UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WAS HI NGT O N , D .C. 20 4 6 0



### CERT IFIED MAIL May 9, 2012 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVEtrrlON

Subject: DOH Data Compensation Dear DGH Registrant s : The purpose of this letter i s to clarify issues concerni ng data compensation th at have arisen in the context of the Addendum to th e 2005 Dodine Reregistration Eligibility Decision ( RED) : Antimicrobial Uses of Dodecy/guan idin e Hydrochloride (DG H )

. In this case , the addendum t o the 2005 Dadine RED was co mpl e te d in 2009 to assess th e reregistrati o n e li g ibility of antimicrob ial DOH registrations. In order to complete the Add endum , the Agency relied upon data submitted in support of the dodine techni cal regi stration. In o rder fo r the DOH an tim ic robial reg i strations to be considered eligible for re registrati o n , you wi ll eithe r need to s ati sfy the s e data sub m iss io n obli g ations o r certify to EPA that yo u have ma de an offe r to compensate the appropriate data submitter for the previously submitted studies listed below wh ich were relied upon to comp lete the 

### 2009 RED Addendum. You are only responsible for addressing data s ubmi s s i on o r co mpen sation ob li gati o n s for tho se studies that were used to assess u se pattern s currently registered on yo ur products. Table 

### 1 presents a s ummary of the dodine human he a lth studies cited in the 

### RED Addendum and the exposure route/ uses that t ri gger compensation. T bl I S



### a e , 

### ummaryo fD d ' H 0 me 

### wnan H aI h S d' R 

## r d U
. th 

### DOH RED dd d e t tu 

### le s e le J Ponm e A en urn Toxicity Study Cited Exposure Route Currently Registered Antimic robial 

### Use Pre - Nata l Developmental Inhalation Residential paint u s e MRlD41900304 C hro nic Dog Oral (indirect dietary) Once-through coo lin g t ower and food MRlD 442461 Ol(referenced a s contac t pulp /paper s limi c ide , paper MRID 00124280') coating preservative and paper adhes ive l 28 -Day Dermal Dermal Residential paint u s e and impre gnate d MRID 4642070 1 diapers 2

The chrome dog stud y wa s r ef

e

r enc ed In c orrect l y In the human health c hapt e r. The DGH regI strant wo ul d be re spon s ible for compen sat i on of th e chronic dog study (MRJD 44246 101) , not the acute to xicity studies (MRID 00 1 24280).2 The Agency has received reque s t s to voluntarily cance l the once·thro ugh cooling towe r and impreg nate d diaper u s e s . 3 If lang u age is added to I he DGH lab els restricting pulp and pap er u ses to n on· f ood co n tact and t h

e volu n tary can ce llation of the once-through cooling tower become s fi nal and effec tive , then the oral route of ex po sure will no longer be of co nc ern and compe nsation will no t b e require d for this rou te of expos ure. Regarding compensation for the dodine ecological s tudie s relied upon in the DOH RED A ddendum , the only DOH use that wo uld ha ve triggered an ecological risk assessment is the once-through cooling tower u se. Th e Agency h as received a reque st to vo luntaril y cancel the onc e -through cooling tower u se f o r E P A Registration N umber 3876

- 145 , the on l y DOH regi strati o n with thi s u se. Ifth e voluntary cancellation becomes final and e ffective , the n data submi ss i o n or compensation will not be require d for data ne cessary to complete th e ecological risk asse ss ment conducted in support of the 2009 RED Adde ndum becaus e the remaining registered u ses of DOH did not trigg er an ecological assessment at th e tim e of the RED

. Failure to address th ese data obligations will re nd er yo ur product s in e li g ible for rereg istration and , as p rovided in section 4(g)(2)(D) , EP A will take appropr iate regulatory action to e n s ure that your products comply with the require m e nts of FIfRA. Ple ase contact Rebecca vo n dem Hagen of my staff if yo u have any question s about thi s l etter. She may be reached at (703) 305 -6 785 o r vondem-hagen.rebecca @ epa.gov .

# 711;~~ Mark Hartman

cc: Mark Dyner, Office of General 1 Counse l Ch ief , Risk Management Branch II A ntimicro bi a l s Division

C atherine Britton, P es ticide Re

-evaluation Di v i s ion Rebecca von de m Hagen and Lance Wonne ll , Antimicrobial s Division