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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. 0277.16

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 the Federal 

Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 

(FQPA) of August 3, 1996 (see Attachment A). Under FIFRA, 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.

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 or other test methods 

that provide acceptable data. 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. All or part of this information 

may be required depending on use and type of product. If EPA’s evaluation of the data shows 

that the statutory requirements of FIFRA are met, a registration is approved. 
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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). Generally, data are not required 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, or Team Leader, 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. These divisions ensure that revisions comply with the applicable labeling 

requirement or guidance.

The Agency has added to its basic registration information collection of 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 expedited review timeframes 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 

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 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., registration review). 

Labeling amendments pertaining to groups of products may be implemented through Pesticide 

Registration Notices (PRN) or Federal Register Notices (FRN).
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2(b) Practical Utility/Users of the Data

The information collected under this ICR is used to support registration decisions for new 

or amended pesticides. Once 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, registration is issued to the applicant.

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 is able to refer to any information previously submitted, thereby 

satisfying data requirements without the burden of providing duplicate information or additional 

data development.

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

EPA announced through a Federal Register Notice on December 14, 2011 (76 FR 

77817), that the Agency was planning to submit a request to renew this currently approved ICR

to the Office of Management and Budget (OMB). The FRN referred the public to a docket, 

EPA-HQ-OPP-2011-0886, which provided copies of draft products to be submitted to OMB. In 

response to this notice, three comments were received and placed in the docket, all of which 

asked to extend the comment period for review of the draft ICR. A response to the three 

comments was placed in the docket, stating that an extension could not be granted, as the ICRs 

would expire. The commenters had further pointed out that EPA’s estimates of cost and burden 

were low compared to their experience but none of the commenters provided specific response to 

the documents in the docket for EPA to analyze. EPA did review its burden estimate, based on 

actual tracking at 2011 year-end and revised burden estimates to reflect best possible data on the 

number of responses. This resulted in an upward change in the estimated number of responses, 

which led to an overall increase in burden estimate, reflected in this supporting statement, rather 

than a decrease in burden statement that was originally estimated.

As part of the renewal process, EPA will publish a notice in the Federal Register prior to 

submitting the ICR to OMB. Pursuant to 5 CFR 1320.8(d), any public comments received will be 

placed in the EPA docket, EPA-HQ-OPP-2011-0886, for this action. 

3(c) Consultations

The Agency consulted with stakeholders who interact with the Agency through the use of 

this collection instrument to solicit stakeholder assessment of the regulatory burden estimates 

expressed in this ICR. One stakeholder responded (See Attachment H). The respondent 

indicated that increased ability to submit data and applications electronically would reduce 

burden, save cost, and improve the overall application process. While some electronic 
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submission is already permitted (see section 3(e) General Guidelines, subtitle Electronic 

Submissions of this supporting statement), EPA acknowledges that additional opportunities for 

electronic submission, including secure transmission of Confidential Business Information, 

would be more efficient for registrants and the Agency. In addition, the Agency recognizes that 

e-submission forms that facilitate application to regulatory agencies in other countries, such as 

aligning with Canada’s Pest Management Regulatory Agency, facilitate registrants’ abilities to 

meet registration requirements. While not available for this renewal, EPA will explore ways to 

increase availability of electronic submissions and amend this ICR to create electronic forms. 

The stakeholder also commented that while the 194 hours estimate for a registration 

application seemed correct, the split between management and technical time may be different 

for the area of “compile and review;” however, given the generally used 2-to-1 ratio of technical 

to management, and the commenter’s statement that management may spend 30-40 hours on 

“compile and review,” the Agency was unable to reconcile the numbers and stay within the 194 

hours estimate. The Agency also believes that 30-40 hours of management time to “compile and 

review” is an overestimate. The Agency believes that since the overall burden estimate is 

considered correct by the one commenter, the mix between technical and management is likely 

also correct and would not make a significant difference if we were to reallocate within the table. 

Finally, the commenter pointed out that wage rates did not reflect the going rates for 

technical consultants. EPA reviewed the rates for technical consultants with the Bureau of Labor 

Statistics (BLS) data, which is consistently used by EPA to estimate burden cost in ICRs. The 

hourly rate of $60.85 for technical and $120.28 for management is an average and is consistent 

with BLS data. 

A sample copy of the ICR questionnaire provided to industry representatives is in 

Attachment G. 

Consultations were sent to the following stakeholders:

Bill Stoneman, Executive Director

Biopesticide Industry Alliance

PO Box 465

McFarland, WI 53558-0465

bstoneman@biopesticideindustryalliance.org

Dr. Ray S. McAllister, Director, Regulatory Affairs

CropLife America

1156 15th Street NW

Washington, DC 20005

rmcallister@croplifeamerica.org

Heather Bjornson, Senior Regulatory Consultant

Technology Science Group, INC

1150 18th Street, NW, Suite 1000

Washington, DC 20036

HBjornson@tsgusa.com
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3(d) Effects of Less Frequent Collection

Not applicable. The Section 3 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 and the environment.

3(e) General Guidelines

Pesticide label 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.

Long-term recordkeeping 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 FIFRA).

Electronic submissions OMB 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. Electronic-Submissions (or "e-Submissions) are available for Section 3 New 

Applications and Section 3 Amendments. There are two methods by which companies can 

assemble the e-submission discs. In both methods, the files to be submitted along with an XML 

data file containing information about the files and the submission itself are “zipped” into a 

single file and placed on a disc (CD/DVD) for submission to the EPA. The first is a new method 

introducing the use of a “builder” application. The second, introduced in July 2008, requires the 

manual editing of the XML file. Additional information on both of e-submission methods can be 

accessed at: http://www.epa.gov/pesticides/regulating/registering/submissions/.
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Ordinarily, registrants would be required to submit three paper copies of study data to 

EPA; however, registrants need only submit 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 

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 less data (e.g., amendments, for currently registered chemicals). There are several 

types of amendments, including “me-too” products that require little or no data. 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 
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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 

physical chemistry, toxicology, environmental fate, ecological effects, worker exposure, residue 

chemistry, environmental chemistry, and product performance, 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:

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

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

3. EPA Form 8570-27, Formulator’s Exemption Statement

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

5. EPA Form 8570-35, Data Matrix

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

7. 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 seeking registration 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.
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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 that are given expedited processing. An applicant must prepare an application that includes specific information as described in PR 

notice 97-3 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, the Agency will accept the application as 

"reduced risk” 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."
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5. THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT.

5(a) Agency Activities

OPP activities in conjunction with receipt of information in this ICR are summarized by

the following steps:

1. Receive Application

 The pesticide registration application package, complete with the required forms, 

necessary data, and proposed labels, 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 refers 

the 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 

inputting into the tracking database. After this is completed, the data package is 

routed to the appropriate regulatory division for processing.

2. Review Application

 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 reviewer. If its 

similarity to a pesticide currently registered by the EPA is questionable, it may be 

sent for a short interdisciplinary review. The Program Manager or Team Leader 

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 action is taken to correct the assignment of the registration action and to 

route 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. 

3. Make Registration Decision

 The Program Manager or Team Leader 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 a final decision on whether or not to register a pesticide. When a new 

tolerance is established for an already registered active ingredient (e.g., new use), 

the final decision is made by the Division Director of the registering division.

 If the registration action is for revised labeling in response to a Pesticide 

Registration Notice, the revised labeling submitted along with appropriate EPA 

forms will be reviewed by a Program Manager or Team Leader for compliance 
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with the applicable Pesticide Registration Notice and, following the registration 

decision, entered into the tracking database.

4. Notify Applicant

 OPP sends 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.

5. Store and Maintain Data

 OPP stores, files, and maintains copies of any registration notices and labeling 

information.

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” registrations) may require only a minimal review for 

completeness of the application, the adequacy of the labeling, and the satisfaction of data 

compensation requirements. 

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 many

divisions may be actively involved in the data analysis and agency determination of OPP 

registration actions. For conventional pesticides, the application is reviewed by 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 ITRMD, and the Biopesticides 

and Pollution Prevention Division (BPPD). Applications for antimicrobial pesticide products are 

reviewed by ITRMD and the Antimicrobial Division (AD). The Agency notifies an applicant 

when an application is incomplete or is found to be deficient. The applicant is permitted to 

correct the deficiencies and submit the corrections.

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. 

Notifications are registration modifications, typically without need of data review, that 

require the shortest review and approval or denial time. Unlike a new active ingredient or a new 

use, Notifications are reviewed only by the division responsible for registering the product.

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. 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 a shorter 
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review time. This policy specifies the standard format for registrants to use when providing 

justification for a reduced-risk pesticide to facilitate efficient processing within OPP.

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) are also 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, label, 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 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). Annual 

aggregate burden for all respondent registration activities is estimated to be 168,204 hours. When 

the Agency receives applications for registrations and amendments to registrations it 

immediately enters them into the Office of Pesticide Program central database system, called 

OPPIN. From this system, the Agency can provide reporting on actual numbers of applications, 

broken down by several major types. Each registering division further tracks applications in 
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greater detail. Information from the central database and supplemental divisional tracking is used 

at the end of the year as the basis of the burden estimates. 

The annual burden for all respondents completing “Type A” activities is estimated to be 

48,306 hours, based on 249 responses at 194 hours per response.

The annual burden for all respondents completing “Type B” activities is estimated to be

110,208 hours, based on 7,872 responses at 14 hours per response.

The annual burden for all respondents completing “Type C” activities is estimated to be

9,690 hours, based on 15 responses at 646 hours per response.

6(b) Estimating Respondent Costs

There are currently an estimated 1,683 pesticide registrants holding at least one pesticide 

registration. The number of pesticide registrants has decreased since the last ICR renewal from 

1,725 to 1,683 - a difference of 42. For purposes of determining the appropriate number of 

responses for each activity, EPA averaged respondent data for registration activities submitted to

EPA from 2008-2010; The average number of responses annually has changed from the last ICR 

renewal from 3,190 to 8,136 an increase of about 155%.

The annual costs associated with these activities are estimated to be approximately

$13,435,600 per year.

 “Type A” activities are estimated to cost about $3,087,800 per year. 

 “Type B” activities are estimated to cost about $9,701,400 per year. 

 “Type C” activities are estimated to cost about $646,400 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 I.
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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 2010 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

http://www.bls.gov/oes/current/oessrci.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 I). 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 

http://www.bls.gov/oes/current/oes_stru.htm).

Loaded Wage 

Rate

Unless stated otherwise, all benefits represent 43.6% of unloaded wage rates, 

based on benefits for all civilian non-farm workers, from June 2010 data from 

http://www.bls.gov/news.release/ecec.t01.htm. 

Fully Loaded 

Wage Rate

We multiply the loaded wage rate by 50% (EPA guidelines 20-70%) to get 

overhead costs.
April 5, 2012

14

The following tables present estimated annual burden and cost estimates for this ICR. Since

costs are displayed as rounded to nearest ten or hundred dollars, they may not calculate exactly.

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

Collection Activities

Type A

Burden Hours Total

Mgmt Technical Clerical

$120.28 $60.85 $37.11 Hours Costs

per hour per hour per hour

Read Instructions 18 0 0 18 $2,200 

Plan activities 4 0 0 4 $500 

Gather/create information 0 120 0 120 $7,300 

Compile and review 4 8 0 12 $1,000 

Complete paperwork 0 0 30 30 $1,100 

Store/maintain data 0 0 10 10 $400 

TOTAL 26 128 40 194 $12,400 

Annual Burden/Cost Hours per

response

x Responses

per year

= Hours 

per year

x Wage 

per hour

= Costs 

per year

(a) Management: 26 25 650 $120.28 $78,200 

(b) Technical: 128 25 3,200 $60.85 $194,700 

(c) Clerical: 40 25 1,000 $37.11 $37,100 

 Total 194 25 4,850 $310,000 

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

Collection Activities

Type A

Burden Hours Total

Mgmt Technical Clerical

$120.28 $60.85 $37.11 Hours Costs

per hour per hour per hour

Read Instructions 18 0 0 18 $2,200

Plan activities 4 0 0 4 $500

Gather/create information 0 120 0 120 $7,300

Compile and review 4 8 0 12 $1,000

Complete paperwork 0 0 30 30 $1,100

Store/maintain data 0 0 10 10 $400

TOTAL 26 128 40 194 $12,400

Annual Burden/Cost Hours per

response

x Responses

per year

= Hours 

per year

x Wage 

per hour

= Costs 

per year

(a) Management: 26 22 572 $120.28 $68,800

(b) Technical: 128 22 2,816 $60.85 $171,400

(c) Clerical: 40 22 880 $37.11 $32,700

Total 194 22 4,268 $272,800
April 5, 2012

15

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

Collection Activities

Type A

Burden Hours Total

Mgmt Technical Clerical

$120.28 $60.85 $37.11 Hours Costs

per hour per hour per hour

Read Instructions 18 0 0 18 $2,200

Plan activities 4 0 0 4 $500

Gather/create information 0 120 0 120 $7,300

Compile and review 4 8 0 12 $1,000

Complete paperwork 0 0 30 30 $1,100

Store/maintain data 0 0 10 10 $400

TOTAL 26 128 40 194 $12,400

Annual Burden/Cost Hours per

response

x Responses

per year

= Hours 

per year

x Wage 

per hour

= Costs 

per year

(a) Management: 26 202 5,252 $120.28 $631,700 

(b) Technical: 128 202 25,856 $60.85 $1,573,400 

(c) Clerical: 40 202 8,080 $37.11 $299,900 

Total 194 202 39,188 $2,505,000 

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

Processing Division Responses Burden Cost

AD 25 4,850 $310,000

BPPD 22 4,268 $272,800

RD 202 39,188 $2,505,000 

“Type A” Subtotal 249 48,306 $3,087,800 

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

Collection Activities

Type B

Burden Hours Total

Mgmt Technical Clerical

$120.28 $60.85 $37.11 Hours Costs

per hour per hour per hour

Read Instructions 7 0 0 7 $840

Plan activities 0.5 0 0 0.5 $60

Gather/create information 0 1.5 0 1.5 $90

Compile and review 0.5 0.5 0 1 $90

Complete paperwork 0 0 3 3 $110

Store/maintain data 0 0 1 1 $40

TOTAL 8 2 4 14 $1,230
April 5, 2012

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Annual Burden/Cost Hours per

response

x Responses

per year

= Hours 

per year

x Wage 

per hour

= Costs 

per year

(a) Management: 8 2,924 23,392 $120.28 $2,813,600

(b) Technical: 2 2,924 5,848 $60.85 $355,900

(c) Clerical: 4 2,924 11,696 $37.11 $434,100

Total 14 2,924 40,936 $3,603,500

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

Collection Activities

Type B

Burden Hours Total

Mgmt Technical Clerical

$120.28 $60.85 $37.11 Hours Costs

per hour per hour per hour

Read Instructions 7 0 0 7 $840

Plan activities 0.5 0 0 0.5 $60

Gather/create information 0 1.5 0 1.5 $90

Compile and review 0.5 0.5 0 1 $90

Complete paperwork 0 0 3 3 $110

Store/maintain data 0 0 1 1 $40

TOTAL 8 2 4 14 $1,230

Annual Burden/Cost Hours per

response

x Responses

per year

= Hours 

per year

x Wage 

per hour

= Costs 

per year

(a) Management: 8 231 1,848 $120.28 $222,300

(b) Technical: 2 231 462 $60.85 $28,100

(c) Clerical: 4 231 924 $37.11 $34,300

 Total 14 231 3,234 $284,700
April 5, 2012

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

Collection Activities

Type B

Burden Hours Total

Mgmt Technical Clerical

$120.28 $60.85 $37.11 Hours Costs

per hour per hour per hour

Read Instructions 7 0 0 7 $840

Plan activities 0.5 0 0 0.5 $60

Gather/create information 0 1.5 0 1.5 $90

Compile and review 0.5 0.5 0 1 $90

Complete paperwork 0 0 3 3 $110

Store/maintain data 0 0 1 1 $40

TOTAL 8 2 4 14 $1,230

Annual Burden/Cost Hours per

response

x Responses

per year

= Hours 

per year

x Wage 

per hour

= Costs 

per year

(a) Management: 8 4,717 37,736 $120.28 $4,538,900 

(b) Technical: 2 4,717 9,434 $60.85 $574,100 

(c) Clerical: 4 4,717 18,868 $37.11 $700,300 

 Total 14 4,717 66,038 $5,813,200 

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

Processing Division Responses Burden Cost

AD 2,924 40,936 $3,603,500 

BPPD 231 3,234 $284,700 

RD 4,717 66,038 $5,813,200 

“Type B” Subtotal 7,872 110,208 $9,701,400 
April 5, 2012

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

Collection Activities

Type C

Burden Hours Total

Mgmt Technical Clerical

$120.28 $60.85 $37.11 Hours Costs

per hour per hour per hour

Read Instructions 22 0 0 22 $2,600

Gather Information 0 368 0 368 $22,400

Process, Compile and 

Review Information 80 80 0 160 $14,500

Record and Report 

Information 0 0 72 72 $2,700

Store, File and Maintain 

Information 0 0 24 24 $900

TOTAL 102 448 96 646 $43,100

Annual Burden/Costs Hours per 

response

x Responses 

per year

= Hours 

per year

x Wage 

per hour

= Costs 

per year

(a) Management: 102 15 1,530 $120.28 $184,000 

(b) Technical: 448 15 6,720 $60.85 $408,900 

(c) Clerical: 96 15 1,440 $37.11 $53,400 

 Total 646 15 9,690 $646,400 

6(c) Estimating Agency Burden and Cost

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. The projected burden figures use 2008 – 2010 data, 

which includes burden hours from internal OPP Divisions that provide significant support and 

analysis for the FIFRA Section 3 ICR registration program including the Registration Division 

(RD), the Biopesticides and Pollution Prevention Division (BPPD), the Antimicrobial Division 

(AD), the Health and Effects Division (HED), the Biological and Economic Analysis Division 

(BEAD), and the Environmental Fate and Effects Division (EFED). Thus, six OPP Divisions 

work together to complete the activities related to OPP registration actions. The Agency

believes using this 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 source of data, the estimated number of Agency FTE’s dedicated to Section 3 

registration and registration support activities is approximately 25 managerial FTEs, 198 

technical FTEs, and 7 clerical FTEs as shown in Table 4. The aggregated Agency estimated FTE 

dedicated to Section 3 activities is 230 and the burden hours are 478,400. 
April 5, 2012

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Table 4 – Distribution of Agency FTEs Supporting FIFRA Section 3 Registration and 

Registration Support Activities1 

Division: BEAD RD EFED HED AD BPPD Total Wage/hr Cost

Managerial 2.7 7.2 3.1 6.1 2.9 3.2 25.1 $119.85 $6,248,800

Technical 19.2 61.1 21.1 42.9 24.8 28.7 197.9 $71.58 $29,459,500

Clerical 0.7 2.0 0.9 1.3 1.0 1.3 7.1 $43.21 $636,600

Total Sec 3 22.5 70.3 25.1 50.3 28.6 33.1 230.0 $36,344,900

Annual Agency burden hours were calculated using the number of hours per FTE 

multiplied by the number of FTE’s (2080 hours/FTE x 230 FTE=478,400 hours).

To determine Agency costs, the Agency used the Bureau of Labor Statistics estimates of 

2010 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 fully loaded hourly mean wage rate 

estimate is $119.85 for managerial occupations, $71.58 for technical occupations, and $43.21 for 

clerical occupations. (Please see Attachment J - 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 allocated to registration activities (Table 4) is multiplied by these fully loaded labor rates 

and by 2080 hours per FTE, which is estimated to be about $6,248,800 for management; 

$29,459,500 for technical; and $636,600 for clerical. The total estimated Agency cost is 

$36,344,900.

6(d) Bottom Line Burden Hours and Cost

Table 5- Estimated Annual Total Hours and Cost

ANNUAL TOTAL

Responses Hours Costs

Annual “Type A” Responses 249 48,306 $3,087,800 

Annual “Type B” Responses 7,872 110,208 $9,701,400 

Annual “Type C” Responses 15 9,690 $646,400 

Total Annual Response Burden 8,136 168,204 $13,435,600 

Agency Burden Estimate 478,400 $36,344,900 

 

1 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 PRD (Pesticide Review Division) and FEAD (Field and 

External Affairs Division) is significantly less than 1 FTE.
April 5, 2012

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6(e) Reasons for Changes in Burden

There is an annual respondent burden increase of about 92,000 hours as a result of almost 

5,000 additional expected responses primarily from “Type B” activities in the RD (Registration 

Division) and the AD (Antimicrobial Division). The increase reflects the Agency’s tracking of 

information collected under FIFRA section 3 over the past three years, including increased 

responses for labeling or labeling amendments, and is the Agency’s best estimate for the number 

of responses expected.

6(f) Burden Statement 

The annual average reporting and recordkeeping burdens for a registration applicant 

respondent are estimated to range from 14 hours to 840 hours, depending upon the type of 

activity. Estimates for the annual applicant respondent burden for collection of information 

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. However, reduced risk products require both 

“Type A” and “Type C” for a total of 840 hours for both applications. 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-HQOPP-2011-0886 , 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-2011-0886 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
April 5, 2012

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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-HQOPP-2011-0886. These attachments are available for online viewing at 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’ US Code website

Attachment B: Forms for Pesticide Registration – available electronically as a PDF file on the 

internet at 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 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 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 Electronic CFR 

Website

Attachment F: 40 CFR 158 – Data Requirements For Registration. Also available online at the 

National Archives and Records Administration’s Electronic CFR Website

Attachment G: Consultation: List of Standard Questions

Attachment H: Industry Response to Consultation Questions

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

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

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 Electronic CFR Website