RECORDKEEPING AND REPORTING REQUIREMENTS FOR ALLEGATIONS OF SIGNIFICANT ADVERSE REACTIONS TO HUMAN HEALTH OR THE ENVIRONMENT

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
139762	RECORDKEEPING AND REPORTING REQUIREMENTS FOR ALLEGATIONS OF SIGNIFICANT ADVERSE REACTIONS TO HUMAN HEALTH OR THE ENVIRONMENT Form	Migrated

ICR Details

OMB Control No: 2070-0017	ICR Reference No: 199212-2070-003
Status: Historical Active	Previous ICR Reference No: 198908-2070-004
Agency/Subagency: EPA/OCSPP	Agency Tracking No:
Title: RECORDKEEPING AND REPORTING REQUIREMENTS FOR ALLEGATIONS OF SIGNIFICANT ADVERSE REACTIONS TO HUMAN HEALTH OR THE ENVIRONMENT
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: 03/03/1993
	Date Received in OIRA: 12/07/1992
Terms of Clearance: This Section 8(c) renewal ICR is approved, but only for the estimated recordkeeping burden because the supporting statement does not adequately demonstrate the practical utility of reporting 8(c) data. Any use of the 8(c)'s reporting authority by EPA (using either a Federal Register notice or a letter) must be submitted to OMB for review and approval with a short justification of the collection's practical utility. This should include a discussion of the burden estimate and method for alerting potential respondents. OMB review is expected to be prompt (less than 15 calendar days). OMB retains the prerogative to require modification or disapproval of individual reporting actions based on the general requirements of 5 CFR 1320.4. Alternatively, EPA may conduct a detailed evaluation of past 8(c) reports and demonstrate their essential use in risk assessments, testing decisions, or other matters. Based on this study, OMB may ame the terms of clearance including consideration of a "generic" clearance.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/1996	02/28/1996	01/31/1993
Responses	9,518	0	12,283
Time Burden (Hours)	33,313	0	33,317
Cost Burden (Dollars)	0	0	0

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Abstract: TOXIC SUBSTANCES, ADVERSE REACTION, CHEMICALS, HEALTH AND ENVIRONMENT THE TSCA SECTION 8(C) RULE (40 CFR PART 717) REQUIRES MANUFACTURERS AND PROCESSORS OF CHEMICAL SUBSTANCES AND MIXTURES TO KEEP RECORDS OF "SIGNIFICANT ADVERSE REACTIONS" ALLEGED TO HAVE BEEN CAUSED BY SUCH SUBSTANCES OR MIXTURES. THE RULE ALSO PRESCRIBES THE CONDITIONS (I.E., FR NOTICE, LETTER) UNDER WHICH A FIRM MUST MAKE THE RECORDS AVAILABLE TO EPA.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
RECORDKEEPING AND REPORTING REQUIREMENTS FOR ALLEGATIONS OF SIGNIFICANT ADVERSE REACTIONS TO HUMAN HEALTH OR THE ENVIRONMENT	1031.04

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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	9,518	12,283	0	0	-2,765	0
Annual Time Burden (Hours)	33,313	33,317	0	0	-4	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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:

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Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 12/07/1992

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