1

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 C.F.R. 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unpublished health and safety studies under section 8(d) of TSCA (40 CFR 716).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.
2

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.

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

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 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 non-confidential 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
4

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

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 e-mail 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.
5

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:

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 
6

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.

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 
7

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

• 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 
8

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 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 

 

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.
9

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

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%
10

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). 

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
11

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.

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, multidepartmental 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.
12

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.

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.
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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.

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)
14

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 
15

signature. These activities occur only once for each submitter. Some submitters may already

have registered to use the e-TSCAweb 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 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.
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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 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.

 

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-andoverhead 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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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.

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 
18

burden associated with transcribing study title lists and photocopying studies for paperbased 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 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-HQOPPT-2014-0734, 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-HQ-OPPT-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 
19

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

20503.
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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