2570ss02

OMB Review Draft

Supporting Statement for an Information Collection Request (ICR)

Under the Paperwork Reduction Act (PRA)

EXECUTIVE SUMMARY

Identification of the Information Collection – Title and Numbers

Title: Expanded Access to TSCA Confidential Business Information

EPA ICR No.: 2570.02

OMB Control No.: 2070-0209

Docket ID No.: EPA-HQ-OPPT-2017-0652

Abstract

The Toxic Substances Control Act (TSCA) amendments of June 22, 2016, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, expanded the categories of people to whom EPA may disclose TSCA confidential business information (CBI). The amendments authorize EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop. Three guidance documents have been developed, corresponding to the new authorities in TSCA section 14(d)(4), (5), and (6) (Attachments 1 -3).

The conditions for access vary under each of the new provisions, but generally include the following: requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and except in emergency situations EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI. In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA.

In accordance with the requirements of TSCA section 14(c)(4)(B), the guidance documents cover the content and form of the agreements and statements required under each provision and include information on where and how to submit requests to EPA.

Summary Total Burden and Costs

	Annual Burden Hours	Annual Costs
Requesters	89	$5,873.98
Agency	54	$5,921.10

Supporting Statement

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

Section 14(c)(4)(B) of TSCA requires that EPA develop guidance concerning the content and form of the agreements and statements required under TSCA section 14(d)(4), (5), and (6).

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the Agency has made of the information received from the current collection

This information collection complies with the general guidelines found at 5 CFR 1320.5. EPA will review requests for information under section 14(d)(4), (5), and (6), as well as the required agreements and statements of need, to determine whether a given request for TSCA CBI complies with statutory requirements and may be granted. The information (agreements, statements of need, requests for access, and EPA’s determinations of whether access may be granted) will be maintained within the Office of Pollution Prevention and Toxics (OPPT) and the Office of General Counsel (OGC).

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

Requests may be made on paper, electronically (e.g., via email—an electronic request system may be developed in the future), or (at least in emergency situations) orally. Documents relating to the request will be stored by OPPT, most likely in OPPT’s Chemical Information System (CIS). CIS is housed on a secured Local Area Network with approved access only. The system is available to CBI-cleared users exclusively.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

No other Federal agency or department could provide the information necessary for EPA to determine whether a given request for access to TSCA CBI may be granted. The data being collected are not available from any other sources and can only be collected from individuals and/or other governments (e.g., states) themselves.

5. If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.

All requesters are treated in the same manner, in accordance with each statutory provision.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

This collection is made when a requester decides to submit a request for TSCA CBI information to EPA. Such request is not required and occurs at a frequency corresponding to the needs of the requester.

7. Explain any special circumstances that require the collection to be conducted in a manner:

1. requiring respondents to report information to the agency more often than quarterly;

2. requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of the information;

3. requiring respondents to submit more than an original and two copies of all document;

4. requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;

5. in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of the study;

6. requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

7. that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

8. requiring respondents to submit proprietary trade secrets or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

Not applicable.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency’s notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken in response to the comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside EPA to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

Additionally, under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an ICR to OMB for review and approval. In accordance with this regulation, EPA submitted questions to several interested parties via email Attachment 6. The individual entities contacted were:

• California Department of Toxics Substances Control (DTSC)

• Environmental Council of States

• National Tribal Toxics Council

• New Jersey Department of Environmental Protection

A copy of EPA’s consultation to the above potential respondents and the response received are in Attachment 6 and are available in the docket.

EPA received one comment in response to the previously provided 60-day public review opportunity (86 FR 44357) (FRL-8703-01-OCSPP). The California Department of Toxic Substances Control commented in general support of the expanded CBI access program and agreed that EPA’s burden estimates were reasonable.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

Not applicable.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. If the collection requires a systems of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.

The information collected will be stored at EPA Headquarters in paper files and in a secured local area network, the Chemical Information System (CIS) module. Any hard-copy information that is discarded from the system is shredded. Any personal information or CBI included in a request would be treated in accordance with the Privacy Act, section 14 of TSCA, and the Freedom of Information Act.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

No information of a sensitive or private nature is requested in conjunction with these information collection activities, and these information collection activities comply with the provisions of the Privacy Act of 1974 and OMB Circular A-108.

12. Provide estimates of the hour burden of the collection of information. The statement should:

1. Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

2. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.

3. Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included under ‘Annual Cost to Federal Government’.

Respondents affected by this activity are mainly government employees (federal, state, local, tribal), as well as medical professionals, such as doctors and nurses. The NAICS code for health care and social assistance is 62.

There are currently no specific forms used to make a request under these new provisions. The guidance includes text for the statutory-required statements and agreements, and suggests the submission of several narrative statements, as elaborated in the next paragraph (see Attachments). These statements will help EPA to verify the requestor and circumstances meet the criteria for access to the TSCA CBI information, in accordance with TSCA section 14(d).

The process that CBI requestors follow in order to request and maintain access to TSCA CBI involves the following:

For access under TSCA section 14(d)(4) (state, tribal, and local governments), requesters—

1. Review the Guidance Document.

2. Complete and sign an agreement regarding protection of CBI.

3. Develop statement of legal authority.

4. Develop statement of CBI safeguarding procedures.

5. Write request for information.

6. Management review and preparation of submission.

7. Manage CBI information.

8. Keep records (store, file, or maintain copy of agreements for in-house reference)

For access under TSCA section 14(d)(5) (health and environmental professionals, non- emergency), requesters—

1. Review the Guidance Document.

2. Gather required information and complete statement of need (selecting statement of need, providing eligibility information, describing circumstance of request).

3. Read and sign confidentiality agreement.

4. Review and prepare submission.

5. Manage CBI information

6. Keep records (store, file, or maintain copy of agreements for in-house reference).

For access under TSCA section 14(d)(6) (emergencies), requesters—

1. Review the Guidance Document.

2. Review and prepare submission.

3. Manage CBI information.

4. May be required to prepare a statement of need.

5. May be required to sign a confidentiality agreement.

6. Keep records (store, file, or maintain copy of agreements, if any, for in-house reference).

State, local, or tribal governments; health and environmental professionals in non- emergency situations; and emergency responders choosing to request access to TSCA CBI will undertake a number of actions associated with TSCA sections 14(d)(4), (5), and (6), respectively. Because this ICR presents new requirements, EPA has used its best professional judgement and experience from previous ICRs with similar activities to determine the amount of time that would be required to complete the tasks outlined in section 4 (b) of this ICR. It is estimated that in the next three years the total number of submissions under TSCA section 14(d)(4), (5), and (6) will be 18 (six per year, under TSCA section 14(d)(4), (5), and (6) combined).

The state, local, or tribal government annual burden is given in Table 1. The annual burden for health and environmental professionals in non-emergency situations is given in Table 2. The annual burden for emergency requesters is provided in Table 3. The total annual burden for all state, local, or tribal governments is estimated to be 42 hours. The total annual burden for health or environmental professionals in non-emergency situations is 37 hours. For emergency requests, the total annual burden is 10 hours.

Table 1: Total Annual Respondent Burden and Costs Associated with a TSCA Section 14(d)(4) request. State, Local, or Tribal government.

Activity	Managerial Hours $90.35	Technical Hours $74.17	Clerical Hours $33.17	Request per Year	Annual Burden Hours	Annual Costs ($)
Rule Familiarization (one-time burden)
Review of the guidance	0.27	0.55	0	2	1.64	$130.38
Request Submission
Filling in the model agreement	0	0	2	2	4	$132.68
Developing statement of legal authority	0	4	0	2	8	$592.96
Developing statement of CBI safeguarding procedures	0	3	0	2	6	$444.72
Written request for information	0	2	0	2	4	$296.48
Management review and preparation of submission	3	0	0	2	6	$542.10
Management of CBI information	0	2	2	2	8	$429.16
Recordkeeping
Recordkeeping (store, file, or maintain copy of agreements for in-house reference)	0	0	2	2	4	$132.68
TOTAL	3.27	11.55	6		41.64	$2,701.16

Table 2: Total Annual Respondent Burden and Costs Associated with a TSCA Section 14(d)(5) request. (Health or environmental professional – non-emergency)

Activity	Managerial Hours $90.35	Technical Hours $74.17	Clerical Hours $33.17	Request per Year	Annual Burden Hours	Annual Costs
Rule Familiarization (one-time burden)
Review the Guidance	0	0.55	0	3	1.65	$122.38
Request Submissions
Gather required information and complete statement of need (selecting statement of need, providing eligibility information, describing circumstance of request)	0	4	0	3	12	$890.04
Read and sign the confidentiality agreement	0	0.75	0	3	2.25	$166.88
Review and preparation of submission	0	3	0	3	9	$667.53
Management of CBI information	0	2	0	3	6	$445.02
Recordkeeping
Recordkeeping (store, file, or maintain copy of agreements for in-house reference)	0	0	2	3	6	$199.02
TOTAL	0	10.3	2		36.9	$2490.87

Table 3: Total Annual Respondent Burden and Costs Associated with a TSCA Section 14(d)(6) request. (Health or environmental professional - emergency)

Activity	Managerial Hours $90.35	Technical Hours $74.17	Clerical Hours $33.17	Request per Year	Annual Burden Hours	Annual Costs
Rule Familiarization (one-time burden)
Review of the guidance	0	0.55	0	1	0.55	$40.79
Request Submission
Gather required information and complete statement of need (selecting statement of need, providing eligibility information, describing circumstance of request) (*)(**)	0	2	0	1	2	$148.34
Read and sign the confidentiality agreement (**)	0	0.75	0	1	0.75	$55.63
Review and Preparation of submission (*) (**)	0	3	0	1	3	$222.51
Management of CBI information	0	2	0	1	2	$148.34
Recordkeeping
Recordkeeping ((store, file, or maintain copy of agreements for in-house reference)	0	0	2	1	2	$66.34
TOTAL	0	8.3	2		10.3	$681.95
(*) Requests may be made over the phone (including describing the emergency and information needed, as well as, personal identification information. (**) Some requesters may not ultimately have to make the statement of need and sign a confidentiality agreement—this is only required where the person who made the CBI claim so requests.

Respondent hourly costs in this ICR have been calculated using the Bureau of Labor Statistics’ Employer Costs for Employee Compensation Supplementary Tables: September 2017, US Bureau of Labor Statistics, December 20 (BLS 2020, accessed March 23, 2021). Hourly costs were calculated for workers in professional and business services industries.¹ Total hourly cost estimates include wages, fringe benefits, and overhead. The wage and fringe benefit numbers are from the BLS data, and the overhead allowance is calculated at 20% of the hourly wage.²

Table 4: Wage Rates

Category3	Hourly wage	Fringe benefits	Overhead	Total hourly cost
Managerial	$ 53.32	$21.97	$15.06	$90.35
Technical	$43.85	$ 17.96	$12.36	$74.17
Clerical	$19.76	$7.88	$5.53	$33.17

Estimated total annual costs to the respondents (under TSCA 14(d)(4), (5), and (6)) are equal to $ 5,873.98 and are presented in Table 5. There are no capital costs for the contractors associated with this collection.

Table 5: Annual Respondent Costs estimated associated with TSCA 14(d)(4), (5), and (6).

	Hours per Labor Category			Number of Requests	Annual Burden Hours	Annual Costs
	Managerial ($90.35)	Technical ($74.17)	Clerical ($33.17)
TSCA 14(d) (4)	3.27	11.55	6	2	41.64	$2.701.16
TSCA 14(d) (5)	0	10.3	2	3	36.9	$2,490.87
TSCA 14(d) (6)	0	8.3	2	1	10.3	$681.95
Totals	3.27	30.15	10	6	88.9	$5,873.98

13. Provide an estimate for the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected on the burden worksheet).

1. The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.

2. If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.

3. Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

There are no operational or maintenance costs associated with this ICR.

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.

Upon receipt of a request for CBI access, EPA (principally OPPT and OGC staff and management) will evaluate the information provided by the requestor to determine whether access to the information requested may be granted pursuant to TSCA section 14(d). EPA may ask the requestor clarifying questions and will notify the requestor of the decision to grant or deny the request. When a request is granted, EPA will advise the requestor on how to access the information, or where practical, simply provide the information orally. Prior to release (in the case of the non-emergency access provisions) or shortly after release (in the case of emergencies), EPA is required by TSCA section 14(g)(2) to notify the person who made the CBI claim of the release.

The costs and hours to the Federal Government are presented in the Table 6.5. The Office of Pollution Prevention and Toxics bases its hour estimates on prior experience processing requests and eligibility determination with other information collections. The activities associated with Agency responses to TSCA section 14(d)(4), (5), and (6) requests are assumed to be accomplished by two GS 13, step 5 federal employees (technical and attorney). The 2020 hourly wage rate for this level of employee in the Washington, D.C., locality is $55.75 per hour. The hourly rates were taken from the U.S. Office of Personnel Management’s 2020 General Schedule for workers with the Washington, D.C., locality payment table (Table 2020-DCB).

The total compensation - the sum of hourly wage ($55.75) and fringe benefits ($35.62⁴) – is equal to $91.37. An overhead rate of 20% ($18.27) is then applied to the total compensation (Handbook on Valuing Changes in Time Use Induced by regulatory Requirements and Other U.S EPA Actions (EPA 2020). The hourly cost estimates adjusted for benefits and overhead is $ 109.65. The total cost to the Agency to maintain the collection system is $5,921.04 per annum and the total Agency burden is estimated at 54 hours.

Table 6. Agency Annual Cost Estimates

Collection Activity	Weighted Average Hours per request	Total number of requests (14(d) 4, 5 and 6)	Total Number of hours	Total Annual Cost
Request processing and eligibility determination	6	6	36	$3,947.4
Notify the requestor and provide instructions to access the CBI data	2	6	12	$1,315.8
Notify companies and store or file request for in-house reference	1	6	6	$657.90
Totals	9		54	$5,921.10
Source: OPM 2020 hourly rate table for the Washington-Baltimore-Northern Virginia Locality Pay Area, with fringe benefits and overhead added.

15. Explain the reasons for any program changes or adjustments reported in hour or cost burden.

There is no change in the estimated total annual burden compared with that identified in the ICR currently approved by OMB, but there is an increase in the estimated burden costs and a decrease in the estimated number of total respondents. This change is an adjustment.

The increase in the respondent burden and agency costs were caused by an increase in the hourly wages and a change in the methodology to calculate loaded wages (wages plus fringe benefits and overhead). Please refer to Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (Attachment 4). The change in the estimated number of respondents is based on EPA experience.

16. For collections whose results will be published, outline the plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

Not applicable.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons why display would be inappropriate.

Not applicable.

18. Explain each exception to the certification statement identified in “Certification for Paperwork Reduction Act Submissions.”

EPA does not request an exception to the certification of this information collection.

Supplemental Information

This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0209). Responses to this collection of information are voluntary for certain persons, as specified in TSCA Section 14(d). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The public reporting and recordkeeping burden for this collection of information is estimated to be 14.8 hours per response. Send comments on the Agency’s need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.

You can also provide comments to the Office of Information and Regulatory Affairs, Office of Management and Budget via http://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function.

All comments received by EPA will be included in the docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

Please note that due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is by appointment only. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

List of Attachments

The attachments listed below can be found in the docket for this ICR or by using the hyperlink that is provided in the list below. The docket for this ICR is accessible electronically through http://www.regulations.gov using Docket ID Number: EPA-HQ-OPPT-2017-0652.

Ref.	Title
1.	Attachment 1: EPA Guidance documents outlining the circumstances under which TSCA allows the Agency to disclose CBI and how representatives of the three groups listed above can request disclosure: “Access to Toxic Substances Control Act Confidential Business Information: A guide for access to TSCA CBI for state, local, and tribal governments”
2.	Attachment 2: EPA Guidance documents outlining the circumstances under which TSCA allows the Agency to disclose CBI and how representatives of the three groups listed above can request disclosure: “Access to Toxic Substances Control Act Confidential Business Information: A guide for access to TSCA CBI for medical and environmental professionals in non-emergency situations”
3.	Attachment 3: EPA Guidance documents outlining the circumstances under which TSCA allows the Agency to disclose CBI and how representatives of the three groups listed above can request disclosure: “Access to Toxic Substances Control Act Confidential Business Information: A guide for access to TSCA CBI in emergency situations”
4.	Attachment 4: Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions
5.	Attachment 5: Falk, J. (2012) Comparing the Compensation of Federal and Private-Sector Employees 2011 to 2015
6	Consultation Email

1 Specifically, EPA used Supplementary Table 10. “Employer costs per hour worked for employee compensation and costs as a percent of total compensation: private industry workers in professional and business service industries, by occupation group and establishment size, September 2017.”

2 An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions.

3 The Managerial category corresponds to “Management, business, and financial” in Supplementary Table 10. Likewise, the Technical category corresponds to “Professional and related” in that table and Clerical corresponds to “Office and administrative support.”

4 Fringe benefits were calculated as 63.90 % of the hourly rate based on assumption in Falk, J. (2012) Comparing the Compensation of Federal and Private-Sector Employees 2011 to 2015 (Attachment 5)

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