Procedures for Chemical Risk Evaluation under TSCA (Final Rule)

Forms and Documents

Document Name	Status
2559ss02_Attachment 2_PrepubCopy_TSCA RiskEval_Final Rule_2017-06-22.pdf Supplementary Document	2017-07-20
2559ss02-Attachment 1_Manufacturing industry wage rates 2010-16.xlsx Supplementary Document	2017-07-20
2559ss02.docx Supporting Statement A	2017-07-20

IC Document Collections

IC ID	Document Title	Status
225236	Chemical Manufacturer Chemical Substance Risk Evaluation Submission Request	Modified

ICR Details

OMB Control No: 2070-0202	ICR Reference No: 201707-2070-001
Status: Active	Previous ICR Reference No: 201701-2070-005
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2559.02
Title: Procedures for Chemical Risk Evaluation under TSCA (Final Rule)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/29/2017
	Date Received in OIRA: 07/20/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved
Responses	5	0	0
Time Burden (Hours)	419	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR is related to a requirement contained in final rule issued by EPA in June 2017 to implement new provisions outlined in the Frank R. Lautenburg Chemical Safety of the 21st Century Act which passed in June 2016. The final rule establishes the process the Agency will adhere to in conducting risk evaluations under the Toxic Substances Control Act (TSCA). Chemicals that will undergo this evaluation include chemicals the Agency has prioritized, as well as chemicals for which EPA has granted requests made by manufacturers to have the chemicals evaluated under EPA’s risk evaluation process. The final rule outlines the criteria and information chemical manufacturers must provide for EPA to consider a chemical substance for risk evaluation. The final rule only outlines what information must be provided, the formats acceptable, and provides details on the risk evaluation process and the commitment a chemical manufacturer makes to the process when submitting a chemical substance for evaluation consideration. The information collection activities covered by this new ICR are those carried out by a chemical manufacturer in requesting a specific chemical risk evaluation under TSCA be conducted by EPA, and are necessary in order for EPA to review information covered by chemical manufacturers and determine if the chemical substance is suitable for risk evaluation.

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Authorizing Statute(s): US Code: 15 USC 2605 Name of Law: Toxic Substances Control Act
  

Citations for New Statutory Requirements: PL: Pub.L. 114 - 182 114-182 Name of Law: Frank R. Lautenberg Chemical Safety for the 21st Century Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2070-AK20	Final or interim final rulemaking	82 FR 33726	07/20/2017

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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
Chemical Manufacturer Chemical Substance Risk Evaluation Submission Request

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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	5	0	5	0	0	0
Annual Time Burden (Hours)	419	0	419	0	0	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: This is a new ICR that addresses the information collection activities that are contained in a final rule.

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Annual Cost to Federal Government: $2,312,648

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: 07/20/2017

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