67.05/hr	Cler.

$33.85/hr	Hours	Costs $

Read Instructions	18	0	0	18	1,865.16

Plan activities	4	0	0	4	414.48

Gather/create information	0	120	0	120	8,046.00

Compile and review	4	8	0	12	950.80

Complete paperwork	0	0	30	30	1,015.50

Store/maintain data	0	0	10	10	338.50

TOTAL	26	128	40	194	$12,630.52

Annual Costs:	194 hours x 16 responses per year = 3,104 hours	

(a) Management:	26 hours x $103.62 x 16 Responses =	$  43,105.92	

(b) Technical:	128 hours x $67.05 x 16 Responses =	$137,318.40

(c) Clerical:	40 hours x $33.85 x 16 Responses =	$  21,664.00

Total = 	$202,008.32

Table 1-B: Est. Burden/Cost per “Type A” Antimicrobial Registration
Application (BPPD)

Collection Activities	Burden Hours	Total

	Mgmt.

$103.62/hr	Tech.

$67.05/hr	Cler.

$33.85/hr	Hours	Costs $

Read Instructions	18	0	0	18	1,865.16

Plan activities	4	0	0	4	414.48

Gather/create information	0	120	0	120	8,046.00

Compile and review	4	8	0	12	950.80

Complete paperwork	0	0	30	30	1,015.50

Store/maintain data	0	0	10	10	338.50

TOTAL	26	128	40	194	$12,630.52

Annual Costs:	194 hours x 35 responses per year = 6,790 hours	

(a) Management:	26 hours x $103.62 x 35 Responses =	$  94,294.20

(b) Technical:	128 hours x $67.05 x 35 Responses = 	$300,384.00

(c) Clerical:	40 hours x $33.85 x 35 Responses = 	$  47,390.00

	Total = 	$442,068.20



Table 1-C: Est. Burden/Cost per “Type A” Registration Application
(RD)

Collection Activities	Burden Hours	Total

	Mgmt.

$103.62/hr	Tech.

$67.05/hr	Cler.

$33.85/hr	Hours	Costs $

Read Instructions	18	0	0	18	1,865.16

Plan activities	4	0	0	4	414.48

Gather/create information	0	120	0	120	8,046.00

Compile and review	4	8	0	12	950.88

Complete paperwork	0	0	30	30	1,015.50

Store/maintain data	0	0	10	10	338.50

TOTAL	26	128	40	194	$12,630.52

Annual Costs:	194 hours x 89 responses per year = 17,266 hours	

(a) Management:	26 hours x $103.62 x 89 Responses =	$239,776.68

(b) Technical:	128 hours x $67.05 x 89 Responses =	$763,833.60

(c) Clerical:	40 hours x $33.85 x 89 Responses = 	$120,506.00

	                                              Total =  	 $1,124,116.28

Table 1-D: “Type A” Annual Activity Burden/Cost Subtotals

Processing Division	Responses	Burden	Cost

AD	16	3,104 hours	$202,008.32

BPPD	35	6,790 hours	$442,068.20

RD	89	17,266 hours	$1,124,116.28

“Type A” Subtotal	  =SUM(ABOVE)  140 	27,160 hours	  =SUM(ABOVE) 
$1,768,192.80 

Table 2-A: Est. Burden/Cost per “Type B” Application/Notification
(AD)

Collection Activities	Burden Hours	Total

	Mgmt.

$103.62/hr	Tech.

$67.05/hr	Cler.

$33.85/hr	Hours	Costs $

Read Instructions	7.0	0.0	0.0	7.0	725.34

Plan activities	0.5	0.0	0.0	0.5	51.81

Gather/create information	0.0	1.5	0.0	1.5	100.58

Compile and review	0.5	0.5	0.0	1.0	85.34

Complete paperwork	0.0	0.0	3.0	3.0	101.55

Store/maintain data	0.0	0.0	1.0	1.0	33.85

TOTAL	8.0	2.0	4.0	14.0	  =SUM(ABOVE)  1,098.47 

Annual Costs:	14 hours x 1,727 responses per year = 24,178 hours

(a) Management:	8 hours x $103.62 x 1,727 responses =	$1,431,613.92

(b) Technical:	2 hours x $ 67.05 x 1,727 responses =	  $   231,590.70

(c) Clerical:	4 hours x $ 33.85 x 1,727 responses =	  $   233,835.80

	                                                   Total = 
$1,897,040.42



Table 2-B: Est. Burden/Cost per “Type B” Application/Notification
(BPPD)

Collection Activities	Burden Hours	Total

	Mgmt.

$103.62/hr	Tech.

$67.05/hr	Cler.

$33.85/hr	Hours	Costs $

Read Instructions	7.0	0.0	0.0	7.0	725.34

Plan activities	0.5	0.0	0.0	0.5	51.81

Gather/create information	0.0	1.5	0.0	1.5	100.58

Compile and review	0.5	0.5	0.0	1.0	85.34

Complete paperwork	0.0	0.0	3.0	3.0	101.55

Store/maintain data	0.0	0.0	1.0	1.0	33.85

TOTAL	8.0	2.0	4.0	14.0	  =SUM(ABOVE)  1,098.47 

Annual Costs:	14 hours x 251 responses per year = 3,514 hours

(a) Management:	8 hours x $103.62 x 251 Responses =$208,068.96

(b) Technical:	2 hours x $67.05 x 251 Responses =	$  33,659.10

(c) Clerical:	4 hours x $33.85 x 251 Responses =	$  33,985.40

	                                              Total =	$275,713.46

Table 2-C: Est. Burden/Cost per “Type B” Application/Notification
(RD)

Collection Activities	Burden Hours	Total

	Mgmt.

$103.62/hr	Tech.

$67.05/hr	Cler.

$33.85/hr	Hours	Costs $

Read Instructions	7.0	0.0	0.0	7.0	725.34

Plan activities	0.5	0.0	0.0	0.5	51.81

Gather/create information	0.0	1.5	0.0	1.5	100.58

Compile and review	0.5	0.5	0.0	1.0	85.34

Complete paperwork	0.0	0.0	3.0	3.0	101.55

Store/maintain data	0.0	0.0	1.0	1.0	33.85

TOTAL	8.0	2.0	4.0	14.0	  =SUM(ABOVE)  1,098.47 

Annual Costs:	14 hours x 1,062 responses per year = 14,868 hours

(a) Management:	8 hours x $103.62 x 1,062 Responses = $880,355.52

(b) Technical:	2 hours x $67.05 x 1,062 Responses = 	$142,414.20

(c) Clerical: 	4 hours x $33.85 x 1,062 Responses =   $143,794.80

		  Total =   1,166,564.52 

Table 2-D: Type B Activity Burden/Cost Subtotals

Processing Division	Responses	Burden	Cost

AD	1,727	24,178 hours	$1,897,040.42

BPPD	251	3,514 hours	$275,713.46

RD	1,062	14,868 hours	$1,166,564.52

“Type B” Subtotal	  =SUM(ABOVE)  3,040 	42,560 hours	  =SUM(ABOVE) 
$3,339,318.40 

Table 3: Est. Burden/Cost per “Type C” Reduced Risk Application (RD
only) 

Collection Activities	Burden Hours	Total

	Mgmt.

$103.62/hr	Tech.

$67.05/hr	Cler.

$33.85/hr	Hours	Costs $

Read Instructions	22	0	0	22	2,279.64

Gather Information	0	368	0	368	24,674.40

Process, Compile and Review Information	80	80	0	160	13653.60

Record and Report Information	0	0	72	72	2,437.20

Store, File and Maintain

Information	0	0	24	24	812.40

TOTAL	102	448	96	  =SUM(ABOVE)  646 	$  =SUM(ABOVE)  43,857.24 

Annual Costs:	646 Hours x 10 responses per year = 6,460 Hours	

(a) Management:	102 hours x $103.62 x 10 responses = 	$105,692.40

(b) Technical:	448 hours x $67.05 x 10 Responses =	$300,384.00

(c) Clerical:	96 hours x $33.85 x 10 Responses =	$  32,496.00

		Total =	$421,030.40

6(c)	Estimating Agency Burden and Cost

For this ICR renewal, the Agency is using a new data source to estimate
the Agency burden.  The projected burden figures use 2007 data, which
includes burden hours from internal OPP Divisions that provide
significant support and analysis for the FIFRA Section 3 ICR
registration program.  

The Agency is using FIFRA Section 3 registration activity data from the
Time and Attendance Information System (TAIS), which archives the
Agency’s Full Time Equivalents (FTEs) for most OPP program activities.
 In the past, the Agency burden calculations reflected only the Section
3 ICR FTE activities for the Registration Division (RD), the
Biopesticides and Pollution Prevention Division (BPPD), and the
Antimicrobial Division (AD) as used in the last renewal.  The 2008
renewal now also includes the appropriate FTE activity data from the
Heath and Effects Division (HED), the Biological and Economic Analysis
Division (BEAD), Special Review and Reregistration Division (SRRD),
Field and External Affairs Division (FEAD) and the Environmental Fate
and Effects Division (EFED).  Thus, eight (8) OPP Divisions work
together to complete the activities related to OPP registration actions.
 The Agency believes using this new data source reflects the changes to
the internal operations for implementing and administering the FIFRA
Section 3 registration activities.  The major impetus for internal
program realignment was to implement the requirements of the Food
Quality Protection Act of 1996 and the Pesticide Registration
Improvement Act of 2003 (PRIA) as reauthorized.

Using this new source of data the estimated number of Agency FTE’s
dedicated to Section 3 registration and registration support activities
is approximately 22 managerial FTEs as shown in Table 1, 190 technical
FTEs as shown in Table 2, and 15 clerical FTEs as shown in Table 3.  The
aggregated Agency estimated FTE dedicated to Section 3 activities is 227
and the burden hours are 472,160.  

Table 1 – Distribution of Agency Managerial FTEs Supporting FIFRA
Section 3 Registration and Registration Support Activities   

BEAD 	RD	EFED	SRRD	FEAD	HED	AD	BPPD

2.0	6.6	3.0	<1	<1	4.4	2.7	2.6

Agency total 	22

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 x 22=45,760).

Table 2 – Distribution of Agency Technical FTEs Supporting FIFRA
Section 3 Registration and Registration Support Activities2    

BEAD 	RD	EFED	SRRD	FEAD	HED	AD	BPPD

15.4	59.7	23.2	<1	<1	39.1	23.4	28.9

Agency total 	190

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 x 190=395,200).

Table 3 – Distribution of Agency Clerical FTEs Supporting FIFRA
Section 3 Registration and Registration Support Activities2     

BEAD 	RD	EFED	SRRD	FEAD	HED	AD	BPPD

1.5	4.6	1.7	<1	<1	1.3	3.1	1.9

Agency total 	15

Annual Agency burden hours were calculated using the number of hours per
FTE multiplied by the number of FTE’s (2080 x 15=31,200).

To determine Agency costs, the Agency used the Bureau of Labor
Statistics estimates of labor rates for the North American Industry
Classification System (NAICS) code for the Federal Executive Branch
(NAICS 999100).  The managerial labor rate is based on the Standard
Occupational Code (SOC) for management occupations; the technical labor
rate is based on the SOC for life, physical and social science
occupations; and the clerical labor rate is based on the SOC for office
and administrative support occupations.  The labor rates are fully
loaded and indexed to 2007 dollars.  The fully loaded hourly mean wage
rate estimate for managerial occupations is $103.32 for an average
annual cost of $214,906 (i.e., $103.32/hour x 2080 hours).  For
technical occupations, the fully loaded mean wage rate is $71.04 for an
average annual cost of $147,763.  And for clerical occupations, the
fully loaded mean wage rate is $40.76 for an average annual cost of
$84,871. (Please see Attachment H - Worksheet for NAICS 999100 EPA or
Federal Government Worksheet.)

To calculate the Agency’s estimated annual cost of Section 3
activities, the number of FTE’s is multiplied by this number allocated
to registration activities for each year over the next three years,
which is estimated to be $4,727,932 for management (i.e., 22 FTE x
$214,906/FTE); $28,074,970 annually for technical (i.e., 190 FTE x
$147,763/ FTE); and $1,271,715 for clerical (i.e., 15 FTE x
$84,781/FTE).  The total estimated Agency cost is $34,074,617.

	6(d)	Bottom Line Burden Hours and Cost

	ANNUAL TOTAL

	Responses	Hours	Costs

Annual “Type A” Responses	140	27,160	$1,768,192.80

Annual “Type B” Responses	3,040	42,560	$3,339,318.40

Annual “Type C” Responses	10	6,460	$421,030.40

Total Annual Response Burden	  =SUM(ABOVE)  3,190 	76,180	  =SUM(ABOVE) 
$5,528,541.60 

Agency Burden Estimate

472,160	$34,074,617

6(e)	Reasons for Changes in Burden

There is an annual burden reduction of 76,794 hours as a result of 3,831
fewer expected responses across all response types (i.e., Registration
Application Types A through C).  The reduction in EPA’s respondent
response estimate is due, in part, to the identification and elimination
of double-counting in the Agency’s data systems.  In addition, due to
some industry consolidation and based on registration maintenance fee
data, EPA has identified 375 fewer ICR respondents.  Therefore, the
estimated 76,794 hour decline in annual paperwork burden hours is an
adjustment.  

6(f)	Burden Statement 

The annual average reporting and recordkeeping burdens for a
registration applicant respondent are estimated to range from 14 hours
to 646 hours, depending upon the type of activity. Estimates for the
annual applicant respondent burden for collection of information
associated with Type “A” and “B” activities average: 194 hours
per application for “Type A” activities, which include new active
ingredients and new uses and 14 hours per application for “Type B”
activities, which include amendments and notifications. The burdens
estimate for “Type C” reduced risk products, which are handled only
by RD, is an average of 646 hours per product. These estimates include
time spent reading the regulations, planning the necessary data
collection activities, conducting tests, analyzing data, generating
reports and completing other required paperwork, and storing, filing,
and maintaining the data.

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2008-0191, which is available for online viewing at
www.regulations.gov, or in person viewing at the OPP Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal
Drive, Arlington, VA.  This docket facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays.  The docket
telephone number is (703) 305-5805.  You may submit comments regarding
the Agency's need for this information, the accuracy of the provided
burden estimates and any suggested methods for minimizing respondent
burden, including the use of automated collection techniques.  

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2008-0191 and
OMB Control No. 2070-0060, to (1) EPA online using www.regulations.gov
(our preferred method), or by mail to: Public Information and Records
Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs
(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW, Washington, DC
20503.ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public
docket established for this Information Collection Request (ICR) under
the docket identification number EPA-HQ-OPP-2008-0191.  These
attachments are available for online viewing at   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov  or otherwise accessed
as described in the sections below.  

Attachment A:	7 U.S.C. 136a – Section 3 of FIFRA. Also available at
online at the US House of Representatives’   HYPERLINK
"http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+21
64+0++%28%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20AND%20%28USC
%20w%2F10%20%282603%29%29%3ACITE%20%20%20%20%20%20%20%20%20"  US Code
website 

Attachment B:	Forms for Pesticide Registration – available
electronically as a PDF file on the internet at   HYPERLINK
"http://www.epa.gov/opprd001/forms/"  http://www.epa.gov/opprd001/forms/
.

EPA Form 8570-1 - Application for Pesticide, Registration, Amendment,
Other

EPA Form No. 8570-4 - Confidential Statement of Formula

EPA Form No. 8570-27 - Formulator's Exemption Statement

EPA Form No. 8570-34 - Certification with Respect to Citation of Data
Form

EPA Form No. 8570-35 - Data Matrix Form

EPA Form No. 8570-36 - Summary of the Physical/Chemical Properties Form

EPA Form No. 8570-37 - Self-Certification Statement for the Physical/
Chemical Properties

Attachment C:	Pesticide Registration (PR) Notice 97-3 – Guidelines for
Expedited Review of Conventional Pesticides under the Reduced-Risk
Initiative and for Biological Pesticides. Also available at online at  
HYPERLINK "http://www.epa.gov/PR_Notices/pr97-3.html" 
http://www.epa.gov/PR_Notices/pr97-3.html  

Attachment D:	40 CFR 152 – Pesticide Registration and Classification
Procedures. Also available online at the National Archives and Records
Administration’s  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=88d9c3c9f74b07
b1127c67fbfa4acde0&rgn=div5&view=text&node=40:23.0.1.1.3&idno=40"
Electronic CFR Website 

Attachment E:	40 CFR 156 – Labeling Requirements for Pesticides and
Devices. Also available online at the National Archives and Records
Administration’s  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=88d9c3c9f74b07
b1127c67fbfa4acde0&rgn=div5&view=text&node=40:23.0.1.1.7&idno=40"
Electronic CFR Website 

Attachment F:	40 CFR 158 – Data Requirements For Registration. Also
available online at the National Archives and Records Administration’s
 HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=88d9c3c9f74b07
b1127c67fbfa4acde0&rgn=div5&view=text&node=40:23.0.1.1.9&idno=40"
Electronic CFR Website 

Attachment G:	Work Sheets used to Calculate Pesticide Registrant
Industry Labor Costs

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

Attachment I:	Time and Attendance Information System (TAIS) Plan Program
Accomplishment (PPA) codes used to calculate EPA and Federal Government
Burden Hours

Attachment J:	Consultation:  List of Standard Questions

Attachment K:	Display Related to OMB Control #2070-0060 – Listings of
Related Regulations in 40 CFR 9.1. Also available online at the National
Archives and Records Administration’s  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=88d9c3c9f74b07
b1127c67fbfa4acde0&rgn=div5&view=text&node=40:1.0.1.1.9&idno=40"
Electronic CFR Website 

 The Agency burden related to OPP’s Information Technology and
Resource Management Division (ITRMD) processing activities are not
included in the burden estimate because ITRMD provides the preliminary
data processing and tracking for many OPP ICR activities including the
FIFRA Section 3 ICR.  These systems are integrated for efficient
processing, tracking, and maintaining data but they do not readily lend
themselves to a clear burden breakdown by ICR activity.

 The FTE burden in SRRD and FEAD for each labor category (managerial,
technical and clerical) amounted to significantly less than 1 FTE. The
estimate for the Agency FTE for each labor category was rounded up to
account for the contribution of FEAD and SRRD to the Section 3 FTE
burden.

October 16, 2008

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