### Memo To the Docket EPA

-HQ

- OPPT

-2009

-0187

– submitted by Karen Hoffman

RE: EPA Meeting with Environmental Defense Fund (EDF) Date: September 14, 2010 Topic: IUR Modification Proposed Rule EPA/OCSPP Participants: Jim Willis, Ward Penberthy, Susan Shar key, Chenise Farquharson, Karen Hoffman, Laurie Ford EDF Participants: Richard Dennison and Allison Tracy, student intern.

EPA Meeting with Environmental Defense Fund to discuss IUR Proposed Rule
EPA met with Environmental Defense Fund (EDF) on Septem ber 14 to discuss the IUR Proposed Rule. Topics that were covered included: the future inclusion of nanomaterials in the IUR rule, concern about delaying the trigger for reporting production volume until the next cycle, costs for CBI claim substantiations , and the relative low burden and cost estimates of more frequent reporting compared to EPA's cost estimates. EDF stated that they strongly support the proposal and plan to submit mostly supportive comments.



### ( See EDF agenda attached).

### Agenda topics for 9/14 EDF

-EPA meeting on IUR modifications proposed rule

1) Overall we strongly support the proposal and plan to submit comments that are mostly supportive

2) Two issues NOT in the proposed rule we want to discuss:

a) Reporting of IUR in formation to the public i) May well not be appropriate for inclusion in the rule, but critical nonetheless (1) Scope and form of public reporting need to be formalized so that available information is maximized and done consistently over time (2) Is a separate regul ation needed? other options? ii) What is EPA’s thinking (process and substance) as to how it will decide how to report IUR data? (may have implications for how information is collected (i.e., reporting requirements)) iii) EDF had many concerns about limitations to prior reporting, e.g.: (1) Overly broad ranges or yes/no indicators instead of actual data (2) Incomplete records in databases (including relative to online search engine) (3) Blanks that are ambiguous, may mean information was not reported or was CBI (4) Our position: All data reported should be included in each record of a master database file; where such data were claimed CBI, that should be indicated in place of the data b) Nanomaterials : No mention or special provisions for nanomaterial reporting i) Acknowledging ongoi ng debate over definitions, etc., is it not important for IUR to require companies to designate that a chemical they’re reporting under the IUR (or a portion of it) is a nanomaterial? (1) Recent analogous case of EPA acknowledging it registered several nanosi lver pesticides without knowing they used nanosilver ii) Is this not a vital opportunity to build the means for tracking nanomaterial production into EPA data collection activities? iii) May have implications for reporting thresholds and exemptions from them, and for information required regarding properties, uses and exposures

3) Delay in applying expanded trigger : Proposal would delay use of the next triggering approach (exceedance of production volume threshold in any calendar year of a cycle) until the cycle afte r next

– why? a) We noticed this was a change made by OMB b) But OMB accepted that, where the trigger is met in 2010, reporting of production volume is to be required for 2006

- 2009

– that means those companies still have to collect and report data for those inte rim years c) So doesn’t the added burden from imposing the new triggering approach in this next cycle fall only on those companies that would not trigger based solely on 2010, but would trigger based on 2006

- 2009 data? That is, only those companies whose pro duction actually is lower in 2010 than in earlier years would benefit from the delay? i) Does EPA have a sense for how many companies would be affected? ii) This is the very kind of fluctuation we want to capture ASAP, so it does not distort the next picture we get from the IUR as to which chemicals are in commerce. d) As we dive deeper into TSCA reform, delaying getting accurate annual production information on what could be hundreds or thousands of chemicals for up to 5 more years would be tragic!4) EPA's estimate s of efficiencies gained in future cycles

a) In general, we think these may be too conservative. What is EPA’s perspective on this issue? b) Can we obtain copies of the sources that seem to be the root of the estimates? Two memos in particular: i) Memorandum fr om J. Karnes and J. Pratt to B. Meuhling (EPA/OTS) on Revised Estimates of All Reporting Costs for the Proposed CAIR, Centaur Associates, June 30, 1987, pp. 4, 6. Costs are presented in 1987 dollars. The CAIR analysis uses the hourly wage rate plus fringe benefits (at 40 percent of the wage rate) as the appropriate rate for personnel time. (For detailed discussion on the choice of wage rates see U.S. Environmental Protection Agency, Response Times and Labor Costs. Final Data Element List. Comprehensive Asse ssment Information Rule. Centaur Associates, Inc., August 5, 1985. ii) Skylonda Group, Final Memorandum: Pretest of the SARA Title III Section 313 Forms, September 15, 1987.
5) Incre mental cost of reporting already collection information : We're seeking to use E PA data to derive estimate of the incremental burden/cost from annual reporting of production volume data a) We expect a relatively low added burden/cost of reporting, as such information would already have to be collected as part of compliance determination i) It would make sense to require reporting of annual production volume data if the burden and cost of reporting it is low ii) Our preliminary calculations indicate burden and cost of reporting may be as low as 3% of the total burden and cost of a principle repo rting year b) Questions for which we need clarification: i) Does a company have to keep records if they aren't required to make a submission? ii) What is the cost for company and technical contact CBI substantiation? Does the cost for “Plant site substantiation” inc lude the same for company and technical contact? iii) Submission burden/ cost

– important for our estimate of the cost of reporting but unclear how to separate it out from the estimates in the Economic Analysis c) What is EPA’s perspective on this issue?

6) Costs fo r substantiating CBI claims : It appears to us that EPA did not factor in the actual frequency of CBI claims being made for chemical, company, plant site, technical contact , and rather assumed that all reports would contain CBI claims for these elements a) T his would significantly overestimate burden and cost of reports b) We think EPA data on actual 2006 IUR report CBI claim frequencies should be used to adjust these estimates

7) Who are the best EPA contacts for additional questions/clarifications on the Economi c Analysis?