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

ICR 202205-2070-003

OMB: 2070-0223

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
New
Form and Instruction
New
Supporting Statement A
2022-05-21
ICR Details
202205-2070-003
Received in OIRA
EPA/OCSPP 2706.01
Confidential Business Information Claims under the Toxic Substances Control Act (TSCA) – Proposed Rule
New collection (Request for a new OMB Control Number)   No
Regular 05/23/2022
  Requested Previously Approved
36 Months From Approved
5,996 0
1,332 0
0 0

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:

US Code: 15 USC 2601-2692 Name of Law: Toxic Substances Control Act
  
US Code: 15 USC 2601-2692 Name of Law: Frank R. Lautenberg Chemical Safety for the 21st Century Act.

2070-AK68 Proposed rulemaking 87 FR 29078 05/12/2022

  87 FR 29078 05/12/2022
No

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

  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
No
No
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.

$0
No
    No
    No
No
No
No
No
Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
05/23/2022


© 2024 OMB.report | Privacy Policy