PREMANUFACTURE REVIEW REPORTING AND EXEMPTION REQUIREMENTS FOR NEW CHEMICAL SUBSTANCES AND SIGNIFICANT NEW USE REPORTING REQUIREMENTS FOR CHEMICAL SUBSTANCES

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
139751	PREMANUFACTURE REVIEW REPORTING AND EXEMPTION REQUIREMENTS FOR NEW CHEMICAL SUBSTANCES AND SIGNIFICANT NEW USE REPORTING REQUIREMENTS FOR CHEMICAL SUBSTANCES Form	Migrated

ICR Details

OMB Control No: 2070-0012	ICR Reference No: 199302-2070-004
Status: Historical Inactive	Previous ICR Reference No: 199010-2070-002
Agency/Subagency: EPA/OCSPP	Agency Tracking No:
Title: PREMANUFACTURE REVIEW REPORTING AND EXEMPTION REQUIREMENTS FOR NEW CHEMICAL SUBSTANCES AND SIGNIFICANT NEW USE REPORTING REQUIREMENTS FOR CHEMICAL SUBSTANCES
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 04/12/1993
	Date Received in OIRA: 02/11/1993
Terms of Clearance: This ICR associated with the proposed Premanufacturer Notification (PMN) Revisions rule is not approved. EPA has not adequately demonstrated that this collection of information is the least burdensome necessary for the proper performance of the agency's functions to comply with legal requirements and achieve program objectives required by 5 CFR 1320.4(b)(1). EPA is to be commended for attempting to reduce the burden for the manufacture or import of chemicals that do not pose an unreasonable risk to health and the environment. EPA has proposed expanding the eligibility for exemptions from PMN requirements. However, EPA has increased the burden of applying for exemptions through the following provisions: (1) EPA is requiring that firms seeking a low volume or low exposure exemption provide extensive exposure and release information and must use the PMN form to submit the information; (2) If EPA decides to deny the exemption, firms must cease manufacture or import within twenty-four hours; and (3) EPA has extended its review time of exemption applications from twenty-one to thirty days. These requirements may discourage firms to make use of exemption opportunities and may have the unintended effect of actually increasin the number of PMN submissions. EPA should examine these and all other new requirements in light of the public comments to determine whether they are the least burdensome requirements necessary.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		01/31/1994	01/31/1994
Responses	0	0	2,289
Time Burden (Hours)	0	0	298,550
Cost Burden (Dollars)	0	0	0

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Abstract: TSCA REQUIRES BUSINESSES TO NOTIFY EPA 90 DAYS PRIOR TO MANUFACTURE OR IMPORT OF A NEW CHEMICAL SUBSTANCE OR AN EXISTING CHEMICAL SUBSTANC FOR A SIGNIFICANT NEW USE. EPA REVIEWS THE INFORMATION TO EVALUATE THE EFFECTS OF THE CHEMICAL ON HUMAN HEALTH AND THE ENVIRONMENT. THE SUBMITTER IS FREE TO MANUFACTURE OR IMPORT THE NEW CHEMICAL SUBSTANCE IF THE AGENCY TAKES NO FURTHER REGULATORY ACTION WITHIN 90 DAYS.

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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
PREMANUFACTURE REVIEW REPORTING AND EXEMPTION REQUIREMENTS FOR NEW CHEMICAL SUBSTANCES AND SIGNIFICANT NEW USE REPORTING REQUIREMENTS FOR CHEMICAL SUBSTANCES	0574.05

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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: 02/11/1993

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