UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

		     WASHINGTON, D.C. 20460

							                                             		

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES			

		

August 29, 2008

MEMORANDUM

SUBJECT:	Response to comments on the  Risk Assessment for the Creosote
Reregistration Eligibility Decision (RED) Document. EPA Docket 
EPA-HQ-OPP-2003-0248 as related to hazard and risk assessment.

FROM:	Timothy F. McMahon, Ph.D.

		 Senior Toxicologist

Antimicrobials Division (7510P)

 

THRU:	Jacqueline Campbell-McFarlane

		Regulatory Management Branch 2

Antimicrobials Division (7510P)

Norm Cook, Chief

Risk Assessment and Science Support Branch

Antimicrobials Division (7510P)

TO:		Public Docket EPA-HQ-OPP-2003-0248

This memorandum addresses the comments received on the preliminary risk
assessment for Creosote as related to hazard and risk assessment. Other
scientific disciplines will be addressed by the appropriate personnel.
The responses in this memorandum relate to comments on toxicology and
risk assessment for creosote. 

 

Comments by Beyond Pesticides

Beyond Pesticides submitted comments in a letter dated June 16, 2008
(EPA docket # .  HQ-OPP-2003-0248-0054) Among the comments in this
letter were comments related to the dermal absorption assessment
performed. 

Comment: “In the case of creosote, the agency accepted data from the
Creosote Council that significantly reduced the previously assessed
dermal absorption data, despite uncertainties in the Creosote
Council’s study. During the discussions of these studies on how to
use/interpret them, EPA received the Creosote Council’s presentation
of its interpretation of the data to the agency without the benefit of
an outside independent assessment. Because the Creosote Council has a
vested interest in maintaining the registration of creosote, it is to
its benefit to downplay occupational exposure. If the agency is
interested in external input regarding the interpretation of scientific
studies, it should open this discussion to all members of the scientific
community with expertise in this area, and not limit its consultation to
scientists employed by the Creosote Council.”

Response: The dermal absorption assessment performed by the Agency was
the result of several discussions with the Creosote Council regarding
the design and purpose of the study.  The history and outcome of these
discussions is detailed within the risk assessment chapter for creosote
and the Agency’s justification for selection of a value fo 5% dermal
absorption for creosote is also discussed in detail.  

Comments by the Creosote Council

Comment: The Creosote Council, in a letter dated June 16, 2008 (EPA
docket HQ-OPP-2003-0248-0057) noted that EPA failed to acknowledge that
newer studies on the dermal sensitization potential of creosote were
submitted to the Agency for review but were not included in the revised
toxicology disciplinary chapter. 

Response:  The Agency will have these studies reviewed and update the
acute toxicity tables to reflect the outcome of the reviews of the new
studies. 

Comment: The Creosote Council also pointed out that on page 8 of the
Toxicity Endpoint Selection memorandum for creosote dated February 21,
2008, there appears to be an error in the discussion of the study
selected for long-term dermal risk assessments. The value of 50% is
stated to have appeared on this page and it should be corrected to
reflect the newer data submitted and reviewed by the Agency which
changed the dermal absorption factor to 5%.

Response: The Agency acknowledges that the dermal absorption factor was
changed to 5% and will correct the error in the endpoint selection
memorandum to reflect this.  

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