This ICR for the 8(e) program is approved for two years with the understanding that EPA intends to substantially reduce the reporting requirements through notice and comment rulemakings over the next year. EPA is to be commended for completing the study OMB requested during its last review and identifying studies that have little practical utility when submitted as adverse effects reports under 8(e). These studies include acute toxicity, neurotoxicity and certain environmental effects as well as non-TSCA chemicals such as R & D chemicals. EPA should work closely with the respondents to identify burdensome provisions in the 8(e) Policy and expeditiously eliminate unnecessary requirements. EPA should look closely at the comments submitted to OMB as well as comments received on its March 1995 notice and make appropriate modifications. In addition, OMB is approving this collection at the current burden level, 1,120 above EPA's request to take into account, in part, information received from commenters that the burden is understated. OMB agrees with EPA that some burdens claimed by respondents are not apart of the 8(e) collection, but self imposed or associated with other ICRs (e.g. MSDSs). However, the burden should reflect the efforts of respondents to put together a process to review data and deter- mine if it meets the criteria for submittal. EPA should continue to examine the burden estimates as part of its reform initiative.
Inventory as of this Action
Requested
Previously Approved
06/30/1997
06/30/1997
06/30/1995
1,440
0
0
14,530
0
13,400
0
0
0
THE PURPOSE OF THE TSCA, SECTION 8(E), A SELF-IMPLEMENTING STATUTORY PROVISION OF TSCA, IS TO ENSURE THAT ANY INFORMATION THAT REASONABLY SUPPORTS A CONCLUSION THAT A TSCA-COVERED CHEMICAL OR MIXTURE PRESENTS A SUBSTANTIAL RISK OF INJURY TO HEALTH OR THE ENVIRONMENT IS BROUGHT TO EPA'S ATTENTION IMMEDIATELY UPON DISCOVERY BY ANY PERSON WHO MANUFACTURES, IMPORTS, PROCESSES, OR DISTRIBUTES THAT SUBSTANCE OR MIXTURE.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
NOTIFICATION OF SUBSTANTIAL RISK OF INJURY TO HEALTH AND THE ENVIRONMENT UNDER SECTION 8(E) OF THE TOXIC SUBSTANCES CONTROL ACT (TSCA)