UNITED STATES ENVIRONMENTAL PROTECTIO N AGENCY

WASHINGTON, D,C, 20460

OFFICE OF

PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES

MEMORANDUM

Date: 18-f EB-20 1O

Su bject: Hexaflumuro n. Public Comments Regarding the Health Effects Division's

(liED's) Human-Health Assessment Scopi ng Document in Support of

Registration Review of 12-AUG-2009. HED's Response to Public Comments.

PC Code: 11 8202

Decision No.: 406509

Kit Farwell. D.V.M

Risk Assessment Branch 7 (RAB7)

From:

DP Ba rco de : D362321

Registration Nos.: 62719-244.62719-270. 62719-272,

62719-273, 627 19-EUP-25

Petition No.: N/A Regulatory Action: Registration Review

Risk Assessment Type: N/A Case No.: N/A

TXR No.: N/A CAS No.: 86479-06-3

MRID No.: N/A 40 CFR: N/A

/

Sarah J. Levy, Chemist A.. Risk Assessment Branch I (RAB1)

t;))ca

Thro ugh: Dana M. Vogel, Branch Chief

RABl/HEDfOPP (7509P)

To: Russell Wasem/Anne Overstreet

Special Review and Reregistration Division (SRRD)/OPP (7508P)

Executive Summary

HED previously completed a human-health risk assessment scoping document for hexa tlumuron

to support the Registration Review of hexaflumuron (Memo, S, Levy et at., 12-AUG-2009;

0 362302), In that memo, liED evaluat ed the status of the human-health assessments for

hexaOumuron to determine if sufficient data are available and if any updates arc required to

support Registration Review, liED considered the toxicity, exposure, and usage databases; and

the most updated Agency science policy and risk assessment methodologies to determine the

scope of work necessary to support Registration Review, In addition, HED conducted an open

search to look for new literature relevant to the human-health risk assessment. Dow

AgroSciences (DAS) has submitted respon ses to the Hexaflumuron Docket (Docket 10 : EPAHQ-OPP-2009-0568) regarding HED's human- health risk assessment scoping document for

Pagel of 5
Hexaflumuron 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 RecruitTM 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: RecruitTM 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). RecruitTM 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 hexaflumuron. 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 studies. 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: RecruitTM 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 

ShatterTM and RecruitTM 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 by 
Hexaflumuron 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 exterior 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