## December 16, 2009

—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 Section 4 Test Rule for High Production Volume Chemicalsi 

## 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.iiiii 

## Contents

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

.................. 1-1

1.1 Statement of Need..............................................................................................................

........... 1-1

1.2 Organization of This Report ....................................................................................................

..... 1-3

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

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

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

2.3 Chemical-Specific Use and Market Information ........................................................................ 2-10

Chapter 3 – Social Costs of the Proposed Rule ..................................................................................

... 3-1

3.1 Industry Costs .................................................................................................................

.............. 3-1

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

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

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

4.1 Company-Level Impact ...........................................................................................................

..... 4-1

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

Chapter 5 – Benefits...........................................................................................................

...................... 5-1

5.1 Use Values .....................................................................................................................

............... 5-1

5.2 Non-Use Values.................................................................................................................

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

5.3 Benefits of the Required Tests.................................................................................................

..... 5-2

5.4 Benefits Related to E ach Regulated Chemical ........................................................................... 5-10

5.5 Potential Users of Information Generated by the Proposed Rule ............................................... 5-21

Chapter 6 – Other Impact Analyses..............................................................................................

......... 6-1

6.1 Paperwork Reduction Act........................................................................................................

..... 6-1

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

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

6.4 Executive Order 13175 – Consultation and Coordi nation with Indian Tribal Governments........ 6-4

6.5 Executive Order 13045 - Children’s Health ................................................................................. 6-4

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

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

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

Chapter 7 – References.........................................................................................................

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

Appendix A – Derivation of Ch emical Price Estimates....................................................................... A-1

A.1 Chemical Market Reporter

.......................................................................................................... A-1

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

......................... A-2

A.3 Similar Chemical Prices – CMR

.................................................................................................. A-2

A.4 Small Quantity Catalog Prices ..................................................................................................

... A-3

A.5 Small Quantity Catalog Prices for Similar Chemicals................................................................. A-7

A.6 American Chemistry Council Prices.......................................................................................... A-10

Appendix B – Cost Details......................................................................................................

................ B-1

Appendix C – Wage Rate Calculations............................................................................................

..... C-1

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

## Exhibits

Exhibit 2-1: Chemicals Included in the Proposed High Production Volume Chemical Test Rule............ 2-2 Exhibit 2-2: Employee and Sales Information for Potentially Impacted Companies Included in the Analysis............................................................................................................................................... 2-5 Exhibit 2-3: Distribution of Potentially Impacted Companies by Number of Employees......................... 2-6 Exhibit 2-4: Distribution of Potentially Impacted Companies by Annual Sales........................................ 2-6 Exhibit 2-5: Distribution of Production Volumes for Chemicals Included in the Proposed Rule (2006) . 2-7

Exhibit 2-6: Chemical Price and Production Volume Information............................................................ 2-8 Exhibit 2-7: Summary Statistics for Chemical Prices: $2008.................................................................... 2-9 Exhibit 2-8: Distribution of Prices for Chemicals Included in the Proposed Rule in 2008$ ................... 2-10

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

......... 2-10 Exhibit 3-1: Tests Required by EPA for HPV Chemic als, Based on the OECD’s Screening Information Data Set (SIDS) ................................................................................................................

................... 3-2 Exhibit 3-2: Test Requirements for Chemicals Included in the Proposed Rule......................................... 3-5 Exhibit 3-3: EPA Estimates of Laboratory Costs of Proposed Tests (2008$) ........................................... 3-9 Exhibit 3-4: Costs for Analytical Methodology Validation..................................................................... 3-13

Exhibit 3-5: Derivation of Loaded Hour ly Rates by Labor Category...................................................... 3-14 Exhibit 3-6: Industry Reporting Cost and Burden Esti mate for the Proposed Rule (2008$)................... 3-14 Exhibit 3-7: Export Notification Cost Estimate for the Proposed Rule (2008$) ..................................... 3-16 Exhibit 3-8: Summary of Total Industry Complianc e Costs Triggered b y the Proposed Rule (2008$) .. 3-16

Exhibit 3-9: Estimated Government Costs for the Proposed Rule (2008$)

............................................. 3-18 Exhibit 3-10: Summary of Total Social Cost s Triggered by the Proposed Rule (2008$)........................ 3-18

Exhibit 4-1: Annualized Costs Under Least and Aver age Cost Scenarios (Total for All Chemicals) ($2008)

................................................................................................................................................ 4-3 Exhibit 4-2: Summary Statistics for Ch e mical-Specific Cost-to-Sales Ratios 1

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

....... 4-5 Exhibit 4-4: Sensitivity Analysis: Summary Statis tics for Chem ical-Specific Cost-to-Sales Ratios ........ 4-5 Exhibit 4-5: Sensitivity Analysis: Summary Statisti cs for Com pany-Specific Cost-to-Sales Ratios, for

Chemicals with Cost-to-Sales Ra tios Greater Than 1 Percent ............................................................ 4-6 Exhibit 4-6: Summary Statistics for Company-Speci fic Cost-to-Sales Ratios for S mall Companies ....... 4-8 Exhibit 6-1: Reporting Burden Estimate for the Proposed Rule................................................................ 6-1 Exhibit 6-2: Total Industry Burden Ho ur Estimate for the Proposed Rule

................................................ 6-2

Exhibit 6-3: Estimated Government Burden for the Pr oposed Test Rule.................................................. 6-3 Exhibit A-1: Summary of Chemical Price Sources and Estimation Methods........................................... A-1

Exhibit A-2: Chemical Ma rket Reporter Prices (2008$) .......................................................................... A-2

Exhibit A-3: USITC Synthetic Organic Chemicals Pr ices (2008$).......................................................... A-2

Exhibit A-4: Chemical Ma rket Reporter Similar Chemical Prices (2008$) ............................................. A-3 Exhibit A-5: Comparison Between Chemical M arket Reporter and Sigma-Aldrich Prices..................... A-4 Exhibit A-6: Comparison Between CMR and Fisher Scientific Prices..................................................... A-4 Exhibit A-7: Prices Derived from Sigma-Aldrich .................................................................................

... A-6

Exhibit A-8: Prices of Similar Chemicals.......................................................................................

.......... A-8 Exhibit A-9: American Chemistry Council Prices.................................................................................

. A-10 Exhibit B-1: Industry Compliance and Government Costs, Least Cost Scenario..................................... B-3 Exhibit B-2: Industry Compliance and Government Costs, Average Cost Scenario................................ B-4

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

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

. B-6

Exhibit C-1: Detail of Labor Ca tegories Used in the Analy sis................................................................. C-1 Exhibit C-2: Derivation of Loaded Wage Rates ................................................................................... .... C-31-1 

## Chapter 1 – Introduction

Under the Toxic Substances Control Act (TSCA), th e U.S. EPA (EPA) can impose information reporting and other requirements on producers, importers, pr ocessors, users, distributors, and disposers of chemicals to ensure the safe management of toxic ch emicals. Under TSCA Section 4, EPA is authorized to require by rule that manufacturers and/or pr ocessors of chemical substances conduct testing to

determine the effect of chemical substances on human health and the environment. In particular, the Administrator requires that testing be conducted if the Agency finds that:

(1)(A) (i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or any combination of such activities, may pres ent an unreasonable risk of injury to health or the environment,

(ii) there are insufficient data an d experience upon which the effects of such manufacture, distribution in commerce, processing, use, or dis posal of such substance or mixtur e 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 pr oduced in substantial quantities, and (I) it enters or may reasonably be anticipated to enter the environment in substa ntial quantities or (II) there is or may be significant or substantial human exposure to such substance or mixture,

(ii) there are insufficient data an d experience upon which the effects of the manufacture, distribution in commerce, processing, use, or dis posal of such substance or mixtur e or of any combination of such activities on health or the environment can reasonably be determined or predicted, and

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

.

In 1998, a national effort was announ ced to expand the availability of information regarding the most widespread chemicals in co mmerce. To support this effort, in 2006, EPA promulgated its first test rule for 17 high production volume (HPV) chemicals that, unde r TSCA Section 4, have annual production and/or importation volumes of one million pounds or more. In 2008, EPA proposed a second test rule for an additional 19 HPV chemicals. Now, EPA is proposing a third test rule for 29 more HPV chemicals. The proposed rule will require the development of data si milar to that specified under Screening Information Data Set (SIDS) testing battery of the Organi sation for Economic Co-operation and Development (OECD).



### 1.1 Statement of Need

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

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

actions and make decisions based on the full costs of th eir own actions. On the other hand, if the market is unable to efficiently allocate goods and services, a market failure exists.

Executive Order 12866 requires the identification of the specific market failure that the significant rule addresses. The major causes of mark et failure identified in the Offi ce of Management and Budget (OMB) guidance (OMB, 2003) on Executive Order 12866 are exte rnality, natural monopoly, market power, and inadequate or asymmetric information. The proposed test rule is designed to address the issue of inadequate information and, to the extent that the in formation 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.1-2 1.1.1 Inadequate Information

Economic theory supports perfect information among buyers and selle rs as a requirement for rational decision making and for the efficient allocation of resources. When buyers or sellers do not have complete information about the true costs or bene fits of their choices, rational decision making cannot occur and the market fails. As an example, a pr oducer 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 info rmation; that is, a case in which consumers and producers do not have the same level of information re garding the hazards posed by a chemical substance. Typically, the producers’ level of information rega rding a product exceeds the consumers’ level of

information.

In the second case, chemical hazard information is inadequate (e.g., unknow n 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 info rmation. Information is non-rival (one person’s use

of information does not diminish the amount remain ing 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 th e information, resulting in a failure of the market to efficiently provide the information. In addition, individual consumers are unlikely to be willing to pay the cost of chemical tests to acquire the information if they can use information developed and paid for by

others.

1.1.2 Externalities

Externalities, another cause of market failure, occu r when the actions of one economic entity impose costs (or benefits) on parties that are “external” to the mark et 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 h ealth 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 busin ess 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 chemi cals 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. Give n that EPA’s TSCA Inventory recognizes more than 75,000 chemicals in commerce, chemical risk screeni ng represents a significant effort. Risk is a function1-3 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 regula tion will address market failure due to inadequate information by ensuring that basic information about th e health and environmental effects of certain HPV chemicals is available to the public. This informatio n 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 exte nt that the availability of this information induces the producers to account for these social costs, either because of fear of litigation, or because of the benefits of corporate stewardship, availability of information will address the negative externalities generated by producing or using these chemicals.



### 1.2 Organization of This Report

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

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

governm ent costs, are reported in Chapter 3. The economic impact analysis for the proposed rule is presented in Chapter 4. This chapter also includes a small business impact analysis as mandated by the Regulatory Flexibility Act (RFA), and amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA). Chapter 5 addresses the benefits of the proposed rule using a “value of inform ation” framework. The benefits analysis was undertaken to address the implicit call for cost-benefit balancing contained in TSCA, as well as the requirements of Executive Order 12866. Several additional impact analyses are presented in Chapter 6: an unfunded mandates statement, which is required b y the Unfunded Mandates Reform Act (UMRA); an environmental justice statement, which addresses the requirements of Executive Order 12898; a children’s health statement, which is mandated by Executive Order 13045; and the burden hour analysis, which responds to the re quirements of the Paperwork Reduction Act (PRA).

Note that all dollar amounts in this analysis are reported in 2008 dollars. For cost inputs that were estimated prior to 2008, EPA applied the most relevant adjustment factor to ensure that all costs were comparable.2-1 

## Chapter 2 – Use, Production, and Market Information

2.1 Introduction

This chapter presents use, production, and market information for the 29 chemicals included in the proposed rule. Exhibit 2-1 provides the Chemical Abstracts Service Registry Number (CASRN) assigned by the Chemical Abstracts Service (CAS) to each of these chemicals, the chemicals’ common names, and other synonyms used to research information pr esented in this analysis on the chemicals. 1, 2

1 The CAS is a division of the American Chemical Society, and assigns unique CASRNs to chemical substances. All CASRNs are compiled in the CAS Registry, the largest and most current database of its kind. Each CASRN designates only one chemical substance, and is a link to significant information about the chemical. For more information, see the American Chemical Society’s Chemical Abstracts Service at http://www.cas.org.

2 EPA identified synonyms for each chemical by searchin g the National Institute of Standards and Technology (NIST) WebBook and the U.S. NLM ChemIDplus Lite by CAS number.2-2Exhibit 2-1: Chemicals Included in the Proposed High Production Volume Chemical Test RuleCASRNCommon Chemical NameSynonyms1 83-41-0 2-Nitrobenzene, 1,2-dimethyl-o-Xylene, 3-nitro-; 1,2-Dimethyl-3-nitrobenzene; 2,3-Dimethylnitrobenzene; 3-Nitro-o-xylene2 96-22-0 3-PentanoneDiethyl ketone; 1,3-Dimethylacetone; DEK; Ethyl Ketone; Metacetone; Methacetone; Propione; (C2H5)2CO; Ethyl propionyl;Pentan-3-one; Diethylcetone; Pentanone-3; UN 1156; DimethylacetoneAI3-243373 98-09-9 Benzenesulfonyl chlorideBenzene sulfochloride; Benzene sulfonechloride; Benzenesulfonic chloride; Phenylsulfonyl chloride; Benzenesulfonic acidchloride; Benzenosulfochlorek; Benzenosulfochloride; Benzene sulphonyl chloride;Benezenesulfochloride; Benzenesulfonchloride; Benzenesulfonic(acid)chloride; Benzenesulphonyl chloride; Benzenosulphochloride; Benzolsulfochloride;Benzenesulfonyl chloride; Benzenesulphonyl chloride; Benzenesulfonyl chloride4 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)-Toluene, p-chloro-α,α,α-trifluoro-; (p-Chlorophenyl)trifluoromethane; p-(Trifluoromethyl)chlorobenzene; p-Chloro-α,α,αtrifluorotoluene; p-Chlorobenzotrifluoride; p-Chlorotrifluoromethylbenzene; p-Trifluoromethylphenyl chloride; 1-Chloro-4-(trifluoromethyl)benzene; 4-Chloro-α,α,α-trifluorotoluene; 4-Chlorobenzotrifluoride; para-Chlorobenzotrifluoride; 1-(Trifluoromethyl)-4-chlorobenzene; 1-Chloro-4-(trifluoromethyl)benzene; Benzene, 1-chloro-4-(trifluoromethyl)-;alpha,alpha,alpha-Trifluoro-4-chlorotoluene; para-Chloro-alpha,alpha,alpha-trifluorotoluene; paraChlorotrifluoromethylbenzene; Benzene, 1-chloro-4-(trifluoromethyl)-; Benzene, 1-chloro-4-(trifluoromethyl)-5 111-44-4 Ethane, 1,1'-oxybis[2-chloroBis(2-chloroethyl) ether; s-Dichloroethyl ether; Ethane,1,1'-oxybis[2-chloro-; Ether, bis(2-chloroethyl);β,β'-Dichlorodiethylether;β,β'-Dichloroethyl ether; Bis(β-chloroethyl) ether; Bis(chloro-2-ethyl) oxide; Chlorex; Di(β-chloroethyl) ether; DCEE;Khloreks; 1-Chloro-2-(β-Chloroethoxy)ethane; 2-Chloroethyl ether; 2,2'-Dichlorethyl ether; 2,2'-Dichlorodiethyl ether; 2,2'-Dichloroethyl ether; 2,2'-Dichlorodiethyl oxide; sym-Dichloroethyl ether; Bis(chloroethyl) ether; Chloroethyl ether; Clorex;Di(2-chloroethyl) ether; Dichlorodiethyl ether; Dichloroether;Dichloroethyl ether; Dichloroethyl oxide; Dwuchlorodwuetylowyeter; Ether dichlore; ENT 4,504; Oxyde de chlorethyle; 1,1'-Oxybis(2-chloroethane); 1,5-Dichloro-3-oxapentane; 2,2'-Dichloorethylether; 2,2'-Dichlor-diaethylaether; 2,2'-Dicloroetiletere;β,β-Dichlorodiethyl ether; Ethane, 1,1'-oxybis*2-chloro-;Diethylene glycol dichloride; Ether, bis(chloroethyl); 1-Chloro-2-(2-chloroethoxy)ethane; 2,2'-Dichloorethylether; 2,2'-Dichlordiaethylaether; Dichloroether; Dichloroethyl ether6 127-68-4Benzenesulfonic acid, 3-nitro-, sodium salt(1:1)3-Nitrobenzenesulfonic acid, sodium salt; Benzenesulfonic acid, 3-nitro-, sodium salt; Sodium3-nitrobenzenesulfonate;Sodium m-nitrobenzenesulfonate;Benzenesulfonic acid, 3-nitro-,sodium salt; Benzenesulfonic acid, m-nitro-, sodium salt;Ludigol; Ludigol F,60; Nacan; Nitrobenzen-m-sulfonan sodny; Nitrobenzen-m-sulfonansodny [Czech]; Nitrol S; Sodium 3-nitrobenzenesulfonate; Sodium m-nitrobenzenesulfonate; Tiskan; Tiskan [Czech];m-Nitrobenzenesulfonicacid sodium salt;Benzenesulfonic acid, 3-nitro-, sodium salt (1:1); Benzenesulfonic acid, m-nitro-, sodium salt; Sodium 3-nitrobenzenesulphonate; Benzenesulfonic acid, m-nitro-, sodium salt; m-Nitrobenzenesulfonic acid, sodium salt7 506-51-4 1-Tetracosanoln-Tetracosanol; Lignoceric alcohol; Lignoceryl alcohol; 1-Tetracosanol; Tetracosan-1-ol; Tetracosyl alcohol; Lignocerol;Tetracosanol8 506-52-5 1-Hexacosanoln-Hexacosanol; Ceryl alcohol; Cerylic alcohol;Hexacosyl alcohol; 1-Hexacosanol9 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)-Neophyl chloride; 2-Chloromethyl-2-phenylpropane; (2-Chloro-1,1-dimethylethyl)benzene; Benzene, (2-chloro-1,1-dimethylethyl)-;β-Chloro-tert-butylbenzene;β,β-Dimethylphenethyl chloride; (β-Chloro-α,α-dimethyl)ethylbenzene; 2-Methyl2-phenylpropyl chloride; (beta-Chloro-tert-butyl)benzene10 2494-89-5Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate)4-((2-Sulfatoethyl)sulfonyl)aniline; 2-((p-Aminophenyl)sulphonyl)ethyl hydrogensulphate; Ethanol, 2-((4-aminophenyl)sulfonyl)-, 1-(hydrogen sulfate); Ethanol, 2-sulfanilyl-, hydrogen sulfate (ester)11 5026-74-42-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-Oxiranemethanamine, N-[4-(oxiranylmethoxy)phenyl]-N-(oxiranylmethyl)-; Aniline, p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)-; p-(Diglycidylamino)phenyl glycidyl ether; p-Aminophenol triglycidyl ether; ERL 0500; ERL-0510(Triglycidyl-pAminophenol); N,N,O-Tris(epoxypropyl)-p-aminophenol; 4-(Diglycidylamino)phenyl glycidyl ether; 4-(2-Oxiranylmethoxy)-N,N-bis(2-oxiranylmethyl)aniline; BRN1393091; N-(4-(Oxiranylmethoxy)phenyl)-N-(oxiranylmethyl)oxiranemethanamine; TK12759; 2-Oxiranemethanamine, N-(4-(2-oxiranylmethoxy)phenyl)-N-(2-oxiranylmethyl)-; p-(2,3-Epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline;12 22527-63-5Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester3-Benzoyloxy-2,2,4-trimethylpentyl isobutyrate; Isobutyricacid, 3-hydroxy-2,2,4-trimethylpentyl ester benzoate2-3Exhibit 2-1: Chemicals Included in the Proposed High Production Volume Chemical Test RuleCASRNCommon Chemical NameSynonyms13 24615-84-7 2-Propenoic acid, 2-carboxyethyl ester3-Acryloyloxypropionic acid; 2-Carboxyethyl 2-propenoate; 2-Carboxyethyl acrylate; Sipomer B-CEA; beta-(Acryloyloxy)propionic acid; beta-Carboxyethyl acrylate; 2-Carboxyethyl acrylate; 2-Propenoic acid, 2-carboxyethyl ester;Hydracrylic acid, acrylate (6CI,8CI); Hydracrylic acid, acrylate14 25321-41-9 Benzenesulfonic acid, dimethyl- Dimethylbenzenesulfonic acid; Xylene sulfonic acid; Xylenesulphonic acid; Xylenesulfonic acid15 25646-71-3Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate(2:3)Methanesulfonamide, N-(2-((4-amino-3-methylphenyl)ethylamino)ethyl)-, sulfate (2:3); N-(2-(4-Amino-N-ethyl-mtoluidino)ethyl)methanesulfonamide sulfate (2:3); Methanesulfonamide, N-(2-((4-amino-3-methylphenyl)ethylamino)ethyl)-,sulfate (2:3); Methanesulfonamide, N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)-, sulfate (2:3); N-(2-(4-Amino-N-ethyl-mtoluidino)ethyl)methanesulphonamide sesquisulphate; Methanesulfonamide, N-(2-((4-amino-3-methylphenyl)ethylamino)ethyl)-, sulfate (2:3)16 52556-42-01-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)1-Propanesulfonic acid, 2-hydroxy-3-(2-propenyloxy)-, monosodium salt; 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1); Sodium 3-(allyloxy)-2-hydroxypropanesulphonate; 1-Propanesulfonic acid, 2-hydroxy-3-(2-propenyloxy)-, monosodium salt17 61788-76-9 Alkanes, chloroAlkanes, chloro; Paraffins, chloro; Alkanes, chloro; Alkanes, chloro; [Chlorinated paraffins]18 65996-79-4 Solvent naphtha (coal)Solventnaphtha (coal); Solvent naphtha (coal); Solvent naphtha, coal; Solvent naphtha, (coal)19 65996-82-9 Tar oils, coalChemical oil (coal); High flash acid fraction; Intermediate naphthalene; Tar oils, coal; Tar oils,coal20 65996-89-6 Tar, coal, high-temp.Coal tar; Coal, high-temp. tar; Tar decanter sludge; Coal-tars, high temperature21 65996-92-1 Distillates (coal tar)Coal tar distillate; Middle coal tar distillate; Middle tar distillate (coal); Distillates (coal tar); Distillates, coal tar; Coal tardistillates, flammable [UN1136] [Flammable liquid]; Distillates (coal tar); Distillates, (coal tar)22 68082-78-0 Lard, oil, Me estersLard oil fatty acids, methyl esters; Lard oil methyl esters; Lard oil, methyl ester; Lard oil, methyl esters; Lard, methyl ester;Lard, methyl esters; Lard, oil, Me esters; Oils, lard, Me esters; Lard, oil, Me esters23 68187-57-5 Pitch, coal tar-petroleumAromatic pitch (coal-petroleum)24 68442-60-4Acetaldehyde, reaction products withformaldehyde, by-products fromEINECS 270-480-625 68610-90-22-Butenedioic acid (2E)-, di-C8-18-alkylesters(C8-C18)Dialkyl fumarate; 2-Butenedioicacid (E)-, di-C8-18-alkyl esters26 68988-22-71,4-Benzenedicarboxylic acid, 1,4-dimethylester, manuf. of, by-products fromDimethyl terephthalate stripper bottoms; Polyphenyl polyesterbottoms; Polyphenylcarboxylic acids, methyl esters; 1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from27 70693-50-4Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-2-Nitro-2'-hydroxy-3',5'-bis(alpha,alpha-dimethylbenzyl)azobenzene; 2,4-Bis(1-methyl-1-phenylethyl)-6-((2-nitrophenyl)azo)phenol; Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-(2-(2-nitrophenyl)diazenyl)-; Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-((2-nitrophenyl)azo)-28 72162-15-3 1-Decene, sulfurized1-Decene, sulfurized; 1-Decene, sulfurized29 73665-18-6Extract residues (coal), tar oil alk.,naphthalene distn. residuesNaphthalene still residue; Extract residues (coal), tar oil alk., naphthalene distn. Residues; Extract residues, coal, tar oilalk,naphthalene distn. Residues; Extract residues, (coal), tar oil alk., naphthalene distn. residuesSources:National Institute of Standards and Technology, 2008, and U.S. U.S. NLM, 2008a.2-4 

### 2.2 Chemical Use and Market Information

EPA collected chemical use and market information fo r the chemicals included in the proposed rule to analyze the rule’s potential impact on manufacturers of these substances. For example, chemical use information is useful in determining the markets the chemicals are sold in and the general profitability of those markets. Producer, price, and production volume data are used more specifically to estimate the

annual revenue that each manufacturer of the chemic als in the proposed rule generates from those chemicals, and to compare these revenues to the compliance costs for each chemical pursuant to the proposed rule.

The current chapter discusses methods employed to evaluate use and market information for each chemical included in the proposed rule, and presents a summary of results. Market information presented includes publicly available producer, production, trade, and price information, where these data were available. Chemical-specific use and market informati on for each chemical included in the proposed rule is presented in Section 2.3.

2.2.1 Chemical Producer and Production Information

EPA acquired chemical producer and production info rmation from submissions required by the Toxic Substances Control Act (TSCA) Inventory Update Reporting (IUR) Revisions rule (70 FR 75059, December 19, 2005) and the Preliminary Assessment Information Reporting (PAIR); Addition of Certain Chemicals rule (71 FR 47122, August 16, 2006).

The IUR rule requires manufacturers and importers of certain chemical substances contained in the TSCA Chemical Substances Inventory with a site-specifi c production/import volume of 25,000 pounds or more to report current data on their production volumes, pl ant sites, and other information related to the manufacture of the chemicals. Since 1986, reporting under the IUR rule has taken place at four-year

intervals. 3 The data presented in this chapter are from t he 2006 reporting cycle, which covers production in calendar year 2005, and represents the most recent data available.

The PAIR rule requires manufacturers and importe rs that manufactured or imported certain HPV Challenge Program 4 orphan (unsponsored) chemicals during their latest complete corporate fiscal year (which could be the calendar year 2005, or a year sp anning months in 2005 or 2006) to submit a one-time report on general production/importation volume, end u se, and exposure-related information to EPA.

Manufacturers were included in this analysis if they reported, through either rule, any production volume for any of the chemicals regulated under this propo sed High Production Volume Chemical test rule. In cases where the volumes reported under both rules did not match, the higher production volume was used in this analysis.

IUR rule and PAIR rule submissions can include both confidential business information (CBI) and nonconfidential information related to producers a nd production volumes. Manufacturer’s identities and production volumes used in calculations for this anal ysis were considered CBI; however, this report presents those data in a non-CBI format.

3 The 2005 amendments to the IUR rule ch anged the reporting cycle from four year s to five years; the next reporting cycle will cover calendar year 2010.

4 EPA’s voluntary HPV Challenge Program was created to encourage the development of a baseline set of data on approximately 2,800 HPV chemicals. Since the Program’s inception in 1998, industry chemical manufacturers and importers have participated in the Challenge by sponsoring 2,250 chemicals. More than 350 companies and 100 consortia have sponsored chemicals directly in the Pr ogram. HPV chemicals that are not sponsored under the Program may be subject to a test rule under TSCA Section 4, such as this proposed rule.2-5 Based on IUR and PAIR reporting, EPA identified 54 gl obal ultimate parent companies that produce the 29 chemicals included in the proposed test rule. A company was included in this analysis if it reported under either the IUR or PAIR rule. This figure may not include all potentially affected entities because, for example, companies that manufactured or imported less than 25,000 pounds of a subject chemical at an individual site in 2006 are not required to comp ly with IUR reporting; however, EPA believes this figure presents a reasonable estimate for the purpose of analyzing the effects of the proposed rule. If the 2006 production volumes reported by a company for a specific chemical differed between the submissions for the IUR and PAIR rule, the larger of the reported volumes was used in this analysis.

Once producers of each chemical were identified, EPA used facility-specific Dun & Bradstreet identification numbers (DUNS numbers) from Dun & Bradstreet’s DUNS Market Identifier database (Dun & Bradstreet, 2008) and information about facility location provided in the IUR database to identify facilities and their global ultimate parent companies. 5 A search conducted using the Dun & Bradstreet database also provided data on annual sales and number of employees at the parent company level for all facilities determined to be potentially subject to the proposed rule. EPA was able to collect information on sales and employment for most of the parent comp anies using the Dun & Bradstreet database. Annual sales data and employee data were available for 52 of the 54 global ultimate parent companies identified. 6
Exhibit 2-2 provides summary statistics of the available data for the 54 companies included in this analysis. As shown in Exhibit 2-2, potentially impacted companies vary widely as measured by both

num ber of employees and annual sales.

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

Statistical Measure Number of Employees Annual Sales

Minimum Value 2 $176,770

Maximum Value 328,700 $404,552,000,000

Median Value 4,072 $1,866,290,799

Mean Value 22,257 $21,001,345,806

Standard Deviation 51,185 $62,239,022,706

Source: Dun & Bradstreet, 2008. Note: Employee and annual sales data were available for 52 of the 54 global ultimate parent companies
identified.

Exhibit 2-3 and Exhibit 2-4 show the distribution of potentially impacted companies considered in the analy sis by number of employees and annual sales, respectively.

5 Dun & Bradstreet is a New York-based company that pr ovides business information through a global commercial database. It assigns DUNS numbers to identify businesses around the world. These numbers are required for many U.S. federal government transactions and therefore are widely used and assigned. DUNS numbers are also frequently used in corporate research. Database entries provide legal and trade names, physical and mailing addresses, geographical descriptions, product and industry descriptors, sales and number of employees for three years and associated growth rates, as well as up to 40 vital statistics about each organization.

6 The reporting year for the most current data in the Dun & Bradstreet database varied across companies.2-6 Exhibit 2-3: Distribution of Potentially Impacted Companies by Number of Employees

0 2 4 6 8 10 12 14 16

0 to 100 101 to 500 501 to 5,000 5,001 to

10,000 10,001 to

50,000 > 50,000

Number of EmployeesNumber of Companies

Source: Dun & Bradstreet, 2008.

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

0 2 4 6 8 10 12 14 16

$0 to $100 $101 to $500 $501 to $2,000 $2,001 to

$10,000 > $10,000

Annual Sales ($Millions)Number of Companies

Source: Dun & Bradstreet, 2008.

The distribution of chemicals included in the proposed rule by production volume range is illustrated in Exhibit 2-5. As shown, approximately 70 percent of the che micals included in the proposed rule are produced in volumes of 50 milli on pounds or less annually.2-7 Exhibit 2-5: Distribution of Production Volum es for Chemicals Included in the Proposed Rule (2006)

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 <1B 1 Billion or

more

Production Volume (lbs)Number of Chemicals

Source: U.S. EPA, 2008b.

2.2.2 Chemical Price Information

Published price data were available for some chemicals from the Chemical Market Reporter (CMR) (ICIS, 2006). Other chemicals were listed in the U. S. International Trade Commission’s report entitled Synthetic Organic Chemicals (USITC, 1992); for the remainder of chemicals, EPA derived prices from these and other publications using a number of assumptions. This section first discusses the method used to obtain chemical prices from the CMR and USITC, and then discusses the methods used to derive chemical prices for the remaining ch emicals. Based on this chemical price search method, EPA has either obtained or derived price data for all 29 chemicals included in the proposed rule.

Price Data Available from the CMR and USITC. Using the following sequential methodological steps, EPA was able to locate price data for three chemicals:

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

CMR for price data using synonyms for each common chemical name as summarized in Exhibit 2-1. Price data on only one of the chemicals were available from the CMR.

• USITC: Where available, EPA used the average price per pound of chemicals from various Harmonized Tariff Schedule (HTS) chemical groups in USITC’s report entitled Synthetic Organic

Chemicals. For two chemicals, the price was available as part of an HTS group. Because the last USITC report was published in 1992, EPA then infl ated these costs using the producer price index (PPI) for chemical manufacturing.

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

below.

• Similar Chemical Prices. For two chemicals, EPA used CMR data for another chemical that is similar in chemical composition, use, or manufacture.2-8 • Small Quantity Catalog Prices. Online chemical catalogs pub lished by Sigma-Aldrich Company (2008), and Fisher Scientific (2008) provided small quantity price information for 11 of the remaining

chemicals for which data were not available using the sources and methods described above. However, because small quantity catalog prices are often significantly higher than the bulk quantity prices reported in the CMR, EPA adjusted the small quantity catalog prices for these 11 chemicals to approximate bulk quantity prices. To determine th e appropriate adjustment factor, EPA randomly selected 12 chemicals (not subject to this proposed rule) for which price data were available from

both the CMR (2006, inflated to 2008 prices using PPI) and Sigma-Aldrich (2008), and compared the prices to develop scaling factors (see Exhibit A-5 in Appendix A). For example, the price of a 1-kilogram quantity of 3-Pentanone (CASRN 96-22-0), as found in the Sigma-Aldrich catalog, is $42.00. Using standard conversion methods (1 kilogram = 2.204 pounds), the implied small quantity price per pound for this chemical is $19.06. This small quantity price is then divided by a scaling

factor of 46.52 to arrive at an estimated bulk quantity price of $0.41 per pound for this chemical.

• Small Quantity Catalog Prices of Similar Chemicals. For 10 additional chemicals, EPA was able to find “similar chemicals” with prices quoted in the Sigma-Aldrich or Fisher Scientific catalog. The Agency followed the same met hod as that described above to scale these small quantity catalog prices to approximate bulk quantity prices.

• American Chemistry Council Prices. The American Chemistry Council (ACC) publishes a “Guide to the Business of Chemistry,” which contains price information for certain types of chemicals. According to the guide published in 2008 (ACC, 2008) , a rule of thumb for specialty chemicals is that the price is greater than $1.25 per pound and a rule of thumb for basic chemicals is that the price is less than $0.75 per pound. To be conservative, EPA used a price of $0.75 per pound for the remaining

three chemicals.

Appendix A provides further detail on the methods used to estimate chemical prices. Exhibit 2-6 presents the price per poun d for the chemicals included in this proposed rule, as well as the publicly available production volume ranges (as noted earlier, this analysis uses actual production volumes as reported through the IUR or PAIR rules, which may be considered CBI). Exhibit 2-7 presents summary statistics of this price i nformation. Exhibit 2-8 presents the distribution of chemical prices.

Exhibit 2-6: Chemical Price and Production Volume Information

Chemical (CASRN) Price/lb ($2008) Source for Pricing Production Volume Range (lbs) Source for

Production

Volume 1

2-Nitrobenzene, 1,2-dimethyl- (83-41-0) $0.31 Sigma-Aldrich 10M to < 50M PAIR

3-Pentanone (96-22-0) $0.41 Sigma-Aldrich 10M to < 50M IUR

Benzenesulfonyl chloride (98-09-9) $0.59 USITC 1M to < 10M IUR

Benzene, 1-chloro-4-(trifluoromethyl)- (98-56-6) $0.25 Sigma-Aldrich 1M to < 10M IUR

Ethane, 1,1'-oxybis[2-chloro- (111-44-4) $0.51 Sigma-Aldrich 1M to < 10M IUR

Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) (127-68-4) $0.30 Sigma-Aldrich 1M to < 10M IUR

1-Tetracosanol (506-51-4) $10.17 Sigma-Aldrich 1M to < 10M PAIR

1-Hexacosanol (506-52-5) $7.99 Sigma-Aldrich 1M to < 10M PAIR

Benzene, (2-chloro-1,1-dimethylethyl)- (515-40-2) $1.27 Sigma-Aldrich 1M to < 10M IUR2-9 Exhibit 2-6: Chemical Price and Production Volume Information

Chemical (CASRN) Price/lb ($2008) Source for Pricing Production Volume Range (lbs) Source for

Production

Volume 1

Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate) (2494-89-5) $0.74 Sigma-Aldrich (by proxy) 1M to < 10M IUR

2-Oxiranemethanamine, N-[4-(2- oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)- (5026-74-4) $0.73 Sigma-Aldrich 1M to < 10M IUR

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4- trimethylpentyl ester (22527-63-5) $1.25 ACC 1M to < 10M IUR

2-Propenoic acid, 2-carboxyethyl ester (24615-84-7) $2.26 Sigma-Aldrich 1M to < 10M IUR

Benzenesulfonic acid, dimethyl- (25321-41-9) $2.89 USITC 1M to < 10M IUR

Methanesulfonamide, N-[2-[(4-amino-3- methylphenyl)ethylamino]ethyl]-, sulfate (2:3) (25646-71-3) $0.73 Sigma-Aldrich (by proxy) 1M to < 10M IUR

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1- yloxy)-, sodium salt (1:1) (52556-42-0) $1.13 Sigma-Aldrich 1M to < 10M IUR

A lkanes, chloro (61788-76-9) $0.89 CMR 10M to < 50M IUR

Solvent naphtha (coal) (65996-79-4) $0.75 ACC 10M to < 50M IUR

Tar oils, coal (65996-82-9) $0.49 Sigma-Aldrich (by proxy) 100M to < 500M IUR

Tar, coal, high-temp. (65996-89-6) $1.13 Sigma-Aldrich (by proxy) >1 billion IUR

Distillates (coal tar) (65996-92-1) $0.75 ACC 100M to < 500M IUR

Lard, oil, Me esters (68082-78-0) $0.72 Sigma-Aldrich (by proxy) 1M to < 10M IUR

Pitch, coal tar-petroleum (68187-57-5) $0.71 Sigma-Aldrich (by proxy) 100M to < 500M IUR

A cetaldehyde, reaction products with formaldehyde, by-products from (68442-60-4) $0.24 CMR 1M to < 10M IUR

2-Butenedioic acid (2E)-, di-C8-18-alkyl esters (68610-90-2) $33.52 Fisher (by proxy) 1M to < 10M IUR

1,4-Benzenedicarboxylic acid , 1,4-dimethyl ester, manuf. of, by-products from (68988-22-7) $0.49 CMR 10M to < 50M IUR

Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2- nitrophenyl)diazenyl]- (70693-50-4) $5.97 Sigma-Aldrich (by proxy) 1M to < 10M IUR

1-Decene, sulfurized (72162-15-3) $0.21 Sigma-Aldrich (by proxy) 1M to < 10M IUR

Extract residues (coal), tar oil alk., naphthalene

distn. residues (73665-18-6) $0.49 Sigma-Aldrich (by proxy) 50M to < 100M IUR

1 “IUR” production volume information from U.S. EPA, 2009. “ PAIR” production volume information from U.S. EPA, 2008c.

Exhibit 2-7: Summary Statistics for Chemical Prices: $2008

Minimum price per pound $ 0.21 Maximum price per pound $33.52 Mean price per pound $ 2.67 Median price per pound $ 0.73

Standard deviation $ 6.392-10 Exhibit 2-8: Distribution of Prices for Chem icals Included in the Proposed Rule in 2008$

0 2 4 6 8 10 12

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

Price Range ($/lb)Number of Chemicals



### 2.3 Chemical-Specific Use and Market Information

This section presents use information for each of the ch emicals included in the proposed test rule. To find information on chemical uses, EPA relied on readily av ailable 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 inform ation for 27 of the 29 chemicals using various sources. Chemical use information is presented in Exhibit 2-9. Data reported to EPA through the IUR rule reporting req uirements (2006 reporting cycle) are also shown.

Exhibit 2-9: Chemical Use Information

Chemical (CASRN) Use IUR-Reported Use Information

1 3-Nitrobenzene, 1,2-dimethyl- (83-41-0) • plasticizer

• raw material for mefenamic acid, an antiinflammatory and others (BSM Chemical Co., 2009; Milne, 2005) • None reported

2 3-Pentanone (96-22-0) • in the manufacture of medicines

• solvent for paints

• ingredient in flavors and cosmetics (U.S. NLM, 2008b; Ash, 2003) • Industrial Sectors: Other Basic Organic Chemical Manufacturing; Pesticide and Other Agricultural Chemical Manufacturing; Other

Chemical and Allied Products

Merchant Wholesalers

3 Benzenesulfonyl chloride (98-09-9) • chemical intermediate for benzene sulfonamides, thiophenol, glybuzole, n-2-chloroethyl amides, and

benzonitrile

• reagent for Friedel-Crafts sulfonylation

• esters are useful as in secticides and miticides (U.S. NLM, 2008b) • Industrial Sector: Other Basic Organic Chemical Manufacturing

• Commercial/Consumer Product

Category: Rubber and plastic products2-11 Exhibit 2-9: Chemical Use Information

Chemical (CASRN) Use IUR-Reported Use Information

4 Benzene, 1-chloro-4- (trifluoromethyl)- (98-56-6) • solvent for industrial cl eaning, aerosols, adhesives, coatings, inks, and electronic applications.

• 1,1,1-trichloroethane alternative

• dye intermediate

• dielectric fluid

• dinitroaniline herbicide intermediate

• ingredient in home maintenance product (Ash, 2003; Merck Index, 2001; U.S. NLM, 2009) • Industrial Sectors: Adhesive Manufacturing; All Other Chemical Product and Preparation Manufacturing; Other Basic Inorganic Chemical Manufacturing; Other Basic Organic Chemical Manufacturing; Paint and Coating Manufacturing; Resin and Synthetic Rubber Manufacturing

5 Ethane, 1,1'-oxybis[2-chloro- (111-44-4) • scavenges lead deposits in gasoline

• an anesthetic

• an acaricide

• in the manufacture of medicines and

pharmaceuticals

• in an oil solution sprayed on corn silks to control

earworms

• general solvent

• selective solvent for production of high-grade

lubricating oils

• intermediate and crosslinking agent in organic

synthesis

• textile scouring and cleansing

• in fulling compounds

• in wetting and penetrating compounds

• in paints, varnishes, lacquers, finish removers,

spotting and dry cleaning

• in soil fumigants (U.S. NLM, 2008b; Ash, 2003; Merck Index, 2001) • Industrial Sector: Basic Organic Chemical Manufacturing (functions

as a corrosion inhibitor or antiscaling agent)

6 Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) (127-68-4) • stabilizer for fiber reactive dyeing

• assistant in discharge printing

• viscosity control agent in cosmetics

• oxidizing agent in demetalizers and industrial

cleaners

• anti-reduction agent (Ash, 2003; U.S. NLM, 2008b) • None reported

7 1-Tetracosanol (506-51-4) • ingredient in dietary supplements and pharmaceuticals

• protect water against evaporation
Note: information is for l ong chain-length fatty alcohols

generally. (Ash, 2003; U.S. NLM, 2008b) • None reported

8 1-Hexacosanol (506-52-5) • wood office work surfaces, particularly modular

units

• rhombic plates (Scorecard, 2008; Milne, 2005) • None reported

9 Benzene, (2-chloro-1,1- dimethylethyl)- (515-40-2) • pesticide raw material

• precursor to catalysts used for olefin polymerization (Chemhost, Inc., 2009; U.S. Patent and Trade Office, 1984 and 2006) • Industrial Sector: Pesticide and Other Agricultural Chemical Manufacturing

• Commercial/Consumer Product

Category: Agricultural products (nonpesticidal)

10 Ethanol, 2-[(4- aminophenyl)sulfonyl]-, 1- (hydrogen sulfate) (2494-89-5) • indicator and/or reagent (U.S. NLM, 2008a) • Reported as CBI2-12 Exhibit 2-9: Chemical Use Information

Chemical (CASRN) Use IUR-Reported Use Information

11 2-Oxiranemethanamine, N-[4-(2- oxiranylmethoxy)phenyl]-N-(2- oxiranylmethyl)- (5026-74-4) • in epoxy resins (composit e aircraft bodies/parts) (Ashford’s Dictionary of Industrial Chemicals, 2001) • Industrial Sectors: Resin and Synthetic Rubber Manufacturing; Aerospace Product and Parts Manufacturing

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

ester (22527-63-5) • plasticizer (Velsicol Chemical Corporation, 2009) • Industrial Sector: Other Plastics Product Manufacturing

• Commercial/Consumer Product

Category: Rubber and plastic products

13 2-Propenoic acid, 2-carboxyethyl

ester (24615-84-7) • reactive monomer for emulsion polymerization

• in adhesives; adhesion promoter.

• improves latex stability and rheology (Ash, 2003) • Industrial Sector: All Other Chemical Product and Preparation Manufacturing

• Commercial/Consumer Product

Category: Other

14 Benzenesulfonic acid, dimethyl- (25321-41-9) • esterification an acetylation catalyst

• catalyst for coatings and foundry resins

• in the preparation of esters

• hardening agent in plastics

• activator for nicotine insecticides

• curing agent for resins, phenolic foundry resins

• descaling agent in foundry sand castings

• plating aid in electroplating baths

• hydrotrope for agricultural formulations

• surfactant in cosmetics (Ash, 2003; Ashford, 2001) • None reported

15 Methanesulfonamide, N-[2-[(4-

amino-3- methylphenyl)ethylamino]ethyl]-, sulfate (2:3) (25646-71-3) • photographic developing agent

• non-steroidal anti-inflammatory agent (Ashford, 2001; U.S. NLM, 2008a) • Industrial Sectors: Other Basic Organic Chemical Manufacturing; All
Other Chemical Product and Preparation Manufacturing

• Commercial/Consumer Product

Category: Photographic supplies

16 1-Propanesulfonic acid, 2-hydroxy3-(2-propen-1-yloxy)-, sodium salt (1:1) (52556-42-0) • polymerizable surfactant for vinylic systems

• antistatic properties

• promotes adhesion of pigments

• emulsion polymerization in paper, textile, fiber, and

adhesives industries (Ash, 2003) • Industrial Sectors: All Other Chemical Product and Preparation Manufacturing; Other Basic Organic Chemical Manufacturing.

• Commercial/Consumer Product

Category: Other

17 Alkanes, chloro (61788-76-9) • lubricant

• curing agent (Ash, 2003) • Industrial Sectors: Adhesive Manufacturing; Other Petroleum and Coal Products Manufacturing;

Rubber and Plastics Hoses and Belting Manufacturing;

• Industrial Functions: Adhesives and

binding agents; Lubricant; Flame retardant; functional fluid.

• Commercial/Consumer Product

Category: Adhesives and sealants.

18 Solvent naphtha (coal) (65996-79-4) • fullerene synthesis (U.S. Patent and Trade Office, 1984, 2006) • Industrial Sectors: Other Basic Organic Chemical Manufacturing

• Industrial Function: Fuel

• Commercial/Consumer Product

Category: Other2-13 Exhibit 2-9: Chemical Use Information

Chemical (CASRN) Use IUR-Reported Use Information

19 Tar oils, coal (65996-82-9) • pesticide products

• wood preservers

• disinfectants (Scorecard, 2008) • Industrial Sector: Other Basic Organic Chemical Manufacturing

• Commercial/Consumer Product

Categories: Rubber and plastic products; Wood and wood furniture;
Other

20 Tar, coal, high-temp. (65996-89-6) • epoxies (Seton, 2009) • Industry Sectors: Iron and Steel Mills and Ferroalloy Manufacturing; Other Basic Organic Chemical Manufacturing; Other Petroleum and Coal Products Manufacturing; Asphalt Paving, Roofing, and Saturated Materials Manufacturing; Paint and Coating Manufacturing.

• Commercial/Consumer Product

Category: Paints and coatings

21 Distillates (coal tar) (65996-92-1) • topical pharmaceuticals (Mediceutical Laboratories, Inc., 2009) • Industry Sectors: Other Basic Organic Chemical Manufacturing; All Other Miscellaneous Manufacturing;

• Commercial/Consumer Product

Categories: Rubber and plastic products; Wood and wood furniture;
Other

22 Lard, oil, Me esters (68082-78-0) • lubricants (Lubriplate Lubricants Co., 2009) • Industry Sector: Other Basic Organic Chemical Manufacturing

23 Pitch, coal tar-petroleum (68187-57-5) • rubber resin coatings (U.S. Bureau of Land Management, 2009) • Industry Sector: Alumina and

Aluminum Production and Processing

• Commercial/Consumer Product

Category: Metal products

24 Acetaldehyde, reaction products with formaldehyde, by-products from (68442-60-4) This includes the complex combination obtained by the reaction of acetaldehyde with formaldehyde; it contains pentaerythritol o ligomers and their acetals, formals, hemiacetals and hemiformals.
No use information found. • Reported as CBI

25 2-Butenedioic acid (2E)-, di-C8-18- alkyl esters (68610-90-2) No use information found. • Industry Sector: Other Basic Organic Chemical Manufacturing

• Industrial Function: Lubricant

26 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, manuf. of, byproducts from (68988-22-7) This chemical is a complex residuum from the distillation of products from the manufacture of dimethyl terephalate by air oxidation and esterification of p-xylene. It consists of polyphenyl polyesters.
No use information found. (U.S. NLM, 2008a) • Industry Sectors: Resin and Synthetic Rubber Manufacturing; Other Basic Organic Chemical Manufacturing

27 Phenol, 2,4-bis(1-methyl-1- phenylethyl)-6-[2-(2- nitrophenyl)diazenyl]- (70693-50-4) No use information found. • Reported as CBI

28 1-Decene, sulfurized (72162-15-3) • Sulfurized alpha-olefins in the C 16 – C 24 range are used as extreme-pressure agent in end uses such as metalworking, auto and industrial gear, oils and greases, and to some extent hydraulic fluids. (SRI Consulting, 2007) • Industry Sector: Other Petroleum and Coal Products Manufacturing;

• Industrial Function: Lubricant2-14 Exhibit 2-9: Chemical Use Information

Chemical (CASRN) Use IUR-Reported Use Information

29 Extract residues (coa l), tar oil alk., naphthalene distn. residues (73665-18-6) Tar-derived products include:

• ammonium sulfate

• sulfuric acid

• phenols

• cresols

• BTX

• Naphthalene

• Pyridine

• Phenanthrene

• Anthracene

• creosote

• road tars

• roofing pitches

• pipeline enamels. (SRI Consulting, 1997) • Industry Sector: Other Basic Organic Chemical Manufacturing

• Commercial/Consumer Product

Category: Wood and wood furniture3-1 

## Chapter 3 – Social Costs of the Proposed Rule

This chapter presents estimates of the social costs that industry (chemical manufacturers and other entities affected by the proposed rule) and EPA may incur due to the requirements included in the proposed rule,

and discusses the method used to measure each. Industr y may incur costs related to laboratory testing requirements (discussed in Section 3.1.1), analytical methodology validation (Section 3.1.2),

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

industr y compliance costs are summarized in Section 3. 1.5. Non-monetized costs are described in Section 3.1.6. EPA may incur costs related to reviewing and pr ocessing letters of intent, study plans, final reports, and exemption applications submitted by industry (Section 3.2). The total social costs are summarized in

Section 3.3.



### 3.1 Industry Costs

Industry compliance costs include costs for laboratory testing, analytical methodology validation, administration, and export notification. The methodology for estimating each of these cost types is described below in greater detail.

3.1.1 Laboratory Testing Costs

The premise of the proposed rule is that basic toxic ity information, comparable to that generated by the Screening Information Data Set (SIDS) Programme of the Organisation for Economic Co-operation and Development (OECD), should be available for all HP V chemicals included in the rule. The OECD HPV SIDS Programme seeks information on the identity of each chemical; its uses, sources, and extent of exposure; physical and chemical properties; enviro nmental fate; and certain limited toxicity data for humans and the environment. While SIDS is more comp rehensive in data covera ge 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 necessar y. Included in the OECD HPV SIDS Programme is the development of test data, if such data are not alre ady available, related to si x health and environmental effect endpoints for international HPV chemicals: (1) acute toxicity; (2) repeat dose toxicity; (3) developmental and reproductive toxicity; (4) gene tic 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 iden tified under SIDS have been agreed upon by the 29 member countries of the OECD as providing the mini mum data set required to make an informed preliminary judgment about the hazards of a given HPV chemical.

EPA’s proposed required testing follows the SIDS model. Exhibit 3-1 provides a description of the tests that may be required for chemicals under the propos ed rule. To determine which testing would be required for each chemical, EPA examined available test data for the chemicals in the proposed rule (U.S. EPA, 2009b). Based upon this review, EPA is requiring testing only for those endpoints where data are unavailable or deemed inadequate. Tests required for each chemical included in the proposed rule are

summarized in Exhibit 3-2.3-2Exhibit 3-1: Tests Required by EPA for HPV Chemicals,Based on the OECD’s Screening Information Data Set (SIDS)Protocol NameProtocol Number(s)DescriptionTest Code(used in thisanalysis)Melting PointASTM E 324-99The melting point is the temperature at which a substancetransitions from the solid to liquid phase. The ASTM E 324-99melting point test determines the initial and final melting points (melting range) of stable, crystalline organic solids whosemelting points fall between 30 and 250°C.A1Boiling PointASTM E 1719-05The 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 between12 and 302°C.A2Vapor PressureASTM E 1782-03The vapor pressure indicates the tendency of a solid orliquid to evaporate. The ASTM E 1782-03 vapor pressure testdetermines the vapor pressure of pure liquids or meltedsolids within the temperature range 0°C to 500°C and thepressure range 5 kPa to 2000 kPa using differential thermal analysis, differential scanning calorimetry, or preferably highpressure versions of these instruments.A3Partition Coefficient799.6755; or ASTME 1147-92(2005); or799.6756The octanol/water partition coefficient (log KOW) indicates how easily a compound might dissolve in water or in fat. TheASTM E 1147-92 partition coefficient test determines the logarithm of the log KOWof non-ionizable and ionizablecompounds by inputting the retention time on a liquid chromatographic column into an empirically derived equation. Thisinformation is used to assess the lipophilicity (i.e., the ability to dissolve in fat) of chemicals.A4Water SolubilityASTM E 1148-02; or799.6784; or799.6786The physical property describing the ability of a given substance to dissolve in water is termed water solubility. The ASTME1148-02 water solubility test determines the affinity of water- and air-stable chemicals to water.A5Ready BiodegradationChoice of: ASTM1720-01, ISO 14593,ISO 7827, ISO 9408,ISO 9439, ISO10707, or ISO 10708The biodegradation test provides a measure of how quickly chemicals will be brokendown in the environment by naturalprocesses such as bacterial digestion. The ASTM E 1720-01 ready biodegradability test uses the generation of carbondioxide by a dilute sewage inoculum as a proxy to determine the biodegradability of organic compounds in a closedvessel. Biodegradation of 60% or more during the closed vessel test indicates that in most environmental compartmentsthe chemical’s biodegradation will go to completion.BAcute Toxicity to FishASTM E 729-96(2002)The ASTM E 729-96 acute toxicity test determines the concentration of chemical needed to reach a toxicity threshold incertain species of freshwater and saltwater fish. The standardthresholds used are the concentration at which there is a50% fatality rate in the test organisms (LC50) or the concentration at which there is a 50% adverse effect response rate inthe test organisms (EC50) during 2- to 8-day exposures in either static(no replacement of toxicant), renewal (periodicreplacement of toxicant), or flow-through (continuous or intermittent replacement of makeup water and toxicant)conditions. Lower thresholdsrepresent higher toxicity in the target organisms.Acute Toxicity toDaphniaASTM E 729-96(2002)The ASTM E 729-96 acute toxicity test determines the concentration of chemical needed to reach a toxicity threshold inDaphniacrustaceans. The standard thresholds used are the concentration at which there is a 50% fatality rate in the testorganisms (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), orflow-through (continuous or intermittent replacement of makeup water and toxicant) conditions.Lower thresholdsrepresent higher toxicity in the target organisms.Acute Toxicity to Plants ASTM E 1218-04e1The ASTM E 1218-04e1 toxicity test determines the concentration of chemical needed to reach a toxicity threshold infreshwater and saltwater microalgae. The standard thresholdused is the concentration at which there is a 50% growthinhibition rate (IC50) during 72-, 96-, or 120-hour exposures in static (no replacement oftoxicant) conditions.Chronic Toxicity toDaphniaASTM E 1193-97(2004)The ASTM E 1193-97 chronic toxicity test determines the concentration of chemical needed to reach a toxicity thresholdinDaphnia magnaStraus crustaceans. Exposuresare conducted using flow-through(continuous or intermittentreplacement of makeup water and toxicant) methodsand last over the life cycle of the organisms.C3-3Exhibit 3-1: Tests Required by EPA for HPV Chemicals,Based on the OECD’s Screening Information Data Set (SIDS)Protocol NameProtocol Number(s)DescriptionTest Code(used in thisanalysis)Acute Inhalation Toxicity 799.9130This test gives an indication of potential harm from inhaling a chemical compound. The standard test to measure theacute inhalation toxicity of gases, volatile substances, and aerosols in mammalsis defined in 40 CFR §799.9130. Thistest 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 manybehaviorally and clinically abnormal outcomes as possible should be catalogued during the experiment, and an attempt todetermine the relationship between dose level and effect should be made. This test can be used to determine a regimenof doses for longer-term (i.e., subchronicand chronic) inhalation toxicity studies.Acute Oral ToxicityASTM E 1163-98(2002) or799.9110(d)(1)(i)(A)This test gives an indication of harm from ingesting a chemical compound. The standard test to measure the acute oraltoxicity of liquid or solid chemicals inmammals is defined in 40 CFR §799.9110. Thistest is conducted during a period of24 hours or less using single or multipleingestion doses at no less than three dose levels (and a control, when using avehicle other than water) in animals of both sexes. Occurrence, severity, and reversibility for as many behaviorally andclinically abnormal outcomes as possible should be catalogued during the experiment, and an attempt to determine therelationship between dose level and effect should be made. Thistest can be used to determine a regimen of doses forlonger-term (i.e., subchronic and chronic) oral toxicity studies.BALB/c 3T3 Neutral Red UptakeCytotoxicity; orN/AThis test provides an indication of a chemical’s toxic effect on a cell, thebasic building block of the body. The BALB/c 3T3Neutral Red Uptake Cytotoxicity test determines the magnitude of cellular toxicity of water-soluble chemicals on theBALB/c 3T3 mouse fibroblast cell line. Cell viability after short-term (24 hour)in vitrochemical exposure is measuredusing the cells’ ability to take upthe Neutral Red dye as a proxy.BHK Neutral Red UptakeCytotoxicityN/AThis test provides an indication of a chemical’s toxic effect on a cell, the basic building block of the body. The BHK NeutralRed Uptake Cytotoxicity test determines the magnitude of cellular toxicity of chemicals on a baby hamster kidney (BHK)fibroblast cell line. Cell viability afterin vitrochemical exposures ofunknown length is measured using the cells’ ability totake up the Neutral Red dye as a proxy.DBacterial Reverse Mutation 799.9510This test measures a chemical’s ability to change the genetic code of bacteria, which is an indicator of the chemical’sability to change the genetic code of humans. The Bacterial Reverse Mutation test described in 40 CFR §799.9510 seeksto determine the existence of genotoxicity during chemical exposure using mutatedSalmonella typhimuriumandEscherichia colibacterial cultures. Reversal of the test organism mutations (e.g., substitution, addition, deletion) by thetest chemical after 48-72 hourin vitrochemical exposure is measured using the bacteria’s ability to synthesize specificamino acids as a marker. Positive results in this test are used to determine chemicals that should be further tested forcarcinogenic, reproductive, and developmental effect potential.E1Chromosome Aberration,invitro; or799.9537Thein vitroChromosome Aberration test described in 40 CFR §799.9537 seeks to determine whether chemical exposurecauses chromosomal aberrations in primary cell cultures, such as Chinese hamster fibroblasts, human, or othermammalian peripheral blood lymphocytes. Generation of chromosomal aberrations such as polyploidy (excesschromosomes) or endoreduplication (duplication of the genome without mitosis) by the testchemical is measured usingbasic microscopy techniques after exposure. Positive results in this testare used to determine chemicals that should befurther tested for carcinogenic, reproductive, and developmental effect potential.In VivoMammalianCytogenetics Tests: BoneMarrow Chromosomal Analysis;or799.9538Thein vivoMammalian Bone Marrow Chromosomal Aberration test described in 40 CFR §799.9538 seeks to determinewhether chemical exposure causes chromosomal aberrations in rodents, such as rats, mice, and Chinese hamsters.Generation of chromosome or chromatid aberrations suchas polyploidy (excess chromosomes) or endoreduplication(duplication of the genome without mitosis) by the test chemical is measured using basic microscopy techniques. Positiveresults in this test are used to determine chemicals thatshould be further tested for carcinogenic potential, particularly inbone marrow.Erythrocyte Micronucleus (bonemarrow),in vivo799.9539The Mammalian Erythrocyte Micronucleus test described in40 CFR §799.9539 seeks to determine whether chemicalexposure causes damage to the chromosomes or the mitotic apparatus of erythroblasts (immediate precursor to red bloodcells) in the bone marrow of rodents, such as rats or mice.The proportion of immature erythrocytes among the total isE23-4Exhibit 3-1: Tests Required by EPA for HPV Chemicals,Based on the OECD’s Screening Information Data Set (SIDS)Protocol NameProtocol Number(s)DescriptionTest Code(used in thisanalysis)measured using basic microscopytechniques, and a dose-response relationship is investigated.Positive results in thistest are used to determine chemicals that should be further tested for carcinogenic potential, particularly with regard toerythrocyte production.Repeated Dose Oral Toxicity 799.9305This test gives an indication of harm from ingesting a chemical compound. The standard test to measure the repeateddose oral toxicity of liquid or solid chemicals in mammalsis defined in 40 CFR §799.9305. The test should be conductedafter the acute oral test described in 40 CFR §799.9110 in order to establish an appropriate dose range. This test isconducted 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 clinicallyabnormal outcomes as possible should be catalogued during the experiment, and histopathological investigations aredone on specific sets of organs.Repro/Devel Toxicity Screening 799.9355These tests indicate the likelihood of a chemical to have an impact on the offspring of those exposed to the chemical. Thestandard test to measure the reproductive or developmentaltoxicity of chemicals in mammals is defined in 40 CFR§799.9355. Male animals are dosed for a minimum of 4 weekswith a schedule as follows: a minimum of 2 weeks premating, during the mating period, and approximately 2 weekspost-mating. Females are dosed with a schedule as follows:at least 2 weeks pre-mating, time-to-conception, duration of pregnancy, and at least 4 days post-delivery. Occurrence andseverity of changes in gonadal function, mating behavior, conception, development of the conceptus, and parturition(birth) are catalogued during the experiment.Combined Repeated Dose withRepro/Devel Toxicity Screen799.9365The standard test to measure the reproductive or developmentaltoxicity of chemicals in mammals is defined in 40 CFR§799.9365. Male animals are dosed for a minimum of 4 weekswith a schedule as follows: a minimum of 2 weeks premating, during the mating period, and approximately 2 weekspost-mating. Females are dosed with a schedule as follows:at least 2 weeks pre-mating, time-to-conception, duration of pregnancy, and at least 4 days post-delivery. Occurrence andseverity for as many behaviorally and clinically abnormal outcomes as possible in the adult animals should be cataloguedduring the experiment, and histopathological investigations are done on specific sets of organs. Additionally, occurrenceand severity of changes in gonadal function, mating behavior,conception, development of the conceptus, and parturition(birth) are catalogued during the experiment.F1Repro/Devel Toxicity Screening 799.9355The standard test to measure the reproductive or developmentaltoxicity of chemicals in mammals is defined in 40 CFR§799.9365. Male animals are dosed for a minimum of 4 weekswith a schedule as follows: a minimum of 2 weeks premating, during the mating period, and approximately 2 weekspost-mating. Females are dosed with a schedule as follows:at least 2 weeks pre-mating, time-to-conception, duration of pregnancy, and at least 4 days post-delivery. Occurrence andseverity for as many behaviorally and clinically abnormal outcomes as possible in the adult animals should be cataloguedduring the experiment, and histopathological investigations are done on specific sets of organs. Additionally, occurrenceand severity of changes in gonadal function, mating behavior,conception, development of the conceptus, and parturition(birth) are catalogued during the experiment.F23-5 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 83-41-0 2-Nitrobenzene, 1,2-dimethyl- A3, A4, A5, D, E2, F1

2 96-22-0 3-Pentanone E1, F2 3 98-09-9 Benzenesulfonyl chloride C2, E1, E2, F1 4 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)- A4, B, C1, F2 5 111-44-4 Ethane, 1,1'-oxybis[2-chloro- C6, F1
6 127-68-4 Benzenesulfonic acid, 3-ni tro-, sodium salt (1:1) A3, F2

7 506-51-4 1-Tetracosanol A2, A3, A4, A5, B, C1, D, E1, E2, F1

8 506-52-5 1-Hexacosanol A2, A3, A4, A5, C1, D, E1, E2, F1 9 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)- A1, A3, A4, A5, B, C1, D, E1, E2, F1

10 2494-89-5 Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate) A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

11 5026-74-4 2-Oxiranemethanamine, N-[4-(2- oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)- A1, A2, A3, A4, A5, B, C2, F1

12 22527-63-5 Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4- trimethylpentyl ester A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

13 24615-84-7 2-Propenoic acid, 2-carboxyethyl ester A1, A2, A3, A4, A5, B, C1, E1, E2, F1 14 25321-41-9 Benzenesulfonic acid, dimethyl- A2, A3, A4, A5, B, C1, D, E1, E2, F1

15 25646-71-3 Methanesulfonamide, N-[2-[(4-amino-3- methylphenyl)ethylamino]ethyl]-, sulfate (2:3) A1, A2, A3, A4, A5, B, C1, F1

16 52556-42-0 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1- yloxy)-, sodium salt (1:1) A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

17 61788-76-9 Alkanes, chloro A2, A3, A4, A5, B, 18 65996-79-4 Solvent naphtha (coal) A3, A4, A5, B, C1, D, E1, E2, F1
19 65996-82-9 Tar oils, coal A3, A4, A5, B, C1, D, E1, E2, F1 20 65996-89-6 Tar, coal, high-temp. A4, A5, B, C1, D, E1, E2, F1 21 65996-92-1 Distillates (coal tar) A3, A4, A5, B, C1, D, E1, E2, F2
22 68082-78-0 Lard, oil, Me esters A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 23 68187-57-5 Pitch, coal tar-petroleum A4, A5, B, C6, D, E1, E2, F1

24 68442-60-4 Acetaldehyde, reaction produc ts with formaldehyde, by-products from A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

25 68610-90-2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

26 68988-22-7 1,4-Benzenedicarboxylic acid , 1,4-dimethyl ester, manuf. of, by-products from A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

27 70693-50-4 Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2- nitrophenyl)diazenyl]- A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1

28 72162-15-3 1-Decene, sulfurized A2, A3, A4, A5, B, C1, D, E1, E2, F1

29 73665-18-6 Extract residues (coal), ta r oil alk., naphthalene distn.

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

.3-6 Although the rule includes a variety of voluntary consensus standard protocols (for example, ASTM E 729 for acute toxicity or ISO 9408 for ready biodegradation), cost estimates are based on OECD or EPA protocols, which are expected to be represen tative of the voluntary consensus standards. 7 These testing cost estimates generally include direct labor, overhead, other direct costs such as laboratory supplies, and general and administrative services.

Estimating the potential testing costs for each chem ical pursuant to requirements contained in the proposed rule is complicated in that industry may ha ve choices associated with the species and/or route of administration used in a particular test, as well as choices between multiple tests to satisfy a particular endpoint testing requirement. Therefore, if cost data for a specific OECD test protocol were available for multiple species and routes of administration, EPA used the average cost for all available species and routes of administration as the test cost estimate. In addition, EPA computed a “least cost” and an “average cost” scenario where multiple test protocols were available to satisfy a test requirement. The

“least cost” scenario assum es that manufacturers will choose the l east 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 t est based on availability, suitability for a particular chemical, quality control reasons, or other factors unkn own to EPA at this time. Therefore, the “average

cost” scenario assumes that the manufacturer may choose any of th e tests that fulfill the testing requirement, and is calculated as the average of all the available testing options’ costs.

Individual estimates of test costs will vary across testing laboratories based upon factors such as labor costs, discounts provided to clients for volume testing, profit margins, and other testing. In some cases, EPA has accommodated this variation by developing multiple estimates for a particular test and using the average of the estimates to represent the cost of th e test. The following paragraphs list the known test protocols for each of the tests required by the proposed rule, and describe, for each, which protocols this analysis includes in the least co st and average cost scenarios. Exhibit 3-3 presents the protocols required by the rule, the basis for the co st estimate, and final cost estimates used in the analysis.

Category A. Physical/chemical property testing. Physical/chemical property testing includes tests to measure the melting point (A1; ASTM E 324); boiling point (A2; ASTM E 1719); vapor pressure (A3; ASTM E 1782); n -Octanol/Water Partition Coefficient (log 10 basis) or log K

ow (A4; 40 CFR §799.6755, ASTM E 1147, or 40 CFR 7§99.6756, depending on the estimated log K

ow of the chemical); and water solubility (A5; ASTM E 1148, 40 CFR §799.6784, 40 CFR §799.6784, or 40 CFR §799.6786, depending on the chemical’s estimated water solubility) of a chemical. 8 For each individual physical/chemical property test, EPA used only one OECD protocol as a basis for the cost estimate. Therefore, the least and average cost scenarios for each of these test costs is the same.

Category B. Environmental fate testing. To test environmental fate, a manufacturer can choose one of the following ready biodegradation t ests: ASTM 1720 (sealed vessel CO 2 production test), ISO 14593

7 Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, directs EPA to use voluntary consensus standards in its re gulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies, such as ASTM International, formerly the American Society for Testing and Materials (ASTM). Another voluntary consensus standard body is the International Organization for Standardization (ISO).

8 EPA recommends, but does not require, that log K

ow be quantitatively estimated prior to initiating the n

Octanol/Water Partition Coefficient (log 10 basis) or log K

ow test requirement. One method, among many similar methods, for estimating log K

ow 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 wate r solubility is described in Meylan et al. (1996).3-7 (CO 2 headspace test), ISO 7827 (analysis of DOC), ISO 9408 (determination of oxygen demand in a closed respirometer), ISO 9439 (CO 2 evolution test), ISO 10707 (closed bottle test), or ISO 10708 (twophase closed bottle test). OECD protocols for ready biodegradation, on which cost estimates are based, are the following: OECD 301A (DOC die-away test), OECD 301B (carbon dioxide evolution test), OECD 301C (modified MITI test (I)), OECD 301D (closed bottle test), OECD 301E (modified OECD screening test), and OECD 301F (manometric respirometry test). For this test category, the test cost used

in the least cost scenario is based on the cheapest of the OECD tests (OECD 301D). The test cost used in the average cost scenario is based on the average of all of the OECD tests, because there are no special conditions requiring a manufacturer to use one or the other.

Category C. Aquatic toxicity testing. If aquatic toxicity testing is required for a particular chemical, a manufacturer must determine if the test chemical falls into one of two test groups, based on the chemical’s log K

ow . Test Group 1 consists of chemicals with a log K

ow of less than 4.2. Test Group 2 consists of test chemicals with a log K

ow greater than or equal to 4.2. Each test group has different testing requirements and, therefore, different testing costs. Because EPA does not know which test group a chemical will fall within (i.e., the log K

ow is unknown), the testing costs of both groups are estimated. For example, the following situations occur under testing categories C1 and C2:

• C1: Conduct the Acute Toxicity to Fish test (ASTM E 729), Acute Toxicity to Daphnia test (ASTM E 729), and the Toxicity to Plants test (ASTM E 1218) [Test Group 1] or conduct the Chronic Toxicity to Daphnia test (ASTM E 1193) and the Toxicity to Plants test (ASTM E 1218) [Test Group 2]. In this case, the sum of the acute testing costs is averaged with the chronic test cost to obtain the testing cost estimate for testing categories C1 and C2 under both the least and average cost scenarios.

• C2: Conduct the Acute Toxicity to Daphnia test (ASTM E 729) and the Toxicity to Plants test (ASTM E 1218) [Test Group 1] or conduct the Chronic Toxicity to Daphnia test (ASTM E 1193) and the Toxicity to Plants test (ASTM E 1218) [Test Grou p 2]. In this case, the two test costs are averaged to obtain the testing cost estimate for testing cat egory C2 under both the least and average cost

scenarios.

Category D. Mammalian toxicity testing – acute. The acute mammalian toxicity testing requirement is met by implementing one of two methods defined in the proposed rule (Method A or Method B). The

method a manufacturer selects is based on the chemical’s physical state at room temperature. For those test substances that are gases at room temperat ure, Method A is required; otherwise, Method B is required. Method A requires an Acute Inhalation Toxi city test in rats (40 CFR 799.9130). Method B requires an Acute Oral Toxicity test (ASTM E 1163 or 40 CFR §799.9110(d)(1)(i)(A) and, if the manufacturer chooses to, a Neutral Red Uptake Cytotoxi city test (BALB/c 3T3 or BHK). The cost of the cytotoxicity test is estimated as the sum of the two cytotoxicity test costs (BALB/c 3T3 plus BHK), which is a conservative estimate that is likely to overes timate actual cytotoxicity test costs. Because the chemical's physical state at room temperature is unkn own, a least and average co st scenario are estimated. Under the least cost scenario, the co st of the acute mammalian toxicity testing requirements is assumed to be the cost of the Acute Oral Toxicity Test, which is the cheaper of the two methods. Under the average cost scenario, the cost of the acute mammalian toxicity testing requirements is assumed to be the average of the Method A testing requirement and the sum of the Method B testing requirement and the least expensive cytotoxicity test. The cytotoxicity tests are included in the average cost scenario even though they are optional, because they are animal -saving tests and so may be preferred.3-8 Category E. Mammalian toxicity testing – genotoxicity. For gene mutations (E1), manufacturers are required to conduct the in vitro Bacterial Reverse Mutation test (40 CFR §799.9510). For chromosomal damage (E2), manufacturers can conduct one of three tests: the in vitro Mammalian Chromosome Aberration test (40 CFR §799.9537), the Mammalian Bone Marrow Chromosomal Aberration test (40 CFR §799.9538), or the Mammalian Erythrocyte Micronuc leus test (40 CFR §799.9539). Under the least cost scenario, the cost of chromosomal testing is assume d to be the cost of the least expensive test (40 CFR §799.9539), while under the average cost scenario, th e cost of chromosomal testing is assumed to be the average of all three test options because th e test the manufacturer may conduct is unknown.

Category F. Mammalian toxicity testing – repeated dose/reproduction/developmental. For test category F1, a manufacturer can either conduct the Co mbined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (40 CFR §799.9365), or conduct the Reproduction/Developmental Toxicity Screening Test (40 CFR §799.9355) and the Repeated Dose 28- Day Oral Toxicity Study in rode nts (40 CFR §799.9305). Testing costs under the least cost scenario are assumed to be the cheaper of these two options (c onducting 40 CFR §799.9365). Testing costs under the average cost scenario are assumed to be the highe r cost option (conducting both 40 CFR §799.9355 and 40 CFR §799.9305). For test category F2, the manufacturer would conduct the individual protocol 40 CFR §799.9355 under both the least and average cost scenarios.

Estimated Total Test Costs. The proposed rule requires only that the required test results be obtained once for each chemical; each manufacturer is not re quired to do the tests separately. Typically, manufacturers form a “task force” or panel throug h 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 chemi cals, and then the total cost per chemical was summed across all chemicals included in the proposed rule.

Following this method, the total laboratory cost for t esting the chemicals included in the proposed rule is estimated to range from approximately $5.75 million under the least cost scenario to approximately $7.05 million under the average cost scenario. ( Exhibit B-1 and Exhibit B-2 in Appendix B provide the total test

costs for each chemical, under the least and averag e cost scenarios, respec tively.) 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 co sts could be lower due to economies of scale (for example, the test’s quality co ntrol procedures can be performed by batch, making the per-chemical cost lower). Dividing these totals by the 29 chemicals in the proposed rule yields an average laboratory test cost per chemical of approx imately $198,000 under the least cost scenario and approximately $243,000 under the average cost scenario.3-9Exhibit 3-3: EPA Estimates of Laboratory Costs of Proposed Tests (2008$)Testing CategoryTest CodeProtocol NameRequired Protocol Number(s)Basis for CostEstimateCostEstimate2008$1A1 Melting PointASTM E 324-99OECD 102(Least & AverageCost Scenarios)$1,632A2 Boiling PointASTM E 1719-05OECD 103(Least & AverageCost Scenarios)$1,667A3 Vapor PressureASTM E 1782-03OECD 104(Least & AverageCost Scenarios)$9,953A4 Partition CoefficientMethod A: 799.6755; or Method B: ASTM E 1147-92(2005) or Method C:799.6756OECD 107(Least & AverageCost Scenarios)$7,945Physical/ChemicalPropertiesA5 Water SolubilityMethod A: ASTM E 1148-02; or Methods B or C: 799.6784 (shake flaskand column elution); or Method D: 799.6786OECD 105(Least & AverageCost Scenarios)$6,958OECD 301A$10,500OECD 301B$9,201OECD 301C$23,300OECD 301D$7,621OECD 301E$10,443Ready BiodegradationChoice of: ASTM 1720 (sealed vessel CO2 production test), ISO 14593(CO2 headspace test), ISO 7827 (analysis of DOC), ISO 9408(determination of oxygen demand in a closed respirometer), ISO 9439(CO2 evolution test), ISO 10707 (closed bottle test), or ISO 10708 (twophase closed bottle test)OECD 301F$10,288Least Cost Scenario (OECD 301D)$7,621EnvironmentalFate andPathwaysBAverage Cost Scenario (Average of All Protocols)$11,892Acute Toxicity to Fish ASTM E 729-96(2002)OECD 203$11,511Acute Toxicity toDaphniaASTM E 729-96(2002)OECD 202 (Part 1)$6,098Acute Toxicity to Plants ASTM E 1218-04e1OECD 201$10,387(TestGroup1)Test Group 1 Sum$27,997Chronic Toxicity toDaphniaASTM E 1193-97(2004)OECD 202$37,451Acute Toxicity to Plants ASTM E 1218-04e1OECD 201$10,387(TestGroup2)Test Group 2 Sum$47,838C1Least & Average Cost Scenarios (Average of C1 Test Group 1 and 2 Sums)$37,917Acute Toxicity toDaphniaASTM E 729-96(2002)OECD 202 (Part 1)$6,098Acute Toxicity to Plants ASTM E 1218-04e1OECD 201$10,387(TestGroup1)Test Group 1 Sum$16,485Chronic Toxicity toDaphniaASTM E 1193-97(2004)OECD 202$37,451Acute Toxicity to Plants ASTM E 1218-04e1OECD 201$10,387(TestGroup2)Test Group 2 Sum$47,838Aquatic ToxicityC2Least & Average Cost Scenarios (Average of C2 Test Group 1 and 2 Sums)$32,1623-10Exhibit 3-3: EPA Estimates of Laboratory Costs of Proposed Tests (2008$)Testing CategoryTest CodeProtocol NameRequired Protocol Number(s)Basis for CostEstimateCostEstimate2008$1Acute Toxicity to Fish ASTM E 729-96(2002)OECD 203$11,511Acute Toxicity to Plants ASTM E 1218-04e1OECD 201$10,387(TestGroup1)Test Group 1 Sum$21,898Chronic Toxicity toDaphniaASTM E 1193-97(2004)OECD 202$37,451Acute Toxicity to Plants ASTM E 1218-04e1OECD 201$10,387(TestGroup2)Test Group 2 Sum$47,838C3Least & Average Cost Scenarios (Average of C3 Test Group 1 and 2 Sums)$34,868Acute Toxicity to Fish ASTM E 729-96(2002)OECD 203$11,511Acute Toxicity toDaphniaASTM E 729-96(2002)OECD 202 (Part 1)$6,098(TestGroup1)Test Group 1 Sum$17,610(TestGroup2)Chronic Toxicity toDaphniaASTM E 1193-97(2002) OECD 202$37,451C4Least & Average Cost Scenarios (Average of C4 Test Group 1 and 2 Sums)$27,530(TestGroup1)Acute Toxicity toDaphniaASTM E 729-96(2002) OECD 202 (Part 1)$6,098(TestGroup2)Chronic Toxicity toDaphniaASTM E 1193-97(2004) OECD 202$37,451C5Least & Average Cost Scenarios (Average of C5 Test Group 1 and 2 Sums)$21,775C6 Acute Toxicity to Plants ASTM E 1218-04e1OECD 201(Least & AverageCost Scenarios)$10,387(MethodA)Acute Inhalation Toxicity 799.913OECD 403$14,958Acute Oral ToxicityASTM E 1163-98(2002)or 799.9110(d)(1)(i)(A)OECD 423$2,570BALB/c 3T3 Neutral RedUptake Cytotoxicity; orN/A N/A$3,838BHK Neutral Red UptakeCytotoxicityN/A N/A$4,955(MethodB)Sum of Cytotoxicity Tests$8,793Least Cost Scenario (OECD 423)$2,570MammalianToxicity - AcuteDAverage Cost Scenario (Average of 403 and (423 + least expensive Cytotoxicity test))$10,683E1 Bacterial Reverse Mutation 799.9510OECD 471(Least & AverageCost Scenarios)$8,369MammalianToxicity –GenotoxicityE2Chromosome Aberration, invitro; or799.9537 OECD 473$23,6103-11Exhibit 3-3: EPA Estimates of Laboratory Costs of Proposed Tests (2008$)Testing CategoryTest CodeProtocol NameRequired Protocol Number(s)Basis for CostEstimateCostEstimate2008$1In Vivo MammalianCytogenetics Tests: BoneMarrow ChromosomalAnalysis; or799.9538 N/A$49,616Erythrocyte Micronucleus(bone marrow), in vivo799.9539 OECD474$17,105Least Cost Scenario (OECD 474)$17,105Average Cost Scenario (Average of 473, 799.9538, and 474)$30,110Repeated Dose Oral Toxicity;and,799.9305 OECD407$64,714Repro/Devel ToxicityScreening; or,799.9355 OECD421$130,933Combined Repeated Dosewith Repro/Devel ToxicityScreen799.9365 OECD 422$132,795Least Cost Scenario (OECD 422)$132,795F1Average Cost Scenario (Sum of OECD 407 and OECD 421)$195,648MammalianToxicity –Repeated Dose/Reproduction/DevelopmentalF2Repro/Devel ToxicityScreening799.9355OECD 421(Least & AverageCost Scenarios)$62,9831Test costs were estimated in different years, so EPA used theEmployment Cost Index (ECI) Current-Dollar Historical Listing from the Bureau of Labor Statistics (BLS, 2009), U.S.Department of Labor, to convert all test cost estimates to 2008$.3-12 3.1.2 Analytical Methodology Validation Costs

When conducting tests, laboratories perform analytical methodology validation to ensure that proper dose concentrations are used in toxicity studies. An an alytical methodology validation approach assumes that an acceptable analytical method is available for a par ticular chemical and that the method is directly

related to the matrix used for the test. When an alytical methodologies are not suitable or known, they must be developed or modified.

Analytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given ma trix is reliable and repr oducible for the intended use. The fundamental parameters for this validati on include (1) accuracy, (2) precision, (3) selectivity, (4) sensitivity, (5) reproducibility, and (6) stability. Validation involves documenting, through the use of specific laboratory investigations, that the perform ance characteristics of the method are suitable and reliable for the intended analytical applications. The acceptability of analytical data corresponds directly

to the criteria used to validate the method.

Factors that may increase the cost of analytical method development and validation costs include (1) testing new chemicals that lack any established methodology or historical analytical data to use as a starting point, and (2) testing chemicals that present challenging conditions or possess characteristics that require special or additional procedures during sample preparation and analysis. If previous testing on a chemical of interest has been conducted by either a laboratory or client, information may be available that can assist with sample preparation and analytical tes ting. This can help to minimize the costs of method development and validation.

Analytical method development and analytical costs can also vary depending on characteristics of the test substance. Characteristics of chemicals that may impa ct the cost of analytical method development and validation include chemical stability, chemical proper ties, 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 usi ng the same dosing matrix), provided testing is done at the same laboratory. However, it is possible that analytical methodology validation may be required for both short-term and long-term tests where there are separate requirements for dose concentration ranges (e.g., parts per million for acute tests and parts per billion for chronic tests).

For this proposed rule, EPA has assumed an exposur e concentration in the parts per billion range requiring multi-step preparation, concentration, and cl eanup 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 co st of $3,500 has been assigned for shor t-term tests (acute), and a cost of $8,500 has been assigned for tests that are assumed to be long-term tests (genotoxicity and reproductive/developmental toxicity), as shown in Exhibit 3-4. Because analytical method validation may not be necessary for all tests when multiple tests are completed on the same chemical, these costs could

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

Testing Category Test Symbol Cost Estimate $2008

Physical Chemical Properties A no additional costs

Environmental Fate and Pathways B no additional costs

Test Group 1 $3,500

Test Group 2 $8,500 Aquatic Toxicity C

Test Group 1 and 2 Average $6,000

Mammalian Toxicity - Acute D $3,500

Mammalian Toxicity - Genotoxicity E $3,500

Mammalian Toxicity – Repeated Dose/ Reproduction/

Developmental F $3,500

3.1.3 Administrative Costs

In addition to laboratory costs, entities 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 applicatio ns, and final reports, and “non-reporting activities,” such as soliciting laboratory bids, selecting laboratories, monitoring tests under progress, developing cost-sharing agreements, and a uditing the laboratories for compliance with EPA’s Good Laboratory Practice (GLP) standards. Total admi nistrative costs are calculated as the sum of the costs of reporting and non-reporting activities. This section discusses the methods and data employed to estimate reporting and non-reporting costs.

Reporting Activities. Reporting activities include preparing letters of intent, study plans, exemption applications, final reports, and robust summaries. As noted above, manufacturers typically form a “task force” or panel through a common trade organization to coordinate testing and reporting required by TSCA Section 4. One panel may often represent groups of chemicals. EPA reviewed the list of chemicals subject to the proposed test rule, and sorted them into groups of similar chemicals (e.g., hydrocarbons, dyes, alkyl halides). This sorting results in an estimated 16 chemical groupings. Assuming that each grouping is sponsored by a panel, EPA estimates that 16 panels will be formed in response to the rule.

Reporting costs per panel include costs associated with submitting letters of inte nt, study plans, final reports, and exemption applications. The analysis assu mes that the panels will each submit one letter of intent and one set of study plans for their group of chemicals, resulting in 16 letters of intent and 16 study plans submitted to EPA. In addition, one final report is assumed to be required for each test conducted for

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

chemical is summed across all chem icals, which results in an estimat ed 241 final reports that will be submitted to EPA in response to this rule. EPA al so assumes that it will receive five exemption applications per panel, resulting in a total of 80 requests.

Finally, respondents may choose to develop and subm it robust summaries of the full, final toxicological study reports. The robust summaries should contain t echnical information to adequately describe the study and results, and should be written such that th e information provided is sufficient to allow a technically qualified person to evaluate study results without needing to review an entire study report.

9 While some of the chemicals may require longer-term aquatic testing based on chemical characteristics, EPA could not be certain of the number. Therefore, EPA di d not include an estimate for progress reports.3-14 Typically, a robust summary would include a description of the test substance, methods, results, conclusions, data quality d escription, and references associated wi th the full study. Based on professional judgment, EPA estimates that 8 to 16 hours of technical time are needed to develop and review a robust summary, depending on the type of study conducted. Therefore, for this analysis, EPA assumes an average of 12 hours of technical time to prepar e a robust summary. Because submission of robust summaries is voluntary, EPA does not expect that many companies will undertake this activity. EPA estimates that 10 percent of full, final toxicol ogical study reports may include a robust summary. Therefore, EPA expects approximately 24 robust summaries.

EPA estimates that it takes a respondent 40 hours to prep are a letter of intent and study plan, 73 hours to write a final report, and 2 hours to prepare an exemption application (U.S. EPA, 2002). These unit labor hours were derived from previous information collecti on requests and are believed to reflect the burdens that will be incurred for the proposed test rule.

Wage rates associated with the predominant skill leve l (managerial, technical, and clerical) required to complete each of the reporting activities d escribed in this section are presented in Exhibit 3-5. These wage rates have been esti mated following the method described in a memorandum titled, “Wage Rates for Economic Analyses of the Toxics Release Inventory Program” (Rice, 2002). This method uses average September 2008 wages, benefits, and total compensat ion data extracted from the Employer Costs for Employee Compensation Summary available from the BLS Web site. Appendix C provides detailed

inform ation on the estimation of these wage rates.

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

Labor Category 2008 Wage Rate 2008 Benefits and Overhead Loading Factor 2008 Loaded Hourly Wage Rate Managerial $43.22 162% $70.03 Technical $35.29 167% $58.84 Clerical $17.22 166% $28.48 Source: Methodology from “Wage Rates for Economic A nalyses of the Toxics Release Inventory Program” (Rice, 2002). Wage rates and benefits extracted from the Employer Costs for Employee Compensation Summary, Bureau of Labor Statistics (BLS, 2009c); assumed overhead rate of 17% applied to wage rates based on assumptions in Rice (2002) and U.S. EPA (2002).

Exhibit 3-6 details the respondents’ reporting cost and burden estimates. As shown, the total reporting cost and burden estimates are approximately $961,789 and 18,682 hours, respectively.

Exhibit 3-6: Industry Reporting Cost and Burden Estimate for the Proposed Rule (2008$)

Unit Labor Total

Reporting Activity Category 1 Hours Wage

Rate Cost Annual
Submissions Hours Cost

Letter of Intent and Study Plan T 40 $58.84 $2,354 16 640 $37,658

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 $58.84

$58.84 $70.03 $28.48 $28.48 $2,354

$353 $420 $570 $28.48 241 9,640

1,446 1,446 4,820

241 $567,218

$85,083 $101,263 $137,274

$6,864

Robust Summaries T 12 $58.84 $706 24.1 289 $17,017
Exemption Applications T 2 $58.84 $118 80 160 $9,414

TOTAL 18,682 $961,789

1 Labor categories are as follows: T = Tec hnical; M = Managerial; C = Clerical.

Non-Reporting Activities. In addition to reporting activities, manuf acturers need to conduct a number of non-reporting activities. In January 2007, EPA conducte d a brief study to investigate the types of non-3-15 reporting activities manufacturers conduct and the magnitude of associated costs. 10 The non-reporting activities identified include soliciting laboratory bids, selecting laboratories, monitoring tests in progress, developing cost-sharing agreemen ts, and auditing the laboratories for compliance with EPA’s GLP standards. These activities, in addition to identifyi ng manufacturers, arranging meetings, and employing toxicologists who may be hired to pr ovide testing expertise for the testi ng, 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 assu mption 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 $5.75 million under the least cost scenario and $7.05 million under the average cost scenario, non -reporting costs are approximately $1.44 million and $1.76 under the least and average cost scenarios, respectively.

Total Administrative Costs. As stated previously, total administ rative costs pursuant to the proposed rule are estimated as the sum of reporting and non-re porting costs. Thus, total administrative costs are estimated to be $2.40 million under the least cost scenario and $2.72 million under the average cost

scenario.

3.1.4 Export Notification Costs

Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical subject to various TSCA sections (40 CFR §707.60 thr ough 75). Therefore, all exporters of chemicals regulated under the proposed rule must notify EPA a bout 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 chemi cal for the first time to a country for which it has not previously submitted a notification.

A detailed analysis of the impact of export notificatio ns would require data on the identity and/or number of exporters exporting chemicals included in the pr oposed rule and the identity and/or number of countries to which each chemical included in the pr oposed 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 th e chemicals included in the proposed rule are not readily available from secondary data sour ces. 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 notif ications 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 notificati ons 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.

U.S. EPA (1992a) estimated that the export notifica tion 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-gener ated form letters (Blake-Hedges, 1999). While it might take 1 hour of technical time to prepare an in itial 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.

10 U.S. EPA, 2007.3-16 EPA (1992a) estimate for clerical time to print and send. Because notification letters are expected from both first-time filers and more experienced filers, th e present analysis assumes that the export notification burden of the proposed rule ranges from 0.5 hours to 1. 5 hours. The 2008$ wage rate for technical staff is $58.84 per hour, while that for clerical staff is $28.48 per hour (see Exhibit 3-5). This translates into a

low-end labor cost estimate of $14.24 per notice and a high-end labor cost estimate of $73.08 per notice. In addition, industry incurs approximately $12.62 pe r notice (2008$) for sending each notice to EPA via registered mail ($10.00 for registered mail, $2.20 fo r a return receipt, and $0.42 for postage) (USPS, 2008). Accounting for labor and shipping costs, the total cost of preparing and submitting an export notification is estimated to range from $26.86 per no tice to $85.70 per notice. For the least cost scenario, the analysis uses the 0.5 hour labor burden and $26.86 cost per notice; for the average cost scenario, the analysis uses a 1.0 hour labor burden and the aver age of the low-end and high-end notification cost, which is $56.28. Assuming that 29 chemicals are regulated under the proposed rule, and that 25
notifications will be submitted for each chemical, it is estimated that a total of 725 notifications will be submitted in response to the proposed rule. Thus, the total cost of export notifications triggered by the proposed rule is $19,474 under the least cost scenario and $40,803 under the average cost scenario. These

estimates are summarized in Exhibit 3-7.

Exhibit 3-7: Export Notification Cost Estimate for the Proposed Rule (2008$)

Cost

Compliance Cost Category Category Hours Wage

Rate Least Cost
Scenario Highest
Cost
Scenario Average
Cost
Scenario
Write Export Notification Letter Technical

Labor 0 - 1 $58.84 $0 $58.84 $29.42

Copy or Print and Send Export
Notification Letter Clerical

Labor 0.5 $28.48 $14.24 $14.24 $14.24

Total Labor Cost per Letter $14.24 $73.08 $43.66 Shipping Cost per Letter Fixed Cost -- -- $12.62 $12.62 $12.62 Total Cost per Letter (Labor and Shipping) $26.86 $85.70 $56.28

Total Cost for 725 Notification Letters $19,474 $62,133 $40,803

3.1.5 Total Industry Compliance Costs

The total compliance costs borne by the regulated industry are summarized in Exhibit 3-8. The total

industr y compliance costs triggered by the proposed rule are estimated to equal $8.57 million under the least cost assumption and $10.21 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 co uld 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 ta x deductions for some of these costs.

Exhibit 3-8: Summary of Total Industry Compliance Costs Triggered by the Proposed Rule (2008$)

Cost ($ million, unadjusted)

Compliance Cost Category Least Cost
Scenario Average Cost
Scenario Laboratory costs (Section 3.1.1) 5.75 7.05 Analytical methodology validation costs (Section 3.1.2) 0.40 0.40 Administrative costs (Section 3.1.3) 2.40 2.72 Export notification costs (Section 3.1.4) 0.02 0.04 Total industry compliance costs (Section 3.1.5) 8.57 10.21 Average compliance cost per chemical 0.30 0.353-17 3.1.6 Non-Monetized Costs

The proposed rule requires that manufacturers, importe rs, and/or processors of chemicals included in the proposed rule perform screening-level toxicity t ests on the chemicals. EPA routinely conducts an assessment of laboratory capacity and has applied thos e findings to this analysis, which allowed EPA to examine the potential for laboratory capacity to become a factor in the economic impact of the rule (U.S. EPA, 2004b).

Pharmaceutical testing demands currently dictate la boratory capacity for the chemical testing industry. For example, one major testing laboratory indicated that its non-pharmaceutical market (e.g., industrial chemicals) accounts for only 6 to 8 percent of its total sales. Therefore, changes in testing demand generated by the pharmaceutical industry are expected to dominate other influences on laboratory testing capacity, such as EPA regulatory activity.

EPA anticipates that Contract Research Organizations (CROs) will conduct the majority of testing rather than in-house laboratories. The Agen cy’s communication with laboratori es indicates that there has been a downward trend in testing demand over the last 2 or 3 year s, attributed (at least in part) to consolidations and mergers among major pharmaceutical clients (for ex ample, the merger of Bayer and Aventis). These mergers have had several effects, including consolid ation of product lines, with fewer new products translating into fewer required tests, and greater reliance on in-house testing capabilities. The increase in in-house testing at pharmaceutical companies may re sult in increased testing capacity at CROs. For example, one CRO laboratory, approximately 65,000 squa re feet in size, reports that it currently performs 200 to 300 acute toxicity studies in a year but could easily double the volume of acute toxicity studies it conducts if sufficient demand existed. However, other fields of testing (biodegradation tests, tests of reproductive toxicity, and toxicity tests involving inha led chemicals) are currently operating closer to current laboratory test capacity.

EPA’s communication with laboratories also indicat es that testing resulting from EPA’s voluntary HPV Challenge Program has not produced the amount of ne w business for the chemical testing industry that was anticipated when the Challenge Program was orig inally announced. The testing demand generated by the HPV Challenge Program has been lower than expect ed because many of the data gaps identified by the initiative have been filled using existing, unpublis hed research rather than new testing. In addition, manufacturers have used Program guidance concerning the use of Structure Activity Relationships (SAR) and category proposals extensively, which has also reduced the need for new testing. New testing has been proposed for fewer than 10 percent of the chemicals’ endpoints (U.S. EPA, 2004b).

Overall, the current economic condition of the chem ical testing industry is mixed. Some testing laboratories report slack demand, while others (particularly those with a strong base of clients in pharmaceutical research and development) report ex cellent sales and ongoing facility expansion. The ability of laboratories to expand capacity depends on sev eral factors, such as equipment, building costs, and test complexity. For example, laboratories that do not conduct inhalation tests may require extensive new equipment in order to do so. However, the screeni ng tests that are required by the proposed rule are less complex than inhalation tests, and would likely be easier for laboratories to expand capacity to implement.

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 capac ity is not a significant factor in meeting the requirements of the proposed rule. In addition, the less than expected level of demand for screening-level testing resulting from the HPV Challenge Program shoul d allow CROs to meet testing needs as a result of the proposed rule.3-18 

### 3.2 EPA Costs

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.

EPA assumes that, on average, a Federal GS-13, Step 1, full-time equivalent (FTE), equivalent to 2,080 hours per year, will conduct its collection procedur es under the proposed rule. The annual 2008 fully loaded salary for a GS-13, Step 1, FTE is $132,738. This includes a base salary of $82,961 plus 60 percent for overhead and benefits (i.e., $49,777). 11 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 $63.82 for the FTE. Appendix C provides a de tailed description of these calculations.

As explained earlier in Section 3.1.2, approximately 16 letters of intent and study plans, 80 exemption applications, 241 fi nal reports, and 24 robust summari es are estimated to be filed in response to the proposed rule. It is estimated that it takes on average 3 hours to process a letter of intent and study plan, 5 hours to process a final report, 1 hour to review a robust summary, and 1 hour to review each exemption application. Exhibit 3-9 presents the estimated total gove rnm ent costs based on these assumptions. As shown, the total government costs for the proposed rule are estimated to be approximately $86,610.

Exhibit 3-9: Estimated Government Costs for the Proposed Rule (2008$)

Unit Labor

Item Hours Rate Cost/Item Total Items Total Cost
Letter of Intent and Study Plans 3 $63.82 $191.46 16 $3,063
Final Reports 5 $63.82 $319.10 241 $76,903

Robust Summaries 1 $63.82 $63.82 24.1 $1,538
Exemption Applications 1 $63.82 $63.82 80 $5,106 Total $86,610



### 3.3 Summary of Total Social Costs

The estimated total social costs of the proposed rule are the sum of industry and EPA costs ( Exhibit 3-10). The total social costs under the least and average cost scenarios are $8.57 million and $10.21 million, respectively. Industry compliance costs are presented befo re tax. As with any co sts, 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 incr ease. 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 3-10: Summary of Total Social Cost s Triggered by the Proposed Rule (2008$)

Cost ($ million)

Cost Category Least Cost
Scenario Average Cost
Scenario Total industry compliance costs (unadjusted) a 8.57 10.21 Total government costs (unadjusted) 0.09 0.09 Total social costs triggered by the proposed rule (unadjusted) 8.65 10.30 Annualized social costs (3 years, 3% discount rate) 3.06 3.64 Annualized social costs (3 years, 7% discount rate) 3.30 3.93

a Total industry compliance costs include laboratory, analyt ical methodology validation, administration, and export
notification costs.

11 The unloaded Federal GS-13 Step 1 salary ($82,961, effective January 2008), from the Office of Personnel Management salary table for Washington-Baltimore-North ern Virginia (OPM, 2007). Th e 60 percent fringes-andoverhead rate is from an EPA/OPPE guide (U.S. EPA, 1992b).3-19 Chemical-specific estimates of laboratory, analytical methodology validation, administration, export notification, and government costs under the least and average cost scenarios can be found in Appendix C of this report. These costs a re not expected to occur in a single year, however. They are expected to occur over the several years during which the actual testing occurs and EPA reviews studies. A three-year time period is assumed for this analysis. Thus, total social co sts of the rule have been annualized over 3 years.

The issues involved in selecting the appropriate so cial discount rate are complex and subject to

considerable debate in the economics literature. This literature largely focuses on the appropriate treatment of displaced private investment, often referre d to as the private rate of return to capital, and displaced consumption, often referred to as the cons umption rate of interest. The literature and EPA’s economic guidance document suggest that the appropriate rate to use for environmental actions is usually the consumption rate of interest. Historical rates of return on relatively risk-free investments, adjusted for taxes and inflation, suggest that a consumption rate of interest of 2 to 3 percent is appropriate (U.S. EPA, 2000). A 3 percent discount rate is used for the primary analysis in this report, following common EPA convention. EPA guidance also recommends follo wing 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 pres ented for the 3 percent and 7 percent discount rates. As shown, total annualized social costs under the least cost scenario range from $3.06 to $3.30 million using a 3 percent and a 7 pe rcent discount rate, respectively. Total annualized social costs under the average cost scenario range from $3.64 to $3.93 million using a 3 percent and a 7 percent discount rate, respectively. Of these costs, $3.61 and $3.89 million are industry compliance costs.

Detailed social cost estimates are presented in Appendix B, in Exhibit B-1 through Exhibit B-4.4-1 

## Chapter 4 – Company-Level Impact and Sm all Business Impact Analy sis

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 indus try 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 Flexib ility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Act (SBREFA) of 1996.



### 4.1 Company-Level Impact

When a chemical manufacturer/importer faces a mandator y test rule, it must decide whether to comply with the testing requirement or to discontinue produc tion/importation of the chemical. Once the rule is finalized, a company would have 30 days to stop pr oduction/importation before it becomes responsible for testing. The costs associated with testing requi rements increase the cost of manufacturing/importing chemicals for these companies and decrease the overa ll profitability of the affected products. If profitability falls below acceptable levels, firms may choose to discontinue production of the chemical (provided this can occur within 30 days of publication of the final rule), to raise prices of products, or to suffer reduced profitability for continued production of the chemical.

The profitability of producing and selling a chemical is measured by the flow of costs and revenues associated with the chemical over time. The testing require d by this rule is a short-term effort to develop basic toxicological data. Evaluations of profitability of a chemical product line, however, are not based on one or even a very few years’ results, but rather on the total expected earnings stream (appropriately discounted) associated with a chemical over time. Thus, losses in one year may be appropriately balanced against revenues in another year to assess the net pr esent value of the stream of earnings (revenues less costs) of a chemical. 12

The development of a complete net present value anal ysis of the company-specific profitability of a particular chemical, with and without testing costs, would ideally require company-level information on expected costs and the revenues stream, which is typi cally difficult to obtain. Although data on revenues are available at the company level, these revenues ar e often the combined revenues from all operations of the company. Thus, the revenues may include operati ons that are independent of chemical sales, and therefore are not relevant to include in the analysis. Further, the financial structures of companies vary, making it difficult to meaningfully compare acros s companies; budgets within companies may be organized such that full company resources are not availa ble to cover testing costs, and costs are borne by only a small unit or division within the company. Dete rmining the specific levels at which testing costs may affect all of the individual companies that manufact ure chemicals affected by this proposed test rule is not possible given available data. Therefore, this an alysis is performed in a two-part method, whereby a chemical-level analysis is performed to compare th e total annualized cost of testing with the annual revenues for the chemical in question, across all ma nufacturers. If the testing costs are greater than 1 percent of the annual revenue for a particular chem ical, then in the second part, the affected companies are examined to evaluate the potential of testing costs to adversely affect the companies’ profitability. The

annualization is based on standard values for the econom ic life of the chemical and the discount rate for

all chemicals considered.

12 The use of net present value calculations to evaluate the pr ofitability of an investment or a business is discussed in many financial management texts, including Brealey and Myers (1996), Schall and Haley (1991), and Van Horne and Wachowicz (1997).4-2 Such a chemical-level analysis serv es as a proxy for company-level analysis if testing costs borne by each individual company that manufactures the chemical are in proportion to the total revenue of a company (assuming that the price of the chemical is the same ac ross companies). To the extent that this is not true,

costs will be over- or underestimated. To minimi ze the possibility of underestimating impacts, the purpose of the second step of this analysis is to consid er the impacts, at the co mpany level, for companies that manufacture chemicals with a cost-to-sales ratio gr eater than 1 percent. In this analysis, the overall revenue of the company is accounted for when estimat ing the cost-to-sales ratio. The steps used in this analysis are described below.

4.1.1 Calculate Annualized Costs

Because testing is a short-term effort to develop basic toxicological data, while the profitability of a chemical product line is based on the total earnings stream associated with the chemical over time and appropriately discounted, a company that experiences losses in a product line in one year due to testing requirements may also recoup these losses through profits earned in future years from the tested chemical. Annualized costs represent the amount that a company would have to pay each year over the period of analysis, such that the sum of these annual payments equal the present value of the overall cost of the

rule.

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

A = I 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).

The initial lump sum costs to comply with the propos ed rule under the least and average cost scenarios are presented in Chapter 3. Testing costs represent an opportunity cost to the com pany conducting the testing, as the company is not able to otherwise use or inv est the money spent on testing. In order to annualize those costs, they are discounted over an appropriate time period at a discount rate that reflects this opportunity cost of capital. The discount rate reflecting the opportunity cost of capital is estimated to be 7 percent and is consistent with OMB Circular A- 4 (OMB, 2003). This represents the average rate of return on low-yielding capital investments, such as hous ing, and the returns on high-yielding investments, such as corporate capital. Determining the number of years, n , to use in the annualization formula requires consideration of the “useful life” of the investment, which is longer than the time in which costs are actually incurred. This is because the analysis of impacts looks at the long-term profitability of the chemical product line, and it is not uncommon for produc t lines to be profitable in some years and operate at a loss during others, with overall profitability in the long term. For this analysis, the life of the chemical product line is assumed to be 15 years. The one-time testing costs are thus annualized over a 15-year period using a 7 percent discount rate. Exhibit 4-1 summarizes EPA’s estimates of total annualized testing

costs under both the least and the average cost scenarios. ( Appendix B, Exhibit B-4, presents the complete

list of chem ical-specific estimates of annualized co sts.) The annualized total industry compliance costs are $0.94 million under the least cost scenario and $1 .12 million under the average cost scenario. Industry compliance costs are likely to be overstated b ecause this analysis does not account for the tax deductibility of these costs.4-3 Exhibit 4-1: Annuali z ed Costs Under Least and Average Cost Scenarios (Total for All Chemicals) ($2008)

Cost ($ million) 1
Category Least Cost Scenario Average Cost Scenario Annualized Laboratory Cost $631,313 $774,140 Annualized Methodology Development Cost $43,753 $43,753

Annualized Administration Cost $263,428 $299,134 Annualized Export Notification Cost $2,138 $4,480 Annualized Industry Compliance Costs 2 $940,632 $1,121,508

1 All costs were annualized over a 15-year ti me horizon using a 7 percent discount rate.

2 Industry compliance costs include laboratory costs, methodol ogy development costs, administration costs, and export
notification costs.

4.1.2 Compare Annualized Compliance Costs to Annual Revenues

To determine if the annualized compliance costs of te sting could result in an adverse economic impact for a given chemical, the annualized compliance costs of testing for each specific chemical were compared to

the annual revenues for those chemicals. As described ear lier, this chemical-level analysis is performed to screen for impacts at a 1 percent threshold and higher. For chemicals with an impact greater than this threshold, further analysis is perform ed on individual manufacturers (see Section 4.1.3).

To develop a n estimate of expected annual sal es revenue, the price per pound of each chemical 13 was multiplied by the total volume of production and importation in the United States. 14 The annualized cost of testing each of these chemicals was then divi ded by the annual sales revenue the chemical was expected to generate. If a chemical-specific cost-to-sal es ratio is less than 1 percent, the test rule isassumed to have low potential for an adverse economic impact on the affected chemicals. If a chemicalspecific cost-to-sales ratio is 1 percent or greater, it is assumed that there could be a potential for an adverse impact on a chemical’s profitability. Exhibit 4-2 presents the distribution, under the least and

average cost scenarios, of cost-to-sales ratios for the chemicals in the proposed test rule as well as summary statistics.

Under the least cost scenario, 17 out of the 29 chemical s (59 percent) are affected at a level of less than 1 percent of their sales. Under the average cost scenario, 16 out of 29 chemicals (55 percent) are affected at a level of less than 1 percent. Therefore, th e potential for adverse economic impacts due to the proposed test rule is judged to be low for at least 55 percent of the regulated chemicals. However, 12 chemicals (41 percent) and 13 chemicals (45 percent) of the 29 chemicals are affected at a level greater than or equal to 1 percent of their sales under the least and average cost scen arios, respectively. These

chemicals are further evaluated below.

13 The method used to derive chemical price estimates is found in Appendix A.

14 Production/import volumes were obtained through reports submitted by manufacturers as required by the IUR and PAIR rules; see Chapter 2. Volumes used in this calcu lation may be considered confidential business information and are not shown in this report.4-4 Exhibit 4-2: Summary Statistics for Chemical-Specific Cost-to-Sales Ratios 1

Statistical Measure Least Cost Scenario Average Cost Scenario Total Number of Regulated Chemicals 29 29

Number of Chemicals with Production Volume and Price Data 29 29 Number of Chemicals with Cost-to-Sales Ratio <1 percent 17 16 Number of Chemicals with Cost-to-Sales Ratio 1 to 3 percent 8 9 Number of Chemicals with Cost-to-Sales Ratio 3 to 5 percent 2 2 Number of Chemicals with Cost-to-Sales Ratio 5 to 10 percent 2 1 Number of Chemicals with Cost-to-Sales Ratio > 10 percent 0 1

Mean Cost-to-Sales Ratio 1.40% 1.66%

Median Cost-to-Sales Ratio 0.63% 0.75%

Standard Deviation 2.12% 2.55%

1 Compliance costs were annualized over a 15-year time horizon using a 7 percent discount rate.

4.1.3 Conduct Further Analysis on Chemicals Affected at 1 Percent

For chemicals with a cost-to-sales ratio greater than 1 percent, EPA conducted further analysis to evaluate the potential of testing costs to adversely affect the profitability of the affected companies. 15 EPA attempted to understand potential impacts on companies that produce chemicals with testing cost-to-sales ratios greater than 1 percent by examining these companies’ individual revenue data compared to their share of compliance costs.

To calculate each company’s share of compliance co sts, EPA assumed that the annualized cost of performing chemical-specific testing is borne by companies in proportion to their production and/or importation volume. For example, Company A’s cost sh are for testing chemical X was computed by first calculating Company A’s fraction of overall chemical X production (the volume of chemical X produced/imported by Company A divided by the total production of chemical X.) This fraction was then multiplied by the total annualized testing costs for th e chemical to obtain Company A’s cost share. The cost share was computed under both th e least and average cost scenarios.

Using revenue data on global parent companies (Dun & Bradstreet, 2008) for companies that produce chemicals for which the cost-to-sales ratio is greater than 1 percent, EPA estimated company-specific cost-to-sales ratios. Based on this analysis, EPA concl udes that the costs of the testing requirements for chemicals produced by a specific company exceed 1 percent of company revenues for only one of the companies.

Exhibit 4-3 provides summary information on company- specific cost-to-sales ra tios, and indicates that the impact of companies’ share of testing costs is less than 1 percent of a company’s revenues, on average. This result is due to a company’s overall revenue typi cally being larger than the revenue generated only by the specific chemical of inter est. Company-specific testing costs ra nge from less than 0.01 percent to approximately 16 percent of company revenues. These da ta suggest that even if revenues generated from the tested chemical included in the proposed rule w ould not support the costs of its testing, other product lines in the company could potentially support these cost s. Finally, it may be possible for companies to increase the prices of the chemicals somewhat to r ecoup testing costs; however, because price elasticity information was not available for the chemicals, it is not possible to estimate the extent to which this could occur. As noted above, in sofar as company revenues are generated from independent operations

such that these resources are not available to fund t esting costs, the company-specific ratio may be an underestimate of the actual impact of the costs of testing.

15 EPA used a 1 percent threshold based on an EPA study entitled “Review of Economic Impact Methodology Applied to TSCA Section 4 Test Rules.” This study found that chemical-specific cost-to-sales ratios for voluntary testing initiatives were less than 1 percent. While the study did not conclude that a cost-to-sales ratio greater than 1 percent would lead to adverse financial impacts, EPA used this estimate as a reasonable threshold to determine whether there is a need to further evaluate impacts on a firm (D’Ruiz and Riordan, 1998).4-5 Exhibit 4-3: Summary Statistics for Company-Specific Cost-to-Sales Ratios, for
Chemicals with Cost-to-Sales Ratios Greater Than 1 Percent

Statistical Measure Least Cost Scenario Average Cost Scenario Total Number of Affected Companies 30 31 Number of Companies with Sales Data 29 29

Total Number of Affected Chemicals 12 13

Minimum Cost-to-Sales Ratio < 0.01% <0.01%

Maximum Cost-to-Sales Ratio 13.43% 16.23%

Mean Cost-to-Sales Ratio 0.41% 0.49%

Median Cost-to-Sales Ratio < 0.01% < 0.01%

Standard Deviation 2.30% 2.78% Notes: Compliance costs were annualized over a 15-ye ar time horizon using a 7 percent discount rate. Information is presented at the global parent company level.

4.1.4 Conduct a Sensitivity Analysis

Many chemicals may have a useful life that differs from the 15-year assumption used above. Therefore, EPA conducted a sensitivity analysis to examine th e robustness of the results to a change in the annualization assumptions. If total compliance costs are annualized over a shorter horizon of seven years, 55 percent of the chemicals are affected at a level of less than 1 percent under both the least cost scenario and the average cost scenario. Exhibit 4-4 summarizes the impact of the proposed rule if costs are

annualized ov er a seven-year time horizon.

A maximum of 15 chemicals are affected at a level of greater than 1 percent if costs are computed under both the least and average cost methods, and annuali zed over a seven-year period. Using the alternative scenario assumptions shifts three and two chemicals fr om a level of less than 1 percent to a level of greater than 1 percent under the least and average cost scenarios, respectively.

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

Impact Category Least Cost Scenario Average Cost Scenario Total Number of Regulated Chemicals 29 29 Number of Chemicals with Cost-to-Sales Ratio <1 percent 14 14 Number of Chemicals with Cost-to-Sales Ratio 1 to 3 percent 8 8 Number of Chemicals with Cost-to-Sales Ratio 3 to 5 percent 3 2 Number of Chemicals with Cost-to-Sales Ratio 5 to 10 percent 2 3 Number of Chemicals with Cost-to-Sales Ratio > 10 percent 2 2 Notes: Compliance costs were annualized over a 7-ye ar time horizon using a 7 percent discount rate.

Using the same method described in Section 4.1.3, EPA concludes that the cost of the company -specific testing requirements for the chemicals affected at a le vel greater than 1 percent, if costs are annualized over a seven-year time horizon, also exceed 1 per cent of company revenues for only one of the companies. This conclusion is supported by the analysis presented in Exhibit 4-5, which demonstrates that the average im pact of each company’s share of t esting costs is less than 1 percent of that company’s

revenues.4-6 Exhibit 4-5: Sensitivity Analysis: Summary Statistics for Company-Specific Cost-toSales Ratios, for Chemicals with Cost-to-Sales Ratios Greater Than 1 Percent

Statistical Measure Least Cost Scenario Average Cost Scenario Total Number of Affected Companies 34 34 Number of Companies with Sales Data 32 32

Total Number of Affected Chemicals 15 15

Minimum Cost-to-Sales Ratio < 0.01% < 0.01%

Maximum Cost-to-Sales Ratio 25.28% 30.55%

Mean Cost-to-Sales Ratio 0.71% 0.86%

Median Cost-to-Sales Ratio < 0.01% < 0.01%

Standard Deviation 4.10% 4.95% Note: Compliance costs were annualized over a 7-year time horizon using a 7 percent discount rate Information is presented at the global parent company level.



### 4.2 Small Entity Impact Analysis

To determine the impact that the rule might ha ve on small businesses, this section examines the relationship between the compliance costs and company sales for small businesses. Since companies that are small (as defined by SBA) are most likely to be a dversely affected by the rule, this analysis focuses on these companies.

The RFA, as amended by SBREFA, requires regulators to assess the effects of regulations on small entities, including businesses, nonprofit organizations, and governments. In some instances, agencies are also required to examine regulatory alternativ es that may reduce adverse economic effects on significantly impacted small entities. The RFA requires agencies to prepare an initial and final regulatory flexibility analysis for each rule unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA, however, does not specifically define “a significant economic impact on a substantial number” of small entities. Sections 603 and 604 of the RFA require that regulatory flex ibility analyses identify the types, and estimate the numbers, of small entities to which the rule will apply; and describe th e rule requirements to which small entities will be subject and any regulatory alternatives, including exem ptions and deferral, that would lessen the rule’s

burden on small entities.

The proposed rule is not expected to affect sma ll governments and small organizations, as defined under RFA Section 601. However, some small businesses may be affected by the proposed rule. Thus, this section assesses the potential impact of the proposed rule on small businesses. The major steps used in the analysis are described below.

4.2.1 Select a Relevant Small Business Definition

The RFA relies on the definition of a “small business” found in the Small Business Act, which authorizes SBA to develop definitions for “small business” ty pically based upon a sales or employment level depending on the relevant North Am erican Industry Classification System (NAICS) code for the industry. For this analysis, EPA uses SBA’s definition of a small business for each industry. Entities potentially affected by the proposed testing rule include manuf acturers and processors of one or more of the 29 subject chemical substances, i.e ., chemical manufacturing and petroleum refineries (NAICS codes 325 and 324110). Under 13 CFR 121, SBA defines small business for the six-digit NAICS industry based on employment thresholds (SBA, 2004). These size standards range from 500 employees to 1,500 employees for the six-digit NAICS codes that are potentially affected by the proposed rule. For example, SBA defines a company in NAICS 325320 (Pesticide and Other Agricultural Chemical Manufacturing) as small if it has fewer than 500 employees. On the other hand, a company in NAICS 324110 (Petroleum Refineries) is considered small if it has fewer than 1,500 employees. To obtain a worst-case estimate of the number of small businesses affected by the propo sed rule, EPA chose an employment threshold of4-7 1,500 employees to determine small business status. Throughout the remainder of this report, this

definition is referred to as an “employment-based definition.”

For this analysis, EPA considered an alternative definition based up on sales for the purpose of sensitivity analysis. Under this definition, a manufacturer or importer is defined as small under 40 CFR 704.3 if it meets either of the following criteria:

(1) Total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volum e or importation volume at the facility is less than or equal to 100,000 lbs.; or (2) Total annual sales of the company, combined with those of any parent company, are below $4 million.

This “sales-based definition” also includes a provision that allows adjustment to the total annual sales

values for inflation whenever EPA deems it necessary to do so.

4.2.2 Identify the Affected Population

For each manufacturer/importer of the chemicals identified in Chapter 2, EPA identified the ultimate

parent co mpany and obtained sales and employment data for companies for which data are available from Dun & Bradstreet Market Identifier (Dun & Bradstreet, 2008). 16

The search identified 54 affected global ultimate pa rent companies as defined by their global DUNS number or the highest parent level found in other so urces. Sales and employment data could be found for 52 of the global ultimate parent companies. EPA wa s not able to locate the global ultimate parent company for two companies that submitted produc tion information for the 2006 Inventory Update Reporting (IUR) rule.

4.2.3 Identify Small Businesses

Parent company sales data, collected as explained abov e, were used to identify companies that qualified for “small business” status, per both the employment -based and the sales-based definitions specified above. Based on the employment criteria, 21 comp anies (39 percent) were identified as small. Furthermore, five companies (9 percent) were id entified as small according to the sales criteria.

4.2.4 Calculate Each Company’s Share of Testing Costs

As explained in Chapter 3, the industry compliance costs (the sum of laboratory costs, methodology developm ent costs, administration costs, and export notification costs) were computed under least and average cost scenarios. These costs were annuali zed over a 15-year time horizon using a 7 percent

16 Dun and Bradstreet is a New York-based company th at provides business information through a global commercial database. It assigns DUNS numbers to iden tify businesses around the world. These numbers are required for many U.S. federal government transactions and therefore are widely used and assigned. DUNS numbers are also frequently used in corporate research. Database entries provide legal and trade names, physical and mailing addresses, geographical descriptions, product and industry descriptors, sales and number of employees for three years and associated growth rates, as well as up to 40 vital statistics about each organization. While the reporting year varied by company, company sales and employment data were primarily retrieved from the database in October

2008.4-8 discount rate. The annualized compliance costs for all 29 chemicals were approximately $0



### . 94 million under the least cost scenario and approximately $1.12 million under the average cost scenario. 17

Similar to the analysis above, to calculate each company’s share of compliance costs, EPA assumed that the cost of performing chemical-specific testing is borne by companies in proportion to their production and/or importation volume. This fraction was then mu ltiplied by the total annualized testing costs for the chemical to obtain Company A’s cost share. Total per-company testing costs were computed by summing all the chemical-specific cost shares for each company. This method was used to get a worst-case estimate of the rule’s impact on small businesses. For example, if Company A produced Chemicals X, Y, and Z,

then one combined cost was examin ed rather than three chemical-s pecific shares. Cost shares were computed under both the least and average cost scenarios.

4.2.5 Determine the Size of the Adverse Impact for Small Businesses

To determine the size of the adverse impact, each company’s total share of testing costs (for all chemicals it manufactures/imports) was then compared to its total sales.

Small businesses were grouped based on the cost-to- sales ratios: less than 1 percent, greater than 1 percent, and greater than 3 percent. Exhibit 4-6 presents summary statistics for company-specific costto-sales ratios for small companies, as well as a summa ry of the results using the employment-based, as well as the sales-based, definition of a small business, under both the least and the average cost scenarios.

Exhibit 4-6 indicates that the number of small businesses a ffe cted at the 1 and 3 percent levels is identical regardless of the small business definition used: the an alysis based on employment data correlates quite closely with the one based on sales data for the comp anies. Of the 21 companies that qualified for small business status per the employment criteria, one had cost-to-sales ratios of greater than 1 percent under the least and average cost scenar ios. The results are identical if the sales definition is used.

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

Employment Definition 1 Sales Definition 2

Statistical Measure Least Cost
Scenario Average Cost
Scenario Least Cost
Scenario Average Cost
Scenario Total Number of Identified Companies 54 54 54 54 Number of Companies with Data 52 52 52 52 Total Number of Identified Small Companies 21 21 5 5 Number Impacted at >1 percent 1 1 1 1 Number Impacted at >3 percent 1 1 1 1

Minimum Cost-to-Sales Ratio <0.01% <0.01% <0.01% <0.01%

Maximum Cost-to-Sales Ratio 13.40% 16.20% 13.40% 16.20%

Mean Cost-to-Sales Ratio 0.01% 0.01% 0.03% 0.03%

Median Cost-to-Sales Ratio 0.70% 0.85% 2.80% 3.39%

Standard Deviation 2.92% 3.53% 5.95% 7.19% Compliance costs are annualized over a 15-year ti me horizon using a 7 percent discount rate.

1 Companies with fewer than 1,500 employees 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 m illion are considered small under this definition.

4.2.6 Companies without Data

Data on sales and employees are missing for two of th e 54 companies. An analysis was conducted to determine the potential impact on these companies, us ing the median revenue for small companies with revenue data to estimate the likely revenue of the co mpanies without data. The median revenue for small

17 Annualized over 15 years using a 7 percent discount rate. Note that these figures include only the industry compliance cost and not the cost to th e government. Also note that industry compliance costs may be overestimated to the extent that companies can claim tax deductions for some of these costs.4-9 companies with revenue data is $24.7 million (using the employment-based definition of small business

as described in Section 4.2.1). If this figure represented the sales for the com panies without sales data, the cost-to-sales ratio would be less than 1 percent. Anot her way to look at this figure is that the overall revenue of either of the two companies would need to be less than $50,000 in order for testing cost impacts to be near or exceed 1 percent of sales. This value is approximately a quarter of the revenue of the company in this analysis with the lowest known revenue.

4.2.7 Conclusions

EPA estimates that small entities will not be adversel y affected by the proposed testing rule. For the proposed rule, EPA estimates that the small entities that are potentially directly regulated by this rule include small for-profit businesses; no nonprofit organiza tions or governments are expected to be affected by this proposed rule. EPA estimates that there are 21 small entities that would be affected by this proposed rule under the number of employees-based definition, and 5 small entities that would be affected under the sales-based definition. Of these, EPA estimat es that there is one small business for which the cost impact of the testing exceeds 1 percent of the company’s revenue.5-1 

## Chapter 5 – Benefits

The proposed rule targets high production volume (H PV) chemicals for which basic toxicological (hazard) information is unavailable a nd 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 informatio n developed because of the proposed rule will be made publicly available and is expected to yield bene fits resulting from the direct use of the information (use value). In addition, there may be non-use bene fits 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 inform ation that would result from the proposed rule, non-use benefits are not likely to comprise a large percentage of the total benefits.



### 5.1 Use Values

The proposed rule will increase the publicly available da ta about a chemical’s risks and consequently is likely to result in (a) a reduction in the costs of risk-based decisions about the chemical, and (b) an improvement in the expected outcome of the decisions (U.S. EPA, 2006).

Reduced cost of risk-based decision making. By making new information about toxic substances available to the public (including EPA and other govern ment agencies), this proposed rule can serve to replace other information-gathering, management, a nd 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 perfo rm these activities. In effect, the proposed rule increases the efficiency (and strength) of the decision-making process.

Improved outcome of decisions. Information-based policies contribute to better decisions by redirecting resources toward their most highly valued uses. With incomplete information regarding toxic chemicals, public and private decision makers are not able to ade quately 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 bette r direct its limited resources toward high-priority risks. It is also likely that once detailed toxicolo gical information is available on these HPV chemicals, producers and users of these chemicals will adjust th e volume of production and use to minimize adverse effects. Improved information can therefore help lead to more socially optimal reductions in risks to

humans and the environment.

This chapter discusses the use benefits of the HPV chem ical test rule qualitatively. Quantification of the benefits of the proposed rule woul d require more specific information about each user’s use patterns and preferences, and the changes in these that would r esult from the additional information made available under the proposed rule. These data are not readily av ailable; 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 th e public places on the availability of the information resulting from the test rule. However, such a survey (or one for similar information) has not been

conducted.

Furthermore, the exact nature and scope of the bene fits resulting from this proposed rule would depend on the outcome of the tests that would be performed; to th e extent that the test results did indicate a potential5-2 health or environmental risk from a chemical, the bene fits related to understandi ng and avoiding this risk would be greater.



### 5.2 Non-Use Values

The value that society places on the information resu lting from this proposed rule may go beyond whatpeople 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 regard less of whether they ever use the

information. Non-use values have also been refe rred to as “existence” or “intrinsic” values and encompass a variety of motivations. For example, indi viduals may place a value on the availability of the test data for others to use in the current time pe riod (vicarious consumption), or place value on preserving or ensuring the availability of the data (or the decisi ons or policies that result from the information) for the benefit of family and others in the future (be quest 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 notassociated with easily observable behaviors. Third, non-use values may be held by both users and nonusers of a resource, and non-users may be less familiar with particular services provided by the resources in question.



### 5.3 Benefits of the Required Tests

Taken together, the tests required under the 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 associat ed with the chemical. Consistent with the HPV Screening Information Data Set (SIDS) program of the Organisation for Economic Co-operation and Development (OECD) (described in Chapter 3 of this report) the data obtained by this battery of tests

relate to six health and env ironmental effect endpoi nts for HPV chemicals – acute toxicity; repeat dose toxicity; developmental and reproductive toxicity; ge netic toxicity (gene mutations and chromosomal aberrations); ecotoxicity (studies in fish, Daphnia, an d 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 judgme nt 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.

Screening-level tests that provide information on the toxicity of a chemical (e.g., aquatic toxicity, mammalian toxicity) provide information on the health and environmental effects of the chemical, and can be used to assess how “danger ous” 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 c ontrols, 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 ma y interact with the environment or the body, and5-3 the methods by which it may be dispersed. The inform ation 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 chem ical 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 be nefits associated with each individual test). Section 5.4 lists the tests required for each chemical.

5.3.1 Physical/Chemical Properties

Melting Point (ASTM E 324-99) (ASTM, 2009c)

. The melting point is the temperature at which a substance transitions from the solid to liquid phase. The ASTM E 324-99 melting point test determines the initial and final melting points (melting range) of stable, crystalline organic solids whose melting points fall between 30°C and 250°C.

The data generated by this test benefit industry an d workers through the determination of the physical phase of the chemical in industrial settings or duri ng 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, liqui d, 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 ambien t 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 liq uid phase are more readily absorbed by skin than those in the solid phase). This benefit in turn indir ectly helps workers, consumers, or persons living in locations impacted by chemical emissions, as gove rnment 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 an d workers through the determination of the physical phase of the chemical in industrial settings or duri ng transport, making the identification of optimal storage temperatures and container systems possible. Information on a chemical’s boiling point can help to determine whether a chemical exists in the liquid or gas phase. The buildup of pressure in containers due to low boiling point and high vapor pressure li quids can be a severe workplace and transportation hazard. Thus, the use of these data to provide safe, hazard-free transportation and workplaces will benefit the general public, industrial workers, and the industries they work in by decreasing the liability of transport and workplace accidents. Since the boiling point is an intrinsic property of a chemical, this test can also be used to help identify unknown chemicals at industrial sites.

A chemical’s boiling point also benefits government and industry scientists unde rtaking 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).5-4 • 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 exis ts 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 i ndicates 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 prefer ably high-pressure versions of these instruments (HPDTA and HPDSC).

The data generated by this test benefit industry an d workers through the determination of the physical phase (e.g., liquid or gas) of the chemical in in dustrial settings or during transport, making the identification of optimal storage temperatures and c ontainer 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 al so benefits government and industry scientists undertaking occupational and environm ental exposure and risk assessment s because of its impact on the expected fate of the chemicals, the expected tran sport of the chemicals, and the exposure outcome.

Partition Coefficient (ASTM E 1147-92(2005)) (ASTM, 2005). The octanol-water partition coefficient (logK

ow ) indicates how a compound partitions between wate r and non-polar organic chemicals (e.g., fats and oils). The ASTM E 1147 partition coefficient t est 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 u sers involve cleanup, waste-handling procedures, and chemical identification. Cleanup procedures are highl y 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 th e determination of chemic als’ solubility in fat. Persistent, fat-soluble chemicals can bioaccumulate in regularly exposed workers, or consumers of enduse products. This information can help identify the ne ed 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 i ndustry and benefiting workers. It can also help preemptively identify products whose use is likel y to result in bioaccumulation in consumers.

Partition coefficient information also benefits govern ment and industry scientists undertaking fate and transport studies. Chemical fate and transport is high ly influenced by the tendenc y of chemicals to adsorb to non-polar organic matter such as sediment, soil, and dust. Chemicals with high logK

ow partition coefficients are more likely to adsorb to these particles, which can impede or accelerate their dispersal,5-5 depending on local conditions . In soil matrices, these chemicals pre dominately adsorb to organic material, while chemicals that are more water soluble perc olate 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 assesso rs benefit from these data because logK

ow heavily influences the magnitude of chemical uptake in the human body (e.g., a high logK

ow 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 logK

ow partition coefficients often results in extensive bioaccumulation). This benefit in turn indirectly helps workers, cons umers, or persons living in locations impacted by chemical emissions, as government regulation and r esponse 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 wate r solubility. The ASTM E1148-02 water solubility test determines the affinity of water- and air-stable ch emicals 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 u sers involve cleanup, waste-handling procedures, and chemical identification. Cleanup procedures are highl y 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 th e determination of chemic als’ solubility in fat. Persistent, fat-soluble chemicals can bioaccumulate in regularly exposed workers, or consumers of enduse products. This information can help identify the ne ed 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 i ndustry and benefiting workers. It can also help preemptively identify products whose use is likel y to result in bioaccumulation in consumers.

Water solubility information also benefits government and industry scientists undertaking fate and transport studies. Chemical fate and transport is highly influenced by the affinity of chemicals to water. Chemicals with high solubility are more likely to tr avel with water flows (i.e., rivers, aquifers, rain percolation through soil and sediment) , and as a result can travel exte nsive 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 upt ake in the human body (e.g., high water solubility typically results in lower dermal transfer coefficien ts and inhalation efficiency ) and the possible site of toxic effects (e.g., upper respiratory tract versus lungs). It also influences the partitioning of the chemical inside of the body and consequently is used in the es timation of chemical half-lif e. This benefit in turn indirectly helps workers, consumers, or persons liv ing in locations impacted by chemical emissions, as government regulation and response to long-term and emergency releases can be more targeted and

effective.

5.3.2 Environmental Fate and Pathways

Ready Biodegradation (ASTM 1720-01, sealed vessel CO 2 production test) (ASTM, 2008b). The biodegradation test measures how quickly chemicals will be broken down in the environment by natural5-6 processes such as bacterial digestion. The ASTM E 1720-01 ready biodegradability test uses the generation of carbon dioxide by a dilu te sewage inoculum as a proxy to determine the biodegradability of organic compounds in a closed vessel. Biodegradation of 60 percent or more during the closed-vessel test indicates that in most environmental compartments the chemical will biodegrade completely. The International Organization for Standardization (ISO)’s standards ISO 14593, ISO 7827, ISO 9408, ISO 9439, ISO 10707 and ISO 10708 provide alternate protocols test for biodegradation. The appropriate method is determined by the test substance’s physical and chemical properties, including its water solubility. ISO 10634 provides guidance for selection of an appropriate test method for a given test

substance.

For industries that keep chemicals in stock for extended periods of time, these data have a significant benefit, since biodegradability influences the choi ce of storage conditions, in cluding container type, humidity, temperature, and expected storage time. These data also benefit government and industry scientists undertaking fate and transport studies, as well as occupational and environmental exposure and risk assessments. They can be used as a proxy measure for persistence in the environment. All else being equal, chemicals expected to biodegrade in most environmental compartments will neither have as long a residence time nor travel as far as a non-biodegradable equivalent. This, in turn, affects the potential for ecological and human exposure and consequent risk.

5.3.3 Aquatic Toxicity

Aquatic toxicity data are beneficial to industry, regulators, and the public for a variety of reasons. Industry and regulators may use the information durin g the formulation of plans for water emissions schedules and the filing of National Pollutant Disch arge 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 assess ments. 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 em issions 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; microa lgae 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 ot her aquatic life. They can also be used as general indicators of toxicity, such as in lifecycle analyses. Government response to industrial emissions as a consequence of ecological risk assessment results can therefore be better tailored to protect ecological resources, benefiting the general public. More detail on these aquatic toxicity tests is provided below.

Acute Toxicity to Fish (ASTM E 729-96) (ASTM, 2007b). The ASTM E 729-96 acute toxicity test

determines the concentration of chemical needed to reach a toxicity threshold in certain species of

freshwater and saltwater fish. The standard thresholds used are the concentration at which there is a 50 percent fatality rate in the test organisms (LC 50 ) or the concentration at which there is a 50 percent adverse effect response rate in the test organisms (EC 50 ) during two- to eight-day exposures in either static (no replacement of toxicant), renewal (per iodic replacement of toxicant), or flow-through (continuous or intermittent replacement of makeup wa ter and toxicant) exposures (Hoffman et al., 2003). Lower thresholds represent higher toxicity in the target organisms. Because the toxic endpoint in the LC 50 is death, it represents a very crude measure of chemical toxicity, unlike the EC 50 or chronic studies, which

measure more subtle effects.

Acute Toxicity to Daphnia (ASTM E 729-96) (ASTM, 2007b). The ASTM E 729-96 acute toxicity test

determines the concentration of chemical needed to reach a toxicity threshold in Daphnia crustaceans.

The standard thresholds used are the concentration at which there is a 50 percent fatality rate in the test organisms (LC 50 ) or the concentration at which there is a 50 percent adverse effect response rate in the5-7 test organisms (EC 50 ) during two- to eight-day exposures in e ither static (no replacement of toxicant), renewal (periodic replacement of toxicant), or flow -through (continuous or inte rmittent replacement of makeup water and toxicant) exposures. 8 Lower thresholds represent higher toxicity in the target organisms. Because the toxic endpoint in the LC 50 is death, it represents a very crude measure of chemical toxicity, unlike the EC 50 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 r each a toxicity threshold in freshwater and saltwater microalgae. The standard threshold used is the c oncentration at which there is a 50 percent growth inhibition rate (IC 50 ) 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 need ed to reach a toxicity threshold in Daphnia magna crustaceans. Exposures are conducted using flow-thr ough (continuous or inte rmittent replacement of makeup water and toxicant) methods and last over the lifecycle of the organisms.

5.3.4 Mammalian Toxicity – Acute

Several types of mammalian acute toxicity tests are available. Industry can use acute inhalation toxicity

data to determine the level of h azard 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 cy totoxicity indicate the potential for adverse health outcomes on cells, the smallest building block of the bo dy.) This hazard level can help identify the need for special containers, engineering controls, and pe rsonal 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 info rmation 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, cons umers, or persons living in close proximity to

emissions streams. This benefit in tu rn indirectly helps workers, consum ers, or persons living in locations impacted by chemical emissions, as government re gulation and response to long-term and emergency releases can be more targeted and effective. Toxici ty assessments are able to use the cytotoxicity information to estimate the potential for adverse health effects in workers, consumers, or the general public. As a result, government responses, primarily in the form of demands for further toxicity testing, are likely to be more targeted and effective. More detail on various types of mammalian acute toxicity tests is provided below.

Acute Inhalation Toxicity (40 CFR §799.9130). This test gives an indication of potential harm from inhaling a chemical compound. The regulation at 40 CFR §799.9130 defines the standard test to measure the acute inhalation toxicity of gases, volatile substanc es, 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 bot h sexes. Occurrence, severity, and reversibility for as many behaviorally and clinically abnormal out comes as possible should be catalogued during the experiment, and an attempt to determine the relati onship between dose level a nd effect should be made. This test can be used to determine a regimen of doses for longer-term (i.e., subchronic and chronic) inhalation toxicity studies.5-8 Acute Oral Toxicity (40 CFR §799.9110). This test gives an indication of harm from ingesting a chemical compound. The regulation at 40 CFR §799.9110 defines the standard test to measure the acute oral toxicity of liquid or solid chemicals in mammals. This test is conducted during a period of 24 hours or less using single or multiple ingestion doses at no less th an 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 Ne utral 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 me asured using their ability to take up the Neutral Red dye as a proxy (Shirai et al., 1989).

5.3.5 Mammalian Toxicity - Genotoxicity

Industry can use genotoxicity data to approximate the potential risk of carcinogenicity, or reproductive and developmental effects posed by chemicals prior to conducting a full risk assessment. Elevated levels of genotoxicity, chromosomal aberrations, or aberrant erythrocyte production during the test indicate increased potential for these effects. High genotoxicity might require the use of special containers, engineering controls, and personal protective equipmen t 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 in dustry 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 likel y to be more targeted a nd 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 descr ibed 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 or ganism 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 determin e whether chemical exposure causes chromosomal aberrations in primary cell cultures, such as Chinese hamster fibroblasts, human, or other mammalian5-9 peripheral blood lymphocytes. Generation of chro mosomal 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 expos ure. 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 Aberra tion 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 chromoso me 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 t est 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 seek s to determine whether chemical exposure causes damage to the chromosomes or the mitotic apparatus of erythroblasts (immediate precursor to red blood cells) in the bone marrow of rodents, such as rats or mice. The proportion of immature erythrocytes among the total is measured using basic microscopy techniques, and a dose-response relationship is investigated. Positive results in this test are used to determine chemicals that should be further tested for carcinogenic potential, particularly with regard to erythrocyte production.

5.3.6 Mammalian Toxicity - Repeated Dose/Reproduction/Developmental

Industry can use repeated dose oral toxicity data al ong with reproductive and deve lopmental toxicity data to determine the level of hazard or potential risk po sed 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 benefiti ng workers. Industry can also benefit from this information during safety testing of consumer produc ts, 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 envir onmental 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, consumer s, persons living in close proximity to emissions streams, and sensitive subpopulations (e.g., pregnant women, young ch ildren), 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 re gulation and response to long-term and emergency releases can be more targeted and effective. Mo re 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 chem icals 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 us ing 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 to5-10 determine the relationship between dose level and effect should be ma de with the no observed effects level (NOEL) serving as one of the parameters of im portance. 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 (ED 50 ) should be determined.

Reproductive and Developmental Toxicity Screening (40 CFR §799.9355). These tests give an

indication of the likelihood of a chemical to have an impact on the offspring of those exposed to the chemical. The regulation at 40 CFR §799.9355 defines the standard test to measure the reproductive or developmental toxicity of chemicals in mammals. Ma le animals are dosed for a minimum of four weeks

with a schedule as follows: a minimum of two w eeks pre-mating, during the mating period, and approximately two weeks post-mating. Females are do sed 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 shoul d be made with the no observed e ffects level (NOEL) serving as one of the parameters of importance. If possible, th e no observed adverse effect level (NOAEL), lowest observed adverse effect level (LOAEL), and dose at wh ich an effect is seen in 50 percent of the test animal population (ED 50 ) 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. Ma le animals are dosed for a minimum of four weeks

with a schedule as follows: a minimum of two w eeks pre-mating, during the mating period, and approximately two weeks post-mating. Females are do sed 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 histop athological 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 th e 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 (ED 50 ) should be determined.



### 5.4 Benefits Related to Each Regulated Chemical

Total benefits that result from the required tests discussed above would depend on the production volume of chemical substances included in this 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 t esting if it finds that a chemical is reasonably expected to be released into the environment in substantial quantities, or if there may be substantial or significant human exposure. For all of the chemical substances included in this 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 sec tions below briefly describe EPA’s findings for each chemical (U.S. EPA, 2009), which indicate why society may benefit when screening-level hazard and risk

information is known. The total benefit of this proposed testing rule will depend on the production volume of chemicals, insofar as greater volume impli es a greater risk of exposure. The production volume for each chemical was provided in Exhibit 2-6 ( Chapter 2 of this report). Any known information about5-11 exposure volume is included with the description of th e findings. For each chemical, a chart shows which specific tests are required by this proposed rule. Test s are only required where the resulting data are not

otherwise available for the chemical.

5.4.1 2-Nitrobenzene, 1,2-dimethyl- (CASRN 83-41-0)

Submissions required by the Preliminary Assessment Information Reporting (PAIR) rule indicate that more than 1 million pounds of this chemical is released to the environment (U.S. EPA, 2008c). EPA

believes that this chemical meets the criterion of “significant or substantial release.” (U.S. EPA, 2009). A significant number of workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulati ons) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Ru le for 2-Nitrobenzene, 1,2-dimethyl- (CASRN 83-41-0)

Melting

Point Boiling Point Vapor

Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.2 3-Pentanone (CASRN 96-22-0)

Submissions required by the Preliminary Assessm ent Information Reporting (PAIR) rule indicate consumer use. It is expected that products contai ning this chemical may be used by more than 10,000 consumers (U.S. EPA, 2008c). Based on this information, EPA believes that this chemical may have “substantial or significant human exposure” (U.S. EPA, 2009). Furthermore, other sources report that the chemical is used in the manufacture of medicines, as a solvent for paint ingredients, and in flavors and cosmetics (U.S. NLM, 2008b; Ash, 2003). Therefore, a substantial or significant number of consumers or others who are exposed to the chemical would benefi t from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 3-Pentanone (CASRN 96-22-0)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.3 Benzenesulfonyl chloride (CASRN 98-09-9)

The Inventory Update Reporting (IUR) commercia l/consumer product cate gory “Rubber and plastic products” was reported for this chemical. Chemicals in this category may be in such products as tires, footwear, flooring, bottles, sporting equipment, games, and toys. It is expected that these products will be widely used by consumers (including children); hence, the number of people exposed is likely to exceed 10,000. Additionally, products such as tires and floori ng are also used in a commercial setting, which may lead to exposures of more than 1,000 commercial workers. Based on this information, EPA believes that this chemical may have “substantial or significan t human exposure” (U.S. EPA, 2009). A substantial or significant number of consumers, workers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulations) when hazard information is known.5-12 Tests Required under the Proposed HPV Chemical Test Rule for Benzenesulfonyl chloride (CASRN 98-09-9)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.4 Benzene, 1-chloro-4-(trifluor om ethyl)- (CAS RN 98-56-6)

The number of potentially exposed consumers is estimated to be very large based on the use (home maintenance product) cited in the Household Chemical s Database (U.S. NLM, 2009). It is expected that home maintenance products will be widely used by c onsumers; hence, the number of people exposed is likely to exceed 10,000. Based on this information, EPA believes that this chemical may have “substantial or significant human exposure” (U.S. EPA, 2009). A subs tantial or significant number of consumers, workers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Benzene, 1-chloro-4-(trifl uoromethyl)- (CASRN 98-56-6)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.5 Ethane, 1,1'-oxybis[2-chloro- (CASRN 111-44-4)

The IUR commercial/consumer product category “Oth er” (chemicals contained in commercial and consumer products not elsewhere classified) was repor ted for this chemical. This indicates that this chemical is present in an unknown number of commerc ial and consumer products that may potentially have a high number of exposures. Based on this inform ation, EPA believes that this chemical may have “substantial or significant human exposure” (U.S. EPA, 2009). Other sources report that the chemical is used in a variety of ways, including use in the manufacture of medicines and pharmaceuticals; in paints, varnishes, lacquers, finish removers, spotting, an d dry cleaning; and in the production of high-grade lubricating oils (U.S. NLM, 2008b; Ash, 2003; Merck Index, 2001). Therefore, a substantial or significant number of workers, consumers, or others who ar e exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulations ) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Ethane, 1,1'-oxybis[2-chloro- (CASRN 111-44-4)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.6 Benzenesulfonic acid, 3-nitro-, sodi u m salt (1:1) (CASRN 127-68-4)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990) (U.S. EPA, 2009). Other sources report that the chemical is used in a variety of ways, including as a viscosity control agent in cosmetics and an oxidizing agent in in dustrial cleaners (U.S. NLM, 2008b). The workers,5-13 consumers, or others who are exposed to the chemic al would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical T est Rule for Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) (CASRN 127-68-4)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.7 1-Tetracosanol (CASRN 506-51-4)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990) (U.S. EPA, 2009). Other sources report that this chemical (or othe r long-chain fatty acids generally) are used as an ingredient in dietary supplements and pharmaceutical s and to protect water ag ainst evaporation (Ash, 2003; U.S. NLM, 2008b). The workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., polici es, regulations) when hazard and toxicity information

is known.

Tests Required under the Proposed HPV Chemical T est Rule for 1-Tetracosanol (CASRN 506-51-4)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity –

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.8 1-Hexacosanol (CASRN 506-52-5)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990) (U.S. EPA, 2009). Other sources report that the chemical is used in wooden work surfaces for offices, particularly modular units (Scorecard, 2008). The workers, consumer s, or others who are exposed to the chemical would benefit from the decisions that are made (e.g ., policies, regulations) when hazard and toxicity

information is known.

Tests Required under the Proposed HPV Chemical T est Rule for 1-Hexacosanol (CASRN 506-52-5)

Melting

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Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity –

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.9 Benzene, (2-chloro-1,1-dimethylethyl)- (CASRN 515-40-2)

The IUR commercial/consumer product category “Agric ultural products (non-pes ticidal)” was reported

for this chemical. Chemical s in this category may be used to increase the productivity and quality of farm crops; examples include fertilizers and soil conditioners. It is expected that these products will be widely used by commercial workers and consumers; hence, the number of people exposed is likely to exceed 1,000 commercial workers and 10,000 consumers. Based on this information, EPA believes that this chemical may have “substantial or significant hum an exposure.” (U.S. EPA, 2009). A substantial or5-14 significant number of workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulati ons) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Benzene, (2-chloro-1,1-dimethylethyl)- (CASRN 515-40-2)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.10 Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1 -(hy drogen sulfate) (CASRN 2494-89-5)

The IUR commercial/consumer product category(ies) were claimed as confidential business information

for this chemical. This indicates that this chemic al is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Based on this information,

EPA believes that this chemical may have “substantial or significan t human exposure.” (U.S. EPA, 2009). Other sources report that the chemical is used as an indicator and/or reagent (U.S. NLM, 2008a). A substantial or significant number of workers, consum ers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g ., policies, regulations) when hazard and toxicity

information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate) (CASRN 2494-89-5)

Melting

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.11 2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)- ( CASRN 5026-74-4)

The total number of potentially exposed workers is likely to exceed 1,000 based on reported IUR data (U.S. EPA, 2009). IUR submitters reporte d that this chemical is used in the “Resin and synthetic rubber manufacturing” and the “Aerospace product and parts manufacturing” categories. Another source reports that this chemical is used in epoxy resins for composite aircraft bodies/parts (Ashford, 2001). The workers, travelers, or others who are exposed to th e chemical would benefit from the decisions that are made (e.g., policies, regulations) when hazar d and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)- (CASRN 5026-74-4)

Melting

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Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.5-15 5.4.12 Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester (CASRN 22527-63-5)

The IUR commercial/consumer product category “Rubbe r and plastic products” was reported for this chemical. Chemicals in this category may be in such products as tires, footwear, flooring, bottles, sporting equipment, games, and toys. It is expected that these products will be widely used by consumers (including children); hence, the number of peopl e exposed is likely to exceed 10,000. Additionally, products such as tires and flooring are also used in a commercial setting, which may lead to exposures of more than 1,000 commercial workers. Other product categories identified in the IUR were claimed as confidential business information. Based on this information, EPA believes that this chemical may have “substantial or significant human exposure” (U.S. EPA , 2009). A substantial or significant number of workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulations) when h azard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Propanoic acid, 2-methyl-, 3-(benzoyloxy)- 2,2,4-trimethylpentyl ester (CASRN 22527-63-5)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.13 2-Propenoic acid, 2-carboxyethyl ester (CASRN 24615-84-7)

The IUR commercial/consumer product category “Oth er” (chemicals contained in commercial and consumer products not elsewhere classified) was repor ted for this chemical. This indicates that this chemical is present in an unknown number of commerc ial and consumer products that may potentially have a high number of exposures. Based on this inform ation, EPA believes that this chemical may have “substantial or significant human exposure.” (U.S. EPA, 2009). Other sources report that this chemical is used in adhesives as an adhesion promoter; the ch emical improves latex stability and rheology (Ash, 2003). A substantial or significant number of workers, consumers, or others who are exposed to the

chemical would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 2-Propenoic acid, 2-carboxyethyl ester (CASRN 24615-84-7)

Melting

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Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.14 Benzenesulfonic acid, dimethyl- (CASRN 25321-41-9)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990) (U.S. EPA, 2009). Other sources report that this chemical is used in a variety of ways, including as a catalyst for coatings and foundry resins, a hardening agent in plast ics, an activator for nicotine insecticides, and a plating aid in electroplating baths (Ash, 2003; Ashford, 2001). The workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.5-16 Tests Required under the Proposed HPV Chemical T est Rule for Benzenesulfonic acid, dimethyl- (CASRN 25321-41-9)

Melting

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.15 Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3) (CASRN 25 646-71-3)

The total number of potentially exposed workers is likely to exceed 1,000 based on reported IUR data. Additionally, the IUR commercial/consumer product category “Photographic supplies” was reported for this chemical. Chemicals in this category may be in photographic apparatus, equipment, and parts; film, paper, plates, and prepared photographic chemicals for commercial and consumer use. It is expected that these products will be widely used by commercial wo rkers and consumers; hence, the number of people exposed is likely to exceed 1,000 commercial worker s and 10,000 consumers. Based on this information,

EPA believes that this chemical may have “substantial or signifi cant human exposure” (U.S. EPA, 2009). A substantial or significant number of workers, consum ers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g ., policies, regulations) when hazard and toxicity

information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Methanesulfonamide, N-[2-[(4-amino-3- methylphenyl)ethylamino]ethyl]-, sulfate (2:3) (CASRN 25646-71-3)

Melting

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Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.16 1-Propanesulfonic acid, 2-hydroxy-3-(2-pro pen -1-yloxy)-, sodium salt (1:1) (CASRN 52556-42-0)

The IUR commercial/consumer product category “Oth er” (chemicals contained in commercial and consumer products not elsewhere classified) was repor ted for this chemical. This indicates that this chemical is present in an unknown number of commerc ial and consumer products that may potentially have a high number of exposures. Based on this inform ation, EPA believes that this chemical may have “substantial or significant human exposure” (U.S. EPA, 2009). Other sources report that this chemical is used as an emulsion polymerization in paper, textile, fiber, and adhesives industries (Ash, 2003). A substantial or significant number of workers, consum ers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g ., policies, regulations) when hazard and toxicity

information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) (CASRN 52556-42-0)

Melting

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.5-17 5.4.17 Alkanes, chloro (CASRN 61788-76-9)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990). Additionally, the number of potentially exposed consumers is estim ated to be very large based on the reported IUR commercial/consumer product categories for this chemical: “Adhesives and sealants” and “Other” (chemicals contained in commercia l and consumer products not elsewhere classified). Chemicals in these product categories may be in industrial and household adhesives, glues, caulking compounds, and sealants, along with an unknown number of commercial and consumer products that may potentially have a high number of exposures. It is expected that these products will be widely used by commercial workers and consumers; hence, the number of people exposed is likely to exceed 1,000 commercial workers and 10,000 consumers. Based on this information, EPA belie ves that this chemical may have “substantial or significant human exposure” (U.S. EPA, 2009). A substantial or significant number of workers, consumers, or others who are exposed to the chemic al would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical T est Rule for Alkanes, chloro (CASRN 61788-76-9)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.18 Solvent naphtha (coal) (CASRN 65996-79-4)

The IUR commercial/consumer product category “Oth er” (chemicals contained in commercial and consumer products not elsewhere classified) was repor ted for this chemical. This indicates that this chemical is present in an unknown number of commerc ial and consumer products that may potentially have a high number of exposures. Based on this inform ation, EPA believes that this chemical may have “substantial or significant human exposure” (U.S. EPA , 2009). A substantial or significant number of workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulations) when h azard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Ru le for Solvent naphtha (coal) (CASRN 65996-79-4)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.19 Tar oils, coal (CASRN 65996-82-9)

The IUR commercial/consumer product categories “Rubber and plastic pr oducts,” “Wood and wood furniture,” and “Other” (chemicals contained in commercial and consumer products not elsewhere classified) were reported for this chemical. Chemic als in these product categories may be in tires, footwear, flooring, bottles, sporting equipment, ga mes, toys, wood products, and wood furniture, along

with an unknown number of commerc ial and consumer products that ma y potentially have a high number of exposures. It is expected that these products will be widely used by commercial workers and consumers; hence, the number of people exposed is likely to exceed 1,000 commercial workers and 10,000 consumers. Based on this information, EPA belie ves that this chemical may have “substantial or significant human exposure” (U.S. EPA, 2009). A substantial or significant number of workers, consumers, or others who are exposed to the chemic al would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.5-18 Tests Required under the Proposed HPV Chemical Test Rule for Tar oils, coal (CASRN 65996-82-9)

Melting

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.20 Tar, coal, high-temp. (CASRN 65996-89-6)

The total number of potentially exposed workers is likely to exceed 1,000 based on reported PAIR data (U.S. EPA, 2008). Additionally, the number of potentiall y exposed consumers is estimated to be very large based on the reported IUR commercial/consumer product categories for this chemical: “Paints and coatings” and “Other” (chemicals contained in commercial and consumer products not elsewhere classified). Chemicals in these product categories may be in commercial and consumer paints (paste or ready-mix) including artists’ paints, varnishes, lacque rs, enamels and shellac, paint and varnish removers and cleaners, along with an unknown number of comme rcial and consumer produc ts that may potentially have a high number of exposures. It is expected th at these products will be widely used by commercial workers and consumers; hence, the number of pe ople exposed is likely to exceed 1,000 commercial workers and 10,000 consumers. PAIR data indicate that more than 1 million pounds of this chemical is

released to the environment. Based on this inform ation, EPA believes that this chemical may have “substantial or significant human exposure” as well as “significant or substantial release” (U.S. EPA, 2009). A substantial or significant number of workers, consumers, or others who are exposed to the

chemical would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Tar, coal, high-temp. (CASRN 65996-89-6)

Melting

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Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.21 Distillates (coal tar) (CAS RN 6 5996-92-1)

The IUR commercial/consumer product categories “Rubber and plastic pr oducts,” “Wood and wood furniture,” and “Other” (chemicals contained in commercial and consumer products not elsewhere classified) were reported for this chemical. Chemic als in these product categories may be in tires, footwear, flooring, bottles, sporting equipment, ga mes, toys, wood products and wood furniture, along

with an unknown number of commerc ial and consumer products that ma y potentially have a high number of exposures. It is expected that these products will be widely used by commercial workers and consumers; hence, the number of people exposed is likely to exceed 1,000 commercial workers and 10,000 consumers. Based on this information, EPA belie ves that this chemical may have “substantial or significant human exposure” (U.S. EPA, 2009). A substantial or significant number of workers, consumers, or others who are exposed to the chemic al would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.5-19 Tests Required under the Proposed HPV Chemical Test Rule for Distillates (coal tar) (CASRN 65996-92-1)

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

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Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.22 Lard, oil, Me esters (CASRN 6808 2-78-0)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990) (U.S. EPA, 2009). Other sources report that this chemical is used as a lubricant (Lubriplate Lubricants Co., 2009) The workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulations) when hazar d and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Lard, oil, Me esters (CASRN 68082-78-0)

Melting

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Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.23 Pitch, coal tar-petroleum (CASRN 68187-57-5)

The IUR commercial/consumer product category “Metal products” was reported for this chemical. Chemicals in this category may be in metal products for commercial and consumer use; metal furniture and furnishings are included in this category. It is expected that these products will be widely used by commercial workers and consumers (including children); hence, the number of people exposed is likely to exceed 1,000 commercial workers and 10,000 consumers. Based on this information, EPA believes that this chemical may have “substantial or significan t human exposure” (U.S. EPA, 2009). A substantial or significant number of workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulati ons) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Ru le for Pitch, coal tar-petroleum (CASRN 68187-57-5)

Melting

Point Boiling Point Vapor

Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.24 Acetaldehyde, reaction products with formaldehyde, by-products from (CASRN 68 442-60-4)

The IUR commercial/consumer product category(ies) were claimed as confidential business information for this chemical (U.S. EPA, 2006b). This indicates th at this chemical is present in an unknown number of commercial and consumer produc ts that may potentially have a high number of exposures. Additionally, PAIR data indicate consumer use; ther efore, it is expected that products containing this chemical may be used by more than 10,000 consumers. Based on this information, EPA believes that this chemical may have “substantial or significant hum an exposure” (U.S. EPA, 2009). A substantial or significant number of workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulati ons) when hazard and toxicity information is known.5-20 Tests Required under the Proposed HPV Chemical Test Rule for Acetaldehyde, reaction products with formaldehyde, by-products from (CASRN 68442-60-4)

Melting

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.25 2-Butenedioic acid (2E)-, di-C8-18 -alk yl esters (CASRN 68610-90-2)

PAIR data indicate consumer use; therefore, it is e xpected that products containing this chemical may be used by more than 10,000 consumers. Based on this information, EPA believes that this chemical may have “substantial or significant human exposure” (U .S. EPA, 2009). A substantial or significant number of workers, consumers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters (CASRN 68610-90-2)

Melting

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Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.26 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, manuf. of, b y-products from (CASRN 68988-22-7)

PAIR data indicate that more than 1 million pounds of this chemical are released to the environment. Based on this information, this chemical would m eet the exposure-based findings criterion of “significant or substantial release” (U.S. EPA, 2009). A substantial or significant number of workers, consumers, or others who are exposed to the chemical would benefi t from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Ru le for 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, manuf. of, by-products from (CASRN 68988-22-7)

Melting

Point Boiling Point Vapor

Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.27 Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]- (CASRN 70 693-50-4)

The IUR commercial/consumer product category(ies) were claimed as confidential business information

for this chemical. This indicates that this chemic al is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Based on this information,

EPA believes that this chemical may have “substantial or signifi cant human exposure” (U.S. EPA, 2009). A substantial or significant number of workers, consum ers, or others who are exposed to the chemical would benefit from the decisions that are made (e.g ., policies, regulations) when hazard and toxicity

information is known.5-21 Tests Required under the Proposed HPV Chemical Test Rule for Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]- (CASRN 70693-50-4)

Melting

Point Boiling Point Vapor

Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.28 1-Decene, sulfurized (CASRN 72162-15-3)

The total number of potentially exposed workers exceeds 1,000, based on NIOSH (1990) (U.S. EPA, 2009). Other sources report that sulfurized alpha-olefins in the C 16 –C 24 range are used as extremepressure agents in end uses such as metalworking, auto and industrial gear, oils and greases, and to some extent hydraulic fluids (SRI Consulting, 2007). Worker s, consumers, or others who are exposed to the

chemical would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 1-Decene, sulfurized (CASRN 72162-15-3)

Melting

Point Boiling Point Vapor

Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.

5.4.29 Extract residues (coal), tar oil alk., naphtha len e distn. residues (CASRN 73665-18-6)

The IUR commercial/consumer product category “Wood and wood furniture” was reported for this chemical. Chemicals in this category may be in wood products and wood furniture for commercial and consumer use. It is expected that these products will be widely used by commercial workers and consumers (including children); hence, the number of people exposed is likely to exceed 1,000 commercial workers and 10,000 consumers. Based on this information, EPA believes that this chemical may have “substantial or significant human exposure” (U.S. EPA, 2009). A substantial or significant number of workers, consumers, or others who ar e exposed to the chemical would benefit from the decisions that are made (e.g., policies, regulations) when hazard and toxicity information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Extract residues (coal), tar oil alk., naphthalene distn. residues (CASRN 73665-18-6)

Melting

Point Boiling Point Vapor

Pressure Partition
Coefficient Water Solubility ReadyBiodegradation Aquatic Toxicity Mammalian Toxicity -

Acute Mammalian Toxicity -
Genotox Mammalian Toxicity – Repeated Dose/Repro/

Devel 9 9 9 9 9 9 9 9 9

Note: Specific benefits related to these tests are described in Section 5.3.



### 5.5 Potential Users of Information Generated by the Proposed Rule

As discussed above, a wide range of groups are e xpected 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-ma king processes, users will achieve benefits resulting from improved decision-making processes, and ultimately risk reduction.5-22 The data would be made available to the public, an d may be incorporated into numerous databases and sources that contain toxicological information. A few examples of these sources include the Hazardous Substances Data Bank (HSDB), Registry of Toxic Effects of Chemical Substances (RTECS), Integrated Risk Information System (IRIS), the Toxic Substances Control Act Test Submissions (TSCATS), and TOXicology information onLINE (TOXLINE). These databases provide a variety of toxicological information in the form of study abstracts, inform ation on effects, and more comprehensive information combining hazard and exposure information to provide risk information (e.g., IRIS). The U.S. National Library of Medicine (NLM) houses TOXLINE, a bibliographic database that includes the toxicological effects of drugs and other chemicals. Users can access TOXLINE through the Internet. NLM estimates that a single month’s access to the database (February 2009) consisted of 72,552 searches via the Internet (Thomas, 2009).

The distribution of TSCATS user accounts purchased through a past vendor, Oxford Molecular Group (OMG), 18 indicates that the users of toxicological data are diverse. In 1998, a representative of OMG suggested that 6 percent of account holders were government, 38 percent were the private sector, 4 percent were academic organizations, 40 percent were foreign interests, and 11 percent were nonsubscribers (estimates may not add due to roundi ng) (Hoffman, 1998). The current vendor, National Information Services Corp. (NISC), does not track this information. However, it does track the

subscribers and non-subscribers to whom NISC s upplies copies of toxicological studies cited in the TSCATS database. NISC supplies approximately 38 pe rcent 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 internationa l consultants (Earle, 2003).

Clearly, there is a wide variety of users of toxicologica l 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 be nefits they derive from, toxicological information

are discussed in more detail below.

5.5.1 Consumers/Buyers

Economic theory maintains that competitive markets provide goods and services to the extent that the marginal benefit of the good or service to consumers is more than or equal to the marginal cost of production. Underlying this conclusion are two assump tions: that both consumers and producers have perfect information, and that the cost of conductin g a market transaction is negligible. The need for chemical testing information stems from the fact th at, in some cases, neither producers nor consumers have perfect information regarding the hazards associ ated with certain chemicals. If basic information on chemical hazards were known, consumers might alte r the amount they would be willing to pay for the chemical. Therefore, in the absence of complete info rmation, the private market may be misallocating resources to the production of the chemical substance.

Thus, one advantage of mandatory testing and dissemination of test results is that consumers can make better choices about products containing chemicals if they are better aware of the potential hazards. Consumers can respond to additiona l 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, us e, 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.

18 Oxford Molecular Group’s Chemical Information Sy stem, which housed TSCATS, was acquired by National Information Services Corp. (NISC) in 2000.5-23 5.5.2 Workers

Hazard information can play a role in guiding workers’ employment decisions and work practices. If workers are aware of workplace hazards (e.g., the haza rd 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 in clude 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 me asured by the increase in the wage premium (differential) as a greater understanding of workplace risk is gained. Thus, worker s 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 with at work. EPA expects the potential benefits to workers to be large for chemicals included in the proposed rule since they are manuf actured and processed in large volumes.

5.5.3 Science and Health Communities

Chemical toxicity information is useful to a variet y 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 treat ment associated with poisoning, and scientists use toxicity information to characterize the effects of ch emicals and to assess risks of chemical exposure. The literature includes specific examples where toxicity da ta 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 fo r 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). Numer ous 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 tumo rigens, 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 al so expected to be used by scientists to increase the understanding of the health and environmental effect s of these chemicals to which people may be exposed in the places where they live, work, study, and play.

5.5.4 The General Public

In addition to its impact on consumers of chemical s 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 consump tion 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 individua l actions they may take to protect themselves from5-24 exposure to the chemical substance (averting beha viors) 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 dissemi nated to the public, community and public interest groups can initiate a dialogue with the manufacturer s of hazardous chemicals and encourage them to improve their safety measures and assess their environmental management plans.

5.5.5 Firms and their Shareholders

As noted earlier, industry is an important user of chemical hazard information. Physical/chemical properties and environmental fate information is used to better develop the handling and safety procedures for chemicals, develop emergency prepar edness plans, follow principles of the Responsible Care® Initiative of the American Chemistry Counc il (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 incl udes as guiding principles the following:

• “To make health, safety, the environment, and r esource conservation critical considerations for all new and existing products and processes;

• To work with customers, carriers, suppliers, dist ributors, and contractors to foster the safe use, transport, and disposal of chemicals; and

• To support education and research on the health, safety, and environm ental effects of our products and processes” (ACC, 2006).

Consideration of these principles supports the need fo r toxicological information on chemical products used and manufactured by this industry. The Chemical Industry Institute of Toxicology, a research institute sponsored by ACC, government, and industry, notes that chemical research has helped companies ensure safety in manufacturing, use, and di sposal of chemicals (Chemical Industry Institute of Toxicology, 1998, 2001). Thus, companies are more likely to avoid potential liability concerns from inappropriate handling of chemical s. 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 othe r countries where they may also manufacture and sell

certain chemicals. This could lead to cost savi ngs for companies that operate internationally.

Corporate shareholders also benefit from the data developed in the rule. Basic microeconomic theory assumes that the primary objective of any firm, whether privately or publicly held, is to maximize profits. When a firm is incorporated and its shares are traded on the stock market, maximizing a firm’s profits is analogous to maximizing shareholder value. There ar e a number of ways in which the provision of information regarding the production pr actices and output of a firm can a ffect shareholder value. First, production processes and output that result in adverse consequences to human health and the environment may eventually result in substan tial liabilities to the firm. Therefore, any new information regarding potential threats to human health or the environm ent 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.5-25 There is a growing body of empirical literature ev aluating the effects of environmental information

disclosures on firms and their shareholders. In an effo rt to estimate the economic cost of hazardous waste mismanagement, Muoghalu and Roge rs (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. Blacc oniere and Patten (1994) examined the effect of the 1984 Union Carbide chemical leak in Bhopal, India, on other chemical firms’ stock prices. They found that firms in which chemical operations made up a larger portion of total revenue experienced greater losses in stock value immediately following the leak.

Thus, some evidence suggests that investors respond to new information regarding a firm’s potential environmental liabilities by reassessing the value of the fi rm’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 co mpany if share values drop. These costs would offset

some of the benefits to shareholders.

5.5.6 Government

The information developed in response to the propo sed rule will benefit society by reducing costs and improving the quality of government decision and polic y 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 subs tance or mixture to protect society. Basic toxicity data are not available for many chemicals, but e xposure controls have no e nvironmental 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 deri ved 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 in formation in supporting decisions about the control of chemicals whose cancer potency is untested or un known. 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 le vels 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 perf ectly 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-re sponse 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 Ot her Government Agencies . Under TSCA Section 4, EPA has the authority to require firms to conduct tests of specific chemical s to determine the potential risk posed by these5-26 substances. However, other governmental agenci es, such as the Food and Drug Administration, Consumer Product Safety Commission, NIOSH, and Occupational Safety and Health Administration, share regulatory authority over chemical substan ces or products containing them, or, in the case of NIOSH, compile summaries of ava ilable information and recommend exposure limits. Therefore, EPA

serves as a conduit for chemical hazard informati on 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 su ch as state, local, and tribal government agencies, which can use the data to inform their own decision making.

Information Provision as an Alt ernative to Traditional Regulation . Publicly disclosing TSCA Section 4 chemical test results also provides an alternativ e 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 appropria te in response to chemical risks. In addition to fulfilling democratic notions of “right-to-know” information, regulations provide a low-cost avenue for pollution and hazard control when regulatory resources are scarce due to the large number of substances to be controlled (Tietenberg, 1998).

5.5.7 Foreign Interests

The toxicity data developed as a result of the test rule are also expected to save other countries the expense of collecting and interpreting toxicol ogical 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 ch emical hazards. The International Forum on Chemical Safety (IFCS) was formed in 1994 and has develope d priorities for action in the implementation of Agenda 21. These include recognition of the activiti es sponsored by OECD in the area of chemical management and encouragement of the use of OECD as a means to carry out activities on chemical safety (IFCS, 1998). Data developed as a result of the 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 21.6-1 

## Chapter 6 – Other Impact Analyses

Several statutes and executive orders (EOs) pertain to the proposed test rule. This chapter presents statements discussing unfunded mandates, environmen tal justice, children’s health, and paperwork burden, among others.



### 6.1 Paperwork Reduction Act

The Paperwork Reduction Act mandate s 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, ma intain, 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 industr y respondents and the government are estimated.

6.1.1 Industry Burden

In this report, total industry burden hours represen t the sum of time spent on reporting and on other administrative activities. Industry respondents w ill 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 laborator y 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 avoluntary basis. In addition to the reporting burden, respondents will spend additional time on other, nonreporting administrative activities such soliciting labora tory bids, selecting laboratories, monitoring tests under progress, developing cost-sharing agreements, and auditing the laboratories for compliance with EPA’s Good Laboratory Practice (GLP) standards. The procedure for estimating the total industry burden

follows.

Estimate the Reporting Burden. As shown in Section 3.1.3 of this report, EPA estimates that approxim ately 16 panels will submit le tters of intent and study plans, resulting in 241 final reports. EPA also assumes that it will receive five exemption applica tions per panel, resulting in a total of 80 requests pursuant to the proposed rule. Additionally, it is estim ated that 10 percent of final test reports will be accompanied by a robust summary of results. EPA estimat ed that it takes a respondent 40 hours to prepare a letter of intent and study plan, 73 hours to write a final report for a short-term study, 12 hours to prepare a robust summary, and 2 hours to prepare an exemption application. The unit labor hours are derived from the previous information collection requests and are believed to reflect the burden that will be incurred for the proposed rule. The reporting burden est imates for this rule are detailed in Exhibit 6-1. The total reporting burden generated by the rule is est imated to be approximately 18,682 hours.

Exhibit 6-1: Reporting Burden Estimate for the Proposed Rule

Item Hours per Item Total Items Total Hours Letter of Intent and Study Plans 40 16 640 Final Reports 73 241 17,593

Robust Summaries 12 24.1 289 Exemption Applications 2 80 160

Total 18,682

Estimate the Other Administrative Burden. Respondents also spend time on other administrative activities including soliciting laboratory bids, selec ting laboratories, monitoring tests under progress,6-2 developing cost-sharing agreemen ts, and auditing the laboratories for compliance with EPA’s Good Laboratory Practice (GLP) standards. EPA has calcu lated the costs and burdens of these activities as 25 percent of the total laboratory testing costs. B ased on this calculation, other administrative costs associated with laboratory testing are estimated to am ount to $1.44 million ($1.76 million) under the least (average) cost assumption. These costs are translated in to burden estimates using an average labor cost of $53.78 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 26,730 (32,777) hours under the least (average) cost assumption.

Estimate the Export Notification Burden. As explained in Section 3.1.4, EPA expects 25 export

notifications t o be filed for each chemical included in the proposed rule (725 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 notificati on requires 0.5 hours per notice under the least cost scenario and 1 hour per notice under the average co st scenario. Consequently, the export notification burden triggered by the proposed rule is estimat ed to equal 363 hours (725 hours) under the least (average) cost scenario.

Estimate the Total Industry Burden. The total industry burden is the sum of the total administrative burden and the export notification burden. Total industry burden estimates are summarized in Exhibit 6-2. The total industry burden i s estimated to equal 45,775 hours (52,184 hours) in the least (average) cost scenario. The average burden per panel is estimated to be 2,861 (3,262) hours in the least (average) cost

scenario. 19

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

Activity Least Cost Scenario (Hours) Average Cost Scenario (Hours) Reporting Activities 18,682 18,682

Other Administrative Activities 26,730 32,777 Export Notification Burden 363 725 Total Industry Burden 45,775 52,184 Burden Per Panel (16 panels) 1 2,861 3,262

1 The per-panel cost assumes that the export notif ication burden is distributed evenly across all panels.

6.1.2 Government Burden

The government will also spend time processing, review ing, and analyzing the information that will be collected under the proposed test rule. As explained in Section 3.2, this work is assumed to be performed by a GS-13, Step 1, FTE employee.

It is further assumed that 16 letters of intent and study plans, 241 final repor ts, 24.1 robust summaries, and 80 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 fro m the previous information collection requests. Exhibit 6-3 presents the esti mated government burden hour s based on these assumptions. The total government burden is estimated to equal 713 hours.

19 The per-panel cost assumes that the export notification burden is distributed evenly across all panels.6-3 Exhibit 6-3: Estimated Government Burden for the Proposed Test Rule

Item Hours per Item Total Items Total Hours Letter of Intent and Study Plans 3 16 48 Final Reports 5 80 400

Robust Summaries 1 241 241 Exemption Requests 1 24.1 24.1

Total 713



### 6.2 Unfunded Mandates Reform Act

Federal agencies are required to assess the effects of federal regulations on state, local, or tribal governments, and on the private sector under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA). In particular, UMRA requires that agen cies prepare a written statement to accompany any rulemaking that “includes any Federal mandate that ma y result in the expenditure by State, local, and tribal governments, in the aggregate, or to the pr ivate sector, of $100 million or more (annually adjusted for inflation) in any one year” (Section 202(a)). Th e written impact statement under Section 202 must include (1) an identification of the statutory authorit y; (2) an assessment of the benefits and costs of the rule; and (3) a description of the agency’s consultatio n 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 Chapter 3, the maximum total cost incu rred by the private sector in complying with the proposed rule and associated requirements triggered by the rule is approximately $10.21 million (average cost scenario). This includes laboratory and administrative costs, as well as the cost of export notifications under the average cost scenario. Assumi ng a 3 percent and 7 percent discount rate and a 3- year amortization period, the annualized compliance cost for industry is estimated to be $3.61 and $3.89 million, respectively (average cost scenario).

Furthermore, because the proposed ru le is focused on manufacturers and importers of chemicals, EPA does not believe that it imposes costs on any non-federal government entity, or on state, local, and tribal governments. Moreover, while it does not impose costs on state, local, and tribal governments, the proposed rule can be of value to these agencies. As explained in Chapter 5, if EPA makes the test data

collected as a result of the proposed rule publicly av ailable, then other government agencies can use the data to inform their own regulations and decision making.

Executive Order 12875, “Enhancing the Intergovernme ntal Partnership” (58 FR 58093, October 28, 1993), requires federal agencies to determine whethe r certain regulatory actions create unfunded federal mandates on state, local, or tribal governments.

EPA’s determination under UMRA a nd EO 12875 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 subm itted letters of intent to test, exemption applications, or export notifications to EPA.



### 6.3 Executive Order 13132 – Federalism

Under Executive Order 13132, “Federalism” (64 FR 43255, August 10, 1999), EPA has determined that the proposed rule does not have “federalism implic ations” because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the va rious levels of government, as specified in the executive order. The proposed rule establishes testi ng and recordkeeping requirements that apply to manufacturers (including importers) and processors of certain chemicals. Because EPA has no6-4 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. Thus , EO 13132 does not apply to the proposed rule.



### 6.4 Executive Order 13175 – Consultation and Coordination w ith Indian Tribal
Governments

Under Executive Order 13175, “Consultation and C oordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), EPA has determined that th e proposed rule does not have tribal implications because it will not have any effect on tribal gove rnments, on the relationship between the federal government and the Indian tribes, or on the distribu tion of power and responsib ilities between the federal government and Indian tribes, as specified in the executive order. EPA’s determination under EO 12875 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 submissi ons to EPA. This search demonstrated that state, local, or tribal governments have never submitte d letters of intent to test, exemptio n applications, or export notifications to EPA. Furthermore, based on the s ubmissions received for the most re cent IUR and PAIR rule reporting periods, 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, and EO 13175 does not apply to this proposed rule.



### 6.5 Executive Order 13045 - Children’s Health

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 19 97), 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 not subject to EO 13045, because it does not establish an environmental standard intended to mitigate health or safety

risks and will not have an annual effect on the ec onomy of $100 million or more, nor does it otherwise have a disproportionate effect on ch ildren. Nevertheless, the information obtained by the testing in this rule will be used to inform the Agency’s decision-making process rega rding chemicals to which children may be disproportionately exposed. This informa tion 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.



### 6.6 Executive Order 13211 – Energy Su ppl y, Distribution, or Use

This proposed rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because it is unlikely to have any significant adverse effect on the supply, distribution, or use of energy.



### 6.7 National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113 (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory

activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g ., materials specifications, test methods, sampling procedures, and business practices) that are devel oped 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 app licable voluntary consensus standards.6-5 This proposed rule involves technical standards beca use it proposes to require the use of particular test methods. If the Agency makes findings under TSCA sec tion 4(a), EPA is required by TSCA section 4(b) to include specific standards or test methods that ar e to be used for the development of the data required

in the test rules issued under TSCA se ction 4. For some of the testing that would be required by this rule, EPA is proposing the use of voluntary consensus standards issued by ASTM and ISO that evaluate the same type of toxicity as the TSCA and OECD test guidelines, where applicable. Copies of the 17 ASTM and ISO standards referenced in the proposed regulat ory text at §799.5087(h) have been placed in the docket for this proposed rulemaking. Interested pa rties may obtain copies of the ASTM standards from the American Society for Testing and Materials, 100 Bar Harbor Dr., West Conshohocken, PA 19428– 2959, and copies of the ISO standards from the International Organization for Standardization, Case Postale 56, CH-1211 Geneva 20, Switzerland. In the final rule, EPA intends to seek approval from the

Director of the Federal Register for the incorporation by reference of the ASTM and ISO standards used in the final rule in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

EPA is not aware of any potentially applicable vol untary consensus standards that evaluate partition coefficient ( n -octanol/water) generator column, water solub ility (column elution and generator column), acute inhalation toxicity, b acterial 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.



### 6.8 Executive Order 12898 – Environmental Justice

Executive Order 12898, “Federal Actions to Address E nvironmental 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 that require special consideration by the Agency under EO 12898. The Agency believes that the information collected under this proposed rule, if finalized, will assist EPA and others in determining the potential hazards and risk s associated with the chemicals covered by the rule. Although not directly impacting envi ronmental justice-related concerns, this information will enable the Agency to better protect human health and the environment, including in low-income and minority

communities.

The proposed rule is directed at 29 chemicals for whic h 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 do es not appear that the costs and the benefits of the proposed rule will be disproportionately distribut ed across different geographic regions or among different categories of individuals.7-1 

## Chapter 7 – References

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## Appendix A – Derivation of Chemical Price Estimates

This appendix describes the derivation price estimates for the chemicals included in the proposed third test rule for high production volume chemicals. Base d on data availability, six different estimation methodologies were used; all prices are in 2008 dollars. Exhibit A-1 summarizes each of the sources and methods for p rice estimation.

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

Source Name Type Date

Published Number of Chemical

Prices Found Range of Prices for
Chemicals in This Test Rule (2008$) Chemical Market Reporter Bulk quantity prices 2006 1 $0.89

USITC Synthetic Organic
Chemicals Bulk quantity prices 1992 2 $0.59 - $2.89

Chemical Market Reporter (Similar chemicals) Bulk quantity prices 2006 2 $0.24 - $0.49

Sigma-Aldrich Small quantity chemical catalog 2008 11 $0.25 - $10.17

Sigma-Aldrich (Similar chemicals) Small quantity chemical catalog 2008 9 $0.21 - $5.97

Fisher Chemical Company (Similar chemicals) Small quantity chemical catalog 2008 1 $33.52

American Chemistry Council General estimates 2008 3 $0.75 - $1.25

EPA used bulk quantity prices when they were available because the bulk quantity prices of chemicals are most accurate when estimating the impact of this proposed test rule on hi gh production volume manufacturers. The prices listed in the Chemical Market Reporter ( CMR ) were preferred over those in the United States International Trade Commission’s (USITC’s) report Synthetic Organic Chemicals because the

CMR data are more recent. When prices were not available through either source, EPA identified chemicals similar in composition, manufacture, or use to the regulated chemical with the expectation that prices for these proxy chemicals would be similar.

When bulk chemical prices were not available either for the regulated chemical or a similar chemical, EPA used small quantity chemical ca talogs published by Sigma-Aldric h and Fisher Chemical Company. Small quantity catalog prices are known to be significantly more expensive per unit than bulk quantity pricing; therefore, EPA developed bulk quantity sca ling factors for each catalog to estimate bulk quantity pricing. Again, for chemicals without prices availa ble in these catalogs, EPA used similar chemicals as proxies.

Finally, for chemical prices that were not availa ble for either bulk or small quantities, EPA used the American Chemistry Council’s Guide to the Business of Chemistry , which provides a “rule of thumb” for basic and specialty chemical prices. To be conserva tive, EPA used the basic chemical price estimate of $0.75 per pound. This price is within th e ranges estimated using the other methods.



### A.1 Chemical Market Reporter

EPA searched the CMR (last published in 2006) for price data using common chemical names, and using synonyms for each common chemical name as summarized in Exhibit A-2. Price data on only one of the

chem icals regulated under the proposed rule was available from the CMR. Several different formulations of “Alkanes, chloro” are listed in the CMR, and the price estimate derived from these is outlined in

Exhibit A-2.A-2 Exhibit A-2: Chemical Market Reporter Prices (2008$)

CASRN Chemical

Name Formulation Price/lb (2006$) 1 Mean Price/lb (2006$)

(a) Inflation factor (2006$ to 2008$) 2

(b) Estimated
Price/lb (2008$) (c) = (a) ∗ (b) 60% chlorine bgs.,

bulk $0.690-$0.755 $0.7225 1.16 $0.84

70% chlorine, resinous bgs., bulk $0.70-$0.75 $0.725 1.16 $0.84

US Gulf, domestic, quarter contract $0.705-$0.750 $0.7275 1.16 $0.85

US Gulf, spot explant $0.89 $0.89 1.16 $1.04 61788-76-9 Alkanes,

chloro [listed as
Chlorinated paraffin]

Average $0.89

1 Chemical Market Reporter (ICIS, 2006).

2 The producer price index (PPI) for chem ical manufacturing in August 2006 was 197.8; the same index for December 2008 was 230.1 (preliminary data, BLS, 2009b). The costs from the CMR were inflated using a factor of 230.1 / 197.8 = 1.16.



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

For four chemicals, EPA used the average pri ce per pound of chemicals as reported in various Harmonized Tariff Schedule (HTS) chem ical groups in USITC’s report titled Synthetic Organic

Chemicals. For three chemicals, the price was available as part of an HTS group. Because the last USITC report was published in 1992, EPA then inflated th ese costs using the producer price index (PPI) for chemical manufacturing. Exhibit A-3 shows these prices. To the extent that these prices may have changed since 1992, f or reasons other than inflation, the actual price may be higher or lower than the estimate provided here.

Exhibit A-3: USITC Synthetic Organic Chemicals Prices (2008$)

CASRN Chemical Name Price/kg (1992$)

(a) Inflation Factor (1992$ to 2008$) 1
(b) Price/kg (2008$) (c) = (a) ∗ (b) Estimated
Price/lb (2008$) 2
(d) = (c) ∗ 2.205 98-09-9 Benzenesulfonyl

chloride $0.71 1.83 $1.30 $0.59

25321-41-9 Benzenesulfonic acid, dimethyl- $3.48 1.83 $6.37 $2.89

1 The PPI for chemical manufacturing in 1992 was 125.8; the same index for December 2008 was 230.1 (preliminary data, BLS 2009b). The costs from the USITC report were inflated using a factor of (230.1/125.8) = 1.83.

2 1 kg = 2.205 lb.



### A.3 Similar Chemical Prices – CMR

EPA identified chemicals that were similar in compos ition, manufacture, or use, and used prices for these chemicals as proxies for the chemicals for which prices could not be found in either of the bulk price

sources described above. The CMR, last published in August 2006, cont ained price information for two of these chemicals (see Exhibit A-4). To the extent that a proxy chemical is different from the regulated

che mical, the actual price may be higher or lower than the estimate provided here.A-3 Exhibit A-4: Chemical Market Reporter Similar Chemical Prices (2008$)

CASRN Chemical Name Similar

Chemical Name [CASRN] Price/lb (2006$) 1
(a) Inflation Factor (2006$ to 2008$) 2
(b) Estimated price/lb (2008$) (c) = (a) ∗ (b) 68442-60-4 Acetaldehyde, reaction products withformaldehyde, byproducts from Formaldehyde [50-00-0] $0.21 1.16 $0.24

68988-22-7 1,4- Benzenedicarboxylic acid, 1,4-dimethylester, manuf. of, byproducts from Terephthalic

acid [100-21-0] $0.42 1.16 $0.49

1 Chemical Market Reporter (ICIS, 2006).

2 The PPI for chemical manufacturing in August 2006 was 197.8; the same index for December 2008 was 230.1 (preliminary data, BLS, 2009b). The costs from the CMR were inflated using a factor of 230.1 / 197.8 = 1.16.



### A.4 Small Quantity Catalog Prices

An online chemical catalog published by the Sigm a-Aldrich Company (Sigma-Aldrich, 2008) provided small quantity price information for 11 of the rema ining chemicals for which data were not available using the sources and methods described above. Howeve r, because small quantity catalog prices are often significantly higher than the bulk quantity prices reported in the CMR, EPA adjusted the small quantity catalog prices for these 11 chemicals to approximate bulk quantity prices, using scaling factors derived as

described below.

A.4.1 Derivation of Small Quantity Scaling Factors

To determine the appropriate scaling factor to adju st small quantity prices to approximate bulk quantity prices, EPA selected 15 chemicals (not subject to this proposed rule) for which price data were available

from both the CMR (ICIS, 2006, inflated to 2008 prices usi ng the PPI) and Sigma-Aldrich (2008), and compared the prices. Similarly, EPA selected 10 chemi cals, for which price data were available from both

the CMR and the Fisher Scientific chemical catalog, to develop scaling factors for prices from that catalog (used in Section A.5).

Prices were o btained from the catalogs for chemical fo rmulations sold in (1) 1 kg quantities, (2) quantities between 100 g and 500 g, and (3) quantities less than 1 g. EPA estimated the implied price per pound using the largest quantity range available for each chemical.

EPA estimated the implied price per pound (assuming th at prices were directly proportional to volume), and within each of the three quantity categories, de veloped scaling factors by dividing the Sigma-Aldrich implied price per pound by the CMR price per pound. 20

Exhibit A-5 shows the scaling factors developed to estimate the bulk price of chemicals available from the Sigm a-Aldrich Company.

20 A fourth scaling factor was developed because one chemical was only available in a 1.2 mg quantity.A-4 Exhibit A-5: Comparison Between Chemical Market Reporter and Sigma-Aldrich Prices

Sigma-Aldrich Price (Varies by Quantity (Q)) Q = 1 kg 500 g

 ≥ Q ≥ 100 g Q ≤ 1 g

CASRN CMR

Price/lb 1
(a) Implied
Price/lb 2
(b) Scaling

Factor (c) = (b) / (a) Implied
Price/lb 2
(d) Scaling

Factor (e) = (d) / (a) Implied
Price/lb 2
(f) Scaling

Factor (g) = (f) / (a) 108-31-6 $0.58 $25.95 44.61 $58.42 100.44 n/a n/a 64-19-7 $0.53 $19.30 36.46 $71.94 135.91 $12,247 23,138 58-08-2 $8.14 $74.50 9.15 $690.28 84.77 $5,715 702 75-20-7 $0.26 $27.03 102.38 $87.23 330.32 n/a n/a 67-48-1 $0.62 $35.83 57.58 $654.28 1,051.28 $65,771 105,679 85-44-9 $0.64 $9.21 14.39 $33.02 51.61 n/a n/a 532-32-1 $0.94 $17.33 18.39 $46.33 49.17 $6,305 6,691 112-57-2 $1.98 $29.85 15.09 $64.55 32.64 n/a n/a 112-27-6 $0.81 $13.15 16.15 n/a n/a n/a n/a 7446-70-0 $0.99 $34.44 34.83 $132.00 133.49 n/a n/a 1317-39-1 $1.79 n/a n/a $38.96 21.75 n/a n/a 143-07-7 $0.33 $25.21 76.03 $81.42 245.58 n/a n/a 7719-12-2 $0.57 $33.75 59.20 $664.12 1,165.09 n/a n/a 7447-40-7 $0.63 $39.08 62.21 $128.63 204.77 n/a n/a 7646-69-7 $7.15 $748.43 104.61 $311.38 43.52 n/a n/a
Average 46.51 260.74 34,053

1 The CMR price per pound was inflated, using the PPI for chemical m anufacturing, from August 2006 dollars to December 2008 dollars.

2 The Sigma-Aldrich implied price per pound was calculated by di viding the stated price per unit quantity by the appropriate conv ersion factor (e.g., 2.205 lb/kg).
Sources: Chemical Market Reporter (ICIS, 2006) and Sigma-Aldrich, 2008.

Exhibit A-6 shows the scaling factors developed to estimate the bulk price of chemicals available from Fisher Scientific, using the same methodology as fo r the Sigma-Aldrich catalog. Only the volume range actually used in the analysis is shown.

Exhibit A-6: Comparison Between CMR and Fisher Scientific Prices

Fisher Scientific Price (Varies by Quantity (Q)) 500 g

 ≥ Q ≥ 100 g

CASRN CMR

Price/lb 1
(a) Implied Price/lb 2
(b) Scaling Factor (c) = (b) / (a) 58-08-2 $8.14 $155.71 19.12 75-20-7 $0.26 $59.46 225.18 85-44-9 $0.64 $49.72 77.71 532-32-1 $0.94 $60.26 63.95 112-57-2 $1.98 $33.38 16.88 7446-70-0 $0.99 $77.84 78.72 1317-39-1 $1.79 $32.93 18.38 143-07-7 $0.33 $43.29 130.58 7447-40-7 $0.63 $49.05 78.08 7646-69-7 $7.15 $111.24 15.55 Average 65.83

1 The CMR price per pound was inflated, using the PPI for chemical manufacturing, from August 2006 dollars to December 2008 dollars.

2 The Fisher Scientific implied price per pound was calculated by dividing the stated price per unit quantity by the appropriate conversion factor (e.g., 2.205 lbs/kg).

Sources: Chemical Market Reporter (ICIS

, 2006) and Fisher Scientific, 2008.

A.4.2 Conversion of Small Quantity Catalog Prices

For the chemicals included in the proposed rule for which EPA did not find prices using the steps

described in Sections A.1 through A.3, EPA searched the Sigma-Aldrich catalog (as well as the Fisher

Scientific cat alog). The Agency collected price in formation for each formulation and quantity of the

available chemicals. If a chemical was available in a 1-kilogram quantity, EPA used the price(s) given for this quantity. If multiple formulations of a particul ar quantity were available, EPA used the arithmeticA-5 mean of these prices. This price-per-kilogram estim ate was then adjusted, using the scaling factors as derived above, to estimate the bulk quan tity price-per-pound of each chemical.

Several chemicals were not available in 1-kilogram quantities, and in these cases, EPA estimated the price per pound using the largest available quantity range.

Exhibit A-7 shows the prices gathered from Sigma-Al drich for chemical s included in the proposed test rule, and the derivation of their bulk quantity price estimates.A-6Exhibit A-7: Prices Derived from Sigma-AldrichCASRNChemical NameFormulation DetailsQuantity(a)Price(b)ImpliedPrice/kg1(c)ImpliedPrice/lb(d) = (c) /2.205ScalingFactor2(e)EstimatedBulk Price/lb(f) = (d)∗(e)83-41-0 2-Nitrobenzene, 1,2-dimethyl- 97%500 g $90.20 $180.40 $81.83 260.74$0.3196-22-0 3-Pentanone≥99%1 kg $42.00 $42.00 $19.05 46.51$0.41250 g $35.10 $140.4098%100 g $15.10 $151.0098-56-6 Benzene, 1-chloro-4-(trifluoromethyl)-Average3$145.70 $66.09 260.74$0.25500 g $56.10 $112.2099%100 g $47.90 $479.00111-44-4 Ethane, 1,1'-oxybis[2-chloroAverage3$295.60 $134.08 260.74$0.5198% 500g$50.7$101.4098% 100g$24.7$247.00127-68-4 Benzenesulfonic acid, 3-nitro-,sodium salt (1:1)Average3$174.20 $79.02 260.74$0.301 g$583 $583,000≥99% (capillary GC)0.25 g $209 $836,000purum,≥98.0% (GC) 0.25 g$218 $872,000506-51-4 1-TetracosanolAverage3$763,666.67 $346,493 34,053 $10.171 g$59 $590,000≥97% (capillary GC)0.25 g $127 $508,000purum, synthetic,≥97.0% (GC)1 g $70.20 $702,000506-52-5 1-HexacosanolAverage3$600,000.00 $272,155 34,053 $7.99515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)-99% 1 kg $130.50 $130.50 $59.19 46.51 $1.275026-74-4 2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-Sigma(1.22 g/mL)0.25 L $127.50 $418.03 $189.62 260.74 $0.730.5 L $104.50 $180.172-Carboxyethylacrylate(1.16 g/mL)0.25 L $82.20 $283.4524615-84-7 2-Propenoic acid, 2-carboxyethyl esterAverage3$231.81 $105.15 46.51$2.2652556-42-0 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-,sodium salt (1:1)Solution 40 wt. % inH2O(1.17 g/mL)1 L $70.10 $116.24 $52.73 46.51 $1.131The implied price per kilogram is the price per unit quantity,converted to price per kilogram. For example, ($90.20 / 500g)(1,000g / 1 kg) = $180.40 / kg.2The scaling factors are derived inExhibit A-5 and Exhibit A-6 above.3The average price is calculated when morethan one price is available for a chemical, within a given quantity range. The average price is then converted to a price per pound andscaled to a bulk quantity price estimate using scaling factors.A-7 

### A.5 Small Quantity Catalog Prices for Similar Chemicals

If none of the above methods yielded a price estimate, EPA used the same method as described in Section A.4 for small quantity chemical catalogs to estimat e the bulk price per pound of chemicals, using proxy chemicals similar in composition, manufacture, or use.

One similar chemical was not available in the Sigma-Aldrich catalog but was available in the Fisher Scientific catalog.

Exhibit A-8 shows the prices gathered from Sigma-Aldrich and Fisher Scientific for chemicals similar to

those include d in the proposed test rule, and the calculation of their bulk quantity price estimates.A-8Exhibit A-8: Prices ofSimilar ChemicalsCASRNChemical NameSimilarChemicalPrice UsedFormulationDetails [Source]Quantity(a)Price(b)ImpliedPrice/kg(c)Implied Price/lb(d) = (c) / 2.205ScalingFactor(e)EstimatedBulkPrice/lb(f) = (d)∗(e)2494-89-5 Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate)Acetanilide[103-84-4]reagent grade,97% [SigmaAldrich]1 kg $76.00 $76.00 $34.47 46.51 $0.7425646-71-3 Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3)Toluene-2,4-diamine[95-80-7]98% [SigmaAldrich]1 kg $75.10 $75.10$34.06 46.51 $0.73purum,≥98.0%(GC) [SigmaAldrich]1 kg $32.80 $32.80scintillation grade,≥99% [SigmaAldrich]1 kg $87.00 $87.0099% [SigmaAldrich]1 kg $32.00 $32.0065996-82-9 Tar oils, coalNaphthalene[91-20-3]Average$50.60 $22.95 46.51 $0.49500 g $247.50 $495.0098% [Sigma-Aldrich]100 g $73.50 $735.00purum, forfluorescence,≥97.0% (HPLC)[Sigma-Aldrich]100 g $84.20 $842.00Technical grade,90% [SigmaAldrich]100 g $51.50 $515.0065996-89-6 Tar, coal, high-temp. Phenanthrene[85-01-8]Average$646.75 $293.36 260.74 $1.1368082-78-0 Lard, oil, Me esters Methylpalmitate [112-39-0]≥97% [SigmaAldrich]1 kg $74.00 $74.00$33.57 46.51 $0.7268187-57-5 Pitch, coal tar-petroleum Anthracene[120-12-7]technical,≥90%(GC) [SigmaAldrich]1 kg $73.30 $73.30$33.25 46.51 $0.7168610-90-2 2-Butenedioic acid (2E)-,di-C8-18-alkyl esters2-Ethylhexylfumarate[141-02-6]Di-2-ethylhexylFumarate, MPBiomedicals[Fisher]100 g $486.43 $4,864.30 $2,206.41 65.83 $33.5270693-50-4 Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-Azobenzene[103-33-3]96% [SigmaAldrich]100 g $343.40 $3,434.00 $1,557.54 260.74 $5.9772162-15-3 1-Decene, sulfurized 1-Decene[872-05-9]ampule of1000 mg [SigmaAldrich]1 g $15.40 $15,400.00 $6,985.32 34,052 $0.21A-9Exhibit A-8: Prices ofSimilar ChemicalsCASRNChemical NameSimilarChemicalPrice UsedFormulationDetails [Source]Quantity(a)Price(b)ImpliedPrice/kg(c)Implied Price/lb(d) = (c) / 2.205ScalingFactor(e)EstimatedBulkPrice/lb(f) = (d)∗(e)purum,≥98.0%(GC) [SigmaAldrich]1 kg $32.80 $32.80scintillation grade,≥99% [SigmaAldrich]1 kg $87.00 $87.0099% [SigmaAldrich]1 kg $32.00 $32.0073665-18-6 Extract residues (coal), taroil alk., naphthalene distn.residuesNaphthalene[91-20-3]Average$50.60 $22.95 46.51 $0.49A-10 

### A.6 American Chemistry Council Prices

For three chemicals, EPA could not estimate the price using any of the five methods described above. For these chemicals, EPA used the American Chemistry Council’s Guide to the Business of Chemistry , which contains price information for certain types of chemicals. According to the guide published in 2008 (ACC, 2008), a rule of thumb for speci alty chemicals is that the price is greater than $1.25 per pound and

a rule of thumb for basic chemicals is that the price is less than $0.75 per pound. As shown in Exhibit A9, one chem ical is a specialty chemical and the other two are commodity (basic) chemicals.

Exhibit A-9: American Chemistry Council Prices

CASRN Chemical Name Chemical Type Estimated Price/lb 22527-63-5 Propanoic acid, 2-methyl-, 3- (benzoyloxy)-2,2,4-trimethylpentyl ester specialty $1.25

65996-79-4) Solvent naphtha (coal) basic $0.75 65996-92-1 Distillates (coal tar) basic $0.75B-1 

## Appendix B – Cost DetailsB-2B-3Exhibit B-1: Industry Compliance and Government Costs, Least Cost ScenarioCASRNChemical NameTesting CostAnalyticalMethodologyValidationCostTotalAdministrativeCost1ExportNotificationCostTotal IndustryComplianceCost2GovernmentCostTotal SocialCost31 83-41-0 2-Nitrobenzene, 1,2-dimethyl-$177,326 $10,500 $70,047 $671 $258,545 $2,235 $260,7792 96-22-0 3-Pentanone$71,351 $7,000 $26,900 $671 $105,923 $933 $106,8553 98-09-9 Benzenesulfonyl chloride$190,430 $13,000 $65,732 $671 $269,833 $1,584 $271,4174 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)-$116,466 $9,500 $45,034 $671 $171,672 $1,584 $173,2555 121-82-4 1,3,5-Triazine, hexahydro-1,3,5-trinitro-$143,182 $9,500 $44,122 $671 $197,475 $933 $198,4086 127-68-4 Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) $72,936 $3,500 $27,296 $671 $104,403 $933 $105,3367 506-51-4 1-Tetracosanol$232,901 $16,500 $97,651 $671 $347,723 $3,537 $351,2608 506-52-5 1-Hexacosanol$225,280 $16,500 $91,951 $671 $334,402 $3,211 $337,6139 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)- $232,865 $16,500 $96,907 $671 $346,943 $3,537 $350,48010 2494-89-5Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogensulfate)$234,532 $16,500 $103,326 $671 $355,030 $3,862 $358,89211 5026-74-42-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-$200,733 $9,500 $83,489 $671 $294,394 $2,886 $297,27912 22527-63-5Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester$234,532 $16,500 $101,855 $671 $353,559 $3,862 $357,42113 24615-84-7 2-Propenoic acid, 2-carboxyethyl ester$231,962 $13,000 $97,417 $671 $343,050 $3,537 $346,58614 25321-41-9 Benzenesulfonic acid, dimethyl- $232,901 $16,500 $97,651 $671 $347,723 $3,537 $351,26015 25646-71-3Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3)$206,489 $9,500 $84,928 $671 $301,588 $2,886 $304,47416 52556-42-01-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)$234,532 $16,500 $103,326 $671 $355,030 $3,862 $358,89217 61788-76-9 Alkanes, chloro$34,145 $0 $28,249 $671 $63,065 $1,909 $64,97418 65996-79-4 Solvent naphtha (coal)$231,233 $16,500 $92,458 $671 $340,863 $3,211 $344,07419 65996-82-9 Tar oils, coal$231,233 $16,500 $92,458 $671 $340,863 $3,211 $344,07420 65996-89-6 Tar, coal, high-temp.$221,280 $16,500 $86,174 $671 $324,626 $2,886 $327,51121 65996-92-1 Distillates (coal tar)$161,421 $16,500 $75,005 $671 $253,597 $3,211 $256,80822 68082-78-0 Lard, oil, Me esters$234,532 $16,500 $101,855 $671 $353,559 $3,862 $357,42123 68187-57-5 Pitch, coal tar-petroleum$193,750 $16,500 $79,292 $671 $290,213 $2,886 $293,09824 68442-60-4Acetaldehyde, reaction products withformaldehyde, by-products from$234,532 $16,500 $101,855 $671 $353,559 $3,862 $357,42125 68610-90-2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters $234,532 $16,500 $101,855 $671 $353,559 $3,862 $357,42126 68988-22-71,4-Benzenedicarboxylic acid, 1,4-dimethyl ester,manuf. of, by-products from$234,532 $16,500 $103,326 $671 $355,030 $3,862 $358,89227 70693-50-4Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-$234,532 $16,500 $103,326 $671 $355,030 $3,862 $358,89228 72162-15-3 1-Decene, sulfurized$232,901 $16,500 $99,122 $671 $349,194 $3,537 $352,73129 73665-18-6Extract residues (coal),tar oil alk., naphthalenedistn. residues$232,901 $16,500 $96,671 $671 $346,743 $3,537 $350,279Total$5,749,943 $398,500 $2,399,275 $19,473 $8,567,191 $86,610 $8,653,8011Total administrative cost includes both reporting and non-reporting administrative costs.2Total industry compliance cost includes testing cost, analytical methodology validationcost, administrative cost, and export notification cost.3Total social cost includes total industry compliance cost and government cost.B-4Exhibit B-2: Industry Compliance and Government Costs, Average Cost ScenarioCASRNChemical NameTesting CostAnalyticalMethodologyValidationCostTotalAdministrativeCost1ExportNotificationCostTotal IndustryComplianceCost2GovernmentCostTotal SocialCost31 83-41-0 2-Nitrobenzene, 1,2-dimethyl-$229,871 $10,500 $83,183 $1,407 $324,961 $2,235 $327,1962 96-22-0 3-Pentanone$71,351 $7,000 $26,900 $1,407 $106,658 $933 $107,5913 98-09-9 Benzenesulfonyl chloride$234,862 $13,000 $76,840 $1,407 $326,109 $1,584 $327,6924 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)- $120,737 $9,500 $46,102 $1,407 $177,746 $1,584 $179,3305 111-44-4 Ethane, 1,1'-oxybis[2-chloro-$174,608 $9,500 $51,979 $1,407 $237,494 $933 $238,4276 127-68-4 Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) $72,936 $3,500 $27,296 $1,407 $105,139 $933 $106,0727 506-51-4 1-Tetracosanol$289,717 $16,500 $111,855 $1,407 $419,479 $3,537 $423,0168 506-52-5 1-Hexacosanol$277,825 $16,500 $105,087 $1,407 $400,819 $3,211 $404,0309 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)- $289,682 $16,500 $111,111 $1,407 $418,699 $3,537 $422,23610 2494-89-5Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogensulfate)$291,349 $16,500 $117,530 $1,407 $426,786 $3,862 $430,64811 5026-74-42-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-$236,431 $9,500 $92,414 $1,407 $339,752 $2,886 $342,63712 22527-63-5Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester$291,349 $16,500 $116,059 $1,407 $425,315 $3,862 $429,17713 24615-84-7 2-Propenoic acid, 2-carboxyethyl ester$280,665 $13,000 $109,592 $1,407 $404,665 $3,537 $408,20114 25321-41-9 Benzenesulfonic acid, dimethyl- $289,717 $16,500 $111,855 $1,407 $419,479 $3,537 $423,01615 25646-71-3Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3)$242,186 $9,500 $93,853 $1,407 $346,946 $2,886 $349,83216 52556-42-01-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)$291,349 $16,500 $117,530 $1,407 $426,786 $3,862 $430,64817 61788-76-9 Alkanes, chloro$38,416 $ 0 $29,317 $1,407 $69,140 $1,909 $71,04918 65996-79-4 Solvent naphtha (coal)$288,050 $16,500 $106,662 $1,407 $412,619 $3,211 $415,83019 65996-82-9 Tar oils, coal$288,050 $16,500 $106,662 $1,407 $412,619 $3,211 $415,83020 65996-89-6 Tar, coal, high-temp.$278,096 $16,500 $100,378 $1,407 $396,382 $2,886 $399,26721 65996-92-1 Distillates (coal tar)$186,811 $16,500 $81,353 $1,407 $286,070 $3,211 $289,28122 68082-78-0 Lard, oil, Me esters$291,349 $16,500 $116,059 $1,407 $425,315 $3,862 $429,17723 68187-57-5 Pitch, coal tar-petroleum$250,566 $16,500 $93,496 $1,407 $361,969 $2,886 $364,85424 68442-60-4Acetaldehyde, reaction products withformaldehyde, by-products from$291,349 $16,500 $116,059 $1,407 $425,315 $3,862 $429,17725 68610-90-2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters $291,349 $16,500 $116,059 $1,407 $425,315 $3,862 $429,17726 68988-22-71,4-Benzenedicarboxylic acid, 1,4-dimethyl ester,manuf. of, by-products from$291,349 $16,500 $117,530 $1,407 $426,786 $3,862 $430,64827 70693-50-4Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-$291,349 $16,500 $117,530 $1,407 $426,786 $3,862 $430,64828 72162-15-3 1-Decene, sulfurized$289,717 $16,500 $113,326 $1,407 $420,950 $3,537 $424,48729 73665-18-6Extract residues (coal),tar oil alk., naphthalenedistn. residues$289,717 $16,500 $110,875 $1,407 $418,499 $3,537 $422,035Total$7,050,803 $398,500 $2,724,490 $40,803 $10,214,596 $86,610 $10,301,2061Total administrative cost includes both reporting and non-reporting administrative costs.2Total industry compliance cost includes testing cost, analytical methodology validationcost, administrative cost, and export notification cost.3Total social cost includes total industry compliance cost and government cost.B-5Exhibit B-3: Annualized Social Costs1Least Cost ScenarioAverage Cost ScenarioCASRNChemical Name3 years, 3%3 years, 7%3 years, 3%3 years, 7%1 83-41-0 2-Nitrobenzene, 1,2-dimethyl-$92,193$99,370$115,674$124,6792 96-22-0 3-Pentanone$37,777$40,717$38,037$40,9983 98-09-9 Benzenesulfonyl chloride$95,954$103,424$115,849$124,8684 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)-$61,251$66,019$63,399$68,3345 121-82-4 1,3,5-Triazine, hexahydro-1,3,5-trinitro-$70,143$75,604$84,291$90,8536 127-68-4 Benzenesulfonic acid, 3-nitro-, sodium salt (1:1) $37,239 $40,138 $37,500 $40,4197 506-51-4 1-Tetracosanol$124,181$133,848$149,549$161,1918 506-52-5 1-Hexacosanol$119,356$128,648$142,837$153,9569 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)-$123,905$133,551$149,273$160,89410 2494-89-5Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogensulfate)$126,879 $136,756 $152,247 $164,09911 5026-74-42-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-$105,097 $113,279 $121,133 $130,56212 22527-63-5Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester$126,359 $136,196 $151,727 $163,53813 24615-84-7 2-Propenoic acid, 2-carboxyethyl ester$122,529$132,067$144,312$155,54614 25321-41-9 Benzenesulfonic acid, dimethyl-$124,181$133,848$149,549$161,19115 25646-71-3Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3)$107,641 $116,020 $123,676 $133,30416 52556-42-01-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)$126,879 $136,756 $152,247 $164,09917 61788-76-9 Alkanes, chloro$22,970$24,759$25,118$27,07318 65996-79-4 Solvent naphtha (coal)$121,641$131,110$147,009$158,45319 65996-82-9 Tar oils, coal$121,641$131,110$147,009$158,45320 65996-89-6 Tar, coal, high-temp.$115,785$124,799$141,153$152,14121 65996-92-1 Distillates (coal tar)$90,790$97,857$102,270$110,23122 68082-78-0 Lard, oil, Me esters$126,359$136,196$151,727$163,53823 68187-57-5 Pitch, coal tar-petroleum$103,619$111,686$128,987$139,02824 68442-60-4Acetaldehyde, reaction products withformaldehyde, by-products from$126,359 $136,196 $151,727 $163,53825 68610-90-2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters$126,359$136,196$151,727$163,53826 68988-22-71,4-Benzenedicarboxylic acid, 1,4-dimethyl ester,manuf. of, by-products from$126,879 $136,756 $152,247 $164,09927 70693-50-4Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-$126,879 $136,756 $152,247 $164,09928 72162-15-3 1-Decene, sulfurized$124,701$134,409$150,069$161,75129 73665-18-6Extract residues (coal),tar oil alk., naphthalenedistn. Residues$123,834 $133,474 $149,202 $160,817Total$3,059,382 $3,297,545 $3,641,789 $3,925,2921Total 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 thefew years during which the actual testing occurs and EPA reviews studies. Discount rates of both 3 and 7 percent are presented following OMB Guidance contained in Circular A-4.B-6Exhibit B-4: Annualized Industry Compliance Costs1Least Cost ScenarioAverage Cost ScenarioCASRNChemical Name15 years, 7%7 years, 7%15 years, 7%7 years, 7%1 83-41-0 2-Nitrobenzene, 1,2-dimethyl-$28,387$47,974$35,679$60,2982 96-22-0 3-Pentanone$11,630$19,654$11,710$19,7913 98-09-9 Benzenesulfonyl chloride$29,626$50,068$35,805$60,5114 98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)-$18,849$31,854$19,516$32,9815 121-82-4 1,3,5-Triazine, hexahydro-1,3,5-trinitro-$21,682$36,642$26,076$44,0686 127-68-4 Benzenesulfonic acid, 3-nitro-,sodium salt (1:1)$11,463$19,372$11,544$19,5097 506-51-4 1-Tetracosanol$38,178$64,521$46,057$77,8368 506-52-5 1-Hexacosanol$36,716$62,049$44,008$74,3739 515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)- $38,093 $64,376 $45,971 $77,69110 2494-89-5Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogensulfate)$38,980 $65,877 $46,859 $79,19111 5026-74-42-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-$32,323 $54,626 $37,303 $63,04212 22527-63-5Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester$38,819 $65,604 $46,697 $78,91813 24615-84-7 2-Propenoic acid, 2-carboxyethyl ester$37,665$63,654$44,430$75,08714 25321-41-9 Benzenesulfonic acid, dimethyl-$38,178$64,521$46,057$77,83615 25646-71-3Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3)$33,113 $55,961 $38,093 $64,37716 52556-42-01-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)$38,980 $65,877 $46,859 $79,19117 61788-76-9 Alkanes, chloro$6,924$11,702$7,591$12,82918 65996-79-4 Solvent naphtha (coal)$37,425$63,248$45,303$76,56319 65996-82-9 Tar oils, coal$37,425$63,248$45,303$76,56320 65996-89-6 Tar, coal, high-temp.$35,642$60,235$43,521$73,55021 65996-92-1 Distillates (coal tar)$27,844$47,056$31,409$53,08122 68082-78-0 Lard, oil, Me esters$38,819$65,604$46,697$78,91823 68187-57-5 Pitch, coal tar-petroleum$31,864$53,850$39,742$67,16424 68442-60-4Acetaldehyde, reaction products withformaldehyde, by-products from$38,819 $65,604 $46,697 $78,91825 68610-90-2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters $38,819 $65,604 $46,697 $78,91826 68988-22-71,4-Benzenedicarboxylic acid, 1,4-dimethyl ester,manuf. of, by-products from$38,980 $65,877 $46,859 $79,19127 70693-50-4Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-$38,980 $65,877 $46,859 $79,19128 72162-15-3 1-Decene, sulfurized$38,340$64,794$46,218$78,10929 73665-18-6Extract residues (coal),tar oil alk., naphthalenedistn. residues$38,070 $64,339 $45,949 $77,654Total$940,632 $1,589,670 $1,121,508 $1,895,3511Total industry compliance cost includes testing cost, analytical methodology validationcost, administrative cost, and export notification cost. Total industry compliance costs areannualized at a 7 percent discount rate, whichreflects the opportunity cost of capital,and over 15 years, which represents the life of the chemical. Results are also presented using adiscounting timeline of 7 years to test the sensitivity of results to a shorter chemical lifetime, as some chemicals included in the proposed rule may have a lifetime that is less than 15years. Industry compliance costs are used in the analysis ofimpacts of the rule on companiesand the discount period differs from that used to calculate social costs.C-1 

## Appendix C – Wage Rate Calculations

This appendix describes the derivation of the fully lo aded labor rates and inflation factors used in calculating costs of labor, materials, and other inputs. All cost estimates are presented in 2008 dollars.

C.1 Derivation of Loaded Wage Rates

The fully loaded unit labor cost for managerial, prof essional/technical, and clerical labor in the regulated industry and for EPA staff is estimated by adding fringe benefits and overhead costs to the hourly wage or annual salary for each category following the method described in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (Rice, 2002). This appendix describes the method employed to estimate the fully loaded unit labor costs for each labor category, and presents the results of the analysis.

Labor categories used in the analysis correspond to th e U.S. Bureau of Labor Statistics (BLS) Standard Occupational Classification (SOC) system. In Ma rch 2004, BLS began using the North American Industry Classification System (NAICS) instead of th e Standard Industrial Classification (SIC) System, and the Standard Occupational Classification (SOC) system instead of the Occupational Classification System (OCS). Exhibit C-1 summarizes the crosswalk between old and new occupational titles, and lists the SOC titles that correspond t o the managerial, professional/technical, and clerical labor categories used in this analysis.

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

Labor Category Used in the Analysis BLS Old Title (OCS) BLS New Title (SOC) Managerial Executive, administrative, and managerial Management, business, and financial

Professional/Technical Professional specia lty and technical Professional and related

Clerical Administrative support, including cl erical Office and administrative support Source: BLS (2006, Table 2); Weinstein (2004).

C.1.1 Derivation of Unit Labor Rates for Manageria l, Profes sional/Technical, and Clerical Industry Employees

Wages and fringe benefit data for managerial, prof essional/technical, and clerical labor are from the BLS Employer Costs for Employee Compensation (ECEC) historical data, for September 2008 (BLS, 2008, Table 2). 21

The costs of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same BLS report (BLS, 2008). Fringe benefits as a percentage of wages are calculated separately for each labor category. For example, for September 2008, the average wage rate for professional/technical labor was $33.99, and the average fringe benefit was $16.79. 22 Therefore, fringe benefits as a percentage of wages were $16. 79/$33.99, or approximately 49 percent (see Exhibit C-2).

21 Past economic analyses used ECEC data series speci fic 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.

22 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 sy stem, SOC. In the process, the “Professional specialty and technical” category became the “Professional and related” category. However, the coverage of the old and new
occupational groups is approximately the same. See 

### the BLS article, “ Comparing Current and Former Industry and Occupation ECEC Series” (Weinstein, 2004).C-2 An additional loading factor of 17 percent is applied to wages to account for overhead. 23 This approach is used for consistency with Office of Pollution Prev ention and Toxics (OPPT) economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program , June 10, 2002 (Rice, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report , August 2002 (U.S. EPA, 2002). This overhead loadin g 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 September 2008 fully loaded wage for professional/te chnical labor is $33.99 × (1+ 0.494 + 0.17) = $56.56.

Fully loaded costs for managerial and clerical la bor are calculated in a similar manner, as shown in

Exhibit C-2.

C.1.2 Derivation of Unit Labor Rates for EPA Staff

Unit labor rates for EPA staff are calculated b ased on annual federal salaries for the WashingtonBaltimore area published by the Office of Personne l Management (OPM) and effective January 2008 (OPM, 2007). The average salary for one full-time equi valent (FTE) staff member is estimated as the salary for a GS-13 Step 1 employee, which is $82,961 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 $132,738.

The Agency loading factor of 1.6 is from an EPA guide entitled Instructions for Preparing Information Collection Requests (ICRs) (U.S. EPA, 1992b, page 30, footnote 9). The 60 percent assumption was labeled “the benefits multiplication factor” in the EPA guide, but has been used in many EPA Office of Pollution Prevention and Toxics ICRs to reflect both fringe benefits and overhead for federal staff. For example, it was used in an August 2000 document supporting ICR No. 1139.06, with the following explanation:

The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits multiplication factor). The multiplication factor used is recommended in EPA’s Office of Policy, Planning, and Evaluation’s Instructions for Preparing Information Collection Requests (ICRs) (June 1, 1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits

but also overhead.

23 The change was used in the 2003 PMN SNUR economic analysis (U.S. EPA, 2003). In some earlier reports, the 17 percent had been applied to wages-plus-fringe benefits.C-3Exhibit C-2: Derivation of Loaded Wage RatesWageFringeBenefitFringes as %wageOverhead as% wage1Fringe +overheadfactorLoaded WagesLabor CategoryData Source for Wage InformationDate(a)(b)(c)=(b)/(a)(d)(e)=(c)+(d)+1(f)=(a)×(e)Managerial BLSECEC, Private Manufacturing industries,“Management, business, and financial occupations”2Dec-08 $43.22 $19.46 45.03% 17% 1.62 $70.03Professional/TechnicalBLSECEC, Private Manufacturing industries,“Professional and related occupations“2Dec-08 $35.29 $17.55 49.73% 17% 1.67 $58.84Clerical BLSECEC, Private Manufacturing industries, “Officeand administrative support occupations”2Dec-08 $17.22 $8.33 48.37% 17% 1.66 $28.48$82,961(annual)-- $132,738(annual)EPA staff FTE Annual federal staff cost: OPM Washington-BaltimoreNorthern Virginia, DC-MD-PA-VA-WV, area, GS-13Step 1 pay rates, with 60% overhead.3Jan-08$39.89(hourly)--[Included in60%overhead]60% 1.60$63.82(hourly)Notes:1An overhead rate of 17% was used based on assumptions in Rice (2002) and U.S. EPA (2002).2BLS (2009c, Supplemental Table 2).3The federal salary is the unloaded federal GS-13 Step 1salary ($82,961 for 2008), from the OPM salary table forWashington-Baltimore-Northern Virginia(OPM, 2007). The 60%fringes-and-overhead rateis from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs)(U.S. EPA, 1992b, page 30, footnote 9). Hourly rates are based onannual salary divided by 2,080 hours.