UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

CERTIFIED MAIL 

May 9, 2012 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVEtrrlON 

Subject: DOH Data Compensation 

Dear DGH Registrants: 

The purpose of this letter is to clarify issues concerning data compensation that have arisen in the 

context of the Addendum to the 2005 Dodine Reregistration Eligibility Decision (RED): 

Antimicrobial Uses of Dodecy/guanidine Hydrochloride (DGH). In this case, the addendum to 

the 2005 Dadine RED was completed in 2009 to assess the reregistration eligibility of 

antimicrobial DOH registrations. In order to complete the Addendum, the Agency relied upon 

data submitted in support of the dodine technical registration. 

In order for the DOH antimicrobial registrations to be considered eligible for reregistration, you 

will either need to satisfy these data submission obligations or certify to EPA that you have made 

an offer to compensate the appropriate data submitter for the previously submitted studies listed 

below which were relied upon to complete the 2009 RED Addendum. You are only responsible 

for addressing data submission or compensation obligations for those studies that were used to 

assess use patterns currently registered on your products. Table 1 presents a summary of the 

dodine human health studies cited in the RED Addendum and the exposure route/uses that 

trigger compensation. 

T a bl e I , S ummaryo fD 0 dme ' H wnan H e aI t h S tu d' les R er le d U JPonm . th e DOH RED A dd en d urn 

Toxicity Study Cited Exposure Route Currently Registered Antimicrobial 

Use 

Pre-Natal Developmental Inhalation Residential paint use 

MRlD41900304 

Chronic Dog Oral (indirect dietary) Once-through cooling tower and food 

MRlD 442461 Ol(referenced as contact pulp/paper slimicide, paper 

MRID 00124280') coating preservative and paper 

adhesive

l 

28-Day Dermal Dermal Residential paint use and impregnated 

MRID 4642070 1 diapers2 

The chrome dog study was referenced Incorrectly In the human health chapter. The DGH regIstrant would be 

responsible for compensat ion of the chronic dog study (MRJD 44246 101), not the acute toxicity studies (MRID 

00 124280). 
2 The Agency has received requests to voluntarily cancel the once·through cooling tower and impregnated diaper 

uses. 

3 If language is added to Ihe DGH labels restricting pulp and paper uses to non· food contact and the voluntary 

cancellation of the once-through cooling tower becomes final and effective, then the oral route of exposure will no 

longer be of concern and compensation will not be required for this route of exposure. 

Regarding compensation for the dodine ecological studies relied upon in the DOH RED 

Addendum, the only DOH use that would have triggered an ecological risk assessment is the 

once-through cooling tower use. The Agency has received a request to voluntarily cancel the 

once-through cooling tower use for EPA Registration Number 3876-145, the only DOH 

registration with this use. Ifthe voluntary cancellation becomes final and effective, then data 

submission or compensation will not be required for data necessary to complete the ecological 

risk assessment conducted in support of the 2009 RED Addendum because the remaining 

registered uses of DOH did not trigger an ecological assessment at the time of the RED. 

Failure to address these data obligations will render your products ineligible for reregistration 

and, as provided in section 4(g)(2)(D), EPA will take appropriate regulatory action to ensure that 

your products comply with the requirements of FIfRA. 

Please contact Rebecca von dem Hagen of my staff if you have any questions about this letter. 

She may be reached at (703) 305-6785 or vondem-hagen.rebecca@epa.gov. 

711;~~ Mark Hartman 

cc: Mark Dyner, Office of General 1 Counsel 

Chief, Risk Management Branch II 

Antimicrobials Division 

Catherine Britton, Pesticide Re-evaluation Division 

Rebecca von dem Hagen and Lance Wonnell, Antimicrobials Division