ICR Attachment 5-C: EPA Response to Public Comments

OMB Control Number 2070-0162; EPA ICR Number 1884.04

ICR 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:

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648079459d&disposition=attachment&contentType=pdf

and

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480787934&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: 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.

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