Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a...
Transcript of Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a...
![Page 1: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/1.jpg)
Consultation to Obtain Input on the New TSCA Provision
to Collect FeesAugust 11 – 12, 2016
1
![Page 2: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/2.jpg)
THE NEW LAW
• The “Frank R. Lautenberg Chemical Safety for the 21st Century Act” was signed by the President and went into effect on June 22, 2016
• Amends and updates the Toxic Substances Control Act of 1976
• Passed by large bipartisan margins in the U.S. House and Senate
• Received broad stakeholder support
2
![Page 3: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/3.jpg)
FUNDING SOURCE
• Provides new funding source of up to 25% of costs to carry out Sections 4, 5, 6 and 14 or $25 million (whichever is lower) in annual user fees, supplemented by Congressional appropriations− Old TSCA, 1976 – Cap on individual user fees at $2,500,
and limited fee collection authority
• Section 26(b)(4)(E) of TSCA requires EPA to consult: − with “parties potentially subject to the fees or their
representatives” − “prior to the establishment or amendment of any fees”
3
![Page 4: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/4.jpg)
CONSULTATION MEETING
• Purpose:− To consult with manufacturers and processors
potentially subject to the fees, or their representatives
− To inform the development of a proposed rule on the establishment of fees under TSCA
• Proposed rule: December 2016• Final Rule: June 2017
Comments provided orally at this meeting, as well as comments submitted to docket EPA-HQ-2016-0401 will be considered
• Written comments should be submitted by August 24, 2016
4
![Page 5: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/5.jpg)
DESIRED OUTCOMES
• Industry understanding of the types of activities associated with TSCA Sections with authorized cost defrayment
• EPA understanding of industry considerations
• Industry dialogue on approaches for fee responsibilities
• Clear expectation of procedural rule timeframe
5
![Page 6: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/6.jpg)
AGENDA
• Thursday, August 11− Introduction− Review of Statute Authorities− Review of Activities Associated with Sections 4, 5, 6 and
14− Questions for Industry to Consider− Open the floor for Industry comments
• Friday, August 12− Opening− Review of Consultation Input, Day 1− Industry Comments/Proposals− Next Steps & Close of Meeting
6
![Page 7: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/7.jpg)
REVIEW OF STATUTE AUTHORITIES
7
![Page 8: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/8.jpg)
FEES - GENERAL
• In setting fees, EPA shall--− prescribe lower fees for small business concerns− set the fees at levels such that the fees will, in
aggregate, provide a sustainable source of funds
8
![Page 9: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/9.jpg)
FEES - COLLECTION
• EPA has authority to collect fees from manufacturers and processors who:
− Are required to submit test data (§4);
− Submit notification of or information related to intent to manufacture a new chemical or new use of a chemical (§5);
− Manufacture or process a chemical substance that is subject to a risk evaluation (§6); or
− Request EPA to conduct risk evaluation on an existing chemical (§6)
9
![Page 10: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/10.jpg)
FEES - USE
• Fees are to annually defray the lower of--− 25 % of the costs of carrying out sections 4, 5, 6
and 14 (CBI) responsibilities for chemical substances under this title; or
− $ 25,000,000
10
![Page 11: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/11.jpg)
FEES - MANUFACTURER-REQUESTEDASSESSMENT
• Allows for manufacturers to request that EPA evaluate specific chemicals, and pay costs as follows:
− For chemicals on the TSCA Workplan, manufacturers pay 50% of costs of risk evaluation;
− For all other chemicals, manufacturers pay 100% of costs of risk evaluation
11
![Page 12: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/12.jpg)
FEES
• Fees must be set via rulemaking
• Goal – publish proposed rule by mid-December 2016 and final rule by mid-June 2017
12
![Page 13: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/13.jpg)
REVIEW OF ACTIVITIESSections 4, 5, 6 and 14
13
![Page 14: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/14.jpg)
SECTION 4: TESTING OF CHEMICAL SUBSTANCES& MIXTURES
• Provides authority by rule, order, or consent agreement to require testing and the development of new information
14
![Page 15: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/15.jpg)
SECTION 4 - ACTIVITIES
• Activities include but are not limited to:− Order/Rule Development− Test Plan Review− Data Analysis− Data Management− Transparency− Confidential Business Information
15
![Page 16: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/16.jpg)
SECTION 5: MANUFACTURING & PROCESSINGNOTICES (NEW CHEMICALS)
• Section 5 of TSCA requires notice be provided to EPA before initiating manufacture (this includes import) of:− a new chemical substance or− a significant new use of a chemical substance
• Amended TSCA requires affirmative determinations for all notices EPA reviews
• Risk Management action as needed
16
![Page 17: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/17.jpg)
SECTION 5 – NOTICES & INFORMATION
Examples of notices or other information:
• Pre-Manufacture Notices (PMNs)
• Exemption Notices:− Low Volume Exemptions (LVEs)− Test Marketing Exemption Applications (TMEAs)− Low Release/Low Exposure Exemption (LoREX)
• Biotechnological related submissions, such as:− Microbial Commercial Activity Notice (MCAN)− TSCA Experimental Release Application (TERA)
• Exemption Modifications
• Test/Exposure Data (follow-up)
• Notices of Commencement (NOCs)
• Significant New Use Notifications (SNUNs)
17
![Page 18: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/18.jpg)
SECTION 5 – RISK MANAGEMENT ACTIONS
18
Examples of Risk Management Actions: • Determination of Not Likely to Present Unreasonable
Risk
• Section 5(e) Consent Orders• Significant New Use Rules (SNURs) following
Section 5(e), Consent Orders
• SNURs following PMN Review
• Voluntary testing actions
• PMNs withdrawn in face of action
• Action to grant or deny Exemption
![Page 19: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/19.jpg)
SECTION 5 – ACTIVITIES
• Activities include but are not limited to:− Notice Review/Data Analysis− Affirmative Determination− Development/Refinement of Analytical Tools− Order/Rule Development/Risk Reduction− Data Management− Transparency− Confidential Business Information
19
![Page 20: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/20.jpg)
SECTION 6: PRIORITIZATION, RISKEVALUATION & REGULATION
• Risk Evaluations:− Within 3.5 years, EPA must have 20 risk evaluations
ongoing at all times
− Manufacturer requested, capped at 25% - 50% of ongoing reviews (e.g., if EPA is evaluating 20 high priority chemicals, an additional 5-10 industry petitioned evaluations could proceed in parallel)
• Risk Management:− For unreasonable risk determination, propose regulation
NLT 1 year and issue final NLT 2 years after final risk evaluation published
20
![Page 21: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/21.jpg)
SECTION 6 – ACTIVITIES
• Activities include but are not limited to:− Prioritization – high & low− Risk Evaluation – Data gathering, Data analysis,
Unreasonable Risk− Rule Development/Risk Management – Data gathering,
Data analysis− Data Management− Transparency− Confidential Business Information − Development/Refinement of Analytical Tools− Peer Review, as appropriate
21
![Page 22: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/22.jpg)
SECTION 14: CONFIDENTIAL INFORMATION
• Statutory requirements include but are not limited to:− In 90 days review all CBI claims for chemical identity and
make a determination− In 90 days review a representative 25% for most other CBI
claims− 10 year claim period unless reasserted− After Inventory Active list set, review chemical identity
claims within 5 years
22
![Page 23: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/23.jpg)
SECTION 14 – ACTIVITIES
• Activities include but are not limited to:− CBI docket− Data Management specifically for receiving and managing
CBI data− Tracking and notification for reassertion of claims− Claims Reviews− Transparency, as appropriate− Disclosure to authorized persons, including States− Clearance and Security
23
![Page 24: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/24.jpg)
SECTIONS 4, 5, 6 AND 14 – INDIRECT COSTS
24
• Indirect Costs may include but not limited to:
− Agency infrastructure − Office of Inspector General – support
fees audit function− Office of General Counsel
![Page 25: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/25.jpg)
WHAT IS EPA CONSIDERING IN REGARDS TO FEE COLLECTION?
25
![Page 26: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/26.jpg)
CONSIDERATIONS
• EPA has discretion to establish fees based on different factors− After consultation with parties potentially subject to fees
• Fee structure should not be complicated• Fee structure must take into account factors
such as:− the costs to EPA of carrying out activities− lower fees for small businesses
• Fee structure should defray, as appropriate, 25% of costs for administering Sections 4, 5, 6 and 14
26
![Page 27: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/27.jpg)
WE WANT TO HEAR FROM YOU
27
![Page 28: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/28.jpg)
QUESTIONS
• To be able to defray 25% of costs of administering Sections 4, 5, and 6, and CBI, does industry have considerations of weight amongst the three areas of fee collection?
• Does industry have thoughts on the types of factors (types of submissions, numbers of submissions, level of difficulty, etc.) that EPA should consider when structuring the fees?
28
![Page 29: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/29.jpg)
QUESTIONS
• Has industry considered how to distribute payment amongst multiple manufacturers and/or processors?
• Does industry have thoughts on how to identify the whole universe of manufacturers, including importers, and processors affected?
• Does industry have thoughts on how to arrive at an appropriate balance between manufacturers and processors?
29
![Page 30: Consultation to Obtain Input on the New TSCA Provision to ... · −To inform the development of a proposed rule on the establishment of fees under TSCA • Proposed rule: December](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f4209a924ca59456f6fe550/html5/thumbnails/30.jpg)
30
Meeting to Obtain Input on the New TSCA Provision to Collect Fees
EPA will consider comments submitted to docket
EPA-HQ-OPPT-2016-0401Submit comments at www.regulations.gov by August 24, 2016.