Technical Support Document 

Scientific Issues Associated with Product Performance Data 

Needs for Pesticide Products Claiming Efficacy against Invertebrate Pests

Of Significant Public Health or Economic Importance

Submitted to the FIFRA Scientific Advisory Panel

For Review and Comment

March 19-21, 2013

U.S. Environmental Protection Agency

Office of Chemical Safety and Pollution Prevention 

Office of Pesticide Programs
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I. Why are we bringing these questions to the SAP?

EPA is seeking the expert opinion and recommendations from the FIFRA Scientific 

Advisory Panel (SAP) on the types of product performance data that might be needed for EPA to 

evaluate the efficacy of pesticide products used to control three categories of invertebrate pests: 

those identified to be of significant public health importance (e.g., ticks, mosquitoes, 

cockroaches,), wood-destroying insects (e.g., termites), and invasive invertebrate species (e.g., 

Asian long-horned beetle). The two latter categories are considered to be of significant economic 

importance. Unit V provides additional information on these categories.

EPA acknowledges that for public health pests and wood–destroying insects, the term 

arthropod could be more appropriate. However, for invasive species, product performance data 

for invertebrate species such as mussels could be needed, in the future. For ease of use in this 

document, EPA will use the terms invertebrates or invertebrate pests to describe all three 

categories. EPA will consider the SAP’s recommendations as EPA works to develop a proposed 

rulemaking concerning product performance data requirements, and new or revised product 

performance testing guidelines (test protocols) for pesticide products claiming efficacy against

these three categories of invertebrate pests. 

The EPA believes that several new guidelines for product performance are needed. The 

new guidelines will include testing procedures and methods for: (1) spatial repellents; (2) 

insecticide impregnated fabrics; (3) attractants; and (4) fumigants. Testing guidance on the 

insecticidal uses of novel biotechnology and/or nanotechnology may be considered. General 

factors and considerations for revisions to OCSPP Guidelines 810.3000-810.3600 are also being 

considered. 

The data that EPA is considering for codification are consistent with the agency’s current

practices when considering the product performance data needed to register a pesticide product 

that bears a pesticidal claim against one or more of these pests. The Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) section 3(c)(2) directs EPA to specify the kinds of data 

that applicants and registrants must submit to EPA to support regulatory determinations under 

FIFRA. The data requirements for pesticide products are codified in 40 CFR parts 158 and 161.

Product performance data (efficacy studies) document how well the product performs the 

intended function (such as killing or repelling) against an invertebrate pest. The draft product 

performance data needs being considered would link the label claim for pesticide products 

claiming efficacy against an invertebrate pest with the data needed to substantiate that claim. 

Draft numerical performance standards specify the level of efficacy that would need to be 

achieved for EPA to register a product bearing the specified claims against the invertebrate pest. 

The agency is asking the FIFRA SAP to evaluate the clarity, accuracy, and completeness 

of the product performance data that might be needed for EPA to evaluate the efficacy of 

pesticide products used to control invertebrate pests. This technical support document is intended 

as a basic guide and source of information. It includes many of the scientific issues identified 

during the agency’s internal discussions and deliberations on this specific topic (i.e., the product 

performance data needed to support registration of a product claiming pesticidal activity against 
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the three categories of invertebrate pests previously identified). The charge questions to the Panel

are in a separate document. 

This document is organized as follows:

Units II, III, and IV contain background information on EPA’s statutory and legal 

framework, guidance documents and labeling requirements for pesticides.

Unit V explains the three categories of invertebrate pests: public health pests, 

wood-destroying insects, and invasive species.

Unit VI describes the group/sub-group concept used to determine the 

representative test species.

Unit VII explains the relationship of the product performance rulemaking to other 

agency actions.

Unit VIII describes EPA’s Product Performance Test Guidelines.

Unit IX describes changes being considered for Product Performance Standards.

Unit X describes important parameters for product performance testing guideline 

development.

Unit XI discusses the availability of international guidance on product 

performance testing.

Unit XII discusses extrapolating from other sources of efficacy data.

Unit XIII is a list of references.

Appendix 1 includes three pest tables listing the groups and subgroups

Appendix 2 provides a draft Data Evaluation Record for a Product Performance 

Study.

Appendix 3 provides needed EPA definitions.

Appendix 4 provides information on the European Commission’s approach to 

efficacy label claims and related definitions.

Appendix 5 describes the label claim and the representative test species needed to 

substantiate that claim.

II. Statutory and Legal Framework 

According to FIFRA section 3(c)(5), EPA shall register a pesticide if, when considered 

with any restrictions imposed: 

Its composition is such as to warrant the proposed claims for it; 

Its labeling and other material required to be submitted comply with the 

requirements of FIFRA; 

It will perform its intended function without unreasonable adverse effects on the 

environment; and

When used in accordance with widespread and commonly recognized practice it 

will not generally cause unreasonable adverse effects on the environment.

FIFRA section 3(c)(5) also states: “In considering an application for the registration of a 

pesticide, the Administrator may waive data requirements pertaining to efficacy, in which event 
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the Administrator may register the pesticide without determining that the pesticides’ composition 

is such as to warrant proposed claims of efficacy.” 

The process of registering a pesticide begins with submission to EPA of an application 

package and required data. In reviewing applications for pesticide product registration under 

FIFRA, EPA must determine that the pesticide product meets the registration standard in FIFRA 

section 3(c). EPA then grants a license, called a registration, to sell or distribute the pesticide 

product in the United States.

The data requirements for product performance for conventional pesticides are contained 

in 40 CFR part 158, subpart E, and are specific to microorganisms and vertebrates. However, 

consistent with the discretion accorded to EPA under FIFRA section 3(c)(5) to waive data 

requirements pertaining to efficacy, subpart E does not specifically require submission of 

product performance data for those pesticide products claiming effectiveness against invertebrate

pests. Instead, and as explained in the test note in § 158.400(e)(1) that applies to the Product 

Performance Data Requirements Table in part 158: 

The Agency has waived the requirement to submit product 

performance data unless the pesticide product bears a claim to 

control pest microorganisms that pose a threat to human health and 

whose presence cannot readily be observed by the user including, 

but not limited to, microorganisms infectious to man in any area of 

the inanimate environment, or a claim to control vertebrates (such 

as rodents, birds, bats, canids, and skunks) that may directly or 

indirectly transmit diseases to humans. However, each registrant 

must ensure through testing that his product is efficacious when 

used in accordance with label directions and commonly accepted 

pest control practices. The Agency reserves the right to require, on 

a case-by-case basis, submission of product performance data for 

any pesticide product registered or proposed for registration.

For some years, EPA has relied on the last sentence of the test note in § 158.400(e)(1), as 

well as § 158.75, when requiring on a case-by-case basis product performance data for 

invertebrate control agents for conventional pesticides. Under § 158.75, if the information that is 

required for registration “is not sufficient to evaluate the potential of the product to cause

unreasonable adverse effects on man or the environment, additional data requirements will be 

imposed.”

On October 26, 2007, EPA promulgated a final rule to update and revise its data 

requirements for biochemical and microbial pesticides (72 FR 60934). In the 2007 rulemaking, 

the agency codified separate product performance data requirements for biochemical and 

microbial pesticides in §§ 158.2070 and 158.2160, respectively. That final rule required 

applicants to submit efficacy data to support registration of biochemical and microbial pesticide 

products claiming to control invertebrate species. The following are the product performance 

data requirements for biochemicals in § 158.2070. 
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Product performance data must be developed for all biochemical 

pesticides. However, the Agency typically does not require 

applicants to submit such efficacy data unless the pesticide product 

bears a claim to control public health pests, such as pest 

microorganisms infectious to man in any area of the inanimate 

environment or a claim to control vertebrates (including but not 

limited to: rodents, birds, bats, canids, and skunks) or invertebrates 

(including but not limited to: mosquitoes and ticks) that may 

directly or indirectly transmit diseases to humans. However, each

registrant must ensure through testing that his products are 

efficacious when used in accordance with label directions and 

commonly accepted pest control practices. The Agency reserves 

the right to require, on a case-by-case basis, submission of efficacy 

data for any pesticide product registered or proposed for 

registration.

The product performance data requirements for microbials in § 158.2160 are almost 

identical.

III. EPA’s Guidance Documents

The agency has addressed the product performance data for products claiming 

effectiveness against invertebrate control agents in two guidance documents: The Label Review 

Manual (LRM) and Guideline 810.1000. The LRM compiles interpretations of statutory and 

regulatory provisions, and reiterates agency policies. As stated in the LRM, EPA generally 

requires submission of product performance data for products intended for “Invertebrate 

Control,” which is described as follows: “Products intended for use in or on humans (or in or on 

pets for control of pests which attack humans such as fleas, ticks, mosquitoes, and biting flies) 

and in premises or in the environment to control pests of sanitary or public health significance 

such as.... termites, wasps, scorpions, poisonous spiders, fire ants, cockroaches, centipedes, and 

bedbugs” (EPA 2011). 

OPPTS Product Performance Guideline 810.1000 entitled, “Overview, Definitions, and 

General Considerations,” discusses the product performance data needed for any product that 

“bears a claim to control pests that may pose a threat to human health.” Guideline 810.1000 goes 

on to identify public health uses of invertebrate control agents as including, but not limited to:

....agents intended to control the following: Mosquitoes, biting 

flies, ticks, fleas, houseflies, cockroaches, fire ants, hornets, wasps, 

poisonous spiders, scorpions, biting midges, centipedes, bedbugs, 

human lice, and dust mites (EPA 1998a). 

IV. Labeling Requirements

Pesticide product labeling provides information to users on, among other things, the 

product’s intended uses, and how to handle and apply the product. EPA’s labeling regulations are 
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contained in 40 CFR part 156. EPA reviews pesticide labels to determine whether the labeling is

consistent with EPA’s regulations, and is accurate, clear and enforceable. The accuracy of the 

information on the labeling is of particular importance for products claiming to kill or repel 

public health pests. Such pests, if uncontrolled, can transmit disease pathogens, thus posing a 

widely-recognized and significant risk to human health. 

Consumers purchase products that claim effectiveness against a public health pest 

precisely to avoid the harm these pests can cause. Consumers have a reasonable expectation that 

the claims on the pesticide label have a scientific basis, i.e., are based on valid evidence, and are 

neither false nor misleading. Such claims should be expressed using wording or graphics that are 

easily understood and require little or no interpretation by the consumer.

To ensure that labeling provides consumers with accurate information concerning how 

long and how well the product works, EPA reviews and evaluates product performance 

(efficacy) data. Once the data have been reviewed and evaluated, then the agency works to 

assure that the labeling use directions and labeling claims are consistent with the results of the 

supporting product performance data. 

EPA will consider recommendations from this SAP meeting to help ensure that in the 

future EPA will be asking for reliable information about the effectiveness of pesticide products 

making claims against invertebrate pests. Reliable information results in sound regulatory 

decisions which mean accurate, information on the labeling. Accurate labeling claims provide 

consumers with accurate information concerning the effectiveness of the pesticide. 

V. Invertebrate Pests Considered for this Action 

EPA is considering codifying requirements for product performance data for three 

categories of invertebrate pests: Public Health Pests, Wood-destroying Insects, and Invasive 

Species 

A. Public Health Pests

In 2002, EPA issued Pesticide Registration Notice (PRN) 2002-1 (EPA 2002), which 

presented the “List of Pests of Significant Public Health Importance.” This list was derived in 

large part from review of the pesticide/pest combinations for which product performance data 

have been required on a case-by-case basis to be submitted and reviewed prior to registration. 

This list was developed cooperatively by the U.S. Department of Health and Human Services, 

United States Department of Agriculture (USDA), and the EPA, with input from some nongovernmental entities. EPA’s Office of Pesticide Programs coordinated the review by experts in 

public health and/or pesticide use patterns to compile this list. 

As indicated in PRN 2002-1 (page 1), the criteria for inclusion on the list were defined 

“broadly, to include pests that pose a widely recognized risk to significant numbers of people.” 

The listing of invertebrate pests (pages 6-9) is specified by the taxonomic name, as not all 

members of a particular taxon may be considered a public health pest. EPA takes this approach 

when only certain members of a taxonomic group may be public health pests because labels 
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usually do not identify specific individual species. However, even if the label did identify a 

specific species, most product users are not able to distinguish among the members of a 

taxonomic group (i.e. identifying one tick species from another). 

The list of public health invertebrate species, being presented to the SAP in connection 

with the needed product performance data are consistent with the invertebrate pest list identified 

in 2002, but have evolved over the intervening 10-year timeframe (Bonnefoy et al. 2008, Mallis 

2004). Table 1 provides the rationale for inclusion of an invertebrate pest as a public health pest. 

Table 1: Public Health Pests from PRN 2002-1

Invertebrate Pest (Common 

Species Name)

Rationale for Inclusion

Mites Produces allergens

Triggers asthma

Scabies

Itching and skin irritation with risk of secondary infection

Chiggers Itching and skin irritation with risk of secondary infection

Ticks Rocky Mountain Spotted Fever

Lyme Disease

Ehrlichiosis

Scorpions Venomous bite

Spiders Venomous bite

Centipedes Venomous bite

Lice Skin irritation and rashes

Epidemic typhus

Trench fever

Fleas Annoying bites, allergic reactions, and rash

Plague

Cockroaches Allergies

Transmission of Salmonella

Fecal contamination

Hepatitis

Bot Flies Infest host and live under the skin with risk of secondary 

infection

Filth Flies Carry pathogens

Food-borne illness

Mosquitoes West Nile Virus

Dengue Fever

Malaria

Encephalitis

Yellow Fever

Chikungunya fever

Biting Flies Painful or annoying bites with allergic reactions

Sand Flies Leishmaniasis

True Bugs Allergic reactions
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Chagas disease

Bed Bugs Bites and allergic reactions

Ants Stings to painful stings;

May be accompanied by severe or life-threatening reactions

Bees Painful stings that may cause life-threatening reactions

Wasps, Hornets, and Yellow 

Jackets

Painful stings that may cause life-threatening reactions

EPA has developed a list of the Public Health Pests (See Appendix 1, Table 1), which it believes 

to be inclusive of the arthropods that pose a threat of injury, disease transmission and/or 

pathogen transfer, and allergen production. In some instances individual species are identified, 

while in other cases entire taxonomic groups were deemed appropriate for inclusion due to the 

life history characteristics of the assemblage. See Unit VI for additional information.

B. Wood-destroying Insects 

Structural pests differ from other non-public health pests because the effectiveness of the 

treatment is not readily apparent to the applicator at the time of application or during the 

occupancy of the building or home, and a potential for significant financial loss to the property 

owner exists. Thus, demonstrating the efficacy of pesticides intended to control structural pests 

has a unique importance. Data on the level of economic damage caused by structural pests on an 

annual basis are difficult to obtain but several authors have attempted to quantify it. The 

estimates for termites alone in the U.S. vary from approximately 500 million dollars to more than 

a billion dollars, with several estimates in-between (Su and Scheffrahn 1990). While these 

estimates are indicative of the cost nationwide, the costs borne by an individual property owner 

can be significant in their own right, up to and including loss of the property. The wooddestroying insects included are those that have the potential to cause structural damage (Mallis 

2004, Pearce 1997).

EPA has generally required submission of product performance data for wood-destroying 

insects for over 20 years. The agency issued PRN 96-7(EPA 1996), entitled “Termiticide 

Labeling,” (October 1, 1996) to provide guidance on label statements and minimum levels of 

product performance for soil treatment use of termiticide products. According to the PRN:

The Agency believes that registration of a [termiticide] product 

demonstrating less than five (5) years of efficacy for control of 

termites is generally not appropriate from a safety or efficacy 

standpoint, considering the costs of treatment and the potential 

damage that could occur. The Agency does not believe that the 

homeowner should be subjected to such costly protection as would 

occur with products that are only efficacious for one year. Such 

products could, quite possibly, pose unreasonable adverse effects 

to the environment and/or humans because of higher risks than 

longer-acting alternatives. The more frequent treatments required 

could result in greater exposure and risk, or lower benefits, because 
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of being less effective if not retreated, or more expensive if 

retreated.

...

EPA has always required efficacy data to be submitted by 

registrants to demonstrate that termiticides perform their intended 

function as claimed. EPA has reviewed such data prior to 

registration to assure that the benefits of the use would outweigh 

the potential risks.

C. Invasive Species 

Executive Order

President Clinton signed Executive Order 13112 on February 3, 1999 (FR 1999a). The 

purpose of Executive Order 13112 is “...to prevent the introduction of invasive species and 

provide for their control and to minimize the economic, ecological, and human health impacts 

that invasive species cause....” EPA intends to include several of the definitions from that 

Executive Order in the upcoming rulemaking, as follows:

“Alien species” means, with respect to a particular ecosystem, any 

species, including its seeds, eggs, spores, or other biological 

material capable of propagating that species, that is not native to 

that ecosystem.

...

“Introduction” means the intentional or unintentional escape, 

release, dissemination, or placement of a species into an ecosystem 

as a result of human activity.

...

“Invasive species” means an alien species whose introduction does 

or is likely to cause economic or environmental harm or harm to 

human health. 

...

“Species” means a group of organisms all of which have a high 

degree of physical and genetic similarity, generally interbreed only 

among themselves, and show persistent differences from members 

of allied groups of organisms.
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The Executive Order also directed each federal agency to use relevant programs and 

authorities to:

(i) prevent the introduction of invasive species;

(ii) detect and respond rapidly to and control populations of such 

species in a cost-effective and environmentally sound manner; 

(iii) monitor invasive species populations accurately and reliably; 

(iv) provide for restoration of native species and habitat conditions 

in ecosystems that have been invaded; 

(v) conduct research on invasive species and develop technologies 

to prevent introduction and provide for environmentally sound 

control of invasive species; and 

(vi) promote public education on invasive species and the means to 

address them (FR 1999b).

Economic Impacts

Invertebrate invasive species can impose serious economic costs by causing or vectoring 

diseases against native species that have little or no natural defenses. For example, an invasive 

species of significant note is the emerald ash borer (EAB), a wood boring beetle that is native to 

Asia. The EAB kills ash trees. Its presence was reported in southeast Michigan and Windsor, 

Ontario in 2002. Since then it has spread to at least 15 states and two Canadian provinces

(Hermes et al. 2009). Infested areas are under quarantine and restrictions have been imposed on 

moving fire wood (USDA-APHIS 2006). EPA has registered several pesticide products for use 

against the EAB after reviewing submitted efficacy data. 

Another invasive invertebrate species, the Asian longhorn beetle (ALB), is also native to 

Asia and was first discovered in New York in 1996. The ALB kills maple trees and other 

hardwoods (USDA-APHIS 2005). A very serious situation/crisis exists in New England and 

USDA has established an extensive eradication program. EPA has also registered several 

products for use against the ALB. 

Invertebrates such as the EAB and the ALB kill trees over very large geographic areas, 

thus destroying both urban cover and forests used for recreation purposes and timber stands. 

According to a 2011 analysis entitled, “Economic Impacts of Non-Native Forest Insects in the 

Continental United States,” (Aukema et al. 2011) the following five categories of expenditures

and losses can be used to illustrate impacts on forests. 

Federal government expenditures (survey, research, regulation, management, and 

outreach), 

Local government expenditures (tree removal, replacement, and treatment), 

Household expenditures (tree removal, replacement, and treatment), 

Residential property value losses, and 

Timber value losses to forest landowners.

Within the 2011 analysis were cost estimates using the five previously-described 

categories of the damage caused by three types of invasive insects: borers, sap feeders, and 
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foliage feeders. Since some of the economic categories overlap, the total sum of all economic 

categories would include some double counting. However, the total of the insect types can be 

summed without double counting, which means that it is appropriate to sum the columns, but not 

the rows. Table 2 shows that most of the costs are borne by local governments and households, 

and the total damage is several billion dollars.

Table 2: Annualized Invasive Species Damages in the U.S. ($ millions)

Federal 

Government 

Expenditures

Local 

Government 

Expenditures

Household 

Expenditures

Residential 

Property 

Value Loss

Forest 

Landowner 

Timber 

Costs

Borers $92 $1,700 $760 $830 $130

Sap Feeder $14 $170 $130 $260 $4

Foliage Feeders $110 $170 $160 $410 $18

Total $216 $2,040 $1,050 $1,500 $152

Pesticide products are an important tool for managing the spread of an invertebrate 

invasive species and the related significant economic impacts. The availability of pesticide 

products with proven performance against an invasive species is important to slowing the spread 

of the invasive species. When circumstances necessitate the submission or citation of reliable 

data to support claims for controlling invasive species, EPA has the authority to require such 

product performance data. 

Due to the sudden appearance and often rapid spread of invasive species, EPA does not 

presently intend to list the specific invasive species for which product performance data might be 

deemed necessary. Instead, the submission of product performance data to support claims for 

effectiveness against invasive invertebrate pests will be considered on a case-by-case basis.

VI. Development of Groups and Subgroups

EPA has identified pest groupings on the basis of the biology and life history 

characteristics of the pests identified as public health or wood destroying pests. These 

assemblages, both groups and sub-groups are listed in Appendix 1 (Tables I & II). The groupings 

are taxonomically based, although not necessarily monophyletic, pest assemblages of adequate 

similarity to provide reasonable certainty that testing using representative taxa would yield a 

conservative assessment of efficacy against any member of the group. “Groups” and “subgroups” are designations simply intended to convey the fact that some pests groups are part of 

larger groups. The number of representative taxa increases with increasing group diversity. 

Therefore, when practical and meaningful, “sub-groups” have been identified to provide an 

opportunity to support a subset of the larger group.

Groups and sub-groups were developed with the intention that data reported for 

representative test species can reliably support all members included in the grouping. The agency 

intends these pest groupings to decrease data submission burdens on registrants and data review 
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burden on the agency; to increase consistency, reliability, and integrity of data submitted to the 

agency; and to provide for more recognizable pest claims on product labels for consumers. 

VII. Impacts of the Product Performance Rulemaking on other Agency Actions

A. Insect Repellency Voluntary Program

EPA is developing a program for skin-applied insect repellent products that claim to repel 

mosquitoes and/or ticks. A manufacturer’s participation in the program would be voluntary.

Information derived from the review and comment by the SAP may be used to further refine the 

criteria for the voluntary program.

The Insect Repellency Voluntary Program would use a standardized graphic to clearly 

communicate to consumers the product’s effective repellency against mosquitoes and/or ticks 

when the product is used as directed on the label. The graphic would specify the number of hours 

that the product is effective. At this time, there are three possible claims under development that 

will be represented graphically: Efficacy against mosquitoes only, against ticks only, or against 

both. 

The graphic will convey in a succinct format on the front product label of an insect 

repellent product, information that consumers look for and want to protect themselves and their 

families from pests such as mosquitoes and/or ticks. Currently, such information is typically 

provided in relatively small print on a back or side panel of the label. EPA believes that a graphic 

can effectively convey the essence of this information accurately but concisely in a prominent 

location on the front panel of the product’s label. Additionally, the graphic will provide a way of 

standardizing the presentation of this information much like the SPF rating standardizes the 

presentation of information for sunscreen product labels. Thus, the graphic is intended to 

increase public health protection by addressing the consumer’s need for information. Producers 

will have to provide information to EPA on the efficacy of each product for EPA to approve the 

addition of the graphic to a product label.

B. Minimum Risk Pesticides

In 1996, EPA exempted certain minimum risk pesticides from FIFRA requirements if 

they satisfy certain conditions. EPA exempted the products described in 40 CFR 152.25(g), later 

redesignated as § 152.25(f), in part to reduce the cost and regulatory burdens on businesses as 

well as the public for pesticides posing little or no risk, and to focus EPA’s limited resources on 

pesticides which pose greater risk to humans and the environment. Some pesticide products 

claiming efficacy against invertebrate species are marketed under this exemption.

Pesticides qualifying for the exemption under § 152.25(f) are not subject to any FIFRA 

requirements, other than those specified in the exemption. Unlike other pesticides, the producer 

does not register a product with EPA, pay registration fees, or report production to EPA. As 

described in Pesticide Registration Notice 2000-6, (EPA 2000), entitled, “Minimum Risk 

Pesticides Exempted under FIFRA Section 25(b) Clarification of Issues,” to be considered 
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exempt under the § 152.25(f) exemption, the pesticide product must meet the following criteria 

for labeling and composition:

1. Contain only certain active and inert ingredients, specified on EPA-determined lists;

2. List active ingredients by name with the percentage by weight in the product;

3. List inert ingredients by name;

4. Not include any false or misleading labeling statements;

5. Not bear claims either to control or mitigate microorganisms that pose a threat to 

human health, including but not limited to disease transmitting bacteria or viruses, or 

claims to control insects or rodents carrying specific diseases, including, but not 

limited to ticks that carry Lyme disease.

 Even if a pesticide product is exempt from FIFRA requirements, the product may not be 

exempt from state registration or other regulatory requirements. Each state has its own statutes 

and regulations concerning pesticide registration and regulation. A pesticide product exempted 

from federal regulation is not automatically exempted from state regulation. In fact, over 35 

states require registration of these federally-exempted products.

While exempted products cannot claim to kill or repel ticks that carry Lyme disease, or 

mosquitoes that carry West Nile Virus, such products can claim to kill or repel ticks and/or 

mosquitoes including specific species that can carry a specific disease. That is, while an 

exempted product label could say, for example, “repels deer ticks,” the label could not say 

“repels ticks that carry Lyme disease” or “repels deer ticks that can carry Lyme disease.” 

In a future rulemaking, EPA is considering a proposal to remove personal mosquito and 

tick repellents from the minimum risk pesticides exemption currently in § 152.25(f). This means 

that once removed from the exemption, personal mosquito and tick repellents would need to be 

registered as a pesticide product with EPA before sale or distribution in the United States. EPA is 

considering a 5-year time-frame for personal mosquito and tick repellents that currently meet the 

active and inert ingredient criteria of the exemption in order to allow sufficient time for the 

product to become a registered pesticide product. EPA’s product performance rulemaking would 

serve as a foundation for determining the product performance data requirements for these 

minimum risk personal mosquito and tick repellents. Additional information on this future 

rulemaking can be found at regulations.gov using the docket identifier EPA-HQ-OPP-2010-

0227.

VIII. Current Status of EPA’s Product Performance Guidelines

A. Background

EPA’s Harmonized Test Guidelines (EPA 1998b) for Product Performance, Series 810, 

group C – Invertebrate Control Agents, (810.3000 through 810.3800) (Table 3) identify 
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performance standards for determining whether or not a product is effective. However, these are 

guidance documents, not codified requirements.

Table 3: EPA’s Series 810 Product Performance Guidelines

Guideline Number Guideline Title (Date)

810.3000 General Considerations for Efficacy of 

Invertebrate Control Agents (1998)

810.3100 Soil Treatments for Imported Fire Ants (1998)

810.3200 Livestock, Poultry, Fur- and Wool-Bearing 

Animal Treatment (1998)

810.3300 Treatments to Control Pests of Humans and 

Pets (March 1998)

810.3400 Mosquito, Black Fly, and Biting Midge (Sand 

Fly) Treatments (1998)

810.3500 Premise Treatments (1998)

810.3600 Structural Treatments (1998)

810.3700 Insect Repellents to Be Applied to Human Skin 

(2010)

810.3800 Methods for Efficacy Testing of Termite Baits 

(2004) 

On March 6-7, 2012, EPA presented to the SAP, a draft guideline regarding bed bugs. 

EPA intends to finalize this guideline, tentatively entitled “Methods for Efficacy Testing of Bed 

Bug Pesticide Products” during 2013, and would then post it on EPA’s Harmonized Guidelines 

website as 810.3900 (EPA 2012).

Current EPA guidelines present a variety of approaches to testing. However, the older 

(1998) guidelines, in particular, generally lack adequate guidance on efficacy data development, 

test protocols, and representative test species. Tables 4 - 11 summarize the information currently 

contained in these guidelines. This information provides much of the context for the discussion

for this SAP meeting on revising testing guidance, producing new guidelines, and standardizing

testing approaches while considering data harmonization with other regulatory agencies and the 

World Health Organization Pesticide Evaluation scheme, to the extent possible. 
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Table 4: Guidelines 810.3000 and 810.3100 (EPA 1998b, c)

Guideline Number & 

Title

Pest(s) Sites Treatments/Replicates Recommended Performance 

Standards

810.3000 

General Considerations 

for Efficacy of 

Invertebrate Control 

Agents (1998)

Public Health 

Pests and 

Termites

All None stated

810.3100

Soil Treatments for 

Imported Fire Ants 

(1998)

Imported 

Fire Ants

Soil applied treatments 

to: 

3 sites

10 mounds per plot

3 to 4 treated

1 untreated control

Nursery containers for 

quarantine use

None stated but in practice:

1-3 sites

10 containers treated and 

10 untreated

None stated but in practice: 90%

Individual mounds; 3 sites

10 mound per plot.

3 to 4 treated

1 plot untreated control

“Control:” at least 90% for 30 days

Wide-area broadcast 3 sites

10 mound per plot.

3 to 4 treated

1 plot untreated control

“Control:” at least 90% for 60 days

“Suppression:” at least 80% for 60 

days
Page 16 of 88

Table 5: Guideline 810.3200 (EPA 1998d)

Guideline Number 

& Title

Pest(s) Site(s) General Experimental 

Parameters

Treatments/Application Types Recommended 

Performance 

Standard(s)

810.3200

Livestock, Poultry, 

Fur- and WoolBearing Animal 

Treatment (1998)

Nose bot:

sheep ked;

Biting flies 

including 

stable, deer, 

horse and horn 

flies; 

face fly;

house fly;

mosquitoes;

ticks;

Cattle (beef and 

dairy), Sheep Goats 

and Swine

Horses 

Chicken, turkeys, 

and other domestic 

fowl

Fur-bearing animals 

including mink and 

rabbits

5 geographically 

separated sites. 

Data from beef cattle may 

be bridged to dairy cattle.

The number of control 

and treated animals 

should be equal.

Performance values 

should result from 

comparisons between 

untreated and treated 

replicates. Reference 

compounds should be 

used.

Feed, water, mineral salt or protein 

supplement treatments; whole body 

sprays, dips, and pour-ons, dusts, 

backrubbers, LV, ULV and wax bar. 

Smears, baits, ointments, and wipes 

and sponge. Fine mist sprays, 

toxicants and/or repellents in aerosols, 

sponge treated halters.

Horn, stable, deer and 

horse flies.

Larvicide: 90%

Adulticide: 70-95%

Face fly adulticide: 20-

60% in 

2-3 days 

Ticks – 90% at one week 

and 75% at one month.
Page 17 of 88

Table 6: Guideline 810.3300 (EPA 1998e)

Guideline Number 

& Title

Site(s) Pest(s) General Experimental 

Parameters

Treatments/Application Types Recommended 

Performance 

Standard(s)

810.3300

Treatments to 

Control Pests of 

Humans and Pets 

(March 1998)

Humans

Pets (dogs, cats, 

birds)

Body louse, head 

louse and crab

louse.

Ticks

Fleas 

Mites

Mosquitoes

Biting flies

Lice, 

Fleas including cat 

fleas.

Ticks including 

brown dog tick, 

American dog tick, 

Lone star tick, 

Rocky Mountain 

wood tick

5 large scale field trials

6 animals per group as a 

minimum; 10 animals is 

preferred.

Reinfestation interval is 7 

days.

Sprays, dusts, lotions, towels, 

ointments, creams, sticks, soaps, and 

shampoos.

Sprays, dusts, foams, flea collars, flea 

tags, soaps, and shampoos.

100% kill of lice, ticks, 

fleas and mites

Skin applied repellency 

2-3 hour minimum 

protection time

90% kill of ticks and 

fleas.

100% kill or repellency 

of mites

100% kill or repellency 

of lice
Page 18 of 88

Table 7: Guideline 810.3400 (EPA 1998f)

Guideline Number 

& Title

Site(s) Pest(s) General Experimental 

Parameters

Treatments/Application Types Recommended 

Performance 

Standard(s)

810.3400

Mosquito, Black 

Fly, and Biting

Midge (Sand Fly) 

Treatments (1998)

Aquatic and 

terrestrial

Mosquitoes

Black flies

Biting midges 

(Ceratopogonidae)

Non-biting midges 

(Chironomidae and 

Chaoboridae)

5 large geographically 

separated trials

As specified by the label

Mosquitoes – field tests 

recommended.

Black fly larvae test in lab and with 

single stream technique 

Black fly adults –large scale control 

operation

Biting Ceratopogonid midges larvae 

and adults – field studies

Mosquito larvae and 

adults – 95% kill under 

field conditions.

Black fly larvae-80% kill

Black fly adults – no 

performance standard 

Biting midge larvae and 

adults – 95% 
Page 19 of 88

Table 8: Guideline 810.3500 (EPA 1998g)

Guideline 

Number & 

Title

Site(s) Pest(s) General Experimental 

Parameters

Treatments/Application Types Recommended 

Performance 

Standard(s)

810.3500

Premise 

Treatments 

(1998)

Spaces within 

structures, their walls

(inside and outside), 

and the immediate 

adjacent surrounding 

grounds.

This includes houses, 

apartments,

commercial, industrial 

and institutional 

buildings; agricultural 

structures; and foodhandling 

establishments.

Labeled 

flying and/or 

crawling 

insects

Under laboratory 

conditions,

at least 5 trials are 

usually necessary. A 

minimum of 5 largescale field trials are 

generally needed.

Application Types

Laboratory: 

The following absorptive and nonabsorptive surfaces should be tested for 

crawling pests: vinyl tile or linoleum, 

stainless steel, painted and unpainted wood 

and ceramic tile.

Field: the application technique should 

reflect the claims proposed on the label, 

whether crack and crevice, spot, general, 

space spray, contact spray or total release. 

Treatments

(1) Non-residual aerosols and space 

sprays— Flying insects.

(2) Crawling insects—Contact spray.

(3) Indoor space spray fogger.

Use German cockroaches for evaluations 

and Oriental cockroaches and/or American 

cockroaches at low application rates. 

(4) Residual spray testing

(5) Baits

(6) Choice box testing for evaluating 

repellency

Reference is made to 

older CSMA test 

methods and ASTM 

methods. 

The performance 

standard for these tests

was generally 95%.

No performance standard 

stated in the guideline.
Page 20 of 88

Table 9: Guideline 810.3600 (EPA 1998h)

Guideline 

Number & 

Title

Site(s) Pest(s) General Experimental 

Parameters

Treatments Recommended 

Performance 

Standard(s)

810.3600

Structural 

Treatments 

(1998)

Residential and 

commercial indoor 

and outdoor. Those 

sites receiving 

applications of soil 

applied termiticides or 

impregnated wood

products.

Subterranean 

termites, 

dampwood 

termites, 

drywood 

termites

3 large scale field trials Stake method, ground board method and 

modified ground board method – concrete 

slab test.

Wood impregnation – dips, brush-on, 

pressure treatments, dips

Fumigation, absorptive dusts, and liquids 

applied to wood – conduct under field 

conditions

Soil applied termiticides -

100% at 5 years posttreatment against 

subterranean termite 

attack.

Wood impregnated 

products – 100% for 2 

years against subterranean 

drywood and dampwood 

termite attack.

100% against drywood 

termites
Page 21 of 88

Table 10: Guideline 810.3700 (EPA 2010)

Guideline 

Number & 

Title

Site(s) Pest(s) General Experimental 

Parameters

Treatments Recommended 

Performance 

Standard(s)

810.3700

Insect 

Repellents to 

Be Applied to 

Human Skin 

(2010)

Human skin Mosquitoes,

Stable flies,

Black flies

Biting flies 

Ticks 

including 

Chiggers

Positive control is 20% 

DEET in ethanol 

solution.

Laboratory –stable flies and mosquitoes.

Laboratory –

Ticks and chiggers

Field TestsMosquitoes, black flies, biting flies, 

Report Median Complete 

Protection Time 

Mosquitoes -

Aedes aegypti, an 

Anopheles species such as 

An. albimanus, or a Culex 

species, preferably Cx. 

quinquefasciatus. 

Hard ticks – Ixodes 

scapularis, Ix. pacificus,

Dermacentor variabilis, 

and Amblyomma 

americanum. Soft tick -

Ornithodoros turicata;

Chigger -

Eutrombicula splendens; 

or E. cinnabars. 
Page 22 of 88

Table 11: Guideline 810.3800 (EPA 2004)

Guideline 

Number & 

Title

Site(s) Pest(s) General Experimental 

Parameters

Treatments Recommended 

Performance 

Standard(s)

810.3800

Methods for 

Efficacy 

Testing of 

Termite Baits 

(2004)

Subterranean, 

dampwood and 

drywood termites

Lab – three colonies and 

five replicates as a 

minimum. 

Field plots use a 

minimum of 5 reps.

Field plots and area-wide 

field tests structures 

should be evaluated for a 

minimum of two years.

For field studies, 100 

structures should be 

evaluated.

At a minimum, field sites 

should be located in EPA 

Regions 4, 6 and 9. 

Laboratory testing to assess whether the 

bait: Is readily fed upon by termites, 

exhibits slow-acting delayed toxicity, is 

effective at the proposed product label 

concentration with a palatable alternative 

food source concurrently available, and 

causes 100 percent mortality in greater than 

two weeks but less than ten weeks posttreatment at the tested dose.

Reticulitermes flavipes, 

R. virginicus, R. 

hesperus, R. hageni, and 

R. tibialis. Heterotermes 

aureus and Coptotermes 

formosanus

Eliminate infestation in 

12 months. Reinfestation should not 

occur for the following 

12 months.
Page 23 of 88

B. Removing Performance Standards from the Guidelines

As part of its ongoing consideration of the product performance data needed for a 

pesticide product making claims against invertebrate pests, EPA presently envisions including 

the product performance standards as part of the description of the needed data. These standards 

(e.g., 95% mortality for a product claiming to kill an invertebrate pest) would define the levels of 

product performance that would need to be met in order for the studies to support product 

registration and labeling. The agency believes that requiring a pesticide product to meet a 

specified threshold level (performance standard) of effectiveness is the best means to assure that 

the products used to control invertebrate species are effective under conditions of use. 

If a product performance data requirement rule that includes product performance 

standards is finalized, then the existing performance standards will no longer be needed in the 

guidelines. Therefore, at that time, it would be necessary to revise existing guidelines in order to 

remove the performance standards currently contained there. This may also necessitate some 

clarifying text changes to account for removing entire paragraphs and sentences from the 

guidance documents. EPA will also take that opportunity to update the Introduction Section of 

the guidelines to provide up-to-date information on accessing the guidelines.

C. Need for New EPA Guidelines 

The EPA believes that several new guidelines for product performance are needed

because current EPA guidelines do not include guidance on testing certain types of products and 

their use patterns. The new guidelines could include testing procedures and methods for: (1) 

spatial repellents; (2) insecticide impregnated fabrics; (3) attractants and (4) fumigants. Testing 

guidance on the insecticidal uses of RNAi and related technologies for urban pest control 

especially baits, could also be needed. Efficacy assessments of insecticides formulated and 

applied using nanotechnology may also be necessary.

D. Suggested Revisions to OCSPP Product Performance Guidelines 810.3000-36000

General factors and considerations for revisions to OCSPP Guidelines 810.3000-

810.3600 are also being contemplated. General factors include standardizing the approaches to 

testing, protocol development, study reporting and evaluation. EPA believes these guidelines 

require updating to reflect changes to testing practices since 1998. Additionally, EPA is 

considering transforming OCSPP 810.3300 into a topical pet product testing guideline with the 

remaining topics currently covered in that guideline moved to other guidelines. Suggested 

guideline changes and considerations include: 

810.3000 General Considerations for Efficacy of Invertebrate Control Agents

New and revised definitions

Expectations for active ingredient and product specific efficacy data development 

Guidance on protocol development, study execution and reporting study results. 
Page 24 of 88

Data Evaluation Record (DER) template for consideration as a study and 

evaluation reporting tool

Discussion on power analysis as the basis for sample size selection and replication

Data analyses

Data extrapolation

Use of foreign data

Use of public domain data

Role of international guidance and data harmonization

OSCPP Guidelines 810.3100-3600 should (1) provide specific guidance on testing 

methods and (2) present examples of protocols that are considered acceptable by EPA for 

generating product performance data to support product registration. These protocols should be 

specific to laboratory and/or small scale simulated use and/or large scale studies under 

operational conditions as intended by the label. Substantiation of label claims could also be 

included. Each guideline should include an appropriate list of pests that could be tested using the 

guideline and a consideration of international guidance, when appropriate. 

OCSPP 810.3100 Soil Treatments for Imported Fire Ants

Rename the guideline and broaden the content to include testing for ants of public 

health significance 

OCSPP 810.3200 Livestock, Poultry, Fur- and Wool-Bearing Animal Treatments

Restrict content to livestock (beef and/or dairy cattle, pigs, and sheep) and horses

OCSPP 810.3300 Treatments to Control Pests of Humans and Pets

Restrict content to products applied to pets (dogs and cats) such as spot-ons, 

shampoos, and collars

Move pests of humans to other guidelines as appropriate

OCSPP 810.3400 Mosquito, Black Fly, and Biting Midge (Sand Fly) Treatments

Rename to include Mosquitoes and Biting Flies

OCSPP 810.3500 Premise Treatments

Complete revision with guidance and protocols for crawling and flying insects. 

Site specificity in the title should be considered. Consider reference to crawling 

and flying insect pests of public health importance

OCSPP 810.3600 Structural Treatments
Page 25 of 88

Add complete description of USDA-FS laboratory and field protocols for soil 

applied termiticide testing.

Consider adding protocols for testing exterior perimeter treatments that include 

modifications to soil treatments including depth of treatment, rodding and 

trenching, and amount of finished dilution delivered per unit area

Address testing of wood destroying insects other than termites

IX. Changes being Considered for Performance Standards

EPA is considering the performance standards shown in Table 12 because they represent 

widely accepted standards (WHOPES 2009 a-c; EC 2010, HC 2003).

Table 12: Performance Standards for Public-Health Pests

Performance Label Claim Performance Standard

Controls (residual claims) ≥ 95% mortality

Kills (non-residual claims) ≥ 95% mortality

Knockdown ≥ 95% knockdown

Repellency (all repellents except skin applied) ≥ 95% repellency

Skin-Applied Human Repellent ≥ 2-hour complete protection time

Note that the performance standards for mites are different than those in Table 12.

Dust mites pose no direct threat of injury, disease transmission, or discomfort. Dust mites 

are included as public health pests because they produce allergens in their feces and cast 

exoskeleton that can result in asthma and allergic reactions. It is impractical to expect complete 

elimination of the dust mite population in a structure. The focus should be to reduce the agent of 

concern (i.e., the allergen) to acceptable levels. This can be achieved through a reduction in the 

target pest that is less than is generally necessary for a pest that acts directly against its host.

Thus, a performance standard for dust mites of 75% is being considered for surface and fabric 

treatments.

Scabies mites directly infect and are easily transferred among hosts. Therefore, 

performance standards of 100% mortality resulting from products for direct application, surface 

treatment, fabric treatment, application to livestock, or application to pets are being considered. 

A human skin applied topical repellent performance standard of ≥ 2-hour complete protection 

time is under consideration.
Page 26 of 88

Dog follicle mite infestations are typically commensal in nature, but can cause 

demodectic mange in susceptible animals. This can pose a serious risk to stricken individuals, 

which typically have pre-existing immune system issues. For this reason, a 100% performance 

standard is being considered for applications intended to be applied to the pest directly or 

applications against the mite on pets.

X. Important Parameters for Product Performance Testing Guideline Development

For regulatory purposes, an established framework for testing and evaluation should 

exist, not only to ensure generation of high quality data, but also to clearly communicate the 

expectations of pesticide regulators to all stakeholders. This framework should provide clear 

guidance on product performance testing, data development, reporting, and evaluation. 

Parameters to be considered for testing guideline development should include what substance(s) 

to test, characterization of the intrinsic activity of a pesticide against target pests, dose 

determination, evaluation of diagnostic doses when facing insecticide resistant arthropod 

populations, protocol formulation, and deciding what type of experimental test data to generate –

laboratory, small scale simulations of actual use and/or large scale studies under operational 

conditions as intended by the product label in order to determine if a pesticide product performs 

as claimed.

A. Active Ingredient vs. Product Testing 

Testing should be conducted to characterize the intrinsic pesticidal activity of an active 

ingredient. These tests should be conducted for every active ingredient, be relatively 

straightforward, and restricted to the laboratory. Product specific testing should be conducted to 

substantiate “knockdown,” “kill,” “control,” “repel,” or “attract” claims against a target pest or 

pests for a particular use pattern. 

Testing to Determine the Intrinsic Activity of an Active Ingredient

Laboratory testing should be conducted to characterize the intrinsic activity of pesticide 

and provide data on dose-response against pests of major importance. Typically, topical 

applications or another method appropriate to the pesticidal mode of action should be used to 

generate these data.

Dose Determination 

Currently, the product applicant or registrant proposes the test dose(s), usually the lowest 

dose on the proposed label. If no dose is specified (as for example, for testing of repellents), then 

the researcher should submit a protocol for agency review and approval. Other supporting data 

are rarely provided despite the fact that other approaches are commonplace in international 

guidance and in light of a pesticide resistance. Two major types of dose determinations may be 

necessary to characterize a product’s activity against target pests.
Page 27 of 88

Minimum Effective Dose (MED)(FAO 2006)/Lowest Effective Dose (HC 2003)

To establish the MED, it is necessary to demonstrate that it provides one or more of the 

following:

A higher level of effectiveness compared to a lower dose,

A longer persistence of action compared to a lower dose, or

A more consistent performance under variable conditions compared to a lower 

dose.

Diagnostic Dose or Discriminating Dose

The Diagnostic Dose is defined as twice the LD99 of an insecticide (IRAC 2011a,b and 

WHOPES 2009 a,c) and is important to resistance monitoring and detection. 

Minimum effective dose data together with dose-response data for the active ingredient 

and/or product should be provided for all products against the principal target pests. Diagnostic 

dose data may be needed, especially for pyrethroid insecticides as resistance is becoming 

commonplace.

B. Substantiating Efficacy Claims – Product Performance Testing

Label claims describe what the product will do when it is used according to the label’s 

directions. These claims have two major components: (1) the target pest that the product will be 

effective against; and (2) the effect(s) that product use will have on the target pest. Registrants 

also may want to describe the possible benefits resulting from this product application effect. 

These label claims form the core of any efficacy evaluation. Efficacy is assessed mainly in 

relation to the claims made for the product. The guideline testing criteria and performance 

standards set for each pest will further guide these evaluations.

Efficacy claims on product labels may be very specific or very broad in nature. For 

products making claims against specific pests where only activity against one arthropod order or 

a certain family within that order is claimed, only a limited number of pest species will be tested. 

For example: 

a claim stating, "for use against the stable fly..." - may require testing against 

Stomoxys calcitrans. 

a claim stating "for use against cockroaches..." - may require testing against 

Blattella germanica and Periplaneta americana.

For a product claiming a broader or more general spectrum of activity, e.g. use against 

"crawling insects" (such as cockroaches, ants, fleas, etc.) or for use against "flying insect pests" 

(such as house flies, mosquitoes, wasps, etc.), EPA should define the efficacy data sets required 

for such claims. When broad claims, such as those above are made, tests on representative pest 

species will need to be provided for the ranges of pest orders against which efficacy is claimed. 
Page 28 of 88

Where such a claim covers a diverse range of pest habitats and pest morphology/biology, a 

greater number of representative test species will be required. Likewise, claims for the inhibition 

of growth, respiration or exoskeleton production of an organism should be supported by test data 

covering these parameters. Knockdown data must address this specific parameters. Residual 

activity (e.g. "...control of German cockroaches for up to 3 months...") data must adequately 

demonstrate the effect for the time period stated on the label for the claim to be substantiated. 

Much of the product-specific data are generated to support labeled efficacy claims. Thus, 

both guidelines and performance standards must take into account testing against target pests

which must be undertaken to support a labeled claim.

C. Development of Protocols for Product Performance Studies

The first major stage of product efficacy testing is protocol development, which is critical 

to all later stages of product efficacy testing. All protocols must meet the requirements of EPA’s 

Good Laboratory Practices regulations at 40 CFR 160.120, and all other applicable scientific and 

ethical standards. General considerations in developing a protocol for efficacy studies include its 

scientific design, data collection, data analysis and reporting. Additionally, certain protocols 

need review and approval by EPA. Each of these topics is discussed in more detail in the 

following sub-sections.

Scientific Design of Research 

To be scientifically justified, the proposed research should address an important research 

question that cannot be answered by existing data. In addition, the research should be designed 

so that it is likely to provide a definitive answer to the research question. The protocol should 

include a detailed description of the study parameters.

Objectives. The objective of most efficacy testing is to determine if a product 

application made at the lowest proposed label rate (minimum effective dose) kills, repels, 

controls, etc. the target pest. The objective of efficacy testing is to compare the efficacy of one 

treatment to another treatment and/or to an untreated control. In all cases the scientific objective 

should be stated clearly. 

Test materials. Efficacy should be tested using the end-use formulation as 

registered or as proposed for registration. Test materials should be stored at ambient temperature 

and humidity before use. Active ingredients should be tested to demonstrate intrinsic insecticidal 

activity and dose-response efficacy against important or indicator pest species. 

Choice of endpoints and measures. Endpoints chosen for the study should be 

appropriate for the specific objectives of proposed research and likely to provide a robust answer 

to the research question. Considerations in endpoint selection for dose determination include:

Dose determination. To estimate a test dose, a rate of application, typically 

expressed by weight as ounce(s) per square foot or volumetrically as fluid 
Page 29 of 88

ounces per cubic foot is needed. A rate may also be expressed using metric 

system measurements; by weight as mg of test substance/cm2of test surface or 

volumetrically as ml of test substance/cm2 of treated surface. Typically, the 

rate of application from which dose is determined is the lowest application on 

the product label proposed for registration or amendment.

Efficacy. The endpoint of efficacy testing should be selected to show a 

success of efficacy of a test dose applied to kill or repel the test specie(s). 

Efficacy success in a test may be defined as the percent of pests killed or 

repelled by the product treatment. 

Duration. Testing should continue long enough to fairly assess the duration of 

protection provided by the product. Justification for the prescribed testing interval and evaluation 

period should be provided. 

Representative sampling. The results of efficacy testing should ideally be as 

generalized as possible to the target pest populations 

Sample size. The sample should be large enough to be likely to yield a 

definitive answer to the research question being addressed, and its size should 

be justified statistically, taking into account the specific characteristics of the 

proposed research and the required accuracy and precision of the results. 

Researchers are encouraged to consult a statistician to determine appropriate 

sample size. The protocol should fully describe how sample size was 

determined. Other factors that may affect sample size are the number of 

treatments, the experimental design, and the heterogeneity of the sample 

population (e.g., developmental stage, gender, insecticide susceptibility) and 

the environment (different habitat population densities). As stated previously, 

five replications is the recommended minimum.

Untreated control. An untreated control should be included in all testing. The 

number of untreated control replicates should equal the number of replicates for each treatment. 

Positive control/Reference Standard. A positive control may be appropriate under 

some testing circumstances, such as determining the magnitude of pest tolerance or resistance to 

insecticides.

Statistical analysis plan. Protocols should include a full description, explanation, 

and justification for the statistical methods proposed to analyze both dose determination and 

efficacy test results, taking into account the specific study objectives and variables. 

QA/QC plan. Protocols should provide for periodic quality assurance inspections 

adequate to ensure the integrity of the study and consistent with the requirements of EPA’s Good 

Laboratory Practices regulations (40 CFR part 160).

Data Collection and Reporting
Page 30 of 88

Protocols should provide for collection and reporting of data covering all aspects of the 

research. Each protocol should provide for collecting and reporting all elements required by the 

Good Laboratory Practices regulation at 40 CFR 160.120.

Review of Protocols for Product Performance Studies

For insect repellent studies conducted with human test subjects, protocols must be 

submitted to EPA for review and evaluation before the protocol is submitted to the Human 

Studies Review Board. For all other studies, EPA recommends that study protocols be submitted 

to the agency for review before the study is initiated. The submission of protocols is optional but 

recommended, especially for novel approaches to efficacy testing. 

D. Types of Study Designs and Testing Characteristics for Inclusion into EPA Guidelines

Product Performance study designs typically fall into three general categories:

1. Laboratory assay designs to evaluate intrinsic insecticidal activity (efficacy). 

2. Designs simulating actual uses that are conducted under controlled conditions 

(efficacy).

3. Designs evaluating actual use under operational conditions as intended by the 

product label (effectiveness).

Categories 1 and 2 are efficacy evaluations because they are conducted under controlled 

conditions. Most of the data currently submitted to the EPA falls into these two categories. Data 

generated from test designs in category 3 provide data on pesticide product effectiveness, that is, 

the ability of a product to work as claimed under “real-world” conditions. Effectiveness data are 

submitted concurrently or following satisfactory product performance in categories 1 and 2 

testing, and are usually provided for termiticides, mosquitocides, cockroach baits, and some 

products applied directly to livestock and horses or their environs (poultry houses). Effectiveness 

testing provides valuable information on product performance but many field conditions can 

influence the outcome of any particular testing scenario. 

Laboratory Assays to Evaluate Pesticide Activity

These data sets should be provided where appropriate for all products.

Knockdown and Kill/Control Activity

Precise topical application with active ingredient to determine dose-response 

characteristics 

Direct spray application

Exposure to dried insecticide residues on hard porous, hard non-porous, soil, 

leaf and fabric surfaces with evaluations at prescribed intervals 
Page 31 of 88

Repellency (Choice tests – treated vs. untreated area). Modifications of the 

Ebeling box (Ebeling et al. 1966) may be used for surface tests.

Direct application to human skin

Tube or tunnel testing for spatial repellents

Impregnated fabric 

Treated leaf surface

Soil

Baits 

Palatability

Choice test with bait compared to other food sources

No-choice kill efficacy with fresh and aged baits

Experiment Simulating Actual Use that is Conducted under Controlled Conditions 

Testing results should be provided as appropriate for the intended product use or 

uses as follows: 

Small area field plots for evaluating the efficacy of termite baits, soil applied 

liquid termiticides, fire ant products, mosquito adulticide and larvicide 

applications, and wood preservatives. 

Peet-Grady chambers for evaluating indoor foggers, aerosol sprays, and 

vaporizers.

“Hut” or shed assays for evaluating indoor spatial repellency and/or bed nets

Pet product tests - topically applied and impregnated collar for dogs and cats

Outdoor spatial repellents

Skin applied repellents

Pesticide applications made to livestock and horses including feed-through 

larvicide products

Shed tests for fumigants 

Experiment Evaluating Actual Use under Operational Conditions as Intended by the 

Product Label 

Testing should be conducted for:

Termiticides

Wide area insecticide applications intended to control mosquitoes and/or 

biting flies; fire ants and other public health or invasive ant species.

Wide–area application of attractants 

New active ingredients used in cockroach baits

Impregnated fabrics intended to control public health pests
Page 32 of 88

Treatments and Replications

Minimum of a product treatment, an untreated control, and a reference 

standard/positive control.

A power analysis should be performed to help ensure that differences between 

treatments are due to the tested product’s insecticidal or repellent effect. 

Results of the analysis should help inform the number of replications selected. 

Typically, there are a minimum of 5 replicates per treatment.

Generally, there should be a minimum of 5 individuals per replicate except for 

predatory arthropod tests.

The exact number of replications and number of individuals per replicate may 

vary with product type and/or target pest and other factors. Sample size and 

replication should be justified.

E. Execution of Studies

Execution of protocol. In cases where a protocol has been submitted to EPA for 

review, the research can be initiated after the EPA review is completed, and the protocol is 

accepted. 

Quality Assurance (QA) oversight. Efficacy testing, whether conducted in the field 

or in the laboratory, is subject to the Good Laboratory Practices regulations at 40 CFR Part 160. 

These rules require that each testing facility include an independent QA unit and that the QA unit 

monitors execution of each protocol and document its conduct in accordance with the GLP 

regulations. (40 CFR 160.35) 

Deviations from protocol. Even when executing the best-designed and most 

comprehensive protocols, unanticipated deviations from the protocol may occur. All such 

deviations from the protocol and their impact on the research should be fully reported in the 

study report submitted to EPA. (40 CFR 160.185) EPA makes a distinction between planned 

changes to a protocol and deviations from a protocol. Planned changes must be treated as 

amendments to the protocol (40 CFR 26.1108(a)(4)). 

F. Reporting Study Results

In addition to the standard elements described in the GLP regulation at 40 CFR 160.185, 

the primary report of the study should include these elements, as applicable.

Study identification: Title, identifying study number(s), sponsor, study director, 

investigators, name and location of the testing facility, and dates of the study. 

Testing at locations outside the U.S. If tests are conducted outside the U.S., the 

relevance of the study for U.S. regulatory purposes should be justified in the study report.

Approved or intended label directions for use; preferably as a copy of the draft or 

approved product label.
Page 33 of 88

Study objective(s)

Test conditions: Temperature, relative humidity, ambient light and photoperiod, 

and air flow (where applicable).

Test system, including but not limited to:

Test arena(s): construction material, size, and description.

Description of test substance, i.e., product to be tested

Description of each product treatment and the untreated controls

Description and justification for a positive control/reference standard when 

used

Treatment dose and method of application

Number of product treatments

Number of untreated control treatments

Number of replicates per product treatment and untreated control treatment

Test organisms: Genus, species, and strains of susceptible and resistant and/or 

field populations; development stage, age and sex of test pest; rearing 

technique; and numbers per replicate for each product treatment.

Length of exposure period to each treatment when applicable. Include a 

description of the untreated arena used to hold exposed arthropods for 

evaluation following the exposure period.

When appropriate, provide a description of a harborage for test arthropods 

with placement information. 

Report the following data elements:

Test results on all aspects of the research

Copies of all raw data sheets. 

Endpoints for each replicate of every treatment 

Endpoint for each treatment

Certification of the test substance’s identity and origin

A copy of the protocol with all amendments and deviations

Justification for selecting the approach to data analysis and statistical testing.

A copy of the statistical analyses

The report should include a discussion of the study results and conclusions based 

on treatment endpoints. Conclusions should state why and how the study results do or do not 

support the tested hypothesis.

The following record-keeping requirements apply to some or all records of research 

covered by these guidelines: The record-keeping requirements of 40 CFR §160.190 and 

§160.195 of any study conducted under the Good Laboratory Practices (GLP) rule.

G. Standardizing Data Evaluation Record (DER) Content and Format

The agency is considering the adoption of a standardized DER format for completed 

study review. A copy of the draft DER template is attached as Appendix 2.
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XI. Availability of International Guidance for EPA’s Consideration during Guideline 

Revisions

With the increases in pesticide production and sales, pesticide regulation is increasingly

assuming a global perspective, which has led country level regulatory agencies and international 

organizations to work towards harmonization of pesticide data requirements and approaches to 

testing. International organizations such as the World Health Organization Pesticide Evaluation 

Scheme; the Organization for Economic Cooperation and Development (OECD), Food and 

Agricultural Organization of the United Nations (FAO), and the European Union promote 

policies, strategies and guidelines supporting these efforts, while assisting and monitoring their 

implementation by member states (add references here). In an effort to work within this 

emerging global framework, international guidance and data requirements of importance to EPA 

efficacy data requirements and guideline development are discussed below with 

recommendations for their consideration and/or inclusion. (Please also see IRAC 2011a for a 

summary of testing methods.) 

A. World Health Organization (WHO) 

The WHO Pesticide Evaluation Scheme (WHOPES) promotes and coordinates the testing 

and evaluation of pesticides for public health, especially those used for control of arthropod 

disease vectors WHOPES 2013). WHOPES provides guidelines on public health pesticides 

testing that focus on the intrinsic insecticidal activity of an active ingredient and product specific 

efficacy and effectiveness under operational conditions. It also provides guidance on insecticide 

resistance testing and evaluation. WHOPES guidelines generally consist of a tiered approach to 

testing consisting of three-phases: Phase I - laboratory testing; Phase II - small-scale field trials 

under controlled conditions; and Phase III - large scale testing under operational conditions. A 

95% level of performance is generally expected in WHOPES testing although long–term field 

trials may have slightly lower levels of performance. The following guidelines are being 

considered for incorporation into EPA’s guidelines, as appropriate.

WHO/CDS/NTD/WHOPES/2009.2 Guidelines for efficacy testing of insecticides for 

indoor and outdoor ground-applied space spray applications (WHOPES 2009a)

This document provides specific and standardized procedures and criteria for efficacy 

testing and evaluation of insecticides for indoors and outdoors, ground-applied space sprays 

applications against vectors and pests of public health importance. These methods could be

incorporated into OCSPP Guideline 810.3400 and OCSPP 810.3500 where applicable.

WHO/CDS/NTD/WHOPES/2009.3 Guidelines for efficacy testing of household 

insecticide products - Mosquito coils, vaporizer mats, liquid vaporizers, ambient 

emanators and aerosols (WHOPES (2009c)
Page 35 of 88

This document provides specific and standardized procedures and criteria for efficacy 

testing and evaluation of specific household insecticide products intended for indoor use against 

mosquitoes, namely, mosquito coils, vaporizer mats, liquid vaporizers, ambient emanators and 

aerosols. These methods could be incorporated into OCSPP Guideline 810.3500.

WHO/CDS/WHOPES/GCDPP/2005.13 Guidelines for laboratory and field testing 

of mosquito larvicides (WHOPES 2005b)

This document provides specific and standardized procedures and guidelines for testing 

larvicides, including bacterial larvicides and insect growth regulators against mosquitoes. These 

methods could be incorporated into OCSPP Guideline 810.3400. 

WHO/CDS/NTD/WHOPES/2009.4 Guidelines for efficacy testing of mosquito 

repellents for human skin (WHOPES 2009b)

This document provides specific and standardized procedures and criteria for efficacy 

testing and evaluation of mosquito repellents for human skin. The methods in this guideline 

could be incorporated into OCSPP Guideline 810.8700 for skin applied repellents provided the 

data collection meets U.S. regulations for human subject testing.

WHO/CDS/NTD/WHOPES/GCDPP/2006.3 Guidelines for testing mosquito 

adulticides for indoor residual spraying and treatment of mosquito nets WHOPES 

2005a).

This document provides specific and standardized procedures and guidelines for testing 

mosquito adulticides for indoor residual spraying and for treatment of mosquito nets. The 

methods and procedures described in this guideline should be considered as the basis for the bioefficacy test methods in a new OCSPP Guideline on Insecticide Impregnated Materials.

B. Organization for Economic Cooperation and Development (OECD)

OECD is an intergovernmental organization in which representatives of 34 industrialized 

countries in North and South America, Europe and the Asia and Pacific region, as well as the 

European Commission, meet to co-ordinate and harmonize policies, discuss issues of mutual 

concern, and work together to respond to international problems (OECD 2013a). The OECD 

Guidelines for the testing of chemicals are a collection of the most relevant internationally 

agreed testing methods used by governments, industry and independent laboratories to assess the 

safety and efficacy of chemical products (OECD 2013b). Development of efficacy testing 

guidance for non-crop products has begun recently and “Guidance Document on Assays for 

Testing the Efficacy of Baits against Cockroaches” was published in January of 2013 (OECD 

2013c). This document provides guidance on conducting laboratory tests to determine and assess 

the efficacy of test substances and/or the effectiveness of test products used as baits for the 

control of cockroach species in indoor environments. A 95% level of bait product performance is 

recommended. The methods and procedures described in this guidance could be incorporated 
Page 36 of 88

into OCSPP Guideline 810.3500.

C. European Union (EU)

EU guidance on product specific efficacy data requirements is based largely on efficacy 

claims appearing on the product label (EC 2008). The European Commission (EC) has 

developed guidance for efficacy data requirements, testing, and evaluation for biocidal products, 

which for the EU includes insecticides, repellents and attractants (EC 2010). Similar guidance is 

not always included or only briefly described in EPA product performance guidelines. As a 

result, registrants lack needed guidance to generate data sets and continually request clarification 

on claim specific testing guidance to support their proposed labeling. The Swedish Chemicals 

Agency (KEMI) (2012) has published a summary on biocidal product testing methods that also 

includes a discussion of label claims.

Regulations for Biocidal Products refer to data supporting efficacy claims in paragraph 51

of Annex VI of the Directive (Common Principles for the Evaluation of Dossiers for Biocidal Products)

(EC 1998), which states:

Data shall be submitted and evaluated to ascertain if the efficacy 

claims of the biocidal product can be substantiated. Data submitted 

by the Applicant or held by the Member State must be able to 

demonstrate the efficacy of the biocidal product against the target 

organism when used normally in accordance with the conditions of 

authorization.

The label claims for the product must be submitted as part of the common core data set, 

as set out in Annex IIB (Common Core Data Set for Biocidal Products):

The proposed label claims for the product and efficacy data to 

support these claims, including any available standard protocols 

used, laboratory tests, or field trials, where appropriate.

As the label claims are central to the efficacy evaluation for a biocidal product, it is 

important to understand exactly what an efficacy claim is, and be able to identify the individual 

components of a claim. The EC has provided a description of these components which are 

attached as Appendix 4.

EU Efficacy Testing Methods and performance standards and labeling are summarized in 

“Technical Notes for Guidance Insecticides, acaricides and products to control other arthropods 

(PT 18) and Repellents and attractants (only concerning arthropods) (PT19)” (EC 2010) and the 

Technical Notes for Guidance (TNsG) for Product Evaluation (EC 2008).

D. Food and Agriculture Organization of the United Nations (FAO)

An intergovernmental organization, FAO has 191 Member Nations, two associate 

members and one member organization, the European Union. The FAO, in cooperation with the 
Page 37 of 88

plant science industry and other international organizations, including NGOs, developed a 

voluntary code of conduct, known as the International Code of Conduct, to provide a 

comprehensive standard for pesticide activities and serve as a point of reference in relation to 

sound pesticide management practices. Guidance documents haver been developed that pertain 

to pesticide efficacy, registration and data requirements. Much of the efficacy guidance pertains 

to plant protection products, but the underlying framework of this guidance is applicable across 

pesticide product types and use patterns (FAO 2006, 2010, and 2013).

XII. Extrapolating from Other Sources of Efficacy Data

There are two main (partly overlapping) approaches to limiting the number of efficacy 

trials required for registration: extrapolation or the use of data from other countries; and use of 

data from the public domain that is available in recognized peer reviewed science journals. In 

addition to reducing the number of trials, these approaches can also be used to narrow down the 

scientific objectives of the U.S. studies to more specific questions or problems that have not yet 

been solved by foreign trials, thus increasing the efficiency and value of national studies. 

However, data from U.S. studies will remain an important source of information for efficacy 

evaluation. 

Data extrapolation (bridging) refers to a situation where a full efficacy data set has 

already been accepted by the EPA for a specific product use pattern and target pest(s) whereby 

additional pest control claims are proposed based primarily on scientific rationale and existing 

data. 

For control of one target pest to another closely related one, either with the same 

use pattern and/or site; 

For control with one type of product formulation to data from a different one, but 

containing the same level of active ingredient(s), that are applied at the same or lower rate. 

Extrapolation may be used to form either all or part of the data package submitted for a 

given registration request. Various factors are important when considering if extrapolation is 

appropriate: If a product has already been tested rigorously under variable environmental or pest 

conditions and still performed consistently, extrapolation will be easier compared to a data set 

that contains variable results. A sound biological basis for extrapolation is essential. Close 

taxonomic relationship may be sufficient justification but taxonomy is not always well correlated 

with the biology and behavior of the target organism(s). Therefore, all aspects of pest biology 

and behavior as well as use pattern and site should be carefully considered when making and 

evaluating a case for extrapolation. 

A. Using Efficacy Data from Other Countries 

Efficacy data from other countries may be used to satisfy product performance data 

requirements under some circumstances. The data may be acceptable provided the pest pressure 

and biology, and climatic conditions are comparable to the situation encountered in the country 

where the product is to be authorized. Most often, foreign data are submitted for the same pest, 

but they may sometimes also be used to support extrapolation to other pests. 

The advantage of foreign trials data is that they may be readily available, thus providing a 

larger data set for the registration authority to base its efficacy evaluation on. A disadvantage 
Page 38 of 88

may be that a more in-depth assessment of such data is needed to ensure that the results are 

relevant to the national situation. Also, foreign trial protocols may be different from the ones 

required for national registration, thus complicating evaluation of the results. 

Use of foreign data is more common in agricultural efficacy trials. Many countries accept 

trials data from other countries as part of the registration dossier, on the condition that the 

registrant can justify comparability or relevance. Whether the use of foreign data is appropriate 

needs to be assessed on a case-by-case basis. Increasingly, however, registration authorities of 

neighboring countries are setting up agreements in which trial data from specific pest/crop 

combinations are accepted for an entire group of countries. One option being investigated is the 

definition of comparable agro-climatic or cropping zones within which efficacy trials are 

expected to provide similar results. 

Such mutual acceptance of data can reduce the costs of field testing and may increase the 

speed of registration. It will also increase the number of trials that a registration authority can use 

for its efficacy evaluation, e.g. from a wider range of conditions, which may improve the quality 

of the evaluations.

B. Use of Public Domain Data from Science Literature

Suitable efficacy information may have been published in scientific journals, books or 

other reliable public data sources. The advantages and disadvantages of using public domain 

evidence are similar to using foreign trials data. An additional advantage is that publications in 

peer-reviewed journals or books have generally been submitted to a quality check, reducing the 

risk that inappropriate methods were used or incorrect conclusions drawn. However, public 

domain data may be summarized which means that the raw data are not available for review, 

thus it becomes difficult to assess if the data are comparable or relevant to the U.S. situation.

XIII. List of References

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Pests of Humans and Pets. Available at: 

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Biting Midge (Sand Fly) Treatments. Available at: 

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Available at: http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series810.htm

(accessed 29 January 2013).

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Available at: http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series810.htm

(accessed 29 January 2013).

EPA (2002) Pesticide Registration (PR) Notice 2002-1: List of Pests of Significant Public Health 

Importance. Available at: http://www.epa.gov/PR_Notices/pr2002-1.pdf (accessed29 January 

2013).

EPA (2004) Product Performance Test Guidelines OCSPP 810.3800: Methods for Efficacy 

Testing of Termite Baits. Available at: 

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January 2013).

EPA (2006) Pesticide Registration (PR) Notice 2000-6: Minimum Risk Pesticides Exempted 

under FIFRA Section 25(b) Clarification of Issues. Available at: 

http://www.epa.gov/PR_Notices/pr2000-6.pdf (accessed 29 January 2013).

EPA (2010) Product Performance Test Guidelines OCSPP 810.3700: Insect Repellents to be 

Applied to Human Skin. Available at: 

http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series810.htm (accessed 29 

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EPA (2011) Label Review Manual (pages 4-8&9). Available at: 

http://www.epa.gov/oppfead1/labeling/lrm/chap-04.pdf (accessed 29 January 2013)

EPA (2012) DRAFT Product Performance Test Guidelines OCSPP 810.3900: Testing Methods 

for Bed Bug Pesticide Products. Available at: 

http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series810.htm (accessed 29 

January 2013).

EPA (2013) OCSPP Harmonized Test Guidelines Series 810 – Product Performance Test 

Guidelines. Available at: 

http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series810.htm (accessed 29 

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EPA (2013b) Good Laboratory Practices (GLP) 40 CFR part 160. Available at: 

http://www.gpo.gov/fdsys/pkg/CFR-2011-title40-vol24/xml/CFR-2011-title40-vol24-

part160.xml (accessed 29 January 2013). 

FAO (2006) International Code of Conduct on the Distribution and Use of Pesticides: 

Guidelines on Efficacy Evaluation for Registration of Plant Protection Products. Food and 

Agricultural Organization of the United Nations, Rome, Italy. Available at: 

http://www.fao.org/ag/AGP/AGPP/Pesticid/Code/Download/Efficacy06.pdf (accessed 29 

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of Pesticides: Guidelines for Registration of Pesticides. Food and Agricultural Organization of 

the United Nations, Rome, Italy. Available at: 

http://whqlibdoc.who.int/hq/2010/WHO_HTM_NTD_WHOPES_2010.7_eng.pdf (accessed 29 

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Guidelines on Data Requirements for Registration of Pesticides. Food and Agricultural 

Organization of the United Nations, Rome, Italy. Available at: 

http://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/Code/DataReq201

3.pdf (accessed 29 January 2013).

FR (1999a) Executive Order 13112, (64 FR 6183) (February 8, 1999. Available at: 

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FR (1999b) Executive Order 13112. (64 FR 6184) (February 8, 1999). Available at: 

http://www.gpo.gov/fdsys/pkg/FR-1999-02-08/html/99-3184.htm (Accessed 4 February 2013).

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Regulatory Directive: Efficacy Guidelines for Plant Protection Products. Available at: Available 

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(2009) Insecticide options for protecting ash trees from emerald ash borer. North Central IPM 

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Insecticide Resistance in Vectors of Public Health Importance. Available at: http://www.iraconline.org/content/uploads/2009/09/VM-Layout-v2.6_LR.pdf (Accessed 4 February 2013.
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Household Pests. 9th Ed., 1397 pp. GIE Media, Inc., Richfield, OH USA.

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oclanguage=en (accessed 29 January 2013). 

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(December 2005). Available at: 

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mosquito nets. Ref: WHO/CDS/WHOPES/GCDPP/2005.11. Available at: 

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January 2013).

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Page 44 of 88

APPENDIX 1

Pest Tables

Table I: Pests of Significant Public Health Importance

Table II: Wood Destroying Insects
Page 45 of 88

Table 1. Pests of Significant Public Heath Importance

Dermatophagoides farinae American Dust Mite

Dermatophagoides pteronyssinus European Dust Mite

Scabies Mites Family Sarcoptidae 3

Family Linognathidae 3

Family Haematopinidae 3

Hair Mites (includes Dog Follicle Mite) Family Demodicidae Demodex spp.

Chiggers 1 b Family Trombiculidae Trombicula spp. Chiggers

Ticks Order Ixodida4, as specified

Hard Ticks 2 a Family Ixodidae All Hard Ticks

Soft Ticks 2 b Family Argasidae All Soft Ticks

Cattle Ticks 2 c Family Ixodidae Rhipicephalus (Boophilus) spp. Cattle Tick

Scorpions 3 Family Buthidae Centruroides spp. Scorpions

Order Araneae, as specified

4 a Family Theridiidae Latrodectus spp. Black Widow & Related Spiders

Family Sicariidae Loxosceles reclusa Brown Recluse Spider

Family Agelenidae Tegenaria agrestis Hobo Spider

Cheiracanthium spp.

Trachelas spp.

Centipedes 5 Genus Scolopendromorpa 3 Centipedes

Pediculus humanus capitis Head Louse

Pediculus humanus humanus Body Louse

Species Pthiridae Pthirus pubis Crab Louse

Family Menoponidae 3

Family Boopidae 3

Family Gyropidae 3

Family Trichodectidae 3

Family Philopteridae 3

Order Siphonaptera, as specified

Ctenocephalides felis Cat Flea

Ctenocephalides canis Dog Flea

Echidnophaga gallinacean Sticktight Flea

Pulex irritans Human Flea

Xenopsylla cheopsis Oriental Rat Flea

Hectopsyllidae Tunga penetrans Chigoe Flea

Taxon/Taxa Included

Dust Mites Dermatophagoides

Species Included Common Name of Pest Group or Species Pest 

Group

SubgroupCommon Name of Taxonomic 

Group

Species

Rank of Included 

Taxon/Taxa1,2

Clubionidae Sac Spiders

Lice

6 a

Ectoparasitic Mites

Pulicidae

Fleas

Pediculidae

Spiders

Family

Species

7

4

2

1 a
Page 46 of 88

Table 1. Pests of Significant Public Heath Importance (continued)

Order Blattariac, as specified

Species Blattella germanica German Cockroach

Species Supella longipalpa Brownbanded Cockroach

Species Blatta orientalis Oriental Cockroach

Species Periplaneta australasiae Australian Cockroach

Species Periplanetta americana American Cockroach

Species Hippoboscidae Elophagus ovinus Sheep Keds

Species Oestridae Dermatobia hominis Human Bot Fly

Genus Oestridae Gasterophilus haemorrhoidalis Nose Bots

Gasterophilus intestinalis Horse Bots

Gasterophilus nasalis Throat Bots

Family Calliphoridae Cochliomyia hominivorax Screwworm

Cochliomyia macellaria Secondary Screwworm

Family Calliphoridae Calliphoridae spp. Blow Flies

Pollenia rudis Cluster Flies

Musca autumnalis Face Fly

Musca domesticus House Fliy

Family Fanniidae Fannia canicularis Little House Fly

10c Family Sarcophagidae Sarcophagidae spp. Flesh Flies

Culex spp. Culex

Culiseta spp. Culicseta

Aedes spp. Aedes 

Ochlerotatus spp. Ochlerotatus

Anopheles spp. Anopheles

Psorophora spp. Psorophora

Coquillettidia spp. Coquillettidia

12a Genus Tabanus All Horse Flies

12b Genus Chrysops All Deer Flies

Stomoxys calcitrans Stable Fly

Haematobia irritans Horn Flies

Lutzomyia spp.

Phlebotomus spp.

12e Family Ceratopogonidae Culicoides spp. Punkies, Biting Midges, Granny Nippers

Simulium spp.

Prosimulium spp.

Pest 

Group

SubgroupRank of Included 

Taxon/Taxa1,2 Taxon/Taxa Included Species Included

Muscidae

Family

Mosquitoes

Culicidae

1 1

Cockroaches

Blattellidae

Blattidae

Common Name of Taxonomic 

Group

Family

Common Name of Pest Group or Species

Family

12c

10b

10a

1 0

Keds, Bot Flies, and Screwworms

Filth Flies

Biting Flies

Sand Flies

12f Simuliidae Black Flies

Family

Family

12d Psychodidae

1 2

Muscidae

9 b

9 a

8
Page 47 of 88

Table 1. Pests of Significant Public Heath Importance (continued)

13a Species listed Cimicidae Cimex spp. Bedbug

Reduvius personatus Masked Hunter

Triatoma spp. Kissing Bugs, Conenosed Bugs

Infraorder :Aculeata 

(stinging only)

Apoidea Bees

Apidae spp. Cuckoo, Bumble and Honey Bees

Apis mellifera Honey bee and Africanized (Killer) Bee

Bombus spp. Bumble bees

Andrenidae All Mining Bees

Colletidae All Plasterer, Masked, & Yellow-faced Bees

Halictidae All Sweat Bees

Megachilidae All Leaf-cutter & Mason Bees

"Wasps"

Sphecidae All Digger Wasps & Mud Daubers

Crabronidae All Cicada Killers

Vespoidea Wasps

Vespidae Vespinae spp. Hornets & Yellow Jackets

Vespula spp. Yellow Jackets

Dolichovespula spp. Hornets & Yellow Jackets

Vespa spp. Hornets

Polistinae spp. Paper Wasps

Eumeninae spp. Potter wasps

Pompilidae All Spider & Tarantula wasps

Mutilidae All Velvet ants

Species listed Monomorium pharaonsis Pharoah Ant

Species listed Linepithema humile Argentine Ant

Species listed Pogonomyrmex spp. Harvester Ant

Species listed Solenopsis spp. Fire Ant 

Species Included Common Name of Pest Group or Species Common Name of Taxonomic 

Group

Pest 

Group

SubgroupRank of Included 

Taxon/Taxa1,2 Taxon/Taxa Included

Ants, except Carpenter Ants

True Bugs Reduviidae

15a

Apidae

Taxa listed

13b

Stinging Bees and Wasps 1 4

1 3

1 5
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Table II. Wood Destroying Insects

Carpenter Ants 16 Genus Camponotus All Carpenter Ants

Wood Destroying Beetles Species listed Oedemeridae Narcerdes melanura Old Wharf Borer

Family Anobiidae Anobiidae spp. Anobiid Beetles

Family Bostrichidae Bostrichidae spp. Bostrichid Beetles

Termites Order4 All All Termites

Family Rhinotermitidae Reticulitermes spp. Subterranean Termites

Heterotermes spp. Desert Subterranean Termites

Coptotermes fomosanus Formosan Termite

Family Kalotermitidae Kalotermes spp. Drywood Termites

Incisitermes spp.

Marginitermes spp.

Cryptotermes spp.

18c Family Termitidae Nasutitermes spp. Arboreal termites

18d Family Termopsidae Zootermopsis spp. Dampwood Termites

6 For products intended for the protection of and for direct application to pets, testing of three species, Blacklegged tick ( Ixodes scapularis ), American dog tick ( Dermacentor variabilis ), and Brown dog 

tick ( Rhipicephalus sanguineus ).

1All claims against pests within the specified taxonomic rank are to be supported by the submission of data. If representative taxa are provided, species specific data may not be required, as the group and 

any/all individual species within the group can be supported by supporting the general claim.

2Claims against specific vector/disease combinations are to be supported by testing of the specified vector.

3Each species against which a claim is to be made is to be tested 

4 The taxonomic rank is contested. The specified group is considered to be either an Order or Sub-Order by most authorities. 

5 If carpenter ants are also tested, per Table 2, a general claims against ants is supported.

Common Name Common Name of Taxonomic 

Group

Pest 

Group

SubGroupRank of Included 

Taxa Taxon/Taxa Included

18

18a

18b

17

Species
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APPENDIX 2

Product Performance Study

Draft Data Evaluation Record (DER)
Page 50 of 88

Primary Reviewer’s Name/Title:

STUDY TYPE: PRODUCT PERFORMANCE [OCSPP GUIDELINE NO]

MRID: [ MRID number; study title, author and year]

DP BARCODE: [ ]

DECISION NO: [ ]

SUBMISSION NO: [ ]

 

 SPONSOR: [NAME AND ADDRESS]

TESTING FACILITY: [NAME AND ADDRESS]

STUDY DIRECTOR or 

INVESTIGATOR:

SUBMITTER:

[NAME AND TITLE]

[NAME AND TITLE]

STUDY COMPLETED: [DD/MM/YYYY]

CONFIDENTIALITY 

CLAIMS:

[ ]

GOOD LABORATORY 

PRACTICE:

[List information from GLP statement in study]

TEST MATERIAL:

PROPOSED EFFICACY 

CLAIMS ON LABEL: 

 

[PRODUCT NAME]

[EPA REGISTRATION NUMBER OR FILE SYMBOL]

[ACTIVE INGREDIENT NAME] [CHEMICAL NAME] 

[A.I. %] [PC CODE] [CAS NO.] [FORMULATION 

TYPE]

[PRODUCT APPLICATION RATE(S) lbs/square foot 

and/or per 1000 square feet and g/m2 ]

[ACTIVE INGREDIENT APPLICATION RATE(S): 

lbs/square foot and/or per 1000 square feet and g/m2]

[LIST NEW EFFICACY CLAIMS FROM LABEL]
Page 51 of 88

Product Performance Study Data Evaluation Record 

Title: 

Purpose/Objective: State study purpose/objective. 

Materials and Methods

Test Location: If testing is conducted outside of the U.S., the relevance of the study for U.S. 

regulatory purpose should be justified.

Test Material(s): describe test material(s). 

Test Dose/Application Rate: State the dose/application rate used in the study; is it equivalent to 

the proposed label rate?

Positive Control/Reference Standard, if used: 

Test Species Name, Life Stage, Sex and Age: state common name and scientific name of each 

species; state life stage as egg or nymph or larvae including stadia; or adult and sex and age. 

Describe the insecticide susceptibility status of the test population and origin of field collected 

strains. If female adults are used - are they gravid? Refer to rearing techniques.

Test System: 

Describe how each experiment was conducted: 

List the treatments including the untreated control. Include a description of: 

Describe test arenas and/or apparatus (include site description and location).

Method(s) of application

Number of replicates per treatment

Number of individuals per replicate

Length of exposure to treatment (time in seconds, minutes or hours): Were tested specimens 

transferred to clean containers? 

Experimental conditions (state relative humidity, temperature, and photoperiod)

Describe the harborage if used in the experiment
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State the data and/or endpoints that were recorded.

Data Reported

Results 

The study report should include the following information 

Test results on all aspects of the research

Copies of all raw data sheets

Endpoints for each replicate of every treatment 

Endpoint for each treatment

Certification of the test substance’s identity and origin

A copy of the protocol with all amendments and deviations

Justification for selecting the approach to data analysis and statistics used

A copy of the statistical analyses

Describe any protocol amendments and deviations 

Describe and report experimental results in the untreated controls and treatments. This should be 

done in paragraph form with bullets and/or in table form.

State if the data were corrected using Abbott’s Formula or another applicable formula that 

accounts for untreated control mortality in the treatment results

State how the data were analyzed. What level of significance was used? What were the 

confidence intervals around the mean value(s)? Was a median value also reported? 

Conclusions

Summarize the study conclusions. Conclusions should state why and how the study results do or 

do not support the tested hypothesis/objectives. 

1. Was control mortality greater than 10%? If so, the study is unacceptable.

Recommendations

1. Is the study acceptable? If not, what are the deficiencies and data gaps? Can the study be 

upgraded or will a new study be needed? 

2. Does the study support the addition of the pest or pests to the product label as proposed? State 

the pests and site/pest combinations supported by the data where applicable.
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3. Compare study results to the list of new label claims and make recommendations as to 

whether or not the efficacy data supports each claim.
Page 54 of 88

APPENDIX 3

EPA Definitions

(Including Public Health Claim)
Page 55 of 88

EPA Definitions (including Public Health Claim)

EPA believes that definitions will be needed to assure a common understanding: 

 

Alien species means1, with respect to a particular ecosystem, any species, including its 

seeds, eggs, spores, or other biological material capable of propagating that species, that is not 

native to that ecosystem.

Bait treatment means

2

a pesticide product that kills or controls an invertebrate pest, such 

as, ants, cockroaches, termites or other wood-destroying pests and has at least two principal 

components: A bait matrix, intended to be the equal of or preferred to other available sources of 

food, and a pesticide incorporated into the bait matrix that is intended to kill the invertebrate 

pest.

Complete protection time (CPT) means

3

the time from application of a repellent until 

efficacy failure, as defined in the protocol used to conduct the study. 

Control means to provide residual kill of individuals of a species defined as a pest from 

a site or to suppress the ability of the species to reproduce so that the growth of the pest 

population is impaired for a specified duration following pesticide product application.

Direct application to pest means the product is applied directly to the pest organism 

itself. Pesticides in this category are often used to control flying insects (e.g. flies and wasps). 

Fabric treatments encompass two types of treatments. A fabric surface treatment means 

any application of a pesticide to cloth or clothing. This can include spray-on, or other treatments 

performed by the user before wearing the clothing or using the article, or treatments performed 

 

1 This definition was taken from Executive Order 13112, signed by President Clinton, on February 3, 1999, (64 FR 

6183).

2 This definition is similar to the definition for “termite bait” in OPPTS Guideline 810.3800.

3 This definition is very similar to that found in OPPTS Guideline 810.3700.
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by a manufacturer. An impregnated fabric treatment means cloth or clothing that is treated by 

the manufacturer in a specific way such that the pesticide is bound to the fabric. 

General label claim means a statement on the label of the pesticide product that the 

product is effective against a related group of invertebrate species, such as ticks, mosquitoes, or 

cockroaches.

Genus (plural genera) means a hierarchy of biological classification which includes

several related species that exhibit similar characteristics. 

Group means a set of related species or taxa demonstrating adequate similarity in basic 

biology and life history characteristics to permit identification of representative test species for 

the entire assemblage of taxa.

Invasive species means

4

an alien species whose introduction does or is likely to cause 

economic or environmental harm or harm to human health. 

Invertebrate control pesticide product means5any pesticide product which is intended to 

destroy, repel, mitigate, or prevent or inhibit the establishment, reproduction, development or 

growth of any invertebrate species declared to be a pest.

Invertebrate public health pest means an invertebrate species which poses a risk to man, 

by transmitting pathogens which cause disease, harm, allergic reactions, and life threatening 

situations. 

Introduction means6the intentional or unintentional escape, release, dissemination, or 

placement of a species into an ecosystem as a result of human activity.

Kills means the mortality of the target pest as a result of feeding or contacting a pesticide. 

 

4 This definition was taken from Executive Order 13112, signed by President Clinton, on February 3, 1999. (64 FR 

6183).

5 This definition is similar to the definition for “invertebrate control pesticide” found in OPPTS Guideline 810.3000.

6 This definition was taken from Executive Order 13112, signed by President Clinton, on February 3, 1999. (64 FR 

6183).
Page 57 of 88

Knockdown means7that following the application of the insecticide, the insect is 

disabled, i.e., the insect is unable to maintain its normal functioning mode or there is a state of 

intoxication and partial paralysis which usually precedes death.

Percent control (% control) means the numerical comparison of the pre- and posttreatment pest population counts when evaluated according to a recognized treatment program 

under actual field conditions. 

Percent mortality (% mortality) means the numerical comparison of the numbers of dead 

insects or other arthropods as determined by pre- and post-treatment counts or other measures 

correlated to population pressures against a vulnerable life stage(s) of the target pest.

Percent repellency (% repellency) means the numerical comparison of the numbers of 

insects or other arthropods being driven away from a surface treated with a pesticide compared 

to an untreated surface, or being driven away from a three dimensional space treated with a 

pesticide compared to an untreated space.

Performance label claim means the effect of the product on the target pest asserted on 

the label.

Performance standard means a benchmark or reference against which the ability of the 

pesticide product to control or repel an invertebrate pest species is compared.

Pest-specific label claim means a statement on the label of the pesticide product

indicating that the product is effective against a particular invertebrate species such as German 

cockroach or black gnat.

Preventive/Remedial treatments for wood impregnation means8dips, brush-on 

applications, sprays, or pressure treatments applied to susceptible wood materials. Treatments 

can be preventive (i.e., to provide structural protection before an infestation is present) or 

remedial (i.e., to kill and control an infestation when present). 

 

7

Partially derived from Wickham et.al. Pesticide Science Vol. 5, Issue 5, pages 657-654, October 1974

8 This definition is derived from information in OPPTS Guidelines 810.3600 and 810.3800.
Page 58 of 88

Repellency refers to insects or other arthropods being driven away from a surface or 

space treated with a pesticide.

Representative test species means a species whose response to a pesticide treatment is 

substantially similar to that of other members of the same taxa. For example, the German 

cockroach and the American cockroach are the representative test species for all cockroaches for 

determining the efficacy of a pesticide product.

Skin-applied human repellent means9a product intended to disrupt the host-seeking 

behavior of insects or other arthropods, driving or keeping them away from treated human skin. 

The repellent product, such as liquid, lotion, or spray, is intended to be applied directly to human 

skin.

Soil-applied termiticides means10 pesticide products that are applied to the soil beneath 

and adjacent to the structure, pre- or post-construction to kill or control termites. Treatments can 

be preventive (i.e., to provide structural protection before a termite infestation is present) or 

remedial (i.e., to kill and control a termite infestation when present). 

Spatial treatments include both indoor and outdoor sites. During these treatments 

pesticides are disseminated into the air in enclosed areas (e.g., aerosol or fumigant applications, 

or vaporizing strips), or directly into the atmosphere including, but not limited to, coils for 

controlling mosquitoes, ultra low volume applications for public health pests (e.g. mosquito 

abatement), and misting systems. 

Species means11 a group of organisms all of which have a high degree of physical and 

genetic similarity, generally interbreed only among themselves, and show persistent differences 

from members of allied groups of organisms.

Subgroup means a set of related species or taxa demonstrating adequate similarity in 

basic biology and life history characteristics to permit identification of representative test species 

 

9 This definition is taken from OPPTS Guideline 810.3700.

10 This definition is derived from information in OPPTS Guidelines 810.3600 and 810.3800.

11 This definition was taken from Executive Order 13112, signed by President Clinton, on February 3, 1999. (64 FR 

6183).
Page 59 of 88

and part of a larger identified taxonomic grouping (e.g., Biting flies) that includes other pests 

species, which may or may not have a proposed pest group.

Surface treatments include both indoor and outdoor sites. These treatments are applied 

to inanimate surfaces (e.g. walls, floors, door and window sills; crack and crevice treatments), 

often to create a residual effect that will kill pests not present at the time of application. Such 

pests include, but are not limited to, cockroaches, bed bugs, ants, and centipedes. Products 

include but are not limited to sprays, pour-on treatments, baits and trap treatments. 

Structural protection means

12 the elimination or prevention of termite or other wooddestroying pest activity in a structure as a result of a preventive or curative application of a 

pesticide product.

Taxon (plural taxa) means a population of organisms which have characteristics in 

common, differentiating the population from other populations

Wood-destroying applies to pests that feed on wood, and therefore are highly destructive 

to wood buildings or structures, and stored lumber. The impact on the structural integrity of 

buildings can represent significant economic or safety concerns given the costs of remediation. 

Vector means

13 any organism capable of transmitting the causative agent of human 

disease, including but not limited to mosquitoes, flies, fleas, cockroaches, ticks, or mites.

 

12 This definition is very similar to that in OPPTS Guideline 810.3800.

13 This definition is similar to that in FIFRA 2(oo).
Page 60 of 88

Public Health Claim

A public health claim is asserted if one or more of the following apply:

--A claim is made to control, kill, knockdown, and/or repel specific invertebrate 

organisms that are directly or indirectly infectious or pathogenic or injurious to man (or both 

man and animals). For example: A claim is made to repel mosquitoes and/or ticks. Both 

mosquitoes and ticks transmit disease to man. Or, a claim is made to kill bedbugs. Bedbugs are 

injurious to man.

--The pesticide product is used in public health programs for vector control or for other 

recognized health protection uses to prevent or mitigate threats to public health.

--The pesticide product contains one or more ingredients that, under the criteria in 40 

CFR 153.125(a), is an active ingredient with respect to a public health organism and there is no 

other functional purpose for the ingredient in the product.

--The pesticide product is similar in composition to a registered pesticide product that 

makes explicit public health claims for control of invertebrate organisms. 
Page 61 of 88

APPENDIX 4

European Commission

Label Claims and Related Definitions

(EC 2010) 
Page 62 of 88

LABEL CLAIMS FOR BIOCIDAL PRODUCTS

As efficacy claims are assessed against the product ‘when used normally in accordance with the 

conditions of authorization’ then it is important to define the ‘normal use’ of the product.

There are several pieces of information that form part of the conditions of authorization that 

relate to the efficacy assessment. These are:

1. The Formulation Type 

This is determined by the product itself – e.g. a solvent based ready-for-use, a water based

concentrate, a dusting powder, a gel bait, etc.

2. Application Method 

This is the method by which the product is intended to be applied. e.g. coarse spray, ultra low

volume (ULV) spray, bait station etc. The application method may also describe a specific

pattern of treatment. This is particularly common for spray applications, but may also apply to

other formulation types. General descriptions of some common treatment patterns are given

below.

(i) Surface treatments

These are treatments where the product is applied over surfaces such as walls, floors and ceilings,

or as a treatment to outdoor surfaces. These treatments may involve treating a large area of

surface or may only involve application to a narrow band. Surface treatments can also include

application to temporary or permanent bodies of water (e.g. in mosquito control) and to solid and

semi-solid manure.

(ii) Crack and crevice treatments

These are treatments where products are applied into cracks and crevices where insects hide and

harbourage, or through which they may enter the building. Such openings commonly occur at

expansion joints, between different elements of construction and between equipment and floors.

These openings may lead to voids such as hollow walls, equipment legs and bases, conduits and

junction or switch boxes.

(iii) Contact (direct) spray treatments 

These involve application directly onto insects, and are normally only possible when the insects

are visible and available to be sprayed. In practice this often restricts direct application methods

to controlling flying insects (such as adult moths and houseflies), although some limited control

of minor infestations of crawling insects (such as ants or beetles) may be possible.

(iv) Space treatments
Page 63 of 88

These are treatments where the product is applied into the air rather than onto a surface. They

are intended to disperse small droplets or particles into the atmosphere of a room or other open

space, where they will normally stay for a period of time (very small particles may stay in the air

for several hours under still conditions).

(v) Spot treatments 

These are treatments where products are applied to limited areas on which insect pests are

likely to occur, but which will not be in contact with food or utensils and will not ordinarily

be contacted by workers. These areas may occur on floors, walls and bases or undersides of

equipment.

(vi) Baits

Bait treatments use products that are intended to be ingested by the target. This is normally 

through the insect feeding on the product directly, but may also include products which the target 

will come into contact with and later ingest during grooming/cleaning. The attractiveness of 

these products is through the use of a palatable food base, however they may also incorporate an 

attractant (e.g. a pheromone) which is intended to attract the target pests over a greater distance.

3. Application Rate

This is the rate at which the product will be applied in use, e.g. apply 100 ml of product per 

square meter, apply at a rate of 1 bait station per 3 m

2

, spray for 20 seconds, etc. For efficacy

assessment purposes, it is useful to consider the application rate as the amount of active substance

applied to surface area or volume. Unlike a human health or environmental risk assessment

which look at the maximum amounts of product which are considered to be acceptable (i.e. if the

amount of active or application rate increase, the risks to man or the environment will be

unacceptable), an efficacy evaluation looks at the minimum application/dose rate which will be

effective (i.e. if the application rate decreases, the product may not work).

4. Frequency of treatment and any specific interval between applications

Some products will be used in a way that will require more than one treatment. These products

will give information on the treatment schedule which should be followed (e.g. insecticide retreatment intervals or rodenticide re-baiting periods). Together, these pieces of information

define the ‘normal use’ of the product (e.g. a solvent based ready-for-use product to be applied as

a coarse spray at a rate of 100 ml product m

2

), and efficacy must be demonstrated for the product

when it is used in this way. Whilst information on the application method and rate etc. will

normally be clearly defined, the claims made for the effects of the product are much more

difficult to identify.

LABEL CLAIMS – UNDERSTANDING THE COMPONENTS

For insecticide products, the following claims are the ones that are frequently encountered:
Page 64 of 88

‘Kill’ claims generally refer to the death of an individual or a number of individuals (the death of 

an entire population is more generally found under a ‘control’ claim) and generally refer to an 

existing infestation.

‘Knockdown’ claims are generally restricted to insecticides and acaricides. A knockdown effect 

is one where a target insect becomes unable to carry out coordinated movement, but has not been 

killed.

Knockdown effects are often included in an insecticide product to produce a rapid, visible effect 

on a target in order to satisfy user expectations. These effects can be reversible, with insects able 

to recover after a period of time. Recovery is often dependent upon dose administered.

Knockdown claims may be found in conjunction with a kill claim, and many ‘dual action’ 

insecticide products contain two active substances - with one active substance producing a quick 

knockdown effect (such as a flying insect falling out of the air) whilst a second, slower acting, 

active substance produces the killing effect. Combined claims may be along the lines of 

‘knockdown within 10 minutes and kill within 2 hours’. When it comes to efficacy testing, some 

companies use the two terms interchangeably, so you will get products or test reports mentioning 

‘knockdown’ where a killing effect is actually meant. For evaluation purposes, knockdown and 

kill are considered to be separate effects.

‘Complete control’, ‘colony kill’ or ‘nest kill’ claims will generally refer to the elimination of an 

entire infestation or population - i.e., use of the product will essentially ‘remove the problem’.

As stated above, the mortality of individuals (rather than populations) is considered to be a ‘kill’ 

effect. To highlight the difference between ‘kill’ and ‘control’, we can take the example of an 

ant nest outside of a house, close to the back door. The queen (which does all of the 

reproduction) remains hidden away in the nest and produces new ants for the colony, and the 

only ants seen outside of the nest are the sterile female workers. An aerosol product which is 

intended to be sprayed onto ants wandering around in your kitchen to kill them will only be 

having a ‘kill’ effect. Killing off individuals or numbers of workers will have little effect on the 

nest and the colony as a whole, as the queen and fertile males will remain unaffected in the nest. 

In order to remove the problem, you actually have to kill off the colony. So a product claiming 

to ‘control’ an infestation of ants would have to eliminate the queen or disrupt the ability of the 

colony to reproduce.

MORE COMPLEX LABEL CLAIMS

TABLE 1: COMPONENTS MAKING UP A LABEL CLAIM

A Target organism(s) Against what target organism(s) will the product be used?

Specific insect (e.g. ants)
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• Several insects (e.g. ants and wasps)

• General claim (e.g. flying and crawling insects)

B Type of effect What effect will the use of the product have on the target?

Examples include:

• Kill

• Knockdown

• Control

• Flushing

• Attracting

• Repelling

C Time taken to produce the 

effect

How long will the product take to produce the effect?

Examples include:

• within 5 minutes

• within 1 hour

• within 3 months

D Area of use In what types of environment and on what type of surfaces 

will the product be used?

For example:

• indoors/outdoors

• on hard porous and non-porous surfaces

• on soft furnishings

• in hospitals

• in and around buildings

E Duration of the effect Will the product have a residual effect, and if so, how long 

for?
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For example:

• for 6 weeks

• for 3 months

F User Who can use the product?

• Industrial use

• Professionals

• Consumers

G Other specific claims Does the product claim any other specific benefits?

Examples include:

• works against resistant species

• helps prevent biting

• protects fabric from damage

A label claim will not always contain all 7 components. For example, where no residual activity 

is being claimed, section E will not be represented, and where no specific other claims are being 

made, claims in section G will not be present.

The target organism (A), the type of effect (B) and area of use (D) and the user (F) should always 

be given. On some labels, the time taken to product the effect (C) will not have been given (e.g. 

‘for the control of cockroaches’) or is not a specific value (e.g. ‘kills flies fast’). In these cases, 

the evaluator will use the norms and criteria given per insect for the evaluation of the data.

LINKING THE COMPONENTS OF THE LABEL CLAIM

When initially trying to understand how the components of the label claims fit together, it can 

help to place the assorted claims into a table in order to identify how the various elements 

interact.

B C D E

Knocks down within 5 minutes - on hard porous and

non-porous surfaces for 6 weeks
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Kills within 1 hour - on soft furnishings

The beneficial effect of the product (B) will be accompanied by the timescale in which the effect 

will happen (C). In these cases, it must be demonstrated that the product will be efficacious 

within the stated time. In the above example, it must be demonstrated that the product is capable 

of both knocking down the target insects within 5 minutes AND killing them within 1 hour. The 

area of use (D) gives information about the conditions in which the product will be used and the 

type of surfaces it will be used on. The efficacy data supplied should demonstrate that the 

product will be efficacious in the areas specified or on representative surfaces of the types 

described. In the example, it would have to be demonstrated that the product would produce its 

knockdown and kill effects within the times stated AND on both hard surfaces and soft 

furnishings.

The duration of effect (E) specifies the length of residual activity, which must be demonstrated. 

In the example, it must be demonstrated that the product is still capable of producing the effects 

on the specified surfaces 6 weeks after treatment (although not necessarily to the same degree as 

a fresh treatment).

Other claims can be linked into this process in the same way. For example, if claims were being 

made that the product was to be used against resistant individuals, then all of the above elements 

would have to be proved using a resistant test population to generate the data. Once the various 

elements making up the label claims have been identified then the evaluation of the efficacy data 

submitted can proceed.
Page 68 of 88

APPENDIX 5

Label Claims and Representative Test Species for Pesticide 

Products Claiming Efficacy against Invertebrate 

Pests of Significant Public Health or Economic Importance
Page 69 of 88

Representative Test Species for Public-Health Pests

Mites.

Test Species for Mites 

For Pest-Specific Label Claims

Pest-Specific Label Claim Test Species

Dust Mite

Pest Sub-group 1a

Testing of one of the following species is 

required:

American house dust mite 

(Dermatophagoides farinae) or

European house dust mite 

(Dermatophagoides pteronyssinus

Human Itch or Scabies Mite Human itch mite (Sarcoptes scabiei)

Dog Follicle Mite Dog follicle mite (Demodex canis)

Chiggers

Pest Sub-Group 1b

Chigger (Trombicula alfreddugesi)

Performance Standards for Mites

Label Claim for Specified Application 

Category

Performance Standard

Dust Mite

Kill -- Direct Application to Pest ≥95% mortality

Kill/Control -- Surface Treatment; Spatial 

Treatment; Fabric Treatment

≥75% mortality 

Human Itch or Scabies Mite

Kill -- Direct Application to Pest; Surface 

Treatment; Fabric Treatment; Application 

to Livestock; Application to Pets

100% mortality

Repellency – Surface Treatment; Fabric 

Treatment

100% repellency

Skin-Applied Human Repellent ≥2-hour complete protection time

Dog Follicle Mite

Kill – Direct Application to Pest; 

Application to Pets

≥95% mortality

Kill/Control -- Surface Treatment; Spatial 

Treatment; Fabric Treatments

≥95% mortality

Repellency – Surface Treatment; Spatial 

Treatment; Fabric Treatments

≥95% repellency
Page 70 of 88

Ticks.

Representative Test Species for Ticks 

For General Label Claims

General Label Claim Representative Test Species

Ticks

Pest Group 2

In total, testing of three hard tick species is 

required.

Testing of the two following species is 

required:

Blacklegged tick (Ixodes scapularis), and

Lone star tick (Amblyomma americanum).

Testing of one of the following species is 

required: 

American dog tick (Dermacentor variabilis),

or

Brown dog tick (Rhipicephalus sanguineus)

Hard Ticks

Pest Sub-group 2a

Soft Ticks

Pest Sub-group 2b

Soft tick (Ornithodoros hermsi)

Cattle Ticks

Pest Sub-group 2c

Testing of one of the following species is 

required:

Southern cattle tick (Rhipicephalus microplus), 

or 

Cattle fever tick (Rhipicephalus annulatus)

Additional Information:

For pets, testing in three species is required: Blacklegged tick (Ixodes scapularis),

American dog tick (Dermacentor variabilis), and Brown dog tick (Rhipicephalus sanguineus)
Page 71 of 88

Scorpions.

Representative Test Species for Scorpions 

For General Label Claim

General Label Claim Representative Test Species

Scorpions 

Pest Group 3

Striped bark scorpion (Centruroides vittatus)
Page 72 of 88

Spiders.

Representative Test Species for Spiders

For General Label Claims

Test Species for Spiders 

For Pest-Specific Label Claims 

General Label Claim Representative Test Species

Spiders

Pest Group 4

In total, testing of two species is required: 

Testing of the following species is required:

Brown recluse spider (Loxosceles recluse)

Testing of one of the following species is 

required: 

Southern black widow spider (Latrodectus 

mactans), or

Western black widow spider (Latrodectus 

hesperus), or

Northern black widow spider (Latrodectus 

variolus)

Black Widow Spiders

Pest Sub-group 4a

Testing of one of the following species is 

required:

Southern black widow spider (Latrodectus 

mactans), or

Western black widow spider (Latrodectus 

hesperus), or

Northern black widow spider (Latrodectus 

variolus)

Pest-Specific Label Claim Test Species

Southern black widow spider Southern black widow spider (Latrodectus 

mactans)

Brown widow spider Brown widow spider (Latrodectus 

geometricus)

Northern black widow spider Northern black widow spider (Latrodectus 

variolus)

Western black widow spider Western black widow spider (Latrodectus 

hesperus)

Brown recluse spider Brown recluse spider (Loxosceles reclusa)

Sac spider Sac spider (Cheiracanthium mordax)

Hobo spider Hobo spider (Tegenaria agrestis)
Page 73 of 88

Centipedes.

Representative Test Species for Centipedes 

For General Label Claim

General Label Claim Representative Test Species

Centipedes

Pest Group 5

Testing of one of the following species is 

required:

House centipede (Scutigera coleoptrata), or 

Florida blue centipede (Hemiscolopendra 

marginata)
Page 74 of 88

Lice.

Representative Test Species for Lice 

For General Label Claim

General Label Claim Representative Test Species

Lice

Pest Sub-group 6a

Testing of one of the following species is 

required:

Head louse (Pediculus humanus capitis), or

Body louse (Pediculus humanus humanus)
Page 75 of 88

Fleas. 

Representative Test Species for Fleas 

For General Label Claim

General Label Claim Representative Test Species

Fleas

Pest Group 7

Cat flea (Ctenocephalides felis)
Page 76 of 88

Cockroaches.

Representative Test Species for Cockroaches 

For General Label Claim

General Label Claim Representative Test Species

Cockroaches

Pest Group 8

Testing of two species is required:

German cockroach (Blattella germanica), 

and 

American cockroach (Periplaneta 

americana) 

Test Species for Cockroaches 

For Pest-Specific Label Claims

Pest-Specific Label Claim Test Species

German cockroach German cockroach (Blattella germanica)

Brownbanded cockroach Brownbanded cockroach (Supella longipalpa)

Oriental cockroach Oriental cockroach (Blatta orientalis)

Australian cockroach Australian cockroach (Periplaneta 

australasiae)

American cockroach American cockroach (Periplaneta americana)
Page 77 of 88

Keds, Bot Flies, and Screwworms.

Representative Test Species for Keds, Bot Flies, and Screwworms

For General Label Claims

General Label Claim Representative Test Species

Keds Testing of the following species is required:

Sheep ked (Melophagus ovinus)

Bot Flies (except Human bot fly)

Pest Sub-group 9a

Testing of one of the following species is 

required:

Horse bot fly (Gasterophilus intestinalis), or

Throat bot fly (Gasterophilus nasalis), or

Nose bot fly (Gasterophilus haemorrhoidalis)

Screwworms

Pest Sub-group 9b

Testing of one of the following species is 

required:

Screwworm (Cochliomyia hominivorax), or

Secondary screwworm (Cochliomyia 

macellaria)

Test Species for Bot Flies 

For Pest-Specific Label Claim 

Pest-Specific Label Claim Test Species

Human bot fly Human bot fly (Dermatobia hominis)
Page 78 of 88

Filth Flies.

Representative Test Species for Filth Flies 

For General Label Claim

General Label Claim Representative Test Species

Filth Flies

Pest Sub-Group 10

In total, testing of two species is required: 

Testing of the following species is required:

House fly (Musca domestica)

Testing of one of the following species is 

required:

Flesh fly (Sarcophagidae), or

Blow fly (Phaenicia sericata)

Blow fly

Pest Sub-Group 10a

Blow fly (Phaenicia spp., Calliphora spp., 

and other genera)

House Flies

Pest Sub-Group 10b

House fly (Musca domestica)

Flesh fly

Pest Sub-Group 10c

Flesh fly (Sarcophaga sp., Wohlfahrtia sp., 

and other genera)

Test Species for Filth Flies

For Pest-Specific Label Claims

Pest-Specific Label Claim Test Species

Cluster fly Cluster fly (Pollenia rudis)

Face fly Face fly (Musca autumnalis)

House fly House fly (Musca domestica)

Little house fly Little house fly (Fannia canicularis)
Page 79 of 88

Mosquitoes.

Representative Test Species for Mosquitoes 

For General Label Claim

General Label Claim Representative Test Species

Mosquitoes

Pest Group 11

In total, testing of three genera (Culex, 

Aedes, and Anopheles) of mosquitoes is 

required:

Testing of one of the following Culex

species is required:

Culex pipiens, or

Culex quinquefasciatus, or

Culex tarsalis

Testing of one of the following Aedes 

species is required:

Aedes albopictus, or

Aedes aegypti

Testing of one of the following Anopheles

species is required:

Anopheles quadrimaculatus, or 

Anopheles freeborni, or

Anopheles punctipennis, or

Anopheles gambiae
Page 80 of 88

Biting Flies.

Representative Test Species for Biting Flies

For General Label Claims

General Label Claim Representative Test Species

Biting flies

Pest Group 12

In total, testing of three species is required:

Testing of the two following species is 

required:

Biting midge (punkie, granny nipper, nosee-um) (Culicoides spp.), and Stable fly 

(Stomoxys calcitrans)

Testing of one of the following species is 

required:

Black fly (Simulium spp or Prosimulium 

spp.)

Horse flies

Pest Sub-group 12a

Testing of one of the following species is 

required:

Black horse fly (Tabanus atratus), or

Striped horse fly (Tabanus lineola)

Deer flies

Pest Sub-group 12b

Deer fly (Chrysops spp.)

Stable fly

Pest Sub-group 12c

Testing of two species is required:

Stable fly (Stomoxys calcitrans) and Horn 

fly (Haematobia irritans)

Sand flies 

Pest Sub-group 12d

Testing of one of the following species is 

required:

Sand fly (Lutzomyia spp.), or

Sand fly (Phlebotomus spp.)

Biting Midges (punkie, granny nipper, no-seeum)

Pest Sub-group 12e

Testing of two species is required:

One Biting Midges (punkie, granny nipper, 

no-see-um) (Culicoides sp.) and one

Black gnat (Leptoconops sp.)

Black flies

Pest Sub-group 12f

Testing of one of the following species is 

required:

Black fly (Simulium spp. or Prosimulium 

spp.)

Test Species for Biting Flies 

For Pest-Specific Label Claims

Pest-Specific Label Claim Test Species

Greenhead Greenhead (Tabanus nigrovittatus)
Page 81 of 88

True Bugs.

Representative Test Species for True Bugs

For General Label Claim

General Label Claim Representative Test Species

True Bugs

Pest Group 13

Testing of two species is required:

Bed bug (Cimex lectularius) or

Tropical bed bug (Cimex hemipterus)

and

Kissing bug (Triatoma protracta) or

Conenose bug (Triatoma sanguisuga)

Bed bugs

Pest Group 13a

Testing of one of the following species is 

required:

Bed bug (Cimex lectularius), or

Tropical bed bug (Cimex hemipterus)

True bugs (excluding bed bugs)

Pest Sub-group 13b

Testing of one of the following species is 

required:

Kissing bug (Triatoma protracta), or

Conenose bug (Triatoma sanguisuga)
Page 82 of 88

Stinging Bees, Wasps, Yellow Jackets, and Hornets. 

Representative Test Species for Stinging Bees, Wasps, Yellow Jackets, and Hornets

For General Label Claim

General Label Claim Representative Test Species

Stinging Bees, Wasps, Yellow Jackets 

and Hornets

Pest Group 14 

Testing of the three following species is required:

Yellowjacket (Vespula sp.), 

Bald-faced hornet (Dolichovespula maculata), and 

Paper wasp (Polistes sp.)
Page 83 of 88

Ants (excluding carpenter ants).

Representative Test Species for Ants (excluding carpenter ants)

For General Label Claims 

General Label Claim Representative Test Species

Ants (excluding carpenter ants)

Pest Group 15

In total, testing of three species is required.

Testing of the two following species is 

required:

Pharaoh ant (Monomorium pharaonis), and 

Argentine ant (Linepithema humile)

Testing of one of the following species is 

required: 

Red imported fire ant (Solenopsis invicta), or

Harvester ant (Pogonomyrmex spp.)

Fire and Harvester ants

Pest Sub-group 15a

Testing of one of the following species is 

required: 

Red imported fire ant (Solenopsis invicta), or

Harvester ant (Pogonomyrmex spp.)
Page 84 of 88

Wood-Destroying Insects

Carpenter Ants.

Representative Test Species for Carpenter Ants 

For General Label Claims 

General Label Claim Representative Test Species

Carpenter ants 

Pest Sub-group 16

Testing of one of the following carpenter ant 

species is required:

Black carpenter ant (Camponotus 

pennsylvanicus), or

Western carpenter ant (Camponotus modoc), or

Florida carpenter ant ((Camponotus floridanus)

Performance Standards for Carpenter Ants 

Application Category Performance Standard

Kill -- Direct Application to Pest ≥95% mortality

Kill -- Surface Treatment; Spatial 

Treatment ≥95% mortality

Repellency – Surface Treatment; Spatial 

Treatment ≥95% repellency

Preventive Treatment: Wood 

Impregnation Prevention of damage to wood for ≥ 2 years

Structural Protection 100% prevention of damage to wood ≥ 5 years

Bait Treatment 100% prevention of damage to wood for ≥ 3 

years
Page 85 of 88

Wood-Destroying Beetles. 

Representative Test Species for Wood-Destroying Beetles 

For General Label Claim

General Label Claim Representative Test Species

Wood-destroying or wood-boring beetles

Pest Group 17

Testing of three species is required:

Old house borer (Hylotrupes bajulus), 

Anobiid beetle (Anobiidae sp.), and 

Bostrichid beetle (Bostrichidae sp.)

Performance Standards for Wood-Destroying Beetles

Application Category Performance Standard

Kill -- Direct Application to Pest; Surface 

Treatment; Spatial Treatment ≥95% mortality

Repellency – Surface Treatment; Spatial 

Treatment ≥95% repellency

Preventive/Remedial Treatments for Wood 

Impregnation prevention of damage to wood ≥ 2 years

Structural Protection 100% prevention of damage to wood ≥ 5 years

Bait Treatment 100% prevention of damage to wood ≥ 3 years
Page 86 of 88

Termites.

Representative Test Species for Termites

For General Label Claim

General Label Claim Representative Test Species

Termites

Pest Group 18

In total, testing of four genera of termites is 

required: 

Testing of the following species is required:

Coptotermes formosanus

Testing of one of the following Reticulitermes 

species is required:

Reticulitermes flavipes, or

Reticulitermes virginicus, or 

Reticulitermes hesperus

Testing of one of the following Nasutitermes

species is required:

Nasutitermes corniger or 

Nasutitermes costalis

Testing of one of the following drywood termites

is required:

Incisitermes minor or 

Cryptotermes brevis

Subterranean Termites, except Formosan 

Subterranean Termites

Pest Sub-group 18a

In total, testing of two genera of termites is 

required: 

Testing of the following species is required:

Coptotermes formosanus

Testing of one of the following Reticulitermes 

species is required:

Reticulitermes flavipes, or

Reticulitermes virginicus, or 

Reticulitermes hesperus

Drywood Termites

Pest Sub-group 18b

Testing of one of the following drywood termites

is required:

Incisitermes minor or 

Cryptotermes brevis
Page 87 of 88

Arboreal Termites

Pest Sub-group 18c

Testing of one of the following arboreal termite 

species is required:

Nasutitermes corniger or 

Nasutitermes costalis

Dampwood Termites

Pest Sub-group 18d

Testing of one dampwood termite from the genus 

Zootermopsis is required.

Performance Standards for Termites

Application Category Performance Standard

Kill -- Direct Application to Pest; Surface 

Treatment ≥95% mortality

Repellency – Surface Treatment ≥95% repellency

Preventive/Remedial Treatments for Wood 

Impregnation Prevention of damage to wood ≥ 2 years

Structural Protection -- Soil-Applied 

Termiticides 100% prevention of damage to wood ≥ 5 years

Structural Protection -- Bait Treatment 100% prevention of damage to wood ≥ 3 years
Page 88 of 88

Invasive Species

Once an alien invertebrate species has been determined to be an invasive species, the

agency may require the submission of product performance data with any application for 

registration or amended registration of a product claiming to kill or control that invasive 

invertebrate species.