Document ID: EPA-HQ-OPPT-2015-0744-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2022-02-08T05:00Z

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: Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8(e)
	EPA ICR No.: 0794.17
	OMB Control No.: 2070-0046
	Docket ID No.: EPA-HQ-OPPT-2015-0744
 Abstract
Section 8(e) of the Toxic Substances Control Act (TSCA) states, "any person who manufactures, [imports,] processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the [EPA] Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information." (15 U.S.C. 2607(e); see Attachment 1.)
EPA receives and screens TSCA section 8(e) submissions covering a large number of chemical substances and mixtures on a wide range of chemical toxicity/exposure information. Although EPA's receipt of TSCA section 8(e) information does not necessarily trigger immediate regulatory action under TSCA or other authorities administered by EPA, all section 8(e) submissions receive screening level evaluations by EPA's Office of Pollution Prevention and Toxics (OPPT) to identify priorities for further Agency action and appropriate referrals to other programs.
Section 8(e) data on newly discovered chemical hazards/risks is available via EPA's ChemView https://chemview.epa.gov/chemview). There is also public outreach and information access to section 8(e) data through the TSCA Public Docket
In addition, EPA is offering an electronic reporting option for use both by those who are required to submit a notification of substantial risk under section 8(e) and by those who wish voluntarily to submit "For Your Information" (FYI) notices by registering and submitting information electronically using the Agency's Central Data Exchange (CDX), as described below.
 Summary Total Burden and Costs
Table 1: Industry and Agency Summary of Responses, Respondents, Burdens, and Costs (2020$)
                                   Activity
                               Annual Responses
                                  Respondents
                              Annual Burden Hours
                                  Annual Cost
INDUSTRY
Section 8(e) submission
                                                                            343
                                                                             34
                                                                         17,229
                                                                    $1,604,337 
FYI submission
                                                                              6
                                                                              2
                                                                            303
                                                                       $28,130 
CDX Registration and e-Signature
                                                                             51
                                                                             51
                                                                             33
                                                                        $2,779 
INDUSTRY TOTAL
                                                                            400
                                                                             51
                                                                         17,565
                                                                     $1,635,246
AGENCY TOTAL
                                                                            N/A
                                                                            N/A
                                                                          2,569
                                                                      $281,691 

Supporting Statement
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 8(e) continues to be an important and useful tool for early warning and identification of potential substantial risk situations allowing EPA and others to focus their limited resources on chemicals or mixtures of highest concern. The submission of section 8(e) information makes it possible for the Agency and others to learn quickly about potential new chemical hazards/risks posed by exposure to chemical substances, to conduct more complete assessments and, if needed, effective action to eliminate or reduce such risks in a timely manner.
The statutory authority for this information collection is section 8(e) of TSCA (15 U.S.C. 2607(e)). No formal rule-making by the Agency was required to implement section 8(e), in that section 8(e) was a self-activating reporting provision of TSCA that became immediately effective on January 1, 1977 (the effective date of the Act). However, in order to facilitate compliance with section 8(e), EPA clarified the kinds of information that constitute substantial risk information, specified the types of information exempt from the reporting requirements, and outlined standard reporting procedures, in published proposed guidance (42 FR 45362; September 9, 1977). After holding several public meetings and considering the public comments on the proposed section 8(e) guidance, the Agency published its final "Statement of Interpretation and Enforcement Policy; Notification of Substantial Risk" (43 FR 11110; March 16, 1978). In June 1991, EPA published a "Section 8(e) Reporting Guide" further to assist the regulated community in complying with section 8(e). The 1991 Reporting Guide references examples of submitted information and EPA's comments on these submissions to help persons subject to section 8(e) better understand the types of information that are reportable under section 8(e). The 1991 Guide also includes dose ranges and exposure factors to consider in determining the section 8(e) reportability of acute lethality data.
In February of 1991, the Agency initiated a voluntary section 8(e) "Compliance Audit Program" (CAP). This compliance program, which followed several section 8(e) enforcement cases indicating that some companies were not complying with section 8(e) reporting requirements, was designed to 1) achieve EPA's goal of obtaining any outstanding section 8(e) data, and 2) provide maximum encouragement to companies to voluntarily audit their files for section 8(e)-reportable information. The section 8(e) CAP involved consent agreements/orders pursuant to section 15 of TSCA, stipulated monetary penalties and an overall penalty ceiling. 123 companies elected to participate voluntarily in the Agency's section 8(e) CAP activity. The CAP was terminated on May 15, 1996, and settlements with CAP participants were announced on October 15, 1996.
In implementing the section 8(e) CAP, EPA determined that there was a need to suspend and refine those portions of the 1978 section 8(e) Policy Statement that deal specifically with the reportability of chemical releases to the environment and the detection of toxic chemicals in environmental media. On July 13, 1993 (58 FR 37735), EPA published proposed guidance on the detection of toxic chemicals in environmental media. EPA received comments from 49 companies and industry associations. Based on the submitted comments and a number of meetings with industry representatives, EPA revised the proposed guidance and made it available for additional public comment through a notice in the Federal Register published on March 20, 1995 (60 FR 14756). In response, EPA received an additional 22 comments. While the comments offered additional refinements to the revised guidance, their basic tenor was that industry was in support of the changes.
Beginning in 1996, there was an ongoing collaboration between EPA and industry to develop a question and answer (Q&A) document to promote industry understanding of and compliance with the Agency's anticipated revised section 8(e) reporting criteria for environmental release and contamination information. The intent was to make the Q&A publicly available before the revised guidance was published. However, the finalized Q&A document was not yet available when the revised guidance, "TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance" (68 FR 33129-33139), was published on June 3, 2003. The revised guidance included a re-publication of the 1978 Policy Statement and incorporated revisions that address the reporting of information on the release of chemical substances to the environment and the detection of toxic chemicals in environmental media. Also included in the June 2003 Reporting Guidance was a change in the deadline for reporting "substantial risk" information to the Agency (from 15 working days to 30 calendar days) and the circumstances under which certain information need not be reported to EPA under section 8(e).  In a subsequent Federal Register Notice, "TSCA Section 8(e) Reporting Guidance; Correction, Clarification of Applicability, and Announcement Regarding the Issuance (of) Questions and Answers" (70 FR 2162-2164), EPA announced certain corrections to the June 2003 Reporting Guidance (due to transcription errors from the 1978 Policy Statement that appeared in the June 2003 Guidance), stated that the applicability date for the June 2003 Guidance Document was the publication date, and announced the availability of a Q&A document on the section 8(e) reportability of releases of chemical substances to the environment and the detection of toxic chemicals in environmental media.  This Q&A document included only a few of the items drafted earlier by industry stakeholders with EPA participation. EPA currently maintains section 8(e) information on environmental releases and other aspects of section 8(e) reporting. This information is available via the ChemView  (https://chemview.epa.gov/chemview) There is also public outreach and information access to section 8(e) data through the TSCA Public Docket. .
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
Since 1977, the Agency and members of the chemical industry have devoted significant efforts in fulfilling their respective responsibilities under section 8(e). Between January 1977 through November 2015, EPA has received and screened 20,070 initial section 8(e) notices (includes CAP and non-CAP submissions), covering a broad range of toxicity and exposure-related data on a wide range of chemicals and chemical mixtures. All incoming section 8(e) submissions are reviewed by EPA shortly after receipt. The initial processing of section 8(e) submissions includes a screening level evaluation of the submitted data. Such evaluations are not risk assessments, nor do they consider other available toxicity data on the chemical or exposure-related information on the chemical/mixture being reviewed. The results of screening level evaluations are used for priority-setting to select cases for more detailed assessment, as well as to identify referrals to other Offices and federal agencies.
EPA utilizes section 8(e) submission information for hazard/risk identification purposes in the initial stages of the TSCA chemical screening and review program. Section 8(e) data are also used in ongoing EPA hazard and exposure assessments of both existing and new chemicals, and in support of regulation development under TSCA, e.g., development of chemical testing rules under section 4 of TSCA, as well as regulation development under other authorities administered by the Agency. In addition, section 8(e) submissions have been the basis for chemical advisories to communicate potential health risks and the need for exposure controls, as well as for chemical summaries to identify data availability for chemical hazard and exposure assessment.
Regardless of the type of section 8(e) follow-up action or activity taken, all reported information not claimed as TSCA confidential business information is made available to other EPA Program and Regional Offices, other federal agencies and others (e.g., chemical industry, trade unions, environmental groups, the general public, and international community) who may be interested in the subject chemical or mixture. EPA Offices and other federal agencies routinely utilize section 8(e) data in implementing their regulatory programs. The principal vehicles for making the information publicly available are on ChemView. 
EPA's proactive implementation of section 8(e) has also resulted in heightened corporate awareness of the potential risk of injury posed by exposure to chemical substances. This increased corporate awareness has led to a variety of voluntary corporate actions designed to protect human health and/or the environment. Many companies have reported to EPA that the following types of risk reduction/pollution prevention measures were initiated in direct response to the submitted chemical toxicity and/or exposure data:
 Notification of workers, customers and others;
 Revision of product labels and Material Safety Data Sheets;
 Modification of manufacturing, processing, and/or handling;
 Ceasing production/use either temporarily or permanently;
 Initiation of additional toxicity or exposure studies to further define potential risks.
         
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.
EPA developed the Chemical Information Submission System (CIS) reporting tool for use in submitting data electronically to the Agency. The tool is available for use with Windows, Macs, Linux, and UNIX based computers, using "Extensible Markup Language" (XML) specifications for efficient data transmission across the Internet. The CISS is a tool that provides user-friendly navigation, works with CDX to secure online communication, creates a completed Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other information to be submitted easily as PDF attachments.  
All information sent by the submitter via CDX is transmitted securely to protect Confidential Business Information (CBI). Furthermore, if anything in the submission is claimed as CBI a non-CBI copy of the submission must be provided by the submitter. The guidance document will instruct users on how to submit and substantiate CBI information using CIS. 
The Agency ensures secure transmission of the data, reports, and other documents sent from the user's desktop through the Internet via the Transport Layer Security (TLS) 1.0 protocol. TLS 1.0 and subsequent versions updated as needed are widely used approaches for securing Internet transactions by the National Institute of Standards and Technology (NIST) as a means for protecting data sent over the Internet.  
In addition, CIS enables the submitter to electronically sign, encrypt, and transmit submissions, which EPA subsequently provides back to the submitter as an unaltered copy of record. This assures the submitter that the Agency has received exactly what the submitter sent to EPA. The CISS reporting tool encrypts using a module based on the 256-bit Advanced Encryption Standard (AES) adopted by NIST. Details about AES can be found in FIPS 197 pdf on the NIST website at http://csrc.nist.gov/publications/PubsFIPS.html and EPA may incorporate other encryption modules into future versions of the tool. Information submitted via CDX is processed within EPA by secure systems certified for compliance with Federal Information Processing Standards. 
In order to facilitate the efficiency in communications and cost savings in submissions and correspondence for both EPA and respondents, EPA has incorporated the following data elements into the reporting tool.
1.  Submission Type
Identifies the submission, including the type of submission and whether it is the initial submission, a follow-up or a final report.
2.  Summary of Attachment
Allows the respondent to provide a summary or abstract of the attached study or report, any internal company tracking number, an EPA tracking number, and an indication of the number of studies submitted.
3.  Chemical Identification 
Identifies the chemical(s) addressed in the submission.
4.  Title of Attachment 
Identifies the title of the attached study or report.
5.  Indexing Terms
Allows the respondent to identify the proper terms to use for indexing purposes, which facilitates the search and retrieval of the information.
6.  Submitter Information
Identifies the submitter and/or technical contact, including name, title, company, mailing address, phone and e-mail address.
7.  Comments
Allows the submitter to provide any additional comments, so as to avoid the need for or use of a separate cover letter.

To further facilitate more efficient reporting and industry-EPA cooperation, the indexing terms are now aligned with the international standards developed by the Organisation of Economic Cooperation and Development (OECD) for reporting chemical test summaries. A crosswalk between the former TSCA Voluntary Cover Sheet indexing terms and the OECD standards, known as the OECD Harmonised Templates (http://www.oecd.org/ehs/templates/) is provided in Attachment 2. These indexing terms will be updated periodically to correspond to the most recent standards developed by the OECD. 
EPA staff will be the primary users of the standardized meta-data. EPA employees will use the meta-data collected through CDX to identify the submission when it reaches EPA without having to examine portions of a submission that may be very lengthy and complex, and to subsequently use the information to distribute, locate and track the submission as the submission moves through Agency reviews and decision points, to index the data, and to identify the data within EPA databases in making the data publicly available.
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.
There is no other source of data that can be used in place of the data submitted to EPA under the section 8(e) statutory reporting requirement. The "substantial risk" information required to be reported to EPA is unpublished information not already known to the Agency. In addition, information need not be submitted under section 8(e) if the information has been reported already to EPA pursuant to another mandatory information reporting requirement of TSCA or some other authority administered or delegated to the States by EPA. In the June 2003 Reporting Guidance, the Agency clarified the circumstances under which certain information need not be reported to EPA under section 8(e). This was expected to reduce some of the respondent reporting burden for section 8(e).
If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.
The statutory obligation to report information under section 8(e) of TSCA applies to all manufacturers, importers, processors, and/or distributors of TSCA-covered chemical substances and mixtures. The statutory language of section 8(e) itself does not allow for any reporting exemption or burden minimization based on the size or earnings of a respondent. However, nearly all reporting is by large and medium size companies. This is mainly because only larger companies have the financial resources to conduct toxicity testing that comprises most section 8(e) reporting. Since there is no routine reporting or recordkeeping provisions for section 8(e), the true burden on most small entities is practically nonexistent.
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.
Section 8(e) reporting is not cyclical but rather is self-implementing. The statute states that persons covered under the section 8(e) reporting requirement shall immediately notify the EPA Administrator upon obtaining reportable information. As stated previously, section 8(e) continues to be an extremely important and useful EPA tool for early identification of potential substantial risk situations and allows the Agency as well as others to focus their resources on those chemicals or mixtures of highest concern. The consequences of EPA's not receiving section 8(e) data immediately following receipt by a respondent are serious. The Agency would be prevented from learning about and publicizing new information about substantial risks to health or environmental injury posed by exposure to chemical substances and/or mixtures. Further, EPA would not be in a position to adequately assess and, if necessary, take action to effectively eliminate or reduce such risks in an expeditious manner.
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   Explain any special circumstances that require the collection to be conducted in a manner: 
 requiring respondents to report information to the agency more often than quarterly; 
 requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it; 
 requiring respondents to submit more than an original and two copies of any document; 
 requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years; 
 in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;
 requiring the use of a statistical data classification that has not been reviewed and approved by OMB; 
 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
 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. 
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.
Pursuant to 5 CFR 1320.8(d) in proposing to renew this ICR, EPA will publish a notice in the Federal Register that will provide a 60-day public comment period. The comments received and any additional public comment for this action will be posted in the docket. 
As required under 5 CFR 1320.8(d)(1), in addition to the public notice in the Federal Register, EPA staff will contact appropriate stakeholders and ask them for their assessment of the regulatory burden estimates expressed by the Agency in this ICR. A summary of these consultations will be provided in the supporting statement during the second comment period. 
Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.
Not applicable. 
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.
Any person submitting a notice to EPA under section 8(e) may assert a claim of business confidentiality covering information contained in the submission. Any information covered by a claim will be disclosed by EPA only to the extent and by means of the procedures set forth at 40 CFR Part 2. If no confidentiality claim accompanies a section 8(e) notice, the submission is placed in the TSCA Docket and is available to the public without further notice to the submitting organization. The Agency has established and actively implements well-publicized standard procedures for the handling and safeguarding of information claimed as TSCA Confidential Business Information (TSCA CBI).
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.
Under section 8(e), EPA does not seek submission of information of a sensitive nature.
Provide estimates of the hour burden of the collection of information. The statement should: 
 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.
If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens. 
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'.  
A statutory section 8(e) reporting obligation can be incurred by any person who manufactures, imports, processes or distributes a TSCA-covered chemical substance or mixture. EPA's Section 8(e) Policy Statement defines the term "person" broadly to include "any natural person, corporation, firm, company, joint-venture, partnership, sole proprietorship, association, or any other business entity, any State or political subdivision thereof, any municipality, any interstate body and any department, agency, instrumentality of the Federal Government."  Although this definition is quite broad in terms of subject persons, section 8(e) reporting obligations are most typically incurred by companies engaged in activities classified by the North American Industrial Classification System (NAICS) Codes 325 - Chemicals and Allied Products Manufacturers and 32411- Petroleum and Coal Products Manufacturing.
There is no required collection instrument or reporting form on which section 8(e) information must be submitted to EPA; however, the Section 8(e) Policy Statement requires all respondents to ensure that a written section 8(e) notice:
 is sent to EPA by a method verifying the Agency's receipt;
 states that it is being submitted under section 8(e) of TSCA;
 contains the name, address, job title, phone number and signature of the person reporting, and the name and address of the establishment with which the person is associated;
 identifies the chemical substance(s) or mixture including, if known, the Chemical Abstract Service (CAS) Registry Number(s);
 summarizes adverse health/environmental effects being reported including a description of the nature and extent of the risk; and
 contains the specific source/summary of the supporting data.
         
EPA is continuing its efforts to implement optional electronic reporting of section 8(e) submissions and FYIs to increase processing efficiency for both the Agency and the regulated community. With the TSCA e-reporting initiative in place for other information collections, submitters of section 8(e) information have taken advantage of the new reporting option with virtually all reports submitted via CDX. The option to submit section 8(e) notices and FYIs electronically using the CIS reporting tool and electronic submission via CDX changes the way that companies interact with the Agency. Companies are registered with EPA to submit their data electronically to the Agency via CDX and the Agency in turn is able to communicate back electronically with submitters. This promotes efficiency in communications and cost savings in submissions and correspondence. EPA believes the adoption of electronic communications reduces the reporting burden on industry by reducing both the cost and the time required to review, edit and transmit data to the Agency. All information sent via CDX is transmitted securely to protect CBI. Furthermore, if anything in the submission has been claimed CBI, a sanitized copy of the notice must be provided by the submitter. The Agency also benefits from receiving electronic submissions. Data systems that previously were populated manually are now populated electronically, reducing the potential for human error that exists when data are entered by hand. Agency personnel are also able to communicate more efficiently with submitters electronically, compared to using U.S. mail. 
The overall purpose of section 8(e) reporting is to ensure that new information that reasonably supports a conclusion that a chemical substance or mixture presents a "substantial risk" of injury to health or the environment is brought to EPA's attention immediately upon discovery. It should be noted again that section 8(e) applies to all chemical manufacturers, importers, processors, and distributors and applies also to information that a subject person possesses or about which that person has knowledge. Although compliance with section 8(e) does not require subject persons to search for information or to make extraordinary efforts to acquire information, section 8(e) does apply to information that is "obtained" (i.e., information that a person possesses or about which that person knows). Following a review of existing information and a decision that such information is of the type required under section 8(e), respondents must notify EPA in writing immediately. EPA's June 2003 Reporting Guidance defines the term "immediately" in the context of written section 8(e) reports to mean within 30 calendar days of the date on which the information was obtained; the immediate reporting of an emergency incident of environmental contamination by a toxic substance is defined as a phone report to EPA or to the National Response Center as soon as a person knows about the incident.
Considering that section 8(e) submissions are received by the Agency on an ad hoc basis, there is no standard reporting cycle. Submitters are required to comply with section 8(e) immediately when they come into possession of or know about section 8(e)-reportable information. If section 8(e) information were not made available immediately to EPA, the Agency's ability to learn about, publicize, effectively assess, and respond appropriately to newly discovered chemical-related risks would be severely impeded, if not completely thwarted.
TSCA section 8(e) submissions: 
Pursuant to TSCA section 8(e)(15 U.S.C. 2607(e)), "Any person who manufactures, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information."
FYI voluntary submissions 
EPA has received FYI submissions covering a wide variety of chemical substances and mixtures from chemical companies, trade associations, unions, public interest groups, civic associations, private citizens, academic institutions, state and other federal agencies, as well as similar organizations and agencies in foreign countries. These submissions contain information on human exposure, epidemiology, toxicity test results, monitoring studies, environmental fate, and other information that may be important to risk assessment.
FYI submissions are often submitted to the Agency when a person or company that is not required to submit would like to bring information on a chemical to EPA's attention. Chemical companies, trade associations, public interest groups, and academic institutions are among those who submit FYIs. These entities who wish to submit information to the Agency electronically will have to register with CDX or otherwise submit information by paper. 
In addition, FYI submissions are submissions from a classification system that was established by EPA to distinguish voluntary submissions from "substantial risk" notices submitted formally to EPA under section 8(e), discussed above. The FYI classification was created by EPA to capture submissions by persons or organizations not subject to the reporting requirements, but who wished to inform EPA of a potential risk.
As stated earlier in this document, the majority of  submissions are being received in electronic format. Therefore estimates still account for some paper submission as described below 
8(e) Submissions 
EPA estimates that it should take approximately 49 hours per submission to judge and concur on the section 8(e)-applicability of obtained information and to prepare and submit the necessary information. This figure is based on an average of 45 hours per submission of managerial staff time to review and evaluate data and an additional 4 hours for staff training on section 8(e) regulatory requirements. Additionally, the unit burden for recordkeeping is estimated at 1.06 hours of clerical staff time for electronic 8(e) submissions and 2 hours for paper submissions.  
To quantify the number of submissions for the current ICR renewal, EPA utilizes data on the number of section 8(e) submissions for calendar years 2018 through 2021. The average annual number of section 8(e) submissions is 343, comprised of 281 electronic and 62 paper submissions, as computed to provide the annual basis for this ICR renewal. Table 2 provides a summary of estimates for unit burden and the annual burden associated with the mandatory section 8(e) submissions.
Voluntary FYI Submissions 
EPA believes that the burden associated with filing a voluntary FYI submission is on par with the burden related to filing a mandatory submission because the voluntary submissions usually contain information on human exposure, epidemiology, toxicity test results, monitoring studies, environmental fate, and other information that may be pertinent to risk assessment.  Therefore, the burden associated with filing an FYI submission in paper is also estimated at an average of 45 hours per submission of managerial staff time to review and evaluate data plus an additional 4 hours for staff training on section 8(e) regulatory requirements. Additionally, the unit burden for recordkeeping is estimated at 1.06 hours of clerical staff time for FYI submissions and 2 hours for paper submissions. 
To quantify the number of submissions for the current ICR renewal, EPA utilizes data on the number of FYI submissions for calendar years 2018 through 2021. The average annual number of initial FYI submissions is 6, comprised of 3 electronic and 3 paper submission, as computed to provide the annual basis for this ICR renewal. Table 2 provides a summary of estimates for unit burden and the annual burden associated with the voluntary FYI submissions.
Table 2: Section 8(e) and FYI Submission Unit and Total Burden
                                   Activity
                                     Mode
                  Hours per Submission                       
                              Unit Burden (hours)
                              Number of Responses
                             Number of Respondents
                              Total Annual Burden
 

Managerial
Technical
Clerical
 
 
 
 
Section 8(e) submission
                                  Electronic
                                                                             49
                                                                              0
                                                                           1.06
                                                                          50.06
                                                                            281
                                                                             25
                                                                         14,067

                                     Paper
                                                                             49
                                                                              0
                                                                              2
                                                                             51
                                                                             62
                                                                              9
                                                                          3,162
Subtotal Section 8(e)
                                       
                                                                               
                                                                               
                                                                               
                                                                               
                                                                            343
                                                                             34
                                                                         17,229
FYI submission
                                  Electronic
                                                                             49
                                                                              0
                                                                           1.06
                                                                          50.06
                                                                              3
                                                                              1
                                                                            150

                                     Paper
                                                                             49
                                                                              0
                                                                              2
                                                                             51
                                                                              3
                                                                              1
                                                                            153
Subtotal FYI

                                                                              6
                                                                              2
                                                                            303
TOTAL

 
 
 
 
                                                                            349
                                                                             36
                                                                         17,532

CDX Registration Activities to Enable Electronic Reporting
EPA estimates that technical staff at companies submitting section 8(e) notices and FYIs would incur the following one-time burden to complete CDX registration activities (including obtaining a CDX electronic signature). Some section 8(e) and FYI submitters may already have registered to use the e-TSCA web reporting tool in CDX (and obtained an accompanying electronic signature) in order to comply with the mandatory electronic reporting requirements of EPA's e-PMN rule (EPA, 2015). Those submitters will not need to repeat the CDX registration and e-signature process in order to file section 8(e) and FYI notices. While there may be some overlap in the specific individuals that have already completed CDX activities, EPA is using a conservative assumption that all submitters who will file electronically will need to register with CDX and, thus, incur associated burdens. This assumption may overestimate the burdens and costs actually experienced by respondents. The one-time CDX burden includes the following:
CDX registration:  Based on the TSCA section 5 ICR renewal, EPA assumed that companies would spend about 15 to 20 minutes per technical employee to register with CDX (EPA, 2021). This results in an average estimate of 17 minutes to complete registration.
CDX electronic signature (labor burden)  -  Based on the TSCA section 5 ICR renewal, EPA assumed that companies' technical staff would spend 21 minutes preparing, submitting and filing an electronic signature agreement (Authentication of Identity) form to EPA, per employee (EPA, 2015). 
To estimate the number of CDX registrants who will submit 8(e) and voluntary FYI submissions, EPA averages the total number of distinct section 8(e) and FYI submitters for submissions for calendar years 2018, 2019, 2020, and 2021 to obtain the average of 51 annual registrations for the basis of this ICR renewal. Table 3 provides a summary of estimates for unit burden and the annual burden associated with CDX registrations. 

Table 3: Estimated Annual Burden Associated with CDX Registration Activities
                                   Activity
                         Estimated Hours per Response
                              Unit Burden (hours)
                              Number of Responses
                    Estimated Number of Annual Respondents 
                                 Annual Burden

                                  Managerial
                                   Technical
                                   Clerical
                                       

CDX Registration
                                                                              0
                                                                           0.29
                                                                              0
                                                                           0.29
                                      51
                                      51
                                                                             15
CDX E-Signature
                                                                              0
                                                                           0.35
                                                                              0
                                                                           0.35

                                                                             18
TOTAL
                                                                              0
                                                                           0.64
                                                                              0
                                                                           0.64
                                      51
                                      51
                                                                             33

Based on the figures presented in the preceding tables, the total estimated number of annual section 8(e) and FYI responses and CDX registrations is 400. The industry reporting burden totals 17,565 hours (See also Table 5). Respondents continue to make paper submissions, which comprise 19% of all submissions. 
Non-labor costs include a $0.58 stamp and a $0.02 standard business envelope for each of five required electronic signature agreements (USPS, 2020). The total non-labor cost for electronic signature agreements equals $2.85. This amounts to $145 in non-labor costs per year, and is shown in Table 5.
EPA estimates submitter costs using burden estimates above along with labor rates obtained from the Bureau of Labor Statistics (BLS). Table 4 presents the derivation of the loaded industry wage rates used in this analysis. The wages and fringe benefits for the Managerial, Technical, and Clerical labor categories are drawn from the BLS "Employer Costs for Employee Compensation Supplementary Tables Historical Data" for December 2020 (BLS, 2021). For each labor category, wages are loaded using fringe benefit rate from BLS plus a 20 percent overhead rate Attachment 4. 
In Table 5, the unit burden estimates from the previous sections are combined with the wage rates in Table 4 to compute unit costs (per response) and total costs. Overall, the submissions costs associated with the burden of 17,565 hours totals $1,635,247.
Table 4: Industry Wage Rates (2020$)
Labor Category
Data Sources a
Date
Wage
Fringe Benefit
Total Compens-ation
Over-head % of Total Compens-ation [b]
Overhead
Hourly Loaded Wages [c]

(a)
(b)
(c) =(a)+(b)
(d)
(e)=(c)*(d)
(f)=(c)+(e)
Managerial
BLS ECEC, Private Manufacturing industries, "Mgt, Business, and Financial"
Dec-20
                                    $54.32
                                    $24.46 
                                    $78.78 
                                      20%
                                    $15.76 
                                    $94.54 
Professional / Technical
BLS ECEC, Private Manufacturing industries, "Professional and related"
Dec-20
                                    $44.63 
                                    $22.45 
                                    $67.08 
                                      20%
                                    $13.42 
                                    $80.50 
Clerical
BLS ECEC, Private Manufacturing industries, "Office and Administrative Support"
Dec-20
                                    $20.86 
                                    $9.62 
                                    $30.48 
                                      20%
                                    $6.10 
                                    $36.58 
Footnotes
[a] Source: Employer Costs for Employee Compensation Supplementary Tables: December 2006  -  December 2020 (U.S. Bureau of Labor Statistics, 2021).
[b] 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 (EPA 2020)
c Wage data are rounded to the closest cent in this analysis.

Table 5: Industry Annual Reporting Costs (2020$)
Activity
Mode
                              Unit Burden (hours)
                          Weighted Average Wage Rate
                           Unit Cost (per response)
                              Number of Responses
                             Number of Respondents
                              Annual Burden Hours
                                  Annual Cost
                                 Section 8(e)
                                  Electronic
                                                                          50.06
                                                                        $93.31 
                                                                         $4,671
                                                                            281
                                                                             25
                                                                         14,067
                                                                     $1,312,579

                                     Paper
                                                                             51
                                                                         $92.27
                                                                         $4,706
                                                                             62
                                                                              9
                                                                          3,162
                                                                       $291,758
Subtotal Section 8(e)
                                       
                                                                               
                                                                               
                                                                               
                                                                            343
                                                                             34
                                                                         17,229
                                                                     $1,604,337
                                      FYI
                                  Electronic 
                                                                          50.06
                                                                        $93.31 
                                                                         $4,671
                                                                              3
                                                                              1
                                                                            150
                                                                        $14,013

                                     Paper
                                                                             51
                                                                         $92.27
                                                                         $4,706
                                                                              3
                                                                              1
                                                                            153
                                                                        $14,117
Subtotal FYI
                                       
                                                                               
                                                                               
                                                                               
                                                                              6
                                                                              2
                                                                            303
                                                                        $28,130
CDX Registration
                                      N/A
                                                                           0.29
                                                                        $80.50 
                                                                            $23
                                                                             51
                                                                             51
                                                                             15
                                                                         $1,197
CDX E-Signature
                                      N/A
                                                                           0.35
                                                                        $80.50 
                                                                            $28
                                                                               
                                                                               
                                                                             18
                                                                         $1,437
CDX E-Signature non-labor
                                      N/A
                                                                            N/A
                                                                            N/A
                                                                          $2.85
                                                                               
                                                                               
                                                                            N/A
                                                                           $145
Subtotal CDX 
                                       
                                                                               
                                                                               
                                                                               
                                                                             51
                                                                             51
                                                                             33
                                                                         $2,779
Total
                                       
                                                                               
                                                                               
                                                                               
                                                                            400
                                                                             51
                                                                         17,565
                                                                     $1,635,246

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).
 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.
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.
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 is no operational or maintenance costs associated with this collection. 
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.
As explained in additional detail in the following sections, the Agency's section 8(e) activities involve answering general and specific section 8(e)-related questions, development and maintenance of computerized information tracking (including data extraction, entry and quality assurance/control), microfilming, confidential (restricted-access) and non-confidential (public-access) section 8(e) information filing, initial evaluation of all submitted section 8(e) information (including review of TSCA CBI substantiations), and the posting of section 8(e)-related information on the Internet for public access.
EPA will continue to use case numbers to identify section 8(e) submissions through the format: 8EHQ-YYMM-XXXX. Previously issued case numbers will remain the same, such as initial submissions were assigned as Sequence A; study amendments were assigned Sequence B, C, D, etc. Internal EPA tracking of section 8(e) submissions will still be handled via non-confidential and confidential computerized data bases.
In order to assure that the public is kept apprised of new adverse chemical-related toxicity and exposure information, the Agency provides public access to and actively disseminates non-confidential section 8(e) submission information in many ways. Examples of EPA's public access/outreach activities follow.
Non-confidential 8(e) and FYI  submissions, status reports, submission summaries, and EPA follow-up letters can be viewed/copied in EPA's Chemview database at http://java.epa.gov/chemview.
Under established Freedom of Information Act (FOIA) procedures, EPA responds to requests from industry, other stakeholders and the public. In cooperation with OECD's information-gathering "Switchboard" project, EPA responds as well to international requests for section 8(e) and other unpublished health and safety data on chemicals of concern to OECD members.
As stated previously, EPA routinely notifies other federal agencies on incoming section 8(e) information via biweekly tabular reports of new section 8(e) submissions and by targeted referrals. As the direct result of these public outreach activities, several of these other agencies actively publicize the information even further. For example, the National Library of Medicine (NLM) at the National Institutes of Health makes section 8(e) information available via its publicly available computerized Hazardous Substances Data Bank (HSDB) and Toxline data bases. In addition, the National Institute for Occupational Safety and Health (NIOSH) cites section 8(e) notices in the printed and on-line computerized versions of the "Registry of Toxic Effects of Chemical Substances" (RTECS) data base.
For this ICR, EPA estimates that a GS-13, Step 5, staff member spends 7.1 hours to initially review, process, and/or answer questions on each electronic submission. EPA also estimates the time to process, copy, and file paper submissions in addition to the tasks described for electronic submissions results in an average of 8.5 hours. The Agency wage rate is presented in Table 6.  Given 281 Section 8(e) and 3 FYI electronic submissions, yielding 284 total electronic submissions, with each requiring 7.1 hours of EPA staff time, annual agency burden is 2,016 hours. In addition, given 62 Section 8(e) and 3 FYI paper submissions, yielding 65 total paper submissions, with each requiring 8.5 hours of EPA staff time, annual agency burden is 553 hours. Total annual agency burden is 2,569 hours.  Applying the agency wage rate in Table 6 yields annual agency costs at $281,691 (see also Table 1).
Table 6: Agency Wage Rate (2020$) 
                                Labor Category
                       Data Source for Wage Information
                                 Wage ($/hour)
                             Fringes as % wage[b]
                                Fringe Benefit
                              Total Compensation
                      Overhead as % total compensation[c]
                                   Overhead
                              Loaded Wage ($/hr)

                                      (a)
                                      (b)
                                 (c) = (a)*(b)
                                 (d) = (a)+(c)
                                      (e)
                                (f) = (d)*(e) 
                                 (g) = (d)+(f)
EPA staff
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-13 Step 5 pay rates [a]
                                    $55.75 
                                    63.90%
                                                                        $35.62 
                                    $91.37 
                                      20%
                                    $18.27 
                                   $109.65 

                                       
Footnotes:

[a] Source: U.S. Office of Personnel Management. (2020). Salary Table 2020-DCB. Retrieved June 17, 2020 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/20Tables/html/DCB_h.aspx.

[b] Source: Falk, J. 2012. "Comparing Benefits and Total Compensation in the Federal Government and the Private Sector." Congressional Budget Office Working Paper Series. https://www.cbo.gov/sites/default/files/112th-congress-2011-2012/workingpaper/2012-04fedbenefitswp0.pdf

[c] 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 (EPA 2020).

Explain the reasons for any program changes or adjustments reported in hour or cost burden.
This request represents a decrease in industry reporting burden of 3,847 hours from that currently in the OMB inventory (from 21,412 to 17,565 hours). This reflects an overall decrease in the number of section 8(e) and FYI submissions, which decreased from 408 to 343 submissions and 13 to 6 submissions respectively. 
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. 
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. 
Explain each exception to the certification statement identified in "Certification for Paperwork Reduction Act Submissions."
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. 2070-0046). Responses to this collection of information are mandatory for certain persons, as specified at 15 USC 2607(e). 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 50 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.
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-2015-0744.
Ref.
Title (hyperlink)
1.
15 U.S.C. 2607(e) 
2. 
OECD Harmonized Templates 
3. 
CDX User Guide
4
Wage Rates

List of References 
U.S. Bureau of Labor Statistics (BLS). 2021, Employer Costs for Employee Compensation Supplementary Tables: December 2006  -  December 2020. Accessed March 18, 2021. Available at:  https://www.bls.gov/web/ecec/ecsuphst.pdf. 
US EPA. 2015. Information Collection Request (ICR): Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances. EPA ICR No: 0574.15. OMB Control No: 2070-0012. Available at https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2014-0735-0016 (posted October 5, 2015).
US EPA. 2021. About CDX System Information. Accessed December 27, 2021. Available at https://cdx.epa.gov/About/AboutSystemInformation#REG2.
US Postal Service. 2020. U.S. Postal Service Announces New Prices for 2020.
	Accessed January 6, 2022. Available at 	https://about.usps.com/newsroom/national-releases/2019/1009-usps-announces-	new-prices-for-2020.htm.