Attachment 5

Public Comments on Renewal and EPA Response to Comments

Public comments made with respect to the renewal of this information
collection are available at:

  HYPERLINK
"http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480
79459d&disposition=attachment&contentType=pdf" 
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064807
9459d&disposition=attachment&contentType=pdf 

and

  HYPERLINK
"http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480
787934&disposition=attachment&contentType=pdf" 
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064807
87934&disposition=attachment&contentType=pdf 

MEMORANDUM

SUBJECT:	Response to Comments Received on the ICR Renewal-Partial Update
of the TSCA Section 8(b) Inventory Database (EPA-HQ-OPPT-2008-0504-0001)

FROM:	Jim Willis, Division Director /s/

Chemical Control Division

TO:	  SEQ CHAPTER \h \r 1 Angela Hofmann, Director

Regulatory Coordination Staff

DATE:             January 23, 2009

Background 

Under TSCA section 8(b) (15 USC 2607), the Environmental Protection
Agency (EPA) is required to compile and keep current, via periodic
inquiry, the TSCA Chemical Substance Inventory (TSCA Inventory). The
TSCA Inventory is a listing of chemical substances manufactured,
imported and processed for commercial purposes in the United States.
Under TSCA section 8(a), the Administrator shall promulgate rules to
provide for the maintenance and collection of records from
manufacturers, importers and processors of commercial chemicals. The
Inventory Update Reporting (IUR) rule, codified at 40 CFR 710, collects
updated basic chemical manufacturing, processing, and use information
for selected larger volume chemicals in the TCSA Inventory every five
years. Beginning in 1986, EPA collected information through the IUR six
times. The last collection, in 2006, was the first since the IUR was
amended in 2003; the next collection will be in 2011.  

Approved under OMB Control No. 2070-0162, the previous ICR (EPA ICR No.
1884.02) covered the information collection activities contained in the
IUR as amended in 2003.  

The Consumer Specialty Products Association (CSPA) and American
Petroleum Institute (API) responded to the Federal Register notice (73
FR 51805, September 5, 2008) announcing EPA’s intent to submit the ICR
renewal for TSCA section 8(b) to OMB. A summary of their comments and
EPA’s responses are contained herein.

Public Comments

Jane E. Wishneff 

Regulatory Counsel and Director of International Affairs

The Consumer Specialty Products Association (CSPA)

Information Collection 

EPA should clearly state what information is being requested through the
renewal ICR. It would be useful if EPA could clarify what kind of data
it is looking for with regards to production and site reports. 

Public Availability 

In many cases, any type of production records or site-specific reports
would not be available from a public source.

Electronic Alternatives 

The 2006 electronic reporting option was very efficient and is an
appropriate method for reporting in the future. The use of Central Data
Exchange (CDX), the encrypted internet submission process, and the
ability to use a secure electronic signature method was helpful. 

Burden Cost Analysis

The estimated burden and cost for compiling an information submission is
severely underestimated at 485 hours. Sometimes data has to be obtained
from different people and locations; additional time is needed to obtain
information that is not readily available; and large companies, that may
be compartmentalized, will need additional time to gather information
for IUR submission. 

Howard J. Feldman

Director, Regulatory and Scientific Affairs

American Petroleum Institute (API)

Burden Cost Analysis

API supports EPA’s raising of its burden estimates in comparison with
the previous ICR. 

Release of IUR Data

EPA needs to address the data utility, data availability, and
transparency problems during the ICR process. API emphasized that EPA
has not yet publicly released the data collected under the 2006 IUR
reporting period. API is concerned that EPA is able to use 2006 IUR data
to create risk-based prioritization documents even though the data is
not publicly available. 

TSCA Inventory Reset

EPA should discuss the TSCA Inventory reset in the current ICR or its
Supporting Statement discussion, since the reset will most likely
involve the use of IUR data. The reset should not be a priority for the
Agency, given the challenges the Agency is already undertaking with the
Chemical Assessment and Management Program (ChAMP). Also, an Inventory
reset would require substantial time and resources from the regulated
community. 

Response to Comments

EPA would like to thank Ms. Jane E. Wishneff and Mr. Howard J. Feldman
for submitting comments for this ICR. EPA has carefully reviewed the
comments submitted and believes that changes to the ICR narrative are
not warranted for the following reasons. 

In the ICR, EPA states the specific data items being requested for the
2011 reporting cycle and explains how the data will be used. EPA
understands that additional time may be needed to obtain information
that is not readily accessible. However, EPA estimates are an average
and any particular respondent may be expected to incur burden above or
below the EPA estimate.  The burden estimates for report preparation and
submission in the ICR are based on best available data at the time of
calculation. CSPA’s comment does not provide specific information for
EPA to consider adjusting its estimates, however, if CSPA would like to
provide additional specific data, EPA would be willing to evaluate and
consider these in future burden estimates. 

EPA appreciates the positive comments received on the electronic
reporting process. EPA is now looking at options to ensure electronic
reporting is fully utilized for the next IUR reporting cycle. As noted
in the supporting statement to the ICR, electronic IUR submissions allow
data to be entered into the database more accurately and expeditiously,
resulting in a quick turnaround between the submission of the data to
the Agency and the availability of the data for use. In a large part
because almost half of the IUR reports were submitted in a
non-electronic manner and contained errors, EPA was not able to make a
non-confidential version of the 2006 IUR data publicly available until
December 30, 2008. 

With regard to the TSCA Inventory reset, EPA is committed to resetting
the TSCA Inventory, but the concept is still in the early stages of
development.

 PAGE   

 PAGE   - 2 - 

