Confidential Business Information Claims under the Toxic Substances Control Act (TSCA) – Proposed Rule

Forms and Documents

Document Name	Status
Form 9600-031 CDX Registration Form and Instruction	New
Form 9600-031 Rule Famiilarization Form and Instruction	New
2706ss01.docx Supporting Statement A	2022-05-21

IC Document Collections

IC ID	Document Title	Status
253772	Reporting Health and Safety Data Using Templates	New
253771	Withdrawing Confidentiality Claims and Amending Public Copy	New
253770	Maintaining Company Contact Information	New
253769	CDX Registration Form and Instruction	New
253357	Rule Famiilarization Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202205-2070-003
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2706.01
Title: Confidential Business Information Claims under the Toxic Substances Control Act (TSCA) – Proposed Rule
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/23/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	5,996	0
Time Burden (Hours)	1,332	0
Cost Burden (Dollars)	0	0

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Abstract: EPA is proposing new and amended requirements concerning the assertion and maintenance of claims of business confidentiality (also known as Confidential Business Information or “CBI”) under the Toxic Substances Control Act (TSCA), 15 U.S.C. §2601, et seq. The Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. 114–182 referred to in this Notice as “Lautenberg”), made significant amendments to TSCA including new provisions governing the assertion of CBI claims and requirements concerning Agency review and treatment of confidentiality claims. This proposed rule specifies procedures for submitting and supporting CBI claims in TSCA submissions, including substantiation requirements applicable at the time of submission, exemptions from the requirement to substantiate, electronic reporting enhancements (which include new electronic reporting requirements, as well as integration of TSCA requirements to provide certain certification statements, substantiation, and generic names when making confidentiality claims), and maintenance or withdrawal of confidentiality claims. The proposed rule also specifies Agency procedures for reviewing and communicating with TSCA submitters about confidentiality claims, including requirements for submitters to maintain contact information, procedures EPA will use to provide notices to submitters concerning their claims, and the manner in which EPA will notify submitters concerning the impending expiration of certain claims. The proposed rule includes new provisions, as well as amending and reorganizing existing provisions concerning assertion of confidentiality claims in order to conform to new requirements in Lautenberg. Most procedural requirements for asserting and maintaining a confidentiality claim are organized into a new part of the CFR, which would apply to any TSCA submission, except as modified by or elaborated on elsewhere in parts 704, 707, 716, 717, 720, 721, 723, 725, or 790. The following submissions under TSCA will now have new or amended procedures for substantiated claims of confidentiality:

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Authorizing Statute(s): US Code: 15 USC 2601-2692 Name of Law: Toxic Substances Control Act
  

Citations for New Statutory Requirements: US Code: 15 USC 2601-2692 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-AK68	Proposed rulemaking	87 FR 29078	05/12/2022

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 29078	05/12/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
CDX Registration	9600-031, EPA Form Number 9600-032, EPA Form Number 9600-030, n/a, 7710-25, 9600-035, 7710-25, n/a, 7710-25, 9600-033, 9600-036, 9600-034, 9600-034, 9600-034, 9600-034, 9600-036	TSCA Section 12(b) Export Notification ,   Section 8(d) Health & Safety Data Reporting ,   Section 8(e) Notice ,   General Communication Submission ,   EPA Biotech Form ,   MERCURY ELECTRONIC REPORTING ,   NOTICE OF COMMENCEMENT OF MANUFACTURE OR IMPORT ,   Enforcement and Compliance Communication Submission ,   PREMANUFACTURE NOTICE ,   Polymer Exemption ,   EPA INITIATED RISK EVALUATION ,   Section 4 Submission ,   Section 4 Submission ,   SECTION 4 TEST ORDER - STUDY REPORT ,   Section 4 Submission ,   RISK EVALUATION
Maintaining Company Contact Information
Reporting Health and Safety Data Using Templates
Rule Famiilarization	9600-031, EPA Form Number 9600-032, EPA Form Number 9600-030, n/a, 7710-25, 9600-035, 7710-25, n/a, 7710-25, 9600-033, 9600-036, 9600-034, 9600-034, 9600-034, 9600-034, 9600-036	TSCA Section 12(b) Export Notification ,   Section 8(d) Health & Safety Data Reporting ,   Section 8(e) Notice ,   General Communication Submission ,   EPA Biotech Form ,   MERCURY ELECTRONIC REPORTING ,   NOTICE OF COMMENCEMENT OF MANUFACTURE OR IMPORT ,   Enforcement and Compliance Communication Submission ,   PREMANUFACTURE NOTICE ,   Polymer Exemption ,   EPA INITIATED RISK EVALUATION ,   Section 4 Submission ,   Section 4 Submission ,   SECTION 4 TEST ORDER - STUDY REPORT ,   Section 4 Submission ,   RISK EVALUATION
Withdrawing Confidentiality Claims and Amending Public Copy

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ICR Summary of Burden

	Total Request	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	5,996	0	5,996	0	0	0
Annual Time Burden (Hours)	1,332	0	1,332	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 data collection activity resulting from the Frank R. Lautenberg Chemical Safety for the 21st Century Act. As such, the change being implemented in this ICR period is the addition of new burden and cost for these activities. The total burden to industry for this ICR period is approximately 3,991 hours. This burden is comprised of a one-time burden of 2,945 hours in the first year after the rule is finalized and an annual, ongoing burden of 523 hours in each following year. The total cost to industry for this ICR period is approximately $359,993. This cost is comprised of a one-time labor cost of $270,783 in the first year after the rule is finalized and an annual, ongoing labor costs of $44,605 in each following year.

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Annual Cost to Federal Government: $0

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? No

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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: 05/23/2022

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