OMB Review Draft
Supporting Statement for an Information Collection Request (ICR)
Under the Paperwork Reduction Act (PRA)
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
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.
|
Annual Burden Hours |
Annual Costs |
Requesters |
89 |
$5,873.98 |
Agency |
54 |
$5,921.10 |
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).
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).
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.
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.
All requesters are treated in the same manner, in accordance with each statutory provision.
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.
Not applicable.
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.
Not applicable.
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.
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.
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—
Review the Guidance Document.
Complete and sign an agreement regarding protection of CBI.
Develop statement of legal authority.
Develop statement of CBI safeguarding procedures.
Write request for information.
Management review and preparation of submission.
Manage CBI information.
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—
Review the Guidance Document.
Gather required information and complete statement of need (selecting statement of need, providing eligibility information, describing circumstance of request).
Read and sign confidentiality agreement.
Review and prepare submission.
Manage CBI information
Keep records (store, file, or maintain copy of agreements for in-house reference).
For access under TSCA section 14(d)(6) (emergencies), requesters—
Review the Guidance Document.
Review and prepare submission.
Manage CBI information.
May be required to prepare a statement of need.
May be required to sign a confidentiality agreement.
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 |
There are no operational or maintenance costs associated with this ICR.
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. |
|
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.
Not applicable.
Not applicable.
EPA does not request an exception to the certification of this information collection.
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.
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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File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | OMB Comments;siu.carolyn@epa.gov |
File Modified | 0000-00-00 |
File Created | 2022-03-28 |