Attachment 4: Copy of Public Comment on ICR Renewal and EPA's Response

ATTACHMENT 4

Copy of Public Comment on ICR Renewal and EPA’s Response

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All testing and most of the related physiologically-based pharmacokinetic (PBPK) modeling that HSIA committed to do in the first stage has now been completed and submitted to ATSDR, with the exception of the oral developmental neurotoxicity studies. Because of the complexity of these studies, developing and obtaining ATSDR approval of the test protocols (as required under its voluntary research procedures) has taken longer than expected. Moreover, once a range-finding protocol had been agreed for TCE, and a range-finding study completed, the laboratory which had conducted the study (Syngenta CTL) announced in September 2006 that it would shortly close. As the AP Wistar-derived rats used by this laboratory were not available elsewhere, HSIA had to sponsor a new range-finding study at a different laboratory (Bayer CropScience LP), at significant further cost. The results of the second range-finding study became available in late 2008, and HSIA has now signed a contract with the laboratory to conduct the main TCE study, completion and acceptance of which by ATSDR is expected in early 2010. The perc developmental neurotoxicity study is expected to be completed and accepted by early 2011.

While the first stage testing was under way, EPA requested comment on the implementation of the pilot phase of VCCEP. 71 Fed. Reg. 67121 (November 20, 2006). In this notice, EPA expressed a desire for all Tier 1 Peer Consultations in the pilot program to be completed as soon as possible. Following comments and correspondence between HSIA, ATSDR, and EPA, it was agreed that HSIA would move directly to the Peer Consultation despite the developmental neurotoxicity studies remaining outstanding. Based on this understanding, HSIA has committed over $600,000 to develop hazard, exposure, risk, and data needs assessments and Peer Consultation documents for TCE and perc, in the expectation that these documents will be ready for submission to a Peer Consultation panel for perc by the end of Summer and for TCE by the end of Autumn 2009, thus allowing for review of the former by FY 2009 4Q and the latter by FY 2010 1Q.

The foregoing is a lengthy but necessary explanation of the reasons that HSIA supports the proposed information collection, as long as there will be in place a procedure for review of these documents by an “independent third party contractor”/ “external, third party scientific organization” to conduct the Peer Consultations, compile the results for EPA, and assess the accuracy of the documents being developed, as was always envisioned under VCCEP (see 65 Fed. Reg. at 81713-714). In the absence of such a third party contractor-driven Peer Consultation, the information being requested would have little or no “practical utility” for purposes of § 3506(c)(2)(A) of the Paperwork Reduction Act, as EPA has identified no other review process that would enable it to meet the objectives of VCCEP.

HSIA understands that, given current EPA budget priorities, it now appears that funding for VCCEP pilot Peer Consultations will not be available in FY 2009 or 2010. This is disappointing, as many commenters, including EPA’s Children’s Health Protection Advisory Committee, have expressed concern that industry funding of the Peer Consultations would taint their outcome. And HSIA, having expended some $2.5 million on the combined ATSDR/ VCCEP program for TCE and perc, does not have in place any mechanism to fund the Peer Consultations.

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In the circumstances, HSIA has met with EPA to review options that would permit independent Peer Consultations for TCE and perc to take place within the next 12 -18 months. One possibility discussed was the Chemicals Assessment and Management Program (ChAMP). It was considered that this approach could permit Peer Consultations to take place by early 2010. On this basis, HSIA invited the Agency to consider introducing TCE and perc into ChAMP at its earliest opportunity. We believe that they could serve as models for future data-rich cases where timely review and assessment of the available data is important to several EPA program offices.

In conclusion, HSIA urges EPA to put in place a satisfactory review procedure for the information that is the subject of the ICR, so that it will have “practical utility” for purposes of § 3506(c)(2)(A) of the Paperwork Reduction Act.

Respectfully submitted,

Steve Risotto

Stephen P. Risotto Executive Director

Enclosure

March 23, 2009

MEMORANDUM

SUBJECT: Response to comments on second renewal of VCCEP ICR

FROM: Jim Willis, Director

Chemical Control Division (7405M)

TO: Angela Hofmann, Director

Regulatory Coordination Staff (7101M)

One public comment on the second renewal of the VCCEP ICR was received from Stephen P. Risotto of the Halogenated Solvents Industry Alliance (HSIA). Mr. Rissotoa, on behalf of HSIA, commented that HSIA supports the ICR renewal if Peer Consultation by a third party is retained as the review procedure for chemical assessments and that the sponsor should not have to pay for Peer Consultation.

HSIA’s comments on the ICR renewal did not address the accuracy of the estimated cost burden for which comment was sought, or how the estimated sponsor’s burden might be minimized. Instead, HSIA’s comments focused on two possible program modifications that have not been finalized nor for which cost burden estimates have been given in the ICR renewal (i.e., that Peer Consultation will not be used in the future as the review procedure for chemical assessments and that the sponsor will pay for Peer Consultation in its new role). The ICR cost burden estimate was not based on these possible program modifications, but on the original VCCEP process and, therefore, comments on these modifications are beyond the scope of the ICR renewal.

EPA solicited comments on possible modifications to the VCCEP process through two public meetings in 2008, and in a Federal Register notice (71 FR 67121, Nov 20, 2006) requesting comment on the VCCEP pilot (in particular, Peer Consultation) in 2006. Based on the comments received in response to the 2006 FR notice, possible modifications to VCCEP, including that the sponsor might have to pay for future Peer Consultations, were listed in an FR notice announcing a public meeting on that subject in July 2008 (73 FR 36512, June 27, 2008). HSIA did not attend the July 2008 public meeting or provide comments. Comments taken at the July 2008 public meeting, however, moved EPA to consider another program modification: To not use Peer Consultation as the review procedure for chemical assessments. In early October 2008, EPA informed the public and VCCEP stakeholders, including HSIA, that EPA was seeking comment on additional possible modifications to VCCEP including the elimination of Peer Consultation as the review procedure for chemical assessments. EPA asked that any comments on the possible modifications be presented at a public meeting to be held on October 21-23, 2008. HSIA did not attend the public meeting or provide comment that it disagreed with eliminating Peer Consultation as the chemical assessment review procedure nor did anyone else.

No changes were made to the draft ICR renewal as a result of HSIA’s comments objecting to two possible program modifications because these modifications have not been finalized nor included in the cost burden estimate. If the program modifications are finalized, they will be captured in the next renewal of the ICR in 2012. If the program modifications are finalized during the three-year effective period of the second renewal of the ICR, the cost burden of VCCEP will be reduced. The cost burden estimates provided in the second ICR renewal will then overestimate the true cost burden during that three-year period.

cc: Catherine Roman