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

Forms and Documents

Document Name	Status
0575.16_ss_Attach4_Consultations.pdf Supplementary Document	2018-11-27
0575.16_ss_Attach3_CommentResponse.pdf Supplementary Document	2018-11-27
0575.16_ss_Attach2_40CFR716.pdf Supplementary Document	2018-11-27
0575.16_ss_Attach1_15USC2607.pdf Supplementary Document	2018-11-27
0575ss16.docx Supporting Statement A	2018-11-27

IC Document Collections

IC ID	Document Title	Status
24838	Compliance Determination and Data Search	Modified
234179	Robust Summaries	New
218078	CDX Registration Activities	Modified
189497	Notification and submission of health and safety studies initiated and/or completed after the reporting period	Unchanged
189496	Submission of health and safety studies during the reporting period	Modified

ICR Details

OMB Control No: 2070-0004	ICR Reference No: 201811-2070-004
Status: Active	Previous ICR Reference No: 201509-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0575.16
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: 11/12/2019
	Date Received in OIRA: 11/27/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved	11/30/2019
Responses	34	0	160
Time Burden (Hours)	313	0	1,605
Cost Burden (Dollars)	23,501	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 2601 et seq. Name of Law: Toxic Substances Control Act (TSCA)
  

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:
	83 FR 35271	07/15/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 60853	11/27/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

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

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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	34	160	0	0	-126	0
Annual Time Burden (Hours)	313	1,605	0	0	-1,292	0
Annual Cost Burden (Dollars)	23,501	0	0	7,352	16,149	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: Although CBI substantiation has added 31.5 burden hours per year to the total estimated burden, there is an overall net decrease of 1,303 hours (from 1,605 to 302) in the total estimated respondent burden compared with that currently in the OMB inventory. This ICR assumes that a historical average (from 1996 to present) of 13 chemicals will be added to the section 8(d) list over the next three years. The previous ICR based the average number of chemicals to be added to the section 8(d) list on the period from 2006 2015. In 2006, 208 chemicals were added to the list, the largest addition since 1996. The final section 8(d) rule issued on January 20, 2008 (73 FR 5190) added 12 Lead and Lead Compounds to 40 CFR 716 120 was included in this ICR. The number of chemicals added to the section 8(d) list has been zero since early 2008. The methodology used in the previous ICR overestimated the burden resulting from the addition of chemicals to the TSCA section 8(d) rule.

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Annual Cost to Federal Government: $4,815

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 11/27/2018

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