ATTACHMENT 2

Copy of Public Comments on ICR Renewal and EPA’s Response
July 17, 2009

MEMORANDUM

FROM: Oscar Hernandez, Director /s/

Risk Assessment Division (7403M)

Office of Pollution Prevention and Toxics

TO: Angela Hofmann, Director

Regulatory Coordination Staff (7101M)

Office of Prevention, pesticides, and Toxic Substances

SUBJECT: Public Comments on TSCA 8(e) ICR Renewal (#0794.12);

OMB Control No. 2070-0046

EPA received one public response on the proposed TSCA 8(e) 2009 Information Collection 

Request renewal published in the Federal Register on February 13, 2009. RAD has reviewed 

these comments, which are from Steven J. Goldberg of the BASF Corporation.

BASF recommends that information collected should be limited to commercialized 

substances on the Inventory or notified to the Agency (e.g., through LVE or polymer 

exemption), and that submissions be delayed until the study is complete. Also, BASF states

that the current guidance to submit any information within the 30 calendar days results in 

submission of preliminary information with additional submission containing 

clarifications. They stated that the consequence is greater numbers of submissions of 

limited information rather than fewer submissions with complete information. Therefore, 

BASF recommends that submission should be delayed until all the biological endpoints of a 

particular study can be evaluated rather than after identification of every toxicological 

change.

EPA stands by its decision for reporting requirements. Information that is reported on chemicals 

varies from one submitter to another. The guidance states that full reports or summarized results 

may be submitted to the Agency and that limited studies, preliminary results, and draft reports 

may constitute sufficient evidence for Section 8(e) reporting. For consistency, EPA finds it 

necessary to enforce the current requirements used in the guidance that will allow for a proper 

evaluation of the risk and/or hazard of a substance based upon full and current disclosure by all 

involved parties. The Agency collects and will continue to collect early documentation of 

potential problems for early warning of the potential hazard of a chemical.
BASF believes that the Agency has underestimated the clerical time to prepare and submit 

confidential information. They stated that the clerical time could be reduced through 

electronic submission. Also, BASF points out that electronic submission can greatly 

decrease the burden of submission and reduce the amount of paper that the Agency needs 

to handle. Encryption technology is available that would allow secure transmission, and 

other forms of electronic submission such as password-protected CD’s could be used. 

Furthermore, BASF states that it is also unclear what the retention policy of the Agency is 

regarding paper submission, but if documents are retained for 10 years, there is a need to 

reduce the paper that the Agency needs to manage.

EPA is currently looking to move to electronic reporting. However, we will continue to use the 

process that is in place at this time.

Attached are copies of the ACC comments and the revised TSCA 8(e) ICR Part 6.

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