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 Sharkey, 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 September 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 information 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 regulation 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 ongoing 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 nanosilver 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 after 

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 interim 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 production 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 estimates 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 from 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 Assessment 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) Incremental cost of reporting already collection information: We're seeking to use EPA 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 reporting 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” include 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 for 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) This 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 Economic Analysis?