### 3333



# August 1 5 , 2011

— Does not contain TSCA CBI

— —

Prepared by: Economic and Policy Analysis Branch Economics, Exposure and Technology Division Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency 1200 Pennsylvania Avenue

Washington, D.C. 20460 

# Economic Analysis for the Proposed High Production Volume Challenge Chemicals Test Rule

- Fourth Group of Chemicals

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

# Proposal Version

### 1

- 1 

## Contributors
The EPA analyst responsible for this report was Lynne Blake

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

- W08

- 0100.

### 1

- 2 

## Cont ent s Chapter 1

– Introduction

................................ ................................ ................................ ............................ 1

- 6 1.1 Statutory Authority

................................ ................................ ................................ ....................... 1

- 6 1.2 Regulatory Background

................................ ................................ ................................ ................ 1

- 6 1.3 Statement of Need

................................ ................................ ................................ ......................... 1

- 7 1.4 Summary of Analytic Approach

................................ ................................ ................................ ... 1

- 8 1.5 Organization of This Report

................................ ................................ ................................ ......... 1

- 9 Chapter 2

– Affected Entities

................................ ................................ ................................ ..................... 2

- 1 2.1 Chemicals Sub ject to the Proposed Rule

................................ ................................ ...................... 2

- 1 2.2 The Regulated Community

................................ ................................ ................................ ........... 2

- 4 2.3 Chemical Production Information

................................ ................................ ................................ . 2

- 5 2.4 Chemical

- Specific Use and Market Information

................................ ................................ .......... 2

- 6 Chapter 3

– Tests Required by the Proposed Rule

................................ ................................ ..................... 3

- 1 3.1 Introduction

................................ ................................ ................................ ................................ ... 3

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

................................ ....... 3

- 1 3.3 Specific Test Requirements in the Pr oposed Rule

................................ ................................ ........ 3

- 5 Chapter 4

– Industry Compliance Costs

................................ ................................ ................................ .... 4

- 1 4.1 Introduction

................................ ................................ ................................ ................................ ... 4

- 1 4.2 Unit Costs

................................ ................................ ................................ ................................ ..... 4

- 1 4.3 Total Industry Compliance Costs

................................ ................................ ................................ 4

- 12 4.4 Non

- Monetized Costs

................................ ................................ ................................ ................. 4

- 12 Chapter 5

– Agency Costs

................................ ................................ ................................ .......................... 5

- 1 5.1 Introduction

................................ ................................ ................................ ................................ ... 5

- 1 5.2 EPA Costs

................................ ................................ ................................ ................................ ..... 5

- 1 Chapter 6

– Social Costs

................................ ................................ ................................ ............................ 6

- 1 6.1 Total Social Costs

................................ ................................ ................................ ......................... 6

- 1 6.2 Annualized Costs

................................ ................................ ................................ .......................... 6

- 1 Chapter 7

– Small Entity Impact Analysis

................................ ................................ ................................ . 7

- 1 7.1 Identify the Affected Population

................................ ................................ ................................ ... 7

- 1 7.2 Select a Relevant S mall Business Definition

................................ ................................ ................ 7

- 3 7.3 Identify Small Businesses

................................ ................................ ................................ ............. 7

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

................................ ................................ ...... 7

- 4 7.5 Cost

- to

- Sales Ratio

................................ ................................ ................................ ....................... 7

- 4 7.6 Companies without Sales Data

................................ ................................ ................................ ..... 7

- 5 7.7 Results

................................ ................................ ................................ ................................ ........... 7

- 5 Chapter 8

– Benefits

................................ ................................ ................................ ................................ ... 8

- 1 8.1 Use Values

................................ ................................ ................................ ................................ .... 8

- 1 8.2 Non

- Use Values

................................ ................................ ................................ ............................ 8

- 2 8.3 Benefits of the Required Tests

................................ ................................ ................................ ...... 8

- 2 8.4 Benefits Related to Each Regulated Chemical

................................ ................................ ........... 8

- 10 8.5 Potential Users of Information Generated by the Proposed Rule

................................ ............... 8

- 21 Chapter 9

- Other Impact Analyses

................................ ................................ ................................ ............ 9

- 1 9.1 Paperwork Reduc tion Act

................................ ................................ ................................ ............. 9

- 1 9.2 Unfunded Mandates Reform Act

................................ ................................ ................................ .. 9

- 3 9.3 Executive Order 13132

– Federalism

................................ ................................ ............................ 9

- 4 9.4 Executive Order 13175

– Consultation and Coordination with Indian Tribal Governments

........ 9

- 4 9.5 Executive Order 13045

- Children’s Health

................................ ................................ ................. 9

- 4 9.6 Executive Order 13211

– Energy Supply, Distribution, or Use

................................ .................... 9

- 4 9.7 National Technology Transfer and Advancement Act

................................ ................................ .. 9

- 5 9.8 Executive Order 12898

– Environmental Justice

................................ ................................ .......... 9

- 5

### 1

- 3 Chapter 10

– References

................................ ................................ ................................ .......................... 10

- 1 Appendix A Laboratory Test Co st Estimate

................................ ................................ ........................... A

- 1 Appendix B Wage Rate Calculations

................................ ................................ ................................ ...... B

- 1 Appendix C Costs

................................ ................................ ................................ ................................ ... C

- 1

### 1

- 4 

## Exhibits

Exhibit 2

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

............ 2

- 2 Exhibit 2

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

............. 2

- 6 Exhibit 2

- 3: Chemical Use Information

................................ ................................ ................................ ..... 2

- 7 Exhibit 3

- 1: Tests Required by EPA for HPV Chemicals, Based on the OECD’s Screenin g Information Data Set (SIDS)

................................ ................................ ................................ ............................ 3

- 2 Exhibit 3

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

................................ ......... 3

- 6 Exhibit 4

- 1: EPA Esti mates of Laboratory Costs of Proposed Tests (2009$)

................................ ........... 4

- 2 Exhibit 4

- 2: Total Laboratory Test Costs per Chemical

................................ ................................ ........... 4

- 6 Exhibit 4

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

................................ ........ 4

- 8 Exhibit 4

- 4: Derivation of Loaded Hourly Rates by Labor Category

................................ ........................ 4

- 9 Exhi bit 4

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

................... 4

- 10 Exhibit 4

- 6 : Export Notification Cost Estimate for the Proposed Rule

................................ ................... 4

- 12 Exhibit 4

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

.. 4

- 12 Exhibit 5

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

................................ ............... 5

- 1 Exhibit 6

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

............................ 6

- 1 Exhibit 6

- 2: Annualized Costs Under Least and Average Cost Scenarios (Total for All Chemicals) ($2009)

................................ ................................ ................................ ................................ .......... 6

- 2 Exhibit 7

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

................................ ................................ ................................ ................................ ........ 7

- 1 Exhibit 7

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

......................... 7

- 2 Exhibit 7

- 3: Distribution of Potentially Impacted Companies by Annu al Sales

................................ ........ 7

- 3 Exhibit 7

- 4: Summary Statistics for Company

- Specific Cost

- to

- Sales Ratios for Small Companies

....... 7

- 5 Exhibit 9

- 1: Reporting Burden Estimate for the Proposed Rule

................................ ................................ 9

- 1 Exhibit 9

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

................................ ................ 9

- 2 Exhibit 9

- 3: Esti mated Government Burden for the Proposed Test Rule

................................ .................. 9

- 3

Exhibit B

- 1: Detail of Labor Categories Used in the Analysis

................................ ................................ . B

- 1 Exhibit B

- 2: Derivation of Loaded Wage Rates

................................ ................................ ....................... B

- 3 Exhibit C

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

................................ ..... C

- 1 Exhibit C

- 2 : Industry Compliance and Government Costs, Average Cost Scenario

................................ C

- 3 Exhibit C

- 3: Annualized Social Costs

................................ ................................ ................................ ...... C

- 5 Exhi bit C

- 4: Annualized Industry Compliance Costs

................................ ................................ ............... C

- 6

### 1

- 5 

## Executive Summary
EPA is proposing a chemical test rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA ) that would require manufacturers, importers, and processors 1 

### of a group of 23 high production volume (HPV) chemical substances to conduct testing to obtain screening level data for health and environmental effects and chemical fate . This report provides the economic analysis for the proposed test rule

. EPA seeks to investigate chemicals produced in substantial quantities to determine their effects on human health and the environment . HPV chemicals are those substances with a U.S. production or import volume exceeding one million pounds (lbs.) per year

. If EPA determines that the manufacture of an HPV chemical may enter the environment in large quantities and/or impose a significant human exposure, the Agency can require producers of the chemical to conduct chemical testing to determine any of its enviro nmental and health risks. Additionally, the Agency can require such chemical testing and data collection if the environmental hazard information of the HPV chemical is unknown or insufficient

. The test rule would require companies whose chemicals meet thes e criteria to perform tests concerning environmental fate, aquatic toxicity, and mammalian toxicity

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

. The costs to industry and government are estimated quantitatively, wh ile the benefits of the rule are explained qualitatively

. The total industry compliance costs triggered by the proposed rule are $5. 73 million under least cost assumptions and $7. 6 5 million under average cost assumption s. C osts to industry include laborato ry testing costs, analytical method valuation costs, administrative costs, and export notification costs

. The total government cost to EPA for the proposed rule is approximately $7 2 ,000 , which considers the costs to review data collection materials and to administer the rule

. The total estimated social costs of the proposed rule are the sum of industry and government costs, $5. 80 million and $7. 72 million for the least

and average

- cost scenarios, respectively

. The benefits of the testing requirement result from disclosure of chemical hazard information to the public, industry, and government

. These benefits include improved information, reduced costs to risk

- based decisions, lowered chemical exposures, and better outcomes of decisions

. This report also in cludes several impact analyses concerning federal regulations and Executive Orders, as well as a separate designated chapter for a small entity impact analysis

. The small entity impact analysis explains how small companies are identified and estimates the per
- company cost incurred because of the proposed rule

. EPA estimates that no companies will be impacted at greater than a one percent cost

- to

sales ratio.

1 P rocessors of the subject chemicals are “persons not initially required to comply.” Therefore, while they would legally be subject to the proposed test r ule, processors of a subject chemical would be required to comply with the requirements of the rule only if they are directed to do so by EPA in a future Federal Register notice.

### 1

- 6 

# Chapter 1

– Introduction This report assesses the costs and benefits expected to result from EPA’s proposed H igh Production Volume (HPV) Chemical Testing rule, the fourth testing rule for a group of high production volume chemicals. The proposed rule would require manufacturers, importers, and processors of certain HPV chemical substances to conduct testing to ob tain screening level data for health and environmental effects and chemical fate. This chapter provides background information on EPA’s statutory authority for requiring this testing, regulatory background, a discussion of the need for the regulation, a br ief summary of the methodology used in the analysis, and a description of the organization of the remainder of this report.


### 1.1 Statutory Authority Under the Toxic Substances Control Act (TSCA), the U.S. EPA (EPA) can impose information reporting and other req uirements on producers, importers, processors, users, distributors, and disposers of chemicals to ensure the safe management of toxic chemicals. Under TSCA Section 4, EPA is authorized to require by rule that manufacturers and/or processors of chemical sub stances conduct testing to determine the effect of chemical substances on human health and the environment. In particular, the Administrator requires that testing be conducted if the Agency finds that:
(A) (i) the manufacture, distribution in commerce, pro cessing, use, or disposal of a chemical substance or mixture, or any combination of such activities, may present an unreasonable risk of injury to health or the environment,
(ii) there are insufficient data and experience upon which the effects of such manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and (iii) testing of such substance or mixtur e with respect to such effects is necessary to develop such data; or
(B) (i) a chemical substance or mixture is or will be produced in substantial quantities, and (I) it enters or may reasonably be anticipated to enter the environment in substantial quant ities or (II) there is or may be significant or substantial human exposure to such substance or mixture, (ii) there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of su ch substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and
(iii) testing of such substance or mixture with respect to such effects is necessary to develop such data



### . 

### 1.2 Regulat ory Background In 1998, a national effort was announced to expand the availability of information regarding the most widespread chemicals in commerce. To support this effort, in 2006, EPA promulgated a test rule under TSCA Section 4, for 17 HPV chemicals t hat have annual production and/or importation volumes of one million pounds or more (71 FR 13708, March 16, 2006). On December 8, 2006, EPA issued a direct final rule that revoked testing requirements for one of the chemicals subject to the test rule (71 F R 71508)

. The data obtained under the first test rule has provided information about the remaining 16 chemicals which will better enable the Agency to evaluate the potential risks of these substances and take any appropriate management actions regarding th em.

### 1

- 7 In 2008, EPA proposed a second HPV chemical test rule for an additional 19 chemicals (73 FR 43314, July 24, 2008), and in 2010, EPA proposed a third HPV chemical test rule for 29 more chemicals (75 FR 8575, February 25, 2010)

. Now, EPA is proposing a fourth test rule for 23 HPV chemicals. Like the other HPV chemical test rules, this proposed rule will require the development of data similar to that specified under Screening Information Data Set (SIDS) testing battery of the Organisation for Economic C o
- operation and Development (OECD) (see Chapter 3 for more inf ormation on specific test requirements).


### 1.3 Statement of Need Executive Order 12866 requires the identification of the specific market failure that a si gnificant rule addresses. The major causes of market failure identified in the Office of Management and Budget (OMB) guidance (OMB, 2003) on Executive Order 12866 are externality, natural monopoly, market power, and inadequate or asymmetric information. Fu lly functioning competitive markets result in a socially efficient allocation of resources if each seller and each buyer have complete information on their own actions and make decisions based on the full costs of their own actions. If such information is missing the market is unable to efficiently allocate goods and services resulting in market failure. The proposed test rule is designed to address the issue of inadequate information. In addition, to the extent that the information provided by the rule hel ps firms internalize social costs, the rule addresses the negative externalities that are generated from the manufacture/use of certain HPV chemicals.

1.3.1 Inadequate Inform ation 

### Economic theory notes that complete information among buyers and sellers is a requ irement for rational decision making and for the efficient allocation of resources. When buyers or sellers do not have complete information about the true costs or benefits of their choices, rational decision making cannot occur and the market fails. As an example, a producer may not consider substituting a less hazardous chemical for a hazardous chemical if knowledge about either chemical’s hazard is unknown or uncertain. More complete information on the hazards associated with the chemical will allow a pr oducer 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 cus tomers (because the costs are not borne by the producer and are external to the producer)

. **•** This information may be unknown to both the producers and their customers. The first of these reasons is known as asymmetric information; that is, a case in which c onsumers and producers do not have the same level of information regarding the hazards posed by a chemical substance. Typically, the producers’ level of information regarding a product exceeds the consumers’ level of information. In the second case, chemic al hazard information is inadequate (e.g., unknown to both consumers and producers); producers may have little incentive to acquire such information due to the potential costs associated with its acquisition. Because information is by nature a public good and likely to impose costs on producers, they have little incentive to develop information. Information is non

- rival (one person’s use of information does not diminish the amount remaining for other users) and non

- excludable (once made available, informati on cannot be easily withheld from others). Thus, where information is provided by one person, others are free to use and benefit from that information without having made a contribution to its development. This reduces the incentive to provide the informat ion, resulting in a failure of the market

### 1

- 8 to efficiently provide the information. In addition, individual consumers are unlikely to be willing to pay the cost of chemical tests to acquire the information if they can use information developed and paid for b y others.

1.3.2 Extern alities 

### Externalities, another cause of market failure, occur when the actions of one economic entity impose costs (or benefits) on parties that are “external” to the market transaction; that is, these costs (or benefits) are not borne by the producers or consumers involved in the market transaction. Such is the case where manufacturing or other business activities harm human health or the environment, resulting in negative externalities. When information is missing about the human health a nd/or environmental costs to producers or if the costs are external to producers’ decision making, these costs are not internalized by the business entity and not incorporated into business decisions. The result can be the overuse or overproduction of cert ain 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 che micals. As a first step in mitigating externalities, the EPA Office of Pollution Prevention and Toxics (OPPT) routinely screens chemicals for the potential risks they may pose. This screening is used to determine if risks from the manufacture, processing, or use of chemicals are of sufficient concern to warrant risk management. Given that EPA’s TSCA Inventory recognizes more than 83,000 chemicals in commerce (U.S. EPA, 2008), chemical risk screening represents a significant effort. Risk is a function of haz ard and exposure, and when information on either is lacking, EPA’s ability to effectively identify significant risks arising from externalities is compromised. By providing information, the proposed test regulation will address market failure due to inadeq uate information by ensuring that basic information about the health and environmental effects of certain HPV chemicals is available to the public. This information can be used by consumers, producers, the public sector, and others to make more informed de cisions regarding chemicals. These users may also apply this information toward remedying externalities. To the extent that the availability of this information induces the producers to account for these social costs, either because of fear of litigation, or because of the benefits of corporate stewardship, availability of information will address the negative externalities generated by producing or using these chemicals.


### 1.4 Summary of Analytic Approach This analysis seeks to quantify, to the extent possible, the costs to society of the proposed HPV chemical test rule by identifying the costs to industry associated with performing the required tests and the costs to EPA of administering the rule

. Costs to industry include the costs incurred by the laboratory te sting of the chemicals itself, as well as costs associated with validating the analytical method , administrative costs, and costs to comply with the export notification requirement that is triggered by the test rule. Agency costs include reviewing and proc essing the data received as a result of the rule. Data sources for this analysis include test costs estimated by laboratories and burden estimates derived from information collection requests for similar regulations. Because the specific tests required fo r each chemical may be different, costs are presented for each individual chemical and aggregated to show the cost of the rule as a whole

. This report also presents a small entity impact analysis that assess es the effect of the proposed rule on small enti ties

. The methodology includes identifying the chemical producers and then identify ing small businesses (using a n SBA

- based and a TSCA

- based definition) with parent

- company data from Dun & Bradstreet. For each small entity, a ratio was calculated to compar e the cost of the rule (the sum of the

### 1

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

. Impacts at or above 1 percent are evaluated further. Additionally, this report qualitatively discusses the benefits of the proposed action, based on the value of the information it will provide . The benefits analysis was undertaken to address the implicit call for cost

benefit balancing contained in TSCA, as well as the requirements of Executive Order 12866. Quantifica tion of the benefits of the proposed rule would require more specific information about each user’s use patterns and preferences, and the changes in these that would result from the additional information made available under the proposed rule. These data are not readily available , and collecting such data would be cost

- prohibitive.


### 1.5 Organization of This Report This report presents EPA’s economic analysis for this proposed rule. Regulated chemicals and companies are characterized in Chapter 2

. Chapter 3 explains the tests that are required by this testing rule. Costs to industry, including laboratory, administrative, and export notification are reported in Chapter 4 . Agency costs are shown in Chapter 5 . Total social costs (industry plus agency) are presented in Chapter 6

. The small entity impact analysis for the proposed rule , as mandated by the Regulatory Flexibility Act (RFA), and amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), is presented in Chapter 7

. Chapter 8 addresses the benefits of the proposed rule using a “value of informa tion” framework. Several additional impact analyses are presented in Chapter 9 including an analysis of unfunded mandates, which is required by the Unfunded Mandates Reform Act (UMRA); an examination of environmental justice an d children’s health pertaining to the requirements of Executive Order 12898; and Executive Order 13045, respectively, and a burden hour analysis, which responds to the requirements of the Paperwork Reduction Act (PRA). Cited references are listed in Chapter 10

. Note that all dollar amounts in this analysis are reported in 2009 dollars. For cost inputs that were estimated prior to 2009, EPA applied the most relevant adjustment factor to ensure that all costs were comparable.

### 2

- 1 

# Chapter 2

– Affected Entities

2.1 Chemicals Subject to the Propos ed Rule This chapter presents information about the production and use of the 23 HPV chemicals included in the proposed rule

. To be included in this proposed rule, EPA has made preliminary findings for the se chemical substances under TSCA section 4(a)(1)(B) that:

**•** t hey are produced in substantial quantities;

**•** t here is or may be substantial human exposure to them;

**•** e xisting data are insufficient to determine or predict their health and environmental effects; and

**•** t esting is necessary to develop such data. The criteria and standards used by EPA for evaluating whether there is substantial production, substantial release, and substantial or significant human exposure, as the terms are used in TSCA section 4(a)(1) (B)(i), are explained in EPA’s Final Statement of Policy; Criteria for Evaluating Substantial Production, Substantial Release, and Substantial or Significant Human Exposure set forth at 58 FR 28736 (May 14, 1993). Refer to EPA’s Exposure Findings Supportin g Information for the proposed rule (U.S. EPA, 2010b) for more information.
Exhibit 2

- 1 provides the Chemical Abstracts Service Registry Number (CASRN) assigned by the Chemical Abstracts Service (CAS) to each of t hese 23 chemicals, the chemicals’ common names, and other synonyms used to research information presented in this analysis on the chemicals. 2 , 3

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

. 3 EPA identified synonyms for each chemical by searching the National Institute of Standards and Technology (NIST) WebBook and the U.S. NLM ChemIDplus Lite by CAS number.

### 2

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

CASRN C A Index Name Synonyms

1 56

- 40

- 6 Glycine 2

- Aminoacetic acid; AI3

- 04085; Acetic acid, amino

- ; Aciport; Aminoacetic acid; Acide aminoacetique; Aciport; Aminoethanoic acid; CCRIS 5915; EINECS 200

- 272

- 2; FEMA No. 3287; G licoamin; Glycocoll; Glycolixir; Glycosthene; HSDB 495; L

- Glycine; Leimzucker; NSC 25936; Padil; NH2CH2COOH; Glycine U.S.P. XIX; Amitone; Glycine, non - medical; Hampshire glycine; Amino acid; Athenon; component of Corilin; G salt; Gly; Glycine

- iron sulfate (1:1); Glycine, free base; Gyn

- hydralin; Iconyl; Monazol; UNII

TE7660XO1C

2 67

- 72

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

- hexachloro

Avlothane; Carbon hexachloride; Distokal; Distopan; Distopin; Egitol; Falkitol; Fasciolin; Hexachlorethane; Hexachloroethane; Hexachloroet hylene; Mottenhexe; Perchloroethane; Phenohep; CCl3CCl3; Ethane hexachloride; Ethylene hexachloride; 1,1,1,2,2,2

- Hexachloroethane; Hexachlor

- aethan; NCI

- C04604; NA 9037; Rcra waste number U131; C2Cl6; 4

- 01

- 00

- 00148 (Beilstein Handbook Reference as cited b y Milne, 2005); AI3

- 00633; BRN 1740341; CCRIS; 330; Caswell No. 479; EINECS 200

- 666

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

- C04604; NSC 9224; RCRA waste number U131; UNII

- G30K3QQT4J

3 78

- 00

- 2 Plumbane, tetraethyl

Tetraethyllead; P lumbane, tetraethyl

- ; Lead tetraethyl; Tetraethylplumbane; TEL; (C2H5)4Pb; Czteroetylek olowiu; NCI

- C54988; Tel

- tml, reacted; Tetra(methylethyl)lead; NA 1649; Piombo tetra

- etile; Tetraethylolovo; Tetraethylplumbium; UN 1649; 4

- 04

- 00

- 04349 ( Beilstein Handbo ok Reference as cited by Milne, 2005 ); BRN 3903146; CCRIS 1565; EINECS 201

- 075

- 4; HSDB 841; NSC 22314; RCRA waste number P110

4 95

- 14

- 7 1H

- Benzotriazole Azimidobenzene; Aziminobenzene; Benzene azimide; Benzisotriazole; Benzotriazole; Benztriazole; Cobrate c 99; 1,2

- Aminoazophenylene; 1,2,3

- Benzotriazole; 1,2,3

- Triaza

1H

- indene; 1,2,3

- Triazaindene; 1H

- 1,2,3

- Benzotriazole; 2,3

- Diazaindole; Cobratec No. 99; NCI

- C03521; NSC

- 3058; U

- 6233; 1,2

- Aminozophenylene; 1,2,3

- Benztriazole; 2,3

- Diazaindole 1,2,3

- riazainden e; ADK STAB LA

- 32; Benzotriazole1H

- benzotriazole; Cobratec; Preventol Cl 8; 4

- 26

- 00

- 00093 (Beilstein Handbook Reference); AI3

- 15984; BRN 0112133; CCRIS 78; Cobratec #99; EINECS 202

- 394

- 1; HSDB 4143

5 118

- 48

- 9 2H

- 3,1

- Benzoxazine

2,4(1H)

- dione Isatoic anhyd ride; Isato acid anhydride; Anthranilic acid, N

- carboxy

- , cyclic anhydride; Benzoic acid, 2

- (carboxyamino)

- , cyclic anhydride; IA; 2H

- 3,1

- Benzoxazine

- 2,4(1H)

- dione; 4

- 27

- 00

- 03330 (Beilstein Handbook Reference); AI3

- 24983; BRN 0136786; EINECS 204

- 255

- 0; HSD B 5017; Isatoic anhydride; N

Carboxyanthranilic anhydride; NSC 104662

6 128

- 44

- 9 1,2

- Benzisothiazol

- 3(2H)

- one, 1,1

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

- Dioxide

- 1,2

- benzisothiazol

- 3(2H)

- one, sodium salt; Saccharin sodium anhydrous; Artificial s weetening substanz gendorf 450; Benzoic acid sulfimide, sodium; CCRIS 706; Cristallose; Crystallose; Dagutan; EINECS 204

- 886

- 1; FEMA No. 2997; Kristallose; Madhurin; NSC 4867; ODA; Saccharin sodium, anhydrous; Saccharin soluble; Saccharin, sodium; Sacchari n, sodium salt; Saccharinnatrium; Saccharoidum natricum; Saxin; Sodium 1,2 benzisothiazolin

- 3

- one 1,1

- dioxide; Sodium o - benzosulfimide; Sodium saccharide; Sodium saccharin; Sodium saccharinate; Soluble gluside; Sucra; Sucromat; Sulphobenzoic imide, sodium salt; Sweeta; Sykose; UNII

- I4807BK602; Willosetten; o

- Sulfonbenzoic acid imide sodium salt

7 928

- 72

- 3 Glycine, N

- (carboxymethyl)

- , sodium salt (1:2) Acetic acid, iminodi

- , disodium salt; Acetic acid, iminodi

- , disoidum salt; Disodium iminodiacetate; Disod ium iminodi(acetate); EINECS 213

- 181

- 8; Iminodiacetic acid sodium salt; Iminodiacetic acid, disodium salt; Iminodioctan disodny; Iminodioctan sodny; Glycine, N

- (carboxymethyl)

- , disodium salt; Glycine, N

- (carboxymethyl)

- , disodium salt, hydrate; Glycine, N

- (carboxymethyl)

- , sodium salt (1:2)

8 1809

- 19

- 4 Phosphonic acid, dibutyl ester Dibutyl hydrogen phosphate; Dibutyl phosphite; di

- n - Butylphosphite; Butyl alcohol, hydrogen phosphite; Butyl phosphonate ((BuO)2HPO); Di

- n - butyl hydrogen phosphite; Dibutoxyph osphine oxide; Dibutyl hydrogen phosphonate; Dibutyl phosphonate; Phosphorous acid, dibutyl ester; Dibutylfosfit; Mobil DBHP; Syn

- O

Ad P

- 316; 4

- 01

- 00

- 01525 (Beilstein Handbook Reference); BRN 1099706; EINECS 217

- 316

- 1; HSDB 2597; NSC 2668

9 25377

- 73

- 5 2,5

- Furandione, 3

- (dodecen

- 1

- yl)dihydro

Dodecenylsuccinic anhydride; 2

- (Dodecyl)succinic anhydride; CCRIS 698; DDSA; Dodecenylsuccinic acid anhydride; Dodecenylsuccinic anhydride; EINECS 246

- 917

- 1; HSDB 4374; K 12; K 12 (anhydride); Rikacid DDSA; Succinic an hydride, dodecenyl

- ; 2,5

- Furandione, 3

- (dodecen

- 1

- yl)dihydro

- ; Dodecenylsuccinic anhydride; Succinic anhydride, dodecenyl

-

### 2

- 3 Exhibit 2
- 1 : Chemicals Included in the Proposed High Product ion Volume Chemical Test Rule

CASRN C A Index Name Synonyms

10 26544

- 38

- 7 2,5

- Furandione, dihydro

3

- (tetrapropenyl)

- AI3

- 28007; DSA; Dihydro

- 3

- (tetrapropenyl)

- 2,5

- furandione; EINECS 247

- 781

- 6; RD 174; Tetrapropenylsuccinic anhydride; 2,5

- Furandione, dihydro

- 3,3,4,4

- tetra

1

- propenyl

- ; Dihydro

- 3

- (tetrapropenyl)furan

- 2,5

- dione; Succinic anhydride, (tetrapropenyl)

- ; Succinic anhydride, (tetrapropenyl)

- 11 27859

- 58

- 1 Butanedioic acid, 2

- (tetraprope nyl)

- (Tetrapropenyl)butanedioic acid; EINECS 248

- 698

- 8; (Tetrapropenyl)succinic acid; Butanedioic acid, 2

- (tetrapropenyl)

- ; Succinic acid, (tetrapropenyl)

-

12 28777

- 98

- 2 2,5

- Furandione, dihydro

3

- (octadecen

- 1

- yl)

- Dihydro

- 3

- (octadecenyl)

- 2,5

- furandione; EINECS 249

- 210

- 6; Octadecenylsuccinic anhydride; 2,5

- Furandione, dihydro

- 3

- (octadecen

- 1

- yl)

- ; Dihydro

- 3

- (octadecenyl)furan

- 2,5

- dione; Succinic anhydride, octadecenyl

- (6CI,7CI,8CI)

13 29385

- 43

- 1 1H

- Benzotriazole, 6 (or 7 )

- methyl

1H

- Benzotriazole, 6(or 7)

- methyl

- ; 1H

- Benzotriazole, 4(5)

- methyl

- ; CCRIS 4738; Cobratec TT 100; EINECS 249

- 596

- 6; Methyl

- 1H

- benzotriazole; Methylbenzotriazole; Olin 53734; Preventol CI 7

- 100; Seetec T; Seetec TT; Stabinol MBTZ; Tolutriazole; Tolyl triazole; Tolyltriazole; 1H

- Benzot riazole, methyl

- ; Methyl

- 1H

- benzotriazole

14 32072

- 96

- 1 2,5

- Furandione, 3

- (hexadecen

- 1

- yl)dihydro

Hexadec

- 2

- enylsuccinic anhydride; 2

- Hexadecenyl succinic anhydride; n

Hexadecenylsuccinic anhydride; 3

- [(2E)

- 2

- Hexadecenyl]dihydro

- 2,5

- furandione; EINECS 25 0

- 911

- 4; Succinic anhydride, hexadecenyl

15 61789

- 73

- 9 Quaternary ammonium compounds, benzylbis (hydrogenated tallow alkyl) dimethyl, chlorides EINECS 263

- 082

- 9; Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides

16 646 65

- 57

- 2 1H

- Benzotriazole, 6 (or 7 )

- methyl

- , sodium salt EINECS 265

- 004

- 9; Tolyl triazole sodium salt; Tolyltriazole, sodium salt; 1H

Benzotriazole, 6(or 7)

- methyl

- , sodium salt (1:1); Sodium 4(or 5)

- methyl

- 1H

benzotriazolide; 1H

- Benzotriazole, 4(or 5)

- methy l

- , sodium salt; Methyl

- 1H

benzotriazole, sodium salt

17 68131

- 13

- 5 Naphthenic acids, reaction products with diethylenetriamine Diethylenetriamine naphthenate; Diethylenetriamine, naphthenic acid condensate; EINECS 268

- 610

- 1; Naphthenic acid, diethylenetr iamine condensate; Naphthenic acids, diethylenetriamine condensate

18 68153

- 60

- 6 Fatty acids, tall

- oil, reaction products with diethylenetriamine, acetates Tall oil fatty acid, N

- (2

- aminoethyl)

- 1,2

- ethanediamine reaction product, acetate salt; Tall oil f atty acids, reaction products with diethylenetriamine, acetic acid salt; EINECS 268

- 887

- 9

19 68424

- 85

- 1 Quaternary ammonium compounds, benzyl

- C12

- 16

- alkyldimethyl, chlorides Alkyl(C12

- 16)dimethylbenzylammonium chloride; Ammonium, alkyl(C12

- C16)dimethylbe nzyl

- , chlorides; BTC 835; Barquat MB 80; Benzyl

- C12

- C16

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

- 16

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

- 325

- 2; Gardiquat 1250AF; Hyamine 3500; M aquat MC 1412; Protek Q; Rolquat cdm/BC; Tret

O

- lite WF 828; Tret

- O

- lite WF 88

20 68442

- 77

- 3 2

- Butenediamide, (2E)

- , N1,N4

- bis[2

- (4,5

- dihydro

2

- nortall

- oil alkyl

- 1H

imidazol

- 1

- yl)ethyl] derivs. 2

- Butenedioic acid (E), diamide with 1

- (2

- aminoethyl)

- 2

- (tall oil alkyl)

- 2

- imidazoline; 2

- Butenediamide, (2E)

- , N,N'

- bis(2

- (4,5

- dihydro

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- yl)ethyl) derivs.; 2

- Butenediamide, (E)

- , N,N'

- bis(2

- (4,5

- dihydro

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- yl)ethyl) derives

. ; EINECS 270

- 489

- 5

21 68607

- 28

- 3 Quaternary ammonium compounds, (oxydi

- 2,1

- ethanediyl)bis[coco alkyldimethyl, dichlorides (Oxydi

- 2,1

- ethanediyl)bis(coco alkyl)dimethyl ammonium dichlorides; Caswell No. 627B; Dimethylcocoamine, bis(chloroethyl) ether, diquaternary ammonium salt; EINEC S 271

- 761

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

- dimethyl ammonium chloride) *(derived from coconut oil fatty acids); (Oxydiethyleneglycol)bis(coco alkyl)dimethyl ammonium chloride

22 68909

- 18

- 2 Pyridinium, 1

- (phenylmethyl)

- , Et Me derivs., chlorides 1

- (Phenylmethyl)pyridinium Et Me derivs., chlorides; Alkyl pyridine, benzylchloride quaternized; Benzyl (C1

- C2)

- alkylpyridinium chloride; EINECS 272

- 695

- 0; EINECS 273

- 252

- 4; Pyridinium, ethyl

- 1

- (phenylmethyl)

- , chloride, mixed with meth yl

- 1

- (phenylmethyl)pyridinium chloride 23 69834

- 17

- 9 Benzene, decylphenoxy

- (Decylphenoxy)benzene; Decylphenoxybenzene; EINECS 274

- 140

- 8 Sources : NIST, 200 8 , and U.S. NLM, 2009a

### 2

- 4 2.2 The Regulated Community Entities potentially affected by the proposed te st rule include those that manufacture (defined by statute to include import) or process any of the chemical substances that are included in the proposed rule. In addition, after the Agency issues a final rule, any person who exports, or intends to export, any of the chemical substances included in the final rule will be subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D , if the chemicals are not already subject to a TSCA rule that triggers section 12( b) . Potentially affected entities may include, but are not limited to:

**•** 

### Manufacturers (defined by statute to include importers) of one or more of the 23 subject chemical substances (NAIC S codes 325 and 324110), e.g., chemical manufacturing and petroleum ref ineries.

**•** 

### Processors of one or more of the 23 subject chemical substances (NAIC S codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. The testing rule i mposes a one
- time requirement

. However, companies that begin manufacturing a su bject chemical within a five

- year period after data from a required test is submitted to EPA may be subject to reimburseme nt for the costs of the testing (that is, companies that have already paid for the testing may seek to be reimbursed by companies that later begin to manufacture the chemical)

. EPA’s reimbursement procedures are found at 40 CFR part 791.

2.2.1 Chemical Manufacturers 

### EPA acquired chemical producer information for each of the 23 chemical substances from submissions required by the TSCA Inventory Update Reporting (IUR) Revisions rule (70 FR 75059, December 19, 2005)

. The IUR rule requires manufacturers and importers of certain chemical substances contained in the TSCA Chemical Substances Inventory with a site

- specific production /import volume of 25 ,000 pounds or more to report current data on their production volumes, plant sites, and other information related to the manufacture of the chemicals. Since 1986, reporting under the IUR rule has taken place at four

- year intervals

. 4



### Manufacturers were included in this analysis if they reported, through IUR, any production volume for any of th e chemicals regulated under this proposed HPV Chemical test rule (U.S. EPA, 2009d). The data presented i n this chapter are from the 2006 reporting cycle, which covers production in calendar year 2005 , and represent the most recent data available

.

Based on IUR reporting, EPA identified 48 unique sites that produce the 23 chemicals included in the proposed test rule. This figure may not include all potentially affect ed entities because, for example, companies that manufactured or imported less than 25,000 pounds of a subject chemical at an individual site in 2006 are not required to comply with IUR reporting. Further, the data are from 2006 and may not be current. The refore, EPA investigated other sources to obtain manufacturer information.

4 The 2005 amendments to the IUR rule changed the reporting cycle from four years to five years; the next reporting cycle will cover calendar year 2010.

Note: IUR rule submissions can include both confidential business information (CBI) and non - confidential information related to producers and production volumes. Manu facturer’s identities and production volumes used in calculations for this analysis were considered CBI; however, this report presents those data in a non

- CBI format.

### 2

- 5 The Directory of World Chemical Producers is a database containing over 18,000 worldwide producers of more than 150,000 chemicals, used to search for producers of chemicals and bul k pharmaceuticals. EPA used the directory to identify any U.S. producers of the 23 chemicals subject to the proposed test rule that were not already identified based on IUR reporting . This resulted in an additional 2 3 sites producing one or more of the sub ject chemicals (DWCP, 2009)

. EPA believes these figures present a reasonable estimate for the purpose of analyzing the effects of the proposed rule.

2.2.2 Chemical Proces s ors 

### According to the proposed rule, processors of the subject chemicals are assigned “Tier 2” status, meaning they are “persons not initially required to comply.” Therefore, w hile they would legally be subject to the proposed test rule, processors of a subject chemical would be required to comply with the requirements of the rule only if they a re directed to do so by EPA in a future Federal Register notice

. Because the proposed rule requires only that the required test results be obtained once for each chemical, EPA would only require processors to test if no manufacturer has submitted a notice of its intent to conduct testing, or if a problem occurs with the initiation, conduct, or completion of the required testing or the submission of the required data to EPA. Because EPA has identified at least one manufacturer for each subject chemical, the Agency assumes that, for each chemical substance in this proposed rule, at least one such person will submit a letter of intent to conduct the required testing and that person will conduct such testing and will submit the test data to EPA. Because process ors would not need to comply with the proposed rule initially, this economic analysis does not address processors.



### 2.3 Chemical Production Information
Production volume data are used in Chapter 7 to estimate the share of complianc e costs associated with each producer, in order to compare it with the company’s revenue. Production volume was acquired for each of the 23 chemical substances from submissions required by the TSCA IUR rule. Production volume for each of the additional man ufacturers identified through the DWCP was not available

. Because these manufacturers did not report through IUR requirements, EPA assumes that the production volume at these companies is less than the 25,000

- lb reporting threshold , and conservatively (i.e ., to provide an upper bound cost estimate for these companies) estimates a production volume of 24,999 pounds

. The distribution of chemicals included in the proposed rule by the publicly available aggregated national production volume range ( U.S. EPA, 20 10a) is illustrated in Exhibit 2

- 2 . As shown, approximately 83 percent of the chemicals included in the proposed rule are produced in volumes of 10 million pounds or less annually.

### 2

- 6 Exhibit 2
- 2 : Distribution of Production Volumes for Chemicals Included in the Proposed Rule (as reported through the 2006 IUR)

Source: Publicly available IUR data ( U.S. EPA, 20 10a)


### 2.4 Chemical

- Specific Us e and Market Information
This sect ion presents use information for each of the chemicals included in the proposed test rule. To find information on chemical uses, EPA relied on readily available secondary sources. This section is meant to provide a broad overview of uses and , due to resour ces available, is not expected to be a complete, exhaustive review. EPA was able to obtain use information for 21 of the 2 3 chemicals using various
sources
. Chemical use information is presented in Exhibit 2

- 3

. Publicly available data reported to EPA through the IUR rule reporting requirements (2006 reporting cycle) are also shown. 0 2 4 6 8 10 12 14 16 18 20

1M to <10M 10M to <50M 50M to <100M 100M to <500M 500M to <1,000M Production Volume (lbs)Number of Chemicals

### 2

- 7 Exhibit 2
- 3 : Chemical Use Information Chemical (CASRN) Use s IUR
- Reported Use Information
1 Glycine (56

- 40

- 6) • s weetener and flavor enhancer in food, beverage, pharmaceutical, and animal feed products • b uffering agent in certain products and manufacturing proce sses including organic, pharmaceutical synthesis • a ntacids, parenteral nutrition • b iochemical research • c osmetics, personal care products • d ietary supplement • m etal finishing ( U.S. ITC, 2007; U.S. NLM, 2009b; U.S. H H S, 2009 ) • Industrial S ectors: All Other Chemical Product and Preparation Manufacturing; c attle r anching and f arming, including f eedlots • Commercial/Consumer Product Category: Other

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

- hexachloro

- (67

- 72

- 1) • l ubricating greases and oils • n onstructural caulking compounds and sealants • l aundry aids, including ironing aids and dry cleaning • p yrotechnics • f ire extinguishing fluids, flameproofing • p olymer additive • p lasticizer for cellulose esters • i nsec ticide and moth repellant • a nthelmintic drug • r ubber process solvent • c amphor substitute in nitrocellulose solvent • r etardant in fermentation process • m etallurgy for refining aluminum alloys, removing impurities from molten metals, recovering metal fr om ores or smelting products • d egassing agent for magnesium • p roduction of synthetic diamonds (Scorecard, 200 9a; U.S. NLM , 2009b) • None reported

3 Plumbane, tetraethyl

- (78

- 00

- 2) • a n tiknock additive in leaded gasoline • e ngine lubricant (U

. S

. NLM , 2009b ) • Industrial S ector: Petroleum Refineries • Commercial/Consumer Product Category: Lubricants, greases and fuel additives 4 1H

- Benzotriazole (95

- 14

- 7) • c orrosion inhibitor in auto radiator fluids, metalworking fluids, water

- cooling systems ; for copper, brass, and bronze; anticorrosive in art restoration • p olishing preparations and related products; tarnish pr evention and remover, dishwashing detergents • r ug and upholstery cleaners • p rotective coating in construction industry • a ntifreeze, cleaners, packaging materials • r estrainer, developer, and antifogging agent in photographic emulsions • c omponent of mil itary aircraft deicing fluids • a ntimicrobial in cosmetics • c hemical intermediate for dyes, pharmaceuticals, and fungicides (Scorecard , 2009b; U.S. NLM , 2009b; Milne , 2005) • Industrial S ecto r: Other Apparel Knitting Mills • Commercial/Consumer Product Category: Lubricants, greases, and fuel additives; Metal products; Other

### 2

- 8 Exhibit 2
- 3 : Chemical Use Information Chemical (CASRN) Use s IUR
- Reported Use Information 5 2H

- 3,1

- Benzoxazine

- 2,4(1H)

- dione (118

- 48

- 9) • c hemical intermediate for pesticides, saccharin, flavors, fragrances, polyurethane diamine curing agents, pigments, dyes, intumescent agents, antioxidants, optical brighteners, anthranilate esters, anthranilic acid and amides, viscosity stabilizers, photographic chemicals, epoxy c uring agents • c orrosion inhibitor in engine lubricants • m odifier of natural and synthetic polymers and resins • b lowing agent for foamed plastics (U

. S

. NLM , 2009b; PMC Specialties Group, Inc., 2009a ) • Industry S ector: Other Basic Organic Chemical Manufa cturing; Pesticide and Other Agricultural Chemical Manufacturing • Commercial/Consumer Product Category: Agricultural products (non

- pesticidal)

6 1,2

- Benzisothiazol

- 3(2H)

- one, 1,1

- dioxide, sodium salt (1:1) (128

- 44

- 9) • no n - caloric sweetener • p ersonal care products, such as cologne, toothpaste • c hemical intermediate for pharmaceuticals, agricultural chemicals • m etal coatings ( Scorecard, 2009c, U.S. H H S, 2009; IARC, 1999; PMC Speci alties Group, Inc. , 2009b; Attarzadeh et al., 2008 ) • Industrial Sectors: Animal Food Manufacturing; Coating, Engraving, Heat Treating, and Allied Activities; Flavoring Syrup and Concentrate Manufacturing; Pharmaceutical and Medicine Manufacturing; Tobacco Product Manufacturing; Toilet Preparation Manufacturing; Other Basic Organic Chemical Manufacturing • Commercial/Consumer Product Category: Other 7 Glycine, N

- (carboxymethyl)

- , sodium salt (1:2) (928

- 72

- 3) • u sed to produce glyphosphate which is used in pesticide production (China Chemical Reporter, 2010) **•** Industrial Sector: Pesticide and Other Agricultural Chemical Manufacturing

**•** Commercial/Consumer Product Category: None reported 8 Phosphonic acid, dibutyl ester (1809

- 19

- 4) • antioxidant • i ntermediates in the formation of extreme pressure antiwear and friction modifier additives and lubricating oils and greases • a mine salts in mineral and synthetic base stocks (U

. S

. NLM , 2009b; Milne , 2005) • Industr y Sector: Other Basic Organic Chemical Manufacturing • Commercial/Consumer Product Category: Reported as CBI

9 2,5

- Furandione, 3

- (dodecen

- 1

- yl)dihydro

- (25377

- 73

- 5) • c uring agent in epoxy resins systems, including for elec tron microscopy • i ntermediate for the preparation of imides in lubricating oils; fuel/grease additive (Dixie Chemical Company, 2007; E lectron M icroscopy Sciences, 2007) • Industrial Sector: Petrochemical Manufacturing • Commercial/Consumer Product Categ ory: Other

10 2,5

- Furandione, dihydro

- 3

- (tetrapropenyl)

- (26544

- 38

- 7) • c orrosion inhibitor • v isco s ity improver in lubricants • g elling agent in greases • e poxy resin curing agent • a lkyd resin modifier • b rake fluids • s urfactant • c hemical intermedia te for esters, amides, imides, etc. (Trigon Chemie GmbH , 2006 ) • Industrial S ector s : Other Basic Organic Chemical Manufacturing; All Other Chemical Product and Preparation Manufacturing; Synthetic Dye and Pigment Manufacturing • Commercial/Consumer Product Category: Lubricants, greases and fuel additives; Paints and coatings. 11 Butanedioic acid, 2

- (tetrapropenyl)

- (27859

- 58

- 1) • f uel additive • r ust inhibitor ( EPO, 1998; U.S. PTO , 1995 ) • Industrial Sector: All Other Chemi cal Product and Preparation Manufacturing • Commercial/Consumer Product Category: Lubricants, greases and fuel additives

### 2

- 9 Exhibit 2
- 3 : Chemical Use Information Chemical (CASRN) Use s IUR
- Reported Use Information
12 2,5

- Furandione, dihydro

- 3

- (octadecen

- 1

- yl)

- (28777

- 98

- 2) • antifreeze lubricant • engine oil lubricant additive • viscosity and po ur - point improver • epoxy • intermediate in alkaline paper sizing • copy paper • gypsum board sheets • water treatment • corrosion inhibitor • surfactant intermediate • moisture control for leather goods (Dixie Chemical Company, 2005a ; Albemarle , 2005a ) • Industry Sectors: Paper Mills; All Other Chemical Product and Preparation Manufacturing; Petrochemical Manufacturing • Commercial/Consumer Product Category: Paper products

13 1H

- Benzotriazole, 6 (or 7 )

- methyl

- (29385

- 43

- 1) • corro sion inhibitors in auto radiator fluids, metalworking fluids, lubricants, antifreeze, paints, petroleum fuels, industrial water cooling, plating baths • corrosion inhibitor for copper, brass, bronze, ferrous metals • gasoline antiknock additive • biocide

• chelating agent • stabilizer for polyurethane prepolymers • antioxidant • styrene polymerization catalyst • intermediate for dyes, agricultural chemicals, ultraviolet light absorbers and pharmaceuticals (Scorecard, 200 9d; PMC Specialties Group, Inc., 2009 c ) • Industry Sectors: Other Apparel Knitting Mills; Other Petroleum and Coal Products Manufacturing • Commercial/Consumer Product Category: Lubricants, greases and fuel additives

14 2,5

- Furandione, 3

- (hexadecen

- 1

- yl)dihydro

- (32072

- 96

- 1) • antifreeze lu bricant • engine oil lubricant additive • viscosity and pour

- point improver • epoxy • intermediate in alkaline paper sizing • copy paper • gypsum board sheets • water treatment • corrosion inhibitor • surfactant intermediate • moisture control for leather goods (Dixie Chemical Company, 2005b ; Albemarle , 2005b ) • Industry Sectors: Paper Mills; Petrochemical manufacturing • Commercial/Consumer Product Category: Paper products

15 Quaternary ammonium compounds, benzylbis (hydrogenated tallow alkyl) dimethyl, chlorides (61789

- 73

- 9) • inert ingredient in nonfood use pesticide products • antistatic • hair conditioning • surfactant (U.S. EPA, 2009b, EU Commission, 2009) • Industry S ector: Other Nonmetallic Mineral Mining and Quarr ying • Commercial/Consumer Product Category: None reported

16 1H

- Benzotriazole, 6 (or 7 )

- methyl

- , sodium salt (64665

- 57

- 2) • cooling water treatment • automotive radiator treatment fluid, engine coolant • corrosion inhibitor • metalwo rking coolant • antifreeze • aircraft de

- icing fluids (Berryman Products , Inc. , 2001; Coolant Control, Inc., 2007; Penray Cmpanies, Inc., 1991; Drew Chemical, 1987; Pitt Penn Oil Company, 1997; 4

- Tek Industries, Inc., 1991) • Industry Sector: Invalid data provided • Commercial/Consumer Product Category: Other

### 2

- 10 Exhibit 2
- 3 : Chemical Use Information Chemical (CASRN) Use s IUR
- Reported Use Information
17 Naphthenic acids, reaction products with diethylenetriamine (68131

- 13

- 5) • corrosion inhibitor and anti

- foulant in refinery systems and petrochemical industry (U.S PTO, 1985; U.S. PTO, 1989; U.S. PTO, 1992) • Industry Sector: N one reported • Commercial/Consumer Product Category: None reported

18 Fatty acids, tall

- oil, reaction products with diethylenetriamine, acet ates (68153

- 60

- 6) • f ood fortification • i ntermediate to corrosion inhibitors • s urface

- active polymers used to control and stabilize dispersion (B e rry , 2010 ; Kurz i n , 2009 ; Fis c her and Parker, 1997) • Industry Sector: Oil and Gas Extraction; Other Basic Organic Chemical Manufacturing • Commercial/Consumer Product Category: None reported 19 Quaternary ammonium compounds, benzyl

- C12

- 16

- alkyldimethyl, chlorides (68424

- 85

- 1) • m icrobiocide, disinfectant, sanitizer (Scorecard, 200 9e; U.S. HHS, 2009 ) • Industry Sector: Other Basic Organic Chemical Manufacturing • Commercial/Consumer Product Category: Other 20 2

- Butenediamide, (2E)

- , N1,N4

- bis[2

- (4,5

- dihydro

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- yl)ethyl] derivs. (68442

- 77

- 3) **•** no use information found • Industry Sector: Reported as CBI • Commercial/Consumer Product Category: None reported

21 Quaternary ammonium compounds, (oxydi

- 2,1

- ethanediyl)bis[coco alkyldimethyl, dichlorides (68607

- 28

- 3) • microbiocide • corrosion inhibitor (PAN, 2009; Baker Petrolite, 2009) • Industry Sectors: Other Basic Organic Chemical Manufacturing • Commercial/Consumer Product Category: Other

22 Pyridinium, 1

- (phenylm ethyl)

- , Et Me derivs., chlorides (68909

- 18

- 2) • water soluble and/or oil dispersible corrosion inhibitors for oil field and other water treating systems (Lonza, 2009) • Industry Sectors: Oil and Gas E xtraction; Other Basic Organic Chemical Manufacturing • Commercial/Consumer Product Category: Other 23 Benzene, decylphenoxy

- (69834

- 17

- 9) • n o use information found • Industry Sector: All Other Chemical Product and Preparation Manufacturing • Commercial/Consumer Product Category: Soaps and detergents

### 3

- 1 

# Chapter 3

– Tests Required by the Proposed Rule

3.1 Introduction The premise of the proposed rule is that basic toxicity information, comparable to that generated by the Screening Information Data Set (SIDS) Program of the Organisation for Economic Co

- operation and Development (OECD), can assist EPA and others with making an informed preliminary judgment about the hazards of HPV chemicals. EPA intends to make the information collected under the final rule available to the public, other Federal agencies, and any other interested parties on its website and in the public docket for the final rule. As appropriate, this information will be used to help ensu re a scientifically sound basis for risk assessment/management actions. This effort will serve to further the Agency’s goal of identifying and controlling human and environmental risks as well as providing greater protection and knowledge to the public.


### 3.2 Ty pes of Tes ts Required by EP A High Production Volume Tes t Rules The testing required under EPA’s proposed rule follows the SIDS model. The OECD HPV SIDS Program seeks information on the identity of each chemical; its uses, sources, and extent of exposure; p hysical and chemical properties; environmental fate; and certain limited toxicity data for humans and the environment. While SIDS is more comprehensive in data coverage than the requirements of the proposed rule (e.g., uses, sources, and extent of exposure ), it is not intended to describe a chemical thoroughly, but rather to provide enough information to support an initial (or screening

- level) assessment and to assign a priority for further work, if necessary. Included in the OECD HPV SIDS Program is the de velopment of test data, if such data are not already available, related to six health and environmental effect endpoints for international HPV chemicals: (1) acute toxicity; (2) repeat dose toxicity; (3) developmental and reproductive toxicity; (4) genetic toxicity (gene mutations and chromosomal aberrations); (5) ecotoxicity (studies in fish, Daphnia, and algae); and (6) environmental fate (including physical/chemical properties). The test data identified under SIDS have been agreed upon by the 29 member c ountries of the OECD as providing the minimum data set required to make an informed preliminary judgment about the hazards of a given HPV chemical. Under the proposed test rule, EPA would require that the American Society for Testing and Materials (ASTM) or the TSCA test guidelines at 40 CFR part 799 ( § 799 guidelines) be used because the language in the § 799 guidelines makes clear which steps are mandatory and which steps are only recommended. EPA ’ s § 799 guidelines have been harmonized with the OECD guidel ines. Most of the proposed testing requirements for a particular endpoint are specified in one test standard. In the case of certain endpoints, however, any of multiple listed methods can be used. By using the same approach to testing as that of the OECD H PV SIDS Program, EPA is assuring that the data developed under this proposed rulemaking activity and the voluntary HPV Challenge Program will be comparable to the data being developed in other countries, thereby enabling an international sharing of data an d the prevention of unnecessary and duplicative testing.
Exhibit 3

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

.

### 3

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

Protocol Name Protocol Number(s) Description Test Code (used in

this analysis) CATEGORY A: PHYSICAL/CHEMICAL PROPERTIES

Melting Point ASTM E 324

- 99 The melting point is the temper ature at which a substance transitions from the solid to liquid phase. The ASTM E 324

- 99 melting point test determines the initial and final melting points (melting range) of stable, crystalline organic solids whose melting points fall between 30 and 250°C

. A1

Boiling Point ASTM E 1719

- 05 The ASTM E 1719

- 05 boiling point test determines the boiling point and vapor pressure of pure liquids and azeotropes (i.e., mixtures of two chemicals that boil at a unique temperature) that are condensable at total reflux and boil in between 12 and 302°C. A2

Vapor Pressure ASTM E 1782

- 03 The vapor pressure indicates the tendency of a solid or liquid to evaporate. The ASTM E 1782

- 03 vapor pressure test determines the vapor pressure of pure liquids or melted solids within t he temperature range 0°C to 500°C and the pressure range 5 kPa to 2000 kPa using differential thermal analysis, differential scanning calorimetry, or preferably high

- pressure versions of these instruments. A3

Partition Coefficient §799.6755; or ASTM E 11 47

- 92(2005); or §799.6756 The octanol/water partition coefficient (log K OW ) indicates how easily a compound might dissolve in water or in fat. The ASTM E 1147

- 92 partition coefficient test determines the logarithm of the log K OW of non

- ionizable and ioniza ble compounds by inputting the retention time on a liquid chromatographic column into an empirically derived equation. This information is used to assess the lipophilicity (i.e., the ability to dissolve in fat) of chemicals. A4

Water Solubility ASTM E 11 48

- 02; or §799.6784; or §799.6786 The physical property describing the ability of a given substance to dissolve in water is termed water solubility. The ASTM E1148

- 02 water solubility test determines the affinity of water

- and air

stable chemicals to water

. A5

CATEGORY B: ENVIRONMENTAL FATE AND PATHWAYS

Ready Biodegradation ASTM 1720

- 01, ISO 14593, ISO 7827, ISO 9408, ISO 9439, ISO 10707, or ISO 10708 The biodegradation test provides a measure of how quickly chemicals will be broken down in the environmen t by natural processes such as bacterial digestion. The ASTM E 1720

- 01 ready biodegradability test uses the generation of carbon dioxide by a dilute sewage inoculum as a proxy to determine the biodegradability of organic compounds in a closed vessel. Biode gradation of 60% or more during the closed vessel test indicates that in most environmental compartments the chemical’s biodegradation will go to completion. B

CATEGORY C: AQUATIC TOXICITY

Acute Toxicity to Fish ASTM E 729

- 96(2002) The ASTM E 729

- 96 ac ute toxicity test determines the concentration of chemical needed to reach a toxicity threshold in certain species of freshwater and saltwater fish. The standard thresholds used are the concentration at which there is a 50% fatality rate in the test organi sms (LC 50 ) or the concentration at which there is a 50% adverse effect response rate in the test organisms (EC 50 ) during 2

- to 8

- day exposures in either static (no replacement of toxicant), renewal (periodic replacement of toxicant), or flow

- through (conti nuous or intermittent replacement of makeup water and toxicant) conditions. Lower thresholds represent higher toxicity in the target organisms. C 1

Acute Toxicity to Daphnia ASTM E 729

- 96(2002) The ASTM E 729

- 96 acute toxicity test determines the concentr ation of chemical needed to reach a toxicity threshold in

### 3

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

Protocol Name Protocol Number(s) Description Test Code (used in

this analysis) Daphnia crustaceans. The standard thresholds used are the concentration at which there is a 50% fatality rate in the test organisms (LC 50 ) or the concentration at which there is a 50% adverse effect response rate in the test organisms (EC 50 ) during 2

- to 8

- day exposures in either static (no replacement of toxicant), renewal (periodic replacement of toxicant), or flow

- through (continuous or intermittent replacement of makeup water and toxicant) condit ions. Lower thresholds represent higher toxicity in the target organisms.

Acute Toxicity to Plants ASTM E 1218

- 04e1 The ASTM E 1218

- 04e1 toxicity test determines the concentration of chemical needed to reach a toxicity threshold in freshwater and saltwat er microalgae. The standard threshold used is the concentration at which there is a 50% 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(200 4) The ASTM E 1193

- 97 chronic toxicity test determines the concentration of chemical needed to reach a toxicity threshold in Daphnia magna Straus crustaceans. Exposures are conducted using flow

- through (continuous or intermittent replacement of makeup wate r and toxicant) methods and last over the life cycle of the organisms. CATEGORY D: MAMMALIAN TOXICITY

– ACUTE

Acute Inhalation Toxicity §799.9130 This test gives an indication of potential harm from inhaling a chemical compound. The standard test to m easure the acute inhalation toxicity of gases, volatile substances, and aerosols in mammals is defined in 40 CFR §799.9130. This test is conducted during a period of 24 hours or less using inhalation at no less than three dose levels (and a control, when u sing 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 relationshi p between dose level and effect should be made. This test can be used to determine a regimen of doses for longer

- term (i.e., subchronic and chronic) inhalation toxicity studies.

D

Acute Oral Toxicity ASTM E 1163

- 98(2002) or §799.9110(d)(1)(i)(A) This test gives an indication of harm from ingesting a chemical compound. The standard test to measure the acute oral toxicity of liquid or solid chemicals in mammals is defined in 40 CFR §799.9110. This test is conducted during a period of 24 hours or less using s ingle or multiple ingestion doses at no less than three dose levels (and a control, when using a vehicle other than water) in animals of both sexes. Occurrence, severity, and reversibility for as many behaviorally and clinically abnormal outcomes as possib le 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 stu dies.
BALB/c 3T3 Neutral Red Uptake Cytotoxicity; or N/A This test provides an indication of a chemical’s toxic effect on a cell, the basic building block of the body. The BALB/c 3T3 Neutral Red Uptake Cytotoxicity test determines the magnitude of cellul ar toxicity of water

- soluble chemicals on the BALB/c 3T3 mouse fibroblast cell line. Cell viability after short

- term (24 hour) in vitro

### 3

- 4 Exhibit 3
- 1 : Tests Required by EPA for HPV Chemicals, Based on the OECD ’s Screening Information Data Set (SIDS)

Protocol Name Protocol Number(s) Description Test Code (used in

this analysis) chemical exposure is measured using the cells’ ability to take up the Neutral Red dye as a proxy.

BHK Neutral Red Upta ke Cytotoxicity N/A This test provides an indication of a chemical’s toxic effect on a cell, the basic building block of the body. The BHK Neutral Red Uptake Cytotoxicity test determines the magnitude of cellular toxicity of chemicals on a baby hamster kid ney (BHK) fibroblast cell line. Cell viability after in vitro chemical exposures of unknown length is measured using the cells’ ability to take up the Neutral Red dye as a proxy. CATEGORY E: MAMMALIAN TOXICITY

– GENOTOXICITY

Bacterial Reverse Mutation § 799.9510 This test measures a chemical’s ability to change the genetic code of bacteria, which is an indicator of the chemical’s ability to change the genetic code of humans. The Bacterial Reverse Mutation test described in 40 CFR §799.9510 seeks to determ ine the existence of genotoxicity during chemical exposure using mutated Salmonella typhimurium and Escherichia coli bacterial cultures. Reversal of the test organism mutations (e.g., substitution, addition, deletion) by the test chemical after 48

- 72 hour in vitro chemical exposure is measured using the bacteria’s ability to synthesize specific amino acids as a marker. Positive results in this test are used to determine chemicals that should be further tested for carcinogenic, reproductive, and developmenta l effect potential. E1

Chromosome Aberration, in vitro ; or §799.9537 The in vitro Chromosome Aberration test described in 40 CFR §799.9537 seeks to determine whether chemical exposure causes chromosomal aberrations in primary cell cultures, such as Chines e hamster fibroblasts, human, or other mammalian peripheral blood lymphocytes. Generation of chromosomal aberrations such as polyploidy (excess chromosomes) or endoreduplication (duplication of the genome without mitosis) by the test chemical is measured u sing basic microscopy techniques after exposure. Positive results in this test are used to determine chemicals that should be further tested for carcinogenic, reproductive, and developmental effect potential.

E2 In Vivo Mammalian Cytogenetics Tests: Bone Marrow Chromosomal Analysis; or §799.9538 The in vivo Mammalian Bone Marrow Chromosomal Aberration test described in 40 CFR §799.9538 seeks to determine whether chemical exposure causes chromosomal aberrations in rodents, such as rats, mice, and Chinese ha msters. Generation of chromosome or chromatid aberrations such as polyploidy (excess chromosomes) or endoreduplication (duplication of the genome without mitosis) by the test chemical is measured using basic microscopy techniques. Positive results in this test are used to determine chemicals that should be further tested for carcinogenic potential, particularly in bone marrow.

Erythrocyte Micronucleus (bone marrow), in vivo §799.9539 The Mammalian Erythrocyte Micronucleus test described in 40 CFR §799.953 9 seeks to determine whether chemical exposure causes damage to the chromosomes or the mitotic apparatus of erythroblasts (immediate precursor to red blood cells) in the bone marrow of rodents, such as rats or mice. The proportion of immature erythrocytes among the total is measured using basic microscopy techniques, and a dose

- response relationship is investigated. Positive results in this test are used to determine chemicals that should be further tested for carcinogenic potential,

### 3

- 5 Exhibit 3
- 1 : Tests Required by EPA for HPV Chemicals, Based on the OECD ’s Screening Information Data Set (SIDS)

Protocol Name Protocol Number(s) Description Test Code (used in

this analysis) particularly with regar d to erythrocyte production. CATEGORY F: MAMMALIAN TOXICITY

– REPEATED DOSE/REPRODUCTION/DEVELOPMENTAL

Repeated Dose Oral Toxicity §799.9305 This test gives an indication of harm from ingesting a chemical compound. The standard test to measure the repea ted dose oral toxicity of liquid or solid chemicals in mammals is defined in 40 CFR §799.9305. The test should be conducted after the acute oral test described in 40 CFR §799.9110 in order to establish an appropriate dose range. This test is conducted duri ng a period of 14 or 28 days using multiple ingestion doses at no less than three dose levels plus a control (dose = 0) in animals (typically rodents) of both sexes. Occurrence and severity for as many behaviorally and clinically abnormal outcomes as possi ble should be catalogued during the experiment, and histopathological investigations are done on specific sets of organs.

F Repro/Devel Toxicity Screening §799.9355 These tests indicate the likelihood of a chemical to have an impact on the offspring of t hose exposed to the chemical. The standard test to measure the reproductive or developmental toxicity of chemicals in mammals is defined in 40 CFR §799.9355. Male animals are dosed for a minimum of 4 weeks with a schedule as follows: a minimum of 2 weeks p re - mating, during the mating period, and approximately 2 weeks post

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

- mating, time

- to

- conception, duration of pregnancy, and at least 4 days post

- delivery. Occurrence and severity of changes in gonadal function, mating behavior, conception, development of the conceptus, and parturition (birth) are catalogued during the experiment.

Combined Repeated Dose with Repro/Devel Toxicity Screen §799.9365 The standard test to measure the repr oductive or developmental toxicity of chemicals in mammals is defined in 40 CFR §799.9365. Male animals are dosed for a minimum of 4 weeks with a schedule as follows: a minimum of 2 weeks pre

- mating, during the mating period, and approximately 2 weeks post

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

- mating, time

- to

- conception, duration of pregnancy, and at least 4 days post

- delivery. Occurrence and severity for as many behaviorally and clinically abnormal outcomes as possible in the adult animals should be catalogued during the experiment, and histopathological investigations are done on specific sets of organs. Additionally, occurrence and severity of changes in gonadal function, mating behavior, conception, development of the conceptus, and parturition (birth) are catalogued during the experiment.

1 Aquatic Toxicity requirements include test codes C1, C2, C3, C4, C5, C6, and C7. These tests groups include various combinat ions of the four protocols listed in this table unde r the general test code “C”, depending on specific data needs. For more information, see Appendix A

.



### 3.3 Specific Tes t Requirements in the Propos ed Rule To determine which tests would be required for each chemical under the propo sed rule, EPA examined available test data (U.S. EPA, 2010b). Based upon this review, EPA is requiring testing only for those endpoints where data are unavailable or deemed inadequate. Tests required for each chemical included in the proposed rule are summ arized in Exhibit 3

- 2.

### 3

- 6 Exhibit 3
- 2 : Test Requirements for Chemicals Included in the Proposed Rule
CASRN Chemical Name Required Tests (See Test Codes in Exhibit 3
- 1) 1 56

- 40

- 6 Glycine A3 2 67

- 72

- 1 Ethan e , 1,1,1,2,2,2

- hexachloro

- C6 3 78

- 00

- 2 Plumbane, tetraethyl

- A4, A5, C6 , E2 4 95

- 14

- 7 1H

- Benzotriazole A3, C6, F4 5 118

- 48

- 9 2H

- 3,1

- Benzoxazine

- 2,4(1H)

- dione A3, A4, A5, C3, E1, E2, F1 6 128

- 44

- 9 1,2

- Benzisothiazol

- 3(2H)

- one, 1,1

- dioxide, sodium salt (1:1) A2, A3, A4, A5, C1, F1 7 928

- 72

- 3 Glycine, N

- (carboxymethyl)

- , so dium salt (1:2) A1, A3, A4, A5, B 8 1809

- 19

- 4 Phosphonic acid, dibutyl ester A1, A4, C1, E1, E2, F1 9 25377

- 73

- 5 2,5

- Furandione, 3

- (dodecen

- 1

- yl)dihydro

- A1, A2, A3, A 4, A5, B, C1, D, E2, F1 10 26544

- 38

- 7 2,5

- Furandione, dihydro

- 3

- (tetrapropenyl)

- A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 11 278 59

- 58

- 1 Butanedioic acid, 2

- (tetrapropenyl)

- A1, A2, A3, A4, A5, C1, D, E1, E2, F1 12 28777

- 98

- 2 2,5

- Furandione, dihydro

- 3

- (octadecen

- 1

- yl)

- A2, A3, A4, A5, C1, D, E1, E2, F1 13 29385

- 43

- 1 1H

- Benzotriazole, 6 (or 7 )

- methyl

- A3, A4, A5, E2, F1 14 32072

- 96

- 1 2,5

- Furandione, 3

- (hexadecen

- 1

- yl)dihydro

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

15 61789

- 73

- 9 Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides A3

16 64665

- 57

- 2 1H

- Benzotriazole, 6 (or 7 )

- methyl

- , sodium salt A1, A3, A4, A5, E1, E2, F1 17 68131

- 13

- 5 Naphthenic acids, reaction products with diethylenetriamine C1, D, E1, E2, F1

18 68153

- 60

- 6 Fatty acids, tall

- oil, reaction products with diethylenetriamine, acetates A1, A2, A3, A4, A5, B, C1, D, E1, E2, F1 1 9 68424

- 85

- 1 Quaternary ammonium compounds, benzyl

C12

- 16

- alkyldimethyl, chlorides A1, A2, A3

20 68442

- 77

- 3 2

- Butenediamide, (2E)

- , N1,N4

- bis[2

- (4,5

- dihydro

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- yl)ethyl] derivs. A1, A2, A3, A4, A5, B, C1, D, E1, E2 , F1

21 68607

- 28

- 3 Quaternary ammonium compounds, (oxydi

- 2,1

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

22 68909

- 18

- 2 Pyridinium, 1

- (phenylmethyl)

- , Et Me derivs., chlorides A1, A2, A3, A4, A5, C1, D, E1, E2, F1 23 69834

- 17

- 9 Benz ene, decylphenoxy

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

### 4

- 1 

# Chapter 4

– Industry Compliance Costs

4.1 Introduction This chapter presents estimates of the cost s that industry (chemical manufacturers and importers) affected by the proposed rule) may incur due to the requirements included in the proposed rule, and discusses the method used to measure each. Industry may incur costs related to laboratory testing req uirements (discussed in Section 4.2.1 ), analytical methodology validation (Section 4.2.2 ), administrative activities (Section 4.2.3 ), and export notification requirements (Section 4.2.4 ). Total industry compliance costs are summarized in Section 4.3 . Non

- monetized costs are described in Section 4.4

. 

### 4.2 Unit Cos ts The following sections describe, on a per

- unit basis, each of the types of costs that would be incurred by industry to comply with the proposed testing rule.

4.2.1 Laboratory Tes ting Cos ts **Individual Test Co st Estimates**  

### EPA obtained test cost estimates by contacting nine or fewer laboratories known to perform each test and requesting pricing information, or, when such direct estimates were not available, by obtaining a best professional estimation f rom indust ry experts. Although the rule requires that testing be conducted in accordance with the specified mandatory and enforceable r equirements in the ASTM or § 799 guidelines (see Section 3.2 ), the cost estimates used in this analysis may also be based on OECD or other EPA protocols, which are representative of the desired testing endpoint (as summarized in Exhibit 4

- 1 and discussed in more detail in Appendix A ). Testing cost estimates generally include direct labor, overhead, other direct costs such as laboratory supplies, and general and administrative services. Estimating the potential testing costs for each chemical pursuant to requirements conta ined in the proposed rule is complicated in that industry may have choices associated with the species and/or route of administration used in a particular test, as well as choices between multiple tests to satisfy a particular endpoint testing requirement. Therefore, if cost data for a specific test protocol were available for multiple species and routes of administration, EPA used the average cost for all available species and routes of administration as the test cost estimate. In addition, EPA computed a “least cost” and an “average cost” scenario where multiple test protocols were available to satisfy a test requirement. The “least cost” scenario assumes that manufacturers will choose the least costly protocol when choices are available. While EPA does ex pect that manufacturers will choose the least expensive protocol, there may be cases where the manufacturer chooses an alternate test based on availability, suitability for a particular chemical, quality control reasons, or other factors unknown to EPA at this time. Therefore, the “average cost” scenario assumes that the manufacturer may choose any of the tests that fulfill the testing requirement, and is calculated as the average of all the available testing options’ costs.
Individual estimates of test co sts will vary across testing laboratories based upon factors such as labor costs, discounts provided to clients for volume testing, profit margins, and other testing. As described in Appendix A , in some cases, EPA has accommoda ted this variation by developing multiple estimates for a particular test and using the average of the estimates to represent the cost of the test.

### 4

- 2 Exhibit 4

- 1 presents the protocols required by the rule, the basis for the cost estimate, and final cost
e stimates used in the analysis.

Exhibit 4
- 1 : EPA Estimates of Laboratory Costs of Proposed Tests (2009$) Testing Category Test Code Protocol Name Required Protocol Number(s) Basis for Cost Estimate Cost Es timate

2009$ 1

Physical/Chemic

al Properties A1 Melting Point ASTM E 324

- 99 OECD 102 (Least & Average Cost Scenarios) $1,000

A2 Boiling Point ASTM E 1719

- 05 OECD 103 (Least & Average Cost Scenarios) $2,000

A3 Vapor Pressure ASTM E 1782

- 03 OECD 104 (Leas t & Average Cost Scenarios) $17,000

A4 Partition Coefficient Method A: §799.6755 OECD 107 $7,000
Method B: ASTM E 1147

- 92(2005) OECD 117 $5,000 Method C: §799.6756 §830.7560 $7,000 Least Cost Scenario (Method B) $5,000 Average Cost Scena rio (Average of All Methods) $6,000

A5 Water Solubility Method A: ASTM E 1148

- 02; or Methods B or C: 799.6784 (shake flask and column elution); or Method D: 799.6786 OECD 105 (Least & Average Cost Scenarios) $10,000

Environmental Fate and Pathways B Rea dy Biodegradation Choice of: ASTM 1720 (sealed vessel CO2 production test), ISO 14593 (CO2 headspace test), ISO 7827 (analysis of DOC), ISO 9408 (determination of oxygen demand in a closed respirometer), ISO 9439 (CO2 evolution test), ISO 10707 (closed bot tle test), or ISO 10708 (two

- phase closed bottle test) OECD 301A

- F (Least & Average Cost Scenarios) $6,000

Aquatic Toxicity C1 (Test Group

1) Acute Toxicity to Fish ASTM E 729

- 96(2002) OECD 203 $12,000 Acute Toxicity to Daphnia ASTM E 729

- 96(2002) OEC D 202 (Part 1) $6,000 Acute Toxicity to Plants ASTM E 1218

- 04e1 OECD 201 $10,000 Test Group 1 Sum $28,000
(Test Group

2) Chronic Toxicity to Daphnia ASTM E 1193

- 97(2004) OECD 202 $130,000 Acute Toxicity to Plants ASTM E 1218

- 04e1 OECD 201 $ 10,000 Test Group 2 Sum $140,000 Least Cost Scenario (Test Group 1 Sum) $28,000

### 4

- 3 Exhibit 4
- 1 : EPA Estimates of Laboratory Costs of Proposed Tests (2009$) Testing Category Test Code Protocol Name Required Protocol Number(s) Basis for Cost Estimate Cost Es timate

2009$ 1 Average Cost Scenario (Average of Test Group 1 and 2 Sums) $84,000

C2 (Test Group

1) Acute Toxicity to Daphnia ASTM E 729

- 96(2002) OECD 202 (Part 1) $6,000
Acut e Toxicity to Plants ASTM E 1218

- 04e1 OECD 201 $10,000 Test Group 1 Sum $16,000
(Test Group

2) Chronic Toxicity to Daphnia ASTM E 1193

- 97(2004) OECD 202 $130,000 Acute Toxicity to Plants ASTM E 1218

- 04e1 OECD 201 $10,000 Test Group 2 Sum 140 ,000 Least Cost Scenario (Test Group 1 Sum) $16,000 Average Cost Scenario (Average of Test Group 1 and 2 Sums) $78,000

C3 (Test Group 1) Acute Toxicity to Fish ASTM E 729

- 96(2002) OECD 203 $12,000 Acute Toxicity to Plants ASTM E 1218

- 04e1 OECD 201 $10,000 Test Group 1 Sum $22,000

(Test Group 2) Chronic Toxicity to Daphnia ASTM E 1193

- 97(2004) OECD 202 $130,000 Acute Toxicity to Plants ASTM E 1218

- 04e1 OECD 201 $10,000 Test Group 2 Sum $140,000 Least Cost Scenario (Test Group 1 Sum) $22,000 Average Cost Scenario (Average of Test Group 1 and 2 Sums) $81.000

C4 (Test Group 1) Acute Toxicity to Fish ASTM E 729

- 96(2002) OECD 203 $12,000 Acute Toxicity to Daphnia ASTM E 729

- 96(2002) OECD 202 (Part 1) $6,000 Test Group 1 Sum $18,000 (Test Group 2) Chronic Toxicity to Daphnia ASTM E 1193

- 97(2002) OECD 202 $130,000 Least Cost Scenario (Test Group 1 Sum) $18,000 Average Cost Scenario (Average of Test Group 1 and 2 Sums) $74,000

C5 (Test Group 1) Acute Toxicity to D aphnia ASTM E 729

- 96(2002) OECD 202 (Part 1) $6,000 (Test Group 2) Chronic Toxicity to Daphnia ASTM E 1193

- 97(2004) OECD 202 $130,000 Least Cost Scenario (Test Group 1) $6,000 Average Cost Scenario (Average of Test Group 1 and 2) $68,000

C6 Acu te Toxicity to Plants ASTM E 1218

- 04e1 OECD 201 (Least & Average Cost Scenarios) $10,000

C7 (Test Group

1) Acute Toxicity to Fish ASTM E 729

- 96(2002) OECD 203 $12,000 (Test Group

2) Chronic Toxicity to Daphnia ASTM E 1193

- 97(2004) OECD 202 $130,000 Least Cost Scenario (Test Group 1) $12,000 Average Cost Scenario (Average of Test Group 1 and 2) $71,000

### 4

- 4 Exhibit 4
- 1 : EPA Estimates of Laboratory Costs of Proposed Tests (2009$) Testing Category Test Code Protocol Name Required Protocol Number(s) Basis for Cost Estimate Cost Es timate

2009$ 1

Mammalian Toxicity

- Acute D (Method A) Acute Inhalation Toxicity 799.913 OECD 403 $27,000

(Method B) Acute Oral Toxicity ASTM E 1163

- 98(2002) or §799.9110(d)(1)(i)(A) OECD 423 $4,000 BALB/c 3T3 Neutral Red Uptake Cytotoxicity; or N/A N/A $4,000

BHK Neutral Red Uptake Cytotoxicity N/A N/A $5,000 Least Cost Scenario (OECD 423 + least expensive cytotoxicity test) $8,000 Average Cost Scenario (Average of Method A and Least Cost Scenario) $17,000

Mammalian Toxicity

– Genotoxicity E1 Bacterial Reverse Mutation §799.9510 OECD 471 (Least & Average Cost Scenarios) $5,000

E2 Chromosome Aberration, in vitro; or §799.9537 OECD 473 $28,000

In Vivo Mammalian Cytogenetics Tests: Bone Marrow Chromosomal Analysis; or §799.9538 N/A $33,000

Erythrocyte Micronucleus (bone marrow), in vivo §799.9539 OECD 474 $23,000 Least Cost Scenario (OECD 474) $23,000 Average Cost Scenario (Average o f E2 Methods) $28,000

Mammalian Toxicity

– Repeated Dose/

Reproduction/ Developmental F1 (Method A) Repeated Dose Oral Toxicity; and, §799.9305 OECD 407 $85,000 Repro/Devel Toxicity Screening; or, §799.9355 OECD 421 $129,000
Method A Sum $214,000 (Method B) Combined Repeated Dose with Repro/Devel Toxicity Screen §799.9365 OECD 422 $135,000
Least Cost Scenario (Method B) $135,000 Average Cost Scenario (Average of Method A Sum and Method B) $175,000

F2 Repro/Devel Toxicity Screening §799. 9355 OECD 421 (Least & Average Cost Scenarios) $129,000

F3 Repeated Dose Oral Toxicity §799.9305 OECD 407 (Least & Average Cost Scenarios) $85,000

F4 Repro/Devel Toxicity Screening; or, §799.9355 OECD 421 $129,000

### 4

- 5 Exhibit 4
- 1 : EPA Estimates of Laboratory Costs of Proposed Tests (2009$) Testing Category Test Code Protocol Name Required Protocol Number(s) Basis for Cost Estimate Cost Es timate

2009$ 1 Combined Repeated Dose with Repro/ Devel Toxicity Screen §799.9365 OECD 422 $135,000

Least Cost Scenario ( Repro/Devel Toxicity Screening) $129,000 Avera ge Cost Scenario (Average of Methods) $132,000

1 Test costs were estimated in different years, so EPA used the Employment Cost Index (ECI) Current

- Dollar Historical Listing from the Bureau of Labor Statistics (BLS, 20 10b ), U.S. Department of Labor, to convert all test cost estimates to 2009$. Note: Values may not sum due to rounding.

**Total Test Costs per Chemical** 

### The proposed rul e requires only that the required test results be obtained once for each chemical; each entity is not required to do the tests separately. Typically, manufacturers form a consortium through a common trade organization to coordinate any testing required by TSCA Section 4. Therefore, in order to obtain the total test costs under the proposed rule, EPA assumes that a required test will be performed only once per chemical. The costs of the tests required for each chemical were summed for all the chemicals, and then the total cost per chemical was summed across all chemicals included in the proposed rule. Exhibit 4

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

### 4

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

CASRN Chemical Name Laboratory Testing Cost (Test Requirements as listed in Exhibit 3
- 2 )
Least Cost Scenario Average Cost Scenario 1 56

- 40

- 6 Glycine $17,000 $17, 000 2 67

- 72

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

- hexachloro

- $10,000 $10,000 3 78

- 00

- 2 Plumbane, tetraethyl

- $47,000 $54,000 4 95

- 14

- 7 1H

- Benzotriazole $156,000 $159,000 5 118

- 48

- 9 2H

- 3,1

- Benzoxazine

- 2,4(1H)

- dione $216,000 $321,000
6 128

- 44

- 9 1,2

- Benzisothiazol

- 3( 2H)

- one, 1,1

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

7 928

- 72

- 3 Glycine, N

- (carboxymethyl)

- , sodium salt (1:2) $39,000 $40,000
8 1809

- 19

- 4 Phosphonic acid, dibutyl ester $197,000 $299,000
9 25377

- 73

- 5 2,5

- Furandione, 3

- (dodecen

- 1

- yl)dihydro

- $234, 000 $346,000

10 26544

- 38

- 7 2,5

- Furandione, dihydro

- 3

- (tetrapropenyl)

- $239,000 $351,000
11 27859

- 58

- 1 Butanedioic acid, 2

- (tetrapropenyl)

- $233,000 $345,000
12 28777

- 98

- 2 2,5

- Furandione, dihydro

- 3

- (octadecen

- 1

- yl)

- $231,000 $343,000
13 29385

- 43

- 1 1H

- Be nzotriazole, 6 (or 7 )

- methyl

- $189,000 $236,000
14 32072

- 96

- 1 2,5

- Furandione, 3

- (hexadecen

- 1

- yl)dihydro

- $239,000 $351,000

15 61789

- 73

- 9 Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides $17,000 $17,000

16 64665

- 57

- 2 1H

- Benzotriazole, 6 (or 7 )

- methyl

- , sodium salt $196,000 $242,000

17 68131

- 13

- 5 Naphthenic acids, reaction products with diethylenetriamine $198,000 $309,000

18 68153

- 60

- 6 Fatty acids, tall

- oil, reaction products with diethylenetriamine, acetates $239,000 $ 351,000

19 68424

- 85

- 1 Quaternary ammonium compounds, benzyl

- C12

- 16

- alkyldimethyl, chlorides $20,000 $20,000

20 68442

- 77

- 3 2

- Butenediamide, (2E)

- , N1,N4

- bis[2

- (4,5

- dihydro

- 2

- nortall

- oil alkyl

- 1H

imidazol

- 1

- yl)ethyl] derivs. $239,000 $351,000

21 68607

- 28

- 3 Quaternary ammonium compounds, (oxydi

- 2,1

- ethanediyl)bis[coco alkyldimethyl, dichlorides $34,000 $36,000

22 68909

- 18

- 2 Pyridinium, 1

- (phenylmethyl)

- , Et Me derivs., chlorides $233,000 $345,000
23 69834

- 17

- 9 Benzene, decylphenoxy

- $239,000 $351,000 TOT AL $3,654,000 $5,182,000 AVERAGE $159,000 $225,000 Note: Values may not sum due to rounding.



### As show n in Exhibit 4

- 2 , the total laboratory cost for testing the chemicals included in the proposed rule is es timated to range from approximately $3. 65 million under the least cost scenario to approximately

### 4

- 7 $ 5. 18 million under the average cost scenario . These estimates may overstate the true testing burden because they are based on the assumption that each chemica l 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 sam e time), testing costs could be lower due to economies of scale (for example, the test’s quality control procedures can be performed by batch, making the per

- chemical cost lower). Dividing these totals by the 23 chemicals in the proposed rule yields an average laboratory test cost per chemical of approximately $ 1 5 9 ,000 under the lea st cost scenario and approximately $ 2 2 5 ,000 under the average cost scenario.

4.2.2 An alytical Methodology Validation Cos ts 

### When conducting tests, laboratories perform analytical methodology validation to ensure that proper dose concentrations are used in toxicit y studies. Analytical methodology validation costs are passed on to the company requesting the test, and are therefore part of the total industry cost. An analytical methodology validation approach assumes that an acceptable analytical method is available for a particular chemical and that the method is directly related to the matrix used for the test. When analytical methodologies are not suitable or known, they must be developed or modified. Analytical method ology validation includes all of the procedure s that demonstrate that a particular method used for quantitative measurement of analytes in a given matrix is reliable and reproducible for the intended use. The fundamental parameters for this validation include (1) accuracy, (2) precision, (3) selectivi ty, (4) sensitivity, (5) reproducibility, and (6) stability. Validation involves documenting that through the use of specific laboratory investigations, the performance characteristics of the method are suitable and reliable for the intended analytical app lications. The acceptability of analytical data corresponds directly to the criteria used to validate the method. Factors that may increase the cost of analytical method ology development and validation costs include (1) testing new chemicals that lack any established methodology or historical analytical data to use as a starting point, and (2) testing chemicals that present challenging conditions or possess characteristics that require special or additional procedures during sample preparation and analysis. If previous testing on a chemical of interest has been conducted by either a laboratory or client, information may be available that can assist with sample preparation and analytical testing. This can help to minimize the costs of method development and v alidation. Analytical method development and validation costs can also vary depending on characteristics of the test substance. Characteristics of chemicals that may impact the cost of analytical method development and validation include chemical stabilit y, chemical properties, matrix properties and interactions with the chemical, and whether the chemicals are mixtures or multi

- component chemicals or polymers. For example, chemicals are not always stable under every test or analysis condition, and a chemic al 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 fo r 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 tha t can impact the level of method development efforts. Once analytical methodology validation is completed for a specific chemical, however, it need not be repeated for tests of a similar nature (e.g., tests using the same dosing matrix), provided testing is done at the same laboratory. However, it is possible that analytical methodology validation may be required for both short

- term and long

- term tests where there are separate requirements for dose concentration ranges (e.g., parts per million for acute te sts and parts per billion for chronic tests). In this analysis, the cost of analytical methodology validation is counted only once per testing category (i.e., not per test), for each

### 4

- 8 chemical. For example, if the rule requires both tests E1 and E2 (multip le tests in the same testing category) for a specific chemical, the analytical methodology validation cost for test category E is only counted once, not twice, in determining the total cost of the rule for that chemical. For this proposed rule, EPA has a ssumed an exposure concentration in the parts per billion range requiring multi

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

- pressure liquid spectroscopy, resulting in an estimated analytical method vali dation cost ranging from $2,500 to $10,000. For the purpose of this analysis, a cost of $3,500 has been assigned for short

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

- term tests (genotoxicity and reprodu ctive/developmental toxicity), as shown in Exhibit 4

- 3

.
Exhibit 4
- 3 : Costs for Analytical Methodology Validation, per Test Category Testing Category Test Symbol Cost Estimate Physical Chemical Properties A no additional costs Environmental Fate and Pathways B no additional costs

Aquatic Toxicity C Test Group 1 $3,500 Test Group 2 $8,500 Test Group 1 and 2 Average $6,000 Mammalian Toxicity

- Acute D $3,5 00 Mammalian Toxicity

- Genotoxicity E $ 8 ,500 Mammalian Toxicity

– Repeated Dose/

Reproduction/ Developmental F $ 8 ,500

4.2.3 Ad minis trative Cos ts 

### In addition to laboratory costs, chemical manufacturers/importers subject to the proposed test rule will also in cur expenses associated with the administration of the testing program itself. Administrative activities include “reporting activities,” such as preparing letters of intent, study plans, exemption applications, and final reports, and “non

- reporting activit ies,” such as soliciting laboratory bids, selecting laboratories, monitoring tests under progress, developing cost

- sharing agreements, and auditing the laboratories for compliance with EPA’s Good Laboratory Practice (GLP) standards. Total administrative
co sts 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 o f intent, study plans, final reports, robust summaries , and exemption applications

. Letters of Intent and Study Plans. The analysis assumes that one letter of intent and one study plan will be submitted per chemical, resulting in 23 letters of intent and study plans submitted to EPA. Final Reports . O ne final report is assumed to be required for each test conducted for each chemical. To estimate the total number of final reports, the total number of tests required for each chemical is summed across all che micals, which results in an estimated 15 3 final reports that will be submitted to EPA in response to this rule.

### 4

- 9 Robust Summaries. R espondents are also required to d evelop and submit robust summaries of the full, final toxicological study reports. The robu st summaries should contain technical information to adequately describe the study and results, and should be written such that the information provided is sufficient to allow a technically qualified person to evaluate study results without needing to revi ew an entire study report. Typically, a robust summary would include a description of the test substance, methods, results, conclusions, data quality description, and references associated with the full study. The number of robust summaries will be the sam e as the number of final reports, 15 3

. Exemption Applications . As noted above, t he proposed rule requires only that the required test results be obtained once for each chemical; each manufacturer is not required to do the tests separately. Typically,
manu facturers form a consortium to coordinate any testing required by TSCA Section 4 . Therefore, following the methodology outlined in the Economic Assessment for the Proposed ATSDR Test Rule for Four Chemicals (U.S. EPA, 2006 ) , we assume that one member of th e consortium will submit the materials described above, and the others will submit exemption applications. Based on this assumption and the number of identified manufacturers for each chemical, EPA assumes that it will receive a total of 88 exemption reque sts. EPA estimates that it takes a respondent 40 hours to prepare a letter of intent and study plan, 73 hours to write a final report, and 2 hours to prepare an exemption application. These unit labor hours were derived from previous information collectio n requests and are believed to reflect the burdens that will be incurred for the proposed test rule (U.S. EPA, 2002 a ). Based on best professional judgment, EPA estimates that 8 to 16 hours of technical time are needed to develop and review a robust summary , depending on the type of study conducted. Therefore, for this analysis, EPA assumes an average of 12 hours of technical time to prepare a robust summary. Wage rates associated with the predominant skill level (managerial, technical, and clerical) require d to complete each of the reporting activities described in this section are presented in Exhibit 4

- 4 . These wage rates have been estimated following the method described in a memorandum titled, “Wage Rates for Eco nomic Analyses of the Toxics Release Inventory Program” ( U.S. EPA, 2002 a ). This method uses average December 2009 wages, benefits, and total compensation data extracted from the Employer Costs for Employee Compensation Summary available from the BLS Web si te

. Appendix B provides detailed information on the estimation of these wage rates.

Exhibit 4
- 4 : Derivation of Loaded Hourly Rates by Labor Category
Labor Category 2009 Wage Ra te 2009 Benefits and Overhead Loading Factor 2009 Loaded Hourly Wage Rate Managerial $42.36 1.61 $68.24 Technical $35.96 1.65 $59.49 Clerical $17.21 1.64 $28.31 Source: Methodology from “ Wage Rates for Economic Analyses of the Toxics Release Inven tory Program” ( U.S. EPA, 2002b). Wage rates and benefits extracted from the Employer Costs for Employee Compensation Summary, Bureau of Labor Statistics ( BLS, 2010 a ); assumed overhead rate of 17% applied to wage rates based on assumptions in U.S. EPA, 2002 b and U.S. EPA 2002a

. 

### Exhibit 4

- 5 details the respondents’ reporting cost and burden estimates. As shown, the total reporting cost and burden estimates are approximately $ 7 4 7 , 000 and 14 ,000 hours, respectively.

### 4

- 10 Exhibit 4
- 5 : Industry Reporting Cost and Burden Estimate for the Proposed Rule (2009$)
Reporting Activity Unit Labor Annual Items Submitted Total Category 1 Hours/ Item Wage Rate Cost/ Item Hours Cost Letter of Intent and Study Plan T 40 $59.49 $2, 000 23 920 $ 55,000 Final Report Record & Prepare Test for Submission Laboratory Review Corporate Review Type & Print Results Record Keeping T
T M C C 40
6 6 20 1 $59.49 $59.49 $68.24 $28.31 $28.31 $2, 000 $357 $409 $566 $28 15 3
15 3 15 3 15 3 15 3 6, 000
9 18 9 18 3, 000

15 3 $36 4 , 000 $5 5 ,000 $6 3 ,0 00 $8 7 , 000 $4, 000 Robust Summaries T 12 $59.49 $714 15 3 2,000 $ 10 9 ,000 Exemption Applications T 2 $59.49 $119 88 176 $10, 000 TOTAL 14, 000 $7 47 , 000 1 Labor categor ies are as follows: T = Technical; M = Managerial; C = Clerical. Note: Values may not sum due to rounding.



### Non

- Reporting Activities. In addition to reporting activities, manufacturers need to conduct a number of
non
- reporting activities. In January 2007 , EPA conducted a brief study to investigate the types of non

reporting activities manufacturers conduct and the magnitude of associated costs (U.S. EPA, 2007). The
non
- reporting activities identified include soliciting laboratory bids, selecting laborator ies, monitoring tests in progress, developing cost

- sharing agreements, and auditing the laboratories for compliance with EPA’s GLP standards. These activities, in addition to identifying manufacturers, arranging meetings, and employing toxicologists who ma y be hired to provide testing expertise for the testing, are considered to represent the costs of managing the testing consortium. While these costs will vary based on a number of circumstances, the report suggests that managing the testing consortium is e quivalent, on average, to 15 percent of the chemical testing costs, which is the assumption used in this analysis. Based on the study, an additional 10 percent of the testing costs are estimated to cover the costs of the technical expert who may work for t he 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 estima ted as $3. 65 million under the least cost scenario and $5. 18 million under the average cost scenario, non

- reporting costs are approximately $9 1 4 ,000 and $1. 30 million under the least and average cost scenarios, respectively.
Total Administrative Costs. As stated previously, total administrative costs pursuant to the proposed rule are estimated as the sum of reporting and non

- reporting costs. Thus, total administrative costs are estimated to be $1. 66 million under the least cost scenario and $2.0 4 million un der the average cost scenario.

4.2.4 Export Notification Cos ts 

### Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical subject to various TSCA sections (40 CFR §707.60 through 75). Therefore, all exporters of chemica ls regulated under the proposed rule must notify EPA about each country to which a chemical included in the proposed rule is shipped. This is a one

- time notification requirement, and the exporter needs to submit the notice only when it is exporting a parti cular chemical for the first time to a country for which it has not previously submitted a notification. Note that if any of the chemicals subject to this test rule are already subject to a TSCA regulation that triggers section 12(b), these costs will not be incurred again. Therefore, to the extent that any of the chemicals are already subject to section 12(b), the costs in this analysis are overestimated.

### 4

- 11 A detailed analysis of the impact of export notifications would require data on the identity and/or n umber of exporters exporting chemicals included in the proposed rule and the identity and/or number of countries to which each chemical included in the proposed rule is exported. While data on aggregate export volumes for various chemicals are published in U.S. Department of Commerce publications, detailed data identifying exporters and destination countries for all the chemicals included in the proposed rule are not readily available from secondary data sources. For this reason, it is difficult to estimate the number of export notifications that would be triggered by the promulgation of the proposed rule. Given these data limitations, the costs of export notifications for the proposed rule are based on data available from EPA’s Export Notifications Tracking System (U.S. EPA, 2004a). According to these data, EPA received approximately 786 export notifications associated with 30 unique chemicals. Therefore, on average, there were approximately 25 export notifications per chemical in 2003 that were related to T SCA Section 4. This analysis assumes that there will also be 25 export notifications per chemical subject to the proposed rule. In an economic analysis for a final rule promulgated under TSCA Section 12(b), ( U.S. EPA 1992a) estimated that the export notifi cation burden was 1.5 hours per notification letter. In particular, the analysis assumed that it takes 1 hour of technical time to write each export notification letter and 0.5 hours of clerical time to print and send out each letter. However, most of the repeat submissions received by EPA are only computer

- generated form letters ( U.S. EPA , 1999). While it might take 1 hour of technical time to prepare an initial letter, for subsequent submissions the analysis assumed that it would require only 0.5 hours of clerical time to reproduce the letter, based on the U.S. EPA (1992a) estimate for clerical time to print and send. Because notification letters are expected from both first

- time filers and more experienced filers, the present analysis assumes that the exp ort notification burden of the proposed rule ranges from 0.5 hours to 1.5 hours. The 2009$ wage rate for technical staff is $59.49 per hour, while that for clerical staff is $28.31 per hour (see Exhibit 4

- 4 ). This translates into a low

- end labor cost estimate of $14.16 per notice and a high

- end labor cost estimate of $73.65 per notice. In addition, industry incurs approximately $13.34 per notice for sending each notice to EPA via registered mail ($10.60 for register ed mail, $2.30 for a return receipt, and $0.44 for postage) (USPS, 2010). Accounting for labor and shipping costs, the total cost of preparing and submitting an export notification is estimated to range fro m $27.50 per notice to $86.99 per notice. For the least cost scenario, the analysis uses the 0.5 hour labor burden and $27.50 cost per notice; for the average cost scenario, the analysis uses a 1.0 hour labor burden and the average of the low

- end and high

- end notification cost, which is $57.24. Assuming that 25 notifications will be submitted for each of the 23 chemicals regulated under the proposed rule, it is estimated that a total of 575 notifications will be submitted in response to the proposed rule. Thus, the total cost of export notifications trigg ered by the proposed rule is approximately $16,000 under the least cost scenario and $33,000 under the average cost scenario. These estimates are summarized in Exhibit 4

- 6

.

### 4

- 12 Exhibit 4
- 6 : Export Notification Cost Estimate for the Proposed Rule
Compliance Cost Category Cost (2009$) Category Hours (min.) Hours (max.) Wage Rage Least Cost Scenario Highest Cost Scenario Average Cost Scenario Write Export Notification L etter T 0 1 $59.49 $0.00 $59.49 $29.75 Copy or Print and Send Export Notification Letter C 0.5 0.5 $28.31 $14.16 $14.16 $14.16 Total Labor Cost per Letter $14.16 $73.65 $43.90 Shipping Costs per Letter Fixed NA $13.34 $13.34 $13.34

Tota l Cost per Letter (Labor and Shipping) $27.50 $86.99 $57.24 Total Cost for 575 Notifications $ 16,000 $50,0 00 $ 33,000 Note: Values may not sum due to rounding.



### 4.3 Total Indus try Compliance Cos ts The total compliance costs borne by the regulated indu stry are summarized in Exhibit 4

- 7 . The total industry compliance costs triggered by the proposed rule are estimated to equal $5. 73 million under the least cost assumption and $7. 65 million under the average cost assumption. Thes e estimates include laboratory, methodology validation, administrative, and export notification costs. Laboratory costs may be overestimated due to the economies of scale that could arise if multiple chemicals are tested together
or mu ltiple tests are conducted on the same chemical. Total compliance costs may also be overestimated to the extent that firms can claim tax deductions for some of these costs.

Exhibit 4
- 7 : Summary of Total Ind ustry Compliance Costs Triggered by the Proposed Rule (2009$)
Compliance Cost Category Cost ($ million ) Least Cost Scenario Average Cost Scenario Laboratory costs (Section 4.2.1 ) $3. 65 $5. 18 Analytical met hodology validation costs (Section 4.2.2 ) $0. 39 $0. 39 Administrative costs (Section 4.2.3 ) $1. 66 $2.0 4 Export notification costs (Section 4.2.4 ) $0.02 $0.03 Total industry compliance costs $5. 73 $7. 65 Average compliance cost per chemical $0.2 5 $0. 3 3 Note: Values may not sum due to rounding.


### 4.4 Non

- Monetized Cos ts The proposed rule requires that manufacturers, importers, and/or processors of chemicals included in the proposed rule perform screening

- level toxicity tests on the chemicals. EPA routinely conducts an assessment of laboratory capacity and has applied those findings to this analysis, which allowed EPA to examine the potential for laboratory capacity to become a factor in the economic impact of the proposed rule. The following summarizes conclusions from the most recent laboratory capacity assessment (U.S. EPA, 20 10c ). EPA anticipates that Contract Resea rch Organizations (CROs) will conduct the majority of testing rather than in

- house laboratories. Currently, the testing industry in general appe ar s to be operating well under capacity due to the economic recession

. Many CROs rely on the pharmaceutical and biotechnology

### 4

- 13 sectors for a substantial part of their business. During economic downturns, customers in these sectors tend to curtail research and development, including toxicological testing, on new products. Combined with recent consolidations in the tes ting industry, these conditions have produced a notable decrease in testing demand. The one possible caveat is that implementation of the European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation that could still create a spike in testing demand. REACH requires the registration of chemicals and submission of test data to identify risks th at chemical s may pose. The registration of the first group of chemicals began in June 2008 and is scheduled to end in Dece mber 2010. The fact that laboratories have still not seen an influx in testing as the first registration deadline approaches, however, may indicate that manufacturers and importers have existing data ready to submit, plan to use alternative methods (e.g., SAR) to meet the data requirements, or the number of chemicals

Because it is operating under capacity, it appears that the testing industry would be able to adjust to any potential increase in demand over a reasonable time frame. Such an expansion would on ly be initiated, however, once a backlog of test requests has been sustained for several months and is anticipated to continue over a long period of time. Due to their historical reliance on pharmaceutical and biotechnology client testing, few U.S. laborat ories would engage in speculative expansion in anticipation of increased future testing driven by EPA or European chemical testing initiatives. Additionally, the testing industry is increasing becoming a global market. China, and to a lesser extent India , are emerging as serious potential competitors to what has historically been a largely U.S. and European controlled market. While there are still barriers to overcome, the capabilities of Chinese and Indian CROs are quickly approaching those of establishe d laboratories in the United States and Europe. With labor costs representing a significant proportion of testing costs, China and India can offer similar capabilities at a much reduced cost. Manufacturer’s willingness to move business to these overseas pr oviders will depend on China and India’s ability to demonstrate credibility and quality, and for the results of work done in their facilities to be accepted by industry stakeholders, including regulatory bodies. Given that the amount of testing required b y the proposed rule is not extensive and the tests are not significantly complex, it appears that testing capacity is not a significant factor in meeting the requirements of the proposed rule in the short

- term . In addition, the less than expected level of demand for screening

- level testing resulting from other initiatives, such as REACH, should allow CROs to meet testing needs as a result of the proposed rule. In the long

- term, the supply should adjust to the demand, so that capacity is not a concern.

### 5

- 1 

# Chapter 5

– Age ncy Costs

5.1 Introduction EPA will also incur costs resulting from the proposed rule. Once data are collected and submitted by industry, EPA must review and process letters of intent, study plans, final reports, robust summaries, and exemption applications f or completeness, adherence to protocols, and findings.


### 5.2 EPA Cos ts EPA assumes that, on average, a Federal GS

- 13, Step 1, full

- time equivalent (FTE) 5 

### will conduct its collection procedures under the proposed rule. The annual 2009 fully loaded salary for a GS

- 13, Step 1, FTE is $139,083. This includes a base salary of $86,927 plus 60 percent for overhead and benefits (i.e., $52,146). 6 

### Exhibit 5

- 1 Dividing the fully loaded annual salary by 2,080 (i.e., the number of hours in a work year) yields an hourly wage rate of $66.8 7 for the FTE. provides a detailed description of these calculations. As explained earlier in Section 4.2.3 , approximately 23 letters of intent and study pl ans, 15 3 final reports, 15 3 robust summaries, and 88 exemption applications are estimated to be filed in response to the proposed rule. Based on EPA’s experience and best professional judgment, it is estimated that it takes on average 3 hours to process a letter of intent and study plan, 5 hours to process a final report, 1 hour to review a robust summary, and 1 hour to review each exemption application. Exhibit 5

- 1 presents the estimated total government costs base d on these assumptions. As shown, the total government costs for the proposed rule are estimated to be approximately $7 2 , 000

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

Item Unit Labor Total Items Total Cost Hours Rate Cost/Item Letter of Intent and Study Plans 3 $66.87 $200.60 23 $5,000 Final Reports 5 $66.87 $334.33 15 3 $51,000 Robust Summaries 1 $66.87 $66.87 15 3 $10,000 Exemption Applications 1 $66.87 $66.87 88 $6, 000 Total $7 2 ,000 Note: Values may not sum due to rounding

5 A full

- time equivalent (FTE) is equivalent to 2,080 hours per year. 6 The unloaded Federal GS

- 13 Step 1 salary ($86,927, effective January 2009 ), from the Office of Personnel Management salary table for Washington

- Baltim ore
- Northern Virgini a (OPM, 2010). T he 60 percent fringes

- and

overhead rate is from an EPA/OPP E g uide (U.S. EPA , 1992 b ).

### 6

- 1 

# Chapter 6

– Social Costs

6.1 Total Social Cos ts The estimated total social costs of the proposed rule are estimated as the sum of industry and EPA costs ( Exhibit 6

- 1 ). The total social costs under the least and average cost scenarios are $5. 73 million and $7. 65 million, respectively. The average (mean) social cost per chemical is approximately $2 5 2 ,000 under the least cost scenario and $ 33 6 ,000 under the average cost scenario. In dustry compliance costs are presented before tax. As with any costs, tax deductions would lower the portion borne by industry, but the amount deducted would still represent a cost to society because the costs borne by the government will increase. Similarl y, some costs may be passed on to customers, suppliers, and/or workers in the form of changed prices and wages. However, a detailed analysis of such cost redistribution is beyond the scope of this report.

Exhibit 6
- 1 : Summary of Total Social Cost s Triggered by the Proposed Rule (2009$)
Cost Category Cost ($ million) Least Cost Scenario Average Cost Scenario Total industry compliance costs (unadjusted) a $5. 73 $7. 65 Total government costs (unadjusted) $0 .07 $0.07 Total social costs triggered by the proposed rule (unadjusted) $5. 80 $7. 72 Average social cost per chemical $0.2 5 $0.3 4

a Total industry compliance costs include laboratory, analytical methodology validation, administration, and export notif ication costs. Note: Values may not sum due to rounding



### Chemical

- specific estimates of laboratory, analytical methodology validation, administration, export notification, and government costs under the least and average cost scenarios can be found in Appendix C of this report.


### 6.2 Annualized Cos ts Costs associated with this test rule are expected to occur over the several years during which the actual testing occurs and EPA reviews studies. A three

- year time period is assumed for this analysis. Thus, total social costs of the rule have been annualized over three years. A three percent discount rate is used for the primary analysis in this report, following common EPA convention. EPA guidance also recommends following OMB’s basic guidance on discount rates for regulatory and other analyses provided in OMB Circular A

- 4 (OMB, 2003). The OMB suggests using both a 3 and a 7 percent discount rate, in real terms. Therefore, results are presented for the 3 percent and 7 percent discount r ates. 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 dis count rate, and n is the useful life of the investment (equal to the financial life of the affected company).

### 6

- 2 The initial lump sum costs to comply with the proposed rule under the least and average cost scenarios are presented in Exhibit 6

- 2

. As shown, total annualized social costs under the least cost scenario range from $ 2. 0 5 to $ 2. 2 1 million using a 3 percent and a 7 percent discount rate, respectively. Total annualized social costs under the average cost scenar io range from $ 2. 7 3 to $ 2 .94 million using a 3 percent and a 7 percent discount rate, respectively.

Exhibit 6
- 2 : Annualized Costs Under Least and Average Cost Scenarios (Total for All Chemicals) ($2009)

Category Cost ($ million) 1 Least Cost Scenario Average Cost Scenario 3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate Annualized Industry Compliance Costs $2.0 2 $2. 18 $2. 71 $ 2.9 2 Annualized Government Costs $0.03 $0.03 $0.03 $0.0 3 TOTAL ANNUALIZED SOCIAL COSTS $2. 05 $2. 21 $2. 73 $ 2.9 4 1 All costs were annualized over a 3

- year time horizon.

### 7

- 1 

# Chapter 7

– Small Entity Impact Analysis

This chapter assesses the impact of the proposed HPV test rule on the manufacturers of chemicals subject to the rule. In the previous chapter, the total industry costs were presented, and in this chapter EPA estimates the per

- company cost incurred because of this proposed rule. Such an analysis is particularly relevant for small businesses, as defined by the U.S . Small Business Administration (SBA). This analysis satisfies the requirements of the Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Act (SBREFA) of 1996.


### 7.1 Identify the Affected Population
For each of the 71 manufacturer/importer sites for the chemicals identified in Chapter 2 , EPA identified the ultimate parent company and obtained sales and employment data for companies for which data are available from Dun & Bradstreet Market Identifier (Dun & Bradstreet, 2010 ). 7



### This sea rch identified 59 affected global ultimate parent companies as defined by their global DUNS number or the highest parent level found in other sources. Employee data could be found for 57 of the global ultimate parent companies, and revenue data could be fo und for 5 2 of the global ultimat e companies. Exhibit 7

- 1 provides summary statistics of the available data for the companies for which either type of data was available

. As shown in Exhibit 7

- 1, potentially impacted companies vary widely as measured by bot h number of employees and annual sales. Where employment and sales data was not available from Dun & Bradstreet, EPA used other available online sources, such as company websites or business resource websites (e.g., Manta.com) to obtain estimates.

Exhibit 7 - 1 : Employee and Sales Information for Potentially Impacted Companies Included in the Analysis
Statistical Measure Number of Employees Annual Sales Minimum Value 1 $410,000 Maximum Value 92,000 $239,272,000,000 Median Value 750 $256,790,000 Mean Value 9, 000 $8,824,531,000 Standard Deviation 18, 000 $33,948,284,000 Source: Dun & Bradstreet, 2010 ; Manta, 2010

. Note: Employee and annual sales data were avai lable for 57 and 52 of the 59 global ultimate parent companies identified. Note: Values may not sum due to rounding.



### Exhibit 7

- 2 and Exhibit 7

- 3 show the distributi on of potentially impacted companies considered in the analysis by number of employees an d annual sales, respectively.

7 Dun and Bradstreet is a New York

- based company that provides business information through a global commercial database. It assigns DUNS numbers to identify businesses around the world. These numbers are required for many U.S. fed eral 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 ind ustry 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 retriev ed from the database in 2010.

### 7

- 2 Exhibit 7

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



### 0 5 10 15 20 25

0 to 100 101 to 500 501 to 1,000 1,001 to 5,000 5,001 to 10,000 10,000 to 50,000 > 50,000
Number of EmployeesNumber of Companies

### 7

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



### 7.2 Select a Relevant Small Bus ines s Definition
The RFA relies on the definition of “small business” found in the Small Business Act, which authorizes the Small Business Administration to develop definitions for “small business” based upon a sales or employment level. The Small Business Administration provides a table of size standards in the Small Business Size Regulations, 13 CFR 121.201 . These definitions for small business are provided for the six

digit NAICS codes, based on employment thresholds or annual sales volume (U.S. SBA, 2008). Throughout the remainder of this report, this definition is referred to as the “SBA definition.” EPA used the table provided in U.S. SBA 2008 to identify the size standards for the NAI CS codes corresponding with each global parent ultimate company identified in section 7.1 . Company NAICS codes were obtained from Dun & Bradstreet (2010), or, when not available from this source, from entries in EPA’s Facility Registry System (U.S. EPA, 2010d). SBA size standards range from 100 employees to 1,000 employees, or $4,500,000 to $7,000,000 in revenue (U.S. SBA, 2008). For this analysis, EPA also considered an alternative definition based upon the TSCA definition for the sensitivity analysis. Under this definition, a manufacturer or importer is defined as small, as under 40 CFR 704.3, if it meets either of the following criteria: 

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

### 0 5 10 15 20 25 30

$0 to $100 $101 to $500 $501 to $1,000 $1,001 to $5,000 $5,000 to $10,000 $10,000 to $50,000 >$50,000
Revenue (millions of dollars)Number of Companies

### 7

- 4 (2) Total annual sales of the company, combined with those of any parent company, are below $4 million



### . 7.3 Identify Small Bus ines s es
P arent company sales data, collected as explained above, were used to identify companies that qualified for “small business” status, per both the SBA

- based and the TSCA

- based definitions specified above. Based on the SBA criteria, 25 companies (42.4 percent ) were identified as small. Furthermore, 17 companies (28.8 percent) were identified as small according to the TSCA definition.


### 7.4 Calculate Each Company’s Share of Tes ting Cos ts As explained in Chapter 4 , the industry compliance costs (the sum of laboratory costs, methodology development costs, administration costs, and export notification costs) were computed under least and average cost scenarios. For this small entity analysis, the costs were annualized over a 15

- year time hor izon using a 3 percent discount rate. The total annualized compliance costs for all 23 chemicals were approximately $ 480 ,000 under the least cost scenario and approximately $ 641 ,000 under the average cost scenario. 8 

### To calculate each company’s share of co mpliance costs, EPA assumed that the cost of performing chemical

- specific testing is borne by companies in proportion to their production and/or importation volume. Therefore, using volumes reported under IUR (supplemented with assumptions for companies id entified using DWCP, as described in Chapter 2 ), EPA calculated the fraction of the total production/importation volume for each chemical that each company is responsible for. This fraction was then multiplied by the total annu alized testing costs for the chemical to obtain each company’s cost share. Total per

- company testing costs were computed by summing all the chemical

- specific cost shares for each company. This method was used to get a worst

- case estimate of the rule’s impa ct on small businesses. For example, if Company A produced Chemicals X, Y, and Z, then one combined cost was examined rather than three chemical

- specific shares. Cost shares were computed under both the least and average cost scenarios. Because production volumes are considered CBI, detailed results of this analysis are not reported here.


### 7.5 Cost

- to

- Sales Ratio To determine the size of the adverse impact, each company’s total share of testing costs (for all chemicals it manufactures/imports) was then compared to its total sales. Small businesses were grouped based on the cost

- to

- sales ratios: less than 1 percent, greater than 1 percent, and greater than 3 percent. Exhibit 7

- 4 presents summary statistics for company

- spe cific cost

to

- sales ratios for small companies, as well as a summary of the results using the employment

- based, as well as the sales

- based, definition of a small business, under both the least and the average cost scenarios.
Exhibit 7

- 4 indicates that the number of small businesses affected at the 1 and 3 percent levels is identical regardless of the small business definition used: the analysis based on employment data correlates quite closely with the one based on sales data for the companies. Of the 2 2 companies which had sales data available and qualified for small business status per the SBA criteria, none had a cost

- to

- sales ratio greater than 1 percent under the least or average cost scenarios. Of the 17 compan ies that qualified for

8 Note that these figures include only the industry compliance cost and not the cost to the government. Also note that industry compliance costs may be overestimated to the extent that companies can claim tax deductions for so me of these costs.

### 7

- 5 small business status per the TSCA criteria, no company had a cost

- to

- sales ratio of greater than 1 percent under the least or average cost scenarios.

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

Statistical Measure SBA Definition 1 TSCA Definition 2 Least Cost Scenario Average Cost Scenario Least Cost Scenario Average Cost Scenario Total Number of Identified Companies 59 59 59 59 Tot al Number of Identified Small Companies 25 25 17 17 Number of Small Companies with Sales Data 22 22 17 17 Number Impacted at >1 percent 0 0 0 0 Number Impacted at >3 percent 0 0 0 0 Minimum Cost

- to

- Sales Ratio 0.0000 1 % 0.0000 1 % 0.0000 1 % 0.0000 1 % Maxim um Cost

- to

- Sales Ratio 0.1 4 % 0.2 0 % 0.0 62 % 0. 089 % Mean Cost

- to

- Sales Ratio 0. 017 0.0 23 % 0.0 087 % 0.0 10 % Median Cost

- to

- Sales Ratio 0.00 11% 0.00 11 % 0.000 64 % 0.000 75 % Standard Deviation 0.000 4 0.000 5 0.0002 0.000 2 Notes: Compliance costs are annualized ove r a 15

- year time horizon using a 3 percent discount rate. 1 Companies meeting SBA’s NAICS

- specific size thresholds (based on either employee number or revenue) are considered small under this definition. 2 Companies with either (1) total annual sales below $ 40 million and annual production volume or importation volume less than or equal to 100,000 lbs.; or (2) total annual sales below $4 million are considered small under this definition.



### 7.6 Companies without Sales Data Data on sales are missing for seven of t he companies; three of these companies were identified as small based on SBA employment data. An analysis was conducted to determine the potential impact on these companies, using the median revenue for small companies with revenue data to estimate the lik ely revenue of the companies without data. The median revenue for small companies with revenue data is $ 5 million (using the SBA employment

- based definitions of small business as described in Section 7.3 ). If th is figure represented the sales for the companies without sales data, no companies would have a cost

- to

sales ratio would be between 1 and 3 percent under the least

- cost scenario, and no ne would have a cost

to

- sales ratio between 1 and 3 percent under the average
- cost scenario. Another way to examine the impact on companies where revenue data is not available is to calculate what the revenue would need to be in order for testing cost impacts to be near or exceed 1 percent of sales

. At the worst case, one o f the companies would need to have a revenue of less than approximately $ 3 million. This is approximately one tenth of the average revenue ($28.3 million) for the small businesses where sales data is known.


### 7.7 Res ults
EPA estimates that the small entities th at are potentially directly regulated by th e proposed rule include small for

- profit businesses; no nonprofit organizations or governments are expected to be affected by this proposed rule. EPA estimates that there are 2 5 small entities that would be affect ed by this proposed rule under the SBA

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

- based definition. Of these, EPA estimates that there is no small business for which the cost impact of the testing exceeds 1 percent of the company’s revenue.

### 8

- 1 

# Chapter 8

– Benefits

Th e proposed rule targets HPV chemicals for which basic toxicological (hazard) information is unavailable and requires testing of these chemicals to provide information on their effects on human health and the environment. The benefit s 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. Th e information developed because of the proposed rule will be made publicly available and is expected to yield benefits resulting from the direct use of the information (use value)

. In addition, there may be non

- use benefits because of the value that society places on just knowing that the test data exist , r egardless of whether they ever use the information (non

- use value). This chapter discusses the use value of the proposed rule qualitatively. The non

- use values are only discussed briefly. Due to the scientific nature of the information that would result fr om the proposed rule, non

- use benefits are not likely to comprise a large percentage of the total benefits. This chapter discusses the use benefits of the HPV chemical test rule qualitatively. Quantification of the benefits of the proposed rule would requi re more specific information about each user’s use patterns and preferences, and the changes in these that would result from the additional information made available under the proposed rule. These data are not readily available; to collect such data would be cost

prohibitive. For example, one approach would be to conduct a national willingness

- to

- pay (WTP) survey of the general public to determine the value that the public places on the availability of the information resulting from the test rule. However, such a survey (or one for similar information) has not been conducted.


### 8.1 Us e Values
T he proposed rule will increase the publicly available data about a chemical’s risks and consequently is likely to result in (a) a reduc tion in the costs of risk

- based decis ions about the chemical, and (b) an improve ment in the expected outcome of the decisions (U.S. EPA, 2006)

. It is important to note that both of these types of benefits are dependent upon the information being usable by the intended audience. That is, the r aw data may need to be processed and disseminated before certain potential users, such as workers and the general public, can use it to make decisions. There are additional costs and timeframes involved in the activities required to synthesize the informat ion into documents that are easily accessible to the public (worker safety procedures, etc.), such that the benefits of this rule may not be realized immediately and are further difficult to isolate. Improved outcome of decisions. Information

- based policie s contribute to better decisions by redirecting
reso urces toward their most highly valued uses. With incomplete information regarding toxic chemicals, public and private decision makers are not able to adequately assess the benefits and costs of actions th at involve these substances. For example, EPA decisions regarding whether, when, and how to target chemicals for further risk assessment c an be misdirected if basic risk

- screening information is unavailable or inadequate. With more information, EPA can bet ter direct its limited resources toward high

- priority risks. It is also likely that once detailed toxicological information is available on these HPV chemicals, producers and users of these chemicals will adjust the volume of production and use to minimize adverse effects. Improved information can therefore help lead to more socially optimal reductions in risks to humans and the environment

.

### 8

- 2 Furthermore, the exact nature and scope of the benefits resulting from this proposed rule would depend on the outcom e of the tests that would be performed; to the extent that the test results did indicate a potential health or environmental risk from a chemical, the benefits related to understanding and avoiding this risk would be greater

. Reduced cost of risk

- based dec ision making. By making new information about toxic substances available to the public (including EPA and other government agencies), this proposed rule can serve to replace other information

- gathering, management, and dissemination activities related to t he regulated chemicals. Once the data are publicly available, information users and decision makers will avoid the time and resource costs required to individually perform these activities. In effect, the proposed rule increases the efficiency ( and strengt h ) of the decision

- making process.


### 8.2 Non

- Us e V alues The value that society places on the information resulting from this proposed rule may go beyond what people experience through the use of the data. Specifically, members of society may experience a “non

u se” value associated with just knowing that the test data exist regardless of whether they ever use the information. Non

- use values have also been referred to as “existence” or “intrinsic” values and encompass a variety of motivations. For example, individ uals may place a value on the availability of the test data for others to use in the current time period (vicarious consumption), or place value on preserving or ensuring the availability of the data (or the decisions or policies that result from the infor mation) for the benefit of family and others in the future (bequest value). However, a quantitative discussion of these benefits is not provided here, as measuring non

- use values can be extremely difficult for several reasons. First, there is no market equ ivalent to accurately reflect these values. Second, non

- use values are not associated with easily observable behaviors. Third, non

- use values may be held by both users and non

users of a resource, and non

- users may be less familiar with particular services provided by the resources in question.


### 8.3 Benefits of the Required Tes t s 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 i s warranted to completely characterize the hazards and risks associated with the chemical. Consistent with the HPV SIDS program of the OECD (described in Chapter 3 of this report) the data obtained by this batte ry of tests relate to six health and environmental effect endpoints for HPV chemicals

– acute toxicity; repeat dose toxicity; developmental and reproductive toxicity; genetic toxicity (gene mutations an d chromosomal aberrations); ecotoxicity (studies in fi sh, Daphnia, and algae); and environmental fate (including ready biodegradation)

– as well as physical/chemical properties. The test data identified under SIDS have been internationally agreed upon by the 29 member countries of OECD as providing the minimu m data set required to make an informed preliminary judgment about the hazards of a given HPV chemical. For the purposes of the proposed rule, EPA has grouped required tests into six categories: 

### (1) Physical/chemical properties (2) Environmental fate and pathways (3) Aquatic toxicity (4) M ammalian t oxicity

- acute (5) M ammalian toxicity

- genotoxicity (6) M ammalian toxicity

- repeate d dose/reproduction/ developmental

.

### 8

- 3 Screening

- level t ests that provide information on the toxicity of a chemical (e.g., aquat ic toxicity, mammalian toxicity) provide information on the health and environmental effects of the chemical, and can be used to help assess how hazardous the chemical is to the populations exposed. Results of these screening

- level tests

– and any further research as necessary

– may help reveal the need for special containers and storage procedures , engineering controls, and pers onal protective equipment in the workplace to adequately control health and environmental risks associated with manufacture, proce ssing, 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 chemic al may interact with the environment or the body, and the methods by which it may be dispersed. The information developed from these tests benefits workers , consumers, or persons living in locations impacted by chemical emissions , as government regulation and response to long

- term and emergency releases can be more targeted and effective. In particular, the tests help agencies prioritize the regulation of chemical emissions based on the level of exposure. The following sections describe the tests that could be required for a chemical under this proposed rule and the test’s role as a screening

- level indicator (the b enefit s associated with each individual test)

. Section 8.4 lists the tests required for each chemical.

8.3.1 Ph ys ical/Chem ical Properties 

### Melting Point (ASTM E 324

- 99) ( ASTM , 2009c)

. The melting point is the temperature at which a substance transitions from the solid to liquid phase. The ASTM E 324

- 99 melting point test determines the initial and final melting points (melting range) of stable, crystalline organic solids whose melting points fall between 30°C and 250°C.
The data generated by this test benefit industry and workers through the determination of the physical phase of the chemical in industrial settings or during tra nsport, 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 chem ical, this test can also be used to help identify unknown chemicals at industrial sites. Melting point information also benefits government and industry scientists undertaking occupational and environmental exposure and risk assessments. A chemical’s phase (e.g., solid, liquid, or gas) has a large impact on the expected fate and transport of the chemical in the environment and within the body. With information on a chemical’s melting point, the ambient temperature can be used to help determine whether the c hemical exists in a solid or liquid phase. The chemical’s phase also affects the magnitude of certain exposure pathways (e.g., chemicals in the liquid pha se are more readily absorbed by skin than those in the solid phase). Once the information becomes avai lable to them t his benefit in turn indirectly helps workers , consumers, or persons living in locations impacted by chemical emissions , as government regulation and response to long

- term and emergency releases can be more targeted and effective. Boiling Po int ( 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 condensabl e at total reflux and boil between 285 K and 575 K (approximately 12°C and 302°C, respectively). The data generated by this test benefit industry and workers through the determination of the physical phase of the chemical in industrial settings or during transport, making the identification of optimal storage temperatures and container systems possible. Information on a chemical’s boiling point can help determine whether a chemical exists in the liquid or gas phase. The buildup of pressure in containers du e to low boiling point and high vapor pressure liquids can be a severe workplace and transportation hazard. Thus, the use of these data to provide safe, hazard

- free transportation and workplaces will benefit the

### 8

- 4 general public, industrial workers, and the industries they work in by decreasing the liability of transport and workplace accidents. Since the boiling point is an intrinsic property of a chemical, this test can also be used to help identify unknown chemicals at industrial sites.
A chemical’s boilin g point also benefits government and industry scientists undertaking occupational and environmental exposure and risk assessments for a number of reasons:

**•** It has a marked impact on the expected fate of chemicals in the environment and in the body (i.e., g ases are frequently exposed to different transfo rmative chemistry than liquids).

**•** It has an impact on the expected transport of chemicals in the environment and in the body (i.e., gases travel more extensively than liquids due to conve ction and diffusion in air).

**•** It can help determine whether the chemical exists in the liquid or gas phase during the exposure period, which can affect the exposure outcomes (e.g., chemicals in the gas phase can be inhaled, increasing the magnitude of exposure).
Vapor Pressure (ASTM E 1782

- 08) (ASTM, 2009b)

. The vapor pressure indicates the tendency of a solid or liquid to evaporate. The ASTM E 1782

- 08 vapor pressure test determines the vapor pressure of pure liquids or melted solids within the temperature range 273 K to 773 K (approximately 0°C to 500°C, respectively) and the pressure range 5 kPa to 2000 kPa using differential thermal analysis (DTA), differential scanning calorimetry (DSC), or preferably high

- pressure versions of these instruments (HPDTA and HPDSC).
The data g enerated by this test benefit industry and workers through the determination of the physical phase (e.g., liquid or gas) of the chemical in industrial settings or during transport, making the identification of optimal storage temperatures and container sys tems 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 b enefit the general public, industrial workers, and the industries they work in by decreasing the liability of transport and workplace accidents. Like boiling point, v apor pressure information also benefits government and industry scientists undertaking occ upational and environmental exposure and risk assessments because of its impact on the expected fate of the chemicals, the expected transport of the chemicals, and the exposure outcome. Partition Coefficient (ASTM E 1147

- 9 2(2005) ) ( ASTM , 2005). The octano l

- water partition coefficient ( logK ow 

### ) indicates how a compound partitions between water and non

- polar organic chemicals (e.g., fat s and oils) . The ASTM E 1147 partition coefficient test determines the logarithm of the octanol/water partition coefficient o f non

- ionizable and ionizable compounds by inputting the ir 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 pa rtition coefficient.) This information is then used to assess the chemical’s lipophilicity , or affinity to non

- polar organic chemicals. Some important benefits to industry chemica l users involve clean up , waste

- handling procedures , and chemical identificati on . Cleanup procedures are highly dependent on these data, since facilities need to know what materials the chemical tends to adsorb to. Waste storage is also affected, since facilities typically store miscible substances together. Additionally, the test c an be used to help identify unknown chemicals at industrial sites.
Industrial users also benefit from these data through the determination of chemicals’ solubility in fat. Persistent, fat

- soluble chemicals can bioaccumulate in regularly exposed workers , or consumers of end

-

### 8

- 5 use products

. This information can help identify the need for special containers, engineering controls, and pers onal protective equipment in the workplace . Proper controls can reduce the likelihood of occupational injury and death, thereb y reducing liability to industry and benefiting workers. It can also help preemptively identify products whose use is likely to result in bioaccumulation in consumers

. Partition coefficient information also benefits government and industry scientists under taking fate and transport studies. Chemical fate and transport is highly influenced by the tendency of chemicals to adsorb to non

- polar organic matter such as sediment, soil, and dust. Chemicals with high logK ow 

### partition coefficients are more likely to ad sorb to these particles, which can impede or accelerate their dispersal, depending on local conditions. In soil matrices, these chemicals predominately adsorb to organic material, while chemicals that are more water soluble percolate through the soil more rapidly, potentially contaminating groundwater . In dusty conditions, they predominately travel with the particulate matter, rather than move by convection and diffusion. Occupational and environmental risk assessors benefit from these data because 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 an d 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 , consumers, or persons living in locations impacted by chemical emissions , as government regulation and response to long

- term and emergency releases can be more targeted and effective. Water Solubility (ASTM E 1148

- 02) ( ASTM , 2008a). The physical property describing the ability of a given substance to dissolve in water is termed water solubility. The ASTM E1148

- 02 water solubility test determines the affinity of water

- and air

- stable chemicals to water. (The regulations at 40 CFR 799.6784 and 799.6786 provide alternate protocols for obtain ing a chemical’s water solubility.) Some important benefits to industry chemica l users involve clean up , waste

- handling procedures , and chemical identification . Cleanup procedures are highly dependent on these data, since facilities need to know to what mat erials the chemical tends to adsorb. Waste storage is also affected, since facilities typically store miscible substances together. Additionally, the test can help identify unknown chemicals at industrial sites.
Industrial users also benefit from these dat a through the determination of chemicals’ solubility in fat. Persistent, fat

- soluble chemicals can bioaccumulate in regularly exposed workers , or consumers of end

use products

. This information can help identify the need for special containers, engineering controls, and pers onal protective equipment in the workplace . Proper controls can reduce the likelihood of occupational injury and death, thereby reducing liability to industry and benefiting workers. It can also help preemptively identify products whose use is likely to result in bioaccumulation in consumers. Water solubility information also benefits government and industry scientists undertaking fate and transport studies. Chemical fate and transport is highly influenced by the chemical’s affinity of ch emicals to water. Chemicals with high solubility are more likely to travel with water flows (i.e., rivers, aquifers, rain percolation through soil and sediment), and as a result can travel extensive distances. In soil matrices, these chemicals predominatel y percolate through the organic matrix , potentially threatening groundwater supplies

. Occupational and environmental risk assessors will benefit from these data because water solubility heavily influences the magnitude of chemical uptake in the human body (e.g., high water solubility typically results in lower dermal transfer coefficients and inhalation efficiency) and the possible site of

### 8

- 6 toxic effects (e.g., upper respiratory tract versus lungs) . It also influences the partitioning of the chemical inside of the body and consequently is used in the estimation of chemical half

- life. This benefit in turn indirectly helps workers , consumers, or persons living in locations impacted by chemical emissions , as government regulation and response to long

- term and e mergency releases can be more targeted and effective.

8.3.2 Environmental Fate a nd 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 en vironment by natural processes such as bacterial digestion . The ASTM E 17 2 0

- 01 ready biodegradability test uses the generation of carbon dioxide by a dilute sewage inoculum as a proxy to determine the biodegradability of organic compounds in a closed vesse l. Biodegradation of 60 percent or more during the closed

- vessel test indicates that in most environmental compartme nts the chemical will biodegrade completely. The International Organization for Standardization (ISO)’s standards ISO 14593, ISO 7827, ISO 9 408, ISO 9439, ISO 10707 and ISO 10708 provide alternate protocols for test s for biodegradation. The appropriate method is determined by the test substance’s physical and chemical properties, including its water solubility. ISO 10634 provides guidance on s electin g an appropriate test method for a given test substance. For industries that keep chemicals in stock for extended periods of time , these data have a significant benefit, since biodegradability influences the choice of storage conditions, including container type, humidity, temperature, and expected storage time. These data also benefit government and industry scientists undertaking fate and transport studies, as well as occupational and environmental exposure and risk assessments. They can be used a s 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 , a ffects the potential for ecological and human exposure and consequent risk.

8.3.3 Aq uatic Toxicity 

### Aquatic toxicity data are beneficial to industry, regulators , and the public for a variety of reasons. Industry and regulators may use the information during the formulation of plans for water emissions schedules and the filing of National Pollutant Discharge Elimination System (NPDES) permits with EPA’s Office of Wastewater Management (OWM). These data also benefit government and industry scientists undertaking ec ological toxicity and risk assessments. The assessments use , in conjunction with fate and transport and ecological exposure models , acute fish toxicity thresholds to estimate the acute effects of a particular emission or pattern of emissions on targeted po pulations of fish ; acute Daphnia toxicity thresholds to estimate the acute effects of a particular emission or pattern of emissions on targeted populations of crustaceans or other aquatic life ; microalgae toxicity to estimate the short

- term effects of a pa rticular emission or pattern of emissions on targeted populations of aquatic plant life ; or chroni c Daphnia toxicity thresholds to estimate the long

- term effects of a particular emission or pattern of emissions on targeted populations of crustaceans or oth er aquatic life. They can also be used as general indicato rs of toxicity, such as in life cycle analyses. Government response to industrial emissions as a consequence of ecological risk assessment results can therefore be better tailored to protect ecologic al resources, benefiting the general public. More detail on these aquatic toxicity tests is provided below. Acute Toxicity to Fish ( ASTM E 729

- 96 ) ( ASTM , 2007b). The ASTM E 729

- 96 acute toxicity test determines the concentration of a chemical needed to rea ch 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 ad verse effect response rate in the test organisms (EC 50 

### ) during two

- to eight

- day exposures in either

### 8

- 7 static (no replacement of toxicant), renewal (periodic replacement of toxicant), or flow

- through (continuous or intermittent replacement of makeup water an d 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 a chemical needed to reach a toxicity threshold in Daphnia crustaceans. The standard threshol ds 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 eith er static (no replacement of toxicant), renewal (periodic replacement of toxicant), or flow

- through (continuous or intermittent replacement of makeup water and toxicant) exposures. 8 

### Lower thresholds represent higher toxicity in the target organisms. Becaus e 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 toxicit y test determines the concentration of chemical needed to reach a toxicity threshold in freshwater and saltwater microalgae. The standard threshold used is the concentration at which there is a 50 percent growth inhibition rate (IC 50 

### ) during 72

- , 96

- , or 1 20

- hour exposures in static (no replacement of toxicant) conditions. Chronic Toxicity to Daphnia ( ASTM E 1193

- 97 ) ( ASTM , 2004). The ASTM E 1193

- 97 chronic toxicity test determines the concentration of chemical needed to reach a toxicity threshold in Daphn ia magna crustaceans. Exposures are conducted using flow

- through (continuous or intermittent replacement of makeup water and toxicant) methods and last over the life cycle of the organisms.

8.3.4 Mammalian Toxicity

– Acute 

### Several types of mammalian acute toxici ty tests are available. Industry can use acute inhalation toxicity data to determine the level of hazard or potential risk posed by gases, or other volatile chemicals ; and acute oral toxicity data or cytotoxicity data to determine the level of hazard or po tential risk posed by liquid or solid chemicals . (E levated levels of cytotoxicity indicate the potential for adverse health outcomes on cells, the smallest building block of the body. ) This hazard level can help identify the need for special containers, en gineering controls, and pers onal 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 bene fit government and industry scientists undertaking occupational and environmental exposure and risk assessments or toxicity assessments. O ccupational and environmental exposure and risk assessments use acute toxicity information in conjunction with fate an d transport and exposure models to estimate the acute effects of ambient workplace concentrations or end

- of

- pipe emissions on targeted populations of workers , consumers, or persons living in close proximity to emissions streams. This benefit in turn indire ctly helps workers , consumers, or persons living in locations impacted by chemical emissions , as government regulation and response to long

- term and emergency releases can be more targeted and effective. Toxicity assessments are able to use the cytotoxicit y information to estimate the potential for adverse health effects in workers , consumers, or the general public. As a result, government responses, primarily in the form of demands for further toxicity testing, are likely to be more targeted and effective. More detail on various types of mammalian acute toxicity tests is provided below.

### 8

- 8 Acute Inhalation Toxicity (40 CFR § 799.9130 ). This test gives an indication of potential harm from inhaling a chemical compound. The regulation at 40 CFR § 799.9130 defines t he standard test to measure the acute inhalation toxicity of gases, volatile substances, and aerosols in mammals. This test is conducted during a period of 24 hours or less us ing inhalation at no less than three dose levels (and a control, when using a veh icle other than water) in animals of both sexes. Occurrence, severity, and reversibility for as many behaviorally and clinically abnormal outcomes as possible should be catalogued during the experiment, and an attempt to determine the relationship between dose level and effect should be made. This test can be used to determine a regimen of doses for longer

- term (i.e., subchronic and chronic) inhalation toxicity studies. Acute Oral Toxicity (40 CFR §799.911 0 ). This test gives a n indication of harm from inges ting a chemical compound. The regulation at 40 CFR § 799.9110 defines the standard test to measure the acute oral toxicity of liquid or solid chemicals in mammals. This test is conducted during a period of 24 hours or less using single or multiple ingestion doses at no less than three dose levels (and a control, when using a vehicle other than water) in animals of both sexes. Occurrence, severity, and reversibility for as many behaviorally and clinically abnormal outcomes as possible should be catalogued dur ing 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 Cy totoxicity test determines the magnitude of cellular toxicity of water soluble chemicals on the BALB/c 3T3 mouse fibroblast cell line. Cell viability after short

- t erm (24

- hour) in vitro chemical exposure is measured using the cells’ ability to take up the Neutral Red dye as a proxy ( MB Research Laboratories , 2009)

. BHK Neutral Red Uptake Cytotoxicity. This test provides an indication of a chemical’s toxic effect on a cell, the basic building block of the body. The BHK Neutral Red Uptake Cytotoxicity test de termines the magnitude of cellular toxicity of chemicals on a baby hamster kidney (BHK) fibroblast cell line. Cell viability after in vitro chemical exposures of unknown length is measured using their ability to take up the Neutral Red dye as a proxy ( Shir ai et al. , 1989)

. 8.3.5 Mammalian Toxicity

- Genotoxicity 

### Industry can use genotoxicity data to approximate the potential risk of carcinogenicity, or reproductive and developmental effects posed by chemicals prior to conducting a full risk assessment. Elevated l evels 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 pers onal protective equipment in the workplace. Proper use of this information can reduce the likelihood of chronic disease or risk to specific groups of workers (e.g., pregnant women) due to occupational exposure, thereby reducing liability to industry and benefiting workers

. These toxicity data also benefit government and industry scientists undertaking toxicity assessments. Such assessments can use genotoxicity information to estimate the potential for carcinogenicity in workers , consumers, or the general public exposed to certain compounds. Genotoxicity can also serve as a carcinogenicity screening tool for new chemicals. As a result, government responses, primarily in the form of demands for further toxicity testing, are likely to be more targeted and effective. More deta il on specific mammalian genotoxicity tests is provided below.
Bacterial Reverse Mutation ( 40 CFR §799.951 0 )

. This test measures a chemical’s ability to change the genetic code of bacteria, which is an indicator of the chemical’s abilit y to change the gene tic code of humans. The Bacterial Reverse Mutation test described in 40 CFR § 799.9510 seeks to determine the

### 8

- 9 existence of genotoxicity during chemical exposure using mutated Salmonella typhimurium and Escherichia coli bacterial cultures. Reversal of the te st organism mutations (e.g., substitution, addition, deletion) by the test chemical after 48

- to 72

- hour in vitro chemical exposure is measured using the bacteria’s ability to synthesize specific amino acids as a marker. Positive results in this test are u sed to determine chemicals that should be further tested for carcinogenic, reproductive, and developmental effect potential. Chromosome Aberration, in vitro ( 40 CFR §799.9537 )

. The in vitro Chromosome Aberration test described in 40 CFR § 799.9537 seeks to determine whether chemical exposure causes chromosomal aberrations in primary cell cultures, such as Chinese hamster fibroblasts, human, or other mammalian peripheral blood lymphocytes. Generation of chromosomal aberrations such as polyploidy (excess chrom osomes) or endoreduplication (duplication of the genome without mitosis) by the test chemical is measured using basic microscopy techniques after exposure. Positive results in this test are used to determine chemicals that should be further tested for carc inogenic, reproductive, and developmental effect potential. In Vivo Mammalian Cytogenetics Tests: Bone Marrow Chromosomal Analysis (40 CFR §799.9538). The in vivo Mammalian Bone Marrow Chromosomal Aberration test described in 40 CFR § 799.9538 seeks to dete rmine whether chemical exposure causes chromosomal aberrations in rodents, such as rats, mice, and Chinese hamsters. Generation of chromosome or chromatid aberrations such as polyploidy (excess chromosomes) or endoreduplication (duplication of the genome w ithout mitosis) by the test chemical is measured using basic microscopy techniques. Positive results in this test are used to determine chemicals that should be further tested for carcinogenic potential, particularly in bone marrow. Erythrocyte Micronucleu s (bone marrow), in vivo: ( 40 CFR §799.9539). The Mammalian Erythrocyte Micronucleus test described in 40 CFR § 799.9539 seeks to determine whether chemical exposure causes damage to the chromosomes or the mitotic apparatus of erythroblasts (immediate precu rsor to red blood cells) in the bone marrow of rodents, such as rats or mice. The proportion of immature erythrocytes among the total is measured using basic microscopy techniques, and a dose

- response relationship is investigated. Positive results in this test are used to determine chemicals that should be further tested for carcinogenic potential, particularly with regard to erythrocyte production.

8.3.6 Mamm alian Toxicity

- Repeated Dos e/Rep roduction/ Developmental 

### Industry can use repeated dose oral toxicity da ta along with reproductive and developmental toxicity data to determine the level of hazard or potential risk posed by chemicals. This hazard level can help identify the need for special containers, engineering controls, and pers onal protective equipment i n the workplace. Proper use of this information can reduce the likelihood of occupational injury , disease, and death, thereby reducing liability to industry and benefiting workers. Industry can also benefit from this information during safety testing of co nsumer products, as it prevents the commercialization of hazardous products and the resulting liability. Mammalian toxicity data can be used in developing regulatory standards, such as those found in EPA’s Integrated Risk Information System (IRIS), to the benefit of government and industry scientists undertaking occupational and environmental exposure and risk assessments. Such assessments use both repeated dose and reproductive and developmental toxicity information in conjunction with fate and transport and exposure models to estimate the effects of ambient workplace concentrations or end

- of

- pipe emissions on targeted populations of workers, consumers, persons living in close proximity to emissions streams, and sensitive subpopulations (e.g., pregnant wom en , young children ), and/or on the general population. This benefit in turn indirectly helps workers , consumers, or persons living in locations impacted by chemical emissions , as government regulation and response to long

- term and emergency

### 8

- 10 releases can be more targeted and effective

. More detail on various types of mammalian repeated dose/reproduction/developmental toxicity tests is provided below. Repeated Dose Oral Toxicity (40 CFR §799.9305). This test gives a n indication of harm from ingesting a chemic al compound. The regulation at 40 CFR §799 .9305 defines the standard test to measure the repeated dose oral toxicity of liquid or solid chemicals in mammals. The test should be conducted after the acute oral test described in 40 CFR §799 .9110 in order to e stablish an appropriate dose range. This test is conducted during a period of 14 or 28 days using multiple ingestion doses a t no less than three dose levels plus a control (dose = 0) in animals (typically rodents) of both sexes. Occurrence and severity for as many behaviorally and clinically abnormal outcomes as possible should be catalogued during the experiment, and histopathological investigations are done on specific sets of organs. An attempt to determine the relationship between dose level and effect should be made with the no observed effects level (NOEL) serving as one of the parameters of importance. If possible, the no observed adverse effect level (NOAEL), lowest observed adverse effect level (LOAEL), and dose at which an effect is seen in 50 perc ent 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 a chemical will impact the offspring of th e individual’s exposed to the ch emical. The regulation at 40 CFR §799 .9355 defines the standard test to measure the reproductive or developmental toxicity of chemicals in mammals. Male animals are dosed for a minimum of four weeks with a schedule as follows: a minimum of two weeks pre

- ma ting, during the mating period, and approximately two weeks post

- mating. Females are dosed with a schedule as follows: at least two weeks pre
- mating, time

- to

- conception, duration of pregnancy, and at least four days post

- delivery. Occurrence and severity o f 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 observ ed effects level (NOEL) serving as one of the parameters of importance. If possible, the no observed adverse effect level (NOAEL), lowest observed adverse effect level (LOAEL), and dose at which an effect is seen in 50 percent of the test animal population (ED 50 

### ) should be determined. Combined Repeated Dose with Reproductive and Developmental Toxicity Screen (40 CFR §799.9365). The reg u lation at 40 CFR § 799.9365 defines the standard test to measure the reproductive or developmental toxicity of chemicals in mammals. Male animals are dosed for a minimum of four weeks with a schedule as follows: a minimum of two weeks pre

- mating, during the mating period, and approximately two weeks post

- mating. Females are dosed with a schedule as follows: at least two weeks p re
- 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 h istopathological 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 experime nt. An attempt to determine the relationship between dose level and effect should be made with the no observed effects level (NOEL) serving as one of the parameters of importance. If possible, the no observed adverse effect level (NOAEL), lowest observed a dverse effect level (LOAEL), and dose at which an effect is seen in 50 percent of the test animal population (ED 50 

### ) should be determined.


### 8.4 Benefits Related to Each Regulated Chemical Total benefits that result from the required tests discussed above would depend on the production volume of chemical substances included in this proposed rule, the tests required for each of the chemical substances, and other chemical

- specific characteristics that would impact the exposure of the chemicals. Section 4(a)(1)(B) o f TSCA allows EPA to require testing if it finds that a chemical is reasonably

### 8

- 11 expected to be released into the environment in substantial quantities, or if there may be substantial or significant human exposure. For all of the chemical substances included in this proposed rule, EPA has made preliminary findings that they are produced in substantial quantities; there may be substantial human exposure to them; existing data are insufficient to determine or predict their health and environmental effects; and testing is necessary to develop such data. Under the proposed rule, the chemicals would be required to complete a battery of tests described above that provide screening

- level hazard and environmental fate information. The sections below briefly describe E PA’s exposure findings for each of these chemical s (U.S. EPA, 2009a) , 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 implies a greater risk of exposure. The production volume for each chemical was provided in Section 2.3 of this report. Any known information about exposure volume is included with the descr iption of the findings. For each chemical, a chart shows which specific tests are required by this proposed rule. Tests are only required where the resulting data are not otherwise available for the chemical.

8.4.1 Glycine (CASRN 56

- 40

- 6) 

### The total number of po tentially exposed workers is likely to exceed 1,000 based on reported IUR data for this chemical (U.S. EPA, 2010b). The primary IUR commercial/consumer product category “Other” (chemicals contained in commercial and consumer products not elsewhere classifi ed) was reported for this chemical. The National Library of Medicine database indicates that this chemical is used as an ingredient in sweeteners and flavor enhancers, antacids, dietary supplements, as well as approximately 25 cosmetics/personal care produ cts (U.S. ITC, 2007; U.S. NLM, 2009b; U.S. HHS, 2009; U.S. EPA, 2010b). Additionally, this chemical exists in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Based on this information, EPA believe s this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the deci sions made (e.g. policies, regulations) when hazard and toxic information is known.
Tests Required under the Proposed HPV Chemical Test Rule for Glycine (CASRN 56

- 40

- 6)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Rea dy Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel  **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.2 Ethane, 1,1,1,2,2,2

- hexachloro

- (CASRN 67

- 72

- 1) 

### The total number of potentially exposed workers is likely to exceed 1,000 based on reported IUR data for this chemical (U.S. EPA, 2010b). No IUR consumer/commercial category was reported for this chemic al. Its uses include lubricating greases and oils, nonstructural caulking compounds and sealants, pyrotechnics, plasticizers for cellulose esters, insecticides and moth repellant, and rubber process solvents (Scorecard, 2009b; U.S. NLM, 2009b). EPA believ es this chemical would meet the designation criteria of “substantial or significant human exposure ” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the dec isions made (e.g. policies, regulations) when hazard and toxic information is known.

### 8

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

- (CASRN 67

- 72

- 1)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel  **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.3 Plumbane, tetraeth yl

- (CASRN 78

- 00

- 2) 

### The IUR commercial/consumer product category “Lubricants, greases, and fuel additives” was reported for this chemical. Specific uses include engine lubricants, antiknock additives in leaded gasoline and cleaners for combustion devices (U.S. NLM, 2009b). The total number of potential workers and consumers exposed to this chemical could exceed 10,000; therefore, EPA believes this chemical would meet the designation criteria of “substantial or significa nt human exposure” (U.S. EPA, 2010a). Therefore, a substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is kno wn. Tests Required under the Proposed HPV Chemical Test Rule for Plumbane, tetraethyl

- (CASRN 78

- 00

- 2)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Ma mmalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel     **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.4 1H

- Benzotriazole (CASRN 95

- 14

- 7) 

### Three IUR commercial/co nsumer products categories were reported for this chemical (U.S. EPA, 2010b). The “Lubricants, greases and fuel additives” category includes substances added to gasoline, kerosene, and distillate fuel oil after refining. The “Metal products” category inclu des chemical in metals and metallic substances. The “Other” category includes commercial and consumer products not elsewhere specified. The NLM database identified this chemical as an ingredient in inside

- the

- home products, such as antimicrobials in cosmet ics, rug and upholstery cleaners, chemical intermediates for dyes and pharmaceuticals, dishwasher detergents, and corrosion inhibitors in auto radiator fluids and water

- cooling systems (Scorecard, 2009b; U.S. NLM, 2009b; Milne, 2005). The total number of p otentially exposed workers exceeds 1,000 workers based on NOES data and the number of consumers exposed exceeds 10,000 based on IUR data (U.S. EPA, 2010b). Additionally, the production volume of the chemical increased between 1986 and 2006 IUR data collec tion periods (U.S. EPA, 2010b). Based on this information, EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure ” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers,
consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

### 8

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

- Benzotriazole (CASRN 95

- 14

- 7)

Meltin g Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel    **Note: Specific benefit s related to these tests are described in Section**  **8.3**

**.**
8.4.5 2H

- 3,1

- Benzoxazine

- 2,4(1H)

- dione (CASRN 118

- 48

- 9) 

### The IUR commercial/consumer product categories “Agricultural products (non

- pesticidal)” and “Other” were reported for th is chemical. Some uses of this chemical within the agricultural category include: chemical intermediates for pesticides, fragrances, polyurethane diamine curing agents, pigments, dyes, fertilizers and soil conditioners (U.S. NLM, 2009b; PMC Specialties Gro up, Inc., 2009a). The “Other” categorization indicates that the chemical may be used in an unknown number of additional products in other sectors, thus possibly raising the amount of chemical release or exposure. It is expected that exposure of this chemic al could reach more than 10,000 consumers. Based on this information, EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers , consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.
Tests Required under the Proposed HPV Chemical Test Rule for 2H

- 3,1

- Benzoxazine

- 2,4(1H)

- d ione (CASRN 118

- 48

- 9)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel       **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**


### 8.4.6 1,2

- Benzis othiazol

- 3(2H)

- one, 1,1

- dioxide, s odium s alt (1:1) (CASRN 128

- 44

- 9) 

### The NLM database identified approximately 132 personal care products that include this chemical as an ingredient (U.S. EPA, 2010b). The products include cologne, toothpaste, chemical intermediates for pharmaceuticals, and metal coatings (Scorecard, 2009c; U.S. HHS, 2009; IARC, 1999; PMC Specialties Group, Inc., 200 9b; Attarzadeh et al., 2008). The IUR commercial/consumer product category “Other” was reported for this chemical, indicating that this chemical is present in an unknown number of other products that may potentially have a high number of exposures. Based o n this information, EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed to the chemi cal would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

### 8

- 14 Tests Required under the Proposed HPV Chemical Test Rule for 1,2

- Benzisothiazol

- 3(2H)

- one, 1,1

- dioxide, sodium salt (CASRN 128

- 44

- 9)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel       **Note: Specific benef its related to these tests are described in Section**  **8.3**

**.**
8.4.7 Glycine, N

- (carboxymeth yl)

- , s odium s alt (1:2) (CASRN 928

- 72

- 3) 

### The total number of potentially exposed workers is likely to exceed 1,000 based on reported IUR data for this chemical (U.S. EPA, 2010b ). No IUR consumer/commercial category was reported for this chemical. The chemical is used to produce glyphosphosphate, a herbicide uses to control weeds (China Chemical Reporter, 2010). Because of its consumer and commerci al use, EPA believes this chemical meets the criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the de cisions made (e.g. policies, regulations) when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Glycine, N

- (carboxymethyl)

- , sodium salt (1:2) (CASRN 928

- 72

- 3)

Melting Point Boiling Point Vapor Pressure P artition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel      **Note: Specific benefits related to these tests are describ ed in Section**  **8.3**

**.**
8.4.8 Phos phonic acid, dibutyl es ter (CASRN 1809

- 19

- 4) 

### The IUR commercial/consumer product categories were claimed as confidential business information (CBI) for this chemical (U.S. EPA, 2010a). Products containi ng the chemical include antioxidants, intermediates in the formation of extreme pressure anti

- wear, friction modifier additives and lubricating oils and greases (U.S. NLM, 2009b; Milne, 2005). They may be used by more than 10,000 consumers. Its IUR product ion volume in 2006 falls in the 1 to 10 million pounds range. Based on this information, EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significan t number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.
Tests Required under the Proposed HPV Chemical Test Rule for Phosphonic acid, dibutyl ester (CASRN 1809

- 19

- 4)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro / Devel      **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.9 2,5

- Furandione, 3

- (dodecen

- 1

- yl)dih ydro

- (CASRN 25377

- 73

- 5) 

### The total number of potentially exposed workers exceeds 1,000 b ased on NOES data (U.S. EPA, 2010b) for this chemical. The main IUR commercial/consumer product category was “Other” (chemicals

### 8

- 15 contained in commercial and consumer products not elsewhere classified). This condition indicates this chemical may exist in an unknown number of products that may cause potentially high exposures to consumers and workers. Other sources explain the additional uses for this chemical, including curing agents in epoxy resins systems, intermediates for the preparation of plasticizers a nd thermoplastics and paints, detergent raw material, paper sizing ingredient, waterproofing agents, starch modifier, and germicides (Dixie Chemical Company, 2007; Electron Microscopy, 2007). With several uses and users, EPA believes this chemical would me et the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policie s, regulations) when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 2,5

- Furandione, 3

- (dodecenyl)dihydro

- (CASRN 25377

- 73

- 5)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubi lity Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel           **N Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.10 2,5

- Furandione, dih ydro

- 3

- (tetrapropen yl) (CASRN 26544

- 38

- 7) 

### The IUR commercial/consumer product categories “Lubricants, greases, and fuel additives,” “Paints and coatings” and “NRO” (not readily obtainable) were reported for this c hemical. Chemicals in these product categories include surfactants, intermediates for esters or amides or imides, brake fluids, alkyd resin modifiers, gelling agents, corrosion inhibitors, paints, varnishes, enamels, paint and varnish removers (Trigon Chem ie GmbH, 2006). It is expected that consumers will use a wide variety of these products; hence, the number of persons utilizing these products would likely exceed 10,000 consumers. EPA believes this chemical would meet the designation criteria of “substan tial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of consumers who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known

. Tests Required under the Proposed HPV Chemical Test Rule for 2,5

- Furandione, dihydro

- 3

- (tetrapropenyl) (CASRN 26544

- 38

- 7)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel           **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.11 B utanedioic acid, 2

- (tetrapropen yl) (CASRN 27859

- 58

- 1) 

### The total number of potentially exposed workers exceeds 1,000 based on IUR and NOES data (U.S. EPA, 2010b). Additionally, the number of consumers potentially exposed to this chemical could exceed 10,000 due to its various uses within the IUR commercial/consumer product category, “Lubricants, greases, and fuel additives.” Products containing this chemical include fuel additives and rust inhibitors (EPO, 1998; US PTO, 1995). Based on this information, EPA believes this chemical would m eet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. polici es, regulations) when hazard and toxic information is known.

### 8

- 16 Tests Required under the Proposed HPV Chemical Test Rule for Butanedioic acid, (tetrapropenyl) (CASRN 27859

- 58

- 1)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubilit y Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel          **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.12 2,5

- Furandione, dih ydro

- 3

- (octadecen

- 1

- yl) (CASRN 28777

- 98

- 2) 

### Production volume data from the 2006 IUR indicates that aggregated totals for this chemical existed in the range of 10 to 50 million pounds. This volume may provide evidence fo r a possible “substantial release” designation (U.S. EPA, 2010b). The IUR commercial/consumer product category “Paper products” was reported for this chemical. Applicable uses of this chemical include antifreeze lubricants, engine oil lubricant additives, viscosity improvers, copy paper, epoxy, intermediates in alkaline paper sizing, gypsum board sheets, water treatment, corrosion inhibitor, and surfactant intermediates (Dixie Chemical Company, 2005a; Albemarle, 2005a). It is expected that paper products an d other materials will be used by more than 10,000 consumers or commercial workers. Based on the production volume and use information, EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). A substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.
Tests Required under the Proposed HP V Chemical Test Rule for 2,5

- Furandione, dihydro

- 3

- (octadecenyl) (CASRN 28777

- 98

- 2)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Ge notox Mammalian Toxicity

– Repeated Dose/Repro/ Devel         **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.13 1H

- Benzotriazole, 6 (or 7 )

- methyl

- (CASRN 29385

- 43

- 1) 

### The total number of p otentially exposed workers exceeds 1,000 based on NOES data (U.S. EPA, 2010b). The IUR commercial/consumer product category “Lubricants, greases, and fuel additives” was reported for this chemical. Chemicals reporting under this category are added to gasol ine, kerosene, and distillate fuel oil after refining; their primary use is to enhance or clean combustion devices. Additional sources list other specific uses of these additives: corrosion inhibitors for metals and antifreeze and paints and petroleum fuel s, biocides, chelating agents, stabilizers for polyurethane pre

- polymers, antioxidants, as well as intermediates for dyes, agricultural chemicals, UV light absorbers, and pharmaceuticals (Scorecard, 2009d; PMC Specialties Group, Inc., 2009c) Because many workers and consumers could be exposed to the wide variety of such chemical products, EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant n umber of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

### 8

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

- Benzotriaz ole, 4(or5)

- methyl

- (CASRN 29385

- 43

- 1)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repr o/ Devel      **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.14 2,5

- Furandione, 3

- (hexadecen

- 1

- yl)dih yd ro

- (CASRN 32072

- 96

- 1) 

### Production volume data from the 2006 IUR indicates that aggr egated totals for this chemical existed in the range of 50 to 100 million pounds, the most of the twelve sampled chemicals. This volume may provide evidence for a possible “substantial release” designation (U.S. EPA, 2010b). The IUR commercial/consumer pro duct category “Paper products” was reported for this chemical. Applicable uses of this chemical include copy paper, antifreeze lubricant, engine oil lubricant additive, epoxy, intermediates in alkaline paper sizing, gypsum board sheets, water treatment, co rrosion inhibitor, and surfactant intermediates (Dixie Chemical Company, 2005b; Albemarle, 2005b). It is expected that paper products and other materials will be used by more than 10,000 consumers and more than 1,000 workers (U.S. EPA, 2010b). Based on the production volume, product applications, users and use information, EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). A substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.
Tests Required under the Proposed HPV Chemical Test Rule for 2,5

- Furandione, 3

- (hexadecenyl)dihydro

- ( CASRN 32072

- 96

- 1)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel           **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.15 Quaternary ammonium compounds , benzylbis (h ydrogenated tallow alkyl)methyl, chlo rides (CASRN 61789

- 73

- 9) 

### This chemical is used in a variety of ways: an inert ingredient in nonfood use pesticide products, antistatic, hair conditioning, and surfactants (U.S. EPA, 2009b; EU Commission, 2009). No IUR category was reported for this chemical. It is expected that more than 10,000 individuals (whose identity is confidential business information) would be affected by this chemical’s release or exposure. EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substanti al or significant number of consumers who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

### 8

- 18 Tests Required under the Proposed HPV Chemical Test Rule for Quaternary amm onium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides (CASRN 61789

- 73

- 9)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicit y - Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel  **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**

8.4.16 1H

- Benzotriazole, 6 (or 7 )

- methyl

- , s odium s alt (CASRN 64665

- 57

- 2) 

### The tota l number of potentially exposed workers exceeds 1,000 based on NOES data (U.S. EPA, 2010b). Additionally, it is expected that approximately 10,000 consumers would be exposed to this chemical based on the IUR commercial/consumer product category “Other.” T his chemical is primarily utilized as a coolant in industrial equipment to prevent overheating. Its uses include: automotive radiator treatment fluid, engine coolant, corrosion inhibitor, metalworking coolant, antifreeze, aircraft

- de

- icing fluids, and cool ing water treatments (Berryman Products, Inc., 2001; Coolant Control, Inc., 2007; Penray Companies, Inc., 1991; Drew Chemical, 1987; 4

- Tek Industries, Inc., 1991). EPA believes this chemical would meet the designation criteria of “substantial or significan t human exposure” (U.S. EPA, 2010b). A substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

Tests Re quired under the Proposed HPV Chemical Test Rule 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt (CASRN 64665

- 57

- 2)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel       **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.17 Naphthenic acids , reactio n products with diet hylenetriamin e (CASRN 68131

- 13

- 5) 

### The total number of potentially exposed workers exceeds 1,000 based on NOES data and the total number of consumers exposed exceeds 10,000 based on NLM data (U.S. EPA, 2010b). The U.S. Patent Trademark Office reported that this chemical’s major uses are a corrosion inhibitor and an anti

- foulant in refinery systems and petrochemical industry (U.S. PTO 1985; U.S. PTO 1989; U.S. PTO 1992). Because numerous workers and consumers could be exposed to such chemical products, EPA be lieves this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Naphthenic acids, reaction products with diethylenetriamine (CASRN 68131

- 13

- 5)

Melting Point Boiling Poin t Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel     **Note: Specific benefits related to these tests are described in Section**  **8.3**

**.**

### 8

- 19 8.4.18 Fatty acids , tall

- oil, reaction products wi th diethylenetriamine, acetates (CASRN 68153

- 60

- 6) 

### The total number of potentially exposed workers exceeds 1,000 based on IUR data (U.S. E PA, 2010b). No IUR category was reported for this chemical. The chemical is used as food fortification, intermediate to corrosion inhibitors, and surface

- active polymers to control and stabilize dispersion (Berry, 2010; Kurzin, 2009; Fischer and Parker, 19 97). Based on this information, EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Fatty acids, tall

- oil, reaction products with diethylenetriamine, ac etates (CASRN 68153

- 60

- 6)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel           **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**

8.4.19 Quaternary ammonium compounds , benzyl

- C12

- 16

- alkyld imeth yl, chlorid es (CASRN 68424

- 85

- 1) 

### The total number of potentially exposed w orkers exceeds 1,000 based on IUR and NOES data (U.S. EPA, 2010b). The IUR commercial/consumer product category “Other” (chemicals contained in commercial and consumer products not elsewhere classified) was reported for this chemical. This condition indica tes that the chemical could exist in an unknown number of other products that may potentially have high numbers of exposures. The National Library of Medicine focuses on three particular sectors: automotive products, home products, and personal care produc ts (U.S. NLM, 2009b). More specifically, this chemical is used in microbiocides, disinfectants, and sanitizers (Scorecard, 2009e; U.S. HHS, 2009). It is expected that workers and consumers will use a wide variety of these products; hence, the number of per sons utilizing these products would likely exceed 10,000 consumers. EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). A substantial or significant number of workers, consumers o r others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Quaternary ammonium compounds, benzyl

- C12

- 1 6

- alkyldimethyl, chlorides (CASRN 68424

- 85

- 1)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Do se/Repro/ Devel    **Note: Specific benefits related to these tests are described in Section 8.3** 

8.4.20 2

- Butenediamide, (2E)

- , N1,N4

- bis [2

- (4,5

- dih ydro

- 2

- nortall

- oil alkyl

- 1H

- im idazol

- 1

- yl)eth yl] derivs . (CASRN 68442

- 77

- 3 ) 

### The total number of potentially exposed workers is likely to exceed 1,000 based on reported IUR data for this chemical (U.S. EPA , 2010b)

. No IUR consumer/commercial category was reported for this chemical and no uses of this chemical were explicitly stat ed. Its 2006 IUR production volume ranges from 1 million to 10 million pounds (U.S. EPA, 2010 a ). Based on this information, EPA believes this chemical

### 8

- 20 would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). The refore, a substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for 2

- Butenediamide, (2E)

- , N1,N4

- bis[2

- (4,5

- dihydro

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- yl)ethyl] derivs. (CASRN 68442

- 77

- 3)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel           **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.21 Quaternary a mmonium compounds , (oxydi

- 2,1

- eth anediyl)bis [co co alkyldim ethyl, dichlorides (CASRN 68607

- 28

- 3) 

### The total number of potentially exposed workers exceeds 1,000 (U.S. EPA, 2010b). The IUR commercial/consumer product category “Other” was reported for this chem ical, indicating that it exists in an unknown number of products that may create a high level of chemical exposures. Some of the products containing this chemical include microbiocides and corrosion inhibitors (PAN, 2009; Baker Petrolite, 2009). EPA believ es this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). A substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

Tests Required under the Proposed HPV Chemical Test Rule for Quaternary ammonium compounds, (oxydi

- 2,1

- ethanediyl)bis[coco alkyldimethyl, dichlorides (CASRN 68607

- 28

- 3)

Melting Poin t Boiling Point Vapor Pressure Partition Coefficient Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel      **Note: Specific benefits re lated to these tests are described in Section**  **8.3**

**.**
8.4.22 Pyridinium, 1

- (phen ylmethyl)

- , Et Me derivs ., chlorides (CASRN 68909

- 18

- 2) 

### The total number of potentially exposed workers exceeds 1,000 and the total number of consumers exp osed exceeds 10,000 based on IUR data (U.S. EPA, 2010b). The IUR commercial/consumer product category “Other” was reported for this chemical. The primary use of this chemical is an water soluble or oil dispersible corrosion inhibitors for oil field and oth er water treating systems (Lonza, 2009), but this chemical also exists in an unknown number of other commercial and consumer products. Because numerous workers and consumers could be exposed to such chemical products, EPA believes this chemical would meet the designation criteria of “substantial or significant human exposure” (U.S. EPA, 2010b). Therefore, a substantial or significant number of workers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.

### 8

- 21 Tests Required under the Proposed HPV Chemical Test Rule for Pyridinium, 1

- (phenylmethyl)

- , Et Me derivs., chlorides (CASRN 68909

- 18

- 2)

Melting Point Boiling Point Vapor Pressure Partition Coefficie nt Water Solubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel          **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**
8.4.23 Benzene , decylphenoxy (CASRN 69834

- 17

- 9 ) 

### The IUR commercial/consumer product category “Soaps and detergents” was reported for this chemical. This chemical is used in households as personal soaps, various types of washing detergents, dishwashing compounds, presoaks, and sco uring compounds. The total number of consumers using these products could exceed 10,000 persons; therefore, it could be considered as “significant human exposure” based on its wide commercial use (U.S. EPA, 2010b). A substantial or significant number of wo rkers, consumers or others who are exposed to the chemical would benefit from the decisions made (e.g. policies, regulations) when hazard and toxic information is known.



### 8.5 Potential Us ers of Information Generated by the Propos ed Rule

A s discussed above, a wide range of groups are expected to benefit from the availability of this information, including consumers, workers, scientists, industry representatives, government organizations, public health officials, the medical community, and foreign interests. By incorporating new hazard data on these chemicals into their decision

- making processes, users will achieve benefits resulting from improved decision

- making processes, and ultimately risk reduction. The data would be made available to the public, and may b e 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 Informat ion System (IRIS), the Toxic Substances Control Act Te st Submissions (TSCATS), the High Production Volume Information System (HPVIS), and Tox icology Information O n line (TOXLINE). These databases provide a variety of toxicological information in the form of study abstracts, information on effects, and more comprehensive information combining hazard and exposure information to provide risk information (e.g., IRIS). The U.S. National Library of Medicine (NLM) houses TOXLINE, a bibliographic database that inclu des the toxicological effects of drugs and other chemicals. Users can access TOXLINE through the Internet. NLM estimates that a single month’s a ccess to the database (February 200 9 ) consisted of 72 , 552 s earches via the Internet (U.S. NLM, 2009; U.S. NLM, 2 009c ). Tests Required under the Proposed HPV Chemical Test Rule for Benzene, decylphenoxy (CASRN 69834

- 17

- 9)

Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Sol ubility Ready Biodegra

dation Aquatic Toxicity Mammalian Toxicity

-

Acute Mammalian Toxicity

- Genotox Mammalian Toxicity

– Repeated Dose/Repro/ Devel           **Note: Specific benefits related to these tests are described in Section 8.3** 

**.**

### 8

- 22 The distribution of TSCATS user accounts purchased through a past vendor, Oxford Molecular Group (OMG) , 9



### Clearly, there is a wide variety of users of toxicological data. It is expected that there will be similar uses for the data generated as a result of this proposed test rule, and that some of these data may be incorporated into these databases. Users of, and the benefits they derive from , toxicological information are disc ussed in more detail below. indicates that the users of toxicological data are diverse. In 1998, a representative of OMG suggested that 6 percent of account holders were g overnment, 38 percent were the private sector, 4 percent were academic organizations, 40 percent were foreign interests, and 11 percent were nonsubscribers (estimates may not add due to rounding) (CIS, 1998). The current vendor, National Information Servic es Corp. (NISC), does not track this information. However, it does track the subscribers and non

- subscribers to whom NISC supplies copies of toxicological studies cited in the TSCATS database. NISC supplies approximately 38 percent of the copies to U.S. in dustrial entities, 27 percent to U.S. non

- industrial entities, 19 percent to non

- U.S. governments, 7 percent to U.S. consultants, and 11 percent to international consultants (CIS, 2003).

8.5.1 Cons umers /Bu yers 

### Economic theory maintains that competitive markets provide goods and services to the extent that the marginal benefit of the good or service to consumers is more than or equal to the marginal cost of production . Underlying this conclusion are two assumptions: that both consumers and producers have perfect information, and that the cost of conducting a market transaction is negligible. The need for chemical testing information stems from the fact that, in some ca ses, neither producers nor consumers have perfect information regarding the hazards associated with certain chemicals. If basic information on chemical hazards were known, consumers might alter the amount they would be willing to pay for the chemical. Ther efore, in the absence of complete information, the private market may be misallocating resources to the production of the chemical substance. Thus, one advantage of mandatory testing and dissemination of test results is that, once the information is made available to them, consumers can make better choices about products containing chemicals if they are better aware of the potential hazards. Consumers can respond to additional information by changing their purchasing decisions (i.e., increasing or decreasi ng consumption, as appropriate); by reducing the amount they are willing to pay for the product; or by changing the way they handle, store, use, or dispose of the product. This may move the market toward a more efficient allocation of resources. Thus, the role of toxicity information in resolving uncertainties can be particularly valuable.

8.5.2 Workers 

### When the data has been processed into a format available to workers, hazard information can play a role in guiding workers’ employment decisions and work practice s. If workers are aware of workplace hazards (e.g., the hazard associated with chemical substances to which they are exposed), they may choose not to work at a particular facility. If they decide to work there, informed workers can make better decisions ab out the precautions, if any, they should take to reduce their exposure to that chemical. These precautions may include taking proper care while handling and using certain chemicals or wearing protective clothing. Alternatively, a worker may seek a wage pre mium to compensate for increased workplace risk. Viscusi and O’Connor (1984) conclude that the value of new information to the worker can be measured by the increase in the wage premium (differential) as a greater understanding of workplace risk is gained. Thus, workers can seek a risk premium or take averting actions to protect themselves if information is available about the health effects of the chemicals they come into contact

9 Oxford Molecular Group’s Chemical Information System, which housed TSCATS, was acquired by National Information Services Corp. (NISC) in 2000.

### 8

- 23 with at work. EPA expects the potential benefits to workers to be large for c hemicals included in the proposed rule since they are manufactured and processed in large volumes.

8.5.3 Scien ce and Health Com munities 

### Chemical toxicity information is useful to a variety of scientific and health communities. For example, medical professionals are concerned about the health of patients exposed to chemicals, poison control centers distribute information on toxicity and treatment associated with poisoning, and scientists use toxicity information to characterize the effects of chemicals and to asse ss risks of chemical exposure. The literature includes specific examples where toxicity data have been summarized and interpreted: Kapp et al. (1996) summarize the results of TSCA Section 4 test rule studies for isopropanol, Glickman et al. (1995) report t he results of aquatic toxicity studies for cumene (isopropyl benzene), and Bogdanffy et al. (1990) present results of subchronic inhalation tests for vinyl fluoride. In addition, several published studies also rely on information from the RTECS database. R TECS is a database of toxicological information compiled, maintained, and updated by the National Institute of Occupational Safety and Health (NIOSH). Numerous vendors currently offer access to the database. RTECS currently covers more than 152,000 chemica ls and provides data on mutagenic effects, reproductive effects, tumorgenic effects, and acute toxicity effects, for example (NIOSH, 2005). Examples of published scientific literature using this particular database include Ruder et al. (1990) and Jones et al. (1998). The former study uses toxicity data available from the RTECS database to compute national estimates of occupational exposure to animal bladder tumorigens, while the latter study uses toxicological data from the RTECs database to compute relativ e potency factors for chemical compounds associated with increased risk of atherosclerosis to humans. The test results generated by the proposed rule are also expected to be used by scientists to increase the understanding of the health and environmental effects of these chemicals to which people may be exposed in the places where they live, work, study, and play.

8.5.4 The General Public 

### In addition to its impact on consumers of chemicals or products, the production or use of a chemical substance may impose ex ternal 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 imp acts are unknown to the public, inefficiencies in the production and consumption of the chemical substance will persist. The proposed test rule is valuable because the health and environmental data it generates provide a better understanding of the externa l costs involved in the production and use of chemical substances. Because the information will be made publicly available, members of the general public will then be empowered to help address the market failure through individual actions they may take to protect themselves from exposure to the chemical substance (averting behaviors) or activities designed to pressure firms or governments to reduce the externalities associated with production (e.g., lobbying activities). One can expect that if reliable test data are disseminated to the public, community and public interest groups can initiate a dialogue with the manufacturers of hazardous chemicals and encourage them to improve their safety measures and assess their environmental management plans.

8.5.5 Firms and their Shareholders 

### As noted earlier, industry is an important user of chemical hazard information. Physical/chemical properties and environmental fate information is used to better develop the handling and safety procedures for chemicals, develop emergency preparedness plans, follow principles of the Responsible

### 8

- 24 Care® Initiative of the American Chemistry Council (ACC), and competitively participate in today’s chemical market. Toxicity data help to screen the chemicals for which such precautions are most imp ortant. The ACC’s Responsible Care® Initiative includes as guiding principles the following:

**•** “To design and develop products that can be manufactured, transported, used and disposed of or recycled safely”;

**•** “To work with customers, carriers, suppliers, dist ributors, and contractors to foster the safe and secure use, transport, and disposal of chemicals and provide hazard and risk information that can be accessed and applied in their operations and products ;”

**•** “ To promote pollution prevention, minimization of waste and conservation of energy and other critical resources at every stage of the life cycle of our products”; and

**•** “To support education and research on the health, safety, and environmental effects of our products and processes” (ACC, 2010).

Considera tion of these principles supports the need for toxicological information on chemical products used and manufactured by this industry. The Chemical Industry Institute of Toxicology (CIIT), a research institute sponsored by ACC, government, and industry, not es that chemical research has helped companies ensure safety in manufacturing, use, and disposal of chemicals (CIIT, 1998 and CIIT, 2001). Thus, companies are more likely to avoid potential liability concerns from inappropriate handling of chemicals. Simil ar advantages are expected from the information developed as a result of the proposed rule. Data generated as a result of the proposed rule are also expected to be sufficient for the OECD SIDS program. Data meeting the requirements of the SIDS program can be used to develop initial assessments of chemicals that are shared worldwide. Because this information is shared, companies may avoid duplicative efforts to meet the requirements of other countries where they may also manufacture and sell certain chemical s. This could lead to cost savings for companies that operate internationally. Corporate shareholders also benefit from the data developed in the rule. When a firm is incorporated and its shares are traded on the stock market, maximizing a firm’s profits is analogous to maximizing shareholder value. There are a number of ways in which the provision of information regarding the production practices and output of a firm can affect shareholder value. First, production processes and output that result in adver se consequences to human health and the environment may eventually result in substantial liabilities to the firm. Therefore, any new information regarding potential threats to human health or the environment may cause investors to re

- evaluate the potential future liabilities (and hence profitability) of a firm. Second, when an investor who prefers providing capital to environmentally benign companies discovers that a firm’s use of toxics is inconsistent with his or her preferences, he or she may move invest ment funds toward other, more environmentally friendly firms. There is a growing body of empirical literature evaluating the effects of environmental information disclosures on firms and their shareholders. In an effort to estimate the economic cost of haz ardous waste mismanagement, Muoghalu and Rogers (1992) modeled the effect of Superfund lawsuit announcements on firms’ stock values. The authors estimated that stock values dropped an average of $30.7 million when news of a new Superfund lawsuit was made p ublic. Blacconiere and Patten (1994) examined the effect of the 1984 Union Carbide chemical leak in Bhopal, India, on other chemical firms’ stock prices. They found that firms in which chemical operations made up a larger portion of total revenue experienc ed greater losses in stock value immediately following the leak.

### 8

- 25 Thus, some evidence suggests that investors respond to new information regarding a firm’s potential environmental liabilities by reassessing the value of the firm’s stock. If test results ar e 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 potentia l losses in the capital markets. It is clear that, while beneficial to shareholders, this information may also cost the company if share values drop. These costs would offset some of the benefits to shareholders.

8.5.6 Government 

### The information developed in res ponse to the proposed rule will benefit society by reducing costs and improving the quality of government decision and policy making. EPA itself is a user of TSCA Section 4 test results in three primary ways. First, EPA can use the chemical

- specific inform ation 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 tes t 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.
S upport EPA Regulatory Activities . When developing risk management strategies, EPA must decide whether or not to regulate the use of a chemical substance or mixture to protect society. Basic toxicity data are not available for many chemicals, but exposure c ontrols have no environmental value if these chemicals are not a concern. The lack of data on health and environmental effects can affect sound decision making by government and others (Wehmeier, 2001). Regulating most certainly involves costs to both EPA (e.g., resources required to develop, promulgate, and enforce a regulation) and to society at large (e.g., foregone benefits derived from the use of the chemical substance, resources diverted from other uses). Although not regulating avoids these costs, so ciety will face a welfare loss if the chemical turns out to harm human health and the environment. Taylor et al. (1993) considered the value of test information in supporting decisions about the control of chemicals whose cancer potency is untested or unkn own. While not specifically addressing the value of the basic toxicity testing data required by this proposed rule, their results suggest there is value to (cancer) testing information, particularly at intermediate levels of anticipated human exposure to a chemical. The authors contend that information (from cancer testing) may be less valuable where very high levels of exposure are expected because no test can perfectly distinguish carcinogens from non

- carcinogens. In the EPA context, the probability that a chemical poses a risk depends on the chemical’s toxicological properties, exposure pathways, dose

- response relationships, and other factors. Testing rules help resolve some of these uncertainties. Thus, test information can help EPA decision makers avoi d over

- regulating a relatively safe chemical and under

- regulating a risky chemical. Provide Information to Other Government Agencies

. Under TSCA Section 4, EPA has the authority to require firms to conduct tests of specific chemicals to determine the poten tial risk posed by these substances. However, other governmental agencies, such as the Food and Drug Administration, Consumer Product Safety Commission, NIOSH, and Occupational Safety and Health Administration, share regulatory authority over chemical subs tances or products containing them, or, in the case of NIOSH, compile summaries of available information and recommend exposure limits. Therefore, EPA serves as a conduit for chemical hazard information between the chemical producers and these other agenci es. In addition to providing chemical test results to other federal agencies, EPA may make this information available to other interested parties such as state, local, and tribal government agencies, which can use the data to inform their own decision maki ng.

### 8

- 26 Information Provision as an Alternative to Traditional Regulation. Publicly disclosing TSCA Section 4 chemical test results also provides an alternative to traditional regulation. As described above, the provision of chemical pollution and hazard info rmation can be used to, among other things, empower individuals to take actions that they deem appropriate in response to chemical risks. In addition to fulfilling democratic notions of “right

- to

- know” information, regulations provide a low

- cost avenue for pollution and hazard control when regulatory resources are scarce due to the large number of substances to be controlled (Tietenberg, 1998).

8.5.7 Foreign Interes ts 

### The toxicity data developed as a result of the test rule are not known to be available anywhere in the world community, so the rule is also expected to save other countries the expense of collecting and interpreting toxicological data. At the United Nations Conference on Environment and Development in 1992, delegates adopted Agenda 21 of Chapter 19, which discusses chemical safety and includes program areas. One program area is international assessments of chemical risks, part of which includes the assessment of chemical hazards (United Nations, 1992) . The International Forum on Chemical Safety (IFCS) was formed in 1994 and has developed priorities for action in the implementation of Agenda 21. These include recognition of the activities sponsored by OECD in the area of chemical management and encouragement of the use of OECD as a means to carry out ac tivities on chemical safety (IFCS, 199 4 ). Data developed as a result of the proposed rule will be sufficient for the development of initial assessments of chemicals under OECD’s SIDS program. Thus, other countries will benefit from the development of these data and can use the data without having to independently develop the information. Such information exchange will result in cost savings to other countries and will enable their governments to more effectively manage chemicals for safety as pledged under Agenda 21.

### 9

- 1 

# Chapter 9 - Other Impact Analyses Several statutes and executive orders (EOs) pertain to the proposed test rule. This chapter presents statements discussing unfunded mandates, environmental justice, children’s health, and paperwork burden, among others.


### 9.1 Paperwork Reduction Act The Paperwork Reduction Act mandates that federal agencies estimate the recordkeeping and reporting burden of a proposed rule. In this context, the term “burden” is interpreted as the total time, effort, or financial resources expe nded by people to generate, maintain, retain, disclose, or provide information to or for a federal agency. This includes the time needed by regulated entities to review instructions and to develop, acquire, install, and use technology and systems to collec t, validate, verify, and disclose information. Time taken to adjust existing ways to comply with any previously applicable instructions and requirements and to train personnel to respond to the information collection task is also included. In this section, burden hours for both the industry respondents and the government are estimated.

9.1.1 Indus try Burd en 

### In this report, total industry burden hours represent the sum of time spent on reporting and on other administrative activities. Industry respondents will spe nd time on reporting activities associated with TSCA Section 4 test rules: preparing letters of intent and study plans, preparing test results for submission to EPA, recording test results, preparing laboratory reviews, preparing corporate reviews, conduct ing associated clerical work for final report preparation, conducting recordkeeping activities, and applying for exemptions. Under this proposed rule, respondents are also asked to submit robust summaries on a voluntary basis. In addition to the reporting burden, respondents will spend additional time on other, non

reporting administrative activities such soliciting laboratory bids, selecting laboratories, monitoring tests under progress, developing cost

- sharing agreements, and auditing the laboratories for compliance with EPA’s Good Laboratory Practice (GLP) standards. The procedure for estimating the total industry burden follows. Estimate the Reporting Burden. As shown in Section 4.2.3 of this report, EPA estim ates that manufacturers will submit letters of intent and study plans, resulting in 15 3 final reports. It is additionally required that all final test reports be accompanied by a robust summary of results. EPA also assumes that it will receive 88 exemption applications pursuant to the proposed rule. EPA estimated that it takes a respondent 40 hours to prepare a letter of intent and study plan, 73 hours to write a final report for a short

term study, 12 hours to prepare a robust summary, and 2 hours to prepa re an exemption application. The unit labor hours are derived from the previous information collection requests and are believed to reflect the burden that will be incurred for the proposed rule. The reporting burden estimates for this rule are detailed in Exhibit 9

- 1 . The total reporting burden generated by the rule is estimated to be approximately 14,000 hours.

Exhibit 9
- 1 : Reporting Burden Estimate for the Propos ed Rule Item Hours per Item Total Items Total Hours Letter of Intent and Study Plans 40 23 920 Final Reports 73 15 3 11,000 Robust Summaries 12 15 3 2,000 Exemption Applications 2 88 176 Total 14, 000 Note: Values may not sum due to rounding

### 9

- 2 Estimate the Other Administrative Burden. Respondents also spend time on other administrative activities including soliciting laboratory bids, selecting laboratories, monitoring tests under progress, developing cost

- sharing agreements, and auditing the laboratorie s for compliance with EPA’s Good Laboratory Practice (GLP) standards. EPA has calculated the costs and burdens of these activities as 25 percent of the total laboratory testing costs. Based on this calculation, other administrative costs associated with la boratory testing are estimated to amount to $ 9 1 4 , 000 ($1. 30 million) under the least (average) cost assumption. These costs are translated into burden estimates using an average labor cost of $55.01 per hour , which is based on a labor mix that is 20 percen t managerial, 60 percent technical, and 20 percent clerical. The estimated administrative burden based on this approach is approximately 17, 000 (2 4 , 000 ) hours under the least (average) cost assumption. Estimate the Export Notification Burden. As explained in Section 4.2.4 , EPA expects 25 export notifications to be filed for each chemical included in the proposed rule (575 notification letters in total). This analysis assumes that the export notification burden r anges from 0.5 hours to 1.5 hours per notice. Thus, this analysis assumes that export notification requires 0.5 hours per notice under the least cost scenario and 1 hour per notice under the average cost scenario. Consequently, the export notification burd en triggered by the proposed rule is estimated to equal 28 8 hours (575 hours) under the least (average) cost scenario. Estimate the Total Industry Burden. The total industry burden is the sum of the total administrative burden and the export notification b urden. Total industry burden estimates are summarized in Exhibit 9

- 2

. The total industry burden is estimated to eq ual 3 1 , 000 hours (3 8 , 000 hours) in the least (average) cost scenario. The average burden per chemical is estimated to be approximately 1, 000 ( 2,000 ) hours (rounded) in the least (average) cost scenario.

Exhibit 9
- 2 : Total Industry Burden Hour Estimate for the Proposed Rule Activity Least Co st Scenario (Approximate Hours) Average Cost Scenario (Approximate Hours) Reporting Activities 14,000 14,000 Other Administrative Activities 17,000 2 4 ,000 Export Notification Burden 288 575 Total Industry Burden 3 1 ,000 3 8 ,000 Average Burden Per Chemic al ( 23 chemicals) 1, 3 5 0 1 , 6 60 Note: Values may not sum due to rounding

9.1.2 Government Burden 

### The government will also spend time processing, reviewing, and analyzing the information that will be collected under the proposed test rule. As explained in Sectio n Chapter 5 , this work is assumed to be performed by a GS

- 13, Step 1, FTE employee.
It is further assumed that 23 letters of intent and study plans, 15 3 final reports, 15 3 robust summaries, and 88 exemption requests will be fil ed in response to this rule. The estimated unit government burden for processing letters of intent and study plans (3 hours), final reports (5 hours), and robust summaries and exemption applications (1 hour each) is derived from the previous information co llection requests. Exhibit 9

- 3 presents the estimated government burden hours based on these assumptions. The total government burden is estimated to equal approximately 1,0 00 hours (rounded)

.

### 9

- 3 Exhibit 9
- 3 : Estimated Government Burden for the Proposed Test Rule Item Hours per Item Total Items Total Hours Letter of Intent and Study Plans 3 23 69 Final Reports 5 15 3 7 6 5 Robust Summaries 1 15 3 15 3 Exemption Requests 1 88 88 Total 1,000 Note: Values may not sum due to rounding.



### 9.2 Unfunded Mandates Reform Act Federal agencies are required to assess the effects of federal regulations on state, local, or tribal governments, and on the private sector under Title II of the Unfunded M andates Reform Act of 1995 (UMRA). In particular, UMRA requires that agencies prepare a written statement to accompany any rulemaking that “includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggr egate, or to the private sector, of $100 million or more (annually adjusted for inflation) in any one year” (Section 202(a)). The written impact statement under Section 202 must include (1) an identification of the statutory authority; (2) an assessment of the benefits and costs of the rule; and (3) a description of the agency’s consultation with state, local, and tribal government officials during the development of the rule. EPA estimates that the proposed rule will not cost the private or public sectors $100 million or more in any one year. As shown in Exhibit 4

- 7 the maximum total cost incurred by the private sector in complying with the proposed rule and associated requirements triggered by the rule is approximately $7. 65 milli on (average cost scenario). This includes laboratory and administrative costs, as well as the cost of export notifications under the average cost scenario. Assuming a 7 percent discount rate and a 15

- year amortization period, the maximum annualized complia nce cost for industry is approximately $8 40 ,000 per year (average cost scenario). 10



### Furthermore, because the proposed rule is focused on manufacture rs and importers of chemicals, EPA has not estimated that any costs will be imposed on any non

- federal government entity, or on state, local, and tribal governments. Moreover, while it does not impose costs on state, local, and tribal governments, the prop osed rule can be of value to these agencies. As explained in Government cost, annualized using similar assumptions, is estimated to equal approximately $8,000 per year

.

Chapter 8 , if EPA makes the test data collected as a result of the proposed rule publicly available, then other government agencies can use the data to inform their o wn regulations and decision making. Executive Order 12875, “Enhancing the Intergovernmental Partnership” (58 FR 58093, October 28, 1993), requires federal agencies to determine whether certain regulatory actions create unfunded federal mandates on state, l ocal, or tribal governments. EPA’s estimate that no state, local, or tribal governments would be affected by this proposed rule is based on a search conducted in March 1999 of past submissions to EPA. This search demonstrated that state, local, or tribal governments have never submitted letters of intent to test, exemption applications, or export notifications to EPA.

10 Compliance costs are annualized using a 7 percent discount rate to reflect the opportunit y cost of capital, and over a 15

- year period to reflect the life of the chemical.

### 9

- 4 9.3 Executive Order 13132

– Federalis m Under Executive Order 13132, “ Federalism ” (64 FR 43255, August 10, 199 9), EPA must evaluate the “federali sm implications” of the proposed rule. This proposed rule will not have sub stantial direct effects on the s tates, on the relationship between t he national government and the s tates, or on the distribution of power and responsibilities among the various lev els of government, as specif ied in the executive order. The proposed rule establish es testing and recordkeeping requirements that apply to manufacturers (including importers) and processors of certain chemicals. Because EPA has no in formation to indicate t hat any s tate or local government manufactures or processes the chemical substan ces covered by this action, the proposed r ule does not apply directly to s tates and localities and will not affect s tate and local governments.


### 9.4 Executive Order 13175

– Cons ult ation and Coordination with Indian Tribal Governments Under Executive Order 13175, “ Consultation and Coordination with Indian Tribal Governments ” (65 FR 67249, November 9, 200 0), EPA must determine if the proposed rule has tribal implication s. Tribal impli cations are not expected because the proposed rule will not have any e ffect on tribal governments, on the relationship between the federal government and the Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in the executive order. EPA’s estimation that no s tate, local, or tribal governments would be affected by this proposed rule is based on a search conducted in March 1999 of past submissions to EPA. This search demonstrated that state , local, or tribal governments have never submitted letters of intent to test, exemption applications, or export notifications to EPA. Furthermore, based on the submissions received for the most recent IUR none of the chemicals listed in this pro posed rule are manufactured by state, local, or tribal governments (in quantities of 25,000 lbs or more at a single site). Thus, EPA has no information to indicate that any tribal government manufactures or processes the chemical substances covered by this action

. 

### 9.5 Executive Order 13045

- Children’s Health Executive Order 13045, “ Protection of Children from Environmental Health Risks and Safety Risks ” (62 FR 19885, April 23, 1997), requires that federal agencies examine the impacts of each re gulatory action on children for any economically significant regulation (as defined by Executive Order 12866) that the agency has reason to believe may disproportionately affect children. The proposed rule is does not e stablish an environmental standard intended to mitig ate health or safety risks and will not have an annual effect on the economy of $100 million or more, nor does it otherwise have a disproportionate effect on children. Nevertheless, the information obtained by the testing in this rule will be used to infor m the Agency’s decision

- making process regarding chemicals to which children may be disproportionately exposed. This information will also assist the Agency and others in determining whether the chemicals in this proposed rule present potential risks, allo wing the Agency and others to take appropriate action to investigate and mitigate those risks.


### 9.6 Executive Order 13211

– Energy Supply, Dis tribution, or Us e Eight chemicals in the proposed regulation have been identified as having uses associated with energy supply, distribution or use (see Exhibit 2

- 3 for detail) such as fuel additives and refinery system corrosion inhibitors. Given the low cost of the rule and lack of restrictions on the use of the chemicals resulting from this proposed rule, it is unlikely that there will be significant impacts on the supply, distribution, or use of energy

.

### 9

- 5 9.7 National Technology Trans fer and Advanc ement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104

– 113 (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specificatio ns, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and appl icable voluntary consensus standards. This proposed rule involves technical standards because it proposes to require the use of particular test methods. If the Agency makes findings under TSCA section 4(a), EPA is required by TSCA section 4(b) to include s pecific standards or test methods that are to be used for the development of the data required in the test rules issued under TSCA section 4. For some of the testing that would be required by this rule, EPA is proposing the use of voluntary consensus stand ards issued by ASTM and ISO that evaluate the same type of toxicity as the TSCA and OECD test guidelines, where applicable. EPA is not aware of any potentially applicable voluntary consensus standards that evaluate partition coefficient ( n
- octanol/water) generator column, water solubility (column elution and generator column), acute inhalation toxicity, bacterial reverse mutations, in vivo mammalian bone marrow chromosomal aberrations, combined repeated dose with reproductive/developmental toxicity screen, repeated dose 28

– day oral toxicity screen, or the reproductive developmental toxicity screen that could be considered in lieu of the TSCA guidelines, 40 CFR 799.6756, 799.6784, 799.6786, 799.9130, 799.9510, 799.9538, 799.9365, 799.9305, and 799.9355, resp ectively, upon which the test standards in this proposed rule are based.


### 9.8 Executive Order 12898

– Environmental J us tice Executive Order 12898, “ Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ” (59 FR 7629 , February 16, 1994), requires each agen cy to address and identify

“ disproportionally high and adverse human health or environmental effects of its programs, policies, and activities on minority a nd low

- income populations .”
The proposed rule does not have an adverse impact on the environmental and health conditions in low

income and minority communities

. The information collected under this proposed rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with the chemicals covered by the rule. Although not directly impacting environmental justice

- related concerns, this information will enable the Agency to better protect human health and th e environment, including in low

income and minority communities. The pr oposed rule is directed at 23 chemicals for which basic toxicity information is currently unavailable even though they are widely used in commerce. All consumers of these chemical products and all workers who come into contact with these chemicals could be nefit if data regarding the chemicals’ health and environmental effects were developed. Therefore, it does not appear that the costs and the benefits of the proposed rule will be disproportionately distributed across different geographic regions or among d ifferent categories of individuals.

### 10

- 1 

# Chapter 10

– References

4

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### 1532/1555 Engine Coolant Treatment

-- 6850

- 00F030544

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- 11

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### 10

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. Wage Rates for Economic Analyses of the Toxics Release Inventory Program

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### 10

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### A

- 1 

# Appendix A Laboratory Tes t Cos t Es timates

This appendix descri bes the methodology used in developing each of the test cost estimates used in this analysis . Test costs were estimated by either EPA’s Office of Pollution Prevention and Toxics (OPPT) or Office of Pesticide Programs (OPP) in various years; all costs were inflated to 2009$ for use in this economic analysis. Test cost estimation procedures included obtaining a high and a low estimate; these values were averaged to develop the “best” estimate. Test cost results are shown in Exhibit 4

- 1. Unless otherwise descr ibed in the sections below, the least cost and average cost scenarios for this analysis consider the same “best” estimate cost. 

### Category A. Physical/C hem ical P ropert ies Melting Point (A1)
. This test is required to be conducted according to the American S ociety for Testing and Materials (ASTM) E 324

– 99 (Capillary tube) standard

. This standard corresponds with the OECD 102 protocol, as well as the EPA test guidelines at §796.1300 and §830.7200

. The EPA OPP estimated the cost of this testing endpoint in 2005 by using an industry expert’s best professional judgment ( U.S. EPA, 2009a)

. Boiling point (A2)
. This test is required to be conducted according to the ASTM E 1719

– 05 (Ebulliometry) standard

. This standard corresponds with the OECD 103 protocol, as well a s the EPA test guidelines §796.1220 and §830.7220

. The EPA OPP estimated the cost of this testing endpoint in 2005 by using an industry expert’s best professional judgment ( U.S. EPA, 2009a). Vapor pressure (A3). This test is required to be conducted acco rding to the ASTM E 1782

– 03 (Thermal analysis) standard

. This standard corresponds with the OECD 104 protocol, as well as the EPA test guidelines §796.1950 and §830.7960. The EPA OPP estimated the cost of this testing endpoint in 2005 by using an industry expert’s best professional judgment ( U.S. EPA, 2009a).

n - Octanol/Water Partition Coefficient (A4)
. The selection of the method to complete this test under the proposed rule varies depending on the estimated log K ow 

### of the chemical 11



### • log K ow 

### < 0: no testi ng required. :

**•** log K ow 

### range 0

– 1: Method A or B

**•** log K ow 

### range > 1

– 4: Method A or B or C

**•** log K ow 

### range > 4

– 6: Method B or C

**•** log K ow 

### > 6: Method C Method A is required to be conducted according to the guideline §799.6755 (Shake flask), which corresponds with the OECD 107 protocol, as well as the EPA test guidelines §796.1550 and §830.7550

. The EPA OPP estimated the cost of this testing endpoint in 2007 by using EPA staff scientist best professional judgment ( U.S. EPA, 2009a).

11 EPA recommends, but does not require, that log 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 solubi lity test requirement. One method, among many similar methods, for estimating water solubility is described in Meylan et al. (1996).

### A

- 2 Method B is required to be condu cted according to the ASTME E 1147

– 92(2005) (Liquid chromatography) standard, which corresponds with the OECD 117 protocol, as well as the EPA test guidelines at §796.1570 and §830.7570

. The EPA OPP estimated the cost of this testing endpoint in 2005 by co ntacting up to nine contact research organizations (laboratories) and asking for specific pricing information. ( U.S. EPA, 2009a)

. Method C is required to be conducted according to the guideline §799.6756 (Generator column), which corresponds with the EPA test guidelines at §796.1720 and §830.7560

. The EPA Office of Pesticide Programs estimated the cost of this testing endpoint in 2005 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information ( U.S. EP A, 2009a)

. Because the log K ow 

### of each subject chemical is unknown, the least cost scenario for this analysis assumes the least costly of the methods listed above

. The average cost scenario considers the average value of all of these methods.
Water Solub ility (A5). The selection of the method to complete this test under the proposed rule would be determined by the chemical’s estimated water solubility:

**•** 5,000 milligram/Liter (mg/L): Method A or B.

**•** 10 mg/L

— 5,000 mg/L: Method A, B, C, or D.

**•** 0.001 mg/L

— 10 mg/ L: Method C or D.

**•** ≤ 0.001 mg/L: No testing required. Method A is required to be conducted according to the ASTM E 1148

– 02 (Shake flask) standard

. Method B requires following the guideline at §799.6784 (Shake flask). Method C requires following the guideli ne at §799.6784 (Column elution)

. These protocols all corresponds with the OECD 105 protocol, as well as the EPA test guidelines §796.1840 and §830.7840. The EPA OPP estimated the cost of this testing endpoint in 2007 by using EPA staff scientist best prof essional judgment ( U.S. EPA, 2009a). Method D is required to be conducted according to the guideline at §799.6786 (Generator column) which corresponds with the EPA test guidelines at §796.1860 and §830.7860

. The EPA OPP estimated the cost of this testing endpoint in 2007 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information (U .S. EPA, 2009a)

. Because the water solubility of each subject chemical is unknown, the least cost scenario for this anal ysis assumes the least costly of the methods listed above

. The average cost scenario considers the average value of all of these methods.


### Category B

. Environmental Fate Ready biodegradation (B). The test method used for this endpoint will depend on the p hysical and chemical properties of the test substance, including its water solubility. Method A is required to be conducted according to the ASTM E1720

– 01 (Sealed vessel CO 2 

### production test) standard

. Method B is required to be conducted according to the ISO 14593 (CO 2 

### headspace test) standard. Method C is required to be conducted according to the ISO 7827 (Method by analysis of dissolved organic carbon (DOC)) standard. Method D is required to be conducted according to the ISO 9408 (Determination of oxyge n demand in a closed respirometer)

### A

- 3 standard. Method E is required to be conducted according to the ISO 9439 (CO 2 

### evolution test) standard. Method F is required to be conducted according to the ISO 10707 (Closed bottle test) standard. Method G is required t o be conducted according to the ISO 10708 (Two

- phase closed bottle test) standard. Test cost estimates were based on either the EPA test guideline §835.3110 or the following OECD protocols for ready biodegradation: OECD 301A (DOC die

- away test), OECD 301 B (carbon dioxide evolution test), OECD 301C (modified MITI test (I)), OECD 301D (closed bottle test), OECD 301E (modified OECD screening test), and OECD 301F (manometric respirometry test). The EPA Office of Pollution, Prevention and Toxics estimated the cost of this testing endpoint in 2009 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information. (Abt Associates Inc., 2009)

. 

### Category C. Aquatic Toxicity The proposed testing requirement s in the aq uatic toxicity testing category include some combination of the following tests: acute toxicity to fish, acute toxicity to Daphnia , chronic toxicity to Daphnia , and toxicity to plants (algae). EPA recognizes that, for chemicals with high log K ow 

### values, ac ute toxicity studies are of limited value in assessing the substances’ aquatic toxicity. For such situations, the OECD HPV SIDS Program recommends use of chronic toxicity testing in Daphnia in place of acute toxicity testing in fish and Daphnia . Therefore, if aquatic toxicity testing is required for a particular chemical, a manufacturer must determine if the test chemical falls into one of two test groups, based on the chemical’s log K ow 

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

### of less than 4.2. T est Group 2 consists of test chemicals with a log K ow 

### greater than or equal to 4.2 . Each of the proposed testing requirements (except for C6) have separate requirements by Test Group. Specific testing requirements are as follows: (C1). Test Group 1: Acute Toxicity to Fish; Acute Toxicity to Daphnia ; Toxicity to Plants (Algae)

. Test Group 2 : Chronic Toxicity to Daphnia ; Toxicity to Plants (Algae). (C2). Test Group 1: Acute Toxicity to Daphnia ; Toxicity to Plants (Algae). Test Group 2: Chronic Toxicity to Daphnia ; Toxicity to Plants (Algae.) (C3). Test Group 1: Acute Toxicity to Fish; Toxicity to Plants (Algae). Test Group 2 : Chronic Toxicity to Daphnia ; Toxicity to Plants (Algae). (C4). T est Group 1: Acute Toxicity to Fish; Acute Toxicity to Daphnia

. Test Group 2 : Chronic Toxicity to Daphnia (C5)
. Test Group 1 : Acute Toxicity to Daphnia

. Test Group 2 : Chronic Toxicity to Daphnia

. (C6)
. Toxicity to Plants (Algae)

. (C7). Test Group 1 : Acute Toxicity to Fish.

T est Group 2 : Chronic Toxicity to Daphn ia

.

### A

- 4 The acute toxicity to fish testing endpoint is required to be conducted according to ASTM E 729

– 96 (2002), which corresponds with the OECD 203 protocol, as well as the EPA test guidelines §797.1400 and §8 5 0.1075. The EPA OPP estimated the cost of this testing endpoint in 2008 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information ( U.S. EPA, 2009a)

. The acute toxicity to Daphnia testing endpoint is required to be conducted according to ASTM E 72 9

– 96(2002), which corresponds with the OECD 202 (Part 1) protocol

. The EPA OPPT estimated the cost of this testing endpoint in 2007 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information . (Abt Ass ociates Inc., 2007)

. The chronic toxicity to Daphnia testing endpoint is required to be conducted according to ASTM E 1193

– 97(2004), which corresponds with the OECD 202 protocol as well as the EPA test guidelines §797.133 and §850.1300. The EPA OPP estimat ed the cost of this testing endpoint in 2005 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information ( U.S. EPA, 2009a)

. The toxicity to plants (algae) testing endpoint is required to be conducted a ccording to (ASTM E 1218

– 04e1), which corresponds with the OECD 201 protocol The EPA OPPT estimated the cost of this testing endpoint in 2009 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing informatio n . (Abt Associates, Inc., 2009) For each testing requirement (e.g., C1, C2, etc.), the cost of each test group (i.e., Test Group 1 or 2) is the sum of all the tests required for the group. Because the log K ow 

### of each subject chemical is unknown, for each t esting requirement, the least cost scenario for this analysis assumes the least costly of the test groups. The average cost scenario considers the average value both test groups. Category D. Mammalian Toxicity
- Acute (D)
. The test method used for this en dpoint will depend on the chemical’s physical state at room temperature (25° C):

**•** 

### Gas: Method A

**•** 

### Liquid or solid: Method B
Method A, Acute Inhalation Toxicity (rat), is required to be conducted according to the guideline at §799.9130, which corresponds wi th the OECD 403 protocol as well as the EPA test guidelines §798.1150 and §870.1300. The EPA OPP estimated the cost of this testing endpoint in 2007 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing info rmation ( U.S. EPA, 2009a)

. Method B, Acute Oral Toxicity (rat) , is required to be conducted according to the ASTM E 1163

– 98(2002) standard or the guideline at §799.9110(d)(1)(i)(A)

. These protocols correspond with OECD 423 protocol as well as the EPA test guidelines §798.1175 and §870.1100. The EPA OPP estimated the least and average cost of this testing endpoint in 2005 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information ( U.S. EPA, 2009a)

.

### A

- 5 For Method B, EPA suggests using a neutral red uptake basal cytotoxicity assay (using normal human keratinocytes or mouse BALB/c 3T3 cells) to estimate the starting dose . EPA estimated the costs for these tests in 2003; the least costly of the two species is c onsidered in this analysis.
Because the chemical’s physical state at room temperature is unknown, the least cost scenario for this analysis assumes the least costly of Method A or B. The average cost scenario considers the average of both methods. 

### Category E

. Mammalian Toxicity
- Genotoxicity Bacterial Reverse Mutation Test ( in vitro ) (E1). This test is required to be conducted according to the guideline at §799.9510, which corresponds with the OECD 471 protocol as well as the EPA test guideline at § 798.51 00 and § 870.5100

. The EPA OPP estimated the cost of this testing endpoint in 20 03 by contacting up to nine contact research organiz ations (laboratories) and asking for specific pricing information ( U.S. EPA, 2009a)

. Chromosomal Damage (E2)
. Manufacturers r equired to meet this testing endpoint may conduct one of three tests: t he in vitro mammalian chromosome aberration test; the mammalian bone marrow chromosomal aberration test; or the mammalian erythrocyte micronucleus test.

**•** The in vitro Mammalian Chromoso me Aberration test is required to be conducted according to the guideline at §799.9537, which corresponds with the OECD 473 protocol as well as the EPA test guidelines §798.5375 and §870.5375. The EPA OPP estimated the cost of this testing endpoint in 2007 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information ( U.S. EPA, 2009a).

**•** The Mammalian Bone Marrow Chromosomal Aberration test is required to be conducted according to the guideline at §799.9538 , which corresponds with the OECD 475 protocol as well as the EPA test guidelines §798.5385 and §870.5385. The EPA OPP estimated the cost of this testing endpoint in 2005 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information ( U.S. EPA, 2009a)

. **•** The Mammalian Erythrocyte Micronucleus test is required to be conducted according to the guidelines at §799.9539, which corresponds with the OECD 474 protocol as well as the EPA test guidelines §798.5395 an d §870.5395. The EPA OPP estimated the cost of this testing endpoint in 2005 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information ( U.S. EPA, 2009a).

The least cost scenario assumes the least c ostly of the test methods

. The average cost scenario considers the average of all three methods. 

### Category F. Mammalian Toxicity

– Repeated Dose/ Reproduction/ Developmental The proposed testing requirements in the mammalian toxicity

– repeated dose/ repro duction/ developmental testing category include one or more of the following three tests: Repeated Dose 28

– Day Oral Toxicity Study in rodents; Reproduction/Developmental Toxicity Screening Test; and Combined Repeated Dose Toxicity Study with the Reproducti on/Developmental Toxicity Screening Test.

### A

- 6 (F1). Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, or both the Reproduction/Developmental Toxicity Screening Test and the Repeated Dose 28

– Day Oral Toxicity St udy in rodents (F2). Reproduction/Developmental Toxicity Screening Test. (F3). Repeated Dose 28

– Day Oral Toxicity Study in rodents. (F4). Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test , or Reproductio n/Developmental Toxicity Screening Test

. The combined repeated dose toxicity study with the reproduction/developmental toxicity screening test is required to be conducted according to the guideline at §799.9365, which corresponds with the OECD 422 protoco l as well as the EPA test guideline at §870.3650 . The EPA OPPT estimated the cost of this testing endpoint in 1994, and inflated to 2009$ in a previous economic analysis (U.S. EPA, 2009c).
The reproduction/developmental toxicity screening test is required to be conducted according to the guideline at §799.9355, which corresponds with the OECD 421 protocol as well as the EPA test guideline at §870.3550 . The EPA OPPT estimated the cost of this testing endpoint in 2007 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information. (Abt Associates Inc., 2007)
The repeated dose 28

– day oral toxicity study in rodents is required to be conducted according to the guideline at §799.9305, which corresponds with the O ECD 407 protocol and the EPA test guideline at § 870.3050 . The EPA OPPT estimated the cost of this testing endpoint in 2009 by contacting up to nine contact research organizations (laboratories) and asking for specific pricing information. (Abt Associates I nc., 2007)
Under the F1 and F4 testing requirements, the least cost scenario assumes the least costly of either of the two choices. The average cost scenario considers the average of the two choices.

### B

- 1 

# Appendix B Wage Rate Calculations

This appendix describes the deri vation of the fully loaded labor rates and inflation factors used in calculating costs of labor, materials, and other inputs. All cost estimates are presented in 2009 dollars.


### B.1 Derivation of Loaded Wage Rates The fully loaded unit labor cost for managerial, professional/technical, and clerical labor in the regulated industry and for EPA staff is estimated by adding fringe benefits and overhead costs to the hourly wage or annual salary for each category following the method described in Wage Rates for Economi c Analysis of the Toxics Release Inventory Program (U.S. EPA, 2002b). This appendix describes the method employed to estimate the fully loaded unit labor costs for each labor category, and presents the results of the analysis. Labor categories used in the analysis correspond to the U.S. Bureau of Labor Statistics (BLS) Standard Occupational Classification (SOC) system. In March 2004, BLS began using the North American Industry Classification System (NAICS) instead of the Standard Industrial Classification ( SIC) System, and the Standard Occupational Classification (SOC) system instead of the Occupational Classification System (OCS ). Exhibit B

- 1 summarizes the crosswalk between old and new occupational titles, and list s the SOC titles that correspond to the managerial, professional/technical, and clerical labor categories used in this analysis.

Exhibit B
- 1 : Detail of Labor Categories Used in the Analysis Labor Category Used in the Anal ysis BLS Old Title (OCS) BLS New Title (SOC) Managerial Executive, administrative, and managerial Management, business, and financial Professional/Technical Professional specialty and technical Professional and related Clerical Administrative support, including clerical Office and administrative support Sources: BLS, 2006, Table 2 and Weinstein, 2004

B.1.1 Derivation of Unit Labor Rates for Managerial, Pro fes s ional/Technical, and Clerical Indus try Emplo yees 

### Wages and fringe benefit d ata for managerial, pr ofessional/technical, and clerical labor are from the BLS Employer Costs for Employee Compensation (ECEC) historical data, for December 2009 (BLS, 2010 a , Table 2). 12 

### The costs of fringe benefits such as paid leave and insurance, specific to each labor categ ory, are taken from the same BLS report (BLS, 2010 a ). Fringe benefits as a percentage of wages are calculated separately for each labor category. For example, for December 2009, the average wage rate for professional/technical labor was $35.96, and the ave rage fringe be nefit was $ 17.42

. 13 

### Exhibit B

- 2 Therefore, fringe benefits as a percentage of wages were $17. 42 /$35.9 6 , or approximately 48 percent (see ).

12 Past economic analyses used ECEC data series specific to white

- collar workers in the manufacturing sector. However, thos e data sets were disc ontinued in March 2007, and these historical data were the best alternative. In a phone conversation (February 11, 2009) , a BLS employee could not identify a better data set to use. 13 Past economic analyses have used the term “technica l” labor. Here the category is called “professional/technical” labor, to make clear how it relates to BLS categories. In 2004, BLS changed from the Occupational Classification System, OCS, to the Standard Occupational Classification system, SOC. In the pro cess, the “Professional specialty

### B

- 2 An additional loading factor of 17 percent is applied to wages to account for overhead. 14



### Fully loaded costs for managerial and clerical labor are calculated in a similar manner, as shown in This approach is used for consistency with Office of Pollution Prevention and Toxics (OPPT) economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program , June 10, 2002 (U.S. EPA, 2002a), a nd the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report , August 2002 (U.S. EPA, 2002b). This overhead loading factor is added to the benefits loading factor, and the total is then applied to the base wage to derive the fully lo aded wage. For example, the December 2009 fully loaded wage for profes sional/technical labor is $35.96 × (1+ 0.4 84 + 0.17) = $59.49.

Exhibit B

- 2

. B.1.2 Derivation of Unit Labor Rates for EP A Staff 

### Unit labor rates for EPA staff are calculated based on annual federal salaries for the Washington

Baltimore area published by the Office of Personnel Management (OPM) and effective January 2009 (OPM, 2009). The average salary for one full

- time equivalent (FTE) staff member is estimated as the salary for a GS

- 13 Step 1 employee, which is $ 86,927 annually without fringe benefits and overhead costs

. In order to derive the fully loaded salary, EPA m ultiplied the annual salary by an assumed loading factor of 1.6 to reflect federal fringe benefits and overhead, which results in a fully loaded annual salary of $139,083

. The Agency loading factor of 1.6 is from an EPA guide entitled Instructions for Prep aring Information Collection Requests (ICRs) (U.S. EPA, 1992, page 30, footnote 9). The 60 percent assumption was labeled “the benefits multiplication factor” in the EPA guide, but has been used in many EPA Office of Pollution Prevention and Toxics ICRs to reflect both fringe benefits and overhead for federal staff. For example, it was used in an August 2000 document supporting ICR No. 1139.06, with the following explanation:
The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (th e benefits multiplication factor). The multiplication fa ctor 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 Caro l Rawie (OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits but also overhead.

and technical” category became the “Professional and related” category. However, the coverage of the old and new occupational groups is approximately the same. See 

### the BLS article, “ Comparing Current and Former Industry
an d Occupation ECEC Series ” ( Weinstein et al. , 2004). 14 The change was used in the 2003 PMN SNUR economic analysis (U.S. EPA, 2003). In some earlier reports, the 17 percent had been applied to wages

- plus

- fringe benefits.

### B

- 3 Exhibit B
- 1 : Derivation of Loaded Wage Rates

Labor Category Data Source for Wa ge Information Date Wage Fringe Benefit Fringes as % wage Overhead as % wage 1 Fringe + overhead

factor Loaded Wages (a) (b) (c)=(b)/(a) (d) (e)=(c)+(d)+1 (f)=(a) * (e) Managerial BLS ECEC , Private Manufacturing industries , “Management, business, and f inancial occupations” 2 Dec

- 09 $42.36 $18.68 44.10% 17% 1.61 $68.24
Professional/ Technical BLS ECEC , Private Manufacturing industries, “Professional and related occupations“ 2 Dec

- 09 $35.96 $17.42 48.44% 17% 1.65 $59.49
Clerical BLS ECEC , Private Ma nufacturing industries, “Office and administrative support occupations” 2 Dec

- 09 $17.21 $8.17 47.47% 17% 1.64 $28.31

EPA staff FTE Annual federal staff cost: OPM Washington

Baltimore

- Northern Virginia, DC

- MD

- PA

- VA

- WV, area, GS

- 13 Step 1 pay rates, with 60% overhead. 3 Jan

- 09 $86,927 (annual) -- [Included in 60% overhead] 60% 1.60 $139,083 (annual) $41.79 (hourly) -- $66.87 (hourly) Notes: 1 An overhead rate of 17% was used based on assumptions in U.S. EPA, 2002b and U.S. EPA, 2002a. 2 ( BLS 20 10a , S upplemental Table 2). 3 The federal salary is the unloaded federal GS

- 13 Step 1 salary ($8 6 ,9 27 for 200 9 ), from the OPM salary table for Washington

- Baltimore

- Northern Virginia (OPM, 2009 ) . The 60% fringes

and

- overhead rate is from an EPA guide , Instruction s for Preparing Information Collection Requests (ICRs) (U.S. EPA, 1992 ). Hourly rates are based on annual salary divided by 2,080 hours.

### C

- 1 

# Appendix C Costs

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

C ASRN Chemical Name Testing Cost Analytical Methodology

Validation Cost Total Admini
strative Cost 1 Export Notification Cost Total Industry Compliance Cost 2 Government Cost Total Social Cost 3

1 56

- 40

- 6 Glycine $17,000 $0 $13,000 $687 $31,000 $858 $32,000 2 67

- 72

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

- hexachloro

- $10,000 $6,000 $10,000 $687 $26,000 $858 $27,000 3 78

- 00

- 2 Plumbane, tetraethyl

- $ 47,000 $15,000 $32,000 $687 $9 5 ,000 $2,000 $97,000 4 95

- 14

- 7 1H

- Benzotriazole $156,000 $15,000 $56,000 $687 $226,000 $2,000 $228,000 5 118

- 48

- 9 2H

- 3,1

- Benzoxazine

- 2,4(1H)

- dione $216,000 $23,000 $88,000 $687 $327,000 $3,000 $330,000
6 128

- 44

- 9 1,2

- Benzisothiazol

- 3(2H)

- one, 1,1

- dioxide, sodium salt (1:1) $196,000 $15,000 $78,000 $687 $290,000 $3,000 $293,000

7 928

- 72

- 3 Glycine, N

- (carboxymethyl)

- , sodium salt (1:2) $39,000 $0 $34,000 $687 $74,000 $2,000 $76,000
8 1809

- 19

- 4 Phosphonic acid, dibutyl ester $197,000 $23,000 $79,000 $687 $299,000 $3,000 $302,000 9 25377

- 73

- 5 2,5

- Furandione, 3

- (dodecen

- 1

- yl)dihydro

- $234,00 0 $27,000 $106,000 $687 $367,000 $4,000 $371,000 10 26544

- 38

- 7 2,5

- Furandione, dihydro

- 3

- (tetrapropenyl)

- $239,000 $27,000 $111,000 $687 $377,000 $5,000 $382,000 11 27859

- 58

- 1 Butanedioic acid, 2

- (tetrapropenyl)

- $233,000 $27,000 $105,000 $687 $365,000 $ 4,000 $370,000
12 28777

- 98

- 2 2,5

- Furandione, dihydro

- 3

- (octadecen

- 1

- yl)

- $231,000 $27,000 $101,000 $687 $359,000 $4,000 $364,000
13 29385

- 43

- 1 1H

- Benzotriazole, 6 (or 7 )

- methyl

- $189,000 $17,000 $73,000 $687 $280,000 $2,000 $282,000
14 32072

- 96

- 1 2,5

- Fur andione, 3

- (hexadecen

- 1

- yl)dihydro

- $239,000 $27,000 $111,000 $687 $377,000 $5,000 $382,000

15 61789

- 73

- 9 Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides $17,000 $0 $11,000 $687 $28,000 $1,000 $29,000

16 64665

- 57

- 2 1H

- Benzotriazole, 6 (or 7 )

- methyl

- , sodium salt $196,000 $17,000 $83,000 $687 $296,000 $3,000 $300,000

17 68131

- 13

- 5 Naphthenic acids, reaction products with diethylenetriamine $198,000 $27,000 $74,000 $687 $300,000 $2,000 $303,000

18 68153

- 60

- 6 Fatty acids , tall

- oil, reaction products with diethylenetriamine, acetates $239,000 $27,000 $112,000 $687 $378,000 $5,000 $382,000

19 68424

- 85

- 1 Quaternary ammonium compounds, benzyl

- C12

- 16

- alkyldimethyl, chlorides $20,000 $0 $21,000 $687 $41,000 $2,000 $43,000

20 68442

- 77

- 3 2

- Butenediamide, (2E)

- , N1,N4

- bis[2

- (4,5

- dihydro

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- $239,000 $27,000 $111,000 $687 $377,000 $5,000 $382,000

### C

- 2 yl)ethyl] derivs.

21 68607

- 28

- 3 Quaternary ammonium compounds, (oxydi

- 2,1

- ethanediyl)bis[coco alkyldimeth yl, dichlorides $34,000 $0 $34,000 $687 $69,000 $2,000 $71,000

22 68909

- 18

- 2 Pyridinium, 1

- (phenylmethyl)

- , Et Me derivs., chlorides $233,000 $27,000 $106,000 $687 $365,000 $4,000 $370,000
23 69834

- 17

- 9 Benzene, decylphenoxy

- $239,000 $27,000 $111,000 $6 87 $377,000 $5,000 $382,000 TOTAL $3,6 54 , 000 $3 95 ,000 $1, 6 60 , 000 $1 6 , 000 $5,725 , 000 $7 2 , 000 $5,7 97 , 000 1 Total administrative cost includes both reporting and non

- reporting administrative costs. 2 Total industry compliance cost includes testing cost, analytical methodology validation cost, administrative cost, and export notification cost. 3 Total social cost includes total industry compliance cost and government cost. Note: Values may not sum due to rounding

### C

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

CASRN Chemical Name Testing Cost Analytical Methodology

Validation Cost Total Administrative Cost 1 Export Notification Cost Total Industry Compliance Cost 2 Government Cost Total Social C ost 3

1 56

- 40

- 6 Glycine $17,000 $0 $13,000 $1,000 $31,000 $858 $32,000 2 67

- 72

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

- hexachloro

- $10,000 $6,000 $10,000 $1,000 $27,000 $858 $28,000 3 78

- 00

- 2 Plumbane, tetraethyl

- $ 54 ,000 $ 15,0 00 $ 3 4 ,000 $1,000 $ 104 ,000 $2,000 $ 106 ,000 4 95

- 14

- 7 1H

- Benzotriazole $159,000 $15,000 $56,000 $1,000 $231,000 $2,000 $233,000 4 118

- 48

- 9 2H

- 3,1

- Benzoxazine

- 2,4(1H)

- dione $321,000 $23,000 $114,000 $1,000 $459,000 $3,000 $463,000
6 128

- 44

- 9 1,2

- Benzisothiazol

- 3(2H)

- one, 1,1

- dioxide, s odium salt (1:1) $293,000 $15,000 $103,000 $1,000 $412,000 $3,000 $415,000

7 928

- 72

- 3 Glycine, N

- (carboxymethyl)

- , sodium salt (1:2) $40,000 $0 $35,000 $1,000 $77,000 $2,000 $79,000
8 1809

- 19

- 4 Phosphonic acid, dibutyl ester $299,000 $23,000 $104,000 $1, 000 $428,000 $3,000 $431,000 9 25377

- 73

- 5 2,5

- Furandione, 3

- (dodecen

- 1

- yl)dihydro

- $346,000 $27,000 $134,000 $1,000 $507,000 $4,000 $512,000 10 26544

- 38

- 7 2,5

- Furandione, dihydro

- 3

- (tetrapropenyl)

- $351,000 $27,000 $139,000 $1,000 $518,000 $5,000 $523,00 0 11 27859

- 58

- 1 Butanedioic acid, 2

- (tetrapropenyl)

- $345,000 $27,000 $133,000 $1,000 $506,000 $4,000 $510,000
12 28777

- 98

- 2 2,5

- Furandione, dihydro

- 3

- (octadecen

- 1

- yl)

- $343,000 $27,000 $129,000 $1,000 $500,000 $4,000 $504,000
13 29385

- 43

- 1 1H

- Benzotria zole, 6 (or 7 )

- methyl

- $236,000 $17,000 $84,000 $1,000 $338,000 $2,000 $341,000
14 32072

- 96

- 1 2,5

- Furandione, 3

- (hexadecen

- 1

- yl)dihydro

- $351,000 $27,000 $139,000 $1,000 $518,000 $5,000 $523,000

15 61789

- 73

- 9 Quaternary ammonium compounds, benzylbis(hydro genated tallow alkyl)methyl, chlorides $17,000 $0 $11,000 $1,000 $29,000 $1,000 $30,000

16 64665

- 57

- 2 1H

- Benzotriazole, 6 (or 7 )

- methyl

- , sodium salt $242,000 $17,000 $95,000 $1,000 $355,000 $3,000 $358,000

17 68131

- 13

- 5 Naphthenic acids, reaction product s with diethylenetriamine $309,000 $27,000 $102,000 $1,000 $439,000 $2,000 $441,000

18 68153

- 60

- 6 Fatty acids, tall

- oil, reaction products with diethylenetriamine, acetates $351,000 $27,000 $140,000 $1,000 $518,000 $5,000 $523,000

1 9 68424

- 85

- 1 Quaternar y ammonium compounds, benzyl

- C12

- 16

- alkyldimethyl, chlorides $20,000 $0 $21,000 $1,000 $42,000 $2,000 $44,000

20 68442

- 77

- 3 2

- Butenediamide, (2E)

- , N1,N4

- bis[2

- (4,5

- dihydro

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- yl)ethyl] derivs. $351,000 $27,000 $139,000 $1,0 00 $518,000 $5,000 $523,000

21 68607

- 28

- 3 Quaternary ammonium compounds, (oxydi

- 2,1

- ethanediyl)bis[coco alkyldimethyl, dichlorides $36,000 $0 $34,000 $1,000 $71,000 $2,000 $74,000

### C

- 4 22 68909

- 18

- 2 Pyridinium, 1

- (phenylmethyl)

- , Et Me derivs., chlorides $345 ,000 $27,000 $134,000 $1,000 $506,000 $4,000 $511,000
23 69834

- 17

- 9 Benzene, decylphenoxy

- $351,000 $27,000 $139,000 $1,000 $518,000 $5,000 $523,000 TOTAL $ 5,1 82 , 000 $3 95 ,000 $2,0 42 , 000 $3 3 , 000 $ 7,6 52 , 000 $7 2 ,000 $7, 723 , 000 1 Total administrative cost includes both reporting and non

- reporting administrative costs. 2 Total industry compliance cost includes testing cost, analytical methodology validation cost, administrative cost, and export notification cost. 3 Total social cost includes total indust ry compliance cost and government cost. Note: Values may not sum due to rounding

### C

- 5 Exhibit C
- 3 : Annualized Social Costs 1
CASRN Chemical Name Least Cost Scenario Average Cost Scenario 3 years, 3% 3 years, 7% 3 yea rs, 3% 3 years, 7% 1 56

- 40

- 6 Glycine $11,000 $12,000 $11,000 $12,000 2 67

- 72

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

- hexachloro

- $10,000 $10,000 $10,000 $11,000 3 78

- 00

- 2 Plumbane, tetraethyl

- $ 34 ,000 $ 3 7 ,000 $ 37 , 00 0 $ 40 , 000 4 95

- 14

- 7 1H

- Benzotriazole $81,000 $87,000 $ 82,000 $89,000 5 118

- 48

- 9 2H

- 3,1

- Benzoxazine

- 2,4(1H)

- dione $117,000 $126,000 $164,000 $176,000
6 128

- 44

- 9 1,2

- Benzisothiazol

- 3(2H)

- one, 1,1

- dioxide, sodium salt (1:1) $103,000 $111,000 $147,000 $158,000
7 928

- 72

- 3 Glycine, N

- (carboxymethyl)

- , sodium sal t (1:2) $27,000 $29,000 $28,000 $30,000 8 1809

- 19

- 4 Phosphonic acid, dibutyl ester $107,000 $115,000 $152,000 $164,000 9 25377

- 73

- 5 2,5

- Furandione, 3

- (dodecen

- 1

- yl)dihydro

- $131,000 $141,000 $181,000 $195,000 10 26544

- 38

- 7 2,5

- Furandione, dihydro

- 3

- (tet rapropenyl)

- $135,000 $146,000 $185,000 $199,000 11 27859

- 58

- 1 Butanedioic acid, 2

- (tetrapropenyl)

- $131,000 $141,000 $180,000 $194,000 12 28777

- 98

- 2 2,5

- Furandione, dihydro

- 3

- (octadecen

- 1

- yl)

- $129,000 $139,000 $178,000 $192,000 13 29385

- 43

- 1 1H

- Benzot riazole, 6 (or 7 )

- methyl

- $100,000 $107,000 $120,000 $130,000 14 32072

- 96

- 1 2,5

- Furandione, 3

- (hexadecen

- 1

- yl)dihydro

- $135,000 $146,000 $185,000 $199,000
15 61789

- 73

- 9 Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides $ 10,000 $11,000 $11,000 $11,000
16 64665

- 57

- 2 1H

- Benzotriazole, 6 (or 7 )

- methyl

- , sodium salt $106,000 $114,000 $127,000 $136,000
17 68131

- 13

- 5 Naphthenic acids, reaction products with diethylenetriamine $107,000 $115,000 $156,000 $168,000

18 68153

- 60

- 6 F atty acids, tall

- oil, reaction products with diethylenetriamine, acetates $135,000 $146,000 $185,000 $199,000

1 9 68424

- 85

- 1 Quaternary ammonium compounds, benzyl

- C12

- 16

- alkyldimethyl, chlorides $15,000 $16,000 $15,000 $17,000

20 68442

- 77

- 3 2

- Butenediamid e, (2E)

- , N1,N4

- bis[2

- (4,5

- dihydro

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- yl)ethyl] derivs. $135,000 $146,000 $185,000 $199,000

21 68607

- 28

- 3 Quaternary ammonium compounds, (oxydi

- 2,1

- ethanediyl)bis[coco alkyldimethyl, dichlorides $25,000 $27,000 $26,000 $28,0 00
22 68909

- 18

- 2 Pyridinium, 1

- (phenylmethyl)

- , Et Me derivs., chlorides $131,000 $141,000 $181,000 $195,000 23 69834

- 17

- 9 Benzene, decylphenoxy

- $135,000 $146,000 $185,000 $199,000 TOTAL $2, 049 ,000 $2, 20 9 ,000 $2, 730 , 000 $2,9 43 ,000 1 Tot al social cost includes total industry compliance cost and government cost. Total social costs are discounted over three year s because these costs are expected to occur over the few years during which the actual testing occurs and EPA reviews studies. Disc ount rates of both 3 and 7 percent are presented following OMB Guidance contained in Circular A

- 4. Note: Values may not sum due to rounding

### C

- 6 Exhibit C
- 4 : Annualized Industry Compliance Costs 1
CASRN Chemical Name Least Co st Scenario Average Cost Scenario 15 years, 3% 7 years, 3% 15 years, 3% 7 years, 3% 1 56

- 40

- 6 Glycine $3,000 $5,000 $3,000 $5,000 2 67

- 72

- 1 Ethane, hexachloro

- $2,000 $4,000 $2,000 $4,000 3 78

- 00

- 2 Plumbane, tetraethyl

- $ 8,000 $ 15,000 $ 9,000 $ 17,000 4 95

- 14

- 7 1H

- Benzotriazole $19,000 $36,000 $19,000 $ 37 ,000 5 118

- 48

- 9 2H

- 3,1

- Benzoxazine

- 2,4(1H)

- dione $27,000 $ 53 ,000 $38,000 $ 74 ,000 6 128

- 44

- 9 1,2

- Benzisothiazol

- 3(2H)

- one, 1,1

- dioxide, sodium salt $24,000 $46,000 $34,000 $ 66 ,000 7 928

- 72

- 3 Glycine , N

- (carboxymethyl)

- , sodium salt (1:2) $6,000 $12,000 $6,000 $12,000 8 1809

- 19

- 4 Phosphonic acid, dibutyl ester $ 25 ,000 $ 48 ,000 $ 36 ,000 $ 69 ,000 9 25377

- 73

- 5 2,5

- Furandione, 3

- (dodecenyl)dihydro

- $ 31 ,000 $ 59 ,000 $42,000 $ 81 ,000 10 26544

- 38

- 7 2,5

- Furandi one, dihydro

- 3

- (tetrapropenyl)

- $ 32 ,000 $ 61 ,000 $43,000 $ 83 ,000 11 27859

- 58

- 1 Butanedioic acid, (tetrapropenyl)

- $ 31 ,000 $ 59 ,000 $42,000 $ 81 ,000 12 28777

- 98

- 2 2,5

- Furandione, dihydro

- 3

- (octadecenyl)

- $ 30 ,000 $ 58 ,000 $ 42 ,000 $ 80 ,000 13 29385

- 43

- 1 1H

- Benz otriazole, 4(or 5)

- methyl

- $23,000 $ 45 ,000 $ 28 ,000 $ 54 ,000 14 32072

- 96

- 1 2,5

- Furandione, 3

- (hexadecenyl)dihydro

- $ 32 ,000 $ 61 ,000 $43,000 $ 83 ,000
15 61789

- 73

- 9 Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides $2,000 $5, 000 $2,000 $5,000
16 64665

- 57

- 2 1H

- Benzotriazole, 4(or 5)

- methyl

- , sodium salt $ 25 ,000 $ 48 ,000 $ 30 ,000 $ 57 ,000 17 68131

- 13

- 5 Naphthenic acids, reaction products with diethylenetriamine $ 25 ,000 $ 48 ,000 $ 37 ,000 $ 70 ,000 18 68153

- 60

- 6 Fatty acids, tall

- oil, reaction products with diethylenetriamine, acetates $ 32 ,000 $ 61 ,000 $43,000 $ 83 ,000

19 68424

- 85

- 1 Quaternary ammonium compounds, benzyl

- C12

- 16

- alkyldimethyl, chlorides $3,000 $7,000 $4,000 $7,000

20 68442

- 77

- 3 2

- Butenediamide, (2E)

- , N1,N4

- bis[2

- (4,5

- di hydro

- 2

- nortall

- oil alkyl

- 1H

- imidazol

- 1

- yl)ethyl] derivs. $ 32 ,000 $ 61 ,000 $43,000 $ 83 ,000

21 68607

- 28

- 3 Quaternary ammonium compounds, (oxydi

- 2,1

- ethanediyl)bis[coco alkyldimethyl, dichlorides $6,000 $11,000 $6,000 $11,000
22 68909

- 18

- 2 Pyridinium, 1

- (ph enylmethyl)

- , Et Me derivs., chlorides $ 31 ,000 $ 59 ,000 $42,000 $ 81 ,000 23 69834

- 17

- 9 Benzene, decylphenoxy

- $ 32 ,000 $ 61 ,000 $43,000 $ 83 ,000 TOTAL $ 480,000 $91 9 ,000 $ 6 41 ,000 $1,22 8 ,000 1 Total industry compliance cost includes testing cost, analytical met hodology validation cost, administrative cost, and export notification cost. Total industry compliance costs are annualized at a 3 percent discount rate Industry compliance costs are used in the analysis of impacts of the rule on companies and the discount period differs from that used to calculate social costs. Note: Values may not sum due to rounding