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)