Health and Safety Data Reporting; Submission of Lists and Copies of Health and Safety Studies

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Attachment 2.pdf	Supplementary Document	Uploaded 2012-07-05	Available
Attachment 1.pdf	Supplementary Document	Uploaded 2012-07-05	Available
Attach3.pdf	Supplementary Document	Uploaded 2012-04-02	Available
0575ss13_REVISED_2012-11-19.docx	Supporting Statement A	Uploaded 2012-11-19	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
24838	Compliance Determination and Data Search		Modified
204874	Cadmium		New
189497	Notification and submission of health and safety studies initiated and/or completed after the reporting period		Modified
189496	Submission of health and safety studies during the reporting period		Modified

ICR Details

OMB Control No: 2070-0004	ICR Reference No: 201207-2070-003
Status: Historical Active	Previous ICR Reference No: 200906-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0575.13
Title: Health and Safety Data Reporting; Submission of Lists and Copies of Health and Safety Studies
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/21/2012
	Date Received in OIRA: 07/18/2012
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	36 Months From Approved	11/30/2012
Responses	1,525	0	41
Time Burden (Hours)	8,383	0	456
Cost Burden (Dollars)	0	0	0

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 3766	01/25/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 42304	07/18/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Compliance Determination and Data Search
Submission of health and safety studies during the reporting period
Notification and submission of health and safety studies initiated and/or completed after the reporting period
Cadmium

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ICR Summary of Burden

table that charts list 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	1,525	41	0	1,384	100	0
Annual Time Burden (Hours)	8,383	456	0	7,019	908	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: There is an increase of 7,930 hours (from 456 hours to 8,383 hours) in the total estimated respondent burden compared with that currently in the OMB inventory. Much of the burden increase identified in this ICR is associated with a single TSCA section 8(d) collection for manufacturers and importers of cadmium and cadmium compounds in 2012 (7,019 hours). The remaining 908 hour increase is due to a revised basis for the rate of chemical additions (from 20 to 70 chemicals per year) and to the episodic nature of rulemakings that add chemicals to the TSCA section 8(d) list. In light of most recent history of additions by ICR Period, EPA is basing estimates for this ICR on 70 chemical additions per year -- similar to the 2006-2009 ICR period -- and on reporting implications similar to those brought on by chemical additions to TSCA 8(d) in the 2006 rule.

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Annual Cost to Federal Government: $28,747

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

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Common Form ICR:  No

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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: 07/18/2012

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