N

- METHYLPYRROLIDONE PRODUCERS GROUP, I NC.

2200 PENNSYLVANIA AVENUE, N.W., SUITE 100W, WASHINGTON, D.C. 20037 ● (202) 557

- 3800 ● FAX (202) 557

- 3836

MANAGED BY B&C ® CONSORTIA MANAGEMENT, L.L.C.

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# NMP

February 20, 2014

Via E

- Mail

Ms. Wendy Cleland

- Hamnett

Office of Pollution Prevention and Toxics U.S. Environmental Protection Agency William Jefferson Clinton Building 1200 Pennsylvania Avenue, N.W.

Mail Code: 7401M Washington, DC 20460

Re: Concer ns with Public Comment Opportunities during Peer Review

of Draft Chemical Risk Assessment of N

- Methylpyrrolidone

Dear Ms. Cleland

- Hamnett:

The N

- Methylpyrrolidone (NMP) Producers Group 1 submits this letter to express

its concerns with the ill

- advised sc hedule and public engagement format associated with the peer review committee evaluation of the U.S. Environmental Protection Agency’s (EPA) draft risk assessment of NMP under the Toxic Substances Control Act (TSCA) Work Plan Chemicals program. We believe that these problems have hindered the goals of good science, transparency, and public engagement. We urge EPA to revise the process accordingly and to re

- issue the NMP draft risk assessment for public review.

Background

On August 23, 2013, EPA annou nced the schedule for the independent scientific review panel evaluation of the NMP Work Plan chemical risk assessment. The schedule included three meeting dates of September 26, 2013, October 15, 2013, and November 12, 2013.

Public stakeholders were inv ited to participate in the peer review committee meetings.

In the August 2013 announcement, EPA also indicated that public comments should be submitted by October 22, 2013

-- three weeks prior to the last peer review committee

1 The NMP Producers Group includes domestic manufacturers of NMP and was formed to address efficiently and comprehensively regulatory and stewardship issues pertinent to

NMP.Ms. Wendy Cleland

- Hamnett February 20, 2014 Page 2

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meeting. According to the notice, EPA would consider the peer review report, the recommendations from the panel, and public comments when it prepared the NMP risk

assessment in final.

Due to the government shutdown in October 2013, EPA was forced to revise the peer review commi ttee schedule. While the September 26, 2013, meeting occurred, the final two peer review committee dates had to be rescheduled. On October 25, 2013, EPA notified the public that the remaining peer review meetings on the draft TSCA risk assessment for NMP would be held on November 8, 2013, and December 13, 2013. The public was invited to participate in the peer review committee meetings. While EPA extended the date for public comments to November 22, 2013, EPA announced that the docket would be closed at that time, a full three weeks before the final peer review committee meeting.

Closing Docket Prior to Final Peer Review Meeting Obstructs Public Engagement

Why EPA truncated public comment and closed the public docket three weeks before the final peer review meeting remains a mystery. EPA provided no reason last year or since then as to why public comments were disallowed immediately before or after the final peer review committee meetings. This schedule negated any possibility for stakeholders, such as the NMP Producers Group, to respond publicly to inappropriate, inaccurate, or misleading comments made by committee members during the final peer review meeting. This is a critical process error, given that the final peer review meeting was intended t o provide committee members with an opportunity to make specific recommendations on the assessment approach. Because the docket was closed, however, public stakeholders who participated in the final peer review meeting had no opportunity to weigh in with their views and respond to the committee members’

recommendations. We are at a loss as to why the process was seemingly specifically designed to prevent public comment on the all

- important recommendations of committee members. This inexplicabl e interference with the due process rights of interested public stakeholders virtually assures the absence of balance and thoughtful deliberation on these recommendations, the very antithesis of what the NMP Producers Group, and other stakeholders, were le ad to believe EPA would offer as part of the peer review process.

Comments Submitted to the Docket Not Considered by Peer Review Members

Members of the NMP Producers Group were active public participants throughout the peer review committee evaluation pr ocess. We provided oral comments at each of the three meetings, and submitted comprehensive comments to the public docket after the first and second committee meetings. Those comments addressed specific issues or concerns raised by

committee members duri ng the meetings.Ms. Wendy Cleland

- Hamnett February 20, 2014 Page 3

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During the final peer review committee meeting, it became apparent that peer review committee members, including the committee chair, did not review comments submitted to the docket by the NMP Producers Group. This is most unfortunate a s the comments were prepared in response to specific committee inquiries or interests. The fact that public input was essentially ignored calls into question whether the process was open or transparent.

Time for Committee Members’ Review of NMP Data/Lit erature Insufficient

NMP is a data

- rich chemical. It is apparent from comments made during the peer review process that committee members did not have sufficient time to consider fully the extensive database on NMP. So, while a reviewer may have locat ed information on a certain endpoint in one study, he/she may not have been aware of additional studies looking at that same endpoint, which should also be considered in an evaluation. It is unfortunate that the short timeframe allocated to the peer revie w committee resulted in a “shotgun” approach in which some studies were highlighted and others ignored. This might have been avoided if the peer review process were not so rushed.

As stated in our previous comments, if EPA believes any of the committ ee members’ concerns on a particular endpoint have merit, EPA must bring forward all the information and additional studies on that topic in its final assessment, and not simply rely on the single

- study snapshot from the reviewer.

Review Time for Revised NMP Risk Assessment Insufficient

The NMP Producers Group raises these concerns because we believe the review process that has transpired was insufficient for the NMP risk assessment. As stated in our October 16, 2013, comments, w hile the NMP Producers Group is supportive of EPA’s decision to rely on the Physiologically

- Based Pharmacokinetic (PBPK) model, the outcome of this decision was essentially the generation of a completely new risk assessment document than was presented at the first peer review co mmittee meeting on September 26, 2013. Under the initial

pre

- government shutdown schedule, the public and the peer review committee had less than two weeks to consider this new assessment before the next meeting. While the shutdown afforded the public ad ditional time to consider the new assessment, peer review committee members were not allowed to work on the document during the shutdown. The entire review process was inappropriately and inexplicably rushed from start to finish.

Given the regulatory and commercial impact the final risk assessment could have and the major shift that EPA took from the initial draft assessment to the one presented at theMs. Wendy Cleland

- Hamnett February 20, 2014 Page 4

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September 2013 meeting, the only reasonable approach is for EPA to re

- issue the new assessment for publi c comment and peer review.

* * * * *

Thank you for your prompt consideration and response to this letter.

Regards,

Kathleen M. Roberts Manager, NMP Producers Group