### UN ITED STATES E NVIRONME NTAL PRO TECTIO N AGE NCY

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O FFIC E OF PREVE NTI O N, P E S TI CID E S

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A N D T O X IC S UBSTA N C E S MEMORAND U M

D ate: 1 8- f EB-2 0 1O



### Su bject: Hexa flumuro n. P ubl ic Co mmen t s R egard ing the H ealth Eff ec t s D i vi si on ' s ( li ED' s) H um an-H ealth A ss e ssm e nt S copi n g D ocu ment i n S upport o f R

egi st rati on Rev iew o f 1 2

- A U G-2009

. H ED' s Respo nse to Public C omme n ts

.

PC Code: 11 8 2 0 2 De cision No. : 40 6 5 09

Kit F a r well

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. M R i s k A s s e s sm ent B r anch 7 ( RA B 7) 

### From : D P Ba rco de : D 36 2 3 21 Re gist rati on Nos .: 6 2 7 19-24 4.62 7 1 9

- 2 70. 6 2 7 19 -2 72, 6 2 719

- 2 7 3

, 627 1 9 -EUP -25 P eti tion No.: N / A R egul at or y A ction: R egi s tr at ion Re v ie w 

### R isk Ass e ss ment Type : N / A Case N o.: N / A T XR No .: N/ A C AS No.: 8 6479 -0 6-3 M RID N o.: N / A 40 C F R: N / A 

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. V oge l, B ran ch C hi e f RA B l / HED f OPP (7 50 9P)



### T o: R ussell Wasem/A n n e O ve r st r ee t Spe cial Re view a n d R e r e gi s tra t ion D ivi s i o n (S RRD )/O PP (7 508 P )

E xec u t i ve S u mmary

H ED p revi ou s l y c o mpleted a hum a n

- he alt h ri sk as sess me nt sc o ping d oc um en t f o r hexa tlumur on to s u p po rt t he Re g i stra ti o n R e vie w o f h exa flumuron ( M emo , S

, Le vy 

### e t at., 12 -AUG -2 009 ; 

### 0 36 2 302)

, In t ha t m e m o, li ED e v aluat ed t he s t a t us o f t he h um a n -h e alth a ssess ment s f or h ex aOu m uron t o d ete rmin e i f s u ffi c i e n t da ta a re a v ail able a nd i f a ny up date s ar c r equi red t o

s up port R e gi stra tion R evi ew , li ED co n s idered t he t o xi city

, e xpo s ure , a nd u s age da tabase s; a nd th e mo st u pdated Agenc y s c i e n c e p o li cy and r i sk a ss essment m ethodologie s t o de t e rmin e th e

s co p e o f wo rk n ec e s s a ry t o s u pp o rt R e gi s tr a ti o n R eview

, In a dd i t ion, H ED co nducte d a n o pe n

s e a r c h t o l o ok f or n ew l i t e r ature rel eva n t t o t he h uman-h ealth ri s k a s s e ssme n t. Dow Ag roSc ienc e s ( DAS) h a s s ub m i tt e d re spon ses t o th e H e x a fl u m ur on D ocket ( D ocke t 10 : E P A

H Q-OPP-20 0 9-0 56 8 ) r e g a rd ing H ED ' s h uman- health ri s k a ss e ss m e n t s coping d oc ument f or

P a gel of 5Hexaflumuron Response to Public Comments DP#: 362321



### Page 2 of 5 responses to these comments are organized in a similar manner.

CONCLUSIONS/RECOMMENDATIONS

The Agency thanks DAS for their comments regarding HED’s human-health risk assessment scoping document for hexaflumuron. The Agency has considered these comments and will utilize them, along with any newly available data, during the Registration Review of hexaflumuron.

DETAILED CONSIDERATIONS

DAS to the Agency’s Regulatory Public Docket (7502P). Hexaflumuron Summary Document, Registration Review: Initial Docket, September 2009. Docket Number: EPA– HQ–OPP–2009–0568.

The Agency states on page 1 of 8: Hexaflumuron is an insecticide registered to control termites (Eastern and Formosan subterranean termites)...

DAS Comment: Shatter and Recruit AG termite baits are registered for use to control all economically important species of subterranean termites in the U.S. The Shatter label states “a termite bait for use in an integrated management system for protection of structures from subterranean termites”. The Recruit AG label states “a termite bait for use as an above-ground delivery system for elimination of subterranean termite colonies”. In addition, both labels state “...including Coptotermes, Reticulitermes, and Heterotermes spp”. The Recruit AG label also states “...may be used against all economically important species of termites”. The Shatter label also states “...for the elimination of subterranean termite colonies”.

HED’s Response: The Agency notes this clarification and the updated use pattern information will be reflected in the final registration review risk assessment document.

The Agency states on page 2 of 8: ...are marketed by Dow as Recruit TM 

### AG (alternate brand name ShatterTM 

### AG, 0.5% a.i., 62719-270).

DAS Comment: At this time, the above-ground termite bait system known as Recruit AG is registered for use to support registrations in other countries but is not commercially available (i.e. marketed) by DAS in the U.S.

Shatter termite bait is used in termite stations installed in-ground around structures as directed in the labeling.

HED’s Response: The Agency thanks DAS for its comments and notes this clarification will be reflected in the final registration review risk assessment document.

The Agency states on page 2 of 8: ...there is one experimental use permit (EUP) registration issued for North Carolina in 1993 (0.103% a.i., 62719-EUP-25).Hexaflumuron Response to Public Comments DP#: 362321



### Page 3 of 5 DAS Comment: This EUP issued for North Carolina in 1993 is obsolete and has been cancelled.

HED’s Response: The Agency thanks DAS for its comment and any updated information will be reflected in the final registration review risk assessment document

The Agency states on page 2 of 8: Recruit TM 

### AG and ShatterTM

### can be used outdoors (i.e., nonagricultural buildings/structures, rights-of-way/fence rows/hedge rows, decking, uncultivated areas/soils, ornamentals and/or shade trees). Recruit TM 

### AG can also be used indoors (i.e., eating establishments, food processing plant premises, stores/markets/ supermarkets premises), but not in indoor residences.

DAS Comment: Shatter and Recruit AG termite bait containing hexaflumuron are used to control termites in indoor residential structures but are only used by pest management professionals licensed by the states to apply termite control products. The Shatter label states “target sites for this system can include buildings...Shatter can be used on the inside or outside of foundation walls or crawl space areas or through concrete and asphalt”. In addition, in the monitoring section of the Shatter label it states “identify critical areas suitable for placing of termite stations. Critical areas include...bath traps”. The Recruit AG label, which also contains termite bait with hexaflumuron, states “target sites for use of this product include interior and exterior surfaces of buildings and crawl spaces”. Even though termite bait is used in residential structures, the in-ground bait is confined in tamper-resistant termite stations and these stations are confined to rare use in bath traps through a slab or in crawl spaces. Additionally, in use of the above-ground bait, the bait formulation is confined inside a tamper-resistant plastic bait housing. At this time, the above-ground termite bait system known as Recruit AG is registered for use but is not commercially available in the U.S.

HED’s Response: The Agency thanks DAS for its comments and notes that these clarifications and updated information will be reflected in the final registration review risk assessment document.

The Agency states on page 3 of 8: Since hexaflumuron was registered, there is now a revised Part 158 toxicology data requirements that include an acute neurotoxicity, subchronic neurotoxicity and an immunotoxicity study for non-food/feed use chemicals. However, due to the low human exposure potential (i.e., bait station/bait application only), these requirements should be waived for hexaflumuron.

DAS Comment: DAS agrees with the Agency’s assessment that based on the very low potential for human exposure to hexaflumuron, the acute neurotoxicity, subchronic neurotoxicity and immunotoxicity studies should be waived for he xaflumuron. DAS respectfully requests that a waiver be granted for the requirement to conduce these three toxicology studies.

HED’s Response: The Agency notes that DAS requests that a waiver be granted for the requirement to conduct these three toxicology studi es. During the course of registration review, the Agency will consider data requirement waivers.Hexaflumuron Response to Public Comments DP#: 362321



### Page 4 of 5 The Agency states on page 3 of 8: Recruit TM 

### AG can also be used indoors (i.e., eating establishments, food processing plant premises, stores/markets/supermarkets premises). The bait cartridges can not be re-used or shattered. The timing of the use of the bait station is on an “as needed” basis. A re-entry interval (REI) is not specified.

DAS Comment: Recruit AG does not use the same bait cartridge design as that used for Shatter termite bait. Recruit AG is a self-contained above-ground termite bait delivery system that involves a plastic sachet which contains the bait. This sachet is punctured to allow termites to enter the sachet to get access to the bait. This plastic bait sachet is contained in a hard plastic tamper-resistant bait station having the design of a rectangular box. The station is attached to the surface of the object containing the termite infestation. Attachment is made using wood screws. The lid of the above-ground bait station is removed to inspect for termites and the bait sachet is changed as needed (i.e. when termites have consumed the bait or it has become fouled); or, another bait station containing a bait sachet can be screwed onto the previously installed bait station. The lid is reattached after the bait station contents have been serviced. Use of the bait station is timed to when termites are present in the structure needing termite control. The bait station is kept in use until the termites are eliminated from the structure. A re-entry interval is not applicable for this use pattern.

HED’s Response: The Agency thanks DAS for clarification of the product information for Shatter TM

### and Recruit TM 

### AG. The Agency notes that in the course of registration review, the Agency will consider the information concerning the product descriptions that DAS has submitted.

The Agency states on page 4 of 8: Baiting only occurs in active stations. The bait formulation is comprised of compressed “pellets” which are packaged into the bait cartridge. When no more termite activity is found at the bait stake, it is removed and replaced with a monitoring stake.

DAS Comment: For Shatter termite bait, in some cases baiting may also occur in termite stations that are not active with termites. The label states “in areas where termites, evidence of termite activity or conditions conductive to termite activity are observed, bait cartridges containing Shatter termite bait may be installed in auxiliary stations without termites first having been found in monitoring devices”. The termite baiting system does not use bait stakes or monitoring stakes. Initially, each termite station (except as described above for baited auxiliary stations) contains monitoring devices which are pieces of wood placed into the termite station to intercept termites foraging in the area. When termites or evidence of termite activity is found on the monitoring devices, they are removed and the bait cartridge is installed into the termite station. When no more termite activity is found within the bait cartridge, it is removed from the baited termite station and replaced with monitoring devices.

HED’s Response: The Agency thanks DAS for the additional information and notes that in the course of registration review, the Agency will consider the information concerning the product descriptions that DAS has submitted. The Agency states on page 4 of 8: A residential exposure assessment has not been conducted for hexaflumuron, as there are no proposed uses that would result in residential exposure. Because hexaflumuron cannot be used in indoor residences and the bait products are for use byHexaflumuron Response to Public Comments DP#: 362321



### Page 5 of 5 professional applicators, residential handler exposure is not expected.

DAS Comment: Shatter and Recruit AG termite baits containing hexaflumuron are used to control termites inside residential structures; however, both products are only applied by pest management professionals licensed by the states to apply termite control products. The Shatter label states “target sites for this system can include buildings...Shatter can be used on the inside or outside of foundation walls or crawl space areas or through concrete and asphalt. In addition, in the monitoring section of the Shatter label it states “identify critical areas suitable for placing of termite stations. Critical areas include...bath traps”. The Recruit AG label states “target sites for use of this product include interior and exte rior surfaces of buildings and crawl spaces”. Indeed, the primary use site for an above-ground termite bait delivery system is inside of structures where direct access to termite infestations may be found.

Even though Shatter and Recruit AG are used inside residential structures, the in-ground bait (Shatter) is applied into tamper-resistant termite stations and these stations are used rarely inside of structures (e.g. bath traps areas, inside foundation walls through a slab, or in crawl space areas). In addition, the above-ground bait product (Recruit AG) is comprised of the briquette formulation packaged inside of a plastic sachet, which is contained within the tamper-resistant, rigid plastic station housing.

DAS concurs with the statement that a residential exposure assessment is not needed because “there are no proposed uses that would result in residential exposure” as explained above.

HED’s Response: The Agency thanks DAS for their comments.

cc: S. Levy (RAB1), K. Farwell (RAB7) RDI: D. Vogel (02-FEB-2010) S. Levy:S-10953:Potomac Yard 1 (PY1):(703)305-0783:7509P:RAB1