Supporting Statement for a Request for OMB Review under

The Paperwork Reduction Act

1 IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title and Number of the Information Collection

Title: Notification of Substantial Risk of Injury to Health and the 

Environment under TSCA Section 8(e)

EPA ICR No.: 0794.13 OMB Control No.: 2070-0046

1(b) Short Characterization

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)

From January 1977 through December 2008, EPA received 17,233 initial section 8(e) 

submissions covering a large number of chemical substances and mixtures on a wide range of 

chemical toxicity/exposure information. This includes approximately 10,500 submissions EPA 

received following a 1992 Compliance Audit Program, described below in Part 2(a). Although 

EPA’s receipt of 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.

OPPT routinely disseminates section 8(e) data to EPA’s Program and Regional Offices 

and other federal agencies (e.g., NIOSH, OSHA, CPSC, FDA, NTP) on newly discovered 

chemical hazards/risks. Since June 2001, OPPT has made these referrals primarily via e-mails of 

biweekly tables summarizing all new section 8(e) submissions. There is also public outreach and 

information access to section 8(e) data through the TSCA Public Docket, online data bases that 

include TSCA 8(e) records, as well as through the TSCA 8(e) web page that includes all 

biweekly reports of new 8(e) submissions back to June 2001 with PDF links to the submissions.
2 NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

Section 8(e) of TSCA 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 (U.S. 

Public Law 94-469; 90 Stat. 2029; 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” to further 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 is 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) of TSCA. 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 on the TSCA 8(e) 

web page (http://www.epa.gov/oppt/tsca8e) 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, but EPA will be adding Q&As to the TSCA 8(e) 

web page on environmental releases and other aspects of section 8(e) reporting following further 

comment and review.

2(b) Use/Users of the Data

Since 1977, the Agency and members of the chemical industry have devoted significant 

efforts in fulfilling their respective responsibilities under section 8(e). Since January 1, 1977, 

16,063 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 

have been received by the Agency, screened, and received follow-up attention as needed.

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 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, 

in the SIDS international testing program, in the High Production Volume (HPV) Challenge 

Program, 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, general public, international community) that 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 the TSCATS database, the TSCA docket, and the 

TSCA section 8(e) web page at http://www.epa.gov/opptintr/tsca8e. The TSCA 8(e) web page 

includes all published section 8(e) guidance and full text copies of all new section 8(e) 

submissions.

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.

3 NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION 

CRITERIA

3(a) Non-Duplication

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 3, 

2003 Reporting Guidance, the Agency clarified the circumstances under which certain 

information need not be reported to EPA under section 8(e) of TSCA. This is expected to result 

in some additional reduction of the overall respondent reporting burden for section 8(e).

3(b) Public Notice Required Prior to ICR Submission to OMB

Prior to submission to OMB, this ICR will be made available to the public for comment 

through a Federal Register notice. The public will have 60 days to provide comments. Any

comments received will be given consideration when completing the supporting statement that is 

submitted to OMB.

3(c) Consultations

EPA personnel have participated in numerous public meetings and other fora to discuss 

the section 8(e) Policy Statement and the Agency’s implementation of section 8(e). Large EPAsponsored public meetings at which section 8(e) was a primary topic of discussion were held in 

1978, 1986, 1987, 1990 and 1992 with chemical industry representatives and other interested 

parties. EPA staff also met on numerous occasions with members of the chemical industry to 

discuss section 8(e) in the context of the section 8(e) Compliance Audit Program. In addition, 

EPA staff members have participated in more than 30 industry-sponsored meetings at which 

section 8(e) of TSCA was the major or primary topic of discussion.

EPA proposed amendments to the section 8(e) policy statement in 1993 and again in 

1995. The proposed amendments dealt specifically with clarifications on reporting requirements 

for occurrences of environmental exposure or contamination. The Agency received numerous 

public comments on these proposed amendments and developed a “Comment and Response 

Document for Revised Policy Statement of Section 8(e) of TSCA” (OPPT-2002-0067-0002) to 

record these comments and the Agency’s responses. EPA has also collaborated with industry in 

preparing a question and answer document dealing with revisions to the 1978 Policy Statement 

and from 1994 to the present section 8(e) has been on the agenda of the “Living with TSCA” 

conferences held annually for all TSCA stakeholders.

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 original or 

renewal ICR to OMB for review and approval. In accordance with this regulation, EPA will 

pursue additional consultations with interested parties during the development of the renewal of 

this collection.

3(d) Effects of Less Frequent Collection

TSCA 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.

3(e) General Guidelines

The required reporting that takes place under section 8(e) does not appear to exceed the 

Paperwork Reduction Act-imposed guidelines that are found at 5 CFR 1320.6.

3(f) Confidentiality

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).

3(g) Sensitive Questions

Under section 8(e), EPA does not seek submission of information with regard to sexual 

behavior or attitudes, religious beliefs, or other matters usually considered to be of a private 

nature.

4 RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents/NAICS Codes

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 NAICS 

Codes 325 - Chemicals and Allied Products Manufacturers and 32411- Petroleum Refining.
4(b) Information Requested

(i) Data Items

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 to increase processing efficiency for both the Agency and the regulated community.

(ii) Respondent Activities

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.
5 INFORMATION COLLECTION - EPA ACTIVITIES, COLLECTION 

METHODOLOGY AND INFORMATION MANAGEMENT

5(a) Agency Activities

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 (publicaccess) section 8(e) information filing, initial evaluation of all submitted section 8(e) information 

(including review of TSCA Confidential Business Information (CBI) substantiations), and the 

posting of section 8(e)-related information on the Internet for public access.

5(b) Collection Methodology and Information Management

EPA uses Document Control Numbers (DCNs) to identify TSCA submissions; section 

8(e) has the following format: 88-YYXXXXXXX. The assigned 7-digit ascending numbers 

begin each year with 0000001. EPA also identifies section 8(e) submissions by 8EHQ Numbers, 

which are chronological from January 1977. The format is 8EHQ-MMYY-XXXXX. Initial 

submissions are assigned as Sequence A; supplemental and follow-up submissions are assigned 

Sequence B, C, D, etc. Internal EPA tracking of section 8(e) submission information is 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 nonconfidential section 8(e) submission information in many ways. Examples of EPA’s public 

access/outreach activities follow.

Non-confidential section 8(e) initial and follow-up/supplemental submissions, status 

reports, submission summaries, and EPA follow-up letters can be viewed/copied in the TSCA 

Public Docket located at EPA Headquarters. Non-confidential section 8(e)-related documents 

can also be obtained by writing to EPA’s Freedom of Information Office.

Relevant non-confidential information from section 8(e) submissions is routinely entered 

into TSCATS (Toxic Substances Control Act Test Submissions), a publicly available 

computerized data base that serves as an on-line index of unpublished health and safety studies 

submitted to EPA under TSCA. The most recent version of the TSCATS data base is available 

on the web at http://yosemite.epa.gov/oppts/epatscat8.nsf/ReportSearch?OpenForm. The 

submitted studies themselves are stored and available on microfiche. Microfiche copies of the 

studies referenced in the TSCATS database are available from either CIS or the National 

Technical Information Service (NTIS) in Springfield, VA. EPA has also been creating full 

electronic (PDF) copies of all new section 8(e) submissions since June 2001. Electronic copies 

of these most recent section 8(e) submissions are available to the public from the TSCA Public 

Docket, as well as from the section 8(e) web site at http://www.epa.gov/oppt/tsca8e. 
Under established Freedom of Information Act (FOIA) procedures, EPA responds to 

requests from industry, other stakeholders and the public. And in cooperation with the 

Organization for Economic Cooperation and Development’s (OECD) 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.

5(c) Small Entity Flexibility

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.

5(d) Collection Schedule

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.

6 ESTIMATING THE BURDEN AND COST OF COLLECTION

For the current ICR renewal, EPA utilized data on the number of section 8(e) 

submissions for fiscal years FY 2009-2011. The averaged annual number of initial 8(e) 

submissions was 364 (392+413+286=1,091/3). The averaged annual number of supplemental 

and follow-up 8(e) submissions was 179 (136+114+288=538/3).

In the previous ICR renewal, it was determined that for initial section 8(e)s, submission 

equivalents were also estimated to account for the need to review data that are not ultimately
submitted as TSCA 8(e). For initial section 8(e)s, the number of submission equivalents is used 

instead of the number of actual submissions. Assuming that the number of cases not submitted is 

50% of the number of cases submitted, the number of initial section 8(e) submission equivalents 

per year for the next three years increases from 364 to 546 (364 x 1.5).

6(a) Estimating Submitter Burden

The following discussion provides the basis for the Agency’s upper-bound estimate of 

approximately 28,741 total hours of annual reporting burden for submitters in complying with 

section 8(e).

EPA believes that it should take approximately 49 hours per submission to judge and 

concur on the section 8(e)-applicability of obtained information plus 2 additional hours to 

prepare/submit the necessary information. The first figure is based on an average of 45 hours per 

submission of managerial and technical staff time to review and evaluate data and an additional 4 

hours for staff training on TSCA 8(e) regulatory requirements. Using the calculated average of 

546 initial section 8(e) submission equivalents per year, the total number of hours required for 

initial section 8(e) reporting is estimated to be 27,846 (546 x 51) hours.

The submission of follow-up/supplemental information in response to EPA questions on 

the initial section 8(e) submission, or as a result of further investigation/evaluation by the 

company, is estimated to be 5 hours per notice, assuming 3 hours to assemble the required 

information, 1 hour to prepare the submission, and 1 hour for review. Using the calculated 

average of 136 follow-up/supplemental submissions per year, the total number of hours required 

for follow-up/supplemental section 8(e) reporting is estimated to be 895 (179 x 5) hours. 

Therefore, the total number of section 8(e) initial submission equivalents plus followup/supplemental submissions is 725 (546 + 179) submissions per year with an estimated 

respondent reporting burden of 28,741 (27,846 + 895) hours per year.

INITIAL SUBMISSIONS SUBTOTAL

Burden Item Hours/Submitter Submissions/Year Hours/Year

a

1

49 546 26,754

b

2

2 546 1,092

27,846

1 Reflects managerial/technical review, data evaluation, decision-making and concurrence processes to 

determine the section 8(e)-reportability and crafting the usually 1-2 page section 8(e) notification letter.

2 Reflects general clerical work (typing, copying, and sending the section 8(e) submission).

Considering that the respondent’s decision-making/concurrence activities for determining 

section 8(e)-applicability/reportability has already taken place for the initial submission, the 

activities surrounding the submission of follow-up/supplemental information related to the initial 

submission are viewed by the Agency as being less burdensome as follows:
FOLLOW-UP AND SUPPLEMENTAL SUBMISSIONS SUBTOTAL

Burden Item Hours/Submitter Submissions/Year Hours/Year

a

1

4 179 716

b

2

1 179 179

895

1 This item involves managerial and technical review, concurrence and letter writing activities in 

submitting a follow-up/supplemental section 8(e) submission.

2 This item reflects the typing, copying and transmittal of a follow-up/supplemental section 8(e) 

submission.

Based on the figures presented in the preceding tables, the total submitter burden (in 

hours/year) for initial and follow-up/supplemental section 8(e) submissions to EPA is as follows:

TOTAL HOURLY BURDEN/YEAR

 Initial Follow-Up/Supplemental Total

Submissions + Submissions = Hours/Year

27,846 hours/year + 895 hours/year = 28,741

6(b) Estimating Submitter Costs

EPA estimates that a respondent incurs costs up to $69.21/hour in managerial/technical 

labor costs and $27.59/hour in clerical labor costs in submitting information to EPA under 

section 8(e). These hourly costs take into account the involvement of the respondent’s 

managerial, technical and clerical personnel and takes into account standard labor wage rates 

(including fringe benefits) using Bureau of Labor Statistics (BLS) wage rates for the Private 

Manufacturing industries adjusted for the year 2011. It should be noted that section 8(e) 

reporting does not involve operating/maintenance or capital costs to the respondent. The hourly 

labor wage rates used in the computations appear below.

Hourly Labor Rates *

Labor Category 2007 Hourly Rate

Managerial $ 69.21

Technical $ 55.42

Clerical $ 27.59

EPA staff $ 68.99

*See Appendix A for derivations.
Based on the total estimated reporting burden of 28,741 hours/year and the hourly labor 

rates listed above, the annual cost for submitters to comply with section 8(e) is estimated to be 

$1,936,264 as follows.

TOTAL ANNUAL COSTS

Burden 

Item

Submitter 

Hours/Year 

(Initial)

Submitter Hours/Year 

(Supplemental)

Total 

Hours/Year

Wage 

Rate

Total 

Cost/Year

a

1

26,754 716 27,470 $69.21/hr $1,901,197

b

2

1,092 179 1,271 $27.59/hr $35,067

$1,936,264

1 Reflects managerial/technical review, data evaluation, decision-making and concurrence processes to 

determine the section 8(e)-reportability and crafting the usually 1-2 page section 8(e) notification letter.

2 Reflects general clerical work (typing, copying, and sending the section 8(e) submission).

6(c) Estimating EPA Burden and Costs

Based on reasonable costs for reports received by EPA as the result of general section 8 

rule-making activities, EPA estimates the cost per submission can range from $275 to $900. This 

assumes that it takes a GS-13 Step 5 staff member between 4 and 13 hours to process, copy, file, 

and initially review and/or answer questions on each section 8(e) submission (4 * $68.99 and 13 

* $68.99). Therefore, EPA estimates its total annual cost for these activities involving 725

incoming section 8(e) submissions (546 initial plus 179 follow-up/supplemental notices per year) 

to range from $198,275 - $648,900 per year as follows:

EPA BURDEN/COSTS

Initial/Follow-Up/Supplemental Cost of EPA Total

 Submissions per Year x Processing/ Review = Cost/Year

 

 725 submissions/year x $275-$900/Submission = $199,375 - $652,500/year

6(d) Bottom Line Burden Hours and Costs

General note: A full discussion and description of the rationale used to derive the 

following burden estimates can be found in sections 6(a), 6(b) and 6(c) of this Supporting 

Statement and is summarized below.
(i) Submitters’ Annual Burden (Hours and Costs)

(a) Hours

Initial Section 8(e) Submissions

51 hours x 546 submissions = 27,846 hours

Follow-up/Supplemental Section 8(e) Submissions

5 hours x 179 submissions = 895 hours

Submitters’ Total Annual Hourly Burden

27,846 hours + 895 hours = 28,741 hours

(b) Costs

Submitters’ Total Annual Cost

27,470 managerial hours x $69.21/hour = $1,901,197

1,271 clerical hours x $27.59/hour = $35,067

$1,901,197 + $35,067= $1,936,264

(ii) EPA’s Annual Burden/Cost

Initial Section 8(e) Submissions

546 submissions x $275-$900/submission = $150,150- $491,400

Follow-up/Supplemental Section 8(e) Submissions

179 submissions x $275-$900/submission = $49,225- $161,100

EPA’s Total Annual Estimated Burden/Cost

725 submissions x $275-$900/submission = $199,375 - $652,500

6(e) Change in Burden

There is a decrease of 1,774 hours (30,515 to 28,741 hours) in the total estimated 

respondent burden compared with that identified in the information collection request most 

recently approved by OMB. This difference in burden hours is consistent primarily due to an 

increase in submissions for a number of reasons. First, there has been increased awareness and 
therefore enforcement of the submissions. With the High Production Volume Challenge 

Program, the public has the right to know information on the hazard of certain chemicals. Data 

from the 8(e) submissions is often used for this program. Companies have also been submitting 

information on chemicals to assure that there is no enforcement action taken upon the companies 

due to the chemical hazard assessment, which reviews chemicals on the Toxic Release 

Inventory.

The estimate in submitter annual costs associated with this ICR is higher than the 

previous section 8(e) ICR because of the above considerations as well as the increased hourly 

labor rates. The previous estimate was based on a simpler BLS data series whereas the current 

ICR uses an overhead rate of 17% based on assumptions in Wage Rates for Economic Analyses 

of the Toxics Release Inventory Program (Rice, 2002) and the Revised Economic Analysis for the 

Amended Inventory Update Rule: Final Report (EPAB, 2002). 2007 is the most recent year for 

which wage rates were available not subject to revision by BLS.

6(f) Burden Statement

The annual public burden for this collection of information, which is approved under 

OMB Control No. 2070-0046, is estimated to average 51 hours per initial section 8(e) 

submission and 5 hours per follow-up/supplemental section 8(e) submission. Burden is defined 

in 5 CFR 1320.3(b). 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 OMB control number for this information collection appears above. In addition, the OMB 

control numbers for EPA’s regulations, after initial display in the final rule, are listed in 40 CFR 

part 9.

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPPT-2012-0674, which is available for online viewing at www.regulations.gov, or in person 

viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC). 

The EPA/DC Public Reading Room is located in the EPA West Building, Room 3334, 1301 

Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 

8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number 

for the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the 

Pollution Prevention and Toxics Docket is (202) 566-0280.

You may submit comments regarding the Agency's need for this information, the 

accuracy of the provided burden estimates and any suggested methods for minimizing 

respondent burden, including the use of automated collection techniques. Submit your 

comments, referencing Docket ID No. EPA-HQ- OPPT-2012-0674 and OMB Control No. 2070-

0046, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: 

Pollution Prevention and Toxics Docket, Environmental Protection Agency Docket Center 

(EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) 

OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and 

Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.