Proposed Rule: Procedures for Chemical Risk Evaluation under TSCA

Forms and Documents

Document Name	Status
2559-01_ss_2017-01-19.docx Supporting Statement A	2017-01-19

IC Document Collections

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

ICR Details

OMB Control No: 2070-0202	ICR Reference No: 201701-2070-005
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2559.01
Title: Proposed Rule: Procedures for Chemical Risk Evaluation under TSCA
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: Comment filed on proposed rule	Conclusion Date: 06/26/2017
	Date Received in OIRA: 01/25/2017
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. OMB files this comment in accordance with 5 CFR 1320.11(c). For future submissions of this information collection, reference the OMB Control Number provided. OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates. This action has no effect on any current approvals.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Environmental Protection Agency (EPA) is developing a proposed rule in response to new provisions outlined in the Frank R. Lautenburg Chemical Safety of the 21st Century Act passed in June 2016. The proposed rule establishes the process the Agency will adhere to in conducting chemical risk evaluations. 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 proposed rule outlines the criteria and information chemical manufacturers must provide for EPA to consider a chemical substance for risk evaluation. The proposed 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. Related fees triggered by submitting a chemical substance for consideration for a risk evaluation is being addressed in a separate rulemaking. The portions of the proposed rule that trigger this Information Collection Request (ICR) consist of the submission package of information and criteria required for the Agency to determine whether or not to conduct a risk evaluation of the requested chemical substance.

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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	Proposed rulemaking	82 FR 7562	01/19/2017

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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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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: Increased burden due to new Statute.

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Annual Cost to Federal Government: $5,375,296

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]? 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: 01/25/2017

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