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

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

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

Reporting of IUR information to the public

May well not be appropriate for inclusion in the rule, but critical
nonetheless 

Scope and form of public reporting need to be formalized so that
available information is maximized and done consistently over time

Is a separate regulation needed?  other options? 

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))

EDF had many concerns about limitations to prior reporting, e.g.:

Overly broad ranges or yes/no indicators instead of actual data

Incomplete records in databases (including relative to online search
engine)

Blanks that are ambiguous, may mean information was not reported or was
CBI

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

Nanomaterials:  No mention or special provisions for nanomaterial
reporting

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? 

Recent analogous case of EPA acknowledging it registered several
nanosilver pesticides without knowing they used nanosilver

Is this not a vital opportunity to build the means for tracking
nanomaterial production into EPA data collection activities?

May have implications for reporting thresholds and exemptions from them,
and for information required regarding properties, uses and exposures

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?

We noticed this was a change made by OMB

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

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?  

Does EPA have a sense for how many companies would be affected?

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.

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!

EPA's estimates of efficiencies gained in future cycles 

In general, we think these may be too conservative.  What is EPA’s
perspective on this issue?

Can we obtain copies of the sources that seem to be the root of the
estimates?   Two memos in particular:

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.

Skylonda Group, Final Memorandum: Pretest of the SARA Title III Section
313 Forms, September 15, 1987.

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

We expect a relatively low added burden/cost of reporting, as such
information would already have to be collected as part of compliance
determination

It would make sense to require reporting of annual production volume
data if the burden and cost of reporting it is low 

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

Questions for which we need clarification:

Does a company have to keep records if they aren't required to make a
submission?

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?

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

What is EPA’s perspective on this issue?

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

This would significantly overestimate burden and cost of reports

We think EPA data on actual 2006 IUR report CBI claim frequencies should
be used to adjust these estimates

Who are the best EPA contacts for additional questions/clarifications on
the Economic Analysis?  

