TSCA Section 8(d):Economic Impact Analysis for 

the Addition of Manufacturers and Importers of 

Consumer Products Containing

Cadmium Compounds 

of the TSCA Interagency Testing Committee to the 

Health and Safety Data Reporting Rule

Economics, Exposure and 

TSCA Section 8(d):Economic Impact Analysis for 

the Addition of Manufacturers and Importers of 

Consumer Products Containing Cadmium and 

Cadmium Compounds from the Sixty-Ninth Report 

of the TSCA Interagency Testing Committee to the 

Health and Safety Data Reporting Rule

June 28, 2012

—Does not contain TSCA CBI—

Prepared by:

Economic and Policy Analysis Branch

Economics, Exposure and Technology Division

Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, N.W.

Washington, DC 20460

TSCA Section 8(d):Economic Impact Analysis for 

the Addition of Manufacturers and Importers of 

Cadmium and 

Report 

of the TSCA Interagency Testing Committee to the 

Health and Safety Data Reporting Rule

—

Economic and Policy Analysis Branch

Technology Division

Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency
Contributors

The EPA analyst responsible for this report is Joseph Callahan of the Economic and Policy Analysis 

Branch; Economics, Exposure and Technology Division; Office of Pollution Prevention and Toxics. 

Analytical and draft preparation support was provided by Abt Associates, Inc. under EPA Contract No. 

EP-W-08-010.
i

Table of Contents

Chapter 1 – Introduction.........................................................................................................................1-1

1.1 Statutory Authority .......................................................................................................................1-1

1.2 Regulatory Background ................................................................................................................1-1

1.3 Statement of Need.........................................................................................................................1-1

1.3.1 Inadequate Information ....................................................................................................1-2

1.3.2 Externalities......................................................................................................................1-2

1.3.3 Effect of the Final Rule ....................................................................................................1-3

1.4 Summary of Methodology ............................................................................................................1-3

1.5 Organization of This Report .........................................................................................................1-3

Chapter 2 – Affected Entities..................................................................................................................2-1

2.1 Cadmium and Cadmium Compounds Subject to the Final Rule ..................................................2-1

2.2 The Regulated Community...........................................................................................................2-1

Chapter 3 – Industry Compliance Costs................................................................................................3-1

3.1 Introduction...................................................................................................................................3-1

3.2 Wage Rates...................................................................................................................................3-1

3.3 Industry Compliance Costs...........................................................................................................3-1

3.3.1 Initial Review of the Rule ................................................................................................3-2

3.3.2 Site Identification .............................................................................................................3-3

3.3.3 File Searches at Identified Sites.......................................................................................3-4

3.3.4 Preparing Study Title Lists...............................................................................................3-5

3.3.5 Photocopying Studies.......................................................................................................3-6

3.3.6 Review of Studies for Confidential Business Information...............................................3-7

3.3.7 Post-Reporting Submission of Ongoing or Newly Initiated Studies................................3-8

3.4 Summary Total Industry Compliance Costs.................................................................................3-9

Chapter 4 – Agency Costs .......................................................................................................................4-1

4.1 Introduction...................................................................................................................................4-1

4.2 Derivation of Agency Wage Rates................................................................................................4-1

4.3 Agency Costs................................................................................................................................4-2

Chapter 5 – Total Social Costs................................................................................................................5-1

Chapter 6 – Benefits.................................................................................................................................6-1

Chapter 7 – Small Entity Impact Analysis ............................................................................................7-1

Chapter 8 – Other Impact Analyses.......................................................................................................8-1

8.1 Paperwork Reduction Act (PRA)..................................................................................................8-1

8.1.1 Industry Burden................................................................................................................8-1

8.1.2 Government Burden .........................................................................................................8-2

8.2 Unfunded Mandates Reform Act (UMRA) ..................................................................................8-2

8.3 Executive Order 12866 – Regulatory Planning and Review ........................................................8-2

8.4 Executive Order 13132 – Federalism............................................................................................8-3

8.5 Executive Order 13175 – Consultation and Coordination with Indian Tribal Governments........8-3

8.6 Executive Order 13045 – Children’s Health.................................................................................8-3

8.7 Executive Order 12898 – Environmental Justice..........................................................................8-3

8.8 Executive Order 13211 – Energy Supply, Distribution, or Use....................................................8-4

8.9 National Technology Transfer and Advancement Act..................................................................8-4

Chapter 9 – References............................................................................................................................9-1
ii

List of Tables

Table 2-1: Number of Firms and Sites per NAICS....................................................................................2-1

Table 3-1: Derivation of Loaded Industry Wage Rates (2011$)................................................................3-1

Table 3-2: Unit Industry Burden for Initial Review of the Rule................................................................3-2

Table 3-3: Total Industry Burden for Initial Review of the Rule ..............................................................3-3

Table 3-4: Unit Industry Burden for Site Identification.............................................................................3-3

Table 3-5: Total Industry Burden for Site Identification ...........................................................................3-4

Table 3-6: Unit Industry Burden for File Searches at Identified Sites.......................................................3-4

Table 3-7: Total Industry Burden for File Searches at Identified Sites .....................................................3-5

Table 3-8: Unit Industry Burden for Preparing Study Title Lists..............................................................3-5

Table 3-9: Total Industry Burden for Preparing Study Title Lists.............................................................3-6

Table 3-10: Unit Industry Burden for Photocopying Studies....................................................................3-6

Table 3-11: Total Industry Burden for Photocopying Studies...................................................................3-7

Table 3-12: Unit Industry Burden for CBI Review ...................................................................................3-7

Table 3-13: Total Industry Burden for CBI Review..................................................................................3-8

Table 3-14: Unit Industry Costs for Post-Reporting Submissions.............................................................3-8

Table 3-15: Total Industry Costs for Post-Reporting Submissions ...........................................................3-9

Table 3-16: Summary of Total Industry Costs for the TSCA Section 8(d) Information Collection..........3-9

Table 4-1: Derivation of Loaded Agency Wage Rates..............................................................................4-1

Table 4-2: Total Agency Burden for the TSCA Section 8(d) Information Collection ..............................4-2

Table 5-1: Total Social Cost and Burden of the Final Rule.......................................................................5-1

Table 7-1: Calculations of Average and High Cost per Company.............................................................7-2

Table 8-1: Total Hourly Industry Burden ..................................................................................................8-2

Table 8-2: Total Hourly Industry Burden ..................................................................................................8-2
iii

Executive Summary

This economic analysis estimates and evaluates the costs and benefits of collecting information for 

cadmium and cadmium compounds that are reasonably likely to be, or have been incorporated into 

consumer products by the U.S. Environmental Protection Agency (EPA), under the authority granted by 

Section 8(d) of the Toxic Substances Control Act (TSCA). Manufacturers and importers of cadmium and 

cadmium compounds will be required to submit lists and/or copies of ongoing and completed, 

unpublished health and safety studies. EPA's TSCA Section 8(d) "Health & Safety Data Reporting Rule" 

was developed to gather the health and safety information on chemical substances and mixtures needed 

by EPA to carry out its TSCA mandates (e.g., to support OPPT's Existing Chemicals Program and 

Chemical Testing Program and to set priorities for TSCA risk assessment/management activities).

EPA conservatively estimates that there are approximately 1,384 U.S. cadmium and cadmium compound

manufacturers and importers (see Chapter 2). However, only 28 firms are expected to submit relevant 

studies under the rule (see Chapter 3).

Under the final rule, industry is conservatively estimated to incur a burden and cost of approximately 

7,000 hours and $480,500 (see Chapter 3), while the Agency is expected to incur a burden and cost of 

approximately 300 hours and $23,000 (see Chapter 4), for a total burden and cost of approximately 7,300

hours and $503,000.

As required by the Regulatory Flexibility Act of 1980 and the Small Business Regulatory Enforcement 

Fairness Act of 1996, the small entity impact analysis conducted in Chapter 7 is based on small business 

definitions provided by the U.S. Small Business Administration (SBA). EPA expects that compliance 

with the rule will not have a significant economic impact on a substantial number of small entities.

The benefits resulting from the final rule are discussed qualitatively in Chapter 6 of this report. By 

enhancing the data supplied to Agency risk-screening programs, EPA expects to more effectively and 

expeditiously reduce the potential risks posed by consumer exposure to cadmium The U.S. Consumer 

Product Safety Commission (CPSC) and EPA are concerned with the content of cadmium and cadmium 

compounds in certain children’s toys, jewelry, and other consumer products due to known toxicity and 

health concerns from exposure to cadmium and cadmium compounds (FR Notice, Volume 76, No. 147, p. 

46176). However, neither CPSC nor EPA currently has complete information for assessing the safety of 

consumer products that may contain cadmium or cadmium compounds. Information obtained through the 

rule may assist both EPA and CPSC in taking further action as appropriate to protect consumers and 

children from exposure to cadmium and cadmium compounds in consumer products 
1-1

Chapter 1– Introduction

This report estimates and evaluates the costs and benefits expected to result from an information 

collection rule for cadmium and cadmium compound manufacturers and importers proposed by the U.S. 

Environmental Protection Agency (EPA) under the authority granted by Section 8(d) of the Toxic 

Substances Control Act (TSCA). The rule will require manufacturers (including importers) of cadmium 

and cadmium compounds that are reasonably likely to be, or have been incorporated into consumer 

products to provide copies of unpublished health and safety studies to EPA. Section 1.1 provides 

background information on EPA’s statutory authority for the proposed rule; Section 1.2 reviews the 

regulatory background; Section 1.3 discusses the need for the regulation; Section 1.4 presents a brief 

summary of the methodology used in the analysis; and Section 1.5 describes the organization of the 

remainder of this report.

1.1 Statutory Authority

Under TSCA Section 8(d), EPA has the authority to promulgate rules to require manufacturers, importers, 

processors and distributors to submit lists and/or copies of ongoing and completed, unpublished health 

and safety studies. EPA's TSCA Section 8(d) "Health & Safety Data Reporting Rule" was developed to 

gather health and safety information on chemical substances and mixtures needed by EPA to carry out its 

TSCA mandates (e.g., to support OPPT's Existing Chemicals Program and Chemical Testing Program 

and to set priorities for TSCA risk assessment/management activities). EPA has also used its TSCA 

Section 8(d) authority to gather information needed by other EPA Program Offices and other federal 

agencies. Chemicals that are designated or recommended for testing by the TSCA Interagency Testing 

Committee (ITC) http://www.epa.gov/opptintr/chemtest/pubs/whatitc.html are added to the rule via 

immediate final rulemaking (up to 50 substances/year) unless EPA finds exception under 40 CFR 

716.105(c). Non-ITC chemicals can be added to the Section 8(d) rule via notice and comment 

rulemaking. 

1.2 Regulatory Background

On September 2, 1982, EPA issued the Health and Safety Data Reporting Rule (HSDRR) under Section 

8(d) of the Toxic Substances Control Act (TSCA). The rule was modified in 1986 (51 FR 32720, 

September 15, 1986) and then again in 1998 (63 FR 15765, April 1, 1998). The rule, as modified, 

establishes a set of requirements and procedures for the submission of lists and copies of unpublished 

health and safety studies by manufacturers (including importers) and (if specified) processors of specified 

chemical substances and mixtures. These specified chemical substances and mixtures become subject to 

the requirements of the HSDRR when the Agency adds them to the HSDRR by amendment. The 

amendment process can be triggered by a listing of the substance or mixture by the Interagency Testing 

Committee (ITC). This final rule adds cadmium and cadmium compounds to the list of chemical 

substances at 40 CFR 716.120 resulting from action by the Interagency Testing Committee (ITC) adding 

such chemical substances to the Priority Testing List through its 68th ITC Report.

1.3 Statement of Need

Executive Order 12866 requires regulatory Agencies to identify the specific market failure that a 

significant rule addresses. The major causes of market failure identified in the Office of Management and 

Budget (OMB) guidance (OMB, 2003) on Executive Order 12866 are externality, natural monopoly, 

market power, and inadequate or asymmetric information. The final rule is designed to address the issue 

of inadequate information about the health and safety effects of cadmium exposure and, to the extent that 
1-2

new information indicates the presence of negative externalities, inform future rulemaking governing the 

manufacture and import, of cadmium and cadmium compounds.

1.3.1 Inadequate Information

Economic theory requires that buyers and sellers have complete information about the costs and benefits 

of their economic choices to produce an efficient allocation of resources. When buyers or sellers do not 

have perfect information, rational decision making cannot occur and a market failure exists. As an 

example, a manufacturer may not consider substituting a less hazardous chemical for a hazardous 

chemical if knowledge about either chemical’s hazard is unknown or uncertain. More complete 

information on the hazards associated with the chemical will allow a manufacturer to make more socially 

efficient decisions.

There are many reasons why information regarding the hazards associated with a chemical substance may 

not be widely known. Two of these reasons are:

 Manufactures may know this information but have no incentive to act on it or reveal it to their 

customers (because the costs are not borne by, and are therefore external to, the producer).

 This information may be unknown to both the producers and their customers.

The first of these reasons is known as asymmetric information; that is, a case in which consumers and 

producers do not have the same level of information regarding the aggregate production, uses, and 

hazards of by a chemical substance. Typically, the manufacturer’s level of information regarding these 

items, particularly hazards, exceeds the consumers’ level of information.

In the second case, chemical production, use, and hazard information is inadequate and/or unavailable 

(i.e., unknown to both consumers and producers). Manufacturers may have little incentive to acquire 

such information due to the potential costs associated with its acquisition. Information is by nature a 

public good; that is, non-rival (one person’s use of information does not diminish the amount remaining 

for other users) and non-excludable (once made available, information cannot be easily withheld from 

others). Thus, where information is provided by one person, others are free to use and benefit from that 

information without having made a contribution to its development. This situation reduces the incentive 

to provide the information, resulting in a failure of the market to efficiently provide the information. In 

addition, individual consumers are unlikely to be willing to pay the cost of collecting and reporting 

information if they can use information developed and paid for by others.

1.3.2 Externalities

Externalities are another cause of market failure. An externality occurs when the actions of one economic 

agent impose costs (or benefits) on parties that are “external” to the market transaction; that is, these costs 

(or benefits) are not borne by the producers or consumers directly involved. Such is the case where 

manufacturing or other business activities harm human health or the environment in excess of the costs 

borne by the parties to this activity, resulting in negative externalities. When information is missing about 

the human health and environmental costs to society, or when these costs are external to producers’ 

decision making, the costs are not incorporated into business decisions. The result can be the overuse 

and/or overproduction of certain harmful products.

EPA often intervenes when negative externalities pose risks to human health and the environment. For 

example, risks may arise as a result of chemical exposure to the general population from the manufacture, 

processing, and use of chemicals. As a first step in mitigating externalities, the EPA Office of Pollution 

Prevention and Toxics (OPPT) routinely screens chemicals for the potential risks they may pose. This 

screening is used to determine if risks from the manufacture, processing, or use of chemicals are of 
1-3

sufficient concern to warrant risk management. Given that EPA’s TSCA Inventory recognizes more than 

75,000 chemicals in commerce, chemical risk screening represents a significant effort. Risk is a function 

of hazard and exposure and when information on either is lacking, EPA’s ability to effectively identify 

significant risks arising from externalities is compromised.

1.3.3 Effect of the Final Rule

The final rule may address market failure due to inadequate information by ensuring that basic 

information about the health and safety effects of manufactured or imported cadmium and cadmium 

compounds that have been or are reasonably likely to be incorporated into consumer products is available 

to the Agency. This information can be used by EPA to make more informed decisions regarding the 

production, sale, and use of cadmium and cadmium compounds. 

1.4 Summary of Methodology

This analysis seeks to quantify, to the extent possible, the costs to society of the final rule by identifying 

the costs to industry (and to small entities, in particular) associated with performing the required reporting 

and recordkeeping, and the costs to EPA of administering the rule. Industry costs consist of the collection, 

compilation, and submission of required information by each reporting firm. Agency costs include 

reviewing and processing the data received as a result of the rule. Small entity impact is defined as a small 

business’ estimated cost of compliance with the final rule as a percent of sales. Data sources for this 

analysis include burden estimates derived from information collection requests for similar regulations, 

compensation data acquired from government publications, and supplementary market research to 

produce an estimate of the universe of affected entities. EPA believes the inputs for this analysis (e.g., 

estimated size of universe) are conservative and that the final burden and cost estimates are therefore 

conservative (i.e., the total cost of the final rule may be overestimated).

This report qualitatively discusses the benefits of the final rule based on the value of the information it 

will provide. The benefits analysis was undertaken to address the implicit call for cost-benefit balancing 

contained in TSCA, as well as the requirements of Executive Order 12866.

1.5 Organization of This Report

The remainder of this report provides EPA’s economic analysis in support of the final rule. The affected 

chemical substances and companies are characterized in Chapter 2. Chapter 3 estimates industry cost of 

complying with the final rule, and Chapter 4 estimates government costs associated with the 

administration of the final rule. Chapter 5 presents the total social costs. Chapter 6 addresses the benefits 

of the final rule using a “value of information” framework. Chapter 7 provides the small entity impact 

analysis for the final rule. Several additional impact analyses are presented in Chapter 8, including: a 

burden hour analysis, which responds to the requirements of the Paperwork Reduction Act (PRA); an 

unfunded mandates statement, which is required by the Unfunded Mandates Reform Act (UMRA); an 

environmental justice statement, which addresses the requirements of Executive Order 12898; and a 

children’s health statement, which is mandated by Executive Order 13045. Note that all dollar amounts in 

this analysis are reported in Q4 2011 dollars.1

 

1 Q4 2011 is specified as the three-month period beginning September 1, 2011 and ending December 31, 2011. As 

explained in Chapter 3, industry wage data were acquired from the Bureau of Labor Statistics Employer Costs for 

Employee Compensation tables for Q4 2011. Government wage data were only available for the full calendar year, 

as federal salary grades and steps are fixed in advance.
2-1

Chapter 2 – Affected Entities

This chapter presents information about the chemicals, manufacturers, and importers subject to the final

rule. Section 2.1 provides the chemicals subject to the rule; and Section 2.1 describes and estimates the 

population of affected organizations.

2.1 Cadmium and Cadmium Compounds Subject to the Final Rule

This rule applies to all cadmium and cadmium compounds being manufactured in or imported into the 

United States that have been, or are reasonably likely to be, incorporated into consumer products. This 

rule is not intended to be restricted to specific chemicals. All manufacturers and importers of products 

containing cadmium and cadmium compounds are subject to this final rule.

2.2 The Regulated Community

The number of firms that will be subject to this rule cannot be estimated directly, because of the large 

number of chemicals and products that use cadmium and cadmium compounds. To estimate the number 

of firms EPA has followed the approach used for identifying firms outlined in the TSCA Section 8(d): 

Economic Impact Analysis for Adding Lead and Lead Compounds from the 60th Report of the TSCA 

Interagency Testing Committee to the Health and Safety Data Reporting Rule (EPA, 2007). The Agency

has chosen to estimate the number of affected firms listed in Table 2-1 by using U.S. Census data of the 

number of firms included in certain NAICS categories. The categories are selected with the expectation 

that they include firms which may be engaged in manufacturing or importing cadmium and cadmium 

compounds. All figures in Table 2-1 were taken directly from the 2009 Statistics of U.S. Businesses data

(U.S. Census Bureau, 2009). EPA expects that about 1,384 firms and 1,865 sites will be subject to the 

final rule. 

Table 2-1: Number of Firms and Sites per NAICS

NAICS Industry Description

Number 

of Firms 

in NAICS

Number of 

Sites in 

NAICS

325188

All other basic 

inorganic 

chemical 

manufacturing

This U.S. industry comprises establishments 

primarily engaged in manufacturing basic inorganic 

chemicals (except industrial gases, inorganic dyes 

and pigments, alkalies and chlorine, and carbon 

black).

390 637

325131

Inorganic dye 

and pigment 

manufacturing

This U.S. industry comprises establishments 

primarily engaged in manufacturing inorganic dyes 

and pigments.

66 87

325199

All other basic 

organic chemical 

manufacturing

This U.S. industry comprises establishments 

primarily engaged in manufacturing basic organic 

chemical products (except aromatic petrochemicals, 

industrial gases, synthetic organic dyes and 

pigments, gum and wood chemicals, cyclic crudes 

and intermediates, and ethyl alcohol).

569 729

331419

Primary smelting 

and refining of 

nonferrous metal 

(except copper 

and aluminum)

This U.S. industry comprises establishments 

primarily engaged in (1) making (i.e., the primary 

production) nonferrous metals by smelting ore 

and/or (2) the primary refining of nonferrous metals 

by electrolytic methods or other processes.

143 166
2-2

NAICS Industry Description

Number 

of Firms 

in NAICS

Number of 

Sites in 

NAICS

331492

Secondary 

smelting, 

refining, and 

alloying of 

nonferrous metal 

(except copper 

and aluminum)

This U.S. industry comprises establishments 

primarily engaged in (1) alloying purchased 

nonferrous metals and/or (2) recovering nonferrous 

metals from scrap. Establishments in this industry 

make primary forms (e.g., bar, billet, bloom, cake, 

ingot, slab, slug, wire) using smelting or refining 

processes.

216 246

Total 1,384 1,865

Source:

U.S. Census Bureau, 2009. United States Census Bureau. “2009 Statistics of U.S. Businesses”. Available at 

http://www.census.gov/econ/susb/ (Accessed March, 2012).

.
3-1

Chapter 3 – Industry Compliance Costs

3.1 Introduction

This chapter presents estimates of the total costs that cadmium and cadmium compound manufacturers

and importers may incur due to the requirements included in the final rule and discusses the method used 

to measure each. The final rule requires that firms incur a one-time cost related to the reporting pertaining 

to gathering health and safety studies for cadmium and cadmium compounds. 

3.2 Wage Rates

Wages and fringe benefit data for managerial, professional/technical, and clerical labor are from the BLS 

Employer Costs for Employee Compensation (ECEC) historical data for December 2011 (BLS, 2012).

The costs of fringe benefits such as paid leave and insurance, specific to each labor category, are taken 

from the same BLS report (BLS, 2012). Fringe benefits as a percentage of wages are calculated separately 

for each labor category. For example, for December 2011, the average wage rate for professional/ 

technical labor was $38.48, and the average fringe benefit was $19.64. Therefore, fringe benefits as a 

percentage of wages were $19.64/$38.48, or approximately 51 percent (See Table 3-1).

An additional loading factor of 17 percent is applied to wages to account for overhead. This approach is 

used for consistency with Office of Pollution Prevention and Toxics (OPPT) economic analyses for two 

major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program, June 

2002 (EPA, 2002b), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final 

Report, August 2002 (EPA, 2002a). This overhead loading factor is added to the benefits loading factor, 

and the total is then applied to the base wage to derive the fully loaded wage. For example, the December 

2011 fully loaded wage for professional/technical labor is $38.48 × (1+ 0.51 + 0.17) = $64.66 (See Table 

3-1).

Table 3-1: Derivation of Loaded Industry Wage Rates (2011$)

Wage1 Fringe 

Benefits1

Fringes as % 

Wage

Overhead 

% Wage2

Fringe + 

Overhead 

Factor

Loaded 

Wages

(a) (b) (c) = (b)/(a) (d) (e)=(1)+(c)+(d) (f) = (a) x (e)

Managerial $43.01 $20.40 47.43% 17% 1.644 $70.72

Technical $38.48 $19.64 51.04% 17% 1.680 $64.66

Clerical $17.69 $8.93 50.48% 17% 1.675 $29.63

Notes:

1 Employer Costs for Employee Compensation Supplementary Tables: December 2011, US Bureau of 

Labor Statistics, March 14, 2012 (BLS, 2012).

2 An overhead rate of 17% was estimated based on industry data gathered for the Revised Economic 

Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a)

Loaded wage rates may not calculate due to rounding of the Fringe & Overhead Factor

3.3 Industry Compliance Costs

EPA expects that firms subject to the rule will undertake the following actions in response to a TSCA 

section 8(d) listing:
3-2

1. Rule Review: Determine whether the firm may be required to report, and if so, review the rule in 

more detail;

2. Site Identification: Conduct a corporate review to identify which firm sites must be searched to 

locate the appropriate health and safety studies;

3. File Searches at Identified Sites: Search the files at appropriate sites to locate relevant studies;

4. Preparing Study Title Lists: 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. Photocopying Studies: Photocopy the studies being submitted;

6. Review Studies for CBI: Review the responses for possible confidential business information; 

and

7. Post-Reporting Submissions: Submit studies completed after the reporting period.

This section describes the unit and total industry burdens associated with each of the above tasks. 

3.3.1 Initial Review of the Rule

Firms are expected to use management level personnel to perform an initial review of the rule to 

determine whether they are subject to the reporting requirements and to understand the specific 

requirements. This review is expected to take a total of two hours per firm and cost approximately $141, 

as show in Table 3-2 (EPA, 2008). 

Table 3-2: Unit Industry Burden for Initial Review of the Rule

Collection 

Activity

Burden per Firm1 Cost per Firm (2011$)2

Managerial Technical Clerical Total Managerial

($70.72/hr)

Technical

($64.66/hr)

Clerical

($29.63/hr) Total

Rule

Review

2.00 0.00 0.00 2.00 $141.44 $0.00 $0.00 $141

Sources:

1 Burden estimates are from 2008 ICR for Health and Safety Data Reporting, Submission of Lists and Copies of Health and 

Safety Studies, EPA ICR No: 0575.12 (EPA, 2008 page 10).

2 Loaded wage rates are derived in Table 3-1 of this report

The number of manufacturers was estimated using assumptions made in previous TSCA Section 8(d) 

Economic Analyses (TSCA Section 8(d): Economic Impact Analysis for Adding Lead and Lead 

Compounds from the 60th Report of the TSCA Interagency Testing Committee to the Health and Safety 

Data Reporting Rule (EPA, 2007) and Economic Analysis of the Addition of Chemicals from the 55th, 

56th, and 58th ITC Report to the 8(d) Health and Safety Data Reporting Rule (EPA, 2006) EPA believes 

that all 1,384 firms identified as potential manufacturers or importers of cadmium or cadmium 

compounds in Table 2-1 will complete this step. Therefore, as shown in Table 3-3 the total industry 

burden associated with initial review of the rule is approximately 2,768 hours and $195,800. 
3-3

Table 3-3: Total Industry Burden for Initial Review of the Rule

Collection 

Activity

Unit 

Burden 

(hours)1

Unit Cost 

(2011$)1

Total Number 

of Firms 

Subject to the 

Rule2

Total Number 

of Firms 

Performing 

Activity3

Total 

Burden 

(hours)

Total Cost 

(2011$)

(a) (b) (c) (d)=(c)*1 (e) = (a) * (d) (f) = (b) * (d)

Review of

Rule 2.00 $141.44 1,384 1,384 2,768 $195,753

Sources:

1 Unit burden and cost estimates are derived in Table 3-2 of this report. 

2 The total number of firms is calculated in Table 2-1 of this report 

3 The percentage of firms conducting this activity is taken from TSCA Section 8(d): Economic Impact Analysis for Adding 

Lead and Lead Compounds from the 60th Report of the TSCA Interagency Testing Committee to the Health and Safety Data 

Reporting Rule (EPA, 2007, page 6). 

3.3.2 Site Identification 

Once a firm has determined that it is subject to the rule, it must conduct a corporate review to identify all 

the company sites that need to be searched for relevant health and safety studies. EPA estimates this 

review will take approximately 3 hours of management time and cost approximately $212 per firm (EPA, 

2008). 

Table 3-4: Unit Industry Burden for Site Identification

Collection 

Activity

Burden per Firm1 Cost per Firm2

Managerial Technical Clerical Total Managerial

($70.72/hr)

Technical

($64.66/hr)

Clerical

($29.63/hr) Total

Site 

Identification 3.00 0.00 0.00 3.00 $212.17 $0.00 $0.00 $212

Sources:

1 Burden estimates are from 2008 ICR for Health and Safety Data Reporting, Submission of Lists and Copies of Health and 

Safety Studies, EPA ICR No: 0575.12 (EPA, 2008 page 10).

2 Loaded wage rates are derived in Table 3-1 of this report.

Based on the assumptions used in the TSCA Section 8(d): Economic Impact Analysis for Adding Lead and 

Lead Compounds from the 60th Report of the TSCA Interagency Testing Committee to the Health and 

Safety Data Reporting Rule (EPA, 2007), EPA estimates that 43 percent of the 1,384 firms (595 firms) 

manufacture (or import) cadmium or cadmium compounds and will conduct an additional review to 

identify which corporate sites must be searched to locate any appropriate data. Table 3-5 contains the total 

industry burden and costs associated with site identification for the TSCA Section 8(d) collection; 1,785

hours and $126,200. 
3-4

Table 3-5: Total Industry Burden for Site Identification

Collection 

Activity

Unit 

Burden 

(hours)1

Unit Cost 

(2011$)1

Total Number 

of Firms 

Subject to the 

Rule2

Total Number 

of Firms 

Performing 

Activity3

Total 

Burden 

(hours)

Total Cost 

(2011$)

(a) (b) (c) (d)=(c)*0.43 (e) = (a) * (d) (f) = (b) * (d)

Site 

Identification 3.00 $212.17 1,384 595 1,785 $126,241

Sources:

1 Unit burden and cost estimates are derived in Table 3-4 of this report. 

2 The total number of firms is calculated in Table 2-1 of this report 

3 The percentage of firms conducting this activity is taken from TSCA Section 8(d): Economic Impact Analysis for Adding 

Lead and Lead Compounds from the 60th Report of the TSCA Interagency Testing Committee to the Health and Safety Data 

Reporting Rule (EPA, 2007, page 6). 

3.3.3 File Searches at Identified Sites

Sites that have been identified as possibly having the relevant health and safety data must search their 

files for the appropriate studies. EPA estimates this activity will take approximately 3 hours of technical

time and cost approximately $194 per site (EPA, 2008). 

Table 3-6: Unit Industry Burden for File Searches at Identified Sites

Collection 

Activity

Burden per Firm1 Cost per Firm2

Managerial Technical Clerical Total Managerial

($70.72/hr)

Technical

($64.66/hr)

Clerical

($29.63/hr) Total

File

Searches 0.00 3.00 0.00 3.00 $0.00 $193.98 $0.00 $194

Sources:

1 Burden estimates are from 2008 ICR for Health and Safety Data Reporting, Submission of Lists and Copies of Health and 

Safety Studies, EPA ICR No: 0575.12 (EPA, 2008 page 10).

2 Loaded wage rates are derived in Table 3-1 of this report

Given that 43 percent of firms have determined that they are subject to the rule, EPA assumes that 

subsequently 43 percent of sites will also be subject to the rule and conduct file searches (EPA, 2007). A 

total of 1,865 sites were identified as potential cadmium or cadmium compound manufacturers (including 

importers) (See Table 2-1). Therefore, as shown in Table 3-7, a total 802 sites (1,865 * 0.43) will perform 

file searches. The total industry burden associated with site identification is 2,406 hours and 

approximately $155,600. 
3-5

Table 3-7: Total Industry Burden for File Searches at Identified Sites

Collection 

Activity

Unit 

Burden 

(hours)1

Unit Cost 

(2011$)1

Total Number 

of Sites Subject 

to the Rule2

Total Number 

of Sites 

Performing 

Activity

Total 

Burden 

(hours)

Total Cost 

(2011$)

(a) (b) (c) (d)=(c)*0.43 (e) = (a) * (d) (f) = (b) * (d)

File 

Searches 3.00 $193.98 1,865 802 2,406 $155,572

Sources:

1 Unit burden and cost estimates are derived in Table 3-6 of this report. 

2 The total number of sites is calculated in Table 2-1 of this report 

3 The percentage of firms conducting this activity is taken from TSCA Section 8(d): Economic Impact Analysis for Adding 

Lead and Lead Compounds from the 60th Report of the TSCA Interagency Testing Committee to the Health and Safety Data 

Reporting Rule (EPA, 2007, page 6). 

3.3.4 Preparing Study Title Lists

Each firm that has identified relevant studies for submission to EPA will be required to submit copies of 

the studies along with a list of both their own on-going studies and identified studies that exist but which 

are not in their possession. The company cost of compiling the list is included in the file search cost 

described above. Following the 2008 ICR for Health and Safety Data Reporting, Submission of Lists and 

Copies of Health and Safety Studies , EPA ICR No: 0575.12 (EPA, 2008), this process is assumed to 

require one hour of clerical time per firm for the transcription of a required study title list. The total cost 

per firm is approximately $30 (See Table 3-8 ). 

Table 3-8: Unit Industry Burden for Preparing Study Title Lists

Collection 

Activity

Burden per Firm1 Cost per Firm2

Managerial Technical Clerical Total Managerial

($70.72/hr)

Technical

($64.66/hr)

Clerical

($29.63/hr) Total

Study 

Title Lists 0.00 0.00 1.00 1.00 $0.00 $0.00 $29.63 $29.63

Sources:

1 Burden estimates are from the 2008 ICR for Health and Safety Data Reporting, Submission of Lists and Copies of Health 

and Safety Studies, EPA ICR No: 0575.12 (EPA, 2008 page 10).

2 Loaded wage rates are derived in Table 3-1 of this report.

Based on best professional judgment of the Agency staff, EPA estimates that 2 percent of the 1,384 firms 

(28 firms) will have any relevant studies to submit to EPA. As shown in Table 3-9 the total burden for 

these 28 firms to prepare study title lists is approximately 28 hours and $830.
3-6

Table 3-9: Total Industry Burden for Preparing Study Title Lists

Collection 

Activity

Unit 

Burden 

(hours)1

Unit Cost 

(2011$)1

Total Number 

of Firms

Subject to the 

Rule2

Total Number 

of Firms

Performing 

Activity3

Total 

Burden 

(hours)

Total Cost 

(2011$)

(a) (b) (c) (d)=(c)*0.02 (e) = (a) * (d) (f) = (b) * (d)

Study Title 

Lists 1.00 $29.63 1,384 28 28 $830

Sources:

1 Unit burden and cost estimates are derived in Table 3-8 of this report. 

2 The total number of firms is calculated in Table 2-1 of this report.

3 The percentage of firms conducting this activity is taken from the 2008 ICR for Health and Safety Data Reporting, 

Submission of Lists and Copies of Health and Safety Studies, EPA ICR No: 0575.12 (EPA, 2008 page 14). 

3.3.5 Photocopying Studies

All relevant studies identified by a firm will need to be photocopied and submitted to EPA. For the 

purposes of this analysis, EPA assumes each of the 28 firms that have identified relevant health and safety 

studies will submit on average one study to the Agency. This estimate is based on the professional 

judgment of Agency personnel responsible for the 8(d) program. The 2008 TSCA Section 8(d) ICR (EPA, 

2008) estimates it will take one hour of clerical time to photocopy 9 studies with an average page length 

of 20 pages. Therefore, the total burden associated with photocopying one study is 0.11 hours. The total 

cost is estimated to be $3.29 per firm, as shown in Table 3-10. 

Table 3-10: Unit Industry Burden for Photocopying Studies

Collection 

Activity

Burden per Firm1 Cost per Firm2

Managerial Technical Clerical Total Managerial

($70.72/hr)

Technical

($64.66/hr)

Clerical

($29.63/hr) Total

Photocopy 

Studies 0.00 0.00 0.11 0.11 $0.00 $0.00 $3.29 $3.26

Notes:

Total cost may not exactly equal hourly wage times hourly burden, due to rounding of unit burden and wage estimates.

Sources:

1 Burden estimates are from the 2008 ICR for Health and Safety Data Reporting, Submission of Lists and Copies of Health and 

Safety Studies , EPA ICR No: 0575.12 (EPA, 2008 page 10).

2 Loaded wage rates are derived in Table 3-1 of this report.

Because EPA is assuming each of the 28 firms with relevant data will submit one study on average, a total 

of 28 studies are expected to be submitted from cadmium and cadmium compound manufacturers and 

importers. The total burden associated with photocopying 28 studies is 3.08 hours and approximately $91 

(see Table 3-11). 
3-7

Table 3-11: Total Industry Burden for Photocopying Studies

Collection 

Activity

Unit 

Burden 

(hours)1

Unit Cost 

(2011$)1

Total Number 

of Firms 

Subject to the 

Rule2

Total Number 

of Firms 

Performing 

Activity3

Total 

Burden 

(hours)

Total Cost 

(2011$)

(a) (b) (c) (d)=(c)*0.02 (e) = (a) * (d) (f) = (b) * (d)

Photocopy 

Studies 0.11 $3.26 1,384 28 3.08 $91.28

Sources:

1 Unit burden and cost estimates are derived in Table 3-10 of this report. 

2 The total number of firms is calculated in Table 2-1 of this report.

3 The percentage of firms conducting this activity is taken from the 2008 ICR for Health and Safety Data Reporting, 

Submission of Lists and Copies of Health and Safety Studies , EPA ICR No: 0575.12 (EPA, 2008 page 14). 

3.3.6 Review of Studies for Confidential Business Information 

Firms submitting health and safety studies will need to review responses for possible confidential 

business information (CBI). For each study with CBI claims two versions must be provided to EPA; one 

containing bracketed and underlined CBI information and one without the CBI information (see 

716.55(a)(4)(b)(1)). CBI review is estimated to take an average of one hour of managerial time for each 

study (EPA, 2008) and the total cost is estimated to be $70.72 per study (See Table 3-12).

Table 3-12: Unit Industry Burden for CBI Review

Collection 

Activity

Burden per Firm1 Cost per Firm2

Managerial Technical Clerical Total Managerial

($70.72/hr)

Technical

($64.66/hr)

Clerical

($29.63/hr) Total

CBI 

Review

1.00 0.00 0.00 1.00 $70.72 $0.00 $0.00 $70.72

Sources:

1 Burden estimates are from the 2008 ICR for Health and Safety Data Reporting, Submission of Lists and Copies of Health and 

Safety Studies , EPA ICR No: 0575.12 (EPA, 2008 page 11).

2 Loaded wage rates are derived in Table 3-1 of this report.

EPA believes all studies will need to be reviewed for CBI (EPA, 2008). Table 3-13 contains the total

industry burden associated with CBI review to be 28 hours and $1,980.
3-8

Table 3-13: Total Industry Burden for CBI Review

Collection 

Activity

Unit 

Burden 

(hours)1

Unit Cost 

(2011$)1

Total Number 

of Studies 

Submitted2

Total Number 

of Studies 

Reviewed3

Total 

Burden 

(hours)

Total Cost 

(2011$)

(a) (b) (c) (d)=(c)*.02 (e) = (a) * (d) (f) = (b) * (d)

CBI Review 1.00 $70.72 1,384 28 28.00 $1,980

Sources:

1 Unit burden and cost estimates are derived in Section 3.3.6Error! Reference source not found. of this report. 

2 The total number of studies is calculated in Section 3.3.6 of this report.

3 The percentage of studies reviewed is taken from the 2008 ICR for Health and Safety Data Reporting, Submission of Lists 

and Copies of Health and Safety Studies , EPA ICR No: 0575.12 (EPA, 2008 page 14).

3.3.7 Post-Reporting Submission of 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 

0.11 hours per firm of clerical labor and CBI review will require an average of one hour of managerial 

time (EPA, 2008) (see Table 3-14).

Table 3-14: Unit Industry Costs for Post-Reporting Submissions

Collection

Activity

Burden per Firm1 Cost per Firm2

Managerial Technical Clerical Total Managerial

($70.72/hr)

Technical

($64.66/hr)

Clerical

($29.63/hr) Total

CBI 

Review

1.00 0.00 0.11 1.11 $70.72 $0.00 $3.26 $73.98

Sources:

1 Burden estimates are from the 2008 ICR for Health and Safety Data Reporting, Submission of Lists and Copies of Health and 

Safety Studies, EPA ICR No: 0575.12 (EPA, 2008 page 11).

2 Loaded wage rates are derived in Table 3-1 of this report.

EPA believes a total of 5 percent of the responding firms (28 companies) will complete post reporting 

submissions (EPA, 2008). Therefore, EPA expects a total of 1 firm (28 x 0.05) to complete one postreporting submission apiece. As shown in Table 3-15 the total industry burden associated with postsubmission reporting is approximately 1.1 hours and $74.
3-9

Table 3-15: Total Industry Costs for Post-Reporting Submissions

Collection 

Activity

Unit 

Burden 

(hours)1

Unit Cost 

(2011$)1

Total Number 

Responding 

Firms2

Total Number 

of PostReporting 

Submissions3

Total 

Burden 

(hours)

Total Cost 

(2011$)

(a) (b) (c) (d)=(c)*0.05 (e) = (a) * (d) (f) = (b) * (d)

CBI Review 1.11 $73.98 28 1 1.11 $73.98

Note:

Totals may not exactly equal unit burdens times number of submissions due to rounding of unit burden estimates and the 

number expected submissions. 

Sources:

1 Unit burden and cost estimates are derived in Table 3-14 of this report. 

2 The total number firms is calculated Table 3-9 of this report.

3 The percentage of firms conducting this activity is taken from the 2008 ICR for Health and Safety Data Reporting, 

Submission of Lists and Copies of Health and Safety Studies , EPA ICR No: 0575.12 (EPA, 2008 page 14).

3.4 Summary Total Industry Compliance Costs

Table 3-16 contains the total industry burden to manufacturers and importers of cadmium and cadmium

for compounds for the TSCA Section 8(d) Health and Safety Data collection. The total industry burden is 

expected to be approximately 7,019 hours and $480,535. 

Table 3-16: Summary of Total Industry Costs for the TSCA Section 8(d) Information Collection

Collection 

Activity

Unit 

Burden 

(hours)

Unit Cost 

(2011$)

Total Number 

of Firm, Sites, 

or Studies 

Total Burden 

(hours)

Total Cost 

2

(2011$)

(a) (b) (c) (d) = (a) * (c) (e) = (b) * (c)

Review of Rule 2.00 $141.44 1384 Firms 2,768 $195,753

Site Identification 3.00 $212.16 595 Firms 1,785 $126,235

Site File Search 3.00 $193.98 802 Sites 2,406 $155,572

Study Title Lists 1.00 $29.63 28 Firms 28 $830

Photocopy 

Studies 0.11 $3.26 28 Studies 3.08 $91.28

CBI Review 1.00 $70.72 28 Firms 28 $1,980

Post-Reporting 

Period 

Submission

1.11 $73.98 1 Firms 1.11 $73.98

TOTAL 7,019 $480,535

Note: Not all respondents perform all activities.

Sources:

1 All costs and burdens are derived in Section 3.3 of this report.

 
4-1

Chapter 4 – Agency Costs

4.1 Introduction

EPA will also incur costs in administering the final rule. Specifically, EPA will be required to provide 

industry and public assistance to facilitate compliance and process submissions. These costs are discussed 

in Section 4.3.

4.2 Derivation of Agency Wage Rates

A General Schedule (GS)-13 Step 5 employee is expected to perform all activities associated with the rule 

(EPA, 2008). Unit wage rates for EPA staff are calculated based on annual federal salaries for the 

Washington-Baltimore area published by the Office of Personnel Management (OPM) and effective 

January 2011 (OPM, 2011). The average salary for one full-time equivalent (FTE) staff member is 

estimated as the salary for a GS-13 Step 5 employee, which is $100,904 annually without fringe benefits 

and overhead costs. In order to derive the fully loaded salary, EPA multiplied the annual salary by an 

assumed loading factor of 1.6 to reflect federal fringe benefits and overhead, which results in a fully 

loaded annual salary of $161,446.40 

The Agency loading factor of 1.6 is from an EPA guide entitled Instructions for Preparing Information 

Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9). The 60 percent assumption was labeled 

“the benefits multiplication factor” in the EPA guide, but has been used in many EPA OPPT ICRs to 

reflect both fringe benefits and overhead for federal staff. For example, it was used in a document 

supporting EPA ICR No. 1139.06 (EPA, 2000), with the following explanation:

The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits 

multiplication factor). The multiplication factor used is recommended in EPA’s Office of Policy, 

Planning, and Evaluation’s Instructions for Preparing Information Collection Requests (ICRs) (June 1, 

1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl Koch 

(OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits but also 

overhead.

Table 4-1: Derivation of Loaded Agency Wage Rates 

Labor 

Category

Data Source for Wage 

Information Date Wage Fringe 

Benefit

Fringes 

as %

wage

Overhead 

as % wage

Fringe + 

overhead 

factor

Loaded 

Wages

(a) (b) (c)=(b)/(a) (d) (e)=(c)+(d)+1 (f)=(a) x (e)

EPA staff 

FTE

Annual federal staff cost: OPM 

Washington-Baltimore-Northern 

Virginia, DC-MD-PA-VA-WV, 

area, GS-13 Step 5 pay rates 1

Jan-11

$100,904 

(annual)

--

[Included 

in 60% 

overhead]

60% 21.60

$161,446 

(annual)

$48.51 

(hourly)

$77.62 

(hourly)

Sources:

1 The Agency salary is the unloaded federal GS-13 Step 5 salary ($100,904 for 2011), from the OPM salary table for the

Washington-Baltimore-Northern Virginia Locality Pay Area (OPM, 2010). Hourly rates are based on annual salary divided by 

2,080 hours. Government wage rates are currently frozen at 2010 levels.

2 The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs)

(EPA, 1992, page 30, footnote 9).
4-2

4.3 Agency Costs

The estimated annual burden and cost to the government of adding cadmium and cadmium compounds to

the TSCA Health and Safety Data Reporting Rule is based on the estimates in the 2008 TSCA Section 

8(d) Information Collection Renewal (EPA 2008). 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. Answer respondents’ questions;

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

3. Maintain and distribute the 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, with a loaded annual wage rate of $77.62 per hour. 

The 2008 ICR estimates that the Agency will have a total burden of 0.035 FTEs to process and store 

information from manufacturers, and importers for 7 reports, of which 6 are submitted during the 

reporting period and 1 is submitted after the reporting period (EPA, 2008). For the final rule, 28 firms will 

submit a report during the reporting period and 1 firm will make submissions in the post-reporting period, 

for a total of approximately 29 reports (see Table 3-16). To estimate the burden associated with adding 

cadmium and cadmium compounds to the TSCA Section 8(d) list, EPA multiplied the burdens by a factor 

of 4.152 (29/7), following an approach outlined in Economic Analysis of the Addition of Chemicals from 

the 55th, 56th, and 58th ITC Report to the 8(d) Health and Safety Data Reporting Rule (EPA, 2006); this 

results in an Agency burden of 0.145 FTEs (301.6 hours) and $23,410. 

Table 4-2: Total Agency Burden for the TSCA Section 8(d) Information Collection

Activity

FTEs from

2008 ICR1

FTE for Current 

Rule2 Annual Hours Annual Cost3

(a) (b)=(a)*4.152 (c)=(b)*2,080 (d)=(c)*$77.62

Data 

Processing and 

System

Support

0.025 0.104 216.32 $16,791

Storage and 

Distribution 0.010 0.041 85.28 $6,619

Total 0.035 0.145 301.60 $23,410

Sourc

es:

1

FTE Burden is taken from 2008 ICR for Health and Safety Data Reporting, Submission of Lists and Copies of Health and 

Safety Studies, EPA ICR No: 0575.12 (EPA, 2008 page 17).

2 The burden factor is the total number of submitted reports (during the reporting period and post-reporting period) for the final 

rule divided by the number of annual reports from the 2008 ICR for Health and Safety Data Reporting, Submission of Lists and 

Copies of Health and Safety Studies, EPA ICR No: 0575.12 (EPA, 2008 page 15).

3Loaded Agency wages are derived in Table 4-1 of this report.
5-1

Chapter 5 – Total Social Costs

The total social cost of the final rule is estimated to be 7,321 hours and $503,945, the sum of industry 

compliance costs estimated in Chapter 3 (7,019 hours and $480,535) and EPA administrative costs 

estimated in Chapter 4 (302 hours and $23,410). Total social cost is summarized Table 5-1.

Table 5-1: Total Social Cost and Burden of the Final Rule

Social Cost Component Burden

(hours)

Estimated Cost

(2011$)

Industry Compliance Burden17,019 $480,535

Agency Burden2302 $23,410

Total Cost 7,321 $503,945

Sources:

1 Table 3-15.

2 Table 4-2.
6-1

Chapter 6 – Benefits

The benefits resulting from the final rule are discussed qualitatively in this section. By enhancing the data 

supplied to Agency risk-screening programs, EPA expects to more effectively and expeditiously reduce 

the potential risks posed by consumer exposure to cadmium. The more EPA can base its decisions on 

actual data rather than on assumptions, the better EPA is able to tailor its risk management decisions to 

the level of actual risk whether higher or lower than it would be if based on assumptions alone. 

Ultimately, enhancing the risk screening process will have positive consequences for human health and 

will enable a more efficient allocation of EPA’s and society’s resources. 

Cadmium is a probable carcinogen and high exposure levels may lead to kidney dysfunction, lung 

disease, bone disease, infertility, central nervous system damage, damage to the immune system, and liver 

damage (Kirk-Othmer, 2004 and US DHHS, 2008). Cadmium has been shown to be a developmental 

toxicant in animals, resulting in fetal malformations and other effects, but no conclusive evidence exists 

in humans (FR Notice, Volume 76, No. 147, p. 46176)). The majority of cadmium that enters a person’s 

body will stay in the liver or kidneys for many years (US DHHS, 2008).

The U.S. Consumer Product Safety Commission (CPSC) is concerned with the content of cadmium and

cadmium compounds in certain children’s toys, jewelry, and other consumer products due to known 

toxicity and health concerns from exposure to cadmium and cadmium compounds. For example, in 2010 

CPSC found the amount of cadmium in samples of children's metal jewelry ranged from about 0.03 to 99

percent by weight. CPSC has also assessed potential exposures to cadmium by extraction testing, and

found that potential exposure to cadmium would exceed the acceptable daily intake levels for acute 

exposure to a child (CPSC, 2010). EPA and CPSC are concerned about the possible presence and 

bioavailability of cadmium and cadmium compounds in consumer products generally. However, neither 

CPSC nor EPA currently has complete information for assessing the safety of any other consumer 

products that may contain cadmium or cadmium compounds (FR Notice, Volume 76, No. 147, p. 46176).

The TSCA Section 8(d) information collection would address EPA and CPSC needs for health and safety 

studies for assessing the extent and degree of exposure and potential hazard associated with these 

substances including: epidemiological or clinical studies, occupational exposure and health effects 

studies, ecological effects studies, and environmental fate studies (including relevant physical chemical 

properties). Information obtained through the rule may assist both EPA and CPSC in taking further action 

as appropriate to protect consumers and children from exposure to cadmium and cadmium compounds in 

consumer products (FR Notice, Volume 76, No. 147, p. 46176).
7-1

Chapter 7 – Small Entity Impact Analysis

This chapter estimates the impact that the final rule may have on small entities by examining the 

relationship between the compliance costs and company sales for small companies.

This rule is not subject to the Regulatory Flexibility Act (RFA) which generally requires an agency to 

prepare a regulatory flexibility analysis for any rule that will have a significant economic impact on a 

substantial number of small entities. The RFA applies only to rules subject to notice and comment 

rulemaking requirements under the Administrative Procedure Act (APA) or any other statute. 

Nonetheless, EPA has conducted an analysis on potential impacts to small entities as detailed below. 

The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory 

Enforcement Fairness Act (SBREFA) of 1996, requires regulators to assess the effects of regulations on 

small entities, including businesses, nonprofit organizations, and governments. In some instances, 

agencies also are required to examine regulatory alternatives that may reduce adverse economic effects on 

significantly impacted small entities. The RFA requires agencies to prepare an initial and final regulatory 

flexibility analysis for each rule unless the Agency certifies that the rule will not have a significant 

economic impact on a substantial number of small entities. The RFA, however, does not specifically 

define “a significant economic impact on a substantial number” of small entities. Sections 603 and 604 of 

the RFA require that regulatory flexibility analyses identify the types, and estimate the numbers, of small 

entities to which the rule will apply; and describe the rule requirements to which small entities will be 

subject and any regulatory alternatives, including exemptions and deferral, that would lessen the rule’s 

burden on small entities.

To estimate the impact of the rule on a business, the preferred method is the “sales test,” wherein costs for 

any individual firm are measured as a percent of annual sales. However, because of the uncertainty 

regarding the identity of the firms that will be required to respond to this data collection, it is not possible 

to directly compare the estimated cost to the actual sales volume of those firms. 

Because EPA was unable to use the “sales test” method, EPA followed the approach used TSCA Section 

8(d): Economic Impact Analysis for Adding Lead and Lead Compounds from the 60th Report of the TSCA 

Interagency Testing Committee to the Health and Safety Data Reporting Rule (EPA, 2007), and estimated 

the average cost per company and what a company’s revenue would need to be for costs to exceed one 

percent of sales. EPA also estimated the highest possible cost a company could incur under the rule, 

assuming a firm completed all possible collection activities, and what the revenue would need to be for 

costs to exceed one percent of sales.
7-2

Table 7-1: Calculations of Average and High Cost per Company

Collection 

Activity

Unit Cost 

(2011$)

Average Cost Scenario High Cost Scenario

Percentage of 

Cost Incurred by 

Firm Under 

Scenario

Cost per 

Firm (2011$)

Percentage of 

Cost Incurred by 

Firm Under 

Scenario

Cost per 

Firm

(2011$)

Review of

Rule $141.44 100.00% $141.44 100% $141.44

Site 

Identification $212.16 43.00% $91.23 100% $212.16

Site File 

Search1 $193.98 58.00% $112.51 135% $261.87

Study Title 

Lists $29.63 2.00% $0.59 100% $29.63

Photocopy 

Studies $3.26 2.00% $0.07 100% $3.26

CBI Review $70.72 2.00% $1.41 100% $70.72

Post-Reporting 

Period 

Submission

$73.98 0.00% $0.00 100% $73.98

Total $347.25 - $793.06

Notes:

The average firm is estimated to have 1.35 sites (1,865 sites/1,384 firms). 

EPA estimates that the average cost per firm is $347, meaning a firm would have total annual sales less 

than $34,725 for rule costs to be more than one percent of revenue. Under the more stringent high cost 

scenario firms have a cost of $793 and would have to have annual sales less than $79,306 for costs to be 

more than one percent of revenue. Due to the low level of the impact, EPA does not expect that this action 

will have a significant impact on a substantial number of small entities. Additionally, EPA believes that 

small firms are unlikely to have unpublished health and safety data studies due to the cost of developing 

the information and would only expend resources to review the rule at a cost of $141 per firm. 
8-1

Chapter 8 – Other Impact Analyses

Several statutes and executive orders (EOs) pertain to the final rule. This chapter presents statements 

discussing paperwork reduction, unfunded mandates, regulatory planning and review, tribal governments, 

children’s health, and environmental justice, among others.

8.1 Paperwork Reduction Act (PRA)

According to the Paperwork Reduction Act, 44 USC 3501 et seq., federal agencies are required to 

estimate the reporting burden that would be imposed by a rule. In this context, the term “burden” means 

the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose 

or provide information to or for a federal agency. This includes time needed to review instructions; 

develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and 

verifying information, processing, and maintaining information, and disclosing and providing 

information; adjust the existing ways to comply with any previously applicable instructions and 

requirements, train personnel to be able to respond to a collection of information; search data sources; 

complete and review the collection of information; and transmit or otherwise disclose the information. 

8.1.1 Industry Burden

Those subject to the rule are expected to undertake the following paperwork related activities to provide 

the required reports: 

1. Review the rule to determine if the company must report; 

2. Conduct a corporate review to identify which company sites must be searched to locate any 

appropriate health and safety studies; 

3. Search the files at each site to locate any 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. Review the studies for possible CBI; 

6. Photocopy the studies being submitted; and 

7. Submit studies completed after the reporting period. 

The rule does not require the creation of robust summaries, however, they can be provided on a voluntary 

basis. Because they are not required, EPA does not believe that many companies will choose to submit 

these summaries. However, an estimate of burden hours for this activity is included to illustrate the 

possible burden associated with the activity. 

The activities are listed in Table 8-1 along with the estimated burden hours associated with each activity. 

Total industry burden is estimated to be 7,019 hours as a result of the rule. An estimated 28 firms are 

expected to provide studies in response to the rule. These respondents require an estimated 10.5 hours (2 

hours to review the rule, 3 hours for site identification, 3 hours for file searches, 1 hour for study title 

lists, 1 hour for CBI review, and 0.11 hours for photocopy of studies). There are an additional 1.1 hours if 

a company has post-period reporting. 
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Table 8-1: Total Hourly Industry Burden 

Collection Activity

Unit Burden 

(hours)

Total Number of Firms, 

Sites, or Studies

Total Burden 

(hours)

(a) (b) (c) = (a) * (b)

Review of Rule 2.00 1,384 Firms 2,768

Site Identification 3.00 595 Firms 1,785

Site File Search 3.00 802 Sites 2,406

Study Title Lists 1.00 28 Firms 28

Photocopy Studies 0.11 28 Studies 3.08

CBI Review 1.00 28 Firms 28

Post-Reporting Period 

Submission 1.11 1 Firm 1.11

Total 7,019

Source:

1 Table 3-16.

8.1.2 Government Burden

The government will spend time processing, analyzing and storing of the information collected under this 

rule. It is estimated that the government will spend a total of 301.6 labor hours as a result of this data 

collection. 

Table 8-2: Total Hourly Government Burden 

Activity

FTEs 

from 

2008 

ICR

FTE for Current Rule Hours

(a) (b)=(a)* 4.152 (c)=(b)*2080

Data Processing 

and System 

Support

0.025 0.104 216.32

Storage and 

Distribution 0.010 0.041 85.28

Total 0.035 0.145 301.60

Source:

Table 4-2.

8.2 Unfunded Mandates Reform Act (UMRA)

This action contains no federal mandates under the provisions of Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA, Public Law 104-4), 2 U.S.C. 1531-1538 for state, local, or tribal 

governments or the private sector. Based on EPA’s experience with similar information collection rules, 

state, local, and tribal governments have not been affected by this reporting requirement, and EPA does 

not have any reason to believe that any state, local, or tribal government will be affected by this 

rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable 

duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the 

requirements of Sections 202 or 205 of the UMRA.

8.3 Executive Order 12866 – Regulatory Planning and Review

This action is not a “significant regulatory action”, as defined under section 3(f) of Executive Order 

12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), because the final rule 

does not: (1) have an annual effect on the economy of $100 million or more or adversely affect in a 
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material way the economy, a sector of the economy, productivity, competition, jobs, the environment, 

public health or safety, or State, local, or tribal governments or communities; (2) create a serious 

inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially 

alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations 

of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President’s 

priorities, or the principles set forth in EO 12866. Therefore, the final rule is not subject to OMB review 

under EO 12866.

8.4 Executive Order 13132 – Federalism

Under Executive Order 13132, “Federalism” (64 FR 43255, August 10, 1999), EPA has determined that 

the final rule does not have “federalism implications” because it will not have substantial direct effects on 

the states, on the relationship between the national government and the states, or on the distribution of 

power and responsibilities among the various levels of government, as specified in the executive order. 

The final rule establishes reporting requirements that apply to manufacturers (including importers) of 

certain chemicals. Because EPA has no information to indicate that any state or local government 

manufacturers the chemical substances covered by this action, the final rule does not apply directly to 

states and localities and will not affect state and local governments. Thus, EO 13132 does not apply to the 

final rule.

8.5 Executive Order 13175 – Consultation and Coordination with Indian Tribal 

Governments

As required by Executive Order 13175, entitled Consultation and Coordination with Indian Tribal 

Governments (65 FR 67249, November 9, 2000), EPA has determined that this final rule does not have 

tribal implications because it will not have any effect on tribal governments, on the relationship between 

the federal government and the Indian tribes, or on the distribution of power and responsibilities between 

the federal government and Indian tribes, as specified in the Order. Thus, EO 13175 does not apply to the 

final rule.

8.6 Executive Order 13045 – Children’s Health 

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” 

(62 FR 19885, April 23, 1997), requires that federal agencies examine the impacts of each regulatory 

action on children for any economically significant regulation (as defined by Executive Order 12866) that 

the Agency has reason to believe may disproportionately affect children.

EPA interprets EO 13045 as applying only to those regulatory actions that concern health or safety risks, 

such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. 

The final rule is not subject to EO 13045, because it does not establish an environmental standard 

intended to mitigate health or safety risks and will not have an annual effect on the economy of $100 

million or more, nor does it otherwise have a disproportionate effect on children. Nevertheless, the 

information obtained from the reporting required by this rule will be used to inform the Agency’s 

decision-making process regarding chemicals to which children may be disproportionately exposed. This 

information will also assist the Agency and others in determining whether the chemicals in this final rule 

present potential risks, allowing the Agency and others to take appropriate action to investigate and 

mitigate those risks.

8.7 Executive Order 12898 – Environmental Justice

Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and 

Low Income Populations” (59 FR 7629, February 16, 1994), establishes federal executive policy on 
8-4

environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and 

permitted by law, to make environmental justice part of their mission by identifying and addressing, as 

appropriate, disproportionately high and adverse human health or environmental effects of their programs, 

policies, and activities on minority populations and low-income populations in the United States.

EPA has determined that the final rule will not have disproportionately high and adverse human health or 

environmental effects on minority or low-income populations because it does not affect the level of 

protection provided to human health or the environment. The Agency believes that the information 

collected under this final rule, if finalized, will assist EPA and others in determining the potential hazards 

and risks associated with cadmium and cadmium compounds. Although not directly impacting 

environmental justice-related concerns, this information will enable the Agency to better protect human 

health and the environment, including in low-income and minority communities.

The rule is directed to gather health and safety data for cadmium and cadmium compounds used in 

consumer products. All consumers of products made from these chemicals could benefit from data 

regarding the chemicals’ health and environmental effects. Therefore, it does not appear that the costs and 

the benefits of the final rule will be disproportionately distributed across different geographic regions or 

among different categories of individuals.

8.8 Executive Order 13211 – Energy Supply, Distribution, or Use

This final rule is not subject to Executive Order 13211, “Actions Concerning Regulations That 

Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because it is not 

a significant regulatory action under Executive Order 12866.

8.9 National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 

No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its 

regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. 

Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, 

sampling procedures, and business practices) that are developed or adopted by voluntary consensus 

standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the 

Agency decides not to use available and applicable voluntary consensus standards. 

The final rule does not involve technical standards. Therefore, EPA is not considering the use of any 

voluntary consensus standards.
9-1

Chapter 9 – References 

FR Notice, Volume 76, No. 147. Federal Register Notice: Sixty-Eighth Report of the TSCA Interagency 

Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of 

Report and Request for Comment. August 1, 2011. 

Kirk-Othmer, 2004. Kirk-Othmer Encyclopedia of Chemical Technology 5th edition, “Cadmium and 

Cadmium Alloys” Wiley and Sons. Hoboken, New Jersey 2004.

U.S. Census Bureau, 2009. United States Census Bureau. “2009 Statistics of U.S. Businesses.” Available 

at http://www.census.gov/econ/susb/. Accessed March 2012.

U.S. Census Bureau, Bureau of Labor Statistics (BLS). 2012. “Employer Costs for Employee 

Compensation (ECEC) Supplemental Tables: December 2011.” Available at: 

ftp://ftp.bls.gov/pub/special.requests/ocwc/ect/ecsuptc21.pdf. Accessed March 2012.

U.S. United States Department of Health and Human Services (DHHS), Public Health Service, Agency 

for Toxic Substances and Disease Registry. 2008.. “Draft Toxicological Profile for Cadmium” 

September 2008.” Available at http://www.atsdr.cdc.gov/toxprofiles/tp5.pdf. Accessed July, 

2011. 

U.S. Environmental Protection Agency (EPA), Office of Policy, Planning and Evaluation. 1992. 

Instructions for Preparing Information Collection Requests (ICRs).

U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2000. 

Supporting Statement for EPA ICR No. 1139.06: TSCA Existing Chemical Test Rules, Consent 

Orders, Test Rule Exemptions, and Voluntary Test Data Submissions.

U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2002a. 

Economic Analysis for the Amended Inventory Update Rule: Final Report. EPA-HQ-OPPT-2002-

0054-0260.

U.S. Environmental Protection Agency (EPA). Office of Pollution, Prevention and Toxics. 2002b. Wage 

Rates for Economic Analyses of the Toxics Release Inventory Program.

U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2006. 

Economic Analysis of the Addition of Chemicals from the 55th, 56th, and 58th ITC Report to the 

8(d) Health and Safety Data Reporting Rule EPA-HQ-OPPT-2002-0054-0260. July 2006.

U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2007. TSCA 

Section 8(d): Economic Impact Analysis for Adding Lead and Lead Compounds from the 60th

Report of the TSCA Interagency Testing Committee to the Health and Safety Data Reporting 

Rule. November 2007. 

U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2008. 

Supporting Statement for EPA ICR No. 0575.12: Health and Safety Data Reporting, Submission 

of Lists and Copies of Health and Safety Studies , EPA ICR No: 0575.12
9-2

U.S. Office of Personnel Management (OPM). 2011. “Salary Table 2011 for the Locality Pay Area of 

Washington-Baltimore-Northern Virginia, DC-MD-VA-WV-PA.” Effective January 2011. 

Available at: http://www.opm.gov/oca/10tables/pdf/DCB.pdf. Accessed August 2011.

Weinstein, Harriet G and Mark A. Loewenstein. U.S. Bureau of Labor Statistics (BLS). 2004. 

“Comparing Current and Former Industry and Occupation ECEC Series.” Available at: 

http://www.bls.gov/opub/cwc/cm20040823ar01p1.htm. Accessed October 08, 2009.

White House Office of Management and Budget (OMB). 2003. Circular A-4. Available at: 

http://www.whitehouse.gov/omb/circulars/a004/A-4.html. Accessed October 08, 2009.