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.: 0575.13 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. 2601 et seq.; see, http://www.epa.gov/lawsregs/laws/tsca.html) Section 8(d) Health 

and Safety Data Reporting Rule (40 C.F.R. Part 716; available on the Internet at

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unpublished health and safety studies under section 8(d) of TSCA (40 CFR 716).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. Photocopies 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 microfiched and stored 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.
2

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

estimated at 1,364 hours with an associated cost of $88,588 (119 respondents). The total 

estimated respondent burden has increased due to a revised basis for rate of chemical additions

(from 20 to 70 chemicals per year) and due to the episodic nature of rulemakings that add 

chemicals to the TSCA section 8(d) list.

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 who propose to manufacture, process or 

distribute, any chemical substances or 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 studies submitted have also been utilized by the following offices: 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

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

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

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

submitted to OMB.

3(c) Consultations

Existing Chemical Assessment Division (ECAD) staff met on several occasions during 

1988 and 1989 with interested industry members to discuss aspects of reporting, monitoring and 

modeling health and safety studies under the TSCA section 8(d) model rule. The result of these 

meetings was two interpretative guidance question-and-answer documents that clarify the 

modeling and monitoring studies that are and are not subject to reporting at 40 CFR part 716.

In September 1996, EPA held a public meeting and solicited comments from industry to 

discuss a variety of revisions to TSCA section 8(d). This meeting focused on reducing the 

burden associated with the reporting regulations under TSCA section 8(d) while still providing 

EPA and other federal agencies with the data necessary for risk characterization. These revisions 

were implemented in a Direct Final Rule entitled “Revisions to Reporting Regulations under 

TSCA Section 8(d)” (63 FR 15765, April 1, 1998). These revisions became effective June 30, 

1998.

Additionally, under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with potential 

ICR respondents and data users about specific aspects of ICRs before submitting an ICR to OMB 
4

for review and approval. In accordance with this regulation, EPA will submit questions to 

interested parties during the development of the renewal of this collection. 

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:

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.
5

4(b) Collection Methodology and Management

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

the current requirements (40 CFR 716.30 and 716.35) for the submission of hard copies. EPA is 

continuing to explore alternative reporting procedures involving electronic submission. 

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 members 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.

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) 
6

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

• Types of data to be collected

• Anticipated date of completion

• Name and address of the laboratory conducting the study
7

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), revised to reflect recent experience with the 

program. There are two procedures for using program information to update bases for estimates.

First, for the estimate of the frequency of chemical additions, the number of chemicals added to 

the TSCA section 8(d) Reporting List over time is reviewed. Note that this count is readily 
8

updated upon implementation of new rules. However, for the remainder of the estimates --

reflecting reporting implications per chemical addition -- updates await completion of EPA “callins” for the health reports. In this analysis, the number of chemical additions is based on

historical review, while the estimates for reporting implications are the same as in the previous 

ICR renewal, given that there has been no activity in the section 8(d) information collection since 

2006.

EPA has added chemicals to the TSCA section 8(d) list on an episodic basis. As shown 

in Table 1, chemicals were added to the list three times since 1996. EPA uses a basis of 70 

chemicals per year for the 2012-2015 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 TSCA Section 8(d) Reporting List, by Year and by 

ICR Reporting Period

Year 1996 1997-

2003 2004 2005 2006* 2007-2011 Average/Year

Number 

of

Chemicals 

47 0 15 0 208 0 17

* 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.

ICR Period 

(Nov) 2006 - (Oct) 2009 

ICR Period 

(Nov) 2009 - (Oct) 2012 

BASIS 

ICR Period 

(Nov) 2012 - (Oct) 2015 

Total #/yr Total #/yr Total #/yr

208 69 0 0 210 70

The estimates in this ICR renewal are based primarily on the reporting for the 208 

chemicals added to the TSCA section 8(d) list in 2006. From this experience, EPA has observed 

that chemicals with high production volumes tend to have more unpublished health and safety 

data than other chemicals that may be considered for inclusion on the TSCA section 8(d) list. As 

shown in Table 2, the average number of studies submitted per company was nearly twice as 

high for the HPV chemicals in the 2006 rule compared to the chemicals in the 2004 rule. 

Although continued use of the 2006 basis may possibly overestimate costs and burden of future 

reporting, it is the most recent experience and will be used as the basis for this analysis.
9

Table 2. Reporting Statistics for Recent TSCA Section 8(d) Rules

2004 

rule

2006 

rule

Number of chemicals added to 8(d) list 15 208

Number of chemicals for which 8(d) reports were submitted 3 54

Number of companies submitting 8(d) reports 3 59

Total number of 8(d) studies submitted 14 527

Average number of studies submitted per company 5 9

Average page length of studies submitted 67 20

Median page length of studies submitted 20 14

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 3 summarizes the models and bases, as applied to the 2012-15 ICR 

renewal.

 

1 According to 40 CFR part 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.
10

Table 3: Reporting Implications per Chemical Added

Generic Model

ICR 

2009-12 

Model Sources*

ICR 

2009-2012 

Detailed Model

ICR 

2012-15 

Model 

Sources

BASIS 

ICR 

2012-15 

No. 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

No. 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; 

# 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%
11

6(a) Estimating Respondent Burden

Firms will undertake the following actions in response to a TSCA section 8(d) listing:

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.

The unit burden associated with each of these tasks is discussed in more detail below and 

then summarized in Table 4.

Step 1. 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 

thus may 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 time frame of the reporting period. 

Note that unless EPA specifies otherwise, the coverage of section 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 two hours of 

managerial time for each firm manufacturing a listed chemical.

Step 2. 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 three managerial hours per firm.

Step 3. 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. 
12

It is estimated that the search will take an average of three hours of technical time per site. Per 

Table 3, there is an average of 1.5 sites per firm 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). 

Step 4. 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 been completed yet, 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. Because the major burden of 

compiling this list was incurred during the file search, the only significant remaining burden is 

the clerical time involved in transcribing the lists. The transcription is estimated to require an 

average of one hour of time per firm. 

Step 5. Photocopy Studies. As shown in Table 3, there is a per-firm average of 9 studies 

with an average page length of 20 pages, for an average of 180 pages per firm. Copying the 

studies to be submitted is estimated to require an average of 1 hour of clerical time per firm. 

Step 6. 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 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. It is estimated that 8 to 16 hours of 

technical time are needed to develop and QA/QC a robust summary, depending on the type of 

study conducted. This analysis 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 10% of studies may

include a robust summary. As shown in Table 3, there is a per-firm average of 9 studies which 

yields 0.9 robust summaries per firm. Rounding to one robust summary per firm, the estimated 

average burden per firm for robust summaries is 12 hours of technical time (1 robust summary * 

12 hours/summary).

Step 7. Review Responses for Confidential Business Information. Firms will need to 

review responses for possible confidential business information (CBI) and delete any material 

that is considered by the firm to be CBI from one copy of the study. (Another copy must be 

submitted without deletions.) As shown in Table 3, there is a per-firm average of 9 studies with 

an average page length of 20 pages. CBI review is estimated to take an average of one hour of 

managerial time for each study. This results in an estimate that CBI review will require an 

average of 9 hours of managerial time per firm.

Step 8. 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. Photocopying is estimated to require an average of 

0.1 hours per firm of clerical labor and CBI review will require an average of one hour of 
13

managerial time.

Table 4 summarizes unit burden estimates. These estimates assume that reporting is 

similar to the 2006 experience (see Tables 1-3). Note also that not all respondents incur every

aspect of reporting burden. The proportion of affected respondents are indicated by weights in 

Table 4, with a weight of one assigned to steps which affect all respondents. 

Table 4. 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. Study Title Lists 0.168 1clerical

5. Photocopy Studies

0.168 1

clerical

6. Robust Summaries 0.008 12 technical

7. CBI Review 0.168 9 managerial

8. Post-Reporting Period 

Submission

0.008

1

managerial

0.1 clerical

*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. As with any average, some firms will be 

above the average and others will be below it. 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 than the 

average.

6(b) Estimating Respondent Costs

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 
14

Costs for Employee Compensation (ECEC) manufacturing industry data from 2010. 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 

$69.65/hr; for technical labor at $60.95/hr; and for clerical labor at $28.99/hr. 

Table 5: Loaded Industry Wage Rates (2010)

EPAB Labor 

Category Data Sourcesd Date

Hourly 

Wage

Fringe 

Benefit

Fringes 

as % 

wage

Overhead 

% 

wageb

Fringe + 

overhead 

factorc

Loaded 

Wagesa

(A) (B) (C) 

=(B)/(A)

(D) (E) 

=(C)+(D)+1

(F) 

=(A)*(E)

Managerial

BLS ECEC, 

Private 

Manufacturing 

industries, “Mgt, 

Business, and 

Financial”

Avg of 

Mar, 

June, 

Sept, 

Dec

$42.97 $19.38 45% 17% 1.62 $69.65

Professional/ 

Technical

BLS ECEC, 

Private 

Manufacturing 

industries, 

“Professional and 

related“

Avg of 

Mar, 

June, 

Sept, 

Dec

$36.50 $18.25 50% 17% 1.67 $60.95

Clerical

BLS ECEC, 

Private 

Manufacturing 

industries, “Office 

and Administrative 

Support”

Avg of 

Mar, 

June, 

Sept, 

Dec

$17.29 $8.77 50% 17% 1.68 $28.99

Notes:

a Wage data are rounded to the cent in this table; however, in calculations, 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-Mach 2011, US Bureau of 

Labor Statistics, June 8, 2011 (pp 17,18,20) (http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf, accessed July 13, 2011).

A typical firm submitting a response will engage in review of the rule, site identification, 

site file search, preparing study title lists, photocopying studies, and CBI review, and possibly

submit a robust summary 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

(see Table 3), the average annual cost for a firm is estimated at $744 for 11.5 hours of burden.
15

6(c) Estimating the Respondent Universe and Total Burden and Costs

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 17 chemicals per year. In more recent ICR renewal periods, the frequency of 

additions has been higher (see Table 1). 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 2012 to 2015, for a total of 

210 chemicals over the three year ICR period. 

The total number of responses over the next three years is projected based on the 

frequency of chemical additions (stated above) and anticipated reporting implications, as 

observed in 8(d) reports submitted in response to the 2006 rule (see Table 3). Applying the 

Table 3’s average of 1.7 manufacturers per chemical to the average of 70 chemicals per year that 

are assumed to be added to the section 8(d) list over the next three years results in an estimate 

that there will be 119 manufacturers per year with chemicals added to the section 8(d) list during 

the time frame covered by this ICR. 

Assuming the reporting bases of Table 3, with 17 percent of the manufacturers of listed 

chemicals, or 20 firms (0.17 * 119 manufacturers), will submit reports each year. Of these 20 

firms, an estimated total of 180 studies will be submitted annually (20 firms* 9 studies per firm).

From this group of firms, one firm will submit a robust summary per year. And one 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 activities is summarized in Table 

5. Refer to Section 6(a) for detailed descriptions of the steps. Note that not all respondents incur 

every aspect of reporting burden. For this analysis, the conditions of the 2006 rule and its 

reporting implications (per Table 3) along with the condition of 70 chemical additions per year 

are assumed.

Table 6: Number of Firms Affected, by Activity 

(70 Chemicals Added Per Year; Table 3 Bases)

Collection Activity

BASIS 

ICR 2012-15 

No. of Firms

1. Review of Rule 119

2. Site Identification 119

3. Site File Search 119

4. Study Title Lists 20

5. Photocopy Studies 20

6. Robust Summaries 1

7. CBI Review 20

8. Post-Reporting Period Submission 1
16

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

unit burden hours and cost from Tables 4 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 7. 

Table 7. 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

Subtotal

1. Review of 

Rule

2. Site 

Identification

3. Site File 

Search

2

3

4.5

managerial

managerial

technical

$139

$209

$274

119

119

119

119

238

357

536

1,131

$16,578

$24,867

$32,641

$74,086

Submission of 

health and safety 

studies during the 

reporting period

Subtotal

4. Study Title 

Lists

5. Photocopy 

Studies

6. Robust 

Summaries 

7. CBI Review 

1

1

12

9

clerical

clerical

technical

managerial

$29

$29

$731

$627

20

20

1

20

21

20

20

12

180

232

$580

$580

$731

$12,538

$14,429

Notification and 

Submission of 

health and safety 

studies initiated 

and/or completed 

after the reporting 

period

Subtotal

8. PostReporting 

Period 

Submission 

1

0.1

managerial

clerical

$70

$3

1

1

1

1

0.1

1

$70

$3

$73

Total 141 1,364 $88,588

* “Number of responses” for searching files is presented only to compute total burden. Some firms that search their 

files do not have any studies that must be reported under the TSCA section 8(d) rule. 
17

6(d) Bottom Line Burden Hours and Cost Tables

As shown in Table 7, if EPA adds 70 chemicals per year to the TSCA section 8(d) list 

during the time period covered by this ICR, burden will be incurred by 119 firms yielding an 

estimated total of 1,364 burden hours per year at a cost of $88,588 per year. The average burden 

and cost per firm is estimated at 11.5 hours and $744, respectively.

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

(per Table 3) 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. 

6(e) Estimating Agency Cost 

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

information collected under this rule include processing and analyze rule submissions, 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 2011 hourly wage rate 

for this level of employee in the Washington, D.C. locality is $48.35 per hour. Adding 60% for 

benefits and overhead yields a loaded annual wage rate of $77.36 per hour.2

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

collection totals $5,415, for 70 hours as presented in Table 8.

Table 8. Agency Annual Cost Estimates

Collection Activity FTEs 

Hours 

Annual 

Cost (at $77.36/hour)

Data processing and system support 0.025 50 $3,868 

Storage and distribution 0.010 20 $1,547 

TOTALS 0.035 70 $5,415 

Source: OPM 2011 hourly rate table for the Washington-Baltimore-Northern Virginia Locality Pay Area, with 

60% for benefits and overhead added.

6(f) Reasons For Changes in Burden

There is an increase of 908 hours (from 456 hours to 1,364 hours) in the total estimated 

respondent burden compared with that currently in the OMB inventory. This change is due to a 

 

2 The EPA wage rate is calculated based on the GS-13 Step 5 wage rate for calendar 2011, 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).
18

revised basis for the rate of chemical additions (from 20 to 70 chemicals per year) and to the 

episodic nature of rulemakings that add chemicals to the TSCA section 8(d) list. In light of most 

recent history of additions by ICR Period, EPA is basing estimates for this ICR on 70 chemical 

additions per year -- similar to the 2006-2009 ICR period -- and on reporting implications similar 

to those brought on by chemical additions to TSCA 8(d) in the 2006 rule. 

6(g) 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 9.7 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. In 

addition, the OMB control numbers for EPA’s regulation in Title 40 of the CFR, after initial 

display in the final rule, are listed in 40 CFR part 9.

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPPT-2011-0777, which is available for online viewing at www.regulations.gov, or in person 

viewing at the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., 

NW., Washington, DC. The EPA Docket Center 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 

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-2011-0777 and 

OMB Control No. 2070-0004, to EPA online using www.regulations.gov (our preferred method), 

or by mail to: Document Control Office (DCO), Office of Pollution Prevention and Toxics 

(OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200 Pennsylvania Ave., NW, 

Washington, D.C. 20460.
19

ATTACHMENTS

All of the attachments listed below can be found in the docket for this ICR (unless otherwise 

noted); accessible electronically through www.regulations.gov. On the main page, select 

Advanced Search from the menu bar at the top and select Docket Search. Enter the Docket ID

Number, EPA-HQ-OPPT-2011-0777 in the Docket ID field. Click on the Submit button. From 

the results page, you will be able to link to the docket view or directly open select documents 

found in the docket.

ATTACHMENT 1 - Toxic Substances Control Act Section 8(d), 15 U.S.C. 2607(d)

ATTACHMENT 2 - Health and Safety Data Reporting, 40 CFR 716