                                       
                                       
                                EPA/NMA Meeting
                         Wednesday, February 24, 2016
                               1:00  -  2:30 pm
                           Agenda/Discussion Points
Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements; Proposed Rule
                      80 Fed. Reg. 18330 (April 6, 2015)

Location
U.S. EPA Office of Pollution Prevention & Toxics
New Chemicals Program (7405M)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
(202) 564-8974
For those participating by phone  -  
      Dial-in Number: 1-866-299-3188
      Conference Code: 202 566 0718#


Participants:

EPA:  
Jim Alwood, Program Manager, Chemical Control Division (CCD), Office of Pollution Prevention and Toxics (OPPT) 
Maria Doa, Director, CCD/OPPT
Jeff Morris, Deputy Director for Programs, OPPT 
Greg Schweer, Chief, New Chemical Management Branch, CCD/OPPT

NMA:
In person
By telephone
Greg Clark, Keller and Heckman
John Hilbert, NMA
Andrew Jaques, Emulsion Polymers Council
Martha Marrapese, Keller and Heckman, NMA Counsel
Javeneh Nekoomaram, American Coating Association (ACA)
Phil Sayre, Keller and Heckman
Jack Snyder, Styrene Information and Research Council
Stephen Wieroniey, ACA
Richard Berry, Celluforce 
Rene Gaugan, Celluforce
Jennifer Levin, Trinseo
Megan McCutcheon, BYK USA
Brian O'Connor, FP Innovations

                                       
                                    Agenda
   Welcome and Introductions
          Update on status/progress (EPA) and observations (All) on public comments submitted by NMA and others.
   Rulemaking Process
          Please provide an understanding of the agency's schedule for reviewing the comments submitted on this proposal and next opportunities for input and by whom.
          How may this schedule change if TSCA Reform legislation is passed by Congress and signed by the President this spring or summer?
          Is EPA giving further consideration to coordination with the Canadian information collection request?  
          Discussion of considerations associated with re-proposal requests.
    Goal setting
          Discussion of reasons why NMA believes this rule is not currently in keeping with the law  -  1) the scope of section 8(a) is narrow and the information EPA is proposing is broad; 2) to determine whether you need to comply with the rule would require testing, but section 8(a) does not authorize EPA to require that test data be generated; 3) the 135 day proposal is a de facto premanufacture notification requirement (as evidenced by the form and EPA's comparison with PMN submissions) that is not authorized by section 8. 
          NMA presentation of top tier goals:  separate consideration of 135 day on-going reporting, separate information collection rules for manufacturers and processors, and additional narrowing of scope in terms of substances and physical chemical properties
   Scoping  
          Section 8(a) rules in the past have been limited to manageable amounts of information, in reasonable phases, and on a reasonable number of companies and chemicals.   Why is EPA proposing a different approach in this case?  Is EPA considering ways to make the process more manageable for the reporting companies?  If so, what are some of the concepts EPA is considering?
          How does EPA plan to respond to numerous comments requesting the agency to clarify the criteria for the proposed exemptions?  Will EPA consider additional exemptions substances that meet such criteria?
          Can EPA please provide its understanding of the proposed exemption for nanoscale substances are "manufactured" as part of a film? What activities and substances does EPA mean to include in this description? 
          Would EPA consider providing specific chemical identities in the final rule to more clearly identify the chemicals that are subject to information collection?
          Would the agency consider decoupling the one time reporting proposal from the on-going notification requirement?  This proposed 135 day notification requirement would be the most stringent regulatory hurdle for any existing chemical in any country compared to the requirements, for example, in Canada, Europe, Australia, Japan, China, and Korea.    
          Is EPA considering asking for information from manufacturers first, and then using that information to narrow the information requested from processors?  There are differences among manufacturers and processors in terms of the information the companies can contribute without having this rule become "unnecessarily burdensome" on processors, who are likely to under or over report, given their lack of experience with filling out a PMN form like the one that is proposed, the level of information that processors normally have on the substances they receive, and the resources this exercise entails.  These differences do not lend themselves easily to a one size fits all approach.  
          Is EPA considering adding guidance on the activities it considers to be manufacturing, processing, or use of a chemical substance, so that there is more certainty on who should report and what to report?  For example, when a chemical substance is formed when a film is dried, we think this is not manufacturing or processing, but rather end use.  When a liquid polymer dispersion is purchased to make an article, again, this is end use.  These activities should be exempt from reporting.  
   Physical-chemical property information
          Why is EPA proposing to ask for information for which there are no established regulatory protocols or suitable record of testing?
          Would EPA consider simplifying this approach to request only information on particle size?   This data point is supported by more researched test protocols and would be more in line with other international information needs for reporting nanomaterials.  
          A narrower set of characteristics is preferred compared to the seven or more characteristics that are currently discussed in the proposal.
 How do the physical properties for defining a reportable chemical substance and for distinguishing among discrete forms compare?  Are they the same or different? 
 Other items
 How will EPA judge the success of this initiative?
 Are there any other considerations that EPA would like inform NMA at this time? 
 Other comments
 Adjourn
