Section 8(d) of the Toxic Substances
Control Act (TSCA) and 40 CFR part 716 require manufacturers and
processors of chemicals to submit lists and copies of health and
safety studies relating to the health and/or environmental effects
of certain chemical substances and mixtures. In order to comply
with these reporting requirements, respondents must search their
records to identify any health and safety studies in their
possession, copy and process relevant studies, list studies that
are currently in progress, and submit this information to EPA. EPA
uses this information to construct a complete picture of the known
effects of the chemicals in question, leading to determinations by
EPA of whether additional testing of the chemicals is required. The
information enables EPA to base its testing decisions on the most
complete information available and to avoid demands for testing
that may be duplicative. EPA uses information obtained via this
collection to support its investigation of the risks posed by
chemicals and, in particular, to support its decisions on whether
to require industry to test chemicals under section 4 of
TSCA.
US Code:
15
USC 2607d Name of Law: Reporting and retention of information /
Health and safety studies
There is a net decrease of
6,778 hours (from 8,383 to 1,605) in the total estimated respondent
burden compared with that currently in the OMB inventory. This net
decrease in burden is due to the following: • The previous ICR
incorrectly used a total of 1 robust summary per year as the total
number of annual robust summary responses, yielding a total of 12
hours of annual burden. This ICR corrects this burden estimate by
using a total of 20 robust summary responses per year, yielding a
total annual reporting burden of 240 hours – an increase of 228
hours per year. • This ICR renewal incorporates changes made to
Health and Safety Data reporting under TSCA section 8(d) that
mandate the use of electronic reporting in lieu of traditional
paper-based reporting. The new electronic reporting requirements
eliminated the clerical burden associated with transcribing study
title lists and photocopying studies for paper-based submissions.
This change resulted in a decrease of 40 hours to the average
annual reporting burden. While electronic reporting serves to
streamline and reduce the administrative/clerical costs and burdens
associated with submitting paper-based health and safety studies,
the burden savings were not sufficient to offset the new burden
associated with CDX registration activities. However, it should be
noted that these activities occur only once for each submitter and,
since some respondents while most likely have already registered
with CDX, this analysis conservatively overestimates the burden and
costs actually experienced by respondents. • The new electronic
reporting mandate requires that submitters of health and safety
data under TSCA section 8(d) register with CDX in order to submit
studies electronically. The new annual burden associated with CDX
registration activities is 53 hours. • Finally, EPA has reduced the
burden estimate by 7,019 hours to reflect the 2012 withdrawal of
the cadmium reporting rule as noted above in section 6(d).
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.
0575.15_SS_Attachment-3_ConsultationsMsg.pdf
0575.15_SS_Attachment-2_Regulations.docx
Compliance Determination and Data Search