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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
2070-0004
ICR Reference No:
201509-2070-001
Status:
Historical Active
Previous ICR Reference No:
201207-2070-003
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
0575.15
Title:
Health and Safety Data Reporting; Submission of Lists and Copies of Health and Safety Studies
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
11/10/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/09/2015
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2018
36 Months From Approved
11/30/2015
Responses
160
0
1,525
Time Burden (Hours)
1,605
0
8,383
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
15 USC 2607d
Name of Law: Reporting and retention of information / Health and safety studies
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
80 FR 16672
03/30/2015
30-day Notice:
Federal Register Citation:
Citation Date:
80 FR 61208
10/09/2015
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
CDX Registration Activities
Cadmium
Compliance Determination and Data Search
Notification and submission of health and safety studies initiated and/or completed after the reporting period
Submission of health and safety studies during the reporting period
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
160
1,525
0
-1,364
-1
0
Annual Time Burden (Hours)
1,605
8,383
0
-7,006
228
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Changing Regulations
Short Statement:
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).
Annual Cost to Federal Government:
$4,567
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
10/09/2015
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