Comment submitted by Keller and Heckman LLP

Document ID: EPA-HQ-OPP-2006-0284-0006
Document Type: Public Submission
Agency: Environmental Protection Agency
Received Date: October 23 2006, at 11:14 AM Eastern Daylight Time
Date Posted: October 31 2006, at 12:00 AM Eastern Standard Time
Comment Start Date: August 23 2006, at 09:29 AM Eastern Standard Time
Comment Due Date: October 23 2006, at 11:59 PM Eastern Standard Time
Tracking Number: 801d8c9a
View Document:  View as format xml

View Comment

Docket ID EPA-HQ-OPP-2006-0284 Long Title Aliphatic Solvents Comment: On behalf of Petro Canada, a technical product registrant, Keller and Heckman LLP submits the following comment to this docket. The August 23, 2006 Notice of Availability (Federal Register Vol. 71, No. 163, pages 49443 to 49445) stated that a ?list of additional generic data requirements??have been added to the aliphatic solvents RED document.? Despite numerous attempts to get this list or an updated Guideline Status Report (GSR) for the Aliphatic Solvents, the Agency did not provide any GSR until October 23, 2006. The Aliphatic Solvents RED does not contain any list of generic data used to write the RED or much data on the acceptability of the data used in the RED. The provided GSR is incomplete and inaccurate (see attached file). It does not provide information on the acceptability of most studies submitted and does not list all studies submitted. Several waiver requests submitted by multiple registrants are not listed in the GSR dated October 23, 20006. Furthermore, the GSR provided does not cover all registrants, therefore, it is impossible for any registrant to know who submitted what data, and more importantly, the acceptability of that data. The Aliphatic Solvents RED is a Low Risk RED and therefore did not contain Appendix B, which lists the data requirements , data submitted by all registrants and the acceptability of the submitted data. In the absence of Appendix B in the RED, an accurate and up-to-date GSR is essential. Registrants need an accurate and complete GSR to be able to determine the status of data requirements and the acceptability of data submitted by all registrants. This is especially important in the current RED because data from diverse sources such as the High Production Volume (HPV) Program and the International Program on Chemical Safety were utilized to make the Registration Eligibility Decision for Aliphatic Solvents. We therefore request that the Agency produce an accurate and complete GSR that: (1) lists all the generic data requirements, (2) includes all generic data submitted and utilized in the RED and (3) lists the acceptability of this data. Without this document the Aliphatic Solvents RED cannot be considered complete. We also request that the Agency extend the comment period for this RED until 30 days after the issuance of a revised and accurate GSR for Aliphatic Solvents.

Related Comments

   
Total: 2
Comment submitted by Keller and Heckman LLP
Public Submission    Posted: 10/31/2006     ID: EPA-HQ-OPP-2006-0284-0006

Oct 23,2006 11:59 PM ET
Comment submitted by D. Dawe, Science and Regulatory Consultants
Public Submission    Posted: 11/01/2006     ID: EPA-HQ-OPP-2006-0284-0007

Oct 23,2006 11:59 PM ET