2

Indoxacarb Preliminary Work Plan – Table of Contents 

Overview 4 

Anticipated Data Needs 5 

Statutory and Regulatory Authority 5 

Chemical Facts 6 

Use and Usage Information 7 

Recent Actions 9 

Anticipated Risk Assessments for Registration Review 9 

Timeline 12 

Next Steps 12 

Appendix – Additional Areas Considered in the Indoxacarb Registration Review 13 

References:

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position 

based on the following documents: 

1. Registration Review Problem Formulation for Indoxacarb. Christopher M. Koper, Robin 

Sternberg. May 9, 2013. 

2. Indoxacarb Human Health Risk Assessment Scoping Document in Support of Registration 

Review. Danette Drew. May 9, 2013. 

3. Indoxacarb: Review of Human Incidents. Elizabeth Evans, Shanna Recore. March 13, 

2013. 

4. BEAD Chemical Profile for Registration Review: Indoxacarb (067710). Monisha Kaul. 

December 10, 2012.

5. Indoxacarb (067710) Screening Level Usage Analysis (SLUA). October 12, 2012.

6. PRD Label Data Report: Food/Feed & Non-Food/Non-Feed Uses Considered in 

Registration Review Work Planning. Indoxacarb. November 27, 2012.
3

These and other supporting documents for the indoxacarb registration review case may be found 

in the docket EPA-HQ-OPP-2013-0367 at http://www.regulations.gov. 
4

OVERVIEW

The docket for indoxacarb is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2013-0367). Indoxacarb is a broad-spectrum, 

oxadiazine insecticide registered for use against caterpillars, beetles, leafhoppers, ants, 

cockroaches, and mole crickets. Indoxacarb products are registered for use in agricultural, 

residential, commercial, institutional, and industrial sites. The term “indoxacarb” can refer to 

any of several chemical forms of the compound, differentiated by S-enantiomer to R-enantiomer 

ratio. See Table 3 of this document for more information. This Preliminary Work Plan (PWP) 

document explains what EPA's Office of Pesticide Programs knows about indoxacarb, 

highlighting anticipated data and assessment needs, identifying the types of information that 

would be especially useful to the Agency in conducting the review, and providing an anticipated 

timeline for completing the registration review for indoxacarb. 

 

The registration review process was designed to include a public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inform the public of what it knows about indoxacarb and what types of new data or 

other information would be helpful for the Agency to receive as it moves toward a decision on 

indoxacarb. The Agency encourages all interested stakeholders to review the PWP and 

Appendix and to provide comments and additional information that will help the Agency’s 

decision-making process for this chemical. In addition to general areas on which persons may 

wish to comment, there are some areas identified in the PWP and Appendix about which the 

Agency specifically seeks comments and information. Interested stakeholders could include: 

environmental non-profit or interest groups; pesticide manufacturers; agricultural labor or 

commodity groups; commercial, institutional, residential, and other users of pesticides; or the 

public at large. 

The Preliminary Work Plan begins by listing the anticipated data needs for indoxacarb. Next, it 

discusses the statutory and regulatory authority for Registration Review. Then the document 

provides chemical facts, use and usage information, recent actions, the anticipated risk 

assessments, and a projected registration review timeline for indoxacarb. Finally, the Appendix 

to this document includes identification and discussion of some areas that are considered 

generally in Registration Review along with some additional chemical case-specific information. 

 
5

ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for indoxacarb. For additional discussion of 

the anticipated data needs, see the Registration Review Problem Formulation for Indoxacarb and 

Indoxacarb Human Health Risk Assessment Scoping Document in Support of Registration 

Review. 

Table 1: Anticipated Data Needs for the Indoxacarb Registration Review 

Guideline 

Number1 Study Title1 

Test Material 

Estimated 

Timeframe 

(Months from 

receipt of DCI) 

Anticipated Data Needs for the Parent Indoxacarb

835.4200 Anaerobic soil metabolism TGAI 24 

835.6100 

Terrestrial field dissipation study – Storage 

stability in soil and Analytical methods, soil and 

water 

TGAI 12 

850.1075 Acute toxicity estuarine and marine organisms – 

estuarine/marine fish DPX-MP062 12 

850.2100 Avian oral toxicity (passerine species) DPX-MP062 12 

850.4100 Terrestrial plant toxicity, seedling emergence 

TEP with DPXMP062 and 

TEP with DPXKN128 

12 

850.4150 Terrestrial plant toxicity, vegetative vigor

TEP with DPXMP062 and 

TEP with DPXKN128 

12 

Nonguideline 

(Special 

Study) 

Larval honey bee acute oral toxicity DPX-MP062 12 

Anticipated Data Needs for Indoxacarb Degradates

850.1075 Freshwater fish toxicity, coldwater species Degradate INMP819 12 

TGAI = technical grade active ingredient; TEP = typical end-use product 

STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States (U.S.) generally must be registered by the 

 

1

 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 – Ecological Effects Tests 

– including renumbering and other designations or changes for some guideline studies. See “Final Test 

Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028
6

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. The registration review program is intended to make sure that, as the ability 

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA’s website.2

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The regulations governing registration review begin at 40 CFR 155.40. The 

Agency will consider benefits information and data as required by FIFRA. The public phase of 

registration review begins when the initial docket is opened for each case. The docket is the 

Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses 

and data or information it believes are needed to make a registration review decision. After 

reviewing and responding to comments and data received in the docket during this initial 

comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for 

the registration review of indoxacarb. 

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for indoxacarb. 

Table 2: Chemical Facts for Indoxacarb

PC code 067710; The term ‘indoxacarb’ generally refers to the Senantiomer, but may also refer to a mixture. For a description of 

the various forms of indoxacarb, see Table 3 below. 

Case Number 7613 

CAS Number 173584-44-6 

Year first registered 2000 

Pesticide Type Insecticide 

Chemical class Oxadiazine class 

Reregistration Eligibility 

Decision (RED) 

Because it was registered after November 1984, indoxacarb was not 

subject to reregistration. 

Cumulative group Not applicable. Indoxacarb has not been identified as a member of 

a cumulative group that shares a common mechanism of toxicity. 

40 CFR Citation Tolerances for indoxacarb are established in 40 CFR 180.564(a). 

Pesticide Re-evaluation 

Division, Chemical 

Review Manager 

Katie Weyrauch, weyrauch.katie@epa.gov, (703) 308-0166 

 

2

 http://www.epa.gov/oppsrrd1/registration_review/ 
7

Table 2: Chemical Facts for Indoxacarb

Registration Division, 

Product Manager 

John Hebert, hebert.john@epa.gov, (703) 308-6249 

The term “indoxacarb” generally refers to the S-enantiomer (also called DPX-KN128 or KN128) 

but may also refer to a racemic mixture. Also, there are two indoxacarb degradates that EPA 

plans to consider in the indoxacarb ecological risk assessment. See Table 3 below for more 

information. 

Table 3: Indoxacarb Parent Compounds and Degradates3

Indoxacarb Parent 

Compound Descriptions 

Name Also referred to as 

S-enantiomer DPX-KN128 KN128 

R-enantiomer DPX-KN127 KN127 

75:25 S:R ratio DPX-MP062 MP062 

50:50 S:R ratio DPX-JW062 JW062 

Indoxacarb Degradates to be Considered in the Ecological Assessment

IN-JT333

IN-MP819

USE AND USAGE INFORMATION

Table 4 summarizes the use and usage information for indoxacarb. Please see the BEAD 

Chemical Profile for Registration Review: Indoxacarb (067710) in the registration review docket 

for more details. 

Table 4: Indoxacarb Use and Usage Information

Summary of Use Broad-spectrum insecticide registered for use against caterpillars, 

beetles, leafhoppers, ants, fire ants, cockroaches, mole crickets, 

fleas and ticks. 

Use Sites Indoxacarb products are registered for use in agricultural sites 

including bush berries, cane berries, grapes, nut crops, stone fruits, 

pome fruits, spice crops, cucurbits, fruiting vegetables, leafy and 

stem vegetables (grown for greens and salads), root crop 

vegetables, corn, peas, forage grasses, alfalfa, cotton, soybeans, and 

peanuts. 

Indoxacarb products are also registered for use indoors and 

outdoors in non-agricultural, residential, commercial, institutional, 

and industrial sites, including ornamental plants, ornamental lawns 

and turf, ornamental woody shrubs and vines, ornamental trees, pets 

and animals in enclosures, private or commercial domestic 

 

3

 For more information about the chemical forms of indoxacarb parent and degradates, see p. 2 of the Indoxacarb 

Human Health Risk Assessment and Scoping Document in Support of Registration Review, and p. 40 of the 

Registration Review Problem Formulation for Indoxacarb. 
8

Table 4: Indoxacarb Use and Usage Information

dwellings and their contents, uncultivated non-agricultural areas, 

schools and buildings, commercial transportation facilities, food 

and feed processing plants and areas, eating establishments, food 

marketing/storage/distribution facilities, hospitals and related 

institutions, bathrooms, refuse and solid waste sites, conifers, and 

crack and crevice treatments. 

Summary of Usage From 2007-2011, indoxacarb’s total agricultural usage averaged 

39,000 pounds a.i. for 558,000 treated acres with an overall 

application rate averaging 0.07 lbs a.i. per acre. The crops on 

which the greatest usage was reported were tomato, cotton, 

broccoli, soybean, and peanuts. The available non-agricultural 

usage data sources did not report any usage for the non-agricultural 

use sites. 

Formulation Type(s) Formulation types include granules; impregnated materials; water 

dispersible granules; emulsifiable, flowable, and soluble 

concentrates; and ready-to-use solution. 

Application Method(s) Products can be applied via broadcast spray or spot treatment, 

mound treatment, chemigation, spot-on, and baits. 

Technical Registrant(s) E.I. Du Pont de Nemours and Company 

No. of Registrations 37 Section 3 products4; 2 Section 24c registrations 

Restricted Use No 

Guidance for Commenters: Additional areas of use and usage related information

requested for this registration review, and of particular interest to EPA, are described below. 

 Confirmation of the following label information: sites of application; formulations; 

application methods and equipment; maximum application rates; frequency of 

application, application intervals, and maximum number of applications per season; and 

geographic limitations on use. 

 Use distribution (e.g., acreage and geographical distribution of relevant use sites). 

 Median and 90th percentile reported use rates (lbs ai/A) from usage data – national, state, 

and county. 

 Typical application timing (date of first application and application intervals) – national, 

state, and county. 

 Usage/use information for non-agricultural uses. 

 Typical application interval (days). 

 State or local use restrictions. 

 Foreign technical registrants not listed above who supply technical indoxacarb to the US 

market. 

 

4

 Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website 

(http://oaspub.epa.gov/pestlabl/ppls.home). 
9

RECENT ACTIONS

New use requests are pending for dry bean, snap bean, small fruit vine climbing (subgroup 13-

07F), low-growing berry (subgroup 13-07H). The PRIA due date for these requests is August 

2013. 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for indoxacarb was completed on 

May 2, 2013 in preparation for a new use request. The most recent ecological and environmental 

fate risk assessment was completed January 3, 2013 for the same purpose. Findings and 

conclusions from these risk assessments are summarized in the Registration Review Problem 

Formulation for Indoxacarb and Indoxacarb Human Health Risk Assessment Scoping Document 

in Support of Registration Review. 

During registration review, the Agency anticipates the need to conduct a comprehensive 

ecological risk assessment, including an endangered species assessment, for all uses of 

indoxacarb. For human health, EPA anticipates that there will be no need for revised dietary, 

residential, or occupational risk assessments during registration review, because the toxicological 

database in respect to human health is complete, and all human health assessments have been 

recently updated for the pending new uses. If toxicological endpoints or points of departure are 

revised, they will be considered in future assessments, as well as any changes to the standard 

operating procedures or default exposure assumptions. 

Table 5 below summarizes the anticipated registration review risk assessments based on the 

EFED Problem Formulation and HED Scoping Document. 

Table 5: Anticipated Risk Assessments for the Indoxacarb Registration Review 

Type of Risk Assessment Conduct? Notes 

Ecological and Environmental Fate 

Comprehensive ecological 

(species to be assessed 

include terrestrial and aquatic 

organisms), including 

endangered species 

Y In addition to parent indoxacarb, the aquatic 

ecological risk assessment will consider indoxacarb 

degradates IN-JT333 and IN-MP819 using a toxic 

equivalency (TEQ) approach. 

Incidents Will check for 

updates 

For a discussion of reported ecological incidents for 

indoxacarb, see page 17 of the Problem Formulation. 

Human Health 

Dietary 

Food N In the most recent dietary assessment, there were no 

dietary risk estimates of concern. No new data are 

needed to assess potential dietary exposure and risk 

and there are no dietary risks of concern for 

indoxacarb. A new dietary risk assessment is not 

anticipated for the registration review of indoxacarb. 

Drinking water N 
10

Occupational 

Handlers (mixers, loaders, 

applicators) 

N In the most recent occupational exposure assessment, 

there were no occupational handler or postapplication risk estimates of concern. No new data 

are anticipated to be required to assess potential 

occupational exposure and risk. A new occupational 

exposure assessment is not anticipated for the 

registration review of indoxacarb. 

Post-application N 

Residential 

Handlers N In the most recent residential handler exposure 

assessment, there were no handler risks estimates of 

concern. No new data are anticipated to be required 

to assess potential residential exposure and risk. A 

new residential exposure assessment is not 

anticipated for the registration review of indoxacarb. 

Post-application N In the most recent residential risk assessment for 

indoxacarb, there are no residential risk estimates of 

concern for the current uses, except for indoor surface 

directed sprays when a spot-directed treatment is 

assumed. In that case, non-dietary oral (hand-tomouth) exposures for children (1 to <2 years) 

exceeded the level of concern. When a crack and 

crevice only treatment is assumed for the spray, there 

are no risks estimates of concern. The crack and 

crevice treatment scenario uses a lower exposure 

estimate than the spot-directed treatment scenario. 

The current label does not restrict the indoor spray 

use to crack and crevice only, and EPA is working 

with registrants to address this concern. No new data 

are needed to assess potential residential postapplication risk. A new residential risk assessment is 

not anticipated for the registration review of 

indoxacarb. 

Other 
11

Aggregate N Evaluates the combined risk from dietary and 

residential exposures. In the most recent aggregate 

risk assessment for indoxacarb, there were no 

aggregate risks estimates of concern for indoxacarb 

when the aggregate assessment uses the crack-andcrevice exposure estimates for indoor surface spray. 

Note: the aggregate assessment for indoor surface 

directed sprays assumed only crack and crevice

treatment. The residential post-application (hand-tomouth) exposure to spot-directed sprays, for which 

EPA uses a higher exposure estimate, resulted in a 

risk estimate of concern for children. The Agency is 

working with registrants to address this concern. No 

new data are needed to address potential aggregate 

risk. A new aggregate risk assessment is not 

anticipated for the registration review of indoxacarb. 

Cumulative N The Food Quality Protection Act (FQPA) requires the 

Agency to consider the cumulative risks of chemicals 

sharing a common mechanism of toxicity. EPA does 

not have, at this time, available data to determine 

whether indoxacarb has a common mechanism of 

toxicity with other substances. Therefore, a 

cumulative risk assessment has not been performed 

for indoxacarb, and is not anticipated for the 

registration review of indoxacarb. 

Tolerances N During registration review, the Agency will evaluate 

the tolerance levels to determine if they can be 

harmonized with Codex maximum residue limits 

(MRLs). 

Incidents Will check for 

updates 

For a discussion of reported human incidents for 

indoxacarb, see page 9 of the Scoping Document and 

the Indoxacarb: Review of Human Incidents. 

Guidance for Commenters: Additional ecological information requested for this 

registration review, and of particular interest to EPA, is described below. 

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency. 

 Water quality monitoring data (see Appendix for further details). 
12

TIMELINE

EPA has created the following estimated timeline for the completion of the indoxacarb 

registration review in Table 6 below. 

Table 6: Projected Indoxacarb Registration Review Timeline

Activities Estimated Date

Opening the Docket 

Open Docket and 60-day Public Comment Period 2013 – June 

Close Public Comment 2013 – August 

Case Development 

Final Work Plan 2013 – November 

Issue DCI 2014 July – September 

Data Submission 2016 July – September 

60-day Public Comment Period for Draft Risk 

Assessments5

2018 January – March 

Registration Review Decision 

60-day Public Comment Period for Proposed 

Registration Review Decision 

2018 October – December 

Registration Review Decision and Begin Post-Decision 

Follow-up 

2019 

Total (years) 6 

NEXT STEPS

After the 60-day public comment period closes, the Agency will review and respond to any 

comments received in a timely manner and then issue a Final Work Plan for the registration 

review of indoxacarb. 

 

 

5

 The regulations governing Registration Review generally require the Agency to provide a public comment period 

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments. 
13

Appendix – Additional Areas Considered in the Indoxacarb Registration 

Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency 

where your comments, data submissions, or reference to sources of additional information could 

be of particular use.

Trade Irritants: 

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency 

will work to harmonize tolerances and international maximum residue limits (MRLs) and may 

modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to 

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. 

tolerances and MRLs in key export markets, providing as much specificity as possible regarding 

the nature of the concern. 

Water Quality: 

Indoxacarb is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.6

 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for indoxacarb.7 More information on impaired water bodies and 

TMDLs can be found at the Agency’s website.8 The Agency invites submission of water 

quality data for this pesticide. To the extent possible, data should conform to the quality 

standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process9 in order to ensure they can be used quantitatively or qualitatively in 

pesticide risk assessments. 

Environmental Justice: 

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to indoxacarb compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population.

 

6 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

7

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES

8 http://www.epa.gov/owow/tmdl/

9 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm
14

ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been 

conducted for indoxacarb. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of indoxacarb has “no effect” or “may affect” 

federally listed threatened or endangered species (listed species) or their designated critical 

habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service 

and/or National Marine Fisheries Service (the Services), as appropriate. 

On January 19, 2011, the Center for Biological Diversity and the Pesticide Action Network 

North America filed a lawsuit in the United States District Court for the Northern District of 

California, against the Environmental Protection Agency (EPA) for allegedly failing to undergo 

consultation with the United States Fish and Wildlife Service and the National Marine Fisheries 

Service regarding the effects of over 350 pesticides, including indoxacarb, on over 200 

endangered and threatened species throughout the United States (Center for Biological Diversity, 

et al. v. EPA, et al., No. C 11-00293 (N.D.Cal.). 

ENDOCRINE DISRUPTOR SCREENING PROGRAM: 

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision for indoxacarb, EPA reviewed 

these data and selected the most sensitive endpoints for relevant risk assessment scenarios from 

the existing hazard database. However, as required by FFDCA section 408(p), indoxacarb is 

subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 
15

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Indoxacarb is 

not among the group of 58 pesticide active ingredients on the initial list to be screened under the 

EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data callins, requiring the submission of EDSP screening assays for indoxacarb. For further information 

on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the 

test guidelines and the Tier 1 screening battery, please visit our website.10

HUMAN STUDIES:

Occupational and Residential 

Past indoxacarb risk assessments rely in part on data from studies in which adult human subjects 

were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. 

Many such studies, involving exposure to many different pesticides, comprise generic pesticide 

exposure databases such as the Pesticide Handlers Exposure Database (PHED), the Agricultural 

Reentry Task Force (ARTF) Database, and the Outdoor Residential Exposure Task Force 

(ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide generic 

exposure databases, and has found no clear and convincing evidence that the conduct of any of 

them was either fundamentally unethical or significantly deficient relative to the ethical 

standards prevailing at the time the research was conducted. All applicable requirements of 

EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been 

satisfied, and there is no regulatory barrier to continued reliance on these studies. 

 

10 http://www.epa.gov/endo/