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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: Labeling Change for Certain Minimum Risk Pesticides under FIFRA Section 25(b) 

OMB No. 2070-NEW EPA No. 2475.01

1(b) Short Characterization/Abstract

This information collection request documents a one-time Paperwork Reduction Act (PRA) 

burden for the final rule related changes to labeling requirements for certain minimum risk pesticide 

products exempt from Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration under 

40 CFR 152.25(f). These changes are contained in the final rule entitled: Pesticides; Revisions to 

Minimum Risk Exemption. 

Under current regulations in 40 CFR 152.25(f), EPA has exempted from the requirement of

FIFRA registration certain pesticide products if they are composed of specified ingredients, and labeled 

accordingly. EPA created the exemption for minimum risk pesticides to eliminate the need to expend 

significant resources to regulate products that were deemed to be of minimum risk to human health and 

the environment. In addition, exempting such products freed Agency resources to focus on evaluating 

formulations whose toxicity was less well characterized, or was of higher toxicity. The existing 

regulatory structure, however, led to confusion as to which ingredients are exempt under 152.25(f), and 

how they should be labeled on products.

The final rule reorganizes the ingredients lists and adds specific chemical identifiers to clarify to 

manufacturers, the public, and Federal, state, and tribal inspectors the specific chemical substances that 

are permitted in minimum risk pesticide products. EPA is also modifying the label requirements to 

require the use of specific common chemical names of ingredients and to require producer contact 

information on the label. The primary goal of this rulemaking is to clarify the conditions of exemption 

for minimum risk pesticides by clarifying the specific ingredients that are permitted in minimum risk 

pesticide products and to provide company contact information on the label. 

2. NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

Authorizing legislation is contained in section 3 and 25 of FIFRA, as amended. Requirements for 

labels of minimum risk pesticide products are described in 40 CFR 152.25(f) (See attachments A, B and 

C).

2(b) Practical Utility/Users of the Data

Under FIFRA 25(b)(2), EPA may exempt from the requirements of FIFRA any pesticide that is 

“of a character unnecessary to be subject to [FIFRA]”. Pursuant to this authority, in March 1996, EPA 
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promulgated 40 CFR 152.25(g), which exempted from FIFRA any pesticide products consisting solely 

of specified ingredients that EPA judged to pose minimum risk to humans and the environment (61 FR 

8876, March 6, 1996). This provision was later redesignated as 152.25(f) (66 FR 64759, December 14, 

2001). Unlike producers of registered pesticides, producers of products exempted under 152.25(f) do 

not register their products with EPA, pay registration fees, or report production to EPA. 

This exemption is in contrast to a typical FIFRA section 3 registration of a pesticide. A section 3

registration is a scientific, legal, and administrative process through which EPA examines the 

ingredients of the pesticide; the particular site or crop on which it is to be used; the amount, frequency 

and timing of its use; and storage and disposal practices. In evaluating a pesticide registration 

application, EPA assesses a wide variety of potential human health and environmental effects associated 

with use of the product. The producer of the pesticide must provide data to EPA, using tests done 

according to either EPA guidelines or other methods determined acceptable by EPA on a case-by-case 

basis. The data from these tests are used to 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 label or labeling accompanying 

it at the time of sale, through its use and disposal. The labeling is the primary enforcement mechanism 

for Federal, state, and tribal authorities. 

Since minimum risk pesticide products are not registered by EPA, the product information 

associated with the pesticide registration process under section 3 of FIFRA are never submitted to EPA. 

However, approximately 37 states and the District of Columbia require products that are exempt from 

FIFRA requirements under 152.25(f) to obtain a state-registration. Generally, state registration of a 

federally-registered pesticide relies heavily on the previous Federal review of the product’s toxicity, use 

patterns, and label. In contrast, given that minimum risk pesticides are exempt from Federal registration

under FIFRA, the numerous states that do regulate these products use review criteria that vary from state 

to state. In some states, manufacturers of minimum risk products are only required to pay a registration 

fee; in others, there is a label review, which can include a review of the ingredients used in the product; 

and a few require Material Safety Data Sheets and data on product efficacy. 

Thus, labeling requirements are the key component of the minimum risk exemption since this is 

the only information that enforcement authorities have to assess whether or not the product meets the 

exemption requirements. While EPA does not review these products, and therefore a Federal label 

review is not conducted, to maintain exempt status, an exempt product’s label must meet certain criteria. 

The methods for displaying active and inert ingredient information are detailed in the exemption: labels 

must include percentage (by weight) of active ingredients and list all inert ingredients. The label 

information documented in this rule-related ICR accounts for the burden for a one time label update 

which provides important regulatory information for the Federal, state, and tribal authorities that 

regulate minimum risk products. 

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

3(a) Non-duplication
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Duplication will not occur in this program, as the required label changes are unique to each 

applicant since each applicant must submit information to the public unique to the particular product. 

The rule also will not require submission of information to EPA. The rule standardizes some of the 

information on product labels, which will reduce the burden on industry by creating labels for the same 

product registered for use in different states. 

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

The Notice of Proposed Rulemaking, published in the Federal Register on December 31, 2012 

(77 FR 76979), served as the public notice for this ICR pursuant to 5 CFR 1320.8(d). The Agency did 

not receive any comments on this ICR during the comment period. 

3(c) Consultations

In addition to the public notice and comment period, OMB regulations, 5 CFR 1320.8(d)(1), 

require agencies to consult with potential ICR respondents and data users about specific aspects of an 

ICR before the Agency submits the ICR to OMB for review and approval. In accordance with this 

regulation, EPA solicited feedback from potential ICR respondents and data users with respect to this 

rule related ICR as part of a Small Business Advocacy Review (SBAR) Panel held for a proposed 

rulemaking titled “Insect Repellents: Reconsideration of Exemption (Docket ID EPA-HQ-OPP-2010-

0227)” under the Small Business Regulatory Enforcement Fairness Act (SBREFA). As part of this 

SBAR Panel, EPA solicited feedback on a number of issues (Attachment D and E), including:

 An estimate of the number of small entities to which the proposed rules would apply,

 A description of projected reporting, record keeping, and other compliance requirements

of the proposed rules, including an estimate of the classes of small entities which would

be subject to the requirements and the type of professional skills necessary for 

preparation of the report or record,

 Identification, to the extent practical, of all relevant Federal rules which may duplicate,

overlap, or conflict with the proposed rules,

 An estimate of costs for different timeframes for implementing label changes.

Feedback from the participants in the SBAR Panel indicated that minimum of 2 years would be 

needed to re-label their products to avoid significant costs and burden on minimum risk pesticide 

producers (Attachment F). Since EPA is finalizing a 3-year implementation period, the costs to industry 

will be less than the projected costs provided by the participants. 

3(d) Effects of Less Frequent Collection

Not applicable. This information collection activity is a one-time collection for those existing 

minimum risk products currently in the market that must change their labels to comply with the new 

rule. 

3(e) General Guidelines

This collection of information is consistent with all OMB guidelines under 5 CFR 1320.6. This 

is a one-time collection with no third party reporting or record keeping requirements. 

3(f) Confidentiality
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EPA is not requesting any information be submitted to the Agency. 

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:

• Manufacturers of these products, which includes pesticide and other agricultural chemical 

manufacturers (NAICS codes 325320 and 325311), as well as other manufacturers in similar industries 

such as animal feed (311119), cosmetics (325620), and soap and detergents (325611).

• Manufacturers who may also be distributors of these products, which includes farm supplies 

merchant wholesalers (424910), drug and druggists’ merchant wholesalers (424210), and motor vehicle 

supplies and new parts merchant wholesalers (423120). 

• Retailers of minimum risk pesticide products (some of which may also be manufacturers), 

which includes nursery, garden center, and farm supply stores (444220); outdoor power equipment 

stores (444210); and supermarkets (445110).

• Users of minimum risk pesticides, including the public in general, as well as exterminating and 

pest control services (561710), landscaping services (561730), sports and recreation institutions 

(611620), and child day care services (624410). Many of these companies also manufacture minimum 

risk pesticide products. 

4(b) Information Requested

(i) Data items for minimum risk pesticide products (not registered) 

Minimum risk pesticide products are exempt from federal registration requirements, and 

manufacturers of these products do not submit any data, forms, or labels to EPA. They are also not 

required to conduct annual reporting or recordkeeping. The requirements for minimum risk pesticide 

products are limited to what active and inert ingredients they may contain, and specific information that 

must be on product labels. For instance, each minimum risk pesticide product label must identify the 

name and percentage (by weight) for each active ingredient and the name of each inert ingredient. The 

exemption for minimum risk pesticide products also includes restrictions on claims that may be made: 

The products must not bear claims to control or mitigate microorganisms that pose a threat to human 

health, and they must not include any false and misleading labeling statements. 
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EPA’s final rule is modifying the label requirements for the minimum risk exemption to: 

1) Require that a designated label display name be used for active and inert ingredients listed on 

minimum risk product labels. This will require a one-time labeling change for manufacturers to 

modify how they refer to the chemicals contained in their products, which will result in a onetime burden increase for the manufacturers of these products. 

2) Require that manufacturer contact information (name of company, address, and phone 

number) be included on the minimum risk pesticide product label. Though most products already 

include this information on their labels, it is possible that some companies will need to change 

their labels to include this information. This could be done simultaneously with any changes to 

the way product ingredients are listed on the label, and is included in that burden assessment. 

The relabeling required by the changes to the minimum risk exemption will result in a one-time 

burden increase for manufacturers of currently-exempt products. Though it may result in an 

overestimate of the overall burden, EPA is assuming that all manufacturers will need to modify their 

labels to include the label display name of ingredients and provide company contact information. 

(ii) Respondent Activities for Minimum Risk Pesticide Products 

Respondent Paperwork 

Activity

Description

1. Read instructions Read germane FIFRA legislation, 40 CFR regulations, and applicable 

guidance and correspondence.

2. Plan activities Decide whether pesticide product is a minimum risk product.

3. Create information Determine how to modify labels to list ingredients using a label display 

name, and to include company information if not already present on the 

label. 

5. THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT.

5(a) Agency Activities

Minimum risk pesticide products do not typically require any activity on the part of the Agency. 

However, to help companies transition to the new label requirements, EPA will update the web guidance 

applicable to minimum risk products and consult with stakeholders to assist with the transition. 

5(b) Collection Methodology and Management

None.

5(c) Small Entity Flexibility

EPA created the exemption for minimum risk pesticides to eliminate the need to expend 

significant resources to regulate products that were deemed to be of minimum risk to human health and 

the environment. Since these minimum risk products do not have to be registered at the Federal level, 

significant cost savings are available for small business to benefit from this exemption.
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5(d) Collection Schedule

This is a one-time collection. Respondents have 3 years to finalize the relabeling activities once 

the rule becomes effective. 

6. ESTIMATING BURDEN AND COST OF THE COLLECTION

6(a) Estimating Respondent Burden

No new reporting or recordkeeping burdens are associated with this proposed rule related ICR. 

The total burden for all respondents completing the rule related minimum risk relabeling activities is 

estimated to be 6,369 hours, based on a one-time burden increase for roughly 1,158 responses at 5.5

hours per response. All relabeling activities associated with this rulemaking will be completed within the 

3 years of this ICR.

6(b) Estimating Respondent Costs

There are currently an estimated 216 companies selling approximately 757 minimum risk pesticide 

products in the U.S. These estimates are derived primarily from products registered in various states; 

although minimum risk products are exempt from registration by EPA, most states require registration 

of these pesticide products. Many of these states provide their pesticide registration lists (including for 

minimum risk pesticides) online, and available to the public. In addition, EPA obtained retail store 

scanner data (Nielsen, 2008) for personal insect repellent products and conducted on-line searches for 

products that may not be available in stores. 

However, many products have more than one size or type of package. Each is referred to as a 

stock keeping unit (SKU). Each SKU would have to be relabeled to comply with the new requirements. 

EPA has estimated that there are 1.53 SKUs per product, for a total number of 1,158 products that would 

have to be relabeled. Therefore, approximately 386 products are expected to be relabeled per year over 3 

years.

The total cost for the rule-related relabeling activities over 3 years is estimated to cost $596,434,

for a one-time burden increase. Given three years to comply with the rule-related relabeling activities, 

the annual burden is estimated to cost $198,811 per year. 

Agency economists revised the estimated wages, benefits and overhead for all labor categories 

for affected industries, state government, and EPA employees based on publicly available data from the 

US Bureau of Labor Statistics. The formulas used to estimate the labor rates and formulas used to derive 

the fully loaded rates and overhead costs for this ICR renewal are listed in Attachment G. 

Methodology The methodology uses data on each sector and labor type for an Unloaded 

wage rate (hourly wage rate), and calculates the Loaded wage rate (unloaded 

wage rate + benefits), and the Fully loaded wage rate (loaded wage rate + 

overhead). Fully loaded wage rates are used to calculate respondent costs. 

This ICR uses 2006 data.

Unloaded 

Wage Rate

Wages are estimated for labor types (management, technical, and clerical) 

within applicable sectors. The Agency uses average wage data for the relevant 
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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/oes_nat.htm. 

Sectors The specific North American Industry Classification System (NAICS) code and 

website for each sector is included in that sector’s wage rate table (see 

Attachment G). Within each sector, the wage data are provided by Standard 

Occupational Classification (SOC). The SOC system is used by Federal 

statistical agencies to classify workers into occupational categories for the 

purpose of collecting, calculating, or disseminating data (see 

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

Loaded Wage 

Rate

Unless stated otherwise, all benefits represent 43% of unloaded wage rates, 

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

http://www.bls.gov/news.release/ecec.t01.htm. However, if other sectors are 

listed for which 43% is not applicable, the applicable percentage will be stated.

Fully Loaded 

Wage Rate

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

overhead costs.

The following table presents the estimated burden and cost estimates per label change to comply with 

the information collection activities associated with the rulemaking:

Table 1: Est. Burden/Cost per Label Change (Minimum Risk – No Registration)

Collection Activities

Burden Hours Total

Mgmt.

$103.62/hr

Tech.

$67.05/hr

Cler.

$33.85/hr

Hours Costs $

Read Instructions 3.5 0.0 0.0 3.5 362.67

Plan activities 0.5 0.0 0.0 0.5 51.81

Gather/create information 0.0 1.5 0.0 1.5 100.58

TOTAL 4.0 1.5 0.0 5.5 515.06

Annual Burden & Costs: 5.5 hours x 386 responses/year = 2,123 hours/year

(a) Management: 4.0 hours x $103.62 x 386 Responses = $ 159,989.28

(b) Technical: 1.5 hours x $67.05 x 386 Responses = $ 38,821.95

(c) Clerical: 0 hours x $33.85 x 386 Responses = $ 0

 Total = $ 198.811.23

Total Burden & Costs: 5.5 hours x 1,158 responses = 6,369 hours

(a) Management: 4.0 hours x $103.62 x 1,158 Responses = $ 479,967.84

(b) Technical: 1.5 hours x $67.05 x 1,158 Responses = $ 116,465.85

(c) Clerical: 0 hours x $33.85 x 1,158 Responses = $ 0

 Total = $ 596,433.69

6(c) Estimating Agency Burden and Cost

There is no Agency burden related to registration of minimum risk pesticide products, since they 

are exempt from Federal registration.

6(d) Bottom Line Burden Hours and Cost

TOTAL
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Responses Hours Costs

Annual Relabeling Activities 386 2,123 $198,811.23

Total Response Burden 1,158 6,369 $596,433.69

Agency Burden Estimate 00.00 00.00

6(e) Reasons for Changes in Burden

No change in burden. This is a new rule-related ICR. A new total burden of 6,369 hours as the 

result of a program change: changes to the exemption for minimum risk pesticide products that will

require manufacturers of these products to modify their labels to list the ingredients using common 

chemical names and to provide company contact information on the label. This will result in a one-time 

burden increase for manufacturers of these products.

6(f) Burden Statement 

The respondent burden for this rule-related collection is estimated to be 5.5 hours per product. 

According to the Paperwork Reduction Act, “burden” means the total time, effort, or financial resources 

expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal 

Agency. For this collection, the 5.5 hours includes the time needed to:

 Review instructions.

 Develop, acquire, install and utilize technology and systems for the purposes of collecting, 

validating, and verifying information, processing and maintaining information, and disclosing 

and providing information.

 Adjust the existing ways to comply with any previously applicable instructions and 

requirements; train personnel to be able to respond to a collection of information; search data 

sources.

 Complete and review the collection of information.

 Transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of 

information unless it displays a currently valid OMB control number. The OMB control number for this 

information collection will be designated by OMB upon approval. The OMB control numbers for 

EPA’s regulations in Title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR 

part 9 and included on the related collection instrument or form, if applicable.

The Agency has established a public docket for the proposed and final rule-related ICR under 

Docket ID No. EPA-HQ-OPP-2010-0305, which is available for online viewing at 

http://www.regulations.gov. 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-2010-0305, to (1) EPA online 

using http://www.regulations.gov (our preferred method), or by mail to: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, 

DC 20460-0001, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of 

Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, 

DC 20503.
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ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public docket established for this 

rule related Information Collection Request (ICR) under the docket identification number EPA-HQOPP-2010-0305. These attachments are available for online viewing at http://www.regulations.gov or 

otherwise accessed as described in the sections below. 

Attachment A: 7 U.S.C. 136a – Section 3 of FIFRA. 

This information is available online at 

http://www.gpo.gov/fdsys/pkg/USCODE-2010-title7/pdf/USCODE-2010-

title7-chap6-subchapII-sec136a-1.pdf

Attachment B: 7 U.S.C. 136w – Section 25 of FIFRA. 

This information is available online at 

http://www.gpo.gov/fdsys/pkg/USCODE-2010-title7/pdf/USCODE-2010-

title7-chap6-subchapII-sec136w.pdf

Attachment C:

Attachment D: 

Attachment E:

Attachment F:

40 CFR 152 – Pesticide Registration and Classification Procedures. Also 

available online at the National Archives and Records Administration’s 

Electronic Website http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&sid=88d9c3c9f74b07b1127c67fbfa4acde0&rgn=div5&view=text

&node=40:23.0.1.1.3&idno=40

Insect Repellent SER Cover Letter (11/17/2009). Docket ID No. EPA-HQOPP-2010-0227. Document ID No. EPA-HQ-OPP-2010-0227-0002.

Questions for Small Entity Representatives (11/17/2009). Docket ID No. 

EPA-HQ-OPP-2010-0227. Document ID No. EPA-HQ-OPP-2010-0227-

0003.

Small Entity Representatives (SER) Comments from 2009 SBREFA Panel, 

for Minimum Risk Insect Repellents Proposed Rule. Docket ID No. EPA-HQOPP-2010-0305. Docket ID No. EPA-HQ-OPP-2010-0305-0016.

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

Costs

This information follows in this document.

Attachment G

PESTICIDE REGISTRANT INDUSTRY LABOR COSTS

Labor Category Formula Managerial Technical Clerical

Unloaded Hourly 

Rate1

= W $48.31 $31.26 $15.78 

43% 43% 43%
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Labor Category Formula Managerial Technical Clerical

Benefits 

Percentage2

Lb = B/W

Benefits per hour B = W*Lb $20.77 $13.44 $6.79 

Loaded Hourly 

Rate

Wb = W + B 

 = W(1+Lb)

$69.08 $44.70 $22.57 

Overhead 

Percentage3

Lo = OH/Wb 50% 50% 50%

Overhead per hour OH = Wb*Lo $34.54 $22.35 $11.28 

Fully Loaded 

Hourly Rate

Wf = Wb + OH

= W + B + OH 

$103.62 $67.05 $33.85 

1. Data Source: http://www.bls.gov/oes/current/naics4_325300.htm 

 Management: 11-0000, Management Occupations

 Technical: 19-0000, Life, Physical, and Social Science Occupations

 Clerical: 43-0000, Office and Administrative Support Occupations

 May 2006 data

2. Fringe benefits/wage per hour.

3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth 

Edition, EPA-452-02-001, January 2002, pg. 2-34. The loading for indirect costs is within 

the range of 20-70% of the load labor rate (wage + benefits) suggested in EPA guidance.