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the cage). There were no effects on gross pathology or histopathology. In a combined subchronic/ 

neurotoxicity study in rats, there were no neurotoxic effects when looking at FOB, motor activity, 

or histopathology. Halofenozide showed no evidence for genotoxicity or mutagenicity.

On 10-May-2012, HED’s Hazard and Science Policy Council (HASPOC) used a weight-ofevidence approach to determine that repeated exposure inhalation toxicity, two-generation 

reproductive, and chronic oral toxicity studies were not required at this time (TXR No.

0056312). This weight-of-evidence approach considered both hazard and exposure information 

and was based on the following factors: (1) the use of an oral POD for assessing risks via the 

inhalation exposure yielded Margins of Exposure (MOEs) well above the Agency’s Level of 

Concern (100); (2) the Agency is confident that the conservative estimates used in the 

assessments of risk via drinking water will not under estimate risk via this exposure pathway 

(i.e., drinking water); and (3) the lack of concern for reproductive and chronic toxicity based on 

the toxicity profile of structurally-related compounds (i.e., molting hormone agonists). 

Dietary Exposure: The dietary exposure database is adequate to support Registration Review 

for halofenozide. Halofenozide is not registered for application to agricultural crops or for direct 

application to water; in addition, halofenozide does not meet the mobility/bioaccumulation/

persistence criteria to be classified as a Persistent Bioaccumulative and Toxic (PBT; email from 

M. Barret, 21-Mar-2012, Environmental Fate and Effects Division (EFED)). Therefore, data 

concerning the nature/magnitude of the residue in crops/livestock/fish/shellfish have not been 

submitted and are unnecessary. 

The turf use may result in residues in water and EFED has previously provided screening, healthprotective, estimated drinking water concentrations (EDWCs) resulting from this use (E. Behl, 

16-Jan-1997; R. Jones, 26-Feb-1997). At the time the turf use was registered, HED did not make 

decisions concerning the residues of concern in water and the EDWCs are for parent only. 

EFED indicated that based on the environmental fate data which showed little degradation, the 

previous focus on parent is adequate (email from G. Rothman, 22-May-2012). However, EFED 

is asking for some additional information concerning the environmental fate for halofenozide. 

As part of Registration Review, revised EDWCs will be generated to reflect EFED and HED 

assessment of the environmental fate database and the most recent models for estimation of 

residues in drinking water. In addition, revised acute and chronic dietary exposure analyses may 

be required to reflect the most recent dietary exposure models, current practices for incorporating 

EDWCs in dietary exposure analyses, and/or revised PODs. 

Residential Exposure: The residential exposure database is adequate to support Registration 

Review for halofenozide. Based upon revisions to HED’s Residential Standard Operating 

Procedures (SOPs), Registration Review may require an updated residential exposure 

assessment. It should be noted that the dislodgeable foliar residue (DFR) and turf transferable 

residue (TTR) study (MRID No. 437016-20) used in the 1997 risk assessment to assess 

residential exposure may not have been conducted according to current guidelines, and may not 

be appropriate for use in residential post-application exposure assessments. However, a more 

recent TTR study (2002) has been submitted to the Agency (MRID No. 458866-01). The results 

of this study will be considered for residential post-application exposure during Registration 

Review. In addition, revised residential handler and post-application assessments may also be 

needed if toxicological PODs change or other new data are received by the Agency which impact 

exposure estimates. 
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The risk assessment conducted in support of the turf registration indicated that the granular labels 

should prohibit application to turf using hand-held spreaders (D221027, G. Kramer et al., 16-

May-1997). The need for this restriction will be reevaluated as part of Registration Review 

(current labels indicate that drop or rotary spreaders should be used but do not prohibit hand-held 

spreaders). 

Aggregate Risk Assessment: As part of Registration Review, updated aggregate risk 

assessments may be necessary to reflect revised residential exposure estimates, dietary exposure 

estimates, and/or toxicological PODs. 

Occupational Exposure: The occupational exposure database is adequate to support the 

Registration Review process for halofenozide. Updated occupational handler exposure 

assessments may be required under Registration Review based upon revisions to the Agency’s 

scenario-specific surrogate handler exposure data (http://www.epa.gov/pesticides/science/handlerexposure-table.pdf). Recommended unit exposures for occupational handler assessments have 

generally been derived only from Pesticide Handler Exposure Database (PHED). However, 

recently both the Outdoor Residential Exposure Task Force (ORETF) and Agricultural Handler 

Exposure Task Force (AHETF) have produced pesticide handler exposure monitoring data that the 

Agency is using in place of PHED. As more reliable data become available (such as that from the 

AHETF and ORETF), the Agency will continue to replace existing data. Reviewers will 

incorporate new exposure monitoring data, as necessary, during Registration Review.

Updated occupational post-application assessments may be required under Registration Review

based upon revisions to the Agency’s transfer coefficients. It should be noted that the DFR and 

TTR study (MRID No. 437016-20) used in the 1997 risk assessment to assess occupational 

exposure may not have been conducted according to current guidelines, and may not be 

appropriate for use in occupational post-application exposure assessments. However, a more 

recent study has been submitted to the Agency (MRID No. 458866-01). The results of this study 

will be considered for occupational post-application exposure during Registration Review. In 

addition, revised occupational handler and post-application assessments may also be needed if 

toxicological PODs change or other new data are received by the Agency which impact exposure 

estimates.

As was indicated above, the risk assessment conducted in support of the turf registration 

indicated that the granular labels should prohibit application to turf using hand-held spreaders

(D221027, G. Kramer et al., 16-May-1997). The need for this restriction will be reevaluated as 

part of Registration Review (current labels indicate that drop or rotary spreaders should be used 

but do not prohibit hand-held spreaders). 
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

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Summary - Risk Assessment Updates, Data Deficiencies, and Label Revisions: The risk 

assessment updates that may be required under Registration Review, revisions to the labels, and 

data deficiencies are summarized below.

Risk Assessment Updates and Label Revisions:

●When the required immunotoxicity study is submitted (see below), the current PODs will be 

reevaluated along with evaluation of the toxicological and exposure databases in terms of 

assigning a FQPA SF. 

●Revised dietary risk assessment may be necessary to reflect the most recent EDWCs, dietary 

exposure models, and/or toxicological PODs.

●Revised residential risk assessment may be necessary to incorporate guidance from the updated 

Residential SOPs and/or toxicological PODs. 

●Revised aggregate risk assessment may be necessary to reflect revised residential exposure 

estimates, dietary exposure estimates, and/or toxicological PODs. 

●Revised occupational risk assessment may be necessary to reflect the most recent HED policies

and/or toxicological PODs. 

●The risk assessment conducted in support of the turf registration indicated that the granular

labels should prohibit application to turf using hand-held spreaders (D221027, G. Kramer et al., 

16-May-1997). The need for this restriction will be reevaluated as part of Registration Review 

(current labels indicate that drop or rotary spreaders should be used but do not prohibit hand-held 

spreaders). 

Data Deficiencies:

●870.7800 Immunotoxicity Study (2007 40 CFR Part 158)
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DETAILED CONSIDERATIONS

Registered Use Pattern

Halofenozide is currently only registered for application to turf including residential, 

recreational, and commercial lawns (grounds or lawns around business and office complexes, 

shopping centers, multi-family and residential apartment complexes, airports, military and other 

institutions, cemeteries, parks and picnic areas, playgrounds, school, athletic fields, golf courses, 

and sod farms). Registered formulations include G and SC products; only the granular 

formulations are registered for use on residential lawns. The maximum seasonal application rate 

is 2 lb ai/acre with a 7-day preharvest interval (PHI; 12 hour restricted entry interval (REI)). See 

Attachment D for a summary of the registered end-use products and application scenarios. 

Hazard Identification/Toxicology

Halofenozide is ranked low for acute lethality via all of the acute tests. It is a dermal sensitizer. 

There are no studies available for halofenozide characterizing the chemical’s adsorption, 

distribution, metabolism, and excretion (ADME). A dermal absorption study is available which 

generated dermal absorption factors of 7.59 and 14.35%. The 14.35% value was used in 

previous risk assessments.

In dogs, subchronic oral exposure to halofenozide caused effects in the liver as well as the 

hematopoeitic system. Liver effects consisted of increased liver weights, and hemosiderin 

deposition in kupffer cells. Hematotoxic effects were indicative of adaptive regenerative 

anemia; decreased RBC count, hemoglobin and hematocrit, increased mean corpuscular volume, 

mean cell hemoglobin, methemoglobin and reticulocyte count, and increased spleen 

pigmentation. There were also decreased body weights and body-weight gains. In a combined 

subchronic/neurotoxicity study in rats, effects were body-weight gain decreases, reductions in 

food consumption, hematological effects, alterations in blood chemistry parameters, increased 

liver weights, and histopathological changes.

There is no increased quantitative or qualitative developmental susceptibility for halofenozide. 

In rats, both maternal and fetal toxicity occurred at the same dose. Maternal effects included 

decreased body-weight gains and hematological effects. Developmental effects consisted of 

decreased fetal body weight/litter (94% of control) in concert with decreased ossification of 

caudal vertebrae (11% compared with control) and forelimb metacarpals (9% compared with 

control). In rabbits, maternal effects consisted of mild hematological effects, but there were no 

developmental effects. 

Following dermal exposure in rats for 90-days, the effects were consistent with those observed 

following oral exposure. Both liver and hematological effects were consistent with those 

observed in oral studies. There were also decreased body weights and body-weight gains. 

In the acute neurotoxicity study in rats, clinical signs occurred at the mid- and high-doses, and 

included anogenital staining, red-stained muzzle, and scant feces. For FOB parameters, there 

was one effect at the high dose (vocalization upon removal from the cage). There were no 

effects on gross pathology or histopathology. In a combined subchronic/neurotoxicity study in 

rats, there were no neurotoxic effects when looking at FOB, motor activity, or histopathology. 
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Halofenozide showed no evidence for genotoxicity or mutagenicity.

In accordance with the revised 2007 40 CFR Part 158 Toxicology Data requirements, an 

immunotoxicity study (870.7800) is required. On 10-May-2012, the HASPOC used a weight-ofevidence approach to determine that repeated exposure inhalation toxicity, two-generation 

reproductive, and chronic oral toxicity studies were not required at this time (TXR No.

0056312). This weight-of-evidence approach considered both hazard and exposure information 

and was based on the following factors: (1) the use of an oral POD for assessing risks via the 

inhalation exposure yielded MOEs well above the Agency’s Level of Concern (100); (2) the 

Agency is confident that the conservative estimates used in the assessments of risk via drinking 

water will not underestimate risk via this exposure pathway (i.e., drinking water); and (3) the 

lack of concern for reproductive and chronic toxicity based on the toxicity profile of structurallyrelated compounds (i.e., molting hormone agonists).

Conclusions: The toxicity database for halofenozide is adequate to support current registration 

requirements despite the following critical study currently missing in the database: 

Immunotoxicity - 870.7800. When the required immunotoxicity study is submitted, the current 

PODs will be reevaluated along with evaluation of the toxicological and exposure databases in 

terms of assigning a FQPA SF. See Attachment B for a summary of the halofenozide 

toxicological profile; see Attachment C for a summary of the toxicological PODs used in the risk 

assessment associated with the turf registration(D221027, G. Kramer et al., 16-May-1997).

Endocrine Disruption

As required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal 

Food, Drug, and Cosmetic Act (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 reregistration decision, 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), halofenozide 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 
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

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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 

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. Halofenozide 

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 

call-ins, requiring the submission of EDSP screening assays for halofenozide. 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: 

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

Residue Chemistry, Tolerance Assessment, and International Harmonization

Halofenozide is not registered for application to agricultural crops or for direct application to 

water; in addition, halofenozide does not meet the mobility/bioaccumulation/persistence criteria 

to be classified as a PBT (email from M. Barret, 21-Mar-2012, EFED). Therefore, data 

concerning the nature/magnitude of the residue in crops/livestock/fish/shellfish and food/feed 

tolerances have not been submitted/established and are unnecessary. In additional, there are not 

established Canadian or Codex maximum residue limits (MRLs) for halofenozide (see 

Attachment E).

EDWCs

Halofenozide is currently registered for application to only turf and the following screening, 

health-protective, EDWCs were previously provided by EFED (2.0 lb ai/acre/year): (1) surface 

water - acute and chronic EDWCs of 113 ppb were generated using the Generic Expected 

Environmental Concentration (GENEEC) model (Behl, 16-Jan-1997) and (2) ground water -

acute high, chronic high, and chronic average EDWCs of 150 ppb, 100 ppb, and 10 ppb, 

respectively, were generated using the Pesticide Root Zone Model (PRZM 2.3; R. Jones, 26-Feb1997). EFED also indicated that a preliminary report concerning a prospective halofenozide 

groundwater monitoring study has been submitted to the Agency and this report noted 

halofenozide concentrations of ~50 ppb (email from Gabe Rothman, EFED, 15-May-2012). 

At the time the turf use was registered, HED did not make decisions concerning the residues of 

concern in water and the EDWCs are for parent only. EFED indicated that based on the 

environmental fate data which showed little degradation, the previous focus on parent is 

adequate (email from G. Rothman, 22-May-2012). However, EFED is asking for some 

additional information concerning the environmental fate for halofenozide. As part of 

Registration Review, revised EDWCs will be generated to reflect EFED and HED assessment of 

the environmental fate database and the most recent models for estimation of residues in drinking 

water. 
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Dietary Exposure

As part of the turf registration, HED conducted an acute dietary exposure assessment to

halofenozide from the consumption of drinking water (D221027, G. Kramer et al., 16-May1997). This analysis was conducted using the 150 ppb acute ground water estimate and assumed 

the following consumption and body weight figures: adult - 2 liters/day and 70-kg body weight; 

child - 1 liter/day and 10-kg body weight. The resulting acute MOEs were ≥670 and, therefore,

were not of concern to HED. A quantitative chronic dietary risk assessment was not conducted 

as part of the turf registration as a chronic reference dose had not been established. In the 

absence of this endpoint, the turf risk assessment made the assumption that halofenozide residues 

in drinking water would occupy 10% of the chronic risk cup. As part of Registration Review, 

revised acute and chronic dietary exposure analyses may be required to reflect the most recent 

dietary exposure models, revised EDWCs and current practices for incorporating EDWCs in 

dietary exposure analyses, and/or revised PODs. 

Residential Exposure

Halofenozide end-use products are marketed for use on turf, including residential lawns, golf 

courses, and other turf such as recreational/commercial areas. Only the granular products are 

registered for use on residential lawns and recreational areas, and may be applied using a droptype or rotary (push) type spreader. Although halofenozide is marketed for use by professional 

applicators on turf, the products are not restricted-use pesticides. Therefore, adult residential 

homeowners may experience exposure to halofenozide during application of the chemical (i.e., 

residential handler exposures). Additionally, adults and children may experience exposure to 

halofenozide when contacting halofenozide-treated areas (i.e., residential post-application 

exposure). The 1997 halofenozide risk assessment included risk estimates for short-term 

residential handlers; and short- and intermediate-term post-application exposure scenarios for 

adults and children (D221027, G. Kramer et al., 16-May-1997). 

Residential Handlers: The 1997 risk assessment assessed the residential handler scenarios which 

reflect the major residential uses of halofenozide based on types of application equipment:

Mixer/Loader/Applicator Exposure

Push spreader

Hand-held spreader

Unit exposure values were derived from PHED (1.1). All scenarios reflected the following 

assumptions: a homeowner applicator wearing short-sleeved shirt, long pants, and shoes plus 

socks. Dermal absorption was estimated to be approximately 14.35%, and the female-specific 

body weight was used based on the toxicological endpoints of concern. All residential handler

exposure scenarios resulted in MOEs above HED’s level of concern (LOC; MOE>100), with the 

exception of hand-held spreader applications, which resulted in a short-term MOE of 21 for 

female home applicators.
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Residential Post Application: Halofenozide is registered for use on residential turf, golf courses, 

and other turf such as recreational/commercial areas; all areas that can be frequented by the 

general population. As a result, individuals can be exposed to halofenozide residues by entering 

these areas that have been previously treated. In the 1997 risk assessment, the major residential 

post-application exposure scenarios identified for halofenozide were adult turf activity and child 

turf activity. 

HED calculated MOEs for post-application exposures using standard exposure duration and 

transfer coefficient defaults. A DFR and TTR study (MRID No. 437016-20) submitted to the 

Agency in support of the registration requirements for halofenozide was reviewed by the 

Agency, and included in the 1997 risk assessment. Post-application exposures were calculated 

based on both the DFR and TTR data. Residue levels were corrected for field recovery and 

adjusted for application rate.

All residential post-application exposure scenarios resulted in MOEs above HED’s LOC (MOEs 

> 100) for the products registered for residential uses (i.e., granular formulations). Risks of 

concern were identified in the 1997 risk assessment for the liquid formulations; however, as 

noted above, the liquid formulations are not registered for use in residential areas, and are not 

expected to result in residential post-application exposure.

Residential Bystander Post-application Inhalation Exposure: Based on the Agency's current 

practices, a quantitative residential bystander post-application inhalation exposure assessment 

was not performed for halofenozide at this time. However, volatilization of pesticides may be a 

potential source of post-application inhalation exposure to individuals nearby to pesticide 

applications. The Agency sought expert advice and input on issues related to volatilization of 

pesticides from its FIFRA Science Advisory Panel (SAP) in December 2009. The Agency is in 

the process of evaluating the SAP report and may, as appropriate, develop policies and 

procedures, to identify the need for and, subsequently, the way to incorporate post-application 

inhalation exposure into the Agency's risk assessments. If new policies or procedures are put 

into place, the Agency may revisit the need for a quantitative post-application inhalation 

exposure assessment for halofenozide.

Spray Drift: Spray drift is always a potential source of exposure to residents nearby to spraying 

operations. This is particularly the case with aerial application, but, to a lesser extent, could also 

be a potential source of exposure from the ground application method employed for 

halofenozide. The Agency has been working with the Spray Drift Task Force, EPA Regional 

Offices, and State Lead Agencies for pesticide regulation and other parties to develop the best 

spray drift management practices (see the Agency’s Spray Drift website for more information at 

http://www.epa.gov/opp00001/factsheets/spraydrift.htm). On a chemical-by-chemical basis, the 

Agency is now requiring interim mitigation measures for aerial applications that must be placed 

on product labels/labeling. The Agency has completed its evaluation of the new database 

submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is 

developing a policy on how to appropriately apply the data and the AgDRIFT®computer model 

to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic 

methods. After the policy is in place, the Agency may impose further refinements in spray-driftmanagement practices to reduce off-target drift with specific products with significant risks 

associated with drift.
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

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Conclusions: The residential exposure database is adequate to support Registration Review for 

halofenozide. An updated residential exposure assessment may be required under Registration 

Review based upon revisions to HED’s Residential SOPs. It should be noted that the DFR and 

TTR study (MRID No. 437016-20) used in the 1997 risk assessment may not have been 

conducted according to current guidelines, and may not be appropriate for use in residential postapplication exposure assessments. However, a more recent TTR study (2002) has been 

submitted to the Agency (MRID No. 458866-01). The results of this study will be considered for 

residential post-application exposure during Registration Review. In addition, revised residential 

handler and post-application assessments may also be needed if toxicological endpoints change 

or other new data are received by the Agency which impact exposure estimates. 

The risk assessment conducted in support of the turf registration indicated that the granular labels 

should prohibit application to turf using hand-held spreaders (D221027, G. Kramer et al., 16-

May-1997). The need for this restriction will be reevaluated as part of Registration Review 

(current labels indicate that drop or rotary spreaders should be used but do not prohibit hand-held 

spreaders). 

Aggregate Risk Assessment

An acute aggregate risk assessment (dietary and residential exposure) was conducted as part of 

the HED’s evaluation of the turf use; the resulting aggregate acute MOEs were ≥380 and,

therefore, were not of concern to HED. As part of Registration Review, revised acute, shortterm, intermediate-term, and/or chronic aggregate risk assessments may be required to reflect 

current HED policies.

Occupational Exposure

Halofenozide is registered for use on turfgrass (lawns, sod, and turf areas). The labeled uses 

include residential and commercial lawns, grounds or lawns around business and office 

complexes, shopping centers, multi-family and residential apartment complexes, airports, 

military and other institutions, cemeteries, parks and picnic areas, playgrounds, school, athletic 

fields, golf courses, and sod farms. Based on these uses, there is a potential for exposure to 

halofenozide in occupational scenarios from handling halofenozide products during the 

application process (i.e., mixer/loaders, applicators, and mixer/loader/applicators); as well as a 

potential for post-application worker exposure from entering into areas previously treated with 

halofenozide.

Registered formulations include granular and SC products. The granular formulations of 

halofenozide may be applied using drop-type/rotary sprayers or tractor-drawn spreaders; and the 

SC formulation may be applied using manually- or mechanically-pressurized handguns, 

groundboom equipment, or backpack sprayers. The prescribed personal protective equipment 

(PPE) consists of single layer clothing (long-sleeve shirt, long pants, socks, and shoes) and 

waterproof gloves. The use patterns suggest that short-term (1-30 days) and intermediate-term 

(1-6 months) exposures are expected via inhalation and dermal routes for the occupational 

handler scenarios and dermal routes for occupational post-application scenarios. The 1997 

halofenozide risk assessment included risk estimates for both occupational handler and 

occupational post-application scenarios.
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Occupational Handlers: The 1997 risk assessment evaluated the occupational handler scenarios 

to represent the major halofenozide occupational handler scenarios based on application 

equipment and formulation (D221027, G. Kramer et al., 16-May-1997). The major exposure 

scenarios identified for halofenozide were as follows:

Mixing/Loader Exposure

Open pour liquids, golf fairway applications

Open pour liquids, sod farm turf applications

Open pour liquids, high-pressure handwand applications to golf tees/greens

Open pour liquids, commercial applications to residential turf (single truck)

Open pour granules

Applicator Exposure

Open-cab groundboom application to golf fairway

Open-cab groundboom application to sod farms

High-pressure handwand applications to golf tees/greens

Low-pressure handwand applications to residential turf

Open-cab drop-spreader applications

Mixer/Loader/Applicator Exposure

Backpack applications to golf tees/greens

Open-cab drop-spreader applications

Push-spreader application

Hand-held spreader

Occupational handler exposures were estimated using exposure data from PHED Ver. 1.1. All 

scenarios reflect the following assumptions: long-sleeved shirt and pants, and gloves. Dermal 

absorption is estimated to be approximately 14.35%.

For liquid formulations, all occupational handler exposure scenarios resulted in MOEs above 

HED’s LOC (MOE of >100), with the exception of low-pressure handwand applications to 

residential turf (short-term MOE of 86, and intermediate-term MOE of 98). For granular 

formulations, all occupational handler exposure scenarios resulted in MOEs above HED’s LOC 

(MOE>100), with the exception of hand-held spreader applications (short-term MOE of 36; 

intermediate-term MOE of 24).

Occupational Post-application: Based on the registered use on turfgrass, HED determined that 

there is the potential for occupational post-application exposures to individuals entering areas 

treated with halofenozide. HED calculated MOEs for post-application exposures using standard 

exposure duration and transfer coefficient defaults. A DFR and TTR study (MRID No. 437016-

20) submitted to the Agency in support of the registration requirements for halofenozide was 

reviewed by the Agency, and included in the 1997 risk assessment. Residue levels were 

corrected for field recovery and adjusted for application rate. Occupational post-application 

exposures were calculated based on both the DFR and TR data. The major post-application 

exposure scenarios identified for halofenozide were the golf course mower and the sod farm 

harvester. The MOEs were above HED’s LOC (MOE>100) for all post-application exposure 

scenarios at the label-prescribed PHIs.
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Conclusions: The occupational exposure database is adequate to support the Registration 

Review process for halofenozide. Updated occupational handler exposure assessments may be 

required under Registration Review based upon revisions to the Agency’s scenario-specific 

surrogate handler exposure data (http://www.epa.gov/pesticides/science/handler-exposuretable.pdf). Recommended unit exposures for occupational handler assessments have generally 

been derived only from PHED. However, recently both the ORETF and AHETF have produced 

pesticide handler exposure monitoring data that the Agency is using in place of PHED. As more 

reliable data become available (such as that from the AHETF and ORETF), the Agency will 

continue to replace existing data. Reviewers will incorporate new exposure monitoring data, as 

necessary, during Registration Review.

Updated occupational post-application assessments may be required under Registration Review

based upon revisions to the Agency’s transfer coefficients. It should be noted that the DFR and 

TTR study (MRID No. 437016-20) used in the 1997 risk assessment may not have been 

conducted according to current guidelines, and may not be appropriate for use in occupational 

post-application exposure assessments. However, a more recent study has been submitted to the 

Agency (MRID No. 458866-01). The results of this study will be considered for occupational 

post-application exposure during Registration Review. In addition, revised occupational handler 

and post-application assessments may also be needed if toxicological endpoints change or other 

new data are received by the Agency which impact exposure estimates. 

The risk assessment conducted in support of the turf registration indicated that the granular labels 

should prohibit application to turf using hand-held spreaders (D221027, G. Kramer et al., 16-

May-1997). The need for this restriction will be reevaluated as part of Registration Review 

(current labels indicate that drop or rotary spreaders should be used but do not prohibit hand-held 

spreaders). 

Public Health, Pesticide Epidemiology, and Human Incidence Data

The OPP Incident Data System (IDS) was utilized to retrieve halofenozide incident data reported 

to EPA. In Aggregate IDS, from 1-January-2007 to 22-February-2012, there were five reported

incidents involving halofenozide. For the Main IDS, from 1-January-2007 to 22-February-2012,

there were six incidents reported involving halofenozide which were classified as moderate 

severity. Overall, there are few incidents involving halofenozide reported to IDS. HED notes 

that halofenozide is not included in the Agricultural Health Study (AHS). 

Based on the low frequency and severity of incident cases reported for halofenozide, there does 

not appear to be a concern at this time that would warrant further investigation. The Agency will 

continue to monitor the incident information and if a concern is triggered, additional analysis 

will be included in the risk assessment.
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

Page 14 of 22

Human Studies 

The residential and occupational exposure and risk assessment for halofenozide relied in part on 

data from studies in which adult human subjects were intentionally exposed to a pesticide or 

other chemical. These studies required a review of their ethical conduct and have received the 

appropriate review by the Human Studies Review Board (HSRB). Many such studies, involving 

exposure to many different pesticides, comprise generic pesticide exposure databases such as the 

PHED and the Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the 

studies in these multi-pesticide generic exposure databases, and on the basis of available 

evidence has found them to have been neither fundamentally unethical nor significantly deficient 

relative to standards of ethical research conduct prevailing when they were conducted. There is 

no regulatory barrier to continued reliance on these studies, and all applicable requirements of 

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

satisfied.

Environmental Justice

Potential areas of environmental justice concerns, to the extent possible, are considered in HED 

human-health risk assessments, in accordance with U.S. Executive Order 12898, "Federal 

Actions to Address Environmental Justice in Minority Populations and Low-Income 

Populations," (http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf. As a part of every 

pesticide risk assessment, OPP considers a large variety of consumer subgroups according to 

well-established procedures. In line with OPP policy, HED estimates risks to population 

subgroups from pesticide exposures that are based on patterns of that subgroup’s food and water 

consumption, and activities in and around the home that involve pesticide use in a residential 

setting. Extensive data on food consumption patterns are compiled by the USDA under the 

Continuing Survey of Food Intake by Individuals (CSFII) and are used in pesticide risk 

assessments for all registered food uses of a pesticide. These data are analyzed and categorized 

by subgroups based on age, season of the year, ethnic group, and region of the country. 

Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups and 

exposure assessments are performed when conditions or circumstances warrant. Whenever 

appropriate, non-dietary exposures based on home use of pesticide products and associated risks 

for adult applicators and for toddlers, youths, and adults entering or playing on treated areas 

postapplication are evaluated. Further considerations are currently in development as OPP has 

committed resources and expertise to the development of specialized software and models that 

consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary 

patterns among specific subgroups.
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

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Risk Assessment Updates, Data Deficiencies, and Label Revisions

The risk assessment updates that may be required under Registration Review, revisions to the 

labels, and data deficiencies are summarized below.

Risk Assessment Updates and Label Revisions:

●When the required immunotoxicity study is submitted (see below), the current PODs will be 

reevaluated along with evaluation of the toxicological and exposure databases in terms of 

assigning a FQPA SF.

●Revised dietary risk assessment may be necessary to reflect the most recent EDWCs, dietary 

exposure models, and/or toxicological PODs.

●Revised residential risk assessment may be necessary to incorporate guidance from the updated 

Residential SOPs and/or toxicological PODs. 

●Revised aggregate risk assessment may be necessary to reflect revised residential exposure 

estimates, dietary exposure estimates, and/or toxicological PODs. 

●Revised occupational risk assessment may be necessary to reflect the most recent HED policies

and/or toxicological PODs. 

●The risk assessment conducted in support of the turf registration indicated that the granular

labels should prohibit application to turf using hand-held spreaders (D221027, G. Kramer et al., 

16-May-1997). The need for this restriction will be reevaluated as part of Registration Review 

(current labels indicate that drop or rotary spreaders should be used but do not prohibit hand-held 

spreaders). 

Data Deficiencies and label Revisions:

●870.7800 Immunotoxicity Study

References

Memoranda Relevant to Registration Review

Author Barcode or 

TXR No. Date Title

G. Kramer D221027 16-May-1997 HED Risk Assessment for Use of the New Chemical, Halofenozide 

(121026) on Turfgrass; 

S. Recore D400116 8-May-2012 Halofenozide: Review of Human Incidents

?? TXR No. 

0056312 ?? HASPOC 

Attachment A: Chemical Identity and Physicochemical Properties

Attachment B: Hazard Profile Tables

Attachment C: Toxicological Endpoint Selection Table 

Attachment D: Registered Application Scenarios and Rates

Attachment E: IRL

RDI: RAB1 and J. Rowland (23-May-2012); PRD (7-June-2012)

T. Bloem:Potomac Yard 1:703-605-0217:S10945P
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

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Attachment A: Chemical Identity and Physicochemical Properties

Chemical Identity.

Chemical Structure

Common name halofenozide

Company experimental name RH-0345

IUPAC name N-tert-butyl-N′-(4-chlorobenzoyl)benzohydrazide

CAS name 4-chlorobenzoic acid 2-benzoyl-2-(1,1-dimethylethyl)hydrazide

CAS # 112226-61-6

Physicochemical Properties of the Technical Grade Test Compound.

Melting point 200°C

http://sitem.herts.ac.uk/aeru/footprint/en/

Reports/376.htm

pH not available

Density not available

Water solubility 12 mg/liter (20°C)

Solvent solubility (20°C)

isopropanol - 31,000 mg/liter (20°C)

cyclohexane - 154,000 mg/liter (20°C)

Vapor pressure 4.1 x 10-10 mm Hg (25° C)

Dissociation constant (pKa) not available

Octanol/water partition coefficient Log(KOW) 3.34 (pH 7; 20°C)

UV/visible absorption spectrum not available
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

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Attachment B: Hazard Profile Tables

Acute Toxicity Profile - Halofenozide 

Guideline No. Study Type MRID(s) Results Toxicity Category

870.1100 Acute oral [rat] 43642810 LD50 = 2850 mg/kg III

870.1100 Acute oral [mouse] 43642811 LD50 = 2214 mg/kg III

870.1200 Acute dermal [rat] 43642813 LD50 > 2000 mg/kg III

870.1300 Acute inhalation [rat] 43642812 LC50 > 2.7 mg/L IV

870.2400 Acute eye irritation [rabbit] 43642815

low grade corneal opacity & irritation of iris & 

conjunctiva reversible in 72 hours (only males 

tested)

III

870.2500 Acute dermal irritation [rabbit] 43642816 No irritation at 72 hours or in the study (only 

males tested)

IV

870.2600 Skin sensitization [guinea pig] 43642817 Positive (Buehler Closed Patch Method) N/A

Subchronic, Chronic and Other Toxicity Profile

Guideline No. Study Type MRID No. (year)/ 

Classification /Doses Results

870.3100

Combined 90-Day oral 

toxicity/ Subchronic 

Neurotoxicity (rat)

437145011 (2005)

Acceptable/guideline

0, 1, 7.5, 75 or 750 ppm 0, 

0.07/0.08, 0.54/0.57, 5.53/5.88, 

and 52.72/54.61 mg/kg/day 

[M/F]

NOAEL = 75 ppm (5.53/5.88 mg/kg/day [M/F])

LOAEL = 750 ppm (52.72/54.61 mg/kg/day [M/F]) 

based on body-weight gain decrease, reduction in food 

consumption, hematological effects, alteration in blood 

chemistry parameters, increased liver weight, and 

histopathological changes.

870.3150

14-day Confirmatory 

oral toxicity (dog)

43701611 (1994) 

Acceptable/guideline

0, 200 2000 ppm

0, 28.8 to 43.5 mg/kg/day 

[M/F]

Due to the severity of these signs, the study was 

terminated at 3 days. Results in this study confirmed 

the results observed in the previous dog study (i.e.,

signs of severe neurotoxicity at a dose level of 2000 

ppm)

870.3150

14-dayRange-finding 

oral toxicity (dog)

43701612 (1994) 

Acceptable/guideline

0, 200, 1000, 2000 or 5000 

ppm

0, 7.5/8.7, 37.2/32.9, 37.2/32.9, 

and 39.6/49.1 mg/kg/day [M/F]

NOAEL = 200 ppm (7.5/8.7 mg/kg/day [M/F])

LOAEL = 1000 ppm (37.2/32.9 mg/kg/day [M/F]) 

based on decreased body weights, decreased food 

consumption, signs of regenerative hemolytic anemia, 

increased methemoglobin levels, increased Heinz body 

counts, increased platelets, increased plasma bilirubin, 

increased alkaline phosphatase activity, and increased 

relative spleen, liver and kidney/body weight ratios.

870.3200

90-Day dermal toxicity 

(rat)

43642818 (1995)

Acceptable/guideline

0, 40, 200 and 1000 mg/kg/day 

[M/F]

NOAEL = 40 mg/kg/day

LOAEL = 200 mg/kg/day based on several 

hematological and clinical chemistry effects and 

hepatic hypertrophy.
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

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Subchronic, Chronic and Other Toxicity Profile

Guideline No. Study Type MRID No. (year)/ 

Classification /Doses Results

870.3700a

Prenatal 

developmental in (rat)

43642819 (1994)

Acceptable/guideline

0, 5, 30 and 180 mg/kg/day [F]

Maternal NOAEL = 30 mg/kg/day

LOAEL = 180 mg/kg/day based on death of one dam 

among the twenty five, reduced body weight, and 

body-weight gain, reduced food consumption and 

reduced carcass weight. In addition, certain 

hematology parameters were affected, including 

increased percentage of methemoglobin and number of 

reticulocytes along with decreased white blood cell 

count, hemoglobin concentration and hematocrit. 

There were also alterations in red cell morphology.

Developmental NOAEL = 30 mg/kg/day

LOAEL = 180 mg/kg/day based on decreased fetal 

body weight/litter (94% of control) in concert with 

decreased ossification of caudal vertebrae (11% 

compared with control) and forelimb metacarpals (9% 

compared with control).

870.3700b

Prenatal 

developmental in 

(rabbit)

43642820 (1995)

Acceptable/guideline

0, 10, 20, 60, and 120 

mg/kg/day [F]

Maternal NOAEL = 10 mg/kg/day

LOAEL = 20 mg/kg/day based on clinical signs 

(tremors). .

Developmental NOAEL ≥ 120 mg/kg/day

LOAEL was not established.

Gene Mutation

870.5100 bacterial reverse 

mutation (Ames) assay

43642821(1994)

Acceptable/guideline

Four Salmonella typhimurium 

strains (TA 98, TA 100, TA 

1535, TA 1537) were exposed 

in two independent trials to 

halofenozide technical (91.7% 

a.i) in the presence and absence 

of an exogenous metabolic 

activation system (S9 liver 

fraction from Aroclor 1254-

induced male rats), and the 

number of hisrevertants 

(colonies representing reverse 

gene mutation at the histidine 

locus) determined after 72 

hours treatment.

There were no increases over solvent control in 

revertant counts for any activated or non-activated 

strain in either trial when tested up to precipitating 

concentrations, 750 to 2000 ug/plate. Hence, the 

investigators concluded the test article was not 

mutagenic in the Ames Assay as performed in this lab.

Gene Mutation

870.5100

mammalian cell 

forward gene mutation 

assay

43701613 (1994)

Acceptable/guideline

Duplicate cultures of CHO cells 

were exposed for five hours in 

separate independent assays to 

test article, both in the absence 

and presence of Aroclor 1254-

stimulated metabolic activation 

(S9)

There was no increased induced mutation over solvent 

control values in any test culture treated up to 

precipitating levels, 49 to 99 ug/ml, in either 

experiment, contrasted with positive control cultures, 

which responded appropriately, at levels 100-200 

above background.
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

Page 19 of 22

Subchronic, Chronic and Other Toxicity Profile

Guideline No. Study Type MRID No. (year)/ 

Classification /Doses Results

Cytogenetics 

870.5300

in vitro cytogenetics 

assays

43701614 (1994)

Acceptable/guideline

Chinese hamster ovary (CHO) 

cells in culture were exposed 

for 12 or 22 hours to the test 

material, both in the absence 

and presence of mammalian 

metabolic activation provided 

by Aroclor 1254 - stimulated 

rat S9 hepatic homogenates. 

No increases over solvent controls in structural 

aberrations were found in either activated or nonactivated test cultures exposed to concentrations 

producing cytotoxicity and/or precipitation (150 

ug/ml, the HDT)

Cytogenetics 

870.5300

in vivo cytogenetic 

assay

43701615 (1994)

Acceptable/guideline

Adult CD-1 mice received a 

single oral dose of test article in 

corn oil, and killed 24 or 48 

hours later

There were no significant increases over solvent (corn 

oil) control values in micronucleated polychromatic 

erythrocytes at doses producing systemic toxicity (704 

and the HDT, 1408 mg/kg) or cytotoxicity (141 mg/kg 

and above). Positive control values were significantly 

increased, from 7 to 65 times background.

870.6200a

Acute neurotoxicity 

screening battery (rat)

43701609 (1994) 

Acceptable/guideline 0, 200, 

400, 800 mg/kg [M/F]

NOAEL = 200 mg/kg/day

LOAEL = 400 mg/kg/day based on based on clinical 

signs consisting of anogenital staining, red stained 

muzzle and scant feces, and FOB in females (reactions 

of females upon removal from the cage).

870.6200b

Combined 90-Day oral 

toxicity/ Subchronic 

Neurotoxicity (rat)

437145011 (2005)

Acceptable/guideline

0, 1, 7.5, 75 or 750 ppm

0, 0.07/0.08, 0.54/0.57, 

5.53/5.88, and 52.72/54.61 

mg/kg/day [M/F]

NOAEL ≥ 750 ppm (52.72/54.61 mg/kg/day [M/F])

LOAEL was not established

870.7600

Dermal penetration 

(rats)

43701616 (1995)

Acceptable/guideline 0.4 or 2.4 

mg a.i./cm2

Percent dermal absorption at 10 hours (including active 

ingredient remaining in washed skin at the site of 

application) was 14.35% and 7.59% for doses of 0.4 

and 2.4 mg a.i./cm2respectively. At 10 hours, the 

amount of active ingredient in the skin was less than 

16% of the total amount absorbed. Percent dermal 

absorption at 24 hours was 29.42% and 7.35% for 

doses of 0.4 and 2.4 mg a.i./cm2respectively. At 24 

hours, the amount of active ingredient in the skin was 

less than 22% of the total amount absorbed. A dermal 

absorption factor of 14.35% should be used when 

necessary.
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

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Attachment C: Toxicological Endpoint Selection Table

The following Tables are summaries of the toxicological PODs used in the risk assessment 

associated with the turf registration (D221027, G. Kramer et al., 16-May-1997). 

Summary of Toxicological Doses and Endpoints for Halofenozide for Use in Dietary Human Health Risk 

Assessments

Exposure/ Scenario POD Uncertainty/FQPA 

Safety Factors

RfD, PAD, LOC for 

Risk Assessment Study and Toxicological Effects

Acute Dietary 

(All populations) NOAEL= 10 mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= none

aRfD = 0.1 mg/kg/day

aPAD = none1

Prenatal developmental (rabbit)

Maternal LOAEL = 20 mg/kg/day based 

on clinical signs (tremors).

Cancer (oral, 

dermal, inhalation)

Classification: There were no carcinogenicity studies available for review by the RfD/Peer Review 

Committee and therefore no carcinogenicity classification was made.

Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark 

the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = 

no-observed adverse-effect level. LOAEL = lowest-observed adverse-effect level. UF = uncertainty factor. UFA = extrapolation 

from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. LOC = level of concern. 

Summary of Toxicological Doses and Endpoints for Halofenozide for Use in Residential and Occupational 

Human Health Risk Assessments

Exposure/ Scenario POD Uncertainty 

Factors

LOC for Risk 

Assessment Study and Toxicological Effects

Dermal ShortTerm NOAEL= 10 mg/kg/day UFA=10x

UFH=10x

Occupational LOC for 

MOE ≤ 100

Prenatal developmental (rabbit)

Maternal LOAEL = 20 mg/kg/day based 

on clinical signs (tremors).

Dermal 

Intermediate-Term 

NOAEL= 40 mg/kg/day

1Dermal Absorption 

Factor = 14.35%

UFA=10x

UFH=10x

Occupational LOC for 

MOE ≤ 100

90-Day dermal toxicity (rat)

LOAEL = 200 mg/kg/day based on several 

hematological and clinical chemistry 

effects and hepatic hypertrophy.

Inhalation Shortand Intermediateterm TermNOAEL= 10 mg/kg/day

2

Inhalation Absorption 

Factor = 100%

UFA=10x

UFH=10x

Occupational LOC for 

MOE ≤ 100

Prenatal developmental (rabbit)

Maternal LOAEL = 20 mg/kg/day based 

on clinical signs (tremors).

Cancer (oral, 

dermal, inhalation)

Classification: There were no carcinogenicity studies available for review by the RfD/Peer Review 

Committee and therefore no carcinogenicity classification was made.

Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark 

the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = 

no-observed adverse-effect level. LOAEL = lowest-observed adverse-effect level. UF = uncertainty factor. UFA = extrapolation 

from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). MOE = margin of exposure. LOC = level of concern. 

1

 14.35% dermal absorption factor from MRID #43701616.

2

 100% inhalation exposure assumed. 
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

Page 21 of 22

Attachment D: Registered End-Use Products and Application Scenarios/Rates

Summary of Halofenozide End-Use Products, Application Equipment PPE, REI, and Target Pests.

Product 

Type Trade Names AI Concentration Application Equipment Use Sites PPE REI Target Pests

G

MACH 2 1.5G (38167-29) 1.5%

drop or rotary spreader

turfgrass1-

commercial, 

recreational,

residential, and 

sod farms

long-sleeved 

shirt and 

long pants; 

waterproof 

gloves; 

shoes plus 

socks

12 

hours

white grub larvae such as 

Japanese beetles, European 

chafers, Oriental beetles, 

black turfgrass ataenius, and 

northern/southern masked 

chafers; Lepidoptera larvae 

such as cutworms, sod 

webworms and armyworms

MACH 2 2.5% Granular (62719-472) 2.5%

MACH 2 1.5G Specialty Insecticide (62719-473) 1.5%

MACH 2 Plus Fertilizer Specialty Insecticide (0.86% ai; (62719-474) 0.86%

MACH 2 Plus Fertilizer Specialty Insecticide (0.57% ai; (62719-475) 0.57%

MACH 2 Plus Fertilizer Specialty Insecticide (1% ai; (62719-489) 1%

MACH 2 Plus Fertilizer Specialty Insecticide (1.33% ai; (62719-490) 1.33%

SC MACH 2 2SC Specialty Insecticide (62719-471) 2 lb ai/gallon

sprayer, backpack sprayer; 

do not apply to golf courses 

using low-pressure 

handwand

turgrass2-

commercial, golf 

courses, and sod 

farms

1 Residential and commercial lawns, grounds or lawns around business and office complexes, shopping centers, multi-family and residential apartment complexes, airports, military and other institutions, cemeteries, 

parks and picnic areas, playgrounds, school, athletic fields, golf courses, and sod farms.

2

 Commercial lawns, grounds or lawns around business and office complexes, shopping centers, airports, military and other institutions, cemeteries, golf courses, and sod farms.

Summary of Halofenozide Turf Application Scenario.

Formulation

(EPA Reg. No.)

App. 

Timing App. Rate Max. Seasonal App. Rate Use Directions and Limitations

turf - airports, landing fields, commercial/industrial lawns, golf courses, ornamental lawns and turf, ornamental sod farms (turf), recreational lawns , and residential lawns

MACH 2 1.5G (38167-29)

MACH 2 2.5% Granular (62719-472)

MACH 2 1.5G Specialty Insecticide (62719-473)

MACH 2 Plus Fertilizer Specialty Insecticide.86% A.I. (62719-474)

MACH 2* Plus Fertilizer Specialty Insecticide 0.57% A.I. (62719-475)

MACH 2 Plus Fertilizer Specialty Insecticide (1% A.I.; 62719-489)

MACH 2 Plus Fertilizer Specialty Insecticide (1.33 % A.I.; 62719-490)

MACH 2 2SC Specialty Insecticide (62719-471; not registered for use 

on residential lawns or recreational lawns (excluding golf courses)

when 

needed 2 lb ai/acre 2 lb ai/acre

-Foliar broadcast applications are to be made using a spreader (G) or backpack

sprayer (SC).

-Minimum reentry interval of 12 hours.

-Allow at least 7 days between last application and harvest.

-All labels excluding 62719-472 contain the following language: Not for Sale or 

use in Nassau and Suffolk Counties, New York. New York State requires this

product be used only by professional applicators. 

-Make early applications prior to egg hatch up to when larvae reach the second 

instar (late spring through mid-summer).

-Product is not dependent upon immediate irrigation for activation; however, water 

must transport the material through the thatch. Under conditions of drought it is 

recommend to water in the product. 
Halofenozide (121026) Human-Health Assessment Scoping Document D399620

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Attachment E: IRL

International Residue Limits: halofenozide (121026)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition

US Canada Mexico Codex

There are no US tolerances established for 

halofenozide. None --

2 None

Tolerance/Maximum Residue Limit (ppm)

Commodity1 US Canada Mexico2 Codex

none -- -- -- --

Completed: M. Negussie; 05/25/2012

1

Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those 

proposed by the applicant.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.