Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment (TSCA Section 8(c))

Forms and Documents

Document	Type	Status	Availability
1031ss09.doc	Supporting Statement A	Uploaded 2009-01-13	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
24848	Recordkeeping		Modified
187854	Compliance Determination		New
187853	Reporting		New

ICR Details

OMB Control No: 2070-0017	ICR Reference No: 200901-2070-002
Status: Historical Active	Previous ICR Reference No: 200510-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1031.09
Title: Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment (TSCA Section 8(c))
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 without change	Conclusion Date: 08/19/2009
	Date Received in OIRA: 01/21/2009
Terms of Clearance: This collection is approved. Prior to resubmission of this information collection for renewal, the Agency should confirm that burden estimate are robust or revise as appropriate.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2012	36 Months From Approved	08/31/2009
Responses	6,897	0	13,445
Time Burden (Hours)	23,536	0	24,548
Cost Burden (Dollars)	0	0	0

---

Abstract: Section 8(c) of TSCA requires that "any person who manufactures, processes; or distributes in commerce any chemical substance or mixture" must keep "records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture."

---

Authorizing Statute(s): US Code: 15 USC 2607c Name of Law: Toxic Substances Control Act/Section 8(c)
  

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:
	73 FR 34733	06/18/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 3591	01/21/2009
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Recordkeeping
Reporting
Compliance Determination

---

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	6,897	13,445	0	0	-6,548	0
Annual Time Burden (Hours)	23,536	24,548	0	0	-1,012	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:

---

Annual Cost to Federal Government: $54,872

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

---

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: 01/21/2009

---