August 31, 2015

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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: Health and Safety Data Reporting, Submission of Lists and Copies of Health

and Safety Studies

EPA ICR No.: 0575.15 OMB Control No.: 2070-0004

1(b) Short Characterization

On September 2, 1982, EPA promulgated the final Toxic Substances Control Act (TSCA) (15 

U.S.C. 2607(d); see Attachment 1 and http://www.epa.gov/lawsregs/laws/tsca.html) Section 8(d) Health 

and Safety Data Reporting Rule (40 CFR Part 716; see Attachment 2 and 

http://www.access.gpo.gov/nara/cfr/waisidx_03/40cfr716_03.html). The Model Rule was revised by

amendments on September 15, 1986 (51 FR 32720) and April 1, 1998 (63 FR 15965). The Model Rule 

describes the requirements and procedures for submitting lists and copies of unpublished health and 

safety studies under section 8(d) of TSCA (40 CFR 716). It requires manufacturers and (if specified) 

processors to submit lists and copies of health and safety studies relating to the health and/or 

environmental effects of the chemical substances and mixtures listed in the TSCA section 8(d) rule. The 

listed chemical substances and mixtures include chemicals recommended for testing under section 4 by

the Interagency Testing Committee (ITC) and other chemical substances that EPA (particularly the 

Office of Pollution Prevention and Toxics (OPPT)), or other federal agencies, wish to assess for health 

or environmental effects. EPA amends the TSCA section 8(d) rule periodically to add chemical 

substances and mixtures.

To comply with the reporting requirements of the rule, the respondents (manufacturers and 

processors) must search their files to identify any health and safety studies in their possession, copy and 

process the relevant studies, make lists of studies that are currently in progress, and review the studies 

for confidential business information.

All studies submitted to EPA will be verified and the contents of the submissions recorded and 

inspected for the inclusion of confidential business information. Copies of the documents will then be 

prepared and distributed, based on the associated chemical identity, to program offices at EPA and/or to 

other federal agencies for scientific analysis. A coding form will be completed to capture certain 

descriptive information such as identity, document control number, confidentiality indicator, document 

title, document date, receipt date and chemical identity. The document will be stored electronically for 

archival purposes. EPA will use the studies to support its investigation of the risks posed by listed 

chemicals and, in particular, to support its decisions on whether to require industry to test chemicals 

under section 4 of TSCA.

The total economic burden imposed by TSCA section 8(d) on the regulated community is 

estimated at 1,605 hours with an associated cost of $116,551 (119 respondents). The total estimated 

respondent burden is based on a rate of chemical additions of 70 chemicals per year.
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2 NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

TSCA section 8(d), 15 U.S.C. 2607(d), requires EPA to promulgate rules requiring persons who 

manufacture, process or distribute, or propose to manufacture, process or distribute chemical substances 

and mixtures, to submit to EPA lists and copies of health and safety studies in their possession. OPPT 

reviews these studies to determine the kinds of testing needed to fill the information gaps in known 

effects of the listed chemicals, to make decisions during the risk assessment process, and for considering 

control actions. Other federal agencies use the studies when they are assessing a listed chemical 

substance for health or environmental effects.

2(b) Use/Users of the Data

Studies submitted pursuant to TSCA section 8(d) rules will be evaluated in conjunction with 

other available data. EPA and other federal agencies will use the data to construct a complete picture of 

the known effects of the chemical substance. From this picture, OPPT will be able to determine what 

kinds of testing, if any, are needed. The TSCA section 8(d) studies will ensure that OPPT bases its 

testing decisions on the most complete information available and does not require testing that may have 

already been done.

In addition, EPA will require that copies of health and safety studies be submitted on other 

chemicals that are under investigation either in the early stages of risk assessment or when action to 

control exposure is being considered by EPA or another federal agency. These chemicals may be ones 

for which persons have submitted substantial risk notification under TSCA section 8(e), or other 

chemicals for which data are needed to support a control measure under sections 5 and 6 of TSCA or 

under other EPA-administered statutes. If this information collection did not exist, EPA would not be 

able to obtain the necessary information for evaluating the need for testing under section 4 of TSCA or 

controlling chemical substances under TSCA sections 5 and 6.

In the past, the following offices have also utilized submitted studies: the Office of Air and 

Radiation (OAR) for developing Tier II analyses; the Office of Research and Development (ORD) for 

developing extended risk assessments; the Consumer Product Safety Commission (CPSC) for assessing 

the hazards of known consumer exposure; the American Council for Government Industrial Hygienists 

(ACGIH); and the National Institute for Occupational Safety and Health (NIOSH) for developing 

recommended occupational exposure levels.

3 NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION 

CRITERIA

3(a) Non-Duplication

In drafting a TSCA section 8(d) rule, EPA considers all available information, i.e., published and 

unpublished literature, databases, and all data available from EPA programs and offices and other 

federal entities. If existing data are sufficient for assessment or control purposes, EPA will not require 

TSCA section 8(d) reporting. However, if that information is not sufficient, or is obtained in a way that 

makes EPA doubt its validity, then the Agency must require the submission of non-published health and 
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safety studies.

The health and safety studies to be submitted under the TSCA section 8(d) rule are not available 

from any other source. The TSCA section 8(d) rule requires the listing and submission of studies that are 

conducted in-house by industry or by industry contractors and not published in the scientific literature. 

Under the revisions to the Model Rule promulgated in September 1986, respondents do not have to list 

or submit any studies that have been published in the scientific literature, or submitted previously to 

OPPT on a non-confidential basis. Studies that respondents previously have submitted on a nonconfidential basis to other EPA offices or programs need only be listed.

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

In proposing to renew this ICR, EPA provided a 60-day public notice and comment period that 

ended on May 29, 2015 (80 FR 16672, March 30, 2015). EPA received no comments during the 

comment period.

3(c) Consultations

Under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with potential ICR respondents 

and data users about specific aspects of ICRs before submitting an ICR to OMB for review and 

approval. In accordance with this regulation, EPA submitted questions to nine parties via e-mail. The 

individuals contacted were:

Scott Jensen

American Chemistry Council

Scott_Jensen@AmericanChemistry.com

Jenny Gaines

Specialty Chemical Manufacturing Association

gainesj@socma.com

Dan Turner

E. I. du Pont de Nemours and Company

Daniel.a.Turner@dupont.com

Eric Wohlschlegel

American Petroleum Institute

wohlschlegele@api.org 

Melissa Scanlan

Environmental Law Center, Vermont Law School

MSCANLAN@vermontlaw.edu 

Stacy Cooks

Asthma & Allergy Foundation of America

stacy@aafa.org 

Sharyn Stein

Environmental Defense Fund
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sstein@edf.org

Ken Cook

Environmental Working Group

ken@ewg.org

David Goldston

Natural Resources Defense Council

eheyd@nrdc.org

EPA received no responses to its solicitation for consultations. A copy of EPA’s consultation email to the above potential respondents is included in Attachment 3.

3(d) Effects of Less Frequent Collection

In most instances, respondents will be required to make only initial submissions under the TSCA 

section 8(d) rule. However, after the initial submission of lists and studies, respondents are required to 

notify EPA when certain health and safety studies are initiated by submitting a list of newly initiated 

studies. Because the reporting frequency for the TSCA section 8(d) rule is generally once, the reporting 

frequency cannot be reduced without suspending the information requirement. If this were to happen, 

EPA would not be able to obtain the necessary information for evaluating the need for testing under 

section 4 of TSCA or controlling chemical substances under sections 5 and 6 of TSCA.

3(e) General Guidelines

This information collection activity is necessary to implement the statutory requirements of 

section 8(d) of TSCA and is consistent with the requirements of the PRA, OMB implementing 

regulations (5 CFR 1320.6), and OMB Guidance.

3(f) Confidentiality

Under the TSCA section 8(d) rule, a person submitting a health and safety study may claim 

certain parts of the study confidential. EPA has implemented procedures to protect confidential, trade 

secret and proprietary information from disclosure. These procedures comply with EPA’s confidentiality

regulation, 40 CFR Part 2, Subpart B.

3(g) Sensitive Questions

This section is not applicable. The information requested is not sensitive in nature.

4 THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT

4(a) Agency Activities

The activities routinely conducted by EPA related to the rule development, processing, analysis 

and storage of the information collected under this rule include the following:
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1. Review and select chemicals;

2. Develop and issue an amendment to the TSCA section 8(d) rule to add the substances or 

mixtures;

3. Answer respondents’ questions;

4. Process and analyze rule submissions, including requests for confidentiality; and

5. Maintain and distribute the data.

4(b) Collection Methodology and Management

EPA’s current collection methodology and information management system is based on the 

current requirements in 40 CFR 716.30 and 716.35 for the submission of electronic copies, which was 

implemented by a rule published in the Federal Register on December 4, 2013 (78 FR 72818).

To aid persons subject to this information collection, OPPT has set up a TSCA Hotline that 

provides information regarding TSCA section 8(d) reporting as well as other regulatory information. 

When Hotline staff are unable to answer questions regarding TSCA section 8(d), the questions are 

referred to OPPT staff for appropriate resolution.

All Non-Confidential Business Information submitted under TSCA section 8(d) is placed in the 

OPPT public docket, indexed and available for public inspection. A vast majority of TSCA section 8(d) 

submissions to date are reflected in the TSCA Test Submissions (TSCATS) database, a publicly 

available and searchable database.

4(c) Small Entity Flexibility

The TSCA section 8(d) rule applies to all manufacturers and processors of chemicals and others 

in possession of studies, regardless of size. However, EPA does not anticipate that many small 

businesses possess health and safety studies because they are unlikely to have the financial resources to 

perform the studies on chemicals subject to the rule. Therefore, the burden on such companies should be 

minimal.

4(d) Collection Schedule

The collection scheduled under this ICR is chemical-specific in nature and occurs once in an 

established time frame between 60 days and 2 years. Reporting of information is only required when the 

subject matter information (i.e., the lists of studies and final study reports) is available. Availability of 

study reports on the list may occur after the established reporting period for the list, and must still be 

submitted when they become available. In any case, submission of the list or any study report for a listed 

study occurs once for each chemical covered by a TSCA section 8(d) rule. Studies previously submitted 

to OPPT are exempt. 

Amendments adding substances are made to the Health and Safety Data Reporting Rule 

subsequent to the ITC’s semiannual addition of substances and categories of substances to the TSCA 

section 4(e) Priority List. Other substances are added when there is a demonstrated need for the 

information.
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5 THE RESPONDENTS AND THE INFORMATION REQUESTED

5(a) Respondents/NAICS Codes

Respondents affected by this collection activity are identified mainly by North American 

Industry Classification System (NAICS) codes 325 (chemical manufacturing and allied products) and 

32411 (petroleum refiners).

5(b) Information Requested

(i) Data Items

Persons who manufacture (including import) chemical substances and mixtures, or propose to do 

so, and processors of such substances and mixtures (if specifically identified in a particular rule) must 

submit copies of the unpublished health and safety studies in their possession for the listed substances or 

mixtures. They must also submit lists of reportable studies that they initiate or, about which they know, 

for each of the listed substances or listed mixtures.

All submitted studies must be accompanied by a cover letter that contains the following data (40 

CFR 716.30):

• Name,

• Job title,

• Address, and

• Telephone numbers of the submitting official.

• Name and address of the manufacturing or processing establishment on whose behalf the 

submission was made

• Identify any impurity or additive known to have been present in the substance or listed

mixtures as studied, unless so noted in the study.

• Identify that the study is being submitted under Part 716.

Respondents may voluntarily choose to develop and submit robust summaries of the full 

toxicological study reports in conjunction with the submitted full study reports. The robust summaries 

should contain technical information to adequately describe the study and results, and should be written 

such that the information provided is sufficient to allow a technically qualified person to evaluate study

results without needing to review an entire study report. Typically, a robust summary would include a 

description of the test substance, methods, results, conclusions, data quality description, and references 

associated with the full study.

List of studies shall include (40 CFR 716.35): (1) ongoing health and safety studies conducted by

or initiated by them; (2) studies they know about but do not have copies of; and, (3) studies that have 

been sent to another federal agency with no claims of confidentiality.

For ongoing health and safety studies conducted by or initiated for the respondent, the list should 

include the following data:

• Beginning date of the study

• Purpose of the study
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• Types of data to be collected

• Anticipated date of completion

• Name and address of the laboratory conducting the study

For studies known to the respondent but for which they do not possess copies, the list should 

include the following data:

• Name and address of a person known to them that possess a copy of the study.

For studies previously sent to a federal agency with no claims of confidentiality, the list should 

include the following data:

• Title of the study

• Name and address of the person to whom the study was sent

• Month and year in which the study was submitted

(ii) Respondent Activities

A representative respondent would engage in the following activities in order to produce the lists 

of studies and required data listed in section 5(b)(i) of this supporting statement:

1. Determine whether the firm may be required to report. If so, review the rule in more detail;

2. Conduct a corporate review to identify which firm sites must be searched to locate the 

appropriate health and safety studies;

3. Search the files at appropriate sites to locate relevant studies;

4. Compile and transcribe lists of studies being submitted, ongoing studies, newly initiated studies, 

studies known to exist but not known to be in the respondent’s possession, and studies previously

submitted to other federal agencies without confidentiality claims;

5. Photocopy the studies;

6. Voluntarily prepare robust summaries of the studies; 

7. Review the responses for possible confidential business information; and

8. After initial study submissions, notify EPA when other studies are initiated; submit studies 

completed after the reporting period.

6 ESTIMATING THE COST AND BURDEN OF THE COLLECTION

The methodology used for estimating the burden and costs to industry resulting from the addition 

of chemicals to the TSCA section 8(d) rule over the next three years is derived from the previous 

information collection request (ICR). EPA has added chemicals to the TSCA section 8(d) list on an 

episodic basis. As shown in Table 1, chemicals have been added to the list three times since 1996, 

yielding an average of 15 chemicals per year for the years between 1996 and the present. EPA uses a 

basis of 70 chemicals per year for the 2015-2018 ICR period, using information from the 2006 
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rulemaking, which added 208 new chemicals (averaging 69 chemicals per year during the 2006-2009 

ICR period). 

Table 1. Number of Chemicals Added to the TSCA Section 8(d) Reporting List.

Year 1996 1997-

2003 2004 2005 2006* 2007-2014

Average/

Year

Number of 

Chemicals 47 0 15 0 208 0 15

* EPA issued a TSCA section 8(d) rule (71 FR 47130) on August 16, 2006 for 243 HPV chemicals 

that were not sponsored in the voluntary portion of the HPV Challenge Program. EPA later withdrew

33 of these chemicals in a final rule issued on September 29, 2006 (71 FR 57439). In a subsequent 

direct final rule issued on April 30, 2007, EPA removed two additional chemicals (72 FR 21119), 

resulting in a total of 208 chemicals subject to Section 8(d) reporting.

Moreover, to characterize the reporting implications per chemical addition associated with 

Section 8(d) reporting (including information from the 10-year period prior to the 2006 TSCA section 

8(d) rule), this analysis uses TSCA IUR data from the 1998, 2002, and 2006 reporting cycles. 1Table 2

summarizes the models and bases, as applied to the 2015-2018 ICR Renewal.

Table 2: Reporting Implications per Chemical Added

Generic Model

ICR 

2009-12 

Model Sources*

ICR 

2009-2012 

Detailed Model

ICR 

2012-15 

Model 

Sources

BASIS 

ICR 

2015-

2018

Number of firms 

potentially 

impacted per 

chemical

TSCA IUR data, all 

manufacturers 1998, 

2002, 2006: 344 firms 

associated with 208 

chemicals

same 1.7

Sites per firm

TSCA IUR data, all 

manufacturers 1998, 

2002, 2006: 344 firms 

associated with 208 

chemicals; Sites per firm

same 1.5

Fraction of firms 

potentially affected 

who submit reports 

of studies

TSCA IUR data, all 

manufacturers 1998, 

2002, 2006: 59 firms 

submitted 527 studies 

associated with 208 

chemicals

same 0.17

 

1 According to 40 CFR 716.5, persons are required to report under a TSCA section 8(d) rule if, during the 10 years preceding 

the effective date of the rule, they manufactured (including imported) or planned to manufacture (including import) a listed 

chemical. The IUR data for this analysis is not limited to reporting from chemical manufacturers and petroleum refiners. This 

scope does not affect the accuracy of the results, given that only firms regulated under TSCA 8(d) submit reports.
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Number of studies 

per firm

TSCA IUR data, all 

manufacturers 1998, 

2002, 2006: 59 firms 

submitted 527 studies 

associated with 208 

chemicals

same 9

Average length of 

study, pages

TSCA IUR data, all 

manufacturers 1998, 

2002, 2006: 59 firms 

submitted 527 studies 

associated with 208 

chemicals

20 same 20

Percent studies 

with robust 

summaries; 

number of firms 

affected

10% of total studies 10% of reports same 1 Robust 

Summary

per Firm

Percent of affected 

firms submitting 

second responses

5% of affected firms 5% same 5%

6(a) Estimating Respondent Burden

Firms will undertake a number of actions in response to a TSCA section 8(d) listing and the unit 

burden associated with each of these tasks is discussed in detail below.

Review the Rule. Firms in the relevant industries that may have unpublished health and safety 

studies will have to determine whether they manufacture a listed chemical and may thus be required to 

report. If so, they will have to review the rule in detail to understand its requirements, such as the types 

of health and safety studies EPA is asking for, the grade or purity of the test material, and the timeframe 

of the reporting period. 

Note that, unless EPA specifies otherwise, the coverage of 8(d) rules is limited to chemical 

manufacturers and petroleum refineries. Most firms in these industries will not manufacture a listed 

chemical, and many will spend a de minimis amount of time making that determination. Those firms 

that manufacture a listed chemical must review the rule to understand its specific requirements. This is 

estimated to take an average of 2 hours of managerial time for each firm manufacturing a listed 

chemical.

Conduct Corporate Review for Site Identification. Firms that manufacture a listed chemical will 

need to conduct a corporate review to identify which of the firm’s sites must be searched for appropriate 

health and safety studies. This corporate review is estimated to require an average of 3 managerial hours 

per firm.

Conduct Site File Search. Firms that manufacture a listed chemical must search the files at 

appropriate sites to look for studies that are responsive to the TSCA section 8(d) rule. It is estimated that 

the search will take an average of 3 hours of technical time per site. EPA estimates that each firm will 

have an average of 1.5 sites manufacturing a listed chemical. This yields an average burden of 4.5 

technical hours per firm for site file searching (3 hours per site * 1.5 sites per firm). 
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Provide Study Title Lists. Respondents are required to submit lists containing the titles of any 

studies being submitted, titles of studies that are initiated or ongoing during the reporting period but that 

have not yet been completed, titles of any unpublished studies that the respondent knows to exist but 

does not have in its possession, and titles of studies previously submitted to other federal agencies 

without confidentiality claims. Prior to electronic reporting, an average of 1 hour of clerical time per 

firm was estimated to be dedicated to transcribing the list of study titles. EPA expects that the major 

burden of compiling this list was incurred during the file search and would already be available in 

electronic format; therefore, there is no additional burden associated with this activity.

Prepare Robust Summaries. Respondents may choose to develop and submit robust summaries 

of the full toxicological study reports. The robust summaries should contain technical information to 

adequately describe the study and results, and should be written in such a way that the information 

provided is sufficient to allow a technically qualified person to evaluate study results without needing to 

review an entire study report. Typically, a robust summary would include a description of the test 

substance, methods, results, conclusions, data quality description, and references associated with the full 

study. It is estimated that 8 to 16 hours of technical time are needed to develop and review a robust 

summary, depending on the type of study conducted. This ICR assumes an average of 12 hours of 

technical time to prepare a robust summary. Because submission of robust summaries is voluntary, EPA 

does not expect that many companies will undertake this activity. EPA estimates that each firm will 

submit an average of 9 studies, with 10% of those studies including a robust summary; therefore, EPA 

expects to receive an average of 0.9 robust summaries per firm submitting studies, which we round up to 

1 robust summary per firm submitting studies. The estimated average burden per robust summary is 12

hours of technical time.

Review Responses for Confidential Business Information (CBI). Firms will need to review 

responses for possible CBI and delete any material that is considered by the firm to be CBI from one 

copy of the study. A separate copy of the study must be submitted without deletions of CBI. CBI review 

is estimated to take an average of 1 hour of managerial time for each study. Since each of the 20 firms is 

submitting an average of 9 studies, CBI review results in an estimated average of 9 hours of managerial 

time per firm.

Post-Reporting Period: Submit Ongoing or Newly-Initiated Studies. Firms that have an ongoing 

or newly-initiated study during the reporting period are required to provide EPA with a copy of the 

study once it is completed. CBI review and submission of ongoing or newly-initiated studies are

estimated to require an average of 1 hour of managerial time.
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Table 3. Unit Burden for TSCA Section 8(d) Reporting

Collection Activity

Affected 

Respondents

(Weight)*

Average 

Burden per 

Firm (Hours)

Labor 

Category

1. Review of Rule 1.000 2 Managerial

2. Site Identification 1.000 3 Managerial

3. Site File Search** 1.000 4.5 Technical

4. Robust Summaries 0.008 12 Technical

5. CBI Review 0.168 9 Managerial

6. Post-Reporting Period 

Submission 0.008 1 Managerial

*Not all respondents perform all activities. This weight reflects that for every firm that 

has to check for reports: 17% will submit reports, of which 1 firm (about 5%) will 

provide robust summaries and 5% (about 1 firm) will provide a second response.

** Basis of 1.5 sites per firm

These unit burden estimates are average values. Large multi-divisional, multi-departmental firms 

may require more than the average time to comply. However, there are smaller firms that are less 

complicated, and these firms may have a simpler process that requires less time.

6(b) Estimating the Respondent Universe

The number of chemicals added to the section 8(d) list has varied significantly from year to year 

and has been zero in many years. EPA has added a total of 270 chemicals to the list since 1996 (47 in 

1996, 15 in 2004, and 208 in 2006), which is an overall program historical average of approximately 15 

chemicals per year. For estimates in this ICR, EPA assumes that an average of 70 chemicals per year 

will be added to the section 8(d) list from 2015 to 2018, for a total of 210 chemicals over the three-year 

ICR period. Assuming that each chemical that is added to the list impacts 1.7 firms, then EPA expects 

119 chemical manufacturing firms to be affected per year by this ICR.

Based on the reporting bases stated on Table 2, EPA assumes that 17% percent of the potentially 

affected manufacturers will submit studies each year, yielding 20 firms submitting studies (0.17 * 119

manufacturers). Each submitting firm is expected to submit a total of 9 studies, yielding an estimated 

total of 180 studies annually (20 firms * 9 studies per firm). A total of 10% of the studies are expected to 

contain robust summaries, yielding a total of 1 robust summary per firm (9 studies * 0.10, and rounding 

up to 1); and 1 firm (5% of 20 firms) is estimated to submit a second response (for a newly initiated or 

ongoing study) after the reporting period ends. 

The number of firms estimated to engage in the various reporting activities is summarized in 

Table 4. Note that not all respondents incur every aspect of reporting burden. For this analysis, the 

conditions of the 2006 rule and its reporting implications, along with the condition of 70 chemical 

additions per year, are assumed.
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Table 4: Number of Firms Affected per Year, by Activity 

(70 Chemicals Added Per Year)

Collection Activity No. of Firms

Review of Rule 119

Site Identification 119

Site File Search 119

Robust Summaries 20

CBI Review 20

Post-Reporting Period Submission 1

The number of firms or studies described above is combined with the estimated average unit 

burden hours and wages from Tables 3 and 5 to estimate the total burden hours and cost per year based 

on three types of response activities: searching files, submitting studies during the reporting period, and 

submitting studies after the reporting period. The results are shown in Table 6.

6(c) Estimating Respondent Cost

Unit labor costs are calculated by adding fringe benefits and overhead to the wage or salary to 

derive a fully loaded labor cost. Costs are calculated for managerial, professional/ technical, and 

clerical workers. Wages and fringe benefits for managerial, professional/ technical, and clerical labor 

are taken from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation 

(ECEC) manufacturing industry data from 2013. The cost of fringe benefits such as paid leave and 

insurance are taken from the same ECEC series for each labor category. Fringe benefits as a percent of 

wages are calculated separately for each labor category. Table 5 presents these results with fully

loaded rates for managerial labor at $77.77/hour; for technical labor at $67.59/hour; and for clerical 

labor at $30.35/hour.
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Table 5: Loaded Industry Wage Rates (December 2013)

EPAB Labor 

Category Data Sources d Date

Wage Fringe 

Benefit

Fringes as % 

wage

Overhead 

% wage b

Fringe + 

overhead 

factor c

Loaded 

Wages a

(A) (B) (C ) = 

(B) / (A)

(D) (E ) = 

(C)+(D)+1

(F) =

(A)*(E) 

Managerial

BLS ECEC, 

Private 

Manufacturing

Industries, 

“Mgmt., 

Business and 

Financial”

Dec.

2013 $46.21 $23.70 51.29% 17% 1.68 $77.77

Professional/ 

Technical

BLS ECEC, 

Private 

Manufacturing

Industries,

“Professional 

and Related”

Dec.

2013 $39.70 $21.14 53.25% 17% 1.70 $67.59

Clerical

BLS ECEC, 

Private 

Manufacturing

Industries,

“Office and 

Administrative 

Support”

Dec.

2013 $18.05 $9.23 51.14% 17% 1.68 $30.35

Notes:

a Wage data were rounded to the closest cent in this table; however in calculations using these numbers for this report, 

unrounded values were used.

b An overhead rate of 17% was used 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)

c An inflation factor of “1” means wage data were not escalated to reflect inflation.

d

Source: Employer Costs for Employee Compensation Supplementary Tables: December 2006-March 2014, U.S. Bureau of 

Labor Statistics, September 10, 2014 (pp 31, 33, 37) (http://bls.gov/ncs/ect/sp/ecsuphst.pdf, accessed October 23, 2014)
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6(d) Estimating Reporting Burden and Costs

Table 6. Annual Respondent Cost and Burden Hour Estimates

Information 

Collections

Response 

Activities

Burden 

per 

Response 

(Hours)

Labor 

Category

Cost per 

Response

Number of 

Responses

Total 

Burden 

(Hours)

Total 

Cost

Compliance 

determination and 

data search

Rule review, 

site 

identification 

and site file 

search

9.5 Managerial/ 

Technical $693 119 1,131 $82,468

Submission of 

health and safety 

studies during the 

reporting period

Robust 

summaries 

and CBI 

review

21.0 Managerial/ 

Technical $1,511 20 420 $30,220

Notification and 

submission of health 

and safety studies 

initiated and/or 

completed after the 

reporting period

Postreporting 

period 

submission

1.0 Managerial $78 1 1 $78

Total 140 1,552 $112,766

A typical firm submitting a response is conservatively estimated to engage in review of the rule, 

site identification, site file search, preparing study title lists, CBI review, and possibly submit a robust 

summary and/or a post-reporting period submission. Assuming that 70 chemicals per year are added to 

the TSCA section 8(d) list and that reporting is similar to the 2006 experience, the average annual 

burden and cost per response is 31.5 hours and $2,282, respectively.

Additionally, in late 2012, EPA promulgated a direct final rule requiring the submission of 

unpublished health and safety data by manufacturers and importers of cadmium and cadmium 

compounds. As a result, the number of responses (1,384 responses) and burden hours (7,019 hours) for 

this rule were included in the OMB action notice for the most recent renewal of this information 

collection. Likewise, the respondent and burden hour totals were included in the OMB inventory for this 

information collection. However, subsequent to the publication of the direct final rule, and subsequent to 

OMB’s most recent approval of the TSCA sec. 8(d) information collection, EPA withdrew the cadmium 

reporting rule. Consequently, EPA has eliminated from the current request for OMB approval of this 

information collection a total of 1,384 responses and 7,019 burden hours to reflect the withdrawal of the 

cadmium reporting rule. These values do not otherwise appear in any of the tables included in this 

section.

6(e) CDX Registration Activities to Enable Electronic Reporting

EPA estimates that respondents will incur a small amount of additional burden and costs in 

carrying out the additional paperwork activities that were imposed by the Electronic Reporting under the 

Substances Control Act (TSCA) Final Rule. This includes the burden associated with activities that 

facilitate submission of an electronic report: CDX registration and CDX electronic signature. These 

activities occur only once for each submitter. Some submitters may already have registered to use the eTSCAweb 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 and/or IUR/CDR 

rule. Those submitters will not need to repeat the CDX registration and e-signature process in order to 
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August 31, 2015

file their health and safety studies. While there may be some overlap in the specific individuals already

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 CROMERR Cost Benefit Analysis, EPA assumed that 

companies would spend 11 minutes per employee to register with CDX (EPA, 2004). Furthermore, EPA 

assumed that an average of four technical staff members and one manager would need to register for 

each company, resulting in 55 minutes of burden per firm.

CDX electronic signature (labor burden) – Based on the CROMERR Cost Benefit Analysis, 

EPA assumed that firms would spend 15 minutes preparing, submitting, and filing an electronic 

signature agreement (Authentication of Identity) form to EPA per employee (EPA, 2004). One manager 

and four technical staff members per firm would incur this burden, totaling 75 minutes of burden per 

company. In addition, EPA estimates that a manager would spend an additional 30 minutes accessing, 

preparing, and submitting verification forms (Verification of Authorization) for all authorized submitters 

to EPA. The total burden incurred by firms submitting and then verifying electronic signature 

agreements would be 105 minutes. It should be noted that the burden associated with CDX Electronic 

Signatures does not include costs associated with contacting EPA’s CDX help desk to notify a change of 

submitter status, should one occur.

Table 7. Estimated Burden Associated with New CDX Registration Activities

Information 

Collection

Estimated 

Number of 

Annual 

Respondents

Number of 

Responses/

Respondent

Estimated Burden Hours 

and Cost per Response Estimated 

Burden 

Hours /Year

Estimated 

Labor 

Cost /Year Managerial Technical

Hours Wage 

Rate Hours Wage Rate

CDX 

Registration & 

E-signature

20 1 0.93 $77.77 1.73 $67.59 53.2 $3,785

Non-labor costs include a $0.44 stamp and a $0.02 standard business envelope for each of five 

required electronic signature agreements. The total non-labor cost for electronic signature agreements 

equals $2.30. This amounts to $46 in non-labor costs per year.

Conservatively assuming that all 20 firms submitting studies will need to register with CDX, the 

average burden and cost per CDX registration is 2.66 hours and $189.25, respectively.

6(f) Estimating Agency Cost

The activities routinely conducted by EPA related to processing and storage of the information 

collected under this rule include processing and analyzing the materials submitted under the rule, 

including requests for confidentiality; and maintaining and distributing data.

The activities associated with Agency responses to TSCA section 8(d) listings are assumed to be 

accomplished by a GS 13, Step 5 federal employee. The 2014 hourly wage rate for this level of 

employee in the Washington, D.C. locality is $48.83 per hour. Adding 60% for benefits and overhead 
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August 31, 2015

yields a loaded annual wage rate of $78.13 per hour.2

As a result of the Electronic Reporting under the Substances Control Act (TSCA) Final Rule, 

EPA expects that the Agency will have a burden savings due to the elimination of the need to process 

paper forms, and reduced quality assurance/quality control (QA/QC) and O&M costs for the existing 

system. Potential Agency burden savings associated with electronic reporting of TSCA section 8(d) 

health and safety studies were characterized based on information in the CDX Business Case Analysis

regarding the estimated monetary benefit from using CDX. Of the six Program Data Flows studied in 

the CDX Business Case Analysis, monetary benefits from using CDX as compared to a paper 

submission baseline were quantified for two flows: TRI (Toxic Release Inventory) and e-NOI 

(electronic Notice of Intent under the National Pollution Discharge Elimination System). Benefits 

ranged from eleven percent savings (e-NOI) to 22 percent savings (TRI) compared to the cost of the 

baseline process. For this ICR, EPA assumed an average annual burden savings of 16.5 percent. This 

percentage savings results in a total annual burden of 3,542 hours for electronic submissions.

The estimated annual cost to the federal government for TSCA section 8(d) data collection totals 

$4,566.70, for 58.45 hours, as presented in Table 10.

Table 8. Agency Annual Cost Estimates

Collection Activity FTEs Hours Annual 

Cost

Data processing and system support 0.025 41.75 $3,261.93

Storage and distribution 0.010 16.70 $1,304.77

TOTALS 0.035 58.45 $4,566.70

Source: OPM 2014 hourly rate table for the Washington-Baltimore-Northern Virginia Locality Pay Area, with 

60% for benefits and overhead added.

6(g) Bottom Line Burden Hours and Cost

As shown in Table 6, if EPA adds 70 chemicals per year to the TSCA section 8(d) list during the 

time period covered by this ICR, burden associated with 8(d) review and reporting will be incurred by

119 firms. Note that not all these firms incur every aspect of reporting burden. Those firms that do 

ultimately submit studies incur a small amount of additional burden and cost associated with registering 

with CDX in order to comply with new electronic reporting requirements. The burden activities 

associated with CDX registration occur only once, during the first year of the ICR period.

The average annual reporting burden and cost per response is estimated at 11.1 hours and 

$805.47, respectively, with overall estimated annual totals of 1,552 burden hours and $112,766.

Conservatively assuming that all firms submitting studies will need to complete a one-time CDX 

registration, the average annual burden and cost per CDX registration is 2.66 hours and $189.25, 

respectively. This yields an estimated annual burden and cost per response for CDX-related activities of 

53.2 hours and $3,785.

 

2 The EPA wage rate is calculated based on the GS-13 Step 5 wage rate for calendar 2014, from the Office of Personnel 

Management salary and wage tables for Washington-Baltimore-Northern Virginia. The 60% fringes-and-overhead rate is 

from ICR Handbook: EPA’s Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 1995. 

(EPA Office of Environmental Information, 2005).
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August 31, 2015

As noted earlier, basing the future burden estimates on the reporting from the 2006 rule may

overestimate reporting burden and cost if number and characteristics of the chemicals that are added to 

the TSCA section 8(d) list during the next three years are less burdensome than the 208 HPV chemicals 

that were added in 2006. Moreover, this ICR conservatively estimates that all submitters are new CDX 

registrants and will, therefore, need to incur the additional burden associated with registering with CDX 

and submitting an electronic signature agreement. EPA recognizes that some respondents may have 

already registered for CDX in order to comply with the mandatory electronic reporting requirements of

other TSCA collection activities; those respondents would not need to register again and would avoid 

the associated burden and cost altogether.

The total annual respondent burden and cost for this collection (sum of Tables 6 and 7) is 1,605 

hours and $116,551 respectively.

6(h) Reasons for Changes in Burden

There is a net decrease of 6,778 hours (from 8,383 to 1,605) in the total estimated respondent 

burden compared with that currently in the OMB inventory. This net decrease in burden is due to the 

following:

 The previous ICR incorrectly used a total of 1 robust summary per year as the total number of 

annual robust summary responses, yielding a total of 12 hours of annual burden. This ICR 

corrects this burden estimate by using a total of 20 robust summary responses per year, yielding 

a total annual reporting burden of 240 hours – an increase of 228 hours per year.

 This ICR renewal incorporates changes made to Health and Safety Data reporting under TSCA 

section 8(d) that mandate the use of electronic reporting in lieu of traditional paper-based 

reporting. The new electronic reporting requirements eliminated the clerical burden associated 

with transcribing study title lists and photocopying studies for paper-based submissions. This 

change resulted in a decrease of 40 hours to the average annual reporting burden. While 

electronic reporting serves to streamline and reduce the administrative/clerical costs and burdens 

associated with submitting paper-based health and safety studies, the burden savings were not 

sufficient to offset the new burden associated with CDX registration activities. However, it 

should be notes that these activities occur only once for each submitter and, since some 

respondents while most likely have already registered with CDX, this analysis conservatively 

overestimates the burden and costs actually experienced by respondents.

 The new electronic reporting mandate requires that submitters of health and safety data under 

TSCA section 8(d) register with CDX in order to submit studies electronically. The new annual 

burden associated with CDX registration activities is 53 hours.

 Finally, EPA has reduced the burden estimate by 7,019 hours to reflect the 2012 withdrawal of 

the cadmium reporting rule as noted above in section 6(d).

6(i) Burden Statement

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

Control No. 2070-0004, is estimated to average about 10.0 hours per response. 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 
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August 31, 2015

collection of information unless it displays a currently valid OMB control number. The OMB control 

number for this information collection appears above. The OMB control numbers for EPA’s regulations 

in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included 

on the related collection instrument or form, if applicable.

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT2014-0734, 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 West William Jefferson Clinton Bldg., Room 3334, 1301 Constitution 

Ave., N.W., 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-HQOPPT-2014-0734 and OMB Control No. 2070-0004, 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), Mailcode: 28221T, 1200 Pennsylvania Ave., N.W., 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, N.W., Washington, DC 20503.
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August 31, 2015

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public docket established for this 

ICR under docket identification number EPA-HQ-OPPT-2014-0734. These attachments are available 

for online viewing at www.regulations.gov or otherwise accessed as described in section 6(f) of the 

supporting statement.

Attachment 1: 15 U.S.C. 2607(d) - Section 8(d) of the Toxic Substances Control Act. 

Also available online at the U.S. House of Representatives’ U.S. Code website

Attachment 2: 40 C.F.R. part 716 - Health and Safety Data Reporting. Also available online 

at the National Archives and Records Administration’s Electronic CFR website

Attachment 3: Copy of Consultations Message Sent by EPA to Potential Respondents