Te chnical Support Document

Scientific Issues Associated with Product Performance Data

Needs for Pesticide Products Claiming Efficacy a gainst Invertebrate Pests

Of Significant Public Health o r Economic Importance

Submitted to the FIFRA Scientific Advisory Panel

For Review and Comment

March 19

- 21 , 201 3

U.S. Environmental Protection Agency Office of Chemical Safety and Pollution Prevention

Office of Pesticide ProgramsPage 2 of 88

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 in vertebrate pests : those identified to be of significant public health importance (e.g., ticks, mosquitoes, cockroaches,), wood

- destroying insect s (e.g., termites), and invasive invertebrate species (e.g., Asian long

- horned beetle). The two latter categori es are considered to be of significant economic importance. Unit V provides additional information on these categories.

EPA acknowledges that for public heal th 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 term s invertebrates or invertebrate pests to describe all three categories

. EPA will cons ider t he 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 g uidance 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 codif ication are consistent with the a gency’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 pest s

. 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 pr oducts are codified in 40 CFR part s 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 n umerical performance standards specify the level of efficacy that would need to be

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

The a gency 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 a gency’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 againstPage 3 of 88

the three categories of invertebrate pests previously identified) . The charge question s 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 V I I explains the relationship of the prod uct performance rulemaking to other agency actions.

Unit V I II describes EPA’s Product Performance Test Guidelines.

Unit I X describes changes being considered for Product Performance Standards.

Unit X describes important parameters for product performance t esting guideline development

. Unit X I discusses the availability of international guidance on product performance testing.

Unit X I I discusses e xtrapolating from other sources of efficacy d ata

. Unit XI I I is a list of references. Appendix 1 i ncludes three pe st tables listing the groups and sub groups 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 l abel c laims and re l a ted 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 withou t 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 eventPage 4 of 88

the Administrator may register the pesticide without determining that the pesticides’ composition

is s uch 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 determin e 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 conve ntional 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, subpa rt E does not specific al ly require submission of product performance data for those pesticide products claiming effectiveness against invertebrate

pests

. Instead, and as explained in the t est note in § 158.400(e)(1) t hat applies t o 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 directl y 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 r equire, 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 r equiring 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 pestic ides (72 FR 60934). In th e 2007 rulemaking,

the a gency 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.Page 5 of 88 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

environ ment 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

T he a gency 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 a gency 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 at tack 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, an d bedbugs” (EPA 2011).

OPPTS Product Performance Guideline 810.1000 entitled, “Overview, Definitions, and General Considerations,” discusses th e product performance data needed for any product that “bears a claim to control pests that may pose a threat t o 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 label ing provide s information to users on

, among other things, the product’s int ended uses, and how to handle and apply the product. EPA’s labeling regulations arePage 6 of 88

contained in 40 CFR part 156. EPA reviews pesticide labels to determine whether the label ing is consistent with EPA’s regulations, and is accurate, clear and enforceable. T he accuracy of the

information on the label ing is of particular importance for products claiming to kill or repel public health pests. S uch pests, if uncontrolled, can transmit disease pathogens, thus posing a widely

- recognized and significant risk to huma n health.

Consumers purchase products that c laim 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 label ing provide s consumers wi th 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 a gency works to

assure that the label ing use directions and label ing 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 p esticide products making claims against invertebrate pests. Reliable information results in sound regulatory

decisions which mean accurate, information on the label ing

. Accurate label ing claims provide consumers with accurate information concerning the eff e c tiveness 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

. ” Th i s 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.

Th is l ist wa s developed cooperatively by the U.S. De partment of Health and Human Services, United States Department of Agriculture (USDA), and the EPA, with input from some non

governmental entities. EPA’s Office of Pesticide Programs coordinated the review by experts in public health and/or pesticide use p atterns 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 labelsPage 7 of 88

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 th e 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 Inclu sion

Mites Produ ces 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 reactionsPage 8 of 88 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 un ique 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 cost s borne by an individual property owner

can be significant in their own right , up to an d including loss of the property . The wood

destroying insects included are those that have the poten tial 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 a gency issued PRN 96

- 7 (EPA 1996) , entitled “ Termiticide Labeling,” (October 1, 1996) to provide guidance on label statements and minimum levels of product pe rformance 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 efficaciou s 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, becausePage 9 of 88 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.Page 10 of 88

The Executive Order also directed each f ederal a gency 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 inv asive species and the means to
address them (FR 1999b)

.

Economic Impacts

I nvertebrate i nvasive species can impose serious economic costs by causing or vectoring diseases against native species that have little or no natural defenses

. For example, a n 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 s ubmitted 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 situatio n/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 Fores t 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

outrea ch), 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, andPage 11 of 88

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 a nd 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 availab i l ity of pesticide products with proven performance against an invasive species is important to s lowing 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 ap pearance 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 bas is of the biology and life history characteristics of the pests identified as public health or wood destroying pests. These

assembla ges, both groups and sub

- groups are listed in Appendix 1 ( Tables I & II). The groupings are taxonomically based, although no t 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 “sub

groups” are desi gnations 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, whe n practical and meaningful, “sub

- groups” have been identified to provi de 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 reviewPage 12 of 88

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 c onsumers.

V I I. Impacts of t he 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 standard ized 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 , t here 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 fo rmat 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 . Add itionally , the graphic will provide a way of

standardizin g 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 approv e 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 p esticide products claiming efficacy against invertebrate species ar e 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

, ” t o be consideredPage 13 of 88

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 percent age by weight in the product ;

3. L ist inert ingredients by name ;

4. Not include any false or misleading labeling statements ;

5. Not bear claims either to control or mitigate microorgan isms 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 exempt ed 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, “ r epels 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 pers onal mosquito and tick repellents that currently meet the active and inert ingredient criteria of the exemption in o rder 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

- 201 0

- 0227.

VI I I. 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 ) identifyPage 14 of 88

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 f or Efficacy Testing of Termite Baits (2004)

O n March 6

- 7, 2012 , EPA presented to the SAP, a draft guideline regarding bed bugs

. EPA intends to finalize t

his 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 g uidelines present a variety of approaches to t est ing. 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 . Th is information provides much of the context for the discussion for this SAP meeting on revis ing testing guidance, produc ing new guidelines

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

Wor ld Health O rganization Pesticide Evaluation scheme

, to the extent possible.Page 15 of 88 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 A ll None stated

810.3100

Soil Treatments for Imported Fire Ants (1998) Imported

Fire Ants Soil applied treatments

to: 3 sites

10 mound s 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 daysPage 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 Wool

Bearing 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 eq ual.

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 c rab

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, a nd shampoos.

Sprays, dusts, foams, flea collars, flea tags, soaps, and shampoos. 100% kill of lice, ticks,

fleas and mites Skin applied r epellency

2

- 3 hour minimum protection time

90% kill of ticks and

fleas.

100% kill or repellency

of mites

100% kill or repellency

of licePage 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.

Bla ck 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 food

handling

establishments. Labeled flying and/or crawling

insects Under laboratory

conditions,

at least 5 trials are usually necessary. A minimum of 5 large

scale field tr ials are generally needed. Application Types

Laboratory: The following absorptive and non

absorptive surfaces should be tested for crawling pests: vinyl tile or linoleum, stainless steel, painted and unpainted wood

and ceramic tile.

Field: the applicat ion 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 sp ray.

(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 test s

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 post

treatment against

subterranean termite

attack.

Wood impregnated products

– 100% for 2 years against subterranean drywood and dampwood

termite attack.

100% against drywood

termitesPage 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 Tests

Mosquitoes, 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

sca pularis, 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. Labor atory 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 perce nt mortality in greater than two weeks but less than ten weeks post

treatment at the tested dose. Reticulitermes flavipes, R. virginicus, R. hesperus, R. hageni, and

R. tibialis . Heterotermes

aureus and Coptotermes formosanus

Eliminate infestation in

12 m onths. Re

infestation 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 a gency 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 da ta 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

remov e 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 document s. EPA will also take th at opportunity to update the Introductio n 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) attr actants and (4) fumigants. Testing guidance on the insecticidal uses of RNAi and related technologies for urban pest control especially bait s
, could also be needed. Efficacy a ssessment s of insecticides formulated and applied using nanotechnology may also b e 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 c hanges 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 D ata Evaluation Record (D ER ) 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 Guidel ines 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 specif ic 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 guid eline should include a n 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 Pest s of Humans and Pets

Restrict con tent 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 F ly, 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 im portance

OCSPP 810.3600 Structural TreatmentsPage 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

I X

. Changes being Considered for Performance Standards

EPA is considering t he 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 St andard

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 fec es 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 lev els. 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

treatmen ts.

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 pe ts are being considered

. A human skin applied topical repellent performance stand ard 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 purpose s , an established framework for testing and evaluation should exist, not only to ensure generation of high qual ity 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 fo r 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 populat ions, 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 conduc ted for every active ingredient, be relati vely 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 an o ther 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 sp ecified (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 (H C 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 LD 99 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 again st 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 perfo rmance standards set for each pest will further guide these evaluations.

Efficacy claims on product labels may be very spe cific 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, et c.), EPA should define the efficacy data sets required for such claims. When broad claims, such as those above are made, tests on representative pest

spe cies 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. Likewis e, 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 th is specific parameters. Residual activity (e.g. "...control of German coc kroaches 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.

M uch of the product

- specific data are generated to support labeled efficacy claims

. Thus, both g uidel ine s and performance standards must take into account testing against target pests which must be undertaken to support a labeled claim

.

C

. Development of P rotocols for Product Performance S tudies

The first major stage of product efficacy testing is protocol development , which is critical to all later stages of product efficacy testing. All protocol s must meet the requirements of EPA’s Good Laboratory Practices regulations at 40 CFR 160.120, and all other applicable scientific and

ethical standards

. G eneral 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 deta il 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 descrip tion 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 scien tific 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 ingr edients 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 objec tives 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 fluidPage 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/cm 2 of test surfa ce or volumetrically as ml of test substance/cm 2 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 efficac y 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 shou ld 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, insectic ide 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 c ircumstances, 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 d ose 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 w ith the requirements of EPA’s Good Laboratory Practices regulations (40 CFR part 160)

.

Data Collection and ReportingPage 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 a gency 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

Produc t 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 bec ause 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 concu rrently 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). E ffectiveness 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 intervalsPage 31 of 88 Repellency (Choice tests

– treated vs. untreated area) . Modifications of the

Ebe ling box (Ebeling et al. 1966) may be used for surface tests.
Direct application to human skin
Tube or tunnel testing for spatial repellents
Impregnated f

abric

Treated leaf surface

Soil

Baits
Palatability

Choice test with bait compared to other food sources

No

- choice k ill 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 s prays, 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 s patial repellents
Skin applied repellents

Pesticide applications made to livestock and horses including feed

- through larvicide products

S hed tests for fumigants

Experiment Evaluating Actual Use under Operational Conditions as Intended by the

Product Label

Testing should be conducted for:

Termiticides

Wide area insec ticide 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 pestsPage 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 ex cept 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 regulation s. (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. Pla nned 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 el ements, 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 obj ective(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, siz e , 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

N umber 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 Copie s 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 s tatistical testing. A copy of the statistical analyses The report sho uld 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 hypothes is.

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 und er the Good Laboratory Practices (GLP) rule.

G

. S tandardizing Data Evaluation Record (DER) Content and Format

The a gency is considering the adopt ion of a standardized DER format for completed study review. A copy of the draft DER template is attached as Appendix 2.Page 34 of 88

X I . A vailability of International Guidance for EPA’s Consideration d uring Guideline

Revisions

With the increases in p esticide production and sales, pesticide regulation is increasingly assuming a global perspective, which has led country level regulatory agencies and inte rnational 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 Dev elopment (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 referenc es 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 an d/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, especia lly 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 u nder 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 fi eld 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 a ppropriate.

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 met hods could be incorporated in to 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

emanator s 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, vapo rizer mats, liquid vaporizers, ambient emanators and

aerosols. These methods c ould be incorporated in to OCSPP Guideline 810.3500.

WHO/CDS/WHOPES/GCDPP/2005.13 Guidelines for laboratory and field testing
of mosquit o 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 in to OCSPP Guideline 810.3400.

WHO/CDS/NTD/WHOPES/2 009.4 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 t his guideline

could be incorporated in to 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 in door residual spraying and treatment of mosquito nets WHOPES
2005a).

T his 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 b asis for the bio

efficacy 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 re spond to international problems (OECD 201 3a). 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 eff

icacy 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 incorporatedPage 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 biocida l products

, which for the EU includ es 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 dat a sets and continually request clarification

on claim specific testing guidance to support their proposed labeling. The Swedish Chem ic als 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 organi sm 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,

a s 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 performanc e standards and labeling are summarized in

“ Technical Notes for Guidance Insecticides, acaricides and products to c ontrol other arthropods (PT 18) a nd Repellents and attractants (only concerning arthropods) (PT19) ” (EC 2010) and the

Technical Notes for Guidance ( TNsG ) for P roduct E valuation (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 F AO , in cooperation with thePage 37 of 88

plant science industry and other international organiz ations, including NGOs, develo ped a voluntary code of conduct, known as the International Code of Conduct, to provide a

co mprehensive 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 pr oducts, but the underlying framework of this guidance is applicable across pesticide product types and use patterns (FAO 2006, 2010, and 2013).

X I I . Extrapolating from Other Sources of Efficacy Data

There are two main (partly overlapping) approaches to lim iting 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 patt ern 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 subm itted 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, extra polation 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 si te 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 disadvantagePage 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. A lso, 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 c ountries 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 auth orities 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 authori ty 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 journa ls, 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 asse ss if the data are comparable or relevant to the U.S. situation.

X I I I

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and Wool

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EPA (2006) Pesticide Registration (PR) Notice 2000

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. Available at: http://www.epa.gov/PR_Notices/pr2000

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EPA (2011) Label Review Manual (pages 4

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– Product Performance Test

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Janu ary 2013).

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applied space spray applications . Ref: WHO/CDS/NTD/WHOPES/2009.2. Available at: http://whqlibdoc .who.int/hq/2009/WHO_HTM_NTD_WHOPES_2009.2_eng.pdf (accessed 29 January 2013).

WHOPES (2009 b ) Guidelines for efficacy testing of mosquito repellents for human skin. Ref:

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- Mosquito coils, vaporizer mats, liquid vaporizers, ambient emanators and aerosols . Ref:

WHO/CDS/NTD/WHOPES/2009.3. Available at: http://whqlibdoc.who.int/hq/2009/WHO_HTM_NTD_WHOPES_2009.3_eng.pdf (accessed 29

Janu ary 2013).

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WHOPES (2013) World Health Organization Pesticide Evaluation Scheme. Available at: http://www.who.int/whopes/en/ (accessed 29 January 2013).Page 44 of 88 

## APPENDIX 1

P est Tables

Table I : Pests of Significant Publ ic Health Importance

Table II : Wood Destroying InsectsPage 45 of 88Page 46 of 88Page 47 of 88Page 48 of 88

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 Order 4 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 ). 1 All claims against pests within the specified taxonomic rank are to be supported by the submission of data. If representati ve 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.

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

3 Each 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 Sub

Group Rank of Included

Taxa Taxon/Taxa Included

18 18a

18b 17 SpeciesPage 49 of 88 

## 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/m 2 ]

[ACTIVE INGREDIENT APPLICATION RATE(S): lbs/square foot and/or per 1000 square feet and g/m 2 ]

[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 A ge : 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/o r 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 experimentPage 52 of 88

State the data and/or endpoints that were recorded.

Data Reported

Results

The stu dy 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 an d 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 cont rol 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 sit e/pest combinations supported by the data where applicable.Page 53 of 88

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 Pu blic 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 means 1 , 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 othe r 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 s ite 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. Thi s 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.Page 56 of 88

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

cockroac hes.

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

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 healt h.

Invertebrate control pesticide product means 5 any 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 means 6 the intentional or unintentional esca pe, 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 “inverteb rate 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 means 7 that 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 precede s death.

Percent control (% contro l) means the numerical comparison of the pre

- and post

treatment 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 o f the product o n 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 invertebr ate 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 means 8 dips, 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, p ages 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 means 9 a product intended to disrupt the host

- seeking

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

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

skin.

Soil

- applied termiticides means 10 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 treatmen ts 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, coi ls for

controlling mosquitoes, ultra low volume application s for public health pests (e.g. mosquito

abatement), and misting systems.

Species means 11 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 tax a 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 m ay 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 ef fect 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.

Struc tural protection means 12 the elimination or prevention of termite or other wood

destroying 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 hav e 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 remed iation.

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 p ublic 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 e xample: 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 pr otection 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 fu nctional 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 deter m ined by the product itself

– e.g. a sol v ent based read y

- for

- use, a w a ter based

concentrate, a dusting powder, a gel bait, etc.

2. Application Method

This is the m ethod by which the product is intended to be applied. e.g. coarse spra y
, ultra low

volu m e (ULV) spra y
, bait station etc. The application m ethod m ay also describe a specific

pattern of treat m ent. This is particularly co mm on for spray applications, but m ay also apply to
other for m ulation t y pes. General descriptions of so m e co mm on treat m ent patterns are given

below.

(i) Surface treatments

These are treat m ents where the product is applied over surfaces such as walls, floors and ceilings,

or as a treat m ent to outdoor surfaces. These treat m ents m ay involve treating a large area of

surface or m ay only involve application to a narrow band. Surface treat m ents can also include application to te mporary or per m anent bodies of water (e.g. in m o squito control) and to solid and

se m i

- solid m anure.

(ii) Crack and crevice treatments

These are treat m ents where products are applied into cracks and crevices where insects hide and harbourage, or through which they m ay enter the building. Such openings co mm only occur at expansion joints, between different ele m ents of construction and between equip m ent and floors.

These openings m ay lead to voids such as hollow walls, equip m ent legs and b ases, conduits and junction or switch boxes.

(iii) Contact (direct) spray treatments

These involve application directly onto insects, and are nor m ally only possible when the insects

are visible and available to be spra y ed. In practice this often restricts direct application m ethods

to controlling fl y ing insects (such as adult m o ths and houseflies), although so m e li m ited control

of m inor infestations of crawling insects (such as ants or beetles) m ay be possible.

(iv) Space treatmentsPage 63 of 88

These are treat m ents where the product is applied into the air rather than onto a surface. They

are intended to disperse s m all droplets or particles into the at m o sphere of a room or other open space, where they will nor m ally stay for a period of ti m e (very s m all particles m ay stay in the air

for several hours under still conditions).

(v) Spot treatments

These are treat m ents where products are applied to li m ited 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 m ay occur on floors, walls and bases or undersides of equip m ent.

(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, howe ver 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

s quare m et er
, apply at a rate of 1 bait station per 3 m 2

, spray for 20 seconds, etc. For efficacy

assess m ent purposes, it is useful to c onsider the application rate as the a m ount of active substance applied to surface area or volu m e. Unlike a hu m an health or environ m ental risk assess m ent
which look at the m axi m u m a m ounts of product which are considered to be acceptable (i.e. if the

a m ount of active or application rate increase, the risks to m an or the environ m ent 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 m ay not work).

4. Frequency of treatment and any specific interval between applications

So m e products will be used in a way that will require m o re than one treat m ent. These products

will give infor m ation on the treat m ent schedule which should be followed (e.g. insecticide re

treat m ent intervals or rodenticide re

- baiting periods). Together, these pieces of infor m ation

define the ‘nor m al use’ of the product (e.g. a solvent based read y

- for

- use product to be applied as

a coarse spray at a rate of 100 m l product m 2 ), and efficacy m u st be de m onstrated for the product

when it is used in this wa y . Whilst infor m ation on the application m ethod and rate etc. will

nor m ally be clearly defined, the clai m s m ade for the effects of the product are m u ch m o re difficult to identif

y

.

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 rapi d, 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 wi th 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 prod uces 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 mention ing ‘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 ‘contro l’, 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 quee n 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)Page 65 of 88 • 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?Page 66 of 88 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 t arget 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 fi t 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 weeksPage 67 of 88

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 mu st 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 re presentative 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 sa me 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 usi ng 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 P esticide

Products Claiming Efficacy against Invertebrate

Pests of Significant Public Health or Economic ImportancePage 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 o f 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 alfred d ugesi )

Performance Standards for Mites

Label Claim for Specified Application

Category Performance Standard

Dust Mite

Kill

-- Direct Application to Pest ≥9 5 % 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 ≥9 5 % mortality

Kill /Control

-- Surface Treatment ; Spatial Treatment; Fabric Treatments ≥9 5 % mortality

Repellency

– Surface Treatment ; Spatial Treatment; Fabric Treatments ≥9 5 % repellencyPage 70 of 88



### Ticks.

Representative Test Species for Ticks

F or General Label Claims

General Label Claim Representative Test Species

Ticks Pest Group 2 In total, t esting o f three hard tick species is required. Testing o f the two following species is required: Blacklegged tic k (Ixodes scapularis), and Lone star tick (

Amblyomma americanum). Testing o f one of the following species is required: American dog tick ( Dermacentor variabilis)

,

or Brown dog tick ( Rhipicephalus sanguineus)

Hard Ticks

Pest Sub

- group 2a

S oft Ticks

Pest Sub

- group 2b S oft tick ( Ornithodoros hermsi )

Cattle Ticks

Pest Sub

- group 2c Testing o f 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

F or 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

F or General Label Claims

Test Species for Spiders

F or Pest

- Specific Label Claims General Label Claim Representative Test Species Spiders Pest Group 4 In total, t esting o f two species is required: Testing o f the following species is required: Brown recluse spider (Loxosceles recluse) Testing o f 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 o f one of the following species is required: Southern black widow spider ( Lat rodectus mactans), or Western black widow spider ( Latrodectus hesperus), or Northern black widow spider (Latrodectus variolus)

Pest

- Specific Label Claim Test Species

Southern b lack widow spider Southern b lack 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 spid er ( 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 o f 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

F or General Label Claim

General Label Claim Representative Test Species

Lice

Pest Sub

- group 6a Testing o f 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

F or 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

F or General Label Claim

General Label Claim Representative Test Species

Cockroaches Pest Group 8 Testing o f two species is required: German cockroach ( Blattella germanica ),

and American cockroach ( Periplanet a americana)

Test Species for Cockroaches

F or 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

F or 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 o f one of the following species is required: Horse bot fly (Gasterophilus intestinalis), or
T hroat 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

F or General Label Claim

General Label Claim Representative Test Species

Filth Flies

Pest Sub

- Group 10 In total, t esting o f two species is required: Testing o f the following species is required: House fly (Musca domestica) Testing o f 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

F or 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

F or General Label Claim

General Label Claim Representative Test Species Mosquitoes Pest Group 11 In total, t esting 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 gambiaePage 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, no

see

- um) ( Culicoides spp .), and S table 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

. )

S table fly

Pest Sub

- group 12c Testing of two species is required:

S table fly (Stomoxys calcitrans) and Horn fly (Haematobia irritans)

Sand flies

Pest Sub

- group 12d Testing o f one of the following species is required: Sand fly ( Lutzomyia spp.)

, or Sand fly (Phlebotomus spp.) Biting Midges (punkie, granny nipper, no

- see

um)

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

F or General Label Claim

General Label Claim Representative Test Species

True Bugs Pest Group 13 Testing o f two species is required: Bed bug ( Cimex lectularius) or Tropical bed bug (Cimex hemipterus)

and

K issing bug ( Triatoma protracta) or C onenose bug ( Triatoma sanguisuga) Bed bugs Pest Group 13a Testing o f 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 o f one of the following species is required:

K issing bug ( Triatoma protracta)

, or C onenose 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

F or 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)

F or General Label Claims

General Label Claim Representative Test Species

Ants (excluding carpenter ants) Pest Group 15 In total, t esting of three species is required. Testing of the two following species is required:

P haraoh 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 Harvest e r 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

yearsPage 85 of 88



### Wood

- Destroying Beetles.

Representative Test Species for Wood

- Destroying Beetles

F or 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 ),

An obiid beetle (

Anobiidae sp .), and Bostrichid beetle ( Bostrichida e 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 yearsPage 86 of 88



### Termites.

Representative Test Species for Termites

F or 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 termite s is required:

Incisitermes minor or Cryptotermes brevis

Subterran ean 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 termite s is required:

Incisitermes minor or Cryptotermes brevisPage 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 P revention 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 yearsPage 88 of 88 

## Invasive Species

Once an alien invertebrate species has been determined to be an invasive species, the

a gency 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.