3333

August 15, 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 Proposed High Production 

Volume Challenge Chemicals Test Rule - Fourth Group of Chemicals –

 (EPA DOCKET EPA-HQ-OPPT-2010-0520)

Proposal Version
1-1

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.
1-2

Contents

Chapter 1 – Introduction ............................................................................................................................1-6

1.1 Statutory Authority .......................................................................................................................1-6

1.2 Regulatory Background ................................................................................................................1-6

1.3 Statement of Need.........................................................................................................................1-7

1.4 Summary of Analytic Approach ...................................................................................................1-8

1.5 Organization of This Report .........................................................................................................1-9

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

2.1 Chemicals Subject to the Proposed Rule ......................................................................................2-1

2.2 The Regulated Community...........................................................................................................2-4

2.3 Chemical Production Information.................................................................................................2-5

2.4 Chemical-Specific Use and Market Information ..........................................................................2-6

Chapter 3 – Tests Required by the Proposed Rule.....................................................................................3-1

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

3.2 Types of Tests Required by EPA High Production Volume Test Rules.......................................3-1

3.3 Specific Test Requirements in the Proposed Rule ........................................................................3-5

Chapter 4 – Industry Compliance Costs ....................................................................................................4-1

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

4.2 Unit Costs .....................................................................................................................................4-1

4.3 Total Industry Compliance Costs................................................................................................4-12

4.4 Non-Monetized Costs.................................................................................................................4-12

Chapter 5 – Agency Costs..........................................................................................................................5-1

5.1 Introduction...................................................................................................................................5-1

5.2 EPA Costs.....................................................................................................................................5-1

Chapter 6 – Social Costs............................................................................................................................6-1

6.1 Total Social Costs.........................................................................................................................6-1

6.2 Annualized Costs..........................................................................................................................6-1

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

7.1 Identify the Affected Population...................................................................................................7-1

7.2 Select a Relevant Small Business Definition................................................................................7-3

7.3 Identify Small Businesses.............................................................................................................7-4

7.4 Calculate Each Company’s Share of Testing Costs......................................................................7-4

7.5 Cost-to-Sales Ratio .......................................................................................................................7-4

7.6 Companies without Sales Data .....................................................................................................7-5

7.7 Results...........................................................................................................................................7-5

Chapter 8 – Benefits...................................................................................................................................8-1

8.1 Use Values....................................................................................................................................8-1

8.2 Non-Use Values............................................................................................................................8-2

8.3 Benefits of the Required Tests......................................................................................................8-2

8.4 Benefits Related to Each Regulated Chemical ...........................................................................8-10

8.5 Potential Users of Information Generated by the Proposed Rule ...............................................8-21

Chapter 9 - Other Impact Analyses............................................................................................................9-1

9.1 Paperwork Reduction Act.............................................................................................................9-1

9.2 Unfunded Mandates Reform Act..................................................................................................9-3

9.3 Executive Order 13132 – Federalism............................................................................................9-4

9.4 Executive Order 13175 – Consultation and Coordination with Indian Tribal Governments........9-4

9.5 Executive Order 13045 - Children’s Health .................................................................................9-4

9.6 Executive Order 13211 – Energy Supply, Distribution, or Use....................................................9-4

9.7 National Technology Transfer and Advancement Act..................................................................9-5

9.8 Executive Order 12898 – Environmental Justice..........................................................................9-5
1-3

Chapter 10 – References..........................................................................................................................10-1

Appendix A Laboratory Test Cost Estimate ...........................................................................................A-1

Appendix B Wage Rate Calculations......................................................................................................B-1

Appendix C Costs...................................................................................................................................C-1
1-4

Exhibits

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

Exhibit 2-2: Distribution of Production Volumes for Chemicals Included in the Proposed Rule .............2-6

Exhibit 2-3: Chemical Use Information.....................................................................................................2-7

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 Proposed Rule.........................................3-6

Exhibit 4-1: EPA Estimates of Laboratory Costs of Proposed Tests (2009$)...........................................4-2

Exhibit 4-2: Total Laboratory Test Costs per Chemical ...........................................................................4-6

Exhibit 4-3: Costs for Analytical Methodology Validation, per Test Category ........................................4-8

Exhibit 4-4: Derivation of Loaded Hourly Rates by Labor Category........................................................4-9

Exhibit 4-5: Industry Reporting Cost and Burden Estimate for the Proposed Rule (2009$)...................4-10

Exhibit 4-6: Export Notification Cost Estimate for the Proposed Rule ...................................................4-12

Exhibit 4-7: Summary of Total Industry Compliance Costs Triggered by the Proposed Rule (2009$)..4-12

Exhibit 5-1: Estimated Government Costs for the Proposed Rule (2009$)...............................................5-1

Exhibit 6-1: Summary of Total Social Costs Triggered by the Proposed Rule (2009$)............................6-1

Exhibit 6-2: Annualized Costs Under Least and Average Cost Scenarios (Total for All Chemicals) 

($2009)..........................................................................................................................................6-2

Exhibit 7-1: Employee and Sales Information for Potentially Impacted Companies Included in the 

Analysis ........................................................................................................................................7-1

Exhibit 7-2: Distribution of Potentially Impacted Companies by Number of Employees.........................7-2

Exhibit 7-3: Distribution of Potentially Impacted Companies by Annual Sales........................................7-3

Exhibit 7-4: Summary Statistics for Company-Specific Cost-to-Sales Ratios for Small Companies .......7-5

Exhibit 9-1: Reporting Burden Estimate for the Proposed Rule................................................................9-1

Exhibit 9-2: Total Industry Burden Hour Estimate for the Proposed Rule................................................9-2

Exhibit 9-3: Estimated Government Burden for the Proposed Test Rule..................................................9-3

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

Exhibit B-2: Derivation of Loaded Wage Rates.......................................................................................B-3

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

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

Exhibit C-3: Annualized Social Costs ......................................................................................................C-5

Exhibit C-4: Annualized Industry Compliance Costs...............................................................................C-6
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Executive Summary

EPA is proposing a chemical test rule under section 4(a)(1)(B) of the Toxic Substances Control Act 

(TSCA) that would require manufacturers, importers, and processors1 of a group of 23 high production 

volume (HPV) chemical substances to conduct testing to obtain screening level data for health and 

environmental effects and chemical fate. This report provides the economic analysis for the proposed test 

rule. 

EPA seeks to investigate chemicals produced in substantial quantities to determine their effects on human 

health and the environment. HPV chemicals are those substances with a U.S. production or import 

volume exceeding one million pounds (lbs.) per year. If EPA determines that the manufacture of an HPV 

chemical may enter the environment in large quantities and/or impose a significant human exposure, the 

Agency can require producers of the chemical to conduct chemical testing to determine any of its 

environmental and health risks. Additionally, the Agency can require such chemical testing and data 

collection if the environmental hazard information of the HPV chemical is unknown or insufficient. The 

test rule would require companies whose chemicals meet these criteria to perform tests concerning 

environmental fate, aquatic toxicity, and mammalian toxicity. 

This report includes estimates of the costs and benefits of the proposed test rule. The costs to industry and 

government are estimated quantitatively, while the benefits of the rule are explained qualitatively. The 

total industry compliance costs triggered by the proposed rule are $5.73 million under least cost 

assumptions and $7.65 million under average cost assumptions. Costs to industry include laboratory 

testing costs, analytical method valuation costs, administrative costs, and export notification costs. The 

total government cost to EPA for the proposed rule is approximately $72,000, which considers the costs 

to review data collection materials and to administer the rule. The total estimated social costs of the 

proposed rule are the sum of industry and government costs, $5.80 million and $7.72 million for the leastand average-cost scenarios, respectively. The benefits of the testing requirement result from disclosure of 

chemical hazard information to the public, industry, and government. These benefits include improved 

information, reduced costs to risk-based decisions, lowered chemical exposures, and better outcomes of 

decisions. 

This report also includes several impact analyses concerning federal regulations and Executive Orders, as 

well as a separate designated chapter for a small entity impact analysis. The small entity impact analysis 

explains how small companies are identified and estimates the per-company cost incurred because of the 

proposed rule. EPA estimates that no companies will be impacted at greater than a one percent cost-tosales ratio.

 1 Processors of the subject chemicals are “persons not initially required to comply.” Therefore, while they would legally be 

subject to the proposed test rule, processors of a subject chemical would be required to comply with the requirements of the rule 

only if they are directed to do so by EPA in a future Federal Register notice.
1-6

Chapter 1 – Introduction

This report assesses the costs and benefits expected to result from EPA’s proposed High Production 

Volume (HPV) Chemical Testing rule, the fourth testing rule for a group of high production volume 

chemicals. The proposed rule would require manufacturers, importers, and processors of certain HPV 

chemical substances to conduct testing to obtain screening level data for health and environmental effects 

and chemical fate. This chapter provides background information on EPA’s statutory authority for 

requiring this testing, regulatory background, a discussion of the need for the regulation, a brief summary 

of the methodology used in the analysis, and a description of the organization of the remainder of this 

report.

1.1 Statutory Authority

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 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:

(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.

1.2 Regulatory Background

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 a test rule under 

TSCA Section 4, for 17 HPV chemicals that 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). The 

data obtained under the first test rule has provided information about the remaining 16 chemicals which 

will better enable the Agency to evaluate the potential risks of these substances and take any appropriate 

management actions regarding them. 
1-7

In 2008, EPA proposed a second HPV chemical test rule for an additional 19 chemicals (73 FR 43314, 

July 24, 2008), and in 2010, EPA proposed a third HPV chemical test rule for 29 more chemicals (75 FR 

8575, February 25, 2010). 

Now, EPA is proposing a fourth test rule for 23 HPV chemicals. Like the other HPV chemical test rules, 

this proposed 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) (see Chapter 3 for more information on specific test requirements).

1.3 Statement of Need

Executive Order 12866 requires the identification of the specific market failure that a significant rule 

addresses. The major causes of market failure identified in the Office of Management and Budget (OMB) 

guidance (OMB, 2003) on Executive Order 12866 are externality, natural monopoly, market power, and 

inadequate or asymmetric information. Fully functioning competitive markets result in a socially efficient 

allocation of resources 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. If such information is missing the market is 

unable to efficiently allocate goods and services resulting in market failure. The proposed test rule is 

designed to address the issue of inadequate information. In addition, to the extent that the information 

provided by the rule helps firms internalize social costs, the rule addresses the negative externalities that 

are generated from the manufacture/use of certain HPV chemicals.

1.3.1 Inadequate Inform ation

Economic theory notes that complete information among buyers and sellers is 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 
1-8

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. 

1.3.2 Extern alities

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, 

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

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

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

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

83,000 chemicals in commerce (U.S. EPA, 2008), 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 proposed 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.

1.4 Summary of Analytic Approach

This analysis seeks to quantify, to the extent possible, the costs to society of the proposed HPV chemical 

test rule by identifying the costs to industry associated with performing the required tests and the costs to 

EPA of administering the rule. Costs to industry include the costs incurred by the laboratory testing of the 

chemicals itself, as well as costs associated with validating the analytical method, administrative costs, 

and costs to comply with the export notification requirement that is triggered by the test rule. Agency 

costs include reviewing and processing the data received as a result of the rule. 

Data sources for this analysis include test costs estimated by laboratories and burden estimates derived 

from information collection requests for similar regulations. Because the specific tests required for each 

chemical may be different, costs are presented for each individual chemical and aggregated to show the 

cost of the rule as a whole. 

This report also presents a small entity impact analysis that assesses the effect of the proposed rule on 

small entities. The methodology includes identifying the chemical producers and then identifying small 

businesses (using an SBA-based and a TSCA-based definition) with parent-company data from Dun & 

Bradstreet. For each small entity, a ratio was calculated to compare the cost of the rule (the sum of the 
1-9

company’s share of costs for each regulated chemical it produces) with the company’s annual revenue. 

Impacts at or above 1 percent are evaluated further. 

Additionally, this report qualitatively discusses the benefits of the proposed action, based on the value of 

the information it will provide. The benefits analysis was undertaken to address the implicit call for costbenefit balancing contained in TSCA, as well as the requirements of Executive Order 12866. 

Quantification of the benefits of the proposed 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 proposed rule. These data are not readily available, and collecting

such data would be cost-prohibitive.

1.5 Organization of This Report

This report presents EPA’s economic analysis for this proposed rule. Regulated chemicals and companies 

are characterized in Chapter 2. Chapter 3 explains the tests that are required by this testing rule. Costs to 

industry, including laboratory, administrative, and export notification are reported in Chapter 4. Agency

costs are shown in Chapter 5. Total social costs (industry plus agency) are presented in Chapter 6. The 

small entity impact analysis for the proposed rule, as mandated by the Regulatory Flexibility Act (RFA), 

and amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), is presented in 

Chapter 7. Chapter 8 addresses the benefits of the proposed rule using a “value of information” 

framework. Several additional impact analyses are presented in Chapter 9 including an analysis of 

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

of environmental justice and children’s health pertaining to the requirements of Executive Order 12898; 

and Executive Order 13045, respectively, and a burden hour analysis, which responds to the requirements 

of the Paperwork Reduction Act (PRA). Cited references are listed in Chapter 10.

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 – Affected Entities

2.1 Chemicals Subject to the Propos ed Rule 

This chapter presents information about the production and use of the 23 HPV chemicals included in the 

proposed rule. To be included in this proposed rule, EPA has made preliminary findings for these 

chemical substances under TSCA section 4(a)(1)(B) that: 

• they are produced in substantial quantities; 

• there is or 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.

The criteria and standards used by EPA for evaluating whether there is substantial production, substantial 

release, and substantial or significant human exposure, as the terms are used in TSCA section 

4(a)(1)(B)(i), are explained in EPA’s Final Statement of Policy; Criteria for Evaluating Substantial 

Production, Substantial Release, and Substantial or Significant Human Exposure set forth at 58 FR 28736 

(May 14, 1993). Refer to EPA’s Exposure Findings Supporting Information for the proposed rule (U.S. 

EPA, 2010b) for more information.

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

Chemical Abstracts Service (CAS) to each of these 23 chemicals, the chemicals’ common names, and 

other synonyms used to research information presented in this analysis on the chemicals.2,3

 2 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. 3 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 Proposed High Production Volume Chemical Test Rule

CASRN CA Index Name Synonyms

1 56-40-6 Glycine

2-Aminoacetic acid; AI3-04085; Acetic acid, amino-; Aciport; Aminoacetic acid; Acide 

aminoacetique; Aciport; Aminoethanoic acid; CCRIS 5915; EINECS 200-272-2; FEMA 

No. 3287; Glicoamin; Glycocoll; Glycolixir; Glycosthene; HSDB 495; L-Glycine; 

Leimzucker; NSC 25936; Padil; NH2CH2COOH; Glycine U.S.P. XIX; Amitone; Glycine, 

non-medical; Hampshire glycine; Amino acid; Athenon; component of Corilin; G salt; 

Gly; Glycine-iron sulfate (1:1); Glycine, free base; Gyn-hydralin; Iconyl; Monazol; UNIITE7660XO1C

2 67-72-1 Ethane, 1,1,1,2,2,2- hexachloroAvlothane; Carbon hexachloride; Distokal; Distopan; Distopin; Egitol; Falkitol; Fasciolin; 

Hexachlorethane; Hexachloroethane; Hexachloroethylene; Mottenhexe; 

Perchloroethane; Phenohep; CCl3CCl3; Ethane hexachloride; Ethylene hexachloride; 

1,1,1,2,2,2- Hexachloroethane; Hexachlor-aethan; NCI-C04604; NA 9037; Rcra waste 

number U131; C2Cl6; 4-01-00-00148 (Beilstein Handbook Reference as cited by Milne, 

2005); AI3-00633; BRN 1740341; CCRIS; 330; Caswell No. 479; EINECS 200-666-4; 

EPA Pesticide Chemical Code 045201; Fron 110; HSDB 2033; NCI-C04604; NSC 

9224; RCRA waste number U131; UNII-G30K3QQT4J

3 78-00-2 Plumbane, tetraethylTetraethyllead; Plumbane, tetraethyl-; Lead tetraethyl; Tetraethylplumbane; TEL; 

(C2H5)4Pb; Czteroetylek olowiu; NCI-C54988; Tel-tml, reacted; 

Tetra(methylethyl)lead; NA 1649; Piombo tetra-etile; Tetraethylolovo; 

Tetraethylplumbium; UN 1649; 4-04-00-04349 (Beilstein Handbook Reference as 

cited by Milne, 2005); BRN 3903146; CCRIS 1565; EINECS 201-075-4; HSDB 

841; NSC 22314; RCRA waste number P110

4 95-14-7 1H-Benzotriazole

Azimidobenzene; Aziminobenzene; Benzene azimide; Benzisotriazole; Benzotriazole; 

Benztriazole; Cobratec 99; 1,2-Aminoazophenylene; 1,2,3-Benzotriazole; 1,2,3-Triaza1H-indene; 1,2,3-Triazaindene; 1H-1,2,3-Benzotriazole; 2,3-Diazaindole; Cobratec No. 

99; NCI-C03521; NSC-3058; U-6233; 1,2-Aminozophenylene; 1,2,3-Benztriazole; 2,3-

Diazaindole 1,2,3-riazaindene; ADK STAB LA-32; Benzotriazole1H-benzotriazole; 

Cobratec; Preventol Cl 8; 4-26-00-00093 (Beilstein Handbook Reference); AI3-15984; 

BRN 0112133; CCRIS 78; Cobratec #99; EINECS 202-394-1; HSDB 4143

5 118-48-9 2H-3,1-Benzoxazine2,4(1H)-dione

Isatoic anhydride; Isato acid anhydride; Anthranilic acid, N-carboxy-, cyclic 

anhydride; Benzoic acid, 2-(carboxyamino)-, cyclic anhydride; IA; 2H-3,1-

Benzoxazine-2,4(1H)-dione; 4-27-00-03330 (Beilstein Handbook Reference); AI3-

24983; BRN 0136786; EINECS 204-255-0; HSDB 5017; Isatoic anhydride; NCarboxyanthranilic anhydride; NSC 104662

6 128-44-9

1,2-Benzisothiazol-3(2H)-

one, 1,1-dioxide, sodium 

salt (1:1)

Saccharin sodium; 1,1-Dioxide-1,2-benzisothiazol-3(2H)-one, sodium salt; Saccharin 

sodium anhydrous; Artificial sweetening substanz gendorf 450; Benzoic acid sulfimide, 

sodium; CCRIS 706; Cristallose; Crystallose; Dagutan; EINECS 204-886-1; FEMA No. 

2997; Kristallose; Madhurin; NSC 4867; ODA; Saccharin sodium, anhydrous; 

Saccharin soluble; Saccharin, sodium; Saccharin, sodium salt; Saccharinnatrium; 

Saccharoidum natricum; Saxin; Sodium 1,2 benzisothiazolin-3-one 1,1-dioxide; Sodium 

o-benzosulfimide; Sodium saccharide; Sodium saccharin; Sodium saccharinate; 

Soluble gluside; Sucra; Sucromat; Sulphobenzoic imide, sodium salt; Sweeta; Sykose; 

UNII-I4807BK602; Willosetten; o-Sulfonbenzoic acid imide sodium salt

7 928-72-3

Glycine, N-

(carboxymethyl)-, sodium 

salt (1:2)

Acetic acid, iminodi-, disodium salt; Acetic acid, iminodi-, disoidum salt; Disodium 

iminodiacetate; Disodium iminodi(acetate); EINECS 213-181-8; Iminodiacetic acid 

sodium salt; Iminodiacetic acid, disodium salt; Iminodioctan disodny; Iminodioctan 

sodny; Glycine, N-(carboxymethyl)-, disodium salt; Glycine, N-(carboxymethyl)-, 

disodium salt, hydrate; Glycine, N-(carboxymethyl)-, sodium salt (1:2)

8 1809-19-4 Phosphonic acid, dibutyl 

ester

Dibutyl hydrogen phosphate; Dibutyl phosphite; di-n-Butylphosphite; Butyl alcohol, 

hydrogen phosphite; Butyl phosphonate ((BuO)2HPO); Di-n-butyl hydrogen 

phosphite; Dibutoxyphosphine oxide; Dibutyl hydrogen phosphonate; Dibutyl 

phosphonate; Phosphorous acid, dibutyl ester; Dibutylfosfit; Mobil DBHP; Syn-OAd P-316; 4-01-00-01525 (Beilstein Handbook Reference); BRN 1099706; 

EINECS 217-316-1; HSDB 2597; NSC 2668

9 25377-73-5 2,5-Furandione, 3-

(dodecen-1-yl)dihydroDodecenylsuccinic anhydride; 2-(Dodecyl)succinic anhydride; CCRIS 698; DDSA; 

Dodecenylsuccinic acid anhydride; Dodecenylsuccinic anhydride; EINECS 246-

917-1; HSDB 4374; K 12; K 12 (anhydride); Rikacid DDSA; Succinic anhydride, 

dodecenyl-; 2,5-Furandione, 3-(dodecen-1-yl)dihydro-; Dodecenylsuccinic 

anhydride; Succinic anhydride, dodecenyl-
2-3

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

CASRN CA Index Name Synonyms

10 26544-38-7 2,5-Furandione, dihydro3-(tetrapropenyl)-

AI3-28007; DSA; Dihydro-3-(tetrapropenyl)-2,5-furandione; EINECS 247-781-6;

RD 174; Tetrapropenylsuccinic anhydride; 2,5-Furandione, dihydro-3,3,4,4-tetra1-propenyl-; Dihydro-3-(tetrapropenyl)furan-2,5-dione; Succinic anhydride, 

(tetrapropenyl)-; Succinic anhydride, (tetrapropenyl)-

11 27859-58-1 Butanedioic acid, 2-

(tetrapropenyl)-

(Tetrapropenyl)butanedioic acid; EINECS 248-698-8; (Tetrapropenyl)succinic 

acid; Butanedioic acid, 2-(tetrapropenyl)-; Succinic acid, (tetrapropenyl)-

12 28777-98-2 2,5-Furandione, dihydro3-(octadecen-1-yl)-

Dihydro-3-(octadecenyl)-2,5-furandione; EINECS 249-210-6; Octadecenylsuccinic 

anhydride; 2,5-Furandione, dihydro-3-(octadecen-1-yl)-; Dihydro-3-

(octadecenyl)furan-2,5-dione; Succinic anhydride, octadecenyl- (6CI,7CI,8CI)

13 29385-43-1 1H-Benzotriazole, 6(or 

7)-methyl1H-Benzotriazole, 6(or 7)-methyl-; 1H-Benzotriazole, 4(5)-methyl-; CCRIS 4738; 

Cobratec TT 100; EINECS 249-596-6; Methyl-1H-benzotriazole; 

Methylbenzotriazole; Olin 53734; Preventol CI 7-100; Seetec T; Seetec TT; 

Stabinol MBTZ; Tolutriazole; Tolyl triazole; Tolyltriazole; 1H-Benzotriazole, 

methyl-; Methyl-1H-benzotriazole

14 32072-96-1 2,5-Furandione, 3-

(hexadecen-1-yl)dihydroHexadec-2-enylsuccinic anhydride; 2-Hexadecenyl succinic anhydride; nHexadecenylsuccinic anhydride; 3-[(2E)-2-Hexadecenyl]dihydro-2,5-furandione; 

EINECS 250-911-4; Succinic anhydride, hexadecenyl15 61789-73-9

Quaternary ammonium 

compounds, benzylbis 

(hydrogenated tallow alkyl) 

dimethyl, chlorides

EINECS 263-082-9; Quaternary ammonium compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, chlorides

16 64665-57-2 1H-Benzotriazole, 6(or 7)-

methyl-, sodium salt

EINECS 265-004-9; Tolyl triazole sodium salt; Tolyltriazole, sodium salt; 1HBenzotriazole, 6(or 7)-methyl-, sodium salt (1:1); Sodium 4(or 5)-methyl-1Hbenzotriazolide; 1H-Benzotriazole, 4(or 5)-methyl-, sodium salt; Methyl-1Hbenzotriazole, sodium salt

17 68131-13-5

Naphthenic acids, reaction 

products with 

diethylenetriamine

Diethylenetriamine naphthenate; Diethylenetriamine, naphthenic acid condensate; 

EINECS 268-610-1; Naphthenic acid, diethylenetriamine condensate; Naphthenic 

acids, diethylenetriamine condensate

18 68153-60-6

Fatty acids, tall-oil, 

reaction products with 

diethylenetriamine, 

acetates

Tall oil fatty acid, N-(2-aminoethyl)-1,2-ethanediamine reaction 

product, acetate salt; Tall oil fatty acids, reaction products with diethylenetriamine, 

acetic acid salt; EINECS 268-887-9

19 68424-85-1

Quaternary ammonium 

compounds, benzyl-C12-

16-alkyldimethyl, chlorides

Alkyl(C12-16)dimethylbenzylammonium chloride; Ammonium, alkyl(C12-

C16)dimethylbenzyl-, chlorides; BTC 835; Barquat MB 80; Benzyl-C12-C16-

alkyldimethyl ammonium chlorides; Bioquat 501; Bioquat 80; Black alg aetrine; C12-16-

Alkyldimethylbenzylammonium chloride; Catigene T80; Cyncal 80; EINECS 270-325-2; 

Gardiquat 1250AF; Hyamine 3500; Maquat MC 1412; Protek Q; Rolquat cdm/BC; TretO-lite WF 828; Tret-O-lite WF 88

20 68442-77-3

2-Butenediamide, (2E)-, 

N1,N4-bis[2-(4,5-dihydro2-nortall-oil alkyl-1Himidazol-1-yl)ethyl] derivs.

2-Butenedioic acid (E), diamide with 1-(2-aminoethyl)-2-(tall oil alkyl)-2-imidazoline; 2-

Butenediamide, (2E)-, N,N'-bis(2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl) 

derivs.; 2-Butenediamide, (E)-, N,N'-bis(2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-

yl)ethyl) derives.; EINECS 270-489-5

21 68607-28-3

Quaternary ammonium 

compounds, (oxydi-2,1-

ethanediyl)bis[coco 

alkyldimethyl, dichlorides

(Oxydi-2,1-ethanediyl)bis(coco alkyl)dimethyl ammonium dichlorides; Caswell No. 

627B; Dimethylcocoamine, bis(chloroethyl) ether, diquaternary ammonium salt; 

EINECS 271-761-6; EPA Pesticide Chemical Code 069173; Oxydiethylenebis(alkyl*-

dimethyl ammonium chloride) *(derived from coconut oil fatty acids); 

(Oxydiethyleneglycol)bis(coco alkyl)dimethyl ammonium chloride

22 68909-18-2

Pyridinium, 1-

(phenylmethyl)-, Et Me

derivs., chlorides

1-(Phenylmethyl)pyridinium Et Me derivs., chlorides; Alkyl pyridine, benzylchloride 

quaternized; Benzyl (C1-C2)-alkylpyridinium chloride; EINECS 272-695-0; EINECS 

273-252-4; Pyridinium, ethyl-1-(phenylmethyl)-, chloride, mixed with methyl-1-

(phenylmethyl)pyridinium chloride

23 69834-17-9 Benzene, decylphenoxy- (Decylphenoxy)benzene; Decylphenoxybenzene; EINECS 274-140-8 

Sources:

NIST, 2008, and U.S. NLM, 2009a
2-4

2.2 The Regulated Community

Entities potentially affected by the proposed test rule include those that manufacture (defined by statute to 

include import) or process any of the chemical substances that are included in the proposed rule. In 

addition, after the Agency issues a final rule, any person who exports, or intends to export, any of the 

chemical substances included in the final rule will be subject to the export notification requirements in 

TSCA section 12(b)(1) and at 40 CFR part 707, subpart D, if the chemicals are not already subject to a 

TSCA rule that triggers section 12(b). Potentially affected entities may include, but are not limited to:

• Manufacturers (defined by statute to include importers) of one or more of the 23 subject chemical 

substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum 

refineries. 

• Processors of one or more of the 23 subject chemical substances (NAICS codes 325 and 324110), 

e.g., chemical manufacturing and petroleum refineries.

The testing rule imposes a one-time requirement. However, companies that begin manufacturing a subject 

chemical within a five-year period after data from a required test is submitted to EPA may be subject to 

reimbursement for the costs of the testing (that is, companies that have already paid for the testing may 

seek to be reimbursed by companies that later begin to manufacture the chemical). EPA’s reimbursement 

procedures are found at 40 CFR part 791.

2.2.1 Chemical Manufacturers

EPA acquired chemical producer information for each of the 23 chemical substances from submissions 

required by the TSCA Inventory Update Reporting (IUR) Revisions rule (70 FR 75059, December 19, 

2005).

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.

4

Manufacturers were included in this analysis if they 

reported, through IUR, any production volume for any of 

the chemicals regulated under this proposed HPV 

Chemical test rule (U.S. EPA, 2009d). 

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

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

Based on IUR reporting, EPA identified 48 unique sites

that produce the 23 chemicals included in the proposed test 

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. Further, the data are from 2006 and may not be current. 

Therefore, EPA investigated other sources to obtain manufacturer information. 

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

cycle will cover calendar year 2010.

Note: IUR rule submissions can include both 

confidential business information (CBI) and 

non-confidential 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.
2-5

The Directory of World Chemical Producers is a database containing over 18,000 worldwide producers of 

more than 150,000 chemicals, used to search for producers of chemicals and bulk pharmaceuticals. EPA 

used the directory to identify any U.S. producers of the 23 chemicals subject to the proposed test rule that 

were not already identified based on IUR reporting. This resulted in an additional 23 sites producing one 

or more of the subject chemicals (DWCP, 2009). EPA believes these figures present a reasonable estimate 

for the purpose of analyzing the effects of the proposed rule. 

2.2.2 Chemical Proces s ors

According to the proposed rule, processors of the subject chemicals are assigned “Tier 2” status, meaning 

they are “persons not initially required to comply.” Therefore, while they would legally be subject to the 

proposed test rule, processors of a subject chemical would be required to comply with the requirements of 

the rule only if they are directed to do so by EPA in a future Federal Register notice. Because the 

proposed rule requires only that the required test results be obtained once for each chemical, EPA would 

only require processors to test if no manufacturer has submitted a notice of its intent to conduct testing, or 

if a problem occurs with the initiation, conduct, or completion of the required testing or the submission of 

the required data to EPA. 

Because EPA has identified at least one manufacturer for each subject chemical, the Agency assumes 

that, for each chemical substance in this proposed rule, at least one such person will submit a letter of 

intent to conduct the required testing and that person will conduct such testing and will submit the test 

data to EPA. Because processors would not need to comply with the proposed rule initially, this economic 

analysis does not address processors.

2.3 Chemical Production Information

Production volume data are used in Chapter 7 to estimate the share of compliance costs associated with 

each producer, in order to compare it with the company’s revenue. Production volume was acquired for 

each of the 23 chemical substances from submissions required by the TSCA IUR rule. Production volume 

for each of the additional manufacturers identified through the DWCP was not available. Because these 

manufacturers did not report through IUR requirements, EPA assumes that the production volume at these 

companies is less than the 25,000-lb reporting threshold, and conservatively (i.e., to provide an upper 

bound cost estimate for these companies) estimates a production volume of 24,999 pounds. 

The distribution of chemicals included in the proposed rule by the publicly available aggregated national 

production volume range (U.S. EPA, 2010a) is illustrated in Exhibit 2-2. As shown, approximately 83

percent of the chemicals included in the proposed rule are produced in volumes of 10 million pounds or 

less annually. 
2-6

Exhibit 2-2: Distribution of Production Volumes for Chemicals Included in the Proposed Rule 

(as reported through the 2006 IUR)

Source: Publicly available IUR data (U.S. EPA, 2010a)

2.4 Chemical-Specific Us e and Market Information

This section presents use information for each of the chemicals included in the proposed 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 21 of the 23 chemicals using various 

sources. Chemical use information is presented in Exhibit 2-3. Publicly available data reported to EPA 

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

0

2

4

6

8

10

12

14

16

18

20

1M to <10M 10M to <50M 50M to <100M 100M to <500M 500M to <1,000M

Production Volume (lbs)

Number of Chemicals
2-7

Exhibit 2-3: Chemical Use Information

Chemical

(CASRN) Uses IUR-Reported Use Information

1 Glycine 

(56-40-6)

• sweetener and flavor enhancer in food, beverage, 

pharmaceutical, and animal feed products

• buffering agent in certain products and manufacturing 

processes including organic, pharmaceutical synthesis

• antacids, parenteral nutrition

• biochemical research

• cosmetics, personal care products

• dietary supplement

• metal finishing

(U.S. ITC, 2007; U.S. NLM, 2009b; U.S. HHS, 2009)

• Industrial Sectors: All Other 

Chemical Product and Preparation 

Manufacturing; cattle ranching and 

farming, including feedlots

• Commercial/Consumer Product 

Category: Other

2 Ethane, 1,1,1,2,2,2-

hexachloro- 

(67-72-1)

• lubricating greases and oils

• nonstructural caulking compounds and sealants

• laundry aids, including ironing aids and dry cleaning

• pyrotechnics 

• fire extinguishing fluids, flameproofing

• polymer additive

• plasticizer for cellulose esters

• insecticide and moth repellant

• anthelmintic drug

• rubber process solvent

• camphor substitute in nitrocellulose solvent

• retardant in fermentation process

• metallurgy for refining aluminum alloys, removing 

impurities from molten metals, recovering metal from 

ores or smelting products

• degassing agent for magnesium

• production of synthetic diamonds

(Scorecard, 2009a; U.S. NLM, 2009b)

• None reported

3 Plumbane, tetraethyl- 

(78-00-2)

• antiknock additive in leaded gasoline

• engine lubricant

(U.S. NLM, 2009b)

• Industrial Sector: Petroleum 

Refineries

• Commercial/Consumer Product 

Category: Lubricants, greases and 

fuel additives

4 1H-Benzotriazole 

(95-14-7)

• corrosion inhibitor in auto radiator fluids, metalworking 

fluids, water-cooling systems; for copper, brass, and 

bronze; anticorrosive in art restoration

• polishing preparations and related products; tarnish 

prevention and remover, dishwashing detergents

• rug and upholstery cleaners

• protective coating in construction industry

• antifreeze, cleaners, packaging materials

• restrainer, developer, and antifogging agent in 

photographic emulsions

• component of military aircraft deicing fluids

• antimicrobial in cosmetics

• chemical intermediate for dyes, pharmaceuticals, and 

fungicides

(Scorecard, 2009b; U.S. NLM, 2009b; Milne, 2005) 

• Industrial Sector: Other Apparel 

Knitting Mills

• Commercial/Consumer Product 

Category: Lubricants, greases, and 

fuel additives; Metal products; Other
2-8

Exhibit 2-3: Chemical Use Information

Chemical

(CASRN) Uses IUR-Reported Use Information

5 2H-3,1-Benzoxazine-2,4(1H)-

dione 

(118-48-9)

• chemical intermediate for pesticides, saccharin, flavors, 

fragrances, polyurethane diamine curing agents, 

pigments, dyes, intumescent agents, antioxidants, 

optical brighteners, anthranilate esters, anthranilic acid 

and amides, viscosity stabilizers, photographic 

chemicals, epoxy curing agents

• corrosion inhibitor in engine lubricants

• modifier of natural and synthetic polymers and resins

• blowing agent for foamed plastics

(U.S. NLM, 2009b; PMC Specialties Group, Inc., 2009a)

• Industry Sector: Other Basic 

Organic Chemical Manufacturing; 

Pesticide and Other Agricultural 

Chemical Manufacturing

• Commercial/Consumer Product 

Category: Agricultural products 

(non-pesticidal)

6 1,2-Benzisothiazol-3(2H)-one, 

1,1-dioxide, sodium salt (1:1) 

(128-44-9)

• non-caloric sweetener

• personal care products, such as cologne, toothpaste

• chemical intermediate for pharmaceuticals, agricultural 

chemicals

• metal coatings

(Scorecard, 2009c, U.S. HHS, 2009; IARC, 1999; PMC

Specialties Group, Inc., 2009b; Attarzadeh et al., 2008)

• Industrial Sectors: Animal Food 

Manufacturing; Coating, Engraving, 

Heat Treating, and Allied Activities; 

Flavoring Syrup and Concentrate 

Manufacturing; Pharmaceutical and 

Medicine Manufacturing; Tobacco

Product Manufacturing; Toilet 

Preparation Manufacturing; Other 

Basic Organic Chemical 

Manufacturing

• Commercial/Consumer Product 

Category: Other

7 Glycine, N-(carboxymethyl)-, 

sodium salt (1:2) 

(928-72-3)

• used to produce glyphosphate which is used in

pesticide production

(China Chemical Reporter, 2010)

• Industrial Sector: Pesticide and 

Other Agricultural Chemical 

Manufacturing

• Commercial/Consumer Product 

Category: None reported

8 Phosphonic acid, dibutyl ester 

(1809-19-4)

• antioxidant

• intermediates in the formation of extreme pressure 

antiwear and friction modifier additives and lubricating 

oils and greases

• amine salts in mineral and synthetic base stocks

(U.S. NLM, 2009b; Milne, 2005)

• Industry Sector: Other Basic 

Organic Chemical Manufacturing

• Commercial/Consumer Product 

Category: Reported as CBI

9 2,5-Furandione, 3-(dodecen-1-

yl)dihydro- 

(25377-73-5)

• curing agent in epoxy resins systems, including for 

electron microscopy 

• intermediate for the preparation of imides in lubricating 

oils; fuel/grease additive

(Dixie Chemical Company, 2007; Electron Microscopy 

Sciences, 2007)

• Industrial Sector: Petrochemical 

Manufacturing

• Commercial/Consumer Product 

Category: Other

10 2,5-Furandione, dihydro-3-

(tetrapropenyl)- 

(26544-38-7)

• corrosion inhibitor

• viscosity improver in lubricants

• gelling agent in greases

• epoxy resin curing agent

• alkyd resin modifier

• brake fluids

• surfactant

• chemical intermediate for esters, amides, imides, etc.

(Trigon Chemie GmbH, 2006)

• Industrial Sectors: Other Basic 

Organic Chemical Manufacturing; 

All Other Chemical Product and 

Preparation Manufacturing; 

Synthetic Dye and Pigment 

Manufacturing

• Commercial/Consumer Product

Category: Lubricants, greases and 

fuel additives; Paints and coatings.

11 Butanedioic acid, 2-

(tetrapropenyl)- 

(27859-58-1)

• fuel additive

• rust inhibitor

(EPO, 1998; U.S. PTO, 1995)

• Industrial Sector: All Other 

Chemical Product and Preparation 

Manufacturing

• Commercial/Consumer Product 

Category: Lubricants, greases and 

fuel additives
2-9

Exhibit 2-3: Chemical Use Information

Chemical

(CASRN) Uses IUR-Reported Use Information

12 2,5-Furandione, dihydro-3-

(octadecen-1-yl)-

(28777-98-2)

• antifreeze lubricant

• engine oil lubricant additive

• viscosity and pour-point improver

• epoxy

• intermediate in alkaline paper sizing

• copy paper

• gypsum board sheets

• water treatment

• corrosion inhibitor

• surfactant intermediate

• moisture control for leather goods

(Dixie Chemical Company, 2005a; Albemarle, 2005a)

• Industry Sectors: Paper Mills; All 

Other Chemical Product and 

Preparation Manufacturing; 

Petrochemical Manufacturing

• Commercial/Consumer Product 

Category: Paper products

13 1H-Benzotriazole, 6(or 7)-

methyl- 

(29385-43-1)

• corrosion inhibitors in auto radiator fluids, metalworking 

fluids, lubricants, antifreeze, paints, petroleum fuels, 

industrial water cooling, plating baths

• corrosion inhibitor for copper, brass, bronze, ferrous 

metals

• gasoline antiknock additive

• biocide

• chelating agent

• stabilizer for polyurethane prepolymers

• antioxidant

• styrene polymerization catalyst

• intermediate for dyes, agricultural chemicals, ultraviolet 

light absorbers and pharmaceuticals

(Scorecard, 2009d; PMC Specialties Group, Inc., 2009c)

• Industry Sectors: Other Apparel 

Knitting Mills; Other Petroleum and 

Coal Products Manufacturing

• Commercial/Consumer Product 

Category: Lubricants, greases and 

fuel additives

14 2,5-Furandione, 3-

(hexadecen-1-yl)dihydro-

(32072-96-1)

• antifreeze lubricant

• engine oil lubricant additive

• viscosity and pour-point improver

• epoxy

• intermediate in alkaline paper sizing

• copy paper

• gypsum board sheets

• water treatment

• corrosion inhibitor

• surfactant intermediate

• moisture control for leather goods

(Dixie Chemical Company, 2005b; Albemarle, 2005b) 

• Industry Sectors: Paper Mills; 

Petrochemical manufacturing

• Commercial/Consumer Product 

Category: Paper products

15 Quaternary ammonium 

compounds, benzylbis 

(hydrogenated tallow alkyl) 

dimethyl, chlorides 

(61789-73-9)

• inert ingredient in nonfood use pesticide products

• antistatic 

• hair conditioning

• surfactant

(U.S. EPA, 2009b, EU Commission, 2009)

• Industry Sector: Other Nonmetallic 

Mineral Mining and Quarrying

• Commercial/Consumer Product 

Category: None reported

16 1H-Benzotriazole, 6(or 7)-

methyl-, sodium salt 

(64665-57-2)

• cooling water treatment

• automotive radiator treatment fluid, engine coolant

• corrosion inhibitor

• metalworking coolant

• antifreeze

• aircraft de-icing fluids

(Berryman Products, Inc., 2001; Coolant Control, Inc., 

2007; Penray Cmpanies, Inc., 1991; Drew Chemical, 

1987; Pitt Penn Oil Company, 1997; 4-Tek Industries, 

Inc., 1991)

• Industry Sector: Invalid data

provided

• Commercial/Consumer Product 

Category: Other
2-10

Exhibit 2-3: Chemical Use Information

Chemical

(CASRN) Uses IUR-Reported Use Information

17 Naphthenic acids, reaction 

products with 

diethylenetriamine 

(68131-13-5) 

• corrosion inhibitor and anti-foulant in refinery systems 

and petrochemical industry

(U.S PTO, 1985; U.S. PTO, 1989; U.S. PTO, 1992)

• Industry Sector: None reported

• Commercial/Consumer Product 

Category: None reported

18 Fatty acids, tall-oil, reaction 

products with 

diethylenetriamine, acetates 

(68153-60-6)

• food fortification

• intermediate to corrosion inhibitors 

• surface-active polymers used to control and stabilize 

dispersion

(Berry, 2010; Kurzin, 2009; Fischer and Parker, 1997)

• Industry Sector: Oil and Gas 

Extraction; Other Basic Organic 

Chemical Manufacturing

• Commercial/Consumer Product 

Category: None reported

19 Quaternary ammonium 

compounds, benzyl-C12-16-

alkyldimethyl, chlorides 

(68424-85-1)

• microbiocide, disinfectant, sanitizer

(Scorecard, 2009e; U.S. HHS, 2009)

• Industry Sector: Other Basic 

Organic Chemical Manufacturing

• Commercial/Consumer Product 

Category: Other

20 2-Butenediamide, (2E)-, 

N1,N4-bis[2-(4,5-dihydro-2-

nortall-oil alkyl-1H-imidazol-1-

yl)ethyl] derivs.

(68442-77-3)

• no use information found • Industry Sector: Reported as CBI

• Commercial/Consumer Product 

Category: None reported

21 Quaternary ammonium 

compounds, (oxydi-2,1-

ethanediyl)bis[coco 

alkyldimethyl, dichlorides 

(68607-28-3)

• microbiocide

• corrosion inhibitor

(PAN, 2009; Baker Petrolite, 2009)

• Industry Sectors: Other Basic 

Organic Chemical Manufacturing

• Commercial/Consumer Product 

Category: Other

22 Pyridinium, 1-(phenylmethyl)-, 

Et Me derivs., chlorides 

(68909-18-2)

• water soluble and/or oil dispersible corrosion inhibitors 

for oil field and other water treating systems

(Lonza, 2009)

• Industry Sectors: Oil and Gas 

Extraction; Other Basic Organic 

Chemical Manufacturing

• Commercial/Consumer Product 

Category: Other

23 Benzene, decylphenoxy- 

(69834-17-9)

• no use information found • Industry Sector: All Other 

Chemical Product and Preparation 

Manufacturing

• Commercial/Consumer Product 

Category: Soaps and detergents
3-1

Chapter 3 – Tests Required by the Proposed Rule

3.1 Introduction

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

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

Development (OECD), can assist EPA and others with making an informed preliminary judgment about 

the hazards of HPV chemicals. EPA intends to make the information collected under the final rule 

available to the public, other Federal agencies, and any other interested parties on its website and in the 

public docket for the final rule. As appropriate, this information will be used to help ensure a 

scientifically sound basis for risk assessment/management actions. This effort will serve to further the 

Agency’s goal of identifying and controlling human and environmental risks as well as providing greater 

protection and knowledge to the public.

3.2 Types of Tes ts Required by EP A High Production Volume Tes t Rules

The testing required under EPA’s proposed rule follows the SIDS model. The OECD HPV SIDS Program 

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 proposed 

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 Program 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. 

Under the proposed test rule, EPA would require that the American Society for Testing and Materials 

(ASTM) or the TSCA test guidelines at 40 CFR part 799 (§799 guidelines) be used because the language 

in the §799 guidelines makes clear which steps are mandatory and which steps are only recommended. 

EPA’s §799 guidelines have been harmonized with the OECD guidelines. Most of the proposed testing 

requirements for a particular endpoint are specified in one test standard. In the case of certain endpoints, 

however, any of multiple listed methods can be used.

By using the same approach to testing as that of the OECD HPV SIDS Program, EPA is assuring that the 

data developed under this proposed rulemaking activity and the voluntary HPV Challenge Program will 

be comparable to the data being developed in other countries, thereby enabling an international sharing of 

data and the prevention of unnecessary and duplicative testing.

Exhibit 3-1 provides a description of the tests that may be required for chemicals under the proposed rule.
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)

CATEGORY A: PHYSICAL/CHEMICAL PROPERTIES

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 airstable chemicals to water.

A5

CATEGORY B: ENVIRONMENTAL FATE AND PATHWAYS

Ready Biodegradation

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

CATEGORY C: AQUATIC TOXICITY

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. 

C1

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 
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)

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. 

CATEGORY D: MAMMALIAN TOXICITY – ACUTE

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
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)

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.

CATEGORY E: MAMMALIAN TOXICITY – GENOTOXICITY

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 

marrow), in vivo

§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, 
3-5

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)

particularly with regard to erythrocyte production.

CATEGORY F: MAMMALIAN TOXICITY – REPEATED DOSE/REPRODUCTION/DEVELOPMENTAL

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. 

F

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 postmating. 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 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. 

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 pre-mating, 

during the mating period, and approximately 2 weeks postmating. 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 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. 

1 Aquatic Toxicity requirements include test codes C1, C2, C3, C4, C5, C6, and C7. These tests groups include various combinations of the 

four protocols listed in this table under the general test code “C”, depending on specific data needs. For more information, see Appendix A.

3.3 Specific Tes t Requirements in the Propos ed Rule

To determine which tests would be required for each chemical under the proposed rule, EPA examined 

available test data (U.S. EPA, 2010b). 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 proposed rule are summarized in Exhibit 3-2.
3-6

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

CASRN Chemical Name Required Tests

(See Test Codes in Exhibit 3-1)

1 56-40-6 Glycine A3

2 67-72-1 Ethane, 1,1,1,2,2,2-hexachloro- C6

3 78-00-2 Plumbane, tetraethyl- A4, A5, C6, E2

4 95-14-7 1H-Benzotriazole A3, C6, F4

5 118-48-9 2H-3,1-Benzoxazine-2,4(1H)-dione A3, A4, A5, C3, E1, E2, F1 

6 128-44-9 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, 

sodium salt (1:1) A2, A3, A4, A5, C1, F1

7 928-72-3 Glycine, N-(carboxymethyl)-, sodium salt (1:2) A1, A3, A4, A5, B

8 1809-19-4 Phosphonic acid, dibutyl ester A1, A4, C1, E1, E2, F1

9 25377-73-5 2,5-Furandione, 3-(dodecen-1-yl)dihydro- A1, A2, A3, A4, A5, B, C1, D, E2, 

F1 

10 26544-38-7 2,5-Furandione, dihydro-3-(tetrapropenyl)- A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 

11 27859-58-1 Butanedioic acid, 2-(tetrapropenyl)- A1, A2, A3, A4, A5, C1, D, E1, E2, 

F1 

12 28777-98-2 2,5-Furandione, dihydro-3-(octadecen-1-yl)- A2, A3, A4, A5, C1, D, E1, E2, F1 

13 29385-43-1 1H-Benzotriazole, 6(or 7)-methyl- A3, A4, A5, E2, F1

14 32072-96-1 2,5-Furandione, 3-(hexadecen-1-yl)dihydro- A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1

15

61789-73-9 Quaternary ammonium compounds, 

benzylbis(hydrogenated tallow alkyl)methyl, 

chlorides

A3

16 64665-57-2 1H-Benzotriazole, 6(or 7)-methyl-, sodium salt A1, A3, A4, A5, E1, E2, F1

17 68131-13-5 Naphthenic acids, reaction products with 

diethylenetriamine C1, D, E1, E2, F1

18 68153-60-6 Fatty acids, tall-oil, reaction products with 

diethylenetriamine, acetates

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

E2, F1

19 68424-85-1 Quaternary ammonium compounds, benzylC12-16-alkyldimethyl, chlorides A1, A2, A3

20

68442-77-3 2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-

dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] 

derivs.

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

E2, F1

21 68607-28-3 Quaternary ammonium compounds, (oxydi-2,1-

ethanediyl)bis[coco alkyldimethyl, dichlorides A1, A2, A3, A4, A5

22 68909-18-2 Pyridinium, 1-(phenylmethyl)-, Et Me derivs., 

chlorides

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

F1

23 69834-17-9 Benzene, decylphenoxy- A1, A2, A3, A4, A5, B, C1, D, E1, 

E2, F1 
4-1

Chapter 4 – Industry Compliance Costs

4.1 Introduction

This chapter presents estimates of the costs that industry (chemical manufacturers and importers) affected 

by the proposed rule) may incur due to the requirements included in the proposed rule, and discusses the 

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

(discussed in Section 4.2.1), analytical methodology validation (Section 4.2.2), administrative activities 

(Section 4.2.3), and export notification requirements (Section 4.2.4). Total industry compliance costs are 

summarized in Section 4.3. Non-monetized costs are described in Section 4.4. 

4.2 Unit Cos ts

The following sections describe, on a per-unit basis, each of the types of costs that would be incurred by 

industry to comply with the proposed testing rule.

4.2.1 Laboratory Tes ting Cos ts

Individual Test Cost Estimates

EPA obtained test cost estimates by contacting nine or fewer laboratories known to perform each test and 

requesting pricing information, or, when such direct estimates were not available, by obtaining a best 

professional estimation from industry experts. Although the rule requires that testing be conducted in 

accordance with the specified mandatory and enforceable requirements in the ASTM or §799 guidelines 

(see Section 3.2), the cost estimates used in this analysis may also be based on OECD or other EPA 

protocols, which are representative of the desired testing endpoint (as summarized in Exhibit 4-1 and

discussed in more detail in Appendix A). 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 

proposed 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 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. As described in 

Appendix A, 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. 
4-2

Exhibit 4-1 presents the protocols required by the rule, the basis for the cost estimate, and final cost 

estimates used in the analysis.

Exhibit 4-1: EPA Estimates of Laboratory Costs of Proposed Tests (2009$)

Testing 

Category Test Code Protocol Name Required Protocol Number(s)

Basis for 

Cost 

Estimate

Cost 

Estimate

2009$1

Physical/Chemic

al Properties

A1 Melting Point ASTM E 324-99

OECD 102

(Least & 

Average 

Cost 

Scenarios)

$1,000

A2 Boiling Point ASTM E 1719-05

OECD 103

(Least & 

Average 

Cost 

Scenarios)

$2,000

A3 Vapor Pressure ASTM E 1782-03

OECD 104

(Least & 

Average 

Cost 

Scenarios)

$17,000

A4

Partition Coefficient

Method A: §799.6755 OECD 107 $7,000

Method B: ASTM E 1147-92(2005) OECD 117 $5,000

Method C: §799.6756 §830.7560 $7,000

Least Cost Scenario (Method B) $5,000

Average Cost Scenario (Average of All Methods) $6,000

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)

$10,000

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 (two-phase closed bottle 

test)

OECD 

301A-F

(Least & 

Average 

Cost 

Scenarios)

$6,000

Aquatic Toxicity C1

(Test 

Group 

1)

Acute Toxicity to 

Fish ASTM E 729-96(2002) OECD 203 $12,000

Acute Toxicity to 

Daphnia ASTM E 729-96(2002) OECD 202 

(Part 1) $6,000

Acute Toxicity to 

Plants ASTM E 1218-04e1 OECD 201 $10,000

Test Group 1 Sum $28,000

(Test 

Group 

2)

Chronic Toxicity to 

Daphnia ASTM E 1193-97(2004) OECD 202 $130,000

Acute Toxicity to 

Plants ASTM E 1218-04e1 OECD 201 $10,000

Test Group 2 Sum $140,000

Least Cost Scenario (Test Group 1 Sum) $28,000
4-3

Exhibit 4-1: EPA Estimates of Laboratory Costs of Proposed Tests (2009$)

Testing 

Category Test Code Protocol Name Required Protocol Number(s)

Basis for 

Cost 

Estimate

Cost 

Estimate

2009$1

Average Cost Scenario (Average of Test Group 1 and 2 Sums) $84,000

C2

(Test 

Group 

1)

Acute Toxicity to 

Daphnia ASTM E 729-96(2002) OECD 202 

(Part 1) $6,000

Acute Toxicity to 

Plants ASTM E 1218-04e1 OECD 201 $10,000

Test Group 1 Sum $16,000

(Test 

Group 

2)

Chronic Toxicity to 

Daphnia ASTM E 1193-97(2004) OECD 202 $130,000

Acute Toxicity to 

Plants ASTM E 1218-04e1 OECD 201 $10,000

Test Group 2 Sum 140,000

Least Cost Scenario (Test Group 1 Sum) $16,000

Average Cost Scenario (Average of Test Group 1 and 2 Sums) $78,000

C3

(Test 

Group 1)

Acute Toxicity to 

Fish ASTM E 729-96(2002) OECD 203 $12,000

Acute Toxicity to 

Plants ASTM E 1218-04e1 OECD 201 $10,000

Test Group 1 Sum $22,000

(Test 

Group 2)

Chronic Toxicity to 

Daphnia ASTM E 1193-97(2004) OECD 202 $130,000

Acute Toxicity to 

Plants ASTM E 1218-04e1 OECD 201 $10,000

Test Group 2 Sum $140,000

Least Cost Scenario (Test Group 1 Sum) $22,000

Average Cost Scenario (Average of Test Group 1 and 2 Sums) $81.000

C4

(Test 

Group 1)

Acute Toxicity to 

Fish ASTM E 729-96(2002) OECD 203 $12,000

Acute Toxicity to 

Daphnia ASTM E 729-96(2002) OECD 202 

(Part 1) $6,000

Test Group 1 Sum $18,000

(Test 

Group 2)

Chronic Toxicity to 

Daphnia ASTM E 1193-97(2002) OECD 202 $130,000

Least Cost Scenario (Test Group 1 Sum) $18,000

Average Cost Scenario (Average of Test Group 1 and 2 Sums) $74,000

C5

(Test 

Group 1)

Acute Toxicity to 

Daphnia ASTM E 729-96(2002) OECD 202 

(Part 1) $6,000

(Test 

Group 2)

Chronic Toxicity to 

Daphnia ASTM E 1193-97(2004) OECD 202 $130,000

Least Cost Scenario (Test Group 1) $6,000

Average Cost Scenario (Average of Test Group 1 and 2) $68,000

C6 Acute Toxicity to 

Plants ASTM E 1218-04e1

OECD 201 

(Least & 

Average 

Cost 

Scenarios)

$10,000

C7

(Test 

Group 

1)

Acute Toxicity to 

Fish ASTM E 729-96(2002) OECD 203 $12,000

(Test 

Group 

2)

Chronic Toxicity to 

Daphnia ASTM E 1193-97(2004) OECD 202 $130,000

Least Cost Scenario (Test Group 1) $12,000

Average Cost Scenario (Average of Test Group 1 and 2) $71,000
4-4

Exhibit 4-1: EPA Estimates of Laboratory Costs of Proposed Tests (2009$)

Testing 

Category Test Code Protocol Name Required Protocol Number(s)

Basis for 

Cost 

Estimate

Cost 

Estimate

2009$1

Mammalian 

Toxicity - Acute D

(Method 

A)

Acute Inhalation 

Toxicity 799.913 OECD 403 $27,000

(Method 

B)

Acute Oral Toxicity ASTM E 1163-98(2002) or 

§799.9110(d)(1)(i)(A) OECD 423 $4,000

BALB/c 3T3 Neutral 

Red Uptake 

Cytotoxicity; or

N/A N/A $4,000

BHK Neutral Red 

Uptake Cytotoxicity N/A N/A $5,000

Least Cost Scenario (OECD 423 + least expensive cytotoxicity test) $8,000

Average Cost Scenario (Average of Method A and Least Cost Scenario) $17,000

Mammalian 

Toxicity –

Genotoxicity

E1 Bacterial Reverse 

Mutation §799.9510

OECD 471 

(Least & 

Average 

Cost 

Scenarios)

$5,000

E2

Chromosome 

Aberration, in vitro; 

or

§799.9537 OECD 473 $28,000

In Vivo Mammalian 

Cytogenetics Tests: 

Bone Marrow 

Chromosomal 

Analysis; or

§799.9538 N/A $33,000

Erythrocyte 

Micronucleus (bone 

marrow), in vivo

§799.9539 OECD 474 $23,000

Least Cost Scenario (OECD 474) $23,000

Average Cost Scenario (Average of E2 Methods) $28,000

Mammalian 

Toxicity –

Repeated Dose/

Reproduction/ 

Developmental

F1

(Method 

A)

Repeated Dose Oral 

Toxicity; and, §799.9305 OECD 407 $85,000

Repro/Devel 

Toxicity Screening; 

or,

§799.9355 OECD 421 $129,000

Method A Sum $214,000

(Method 

B)

Combined Repeated 

Dose with 

Repro/Devel Toxicity 

Screen

§799.9365 OECD 422 $135,000

Least Cost Scenario (Method B) $135,000

Average Cost Scenario (Average of Method A Sum and Method B) $175,000

F2 Repro/Devel Toxicity 

Screening §799.9355

OECD 421 

(Least & 

Average 

Cost 

Scenarios)

$129,000

F3 Repeated Dose Oral 

Toxicity §799.9305

OECD 407

(Least & 

Average 

Cost 

Scenarios) 

$85,000

F4 Repro/Devel Toxicity 

Screening; or, §799.9355 OECD 421 $129,000
4-5

Exhibit 4-1: EPA Estimates of Laboratory Costs of Proposed Tests (2009$)

Testing 

Category Test Code Protocol Name Required Protocol Number(s)

Basis for 

Cost 

Estimate

Cost 

Estimate

2009$1

Combined Repeated 

Dose with 

Repro/Devel Toxicity 

Screen

§799.9365 OECD 422 $135,000

Least Cost Scenario (Repro/Devel Toxicity Screening) $129,000

Average Cost Scenario (Average of Methods) $132,000

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, 2010b), U.S. Department of Labor, to convert all test cost estimates to 2009$. 

Note: Values may not sum due to rounding.

Total Test Costs per Chemical 

The proposed rule requires only that the required test results be obtained once for each chemical; each 

entity is not required to do the tests separately. Typically, manufacturers form a consortium 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 proposed 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 the 

chemicals, and then the total cost per chemical was summed across all chemicals included in the proposed 

rule. Exhibit 4-2 shows the laboratory test costs associated with each chemical under the proposed rule.
4-6

Exhibit 4-2: Total Laboratory Test Costs per Chemical

CASRN Chemical Name

Laboratory Testing Cost

(Test Requirements as listed in Exhibit 3-2)

Least Cost Scenario Average Cost 

Scenario

1 56-40-6 Glycine $17,000 $17,000

2 67-72-1 Ethane, 1,1,1,2,2,2-hexachloro- $10,000 $10,000

3 78-00-2 Plumbane, tetraethyl- $47,000 $54,000 

4 95-14-7 1H-Benzotriazole $156,000 $159,000

5 118-48-9 2H-3,1-Benzoxazine-2,4(1H)-dione $216,000 $321,000

6 128-44-9 1,2-Benzisothiazol-3(2H)-one, 1,1-

dioxide, sodium salt (1:1): $196,000 $293,000

7 928-72-3 Glycine, N-(carboxymethyl)-, sodium salt 

(1:2) $39,000 $40,000

8 1809-19-4 Phosphonic acid, dibutyl ester $197,000 $299,000

9 25377-73-5 2,5-Furandione, 3-(dodecen-1-

yl)dihydro- $234,000 $346,000

10 26544-38-7 2,5-Furandione, dihydro-3-

(tetrapropenyl)- $239,000 $351,000

11 27859-58-1 Butanedioic acid, 2-(tetrapropenyl)- $233,000 $345,000

12 28777-98-2 2,5-Furandione, dihydro-3-(octadecen-1-

yl)- $231,000 $343,000

13 29385-43-1 1H-Benzotriazole, 6(or 7)-methyl- $189,000 $236,000

14 32072-96-1 2,5-Furandione, 3-(hexadecen-1-

yl)dihydro- $239,000 $351,000

15 61789-73-9

Quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, chlorides

$17,000 $17,000

16 64665-57-2 1H-Benzotriazole, 6(or 7)-methyl-, 

sodium salt $196,000 $242,000

17 68131-13-5 Naphthenic acids, reaction products with 

diethylenetriamine $198,000 $309,000

18 68153-60-6 Fatty acids, tall-oil, reaction products 

with diethylenetriamine, acetates $239,000 $351,000

19 68424-85-1 Quaternary ammonium compounds, 

benzyl-C12-16-alkyldimethyl, chlorides $20,000 $20,000

20 68442-77-3

2-Butenediamide, (2E)-, N1,N4-bis[2-

(4,5-dihydro-2-nortall-oil alkyl-1Himidazol-1-yl)ethyl] derivs.$239,000 $351,000

21 68607-28-3

Quaternary ammonium compounds, 

(oxydi-2,1-ethanediyl)bis[coco 

alkyldimethyl, dichlorides

$34,000 $36,000

22 68909-18-2 Pyridinium, 1-(phenylmethyl)-, Et Me 

derivs., chlorides $233,000 $345,000

23 69834-17-9 Benzene, decylphenoxy- $239,000 $351,000

TOTAL $3,654,000 $5,182,000 

AVERAGE $159,000 $225,000 

Note: Values may not sum due to rounding.

As shown in Exhibit 4-2, the total laboratory cost for testing the chemicals included in the proposed rule 

is estimated to range from approximately $3.65 million under the least cost scenario to approximately 
4-7

$5.18 million under the average cost scenario. 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 can be performed by batch, making the per-chemical cost lower). 

Dividing these totals by the 23 chemicals in the proposed rule yields an average laboratory test cost per 

chemical of approximately $159,000 under the least cost scenario and approximately $225,000 under the 

average cost scenario.

4.2.2 An alytical Methodology Validation Cos ts

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

concentrations are used in toxicity studies. Analytical methodology validation costs are passed on to the 

company requesting the test, and are therefore part of the total industry cost. 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 methodology 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 that

through the use of specific laboratory investigations, 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 methodology 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 validation 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). In this analysis, the cost of 

analytical methodology validation is counted only once per testing category (i.e., not per test), for each 
4-8

chemical. For example, if the rule requires both tests E1 and E2 (multiple tests in the same testing 

category) for a specific chemical, the analytical methodology validation cost for test category E is only 

counted once, not twice, in determining the total cost of the rule for that chemical. 

For this proposed 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 4-3. 

Exhibit 4-3: Costs for Analytical Methodology Validation, per Test Category

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

4.2.3 Ad minis trative Cos ts

In addition to laboratory costs, chemical manufacturers/importers subject to the proposed 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, final reports, 

robust summaries, and exemption applications.

Letters of Intent and Study Plans. The analysis assumes that one letter of intent and one study plan will be 

submitted per chemical, resulting in 23 letters of intent and study plans submitted to EPA. 

Final Reports. One final report is assumed to be required for each test conducted for each chemical.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 153 final reports that will be submitted to EPA in 

response to this rule. 
4-9

Robust Summaries. Respondents are also required 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. 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. The 

number of robust summaries will be the same as the number of final reports, 153. 

Exemption Applications. As noted above, the proposed 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 consortium to coordinate any testing required by TSCA Section 4. Therefore, 

following the methodology outlined in the Economic Assessment for the Proposed ATSDR Test Rule for 

Four Chemicals (U.S. EPA, 2006), we assume that one member of the consortium will submit the 

materials described above, and the others will submit exemption applications. Based on this assumption 

and the number of identified manufacturers for each chemical, EPA assumes that it will receive a total of 

88 exemption requests.

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. These unit labor hours were derived 

from previous information collection requests and are believed to reflect the burdens that will be incurred 

for the proposed test rule (U.S. EPA, 2002a). Based on best 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.

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 4-4. 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” (U.S. EPA, 2002a). 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 B provides detailed 

information on the estimation of these wage rates.

Exhibit 4-4: 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 1.61 $68.24 

Technical $35.96 1.65 $59.49 

Clerical $17.21 1.64 $28.31 

Source: Methodology from “Wage Rates for Economic Analyses of the Toxics Release Inventory 

Program” (U.S. EPA, 2002b). Wage rates and benefits extracted from the Employer Costs for 

Employee Compensation Summary, Bureau of Labor Statistics (BLS, 2010a); assumed overhead rate 

of 17% applied to wage rates based on assumptions in U.S. EPA, 2002b and U.S. EPA 2002a.

Exhibit 4-5 details the respondents’ reporting cost and burden estimates. As shown, the total reporting 

cost and burden estimates are approximately $747,000 and 14,000 hours, respectively.
4-10

Exhibit 4-5: Industry Reporting Cost and Burden Estimate for the Proposed Rule (2009$)

Reporting Activity

Unit Labor Annual Items 

Submitted

Total

Category1 Hours/ 

Item

Wage 

Rate

Cost/ 

Item Hours Cost

Letter of Intent and 

Study Plan T 40 $59.49 $2,000 23 920 $55,000

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

$2,000

$357

$409

$566

$28

153

153

153

153

153

6,000

918

918

3,000

153

$364,000

$55,000

$63,000

$87,000

$4,000

Robust Summaries T 12 $59.49 $714 153 2,000 $109,000

Exemption Applications T 2 $59.49 $119 88 176 $10,000

TOTAL 14,000 $747,000 1

Labor categories are as follows: T = Technical; M = Managerial; C = Clerical.

Note: Values may not sum due to rounding.

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 (U.S. EPA, 2007). 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 $3.65 million under the least cost scenario and 

$5.18 million under the average cost scenario, non-reporting costs are approximately $914,000 and $1.30

million under the least and average cost scenarios, respectively.

Total Administrative Costs. As stated previously, total administrative costs pursuant to the proposed 

rule are estimated as the sum of reporting and non-reporting costs. Thus, total administrative costs are 

estimated to be $1.66 million under the least cost scenario and $2.04 million under the average cost 

scenario.

4.2.4 Export Notification Cos ts

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 proposed rule must notify EPA about each country to which a chemical included in 

the proposed 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. Note that if any of the chemicals subject to this test rule are 

already subject to a TSCA regulation that triggers section 12(b), these costs will not be incurred again. 

Therefore, to the extent that any of the chemicals are already subject to section 12(b), the costs in this 

analysis are overestimated. 
4-11

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 proposed rule and the identity and/or number of 

countries to which each chemical included in the proposed 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 proposed 

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 proposed rule.

Given these data limitations, the costs of export notifications for the proposed 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 

proposed rule.

In an economic analysis for a final rule promulgated under TSCA Section 12(b), (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 (U.S. EPA, 1999). While it 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 proposed 

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 4-4). This translates into a low-end labor cost 

estimate of $14.16 per notice and a high-end labor cost estimate of $73.65 per notice. In addition, industry 

incurs approximately $13.34 per notice 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 $27.50 per notice to $86.99 per notice. For the least cost scenario, the analysis 

uses the 0.5 hour labor burden and $27.50 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 high-end notification cost, which is $57.24. 

Assuming that 25 notifications will be submitted for each of the 23 chemicals regulated under the 

proposed rule, it is estimated that a total of 575 notifications will be submitted in response to the proposed 

rule. Thus, the total cost of export notifications triggered by the proposed rule is approximately $16,000 

under the least cost scenario and $33,000 under the average cost scenario. These estimates are 

summarized in Exhibit 4-6.
4-12

Exhibit 4-6: Export Notification Cost Estimate for the Proposed Rule

Compliance Cost 

Category

Cost (2009$)

Category Hours 

(min.)

Hours 

(max.)

Wage 

Rage

Least 

Cost 

Scenario

Highest 

Cost 

Scenario

Average 

Cost 

Scenario

Write Export Notification 

Letter T 0 1 $59.49 $0.00 $59.49 $29.75 

Copy or Print and Send 

Export Notification 

Letter

C 0.5 0.5 $28.31 $14.16 $14.16 $14.16 

Total Labor Cost per Letter $14.16 $73.65 $43.90 

Shipping Costs per 

Letter Fixed NA $13.34 $13.34 $13.34 

Total Cost per Letter (Labor and Shipping) $27.50 $86.99 $57.24 

Total Cost for 575 Notifications $16,000 $50,000 $33,000

Note: Values may not sum due to rounding.

4.3 Total Indus try Compliance Cos ts

The total compliance costs borne by the regulated industry are summarized in Exhibit 4-7. The total 

industry compliance costs triggered by the proposed rule are estimated to equal $5.73 million under the 

least cost assumption and $7.65 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 4-7: Summary of Total Industry Compliance Costs Triggered by the 

Proposed Rule (2009$)

Compliance Cost Category

Cost ($ million)

Least Cost 

Scenario

Average Cost 

Scenario

Laboratory costs (Section 4.2.1) $3.65 $5.18

Analytical methodology validation costs (Section 4.2.2) $0.39 $0.39

Administrative costs (Section 4.2.3) $1.66 $2.04

Export notification costs (Section 4.2.4) $0.02 $0.03 

Total industry compliance costs $5.73 $7.65

Average compliance cost per chemical $0.25 $0.33

Note: Values may not sum due to rounding.

4.4 Non-Monetized Cos ts

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, 2010c).

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 
4-13

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 increasing 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.
5-1

Chapter 5 – Agency Costs

5.1 Introduction

EPA will also incur costs resulting from the proposed 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.

5.2 EPA Cos ts

EPA assumes that, on average, a Federal GS-13, Step 1, full-time equivalent (FTE)5 will conduct its 

collection procedures under the proposed rule. The annual 2009 fully loaded salary for a GS-13, Step 1, 

FTE is $139,083. This includes a base salary of $86,927 plus 60 percent for overhead and benefits (i.e., 

$52,146).6

Exhibit 5-1

Dividing the fully loaded annual salary by 2,080 (i.e., the number of hours in a work year) 

yields an hourly wage rate of $66.87 for the FTE. provides a detailed description of these 

calculations. 

As explained earlier in Section 4.2.3, approximately 23 letters of intent and study plans, 153 final reports, 

153 robust summaries, and 88 exemption applications are estimated to be filed in response to the 

proposed rule. Based on EPA’s experience and best professional judgment, 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. Exhibit 5-1 presents the 

estimated total government costs based on these assumptions. As shown, the total government costs for 

the proposed rule are estimated to be approximately $72,000.

Exhibit 5-1: Estimated Government Costs for the Proposed Rule (2009$)

Item Unit Labor Total Items Total Cost Hours Rate Cost/Item

Letter of Intent and Study Plans 3 $66.87 $200.60 23 $5,000

Final Reports 5 $66.87 $334.33 153 $51,000

Robust Summaries 1 $66.87 $66.87 153 $10,000

Exemption Applications 1 $66.87 $66.87 88 $6,000

Total $72,000

Note: Values may not sum due to rounding 

 5 A full-time equivalent (FTE) is equivalent to 2,080 hours per year. 6 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, 2010). The 60 percent fringes-andoverhead rate is from an EPA/OPPE guide (U.S. EPA, 1992b). 
6-1

Chapter 6 – Social Costs

6.1 Total Social Cos ts

The estimated total social costs of the proposed rule are estimated as the sum of industry and EPA costs 

(Exhibit 6-1). The total social costs under the least and average cost scenarios are $5.73 million and 

$7.65 million, respectively. The average (mean) social cost per chemical is approximately $252,000 under 

the least cost scenario and $336,000 under the average cost scenario. 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.

Exhibit 6-1: Summary of Total Social Costs Triggered by the Proposed Rule (2009$)

Cost Category

Cost ($ million)

Least Cost 

Scenario

Average Cost 

Scenario

Total industry compliance costs (unadjusted)a $5.73 $7.65

Total government costs (unadjusted) $0.07 $0.07 

Total social costs triggered by the proposed rule (unadjusted) $5.80 $7.72

Average social cost per chemical $0.25 $0.34 a Total industry compliance costs include laboratory, analytical methodology validation, administration, and export 

notification costs.

Note: Values may not sum due to rounding

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. 

6.2 Annualized Cos ts

Costs associated with this test rule 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 three years. 

A three 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. 

The standard formula for annualizing a lump sum cost is given by:

A = I Χ [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).
6-2

The initial lump sum costs to comply with the proposed rule under the least and average cost scenarios are 

presented in Exhibit 6-2.

As shown, total annualized social costs under the least cost scenario range from $2.05 to $2.21 million 

using a 3 percent and a 7 percent discount rate, respectively. Total annualized social costs under the 

average cost scenario range from $2.73 to $2.94 million using a 3 percent and a 7 percent discount rate, 

respectively.

Exhibit 6-2: Annualized Costs Under Least and Average Cost Scenarios 

(Total for All Chemicals) ($2009)

Category

Cost ($ million) 1

Least Cost Scenario Average Cost Scenario

3% Discount 

Rate

7% Discount 

Rate

3% Discount 

Rate

7% Discount 

Rate

Annualized Industry Compliance Costs $2.02 $2.18 $2.71 $2.92

Annualized Government Costs $0.03 $0.03 $0.03 $0.03

TOTAL ANNUALIZED SOCIAL COSTS $2.05 $2.21 $2.73 $2.94 1 All costs were annualized over a 3-year time horizon.
7-1

Chapter 7 – Small Entity Impact Analysis

This chapter assesses the impact of the proposed 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 proposed 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.

7.1 Identify the Affected Population

For each of the 71 manufacturer/importer sites for 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, 2010).7

This search identified 59 affected global ultimate parent companies as defined by their global DUNS 

number or the highest parent level found in other sources. Employee data could be found for 57 of the 

global ultimate parent companies, and revenue data could be found for 52 of the global ultimate 

companies. Exhibit 7-1 provides summary statistics of the available data for the companies for which 

either type of data was available. As shown in Exhibit 7-1, potentially impacted companies vary widely as 

measured by both number of employees and annual sales.

 Where employment and 

sales data was not available from Dun & Bradstreet, EPA used other available online sources, such as 

company websites or business resource websites (e.g., Manta.com) to obtain estimates.

Exhibit 7-1: Employee and Sales Information for Potentially Impacted 

Companies Included in the Analysis

Statistical Measure Number of 

Employees Annual Sales

Minimum Value 1 $410,000

Maximum Value 92,000 $239,272,000,000

Median Value 750 $256,790,000

Mean Value 9,000 $8,824,531,000

Standard Deviation 18,000 $33,948,284,000

Source: Dun & Bradstreet, 2010; Manta, 2010.

Note: Employee and annual sales data were available for 57 and 52 of the 59 global ultimate parent 

companies identified.

Note: Values may not sum due to rounding. 

Exhibit 7-2 and Exhibit 7-3 show the distribution of potentially impacted companies considered in the 

analysis by number of employees and annual sales, respectively.

 7 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 2010.
7-2

Exhibit 7-2: Distribution of Potentially Impacted Companies by Number of Employees

0

5

10

15

20

25

0 to 100 101 to 500 501 to 1,000 1,001 to

5,000

5,001 to

10,000

10,000 to

50,000

> 50,000

Number of Employees

Number of Companies
7-3

Exhibit 7-3: Distribution of Potentially Impacted Companies by Annual Sales

7.2 Select a Relevant Small Bus ines s Definition

The RFA relies on the definition of “small business” found in the Small Business Act, which authorizes 

the Small Business Administration to develop definitions for “small business” based upon a sales or 

employment level. The Small Business Administration provides a table of size standards in the Small 

Business Size Regulations, 13 CFR 121.201. These definitions for small business are provided for the sixdigit NAICS codes, based on employment thresholds or annual sales volume (U.S. SBA, 2008). 

Throughout the remainder of this report, this definition is referred to as the “SBA definition.” EPA used 

the table provided in U.S. SBA 2008 to identify the size standards for the NAICS codes corresponding 

with each global parent ultimate company identified in section 7.1. Company NAICS codes were obtained 

from Dun & Bradstreet (2010), or, when not available from this source, from entries in EPA’s Facility 

Registry System (U.S. EPA, 2010d). SBA size standards range from 100 employees to 1,000 employees, 

or $4,500,000 to $7,000,000 in revenue (U.S. SBA, 2008).

For this analysis, EPA also considered an alternative definition based upon the TSCA definition for the 

sensitivity analysis. Under this definition, a manufacturer or importer is defined as small, as 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

0

5

10

15

20

25

30

$0 to $100 $101 to

$500

$501 to

$1,000

$1,001 to

$5,000

$5,000 to

$10,000

$10,000 to

$50,000

>$50,000

Revenue (millions of dollars)

Number of Companies
7-4

(2) Total annual sales of the company, combined with those of any parent company, are below 

$4 million.

7.3 Identify Small Bus ines s es

Parent company sales data, collected as explained above, were used to identify companies that qualified 

for “small business” status, per both the SBA-based and the TSCA-based definitions specified above. 

Based on the SBA criteria, 25 companies (42.4 percent) were identified as small. Furthermore, 17 

companies (28.8 percent) were identified as small according to the TSCA definition.

7.4 Calculate Each Company’s Share of Tes ting Cos ts

As explained in Chapter 4, 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. For this small entity analysis, the costs were annualized over a 15-year time 

horizon using a 3 percent discount rate. The total annualized compliance costs for all 23 chemicals were 

approximately $480,000 under the least cost scenario and approximately $641,000 under the average cost 

scenario.8

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. Therefore, using volumes reported under IUR (supplemented with assumptions for companies 

identified using DWCP, as described in Chapter 2), EPA calculated the fraction of the total 

production/importation volume for each chemical that each company is responsible for. This fraction was 

then multiplied by the total annualized testing costs for the chemical to obtain each company’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. Because production volumes are considered CBI, detailed results of this analysis are not 

reported here.

7.5 Cost-to-Sales Ratio

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 7-4 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 7-4 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 22 companies which had sales data 

available and qualified for small business status per the SBA criteria, none had a cost-to-sales ratio 

greater than 1 percent under the least or average cost scenarios. Of the 17 companies that qualified for 

 8 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.
7-5

small business status per the TSCA criteria, no company had a cost-to-sales ratio of greater than 1 percent 

under the least or average cost scenarios.

Exhibit 7-4: Summary Statistics for Company-Specific Cost-to-Sales Ratios for Small Companies

Statistical Measure

SBA Definition1 TSCA Definition2

Least Cost 

Scenario

Average Cost 

Scenario

Least Cost 

Scenario

Average Cost 

Scenario

Total Number of Identified Companies 59 59 59 59

Total Number of Identified Small Companies 25 25 17 17

Number of Small Companies with Sales Data 22 22 17 17

Number Impacted at >1 percent 0 0 0 0

Number Impacted at >3 percent 0 0 0 0

Minimum Cost-to-Sales Ratio 0.00001% 0.00001% 0.00001% 0.00001%

Maximum Cost-to-Sales Ratio 0.14% 0.20% 0.062% 0.089%

Mean Cost-to-Sales Ratio 0.017 0.023% 0.0087% 0.010%

Median Cost-to-Sales Ratio 0.0011% 0.0011% 0.00064% 0.00075%

Standard Deviation 0.0004 0.0005 0.0002 0.0002

Notes:

Compliance costs are annualized over a 15-year time horizon using a 3 percent discount rate. 1

Companies meeting SBA’s NAICS-specific size thresholds (based on either employee number or revenue) are considered small under 

this definition.

2

Companies 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.

7.6 Companies without Sales Data

Data on sales are missing for seven of the companies; three of these companies were identified as small 

based on SBA employment data. 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 companies with revenue data is $5

million (using the SBA employment-based definitions of small business as described in Section 7.3). If 

this figure represented the sales for the companies without sales data, no companies would have a cost-tosales ratio would be between 1 and 3 percent under the least-cost scenario, and none would have a costto-sales ratio between 1 and 3 percent under the average-cost scenario.

Another way to examine the impact on companies where revenue data is not available is to calculate what 

the revenue would need to be in order for testing cost impacts to be near or exceed 1 percent of sales. At 

the worst case, one of the companies would need to have a revenue of less than approximately $3million. 

This is approximately one tenth of the average revenue ($28.3 million) for the small businesses where 

sales data is known.

7.7 Res ults

EPA estimates that the small entities that are potentially directly regulated by the proposed rule include 

small for-profit businesses; no nonprofit organizations or governments are expected to be affected by this 

proposed rule. EPA estimates that there are 25 small entities that would be affected by this proposed rule 

under the SBA-based definition, and 17 small entities that would be affected under the TSCA-based 

definition. Of these, EPA estimates that there is no small business for which the cost impact of the testing 

exceeds 1 percent of the company’s revenue.
8-1

Chapter 8 – Benefits

The proposed rule targets 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 proposed 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 proposed rule qualitatively. The non-use values are only discussed briefly. Due to the 

scientific nature of the information that would result from the proposed rule, non-use benefits are not 

likely to comprise a large percentage of the total benefits.

This chapter discusses the use benefits of the HPV chemical test rule qualitatively. Quantification of the 

benefits of the proposed 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 proposed rule. These data are not readily available; to collect such data would be costprohibitive. 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.

8.1 Us e Values

The proposed 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).

It is important to note that both of these types of benefits are dependent upon the information being usable 

by the intended audience. That is, the raw data may need to be processed and disseminated before certain 

potential users, such as workers and the general public, can use it to make decisions. There are additional 

costs and timeframes involved in the activities required to synthesize the information into documents that 

are easily accessible to the public (worker safety procedures, etc.), such that the benefits of this rule may 

not be realized immediately and are further difficult to isolate.

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. 
8-2

Furthermore, the exact nature and scope of the benefits resulting from this proposed 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.

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 proposed 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 proposed rule 

increases the efficiency (and strength) of the decision-making process. 

8.2 Non-Us e Values

The value that society places on the information resulting from this proposed rule may go beyond what 

people experience through the use of the data. Specifically, members of society may experience a “nonuse” 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.

8.3 Benefits of the Required Tes ts

Taken together, the tests required under the proposed 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 SIDS program of the 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 proposed 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.
8-3

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 help assess how hazardous 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 

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 proposed rule 

and the test’s role as a screening-level indicator (the benefits associated with each individual test). Section 

8.4 lists the tests required for each chemical.

8.3.1 Ph ys ical/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). Once the information becomes available to them 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 

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 
8-4

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).

• 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 end-
8-5

use 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 

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 to what materials the chemical tends to adsorb. Waste storage is also affected, since facilities 

typically store miscible substances together. Additionally, the test can 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 chemical’s 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 
8-6

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.

8.3.2 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 

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 for tests for biodegradation. The appropriate 

method is determined by the test substance’s physical and chemical properties, including its water 

solubility. ISO 10634 provides guidance on selecting 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. 

8.3.3 Aq uatic 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 a 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 
8-7

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 a 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 

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. 

8.3.4 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.
8-8

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.

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).

8.3.5 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 
8-9

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 

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.

8.3.6 Mammalian Toxicity - Repeated Dos e/Rep roduction/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 
8-10

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 

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 a chemical will impact the offspring of the individual’s 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.

8.4 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 proposed 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 
8-11

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 proposed 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 proposed 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 exposure findings

for each of these chemicals (U.S. EPA, 2009a), which indicate why society may benefit when screeninglevel hazard and risk information is known. The total benefit of this proposed 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 Section 2.3 of this report. Any known information 

about exposure volume is included with the description of the findings. For each chemical, a chart shows 

which specific tests are required by this proposed rule. Tests are only required where the resulting data are 

not otherwise available for the chemical. 

8.4.1 Glycine (CASRN 56-40-6)

The total number of potentially exposed workers is likely to exceed 1,000 based on reported IUR data for 

this chemical (U.S. EPA, 2010b). The primary IUR commercial/consumer product category “Other” 

(chemicals contained in commercial and consumer products not elsewhere classified) was reported for 

this chemical. The National Library of Medicine database indicates that this chemical is used as an 

ingredient in sweeteners and flavor enhancers, antacids, dietary supplements, as well as approximately 25 

cosmetics/personal care products (U.S. ITC, 2007; U.S. NLM, 2009b; U.S. HHS, 2009; U.S. EPA, 

2010b). Additionally, this chemical exists in an unknown number of commercial and consumer products 

that may potentially have a high number of exposures. Based on this information, EPA believes this 

chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 

2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed 

to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic 

information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Glycine 

(CASRN 56-40-6)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel



Note: Specific benefits related to these tests are described in Section 8.3.

8.4.2 Ethane, 1,1,1,2,2,2-hexachloro- (CASRN 67-72-1)

The total number of potentially exposed workers is likely to exceed 1,000 based on reported IUR data for 

this chemical (U.S. EPA, 2010b). No IUR consumer/commercial category was reported for this chemical. 

Its uses include lubricating greases and oils, nonstructural caulking compounds and sealants, 

pyrotechnics, plasticizers for cellulose esters, insecticides and moth repellant, and rubber process solvents 

(Scorecard, 2009b; U.S. NLM, 2009b). EPA believes this chemical would meet the designation criteria of 

“substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant 

number of workers, consumers or others who are exposed to the chemical would benefit from the 

decisions made (e.g. policies, regulations) when hazard and toxic information is known.
8-12

Tests Required under the Proposed HPV Chemical Test Rule for Ethane, hexachloro- 

(CASRN 67-72-1)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel



Note: Specific benefits related to these tests are described in Section 8.3.

8.4.3 Plumbane, tetraeth yl- (CASRN 78-00-2)

The IUR commercial/consumer product category “Lubricants, greases, and fuel additives” was reported 

for this chemical. Specific uses include engine lubricants, antiknock additives in leaded gasoline and 

cleaners for combustion devices (U.S. NLM, 2009b). The total number of potential workers and 

consumers exposed to this chemical could exceed 10,000; therefore, EPA believes this chemical would 

meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010a). 

Therefore, a substantial or significant number of workers, consumers or others who are exposed to the 

chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic 

information is known. 

Tests Required under the Proposed HPV Chemical Test Rule for Plumbane, tetraethyl-

(CASRN 78-00-2)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

   

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.4 1H-Benzotriazole (CASRN 95-14-7)

Three IUR commercial/consumer products categories were reported for this chemical (U.S. EPA, 2010b). 

The “Lubricants, greases and fuel additives” category includes substances added to gasoline, kerosene, 

and distillate fuel oil after refining. The “Metal products” category includes chemical in metals and 

metallic substances. The “Other” category includes commercial and consumer products not elsewhere 

specified. The NLM database identified this chemical as an ingredient in inside-the-home products, such 

as antimicrobials in cosmetics, rug and upholstery cleaners, chemical intermediates for dyes and 

pharmaceuticals, dishwasher detergents, and corrosion inhibitors in auto radiator fluids and water-cooling 

systems (Scorecard, 2009b; U.S. NLM, 2009b; Milne, 2005). The total number of potentially exposed 

workers exceeds 1,000 workers based on NOES data and the number of consumers exposed exceeds 

10,000 based on IUR data (U.S. EPA, 2010b). Additionally, the production volume of the chemical 

increased between 1986 and 2006 IUR data collection periods (U.S. EPA, 2010b). Based on this 

information, EPA believes this chemical would meet the designation criteria of “substantial or significant 

human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, 

consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. 

policies, regulations) when hazard and toxic information is known.
8-13

Tests Required under the Proposed HPV Chemical Test Rule for 1H-Benzotriazole 

(CASRN 95-14-7)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

  

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.5 2H-3,1-Benzoxazine -2,4(1H)-dione (CASRN 118-48-9)

The IUR commercial/consumer product categories “Agricultural products (non-pesticidal)” and “Other” 

were reported for this chemical. Some uses of this chemical within the agricultural category include: 

chemical intermediates for pesticides, fragrances, polyurethane diamine curing agents, pigments, dyes, 

fertilizers and soil conditioners (U.S. NLM, 2009b; PMC Specialties Group, Inc., 2009a). The “Other” 

categorization indicates that the chemical may be used in an unknown number of additional products in 

other sectors, thus possibly raising the amount of chemical release or exposure. It is expected that 

exposure of this chemical could reach more than 10,000 consumers. Based on this information, EPA 

believes this chemical would meet the designation criteria of “substantial or significant human exposure” 

(U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who 

are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when 

hazard and toxic information is known. 

Tests Required under the Proposed HPV Chemical Test Rule for 2H-3,1-Benzoxazine-2,4(1H)-dione 

(CASRN 118-48-9)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

     

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.6 1,2-Benzis othiazol-3(2H)-one, 1,1-dioxide, s odium s alt (1:1) (CASRN 128-44-9)

The NLM database identified approximately 132 personal care products that include this chemical as an 

ingredient (U.S. EPA, 2010b). The products include cologne, toothpaste, chemical intermediates for 

pharmaceuticals, and metal coatings (Scorecard, 2009c; U.S. HHS, 2009; IARC, 1999; PMC Specialties 

Group, Inc., 2009b; Attarzadeh et al., 2008). The IUR commercial/consumer product category “Other” 

was reported for this chemical, indicating that this chemical is present in an unknown number of other 

products that may potentially have a high number of exposures. Based on this information, EPA believes 

this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. 

EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who are 

exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard 

and toxic information is known.
8-14

Tests Required under the Proposed HPV Chemical Test Rule for 1,2-Benzisothiazol-3(2H)-one, 1,1-

dioxide, sodium salt (CASRN 128-44-9)

Melting

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

     

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.7 Glycine, N-(carboxymeth yl)-, s odium s alt (1:2) (CASRN 928-72-3)

The total number of potentially exposed workers is likely to exceed 1,000 based on reported IUR data for

this chemical (U.S. EPA, 2010b). No IUR consumer/commercial category was reported for this chemical. 

The chemical is used to produce glyphosphosphate, a herbicide uses to control weeds (China Chemical 

Reporter, 2010). Because of its consumer and commercial use, EPA believes this chemical meets the 

criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or 

significant number of workers, consumers or others who are exposed to the chemical would benefit from 

the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Glycine, N-(carboxymethyl)-, sodium 

salt (1:2) (CASRN 928-72-3)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

    

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.8 Phos phonic acid, dibutyl es ter (CASRN 1809-19-4)

The IUR commercial/consumer product categories were claimed as confidential business information 

(CBI) for this chemical (U.S. EPA, 2010a). Products containing the chemical include antioxidants, 

intermediates in the formation of extreme pressure anti-wear, friction modifier additives and lubricating 

oils and greases (U.S. NLM, 2009b; Milne, 2005). They may be used by more than 10,000 consumers. Its 

IUR production volume in 2006 falls in the 1 to 10 million pounds range. Based on this information, EPA 

believes this chemical would meet the designation criteria of “substantial or significant human exposure” 

(U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who 

are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when 

hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Phosphonic acid, dibutyl ester (CASRN 

1809-19-4)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

    

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.9 2,5-Furandione, 3-(dodecen-1-yl)dih ydro- (CASRN 25377-73-5)

The total number of potentially exposed workers exceeds 1,000 based on NOES data (U.S. EPA, 2010b) 

for this chemical. The main IUR commercial/consumer product category was “Other” (chemicals 
8-15

contained in commercial and consumer products not elsewhere classified). This condition indicates this 

chemical may exist in an unknown number of products that may cause potentially high exposures to 

consumers and workers. Other sources explain the additional uses for this chemical, including curing 

agents in epoxy resins systems, intermediates for the preparation of plasticizers and thermoplastics and 

paints, detergent raw material, paper sizing ingredient, waterproofing agents, starch modifier, and 

germicides (Dixie Chemical Company, 2007; Electron Microscopy, 2007). With several uses and users, 

EPA believes this chemical would meet the designation criteria of “substantial or significant human

exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or 

others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) 

when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 2,5-Furandione, 3-(dodecenyl)dihydro-

(CASRN 25377-73-5)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

N Note: Specific benefits related to these tests are described in Section 8.3.

8.4.10 2,5-Furandione, dih ydro-3-(tetrapropen yl) (CASRN 26544-38-7)

The IUR commercial/consumer product categories “Lubricants, greases, and fuel additives,” “Paints and 

coatings” and “NRO” (not readily obtainable) were reported for this chemical. Chemicals in these product 

categories include surfactants, intermediates for esters or amides or imides, brake fluids, alkyd resin 

modifiers, gelling agents, corrosion inhibitors, paints, varnishes, enamels, paint and varnish removers 

(Trigon Chemie GmbH, 2006). It is expected that consumers will use a wide variety of these products; 

hence, the number of persons utilizing these products would likely exceed 10,000 consumers. EPA 

believes this chemical would meet the designation criteria of “substantial or significant human exposure” 

(U.S. EPA, 2010b). Therefore, a substantial or significant number of consumers who are exposed to the 

chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic 

information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 2,5-Furandione, dihydro-3-

(tetrapropenyl) (CASRN 26544-38-7)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.11 Butanedioic acid, 2-(tetrapropen yl) (CASRN 27859-58-1)

The total number of potentially exposed workers exceeds 1,000 based on IUR and NOES data (U.S. EPA, 

2010b). Additionally, the number of consumers potentially exposed to this chemical could exceed 10,000 

due to its various uses within the IUR commercial/consumer product category, “Lubricants, greases, and 

fuel additives.” Products containing this chemical include fuel additives and rust inhibitors (EPO, 1998; 

US PTO, 1995). Based on this information, EPA believes this chemical would meet the designation 

criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or 

significant number of workers, consumers or others who are exposed to the chemical would benefit from 

the decisions made (e.g. policies, regulations) when hazard and toxic information is known.
8-16

Tests Required under the Proposed HPV Chemical Test Rule for Butanedioic acid, (tetrapropenyl) 

(CASRN 27859-58-1)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

        

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.12 2,5-Furandione, dih ydro-3-(octadecen-1-yl) (CASRN 28777-98-2)

Production volume data from the 2006 IUR indicates that aggregated totals for this chemical existed in 

the range of 10 to 50 million pounds. This volume may provide evidence for a possible “substantial 

release” designation (U.S. EPA, 2010b). The IUR commercial/consumer product category “Paper 

products” was reported for this chemical. Applicable uses of this chemical include antifreeze lubricants, 

engine oil lubricant additives, viscosity improvers, copy paper, epoxy, intermediates in alkaline paper 

sizing, gypsum board sheets, water treatment, corrosion inhibitor, and surfactant intermediates (Dixie 

Chemical Company, 2005a; Albemarle, 2005a). It is expected that paper products and other materials will 

be used by more than 10,000 consumers or commercial workers. Based on the production volume and use 

information, EPA believes this chemical would meet the designation criteria of “substantial or significant 

human exposure” (U.S. EPA, 2010b). A substantial or significant number of workers, consumers or 

others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) 

when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 2,5-Furandione, dihydro-3-(octadecenyl) 

(CASRN 28777-98-2)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

       

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.13 1H-Benzotriazole, 6(or7)-methyl- (CASRN 29385-43-1)

The total number of potentially exposed workers exceeds 1,000 based on NOES data (U.S. EPA, 2010b). 

The IUR commercial/consumer product category “Lubricants, greases, and fuel additives” was reported 

for this chemical. Chemicals reporting under this category are added to gasoline, kerosene, and distillate 

fuel oil after refining; their primary use is to enhance or clean combustion devices. Additional sources list 

other specific uses of these additives: corrosion inhibitors for metals and antifreeze and paints and 

petroleum fuels, biocides, chelating agents, stabilizers for polyurethane pre-polymers, antioxidants, as 

well as intermediates for dyes, agricultural chemicals, UV light absorbers, and pharmaceuticals 

(Scorecard, 2009d; PMC Specialties Group, Inc., 2009c) Because many workers and consumers could be 

exposed to the wide variety of such chemical products, EPA believes this chemical would meet the 

designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a 

substantial or significant number of workers, consumers or others who are exposed to the chemical would 

benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known. 
8-17

Tests Required under the Proposed HPV Chemical Test Rule for 1H-Benzotriazole, 4(or5)-methyl-

(CASRN 29385-43-1)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

    

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.14 2,5-Furandione, 3-(hexadecen-1-yl)dih yd ro- (CASRN 32072-96-1)

Production volume data from the 2006 IUR indicates that aggregated totals for this chemical existed in 

the range of 50 to 100 million pounds, the most of the twelve sampled chemicals. This volume may 

provide evidence for a possible “substantial release” designation (U.S. EPA, 2010b). The IUR 

commercial/consumer product category “Paper products” was reported for this chemical. Applicable uses 

of this chemical include copy paper, antifreeze lubricant, engine oil lubricant additive, epoxy, 

intermediates in alkaline paper sizing, gypsum board sheets, water treatment, corrosion inhibitor, and 

surfactant intermediates (Dixie Chemical Company, 2005b; Albemarle, 2005b). It is expected that paper 

products and other materials will be used by more than 10,000 consumers and more than 1,000 workers 

(U.S. EPA, 2010b). Based on the production volume, product applications, users and use information, 

EPA believes this chemical would meet the designation criteria of “substantial or significant human

exposure” (U.S. EPA, 2010b). A substantial or significant number of workers, consumers or others who 

are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when 

hazard and toxic information is known. 

Tests Required under the Proposed HPV Chemical Test Rule for 2,5-Furandione, 3-

(hexadecenyl)dihydro- (CASRN 32072-96-1)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.15 Quaternary ammonium compounds , benzylbis (h ydrogenated tallow alkyl)methyl, chlo rides 

(CASRN 61789-73-9)

This chemical is used in a variety of ways: an inert ingredient in nonfood use pesticide products, 

antistatic, hair conditioning, and surfactants (U.S. EPA, 2009b; EU Commission, 2009). No IUR category 

was reported for this chemical. It is expected that more than 10,000 individuals (whose identity is 

confidential business information) would be affected by this chemical’s release or exposure. EPA believes 

this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. 

EPA, 2010b). Therefore, a substantial or significant number of consumers who are exposed to the 

chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic 

information is known.
8-18

Tests Required under the Proposed HPV Chemical Test Rule for Quaternary ammonium compounds, 

benzylbis(hydrogenated tallow alkyl)methyl, chlorides (CASRN 61789-73-9)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel



Note: Specific benefits related to these tests are described in Section 8.3.

8.4.16 1H-Benzotriazole, 6(or 7)-methyl-, s odium s alt (CASRN 64665-57-2)

The total number of potentially exposed workers exceeds 1,000 based on NOES data (U.S. EPA, 2010b). 

Additionally, it is expected that approximately 10,000 consumers would be exposed to this chemical 

based on the IUR commercial/consumer product category “Other.” This chemical is primarily utilized as 

a coolant in industrial equipment to prevent overheating. Its uses include: automotive radiator treatment 

fluid, engine coolant, corrosion inhibitor, metalworking coolant, antifreeze, aircraft-de-icing fluids, and 

cooling water treatments (Berryman Products, Inc., 2001; Coolant Control, Inc., 2007; Penray 

Companies, Inc., 1991; Drew Chemical, 1987; 4-Tek Industries, Inc., 1991). EPA believes this chemical 

would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). A 

substantial or significant number of workers, consumers or others who are exposed to the chemical would 

benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule 1H-Benzotriazole, 4(or 5)-methyl-, sodium 

salt (CASRN 64665-57-2)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

     

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.17 Naphthenic acids , reactio n products with diethylenetriamin e (CASRN 68131-13-5)

The total number of potentially exposed workers exceeds 1,000 based on NOES data and the total number 

of consumers exposed exceeds 10,000 based on NLM data (U.S. EPA, 2010b). The U.S. Patent 

Trademark Office reported that this chemical’s major uses are a corrosion inhibitor and an anti-foulant in 

refinery systems and petrochemical industry (U.S. PTO 1985; U.S. PTO 1989; U.S. PTO 1992). Because 

numerous workers and consumers could be exposed to such chemical products, EPA believes this 

chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 

2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed 

to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic 

information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Naphthenic acids, reaction products 

with diethylenetriamine (CASRN 68131-13-5)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

   

Note: Specific benefits related to these tests are described in Section 8.3.
8-19

8.4.18 Fatty acids , tall-oil, reaction products with diethylenetriamine, acetates (CASRN 

68153-60-6)

The total number of potentially exposed workers exceeds 1,000 based on IUR data (U.S. EPA, 2010b). 

No IUR category was reported for this chemical. The chemical is used as food fortification, intermediate 

to corrosion inhibitors, and surface-active polymers to control and stabilize dispersion (Berry, 2010; 

Kurzin, 2009; Fischer and Parker, 1997). Based on this information, EPA believes this chemical would 

meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). 

Therefore, a substantial or significant number of workers, consumers or others who are exposed to the 

chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic 

information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Fatty acids, tall-oil, reaction products 

with diethylenetriamine, acetates (CASRN 68153-60-6)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.19 Quaternary ammonium compounds , benzyl-C12-16-alkyld imeth yl, chlorid es (CASRN 

68424-85-1)

The total number of potentially exposed workers exceeds 1,000 based on IUR and NOES data (U.S. EPA, 

2010b). The IUR commercial/consumer product category “Other” (chemicals contained in commercial 

and consumer products not elsewhere classified) was reported for this chemical. This condition indicates 

that the chemical could exist in an unknown number of other products that may potentially have high 

numbers of exposures. The National Library of Medicine focuses on three particular sectors: automotive 

products, home products, and personal care products (U.S. NLM, 2009b). More specifically, this chemical 

is used in microbiocides, disinfectants, and sanitizers (Scorecard, 2009e; U.S. HHS, 2009). It is expected 

that workers and consumers will use a wide variety of these products; hence, the number of persons 

utilizing these products would likely exceed 10,000 consumers. EPA believes this chemical would meet 

the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). A substantial 

or significant number of workers, consumers or others who are exposed to the chemical would benefit 

from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Quaternary ammonium compounds, 

benzyl-C12-16-alkyldimethyl, chlorides (CASRN 68424-85-1)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

  

Note: Specific benefits related to these tests are described in Section 8.3

8.4.20 2-Butenediamide, (2E)-, N1,N4-bis [2-(4,5-dih ydro-2-nortall-oil alkyl-1H-im idazol-1-yl)eth yl] 

derivs . (CASRN 68442-77-3)

The total number of potentially exposed workers is likely to exceed 1,000 based on reported IUR data for 

this chemical (U.S. EPA, 2010b). No IUR consumer/commercial category was reported for this chemical 

and no uses of this chemical were explicitly stated. Its 2006 IUR production volume ranges from 1 

million to 10 million pounds (U.S. EPA, 2010a). Based on this information, EPA believes this chemical 
8-20

would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). 

Therefore, a substantial or significant number of workers, consumers or others who are exposed to the 

chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic 

information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 2-Butenediamide, (2E)-, N1,N4-bis[2-

(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs. (CASRN 68442-77-3)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.21 Quaternary ammonium compounds , (oxydi-2,1-eth anediyl)bis [co co alkyldim ethyl, 

dichlorides (CASRN 68607-28-3)

The total number of potentially exposed workers exceeds 1,000 (U.S. EPA, 2010b). The IUR 

commercial/consumer product category “Other” was reported for this chemical, indicating that it exists in 

an unknown number of products that may create a high level of chemical exposures. Some of the products 

containing this chemical include microbiocides and corrosion inhibitors (PAN, 2009; Baker Petrolite, 

2009). EPA believes this chemical would meet the designation criteria of “substantial or significant 

human exposure” (U.S. EPA, 2010b). A substantial or significant number of workers, consumers or 

others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) 

when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Quaternary ammonium compounds, 

(oxydi-2,1-ethanediyl)bis[coco alkyldimethyl, dichlorides (CASRN 68607-28-3)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

    

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.22 Pyridinium, 1-(phen ylmethyl)-, Et Me derivs ., chlorides (CASRN 68909-18-2)

The total number of potentially exposed workers exceeds 1,000 and the total number of consumers 

exposed exceeds 10,000 based on IUR data (U.S. EPA, 2010b). The IUR commercial/consumer product 

category “Other” was reported for this chemical. The primary use of this chemical is an water soluble or 

oil dispersible corrosion inhibitors for oil field and other water treating systems (Lonza, 2009), but this 

chemical also exists in an unknown number of other commercial and consumer products. Because 

numerous workers and consumers could be exposed to such chemical products, EPA believes this 

chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 

2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed 

to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic 

information is known.
8-21

Tests Required under the Proposed HPV Chemical Test Rule for Pyridinium, 1-(phenylmethyl)-, Et Me 

derivs., chlorides (CASRN 68909-18-2)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

        

Note: Specific benefits related to these tests are described in Section 8.3.

8.4.23 Benzene, decylphenoxy (CASRN 69834-17-9)

The IUR commercial/consumer product category “Soaps and detergents” was reported for this chemical. 

This chemical is used in households as personal soaps, various types of washing detergents, dishwashing 

compounds, presoaks, and scouring compounds. The total number of consumers using these products 

could exceed 10,000 persons; therefore, it could be considered as “significant human exposure” based on 

its wide commercial use (U.S. EPA, 2010b). A substantial or significant number of workers, consumers 

or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, 

regulations) when hazard and toxic information is known. 

8.5 Potential Us ers of Information Generated by the Propos ed 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), the 

High Production Volume Information System (HPVIS), 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 (U.S. NLM, 2009; U.S. NLM, 2009c). 

Tests Required under the Proposed HPV Chemical Test Rule for Benzene, decylphenoxy 

(CASRN 69834-17-9)

Melting 

Point

Boiling 

Point

Vapor 

Pressure

Partition 

Coefficient

Water 

Solubility

Ready 

Biodegradation

Aquatic 

Toxicity

Mammalian 

Toxicity -

Acute

Mammalian 

Toxicity -

Genotox

Mammalian 

Toxicity –

Repeated 

Dose/Repro/ 

Devel

         

Note: Specific benefits related to these tests are described in Section 8.3.
8-22

The distribution of TSCATS user accounts purchased through a past vendor, Oxford Molecular Group 

(OMG),

9

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 proposed 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. 

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) (CIS, 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 (CIS, 2003). 

8.5.1 Cons umers /Bu yers

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, once the information is 

made available to them, 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.

8.5.2 Workers

When the data has been processed into a format available to 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 contact 

 9 Oxford Molecular Group’s Chemical Information System, which housed TSCATS, was acquired by National 

Information Services Corp. (NISC) in 2000. 
8-23

with at work. EPA expects the potential benefits to workers to be large for chemicals included in the 

proposed rule since they are manufactured and processed in large volumes.

8.5.3 Scien ce and Health Com munities

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 proposed 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. 

8.5.4 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 proposed 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.

8.5.5 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 
8-24

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 design and develop products that can be manufactured, transported, used and disposed of or 

recycled safely”;

• “To work with customers, carriers, suppliers, distributors, and contractors to foster the safe and secure 

use, transport, and disposal of chemicals and provide hazard and risk information that can be accessed 

and applied in their operations and products;”

• “To promote pollution prevention, minimization of waste and conservation of energy and other 

critical resources at every stage of the life cycle of our products”; and 

• “To support education and research on the health, safety, and environmental effects of our products 

and processes” (ACC, 2010).

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 (CIIT), 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 (CIIT, 1998 and CIIT, 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 proposed 

rule.

Data generated as a result of the proposed 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. 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. 
8-25

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 

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.

8.5.6 Government

The information developed in response to the proposed 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 proposed 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. 
8-26

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 

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).

8.5.7 Foreign Interes ts

The toxicity data developed as a result of the test rule are not known to be available anywhere in the 

world community, so the rule is 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 (United Nations, 1992). 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, 1994). 

Data developed as a result of the proposed 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. 
9-1

Chapter 9 - Other Impact Analyses

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

statements discussing unfunded mandates, environmental justice, children’s health, and paperwork 

burden, among others.

9.1 Paperwork Reduction Act

The Paperwork Reduction Act mandates that federal agencies estimate the recordkeeping and reporting 

burden of a proposed 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.

9.1.1 Indus try Burd en

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 proposed 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, nonreporting 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 4.2.3 of this report, EPA estimates that 

manufacturers will submit letters of intent and study plans, resulting in 153 final reports. It is additionally 

required that all final test reports be accompanied by a robust summary of results. EPA also assumes that 

it will receive 88 exemption applications pursuant to the proposed rule. 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 shortterm 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 proposed rule. The reporting burden estimates for this rule are 

detailed in Exhibit 9-1. The total reporting burden generated by the rule is estimated to be approximately 

14,000 hours.

Exhibit 9-1: Reporting Burden Estimate for the Proposed Rule

Item Hours per Item Total Items Total Hours

Letter of Intent and Study Plans 40 23 920

Final Reports 73 153 11,000

Robust Summaries 12 153 2,000

Exemption Applications 2 88 176

Total 14,000

Note: Values may not sum due to rounding
9-2

Estimate the Other Administrative Burden. Respondents also spend time on other administrative 

activities including 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. 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 $914,000 ($1.30 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 approximately 17,000

(24,000) hours under the least (average) cost assumption. 

Estimate the Export Notification Burden. As explained in Section 4.2.4, EPA expects 25 export 

notifications to be filed for each chemical included in the proposed rule (575 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 proposed rule is estimated to equal 288 hours (575 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 9-2. 

The total industry burden is estimated to equal 31,000 hours (38,000 hours) in the least (average) cost 

scenario. The average burden per chemical is estimated to be approximately 1,000 (2,000) hours

(rounded) in the least (average) cost scenario. 

Exhibit 9-2: Total Industry Burden Hour Estimate for the Proposed Rule

Activity Least Cost Scenario

(Approximate Hours)

Average Cost Scenario

(Approximate Hours)

Reporting Activities 14,000 14,000

Other Administrative Activities 17,000 24,000

Export Notification Burden 288 575

Total Industry Burden 31,000 38,000

Average Burden Per Chemical (23 chemicals) 1,350 1,660

Note: Values may not sum due to rounding

9.1.2 Government Burden

The government will also spend time processing, reviewing, and analyzing the information that will be 

collected under the proposed test rule. As explained in Section Chapter 5, this work is assumed to be 

performed by a GS-13, Step 1, FTE employee.

It is further assumed that 23 letters of intent and study plans, 153 final reports, 153 robust summaries, and 

88 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 

9-3 presents the estimated government burden hours based on these assumptions. The total government 

burden is estimated to equal approximately 1,000 hours (rounded).
9-3

Exhibit 9-3: Estimated Government Burden for the Proposed Test Rule

Item Hours per Item Total Items Total Hours

Letter of Intent and Study Plans 3 23 69

Final Reports 5 153 765

Robust Summaries 1 153 153

Exemption Requests 1 88 88

Total 1,000

Note: Values may not sum due to rounding. 

9.2 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 proposed rule will not cost the private or public sectors $100 million or more in 

any one year. As shown in Exhibit 4-7 the maximum total cost incurred by the private sector in 

complying with the proposed rule and associated requirements triggered by the rule is approximately 

$7.65 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 

$840,000 per year (average cost scenario).10

Furthermore, because the proposed rule is focused on manufacturers and importers of chemicals, EPA has 

not estimated that any costs will be imposed 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 

proposed rule can be of value to these agencies. As explained in 

Government cost, annualized using similar assumptions, is 

estimated to equal approximately $8,000 per year.

Chapter 8, if EPA makes the test data 

collected as a result of the proposed 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. 

EPA’s estimate that no state, local, or tribal governments would be affected by this proposed rule 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.

 10 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. 
9-4

9.3 Executive Order 13132 – Federalis m

Under Executive Order 13132, “Federalism” (64 FR 43255, August 10, 1999), EPA must evaluate the 

“federalism implications” of the proposed rule. This proposed 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 proposed 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 proposed rule does not apply directly to states and localities and will not affect state and local 

governments. 

9.4 Executive Order 13175 – Cons ultation 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 the proposed rule has tribal implications. Tribal 

implications are not expected because the proposed rule will not have any effect on tribal governments, 

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

and responsibilities between the federal government and Indian tribes, as specified in the executive order. 

EPA’s estimation that no state, local, or tribal governments would be affected by this proposed rule 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 

none of the chemicals listed in this proposed 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.

9.5 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 proposed rule is does not 

establish an environmental standard intended to mitigate health or safety risks and will not have an annual 

effect on the economy of $100 million or more, nor does it otherwise have a disproportionate effect on 

children. Nevertheless, the information obtained 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 proposed rule present potential risks, allowing the Agency and others to take appropriate action to 

investigate and mitigate those risks.

9.6 Executive Order 13211 – Energy Supply, Dis tribution, or Us e

Eight chemicals in the proposed regulation have been identified as having uses associated with energy

supply, distribution or use (see Exhibit 2-3 for detail) such as fuel additives and refinery system corrosion 

inhibitors. Given the low cost of the rule and lack of restrictions on the use of the chemicals resulting 

from this proposed rule, it is unlikely that there will be significant impacts on the supply, distribution, or 

use of energy.
9-5

9.7 National Technology Trans fer and Advanc ement 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 proposed 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. 

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 proposed rule are 

based. 

9.8 Executive Order 12898 – Environmental J us tice

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 proposed rule does not have an adverse impact on the environmental and health conditions in lowincome and minority communities. The information collected under this proposed 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 lowincome and minority communities.

The proposed rule is directed at 23 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 

proposed rule will be disproportionately distributed across different geographic regions or among 

different categories of individuals.
10-1

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10-2

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A-1

Appendix A Laboratory Tes t Cos t Es timates

This appendix describes the methodology used in developing each of the test cost estimates used 

in this analysis. Test costs were estimated by either EPA’s Office of Pollution Prevention and 

Toxics (OPPT) or Office of Pesticide Programs (OPP) in various years; all costs were inflated to 

2009$ for use in this economic analysis. Test cost estimation procedures included obtaining a 

high and a low estimate; these values were averaged to develop the “best” estimate. Test cost 

results are shown in Exhibit 4-1. Unless otherwise described in the sections below, the least cost 

and average cost scenarios for this analysis consider the same “best” estimate cost. 

Category A. Physical/Chemical Properties

Melting Point (A1). This test is required to be conducted according to the American Society for 

Testing and Materials (ASTM) E 324–99 (Capillary tube) standard. This standard corresponds 

with the OECD 102 protocol, as well as the EPA test guidelines at §796.1300 and §830.7200. The 

EPA OPP estimated the cost of this testing endpoint in 2005 by using an industry expert’s best 

professional judgment (U.S. EPA, 2009a).

Boiling point (A2). This test is required to be conducted according to the ASTM E 1719–05 

(Ebulliometry) standard. This standard corresponds with the OECD 103 protocol, as well as the 

EPA test guidelines §796.1220 and §830.7220. The EPA OPP estimated the cost of this testing 

endpoint in 2005 by using an industry expert’s best professional judgment (U.S. EPA, 2009a). 

Vapor pressure (A3). This test is required to be conducted according to the ASTM E 1782–03 

(Thermal analysis) standard. This standard corresponds with the OECD 104 protocol, as well as 

the EPA test guidelines §796.1950 and §830.7960. The EPA OPP estimated the cost of this 

testing endpoint in 2005 by using an industry expert’s best professional judgment (U.S. EPA, 

2009a). 

n-Octanol/Water Partition Coefficient (A4). The selection of the method to complete this test 

under the proposed rule varies depending on the estimated log Kow of the chemical11

• log Kow < 0: no testing required.

:

• log Kow range 0–1: Method A or B

• log Kow range > 1–4: Method A or B or C

• log Kow range > 4–6: Method B or C

• log Kow > 6: Method C

Method A is required to be conducted according to the guideline §799.6755 (Shake flask), which 

corresponds with the OECD 107 protocol, as well as the EPA test guidelines §796.1550 and 

§830.7550. The EPA OPP estimated the cost of this testing endpoint in 2007 by using EPA staff 

scientist best professional judgment (U.S. EPA, 2009a). 

 11 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). 
A-2

Method B is required to be conducted according to the ASTME E 1147–92(2005) (Liquid 

chromatography) standard, which corresponds with the OECD 117 protocol, as well as the EPA 

test guidelines at §796.1570 and §830.7570. The EPA OPP estimated the cost of this testing 

endpoint in 2005 by contacting up to nine contact research organizations (laboratories) and asking 

for specific pricing information. (U.S. EPA, 2009a).

Method C is required to be conducted according to the guideline §799.6756 (Generator column), 

which corresponds with the EPA test guidelines at §796.1720 and §830.7560. The EPA Office of 

Pesticide Programs estimated the cost of this testing endpoint in 2005 by contacting up to nine 

contact research organizations (laboratories) and asking for specific pricing information (U.S. 

EPA, 2009a).

Because the log Kow of each subject chemical is unknown, the least cost scenario for this analysis 

assumes the least costly of the methods listed above. The average cost scenario considers the 

average value of all of these methods.

Water Solubility (A5). The selection of the method to complete this test under the proposed rule 

would be determined by the chemical’s estimated water solubility:

• 5,000 milligram/Liter (mg/L): Method A or B.

• 10 mg/L—5,000 mg/L: Method A, B, C, or D.

• 0.001 mg/L—10 mg/L: Method C or D.

• ≤ 0.001 mg/L: No testing required.

Method A is required to be conducted according to the ASTM E 1148–02 (Shake flask) standard. 

Method B requires following the guideline at §799.6784 (Shake flask). Method C 

requires following the guideline at §799.6784 (Column elution). These protocols all 

corresponds with the OECD 105 protocol, as well as the EPA test guidelines §796.1840 and 

§830.7840. The EPA OPP estimated the cost of this testing endpoint in 2007 by using EPA staff 

scientist best professional judgment (U.S. EPA, 2009a). 

Method D is required to be conducted according to the guideline at §799.6786 (Generator 

column) which corresponds with the EPA test guidelines at §796.1860 and §830.7860. The EPA 

OPP estimated the cost of this testing endpoint in 2007 by contacting up to nine contact research 

organizations (laboratories) and asking for specific pricing information (U.S. EPA, 2009a).

Because the water solubility of each subject chemical is unknown, the least cost scenario for this 

analysis assumes the least costly of the methods listed above. The average cost scenario

considers the average value of all of these methods.

Category B. Environmental Fate 

Ready biodegradation (B). The test method used for this endpoint will depend on the physical 

and chemical properties of the test substance, including its water solubility. 

Method A is required to be conducted according to the ASTM E1720–01 (Sealed vessel CO2

production test) standard. Method B is required to be conducted according to the ISO 14593 (CO2

headspace test) standard. Method C is required to be conducted according to the ISO 7827 

(Method by analysis of dissolved organic carbon (DOC)) standard. Method D is required to be 

conducted according to the ISO 9408 (Determination of oxygen demand in a closed respirometer) 
A-3

standard. Method E is required to be conducted according to the ISO 9439 (CO2 evolution test) 

standard. Method F is required to be conducted according to the ISO 10707 (Closed bottle test) 

standard. Method G is required to be conducted according to the ISO 10708 (Two-phase closed 

bottle test) standard. 

Test cost estimates were based on either the EPA test guideline §835.3110 or the following 

OECD protocols for ready biodegradation: 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). The EPA Office of Pollution, Prevention and Toxics estimated the cost of this testing 

endpoint in 2009 by contacting up to nine contact research organizations (laboratories) and asking 

for specific pricing information. (Abt Associates Inc., 2009).

Category C. Aquatic Toxicity

The proposed testing requirements in the aquatic toxicity testing category include some 

combination of the following tests: acute toxicity to fish, acute toxicity to Daphnia, chronic 

toxicity to Daphnia, and toxicity to plants (algae). EPA recognizes that, for chemicals with high 

log Kow values, acute toxicity studies are of limited value in assessing the substances’ aquatic 

toxicity. For such situations, the OECD HPV SIDS Program recommends use of chronic toxicity 

testing in Daphnia in place of acute toxicity testing in fish and Daphnia. Therefore, 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 of the proposed testing requirements (except for C6) have 

separate requirements by Test Group. Specific testing requirements are as follows:

(C1). Test Group 1: Acute Toxicity to Fish; Acute Toxicity to Daphnia; Toxicity to Plants 

(Algae). Test Group 2: Chronic Toxicity to Daphnia; Toxicity to Plants (Algae).

(C2). Test Group 1: Acute Toxicity to Daphnia; Toxicity to Plants (Algae). 

Test Group 2: Chronic Toxicity to Daphnia; Toxicity to Plants (Algae.)

(C3). Test Group 1: Acute Toxicity to Fish; Toxicity to Plants (Algae). 

Test Group 2: Chronic Toxicity to Daphnia; Toxicity to Plants (Algae).

(C4). Test Group 1: Acute Toxicity to Fish; Acute Toxicity to Daphnia.

Test Group 2: Chronic Toxicity to Daphnia

(C5). Test Group 1: Acute Toxicity to Daphnia. 

Test Group 2: Chronic Toxicity to Daphnia.

(C6). Toxicity to Plants (Algae).

(C7). Test Group 1: Acute Toxicity to Fish. 

Test Group 2: Chronic Toxicity to Daphnia.
A-4

The acute toxicity to fish testing endpoint is required to be conducted according to ASTM E 

729–96 (2002), which corresponds with the OECD 203 protocol, as well as the EPA test 

guidelines §797.1400 and §850.1075. The EPA OPP estimated the cost of this testing endpoint in 

2008 by contacting up to nine contact research organizations (laboratories) and asking for specific 

pricing information (U.S. EPA, 2009a).

The acute toxicity to Daphnia testing endpoint is required to be conducted according to ASTM

E 729–96(2002), which corresponds with the OECD 202 (Part 1) protocol. The EPA OPPT 

estimated the cost of this testing endpoint in 2007 by contacting up to nine contact research 

organizations (laboratories) and asking for specific pricing information. (Abt Associates Inc., 

2007).

The chronic toxicity to Daphnia testing endpoint is required to be conducted according to 

ASTM E 1193–97(2004), which corresponds with the OECD 202 protocol as well as the EPA test 

guidelines §797.133 and §850.1300. The EPA OPP estimated the cost of this testing endpoint in 

2005 by contacting up to nine contact research organizations (laboratories) and asking for specific 

pricing information (U.S. EPA, 2009a).

The toxicity to plants (algae) testing endpoint is required to be conducted according to (ASTM E 

1218–04e1), which corresponds with the OECD 201 protocol The EPA OPPT estimated the cost 

of this testing endpoint in 2009 by contacting up to nine contact research organizations 

(laboratories) and asking for specific pricing information. (Abt Associates, Inc., 2009)

For each testing requirement (e.g., C1, C2, etc.), the cost of each test group (i.e., Test Group 1 or 

2) is the sum of all the tests required for the group. Because the log Kow of each subject chemical 

is unknown, for each testing requirement, the least cost scenario for this analysis assumes the 

least costly of the test groups. The average cost scenario considers the average value both test 

groups.

Category D. Mammalian Toxicity - Acute

(D). The test method used for this endpoint will depend on the chemical’s physical state at room 

temperature (25° C):

• Gas: Method A 

• Liquid or solid: Method B 

Method A, Acute Inhalation Toxicity (rat), is required to be conducted according to the 

guideline at §799.9130, which corresponds with the OECD 403 protocol as well as the EPA test 

guidelines §798.1150 and §870.1300. The EPA OPP estimated the cost of this testing endpoint in 

2007 by contacting up to nine contact research organizations (laboratories) and asking for specific 

pricing information (U.S. EPA, 2009a).

Method B, Acute Oral Toxicity (rat), is required to be conducted according to the ASTM E 

1163–98(2002) standard or the guideline at §799.9110(d)(1)(i)(A). These protocols correspond 

with OECD 423 protocol as well as the EPA test guidelines §798.1175 and §870.1100. The EPA 

OPP estimated the least and average cost of this testing endpoint in 2005 by contacting up to nine 

contact research organizations (laboratories) and asking for specific pricing information (U.S. 

EPA, 2009a).
A-5

For Method B, EPA suggests using a neutral red uptake basal cytotoxicity assay (using normal

human keratinocytes or mouse BALB/c 3T3 cells) to estimate the starting dose. EPA estimated 

the costs for these tests in 2003; the least costly of the two species is considered in this analysis.

Because the chemical’s physical state at room temperature is unknown, the least cost scenario for 

this analysis assumes the least costly of Method A or B. The average cost scenario considers the 

average of both methods.

Category E. Mammalian Toxicity - Genotoxicity 

Bacterial Reverse Mutation Test (in vitro) (E1). This test is required to be conducted according 

to the guideline at §799.9510, which corresponds with the OECD 471 protocol as well as the EPA 

test guideline at §798.5100 and §870.5100. The EPA OPP estimated the cost of this testing 

endpoint in 2003 by contacting up to nine contact research organizations (laboratories) and asking

for specific pricing information (U.S. EPA, 2009a).

Chromosomal Damage (E2). Manufacturers required to meet this testing endpoint may conduct 

one of three tests: the in vitro mammalian chromosome aberration test; the mammalian bone 

marrow chromosomal aberration test; or the mammalian erythrocyte micronucleus test. 

• The in vitro Mammalian Chromosome Aberration test is required to be conducted 

according to the guideline at §799.9537, which corresponds with the OECD 473 protocol 

as well as the EPA test guidelines §798.5375 and §870.5375. The EPA OPP estimated 

the cost of this testing endpoint in 2007 by contacting up to nine contact research 

organizations (laboratories) and asking for specific pricing information (U.S. EPA, 

2009a).

• The Mammalian Bone Marrow Chromosomal Aberration test is required to be conducted 

according to the guideline at §799.9538, which corresponds with the OECD 475 protocol 

as well as the EPA test guidelines §798.5385 and §870.5385. The EPA OPP estimated 

the cost of this testing endpoint in 2005 by contacting up to nine contact research 

organizations (laboratories) and asking for specific pricing information (U.S. EPA, 

2009a). 

• The Mammalian Erythrocyte Micronucleus test is required to be conducted according to 

the guidelines at §799.9539, which corresponds with the OECD 474 protocol as well as 

the EPA test guidelines §798.5395 and §870.5395. The EPA OPP estimated the cost of 

this testing endpoint in 2005 by contacting up to nine contact research organizations 

(laboratories) and asking for specific pricing information (U.S. EPA, 2009a).

The least cost scenario assumes the least costly of the test methods. The average cost scenario

considers the average of all three methods.

Category F. Mammalian Toxicity – Repeated Dose/ Reproduction/ 

Developmental

The proposed testing requirements in the mammalian toxicity – repeated dose/ reproduction/ 

developmental testing category include one or more of the following three tests: Repeated Dose 

28–Day Oral Toxicity Study in rodents; Reproduction/Developmental Toxicity Screening Test; 

and Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

Screening Test. 
A-6

(F1). Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

Screening Test, or both the Reproduction/Developmental Toxicity Screening Test and the 

Repeated Dose 28–Day Oral Toxicity Study in rodents

(F2). Reproduction/Developmental Toxicity Screening Test.

(F3). Repeated Dose 28–Day Oral Toxicity Study in rodents.

(F4). Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

Screening Test, or Reproduction/Developmental Toxicity Screening Test.

The combined repeated dose toxicity study with the reproduction/developmental toxicity 

screening test is required to be conducted according to the guideline at §799.9365, which 

corresponds with the OECD 422 protocol as well as the EPA test guideline at §870.3650. The 

EPA OPPT estimated the cost of this testing endpoint in 1994, and inflated to 2009$ in a previous 

economic analysis (U.S. EPA, 2009c).

The reproduction/developmental toxicity screening test is required to be conducted according 

to the guideline at §799.9355, which corresponds with the OECD 421 protocol as well as the EPA 

test guideline at §870.3550. The EPA OPPT estimated the cost of this testing endpoint in 2007 by 

contacting up to nine contact research organizations (laboratories) and asking for specific pricing 

information. (Abt Associates Inc., 2007)

The repeated dose 28–day oral toxicity study in rodents is required to be conducted according 

to the guideline at §799.9305, which corresponds with the OECD 407 protocol and the EPA test 

guideline at §870.3050. The EPA OPPT estimated the cost of this testing endpoint in 2009 by 

contacting up to nine contact research organizations (laboratories) and asking for specific pricing 

information. (Abt Associates Inc., 2007)

Under the F1 and F4 testing requirements, the least cost scenario assumes the least costly of 

either of the two choices. The average cost scenario considers the average of the two choices.
B-1

Appendix B 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.

B.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 (U.S. EPA, 2002b). 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 B-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 B-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

Sources: BLS, 2006, Table 2 and Weinstein, 2004

B.1.1 Derivation of Unit Labor Rates for Managerial, Pro fes s ional/Technical, and Clerical 

Indus try Emplo yees

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, 2010a, 

Table 2).12

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

from the same BLS report (BLS, 2010a). 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.

13

Exhibit B-2

Therefore, fringe 

benefits as a percentage of wages were $17.42/$35.96, or approximately 48 percent (see ).

 12 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. 13 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 
B-2

An additional loading factor of 17 percent is applied to wages to account for overhead.14

Fully loaded costs for managerial and clerical labor are calculated in a similar manner, as shown in 

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 (U.S. EPA, 2002a), and the Revised Economic Analysis for the Amended Inventory Update Rule: 

Final Report, August 2002 (U.S. EPA, 2002b). 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. 

Exhibit B-2.

B.1.2 Derivation of Unit Labor Rates for EP A 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, 1992, page 30, footnote 9). The 60 percent assumption was 

labeled “the benefits multiplication factor” in the EPA guide, but has been used in many EPA 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.

 

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 et al., 2004). 14 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.
B-3

Exhibit B-1: 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 WashingtonBaltimore-Northern 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:

1

An overhead rate of 17% was used based on assumptions in U.S. EPA, 2002b and U.S. EPA, 2002a.

2 (BLS 2010a, 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% fringesand-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (U.S. EPA, 1992). Hourly rates are based on annual salary divided by 2,080 hours.
C-1

Appendix C Costs

Exhibit C-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 56-40-6 Glycine $17,000 $0 $13,000 $687 $31,000 $858 $32,000

2 67-72-1 Ethane, 1,1,1,2,2,2-hexachloro- $10,000 $6,000 $10,000 $687 $26,000 $858 $27,000

3 78-00-2 Plumbane, tetraethyl- $47,000 $15,000 $32,000 $687 $95,000 $2,000 $97,000 

4 95-14-7 1H-Benzotriazole $156,000 $15,000 $56,000 $687 $226,000 $2,000 $228,000

5 118-48-9 2H-3,1-Benzoxazine-2,4(1H)-dione $216,000 $23,000 $88,000 $687 $327,000 $3,000 $330,000

6 128-44-9 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, 

sodium salt (1:1) $196,000 $15,000 $78,000 $687 $290,000 $3,000 $293,000

7 928-72-3 Glycine, N-(carboxymethyl)-, sodium salt 

(1:2) $39,000 $0 $34,000 $687 $74,000 $2,000 $76,000

8 1809-19-4 Phosphonic acid, dibutyl ester $197,000 $23,000 $79,000 $687 $299,000 $3,000 $302,000

9 25377-73-5 2,5-Furandione, 3-(dodecen-1-yl)dihydro- $234,000 $27,000 $106,000 $687 $367,000 $4,000 $371,000

10 26544-38-7 2,5-Furandione, dihydro-3-(tetrapropenyl)- $239,000 $27,000 $111,000 $687 $377,000 $5,000 $382,000

11 27859-58-1 Butanedioic acid, 2-(tetrapropenyl)- $233,000 $27,000 $105,000 $687 $365,000 $4,000 $370,000

12 28777-98-2 2,5-Furandione, dihydro-3-(octadecen-1-

yl)- $231,000 $27,000 $101,000 $687 $359,000 $4,000 $364,000

13 29385-43-1 1H-Benzotriazole, 6(or 7)-methyl- $189,000 $17,000 $73,000 $687 $280,000 $2,000 $282,000

14 32072-96-1 2,5-Furandione, 3-(hexadecen-1-

yl)dihydro- $239,000 $27,000 $111,000 $687 $377,000 $5,000 $382,000

15 61789-73-9

Quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, chlorides

$17,000 $0 $11,000 $687 $28,000 $1,000 $29,000

16 64665-57-2 1H-Benzotriazole, 6(or 7)-methyl-, sodium 

salt $196,000 $17,000 $83,000 $687 $296,000 $3,000 $300,000

17 68131-13-5 Naphthenic acids, reaction products with 

diethylenetriamine $198,000 $27,000 $74,000 $687 $300,000 $2,000 $303,000

18 68153-60-6 Fatty acids, tall-oil, reaction products with 

diethylenetriamine, acetates $239,000 $27,000 $112,000 $687 $378,000 $5,000 $382,000

19 68424-85-1 Quaternary ammonium compounds, 

benzyl-C12-16-alkyldimethyl, chlorides $20,000 $0 $21,000 $687 $41,000 $2,000 $43,000

20 68442-77-3 2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-

dihydro-2-nortall-oil alkyl-1H-imidazol-1- $239,000 $27,000 $111,000 $687 $377,000 $5,000 $382,000
C-2

yl)ethyl] derivs.

21 68607-28-3

Quaternary ammonium compounds, 

(oxydi-2,1-ethanediyl)bis[coco 

alkyldimethyl, dichlorides

$34,000 $0 $34,000 $687 $69,000 $2,000 $71,000

22 68909-18-2 Pyridinium, 1-(phenylmethyl)-, Et Me 

derivs., chlorides $233,000 $27,000 $106,000 $687 $365,000 $4,000 $370,000

23 69834-17-9 Benzene, decylphenoxy- $239,000 $27,000 $111,000 $687 $377,000 $5,000 $382,000

TOTAL $3,654,000 $395,000 $1,660 ,000 $16,000 $5,725,000 $72,000 $5,797,000 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.

Note: Values may not sum due to rounding
C-3

Exhibit C-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 56-40-6 Glycine $17,000 $0 $13,000 $1,000 $31,000 $858 $32,000

2 67-72-1 Ethane, 1,1,1,2,2,2-hexachloro- $10,000 $6,000 $10,000 $1,000 $27,000 $858 $28,000

3 78-00-2 Plumbane, tetraethyl- $54,000 $15,000 $34,000 $1,000 $104,000 $2,000 $106,000 

4 95-14-7 1H-Benzotriazole $159,000 $15,000 $56,000 $1,000 $231,000 $2,000 $233,000

4 118-48-9 2H-3,1-Benzoxazine-2,4(1H)-dione $321,000 $23,000 $114,000 $1,000 $459,000 $3,000 $463,000

6 128-44-9 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, 

sodium salt (1:1) $293,000 $15,000 $103,000 $1,000 $412,000 $3,000 $415,000

7 928-72-3 Glycine, N-(carboxymethyl)-, sodium salt 

(1:2) $40,000 $0 $35,000 $1,000 $77,000 $2,000 $79,000

8 1809-19-4 Phosphonic acid, dibutyl ester $299,000 $23,000 $104,000 $1,000 $428,000 $3,000 $431,000

9 25377-73-5 2,5-Furandione, 3-(dodecen-1-yl)dihydro- $346,000 $27,000 $134,000 $1,000 $507,000 $4,000 $512,000

10 26544-38-7 2,5-Furandione, dihydro-3-(tetrapropenyl)- $351,000 $27,000 $139,000 $1,000 $518,000 $5,000 $523,000

11 27859-58-1 Butanedioic acid, 2-(tetrapropenyl)- $345,000 $27,000 $133,000 $1,000 $506,000 $4,000 $510,000

12 28777-98-2 2,5-Furandione, dihydro-3-(octadecen-1-

yl)- $343,000 $27,000 $129,000 $1,000 $500,000 $4,000 $504,000

13 29385-43-1 1H-Benzotriazole, 6(or 7)-methyl- $236,000 $17,000 $84,000 $1,000 $338,000 $2,000 $341,000

14 32072-96-1 2,5-Furandione, 3-(hexadecen-1-

yl)dihydro- $351,000 $27,000 $139,000 $1,000 $518,000 $5,000 $523,000

15 61789-73-9

Quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, chlorides

$17,000 $0 $11,000 $1,000 $29,000 $1,000 $30,000

16 64665-57-2 1H-Benzotriazole, 6(or 7)-methyl-, sodium 

salt $242,000 $17,000 $95,000 $1,000 $355,000 $3,000 $358,000

17 68131-13-5 Naphthenic acids, reaction products with 

diethylenetriamine $309,000 $27,000 $102,000 $1,000 $439,000 $2,000 $441,000

18 68153-60-6 Fatty acids, tall-oil, reaction products with 

diethylenetriamine, acetates $351,000 $27,000 $140,000 $1,000 $518,000 $5,000 $523,000

19 68424-85-1 Quaternary ammonium compounds, 

benzyl-C12-16-alkyldimethyl, chlorides $20,000 $0 $21,000 $1,000 $42,000 $2,000 $44,000

20 68442-77-3

2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-

dihydro-2-nortall-oil alkyl-1H-imidazol-1-

yl)ethyl] derivs.

$351,000 $27,000 $139,000 $1,000 $518,000 $5,000 $523,000

21 68607-28-3

Quaternary ammonium compounds, 

(oxydi-2,1-ethanediyl)bis[coco 

alkyldimethyl, dichlorides

$36,000 $0 $34,000 $1,000 $71,000 $2,000 $74,000
C-4

22 68909-18-2 Pyridinium, 1-(phenylmethyl)-, Et Me 

derivs., chlorides $345,000 $27,000 $134,000 $1,000 $506,000 $4,000 $511,000

23 69834-17-9 Benzene, decylphenoxy- $351,000 $27,000 $139,000 $1,000 $518,000 $5,000 $523,000

TOTAL $5,182,000 $395,000 $2,042,000 $33,000 $7,652,000 $72,000 $7,723,000 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.

Note: Values may not sum due to rounding 
C-5

Exhibit C-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 56-40-6 Glycine $11,000 $12,000 $11,000 $12,000

2 67-72-1 Ethane, 1,1,1,2,2,2-hexachloro- $10,000 $10,000 $10,000 $11,000

3 78-00-2 Plumbane, tetraethyl- $34,000 $37,000 $37,000 $40,000

4 95-14-7 1H-Benzotriazole $81,000 $87,000 $82,000 $89,000

5 118-48-9 2H-3,1-Benzoxazine-2,4(1H)-dione $117,000 $126,000 $164,000 $176,000

6 128-44-9 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, sodium salt

(1:1) $103,000 $111,000 $147,000 $158,000

7 928-72-3 Glycine, N-(carboxymethyl)-, sodium salt (1:2) $27,000 $29,000 $28,000 $30,000

8 1809-19-4 Phosphonic acid, dibutyl ester $107,000 $115,000 $152,000 $164,000

9 25377-73-5 2,5-Furandione, 3-(dodecen-1-yl)dihydro- $131,000 $141,000 $181,000 $195,000

10 26544-38-7 2,5-Furandione, dihydro-3-(tetrapropenyl)- $135,000 $146,000 $185,000 $199,000

11 27859-58-1 Butanedioic acid, 2-(tetrapropenyl)- $131,000 $141,000 $180,000 $194,000

12 28777-98-2 2,5-Furandione, dihydro-3-(octadecen-1-yl)- $129,000 $139,000 $178,000 $192,000

13 29385-43-1 1H-Benzotriazole, 6(or 7)-methyl- $100,000 $107,000 $120,000 $130,000

14 32072-96-1 2,5-Furandione, 3-(hexadecen-1-yl)dihydro- $135,000 $146,000 $185,000 $199,000

15 61789-73-9 Quaternary ammonium compounds, 

benzylbis(hydrogenated tallow alkyl)methyl, chlorides $10,000 $11,000 $11,000 $11,000

16 64665-57-2 1H-Benzotriazole, 6(or 7)-methyl-, sodium salt $106,000 $114,000 $127,000 $136,000

17 68131-13-5 Naphthenic acids, reaction products with 

diethylenetriamine $107,000 $115,000 $156,000 $168,000

18 68153-60-6 Fatty acids, tall-oil, reaction products with 

diethylenetriamine, acetates $135,000 $146,000 $185,000 $199,000

19 68424-85-1 Quaternary ammonium compounds, benzyl-C12-16-

alkyldimethyl, chlorides $15,000 $16,000 $15,000 $17,000

20 68442-77-3 2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-dihydro-2-

nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs. $135,000 $146,000 $185,000 $199,000

21 68607-28-3 Quaternary ammonium compounds, (oxydi-2,1-

ethanediyl)bis[coco alkyldimethyl, dichlorides $25,000 $27,000 $26,000 $28,000

22 68909-18-2 Pyridinium, 1-(phenylmethyl)-, Et Me derivs., chlorides $131,000 $141,000 $181,000 $195,000

23 69834-17-9 Benzene, decylphenoxy- $135,000 $146,000 $185,000 $199,000

TOTAL $2,049,000 $2,209,000 $2,730,000 $2,943,000 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.

Note: Values may not sum due to rounding
C-6

Exhibit C-4: Annualized Industry Compliance Costs1

CASRN Chemical Name Least Cost Scenario Average Cost Scenario

15 years, 3% 7 years, 3% 15 years, 3% 7 years, 3%

1 56-40-6 Glycine $3,000 $5,000 $3,000 $5,000

2 67-72-1 Ethane, hexachloro- $2,000 $4,000 $2,000 $4,000

3 78-00-2 Plumbane, tetraethyl- $8,000 $15,000 $9,000 $17,000

4 95-14-7 1H-Benzotriazole $19,000 $36,000 $19,000 $37,000

5 118-48-9 2H-3,1-Benzoxazine-2,4(1H)-dione $27,000 $53,000 $38,000 $74,000

6 128-44-9 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, sodium salt $24,000 $46,000 $34,000 $66,000

7 928-72-3 Glycine, N-(carboxymethyl)-, sodium salt (1:2) $6,000 $12,000 $6,000 $12,000

8 1809-19-4 Phosphonic acid, dibutyl ester $25,000 $48,000 $36,000 $69,000

9 25377-73-5 2,5-Furandione, 3-(dodecenyl)dihydro- $31,000 $59,000 $42,000 $81,000

10 26544-38-7 2,5-Furandione, dihydro-3-(tetrapropenyl)- $32,000 $61,000 $43,000 $83,000

11 27859-58-1 Butanedioic acid, (tetrapropenyl)- $31,000 $59,000 $42,000 $81,000

12 28777-98-2 2,5-Furandione, dihydro-3-(octadecenyl)- $30,000 $58,000 $42,000 $80,000

13 29385-43-1 1H-Benzotriazole, 4(or 5)-methyl- $23,000 $45,000 $28,000 $54,000

14 32072-96-1 2,5-Furandione, 3-(hexadecenyl)dihydro- $32,000 $61,000 $43,000 $83,000

15 61789-73-9 Quaternary ammonium compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, chlorides $2,000 $5,000 $2,000 $5,000

16 64665-57-2 1H-Benzotriazole, 4(or 5)-methyl-, sodium salt $25,000 $48,000 $30,000 $57,000

17 68131-13-5 Naphthenic acids, reaction products with diethylenetriamine $25,000 $48,000 $37,000 $70,000

18 68153-60-6 Fatty acids, tall-oil, reaction products with diethylenetriamine, 

acetates $32,000 $61,000 $43,000 $83,000

19 68424-85-1 Quaternary ammonium compounds, benzyl-C12-16-

alkyldimethyl, chlorides $3,000 $7,000 $4,000 $7,000

20 68442-77-3 2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-dihydro-2-nortall-oil 

alkyl-1H-imidazol-1-yl)ethyl] derivs. $32,000 $61,000 $43,000 $83,000

21 68607-28-3 Quaternary ammonium compounds, (oxydi-2,1-

ethanediyl)bis[coco alkyldimethyl, dichlorides $6,000 $11,000 $6,000 $11,000

22 68909-18-2 Pyridinium, 1-(phenylmethyl)-, Et Me derivs., chlorides $31,000 $59,000 $42,000 $81,000

23 69834-17-9 Benzene, decylphenoxy- $32,000 $61,000 $43,000 $83,000

TOTAL $480,000 $919,000 $641,000 $1,228,000 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 3 percent discount rate 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.

Note: Values may not sum due to rounding