Generic IC Justification

Planned Test Orders FY23 (IC No.1139.25)

Issuance Under EPA ICR No. 1139.50; OMB Control No. 2070-0033

January 2024

The following information is being provided in accordance with the terms of clearance for the information collection request (ICR) approved under the Office of Management and Budget (OMB) Control Number 2070-0033, which requires the Environmental Protection Agency (EPA) to provide OMB with prior notice and opportunity to review the Test Orders to be issued under the Toxic Substance Control Act (TSCA) Section 4 before EPA may issue the Test Orders under this ICR. Additional information about the collection activities, authority and specific requirements under TSCA and EPA implementing regulations, estimates and related methodologies, is provided in the ICR Supporting Statement that was approved in December 2020.

1. What TSCA Chemicals will be subject to the planned Test Order?

EPA’s Office of Pollution Prevention and Toxics (OPPT) is requesting clearance to issue a Test Order to manufacturers and processors of N-methyl perfluorooctane sulfonamido ethanol (NMeFOSE) (CASRN 24448-09-7).

2. What are the Estimated Total Burdens and Costs for this planned Test Order?

The total paperwork burden and cost for this specific Test Order request is estimated to be 984 hours and $82,587 in burden costs as shown in the following table.

Summary of Study Costs, Burden Costs and Hours for the Test Order in this IC
Chemical	Testing Costs ($)	Paperwork Burden Costs ($)	Paperwork Burden Hours
N-methyl perfluorooctane sulfonamido ethanol (CASRN 24448-09-7)	$1,342,829	$82,587	984

These figures reflect an overestimate because the methodology assumes that all the companies will file Exemption Applications instead of Letters of Intent. However, some companies are likely to only submit a Letter of Intent. The range of burden and cost between Letters of Intent and Exemption Applications are provided below but the upper bound is used in the summary table above. In addition, the company could submit existing data to EPA to determine if the existing data fulfills the data needs and subsequently the testing requirement. If EPA makes the determination submitted existing data does preclude the need for conducting and submitting testing, the respondent’s incurred costs would be lower.

3. What activities are required for the Test Order?

To respond to the Test Order, subject companies must undertake the following activities that may result in burden and costs such as:

• Providing company identification. This consists of identifying as a manufacturer, processor, or both, and in certain cases, may include requesting to modify their corporate identity.

• Providing an initial response to the Test Order.

• Developing and providing a study plan.

• Conduct testing. In certain cases, this may include collecting necessary samples, contracting out the analysis of samples and tests, management of a consortium.

• Providing a final report of study results to EPA.

The details of these activities are explained in Section D of this document. Requirements summarized here are set out in the Test Order and reflect the requirements enumerated in TSCA section 4 and EPA implementing regulations, as applicable. The activities based on these requirements are also described in the Generic ICR.

4. Detailed Description of the Test Order Activities.

Company Identification

EPA has attempted to identify the highest-level US corporate entity for purposes of issuing the Test Order.  The highest-level US corporate entity is ultimately responsible for satisfying the obligations of the Test Order, although the highest-level US corporate entity may delegate its responsibilities under the Order to a U.S. subsidiary. As prescribed by the Test Order, within 30 calendar days of the effective date of the Test Order, a response is required at [email protected] should companies wish to modify the name of the recipient or identify another US corporate entity in the corporate structure as the point of contact in place of the recipient named in the Test Order.

As prescribed by the Test Order, within 30 calendar days of the effective date of the Test Order, a response is required through EPA’s Central Data Exchange (CDX) portal, informing the Agency whether the recipient will be responding to this Order as manufacturer or processor. The estimated burden and cost for the company identification is shown in Table D1.

Table D1. Company Identification - Burden and Cost (2022$)

Activity	Managerial Burden (hrs.) per Response	Technical Burden (hrs.) per Response	Clerical Burden (hrs.) per Response	Respondents (Companies included in Test Order)	Responses per Respondent	Total Responses	Total Burden	Non-Labor Cost	Total, Company ID Costs
Company Identification	0.0625	0.1875	0	2	1	2	0.5	$0.00	$43.02
Total, Reporting	0.0625	0.1875	0	2	1	2	0.5	$0.00	$43.02
Total, Recordkeeping	0	0	0	0	0	0	0	$0.00	$0.00
Total, Company Identification	0.0625	0.1875	0	2	1	2	0.5	$0.00	$43.02

Initial Response

As prescribed by the Test Order, the Letter of Intent is an initial response made by respondents in response to Test Orders and it formally acknowledges that the respondent intends to sponsor required testing under the order. An entity subject to a Test Order may apply for an exemption from one or all of the testing requirements imposed in a Test Order if that testing will be, or has been, performed by another entity subject to the order.

In either case, it is difficult to predict how many exemption applications might be submitted to EPA in any one year. EPA assumes each company may decide to file an Exemption Application instead of a Letter of Intent. EPA also assumes that each application would request the exemption from all of the testing.

As prescribed by the Test Order, within 45 calendar days of the effective date of the Test Order, a response is required through the CDX portal informing the Agency which of the five options articulated in the Test Order the recipient has chosen to comply with the Test Order. Any CDX related burden and cost is covered in a different ICR and therefore not captured here. The estimated burden and cost for the initial response is shown in Table D2. Companies will either respond with a Letter of Intent or Exemption Application, they will not need to perform both. The lower estimates assume all companies submit Letters of Intent and the upper estimates assume all file Exemption Applications.

Table D2. Initial Response - Burden and Cost (2022$)

Activity	Managerial Burden (hrs.) per Response	Technical Burden (hrs.) per Response	Clerical Burden (hrs.) per Response	Respondents (Companies Included in Test Order)	Responses per Respondent	Total Responses	Total Burden	Non-Labor Cost	Total, Initial Response Costs
Initial Response (“Letter of Intent”)	0	1	0	2	1	2	2	$0.00	$166.28
Total, Reporting ("Letter of Intent")	0	1	0	2	1	2	2	$0.00	$166.28
OR
Exemption Application Submission	6	2	0	2	1	2	16	$0.00	$1,469.44
Recordkeeping	0	0	0.5	2	1	2	1	$0.00	$40.13
Total, Exemption Application	6	2	0.5	2	1	2	17	$0.00	$1,509.57
Total, Letter of Intent, Test Orders	0 to 6	1 to 2	0 to 0.5	2	1	2	2 to 17	$0.00	$166.28 to $1509.57

Test Protocols

EPA assumes that a consortium of the companies subject to the Test Order will provide the required data. As prescribed by the Test Order, after expressing an intent to provide information in the initial response, the consortium must submit a Study Plan to EPA for each test to be conducted. The Study Plan includes documents detailing the different types of tests, health effects, and endpoints covered in each chemical report.

EPA expects that companies will incur costs to participate in consortiums to manage testing requirements with shared responsibilities. Consortium management costs, which include activities such as, meetings, organizing payment for testing, and developing contracts for testing, are estimated at 15 percent of total laboratory costs. Costs are also included for technical experts working for the consortium by providing study review and site visits to the laboratory and are estimated at 10 percent of total laboratory costs. Additionally, EPA estimates the that the activities associated with contacting vendors and arranging testing will require 8 hours of technical labor. This estimate was developed using best professional judgment and our experience with contacting vendors.

This Order includes a tiered testing approach to collect certain health effects information. It is difficult to predict if companies will submit Tier 1.2, Tier 1.3, and Tier 2.2 tests to EPA as Tier 1.2 testing requirements depend on the results of Tier 1.1 tests, Tier 1.3 testing requirements depend on the results of Tier 1.1 and Tier 1.2 tests, and Tier 2.2 testing requirements depend on the results of Tier 2.1 tests. Therefore, as a conservative approach, EPA assumes that a consortium of the companies will submit data for all tier tests. Table D3 lists the tests EPA will require of a company and the estimated burden and costs for testing and consortium management.

Table D3. Required Tests – Unit Costs (2022$)

Tier	Testing Protocol	Test Name	Labor Costs						Non-Labor Costs
			Managerial Burden (hrs.)	Technical Burden (hrs.)	Clerical Burden (hrs.)	Unit Burden (hrs.)	Total Labor Cost for Sample Collection	Total Non-Labor Unit Cost for Testing		Total Non-Labor Unit Cost for Consortium Management	Total, Non-Labor Cost for Testing
1.1	OECD 102	Melting Point/ Melting Range	0	8	0	8	$665	$2,285		$571	$2,856
1.1	OECD 105	Water Solubility	0	8	0	8	$665	$9,742		$2,436	$12,178
1.1	OECD 104	Vapour Pressure	0	8	0	8	$665	$25,307		$6,327	$31,634
1.1	OECD 103	Boiling Point	0	8	0	8	$665	$2,334		$584	$2,918
1.1	OECD 102	Melting Point / Melting Range	0	8	0	8	$665	$1,156		$289	$1,445
1.1	OECD 111	Hydrolysis as a Function of pH	0	8	0	8	$665	$104,605		$26,151	$130,756
1.1	OECD 112	Dissociation Constants in Water	0	8	0	8	$665	$4,333		$1,083	$5,416
1.1	OECD 122	Determination of pH, Acidity and Alkalinity	0	8	0	8	$665	$757		$189	$946
1.1	OECD 115 / ASTM D1331	Surface Tension of Aqueous Solutions	0	8	0	8	$665	$1,817		$454	$2,271
1.2	OECD 428	Skin Absorption: In Vitro Method	0	8	0	8	$665	$50,753		$12,688	$63,441
1.2	ISO 4311	Anionic and non-ionic surface active agents — Determination of the critical micellization concentration — Method by measuring surface tension with a plate, stirrup or ring	0	8	0	8	$665	$1,817		$454	$2,271
1.3	OECD 117	Partition Coefficient (n-octanol/water), HPLC Method	0	8	0	8	$665	$5,716		$1,429	$7,145
1.3	OECD 121	Estimation of the Adsorption Coefficient (Koc ) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC)	0	8	0	8	$665	$6,107		$1,527	$7,634
2.1	OECD 305	Bioaccumulation in Fish: Aqueous and Dietary Exposure	0	8	0	8	$665	$155,871		$38,968	$194,839
2.1	OECD 417	Toxicokinetics	0	8	0	8	$665	$458,250		$114,563	$572,813
2.2	OECD 422	Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test	0	8	0	8	$665	$179,628		$44,907	$224,535

Study Plan

As prescribed by the Test Order, after the initial response has occurred, test sponsor respondents must provide a study plan to EPA. The study plan includes documents detailing the different types of tests, protocols to be followed, health effects, and endpoints to be covered in each chemical report. In general, confidential business information (CBI) substantiation to support confidentiality claims for relevant data elements throughout the testing period may be required. For this Order, EPA assumes that there will be no CBI confidentiality claims because chemical ID is known, and other data elements are expected not to be confidential for reasons of transparency. The estimated burden for preparing study plans is shown in Table D4.

Table D4. Study Plan – Burden and Cost (2022$)

Activity	Managerial Burden (hrs.)	Technical Burden (hrs.)	Clerical Burden (hrs.)	Respondents	Responses per Respondent (# of Tests in Test Order)	Total Responses	Total Burden	Non-Labor Cost	Total, Study Plan Costs
Study Plan	0	3.9	0	1	15	15	58.5	$0.00	$4,863.69
CBI Substantiation	0	0	0	0	15	0	0	$0.00	$0.00
Total, Reporting	0	3.9	0	1	15	15	58.5	$0.00	$4,863.69
Total, Recordkeeping	0	0	0	0	15	0	0	$0.00	$0.00
Total, Study Plan	0	3.9	0	1	15	15	58.5	$0.00	$4,863.69
Assumes companies form consortium and the consortium submits a study plan for each test.

Test Results

At the conclusion of each test, respondents are required to provide a final report, which must also undergo both corporate and laboratory review (which includes certified compliance with the applicable Good Laboratory Practice standards (GLPs)). Recordkeeping is also expected for all final report transmittals.

Table D5. Test Results - Burden and Cost (2022$)

Activity	Managerial Burden (hrs.)	Technical Burden (hrs.)	Clerical Burden (hrs.)	Respondents	Responses per Respondent (# of Tests in Test Order/# of Respondents)	Total Responses (# of Tests in Test Order)	Total Burden	Non-Labor Cost	Total, Test Results Costs
Study Final Report	0	40	0	1	15	15	600	$0	$49,884.00
Study Corporate Review	6	0	0	1	15	15	90	$0	$8,526.60
Laboratory Review	0	6	0	1	15	15	90	$0	$7,482.60
Total, Reporting	6	46	0	1	15	15	780	$0	$65,893.20
Total, Recordkeeping	0	0	0.5	1	15	15	7.5	$0	$300.98
Total, Test Results, Test Orders	6	46	0.5	1	15	15	787.5	$0	$66,194.18
Assumes companies form consortium and the consortium submits the test results for each test.

Total Burden

The total burden for this Test Order includes the burden for submitting company identification, initial response, testing, study plan, and test results to the EPA. Note, for the initial response, we assume companies will respond with an exemption application to provide a conservative estimate.

Table D6. Total Burden Costs (2022$)

Test Order Activity	Burden (hours)	Cost
Company Identification	0.5	$43
Initial Response	17	$1,510
Study Plan	58.5	$4,864
Testing	120	$1,270,218
Test Results	787.5	$66,194
Total	983.5	$1,342,829