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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. 0277.17

1(b) Short Characterization/Abstract

This information 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 comprehensively 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.

Pursuant to FIFRA Section 33--Pesticide Registration Service Fees, the 

Consolidated Appropriations Act of 2004 established the Pesticide Registration 

Improvement Act, or PRIA (see Attachment B). This new system created a 

registration service fee system for applications specific to pesticide registrations, 

amended registrations, and associated tolerance actions. Since its approval, PRIA 

has been reauthorized twice (2007, and 2013). Under PRIA, EPA is required to 

make a determination on the application within specified decision time frames.

In evaluating a pesticide registration application, EPA assesses a wide range 

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. The assessments involve to 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. Labeling instructions must be carefully and 

precisely followed in order to ensure safe use.
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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. 

Registrants may seek, at their discretion, to amend a registration by

submitting data and revised proposed labeling to EPA. Also, registrants of EPAregistered pesticide products at times become subject to regulations or guidance 

which necessitate labeling revisions. The revised labeling is submitted to the 

Agency as an amendment along with the completed application (EPA Form 8570-1 

and other forms as needed; see Attachment C). 

In the context of its conventional pesticide registration activities, EPA 

operates a reduced risk program that offers an incentive through a shortened 

regulatory review schedule for proposed uses that might be beneficial to the public 

and the environment owing to their risk profile, compared to alternatives for pest 

control. The reduced risk program is described in a policy notice known as, 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 D). The guidance in this notice is intended to give 

expedited review timeframes to new registrations of 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 provide an explanation 

accompanied by relevant supporting information, including associated tolerance 

petitions for special consideration based on these factors. (The paperwork burden for 
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tolerance petitions is not included in the estimates for the current ICR. They are 

covered in a separate ICR under OMB No. 2070-0024, Tolerance Petitions for 

Pesticides on Food/Feed Crops and New Inert Ingredients.) 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 E, F and G, 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 a PRN or Federal 

Register Notices (FRN).

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 this ICR’s Section 5(c) below, entitled “Small Entity Flexibility.” On amended 

applications, the applicant is able to refer to any previously submitted information, 

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

In proposing to renew this ICR, EPA is providing a 60-day public notice and 

comment period. The materials related to the proposed renewal of this ICR may be 

accessed as described in section 6(f) of this supporting statement.
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3(c) Consultations

Under 5 CFR 1320.8(d)(1), agencies are required to consult with potential 

ICR respondents and data users about specific aspects of ICRs before submitting an 

original or renewal ICR to OMB for review and approval. In accordance with this 

regulation, EPA will consult with representative stakeholders during the public 

comment period. See Attachment H.

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 labels: In accordance with a determination made by the Office of 

Management and Budget (OMB) in 1995, the third party disclosure requirement, 

which involves the registrant’s disclosure of product specific information to 

potential users and the general public through the pesticide label, is not considered a 

collection of information. This is because the information that must be included as 

the product labeling is 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 

whenever any general labeling changes initiated by the Agency result in an 

estimated burden of more than 5,000 burden hours, EPA must seek OMB 

concurrence. 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 under 40 CFR part 169.2(k) require that 

registrants retain records containing research data relating to registered pesticides,

including all data submitted to EPA in support of a registration, 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).
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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)). As will be 

discussed later in this section, OPP is taking the first step towards offering a fully

electronic submission option through the current ICR.

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 available electronic submission 

option is available to registrants via the OPP Internet site at 

http://www2.epa.gov/pesticide-registration/electronic-submissions-pesticideapplications.

There are currently two methods by which companies can assemble the esubmission discs for electronic-Submission (or "e-Submissions). 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 newer method introducing the 

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

manual editing of the XML file. The XML method of information exchange from 

industry to EPA is based on a harmonized XML schema used by Canada's PMRA, 

which OPP has adapted. This harmonization assures industry that a documentation 

package submitted to one participating regulatory agency can also be submitted to 

the other participating agency, increasing standardization and decreasing the burden 

on industry. Additional information about both e-submission methods can be 

accessed at: http://www2.epa.gov/pesticide-registration/assembly-electronicpackages-and-discs.

EPA encourages electronic submissions for the following regulatory actions:

 New pesticide active ingredients.

 New pesticide products containing already-registered pesticide active 

ingredients.

 Amendments to registered pesticide products.

 Experimental use permits.

 Petitions for food tolerance.

 Distributor products.

 Endocrine Disruptor Screening Program (EDSP) Orders.

Overall, EPA is investigating opportunities for technological improvements 

which focus on information collection using fully electronic tools. The ability to 

electronically submit information required for registration reduces the burden of 
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sending, receiving, and archiving paper submissions, and eliminates the need for 

multiple data entries across forms. One of OPP’s priority areas in developing such 

electronic tools is related to electronic submission of data and labels. Some of the 

tools under this initiative are the electronic Confidential Statement of Product 

Specifications (CSPS) form (to be used in lieu of the Confidential Statement of 

Formula or CSF) the SmartLabel, and the web-based portal. 

The development of a web-based submission portal is a critical step in the 

realization of EPA’s long-term vision for secure data exchange between registrants 

and the Agency. Whereas current registration applications require an ink signature, 

the web-based portal will use EPA’s Central Data Exchange (CDX) to allow 

applicants to electronically sign and securely submit the required information. The

use of CDX is intended to save registrants’ and the Agency’s time and resources by

simplifying data submissions, receipt confirmation, information access and 

reporting.

The web-based submission portal initiative is expected to leverage existing 

collaboration between Canada and the US toward a harmonized single portal usable for 

electronic submissions to either Agency. In 2014, under the U.S. - Canada Regulatory

Cooperation Council’s (RCC) Crop Protection Products Initiative, EPA and 

Canada’s Pest Management Regulatory Agency (PMRA) developed a joint product 

specification form (see Attachment I). The Confidential Statement of Product 

Specifications (CSPS) form is intended to provide an optional, fully electronic 

alternate to the Confidential Statement of Formula, or CSF (EPA Form 8570-4). The 

proposed joint form (CSPS) is a combined and harmonized version of the CSF form 

and Canada’s Statement of Product Specification Form (SPSF). The harmonized 

form reflects a baseline level of information already submitted to either agency in 

the registration application. While there are some differences between PMRA and 

EPA information requirements, many CSPS data elements are overlapping. Some

data elements on the form are specific to EPA or PMRA requirements, and PMRA 

requirements that do not overlap with EPA’s will not be required for a US 

registration application. A guidance document as well as detailed form instructions 

are available to help the applicant determine which fields are required to be 

completed based on their product type, and the types of content for those fields. For 

the electronic version of the CSPS, ‘tool tips,’ help text and validation tools will be 

available while using the electronic wizard module.

EPA’s CSF is currently submitted only on paper, and as a result, no 

structured data are collected. Each time any change is needed, some of the common 

data must be re-entered and submitted on a different form. Because the CSPS would 

collect structured data, submitters who opt to use the electronic version would be 

able to access information already stored in the data system to partially complete 

their submissions such that the data would not need to be reentered for every 

submission. As most CSF forms submitted to EPA are modifications to previously 

submitted versions, adoption of an electronic reporting option is anticipated to result 

in significant time savings for the applicant and the reviewing agency or agencies. 
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In addition, the electronic wizard module would perform error checks and 

validations, flagging issues that registrants may need to address before being 

permitted to advance to the next step in a given submission. One of the error checks 

performed in the CDX module is CBI claims. If the submitter of the CSPS checks a 

box to indicate a response includes CBI, the field provided for substantiation of that 

claim cannot be left blank. This technology is expected to provide significant 

improvement in data accuracy by reducing common errors such as mathematical

calculations. The electronic wizard module would also greatly enhance registrants’ 

ability to correctly designate information for pesticide product types and for food 

use applications (e.g., with antimicrobial and inert ingredients).

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 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.

3(h) OMB Terms of Clearance

Upon approval of the expiring ICR, OMB issued the following terms of 

clearance:

The agency is required to display the OMB Control Number and 

inform respondents of its legal significance in accordance with 5 CFR 

1320.5(b).

EPA has addressed these terms, as shown in the forms in Attachment C.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents - NAICS Codes

The information collection under this ICR affects individuals or entities 

engaged in activities related to the registration of pesticide products. There are

approximately 1,751 pesticide respondents holding at least one pesticide 
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registration. 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). These have been described as Types A and B, respectively. In 

“Type A” activities, 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.

"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 less data and complexity than 

"Type A" activities. “Type B” activities include a range of actions from Fee for Service to 

the less involved label amendments and notifications. 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. There 

are several types of amendments, or “Type B” activities, 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 the 

forms listed below to certify that the applicant intends to rely on data previously

submitted to the EPA by another producer, has contacted the appropriate company

(owning the data that the applicant is referencing), and offered to pay reasonable 

compensation for the use of the data.

In addition to the two main categories, EPA operates a reduced risk program

that offers an incentive through an expedited review timeframe for new ingredients 

or proposed new uses of conventional pesticides that might be beneficial to the 

public and the environment owing to their risk profile, compared to alternatives for 

pest control. These activities are described as “Type C” in this ICR. 
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"Type C" 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. In addition to the registration application 

itself, “Type C” activities require that the registrant provide a “reduced risk” 

rationale document addressing risk reduction parameters described in PR Notice 97-

3. The items required to be submitted in applications for “reduced risk” chemicals 

include generic data, product specific data, administrative forms, product labeling, 

and a CSF. Administrative forms usually include the application for registration, 

data compensation form, a data matrix, the CSF, and copies of the complete 

labeling. Applicants for “Type C” registrations provide an explanation accompanied 

by relevant supporting information, including associated tolerance petitions for 

special consideration based on these factors. (The paperwork burden for tolerance 

petitions is covered in a separate ICR under OMB No. 2070-0024.) Products that are 

successfully classified as presenting potentially reduced risk will receive earlier 

registration and consequent earlier marketability.

Response 

Type

Description/Example

Type A

New A.I.s 

& New 

Uses

Description: “Type A” activities support the registration of new active 

ingredients and new uses. They 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, as 

specified in 40 CFR 158. Administrative forms usually include the application 

for registration and the data compensation forms, a data matrix, the CSF, and 

copies of the complete labeling. EPA encourages electronic submission of 

these application types.

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. The applicant 

would format the complete data and submit along with the other items 

required for an application, as described above.

Type B

New or 

Amended 

Products 

Using 

Currently

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 less data and complexity than "Type A" activities. “Type B” 

activities include both Fee for Service actions, as well as less involved label 

amendments and notifications. Individually, “Type B” activities often present 

low burden, but the number of such submissions is high, translating to a large 

work load for the Agency. The items that must be submitted or cited in this 
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Registered

A.I.s

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, the CSF, and copies of the complete labeling. EPA encourages 

electronic submission of these application types.

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

Reduced 

Risk A.I.s 

& Uses

Description: “Type C” activities support the registration of new active 

ingredients and new uses that may qualify as "reduced risk" and be given 

expedited processing. "Type C" 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, the CSF, and copies of the complete 

labeling. In addition to the registration application itself, “Type C” activities 

require that the registrant provide a “reduced risk” rationale document 

addressing risk reduction parameters described in PR Notice 97-3. EPA 

encourages electronic submission of these application types.

Example: An example of a "Type C" activity would be an application for 

registration of a new active ingredient (a.i.) where a “reduced risk” rationale 

per PR Notice 97-3 is also submitted with the registration application. All of 

the data requirements and administrative forms described under “Type A” 

applications must be addressed for “Type C” applications, and in addition the 

“reduced risk” rationale document must be provided. A new a.i. or new use 

associated with “Type C” activity is less likely to have risk concerns that 

would require refined risk assessment on the Agency’s part, or require 

additional information on the registrant’s part to address risk concerns. An 

application determined by the Agency to be "reduced risk” is provided an 

expedited decision time frame under PRIA. This kind of application is of 

equal complexity to the "Type A" activity, but more complex than "Type B."

In addition to the annual reporting and record keeping burden associated 

with a Section 3 registration, the Agency may promulgate guidance that encourages 
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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. Significant modification of an 

existing registration would typically require scientific data. However, data are not 

typically required for revised labeling regulations or guidance. EPA posts accepted 

and approved labels to a web site

The completion and submission of the following forms is necessary to register 

a pesticide product (see Attachment C):

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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5. THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT.

5(a) Agency Activities

In general, the degree and level of Agency activities in the review of data submissions 

will depend on the complexity of the product being registered, 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 will 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 Antimicrobials 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.

Registrants submitting registration applications for new 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 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.

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, 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.

Label reviews are 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 Antimicrobials Division, and 
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the Biopesticides and Pollution Prevention Division. These divisions ensure that revisions 

comply with the applicable labeling requirement or guidance.

A general category of OPP’s activities related to the information collection described in 

this ICR is summarized below:

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 OPP’s central tracking database 

system, called OPPIN. 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

The regulatory divisions, based on the registration action, assign the packages for 

appropriate evaluation. Each scientific discipline reviews the data and may develop a 

Data Evaluation Report (DER) and appropriate risk assessments that summarize the data 

review. 

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. 

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 food use is sought, a 

tolerance or exemption 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.
May 15, 2015

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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 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. If the label 

amendment is approved, a stamped master label is sent to the registrant.

5. Store and Maintain Data

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

information.

5(b) Collection Methodology and Management

All registration actions are entered into OPP’s central database system, called OPPIN, to 

track progress toward registration. Registration actions accompanied by data (e.g., products 

containing new active ingredients or new uses) are also entered into the 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
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Not applicable. The activity is conducted only as a registration application is received for 

consideration. There is no set schedule for the submission of this information to EPA.

6. ESTIMATING BURDEN AND COST OF THE COLLECTION

Paperwork burden from pesticide registration comes from two sources: burden from 

preparing and filing the registration application and burden associated with data generation. 

Previous versions of this ICR did not contain estimates of burden associated with data 

generation. Estimates of paperwork burden hours and costs from both sources are provided in 

this section. 

Paperwork burden from the application process and from data generation varies by the 

type of application. For paperwork burden from the application process, applications are 

grouped into three types—Type A, Type B, and Type C—as previously described. Estimates of 

burden and cost from the application process is described for each of these three categories in 

Section 6(a). 

Paperwork burden from data generation does not occur with all types of registrations, 

only those that require submission of data. Only new active ingredients (AI), new uses, new 

products, and some label amendments require data. Data required for registration of new uses is 

limited to residue data necessary to establish a new tolerance. Therefore, paperwork burden 

from data generation for new uses would be covered by the Tolerance ICR (OMB Control No. 

2070-0024 and is not discussed in this ICR. Estimates of paperwork burden and the costs of data 

generation associated with new AIs and new products is discussed in Section 6(b). 

Tables 1-A and 1-B show the total annual paperwork burden estimates (hours) for this 

information collection. Annual aggregate paperwork burden for all respondent Section 3 

activities is estimated to be 1.61 million hours: 145,213 hours for application activities and 1.38

million hours from data generation. There are currently an estimated 1,751 pesticide registrants 

holding at least one pesticide registration. The number of pesticide registrants has increased 

since the last ICR renewal from 1,683 to 1,751, an increase of 68 registrants. 

The total annual costs associated with paperwork burden from the application process are 

estimated to be approximately $12.47 million per year.

 “Type A” activities are estimated to cost approximately $2.76 million per year.

 “Type B” activities are estimated to cost approximately $9.32 million per year.

 “Type C” activities are estimated to cost approximately $389 thousand per year.
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Table 1-A: Annual Information Collection Paperwork Burden Estimates for Application Process

Application 

Category

Number of 

registrants 

(respondents)

Average 

annual 

responses

Average 

annual 

responses per 

respondent

Burden per 

response 

(hours)

Average 

annual 

burden per 

respondent

Average 

annual 

burden 

(hours)

Type A 1,751 197 0.113 194 22 38,218

Type B 1,751 7,273 4.154 14 58 101,827

Type C 1,751 8 0.005 646 3 5,168

All Types 1,751 7,478 4.271 83 145,213

The total annual costs associated with paperwork burden from data generation are 

estimated to be approximately $96.25 million per year.

 Paperwork burden of data generation for new active ingredients (AI) is estimated to 

cost approximately $62.59 million per year.

 Paperwork burden of data generation for new products is estimated to cost 

approximately $33.66 million per year. 

Table 1-B: Annual Information Collection Paperwork Burden Estimates for Data Generation

Registration 

Type

Number of 

registrants 

(respondents)

Average 

annual 

responses

Average 

annual 

responses per 

respondent

Average 

Burden per 

response 

(hours) 1

Average annual 

burden per 

respondent 

(hours)

Average 

annual 

burden 

(hours) 2

New AI 1,751 30 0.017 37,078 628 897,149

New 

Product 1,751 695 0.397 625 248 482,531

All Types 1,751 725 0.414 876 1,379,680

1 Average burden hours per response across the three registering divisions. See Tables 6-A and 6-B for details.

2 Average annual burden hours are calculated as the sum of average annual burden hours for each registration 

type and cannot be computed from the values in this table. See Tables 6-B and 7-B for details.

To calculate the costs of paperwork burden from the application process and from data 

generation, the burden hours were multiplied by current wages. Agency economists revised the 

estimated wages, benefits and overhead for all labor categories for the affected industry 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 wage rates 

and overhead costs for this ICR renewal are presented in Attachment J. Cost estimates are 

provided in the following sections.

6(a) Respondent Paperwork Burden Hours and Cost from Application Process
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This section describes the methodologies and provides estimates of respondent 

paperwork burden hours and costs from the application process. The reporting and 

recordkeeping burden associated with the Section 3 application process for registering 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). 

To determine the appropriate number of applications (responses) for each category, EPA 

averaged data on pesticide registration activities from 2012-2014. When the Agency receives 

applications for registrations and amendments to registrations, these actions are tracked in the 

Office of Pesticide Programs 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 greater detail. Information from 

the central database and supplemental divisional tracking is used as the basis of the burden 

estimates.

The average number of responses annually has changed from the last ICR renewal from 

8,136 to 7,478, a decrease of about eight percent. Table 2 shows the average number of 

applications per year by type and division. Across all registering divisions, there were 7,478 

Section 3 registration actions annually, on average, during the years 2012-2014. These included 

an average of 197 “Type A” activities, 7,273 “Type B” activities, and 8 “Type C” activities. 

Table 2: Average Annual Number of Actions by Type and Division, 2012-2014 average

AD BPPD RD All Divisions

Type A 16 22 159 197

Type B 2,254 575 4,444 7,273

Type C 0 0 8 8

All Action Types 2,270 597 4,612 7,478

Table 3-A presents estimates for burden hours and costs per “Type A” registration 

application. Each “Type A” application is estimated to require 26 management hours, 128 

technical hours, and 40 clerical hours for a total of 194 hours per application at a cost of 14,019.
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Table 3-A: Estimated Burden/Cost per “Type A” Registration Application

Collection Activities,

Type A

Burden Hours Total

Mgmt Technical Clerical

$121.72 $72.01 $40.93 Hours Costs

per hour per hour per hour

Read Instructions 18 0 0 18 $2,191

Plan activities 4 0 0 4 $487

Gather/create information 0 120 0 120 $8,641

Compile and review 4 8 0 12 $1,063

Complete paperwork 0 0 30 30 $1,228

Store/maintain data 0 0 10 10 $409

TOTAL 26 128 40 194 $14,019

Table 3-B presents the total annual burden hours and costs by division for “Type A” 

registration applications. Registrants spend a total of 3,104 burden hours at a cost of $224 

thousand to prepare and submit “Type A” applications to the Antimicrobial Division, 4,203 

burden hours at a cost of $304 thousand to prepare and submit “Type A” applications to the 

Biopesticides and Pollution Prevention Division, and 30,911 hours at a cost of $2.234 million to 

prepare and submit “Type A” applications to the Registration Division. The total paperwork 

burden and cost associated with preparing and submitting “Type A” registration applications to 

EPA is estimated at $2.762 million per year.

Table 3-B: Total Annual Burden and Cost by Division for "Type A" Applications 1

Labor 

Category 2

AD BPPD RD Total

Hrs. Cost Hrs. Cost Hours Cost Hours Cost

Manageme

nt 416 $50,636 563 $68,569 4,143 $504,245 5,122 $623,450

Technical 2,048 $147,476 2,773 $199,708 20,395 $1,468,620 25,216 $1,815,804

Clerical 640 $26,195 867 $35,473 6,373 $260,861 7,880 $322,528

TOTAL 3,104 $224,307 4,203 $303,749 30,911 $2,233,726 38,218 $2,761,782

1 Hours are calculated by multiplying hours per labor category from Table 3-A by the average number of 

applications for that division from Table 2. For example, 416 management hours for AD is calculated as 26 

management hours per “Type A” application multiplied by 16 “Type A” applications in AD per year. 

2 Hours and wages used to calculate the totals for each labor category are from Table 3-A.

Table 4-A presents estimates for burden hours and costs per “Type B” 

applications/notifications. Each “Type B” application is estimated to require 8 management 

hours, 2 technical hours, and 4 clerical hours for a total of 14 hours per application at a cost of 

1,282. 
May 15, 2015

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Table 4-A: Estimated Burden/Cost per “Type B” Application/Notification

Collection Activities,

Type B

Burden Hours Total

Mgmt Technical Clerical

$121.72 $72.01 $40.93 Hours Costs

per hour per hour per hour

Read Instructions 7 0 0 7 $852

Plan activities 0.5 0 0 0.5 $61

Gather/create information 0 1.5 0 1.5 $108

Compile and review 0.5 0.5 0 1 $97

Complete paperwork 0 0 3 3 $123

Store/maintain data 0 0 1 1 $41

TOTAL 8 2 4 14 $1,282

Table 4-B presents the total annual burden hours and costs by division for “Type B” 

applications/notifications. Registrants spend a total of 31,551 burden hours at a cost of $2.888 

million to prepare and submit “Type B” applications to the Antimicrobial Division, 8,055 burden 

hours at a cost of $737 thousand to prepare and submit “Type B” applications to the 

Biopesticides and Pollution Prevention Division, and 62,221 hours at a cost of $5.695 million to 

prepare and submit “Type B” applications to the Registration Division. The total paperwork 

burden and cost associated with preparing and submitting “Type B” applications to EPA is 

estimated at $9.321 million per year.

Table 4-B: Total Annual Burden and Cost by Division for "Type A" Applications 1

Labor 

Category 2

AD BPPD RD Total

Hrs. Cost Hrs. Cost Hrs. Cost Hours Cost

Management 18,029 $2,194,530 4,603 $560,237 35,555 $4,327,714 58,187 $7,082,481

Technical 4,507 $324,573 1,151 $82,860 8,889 $640,073 14,547 $1,047,505

Clerical 9,015 $368,970 2,301 $94,194 17,777 $727,626 29,093 $1,190,790

Total 31,551 $2,888,074 8,055 $737,290 62,221 $5,695,413 101,827 $9,320,777

1 Hours are calculated by multiplying hours per labor category from Table 4-A by the average number of 

applications for that division from Table 2. For example, 18,029 management hours for AD is calculated as 8 

management hours per “Type B” application multiplied by 2,254 “Type B” applications in AD per year. 

2 Hours and wages used to calculate the totals for each labor category are from Table 4-A.

Table 5-A presents estimates for burden hours and costs per “Type C” reduced risk 

application. Each “Type C” application is estimated to require 102 management hours, 448 

technical hours, and 96 clerical hours for a total of 646 hours per application at a cost of $49 

thousand.
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Table 5-A: Estimated Burden/Cost per “Type C” Reduced Risk Application 

Collection Activities,

Type C

Burden Hours Total

Mgmt Technical Clerical

$121.72 $72.01 $40.93 Hours Costs

per hour per hour per hour

Read Instructions 22 0 0 22 $2,678

Gather Information 0 368 0 368 $26,500

Process, Compile, and 

Review Info 80 80 0 160 $15,498

Record and Report Info 0 0 72 72 $2,947

Store, File, and Maintain Info 0 0 24 24 $982

TOTAL 102 448 96 646 $48,605

Table 5-B presents the total annual burden hours and costs for “Type C” reduced risk 

applications. Registrants spend a total of 5,168 burden hours at a cost of $389 thousand to 

prepare and submit “Type C” applications to the Registration Division. The Antimicrobial 

Division and the Biopesticides and Pollution Prevention Division do not receive “Type C” 

applications.

Table 5-B: Total Annual Burden and Cost for "Type C" Reduced Risk Applications 1

Labor Category 2 RD

Hours Cost

Management 816 $99,324

Technical 3,584 $258,084

Clerical 768 $31,434

Total 5,168 $388,842

1 Hours and costs are calculated using the same method as Tables 3-B and 4-B.

2 Hours and wages used to calculate the totals for each labor category are from Table 5-A.

6(b) Respondent Paperwork Burden Hours and Cost from Data Generation

To calculate the burden and costs associated with the paperwork activities involved in 

data generation, the Agency starts with the cost of the test, typically the market price for the test 

as identified by laboratories that offer testing services. The Agency maintains an archive of the 

basic FIFRA study cost estimates that were developed through surveys of independent testing 

laboratories, Agency economic analyses, and registrant comments during ICR renewal periods. 

To the greatest extent possible, EPA uses multiple sources to provide test cost estimates, which 

are updated as needed.

EPA uses 35% of the estimated total test cost to calculate the total potential cost for the 

paperwork activities related to data generation. The 35% of test cost is disaggregated by labor 
May 15, 2015

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category, and then burden hours are extrapolated by using the loaded labor rates. To 

disaggregate by labor category, the Agency considered the estimated distribution of paperwork 

activity across the labor categories represented and the existing methodology assumption that 

paperwork activities for data generation mostly involve the technical staff to perform the tests, 

with fewer activities related to management and clerical staff.

Figure 1 illustrates the method for calculating the paperwork burden of data generation. 

Figure 1: Method for Calculating Paperwork Burden from Test Costs

Similar to the data call-in or DCI ICR (OMB Control No. 2070-0174), this approach assumes 

and incorporates the following core considerations:

(1) Registrants generate all of the data as specified in the CFR without any changes, and 

none of the data is waived.

(2) All data generation is performed by an independent laboratory.

(3) Paperwork burden is disaggregated by labor category as follows:

a. Managerial (20%)

b. Technical (65%)

c. Clerical (15%)

(4) Labor rates are fully loaded, meaning that they include the estimated costs of wages, 

overhead, and benefits paid to an employee. See Attachment J. 

Using this methodology, Tables 6-A and 6-B below estimate the paperwork burden 

associated with registering a new AI and a new product for each of the three registering 

divisions: the Antimicrobial Division (AD), the Biopesticides and Pollution Prevention Division 

(BPPD), and the Registration Division (RD). The costs of registering a new AI vary depending 

on use parameters, e.g., food or non-food use, indoor or outdoor use pattern. The data costs used 

to calculate paperwork burden are an average of total costs across different types of uses that 

might be registered in that division. 

Table 6-A shows that the average cost of data for registering a new AI ranges from an 

average of $4.65 million for a new biopesticide to an average of $8.97 million for a new

Calculate 

35% of the

Total Cost

of Data 

Generation

Divide 35% of the 

Total Cost into

Labor Categories:

20% for Managerial 

65% for Technical

15% for Clerical

Divide cost for each 

category by Fully 

Loaded Labor Wage 

Rate for that Labor 

Category

Burden 

Hours by 

Labor 

Category
May 15, 2015

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conventional chemical. The paperwork burden, 35% of the cost of data generation, ranges from 

$1.63 million to $3.14 million or between 23 thousand and 45 thousand hours of burden. 

Table 6-A: Estimates of Paperwork Burden Hours from Data Generation for New AIs

Division

Data 

Cost 

($000s)

Paperwork 

Cost 

($000s)

Managerial Technical Clerical Total

Hours FTEs Hours FTEs Hours FTEs Hours FTEs

AD $8,550 $2,993 4,918 2.4 27,016 13.0 10,969 5.3 42,903 20.6

BPPD $4,645 $1,626 2,672 1.3 14,677 7.1 5,959 2.9 23,308 11.2

RD $8,973 $3,141 5,161 2.5 28,352 13.6 11,511 5.5 45,024 21.6

Table 6-B shows the calculation of average annual burden hours and costs from 

paperwork from data generation for new AIs. The burden per registration is taken from Table 6-

A. Average annual burden hours is calculated from the average annual responses and burden per 

registration. Average annual costs is calculated from the average annual responses and average 

paperwork cost from Table 6-A.

Table 6-B: Estimates of Annual Paperwork Burden Hours and Cost from Data Generation for New 

AIs

Burden per 

Registration 1

Average Annual 

Responses

Average Annual 

Burden Hours Average Annual Cost 2

Antimicrobial 42,903 2 85,806 $5,986,000

Biochemical 23,308 20 466,156 $32,520,000

Conventional 45,024 8 345,187 $24,081,000

TOTAL 30 897,149 $62,587,000

1 Burden per registration for New AIs from Table 1-B is the average of these values.

2 Numbers do not compute due to rounding.

Table 7-A shows that the cost of data for registering a new product ranges from $115 

thousand to $155 thousand. The paperwork burden, 35% of the cost of data generation, ranges 

from $36 thousand to $54 thousand or between 520 and 777 hours of burden. 

Table 7-A: Estimates of Paperwork Burden Hours from Data Generation for New Products

Division Data 

Cost1

Paperwork 

Cost1

Managerial Technical Clerical Total

Hours FTEs Hours FTEs Hours FTEs Hours FTEs

AD $103,800 $36,300 60 0.03 328 0.16 133 0.06 520 0.25

BPPD $115,400 $40,400 66 0.03 365 0.18 148 0.07 579 0.28

RD $155,000 $54,200 89 0.04 489 0.24 199 0.10 777 0.37

1 Rounded to nearest hundred.
May 15, 2015

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Table 7-B shows the calculation of average annual burden hours and costs from 

paperwork from data generation for new AIs. The burden per registration is taken from Table 7-

A. Average annual burden hours is calculated from the average annual responses and burden per 

registration. Average annual costs is calculated from the average annual responses and average 

paperwork cost from Table 7-A.

Table 7-B: Estimates of Annual Paperwork Burden Hours and Cost from Data Generation for New 

Products

Burden per 

Registration 1

Average Annual 

Responses

Average Annual 

Burden Hours Average Annual Cost 2

Antimicrobial 520 172 89,325 $6,231,500

Biochemical 579 68 39,187 $2,733,733

Conventional 777 456 354,019 $24,697,133

TOTAL 695 482,531 $33,662,367

1 Burden per registration for New Products from Table 1-B is the average of these values.

2 Numbers do not compute due to rounding.

The costs used to estimate paperwork burden of data generation in this analysis are 

conservative because they assume that all new active ingredients generate and submit all data 

required in 40 CFR Part 158 when, in practice, some of the data requirements may be waived 

based on specific use patterns or label restrictions. Data waivers would make the average cost of 

data generation (and the resulting paperwork burden) lower for both new active ingredients and 

new products. Also, all new products in this analysis are assumed to require toxicology data and 

product chemistry data to register. In cases where products are substantially similar to other 

products, they can cite other data rather than generating data. Again, this approach returns 

conservative estimates of paperwork burden for data generation.

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 2012-2014 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.
May 15, 2015

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Using this source of data, the estimated number of Agency FTEs dedicated to Section 3 

registration and registration support activities is approximately 26 managerial FTEs, 171 

technical FTEs, and 7 clerical FTEs as shown in Table 8 below. The aggregated Agency

estimated FTE dedicated to Section 3 activities is 205 and the burden hours are 426,400. 

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

2014 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 $121.79 for managerial occupations, $80.02 for technical occupations, and $45.56 for 

clerical occupations. (See Attachment J for wage calculations.)

To calculate the Agency’s estimated annual cost of Section 3 activities, the number of 

FTE’s allocated to registration activities (Table 8) is multiplied by these fully loaded labor rates 

and by 2,080 hours per FTE, which is estimated to be about $6.70 million for management; 

$28.44 million for technical; and $703 thousand for clerical. The total estimated Agency cost is 

$35.84 million.

Table 8: Distribution of Agency FTEs Supporting FIFRA Section 3 Registration Activities 1

BEAD RD EFED HED AD BPPD Total FTEs Hourly wage Total Annual Cost2

Managerial 2.9 7.4 2.4 7.1 3.2 3.4 26.4 $121.79 $6,698,844

Technical 16.5 54.6 14.7 38.1 22.7 24.2 170.9 $80.02 $28,441,551

Clerical 0.7 2.0 0.7 1.5 1.1 1.4 7.4 $45.56 $703,397

Total 20.2 64.1 17.8 46.7 26.9 29.0 204.7 $35,843,792

1 Numbers in the table may not add due to rounding.

2 Total annual cost is calculated using the number of hours per FTE multiplied by the number of FTEs and the 

hourly wage. For example, total annual cost of managerial FTES is calculated as 2,080 hours/FTE x 26.4 

FTEs x $121.79. 

6(d) Bottom Line Burden Hours and Cost

Table 9 presents the estimates for total annual hours and cost, for both respondents and 

the agency, associated with Section 3 activities. The total respondent burden is 1.52 million 

hours annually at a cost of $108.72 million. The majority of this paperwork burden, 1.38 million 

hours, is associated with data generation.

Table 9: Estimated Annual Total Hours and Cost

ANNUAL TOTAL

Responses Hours Costs

TOTAL RESPONDENT BURDEN 8,203 1,524,893 $108,720,767

Application Process 7,478 145,213 12,471,401
May 15, 2015

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Annual “Type A” Responses 197 38,218 $2,761,782 

Annual “Type B” Responses 7,273 101,827 $9,320,777 

Annual “Type C” Responses 8 5,168 $388,842 

Data Generation 725 1,379,680 96,249,367

New AIs 30 897,149 $62,587,000

New Products 695 482,531 $33,662,367

TOTAL AGENCY BURDEN 425,873 $35,843,792 

The annual respondent paperwork burden for the application process has decreased by 

about 23,000 hours due to fewer applications in each category. There were 52 fewer “Type A” 

responses, 599 fewer “Type B” responses, and 7 fewer “Type C” responses annually on average 

in the years 2012-2014 than there were in the years 2008-2010. Agency burden also reflects the 

lower number of responses in this renewal cycle; agency hours decreased from 478,400 (230 

FTEs) to 425,873 (205 FTEs).

The increase in total respondent burden is not a change in paperwork burden per se but 

rather a change in what is included in this ICR. Paperwork burden from data generation was not 

previously included in these burden estimates. EPA included estimates of that burden in this 

renewal; the estimates follow the methodology used to estimates the paperwork burden of data 

call-ins or DCIs (OMB Control No. 2070-0174). 

6(f) Burden Statement 

Overall, there is a difference of 1,356,689 hours in the total estimated respondent burden 

compared with that identified in the current ICR approved by OMB. This change reflects EPA’s 

updating of the methodology used to estimate the paperwork burden, and including a previously 

unaccounted for burden for study data generation. However, there is a decrease of 

approximately 23,000 hours in the total estimated respondent burden for the registration 

application process compared with that identified in the ICR currently approved by OMB. This 

decrease reflects EPA's receipt of fewer number of applications. This change is an adjustment.

The annual average reporting and recordkeeping burdens for a registration application are 

estimated to range from 14 hours to 646 hours, depending upon the type of activity. Estimates 

for the respondent’s application 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 

burden estimate for “Type C” reduced risk applications, which are handled only by RD, is an 

average of 646 hours per response. 

The annual average reporting and recordkeeping burdens for data generation associated 

with registration of new active ingredients and new products are estimated to range from 520 

hours to 45,000 hours, depending on the type of activity and division. For new active 

ingredients, estimates for the respondent’s paperwork burden for data generation average 45,024 

hours for a new conventional, 42,903 for a new antimicrobial, and 23,308 for a new biopesticide. 

For new products, estimates for the respondent’s paperwork burden for data generation average 
May 15, 2015

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777 hours for a new conventional product, 520 hours for a new antimicrobial, and 579 hours for 

a new biopesticide. 

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPP-2015-0332, which is available for online viewing at www.regulations.gov or in person 

viewing at the EPA Docket Center Public Reading Room, EPA West Building, Room 3334, 

1301 Constitution Avenue, NW, Washington, DC 20004. The EPA/DC is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, excluding federal holidays. The docket telephone number is 

(202) 566-1744. 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-2015-0332 and OMB 

Control No. 2070-0060, to (1) EPA online using www.regulations.gov (our preferred method), or 

by mail to: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), Mailcode: 

28221T, 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.
May 15, 2015

Page 28 of 28

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-2015-0332. 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 US Code website

Attachment B: 7 U.S.C. 136w-8 – Section 33 of FIFRA. Pesticide registration service fees. 

Also available online at US Code website.

Attachment C: Forms for Pesticide Registration. http://www.epa.gov/opprd001/forms/

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

C – 2. EPA Form No. 8570-4 - Confidential Statement of Formula

C – 3. EPA Form No. 8570-27 - Formulator's Exemption Statement

C – 4. EPA Form No. 8570-34 - Certification with Respect to Citation of Data Form

C – 5. EPA Form No. 8570-35 - Data Matrix Form

C – 6. EPA Form No. 8570-36 - Summary of the Physical/Chemical Properties Form

C – 7. EPA Form No. 8570-37 - Self-Certification Statement for the Physical/Chemical 

Properties

Attachment D:

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 E:

40 CFR 152 – Pesticide Registration and Classification Procedures. Also

available online at the National Archives and Records Administration’s 

Electronic CFR Website

Attachment F: 40 CFR 156 – Labeling Requirements for Pesticides and Devices. Also 

available at: Electronic CFR Website.

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

the Electronic CFR Website.

Attachment H: Consultation: List of Standard Questions & Responses (Reserved)

Attachment I: Proposed New e-CSF with Instructions and Relevant Information

Attachment J:

Work Sheets used to Calculate Pesticide Registrant Industry Labor Costs; 

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 at: Electronic CFR Website.