September 26, 2011

—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

Washington, D.C. 20460

Economic Analysis for the Final Section 4 Test Rule

for Certain High Production Volume Chemicals; Third 

Group of Chemicals

EPA-HQ-OPPT-2009-0112
i

Contributors

The EPA analyst responsible for this report was Lynne Blake-Hedges. Analytical and draft preparation 

support was provided by Abt Associates Inc. under EPA Contract No. EP-W08-0100.
ii

Contents

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

1.1 Statement of Need.........................................................................................................................1-1

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

Chapter 2 – Use, Production, and Market Information.......................................................................2-1

2.1 Introduction...................................................................................................................................2-1

2.2 Chemical Use and Market Information.........................................................................................2-4

2.3 Chemical-Specific Use and Market Information ..........................................................................2-9

Chapter 3 – Social Costs of the Final Rule ............................................................................................3-1

3.1 Industry Costs...............................................................................................................................3-1

3.2 EPA Costs...................................................................................................................................3-18

3.3 Summary of Total Social Costs ..................................................................................................3-18

Chapter 4 – Company-Level Impact and Small Business Impact Analysis........................................4-1

4.1 Company-Level Impact ................................................................................................................4-1

4.2 Small Entity Impact Analysis .......................................................................................................4-6

Chapter 5 – Benefits.................................................................................................................................5-1

5.1 Use Values....................................................................................................................................5-1

5.2 Non-Use Values............................................................................................................................5-2

5.3 Benefits of the Required Tests......................................................................................................5-2

5.4 Benefits Related to Each Regulated Chemical ...........................................................................5-10

5.5 Potential Users of Information Generated by the Final Rule......................................................5-16

Chapter 6 – Other Impact Analyses.......................................................................................................6-1

6.1 Paperwork Reduction Act.............................................................................................................6-1

6.2 Unfunded Mandates Reform Act..................................................................................................6-3

6.3 Executive Order 13132 – Federalism............................................................................................6-3

6.4 Executive Order 13045 - Children‟s Health .................................................................................6-4

6.5 Executive Order 13211 – Energy Supply, Distribution, or Use....................................................6-4

6.6 National Technology Transfer and Advancement Act..................................................................6-4

6.7 Executive Order 12898 – Environmental Justice..........................................................................6-5

Chapter 7 – References............................................................................................................................7-1

Appendix A – Derivation of Chemical Price Estimates.......................................................................A-1

A.1 Chemical Market Reporter ..........................................................................................................A-1

A.2 United States International Trade Commission – Synthetic Organic Chemicals ........................A-2

A.3 Similar Chemical Prices – CMR ..................................................................................................A-2

A.4 Small Quantity Catalog Prices.....................................................................................................A-2

A.5 Small Quantity Catalog Prices for Similar Chemicals.................................................................A-6

A.6 American Chemistry Council Prices............................................................................................A-8

Appendix B – Cost Details...................................................................................................................... B-1

Appendix C – Wage Rate Calculations.................................................................................................C-1

C.1 Derivation of Loaded Wage Rates............................................................................................... C-1
iii

Exhibits

Exhibit 2-1: Chemicals Included in the Final High Production Volume Chemical Test Rule ..................2-2

Exhibit 2-2: Employee and Sales Information for Potentially Impacted Companies Included in the 

Analysis...............................................................................................................................................2-5

Exhibit 2-3: Distribution of Potentially Impacted Companies by Number of Employees.........................2-6

Exhibit 2-4: Distribution of Potentially Impacted Companies by Annual Sales........................................2-6

Exhibit 2-67: Summary Statistics for Chemical Prices: $2009..................................................................2-8

Exhibit 2-89: Chemical Use Information...................................................................................................2-9

Exhibit 3-1: Tests Required by EPA for HPV Chemicals, Based on the OECD‟s Screening Information 

Data Set (SIDS)...................................................................................................................................3-2

Exhibit 3-2: Test Requirements for Chemicals Included in the Final Rule ...............................................3-5

Exhibit 3-3: EPA Estimates of Laboratory Costs of Final Tests (2009$)..................................................3-9

Exhibit 3-4: Costs for Analytical Methodology Validation.....................................................................3-13

Exhibit 3-5: Derivation of Loaded Hourly Rates by Labor Category......................................................3-14

Exhibit 3-6: Industry Reporting Cost and Burden Estimate for the Final Rule (2009$) .........................3-14

Exhibit 3-7: Export Notification Cost Estimate for the Final Rule (2009$)............................................3-16

Exhibit 3-8: Summary of Total Industry Compliance Costs Triggered by the Final Rule (2009$).........3-16

Exhibit 3-9: Estimated Government Costs for the Final Rule (2009$)....................................................3-18

Exhibit 3-10: Summary of Total Social Costs Triggered by the Final Rule (2009$) ..............................3-19

Exhibit 4-1: Annualized Costs Under Least and Average Cost Scenarios (Total for All Chemicals) 

($2009) ................................................................................................................................................4-3

Exhibit 4-2: Summary Statistics for Chemical-Specific Cost-to-Sales Ratios1.........................................4-4

Exhibit 4-3: Summary Statistics for Company-Specific Cost-to-Sales Ratios, for Chemicals with Cost-toSales Ratios Greater Than 1 Percent ...................................................................................................4-5

Exhibit 4-4: Sensitivity Analysis: Summary Statistics for Chemical-Specific Cost-to-Sales Ratios ........4-5

Exhibit 4-5: Sensitivity Analysis: Summary Statistics for Company-Specific Cost-to-Sales Ratios, for 

Chemicals with Cost-to-Sales Ratios Greater Than 1 Percent ............................................................4-6

Exhibit 4-6: Summary Statistics for Company-Specific Cost-to-Sales Ratios for Small Companies .......4-8

Exhibit 6-1: Reporting Burden Estimate for the Final Rule ......................................................................6-1

Exhibit 6-2: Total Industry Burden Hour Estimate for the Final Rule.......................................................6-2

Exhibit 6-3: Estimated Government Burden for the Final Test Rule.........................................................6-2

Exhibit A-1: Summary of Chemical Price Sources and Estimation Methods...........................................A-1

Exhibit A-2: USITC Synthetic Organic Chemicals Prices (2009$)..........................................................A-2

Exhibit A-3: Chemical Market Reporter Similar Chemical Prices (2009$).............................................A-2

Exhibit A-4: Comparison Between Chemical Market Reporter and Sigma-Aldrich Prices.....................A-3

Exhibit A-5: Comparison Between CMR and Fisher Scientific Prices.....................................................A-4

Exhibit A-6: Prices Derived from Sigma-Aldrich ....................................................................................A-5

Exhibit A-7: Prices of Similar Chemicals.................................................................................................A-7

Exhibit A-8: American Chemistry Council Prices....................................................................................A-8

Exhibit B-1: Industry Compliance and Government Costs, Least Cost Scenario.....................................B-2

Exhibit B-2: Industry Compliance and Government Costs, Average Cost Scenario................................B-3

Exhibit B-3: Annualized Social Costs ......................................................................................................B-4

Exhibit B-4: Annualized Industry Compliance Costs...............................................................................B-5

Exhibit C-1: Detail of Labor Categories Used in the Analysis.................................................................C-1

Exhibit C-2: Derivation of Loaded Wage Rates.......................................................................................C-3
1-1

Chapter 1 – Introduction

Under the Toxic Substances Control Act (TSCA), the U.S. EPA (EPA) can impose information reporting 

and other requirements on producers, importers, processors, users, distributors, and disposers of 

chemicals to ensure the safe management of toxic chemicals. Under TSCA Section 4, EPA is authorized 

to require by rule that manufacturers (including importers) and/or processors of chemical substances 

conduct testing to determine the effect of chemical substances on human health and the environment. In 

particular, the Administrator requires that testing be conducted if the Agency finds that:

(1)(A) (i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or 

mixture, or any combination of such activities, may present an unreasonable risk of injury to health or the 

environment,

(ii) there are insufficient data and experience upon which the effects of such manufacture, distribution in 

commerce, processing, use, or disposal of such substance or mixture or of any combination of such 

activities on health or the environment can reasonably be determined or predicted, and 

(iii) testing of such substance or mixture with respect to such effects is necessary to develop such data; or

(B) (i) a chemical substance or mixture is or will be produced in substantial quantities, and (I) it enters or may 

reasonably be anticipated to enter the environment in substantial quantities or (II) there is or may be significant or 

substantial human exposure to such substance or mixture,

(ii) there are insufficient data and experience upon which the effects of the manufacture, distribution in 

commerce, processing, use, or disposal of such substance or mixture or of any combination of such 

activities on health or the environment can reasonably be determined or predicted, and 

(iii) testing of such substance or mixture with respect to such effects is necessary to develop such data.

In 1998, a national effort was announced to expand the availability of information regarding the most 

widespread chemicals in commerce. To support this effort, in 2006, EPA promulgated its first test rule for 

17 high production volume (HPV) chemicals that, under TSCA Section 4, have annual production and/or 

importation volumes of one million pounds or more (71 FR 13708, March 16, 2006). On December 8, 

2006, EPA issued a direct final rule that revoked testing requirements for one of the chemicals subject to 

the test rule (71 FR 71508). In 2011, EPA finalized a second test rule for an additional 19 HPV chemicals 

(76 FR 1067, January 7, 2011). Now, based on a 2010 proposal (75 FR 8575, February 25, 2010), EPA is 

finalizing a third test rule for 15 more HPV chemicals. The final rule will require the development of data 

similar to that specified under Screening Information Data Set (SIDS) testing battery of the Organisation 

for Economic Co-operation and Development (OECD).

1.1 Statement of Need 

Fully functioning competitive markets result in a socially efficient allocation of resources. Efficient 

allocation of resources will occur if each seller and each buyer have complete information on their own 

actions and make decisions based on the full costs of their own actions. On the other hand, if the market is 

unable to efficiently allocate goods and services, a market failure exists.

Executive Order 12866 requires the identification of the specific market failure that the 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 test rule is designed to address the issue of inadequate 

information and, to the extent that the information provided by the rule helps firms internalize social 
1-2

costs, the rule addresses the negative externalities that are generated from the manufacture, distribution in 

commerce, processing, use, or disposal of certain HPV chemicals.

1.1.1 Inadequate Information

Economic theory supports perfect information among buyers and sellers as a requirement for rational 

decision making and for the efficient allocation of resources. When buyers or sellers do not have 

complete information about the true costs or benefits of their choices, rational decision making cannot 

occur and the market fails. As an example, a producer 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 producer to make 

better decisions.

For many reasons information regarding the hazards associated with a chemical substance may not be 

widely known. Two of these reasons are:

Producers may know this information, but have no incentive to reveal it to their customers (because 

the costs are not borne by the producer and are 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 hazards posed by a chemical substance. 

Typically, the producers‟ level of information regarding a product exceeds the consumers‟ level of 

information.

In the second case, chemical hazard information is inadequate (e.g., unknown to both consumers and 

producers); producers may have little incentive to acquire such information due to the potential costs 

associated with its acquisition. Because information is by nature a public good and likely to impose costs 

on producers, they have little incentive to develop information. Information 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 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 chemical tests to acquire the information if they can use information developed and paid for by 

others. 

1.1.2 Externalities

Externalities, another cause of market failure, occur when the actions of one economic entity 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 involved in the market transaction. Such is the case where 

manufacturing or other business activities harm human health or the environment, resulting in negative 

externalities. When information is missing about the human health and/or environmental costs to 

producers or if the costs are external to producers‟ decision making, these costs are not internalized by the 

business entity and not incorporated into business decisions. The result can be the overuse 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, 

distribution in commerce, processing, use, or disposal of chemicals. As a first step in mitigating 

externalities, the EPA Office of Pollution Prevention and Toxics (OPPT) routinely screens chemicals for 
1-3

the potential risks they may pose. This screening is used to determine if risks from the manufacture, 

distribution in commerce, processing, use, or disposal of chemicals are of 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.

By providing information, the final test regulation will address market failure due to inadequate 

information by ensuring that basic information about the health and environmental effects of certain HPV 

chemicals is available to the public. This information can be used by consumers, producers, the public 

sector, and others to make more informed decisions regarding chemicals. These users may also apply this

information toward remedying externalities. To the extent that the availability of this information induces 

the producers to account for these social costs, either because of fear of litigation, or because of the 

benefits of corporate stewardship, availability of information will address the negative externalities 

generated by producing or using these chemicals.

1.2 Organization of This Report

This report presents EPA‟s economic analysis for the final rule. Regulated chemicals and companies are 

characterized in Chapter 2. Costs, including laboratory, administrative, export notification, and 

government costs, are reported in Chapter 3. The economic impact analysis for the final rule is presented 

in Chapter 4. This chapter also includes a small business impact analysis as mandated by the Regulatory 

Flexibility Act (RFA), and amended by the Small Business Regulatory Enforcement Fairness Act 

(SBREFA). Chapter 5 addresses the benefits of the final rule using a “value of information” framework. 

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. Several additional impact analyses are

presented in Chapter 6: 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; a children‟s health statement, which is mandated by Executive Order 13045; and the burden 

hour analysis, which responds to the requirements of the Paperwork Reduction Act (PRA). 

Note that all dollar amounts in this analysis are reported in 2009 dollars. For cost inputs that were 

estimated prior to 2009, EPA applied the most relevant adjustment factor to ensure that all costs were 

comparable. 
2-1

Chapter 2 – Use, Production, and Market Information

2.1 Introduction

This chapter presents use, production, and market information for the 15 chemicals included in the final 

rule. Exhibit 2-1 provides the Chemical Abstracts Service Registry Number (CASRN) assigned by the 

Chemical Abstracts Service (CAS) to each of these chemicals, the chemicals‟ common names, and other 

synonyms used to research information presented in this analysis on the chemicals.1,2

 

1

The CAS is a division of the American Chemical Society, and assigns unique CASRNs to chemical substances. All 

CASRNs are compiled in the CAS Registry, the largest and most current database of its kind. Each CASRN 

designates only one chemical substance, and is a link to significant information about the chemical. For more 

information, see the American Chemical Society‟s Chemical Abstracts Service at http://www.cas.org. 

2

EPA identified synonyms for each chemical by searching the National Institute of Standards and Technology 

(NIST) WebBook and the U.S. NLM ChemIDplus Lite by CAS number.
2-2

Exhibit 2-1: Chemicals Included in the Final High Production Volume Chemical Test Rule

CASRN Common Chemical Name Synonyms

1 98-09-9 Benzenesulfonyl chloride

Benzene sulfochloride; Benzene sulfonechloride; Benzenesulfonic chloride; Phenylsulfonyl chloride; Benzenesulfonic acid 

chloride; Benzenosulfochlorek; Benzenosulfochloride; Benzene sulphonyl chloride; Benezenesulfochloride; Benzenesulfon 

chloride; Benzenesulfonic(acid)chloride; Benzenesulphonyl chloride; Benzenosulphochloride; Benzolsulfochloride; 

Benzenesulfonyl chloride; Benzenesulphonyl chloride; Benzenesulfonyl chloride 

2 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)-

Toluene, p-chloro-α,α,α-trifluoro-; (p-Chlorophenyl)trifluoromethane; p-(Trifluoromethyl)chlorobenzene; p-Chloro-α,α,αtrifluorotoluene; p-Chlorobenzotrifluoride; p-Chlorotrifluoromethylbenzene; p-Trifluoromethylphenyl chloride; 1-Chloro-4-

(trifluoromethyl)benzene; 4-Chloro-α,α,α-trifluorotoluene; 4-Chlorobenzotrifluoride; para-Chlorobenzotrifluoride; 1-

(Trifluoromethyl)-4-chlorobenzene; 1-Chloro-4-(trifluoromethyl)benzene; Benzene, 1-chloro-4-(trifluoromethyl)-; 

alpha,alpha,alpha-Trifluoro-4-chlorotoluene; para-Chloro-alpha,alpha,alpha-trifluorotoluene; paraChlorotrifluoromethylbenzene; Benzene, 1-chloro-4-(trifluoromethyl)-; Benzene, 1-chloro-4-(trifluoromethyl)-

3 111-44-4 Ethane, 1,1'-oxybis[2-chloroBis(2-chloroethyl) ether; s-Dichloroethyl ether; Ethane, 1,1'-oxybis[2-chloro-; Ether, bis(2-chloroethyl); β,β'-Dichlorodiethyl 

ether; β,β'-Dichloroethyl ether; Bis(β-chloroethyl) ether; Bis(chloro-2-ethyl) oxide; Chlorex; Di(β-chloroethyl) ether; DCEE; 

Khloreks; 1-Chloro-2-(β-Chloroethoxy)ethane; 2-Chloroethyl ether; 2,2'-Dichlorethyl ether; 2,2'-Dichlorodiethyl ether; 2,2'-

Dichloroethyl ether; 2,2'-Dichlorodiethyl oxide; sym-Dichloroethyl ether; Bis(chloroethyl) ether; Chloroethyl ether; Clorex; 

Di(2-chloroethyl) ether; Dichlorodiethyl ether; Dichloroether; Dichloroethyl ether; Dichloroethyl oxide; Dwuchlorodwuetylowy 

eter; Ether dichlore; ENT 4,504; Oxyde de chlorethyle; 1,1'-Oxybis(2-chloroethane); 1,5-Dichloro-3-oxapentane; 2,2'-

Dichloorethylether; 2,2'-Dichlor-diaethylaether; 2,2'-Dicloroetiletere; β,β-Dichlorodiethyl ether; Ethane, 1,1'-oxybis*2-chloro-; 

Diethylene glycol dichloride; Ether, bis(chloroethyl); 1-Chloro-2-(2-chloroethoxy)ethane; 2,2'-Dichloorethylether; 2,2'-Dichlordiaethylaether; Dichloroether; Dichloroethyl ether 

4 127-68-4

Benzenesulfonic acid, 3-nitro-, sodium salt 

(1:1)

3-Nitrobenzenesulfonic acid, sodium salt; Benzenesulfonic acid, 3-nitro-, sodium salt; Sodium 3-nitrobenzenesulfonate; 

Sodium m-nitrobenzenesulfonate; Benzenesulfonic acid, 3-nitro-, sodium salt; Benzenesulfonic acid, m-nitro-, sodium salt; 

Ludigol; Ludigol F,60; Nacan; Nitrobenzen-m-sulfonan sodny; Nitrobenzen-m-sulfonan sodny [Czech]; Nitrol S; Sodium 3-

nitrobenzenesulfonate; Sodium m-nitrobenzenesulfonate; Tiskan; Tiskan [Czech]; m-Nitrobenzenesulfonic acid sodium salt; 

Benzenesulfonic acid, 3-nitro-, sodium salt (1:1); Benzenesulfonic acid, m-nitro-, sodium salt; Sodium 3-

nitrobenzenesulphonate; Benzenesulfonic acid, m-nitro-, sodium salt; m-Nitrobenzenesulfonic acid, sodium salt

5 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)-

Neophyl chloride; 2-Chloromethyl-2-phenylpropane; (2-Chloro-1,1-dimethylethyl)benzene; Benzene, (2-chloro-1,1-

dimethylethyl)-; β-Chloro-tert-butylbenzene; β,β-Dimethylphenethyl chloride; (β-Chloro-α,α-dimethyl)ethylbenzene; 2-Methyl2-phenylpropyl chloride; (beta-Chloro-tert-butyl)benzene 

6 2494-89-5

Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-

(hydrogen sulfate)

4-((2-Sulfatoethyl)sulfonyl)aniline; 2-((p-Aminophenyl)sulphonyl)ethyl hydrogensulphate; Ethanol, 2-((4-

aminophenyl)sulfonyl)-, 1-(hydrogen sulfate); Ethanol, 2-sulfanilyl-, hydrogen sulfate (ester)

7 5026-74-4

2-Oxiranemethanamine, N-[4-(2-

oxiranylmethoxy)phenyl]-N-(2-

oxiranylmethyl)-

Oxiranemethanamine, N-[4-(oxiranylmethoxy)phenyl]-N-(oxiranylmethyl)-; Aniline, p-(2,3-epoxypropoxy)-N,N-bis(2,3-

epoxypropyl)-; p-(Diglycidylamino)phenyl glycidyl ether; p-Aminophenol triglycidyl ether; ERL 0500; ERL-0510(Triglycidyl-pAminophenol); N,N,O-Tris(epoxypropyl)-p-aminophenol; 4-(Diglycidylamino)phenyl glycidyl ether; 4-(2-Oxiranylmethoxy)-

N,N-bis(2-oxiranylmethyl)aniline; BRN 1393091; N-(4-(Oxiranylmethoxy)phenyl)-N-(oxiranylmethyl)oxiranemethanamine; TK 

12759; 2-Oxiranemethanamine, N-(4-(2-oxiranylmethoxy)phenyl)-N-(2-oxiranylmethyl)-; p-(2,3-Epoxypropoxy)-N,N-bis(2,3-

epoxypropyl)aniline; 

8 22527-63-5

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-

2,2,4-trimethylpentyl ester 3-Benzoyloxy-2,2,4-trimethylpentyl isobutyrate; Isobutyric acid, 3-hydroxy-2,2,4-trimethylpentyl ester benzoate 

9 25321-41-9 Benzenesulfonic acid, dimethyl- Dimethylbenzenesulfonic acid; Xylene sulfonic acid; Xylenesulphonic acid; Xylenesulfonic acid

10 52556-42-0

1-Propanesulfonic acid, 2-hydroxy-3-(2-

propen-1-yloxy)-, sodium salt (1:1)

1-Propanesulfonic acid, 2-hydroxy-3-(2-propenyloxy)-, monosodium salt; 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-

yloxy)-, sodium salt (1:1); Sodium 3-(allyloxy)-2-hydroxypropanesulphonate; 1-Propanesulfonic acid, 2-hydroxy-3-(2-

propenyloxy)-, monosodium salt

11 68082-78-0 Lard, oil, Me esters Lard oil fatty acids, methyl esters; Lard oil methyl esters; Lard oil, methyl ester; Lard oil, methyl esters; Lard, methyl es ter; 

Lard, methyl esters; Lard, oil, Me esters; Oils, lard, Me esters; Lard, oil, Me esters

12 68442-60-4

Acetaldehyde, reaction products with 

formaldehyde, by-products from EINECS 270-480-6
2-3

Exhibit 2-1: Chemicals Included in the Final High Production Volume Chemical Test Rule

CASRN Common Chemical Name Synonyms

13 68610-90-2

2-Butenedioic acid (2E)-, di-C8-18-alkyl 

esters (C8-C18)Dialkyl fumarate; 2-Butenedioic acid (E)-, di-C8-18-alkyl esters

14 70693-50-4

Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-

(2-nitrophenyl)diazenyl]-

2-Nitro-2'-hydroxy-3',5'-bis(alpha,alpha-dimethylbenzyl)azobenzene; 2,4-Bis(1-methyl-1-phenylethyl)-6-((2-

nitrophenyl)azo)phenol; Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-(2-(2-nitrophenyl)diazenyl)-; Phenol, 2,4-bis(1-methyl-1-

phenylethyl)-6-((2-nitrophenyl)azo)-

15 72162-15-3 1-Decene, sulfurized 1-Decene, sulfurized; 1-Decene, sulfurized

Sources: National Institute of Standards and Technology, 2008, and U.S. U.S. NLM, 2008a.
2-4

2.2 Chemical Use and Market Information

EPA collected chemical use and market information for the chemicals included in the final rule to analyze 

the rule‟s potential impact on manufacturers of these substances. For example, chemical use information 

is useful in determining the markets the chemicals are sold in and the general profitability of those 

markets. Producer, price, and production volume data are used more specifically to estimate the annual 

revenue that each manufacturer of the chemicals in the final rule generates from those chemicals, and to 

compare these revenues to the compliance costs for each chemical pursuant to the final rule. 

The current chapter discusses methods employed to evaluate use and market information for each 

chemical included in the final rule, and presents a summary of results. Market information presented 

includes publicly available producer, production, trade, and price information, where these data were 

available. Chemical-specific use and market information for each chemical included in the final rule is 

presented in Section 2.3.

2.2.1 Chemical Producer and Production Information

EPA acquired chemical producer and production information from submissions required by the Toxic 

Substances Control Act (TSCA) Inventory Update Reporting (IUR) Revisions rule (70 FR 75059, 

December 19, 2005) and the Preliminary Assessment Information Reporting (PAIR); Addition of Certain 

Chemicals rule (71 FR 47122, August 16, 2006).

The IUR rule requires manufacturers and importers of certain chemical substances contained in the TSCA 

Chemical Substances Inventory with a site-specific production/import volume of 25,000 pounds or more 

to report current data on their production volumes, plant sites, and other information related to the 

manufacture of the chemicals. Since 1986, reporting under the IUR rule has taken place at four-year 

intervals.

3 The data presented in this chapter are from the 2006 reporting cycle, which covers production 

in calendar year 2005, and represents the most recent data available.

The PAIR rule requires manufacturers and importers that manufactured or imported certain HPV 

Challenge Program4orphan (unsponsored) chemicals during their latest complete corporate fiscal year 

(which could be the calendar year 2005, or a year spanning months in 2005 or 2006) to submit a one-time 

report on general production/importation volume, end use, and exposure-related information to EPA. 

Manufacturers were included in this analysis if they reported, through either rule, any production volume 

for any of the chemicals regulated under this final High Production Volume Chemical test rule. In cases 

where the volumes reported under both rules did not match, the higher production volume was used in 

this analysis.

IUR rule and PAIR rule submissions can include both confidential business information (CBI) and nonconfidential information related to producers and production volumes. Manufacturer‟s identities and 

production volumes used in calculations for this analysis were considered CBI; however, this report

presents those data in a non-CBI format.

 

3

The 2005 amendments to the IUR rule changed the reporting cycle from four years to five years; the next reporting 

cycle covers calendar year 2010.

4

EPA‟s voluntary HPV Challenge Program was created to encourage the development of a baseline set of data on 

approximately 2,800 HPV chemicals. Since the Program‟s inception in 1998, industry chemical manufacturers and 

importers have participated in the Challenge by sponsoring 2,250 chemicals. More than 350 companies and 100 

consortia have sponsored chemicals directly in the Program. HPV chemicals that are not sponsored under the 

Program may be subject to a test rule under TSCA Section 4, such as this final rule.
2-5

Based on IUR and PAIR reporting, EPA identified 31 global ultimate parent companies that produce the 

15 chemicals included in the final test rule. A company was included in this analysis if it reported under 

either the IUR or PAIR rule. This figure may not include all potentially affected entities because, for 

example, companies that manufactured or imported less than 25,000 pounds of a subject chemical at an 

individual site in 2006 are not required to comply with IUR reporting; however, EPA believes this figure 

presents a reasonable estimate for the purpose of analyzing the effects of the final rule. If the 2006 

production volumes reported by a company for a specific chemical differed between the submissions for 

the IUR and PAIR rule, the larger of the reported volumes was used in this analysis. 

Once producers of each chemical were identified, EPA used facility-specific Dun & Bradstreet 

identification numbers (DUNS numbers) from Dun & Bradstreet‟s DUNS Market Identifier database 

(Dun & Bradstreet, 2008) and information about facility location provided in the IUR database to identify 

facilities and their global ultimate parent companies.5 A search conducted using the Dun & Bradstreet 

database also provided data on annual sales and number of employees at the parent company level for all 

facilities determined to be potentially subject to the final rule. EPA was able to collect information on 

sales and employment for most of the parent companies using the Dun & Bradstreet database. Annual 

sales data and employee data were available for 30 of the 31 global ultimate parent companies identified.6

Exhibit 2-2Exhibit 2-2 provides summary statistics of the available data for the 31 companies included in 

this analysis. As shown in Exhibit 2-2Exhibit 2-2, potentially impacted companies vary widely as 

measured by both number of employees and annual sales.

Exhibit 2-2: Employee and Sales Information for Potentially Impacted 

Companies Included in the Analysis

Statistical Measure

Number of 

Employees Annual Sales

Minimum Value 5 $187,086

Maximum Value 430,000 $170,088,644,172

Median Value 3,272 $1,401,274,101

Mean Value 35,497 $13,715,463,866

Standard Deviation 96,780 $35,322,934,044

Source: Dun & Bradstreet, 2008.

Note: Employee and annual sales data were available for 30 of the 31 global ultimate parent companies 

identified.

Exhibit 2-3Exhibit 2-3 and Exhibit 2-4Exhibit 2-4 show the distribution of potentially impacted 

companies considered in the analysis by number of employees and annual sales, respectively.

 

5 Dun & Bradstreet is a New York-based company that provides business information through a global commercial 

database. It assigns DUNS numbers to identify businesses around the world. These numbers are required for many 

U.S. federal government transactions and therefore are widely used and assigned. DUNS numbers are also 

frequently used in corporate research. Database entries provide legal and trade names, physical and mailing 

addresses, geographical descriptions, product and industry descriptors, sales and number of employees for three 

years and associated growth rates, as well as up to 40 vital statistics about each organization. 

6

The reporting year for the most current data in the Dun & Bradstreet database varied across companies.
2-6

0

1

2

3

4

5

6

7

8

0 to 100 101 to 500 501 to 2,500 2,501 to 

10,000

10,001 to 

50,000

>50,001

Number of Companies

Number of Employees

0

2

4

6

8

10

12

$0 to $100 $101 to $500 $501 to 

$1000

$1,001 to 

$10,000

>$10,001

Number of Companies

Annual Sales ($Millions)

Exhibit 2-3: Distribution of Potentially Impacted Companies by Number of Employees

Source: Dun & Bradstreet, 2008.

Exhibit 2-4: Distribution of Potentially Impacted Companies by Annual Sales

Source: Dun & Bradstreet, 2008.

The distribution of chemicals included in the final rule by publicly-available production volume range 

falls entirely in the range of 10 million pounds or less annually. 

2.2.2 Chemical Price Information

No published price data were available for any of the chemicals in the Chemical Market Reporter (CMR)

(ICIS, 2006). Some chemicals were listed in the U.S. International Trade Commission‟s report entitled 

Synthetic Organic Chemicals (USITC, 1992); for the remainder of chemicals, EPA derived prices from 

Comment [LB-H1]: The exhibit does not show 

this.
2-7

these and other publications using a number of assumptions. This section first discusses the method used 

to obtain chemical prices from the CMR and USITC, and then discusses the methods used to derive 

chemical prices for the remaining chemicals. Based on this chemical price search method, EPA has either 

obtained or derived price data for all 15 chemicals included in the final rule.

Price Data Available from the CMR and USITC. Using the following sequential methodological steps, 

EPA was able to locate price data for two chemicals:

CMR: First, EPA searched the CMR for price data using common chemical names, and searched the 

CMR for price data using synonyms for each common chemical name as listed in Exhibit 2-1. No 

price data was available for any of the chemicals in the CMR.

USITC: Where available, EPA used the average price per pound of chemicals from various 

Harmonized Tariff Schedule (HTS) chemical groups in USITC‟s report entitled Synthetic Organic 

Chemicals. For two chemicals, the price was available as part of an HTS group. Because the last 

USITC report was published in 1992, EPA then inflated these costs using the producer price index 

(PPI) for chemical manufacturing.

EPA-Derived Price Data. EPA derived prices for the remaining chemicals using the methods described 

below. 

Similar Chemical Prices. For one chemical, EPA used CMR data for another chemical that is 

similar in chemical composition, use, or manufacture.

Small Quantity Catalog Prices. Online chemical catalogs published by Sigma-Aldrich Company 

(2008) and Fisher Scientific (2008) provided small quantity price information for six of the remaining

chemicals for which data were not available using the sources and methods described above. 

However, because small quantity catalog prices are often significantly higher than the bulk quantity 

prices reported in the CMR, EPA adjusted the small quantity catalog prices for these six chemicals to 

approximate bulk quantity prices. To determine the appropriate adjustment factor, EPA randomly 

selected 15 chemicals (not subject to this final rule) for which price data were available from both the

CMR (2006, inflated to 2008 prices using PPI) and Sigma-Aldrich (2008), and compared the prices to 

develop scaling factors (see Exhibit A-4 in Appendix A). These prices were then inflated to 2009 

dollars using the PPI for chemical manufacturing. For example, the price of a 1-kilogram quantity of 

Benzene, (2-chloro-1,1-dimethylethyl)- (CASRN 515-40-2), as found in the Sigma-Aldrich catalog, is 

$130.50. Using standard conversion methods (1 kilogram = 2.204 pounds), the implied small quantity 

price per pound for this chemical is $59.19. This small quantity price is then divided by a scaling 

factor of 46.51 to arrive at an estimated bulk quantity price of $1.27 per pound for this chemical.

Small Quantity Catalog Prices of Similar Chemicals. For five additional chemicals, EPA was able to 

find “similar chemicals” with prices quoted in the Sigma-Aldrich or Fisher Scientific catalog. The 

Agency followed the same method as that described above to scale these small quantity catalog prices 

to approximate bulk quantity prices.

American Chemistry Council Prices. The American Chemistry Council (ACC) publishes a “Guide to 

the Business of Chemistry,” which contains price information for certain types of chemicals. 

According to the guide published in 2008 (ACC, 2008), a rule of thumb for specialty chemicals is that 

the price is greater than $1.25 per pound. To be conservative, EPA used a price of $1.25 per pound 

for the remaining one chemical.
2-8

Appendix AAppendix A provides further detail on the methods used to estimate chemical prices. Exhibit 

2-Exhibit 2-5 presents the price per pound for the chemicals included in this final rule, as well as the 

publicly available production volume ranges (as noted earlier, this analysis uses actual production 

volumes as reported through the IUR or PAIR rules, which may be considered CBI). Exhibit 2-65Exhibit 

2-6 presents summary statistics of this price information. Exhibit 2-Exhibit 2-7 presents the distribution of 

chemical prices. 

Exhibit 2-5: Chemical Price and Production Volume Information

Chemical

(CASRN) Price/lb ($2009)

Source for 

Pricing

Production Volume 

Range

(lbs)

Source for 

Production 

Volume1

Benzenesulfonyl chloride

(98-09-9) $0.58 USITC 1M to < 10M IUR

Benzene, 1-chloro-4-(trifluoromethyl)-

(98-56-6) $0.25 Sigma-Aldrich 1M to < 10M IUR

Ethane, 1,1'-oxybis[2-chloro-

(111-44-4) $0.51 Sigma-Aldrich 1M to < 10M IUR

Benzenesulfonic acid, 3-nitro-, sodium salt (1:1)

(127-68-4) $0.30 Sigma-Aldrich 1M to < 10M IUR

Benzene, (2-chloro-1,1-dimethylethyl)-

(515-40-2) $1.25 Sigma-Aldrich 1M to < 10M IUR

Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen 

sulfate)

(2494-89-5)

$0.73

Sigma-Aldrich

(by proxy) 1M to < 10M IUR

2-Oxiranemethanamine, N-[4-(2-

oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-

(5026-74-4)

$0.72 Sigma-Aldrich 1M to < 10M IUR

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-

trimethylpentyl ester

(22527-63-5)

$1.25 ACC 1M to < 10M IUR

Benzenesulfonic acid, dimethyl-

(25321-41-9) $2.84 USITC 1M to < 10M IUR

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-

yloxy)-, sodium salt (1:1)

(52556-42-0)

$1.12 Sigma-Aldrich 1M to < 10M IUR

Lard, oil, Me esters

(68082-78-0) $0.71

Sigma-Aldrich

(by proxy) 1M to < 10M IUR

Acetaldehyde, reaction products with formaldehyde, 

by-products from

(68442-60-4)

$0.24 CMR

(by proxy) 1M to < 10M IUR

2-Butenedioic acid (2E)-, di-C8-18-alkyl esters

(68610-90-2) $33.00 Fisher(by proxy) 1M to < 10M IUR

Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-

nitrophenyl)diazenyl]-

(70693-50-4)

$5.88 Sigma-Aldrich

(by proxy) 1M to < 10M IUR

1-Decene, sulfurized

(72162-15-3) $0.20

Sigma-Aldrich

(by proxy) 1M to < 10M IUR

1 “IUR” production volume information from U.S. EPA, 2009.

Exhibit 2-657: Summary Statistics for Chemical Prices: $2009

Minimum price per pound $ 0.20

Maximum price per pound $33.00

Mean price per pound $ 3.31

Median price per pound $ 0.72

Standard deviation $ 8.34

Formatted: Body Text Char
2-9

Exhibit 2-7: Distribution of Prices for Chemicals Included in the Final Rule in 2009$

2.3 Chemical-Specific Use and Market Information

This section presents use information for each of the chemicals included in the final test rule. To find 

information on chemical uses, EPA relied on readily available secondary sources. This section is meant to 

provide a broad overview of uses and, due to resources available, is not expected to be a complete, 

exhaustive review. EPA was able to obtain use information for 12 of the 15 chemicals using various 

sources. Chemical use information is presented in Exhibit 2-86Exhibit 2-8. Data reported to EPA through 

the IUR rule reporting requirements (2006 reporting cycle) are also shown.

Exhibit 2-869: Chemical Use Information

Chemical

(CASRN) Use IUR-Reported Use Information

1 Benzenesulfonyl chloride

(98-09-9)

chemical intermediate for benzene sulfonamides, 

thiophenol, glybuzole, n-2-chloroethyl amides, and 

benzonitrile

reagent for Friedel-Crafts sulfonylation

esters are useful as insecticides and miticides

(U.S. NLM, 2008b)

Industrial Sector: Other Basic 

Organic Chemical Manufacturing

Commercial/Consumer Product 

Category: Rubber and plastic 

products

2 Benzene, 1-chloro-4-

(trifluoromethyl)- (98-56-6)

solvent for industrial cleaning, aerosols, adhesives, 

coatings, inks, and electronic applications. 

1,1,1-trichloroethane alternative

dye intermediate

dielectric fluid

dinitroaniline herbicide intermediate 

ingredient in home maintenance product

(Ash, 2003; Merck Index, 2001; U.S. NLM, 2009)

Industrial Sectors: Adhesive 

Manufacturing; All Other Chemical 

Product and Preparation 

Manufacturing; Other Basic 

Inorganic Chemical Manufacturing; 

Other Basic Organic Chemical 

Manufacturing; Paint and Coating 

Manufacturing; Resin and Synthetic 

Rubber Manufacturing

0

1

2

3

4

5

6

$0 to $0.50 $0.51 to $1.00 $1.01 to $3.00 >$3.01

Number of Chemicals

Price Range ($/lb)
2-10

Exhibit 2-869: Chemical Use Information

Chemical

(CASRN) Use IUR-Reported Use Information

3 Ethane, 1,1'-oxybis[2-chloro-

(111-44-4)

scavenges lead deposits in gasoline

an anesthetic

an acaricide

in the manufacture of medicines and 

pharmaceuticals

in an oil solution sprayed on corn silks to control 

earworms

general solvent

selective solvent for production of high-grade 

lubricating oils

intermediate and crosslinking agent in organic 

synthesis

textile scouring and cleansing

in fulling compounds

in wetting and penetrating compounds

in paints, varnishes, lacquers, finish removers, 

spotting and dry cleaning

in soil fumigants

(U.S. NLM, 2008b; Ash, 2003; Merck Index, 2001)

Industrial Sector: Basic Organic 

Chemical Manufacturing (functions 

as a corrosion inhibitor or antiscaling agent)

Commercial/Consumer Product 

Category: Other 

4 Benzenesulfonic acid, 3-nitro-, 

sodium salt (1:1) 

(127-68-4)

stabilizer for fiber reactive dyeing

assistant in discharge printing

viscosity control agent in cosmetics

oxidizing agent in demetalizers and industrial 

cleaners

anti-reduction agent

(Ash, 2003; U.S. NLM, 2008b)

None reported

5 Benzene, (2-chloro-1,1-

dimethylethyl)-

(515-40-2)

pesticide raw material

precursor to catalysts used for olefin polymerization

(Chemhost, Inc., 2009; U.S. Patent and Trade Office, 

1984 and 2006)

Industrial Sector: Pesticide and 

Other Agricultural Chemical 

Manufacturing

Commercial/Consumer Product 

Category: Agricultural products (nonpesticidal)

6 Ethanol, 2-[(4-

aminophenyl)sulfonyl]-, 1-

(hydrogen sulfate)

(2494-89-5)

indicator and/or reagent (U.S. NLM, 2008a) Commerical/Consumer Product 

Category: Reported as CBI

7 2-Oxiranemethanamine, N-[4-(2-

oxiranylmethoxy)phenyl]-N-(2-

oxiranylmethyl)-

(5026-74-4)

in epoxy resins (composite aircraft bodies/parts) 

(Ashford’s Dictionary of Industrial Chemicals, 2001)

Industrial Sectors: Resin and 

Synthetic Rubber Manufacturing; 

Aerospace Product and Parts 

Manufacturing 

8 Propanoic acid, 2-methyl-, 3-

(benzoyloxy)-2,2,4-trimethylpentyl 

ester

(22527-63-5)

plasticizer 

(Velsicol Chemical Corporation, 2009)

Industrial Sector: Other Plastics 

Product Manufacturing

Commercial/Consumer Product 

Category: Rubber and plastic 

products

9 Benzenesulfonic acid, dimethyl-

(25321-41-9)

esterification an acetylation catalyst

catalyst for coatings and foundry resins 

in the preparation of esters

hardening agent in plastics

activator for nicotine insecticides

curing agent for resins, phenolic foundry resins

descaling agent in foundry sand castings

plating aid in electroplating baths

hydrotrope for agricultural formulations

surfactant in cosmetics

(Ash, 2003; Ashford, 2001)

None reported
2-11

Exhibit 2-869: Chemical Use Information

Chemical

(CASRN) Use IUR-Reported Use Information

10 1-Propanesulfonic acid, 2-hydroxy3-(2-propen-1-yloxy)-, sodium salt 

(1:1) (52556-42-0)

polymerizable surfactant for vinylic systems

antistatic properties

promotes adhesion of pigments

emulsion polymerization in paper, textile, fiber, and 

adhesives industries

(Ash, 2003)

Industrial Sectors: All Other 

Chemical Product and Preparation 

Manufacturing; Other Basic Organic 

Chemical Manufacturing.

Commercial/Consumer Product 

Category: Other

11 Lard, oil, Me esters

(68082-78-0)

lubricants

(Lubriplate Lubricants Co., 2009)

Industry Sector: Other Basic Organic 

Chemical Manufacturing

12 Acetaldehyde, reaction products 

with formaldehyde, by-products 

from (68442-60-4)

No use information found. Commercial/Consumer Product 

Category: CBI

13 2-Butenedioic acid (2E)-, di-C8-18-

alkyl esters

(68610-90-2)

Non-specified consumer use from PAIR reporting. 

(U.S EPA, 2011)

Industry Sector: Other Basic Organic 

Chemical Manufacturing

Industrial Function: Lubricant

14 Phenol, 2,4-bis(1-methyl-1-

phenylethyl)-6-[2-(2-

nitrophenyl)diazenyl]-

(70693-50-4)

No use information found. Commercial/Consumer Product 

Category: CBI

15 1-Decene, sulfurized

(72162-15-3)

No use information found Industry Sector: Other Petroleum 

and Coal Products Manufacturing; 

Industrial Function: Lubricant
3-1

Chapter 3 – Social Costs of the Final Rule

This chapter presents estimates of the social costs that industry (chemical manufacturers and other entities 

affected by the final rule) and EPA may incur due to the requirements included in the final rule, and 

discusses the method used to measure each. Industry may incur costs related to laboratory testing 

requirements (discussed in Section 3.1.1), analytical methodology validation (Section 3.1.2), 

administrative activities (Section 3.1.3), and export notification requirements (Section 3.1.4). Total 

industry compliance costs are summarized in Section 3.1.5. Non-monetized costs are described in Section 

3.1.6. EPA may incur costs related to reviewing and processing letters of intent, study plans, final reports, 

and exemption applications submitted by industry (Section 3.2). The total social costs are summarized in 

Section 3.3.

3.1 Industry Costs

Industry compliance costs include costs for laboratory testing, analytical methodology validation, 

administration, and export notification. The methodology for estimating each of these cost types is 

described below in greater detail.

3.1.1 Laboratory Testing Costs

The premise of the final rule is that basic toxicity information, comparable to that generated by the 

Screening Information Data Set (SIDS) Programme of the Organisation for Economic Co-operation and 

Development (OECD), should be available for all HPV chemicals included in the rule. The OECD HPV 

SIDS Programme seeks information on the identity of each chemical; its uses, sources, and extent of 

exposure; physical and chemical properties; environmental fate; and certain limited toxicity data for 

humans and the environment. While SIDS is more comprehensive in data coverage than the requirements 

of the final rule (e.g., uses, sources, and extent of exposure), it is not intended to describe a chemical 

thoroughly, but rather to provide enough information to support an initial (or screening-level) assessment 

and to assign a priority for further work, if necessary. Included in the OECD HPV SIDS Programme is 

the development of test data, if such data are not already available, related to six health and environmental 

effect endpoints for international HPV chemicals: (1) acute toxicity; (2) repeat dose toxicity; (3) 

developmental and reproductive toxicity; (4) genetic toxicity (gene mutations and chromosomal 

aberrations); (5) ecotoxicity (studies in fish, Daphnia, and algae); and (6) environmental fate (including 

physical/chemical properties). The test data identified under SIDS have been agreed upon by the 29 

member countries of the OECD as providing the minimum data set required to make an informed 

preliminary judgment about the hazards of a given HPV chemical. 

EPA‟s final required testing follows the SIDS model. Exhibit 3-1Exhibit 3-1 provides a description of the 

tests that may be required for chemicals under the final rule. To determine which testing would be 

required for each chemical, EPA examined available test data for the chemicals in the final rule (U.S. 

EPA, 2009b). Based upon this review, EPA is requiring testing only for those endpoints where data are 

unavailable or deemed inadequate. Tests required for each chemical included in the final rule are 

summarized in Exhibit 3-2Exhibit 3-2. 
3-2

Exhibit 3-1: Tests Required by EPA for HPV Chemicals, Based on the OECD’s Screening Information 

Data Set (SIDS)

Protocol Name Protocol Number(s) Description

Test 

Code 

(used in 

this 

analysis)

Melting Point ASTM E 324-99

The melting point is the temperature at which a substance transitions from the solid 

to liquid phase. The ASTM E 324-99 melting point test determines the initial and final 

melting points (melting range) of stable, crystalline organic solids whose melting 

points fall between 30 and 250°C.

A1

Boiling Point ASTM E 1719-05

The ASTM E 1719-05 boiling point test determines the boiling point and vapor 

pressure of pure liquids and azeotropes (i.e., mixtures of two chemicals that boil at a 

unique temperature) that are condensable at total reflux and boil in between 12 and 

302°C.

A2

Vapor Pressure ASTM E 1782-03

The vapor pressure indicates the tendency of a solid or liquid to evaporate. The 

ASTM E 1782-03 vapor pressure test determines the vapor pressure of pure liquids 

or melted solids within the temperature range 0°C to 500°C and the pressure range 

5 kPa to 2000 kPa using differential thermal analysis, differential scanning 

calorimetry, or preferably high-pressure versions of these instruments. 

A3

Partition Coefficient

799.6755; or ASTM 

E 1147-92(2005); 

or 799.6756

The octanol/water partition coefficient (log KOW) indicates how easily a compound 

might dissolve in water or in fat. The ASTM E 1147-92 partition coefficient test 

determines the logarithm of the log KOW of non-ionizable and ionizable compounds 

by inputting the retention time on a liquid chromatographic column into an empirically 

derived equation. This information is used to assess the lipophilicity (i.e., the ability 

to dissolve in fat) of chemicals. 

A4

Water Solubility

ASTM E 1148-02; 

or 799.6784; or 

799.6786

The physical property describing the ability of a given substance to dissolve in water 

is termed water solubility. The ASTM E1148-02 water solubility test determines the 

affinity of water- and air-stable chemicals to water.

A5

Ready 

Biodegradation

Choice of: ASTM 

1720-01, ISO 

14593, ISO 7827, 

ISO 9408, ISO 

9439, ISO 10707, 

or ISO 10708

The biodegradation test provides a measure of how quickly chemicals will be broken 

down in the environment by natural processes such as bacterial digestion. The 

ASTM E 1720-01 ready biodegradability test uses the generation of carbon dioxide 

by a dilute sewage inoculum as a proxy to determine the biodegradability of organic 

compounds in a closed vessel. Biodegradation of 60% or more during the closed 

vessel test indicates that in most environmental compartments the chemical’s 

biodegradation will go to completion. 

B

Acute Toxicity to 

Fish

ASTM E 729-

96(2002)

The ASTM E 729-96 acute toxicity test determines the concentration of chemical 

needed to reach a toxicity threshold in certain species of freshwater and saltwater 

fish. The standard thresholds used are the concentration at which there is a 50% 

fatality rate in the test organisms (LC50) or the concentration at which there is a 50% 

adverse effect response rate in the test organisms (EC50) during 2- to 8-day 

exposures in either static (no replacement of toxicant), renewal (periodic 

replacement of toxicant), or flow-through (continuous or intermittent replacement of 

makeup water and toxicant) conditions. Lower thresholds represent higher toxicity in 

the target organisms. 

C

Acute Toxicity to 

Daphnia

ASTM E 729-

96(2002)

The ASTM E 729-96 acute toxicity test determines the concentration of chemical 

needed to reach a toxicity threshold in Daphnia crustaceans. The standard 

thresholds used are the concentration at which there is a 50% fatality rate in the test 

organisms (LC50) or the concentration at which there is a 50% adverse effect 

response rate in the test organisms (EC50) during 2- to 8-day exposures in either 

static (no replacement of toxicant), renewal (periodic replacement of toxicant), or 

flow-through (continuous or intermittent replacement of makeup water and toxicant) 

conditions. Lower thresholds represent higher toxicity in the target organisms.

Acute Toxicity to 

Plants ASTM E 1218-04e1

The ASTM E 1218-04e1 toxicity test determines the concentration of chemical 

needed to reach a toxicity threshold in freshwater and saltwater microalgae. The 

standard threshold used is the concentration at which there is a 50% growth 

inhibition rate (IC50) during 72-, 96-, or 120-hour exposures in static (no replacement

of toxicant) conditions.

Chronic Toxicity to 

Daphnia

ASTM E 1193-

97(2004)

The ASTM E 1193-97 chronic toxicity test determines the concentration of chemical 

needed to reach a toxicity threshold in Daphnia magna Straus crustaceans. 

Exposures are conducted using flow-through (continuous or intermittent replacement 

of makeup water and toxicant) methods and last over the life cycle of the organisms. 
3-3

Exhibit 3-1: Tests Required by EPA for HPV Chemicals, Based on the OECD’s Screening Information 

Data Set (SIDS)

Protocol Name Protocol Number(s) Description

Test 

Code 

(used in 

this 

analysis)

Acute Inhalation 

Toxicity 799.9130

This test gives an indication of potential harm from inhaling a chemical compound. 

The standard test to measure the acute inhalation toxicity of gases, volatile 

substances, and aerosols in mammals is defined in 40 CFR §799.9130. This test is 

conducted during a period of 24 hours or less using inhalation at no less than three

dose levels (and a control, when using a vehicle other than water) in animals of both 

sexes. Occurrence, severity, and reversibility for as many behaviorally and clinically 

abnormal outcomes as possible should be catalogued during the experiment, and an 

attempt to determine the relationship between dose level and effect should be made. 

This test can be used to determine a regimen of doses for longer-term (i.e., 

subchronic and chronic) inhalation toxicity studies.

D

Acute Oral Toxicity

ASTM E 1163-

98(2002) or 

799.9110(d)(1)(i)(A)

This test gives an indication of harm from ingesting a chemical compound. The 

standard test to measure the acute oral toxicity of liquid or solid chemicals in 

mammals is defined in 40 CFR §799.9110. This test is conducted during a period of 

24 hours or less using single or multiple ingestion doses at no less than three dose 

levels (and a control, when using a vehicle other than water) in animals of both 

sexes. Occurrence, severity, and reversibility for as many behaviorally and clinically 

abnormal outcomes as possible should be catalogued during the experiment, and an 

attempt to determine the relationship between dose level and effect should be made. 

This test can be used to determine a regimen of doses for longer-term (i.e., 

subchronic and chronic) oral toxicity studies.

BALB/c 3T3 Neutral 

Red Uptake 

Cytotoxicity; or

N/A

This test provides an indication of a chemical’s toxic effect on a cell, the basic 

building block of the body. The BALB/c 3T3 Neutral Red Uptake Cytotoxicity test 

determines the magnitude of cellular toxicity of water-soluble chemicals on the 

BALB/c 3T3 mouse fibroblast cell line. Cell viability after short-term (24 hour) in vitro

chemical exposure is measured using the cells’ ability to take up the Neutral Red 

dye as a proxy.

BHK Neutral Red 

Uptake Cytotoxicity N/A

This test provides an indication of a chemical’s toxic effect on a cell, the basic 

building block of the body. The BHK Neutral Red Uptake Cytotoxicity test determines 

the magnitude of cellular toxicity of chemicals on a baby hamster kidney (BHK) 

fibroblast cell line. Cell viability after in vitro chemical exposures of unknown length is 

measured using the cells’ ability to take up the Neutral Red dye as a proxy.

Bacterial Reverse 

Mutation 799.9510

This test measures a chemical’s ability to change the genetic code of bacteria, which 

is an indicator of the chemical’s ability to change the genetic code of humans. The 

Bacterial Reverse Mutation test described in 40 CFR §799.9510 seeks to determine 

the existence of genotoxicity during chemical exposure using mutated Salmonella 

typhimurium and Escherichia coli bacterial cultures. Reversal of the test organism 

mutations (e.g., substitution, addition, deletion) by the test chemical after 48-72 hour 

in vitro chemical exposure is measured using the bacteria’s ability to synthesize 

specific amino acids as a marker. Positive results in this test are used to determine 

chemicals that should be further tested for carcinogenic, reproductive, and 

developmental effect potential.

E1

Chromosome 

Aberration, in vitro; 

or

799.9537

The in vitro Chromosome Aberration test described in 40 CFR §799.9537 seeks to 

determine whether chemical exposure causes chromosomal aberrations in primary 

cell cultures, such as Chinese hamster fibroblasts, human, or other mammalian 

peripheral blood lymphocytes. Generation of chromosomal aberrations such as 

polyploidy (excess chromosomes) or endoreduplication (duplication of the genome 

without mitosis) by the test chemical is measured using basic microscopy techniques 

after exposure. Positive results in this test are used to determine chemicals that 

should be further tested for carcinogenic, reproductive, and developmental effect 

potential.

E2

In Vivo Mammalian 

Cytogenetics Tests: 

Bone Marrow 

Chromosomal 

Analysis; or

799.9538

The in vivo Mammalian Bone Marrow Chromosomal Aberration test described in 40 

CFR §799.9538 seeks to determine whether chemical exposure causes 

chromosomal aberrations in rodents, such as rats, mice, and Chinese hamsters. 

Generation of chromosome or chromatid aberrations such as polyploidy (excess 

chromosomes) or endoreduplication (duplication of the genome without mitosis) by 

the test chemical is measured using basic microscopy techniques. Positive results in 

this test are used to determine chemicals that should be further tested for 

carcinogenic potential, particularly in bone marrow.

Erythrocyte 

Micronucleus (bone 799.9539 The Mammalian Erythrocyte Micronucleus test described in 40 CFR §799.9539 seeks to determine whether chemical exposure causes damage to the 
3-4

Exhibit 3-1: Tests Required by EPA for HPV Chemicals, Based on the OECD’s Screening Information 

Data Set (SIDS)

Protocol Name Protocol Number(s) Description

Test 

Code 

(used in 

this 

analysis)

marrow), in vivo chromosomes or the mitotic apparatus of erythroblasts (immediate precursor to red 

blood cells) in the bone marrow of rodents, such as rats or mice. The proportion of 

immature erythrocytes among the total is measured using basic microscopy 

techniques, and a dose-response relationship is investigated. Positive results in this 

test are used to determine chemicals that should be further tested for carcinogenic 

potential, particularly with regard to erythrocyte production.

Repeated Dose 

Oral Toxicity 799.9305

This test gives an indication of harm from ingesting a chemical compound. The 

standard test to measure the repeated dose oral toxicity of liquid or solid chemicals 

in mammals is defined in 40 CFR §799.9305. The test should be conducted after the 

acute oral test described in 40 CFR §799.9110 in order to establish an appropriate 

dose range. This test is conducted during a period of 14 or 28 days using multiple 

ingestion doses at no less than three dose levels plus a control (dose = 0) in animals 

(typically rodents) of both sexes. Occurrence and severity for as many behaviorally 

and clinically abnormal outcomes as possible should be catalogued during the 

experiment, and histopathological investigations are done on specific sets of organs. 

F1

Repro/Devel 

Toxicity Screening 799.9355

These tests indicate the likelihood of a chemical to have an impact on the offspring 

of those exposed to the chemical. The standard test to measure the reproductive or 

developmental toxicity of chemicals in mammals is defined in 40 CFR §799.9355. 

Male animals are dosed for a minimum of 4 weeks with a schedule as follows: a 

minimum of 2 weeks pre-mating, during the mating period, and approximately 2

weeks post-mating. Females are dosed with a schedule as follows: at least 2 weeks 

pre-mating, time-to-conception, duration of pregnancy, and at least 4 days postdelivery. Occurrence and severity of changes in gonadal function, mating behavior, 

conception, development of the conceptus, and parturition (birth) are catalogued 

during the experiment. 

Combined 

Repeated Dose with 

Repro/Devel 

Toxicity Screen

799.9365

The standard test to measure the reproductive or developmental toxicity of 

chemicals in mammals is defined in 40 CFR §799.9365. Male animals are dosed for 

a minimum of 4 weeks with a schedule as follows: a minimum of 2 weeks premating, during the mating period, and approximately 2 weeks post-mating. Females 

are dosed with a schedule as follows: at least 2 weeks pre-mating, time-toconception, duration of pregnancy, and at least 4 days post-delivery. Occurrence 

and severity for as many behaviorally and clinically abnormal outcomes as possible 

in the adult animals should be catalogued during the experiment, and 

histopathological investigations are done on specific sets of organs. Additionally, 

occurrence and severity of changes in gonadal function, mating behavior, 

conception, development of the conceptus, and parturition (birth) are catalogued 

during the experiment. 

Repro/Devel 

Toxicity Screening 799.9355

The standard test to measure the reproductive or developmental toxicity of 

chemicals in mammals is defined in 40 CFR §799.9365. Male animals are dosed for 

a minimum of 4 weeks with a schedule as follows: a minimum of 2 weeks premating, during the mating period, and approximately 2 weeks post-mating. Females 

are dosed with a schedule as follows: at least 2 weeks pre-mating, time-toconception, duration of pregnancy, and at least 4 days post-delivery. Occurrence 

and severity for as many behaviorally and clinically abnormal outcomes as possible 

in the adult animals should be catalogued during the experiment, and 

histopathological investigations are done on specific sets of organs. Additionally, 

occurrence and severity of changes in gonadal function, mating behavior, 

conception, development of the conceptus, and parturition (birth) are catalogued 

during the experiment.

F2
3-5

Exhibit 3-2: Test Requirements for Chemicals Included in the Final Rule

CASRN Chemical Name

Required Tests

(See Test Codes in Exhibit 3-1Exhibit 3-1)

1 98-09-9 Benzenesulfonyl chloride C2, E1, E2, F1

2 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)- B, C6

3 111-44-4 Ethane, 1,1'-oxybis[2-chloro- C6, F1

4 127-68-4 Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) A3, F2

5 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)- A1, A3, A4, A5, B, C1, D, E1, E2, F1

6 2494-89-5

Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen 

sulfate) A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

7 5026-74-4

2-Oxiranemethanamine, N-[4-(2-

oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-

A1, A2, A3, A4, A5, B, C2, F1

8 22527-63-5

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-

trimethylpentyl ester A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

9 25321-41-9 Benzenesulfonic acid, dimethyl- A2, A3, A4 

10 52556-42-0

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-

yloxy)-, sodium salt (1:1) A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

11 68082-78-0 Lard, oil, Me esters A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

12 68442-60-4

Acetaldehyde, reaction products with formaldehyde, 

by-products from A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

13 68610-90-2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

14 70693-50-4

Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-

nitrophenyl)diazenyl]-

A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

15 72162-15-3 1-Decene, sulfurized A2, A3, A4, A5, B, C1, D, E1, E2, F1

.
3-6

Although the rule includes a variety of voluntary consensus standard protocols (for example, ASTM E 

729 for acute toxicity or ISO 9408 for ready biodegradation), cost estimates are based on OECD or EPA 

protocols, which are expected to be representative of the voluntary consensus standards.7 These testing 

cost estimates generally include direct labor, overhead, other direct costs such as laboratory supplies, and 

general and administrative services.

Estimating the potential testing costs for each chemical pursuant to requirements contained in the final 

rule is complicated in that industry may have choices associated with the species and/or route of 

administration used in a particular test, as well as choices between multiple tests to satisfy a particular 

endpoint testing requirement. Therefore, if cost data for a specific OECD test protocol were available for 

multiple species and routes of administration, EPA used the average cost for all available species and 

routes of administration as the test cost estimate. In addition, EPA computed a “least cost” and an 

“average cost” scenario where multiple test protocols were available to satisfy a test requirement. The 

“least cost” scenario assumes that manufacturers will choose the least costly protocol when choices are 

available. While EPA does expect that manufacturers will choose the least expensive protocol, there may 

be cases where the manufacturer chooses an alternate test based on availability, suitability for a particular 

chemical, quality control reasons, or other factors unknown to EPA at this time. Therefore, the “average 

cost” scenario assumes that the manufacturer may choose any of the tests that fulfill the testing 

requirement, and is calculated as the average of all the available testing options‟ costs. 

Individual estimates of test costs will vary across testing laboratories based upon factors such as labor 

costs, discounts provided to clients for volume testing, profit margins, and other testing. In some cases, 

EPA has accommodated this variation by developing multiple estimates for a particular test and using the 

average of the estimates to represent the cost of the test. The following paragraphs list the known test 

protocols for each of the tests required by the final rule, and describe, for each, which protocols this 

analysis includes in the least cost and average cost scenarios. Exhibit 3-3Exhibit 3-3 presents the 

protocols required by the rule, the basis for the cost estimate, and final cost estimates used in the analysis. 

Category A. Physical/chemical property testing. Physical/chemical property testing includes tests to 

measure the melting point (A1; ASTM E 324); boiling point (A2; ASTM E 1719); vapor pressure (A3; 

ASTM E 1782); n-Octanol/Water Partition Coefficient (log 10 basis) or log Kow (A4; 40 CFR §799.6755, 

ASTM E 1147, or 40 CFR 7§99.6756, depending on the estimated log Kow of the chemical); and water 

solubility (A5; ASTM E 1148, 40 CFR §799.6784, 40 CFR §799.6784, or 40 CFR §799.6786, depending 

on the chemical‟s estimated water solubility) of a chemical.8For each individual physical/chemical 

property test, EPA used only one OECD protocol as a basis for the cost estimate. Therefore, the least and 

average cost scenarios for each of these test costs is the same. 

Category B. Environmental fate testing. To test environmental fate, a manufacturer can choose one of 

the following ready biodegradation tests: ASTM 1720 (sealed vessel CO2 production test), ISO 14593 

 

7

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 

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, such as ASTM International, formerly the American Society for Testing and 

Materials (ASTM). Another voluntary consensus standard body is the International Organization for Standardization 

(ISO).

8

EPA recommends, but does not require, that log Kow be quantitatively estimated prior to initiating the nOctanol/Water Partition Coefficient (log 10 basis) or log Kow test requirement. One method, among many similar 

methods, for estimating log Kow is described in Meylan and Howard (1992). In addition, EPA recommends, but does 

not require, that water solubility be quantitatively estimated prior to initiating the water solubility test requirement. 

One method, among many similar methods, for estimating water solubility is described in Meylan et al. (1996). 
3-7

(CO2 headspace test), ISO 7827 (analysis of DOC), ISO 9408 (determination of oxygen demand in a 

closed respirometer), ISO 9439 (CO2 evolution test), ISO 10707 (closed bottle test), or ISO 10708 (twophase closed bottle test). OECD protocols for ready biodegradation, on which cost estimates are based, 

are the following: OECD 301A (DOC die-away test), OECD 301B (carbon dioxide evolution test), 

OECD 301C (modified MITI test (I)), OECD 301D (closed bottle test), OECD 301E (modified OECD 

screening test), and OECD 301F (manometric respirometry test). For this test category, the test cost used 

in the least cost scenario is based on the cheapest of the OECD tests (OECD 301D). The test cost used in 

the average cost scenario is based on the average of all of the OECD tests, because there are no special 

conditions requiring a manufacturer to use one or the other.

Category C. Aquatic toxicity testing. If aquatic toxicity testing is required for a particular chemical, a 

manufacturer must determine if the test chemical falls into one of two test groups, based on the 

chemical‟s log Kow. Test Group 1 consists of chemicals with a log Kow of less than 4.2. Test Group 2 

consists of test chemicals with a log Kow greater than or equal to 4.2. Each test group has different testing 

requirements and, therefore, different testing costs. Because EPA does not know which test group a 

chemical will fall within (i.e., the log Kow is unknown), the testing costs of both groups are estimated. For 

example, the following situations occur under testing categories C1 and C2:

C1: Conduct the Acute Toxicity to Fish test (ASTM E 729), Acute Toxicity to Daphnia test (ASTM 

E 729), and the Toxicity to Plants test (ASTM E 1218) [Test Group 1] or conduct the Chronic 

Toxicity to Daphnia test (ASTM E 1193) and the Toxicity to Plants test (ASTM E 1218) [Test Group 

2]. In this case, the sum of the acute testing costs is averaged with the chronic test cost to obtain the 

testing cost estimate for testing categories C1 and C2 under both the least and average cost scenarios. 

C2: Conduct the Acute Toxicity to Daphnia test (ASTM E 729) and the Toxicity to Plants test 

(ASTM E 1218) [Test Group 1] or conduct the Chronic Toxicity to Daphnia test (ASTM E 1193) and 

the Toxicity to Plants test (ASTM E 1218) [Test Group 2]. In this case, the two test costs are averaged 

to obtain the testing cost estimate for testing category C2 under both the least and average cost 

scenarios.

Category D. Mammalian toxicity testing – acute. The acute mammalian toxicity testing requirement is 

met by implementing one of two methods defined in the final rule (Method A or Method B). The method 

a manufacturer selects is based on the chemical‟s physical state at room temperature. For those test 

substances that are gases at room temperature, Method A is required; otherwise, Method B is required. 

Method A requires an Acute Inhalation Toxicity test in rats (40 CFR 799.9130). Method B requires an 

Acute Oral Toxicity test (ASTM E 1163 or 40 CFR §799.9110(d)(1)(i)(A) and, if the manufacturer 

chooses to, a Neutral Red Uptake Cytotoxicity test (BALB/c 3T3 or BHK). The cost of the cytotoxicity 

test is estimated as the sum of the two cytotoxicity test costs (BALB/c 3T3 plus BHK), which is a 

conservative estimate that is likely to overestimate actual cytotoxicity test costs. Because the chemical's 

physical state at room temperature is unknown, a least and average cost scenario are estimated. Under the 

least cost scenario, the cost of the acute mammalian toxicity testing requirements is assumed to be the 

cost of the Acute Oral Toxicity Test, which is the cheaper of the two methods. Under the average cost 

scenario, the cost of the acute mammalian toxicity testing requirements is assumed to be the average of 

the Method A testing requirement and the sum of the Method B testing requirement and the least 

expensive cytotoxicity test. The cytotoxicity tests are included in the average cost scenario even though 

they are optional, because they are animal-saving tests and so may be preferred.
3-8

Category E. Mammalian toxicity testing – genotoxicity. For gene mutations (E1), manufacturers are 

required to conduct the in vitro Bacterial Reverse Mutation test (40 CFR §799.9510). For chromosomal 

damage (E2), manufacturers can conduct one of three tests: the in vitro Mammalian Chromosome 

Aberration test (40 CFR §799.9537), the Mammalian Bone Marrow Chromosomal Aberration test (40 

CFR §799.9538), or the Mammalian Erythrocyte Micronucleus test (40 CFR §799.9539). Under the least 

cost scenario, the cost of chromosomal testing is assumed to be the cost of the least expensive test (40 

CFR §799.9539), while under the average cost scenario, the cost of chromosomal testing is assumed to be 

the average of all three test options because the test the manufacturer may conduct is unknown. 

Category F. Mammalian toxicity testing – repeated dose/reproduction/developmental. For test 

category F1, a manufacturer can either conduct the Combined Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity Screening Test (40 CFR §799.9365), or conduct the 

Reproduction/Developmental Toxicity Screening Test (40 CFR §799.9355) and the Repeated Dose 28-

Day Oral Toxicity Study in rodents (40 CFR §799.9305). Testing costs under the least cost scenario are 

assumed to be the cheaper of these two options (conducting 40 CFR §799.9365). Testing costs under the 

average cost scenario are assumed to be the higher cost option (conducting both 40 CFR §799.9355 and 

40 CFR §799.9305). For test category F2, the manufacturer would conduct the individual protocol 40 

CFR §799.9355 under both the least and average cost scenarios.

Estimated Total Test Costs. The final rule requires only that the required test results be obtained once 

for each chemical; each manufacturer is not required to do the tests separately. Typically, manufacturers 

form a “task force” or panel through a common trade organization to coordinate any testing required by 

TSCA Section 4. Therefore, in order to obtain the total test costs under the final rule, EPA assumes that a 

required test will be performed only once per chemical. The costs of the tests required for each chemical 

were summed for all chemicals, and then the total cost per chemical was summed across all chemicals 

included in the final rule. 

Following this method, the total laboratory cost for testing the chemicals included in the final rule is 

estimated to range from approximately $2.79 million under the least cost scenario to approximately $3.42

million under the average cost scenario. (Exhibit B-1Exhibit B-1 and Exhibit B-2Exhibit B-2) in 

Appendix B provide the total test costs for each chemical, under the least and average cost scenarios, 

respectively.) These estimates may overstate the true testing burden because they are based on the 

assumption that each chemical is tested independently. If more than one chemical is tested at a time (for 

example, if a manufacturer sends a group of chemicals to be tested at the same laboratory at the same 

time), testing costs could be lower due to economies of scale (for example, the test‟s quality control 

procedures may be performed by batch, making the per-chemical cost lower). Dividing these totals by the 

15 chemicals in the final rule yields an average laboratory test cost per chemical of approximately 

$186,000 under the least cost scenario and approximately $228,000 under the average cost scenario.
3-9

Exhibit 3-3: EPA Estimates of Laboratory Costs of Final Tests (2009$)

Testing Category Test Code Protocol Name Required Protocol Number(s)

Basis for Cost 

Estimate

Cost 

Estimate

2009$1

Physical/Chemical 

Properties

A1 Melting Point ASTM E 324-99

OECD 102

(Least & Average 

Cost Scenarios)

$1,651

A2 Boiling Point ASTM E 1719-05

OECD 103

(Least & Average 

Cost Scenarios)

$1,687

A3 Vapor Pressure ASTM E 1782-03

OECD 104

(Least & Average 

Cost Scenarios)

$10,072

A4 Partition Coefficient Method A: 799.6755; or Method B: ASTM E 1147-92(2005) or Method C: 

799.6756

OECD 107

(Least & Average 

Cost Scenarios)

$8,040

A5 Water Solubility Method A: ASTM E 1148-02; or Methods B or C: 799.6784 (shake flask 

and column elution); or Method D: 799.6786

OECD 105

(Least & Average 

Cost Scenarios)

$7,040

Environmental 

Fate and 

Pathways

B

Ready Biodegradation

Choice of: ASTM 1720 (sealed vessel CO2 production test), ISO 14593 

(CO2 headspace test), ISO 7827 (analysis of DOC), ISO 9408 

(determination of oxygen demand in a closed respirometer), ISO 9439 

(CO2 evolution test), ISO 10707 (closed bottle test), or ISO 10708 (twophase closed bottle test)

OECD 301A $10,625

OECD 301B $9,311

OECD 301C $23,578

OECD 301D $7,712

OECD 301E $10,568

OECD 301F $10,411

Least Cost Scenario (OECD 301D) $7,712

Average Cost Scenario (Average of All Protocols) $12,034

Aquatic Toxicity

C1

(Test 

Group 

1)

Acute Toxicity to Fish ASTM E 729-96(2002) OECD 203 $11,648

Acute Toxicity to Daphnia ASTM E 729-96(2002) OECD 202 (Part 1) $6,171

Acute Toxicity to Plants ASTM E 1218-04e1 OECD 201 $10,511

Test Group 1 Sum $28,330

(Test 

Group 

2)

Chronic Toxicity to Daphnia ASTM E 1193-97(2004) OECD 202 $37,897

Acute Toxicity to Plants ASTM E 1218-04e1 OECD 201 $10,511

Test Group 2 Sum $48,408

Least & Average Cost Scenarios (Average of C1 Test Group 1 and 2 Sums) $38,369

C2

(Test 

Group 

1)

Acute Toxicity to Daphnia ASTM E 729-96(2002) OECD 202 (Part 1) $6,171

Acute Toxicity to Plants ASTM E 1218-04e1 OECD 201 $10,511

Test Group 1 Sum $16,682

(Test Chronic Toxicity to Daphnia ASTM E 1193-97(2004) OECD 202 $37,897
3-10

Exhibit 3-3: EPA Estimates of Laboratory Costs of Final Tests (2009$)

Testing Category Test Code Protocol Name Required Protocol Number(s)

Basis for Cost 

Estimate

Cost 

Estimate

2009$1

Group 

2)

Acute Toxicity to Plants ASTM E 1218-04e1 OECD 201 $10,511

Test Group 2 Sum $48,408

Least & Average Cost Scenarios (Average of C2 Test Group 1 and 2 Sums) $32,545

C3

(Test 

Group 

1)

Acute Toxicity to Fish ASTM E 729-96(2002) OECD 203 $11,648

Acute Toxicity to Plants ASTM E 1218-04e1 OECD 201 $10,511

Test Group 1 Sum $22,159

(Test 

Group 

2)

Chronic Toxicity to Daphnia ASTM E 1193-97(2004) OECD 202 $37,897

Acute Toxicity to Plants ASTM E 1218-04e1 OECD 201 $10,511

Test Group 2 Sum $48,408

Least & Average Cost Scenarios (Average of C3 Test Group 1 and 2 Sums) $35,284

C4

(Test 

Group 

1)

Acute Toxicity to Fish ASTM E 729-96(2002) OECD 203 $11,648

Acute Toxicity to Daphnia ASTM E 729-96(2002) OECD 202 (Part 1) $6,171

Test Group 1 Sum $17,820

(Test 

Group 

2)

Chronic Toxicity to Daphnia ASTM E 1193-97(2002) OECD 202 $37,897

Least & Average Cost Scenarios (Average of C4 Test Group 1 and 2 Sums) $27,858

C5

(Test 

Group 

1)

Acute Toxicity to Daphnia ASTM E 729-96(2002) OECD 202 (Part 1) $6,171

(Test 

Group 

2)

Chronic Toxicity to Daphnia ASTM E 1193-97(2004) OECD 202 $37,897

Least & Average Cost Scenarios (Average of C5 Test Group 1 and 2 Sums) $22,034

C6 Acute Toxicity to Plants ASTM E 1218-04e1

OECD 201 

(Least & Average 

Cost Scenarios)

$10,511

Mammalian 

Toxicity - Acute D

(Method 

A) Acute Inhalation Toxicity 799.913 OECD 403 $15,136

(Method 

B)

Acute Oral Toxicity ASTM E 1163-98(2002) or 799.9110(d)(1)(i)(A) OECD 423 $2,601

BALB/c 3T3 Neutral Red 

Uptake Cytotoxicity; or N/A N/A $3,884

BHK Neutral Red Uptake 

Cytotoxicity N/A N/A $5,014

Sum of Cytotoxicity Tests $8,898

Least Cost Scenario (OECD 423) $2,601

Average Cost Scenario (Average of 403 and (423 + least expensive Cytotoxicity test)) $10,811

Mammalian E1 Bacterial Reverse Mutation 799.9510 OECD 471 $8,469
3-11

Exhibit 3-3: EPA Estimates of Laboratory Costs of Final Tests (2009$)

Testing Category Test Code Protocol Name Required Protocol Number(s)

Basis for Cost 

Estimate

Cost 

Estimate

2009$1

Toxicity –

Genotoxicity

(Least & Average 

Cost Scenarios)

E2

Chromosome Aberration, in 

vitro; or 799.9537 OECD 473 $23,892

In Vivo Mammalian 

Cytogenetics Tests: Bone 

Marrow Chromosomal 

Analysis; or

799.9538 N/A $50,207

Erythrocyte Micronucleus 

(bone marrow), in vivo 799.9539 OECD 474 $17,308

Least Cost Scenario (OECD 474) $17,308

Average Cost Scenario (Average of 473, 799.9538, and 474) $30,469

Mammalian 

Toxicity –

Repeated Dose/

Reproduction/ 

Developmental

F1

Repeated Dose Oral Toxicity; 

and, 799.9305 OECD 407 $65,486

Repro/Devel Toxicity 

Screening; or,

799.9355 OECD 421 $132,494

Combined Repeated Dose 

with Repro/Devel Toxicity 

Screen

799.9365 OECD 422 $134,377

Least Cost Scenario (OECD 422) $134,377

Average Cost Scenario (Sum of OECD 407 and OECD 421) $166,178

F2 Repro/Devel Toxicity 

Screening 799.9355

OECD 421 

(Least & Average 

Cost Scenarios)

$63,733

1

Test costs were estimated in different years, so EPA used the Employment Cost Index (ECI) Current-Dollar Historical Listing from the Bureau of Labor Statistics (BLS, 2010a), U.S. 

Department of Labor, to convert all test cost estimates to 2009$.
3-12

3.1.2 Analytical Methodology Validation Costs

When conducting tests, laboratories perform analytical methodology validation to ensure that proper dose 

concentrations are used in toxicity studies. An analytical methodology validation approach assumes that 

an acceptable analytical method is available for a particular chemical and that the method is directly 

related to the matrix used for the test. When analytical methodologies are not suitable or known, they 

must be developed or modified. 

Analytical method validation includes all of the procedures that demonstrate that a particular method used 

for quantitative measurement of analytes in a given matrix is reliable and reproducible for the intended 

use. The fundamental parameters for this validation include (1) accuracy, (2) precision, (3) selectivity, 

(4) sensitivity, (5) reproducibility, and (6) stability. Validation involves documenting, through the use of 

specific laboratory investigations, that the performance characteristics of the method are suitable and 

reliable for the intended analytical applications. The acceptability of analytical data corresponds directly 

to the criteria used to validate the method.

Factors that may increase the cost of analytical method development and validation costs include 

(1) testing new chemicals that lack any established methodology or historical analytical data to use as a 

starting point, and (2) testing chemicals that present challenging conditions or possess characteristics that 

require special or additional procedures during sample preparation and analysis. If previous testing on a 

chemical of interest has been conducted by either a laboratory or client, information may be available that 

can assist with sample preparation and analytical testing. This can help to minimize the costs of method 

development and validation. 

Analytical method development and analytical costs can also vary depending on characteristics of the test 

substance. Characteristics of chemicals that may impact the cost of analytical method development and 

validation include chemical stability, chemical properties, matrix properties and interactions with the 

chemical, and whether the chemicals are mixtures or multi-component chemicals or polymers. For 

example, chemicals are not always stable under every test or analysis condition, and a chemical could 

decompose or transform into a different chemical under testing conditions, which will invalidate the test 

results. Such chemicals will require additional effort to identify alternate conditions or matrices for testing 

to eliminate the potential for stability issues to affect the testing results. Certain properties may also affect 

the costs of analytical method development. Some chemicals may interact with the dosing matrix and 

require special or even different handling and processing procedures that can impact the level of method 

development efforts. 

Once analytical methodology validation is completed for a specific chemical, however, it need not be 

repeated for tests of a similar nature (e.g., tests using the same dosing matrix), provided testing is done at 

the same laboratory. However, it is possible that analytical methodology validation may be required for 

both short-term and long-term tests where there are separate requirements for dose concentration ranges 

(e.g., parts per million for acute tests and parts per billion for chronic tests).

For this final rule, EPA has assumed an exposure concentration in the parts per billion range requiring 

multi-step preparation, concentration, and cleanup before analysis by gas or high-pressure liquid 

spectroscopy, resulting in an estimated analytical method validation cost ranging from $2,500 to $10,000. 

For the purpose of this analysis, a cost of $3,500 has been assigned for short-term tests (acute), and a cost 

of $8,500 has been assigned for tests that are assumed to be long-term tests (genotoxicity and 

reproductive/developmental toxicity), as shown in Exhibit 3-4Exhibit 3-4. Because analytical method 

validation may not be necessary for all tests when multiple tests are completed on the same chemical, 

these costs could be overestimated.
3-13

Exhibit 3-4: Costs for Analytical Methodology Validation

Testing Category Test Symbol

Cost Estimate

Physical Chemical Properties A no additional costs

Environmental Fate and 

Pathways B no additional costs

Aquatic Toxicity C

Test Group 1 $3,500

Test Group 2 $8,500

Test Group 1 and 2 Average $6,000

Mammalian Toxicity - Acute D $3,500

Mammalian Toxicity -

Genotoxicity E $8,500

Mammalian Toxicity – Repeated 

Dose/ Reproduction/ 

Developmental

F $8,500

3.1.3 Administrative Costs

In addition to laboratory costs, entities subject to the final test rule will also incur expenses associated 

with the administration of the testing program itself. Administrative activities include “reporting 

activities,” such as preparing letters of intent, study plans, exemption applications, and final reports, and 

“non-reporting activities,” such as soliciting laboratory bids, selecting laboratories, monitoring tests under 

progress, developing cost-sharing agreements, and auditing the laboratories for compliance with EPA‟s 

Good Laboratory Practice (GLP) standards. Total administrative costs are calculated as the sum of the 

costs of reporting and non-reporting activities. This section discusses the methods and data employed to 

estimate reporting and non-reporting costs.

Reporting Activities. Reporting activities include preparing letters of intent, study plans, exemption 

applications, final reports, and robust summaries. As noted above, manufacturers typically form a “task 

force” or panel through a common trade organization to coordinate testing and reporting required by 

TSCA Section 4. One panel may often represent groups of chemicals. EPA reviewed the list of chemicals 

subject to the final test rule, and sorted them into groups of similar chemicals (e.g., hydrocarbons, dyes, 

alkyl halides). This sorting results in an estimated 11 chemical groupings. Assuming that each grouping is 

sponsored by a panel, EPA estimates that 11 panels will be formed in response to the rule.

Reporting costs per panel include costs associated with submitting letters of intent, study plans, final 

reports, and exemption applications. The analysis assumes that the panels will each submit one letter of 

intent and one set of study plans for their group of chemicals, resulting in 11 letters of intent and 11 study 

plans submitted to EPA. In addition, one final report is assumed to be required for each test conducted for 

each chemical.9 To estimate the total number of final reports, the total number of tests required for each 

chemical is summed across all chemicals, which results in an estimated 118 final reports that will be 

submitted to EPA in response to this rule. EPA also assumes that it will receive five exemption 

applications per panel, resulting in a total of 55 requests.

Finally, respondents may choose to develop and submit robust summaries of the full, final 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. 

 

9 While some of the chemicals may require longer-term aquatic testing based on chemical characteristics, EPA could 

not be certain of the number. Therefore, EPA did not include an estimate for progress reports.
3-14

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. Based on professional 

judgment, EPA estimates that 8 to 16 hours of technical time are needed to develop and review a robust 

summary, depending on the type of study conducted. Therefore, for this analysis, EPA 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 percent of full, final toxicological study reports may include a robust summary. 

Therefore, EPA expects approximately 12 robust summaries.

EPA estimates that it takes a respondent 40 hours to prepare a letter of intent and study plan, 73 hours to 

write a final report, and 2 hours to prepare an exemption application (U.S. EPA, 2002). These unit labor 

hours were derived from previous information collection requests and are believed to reflect the burdens 

that will be incurred for the final test rule.

Wage rates associated with the predominant skill level (managerial, technical, and clerical) required to 

complete each of the reporting activities described in this section are presented in Exhibit 3-5Exhibit 3-5. 

These wage rates have been estimated following the method described in a memorandum titled, “Wage 

Rates for Economic Analyses of the Toxics Release Inventory Program” (Rice, 2002). This method uses 

average December 2009 wages, benefits, and total compensation data extracted from the Employer Costs 

for Employee Compensation Summary available from the BLS Web site. Appendix C provides detailed 

information on the estimation of these wage rates.

Exhibit 3-5: Derivation of Loaded Hourly Rates by Labor Category

Labor Category 2009 Wage Rate

2009 Benefits and Overhead

Loading Factor

2009 Loaded 

Hourly Wage Rate

Managerial $42.36 161% $68.24

Technical $35.96 165% $59.49

Clerical $17.21 164% $28.31

Source: Methodology from “Wage Rates for Economic Analyses of the Toxics Release Inventory Program” (Rice, 

2002). Wage rates and benefits extracted from the Employer Costs for Employee Compensation Summary, Bureau 

of Labor Statistics (BLS, 2010c); assumed overhead rate of 17% applied to wage rates based on assumptions in 

Rice (2002) and U.S. EPA (2002).

Exhibit 3-6Exhibit 3-6 details the respondents‟ reporting cost and burden estimates. As shown, the total 

reporting cost and burden estimates are approximately $482,664 and 9,308 hours, respectively.

Exhibit 3-6: Industry Reporting Cost and Burden Estimate for the Final Rule (2009$)

Reporting Activity

Unit Labor

Annual 

Submissions

Total

Category1 Hours

Wage 

Rate Cost Hours Cost

Letter of Intent and 

Study Plan

T 40 $59.49 $2,380 11 440 $26,176

Final Report

Record & Prepare Test for 

Submission

Laboratory Review

Corporate Review

Type & Print Results

Record Keeping

T

T

M

C

C

40

6

6

20

1

$59.49

$59.49

$68.24

$28.31

$28.31

$2,380

$357

$409

$566

$28.31

118

4,720

708

708

2,360

118

$280,793

$42,119

$48,314

$66,812

$3,341

Robust Summaries T 12 $59.49 $714 12 144 $8,567

Exemption Applications T 2 $59.49 $119 55 110 $6,544

TOTAL 9,308 $482,664

1

Labor categories are as follows: T = Technical; M = Managerial; C = Clerical.

Numbers may not add up due to rounding 
3-15

Non-Reporting Activities. In addition to reporting activities, manufacturers need to conduct a number of 

non-reporting activities. In January 2007, EPA conducted a brief study to investigate the types of nonreporting activities manufacturers conduct and the magnitude of associated costs.10 The non-reporting 

activities identified include soliciting laboratory bids, selecting laboratories, monitoring tests in progress, 

developing cost-sharing agreements, and auditing the laboratories for compliance with EPA‟s GLP 

standards. These activities, in addition to identifying manufacturers, arranging meetings, and employing 

toxicologists who may be hired to provide testing expertise for the testing, are considered to represent the 

costs of managing the testing consortium. While these costs will vary based on a number of 

circumstances, the report suggests that managing the testing consortium is equivalent, on average, to 15 

percent of the chemical testing costs, which is the assumption used in this analysis. Based on the study, an 

additional 10 percent of the testing costs are estimated to cover the costs of the technical expert who may 

work for the consortium, including that expert‟s study review and site visits to the laboratory. Therefore, 

total non-reporting administrative costs are assumed to equal an additional 25 percent of the total testing 

costs. Because laboratory-testing costs are estimated as $2.79 million under the least cost scenario and 

$3.42 million under the average cost scenario, non-reporting costs are approximately $0.70 million and 

$0.85 under the least and average cost scenarios, respectively.

Total Administrative Costs. As stated previously, total administrative costs pursuant to the final rule are 

estimated as the sum of reporting and non-reporting costs. Thus, total administrative costs are estimated 

to be $1.18 million under the least cost scenario and $1.34 million under the average cost scenario. 

3.1.4 Export Notification Costs

Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical 

subject to various TSCA sections (40 CFR §707.60 through 75). Therefore, all exporters of chemicals 

regulated under the final rule must notify EPA about each country to which a chemical included in the 

final rule is shipped. This is a one-time notification requirement, and the exporter needs to submit the 

notice only when it is exporting a particular chemical for the first time to a country for which it has not 

previously submitted a notification.

A detailed analysis of the impact of export notifications would require data on the identity and/or number 

of exporters exporting chemicals included in the final rule and the identity and/or number of countries to 

which each chemical included in the final rule is exported. While data on aggregate export volumes for 

various chemicals are published in U.S. Department of Commerce publications, detailed data identifying 

exporters and destination countries for all the chemicals included in the final rule are not readily available 

from secondary data sources. For this reason, it is difficult to estimate the number of export notifications 

that would be triggered by the promulgation of the final rule.

Given these data limitations, the costs of export notifications for the final rule are based on data available 

from EPA‟s Export Notifications Tracking System (U.S. EPA, 2004a). According to these data, EPA 

received approximately 786 export notifications associated with 30 unique chemicals. Therefore, on 

average, there were approximately 25 export notifications per chemical in 2003 that were related to TSCA 

Section 4. This analysis assumes that there will also be 25 export notifications per chemical subject to the 

final rule.

U.S. EPA (1992a) estimated that the export notification burden was 1.5 hours per notification letter. In 

particular, the analysis assumed that it takes 1 hour of technical time to write each export notification 

letter and 0.5 hours of clerical time to print and send out each letter. However, most of the repeat 

submissions received by EPA are only computer-generated form letters (Blake-Hedges, 1999). While it 

 

10 U.S. EPA, 2007.
3-16

might take 1 hour of technical time to prepare an initial letter, for subsequent submissions the analysis 

assumed that it would require only 0.5 hours of clerical time to reproduce the letter, based on the U.S. 

EPA (1992a) estimate for clerical time to print and send. Because notification letters are expected from 

both first-time filers and more experienced filers, the present analysis assumes that the export notification 

burden of the final rule ranges from 0.5 hours to 1.5 hours. The 2009$ wage rate for technical staff is 

$59.49 per hour, while that for clerical staff is $28.31 per hour (see Exhibit 3-5Exhibit 3-5). This 

translates into a low-end labor cost estimate of $14.15 per notice and a high-end labor cost estimate of 

$73.65 per notice. In addition, industry incurs approximately $13.34 per notice (2009$) for sending each 

notice to EPA via registered mail ($10.60 for registered mail, $2.30 for a return receipt, and $0.44 for 

postage) (USPS, 2010). Accounting for labor and shipping costs, the total cost of preparing and 

submitting an export notification is estimated to range from $27.49 per notice to $86.99 per notice. For 

the least cost scenario, the analysis uses the 0.5 hour labor burden and $27.49 cost per notice; for the 

average cost scenario, the analysis uses a 1.0 hour labor burden and the average of the low-end and highend notification cost, which is $57.24. Assuming that 15 chemicals are regulated under the final rule, and 

that 25 notifications will be submitted for each chemical, it is estimated that a total of 375 notifications

will be submitted in response to the final rule. Thus, the total cost of export notifications triggered by the 

final rule is $10,309 under the least cost scenario and $21,465 under the average cost scenario. These 

estimates are summarized in Exhibit 3-7Exhibit 3-7.

Exhibit 3-7: Export Notification Cost Estimate for the Final Rule (2009$)

Compliance Cost Category

Cost

Category Hours

Wage 

Rate

Least Cost 

Scenario

Highest 

Cost 

Scenario

Average 

Cost 

Scenario

Write Export Notification Letter Technical 

Labor

0 - 1 $59.49 $0 $59.49 $29. 75

Copy or Print and Send Export 

Notification Letter

Clerical 

Labor

0.5 $28.31 $14.15 $14.15 $14.15

Total Labor Cost per Letter $14.15 $73.65 $43.90

Shipping Cost per Letter Fixed Cost -- -- $13.34 $13.34 $13.34

Total Cost per Letter (Labor and Shipping) $27.49 $86.99 $57.24

Total Cost for 375 Notification Letters $10,309 $32,621 $21,465

3.1.5 Total Industry Compliance Costs

The total compliance costs borne by the regulated industry are summarized in Exhibit 3-8Exhibit 3-8. The 

total industry compliance costs triggered by the final rule are estimated to equal $4.28 million under the 

least cost assumption and $5.08 million under the average cost assumption. These estimates include 

laboratory, methodology validation, administrative, and export notification costs. Laboratory costs may 

be overestimated due to the economies of scale that could arise if multiple chemicals are tested together 

or multiple tests are conducted on the same chemical. Total compliance costs may also be overestimated 

to the extent that firms can claim tax deductions for some of these costs.

Exhibit 3-8: Summary of Total Industry Compliance Costs Triggered by the Final

Rule (2009$)

Compliance Cost Category

Cost ($ million, unadjusted)

Least Cost 

Scenario

Average Cost 

Scenario

Laboratory costs (Section 3.1.1) 2.79 3.42

Analytical methodology validation costs (Section 3.1.2) 0.31 0.31

Administrative costs (Section 3.1.3) 1.18 1.34

Export notification costs (Section 3.1.4) 0.01 0.02

Total industry compliance costs (Section 3.1.5) 4.28 5.08

Average compliance cost per chemical 0.29 0.34
3-17

3.1.6 Non-Monetized Costs

The proposed rule requires that manufacturers, importers, and/or processors of chemicals included in the 

proposed rule perform screening-level toxicity tests on the chemicals. EPA routinely conducts an 

assessment of laboratory capacity and has applied those findings to this analysis, which allowed EPA to 

examine the potential for laboratory capacity to become a factor in the economic impact of the proposed 

rule. The following summarizes conclusions from the most recent laboratory capacity assessment (U.S. 

EPA, 2010).

EPA anticipates that Contract Research Organizations (CROs) will conduct the majority of testing rather 

than in-house laboratories. Currently, the testing industry in general appears to be operating well under 

capacity due to the economic recession. Many CROs rely on the pharmaceutical and biotechnology 

sectors for a substantial part of their business. During economic downturns, customers in these sectors 

tend to curtail research and development, including toxicological testing, on new products. Combined 

with recent consolidations in the testing industry, these conditions have produced a notable decrease in 

testing demand. 

The one possible caveat is that implementation of the European Union‟s Registration, Evaluation, 

Authorisation and Restriction of Chemicals (REACH) legislation that could still create a spike in testing 

demand. REACH requires the registration of chemicals and submission of test data to identify risks that

chemicals may pose. The registration of the first group of chemicals began in June 2008 and is scheduled 

to end in December 2010. The fact that laboratories have still not seen an influx in testing as the first 

registration deadline approaches, however, may indicate that manufacturers and importers have existing 

data ready to submit, plan to use alternative methods (e.g., SAR) to meet the data requirements, or the 

number of chemicals

Because it is operating under capacity, it appears that the testing industry would be able to adjust to any 

potential increase in demand over a reasonable time frame. Such an expansion would only be initiated, 

however, once a backlog of test requests has been sustained for several months and is anticipated to 

continue over a long period of time. Due to their historical reliance on pharmaceutical and biotechnology 

client testing, few U.S. laboratories would engage in speculative expansion in anticipation of increased 

future testing driven by EPA or European chemical testing initiatives. 

Additionally, the testing industry is increasingly becoming a global market. China, and to a lesser extent 

India, are emerging as serious potential competitors to what has historically been a largely U.S. and 

European controlled market. While there are still barriers to overcome, the capabilities of Chinese and 

Indian CROs are quickly approaching those of established laboratories in the United States and Europe. 

With labor costs representing a significant proportion of testing costs, China and India can offer similar 

capabilities at a much reduced cost. Manufacturer‟s willingness to move business to these overseas 

providers will depend on China and India‟s ability to demonstrate credibility and quality, and for the 

results of work done in their facilities to be accepted by industry stakeholders, including regulatory 

bodies.

Given that the amount of testing required by the proposed rule is not extensive and the tests are not 

significantly complex, it appears that testing capacity is not a significant factor in meeting the 

requirements of the proposed rule in the short-term. In addition, the less than expected level of demand 

for screening-level testing resulting from other initiatives, such as REACH, should allow CROs to meet 

testing needs as a result of the proposed rule. In the long-term, the supply should adjust to the demand, so 

that capacity is not a concern.
3-18

3.2 EPA Costs

EPA will also incur costs resulting from the final rule. Once data are collected and submitted by industry, 

EPA must review and process letters of intent, study plans, final reports, robust summaries, and 

exemption applications for completeness, adherence to protocols, and findings.

EPA assumes that, on average, a Federal GS-13, Step 1, full-time equivalent (FTE), equivalent to 2,080 

hours per year, will conduct its collection procedures under the final rule. The annual 2009 fully loaded 

salary for a GS-13, Step 1, FTE is $139,083 (annually) and $66.87 (hourly). This includes a base salary of 

$86,927 plus 60 percent for overhead and benefits (i.e., $52,156).11 Multiplying the hourly rate by the 

overhead factor yields an hourly wage of $66.87 for the FTE. Appendix C provides a detailed description 

of these calculations. 

As explained earlier in Section 3.1.2, approximately 11 letters of intent and study plans, 55 exemption 

applications, 118 final reports, and 12 robust summaries are estimated to be filed in response to the final 

rule. It is estimated that it takes on average 3 hours to process a letter of intent and study plan, 5 hours to 

process a final report, 1 hour to review a robust summary, and 1 hour to review each exemption 

application. Error! Reference source not found. presents the estimated total government costs based on 

these assumptions. As shown, the total government costs for the final rule are estimated to be 

approximately $46,138.

Exhibit 3-9: Estimated Government Costs for the Final Rule (2009$)

Item

Unit Labor

Hours Rate Cost/Item Total Items Total Cost

Letter of Intent and Study Plans 3 $66.87 $200.60 11 $2,207

Final Reports 5 $66.87 $334.33 118 $39,451

Robust Summaries 1 $66.87 $66.87 12 $802

Exemption Applications 1 $66.87 $66.87 55 $3.678

Total $46,138

3.3 Summary of Total Social Costs

The estimated total social costs of the final rule are the sum of industry and EPA costs (Exhibit 

3-10Exhibit 3-10). The total social costs under the least and average cost scenarios are $4.33 million and 

$5.13 million, respectively. Industry compliance costs are presented before tax. As with any costs, tax 

deductions would lower the portion borne by industry, but the amount deducted would still represent a 

cost to society because the costs borne by the government will increase. Similarly, some costs may be 

passed on to customers, suppliers, and/or workers in the form of changed prices and wages. However, a 

detailed analysis of such cost redistribution is beyond the scope of this report.

 

11 The unloaded Federal GS-13 Step 1 salary ($86,927, effective January 2009), from the Office of Personnel 

Management salary table for Washington-Baltimore-Northern Virginia (OPM, 2009). The 60 percent fringes-andoverhead rate is from an EPA/OPPE guide (U.S. EPA, 1992b). 
3-19

Exhibit 3-10: Summary of Total Social Costs Triggered by the Final Rule (2009$)

Cost Category

Cost ($ million)

Least Cost 

Scenario

Average Cost 

Scenario

Total industry compliance costs (unadjusted)a4.28 5.08

Total government costs (unadjusted) 0.046 0.046

Total social costs triggered by the final rule (unadjusted) 4.33 5.13

Annualized social costs (3 years, 3% discount rate) 1.53 1.81

Annualized social costs (3 years, 7% discount rate) 1.65 1.95

a

Total industry compliance costs include laboratory, analytical methodology validation, administration, and export 

notification costs.

Chemical-specific estimates of laboratory, analytical methodology validation, administration, export 

notification, and government costs under the least and average cost scenarios can be found in Appendix C

of this report. These costs are not expected to occur in a single year, however. They are expected to occur 

over the several years during which the actual testing occurs and EPA reviews studies. A three-year time 

period is assumed for this analysis. Thus, total social costs of the rule have been annualized over 3 years. 

The issues involved in selecting the appropriate social discount rate are complex and subject to 

considerable debate in the economics literature. This literature largely focuses on the appropriate 

treatment of displaced private investment, often referred to as the private rate of return to capital, and 

displaced consumption, often referred to as the consumption rate of interest. The literature and EPA‟s 

economic guidance document suggest that the appropriate rate to use for environmental actions is usually 

the consumption rate of interest. Historical rates of return on relatively risk-free investments, adjusted for 

taxes and inflation, suggest that a consumption rate of interest of 2 to 3 percent is appropriate (U.S. EPA, 

2000). A 3 percent discount rate is used for the primary analysis in this report, following common EPA 

convention. EPA guidance also recommends following OMB‟s basic guidance on discount rates for 

regulatory and other analyses provided in OMB Circular A-4 (OMB, 2003). The OMB suggests using 

both a 3 and a 7 percent discount rate, in real terms. Therefore, results are presented for the 3 percent and 

7 percent discount rates. As shown, total annualized social costs under the least cost scenario range from 

$1.54 to $1.65 million using a 3 percent and a 7 percent discount rate, respectively. Total annualized 

social costs under the average cost scenario range from $1.81 to $1.95 million using a 3 percent and a 7 

percent discount rate, respectively.

Detailed social cost estimates are presented in Appendix B, in Exhibit B-1Exhibit B-1 through Exhibit 

B-4.
4-1

Chapter 4 – Company-Level Impact and Small Business Impact Analysis

This chapter assesses the impact of this final HPV test rule on the manufacturers of chemicals subject to 

the rule. In the previous chapter the total industry costs were presented, and in this chapter EPA estimates 

the per-company cost incurred because of this final rule. Such an analysis is particularly relevant for small 

businesses, as defined by the U.S. Small Business Administration (SBA). This analysis satisfies the 

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

Regulatory Enforcement Act (SBREFA) of 1996.

4.1 Company-Level Impact 

When a chemical manufacturer/importer faces a mandatory test rule, it must decide whether to comply 

with the testing requirement or to discontinue production/importation of the chemical. Once the rule is 

finalized, a company would have 30 days to stop production/importation before it becomes responsible 

for testing. The costs associated with testing requirements increase the cost of manufacturing/importing 

chemicals for these companies and decrease the overall profitability of the affected products. If 

profitability falls below acceptable levels, firms may choose to discontinue production of the chemical 

(provided this can occur within 30 days of publication of the final rule), to raise prices of products, or to 

suffer reduced profitability for continued production of the chemical.

The profitability of producing and selling a chemical is measured by the flow of costs and revenues 

associated with the chemical over time. The testing required by this rule is a short-term effort to develop 

basic toxicological data. Evaluations of profitability of a chemical product line, however, are not based on 

one or even a very few years‟ results, but rather on the total expected earnings stream (appropriately 

discounted) associated with a chemical over time. Thus, losses in one year may be appropriately balanced 

against revenues in another year to assess the net present value of the stream of earnings (revenues less 

costs) of a chemical.12

The development of a complete net present value analysis of the company-specific profitability of a 

particular chemical, with and without testing costs, would ideally require company-level information on 

expected costs and the revenues stream, which is typically difficult to obtain. Although data on revenues 

are available at the company level, these revenues are often the combined revenues from all operations of 

the company. Thus, the revenues may include operations that are independent of chemical sales, and 

therefore are not relevant to include in the analysis. Further, the financial structures of companies vary, 

making it difficult to meaningfully compare across companies; budgets within companies may be 

organized such that full company resources are not available to cover testing costs, and costs are borne by 

only a small unit or division within the company. Determining the specific levels at which testing costs 

may affect all of the individual companies that manufacture chemicals affected by this final test rule is not 

possible given available data. Therefore, this analysis is performed in a two-part method, whereby a 

chemical-level analysis is performed to compare the total annualized cost of testing with the annual 

revenues for the chemical in question, across all manufacturers. If the testing costs are greater than 

1 percent of the annual revenue for a particular chemical, then in the second part, the affected companies 

are examined to evaluate the potential of testing costs to adversely affect the companies‟ profitability. The 

annualization is based on standard values for the economic life of the chemical and the discount rate for 

all chemicals considered.

 

12 The use of net present value calculations to evaluate the profitability of an investment or a business is discussed in 

many financial management texts, including Brealey and Myers (1996), Schall and Haley (1991), and Van Horne 

and Wachowicz (1997).
4-2

Such a chemical-level analysis serves as a proxy for company-level analysis if testing costs borne by each 

individual company that manufactures the chemical are in proportion to the total revenue of a company 

(assuming that the price of the chemical is the same across companies). To the extent that this is not true, 

costs will be over- or underestimated. To minimize the possibility of underestimating impacts, the 

purpose of the second step of this analysis is to consider the impacts, at the company level, for companies 

that manufacture chemicals with a cost-to-sales ratio greater than 1 percent. In this analysis, the overall 

revenue of the company is accounted for when estimating the cost-to-sales ratio. The steps used in this 

analysis are described below.

4.1.1 Calculate Annualized Costs

Because testing is a short-term effort to develop basic toxicological data, while the profitability of a 

chemical product line is based on the total earnings stream associated with the chemical over time and 

appropriately discounted, a company that experiences losses in a product line in one year due to testing 

requirements may also recoup these losses through profits earned in future years from the tested chemical. 

Annualized costs represent the amount that a company would have to pay each year over the period of 

analysis, such that the sum of these annual payments equal the present value of the overall cost of the 

rule. 

The standard formula for annualizing a lump sum cost is given by:

A = I [I(1 + i)n/ ((1 + i)n- 1)]

where A equals the annualized amount, I is the initial lump sum investment cost (equal to the one-time 

cost to comply with the rule), i is the discount rate, and n is the useful life of the investment (equal to the 

financial life of the affected company). 

The initial lump sum costs to comply with the final rule under the least and average cost scenarios are 

presented in Chapter 3. Testing costs represent an opportunity cost to the company conducting the testing, 

as the company is not able to otherwise use or invest the money spent on testing. In order to annualize 

those costs, they are discounted over an appropriate time period at a discount rate that reflects this 

opportunity cost of capital. The discount rate reflecting the opportunity cost of capital is estimated to be 

7 percent and is consistent with OMB Circular A-4 (OMB, 2003). This represents the average rate of 

return on low-yielding capital investments, such as housing, and the returns on high-yielding investments, 

such as corporate capital. Determining the number of years, n, to use in the annualization formula requires 

consideration of the “useful life” of the investment, which is longer than the time in which costs are 

actually incurred. This is because the analysis of impacts looks at the long-term profitability of the 

chemical product line, and it is not uncommon for product lines to be profitable in some years and operate 

at a loss during others, with overall profitability in the long term. For this analysis, the life of the chemical 

product line is assumed to be 15 years. The one-time testing costs are thus annualized over a 15-year 

period using a 7 percent discount rate. Exhibit 4-1 summarizes EPA‟s estimates of total annualized testing 

costs under both the least and the average cost scenarios. (Appendix B, Exhibit B-4, presents the complete 

list of chemical-specific estimates of annualized costs.) The annualized total industry compliance costs 

are $0.47 million under the least cost scenario and $0.56 million under the average cost scenario. Industry 

compliance costs are likely to be overstated because this analysis does not account for the tax 

deductibility of these costs.
4-3

Exhibit 4-1: Annualized Costs Under Least and Average Cost Scenarios 

(Total for All Chemicals) ($2009)

Category

Cost ($ million) 1

Least Cost Scenario Average Cost Scenario

Annualized Laboratory Cost $305,794 $375,475

Annualized Methodology Development Cost $33,487 $33,487

Annualized Administration Cost $129,427 $146,847

Annualized Export Notification Cost $1,132 $2,357

Annualized Industry Compliance Costs2$469,840 $558,166

1 All costs were annualized over a 15-year time horizon using a 7 percent discount rate.

2

Industry compliance costs include laboratory costs, methodology development costs, administration costs, and export 

notification costs.

4.1.2 Compare Annualized Compliance Costs to Annual Revenues

To determine if the annualized compliance costs of testing could result in an adverse economic impact for 

a given chemical, the annualized compliance costs of testing for each specific chemical were compared to 

the annual revenues for those chemicals. As described earlier, this chemical-level analysis is performed to 

screen for impacts at a 1 percent threshold and higher. For chemicals with an impact greater than this 

threshold, further analysis is performed on individual manufacturers (see Section 4.1.3).

To develop an estimate of expected annual sales revenue, the price per pound of each chemical13 was 

multiplied by the total volume of production and importation in the United States.14 The annualized cost 

of testing each of these chemicals was then divided by the annual sales revenue the chemical was 

expected to generate. If a chemical-specific cost-to-sales ratio is less than 1 percent, the test rule is 

assumed to have low potential for an adverse economic impact on the affected chemicals. If a chemicalspecific cost-to-sales ratio is 1 percent or greater, it is assumed that there could be a potential for an 

adverse impact on a chemical‟s profitability. Exhibit 4-2 presents the distribution, under the least and 

average cost scenarios, of cost-to-sales ratios for the chemicals in the final test rule as well as summary 

statistics.

Under the least cost scenario, 7 out of the 15 chemicals (47 percent) are affected at a level of less than 

1 percent of their sales. Under the average cost scenario, 5 out of 15 chemicals (33 percent) are affected at 

a level of less than 1 percent. Therefore, the potential for adverse economic impacts due to the final test 

rule is judged to be low for at least 33 percent of the regulated chemicals. However, 8 chemicals (53

percent) and 10 chemicals (67 percent) of the 15 chemicals are affected at a level greater than or equal to 

1 percent of their sales under the least and average cost scenarios, respectively. These chemicals are 

further evaluated below.

 

13 The method used to derive chemical price estimates is found in Appendix A.

14 Production/import volumes were obtained through reports submitted by manufacturers as required by the IUR and 

PAIR rules; see Chapter 2. Volumes used in this calculation may be considered confidential business information 

and are not shown in this report. 
4-4

Exhibit 4-2: Summary Statistics for Chemical-Specific Cost-to-Sales Ratios1

Statistical Measure Least Cost Scenario Average Cost Scenario

Total Number of Regulated Chemicals 15 15

Number of Chemicals with Production Volume and Price Data 15 15

Number of Chemicals with Cost-to-Sales Ratio <1 percent 7 5

Number of Chemicals with Cost-to-Sales Ratio 1 to 3 percent 4 5

Number of Chemicals with Cost-to-Sales Ratio 3 to 5 percent 2 3

Number of Chemicals with Cost-to-Sales Ratio 5 to 10 percent 1 1

Number of Chemicals with Cost-to-Sales Ratio > 10 percent 1 1

Mean Cost-to-Sales Ratio 2.38% 2.81%

Median Cost-to-Sales Ratio 1.53% 1.79%

Standard Deviation 2.83% 3.40%

1 Compliance costs were annualized over a 15-year time horizon using a 7 percent discount rate.

4.1.3 Conduct Further Analysis on Chemicals Affected at 1 Percent

For chemicals with a cost-to-sales ratio greater than 1 percent, EPA conducted further analysis to evaluate 

the potential of testing costs to adversely affect the profitability of the affected companies.15 EPA 

attempted to understand potential impacts on companies that produce chemicals with testing cost-to-sales 

ratios greater than 1 percent by examining these companies‟ individual revenue data compared to their 

share of compliance costs. 

To calculate each company‟s share of compliance costs, EPA assumed that the annualized cost of 

performing chemical-specific testing is borne by companies in proportion to their production and/or 

importation volume. For example, Company A‟s cost share for testing chemical X was computed by first 

calculating Company A‟s fraction of overall chemical X production (the volume of chemical X 

produced/imported by Company A divided by the total production of chemical X.) This fraction was then 

multiplied by the total annualized testing costs for the chemical to obtain Company A‟s cost share. The 

cost share was computed under both the least and average cost scenarios.

Using revenue data on global parent companies (Dun & Bradstreet, 2008) for companies that produce 

chemicals for which the cost-to-sales ratio is greater than 1 percent, EPA estimated company-specific 

cost-to-sales ratios. Based on this analysis, EPA concludes that the costs of the testing requirements for 

chemicals produced by a specific company exceed 1 percent of company revenues for only one of the 

companies.

Exhibit 4-3 provides summary information on company-specific cost-to-sales ratios, and indicates that the 

impact of companies‟ share of testing costs is less than 1 percent of a company‟s revenues, on average. 

This result is due to a company‟s overall revenue typically being larger than the revenue generated only 

by the specific chemical of interest. Company-specific testing costs range from less than 0.01 percent to 

approximately 17 percent of company revenues. These data suggest that even if revenues generated from 

the tested chemical included in the final rule would not support the costs of its testing, other product lines 

in the company could potentially support these costs. Finally, it may be possible for companies to 

increase the prices of the chemicals somewhat to recoup testing costs; however, because price elasticity 

information was not available for the chemicals, it is not possible to estimate the extent to which this 

could occur. As noted above, insofar as company revenues are generated from independent operations 

such that these resources are not available to fund testing costs, the company-specific ratio may be an 

underestimate of the actual impact of the costs of testing.

 

15 EPA used a 1 percent threshold based on an EPA study entitled “Review of Economic Impact Methodology 

Applied to TSCA Section 4 Test Rules.” This study found that chemical-specific cost-to-sales ratios for voluntary 

testing initiatives were less than 1 percent. While the study did not conclude that a cost-to-sales ratio greater than 

1 percent would lead to adverse financial impacts, EPA used this estimate as a reasonable threshold to determine 

whether there is a need to further evaluate impacts on a firm (D‟Ruiz and Riordan, 1998).
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Exhibit 4-3: Summary Statistics for Company-Specific Cost-to-Sales Ratios, for 

Chemicals with Cost-to-Sales Ratios Greater Than 1 Percent

Statistical Measure Least Cost Scenario Average Cost Scenario

Total Number of Affected Companies 15 19

Number of Companies with Sales Data 15 19

Total Number of Affected Chemicals 8 10

Minimum Cost-to-Sales Ratio < 0.01% <0.01%

Maximum Cost-to-Sales Ratio 14.30% 17.17%

Mean Cost-to-Sales Ratio 0.65% 0.79%

Median Cost-to-Sales Ratio < 0.01% < 0.01%

Standard Deviation 3.05% 3.66%

Notes: Compliance costs were annualized over a 15-year time horizon using a 7 percent discount rate.

Information is presented at the global parent company level.

4.1.4 Conduct a Sensitivity Analysis

Many chemicals may have a useful life that differs from the 15-year assumption used above. Therefore, 

EPA conducted a sensitivity analysis to examine the robustness of the results to a change in the 

annualization assumptions. If total compliance costs are annualized over a shorter horizon of seven years, 

31 percent of the chemicals are affected at a level of less than 1 percent under the least cost scenario and 

the average cost scenario. Exhibit 4-4 summarizes the impact of the final rule if costs are annualized over 

a seven-year time horizon.

A maximum of 11 chemicals are affected at a level of greater than 1 percent if costs are computed under 

both the least and average cost methods, and annualized over a seven-year period. Using the alternative 

scenario assumptions shifts three and one chemical(s) from a level of less than 1 percent to a level of 

greater than 1 percent under the least and average cost scenarios, respectively.

Exhibit 4-4: Sensitivity Analysis: Summary Statistics for Chemical-Specific Cost-to-Sales Ratios

Impact Category Least Cost Scenario Average Cost Scenario

Total Number of Regulated Chemicals 15 15

Number of Chemicals with Cost-to-Sales Ratio <1 percent 4 4

Number of Chemicals with Cost-to-Sales Ratio 1 to 3 percent 5 3

Number of Chemicals with Cost-to-Sales Ratio 3 to 5 percent 2 3

Number of Chemicals with Cost-to-Sales Ratio 5 to 10 percent 2 3

Number of Chemicals with Cost-to-Sales Ratio > 10 percent 2 2

Notes: Compliance costs were annualized over a 7-year time horizon using a 7 percent discount rate.

Using the same method described in Section 4.1.3, EPA concludes that the cost of the company-specific 

testing requirements for the chemicals affected at a level greater than 1 percent, if costs are annualized 

over a seven-year time horizon, also exceed 1 percent of company revenues for only one of the 

companies. For the sensitivity analysis, the average impact of each company's share of testing costs is 

approximately 1 percent. This result, however, is driven mostly by the cost-to-sales ratio of the single 

firm exceeding 1 percent because the median cost-to-sale ratio is less than 0.1 percent.
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Exhibit 4-5: Sensitivity Analysis: Summary Statistics for Company-Specific Cost-toSales Ratios, for Chemicals with Cost-to-Sales Ratios Greater Than 1 Percent

Statistical Measure Least Cost Scenario Average Cost Scenario

Total Number of Affected Companies 21 21

Number of Companies with Sales Data 21 21

Total Number of Affected Chemicals 11 11

Minimum Cost-to-Sales Ratio < 0.01% < 0.01%

Maximum Cost-to-Sales Ratio 24.16% 29.02%

Mean Cost-to-Sales Ratio 1.03% 1.23%

Median Cost-to-Sales Ratio < 0.01% < 0.01%

Standard Deviation 4.93% 5.92%

Note: Compliance costs were annualized over a 7-year time horizon using a 7 percent discount rate

Information is presented at the global parent company level.

4.2 Small Entity Impact Analysis

To determine the impact that the rule might have on small businesses, this section examines the 

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

are small (as defined by SBA) are most likely to be adversely affected by the rule, this analysis focuses on 

these companies.

The RFA, as amended by SBREFA, requires regulators to assess the effects of regulations on small 

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

also 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.

The final rule is not expected to affect small governments and small organizations, as defined under RFA 

Section 601. However, some small businesses may be affected by the final rule. Thus, this section 

assesses the potential impact of the final rule on small businesses. The major steps used in the analysis are 

described below.

4.2.1 Select a Relevant Small Business Definition

The RFA relies on the definition of a “small business” found in the Small Business Act, which authorizes 

SBA to develop definitions for “small business” typically based upon a sales or employment level 

depending on the relevant North American Industry Classification System (NAICS) code for the industry. 

For this analysis, EPA uses SBA‟s definition of a small business for each industry. Entities potentially 

affected by the final testing rule include manufacturers and processors of one or more of the 15 subject 

chemical substances, i.e., chemical manufacturing and petroleum refineries (NAICS codes 325 and 

324110). Under 13 CFR 121, SBA defines small business for the six-digit NAICS industry based on 

employment thresholds (SBA, 2004). These size standards range from 500 employees to 1,500 employees 

for the six-digit NAICS codes that are potentially affected by the final rule. For example, SBA defines a 

company in NAICS 325320 (Pesticide and Other Agricultural Chemical Manufacturing) as small if it has 

fewer than 500 employees. On the other hand, a company in NAICS 324110 (Petroleum Refineries) is 

considered small if it has fewer than 1,500 employees. To obtain a worst-case estimate of the number of 

small businesses affected by the final rule, EPA chose an employment threshold of 1,500 employees to 
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determine small business status. Throughout the remainder of this report, this definition is referred to as 

an “employment-based definition.”

For this analysis, EPA considered an alternative definition based upon sales for the purpose of sensitivity 

analysis. Under this definition, a manufacturer or importer is defined as small under 40 CFR 704.3 if it 

meets either of the following criteria:

(1) Total annual sales of the company, combined with those of any parent company, are below 

$40 million and annual production volume or importation volume at the facility is less than or equal 

to 100,000 lbs.; or

(2) Total annual sales of the company, combined with those of any parent company, are below 

$4 million.

This “sales-based definition” also includes a provision that allows adjustment to the total annual sales 

values for inflation whenever EPA deems it necessary to do so.

4.2.2 Identify the Affected Population

For each manufacturer/importer of the chemicals identified in Chapter 2, EPA identified the ultimate 

parent company and obtained sales and employment data for companies for which data are available from 

Dun & Bradstreet Market Identifier (Dun & Bradstreet, 2008).16

The search identified 31 affected global ultimate parent companies as defined by their global DUNS 

number or the highest parent level found in other sources. Sales and employment data could be found for 

30 of the global ultimate parent companies. EPA was not able to locate the global ultimate parent 

company for one of the companies that submitted production information for the 2006 Inventory Update 

Reporting (IUR) rule.

4.2.3 Identify Small Businesses

Parent company sales data, collected as explained above, were used to identify companies that qualified 

for “small business” status, per both the employment-based and the sales-based definitions specified 

above. Based on the employment criteria, 13 companies (42 percent) were identified as small. 

Furthermore, three companies (10 percent) were identified as small according to the sales criteria. 

4.2.4 Calculate Each Company’s Share of Testing Costs

As explained in Chapter 3, the industry compliance costs (the sum of laboratory costs, methodology 

development costs, administration costs, and export notification costs) were computed under least and 

average cost scenarios. These costs were annualized over a 15-year time horizon using a 7 percent 

 

16 Dun and Bradstreet is a New York-based company that provides business information through a global 

commercial database. It assigns DUNS numbers to identify businesses around the world. These numbers are 

required for many U.S. federal government transactions and therefore are widely used and assigned. DUNS numbers 

are also frequently used in corporate research. Database entries provide legal and trade names, physical and mailing 

addresses, geographical descriptions, product and industry descriptors, sales and number of employees for three 

years and associated growth rates, as well as up to 40 vital statistics about each organization. While the reporting 

year varied by company, company sales and employment data were primarily retrieved from the database in October 

2008.
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discount rate. The annualized compliance costs for all 15 chemicals were approximately $0.47 million 

under the least cost scenario and approximately $0.56 million under the average cost scenario.

17

Similar to the analysis above, to calculate each company‟s share of compliance costs, EPA assumed that 

the cost of performing chemical-specific testing is borne by companies in proportion to their production 

and/or importation volume. This fraction was then multiplied by the total annualized testing costs for the 

chemical to obtain Company A‟s cost share. Total per-company testing costs were computed by summing 

all the chemical-specific cost shares for each company. This method was used to get a worst-case estimate 

of the rule‟s impact on small businesses. For example, if Company A produced Chemicals X, Y, and Z, 

then one combined cost was examined rather than three chemical-specific shares. Cost shares were 

computed under both the least and average cost scenarios. 

4.2.5 Determine the Size of the Adverse Impact for Small Businesses

To determine the size of the adverse impact, each company‟s total share of testing costs (for all chemicals 

it manufactures/imports) was then compared to its total sales. 

Small businesses were grouped based on the cost-to-sales ratios: less than 1 percent, greater than 

1 percent, and greater than 3 percent. Exhibit 4-6 presents summary statistics for company-specific costto-sales ratios for small companies, as well as a summary of the results using the employment-based, as 

well as the sales-based, definition of a small business, under both the least and the average cost scenarios.

Exhibit 4-6 indicates that the number of small businesses affected at the 1 and 3 percent levels is identical 

regardless of the small business definition used: the analysis based on employment data correlates quite 

closely with the one based on sales data for the companies. Of the 13 companies that qualified for small

business status per the employment criteria, one had cost-to-sales ratios of greater than 1 percent under 

the least and average cost scenarios. The results are identical if the sales definition is used. 

Exhibit 4-6: Summary Statistics for Company-Specific Cost-to-Sales Ratios for Small Companies

Statistical Measure

Employment Definition1 Sales Definition2

Least Cost 

Scenario

Average Cost 

Scenario

Least Cost 

Scenario

Average Cost 

Scenario

Total Number of Identified Companies 31 31 31 31

Number of Companies with Data 30 30 30 30

Total Number of Identified Small Companies 13 13 3 3

Number Impacted at >1 percent 1 1 1 1

Number Impacted at >3 percent 1 1 1 1

Minimum Cost-to-Sales Ratio <0.01% <0.01% <0.01% 0.01%

Maximum Cost-to-Sales Ratio 14.30% 17.17% 14.30% 17.17%

Mean Cost-to-Sales Ratio 1.14% 1.36% 4.78% 5.74%

Median Cost-to-Sales Ratio 0.01% 0.01% 0.03% 0.03%

Standard Deviation 3.95% 4.75% 8.24% 9.90%

Compliance costs are annualized over a 15-year time horizon using a 7 percent discount rate.

1Companies with fewer than 1,500 employees are considered small under this definition.

2Companies with either (1) total annual sales below $40 million and annual production volume or importation volume less than or equal 

to 100,000 lbs.; or (2) total annual sales below $4 million are considered small under this definition.

4.2.6 Companies without Data

Data on sales and employees are missing for one of the 31 companies. An analysis was conducted to 

determine the potential impact on these companies, using the median revenue for small companies with 

revenue data to estimate the likely revenue of the companies without data. The median revenue for small 

 

17 Annualized over 15 years using a 7 percent discount rate. Note that these figures include only the industry 

compliance cost and not the cost to the government. Also note that industry compliance costs may be overestimated 

to the extent that companies can claim tax deductions for some of these costs.
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companies with revenue data is $24.3 million (using the employment-based definition of small business 

as described in Section 4.2.1). If this figure represented the sales for the companies without sales data, the 

cost-to-sales ratio would be less than 1 percent. Another way to look at this figure is that the overall 

revenue of the company would need to be less than $250,000 in order for testing cost impacts to be near 

or exceed 1 percent of sales. This value is slightly greater than the lowest revenue and significantly less 

than the median income. 

4.2.7 Conclusions

EPA estimates that small entities will not be adversely affected by the final testing rule. For the final rule, 

EPA estimates that the small entities that are potentially directly regulated by this rule include small forprofit businesses; no nonprofit organizations or governments are expected to be affected by this final rule. 

EPA estimates that there are 13 small entities that would be affected by this final rule under the number of 

employees-based definition, and 3 small entities that would be affected under the sales-based definition. 

Of these, EPA estimates that there is one small business for which the cost impact of the testing exceeds 

1 percent of the company‟s revenue.
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Chapter 5 – Benefits

The final rule targets high production volume (HPV) chemicals for which basic toxicological (hazard) 

information is unavailable and requires testing of these chemicals to provide information on their effects 

on human health and the environment. The benefits of the testing requirement will result from the 

development of a basic set of hazard information on these chemicals and the use of this information by 

the public, industry, and government. The information developed because of the final rule will be made 

publicly available and is expected to yield benefits resulting from the direct use of the information (use 

value). In addition, there may be non-use benefits because of the value that society places on just knowing 

that the test data exist, regardless of whether they ever use the information (non-use value). This chapter 

discusses the use value of the final rule qualitatively. The non-use values are only discussed briefly. Due 

to the scientific nature of the information that would result from the final rule, non-use benefits are not 

likely to comprise a large percentage of the total benefits.

5.1 Use Values

The final rule will increase the publicly available data about a chemical‟s risks and consequently is likely 

to result in (a) a reduction in the costs of risk-based decisions about the chemical, and (b) an improvement 

in the expected outcome of the decisions (U.S. EPA, 2006).

Reduced cost of risk-based decision making. By making new information about toxic substances 

available to the public (including EPA and other government agencies), this final rule can serve to replace 

other information-gathering, management, and dissemination activities related to the regulated chemicals. 

Once the data are publicly available, information users and decision makers will avoid the time and 

resource costs required to individually perform these activities. In effect, the final rule increases the 

efficiency (and strength) of the decision-making process. 

Improved outcome of decisions. Information-based policies contribute to better decisions by redirecting 

resources toward their most highly valued uses. With incomplete information regarding toxic chemicals, 

public and private decision makers are not able to adequately assess the benefits and costs of actions that 

involve these substances. For example, EPA decisions regarding whether, when, and how to target 

chemicals for further risk assessment can be misdirected if basic risk-screening information is unavailable 

or inadequate. With more information, EPA can better direct its limited resources toward high-priority 

risks. It is also likely that once detailed toxicological information is available on these HPV chemicals, 

producers and users of these chemicals will adjust the volume of production and use to minimize adverse 

effects. Improved information can therefore help lead to more socially optimal reductions in risks to 

humans and the environment. 

This chapter discusses the use benefits of the HPV chemical test rule qualitatively. Quantification of the 

benefits of the final rule would require more specific information about each user‟s use patterns and 

preferences, and the changes in these that would result from the additional information made available 

under the final rule. These data are not readily available; to collect such data would be cost-prohibitive. 

For example, one approach would be to conduct a national willingness-to-pay (WTP) survey of the 

general public to determine the value that the public places on the availability of the information resulting 

from the test rule. However, such a survey (or one for similar information) has not been conducted.

Furthermore, the exact nature and scope of the benefits resulting from this final rule would depend on the 

outcome of the tests that would be performed; to the extent that the test results did indicate a potential 

health or environmental risk from a chemical, the benefits related to understanding and avoiding this risk 

would be greater.
5-2

5.2 Non-Use Values

The value that society places on the information resulting from this final rule may go beyond what people 

experience through the use of the data. Specifically, members of society may experience a “non-use” 

value associated with just knowing that the test data exist regardless of whether they ever use the 

information. Non-use values have also been referred to as “existence” or “intrinsic” values and 

encompass a variety of motivations. For example, individuals may place a value on the availability of the 

test data for others to use in the current time period (vicarious consumption), or place value on preserving 

or ensuring the availability of the data (or the decisions or policies that result from the information) for 

the benefit of family and others in the future (bequest value). However, a quantitative discussion of these 

benefits is not provided here, as measuring non-use values can be extremely difficult for several reasons. 

First, there is no market equivalent to accurately reflect these values. Second, non-use values are not 

associated with easily observable behaviors. Third, non-use values may be held by both users and nonusers of a resource, and non-users may be less familiar with particular services provided by the resources 

in question.

5.3 Benefits of the Required Tests

Taken together, the tests required under the final HPV chemical test rule provide screening-level hazard 

and environmental fate information, used to determine whether more research is warranted to completely 

characterize the hazards and risks associated with the chemical. Consistent with the HPV Screening 

Information Data Set (SIDS) program of the Organisation for Economic Co-operation and Development 

(OECD) (described in Chapter 3 of this report) the data obtained by this battery of tests relate to six health 

and environmental effect endpoints for HPV chemicals – acute toxicity; repeat dose toxicity; 

developmental and reproductive toxicity; genetic toxicity (gene mutations and chromosomal aberrations); 

ecotoxicity (studies in fish, Daphnia, and algae); and environmental fate (including ready biodegradation) 

– as well as physical/chemical properties. The test data identified under SIDS have been internationally 

agreed upon by the 29 member countries of OECD as providing the minimum data set required to make 

an informed preliminary judgment about the hazards of a given HPV chemical. 

For the purposes of the final rule, EPA has grouped required tests into six categories:

(1) Physical/chemical properties

(2) Environmental fate and pathways

(3) Aquatic toxicity

(4) Mammalian toxicity - acute

(5) Mammalian toxicity - genotoxicity

(6) Mammalian toxicity - repeated dose/reproduction/developmental.

Screening-level tests that provide information on the toxicity of a chemical (e.g., aquatic toxicity,

mammalian toxicity) provide information on the health and environmental effects of the chemical, and 

can be used to assess how “dangerous” the chemical is to the populations exposed. Results of these 

screening-level tests – and any further research as necessary – may help reveal the need for special 

containers and storage procedures, engineering controls, and personal protective equipment in the 

workplace to adequately control health and environmental risks associated with manufacture, processing, 

and/or use of the chemicals. A risk assessment is not complete without an estimation of the level of 

population exposure, which is why physical/chemical properties and environmental fate and pathways 

tests are needed. These tests show how the chemical may interact with the environment or the body, and 

the methods by which it may be dispersed. The information developed from these tests benefits workers, 

consumers, or persons living in locations impacted by chemical emissions, as government regulation and 
5-3

response to long-term and emergency releases can be more targeted and effective. In particular, the tests 

help agencies prioritize the regulation of chemical emissions based on the level of exposure.

The following sections describe the tests that could be required for a chemical under this final rule and the 

test‟s role as a screening-level indicator (the benefits associated with each individual test). Section 5.4

lists the tests required for each chemical.

5.3.1 Physical/Chemical Properties

Melting Point (ASTM E 324-99) (ASTM, 2009c).The melting point is the temperature at which a 

substance transitions from the solid to liquid phase. The ASTM E 324-99 melting point test determines 

the initial and final melting points (melting range) of stable, crystalline organic solids whose melting 

points fall between 30°C and 250°C.

The data generated by this test benefit industry and workers through the determination of the physical 

phase of the chemical in industrial settings or during transport, making the identification of optimal 

storage temperatures and container systems possible. Improper storage or containment of hazardous 

chemicals can result in worker injury or plant damage. Since the melting point is an intrinsic property of a 

chemical, this test can also be used to help identify unknown chemicals at industrial sites.

Melting point information also benefits government and industry scientists undertaking occupational and 

environmental exposure and risk assessments. A chemical‟s phase (e.g., solid, liquid, or gas) has a large 

impact on the expected fate and transport of the chemical in the environment and within the body. With 

information on a chemical‟s melting point, the ambient temperature can be used to help determine 

whether the chemical exists in a solid or liquid phase. The chemical‟s phase also affects the magnitude of 

certain exposure pathways (e.g., chemicals in the liquid phase are more readily absorbed by skin than 

those in the solid phase). This benefit in turn indirectly helps workers, consumers, or persons living in 

locations impacted by chemical emissions, as government regulation and response to long-term and 

emergency releases can be more targeted and effective.

Boiling Point (ASTM E 1719-05) (ASTM, 2009a). The ASTM E 1719-05 boiling point (ebulliometric) 

test determines the boiling point and vapor pressure of pure liquids and azeotropes (i.e., mixtures of two 

chemicals that boil at a unique temperature) that are condensable at total reflux and boil between 285 K

and 575 K (approximately 12°C and 302°C, respectively). 

The data generated by this test benefit industry and workers through the determination of the physical 

phase of the chemical in industrial settings or during transport, making the identification of optimal 

storage temperatures and container systems possible. Information on a chemical‟s boiling point can help 

to determine whether a chemical exists in the liquid or gas phase. The buildup of pressure in containers 

due to low boiling point and high vapor pressure liquids can be a severe workplace and transportation 

hazard. Thus, the use of these data to provide safe, hazard-free transportation and workplaces will benefit 

the general public, industrial workers, and the industries they work in by decreasing the liability of 

transport and workplace accidents. Since the boiling point is an intrinsic property of a chemical, this test 

can also be used to help identify unknown chemicals at industrial sites.

A chemical‟s boiling point also benefits government and industry scientists undertaking occupational and 

environmental exposure and risk assessments for a number of reasons: 

It has a marked impact on the expected fate of chemicals in the environment and in the body (i.e., 

gases are frequently exposed to different transformative chemistry than liquids).

It has an impact on the expected transport of chemicals in the environment and in the body (i.e., gases 

travel more extensively than liquids due to convection and diffusion in air).
5-4

It can help determine whether the chemical exists in the liquid or gas phase during the exposure 

period, which can affect the exposure outcomes (e.g., chemicals in the gas phase can be inhaled, 

increasing the magnitude of exposure). 

Vapor Pressure (ASTM E 1782-08) (ASTM, 2009b). The vapor pressure indicates the tendency of a solid 

or liquid to evaporate. The ASTM E 1782-08 vapor pressure test determines the vapor pressure of pure 

liquids or melted solids within the temperature range 273 K to 773 K (approximately 0°C to 500°C, 

respectively) and the pressure range 5 kPa to 2000 kPa using differential thermal analysis (DTA), 

differential scanning calorimetry (DSC), or preferably high-pressure versions of these instruments 

(HPDTA and HPDSC). 

The data generated by this test benefit industry and workers through the determination of the physical 

phase (e.g., liquid or gas) of the chemical in industrial settings or during transport, making the 

identification of optimal storage temperatures and container systems possible. The buildup of pressure in 

containers due to low boiling point and high vapor pressure liquids can be a severe workplace and 

transportation hazard. Thus, the use of these data to provide safe, hazard-free transportation and 

workplaces will benefit the general public, industrial workers, and the industries they work in by 

decreasing the liability of transport and workplace accidents.

Like boiling point, vapor pressure information also benefits government and industry scientists 

undertaking occupational and environmental exposure and risk assessments because of its impact on the 

expected fate of the chemicals, the expected transport of the chemicals, and the exposure outcome. 

Partition Coefficient (ASTM E 1147-92(2005)) (ASTM, 2005). The octanol-water partition coefficient 

(logKow) indicates how a compound partitions between water and non-polar organic chemicals (e.g., fats 

and oils). The ASTM E 1147 partition coefficient test determines the logarithm of the octanol/water 

partition coefficient of non-ionizable and ionizable compounds by inputting their retention time on a 

liquid chromatographic column into an empirically derived equation. (The regulations at 40 CFR 

799.6755-6 provide alternate protocols for obtaining a chemical‟s octanol-water partition coefficient.) 

This information is then used to assess the chemical‟s lipophilicity, or affinity to non-polar organic 

chemicals.

Some important benefits to industry chemical users involve cleanup, waste-handling procedures, and 

chemical identification. Cleanup procedures are highly dependent on these data, since facilities need to 

know what materials the chemical tends to adsorb to. Waste storage is also affected, since facilities 

typically store miscible substances together. Additionally, the test can be used to help identify unknown 

chemicals at industrial sites.

Industrial users also benefit from these data through the determination of chemicals‟ solubility in fat. 

Persistent, fat-soluble chemicals can bioaccumulate in regularly exposed workers, or consumers of enduse products. This information can help identify the need for special containers, engineering controls, and 

personal protective equipment in the workplace. Proper controls can reduce the likelihood of occupational 

injury and death, thereby reducing liability to industry and benefiting workers. It can also help 

preemptively identify products whose use is likely to result in bioaccumulation in consumers.

Partition coefficient information also benefits government and industry scientists undertaking fate and 

transport studies. Chemical fate and transport is highly influenced by the tendency of chemicals to adsorb 

to non-polar organic matter such as sediment, soil, and dust. Chemicals with high logKow partition 

coefficients are more likely to adsorb to these particles, which can impede or accelerate their dispersal, 

depending on local conditions. In soil matrices, these chemicals predominately adsorb to organic material, 

while chemicals that are more water soluble percolate through the soil more rapidly, potentially 
5-5

contaminating groundwater. In dusty conditions, they predominately travel with the particulate matter, 

rather than move by convection and diffusion. 

Occupational and environmental risk assessors benefit from these data because logKow heavily influences 

the magnitude of chemical uptake in the human body (e.g., a high logKow typically results in higher 

dermal transfer coefficients and higher inhalation efficiency). It also influences the partitioning of the 

chemical inside of the body and consequently is used in the estimation of chemical half-life (e.g., 

exposure to chemicals with high logKow partition coefficients often results in extensive bioaccumulation). 

This benefit in turn indirectly helps workers, consumers, or persons living in locations impacted by 

chemical emissions, as government regulation and response to long-term and emergency releases can be 

more targeted and effective.

Water Solubility (ASTM E 1148-02) (ASTM, 2008a). The physical property describing the ability of a 

given substance to dissolve in water is termed water solubility. The ASTM E1148-02 water solubility test 

determines the affinity of water- and air-stable chemicals to water. The regulations at 40 CFR 799.6784 

and 799.6786 provide alternate protocols for obtaining a chemical‟s water solubility.)

Some important benefits to industry chemical users involve cleanup, waste-handling procedures, and 

chemical identification. Cleanup procedures are highly dependent on these data, since facilities need to 

know what materials the chemical tends to adsorb to. Waste storage is also affected, since facilities 

typically store miscible substances together. Additionally, the test can be used to help identify unknown 

chemicals at industrial sites.

Industrial users also benefit from these data through the determination of chemicals‟ solubility in fat. 

Persistent, fat-soluble chemicals can bioaccumulate in regularly exposed workers, or consumers of enduse products. This information can help identify the need for special containers, engineering controls, and 

personal protective equipment in the workplace. Proper controls can reduce the likelihood of occupational 

injury and death, thereby reducing liability to industry and benefiting workers. It can also help 

preemptively identify products whose use is likely to result in bioaccumulation in consumers.

Water solubility information also benefits government and industry scientists undertaking fate and 

transport studies. Chemical fate and transport is highly influenced by the affinity of chemicals to water. 

Chemicals with high solubility are more likely to travel with water flows (i.e., rivers, aquifers, rain 

percolation through soil and sediment), and as a result can travel extensive distances. In soil matrices, 

these chemicals predominately percolate through the organic matrix, potentially threatening groundwater 

supplies. 

Occupational and environmental risk assessors will benefit from these data because water solubility 

heavily influences the magnitude of chemical uptake in the human body (e.g., high water solubility 

typically results in lower dermal transfer coefficients and inhalation efficiency) and the possible site of 

toxic effects (e.g., upper respiratory tract versus lungs). It also influences the partitioning of the chemical 

inside of the body and consequently is used in the estimation of chemical half-life. This benefit in turn 

indirectly helps workers, consumers, or persons living in locations impacted by chemical emissions, as 

government regulation and response to long-term and emergency releases can be more targeted and 

effective.

5.3.2 Environmental Fate and Pathways

Ready Biodegradation (ASTM 1720-01, sealed vessel CO2 production test) (ASTM, 2008b). The 

biodegradation test measures how quickly chemicals will be broken down in the environment by natural 

processes such as bacterial digestion. The ASTM E 1720-01 ready biodegradability test uses the 
5-6

generation of carbon dioxide by a dilute sewage inoculum as a proxy to determine the biodegradability of 

organic compounds in a closed vessel. Biodegradation of 60 percent or more during the closed-vessel test 

indicates that in most environmental compartments the chemical will biodegrade completely. The 

International Organization for Standardization (ISO)‟s standards ISO 14593, ISO 7827, ISO 9408, ISO 

9439, ISO 10707 and ISO 10708 provide alternate protocols test for biodegradation. The appropriate 

method is determined by the test substance‟s physical and chemical properties, including its water 

solubility. ISO 10634 provides guidance for selection of an appropriate test method for a given test 

substance.

For industries that keep chemicals in stock for extended periods of time, these data have a significant 

benefit, since biodegradability influences the choice of storage conditions, including container type, 

humidity, temperature, and expected storage time. These data also benefit government and industry 

scientists undertaking fate and transport studies, as well as occupational and environmental exposure and 

risk assessments. They can be used as a proxy measure for persistence in the environment. All else being 

equal, chemicals expected to biodegrade in most environmental compartments will neither have as long a 

residence time nor travel as far as a non-biodegradable equivalent. This, in turn, affects the potential for 

ecological and human exposure and consequent risk. 

5.3.3 Aquatic Toxicity

Aquatic toxicity data are beneficial to industry, regulators, and the public for a variety of reasons. 

Industry and regulators may use the information during the formulation of plans for water emissions 

schedules and the filing of National Pollutant Discharge Elimination System (NPDES) permits with 

EPA‟s Office of Wastewater Management (OWM). These data also benefit government and industry 

scientists undertaking ecological toxicity and risk assessments. The assessments use, in conjunction with 

fate and transport and ecological exposure models, acute fish toxicity thresholds to estimate the acute 

effects of a particular emission or pattern of emissions on targeted populations of fish; acute Daphnia 

toxicity thresholds to estimate the acute effects of a particular emission or pattern of emissions on targeted 

populations of crustaceans or other aquatic life; microalgae toxicity to estimate the short-term effects of a 

particular emission or pattern of emissions on targeted populations of aquatic plant life; or chronic 

Daphnia toxicity thresholds to estimate the long-term effects of a particular emission or pattern of 

emissions on targeted populations of crustaceans or other aquatic life. They can also be used as general 

indicators of toxicity, such as in lifecycle analyses. Government response to industrial emissions as a 

consequence of ecological risk assessment results can therefore be better tailored to protect ecological 

resources, benefiting the general public. More detail on these aquatic toxicity tests is provided below.

Acute Toxicity to Fish (ASTM E 729-96) (ASTM, 2007b). The ASTM E 729-96 acute toxicity test 

determines the concentration of chemical needed to reach a toxicity threshold in certain species of 

freshwater and saltwater fish. The standard thresholds used are the concentration at which there is a 50

percent fatality rate in the test organisms (LC50) or the concentration at which there is a 50 percent

adverse effect response rate in the test organisms (EC50) during two- to eight-day exposures in either 

static (no replacement of toxicant), renewal (periodic replacement of toxicant), or flow-through 

(continuous or intermittent replacement of makeup water and toxicant) exposures (Hoffman et al., 2003). 

Lower thresholds represent higher toxicity in the target organisms. Because the toxic endpoint in the LC50

is death, it represents a very crude measure of chemical toxicity, unlike the EC50 or chronic studies, which

measure more subtle effects.

Acute Toxicity to Daphnia (ASTM E 729-96) (ASTM, 2007b). The ASTM E 729-96 acute toxicity test 

determines the concentration of chemical needed to reach a toxicity threshold in Daphnia crustaceans. 

The standard thresholds used are the concentration at which there is a 50 percent fatality rate in the test 

organisms (LC50) or the concentration at which there is a 50 percent adverse effect response rate in the 
5-7

test organisms (EC50) during two- to eight-day exposures in either static (no replacement of toxicant), 

renewal (periodic replacement of toxicant), or flow-through (continuous or intermittent replacement of 

makeup water and toxicant) exposures.8 Lower thresholds represent higher toxicity in the target 

organisms. Because the toxic endpoint in the LC50 is death, it represents a very crude measure of chemical 

toxicity, unlike the EC50 or chronic studies that measure more subtle effects.

Acute Toxicity to Plants (ASTM E 1218-04e1) (ASTM, 2007a). The ASTM E 1218-04e1 toxicity test 

determines the concentration of chemical needed to reach a toxicity threshold in freshwater and saltwater 

microalgae. The standard threshold used is the concentration at which there is a 50 percent growth 

inhibition rate (IC50) during 72-, 96-, or 120-hour exposures in static (no replacement of toxicant) 

conditions.

Chronic Toxicity to Daphnia (ASTM E 1193-97) (ASTM, 2004). The ASTM E 1193-97 chronic toxicity 

test determines the concentration of chemical needed to reach a toxicity threshold in Daphnia magna 

crustaceans. Exposures are conducted using flow-through (continuous or intermittent replacement of 

makeup water and toxicant) methods and last over the lifecycle of the organisms. 

5.3.4 Mammalian Toxicity – Acute

Several types of mammalian acute toxicity tests are available. Industry can use acute inhalation toxicity 

data to determine the level of hazard or potential risk posed by gases, or other volatile chemicals; and 

acute oral toxicity data or cytotoxicity data to determine the level of hazard or potential risk posed by 

liquid or solid chemicals. (Elevated levels of cytotoxicity indicate the potential for adverse health 

outcomes on cells, the smallest building block of the body.) This hazard level can help identify the need 

for special containers, engineering controls, and personal protective equipment in the workplace. Proper 

use of this information can reduce the likelihood of occupational injury and death, thereby reducing 

liability to industry and benefiting workers. 

These toxicity data also benefit government and industry scientists undertaking occupational and 

environmental exposure and risk assessments or toxicity assessments. Occupational and environmental 

exposure and risk assessments use acute toxicity information in conjunction with fate and transport and 

exposure models to estimate the acute effects of ambient workplace concentrations or end-of-pipe 

emissions on targeted populations of workers, consumers, or persons living in close proximity to 

emissions streams. This benefit in turn indirectly helps workers, consumers, or persons living in locations 

impacted by chemical emissions, as government regulation and response to long-term and emergency 

releases can be more targeted and effective. Toxicity assessments are able to use the cytotoxicity 

information to estimate the potential for adverse health effects in workers, consumers, or the general 

public. As a result, government responses, primarily in the form of demands for further toxicity testing, 

are likely to be more targeted and effective. More detail on various types of mammalian acute toxicity 

tests is provided below.

Acute Inhalation Toxicity (40 CFR §799.9130). This test gives an indication of potential harm from 

inhaling a chemical compound. The regulation at 40 CFR §799.9130 defines the standard test to measure 

the acute inhalation toxicity of gases, volatile substances, and aerosols in mammals. This test is conducted 

during a period of 24 hours or less using inhalation at no less than three dose levels (and a control, when 

using a vehicle other than water) in animals of both sexes. Occurrence, severity, and reversibility for as 

many behaviorally and clinically abnormal outcomes as possible should be catalogued during the 

experiment, and an attempt to determine the relationship between dose level and effect should be made. 

This test can be used to determine a regimen of doses for longer-term (i.e., subchronic and chronic) 

inhalation toxicity studies.
5-8

Acute Oral Toxicity (40 CFR §799.9110). This test gives an indication of harm from ingesting a chemical 

compound. The regulation at 40 CFR §799.9110 defines the standard test to measure the acute oral 

toxicity of liquid or solid chemicals in mammals. This test is conducted during a period of 24 hours or 

less using single or multiple ingestion doses at no less than three dose levels (and a control, when using a 

vehicle other than water) in animals of both sexes. Occurrence, severity, and reversibility for as many 

behaviorally and clinically abnormal outcomes as possible should be catalogued during the experiment, 

and an attempt to determine the relationship between dose level and effect should be made. This test can 

be used to determine a regimen of doses for longer-term (i.e., subchronic and chronic) oral toxicity 

studies. ASTM E 1163-98(2002) provides an alternate protocol to test for acute oral toxicity. 

BALB/c 3T3 Neutral Red Uptake Cytotoxicity. This test provides an indication of a chemical‟s toxic 

effect on a cell, the basic building block of the body. The BALB/c 3T3 Neutral Red Uptake Cytotoxicity 

test determines the magnitude of cellular toxicity of water soluble chemicals on the BALB/c 3T3 mouse 

fibroblast cell line. Cell viability after short-term (24-hour) in vitro chemical exposure is measured using 

the cells‟ ability to take up the Neutral Red dye as a proxy (MB Research Laboratories, 2009).

BHK Neutral Red Uptake Cytotoxicity. This test provides an indication of a chemical‟s toxic effect on a 

cell, the basic building block of the body. The BHK Neutral Red Uptake Cytotoxicity test determines the 

magnitude of cellular toxicity of chemicals on a baby hamster kidney (BHK) fibroblast cell line. Cell 

viability after in vitro chemical exposures of unknown length is measured using their ability to take up the 

Neutral Red dye as a proxy (Shirai et al., 1989).

5.3.5 Mammalian Toxicity - Genotoxicity

Industry can use genotoxicity data to approximate the potential risk of carcinogenicity, or reproductive 

and developmental effects posed by chemicals prior to conducting a full risk assessment. Elevated levels 

of genotoxicity, chromosomal aberrations, or aberrant erythrocyte production during the test indicate 

increased potential for these effects. High genotoxicity might require the use of special containers, 

engineering controls, and personal protective equipment in the workplace. Proper use of this information 

can reduce the likelihood of chronic disease or risk to specific groups of workers (e.g., pregnant women) 

due to occupational exposure, thereby reducing liability to industry and benefiting workers. 

These toxicity data also benefit government and industry scientists undertaking toxicity assessments. 

Such assessments can use genotoxicity information to estimate the potential for carcinogenicity in 

workers, consumers, or the general public exposed to certain compounds. Genotoxicity can also serve as a 

carcinogenicity screening tool for new chemicals. As a result, government responses, primarily in the 

form of demands for further toxicity testing, are likely to be more targeted and effective. More detail on 

specific mammalian genotoxicity tests is provided below.

Bacterial Reverse Mutation (40 CFR §799.9510). This test measures a chemical‟s ability to change the 

genetic code of bacteria, which is an indicator of the chemical‟s ability to change the genetic code of 

humans. The Bacterial Reverse Mutation test described in 40 CFR §799.9510 seeks to determine the 

existence of genotoxicity during chemical exposure using mutated Salmonella typhimurium and 

Escherichia coli bacterial cultures. Reversal of the test organism mutations (e.g., substitution, addition, 

deletion) by the test chemical after 48- to 72-hour in vitro chemical exposure is measured using the 

bacteria‟s ability to synthesize specific amino acids as a marker. Positive results in this test are used to 

determine chemicals that should be further tested for carcinogenic, reproductive, and developmental 

effect potential.

Chromosome Aberration, in vitro (40 CFR §799.9537). The in vitro Chromosome Aberration test 

described in 40 CFR §799.9537 seeks to determine whether chemical exposure causes chromosomal 

aberrations in primary cell cultures, such as Chinese hamster fibroblasts, human, or other mammalian 
5-9

peripheral blood lymphocytes. Generation of chromosomal aberrations such as polyploidy (excess 

chromosomes) or endoreduplication (duplication of the genome without mitosis) by the test chemical is 

measured using basic microscopy techniques after exposure. Positive results in this test are used to 

determine chemicals that should be further tested for carcinogenic, reproductive, and developmental 

effect potential.

In Vivo Mammalian Cytogenetics Tests: Bone Marrow Chromosomal Analysis (40 CFR §799.9538).

The in vivo Mammalian Bone Marrow Chromosomal Aberration test described in 40 CFR §799.9538 

seeks to determine whether chemical exposure causes chromosomal aberrations in rodents, such as rats, 

mice, and Chinese hamsters. Generation of chromosome or chromatid aberrations such as polyploidy 

(excess chromosomes) or endoreduplication (duplication of the genome without mitosis) by the test 

chemical is measured using basic microscopy techniques. Positive results in this test are used to determine 

chemicals that should be further tested for carcinogenic potential, particularly in bone marrow.

Erythrocyte Micronucleus (bone marrow), in vivo: (40 CFR §799.9539). The Mammalian Erythrocyte 

Micronucleus test described in 40 CFR §799.9539 seeks to determine whether chemical exposure causes 

damage to the chromosomes or the mitotic apparatus of erythroblasts (immediate precursor to red blood 

cells) in the bone marrow of rodents, such as rats or mice. The proportion of immature erythrocytes 

among the total is measured using basic microscopy techniques, and a dose-response relationship is 

investigated. Positive results in this test are used to determine chemicals that should be further tested for 

carcinogenic potential, particularly with regard to erythrocyte production.

5.3.6 Mammalian Toxicity - Repeated Dose/Reproduction/Developmental

Industry can use repeated dose oral toxicity data along with reproductive and developmental toxicity data 

to determine the level of hazard or potential risk posed by chemicals. This hazard level can help identify 

the need for special containers, engineering controls, and personal protective equipment in the workplace. 

Proper use of this information can reduce the likelihood of occupational injury, disease, and death, 

thereby reducing liability to industry and benefiting workers. Industry can also benefit from this 

information during safety testing of consumer products, as it prevents the commercialization of hazardous 

products and the resulting liability. 

Mammalian toxicity data can be used in developing regulatory standards, such as those found in EPA‟s 

Integrated Risk Information System (IRIS), to the benefit of government and industry scientists 

undertaking occupational and environmental exposure and risk assessments. Such assessments use both 

repeated dose and reproductive and developmental toxicity information in conjunction with fate and 

transport and exposure models to estimate the effects of ambient workplace concentrations or end-of-pipe 

emissions on targeted populations of workers, consumers, persons living in close proximity to emissions 

streams, and sensitive subpopulations (e.g., pregnant women, young children), and/or on the general 

population. This benefit in turn indirectly helps workers, consumers, or persons living in locations 

impacted by chemical emissions, as government regulation and response to long-term and emergency 

releases can be more targeted and effective. More detail on various types of mammalian repeated 

dose/reproduction/developmental toxicity tests is provided below.

Repeated Dose Oral Toxicity (40 CFR §799.9305). This test gives an indication of harm from ingesting a 

chemical compound. The regulation at 40 CFR §799.9305 defines the standard test to measure the 

repeated dose oral toxicity of liquid or solid chemicals in mammals. The test should be conducted after 

the acute oral test described in 40 CFR §799.9110 in order to establish an appropriate dose range. This 

test is conducted during a period of 14 or 28 days using multiple ingestion doses at no less than three dose 

levels plus a control (dose = 0) in animals (typically rodents) of both sexes. Occurrence and severity for 

as many behaviorally and clinically abnormal outcomes as possible should be catalogued during the 

experiment, and histopathological investigations are done on specific sets of organs. An attempt to 
5-10

determine the relationship between dose level and effect should be made with the no observed effects 

level (NOEL) serving as one of the parameters of importance. If possible, the no observed adverse effect 

level (NOAEL), lowest observed adverse effect level (LOAEL), and dose at which an effect is seen in 50 

percent of the test animal population (ED50) should be determined.

Reproductive and Developmental Toxicity Screening (40 CFR §799.9355). These tests give an 

indication of the likelihood of a chemical to have an impact on the offspring of those exposed to the 

chemical. The regulation at 40 CFR §799.9355 defines the standard test to measure the reproductive or 

developmental toxicity of chemicals in mammals. Male animals are dosed for a minimum of four weeks 

with a schedule as follows: a minimum of two weeks pre-mating, during the mating period, and 

approximately two weeks post-mating. Females are dosed with a schedule as follows: at least two weeks 

pre-mating, time-to-conception, duration of pregnancy, and at least four days post-delivery. Occurrence 

and severity of changes in gonadal function, mating behavior, conception, development of the conceptus, 

and parturition (birth) are catalogued during the experiment. An attempt to determine the relationship 

between dose level and effect should be made with the no observed effects level (NOEL) serving as one 

of the parameters of importance. If possible, the no observed adverse effect level (NOAEL), lowest 

observed adverse effect level (LOAEL), and dose at which an effect is seen in 50 percent of the test 

animal population (ED50) should be determined.

Combined Repeated Dose with Reproductive and Developmental Toxicity Screen (40 CFR §799.9365).

The regulation at 40 CFR §799.9365 defines the standard test to measure the reproductive or 

developmental toxicity of chemicals in mammals. Male animals are dosed for a minimum of four weeks 

with a schedule as follows: a minimum of two weeks pre-mating, during the mating period, and 

approximately two weeks post-mating. Females are dosed with a schedule as follows: at least two weeks 

pre-mating, time-to-conception, duration of pregnancy, and at least four days post-delivery. Occurrence 

and severity for as many behaviorally and clinically abnormal outcomes as possible in the adult animals 

should be catalogued during the experiment, and histopathological investigations are done on specific sets 

of organs. Additionally, occurrence and severity of changes in gonadal function, mating behavior, 

conception, development of the conceptus, and parturition (birth) are catalogued during the experiment. 

An attempt to determine the relationship between dose level and effect should be made with the no 

observed effects level (NOEL) serving as one of the parameters of importance. If possible, the no 

observed adverse effect level (NOAEL), lowest observed adverse effect level (LOAEL), and dose at 

which an effect is seen in 50 percent of the test animal population (ED50) should be determined.

5.4 Benefits Related to Each Regulated Chemical 

Total benefits that result from the required tests discussed above would depend on the production volume 

of chemical substances included in this final rule, the tests required for each of the chemical substances, 

and other chemical-specific characteristics that would impact the exposure of the chemicals. Section 

4(a)(1)(B) of TSCA allows EPA to require testing if it finds that a chemical is reasonably expected to be 

released into the environment in substantial quantities, or if there may be substantial or significant human 

exposure. For all of the chemical substances included in this final rule, EPA has made preliminary 

findings that they are produced in substantial quantities; there may be substantial human exposure to 

them; existing data are insufficient to determine or predict their health and environmental effects; and 

testing is necessary to develop such data. Under the final rule, the chemicals would be required to 

complete a battery of tests, described above, that provide screening-level hazard and environmental fate 

information. The sections below briefly describe EPA‟s findings for each chemical (U.S. EPA, 2009), 

which indicate why society may benefit when screening-level hazard and risk information is known. The 

total benefit of this final testing rule will depend on the production volume of chemicals, insofar as 

greater volume implies a greater risk of exposure. The production volume for each chemical was provided 

in Exhibit 2-Exhibit 2-6 (Chapter 2 of this report). Any known information about exposure volume is 
5-11

included with the description of the findings. For each chemical, a chart shows which specific tests are 

required by this final rule. Tests are only required where the resulting data are not otherwise available for 

the chemical. 

5.4.1 Benzenesulfonyl chloride (CASRN 98-09-9)

The Inventory Update Reporting (IUR) commercial/consumer product category “Rubber and plastic 

products” was reported for this chemical. Chemicals in this category may be in such products as tires, 

footwear, flooring, bottles, sporting equipment, games, and toys. It is expected that these products will be 

widely used by consumers (including children); hence, the number of people exposed is likely to exceed

10,000. Additionally, products such as tires and flooring are also used in a commercial setting, which may 

lead to exposures of more than 1,000 commercial workers. Based on this information, EPA believes that 

this chemical may have “substantial or significant human exposure” (U.S. EPA, 2011). A substantial or 

significant number of consumers, workers, or others who are exposed to the chemical would benefit from 

the decisions that are made (e.g., policies, regulations) when hazard information is known.

Tests Required under the Final HPV Chemical Test Rule for Benzenesulfonyl chloride (CASRN 98-09-9)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

  

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.2 Benzene, 1-chloro-4-(trifluoromethyl)- (CASRN 98-56-6)

The number of potentially exposed consumers is estimated to be very large based on the use (home 

maintenance product) cited in the Household Chemicals Database (U.S. NLM, 2009). It is expected that 

home maintenance products will be widely used by consumers; hence, the number of people exposed is 

likely to exceed 10,000. Based on this information, EPA believes that this chemical may have “substantial 

or significant human exposure” (U.S. EPA, 2011). A substantial or significant number of consumers, 

workers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., 

policies, regulations) when hazard and toxicity information is known.

Tests Required under the Final HPV Chemical Test Rule for 

Benzene, 1-chloro-4-(trifluoromethyl)- (CASRN 98-56-6)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

 

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.3 Ethane, 1,1'-oxybis[2-chloro- (CASRN 111-44-4)

The IUR commercial/consumer product category “Other” (chemicals contained in commercial and 

consumer products not elsewhere classified) was reported for this chemical. This indicates that this 

chemical is present in an unknown number of commercial and consumer products that may potentially 

have a high number of exposures. Based on this information, EPA believes that this chemical may have 

“substantial or significant human exposure” (U.S. EPA, 2011). Other sources report that the chemical is 

used in a variety of ways, including use in the manufacture of medicines and pharmaceuticals; in paints, 

varnishes, lacquers, finish removers, spotting, and dry cleaning; and in the production of high-grade 

lubricating oils (U.S. NLM, 2008b; Ash, 2003; Merck Index, 2001). Therefore, a substantial or significant 
5-12

number of workers, consumers, or others who are exposed to the chemical would benefit from the 

decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Final HPV Chemical Test Rule for 

Ethane, 1,1'-oxybis[2-chloro- (CASRN 111-44-4)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

 

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.4 Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) (CASRN 127-68-4)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990) (U.S. EPA, 

2011). Other sources report that the chemical is used in a variety of ways, including as a viscosity control 

agent in cosmetics and an oxidizing agent in industrial cleaners (U.S. NLM, 2008b). The workers, 

consumers, or others who are exposed to the chemical would benefit from the decisions that are made 

(e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Final HPV Chemical Test Rule for Benzenesulfonic acid, 3-nitro-, 

sodium salt (1:1) (CASRN 127-68-4)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

 

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.5 Benzene, (2-chloro-1,1-dimethylethyl)- (CASRN 515-40-2)

The IUR commercial/consumer product category “Agricultural products (non-pesticidal)” was reported 

for this chemical. Chemicals in this category may be used to increase the productivity and quality of farm 

crops; examples include fertilizers and soil conditioners. It is expected that these products will be widely 

used by commercial workers and consumers; hence, the number of people exposed is likely to exceed 

1,000 commercial workers and 10,000 consumers. Based on this information, EPA believes that this 

chemical may have “substantial or significant human exposure.” (U.S. EPA, 2011). A substantial or 

significant number of workers, consumers, or others who are exposed to the chemical would benefit from 

the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Final HPV Chemical Test Rule for Benzene, (2-chloro-1,1-dimethylethyl)- (CASRN 

515-40-2)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

        

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.6 Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate) (CASRN 2494-89-5)

The IUR commercial/consumer product category(ies) were claimed as confidential business information

for this chemical. This indicates that this chemical is present in an unknown number of commercial and 

consumer products that may potentially have a high number of exposures. Based on this information, 
5-13

EPA believes that this chemical may have “substantial or significant human exposure.” (U.S. EPA, 2011).

Other sources report that the chemical is used as an indicator and/or reagent (U.S. NLM, 2008a). A 

substantial or significant number of workers, consumers, or others who are exposed to the chemical 

would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity 

information is known.

Tests Required under the Final HPV Chemical Test Rule for Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen 

sulfate) (CASRN 2494-89-5)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.7 2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-

(CASRN 5026-74-4)

The total number of potentially exposed workers is likely to exceed 1,000 based on reported IUR data

(U.S. EPA, 2011). IUR submitters reported that this chemical is used in the “Resin and synthetic rubber 

manufacturing” and the “Aerospace product and parts manufacturing” categories. Another source reports

that this chemical is used in epoxy resins for composite aircraft bodies/parts (Ashford, 2001). The

workers, travelers, or others who are exposed to the chemical would benefit from the decisions that are 

made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Final HPV Chemical Test Rule for 2-Oxiranemethanamine, 

N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)- (CASRN 5026-74-4)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

       

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.8 Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester (CASRN 

22527-63-5)

The IUR commercial/consumer product category “Rubber and plastic products” was reported for this 

chemical. Chemicals in this category may be in such products as tires, footwear, flooring, bottles, sporting 

equipment, games, and toys. It is expected that these products will be widely used by consumers 

(including children); hence, the number of people exposed is likely to exceed 10,000. Additionally, 

products such as tires and flooring are also used in a commercial setting, which may lead to exposures of 

more than 1,000 commercial workers. Other product categories identified in the IUR were claimed as 

confidential business information. Based on this information, EPA believes that this chemical may have 

“substantial or significant human exposure” (U.S. EPA, 2011). A substantial or significant number of 

workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are 

made (e.g., policies, regulations) when hazard and toxicity information is known.
5-14

Tests Required under the Final HPV Chemical Test Rule for Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-

trimethylpentyl ester (CASRN 22527-63-5)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.9 Benzenesulfonic acid, dimethyl- (CASRN 25321-41-9)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990) (U.S. EPA, 

2011). Other sources report that this chemical is used in a variety of ways, including as a catalyst for 

coatings and foundry resins, a hardening agent in plastics, an activator for nicotine insecticides, and a 

plating aid in electroplating baths (Ash, 2003; Ashford, 2001). The workers, consumers, or others who are 

exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulations) when 

hazard and toxicity information is known.

Tests Required under the Final HPV Chemical Test Rule for Benzenesulfonic acid, dimethyl- (CASRN 25321-41-

9)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

  

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.10 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) 

(CASRN 52556-42-0)

The IUR commercial/consumer product category “Other” (chemicals contained in commercial and 

consumer products not elsewhere classified) was reported for this chemical. This indicates that this 

chemical is present in an unknown number of commercial and consumer products that may potentially 

have a high number of exposures. Based on this information, EPA believes that this chemical may have 

“substantial or significant human exposure” (U.S. EPA, 2011). Other sources report that this chemical is 

used as an emulsion polymerization in paper, textile, fiber, and adhesives industries (Ash, 2003). A 

substantial or significant number of workers, consumers, or others who are exposed to the chemical 

would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity 

information is known.

Tests Required under the Final HPV Chemical Test Rule for 1-Propanesulfonic acid, 

2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) (CASRN 52556-42-0)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.11 Lard, oil, Me esters (CASRN 68082-78-0)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990) (U.S. EPA, 

2011). Other sources report that this chemical is used as a lubricant (Lubriplate Lubricants Co., 2009) The 
5-15

workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are 

made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Final HPV Chemical Test Rule for Lard, oil, Me esters (CASRN 68082-78-0)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.12 Acetaldehyde, reaction products with formaldehyde, by-products from 

(CASRN 68442-60-4)

The IUR commercial/consumer product category(ies) were claimed as confidential business information 

for this chemical (U.S. EPA, 2006b). This indicates that this chemical is present in an unknown number 

of commercial and consumer products that may potentially have a high number of exposures.

Additionally, PAIR data indicate consumer use; therefore, it is expected that products containing this 

chemical may be used by more than 10,000 consumers. Based on this information, EPA believes that this 

chemical may have “substantial or significant human exposure” (U.S. EPA, 2011). A substantial or 

significant number of workers, consumers, or others who are exposed to the chemical would benefit from 

the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Final HPV Chemical Test Rule for Acetaldehyde, reaction products with 

formaldehyde, by-products from (CASRN 68442-60-4)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.13 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters (CASRN 68610-90-2)

PAIR data indicate consumer use; therefore, it is expected that products containing this chemical may be 

used by more than 10,000 consumers. Based on this information, EPA believes that this chemical may 

have “substantial or significant human exposure” (U.S. EPA, 2011). A substantial or significant number 

of workers, consumers, or others who are exposed to the chemical would benefit from the decisions that 

are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Final HPV Chemical Test Rule for 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters 

(CASRN 68610-90-2)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.14 Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-

(CASRN 70693-50-4)

The IUR commercial/consumer product category(ies) were claimed as confidential business information 

for this chemical. This indicates that this chemical is present in an unknown number of commercial and 
5-16

consumer products that may potentially have a high number of exposures. Based on this information, 

EPA believes that this chemical may have “substantial or significant human exposure” (U.S. EPA, 2011).

A substantial or significant number of workers, consumers, or others who are exposed to the chemical 

would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity 

information is known.

Tests Required under the Final HPV Chemical Test Rule for Phenol, 

2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]- (CASRN 70693-50-4)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.15 1-Decene, sulfurized (CASRN 72162-15-3)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990) (U.S. EPA, 

2011Workers, consumers, or others who are exposed to the chemical would benefit from the decisions 

that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Final HPV Chemical Test Rule for 1-Decene, sulfurized (CASRN 72162-15-3)

Melting 

Point Boiling Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

BiodegradationAquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

        

Note: Specific benefits related to these tests are described in Section 5.3.

5.5 Potential Users of Information Generated by the Final Rule

As discussed above, a wide range of groups are expected to benefit from the availability of this 

information, including consumers, workers, scientists, industry representatives, government 

organizations, public health officials, the medical community, and foreign interests. By incorporating new 

hazard data on these chemicals into their decision-making processes, users will achieve benefits resulting 

from improved decision-making processes, and ultimately risk reduction. 

The data would be made available to the public, and may be incorporated into numerous databases and 

sources that contain toxicological information. A few examples of these sources include the Hazardous 

Substances Data Bank (HSDB), Registry of Toxic Effects of Chemical Substances (RTECS), Integrated 

Risk Information System (IRIS), the Toxic Substances Control Act Test Submissions (TSCATS), and 

TOXicology information onLINE (TOXLINE). These databases provide a variety of toxicological 

information in the form of study abstracts, information on effects, and more comprehensive information 

combining hazard and exposure information to provide risk information (e.g., IRIS). The U.S. National 

Library of Medicine (NLM) houses TOXLINE, a bibliographic database that includes the toxicological 

effects of drugs and other chemicals. Users can access TOXLINE through the Internet. NLM estimates 

that a single month‟s access to the database (February 2009) consisted of 72,552 searches via the Internet 

(Thomas, 2009). 
5-17

The distribution of TSCATS user accounts purchased through a past vendor, Oxford Molecular Group 

(OMG),

18 indicates that the users of toxicological data are diverse. In 1998, a representative of OMG 

suggested that 6 percent of account holders were government, 38 percent were the private sector, 4 

percent were academic organizations, 40 percent were foreign interests, and 11 percent were 

nonsubscribers (estimates may not add due to rounding) (Hoffman, 1998). The current vendor, National 

Information Services Corp. (NISC), does not track this information. However, it does track the 

subscribers and non-subscribers to whom NISC supplies copies of toxicological studies cited in the 

TSCATS database. NISC supplies approximately 38 percent of the copies to U.S. industrial entities, 27 

percent to U.S. non-industrial entities, 19 percent to non-U.S. governments, 7 percent to U.S. consultants, 

and 11 percent to international consultants (Earle, 2003). 

Clearly, there is a wide variety of users of toxicological data. It is expected that there will be similar uses 

for the data generated as a result of this final test rule, and that some of these data may be incorporated 

into these databases. Users of, and the benefits they derive from, toxicological information are discussed 

in more detail below. 

5.5.1 Consumers/Buyers

Economic theory maintains that competitive markets provide goods and services to the extent that the 

marginal benefit of the good or service to consumers is more than or equal to the marginal cost of 

production. Underlying this conclusion are two assumptions: that both consumers and producers have 

perfect information, and that the cost of conducting a market transaction is negligible. The need for 

chemical testing information stems from the fact that, in some cases, neither producers nor consumers 

have perfect information regarding the hazards associated with certain chemicals. If basic information on 

chemical hazards were known, consumers might alter the amount they would be willing to pay for the 

chemical. Therefore, in the absence of complete information, the private market may be misallocating 

resources to the production of the chemical substance. 

Thus, one advantage of mandatory testing and dissemination of test results is that consumers can make 

better choices about products containing chemicals if they are better aware of the potential hazards. 

Consumers can respond to additional information by changing their purchasing decisions (i.e., increasing 

or decreasing consumption, as appropriate); by reducing the amount they are willing to pay for the 

product; or by changing the way they handle, store, use, or dispose of the product. This may move the 

market toward a more efficient allocation of resources. Thus, the role of toxicity information in resolving 

uncertainties can be particularly valuable.

5.5.2 Workers

Hazard information can play a role in guiding workers‟ employment decisions and work practices. If 

workers are aware of workplace hazards (e.g., the hazard associated with chemical substances to which 

they are exposed), they may choose not to work at a particular facility. If they decide to work there, 

informed workers can make better decisions about the precautions, if any, they should take to reduce their 

exposure to that chemical. These precautions may include taking proper care while handling and using 

certain chemicals or wearing protective clothing. Alternatively, a worker may seek a wage premium to 

compensate for increased workplace risk. Viscusi and O‟Connor (1984) conclude that the value of new 

information to the worker can be measured by the increase in the wage premium (differential) as a greater 

understanding of workplace risk is gained. Thus, workers can seek a risk premium or take averting actions 

to protect themselves if information is available about the health effects of the chemicals they come into 

 

18 Oxford Molecular Group‟s Chemical Information System, which housed TSCATS, was acquired by National 

Information Services Corp. (NISC) in 2000. 
5-18

contact with at work. EPA expects the potential benefits to workers to be large for chemicals included in 

the final rule since they are manufactured and processed in large volumes.

5.5.3 Science and Health Communities

Chemical toxicity information is useful to a variety of scientific and health communities. For example, 

medical professionals are concerned about the health of patients exposed to chemicals, poison control 

centers distribute information on toxicity and treatment associated with poisoning, and scientists use 

toxicity information to characterize the effects of chemicals and to assess risks of chemical exposure. The 

literature includes specific examples where toxicity data have been summarized and interpreted: Kapp et 

al. (1996) summarize the results of TSCA Section 4 test rule studies for isopropanol, Glickman et al. 

(1995) report the results of aquatic toxicity studies for cumene (isopropyl benzene), and Bogdanffy et al. 

(1990) present results of subchronic inhalation tests for vinyl fluoride.

In addition, several published studies also rely on information from the RTECS database. RTECS is a 

database of toxicological information compiled, maintained, and updated by the National Institute of 

Occupational Safety and Health (NIOSH). Numerous vendors currently offer access to the database. 

RTECS currently covers more than 152,000 chemicals and provides data on mutagenic effects, 

reproductive effects, tumorgenic effects, and acute toxicity effects, for example (NIOSH, 2005). 

Examples of published scientific literature using this particular database include Ruder et al. (1990) and 

Jones et al. (1998). The former study uses toxicity data available from the RTECS database to compute 

national estimates of occupational exposure to animal bladder tumorigens, while the latter study uses 

toxicological data from the RTECs database to compute relative potency factors for chemical compounds 

associated with increased risk of atherosclerosis to humans. 

The test results generated by the final rule are also expected to be used by scientists to increase the 

understanding of the health and environmental effects of these chemicals to which people may be exposed 

in the places where they live, work, study, and play. 

5.5.4 The General Public

In addition to its impact on consumers of chemicals or products, the production or use of a chemical 

substance may impose external costs on society in the form of increased health risks to the general public 

and increased risks to the physical environment. If these external costs are known, individuals can take 

averting actions to protect themselves. However, if the adverse impacts are unknown to the public, 

inefficiencies in the production and consumption of the chemical substance will persist.

The final test rule is valuable because the health and environmental data it generates provide a better 

understanding of the external costs involved in the production and use of chemical substances. Because 

the information will be made publicly available, members of the general public will then be empowered 

to help address the market failure through individual actions they may take to protect themselves from 

exposure to the chemical substance (averting behaviors) or activities designed to pressure firms or 

governments to reduce the externalities associated with production (e.g., lobbying activities).

One can expect that if reliable test data are disseminated to the public, community and public interest 

groups can initiate a dialogue with the manufacturers of hazardous chemicals and encourage them to 

improve their safety measures and assess their environmental management plans.

5.5.5 Firms and their Shareholders

As noted earlier, industry is an important user of chemical hazard information. Physical/chemical 

properties and environmental fate information is used to better develop the handling and safety 

procedures for chemicals, develop emergency preparedness plans, follow principles of the Responsible 
5-19

Care® Initiative of the American Chemistry Council (ACC), and competitively participate in today‟s 

chemical market. Toxicity data help to screen the chemicals for which such precautions are most 

important.

The ACC‟s Responsible Care® Initiative includes as guiding principles the following:

“To make health, safety, the environment, and resource conservation critical considerations for all 

new and existing products and processes;

To work with customers, carriers, suppliers, distributors, and contractors to foster the safe use, 

transport, and disposal of chemicals; and

To support education and research on the health, safety, and environmental effects of our products 

and processes” (ACC, 2006).

Consideration of these principles supports the need for toxicological information on chemical products 

used and manufactured by this industry. The Chemical Industry Institute of Toxicology, a research 

institute sponsored by ACC, government, and industry, notes that chemical research has helped 

companies ensure safety in manufacturing, use, and disposal of chemicals (Chemical Industry Institute of 

Toxicology, 1998, 2001). Thus, companies are more likely to avoid potential liability concerns from 

inappropriate handling of chemicals. Similar advantages are expected from the information developed as 

a result of the final rule.

Data generated as a result of the final rule are also expected to be sufficient for the OECD SIDS program. 

Data meeting the requirements of the SIDS program can be used to develop initial assessments of 

chemicals that are shared worldwide. Because this information is shared, companies may avoid 

duplicative efforts to meet the requirements of other countries where they may also manufacture and sell 

certain chemicals. This could lead to cost savings for companies that operate internationally. 

Corporate shareholders also benefit from the data developed in the rule. Basic microeconomic theory 

assumes that the primary objective of any firm, whether privately or publicly held, is to maximize profits. 

When a firm is incorporated and its shares are traded on the stock market, maximizing a firm‟s profits is 

analogous to maximizing shareholder value. There are a number of ways in which the provision of 

information regarding the production practices and output of a firm can affect shareholder value. First, 

production processes and output that result in adverse consequences to human health and the environment 

may eventually result in substantial liabilities to the firm. Therefore, any new information regarding 

potential threats to human health or the environment may cause investors to re-evaluate the potential 

future liabilities (and hence profitability) of a firm. Second, when an investor who prefers providing 

capital to environmentally benign companies discovers that a firm‟s use of toxics is inconsistent with his 

or her preferences, he or she may move investment funds toward other, more environmentally friendly 

firms.

There is a growing body of empirical literature evaluating the effects of environmental information 

disclosures on firms and their shareholders. In an effort to estimate the economic cost of hazardous waste 

mismanagement, Muoghalu and Rogers (1992) modeled the effect of Superfund lawsuit announcements 

on firms‟ stock values. The authors estimated that stock values dropped an average of $30.7 million when 

news of a new Superfund lawsuit was made public. Blacconiere and Patten (1994) examined the effect of 

the 1984 Union Carbide chemical leak in Bhopal, India, on other chemical firms‟ stock prices. They 

found that firms in which chemical operations made up a larger portion of total revenue experienced 

greater losses in stock value immediately following the leak. 

Thus, some evidence suggests that investors respond to new information regarding a firm‟s potential 

environmental liabilities by reassessing the value of the firm‟s stock. If test results are disseminated to the 
5-20

public, shareholders can better consider the importance placed on the firm‟s manufacture or use of 

particular chemicals and may encourage the firm to address shareholder concerns regarding chemical 

production and use to avoid potential losses in the capital markets. It is clear that, while beneficial to 

shareholders, this information may also cost the company if share values drop. These costs would offset 

some of the benefits to shareholders.

5.5.6 Government

The information developed in response to the final rule will benefit society by reducing costs and 

improving the quality of government decision and policy making. EPA itself is a user of TSCA Section 4 

test results in three primary ways. First, EPA can use the chemical-specific information acquired through 

a test rule to help identify hazards of concern and to screen and prioritize regulatory activities, including 

identifying areas where regulatory intervention is not required. Second, EPA can serve its “clients” by 

providing these test results to other agencies within the federal government as well as to public agencies 

at other levels of government. Finally, EPA can use information-reporting rules as an alternative to other 

forms of regulation. Each of these uses is discussed below.

Support EPA Regulatory Activities. When developing risk management strategies, EPA must decide 

whether or not to regulate the use of a chemical substance or mixture to protect society. Basic toxicity 

data are not available for many chemicals, but exposure controls have no environmental value if these 

chemicals are not a concern. The lack of data on health and environmental effects can affect sound 

decision making by government and others (Wehmeier, 2001). Regulating most certainly involves costs 

to both EPA (e.g., resources required to develop, promulgate, and enforce a regulation) and to society at 

large (e.g., foregone benefits derived from the use of the chemical substance, resources diverted from 

other uses). Although not regulating avoids these costs, society will face a welfare loss if the chemical 

turns out to harm human health and the environment.

Taylor et al. (1993) considered the value of test information in supporting decisions about the control of 

chemicals whose cancer potency is untested or unknown. While not specifically addressing the value of 

the basic toxicity testing data required by this final rule, their results suggest there is value to (cancer) 

testing information, particularly at intermediate levels of anticipated human exposure to a chemical. The 

authors contend that information (from cancer testing) may be less valuable where very high levels of 

exposure are expected because no test can perfectly distinguish carcinogens from non-carcinogens. 

In the EPA context, the probability that a chemical poses a risk depends on the chemical‟s toxicological 

properties, exposure pathways, dose-response relationships, and other factors. Testing rules help resolve 

some of these uncertainties. Thus, test information can help EPA decision makers avoid over-regulating a 

relatively safe chemical and under-regulating a risky chemical.

Provide Information to Other Government Agencies. Under TSCA Section 4, EPA has the authority to 

require firms to conduct tests of specific chemicals to determine the potential risk posed by these 

substances. However, other governmental agencies, such as the Food and Drug Administration, 

Consumer Product Safety Commission, NIOSH, and Occupational Safety and Health Administration, 

share regulatory authority over chemical substances or products containing them, or, in the case of 

NIOSH, compile summaries of available information and recommend exposure limits. Therefore, EPA 

serves as a conduit for chemical hazard information between the chemical producers and these other 

agencies. In addition to providing chemical test results to other federal agencies, EPA may make this 

information available to other interested parties such as state, local, and tribal government agencies, 

which can use the data to inform their own decision making. 

Information Provision as an Alternative to Traditional Regulation. Publicly disclosing TSCA Section 4 

chemical test results also provides an alternative to traditional regulation. As described above, the 
5-21

provision of chemical pollution and hazard information can be used to, among other things, empower 

individuals to take actions that they deem appropriate in response to chemical risks. In addition to 

fulfilling democratic notions of “right-to-know” information, regulations provide a low-cost avenue for 

pollution and hazard control when regulatory resources are scarce due to the large number of substances 

to be controlled (Tietenberg, 1998).

5.5.7 Foreign Interests

The toxicity data developed as a result of the test rule are also expected to save other countries the 

expense of collecting and interpreting toxicological data. At the United Nations Conference on 

Environment and Development in 1992, delegates adopted Agenda 21 of Chapter 19, which discusses 

chemical safety and includes program areas. One program area is international assessments of chemical 

risks, part of which includes the assessment of chemical hazards. The International Forum on Chemical 

Safety (IFCS) was formed in 1994 and has developed priorities for action in the implementation of 

Agenda 21. These include recognition of the activities sponsored by OECD in the area of chemical 

management and encouragement of the use of OECD as a means to carry out activities on chemical safety 

(IFCS, 1998). Data developed as a result of the final rule will be sufficient for the development of initial 

assessments of chemicals under OECD‟s SIDS program. Thus, other countries will benefit from the 

development of these data and can use the data without having to independently develop the information. 

Such information exchange will result in cost savings to other countries and will enable their governments 

to more effectively manage chemicals for safety as pledged under Agenda 21.
6-1

Chapter 6 – Other Impact Analyses

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

discussing unfunded mandates, environmental justice, children‟s health, and paperwork burden, among 

others.

6.1 Paperwork Reduction Act

The Paperwork Reduction Act mandates that federal agencies estimate the recordkeeping and reporting 

burden of a final rule. In this context, the term “burden” is interpreted as the total time, effort, or financial 

resources expended by people to generate, maintain, retain, disclose, or provide information to or for a 

federal agency. This includes the time needed by regulated entities to review instructions and to develop, 

acquire, install, and use technology and systems to collect, validate, verify, and disclose information. 

Time taken to adjust existing ways to comply with any previously applicable instructions and 

requirements and to train personnel to respond to the information collection task is also included. In this 

section, burden hours for both the industry respondents and the government are estimated.

6.1.1 Industry Burden

In this report, total industry burden hours represent the sum of time spent on reporting and on other 

administrative activities. Industry respondents will spend time on reporting activities associated with 

TSCA Section 4 test rules: preparing letters of intent and study plans, preparing test results for submission 

to EPA, recording test results, preparing laboratory reviews, preparing corporate reviews, conducting 

associated clerical work for final report preparation, conducting recordkeeping activities, and applying for 

exemptions. Under this final rule, respondents are also asked to submit robust summaries on a voluntary 

basis. In addition to the reporting burden, respondents will spend additional time on other, non-reporting 

administrative activities such soliciting laboratory bids, selecting laboratories, monitoring tests under 

progress, developing cost-sharing agreements, and auditing the laboratories for compliance with EPA‟s 

Good Laboratory Practice (GLP) standards. The procedure for estimating the total industry burden 

follows.

Estimate the Reporting Burden. As shown in Section 3.1.3 of this report, EPA estimates that 

approximately 11 panels will submit letters of intent and study plans, resulting in 118 final reports. EPA 

also assumes that it will receive five exemption applications per panel, resulting in a total of 55 requests

pursuant to the final rule. Additionally, it is estimated that 10 percent of final test reports will be 

accompanied by a robust summary of results. EPA estimated that it takes a respondent 40 hours to prepare 

a letter of intent and study plan, 73 hours to write a final report for a short-term study, 12 hours to prepare 

a robust summary, and 2 hours to prepare an exemption application. The unit labor hours are derived from 

the previous information collection requests and are believed to reflect the burden that will be incurred for 

the final rule. The reporting burden estimates for this rule are detailed in Exhibit 6-1. The total reporting 

burden generated by the rule is estimated to be approximately 9,308 hours.

Exhibit 6-1: Reporting Burden Estimate for the Final Rule

Item Hours per Item Total Items Total Hours

Letter of Intent and Study Plans 40 11 440

Final Reports 73 118 8,614

Robust Summaries 12 12 144

Exemption Applications 2 55 110

Total 9,308

Estimate the Other Administrative Burden. Respondents also spend time on other administrative 

activities including soliciting laboratory bids, selecting laboratories, monitoring tests under progress, 
6-2

developing cost-sharing agreements, and auditing the laboratories for compliance with EPA‟s Good 

Laboratory Practice (GLP) standards. EPA has calculated the costs and burdens of these activities as 25 

percent of the total laboratory testing costs. Based on this calculation, other administrative costs 

associated with laboratory testing are estimated to amount to $0.70 million ($0.85 million) under the least 

(average) cost assumption. These costs are translated into burden estimates using an average labor cost of 

$55.01 per hour, which is based on a labor mix that is 20 percent managerial, 60 percent technical, and 20 

percent clerical. The estimated administrative burden based on this approach is 12,659 (15,543) hours

under the least (average) cost assumption. 

Estimate the Export Notification Burden. As explained in Section 3.1.4, EPA expects 25 export 

notifications to be filed for each chemical included in the final rule (375 notification letters in total). This 

analysis assumes that the export notification burden ranges from 0.5 hours to 1.5 hours per notice. Thus, 

this analysis assumes that export notification requires 0.5 hours per notice under the least cost scenario 

and 1 hour per notice under the average cost scenario. Consequently, the export notification burden 

triggered by the final rule is estimated to equal 187.5 hours (375 hours) under the least (average) cost 

scenario.

Estimate the Total Industry Burden. The total industry burden is the sum of the total administrative 

burden and the export notification burden. Total industry burden estimates are summarized in Exhibit 6-2. 

The total industry burden is estimated to equal 22,154 hours (25,226 hours) in the least (average) cost 

scenario. The average burden per panel is estimated to be 2,014 (2,293) hours in the least (average) cost

scenario.19

Exhibit 6-2: Total Industry Burden Hour Estimate for the Final Rule

Activity

Least Cost Scenario

(Hours)

Average Cost Scenario

(Hours)

Reporting Activities 9,308 9,308

Other Administrative Activities 12,659 15,543

Export Notification Burden 187.5 375

Total Industry Burden 22,154 25,226

Average Burden Per Panel (11 panels)192,014 2,293

6.1.2 Government Burden

The government will also spend time processing, reviewing, and analyzing the information that will be 

collected under the final test rule. As explained in Section 3.2, this work is assumed to be performed by a 

GS-13, Step 1, FTE employee.

It is further assumed that 11 letters of intent and study plans, 118 final reports, 12 robust summaries, and 

55 exemption requests will be filed in response to this rule. The estimated unit government burden for 

processing letters of intent and study plans (3 hours), final reports (5 hours), and robust summaries and 

exemption applications (1 hour each) is derived from the previous information collection requests. Exhibit 

6-3 presents the estimated government burden hours based on these assumptions. The total government 

burden is estimated to equal 715 hours.

Exhibit 6-3: Estimated Government Burden for the Final Test Rule

Item Hours per Item Total Items Total Hours

Letter of Intent and Study Plans 3 11 33

Final Reports 5 118 590

Robust Summaries 1 12 12

Exemption Requests 1 55 55

Total 690

 

19 The per-panel cost assumes that the export notification burden is distributed evenly across all panels.
6-3

6.2 Unfunded Mandates Reform Act 

Federal agencies are required to assess the effects of federal regulations on state, local, or tribal 

governments, and on the private sector under Title II of the Unfunded Mandates Reform Act of 1995 

(UMRA). In particular, UMRA requires that agencies prepare a written statement to accompany any 

rulemaking that “includes any Federal mandate that may result in the expenditure by State, local, and 

tribal governments, in the aggregate, or to the private sector, of $100 million or more (annually adjusted 

for inflation) in any one year” (Section 202(a)). The written impact statement under Section 202 must 

include (1) an identification of the statutory authority; (2) an assessment of the benefits and costs of the 

rule; and (3) a description of the agency‟s consultation with state, local, and tribal government officials 

during the development of the rule.

EPA estimates that the final rule will not cost the private or public sectors $100 million or more in any 

one year. As shown in Chapter 3, the maximum total cost incurred by the private sector in complying 

with the final rule and associated requirements triggered by the rule is approximately $5.08 million

(average cost scenario). This includes laboratory and administrative costs, as well as the cost of export 

notifications under the average cost scenario. Assuming a 7 percent discount rate and a 15-year 

amortization period, the maximum annualized compliance cost for industry is approximately $0.56

million per year (average cost scenario).20 Government cost, annualized using similar assumptions, is 

estimated to equal $5,064 per year.

Furthermore, because the final rule is focused on manufacturers and importers of chemicals, EPA does 

not believe that it imposes costs on any non-federal government entity, or on state, local, and tribal 

governments. Moreover, while it does not impose costs on state, local, and tribal governments, the final 

rule can be of value to these agencies. As explained in Chapter 5, if EPA makes the test data collected as 

a result of the final rule publicly available, then other government agencies can use the data to inform 

their own regulations and decision making.

Executive Order 12875, “Enhancing the Intergovernmental Partnership” (58 FR 58093, October 28, 

1993), requires federal agencies to determine whether certain regulatory actions create unfunded federal 

mandates on state, local, or tribal governments. In March 1999, EPA conducted a search of past 

submissions to the Agency for letters of intent to test, exemption applications, and export notifications 

and found that state, local, or tribal governments have never submitted these to the Agency.

6.3 Executive Order 13132 – Federalism

Under Executive Order 13132, “Federalism” (64 FR 43255, August 10, 1999), EPA must determine if a 

rule has “federalism implications.” This analysis demonstrates that this final rule 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 testing and recordkeeping requirements that apply to 

manufacturers (including importers) and processors of certain chemicals. Because EPA has no 

information to indicate that any state or local government manufactures or processes 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. Executive Order 13175 – Consultation and Coordination with Indian 

Tribal Governments under Executive Order 13175, “Consultation and Coordination with Indian Tribal 

Governments” (65 FR 67249, November 9, 2000), EPA must determine if final rule has tribal 

implications. This analysis demonstrates that this final rule will not have any effect on tribal governments, 

 

20 As described in Chapter 4, compliance costs are annualized using a 7 percent discount rate to reflect the 

opportunity cost of capital, and over a 15-year period to reflect the life of the chemical. 
6-4

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 executive order. 

This is based on a search conducted in March 1999 of past submissions to EPA. This search demonstrated 

that state, local, or tribal governments have never submitted letters of intent to test, exemption 

applications, or export notifications to EPA. Furthermore, based on the submissions received for the most 

recent IUR and PAIR rule reporting periods, none of the chemicals listed in this final rule are 

manufactured by state, local, or tribal governments (in quantities of 25,000 lbs or more at a single site). 

Thus, EPA has no information to indicate that any tribal government manufactures or processes the 

chemical substances covered by this action, and EO 13175 does not apply to this final rule.

6.4 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. 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. Nevertheless, the 

information obtained by the testing in 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.

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

One chemical in the final regulation has been identified as having uses associated with energy supply, 

distribution or use (see Exhibit 2-86Exhibit 2-9 for detail) which is identified by IUR as “other petroleum 

and coal products manufacturing.” Given the low cost of the rule and lack of restrictions on the use of the 

chemicals resulting from the final rule, it is unlikely that there will be significant impacts on the supply, 

distribution, or use of energy.

6.6 National Technology Transfer and Advancement Act

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

104–113 (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. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency 

decides not to use available and applicable voluntary consensus standards.

This final rule involves technical standards because it proposes to require the use of particular test 

methods. If the Agency makes findings under TSCA section 4(a), EPA is required by TSCA section 4(b) 

to include specific standards or test methods that are to be used for the development of the data required 

in the test rules issued under TSCA section 4. For some of the testing that would be required by this rule, 

EPA is proposing the use of voluntary consensus standards issued by ASTM and ISO that evaluate the 

same type of toxicity as the TSCA and OECD test guidelines, where applicable. Copies of the 17 ASTM 

and ISO standards referenced in the final regulatory text at §799.5087(h) have been placed in the docket 

for this final rulemaking. Interested parties may obtain copies of the ASTM standards from the American 

Society for Testing and Materials, 100 Bar Harbor Dr., West Conshohocken, PA 19428–2959, and copies 

of the ISO standards from the International Organization for Standardization, Case Postale 56, CH-1211 

Geneva 20, Switzerland. In the final rule, EPA intends to seek approval from the Director of the Federal 
6-5

Register for the incorporation by reference of the ASTM and ISO standards used in the final rule in 

accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

EPA is not aware of any potentially applicable voluntary consensus standards that evaluate partition 

coefficient (n-octanol/water) generator column, water solubility (column elution and generator column), 

acute inhalation toxicity, bacterial reverse mutations, in vivo mammalian bone marrow chromosomal 

aberrations, combined repeated dose with reproductive/developmental toxicity screen, repeated dose 28–

day oral toxicity screen, or the reproductive developmental toxicity screen that could be considered in lieu 

of the TSCA guidelines, 40 CFR 799.6756, 799.6784, 799.6786, 799.9130, 799.9510, 799.9538, 

799.9365, 799.9305, and 799.9355, respectively, upon which the test standards in this final rule are based. 

6.7 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), requires each agency to address and identify 

“disproportionally high and adverse human health or environmental effects of its programs, policies, and 

activities on minority and low-income populations.”

The final rule does not have an adverse impact on the environmental and health conditions in low-income 

and minority communities that require special consideration by the Agency under EO 12898. 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 the chemicals covered by the rule. 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 final rule is directed at 15 chemicals for which basic toxicity information is currently unavailable 

even though they are widely used in commerce. All consumers of these chemical products and all workers 

who come into contact with these chemicals could benefit if data regarding the chemicals‟ health and 

environmental effects were developed. 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.
7-1

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A-1

Appendix A – Derivation of Chemical Price Estimates

This appendix describes the derivation price estimates for the chemicals included in the final third test 

rule for high production volume chemicals. Based on data availability, six different estimation 

methodologies were used; all prices are in 2009 dollars. Exhibit A-1Exhibit A-1 summarizes each of the 

sources and methods for price estimation.

Exhibit A-1: Summary of Chemical Price Sources and Estimation Methods

Source Name Type

Date 

Published

Number of Chemical 

Prices Found

Range of Prices for 

Chemicals in This 

Test Rule (2009$)

USITC Synthetic Organic 

Chemicals 

Bulk quantity prices 1992 2 $0.58 - $2.84

Chemical Market Reporter

(Similar chemicals)

Bulk quantity prices 2006 1 $0.24

Sigma-Aldrich Small quantity chemical 

catalog 2008 6 $0.25 - $1.25

Sigma-Aldrich

(Similar chemicals)

Small quantity chemical 

catalog 2008 4 $0.20 - $5.88

Fisher Chemical Company

(Similar chemicals)

Small quantity chemical 

catalog 2008 1 $33.00

American Chemistry Council General estimates 2008 1 $1.25

EPA used bulk quantity prices when they were available because the bulk quantity prices of chemicals are 

most accurate when estimating the impact of this final test rule on high production volume manufacturers.

The prices listed in the Chemical Market Reporter (CMR) were preferred over those in the United States 

International Trade Commission‟s (USITC‟s) report Synthetic Organic Chemicals because the CMR data 

are more recent. When prices were not available through either source, EPA identified chemicals similar 

in composition, manufacture, or use to the regulated chemical with the expectation that prices for these 

proxy chemicals would be similar. 

When bulk chemical prices were not available either for the regulated chemical or a similar chemical, 

EPA used small quantity chemical catalogs published by Sigma-Aldrich and Fisher Chemical Company.

Small quantity catalog prices are known to be significantly more expensive per unit than bulk quantity 

pricing; therefore, EPA developed bulk quantity scaling factors for each catalog to estimate bulk quantity 

pricing. Again, for chemicals without prices available in these catalogs, EPA used similar chemicals as 

proxies.

Finally, for chemical prices that were not available for either bulk or small quantities, EPA used the 

American Chemistry Council‟s Guide to the Business of Chemistry, which provides a “rule of thumb” for 

basic and specialty chemical prices. To be conservative, EPA used the speciality chemical price estimate 

of $1.25 per pound. This price is within the ranges estimated using the other methods.

A.1 Chemical Market Reporter 

EPA searched the CMR (last published in 2006) for price data using common chemical names, and using 

synonyms for each common chemical nameError! Reference source not found.. No Price data for any 

of the chemicals regulated under the final rule was available from the CMR.
A-2

A.2 United States International Trade Commission – Synthetic Organic 

Chemicals

For two chemicals, EPA used the average price per pound of chemicals as reported in various 

Harmonized Tariff Schedule (HTS) chemical groups in USITC‟s report titled Synthetic Organic 

Chemicals. For two chemicals, the price was available as part of an HTS group. Because the last USITC 

report was published in 1992, EPA then inflated these costs using the producer price index (PPI) for 

chemical manufacturing. Exhibit A-2Exhibit A-2 shows these prices. To the extent that these prices may 

have changed since 1992, for reasons other than inflation, the actual price may be higher or lower than the 

estimate provided here. 

Exhibit A-2: USITC Synthetic Organic Chemicals Prices (2009$)

CASRN Chemical Name

Price/kg 

(1992$)

(a)

Inflation Factor

(1992$ to 2009$)1

(b)

Price/kg 

(2009$)

(c) = (a) (b)

Estimated 

Price/lb

(2009$)2

(d) = (c) / 2.205

98-09-9 Benzenesulfonyl 

chloride $0.71 1.79 $1.27 $0.58

25321-41-9 Benzenesulfonic 

acid, dimethyl-

$3.48 1.79 $6.23 $2.84

1

The PPI for chemical manufacturing in 1992 was 125.8; the same index for 2009 was 224.7 (preliminary data, BLS 

2010b). The costs from the USITC report were inflated using a factor of (224.7/125.8) = 1.79.

2

1 kg = 2.205 lb.

A.3 Similar Chemical Prices – CMR

EPA identified chemicals that were similar in composition, manufacture, or use, and used prices for these 

chemicals as proxies for the chemicals for which prices could not be found in either of the bulk price 

sources described above. The CMR, last published in August 2006, contained price information for one of 

these chemicals (see Exhibit A-3Exhibit A-3). To the extent that a proxy chemical is different from the 

regulated chemical, the actual price may be higher or lower than the estimate provided here.

Exhibit A-3: Chemical Market Reporter Similar Chemical Prices (2009$)

CASRN Chemical Name

Similar 

Chemical Name 

[CASRN]

Price/lb 

(2006$)1

(a)

Inflation Factor 

(2006$ to 2009$)2

(b)

Estimated 

price/lb

(2009$)

(c) = (a) (b)

68442-60-4 Acetaldehyde, 

reaction products with 

formaldehyde, byproducts from

Formaldehyde 

[50-00-0]

$0.21 1.14 $0.24

1 Chemical Market Reporter (ICIS, 2006).

2

The PPI for chemical manufacturing in 2006 was 196.8; the same index for 2009 was 224.7 (preliminary data, BLS, 

2010b). The costs from the CMR were inflated using a factor of 224.7 / 196.8 = 1.14.

A.4 Small Quantity Catalog Prices

An online chemical catalog published by the Sigma-Aldrich Company (Sigma-Aldrich, 2008) provided 

small quantity price information for six of the remaining chemicals for which data were not available 

using the sources and methods described above. However, because small quantity catalog prices are often 

significantly higher than the bulk quantity prices reported in the CMR, EPA adjusted the small quantity 

catalog prices for these six chemicals to approximate bulk quantity prices, using scaling factors derived as 

described below.
A-3

A.4.1 Derivation of Small Quantity Scaling Factors

To determine the appropriate scaling factor to adjust small quantity prices to approximate bulk quantity 

prices, EPA selected 15 chemicals (not subject to this final rule) for which price data were available from 

both the CMR (ICIS, 2006, inflated to 2008 prices using the PPI) and Sigma-Aldrich (2008), and 

compared the prices. Similarly, EPA selected 10 chemicals, for which price data were available from both 

the CMR and the Fisher Scientific chemical catalog, to develop scaling factors for prices from that catalog 

(used in Section A.5).

Prices were obtained from the catalogs for chemical formulations sold in (1) 1 kg quantities, (2) quantities 

between 100 g and 500 g, and (3) quantities less than 1 g. EPA estimated the implied price per pound 

using the largest quantity range available for each chemical.

EPA estimated the implied price per pound (assuming that prices were directly proportional to volume), 

and within each of the three quantity categories, developed scaling factors by dividing the Sigma-Aldrich 

implied price per pound by the CMR price per pound.21

Exhibit A-4 shows the scaling factors developed to estimate the bulk price of chemicals available from 

the Sigma-Aldrich Company.

Exhibit A-4: Comparison Between Chemical Market Reporter and Sigma-Aldrich Prices

CASRN

CMR

Price/lb1

(a)

Sigma-Aldrich Price (Varies by Quantity (Q))

Q = 1 kg 500 g ≥ Q ≥ 100 g Q ≤ 1 g

Implied 

Price/lb2

(b)

Scaling 

Factor

(c) = (b) / (a)

Implied 

Price/lb2

(d)

Scaling 

Factor

(e) = (d) / (a)

Implied 

Price/lb2

(f)

Scaling 

Factor

(g) = (f) / (a)

108-31-6 $0.58 $25.95 44.61 $58.42 100.44 n/a n/a

64-19-7 $0.53 $19.30 36.46 $71.94 135.91 $12,247 23,138

58-08-2 $8.14 $74.50 9.15 $690.28 84.77 $5,715 702

75-20-7 $0.26 $27.03 102.38 $87.23 330.32 n/a n/a

67-48-1 $0.62 $35.83 57.58 $654.28 1,051.28 $65,771 105,679

85-44-9 $0.64 $9.21 14.39 $33.02 51.61 n/a n/a

532-32-1 $0.94 $17.33 18.39 $46.33 49.17 $6,305 6,691

112-57-2 $1.98 $29.85 15.09 $64.55 32.64 n/a n/a

112-27-6 $0.81 $13.15 16.15 n/a n/a n/a n/a

7446-70-0 $0.99 $34.44 34.83 $132.00 133.49 n/a n/a

1317-39-1 $1.79 n/a n/a $38.96 21.75 n/a n/a

143-07-7 $0.33 $25.21 76.03 $81.42 245.58 n/a n/a

7719-12-2 $0.57 $33.75 59.20 $664.12 1,165.09 n/a n/a

7447-40-7 $0.63 $39.08 62.21 $128.63 204.77 n/a n/a

7646-69-7 $7.15 $748.43 104.61 $311.38 43.52 n/a n/a

Average 46.51 260.74 34,053

1

The CMR price per pound was inflated, using the PPI for chemical manufacturing, from August 2006 dollars to December 2008 dollars.

2

The Sigma-Aldrich implied price per pound was calculated by dividing the stated price per unit quantity by the appropriate conversion 

factor (e.g., 2.205 lb/kg).

Sources: Chemical Market Reporter (ICIS, 2006) and Sigma-Aldrich, 2008.

Exhibit A-5 shows the scaling factors developed to estimate the bulk price of chemicals available from 

Fisher Scientific, using the same methodology as for the Sigma-Aldrich catalog. Only the volume range 

actually used in the analysis is shown.

 

21 A fourth scaling factor was developed because one chemical was only available in a 1.2 mg quantity. 
A-4

Exhibit A-5: Comparison Between CMR and Fisher Scientific Prices

CASRN

CMR

Price/lb1

(a)

Fisher Scientific Price (Varies by Quantity (Q))

500 g ≥ Q ≥ 100 g

Implied Price/lb2

(b)

Scaling Factor

(c) = (b) / (a)

58-08-2 $8.14 $155.71 19.12

75-20-7 $0.26 $59.46 225.18

85-44-9 $0.64 $49.72 77.71

532-32-1 $0.94 $60.26 63.95

112-57-2 $1.98 $33.38 16.88

7446-70-0 $0.99 $77.84 78.72

1317-39-1 $1.79 $32.93 18.38

143-07-7 $0.33 $43.29 130.58

7447-40-7 $0.63 $49.05 78.08

7646-69-7 $7.15 $111.24 15.55

Average 65.83

1 The CMR price per pound was inflated, using the PPI for chemical manufacturing, from 

August 2006 dollars to December 2008 dollars.

2 The Fisher Scientific implied price per pound was calculated by dividing the stated price per 

unit quantity by the appropriate conversion factor (e.g., 2.205 lbs/kg).

Sources: Chemical Market Reporter (ICIS, 2006) and Fisher Scientific, 2008.

A.4.2 Conversion of Small Quantity Catalog Prices

For the chemicals included in the final rule for which EPA did not find prices using the steps described in 

Sections A.1 through A.3, EPA searched the Sigma-Aldrich catalog (as well as the Fisher Scientific 

catalog). The Agency collected price information for each formulation and quantity of the available 

chemicals. If a chemical was available in a 1-kilogram quantity, EPA used the price(s) given for this 

quantity. If multiple formulations of a particular quantity were available, EPA used the arithmetic mean 

of these prices. This price-per-kilogram estimate was then adjusted, using the scaling factors as derived 

above, to estimate the bulk quantity price-per-pound of each chemical. 

Several chemicals were not available in 1-kilogram quantities, and in these cases, EPA estimated the price 

per pound using the largest available quantity range. 

Exhibit A-6Exhibit A-6 shows the prices gathered from Sigma-Aldrich for chemicals included in the final 

test rule, and the derivation of their bulk quantity price estimates. 
A-5

Exhibit A-6: Prices Derived from Sigma-Aldrich

CASRN Chemical Name Formulation Details

Quantity

(a)

Price

(b)

Implied 

Price/kg1

(c)

Implied 

Price/lb

(d) = (c) / 

2.205

Scaling 

Factor2

(e)

Estimated 

Bulk Price/lb

(2009$)4

(f) = (d) (e)

98-56-6 Benzene, 1-chloro-4-

(trifluoromethyl)-

98% 250 g $35.10 $140.40

100 g $15.10 $151.00

Average3

$145.70 $66.09 260.74 $0.25 

111-44-4 Ethane, 1,1'-oxybis[2-chloro- 99% 500 g $56.10 $112.20

100 g $47.90 $479.00

Average3

$295.60 $134.08 260.74 $0.51 

127-68-4 Benzenesulfonic acid, 3-nitro-, 

sodium salt (1:1)

98% 500 g $50.7 $101.40

98% 100 g $24.7 $247.00

Average3

$174.20 $79.02 260.74 $0.30

515-40-2 Benzene, (2-chloro-1,1-

dimethylethyl)-

99% 1 kg $130.50 $130.50 $59.19 46.51 $1.25

5026-74-4 2-Oxiranemethanamine, N-[4-(2-

oxiranylmethoxy)phenyl]-N-(2-

oxiranylmethyl)-

Sigma

(1.22 g/mL)

0.25 L $127.50 $418.03 $189.62 260.74 $0.72

52556-42-0 1-Propanesulfonic acid, 2-

hydroxy-3-(2-propen-1-yloxy)-, 

sodium salt (1:1)

Solution 40 wt. % in 

H2O 

(1.17 g/mL) 

1 L $70.10 $116.24 $52.73 46.51 $1.12

1

The implied price per kilogram is the price per unit quantity, converted to price per kilogram. For example, ($90.20 / 500g)(1,000g / 1 kg) = $180.40 / kg.

2

The scaling factors are derived in Exhibit A-4 and Exhibit A-5 above.

3

The average price is calculated when more than one price is available for a chemical, within a given quantity range. The average price is then converted to a price per pound and 

scaled to a bulk quantity price estimate using scaling factors.

4 Prices were originally scaled to 2008 dollars and were then inflated to 2009 dollars using the PPI for chemical manufacturing.
A-6

A.5 Small Quantity Catalog Prices for Similar Chemicals

If none of the above methods yielded a price estimate, EPA used the same method as described in Section 

A.4 for small quantity chemical catalogs to estimate the bulk price per pound of chemicals, using proxy 

chemicals similar in composition, manufacture, or use. 

One similar chemical was not available in the Sigma-Aldrich catalog but was available in the Fisher 

Scientific catalog. 

Exhibit A-7Exhibit A-7 shows the prices gathered from Sigma-Aldrich and Fisher Scientific for 

chemicals similar to those included in the final test rule, and the calculation of their bulk quantity price 

estimates.
A-7

Exhibit A-7: Prices of Similar Chemicals 

CASRN Chemical Name

Similar 

Chemical 

Price Used

Formulation 

Details [Source]

Quantity

(a)

Price

(b)

Implied 

Price/kg

(c)

Implied Price/lb

(d) = (c) / 2.205

Scaling 

Factor

(e)

Estimated 

Bulk 

Price/lb

(2009$)1

(f) = (d) (e)

2494-89-5 Ethanol, 2-[(4-

aminophenyl)sulfonyl]-, 1-

(hydrogen sulfate)

Acetanilide 

[103-84-4]

reagent grade, 

97% [SigmaAldrich]

1 kg $76.00 $76.00 $34.47 46.51 $0.73

68082-78-0 Lard, oil, Me esters Methyl 

palmitate [112-

39-0]

≥97% [SigmaAldrich]1 kg $74.00 $74.00 $33.57 46.51 $0.71

68610-90-2 2-Butenedioic acid (2E)-, 

di-C8-18-alkyl esters

2-Ethylhexyl 

fumarate 

[141-02-6]

Di-2-ethylhexyl 

Fumarate, MP 

Biomedicals

[Fisher]

100 g $486.43 $4,864.30 $2,206.41 65.83 $33.00

70693-50-4 Phenol, 2,4-bis(1-methyl-1-

phenylethyl)-6-[2-(2-

nitrophenyl)diazenyl]-

Azobenzene 

[103-33-3]

96% [SigmaAldrich]100 g $343.40 $3,434.00 $1,557.54 260.74 $5.88

72162-15-3 1-Decene, sulfurized 1-Decene

[872-05-9]

ampule of 

1000 mg [SigmaAldrich]

1 g $15.40 $15,400.00 $6,985.32 34,053 $0.20

1 Prices were originally scaled to 2008 dollars and were then inflated to 2009 dollars using the PPI for chemical manufacturing.
A-8

A.6 American Chemistry Council Prices

For one chemical, EPA could not estimate the price using any of the five methods described above. For 

these chemicals, EPA used the American Chemistry Council‟s Guide to the Business of Chemistry, which 

contains price information for certain types of chemicals. According to the guide published in 2008 

(ACC, 2008), a rule of thumb for specialty chemicals is that the price is greater than $1.25 per pound. As 

shown in Exhibit A-8Exhibit A-8, one chemical is a specialty chemical. 

Exhibit A-8: American Chemistry Council Prices

CASRN Chemical Name Chemical Type Estimated Price/lb

(2009$)

22527-63-5 Propanoic acid, 2-methyl-, 3-

(benzoyloxy)-2,2,4-trimethylpentyl ester

specialty $1.25
B-1

Appendix B – Cost Details
B-2

Exhibit B-1: Industry Compliance and Government Costs, Least Cost Scenario

CASRN Chemical Name Testing Cost

Analytical 

Methodology 

Validation 

Cost

Total 

Administrative 

Cost1

Export 

Notification 

Cost

Total Industry 

Compliance 

Cost2

Government 

Cost

Total Social 

Cost3

1 98-09-9 Benzenesulfonyl chloride $192,699 $23,000 $66,397 $687 $282,783 $1,756 $284,540

2 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)- $18,222 $6,000 $13,171 $687 $38,080 $1,074 $39,155

3 111-44-4 Ethane, 1,1'-oxybis[2-chloro- $144,888 $14,500 $44,837 $687 $204,913 $1,074 $205,987

4 127-68-4 Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) $73,805 $8,500 $27,562 $687 $110,555 $1,074 $111,629

5 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)- $235,650 $26,500 $98,020 $687 $360,847 $3,802 $364,650

6 2494-89-5

Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen 

sulfate) $237,327 $26,500 $104,237 $687 $368,751 $4,144 $372,895

7 5026-74-4

2-Oxiranemethanamine, N-[4-(2-

oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)- $203,125 $14,500 $84,251 $687 $302,563 $3,120 $305,683

8 22527-63-5

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-

trimethylpentyl ester $237,327 $26,500 $102,750 $687 $367,264 $4,144 $371,408

9 25321-41-9 Benzenesulfonic acid, dimethyl- $19,799 $0 $17,873 $687 $38,359 $1,415 $39,775

10 52556-42-0

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-

yloxy)-, sodium salt (1:1) $237,327 $26,500 $104,237 $687 $368,751 $4,144 $372,895

11 68082-78-0 Lard, oil, Me esters $237,327 $26,500 $102,750 $687 $367,264 $4,144 $371,408

12 68442-60-4

Acetaldehyde, reaction products with 

formaldehyde, by-products from $237,327 $26,500 $104,237 $687 $368,751 $4,144 $372,895

13 68610-90-2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters $237,327 $26,500 $104,237 $687 $368,751 $4,144 $372,895

14 70693-50-4

Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-

nitrophenyl)diazenyl]- $237,327 $26,500 $104,237 $687 $368,751 $4,144 $372,895

15 72162-15-3 1-Decene, sulfurized $235,676 $26,500 $100,012 $687 $362,875 $3,802 $366,678

Total $2,785,144 $305,000 $1,178,807 $10,310 $4,279,260 $46,125 $4,325,385

1

Total administrative cost includes both reporting and non-reporting administrative costs.

2

Total industry compliance cost includes testing cost, analytical methodology validation cost, administrative cost, and export notification cost.

3

Total social cost includes total industry compliance cost and government cost.
B-3

Exhibit B-2: Industry Compliance and Government Costs, Average Cost Scenario

CASRN Chemical Name

Testing 

Cost

Analytical 

Methodology 

Validation Cost

Total 

Administrative 

Cost1

Export 

Notification 

Cost

Total Industry 

Compliance Cost2

Government 

Cost

Total Social 

Cost3

1 98-09-9 Benzenesulfonyl chloride $237,661 $23,000 $77,637 $1,431 $339,729 $1,756 $341,485

2 98-56-6 Benzene, 1-chloro-4-

(trifluoromethyl)-

$22,545 $6,000 $14,251 $1,431 $44,227 $1,074 $45,301

3 111-44-

4

Ethane, 1,1'-oxybis[2-

chloro-

$176,689 $14,500 $52,787 $1,431 $245,407 $1,074 $246,482

4 127-68-

4

Benzenesulfonic acid, 3-

nitro-, sodium salt (1:1)

$73,805 $8,500 $27,562 $1,431 $111,298 $1,074 $112,373

5 515-40-

2

Benzene, (2-chloro-1,1-

dimethylethyl)-

$293,133 $26,500 $112,394 $1,431 $433,458 $3,802 $437,260

6 2494-

89-5

Ethanol, 2-[(4-

aminophenyl)sulfonyl]-, 

1-(hydrogen sulfate)

$294,820 $26,500 $118,610 $1,431 $441,362 $4,144 $445,505

7 5026-

74-4

2-Oxiranemethanamine, 

N-[4-(2-

oxiranylmethoxy)phenyl]-

N-(2-oxiranylmethyl)-

$239,248 $14,500 $93,282 $1,431 $348,461 $3,120 $351,581

8 22527-

63-5

Propanoic acid, 2-

methyl-, 3-(benzoyloxy)-

2,2,4-trimethylpentyl 

ester

$294,820 $26,500 $117,123 $1,431 $439,874 $4,144 $444,018

9 25321-

41-9

Benzenesulfonic acid, 

dimethyl-

$19,799 $0 $17,873 $1,431 $39,103 $1,415 $40,518

10 52556-

42-0

1-Propanesulfonic acid, 

2-hydroxy-3-(2-propen1-yloxy)-, sodium salt 

(1:1)

$294,820 $26,500 $118,610 $1,431 $441,362 $4,144 $445,505

11 68082-

78-0

Lard, oil, Me esters $294,820 $26,500 $117,123 $1,431 $439,874 $4,144 $444,018

12 68442-

60-4

Acetaldehyde, reaction 

products with 

formaldehyde, byproducts from

$294,820 $26,500 $118,610 $1,431 $441,362 $4,144 $445,505

13 68610-

90-2

2-Butenedioic acid (2E)-, 

di-C8-18-alkyl esters

$294,820 $26,500 $118,610 $1,431 $441,362 $4,144 $445,505

14 70693-

50-4

Phenol, 2,4-bis(1-

methyl-1-phenylethyl)-6-

[2-(2-

nitrophenyl)diazenyl]-

$294,820 $26,500 $118,610 $1,431 $441,362 $4,144 $445,505

15 72162-

15-3

1-Decene, sulfurized $293,169 $26,500 $114,386 $1,431 $435,486 $3,802 $439,288

Total $3,419,792 $305,000 $1,337,469 $21,465 $5,083,726 $46,125 $5,129,851

1

Total administrative cost includes both reporting and non-reporting administrative costs.

2

Total industry compliance cost includes testing cost, analytical methodology validation cost, administrative cost, and export notification cost.

3

Total social cost includes total industry compliance cost and government cost.
B-4

Exhibit B-3: Annualized Social Costs1

CASRN Chemical Name

Least Cost Scenario Average Cost Scenario

3 years, 3% 3 years, 7% 3 years, 3% 3 years, 7%

1 98-09-9 Benzenesulfonyl chloride $100,593 $108,424 $120,725 $130,123

2 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)- $13,842 $14,920 $16,015 $17,262

3 111-44-4 Ethane, 1,1'-oxybis[2-chloro- $72,823 $78,492 $87,139 $93,922

4 127-68-4 Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) $39,464 $42,536 $39,727 $42,820

5 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)- $128,915 $138,950 $154,585 $166,619

6 2494-89-

5

Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen 

sulfate)

$131,830 $142,092 $157,500 $169,761

7 5026-74-

4

2-Oxiranemethanamine, N-[4-(2-

oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-

$108,068 $116,481 $124,295 $133,971

8 22527-

63-5

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-

trimethylpentyl ester

$131,304 $141,525 $156,974 $169,194

9 25321-

41-9

Benzenesulfonic acid, dimethyl- $14,062 $15,156 $14,324 $15,440

10 52556-

42-0

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-

yloxy)-, sodium salt (1:1)

$131,830 $142,092 $157,500 $169,761

11 68082-

78-0

Lard, oil, Me esters $131,304 $141,525 $156,974 $169,194

12 68442-

60-4

Acetaldehyde, reaction products with 

formaldehyde, by-products from

$131,830 $142,092 $157,500 $169,761

13 68610-

90-2

2-Butenedioic acid (2E)-, di-C8-18-alkyl esters $131,830 $142,092 $157,500 $169,761

14 70693-

50-4

Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-

nitrophenyl)diazenyl]-

$131,830 $142,092 $157,500 $169,761

15 72162-

15-3

1-Decene, sulfurized $129,632 $139,723 $155,302 $167,392

Total $1,529,155 $1,648,195 $1,813,558 $1,954,738

1

Total social cost includes total industry compliance cost and government cost. Total social costs are discounted over three years because these costs are expected to occur over the 

few years during which the actual testing occurs and EPA reviews studies. Discount rates of both 3 and 7 percent are presented following OMB Guidance contained in Circular A-4.
B-5

Exhibit B-4: Annualized Industry Compliance Costs1

CASRN Chemical Name

Least Cost Scenario Average Cost Scenario

15 years, 7% 7 years, 7% 15 years, 7% 7 years, 7%

1 98-09-9 Benzenesulfonyl chloride $31,048 $52,471 $37,300 $63,038

2 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)- $4,181 $7,066 $4,856 $8,206

3 111-44-4 Ethane, 1,1'-oxybis[2-chloro- $22,498 $38,022 $26,944 $45,536

4 127-68-4 Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) $12,138 $20,514 $12,220 $20,652

5 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)- $39,619 $66,956 $47,591 $80,430

6 2494-89-5

Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen 

sulfate) $40,487 $68,423 $48,459 $81,896

7 5026-74-4

2-Oxiranemethanamine, N-[4-(2-

oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)- $33,220 $56,142 $38,259 $64,658

8 22527-63-5

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-

trimethylpentyl ester $40,324 $68,147 $48,296 $81,620

9 25321-41-9 Benzenesulfonic acid, dimethyl- $4,212 $7,118 $4,293 $7,256

10 52556-42-0

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-

yloxy)-, sodium salt (1:1) $40,487 $68,423 $48,459 $81,896

11 68082-78-0 Lard, oil, Me esters $40,324 $68,147 $48,296 $81,620

12 68442-60-4

Acetaldehyde, reaction products with 

formaldehyde, by-products from $40,487 $68,423 $48,459 $81,896

13 68610-90-2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters $40,487 $68,423 $48,459 $81,896

14 70693-50-4

Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-

nitrophenyl)diazenyl]- $40,487 $68,423 $48,459 $81,896

15 72162-15-3 1-Decene, sulfurized $39,842 $67,333 $47,814 $80,806

Total $469,840 $794,031 $558,166 $943,302

1

Total industry compliance cost includes testing cost, analytical methodology validation cost, administrative cost, and export notification cost. Total industry compliance costs are 

annualized at a 7 percent discount rate, which reflects the opportunity cost of capital, and over 15 years, which represents the life of the chemical. Results are also presented using a 

discounting timeline of 7 years to test the sensitivity of results to a shorter chemical lifetime, as some chemicals included in the final rule may have a lifetime that is less than 15 years. 

Industry compliance costs are used in the analysis of impacts of the rule on companies and the discount period differs from that used to calculate social costs.
C-1

Appendix C – Wage Rate Calculations

This appendix describes the derivation of the fully loaded labor rates and inflation factors used in 

calculating costs of labor, materials, and other inputs. All cost estimates are presented in 2009 dollars.

C.1 Derivation of Loaded Wage Rates

The fully loaded unit labor cost for managerial, professional/technical, and clerical labor in the regulated 

industry and for EPA staff is estimated by adding fringe benefits and overhead costs to the hourly wage or 

annual salary for each category following the method described in Wage Rates for Economic Analysis of 

the Toxics Release Inventory Program (Rice, 2002). This appendix describes the method employed to 

estimate the fully loaded unit labor costs for each labor category, and presents the results of the analysis.

Labor categories used in the analysis correspond to the U.S. Bureau of Labor Statistics (BLS) Standard 

Occupational Classification (SOC) system. In March 2004, BLS began using the North American 

Industry Classification System (NAICS) instead of the Standard Industrial Classification (SIC) System, 

and the Standard Occupational Classification (SOC) system instead of the Occupational Classification 

System (OCS). Exhibit C-1 summarizes the crosswalk between old and new occupational titles, and lists 

the SOC titles that correspond to the managerial, professional/technical, and clerical labor categories used 

in this analysis.

Exhibit C-1: Detail of Labor Categories Used in the Analysis

Labor Category Used in the Analysis BLS Old Title (OCS) BLS New Title (SOC)

Managerial Executive, administrative, and managerial Management, business, and financial

Professional/Technical Professional specialty and technical Professional and related

Clerical Administrative support, including clerical Office and administrative support

Source: BLS (2006, Table 2); Weinstein (2004).

C.1.1 Derivation of Unit Labor Rates for Managerial, Professional/Technical, and Clerical Industry 

Employees

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 2009 (BLS, 2010c, 

Table 2).22

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

from the same BLS report (BLS, 2010c). Fringe benefits as a percentage of wages are calculated 

separately for each labor category. For example, for December 2009, the average wage rate for 

professional/technical labor was $35.96, and the average fringe benefit was $17.42.23 Therefore, fringe 

benefits as a percentage of wages were $17.42/$35.96, or approximately 48 percent (see Exhibit 

C-2Exhibit C-2).

 

22 Past economic analyses used ECEC data series specific to white-collar workers in the manufacturing sector.

However, those data sets were discontinued in March 2007, and these historical data were the best alternative. In a 

phone conversation (February 11, 2009), a BLS employee could not identify a better data set to use.

23 Past economic analyses have used the term “technical” labor. Here the category is called “professional/technical” 

labor, to make clear how it relates to BLS categories. In 2004, BLS changed from the Occupational Classification 

System, OCS, to the Standard Occupational Classification system, SOC. In the process, the “Professional specialty 

and technical” category became the “Professional and related” category. However, the coverage of the old and new 

occupational groups is approximately the same. See the BLS article, “Comparing Current and Former Industry

and Occupation ECEC Series” (Weinstein, 2004).
C-2

An additional loading factor of 17 percent is applied to wages to account for overhead.24 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 

10, 2002 (Rice, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final 

Report, August 2002 (U.S. EPA, 2002). 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 2009 fully loaded wage for professional/technical labor is $35.96 × (1+ 0.484 + 0.17) = 

$59.49. 

Fully loaded costs for managerial and clerical labor are calculated in a similar manner, as shown in 

Exhibit C-2Exhibit C-2.

C.1.2 Derivation of Unit Labor Rates for EPA Staff

Unit labor rates for EPA staff are calculated based on annual federal salaries for the WashingtonBaltimore area published by the Office of Personnel Management (OPM) and effective January 2009 

(OPM, 2009). The average salary for one full-time equivalent (FTE) staff member is estimated as the 

salary for a GS-13 Step 1 employee, which is $86,927 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 $139,083.

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

Collection Requests (ICRs) (U.S. EPA, 1992b, 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 Office of 

Pollution Prevention and Toxics ICRs to reflect both fringe benefits and overhead for federal staff. For 

example, it was used in an August 2000 document supporting ICR No. 1139.06, 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.

 

24 The change was used in the 2003 PMN SNUR economic analysis (U.S. EPA, 2003). In some earlier reports, the 

17 percent had been applied to wages-plus-fringe benefits.
C-3

Exhibit C-2: Derivation of Loaded Wage Rates

Labor Category Data Source for Wage Information Date

Wage

Fringe 

Benefit

Fringes as % 

wage

Overhead as 

% wage1

Fringe + 

overhead 

factor Loaded Wages

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

Managerial BLS ECEC, Private Manufacturing industries,

“Management, business, and financial occupations”2

Dec-09 $42.36 $18.68 44.10% 17% 1.61 $68.24

Professional/

Technical

BLS ECEC, Private Manufacturing industries, 

“Professional and related occupations“2

Dec-09 $35.96 $17.42 48.44% 17% 1.65 $59.49

Clerical BLS ECEC, Private Manufacturing industries, “Office 

and administrative support occupations”2

Dec-09 $17.21 $8.17 47.47% 17% 1.64 $28.31

EPA staff FTE Annual federal staff cost: OPM Washington-BaltimoreNorthern Virginia, DC-MD-PA-VA-WV, area, GS-13 

Step 1 pay rates, with 60% overhead.3

Jan-09 $86,927

(annual)

-- [Included in 

60% 

overhead]

60% 1.60 $139,083

(annual)

$41.79

(hourly)

-- $66.87

(hourly)

Notes:

1An overhead rate of 17% was used based on assumptions in Rice (2002) and U.S. EPA (2002).

2 BLS (2010c, Supplemental Table 2).

3 The federal salary is the unloaded federal GS-13 Step 1 salary ($86,927 for 2009), from the OPM salary table for Washington-Baltimore-Northern Virginia (OPM, 2009). The 60% 

fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (U.S. EPA, 1992b, page 30, footnote 9).