N-METHYLPYRROLIDONE PRODUCERS GROUP, INC.

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: Concerns with Public Comment Opportunities during Peer Review 

of Draft Chemical Risk Assessment of N-Methylpyrrolidone

Dear Ms. Cleland-Hamnett:

The N-Methylpyrrolidone (NMP) Producers Group1 submits this letter to express 

its concerns with the ill-advised schedule 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 announced 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 invited 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

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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 committee 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 to 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 

inexplicable 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 lead 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 process. 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 during the meetings. 
Ms. Wendy Cleland-Hamnett

February 20, 2014

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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 as 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/Literature 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 located 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 review 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 committee 

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, while 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 committee 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 additional 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 the 
Ms. Wendy Cleland-Hamnett

February 20, 2014

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

assessment for public comment and peer review. 

* * * * *

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

Regards,

Kathleen M. Roberts

Manager, NMP Producers Group