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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 9600-049 TPC Annual Report Title VI	Form and Instruction	Modified	Available
Form 9600-049 Annual Report Product AB Title VI	Form and Instruction	Modified	Available
Form 9600-049 Failure to Comply Title VI	Form and Instruction	Modified	Repair queued
Form 9600-049 TPC Failed Quarterly Test Title VI	Form and Instruction	Modified	Available
Form 9600-049 TPC Quality Control Limit Exceedance	Form and Instruction	Modified	Available
Form 9600-049 TPC Reduced Testing and Exemption Notification	Form and Instruction	Modified	Repair queued
Form 9600-049 TPC Reduced Testing and Exemption Notification	Form and Instruction	Modified	Repair queued
General Communications (Gencomms)	Form and Instruction	Modified	Repair queued
Form 9600-032 Section 8(d) Health and Safety Data Reporting	Form and Instruction	Modified	Repair queued
Form 9600-032 Reporting Health and Safety Data Using Templates	Form and Instruction	Modified	Repair queued
Form 7710-25 Notice of Commencement (NOC)	Form and Instruction	Modified	Available
Form 9600-033 Polymer Exemption	Form and Instruction	Modified	Available
Form 9600-034 Section 4 Test Rules Submission	Form and Instruction	Modified	Available
Form 9600-034 Section 4 CFR 766 Submission	Form and Instruction	Modified	Available
Form 9600-034 Section 4 Submission ECA	Form and Instruction	Modified	Available
Form 9600-034 Section 4 Test Order Study Report	Form and Instruction	Modified	Available
Form 9600-036 Risk Evaluation	Form and Instruction	Modified	Available
Form 9600-036 EPA Initiated Risk Evaluation	Form and Instruction	Modified	Available
Form 7710-25 Primary Premanufacture Notice (PMN)	Form and Instruction	Modified	Available
Form 9600-035 Mercury Electronic Reporting	Form and Instruction	Modified	Available
Form 7710-025 Microbial Commercial Activity Notice (MCAN)	Form and Instruction	Modified	Available
Form 9600-030 Section 8(e) Notice	Form and Instruction	Modified	Available
Form 9600-032 Section 8(d) Health and Safety Data Reporting	Form and Instruction	Modified	Available
Form 9600-031 TSCA Sec. 12(b) Export Notification	Form and Instruction	Modified	Available
Form 9600-031 Maintaining Company Contact Information	Form and Instruction	Modified	Repair queued
Form 9600-036 Risk Evaluation	Form and Instruction	Modified	Available
Form 9600-034 Section 4 Test Rules Order Submission	Form and Instruction	Modified	Available
Form 9600-034 Section 4 ECA Submission	Form and Instruction	Modified	Available
Form 9600-034 Section 4 CFR 766	Form and Instruction	Modified	Available
Form 9600-036 EPA Initiated Risk Evaluation	Form and Instruction	Modified	Available
Form 9600-033 Polymer Exemption	Form and Instruction	Modified	Available
Form 7710-25 Primary Premanufacture Notice (PMN)	Form and Instruction	Modified	Available
Enforcement and Compliance submission	Form and Instruction	Modified	Available
Form 7710-25 Notice of Commencement (NOC)	Form and Instruction	Modified	Repair queued
Form 9600-035 Mercury Reporting	Form and Instruction	Modified	Available
Form 7710-25 MCAN EPA Biotech Form	Form and Instruction	Modified	Available
General Communications (GENCOMMS)	Form and Instruction	Modified	Available
Form 9600-030 Section 8(e) Notice	Form and Instruction	Modified	Available
Form 9600-032 Section 8(d) Safety and Health Data Reporting	Form and Instruction	Modified	Available
Form 9600-031 TSCA Section 12(b) Export Notification	Form and Instruction	Modified	Available
Form 9600-031 CDX Registration	Form and Instruction	Modified	Repair queued
Form 9600-034 Section 4 Identification Response	Form and Instruction	Modified	Available
Form 9600-034 Section 4 Initial Response	Form and Instruction	Modified	Available
Form 9600-034 Section 4 Final Study Plan	Form and Instruction	Modified	Available
Form 9600-036 Risk Evaluation (MRRE)	Form and Instruction	Modified	Available
Form 9600-034 Section 4 Test Rules Submission	Form and Instruction	Modified	Available
Form 9600-034 Section 4 Final Study Report	Form and Instruction	Modified	Available
Form 9600-034 Section 4 ECA Submission	Form and Instruction	Modified	Available
Form 9600-034 Section 4 CFR 766 Submission	Form and Instruction	Modified	Available
Form 9600-036 EPA Initiated Risk Evaluation (EIRE)	Form and Instruction	Modified	Available
Form 9600-033 Polymer Exemption	Form and Instruction	Modified	Available
Form 7710-25 Primary Premanufacture Notice (PMN)	Form and Instruction	Modified	Available
Form 7710-25 Notice of Commencement (NOC)	Form and Instruction	Modified	Available
Form 9600-035 Mercury Electronic Reporting	Form and Instruction	Modified	Available
Form 7710-25 Biotech MCAN	Form and Instruction	Modified	Available
OECA Communication Form	Form and Instruction	Modified	Available
Form 9600-030 Section 8(e) Notice	Form and Instruction	Modified	Available
Form 9600-032 Section 8(d) Health and Safety Data Reporting	Form and Instruction	Modified	Available
Form 9600-031 Section 12(b) Export Notification	Form and Instruction	Modified	Available
Form 9600-031 Rule Famiilarization	Form and Instruction	Modified	Repair queued
2706ss02.docx	Supporting Statement A	Uploaded 2023-06-15	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
253772	Reporting Health and Safety Data Using Templates	Form and Instruction	Modified	TPC Annual Report Title VI
253772	Reporting Health and Safety Data Using Templates	Form and Instruction	Modified	Annual Report Product AB Title VI
253772	Reporting Health and Safety Data Using Templates	Form and Instruction	Modified	Failure to Comply Title VI
253772	Reporting Health and Safety Data Using Templates	Form and Instruction	Modified	TPC Failed Quarterly Test Title VI
253772	Reporting Health and Safety Data Using Templates	Form and Instruction	Modified	TPC Quality Control Limit Exceedance
253772	Reporting Health and Safety Data Using Templates	Form and Instruction	Modified	TPC Reduced Testing and Exemption Notification
253772	Reporting Health and Safety Data Using Templates	Form and Instruction	Modified	TPC Reduced Testing and Exemption Notification
253772	Reporting Health and Safety Data Using Templates	Form and Instruction	Modified	General Communications (Gencomms)
253772	Reporting Health and Safety Data Using Templates	Form and Instruction	Modified	Section 8(d) Health and Safety Data Reporting
253772	Reporting Health and Safety Data Using Templates	Form and Instruction	Modified
253771	Withdrawing Confidentiality Claims and Amending Public Copy		Modified
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Notice of Commencement (NOC)
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Polymer Exemption
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Section 4 Test Rules Submission
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Section 4 CFR 766 Submission
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Section 4 Submission ECA
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Section 4 Test Order Study Report
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Risk Evaluation
253770	Maintaining Company Contact Information	Form and Instruction	Modified	EPA Initiated Risk Evaluation
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Primary Premanufacture Notice (PMN)
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Mercury Electronic Reporting
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Microbial Commercial Activity Notice (MCAN)
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Section 8(e) Notice
253770	Maintaining Company Contact Information	Form and Instruction	Modified	Section 8(d) Health and Safety Data Reporting
253770	Maintaining Company Contact Information	Form and Instruction	Modified	TSCA Sec. 12(b) Export Notification
253770	Maintaining Company Contact Information	Form and Instruction	Modified
253769	CDX Registration	Form and Instruction	Modified	Risk Evaluation
253769	CDX Registration	Form and Instruction	Modified	Section 4 Test Rules Order Submission
253769	CDX Registration	Form and Instruction	Modified	Section 4 ECA Submission
253769	CDX Registration	Form and Instruction	Modified	Section 4 CFR 766
253769	CDX Registration	Form and Instruction	Modified	EPA Initiated Risk Evaluation
253769	CDX Registration	Form and Instruction	Modified	Polymer Exemption
253769	CDX Registration	Form and Instruction	Modified	Primary Premanufacture Notice (PMN)
253769	CDX Registration	Form and Instruction	Modified	Enforcement and Compliance submission
253769	CDX Registration	Form and Instruction	Modified	Notice of Commencement (NOC)
253769	CDX Registration	Form and Instruction	Modified	Mercury Reporting
253769	CDX Registration	Form and Instruction	Modified	EPA Biotech Form
253769	CDX Registration	Form and Instruction	Modified	General Communications (GENCOMMS)
253769	CDX Registration	Form and Instruction	Modified	Section 8(e) Notice
253769	CDX Registration	Form and Instruction	Modified	Section 8(d) Safety and Health Data Reporting
253769	CDX Registration	Form and Instruction	Modified	TSCA Section 12(b) Export Notification
253769	CDX Registration	Form and Instruction	Modified
253357	Rule Famiilarization	Form and Instruction	Modified	Section 4 Identification Response
253357	Rule Famiilarization	Form and Instruction	Modified	Section 4 Initial Response
253357	Rule Famiilarization	Form and Instruction	Modified	Section 4 Final Study Plan
253357	Rule Famiilarization	Form and Instruction	Modified	Risk Evaluation (MRRE)
253357	Rule Famiilarization	Form and Instruction	Modified	Section 4 Test Rules Submission
253357	Rule Famiilarization	Form and Instruction	Modified	Section 4 Final Study Report
253357	Rule Famiilarization	Form and Instruction	Modified	Section 4 ECA Submission
253357	Rule Famiilarization	Form and Instruction	Modified	Section 4 CFR 766 Submission
253357	Rule Famiilarization	Form and Instruction	Modified	EPA Initiated Risk Evaluation (EIRE)
253357	Rule Famiilarization	Form and Instruction	Modified	Polymer Exemption
253357	Rule Famiilarization	Form and Instruction	Modified	Primary Premanufacture Notice (PMN)
253357	Rule Famiilarization	Form and Instruction	Modified	Notice of Commencement (NOC)
253357	Rule Famiilarization	Form and Instruction	Modified	Mercury Electronic Reporting
253357	Rule Famiilarization	Form and Instruction	Modified	Biotech MCAN
253357	Rule Famiilarization	Form and Instruction	Modified	OECA Communication Form
253357	Rule Famiilarization	Form and Instruction	Modified	Section 8(e) Notice
253357	Rule Famiilarization	Form and Instruction	Modified	Section 8(d) Health and Safety Data Reporting
253357	Rule Famiilarization	Form and Instruction	Modified	Section 12(b) Export Notification
253357	Rule Famiilarization	Form and Instruction	Modified

ICR Details

OMB Control No: 2070-0223	ICR Reference No: 202306-2070-003
Status: Historical Active	Previous ICR Reference No: 202205-2070-003
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2706.02
Title: Confidential Business Information Claims under the Toxic Substances Control Act (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: 08/07/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/15/2023
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years. In accordance with 1320.10(a), the agency is reminded to submit the ICR for OMB review the day of Federal Register publication for the final rule.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	36 Months From Approved
Responses	2,139	0	0
Time Burden (Hours)	1,332	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: EPA is finalizing 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. 114182 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 final 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 final 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 final 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, 770, or 790. The following submissions under TSCA will now have new or amended procedures for substantiated claims of confidentiality: TSCA Section 8(a); 40 CFR 704 TSCA Section 12(b) Notification of Export; 40 CFR 707.75(d) TSCA Section 8(d) Health and Safety Studies; 40 CFR 716.55(a) and (c) TSCA Section 8(c) Allegations of Adverse Effects; 40 CFR 717.19 TSCA Section 5 Premanufacture Notices (PMNs); 40 CFR 720.85 and 720.90 and 720 Subpart F TSCA Section 5 40 CFR 721 Significant New Use Rules (SNURs) TSCA Section 5 Polymer Exemption; 40 CFR 723.250(f); and Low Volume Exemptions 40 CFR 723.50 TSCA Section 5 microorganisms; 40 CFR 725 Subpart C TSCA Title VI Formaldehyde Emissions Standards for Composite Wood; 40 CFR 770 TSCA Section 4 Test Orders; 40 CFR 790

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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	Final or interim final rulemaking	88 FR 37155	06/07/2023

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
CDX Registration	9600-032, 9600-030, n/a, 7710-25 MCAN, 7710-25, 9600-031, n/a, 9600-035, 7710-25, 9600-033, 9600-036, 9600-034, 9600-034, 9600-034, 9600-036	TSCA Section 12(b) Export Notification ,   Section 8(d) Safety and Health Data Reporting ,   Section 8(e) Notice ,   General Communications (GENCOMMS) ,   EPA Biotech Form ,   Mercury Reporting ,   Notice of Commencement (NOC) ,   Enforcement and Compliance submission ,   Primary Premanufacture Notice (PMN) ,   Polymer Exemption ,   EPA Initiated Risk Evaluation ,   Section 4 CFR 766 ,   Section 4 ECA Submission ,   Section 4 Test Rules Order Submission ,   Risk Evaluation
Maintaining Company Contact Information	9600-031, 9600-032, 9600-030, 7710-025, 9600-035, 9600-036, 7710-25, 9600-036, 9600-034, 9600-034, 9600-034, 9600-034, 9600-033, 7710-25	TSCA Sec. 12(b) Export Notification ,   Section 8(d) Health and Safety Data Reporting ,   Section 8(e) Notice ,   Microbial Commercial Activity Notice (MCAN) ,   Mercury Electronic Reporting ,   Primary Premanufacture Notice (PMN) ,   EPA Initiated Risk Evaluation ,   Risk Evaluation ,   Section 4 Test Order Study Report ,   Section 4 Submission ECA ,   Section 4 CFR 766 Submission ,   Section 4 Test Rules Submission ,   Polymer Exemption ,   Notice of Commencement (NOC)
Reporting Health and Safety Data Using Templates	9600-032, n/a, 9600-049, 9600-049, 9600-049, 9600-049, 9600-049, 9600-049, 9600-049	Section 8(d) Health and Safety Data Reporting ,   General Communications (Gencomms) ,   TPC Reduced Testing and Exemption Notification ,   TPC Reduced Testing and Exemption Notification ,   TPC Quality Control Limit Exceedance ,   TPC Failed Quarterly Test Title VI ,   Failure to Comply Title VI ,   Annual Report Product AB Title VI ,   TPC Annual Report Title VI
Rule Famiilarization	9600-034, 9600-034, 9600-034, 9600-036, 9600-031, 9600-032, 9600-030, n/a, 7710-25, 9600-035, 7710-25, 7710-25, 9600-033, 9600-036, 9600-034, 9600-034, 9600-034, 9600-034	Section 12(b) Export Notification ,   Section 8(d) Health and Safety Data Reporting ,   Section 8(e) Notice ,   OECA Communication Form ,   Biotech MCAN ,   Mercury Electronic Reporting ,   Notice of Commencement (NOC) ,   Primary Premanufacture Notice (PMN) ,   Polymer Exemption ,   EPA Initiated Risk Evaluation (EIRE) ,   Section 4 CFR 766 Submission ,   Section 4 ECA Submission ,   Section 4 Final Study Report ,   Section 4 Test Rules Submission ,   Risk Evaluation (MRRE) ,   Section 4 Final Study Plan ,   Section 4 Initial Response ,   Section 4 Identification Response
Withdrawing Confidentiality Claims and Amending Public Copy

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ICR Summary of Burden

table that charts list 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	2,139	0	2,139	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 524 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 cost of $270,783 in the first year after the rule is finalized and an annual, ongoing cost 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: 06/15/2023

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