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Draft Document for Public Review - EPA is releasing this draft document solely for the purpose of public review 

and comment. This draft document is not now, and has not yet been, formally disseminated by EPA. It does not 

represent and should not be construed to represent any Agency policy or determination. Please submit comments to 

Docket ID # EPA-HQ-OPP-[insert docket #] at www.regulations.gov.

PESTICIDE REGISTRATION (PR) NOTICE 2012-X

***December 12, 2012 DRAFT***

NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS AND 

REGISTRANTS OF PESTICIDE PRODUCTS

ATTENTION: Persons Responsible for Federal Registration, Reregistration and 

Registration Review of Pesticide Products

SUBJECT: Guidance for Antimicrobial Pesticide Products with Mold-Related 

Label Claims 

This Notice presents the Agency’s guidance on product performance (efficacy)

data and labeling for “mold-related” pesticide products. Mold-related pesticides are 

antimicrobial pesticides that bear a label claim to inhibit or destroy mold or mildew 

growth on hard, nonporous and porous surfaces in indoor environments (hereafter 

referred to as a “mold-related pesticides”). A “fungicide” is a substance or mixture of 

substances that destroys fungi (including yeasts) and/or fungal spores pathogenic to 

man or other animals in the inanimate environment. A “fungistat” is a substance or 

mixture of substances that inhibits the growth of fungi in the inanimate environment. 

1

In accordance with 40 CFR Part 161.640, footnote 1, EPA pursuant to FIFRA

requires the submission of efficacy data for fungicides. EPA also requires the 

submission of efficacy data when any specific species of fungus is listed on the label of 

fungicides, or when “residual” or “prevention” claims are made for fungicides. For 

fungistats, registrants must conduct efficacy studies but are not required under 40 CFR 

Part 161 to submit them to EPA, except upon request. 

This Notice is intended to improve protection of public health through labeling 

claims that are supported by valid efficacy data and through proper labeling of moldrelated pesticides. To do this, the Notice explains when the Agency expects to require 

 

1 EPA Product Performance Test Guidelines. OPPTS 810.2000: General 

Consideration for Public Health Uses of Antimicrobial Agents. Draft. November 5, 

2009. At www.regulations.gov, docket EPA-HQ-OPPT-2009-0576.
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applicants or registrants to submit efficacy data in support of the registration of moldrelated pesticide products. In addition, this notice also provides guidance on the 

appropriate labeling of mold-related pesticides more generally. Finally, this notice also 

provides guidance addressing label language for fungicides, fungistats, and products 

used for mold remediation, products used on nonporous and porous surfaces, products 

with residual activity, products used for mold prevention, and products used in heating, 

ventilation, air conditioning and refrigeration (HVAC&R) systems. Once again, by 

providing this guidance, the Agency is seeking to improve protection of public health

through proper use of mold-related pesticides. 

Applicants or registrants who wish to register or amend antimicrobial products 

with mold-related claims are encouraged to refer to the guidance in this notice and, as 

needed, consult with EPA prior to submitting an application. 

I. PR Notice Provides Non-binding Guidance

This PR Notice provides general guidance to EPA and to pesticide registrants 

and applicants, and the public. At places in this guidance, the Agency uses the word 

“should.” Use of “should” is intended to connote a sense of something being optional 

and not mandatory. This guidance is not binding on either EPA or any outside parties, 

and the EPA may depart from the guidance where circumstances warrant and without 

prior notice. In their submissions, registrants and applicants may propose alternatives 

to the recommendations described in this notice, and the Agency will assess them for 

appropriateness on a case-by-case basis and will respond in writing.

II. Scope of the Guidance Provided by this PR Notice

This guidance concerns only mold-related pesticides, i.e., pesticide products that 

claim to inhibit, prevent or destroy mold or mildew growth indoors on nonporous and 

porous surfaces. While there are mold-related pesticides that are registered for use

outdoors, such products may have different data requirements and labeling, and are 

outside the scope of this guidance. If a product has both indoor and outdoor uses, only 

the indoor uses are covered by the guidance provided by this notice. 

III. Definitions

For purposes of this guidance, the following terms are defined as follows:

Fungi–A kingdom of non-photosynthesizing eukaryotes that can be single-celled 

(e.g., yeasts) or multicellular (e.g., mold).

Fungicide—A substance or mixture of substances that destroys fungi (including 
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yeasts) and/or fungal spores pathogenic to man or other animals in the inanimate 

environment. Because a fungicide destroys pathogenic fungi, its use is considered to 

be for public health-related purposes. EPA has historically considered a fungicide to be 

a public health related antimicrobial because it has killing or “cidal” properties which 

must be demonstrated using a pathogenic fungus.

Fungistat—A substance or mixture of substances that inhibits the growth of 

fungi in the inanimate environment. Because a fungistat is not potent enough to destroy

fungi, its use is considered to be for aesthetic or cosmetic (non-public health) purposes 

only and not for public health related purposes. 

Mildew—Any of various fungi or oomycete organisms that form a white or 

grayish coating on surfaces, such as plant leaves, cloth, or leather, especially under 

damp, warm conditions.2 For purposes of this document, mildew can be a fungus that 

grows on moist, indoor surfaces.

Mold—A fungal growth that forms and spreads on various kinds of damp or 

decaying organic matter.3 Mold can grow on surfaces of water-damaged materials, or 

on materials present in a moist, indoor environment.

Prevention–A claim that a fungicide is intended to inhibit the growth of mold on 

an uncontaminated surface with efficacy that continues for more than seven days (as 

supported by efficacy data). 

Residual activity is a claim that a fungicide is intended to destroy existing mold 

on a contaminated surface and leave a pesticidal residue that further inhibits

subsequent fungal growth for more than seven days (as supported by efficacy data). 

Since fungicidal efficacy tests measure fungicidal activity for seven (7) days, residual 

activity is a claim that a product is effective for a period of more than seven (7) days and 

that is based on testing that demonstrates that the product is efficacious for such period. 

A residual activity claim should be made only for a fungicide because a fungicide will 

destroy existing mold, but a fungistat will not. 

IV. Efficacy Data Requirements for Mold-Related Pesticides

According to Agency regulations established in 1984 (40 CFR Part 161.6404), 

EPA requires that the registration of all antimicrobial pesticide products be supported by 

efficacy data generated by the registrant, but waives the requirement for registrants to 

submit such efficacy data in support of registration unless the product bears a claim to 

 

2 Source: The American Heritage® Science Dictionary.

3 Source: http://www.cdc.gov/niosh/topics/indoorenv/mold.html.

4 These regulations were originally designated as Part 158. The antimicrobial data requirements 

regulation currently is designated as 40 CFR Part 161. This is an interim situation until now-proposed 

amendments to Part 158 resulting in Part 158 W become final and effective.
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control microorganisms that pose a threat to human health and whose presence cannot 

be readily observed by the user. This waiver policy means that for products intended to 

destroy microorganisms that pose a threat to public health (i.e., fungicides), the 

efficacy data must be submitted to EPA. However, for pesticide products not intended 

for use against microorganisms that pose a threat to human health (i.e., fungistats), 

efficacy data are not required to be submitted to EPA but must be kept in the 

registrant’s records in case EPA requests it. 

A. Fungicides and Public Health Related Claims

EPA has historically considered fungicides to be public health related 

antimicrobials because they have killing or “cidal” properties which from an efficacy 

standpoint under 40 CFR Part 161’s product performance data requirements need to be

demonstrated using a pathogenic fungus before a product is considered acceptable for 

use against microorganisms pathogenic to man or other animals. Accordingly, EPA has 

required efficacy data to be submitted for fungicides and has reviewed such data prior 

to registering such products or claims. For example, a common fungicidal claim is for 

control of athlete’s foot fungus (Trichophyton mentagrophytes) on inanimate surfaces, 

and standard EPA test protocols are available for use by registrants to generate efficacy

data to support this claim.

5

EPA has also historically required, pursuant to its data requirements, the 

submission of efficacy data to support residual activity and prevention claims for

fungicides (see Unit 1 for definitions of these terms).

For decades, EPA has considered a claim on a fungicide label that lists a specific 

species of a pathogenic mold to be public health related (see EPA’s guidance in 

DIS/TSS 6 at http://www.epa.gov/oppad001/dis_tss_docs/dis-06.htm). Consistent with 

40 CFR Part 161.640, EPA pursuant to FIFRA requires such efficacy data to be 

submitted. As explained below, EPA now considers most species of mold to be 

potentially public health related. Because EPA does not consider fungistats acceptable 

for use against microorganisms pathogenic to humans, EPA does not currently expect 

to approve the listing of any specific species of fungus on a fungistat label. Moreover, 

EPA will require efficacy data (pursuant to 40 CFR part 161.640, footnote 1) to be 

submitted to support the listing of any specific species of fungus on the label of a 

fungicide.

6 Some examples of specific, indoor mold species that may be added to a 

fungicide based on submitted data include:

o Aspergillus versicolor

o Aspergillus niger

o Penicillium chrysogenum

 

5 Pesticide Assessment Guidelines - Subdivision G: Product Performance, U.S. Environmental Protection 

Agency, Washington, D.C., September, 1982. Available from U. S. Department of Commerce, National 

Technical Information Service, PB83-153924.
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o Penicillium aurantiogriseum

o Stachybotrys chartarum

o Stachybotrys atra

o Chaetomium globulosum

B. Fungistats and Non-Health Related Claims

More than 1,000 antimicrobial pesticide products are registered with mold-related 

claims. Of these, the vast majority are fungistats, which EPA has historically not 

considered to be public health related antimicrobials because they have only inhibitory 

or “static” properties instead of killing or “cidal” properties. EPA’s longstanding position 

in implementing its product performance data requirements has been that elimination 

(i.e., “kills” or “destroys”) or significant reduction in the number of microorganisms (as 

achieved by bactericides, fungicides and virucides) must be demonstrated before a 

product is considered acceptable for use against microorganisms pathogenic to man

and other animals. Accordingly, fungistats are not considered to be appropriate for 

public health uses. Typically, registrants conduct efficacy testing for fungistats using a 

standard EPA protocol for Aspergillus niger. Under 40 CFR Part 161, efficacy data for 

fungistats have not been required to be submitted to EPA and EPA has not reviewed 

such data for fungistats because EPA does not consider fungistats acceptable for use 

against microorganisms pathogenic to humans, as explained above. Most fungistats are 

registered for use in residential (e.g., bath and shower areas) and commercial areas, 

institutions, hospitals and food processing plants. 

EPA has not historically viewed most molds to be of potential public health 

concern because of the lack of scientific evidence in the past that most molds posed a 

risk of adverse effects to human health. However, EPA is now aware of a growing body 

of published scientific studies that document a wide range of adverse human health 

effects related to a wide range of molds. Many of these studies are cited by the Centers 

for Disease Control and Prevention (CDC) (www.cdc.gov/mold/faqs.pdf;

http://www.cdc.gov/niosh/topics/indoorenv/mold.html; 

http://www.cdc.gov/mold/basics.html). The available data indicate that exposure to 

most molds may exacerbate allergies or upper respiratory disease in healthy individuals 

and especially those with impaired host defenses. Therefore, EPA concludes that most

species of mold are potentially public health related. A bibliography listing 78 human 

health effects related studies associated with molds is available in the electronic docket 

for this PR Notice (Docket ID No. EPA-HQ-OPP-2010-0539). Hard copies of these 

studies are available in the EPA docket for viewing (see Docket ID No. EPA-HQ-OPP2010-0539 FR Notice of Availability).

V. Labeling and/or Efficacy Data Options for Mold-Related Pesticides

The Agency believes that mold claim products that are intended only for 

aesthetic purposes (i.e., fungistats) should be clearly distinguishable from products that 
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are intended for public health purposes (i.e., fungicides). Accordingly, the Agency has 

developed the following labeling options for applicants and registrants to consider, and 

follow as appropriate. Notably, these are not the only possible options, but rather are 

provided solely for illustration and guidance purposes. As a result, it is certainly the 

case that the Agency will entertain on a case-by-case basis other labeling options along 

these lines that any applicant/registrant might wish to present to the Agency.

A. Products Intended for Aesthetic or Cosmetic Purposes Only

(Fungistats)

For fungistats, applicants and registrants should consider options along the lines 

of the following:

Option 1 – Include the term “Fungistat” and a Limitation Statement

First, fungistat product labels should bear the word “fungistat” on the front panel.

Second, fungistat product labels should also bear the following limitation statement:

“This product is intended to reduce, control or inhibit the growth of mold for 

aesthetic or cosmetic purposes only.” 

The limitation statement should be placed as close as possible to the mold label 

claim (i.e., “fungistat”). The product label may not list a specific species of mold or 

make residual claims; any such listing or claims should be deleted from the label.

Option 2 - Delete All Mold Claims

Applicants or registrants should delete all mold claims from the label. 

B. Products Making a Fungicidal Claim

For products making a fungicidal claim (as defined in Unit III), applicants and 

registrants should consider such options as the following:

Option 1 - Submit the Appropriate Product Performance Data

To register a new fungicidal product, applicants should submit supporting efficacy

data (see EPA’s product performance data requirements at 40 Part 161 and also the 

guidance in DIS/TSS 6 at http://www.EPA.gov/oppad001/dis_tss_docs/dis-06.htm). For 

currently registered fungicidal products, this type of data should have already been 

submitted to EPA. If such data have not already been not submitted, registrants should

contact the Agency.
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Option 2 - Delete the Fungicidal Claim

If registrants decide not to submit efficacy data for a currently registered 

fungicidal product for which appropriate efficacy data were not previously submitted to 

EPA, registrants should delete the fungicidal claim from the label. If the product is to be 

converted to a fungistat, then registrants should consider options along the lines of 

Option 1 under Unit IV.A. above.

C. Products Making a Fungicidal Residual Activity Claim

For products making a fungicidal residual activity claim (as defined in Unit III), 

applicants and registrants should implement one of the following two options:

Option 1 - Submit the Appropriate Product Performance Data

If a product makes a residual activity claim of more than seven days, then the 

applicant or registrant should submit supporting efficacy data. Residual activity 

products may be used to treat indoor areas that may not routinely be visible to the 

dwelling occupants, such as the treatment of building framing that is covered by 

wallboard. Because EPA believes that products with residual activity claims are for 

public health purposes, the product should be labeled as a fungicide.

Option 2 - Delete the Residual Activity Claim

If applicants or registrants do not choose to submit efficacy data, then the 

residual activity claim should be deleted from the label.

D. Products Making a Prevention Claim for Fungicides 

For products making a prevention claim (as defined in Unit III), applicants and 

registrants should implement one of the following two options:

Option 1 - Submit the Appropriate Product Performance Data for 

Fungicides

If a product claims prevention of mold growth on a fungicide label, then 

applicants or registrants should submit efficacy data for a designated period of time 

under conditions conducive to fungal contamination. The Agency believes the 

prevention claim should be limited to new articles or surfaces that are uncontaminated.

Option 2 - Delete the Prevention Claim

If applicants or registrants do not choose to submit efficacy data to support a 

prevention claim for a fungicide, then they should delete the mold prevention claim. The 
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labeling of a fungistat may not bear a prevention claim; any such claim(s) appearing on 

the labeling of a currently registered fungistat should be removed.

VI. Other Labeling Guidance

A. Fungicide Products Used for Mold Remediation on Hard, Nonporous 

Surfaces

For products intended for mold remediation on hard, non-porous surfaces,

product labels should include comprehensive remediation steps in order to assure that 

the source of the problem (e.g., leaking water or flood water) has been fixed so that the 

mold problem will not return, and that appropriate pre-cleaning steps are followed. 

Following are some basic elements that applicants/registrants should consider including 

in the Directions for Use section of labels for products intended for mold remediation on 

hard, nonporous surfaces. Applicants and registrants may consult EPA’s website 

(www.epa.gov/mold) for additional information on mold cleanup. 

1. Directions to correct the source of moisture which has led to the mold problem.

2. Instructions to clean contaminated surfaces prior to applying the product,

including directions to remove visible mold growth and the cleaning method(s) to 

be used. Different surfaces may require different cleaning methods.

3. Instructions on when to dispose of or destroy contaminated or damaged items.

4. Surface drying directions and equipment that may help the drying process.

5. Directions on how to apply the pesticide, including application rate, contact time, 

and equipment (paint brush, low pressure hand wand, airless sprayer, backpack 

sprayer or others).

6. Square footage that a specific amount of product will treat (e.g., 1 gallon will treat 

250 sq. ft.)

7. Personal protective equipment needed to limit exposure to mold hyphae, 

fragments and spores or the pesticide. (See 

http://www.bt.cdc.gov/disasters/mold/report/pdf/2005_moldtable5.pdf and 

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5508a1.htm)

8. Reentry restrictions, if any.

9. Guidance as to when a homeowner should consider using a professional to 

remediate mold damage.

B. Fungicidal Products Used on Porous Surfaces

Mold-related pesticides registered for use on porous surfaces (e.g., ceiling tiles, 

wallboard, insulation and carpet) should bear use directions in addition to those listed in 

Unit VI.A. that state specifically how the product is to be applied to such surfaces. 

Further, the label use directions should direct the user to assess whether a moldcontaminated porous material is treatable. If a porous material is not treatable, the label 

should instruct the user to remove and dispose of such porous material rather than treat 
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it. A sample label statement that should be considered by applicants and registrants is:

“Assess whether contaminated porous materials may be effectively treated. 

Remove and properly dispose of any untreatable porous materials.”

C. Fungicidal Products with Residual Activity or Prevention Claims

Mold-related pesticides with residual or prevention claims should bear use 

directions in addition to the remediation use instructions listed in Unit VI.A. that are 

unique to those claims. For example, products with residual activity claims and 

prevention claims should indicate the period of time after treatment that the product will 

be effective. For residual products, the following statement should also be considered:

“If mold growth reappears, reapply.”

D. Fungicidal Products Used by Homeowners

For mold-related pesticides intended for use by consumers, applicants or 

registrants should consider adding to the label the following guidance for homeowners

(see http://www.epa.gov/mold/moldguide.html):

”If the moldy area is less than a 3 ft. by 3 ft. patch, then the consumer can usually 

handle the cleanup.“

”If mold growth extends over an area greater than 10 square feet, consider hiring 

a professional for remediation. Mold damage caused by clean water may be 

handled by a non-professional; however, mold damage resulting from 

contaminated water should be handled by a professional who has experience 

cleaning buildings damaged by contaminated water.”

”If you have health concerns, consult a health professional prior to mold cleanup 

and pesticide application. Take precautions to limit your exposure to mold and 

mold spores. Wear protective equipment, such as a N-95 respirator, to limit your 

exposure to airborne mold. Gloves and goggles must also be worn to protect 

your hands and eyes.”

E. Fungicidal Products Used in Schools and Commercial Buildings

For mold-related pesticides intended for use in schools and commercial 

buildings, applicants or registrants should consider incorporating applicable guidance

found in the EPA publication “Mold Remediation in Schools and Commercial Buildings” 

(see http://www.epa.gov/mold_remediation.html). 
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F. Fungicidal Products Used In Heating, Ventilation, Air Conditioning

and Refrigeration Systems (HVAC&R)

A few mold-related pesticides are registered for use in HVAC&R systems. For 

these products, applicants or registrants should consider including the following 

statement on the product label to provide guidance to the end-user.

“If you know or suspect mold has contaminated the HVAC&R system, do not 

operate the system. Operating a HVAC&R system that has been contaminated 

with mold may cause the mold to spread throughout the building. Prior to the use 

of a pesticide, inspection and proper cleaning of the components to be treated 

must be performed. If your state requires licensing or certification of persons 

who inspect or clean such components, the inspection and cleaning must be 

done by a licensed or certified person.” 

VII. What Registrants and Applicants Should Do

Applicants and registrants who opt to implement labeling changes discussed in 

this PR Notice should respond along the lines described in Units V and VI via the 

notification, amendment or new registration processes as described below.

A. Adoption of the Fungistat Label Changes through Notification

1. Option 1 Label Changes. Registrants who adopt the label changes consistent 

with or along the lines of those set forth in Unit V.A., Option 1, of this Notice 

should submit a notification (according to PR Notice 98-10) for each product. 

EPA will review the notification to ensure that the label changes do nothing more 

than make the types of changes described in this guidance. The registrant 

should submit one copy of the label (with changes clearly marked in a way that 

can be photocopied) along with a completed Application for Registration form 

(EPA Form 8570-1), which is available for downloading at

http://www.epa.gov/opprd001/forms/. 

2. Delete all mold claims. Registrants who wish to delete all mold claims as 

described in Unit V.A.,Option 2, should submit an amendment to delete those 

claims (see Unit VII.B. below). 

B. Application for Amendment 
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Registrants of existing products covered by this Notice who want to add or revise 

label statements (other than the fungistat label statements described in Unit V.A., 

Option 1) should submit an application for amended registration. An application for 

amendment includes the following items: 

i. A completed EPA application form 8570-1; 

ii. Three copies of the draft label (highlighting the changes made on one copy); 

and 

iii. A description on the application, such as, "Amended consistent with PR 

Notice 2012-X." 

The registrant should clearly identify in the amendment how the registrant is 

responding to this notice. For example, add under Section II. “Explanation” of EPA 

Form 8570-1 the chosen option, such as: (1) “Delete the mold claim,” (2) “Add a

fungistat limitation statement that is a modification of the statement provided in PR

Notice 2012-X,” and (3) “Delete the fungicidal claim and add the fungistat claim and 

limitation statement.” 

The Pesticide Registration Improvement Act of 2003 (PRIA) established a new 

registration service fee system for applications for registration, amended registration, 

and associated tolerance actions. Under this system, registration service fees are 

charged for covered applications received by the Agency on or after March 23, 2004. 

However, applications for EPA-initiated amendments (either with or without data) are 

not subject to a PRIA fee. Therefore, an application to amend a registration submitted 

solely for the purpose of responding to this Notice will not be subject to a registration 

service fee, provided that the only changes being proposed to the labeling for the 

registered product are those undertaken in response to this Notice. 

C. Application for New Registration 

EPA expects that beginning on the effective date of this Notice each 

applicant for registration of new mold-related products will follow the guidance 

described in this Notice to the extent appropriate for the product. 

VIII. Implementation

EPA will consider this guidance when reviewing all applications for new pesticide 

product registrations, for amendments to registered products, and for reregistration and 

registration review of registered products. [Note: The Agency is actively considering its 
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options for implementing this guidance with respect to currently registered pesticide 

products. Among the options the Agency is considering is whether to provide a target 

date by which the registrants of currently registered products could, if affected, adopt 

labeling changes described in this notice and/or submit efficacy data to support 

fungicidal claims, as applicable. Persons reviewing this draft notice may submit 

comments or suggestions on this issue within the time frame described in the Federal 

Register Notice of Availability. EPA would be interested in obtaining input from 

registrants and other interested stakeholders on what the tradeoffs would be of setting a 

specific implementation date versus not setting such a date in terms of the costs of 

making labeling changes, level playing field issues, and other relevant issues. EPA 

would also be interested in knowing the life cycles of labels, how often registrants 

normally amend their labels, and to what extent the changes recommended in this 

notice could implemented with minimal impacts.]

IX. Addresses to Use

Registrants should send notifications and amendments to one of the following 

addresses: 

U.S. Postal Service Deliveries

The following official mailing address should be used for all correspondence or 

data submissions sent to OPP by U.S. mail:

Document Processing Desk (AMEND) or (NOTIF) [as applicable] 

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

1200 Pennsylvania Ave., NW

Washington, D.C. 20460-0001

PLEASE NOTE: Do not address mail to be sent through the U.S. Postal Service 

(USPS) to the Arlington, Virginia address. USPS will return it to you causing 

delay in processing your actions. There is no U.S. Postal Service delivery at the 

Virginia address.

Personal/Courier Service Deliveries

Deliveries in person or by a commercial courier for the regulatory divisions will be 

accepted at OPP’s Document Processing Desk (7504P) in One Potomac Yard, 

Room S-4900. Couriers and delivery personnel must present a valid picture 

identification card to gain access to the building. The following address should 

be used for all correspondence or data submissions that are hand-carried or sent 
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by courier service Monday through Friday, from 8:00 AM to 4:30 PM, excluding

Federal holidays:

Document Processing Desk (AMEND) or (NOTIF) [as applicable]

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Room S-4900, One Potomac Yard

2777 South Crystal Drive 

Arlington, Virginia 22202-4501 

X. Paperwork Reduction Act Notice

The information collection activities associated with the activities described in this 

PR Notice are already approved by the Office of Management and Budget (OMB) under 

the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. The corresponding 

Information Collection Request (ICR) document for pesticide applications and 

amendments and the labeling requirements for pesticides are discussed in the 

Application for New and Amended Pesticide Registration, EPA ICR# 0277, OMB control 

number 2070-0060. The annual average reporting and recordkeeping burden for a 

registration applicant respondent are estimated to range from 14 to 646 hours, 

depending upon the type of activity. For “Type A” activities, which include new active 

ingredients and new uses, the estimated annual applicant burden average is 194 hours 

per application. For “Type B” activities, which include amendments and notifications, 

the estimated annual applicant burden average is 14 hours per application. The 

respondent burden estimate for “Type C” reduced risk products is an average of 646 

hours per product. A copy of the most recent version of EPA ICR number 0277 is 

available under Docket ID No. EPA-HQ-OPP-2008-0191. This docket can be accessed 

at www.regulations.gov.

Under the PRA, “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, it is the time reading the regulations, 

planning the necessary data collection activities, conducting tests, analyzing data, 

generating reports and completing other required paperwork, and storing, filing and 

maintaining the data.

Under the PRA, 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 numbers for EPA's regulations codified in 

Chapter 40 of the CFR, after appearing in the preamble of the final rule, are listed in 40 

CFR part 9, and are displayed either by publication in the Federal Register or by other 
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appropriate means, such as on the related collection instrument or form, if applicable. 

The display of OMB control numbers in certain EPA regulations is consolidated in 40 

CFR part 9. For the ICR activity contained in this PR Notice, EPA is displaying the 

applicable OMB control number in the PR Notice above, and the applicable OMB 

control number also appears on the pesticide application.

XI. For Further Information 

If you wish to obtain further information on this Notice or have questions, you 

may contact Jeff Kempter (kempter.carlton@epa.gov) in the Antimicrobials Division,

Mail Code 7510P, (703) 305-5448. 

_______________________________

Steven Bradbury, Ph.D., Director

Office of Pesticide Programs