Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 3 of 22 the cage). There were no effects on gross pathology or histopathology. In a combined subchronic / neurotoxicity s tudy in rats, t here were no neurotoxic effects when looking at FOB , motor activity, or histopathology. Halofen o zide showed no evidence for genotoxicity or mutagenicity.

On 10

- Ma y

- 2012

, HED’s Hazard and Science Policy Council (HASPOC) use d a weight

- of

evidence 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 ). Th is weight

- of

- evidence approach considered both haza rd 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 t hat 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 app lication to agricultural crops or fo r 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.

T he turf use may result in residues in water and EFED has previously provided screening, hea lth

protective, estimated drinking water concentrations (EDWCs) resulting from th is 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 co ncerning 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 , r evised 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: T he residential exposure database is adequate to support Registration Review for halofenozide. B ased upon revisions to HED’s Residential Standard Operating Procedures ( SOPs )

, Registration Review may require a n 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 a ss ess residential exposure may not have been conducted according to curr ent 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 resid ential 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 estim ates.Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 4 of 22 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 ree val uated as part of R egistration R eview (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
assessment s 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. U pdated occupational handler exposure assessments may be required under Registration Review based upon revisions to the Agency’s

s cenario

- specific surrogate handler exposure data ( http://www.epa.gov/pesticides/science/handler

exposure

- 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 Resi dential 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 AHET F 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 Revie w 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 a ss ess 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 result s 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 wh ich impact exposure estimates.

As was indicated above, t he 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 D 399620

Page 5 of 22 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 reeval uated 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. ●R evised residential risk assessment may be necessary to incorporate guidance from the updated Residential SOPs and/or toxicological PODs. ●R evised aggregate risk assessment may be necessary to reflect revised residential exposure estimates, dietary exposure estimates, and/or toxicological PODs. ●R evised occupational risk assessment may be necessary to reflect the most recent HED policies and/or toxicological PODs. ●The risk assessment conducted in support o f 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 f or this restriction will be reevaluated as part of Registration Review (current la bels 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 )Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 6 of 22 DETAILED CONSIDERATIONS

Registered U se 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 resident ial 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 scenario s

.

Hazard Ident ification/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 mea n 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

- wei ght 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 fo r 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 b ody

- weight gains.

In the acute neurotoxicity study in rats

, clinical signs occurred at the mid

- and high

- doses

, and in cluded anogenital staining, red

- stained muzzle, and scant feces. For FOB parameters

, there was one effect at the high dose (vocalizati on 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.Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 7 of 22 Halofenozide show ed 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

- of

evidence 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 vi a 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).

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, de velopmental, 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, f ertility, 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 Endocr ine 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

c hemical 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 2Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 8 of 22 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and establish a dose

- response relatio nship 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 contain s 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 o rders/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 b attery, 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 c rops/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

Halofenoz ide 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 w ere generated using the Generic Expected Environmental Concentration (G EN EEC ) 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

- Feb

1997). 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).

A t 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 degrad ation, 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 genera ted to reflect EFED and HED assessment of the environmental fate database and the most recent models for estimation of residues in drinking
water.Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 9 of 22 Dietary Exposure

As part of the turf registration, HE D conducted an acute dietary exposure assessment to halofenozide from the consumption of drinking water (D221027, G. Kramer et al. , 16

- May

1997). Th is analysis was conducted using the 150 ppb acute ground water estimate and assumed the following consumption and body weight figure s: adult

- 2 liters/day and 70

- kg body weig ht; 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 chron ic reference dose had not been established . I n 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 EDW Cs 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 drop

type or rotary (push) type spreader. Although h alofenozide is marketed for use by pro fessional applicators on turf, the products are not restricted

- use pesticides. Therefore, adult residential homeowners may experience exposur e to halofenozide du ring application of the chemical ( i.e.
, re sidential handler exposures). Additionally, a dults 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 handler s ; and short

- and intermediate

- term post

- appli cation exposure scenarios for adults and children ( D221027, G. Kramer et al

., 16

- May

- 1997 ).

Residential Handl ers : The 1997 risk assessment assessed the residential handler scenarios which reflect the major residential uses of halofenozide based on types of application equipment :

M ixer/Loader/Applicator Exposure Push spreader Hand

- held spreader

Unit exposure values wer e derived from PHED ( 1.1) . All scenarios ref lected the following assumptions: a homeowner applicator wearing short

- sleeved shirt, long pants

, and shoes plus socks. Dermal absorption wa s estimated to be approximately 14.35% , and the female

- spec ific body weight was used based on the toxicological endpoints of concern. All residential handler exposure scenarios resulted in MOE s above HED’s level of concern (LOC; MOE>100), with the exception of h and

- held spreader applications, which resulted in a short

- term MOE of 21 for female home applicat ors.Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 10 of 22 Residential Post A pplication : 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 p opulation. As a result, individuals can be exposed to halofenozide residues by entering these areas that have been previously treated. In the 1997 risk assessment, t he major residential post

- application exposure s cenarios 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 T T R 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 (MOE s
> 100) for the products registered for residential uses ( i.e.
, granular f ormulations). 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

- ap plication 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 pestic ides 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 applicat ion method emp loyed 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 Drif t 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 asse ssments 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

- drift

management practices to reduce off

- target drift with specific products with signif icant risks associated with drift.Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 11 of 22 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 curr ent 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 resid ential 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 a cute aggregate risk assessment (dietary and residential exposure) was conducted as part of the HED’s evaluation of the turf use; the resulting a ggregate acute MOEs were ≥380 and

, therefore

, were not of concern to HED. As part of Registration Review, revised acute, short

term, intermediate

- term, and/or chronic aggregate risk assessment s 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 r esidential 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 t hese 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

- appl ication 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 spr eaders; 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 p ants, 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 occ upational post

- application scenarios. The 1997 halofenozide risk assessment included risk estimate s for both occupational handler and occupational post

- application scenarios.Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 12 of 22 Occupational Handlers : The 1997 risk assessment evaluated the occupational handler scenarios to represent the major halofenozide occupational handler scenarios based on application equipm ent and formulation ( D221027 , G. Kramer et al. , 16

- M ay

- 1997 ). The major exposure

s cenarios identified for halofenozide were as follows:

Mixing/Loader Exposure Open pour liquid s, 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 applic ations 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 M ixer/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 hand ler 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 handle r 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
exp osure 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.Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 13 of 22 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 s cenario

- specific surrogate handler exposure data ( http://www.epa.gov/pesticides/science/handler

- exposure

table.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 n ew 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 be en submitted to the Agency (MRID No. 458866

- 01). The result s 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 registr ation 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

T he OPP Incident Data System (IDS) w as utilized to retrieve halofenozide incident data reported to EPA

. In A ggregate IDS , from 1

- January

- 200 7 to 22

- February

- 2012, there were five reported incident s involving halofenozide

. For the M ain IDS, from 1

- January

- 200 7 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 h alofenozide is not included in the Agricultural Health Study ( AHS ).

Based o n 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 tri ggered, additional analysis will be included in the risk assessment.Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

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 expos ed 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 h ave 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 requireme nts 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/guidanc e/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 exposur es 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 Continui ng 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 pr oducts 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 D 399620

Page 15 of 22 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 reeval uated 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 tox icological PODs. ●R evised residential risk assessment may be necessary to incorporate guidance from the updated Residential SOPs and/or toxicological PODs. ●R evised aggregate risk assessment may be necessary to reflect revised residential exposure estima tes, dietary exposure estimates, and/or toxicological PODs. ●R evised 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 ind icated 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

- Ma y

- 201 2 ) ; PRD (7

- June

- 2012) T . Bloem:Potomac Yard 1:703

- 605

- 0217:S10945PHalofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 16 of 22 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 (pK a ) not available Octanol/water partition coefficient Log(K OW ) 3.34 (pH 7 ; 20°C ) UV/visible absorption spectrum not availableHalofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 17 of 22 Attachment B: Hazard Profile Table s

Acute Toxicity Profile

- Halofenozide

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

870.1100 Acute oral [rat] 43642810 LD 50 = 2850 mg/kg III

870.1100 Acute oral [mouse] 43642811 LD 50 = 2214 mg/kg III

870.1200 Acute dermal [rat] 43642813 LD 50 > 2000 mg/kg III

870.1300 Acute inhalation [rat] 43642812 LC 50 > 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, i ncreased 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 D 399620

Page 18 of 22 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] Materna l NOAEL = 10 mg/kg/day LOAEL = 20 mg/kg/day based on clinical signs (tremors).

. Developmenta l 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 his revertants (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

- activa ted 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 (S 9) 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

- 20 0 above background.Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

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 solv ent controls in structural aberrations were found in either activated or non

activated 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./cm 2 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./cm 2 respectively. 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 7.3 5% for doses of 0.4 and 2.4 mg a.i./cm 2 respectively. 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 D 399620

Page 20 of 22 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 Do ses and Endpoints for Halofenozide for Use in Dietary Human Health Risk Assessments
Exposure/ Scenario P OD Uncertainty/FQPA Safety Factors RfD, PAD, L OC for

Risk Assessment Study and Toxicological Effects

Acute Dietary (All populations) NOAEL= 10 mg/kg/day UF A = 10x UF H =10x FQPA SF= none a RfD = 0.1 mg/kg/day

aPAD = none 1 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 d eparture (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 releva nt human exposures. NOAEL =

no

- observed adverse

- effect level. LOAEL = lowest

- observed adverse

- effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (i nterspecies). UF H = 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. L OC = level of concern.

Summary of Toxicological Doses and Endpoints for Halofenozide for Use in Residential and Occupational Human Health Risk Assessments

Exposure/ Scenario P OD Uncertainty Factors L OC for Risk

Assessment Study and Toxicological Effects

Dermal Short

Term NOAEL= 10 mg/kg/day UF A =10x UF H =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
1 Dermal Absorption Factor = 14.35% UF A =10x UF H =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 Short

and Intermediate

term Term NOAEL= 10 mg/kg/day
2 Inhalation Absorption Factor = 100% UF A =10x UF H =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 d eparture (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

- eff

ect level. LOAEL = lowest

- observed adverse

- effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). MOE = margin of e xposure. LOC = level of concern.
1 14.35% d ermal a bsorption factor from MRID #43701616.
2 100% inhalation exposure assumed.Halofenozide (121026) Human

- Health Assessment Scoping Document D 399620

Page 21 of 22 Attachment D : Registered End

- Use Products and Application Scenarios /R ates

Summary of Halofenozide End

- Use Products , Application Equipment PPE, REI, and Target Pests

. Product Type Trade Names AI Concentration App lication Equipment Use Sites PPE REI Target Pests

G M ACH 2 1.5G (38167

- 29) 1.5%

drop or rotary spreader turfgrass 1

- 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 M ACH 2 2.5% Granular (62719

- 472) 2.5% M ACH 2 1.5G Specialty Insecticide (62719

- 473) 1.5% M ACH 2 Plus Fertilizer Specialty Insecticide (0.86% ai ; (62719

- 474) 0.86% M ACH 2 Plus Fertilizer Specialty Insecticide (0.57% ai ; (62719

- 475) 0.57% M ACH 2 Plus Fertilizer Specialty Insecticide (1% ai ; (62719

- 489) 1% M ACH 2 Plus Fertilizer Specialty Insecticide (1.33% ai ; (62719

- 490) 1.33%

SC M ACH 2 2SC Specialty Insecticide (62719

- 471) 2 lb ai/gallon sprayer, backpack sprayer ; do not apply to golf courses using low

- pressure handwand turgrass 2

-

c ommercial

, golf courses, and sod farms

1 R esidential 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 C ommercial lawns, grounds or lawns around business and office complexes, shopping centers, airports, military and other instit utions, cemeteries, golf courses, and sod far ms.

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% G ranular ( 62719

- 472 ) MACH 2 1.5G S pecialty Insecticide ( 62719

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

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

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

- 4 89 ) MACH 2 Plus Fertilizer Specialty Insecticide (1.33 % A.I. ; 62719

- 4 90 ) MACH 2 2SC Specialty Insecticide ( 62719

- 47 1 ; not re gistered for use on residential lawns or recreational lawns (excluding golf courses) when needed 2 lb ai/acre 2 lb ai/acre - F oliar 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

u se in Nassau and Suffolk Counties, New York. New York State r equires t his
p roduct be u sed o nly by p rofessional a pplicators

.

- 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 D 399620

Page 22 of 22 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)

Commodity 1 US Canada Mexico 2 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.