Economic Analysis of the Proposed Rule to add 16 

Chemicals to the EPCRA Section 313 List of Toxic 

Chemicals

Prepared for:

Analytical Support Branch

Environmental Analysis Division

Office of Information Analysis and Access

Office of Environmental Information

US Environmental Protection Agency

February 16, 2010
i

Table of Contents

Table of Contents .................................................................................................... i

Table of Tables.......................................................................................................iv

Executive Summary .................................................................................................v

ES.1 Introduction ............................................................................................................................................v

ES.2 Need for Rule .........................................................................................................................................v

ES.3 Addition of Chemicals...........................................................................................................................v

ES.4 Estimated Reporting Activity................................................................................................................v

ES.5 Costs of the Proposed rule ................................................................................................................... vi

ES.5.1 Private Industry Costs ............................................................................................................ vi

ES.5.2 EPA Costs.............................................................................................................................viii

ES.5.3 Summary of Costs .................................................................................................................. ix

ES.6 Small Entity Analysis .......................................................................................................................... ix

ES.7 Benefits of the Proposed rule ................................................................................................................x

Chapter 1 – Background and Overview of Analysis ..............................................1-1

1.1 Overview of TRI ................................................................................................................................1-1

1.1.1 Pollution Prevention Act...................................................................................................... 1-2

1.1.2 Changes to the List of Chemicals........................................................................................1-2

1.1.3 Alternate Threshold..............................................................................................................1-3

1.1.4 Executive Order 12856 ........................................................................................................ 1-3

1.1.5 Changes to the List of Industries.........................................................................................1-3

1.1.6 Changes for Certain PBT Chemicals...................................................................................1-4

1.1.7 Burden Reduction Initiatives...............................................................................................1-4

1.1.8 Toxic Chemical Release Reporting Using North American Industry Classification System 

(NAICS) Rule..................................................................................................................................... 1-4

1.2 Chemicals for Addition to TRI.......................................................................................................... 1-4

1.2.1 NTP Cancer Classifications and Criteria ............................................................................1-5

1.2.2 RoC Review Process............................................................................................................1-6

1.2.3 EPA Review of the 11th RoC...............................................................................................1-6

1.3 Organization of This Report..............................................................................................................1-8

Chapter 2 – Estimates of the Number of Additional Forms and Affected Facilities2-1

2.1 Methods Used to Estimate Additional Reporting ............................................................................2-2

2.1.1 Methods Applicable to all Estimates...................................................................................2-2

2.1.2 Identification of Facilities Manufacturing the Proposed Chemicals................................. 2-3

2.1.3 Identification of Facilities Processing the Chemical during the Manufacture of Other 

Chemicals ...........................................................................................................................................2-4

2.1.4 Identification of Facilities Manufacturing, Processing, or Otherwise Using the Chemical in 

Sectors other than Chemical Manufacturing ....................................................................................2-6

2.2 Application of Estimation Methods by Chemical..........................................................................2-10

2.2.1 Isoprene (78-79-5)..............................................................................................................2-10

2.2.2 Furan (110-00-9).................................................................................................................2-10

2.2.3 1-Amino-2,4-Dibromoanthraquinone (81-49-2) ..............................................................2-12

2.2.4 Tetrafluoroethylene (116-14-3) .........................................................................................2-13

2.2.5 Glycidol (556-52-5)............................................................................................................2-14

2.2.6 Methyl Eugenol (93-15-2) ................................................................................................. 2-15

2.2.7 2,2-bis(Bromomethyl)-1,3-Propanediol (BBMP) (3296-90-0) .......................................2-17

2.2.8 Tetranitromethane (509-14-8)............................................................................................2-17

2.2.9 Nitromethane (75-52-5) .....................................................................................................2-19
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2.2.10 Vinyl Fluoride (75-02-5)....................................................................................................2-20

2.2.11 o-Nitroanisole (91-23-6) ....................................................................................................2-21

2.2.12 Phenolphthalein (77-09-8) ................................................................................................. 2-21

2.3 Estimated Number of Incremental Forms and Facilities...............................................................2-23

Literature Cited ..............................................................................................................................................2-27

Chapter 3 – Cost Estimates ..................................................................................3-1

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

3.2 Industry Cost Estimates.....................................................................................................................3-1

3.2.1 Methodology.........................................................................................................................3-1

3.2.2 Unit Cost Estimates..............................................................................................................3-2

3.2.3 Total Industry Costs .............................................................................................................3-8

3.3 EPA Costs...........................................................................................................................................3-8

3.4 Total Costs.......................................................................................................................................... 3-9

3.5 Summary...........................................................................................................................................3-10

Literature Cited ..............................................................................................................................................3-11

Chapter 4 – Small Entity Analysis ........................................................................4-1

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

4.2 Impact on Small Entities....................................................................................................................4-1

4.3 Definitions of Small Entities.............................................................................................................4-1

4.4 Methodology Overview.....................................................................................................................4-2

4.4.1 Generation of Company Revenue Data...............................................................................4-3

4.4.2 Estimating Impacts...............................................................................................................4-4

4.5 Results.................................................................................................................................................4-5

Literature Cited ................................................................................................................................................4-6

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

Literature Cited ................................................................................................................................................5-4

Appendix A – Background and Methodology for Additions to Polycyclic Aromatic 

Compounds (PACs) Category .............................................................................. A-1

A.1 Background and Methodology for Additions to Polycyclic Aromatic Compounds (PACs) Category

A-1

A.1.1 6-Nitrochrysene Production and 4-Nitropyrene Production............................................. A-1

A.1.2 6-Nitrochrysene and 4-Nitropyrene Processing or Otherwise Use .................................. A-2

A.1.3 Coincidental Manufacture of 1,6-Dinitropyrene and 1,8-Dinitropyrene .........................A-2

A.2 Number of RY2007 PACs Reporters by Sector.............................................................................. A-2

Literature Cited ............................................................................................................................................... A-8

Appendix B – Chemical Descriptions and Methods for Chemicals with no Expected 

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

B.1 Methods Used to Estimate No Reporting .........................................................................................B-1

B.1.1 Pharmaceutical Prescription and Dosage Method..............................................................B-1

B.1.2 Production Volume Method.................................................................................................B-2

B.1.3 Other Methods......................................................................................................................B-3

B.2 Application of Estimation Methods by Chemical............................................................................B-3

B.2.1 2,3-Dibromo-1-Propanol (96-13-9).....................................................................................B-3

B.2.2 4-Vinyl-1-Cyclohexene Diepoxide (117-10-2) ..................................................................B-4

B.2.3 Azacitidine (320-67-2).........................................................................................................B-4

B.2.4 Chloramphenicol (56-75-7) .................................................................................................B-5

B.2.5 Chlorozotocin (54749-90-5) ................................................................................................B-7

B.2.6 Cyclosporin A (59865-13-3)................................................................................................B-7

B.2.7 Danthron (1,8-Dihydroxyanthraquinone) (117-10-2) ........................................................B-9

B.2.8 Diazoaminobenzene (136-35-6) .......................................................................................B-10
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B.2.9 Disperse Blue 1 (2475-45-8).............................................................................................B-10

B.2.10 Tamoxifen (10540-29-1)................................................................................................... B-11

B.2.11 Thiotepa (52-24-4)............................................................................................................. B-12

Literature Cited ............................................................................................................................................. B-14
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Table of Tables

Table ES-1: Estimated Number of Additional Reports by Chemical................................................................vi

Table ES-2: Estimated Number of Additional Reports by Industry..................................................................vi

Table ES-3: Estimated Industry Burden and Cost by Compliance Activity.................................................. viii

Table ES-4: Estimated Number of Form R Submissions and Incremental Agency Cost by 

Media Type..................................................................................................................................... viii

Table ES-5: Summary of Total Costs of Proposed Rule....................................................................................ix

Table ES-6: Summary of Impacts on Small Entities...........................................................................................x

Table 1-1: Chemicals Added Under the Proposed Rule.................................................................................. 1-4

Table 1-2: Chemicals Reviewed by EPA......................................................................................................... 1-7

Table 2-1: Sources Used to Identify Facilities that Manufacture the Proposed Chemicals.......................... 2-4

Table 2-2: Sources Used to Identify Facilities that Process Proposed Chemicals During the 

Manufacture of Other Chemicals.................................................................................................. 2-5

Table 2-3: Estimated Number of Incremental Forms and Facilities by Chemical and Sector Due 

to the Proposed Rule ....................................................................................................................2-24

Table 2-4: Estimated Number of Incremental Forms and Facilities by Sector Due to the 

Proposed Rule...............................................................................................................................2-26

Table 3-1: Estimated Number of Unique Facilities and Chemical Forms Expected Under the 

Proposed Rule................................................................................................................................. 3-4

Table 3-2: Unit Time and Cost Estimates for Activities Performed by Industry .......................................... 3-5

Table 3-3: Loaded Hourly Wage Rates by Labor Category ........................................................................... 3-5

Table 3-4: Estimated Industry Burden and Cost by Compliance Activity..................................................... 3-8

Table 3-5: Agency Forms Processing Cost by Media Type ........................................................................... 3-9

Table 3-6: Estimated Number of Form R Submissions and Incremental Agency Cost by Media 

Type................................................................................................................................................. 3-9

Table 3-7: Summary of Total Costs of Proposed Rule ................................................................................... 3-9

Table 3-8: Summary Burden and Cost Information for the Proposed Rule................................................. 3-10

Table 4-1: Small Business Size Standards for Industries Affected by the Proposed Rule ........................... 4-2

Table 4-2: Cost Estimates for Activities Performed by Industry..................................................................... 4-3

Table 4-3: Summary of Impacts on Small Entities.......................................................................................... 4-5

Table A-1 PACs Reporting to TRI by Sector, RY2007 ..................................................................................A-2

Table A-2: Number of RY2007 PACs Reporters by Sector...........................................................................A-3

Table B-1: Methods Used to Estimate Potential Export of U.S.-Manufactured Pharmaceuticals...............B-2

Table B-2: Methods Used to Estimate Low U.S. Production Volume...........................................................B-3

Table B-3: Azacitidine Use in MDS Treatment ..............................................................................................B-5

Table B-4: Chloramphenicol Use in Medical Treatments ..............................................................................B-6

Table B-5: Chlorozotocin Use in Clinical Trials.............................................................................................B-7

Table B-6: Cyclosporin A Use in Medical Treatments...................................................................................B-8

Table B-7: Tamoxifen Use in Medical Treatments.......................................................................................B-12

Table B-8: Thiotepa Use in Medical Treatments...........................................................................................B-13
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Executive Summary

ES.1 Introduction 

Under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), and section 

6607 of the Pollution Prevention Act (PPA), certain facilities are required to file annual reports to the United 

States Environmental Protection Agency (EPA) and to states on their releases, transfers, and other waste 

management practices for certain toxic chemicals if they are manufactured, processed, or otherwise used 

above certain threshold amounts. This information is included in a publicly available database known as the 

Toxics Release Inventory (TRI).

Currently, there are 581 chemicals and 30 chemical categories on the list of chemicals subject to EPCRA 

section 313. EPCRA section 313(d) authorizes EPA to add chemicals to the list of reportable substances. 

Under this rulemaking, reporting will be required for an additional 16 toxic chemicals identified as 

carcinogens by the National Toxicology Program. 

ES.2 Need for Rule 

EPA believes that the 16 chemicals under consideration meet the EPCRA Section 313(d)(2)(B) criteria for 

listing because they are known to or can reasonably be anticipated to cause cancer in humans. Further, EPA 

believes that facilities currently manufacture, process or otherwise use these chemicals above TRI 

thresholds and therefore would file TRI reports. 

ES.3 Addition of Chemicals 

The 16 chemicals EPA is proposing to add to the list of reportable chemicals were identified based on their 

listing in the National Toxicology Program’s 11th Report on Carcinogens. Since the Report on Carcinogens 

is a peer reviewed publication, its findings on the carcinogenicity of toxic chemicals can be used as basis for 

listing chemicals with TRI under section 313(d). 

The chemicals addressed by this rulemaking are 1-amino-2,4-dibromoanthraquinone, 2,2-

bis(bromomethyl)-1,3-propanediol, furan, glycidol, isoprene, methyl eugenol, o-nitroanisole, nitromethane,

phenolphthalein, tetrafluoroethylene, tetranitromethane, and vinyl fluoride. Additionally, 1,6-dinitropyrene, 

1,8-dinotropyrene, 6-nitrochrysene, and 4-nitropyrene will be added as part of the polycyclic aromatic 

compounds (PACs) chemical category, however, because PACs are reported as a category, no new PACs 

reports are expected due to the proposed rule. 

ES.4 Estimated Reporting Activity 

The number of additional TRI reports expected due to the proposed rule is summarized in Table ES-1 by 

chemical and in Table ES-2 by industry.
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Table ES-1: Estimated Number of Additional Reports by Chemical

Chemical Forms Facilities

Average 

Forms per 

Facility

Isoprene 65 65 1

Furan 46 46 1

1-Amino-2,4-Dibromoanthraquinone (ADBAQ) 22 22 1

Tetrafluoroethylene 16 16 1

Glycidol 13 13 1

Methyl Eugenol 6 6 1

Tetranitromethane (TNM) 5 5 1

Nitromethane 4 4 1

2,2-bis(Bromomethyl)-1,3-Propanediol (BBMP) 3 3 1

Vinyl Fluoride 3 3 1

o-Nitroanisole 2 2 1

Phenolphthalein 1 1 1

Total 186 175 1.06

Note that the total number of facilities reporting to TRI for the 16 proposed chemicals is not a 

sum of the number of facilities reporting for each chemical because some facilities will 

submit reports for more than one chemical addressed by the proposed rule. 

Table ES-2: Estimated Number of Additional Reports by Industry

NAICS NAICS Description Forms Facilities

Average 

Forms Per 

Facility

32411 Petroleum Refineries 19 19 1

324199 All Other Petroleum and Coal Products Mfg. 1 1 1

32511 Petrochemical Mfg. 7 7 1

325132 Synthetic Organic Dye and Pigment Mfg. 23 23 1

325188 All Other Basic Inorganic Chemical Mfg. 1 1 1

32519 Other Basic Organic Chemical Mfg. 1 1 1

325199 All Other Basic Organic Chemical Mfg. 63 56 1.13

325211 Plastics Material and Resin Mfg. 33 32 1.03

325212 Synthetic Rubber Mfg. 4 4 1

32532 Pesticide and Other Agricultural Chemical Mfg. 4 4 1

325611 Soap and Other Detergent Mfg. 1 1 1

325920 Explosives Mfg. 3 3 1

325998 All Other Miscellaneous Chemical Product and Preparation Mfg. 1 1 1

326113 Unlaminated Plastics Film and Sheet (except Packaging) Mfg. 1 1 1

32619 Other Plastics Product Mfg. 2 1 2

32629 Other Rubber Product Mfg. 1 1 1

32731 Cement Mfg. 1 1 1

42471 Petroleum Bulk Stations and Terminals 8 8 1

562112 Hazardous Waste Collection 1 1 1

56221 Waste Treatment and Disposal 1 1 1

562211 Hazardous Waste Treatment and Disposal 7 7 1

56299 All Other Waste Management Services 3 1 3

Total 186 175 1.06

ES.5 Costs of the Proposed rule 

The proposed rule will result in the expenditure of resources by both industry and EPA. Affected facilities 

will spend time reporting the required information to EPA on Form R. The Agency will spend time 

processing these new forms. 

ES.5.1 Private Industry Costs 

For the proposed rule, facilities will undertake the following compliance activities:
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• Rule Familiarization: Facilities that are reporting under section 313 for the first time due to the 

proposed rule must read the reporting package and become familiar with the newly applicable 

EPCRA reporting requirements.

• Report Completion: Facilities must gather data and perform calculations to provide the 

information required on the form. This activity includes the time required to search data sources 

and the time to complete and review the information. 

• Recordkeeping and Submission: Affected facilities must maintain recordkeeping systems and 

submit their reports to EPA and the state in which the facility is located. This activity includes the 

time required to transmit or otherwise disclose the information.

Depending on whether the activity is report- or facility-specific, total costs for a task can be calculated by 

multiplying the unit cost of the activity by the of reports for which the task must be performed or by the 

number of facilities performing it. For this analysis, it was assumed that all chemical reports would be filed 

as Form R reports as the data required for Form A estimation was not readily available (see Chapter Two). 

As such, to the extent that some facilities may be able to file Form As instead, reporting cost may be 

overstated. Each cost estimate is made up of two components: the unit time estimates (i.e., number of labor 

hours required of each type of personnel to complete a task); and the hourly wage rates for each level of 

personnel. The unit burden hour estimates reflect the most current OMB approved burden estimates and are 

taken from the 2007 Form R Information Collection Request (ICR) (USEPA, 2007).1

The following four step procedure outlines the method used by EPA to calculate total industry costs.

Step 1: Identify and describe the tasks that potentially affected facilities will have 

to perform to comply with the section 313 requirements.

Step 2: For each task, estimate the hours of managerial, technical, and clerical labor needed to 

complete it. Based on typical labor rates, calculate the unit cost of each task for the first 

year of compliance, when some learning must take place and for subsequent years when 

less time is needed because facilities are more familiar with the tasks.

Step 3: Estimate the number of unique facilities that will perform each task. 

Estimate the number of reports to be filed in all industry groups.

Step 4: For each task, multiply the unit cost by the number of unique facilities 

and/or reports and then take the sum of the results to estimate total industry 

costs for the first year and subsequent years.

Table ES-3 presents the total cost of the proposed rule in the first and subsequent years.

 1 To comply with the Paperwork Reduction Act, federal agencies must renew ICRs periodically.
viii

Table ES-3: Estimated Industry Burden and Cost by Compliance Activity

Activity Number of 

Forms/Facilities

Hours per 

Form/Facility

Cost per 

Form/Facility

Total Burden 

(hours) Total Cost ($)

FIRST YEAR

Rule Familiarization a

(facility-level) 74 34.5 $1,903 2,553 $140,822 

Calculations and Report 

Completion b (form-level) 186 67.7 $3,626 12,586 $674,506 

Recordkeeping and 

Submission b (form-level) 186 5.0 $231 930 $42,971 

Total 16,069 $858,299 

SUBSEQUENT YEAR

Calculations and Report 

Completion b (form-level) 186 24.7 $1,322 4,587 $245,931 

Recordkeeping and 

Submission b (form-level) 186 5.00 $231 930 $42,971 

Total 5,517 $288,902 

a

 The unit cost for this activity is estimated at the facility level. It is treated as a fixed cost that covers all chemicals reported by a facility.

b

 The unit cost for this activity is estimated to vary with the number of Form Rs submitted. The total cost for this activity at a facility is 

calculated by multiplying the unit cost by the number of forms submitted by that facility.

Note: Total Cost and Total Burden may not equal the product of Number of Facilities/Forms and Cost per Form, and the Number of 

Facilities/Forms and Hours per Form, respectively, due to rounding. For the derivation of cost for each compliance activity, see pages 3-

6 and 3-7.

Sources:

U.S. EPA (2007). Information Collection Request (ICR): TRI Form R Toxic Chemical Release Reporting EPA ICR #1363.15. 

December.

U.S.DOL (2009). Employer Costs for Employee Compensation Historical Listings, March 2004 – June 2009. U.S. Department of Labor. 

Bureau of Labor Statistics. Washington D.C., Table 15, 2009

ES.5.2 EPA Costs 

In general, EPA incurs burden and costs for five categories of activities related to the TRI program: data 

processing, outreach and training, information dissemination, policy and petitions, and compliance and 

enforcement. These activities involve both fixed (e.g., rent for the EPCRA reporting center) and variable 

costs (activities that depend on the number of forms submitted such as data processing). Due to the 

proposed rule, the Agency is only expected to incur variable costs associated with data processing.

Table ES-4 presents the estimated number of forms to be submitted for proposed chemicals by media type, 

total processing cost by media type, and total incremental EPA cost for the proposed rule making. 

Table ES-4: Estimated Number of Form R Submissions and Incremental 

Agency Cost by Media Type

Media Type Estimated Number of 

Form Rs

Form Processing Cost 

Per Form ($)

Processing 

Cost ($)

Paper 6 $ 25.75 $ 152

Mag Media 18 $ 6.50 $ 114

CDX 34 $ 3.12 $ 106

TRIMEweb 129 $ 3.12 $ 401

TOTAL 186 $ 773

Note: Processing cost totals may not equal the product of the rows due to rounding. 
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ES.5.3 Summary of Costs 

The estimated total cost to industry and EPA of the proposed rule is $859,299 in the first year and $289,675 

in subsequent years. Table ES-5 summarizes the total costs to industry and EPA for the proposed rule.

Table ES-5: Summary of Total Costs of 

Proposed Rule

Description First Year Subsequent Years

Industry Costs $ 858,299 $ 288,902

EPA Costs $ 773 $ 773

TOTAL $ 859,072 $ 289,675

ES.6 Small Entity Analysis 

The Regulatory Flexibility Act (RFA) of 1980 (5 U.S.C. § 601 et. seq.) requires Federal agencies to assess 

the effects of regulations on small entities, and, in some instances, to examine alternatives to the regulations 

that may reduce adverse economic effects on significantly impacted small entities. The RFA requires 

agencies to prepare an initial and final regulatory flexibility analysis for each rule unless the Agency 

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

This analysis uses annual cost impact percentages to measure potential impacts on small entities. The cost 

impact percentage is defined as annual compliance costs resulting from the proposed rule as a percentage of 

annual revenues or sales. For purposes of determining small entity impacts, comparing annual compliance 

costs to annual revenues provides a reasonable indication of the magnitude of the regulatory burden relative 

to a commonly available and objective measure of a company's business volume. Where regulatory costs 

represent a small fraction of a typical firm's revenue, the impacts of the regulation are likely to be minimal.

Cost impact percentages are calculated for the incremental compliance costs incurred during first and 

subsequent years of reporting. In the first year, industry costs will consist of rule familiarization costs, 

(incurred by only those facilities filing for the first time), calculations and report completion costs, and 

recordkeeping and submission costs. In subsequent years, the incurred compliance cost will consist of 

calculations and report completion, and recordkeeping and submission costs only.

This analysis calculated the cost impact percentages using the actual compliance costs per facility, the 

number of facilities per parent company for small entities and the annual revenues for each of the small 

entities. For each company, revenue data and number of TRI facilities per small company were taken from 

Dun and Bradstreet’s Private Data Portal (Version 2.5, accessed on December 8, 2009).

The general methodology followed to estimate the impacts on small entities consists of the 

following steps:

1. Estimate the number of reports on proposed chemicals as well as the number of affected facilities in 

each industry sector that may file these reports under the proposed rule2;

2. Estimate the number of small companies affected;

3. Develop company-level annual compliance cost estimates, based on the number of facilities per 

company and the number of reports per facility;

 2

 The term “affected facilities” is used in this report to denote facilities that meet the TRI reporting requirements and 

are expected to submit at least one Form R for a proposed chemical. A Form R is completed for a single chemical. 

Facilities may submit more than one Form R if they manufacture, process, or otherwise use more than one listed TRI 

chemical (including the newly listed chemicals). 
x

4. Identify annual revenues of affected small companies;

5. Estimate the company-level impact percentages for the first and subsequent years, defined as 

compliance costs as a percentage of annual revenues, as a measure of regulatory burden;

6. Estimate the number and percentage of small companies with company-level impact percentages in 

each of three categories: (1) less than one percent of annual revenues; (2) between one and three 

percent of annual revenues; and (3) greater than or equal to three percent of annual revenues.

The estimated impacts to small companies under the proposed rule are presented in Table ES-6 below. Of 

the estimated 109 affected entities, 41 are small businesses. Of the affected small businesses, all 41 have 

cost impacts of less than 1% in both the first and subsequent years of the rulemaking. No small businesses 

are projected to have a cost impact of 1% or greater. In the first year, of the 41 estimated cost impacts, 

there is a maximum impact of .616% and a minimum impact of less than 0.001%. The mean and median 

impacts for the first year are estimated to be 0.147% and 0.072% respectively. In the subsequent years, of 

the 41 estimated cost impacts there is a maximum impact of less than 0.2% and a minimum impact of less 

than 0.001% each affecting one small business. The mean and median impacts for the subsequent years are 

estimated to be less than 0.05% and 0.03% respectively. 

Table ES-6: Summary of Impacts on Small Entities

Estimated Number 

of Affected Entities

Estimated Number of 

Affected Small 

Entities

Estimated Number of 

Small Entities with 

Impacts of 3% or Greater

Estimated Number of 

Small Entities with Impacts 

Between 1 and 3%

Estimated Number of 

Small Entities with 

Impacts Less than 1%

First Year

109 41 0 0 41

% of Small 

Entities - - 0% 0% 100%

Subsequent Years

109 41 0 0 41

% of Small 

Entities - - 0% 0% 100%

ES.7 Benefits of the Proposed rule 

The benefits of the proposed rule include improved understanding, awareness, and decision making related 

to the provision and distribution of information on releases and waste management of the 16 proposed 

chemicals. The provision of information can lead to follow-on activities that create additional costs and 

benefits. In particular, this information can lead to voluntary initiatives by industry to review production 

processes, set goals for reductions in emissions, and institute “good neighbor” policies. 

The potential benefits of additional TRI reporting can be understood by examining the ways in which 

different groups of affected stakeholders—consumers, industry, non-federal governments and the general 

public—utilize the TRI data. Consumers may use the data to make more informed decisions about the 

products they buy and to enter into constructive dialogue with the firms in their communities that release 

any of the 16 proposed chemicals. Industry may find opportunities for waste reduction and cost savings 

through developing data to be used for reporting under the proposed rule. Non-federal governments may 

use the data in lieu of or in support of their own environmental protection activities. In addition, non-users 

of the TRI data benefit from its public provision whenever others use of the data results in improvements in 

environmental quality.

EPA has not attempted to monetize the benefits of the proposed rule for several reasons related to the 

uncertainties associated with data on users and non-users of the TRI and the substantial analytical 
xi

challenges associated with conducting an analysis that accurately predicts behavioral responses to 

information. The analysis was not able to consider variations in quality or other attributes of different 

methods of TRI data access. Finally, the potentially large numbers of beneficiaries who are not users or are 

otherwise unaware of the data further limits EPA’s ability to quantify potential benefits. However, the 

experience since the first forms were submitted to TRI in 1987 suggests that reporting under EPCRA 

section 313 has produced real gains in understanding about communities’ exposure to toxic chemicals. In its 

report entitled: How are the Toxics Release Inventory Data Used? – Government, Business, Academic, 

and Citizen Uses, EPA has documented numerous examples of how multiple stakeholders have used 

TRI data (US EPA, 2003). Moreover, a cursory search on GoogleScholarTM reveals thousands of academic 

articles referencing the Toxics Release Inventory. Listing the additional chemicals should provide similar 

gains in understanding about these chemicals. EPA believes that all of the chemicals under the proposed 

rule meet the statutory toxicity criteria of section 313, and are at least as toxic as some of the chemicals for 

which Congress initially believed there were net benefits due to reporting. 
1-1

Chapter 1 – Background and Overview of Analysis

The Emergency Planning and Community Right-to-Know Act (EPCRA), also known as Title III of the 

Superfund Amendments and Reauthorization Act of 1986 (SARA), created a broad range of emergency 

response planning and reporting requirements for manufacturers, processors, and users of toxic chemicals in 

the United States. Under section 313 of EPCRA, certain facilities are required to submit annual reports to 

the United States Environmental Protection Agency (EPA) and to States on their release(s), transfer(s), and 

waste management activities for certain toxic chemicals if they are manufactured, processed, or otherwise 

used above thresholds amounts. In addition, the Pollution Prevention Act (PPA) of 1990 requires these 

same facilities to report prevention, recycling, and other waste management information for these same 

chemicals. EPA maintains the data collected under EPCRA section 313 and the PPA in a database known as 

the Toxics Release Inventory (TRI).1

EPCRA section 313(f)(1) contains default reporting thresholds for facilities. These reporting thresholds are 

25,000 pounds for toxic chemicals that are manufactured (including imported) or processed, and 10,000 

pounds for toxic chemicals that are otherwise used. Facilities that meet these reporting thresholds, as well as 

other reporting criteria, are required to submit annual reports. Under this rulemaking, reporting will be 

required for an additional 16 toxic chemicals identified as carcinogens by the National Toxicology Program.

This report analyzes the economic impacts of a proposed rule that requires reporting for these additional 16

chemicals under EPCRA section 313. To understand the effects of the proposed rule, however, it is first 

necessary to understand how EPCRA section 313 and TRI currently operate. This chapter provides an 

overview of TRI followed by a description of the rule and organization of the report. 

1.1 Overview of TRI 

In 1986, Congress passed the Emergency Planning and Community Right-to-Know Act (EPCRA). The law 

was passed in response to the accidental release of methyl isocyanate gas in Bhopal, India, in December 

1984, and to a number of chemical accidents in the United States, including one in Institute, West Virginia. 

These accidental releases highlighted the lack of information readily available to the public about toxic 

chemicals being manufactured, processed, used, and transported within their communities. EPCRA is 

based on the premise that the public has the right to know about the use of chemicals, as well as their 

routine and accidental releases. The broad purposes are to encourage planning for response to accidental 

chemical releases as well as daily management of routine releases, and to provide the public and 

government agencies with information about the presence, release, and management of toxic chemicals.

EPCRA contains four main provisions:

• Planning for chemical emergencies (sections 301-303),

• Emergency notification of chemical accidents and releases (section 304),

• Reporting of hazardous chemical inventories (sections 311-312), and

• Toxic chemical release reporting (section 313).

Because this rule falls under section 313 (and not the other sections of EPCRA), the remainder of this 

overview deals only with the TRI provisions of section 313.

 1

 The term EPCRA section 313 properly refers to only the statutory requirements, while the term TRI properly refers to 

the database where the information collected under section 313 and under section 6607 of the PPA is stored. However, 

the terms have often been used interchangeably by the public to refer to the statute, the regulatory requirements, the 

reporting form, the database, and EPA's program to manage the data. In deference to common usage, the terms 

EPCRA section 313 and TRI are sometimes used interchangeably in this report where doing so will make the report 

simpler and easier to read.
1-2

The first regulations implementing EPCRA section 313 were promulgated on February 16, 1988 (53 FR 

4500), and are codified at 40 CFR part 372. Under these original regulations, owners or operators of 

regulated facilities must complete the Toxic Chemical Release Inventory Reporting Form R, which includes 

information on releases to air, water, and land, as well as on-site waste treatment and transfers of the 

chemical to off-site locations. 

A facility must report under section 313 if it meets all of the following three criteria: 

1. It is in an Industrial Classification code covered by the regulations;

2. It has ten or more full-time employees (or the hourly equivalent of 20,000 hours); and

3. It manufactures, processes, or otherwise uses any of the listed toxic chemicals or chemical 

categories above the applicable reporting threshold.

Facilities must submit the forms each calendar year to both EPA and the State in which the facility is 

located by July 1 of the following year.

A completed Form R must be submitted for each toxic chemical manufactured, processed, or otherwise 

used over threshold levels at each regulated facility as described in 40 CFR part 372. For most chemicals, 

threshold levels are set at 25,000 lbs for manufacturing and processing and 10,000 lbs for otherwise use (40 

CFR § 372.25). Over 600 toxic chemicals and chemical compound categories are currently on the list of 

TRI chemicals.

TRI is unique among environmental databases because of the multimedia data it collects, and because it was 

designed for public access. EPCRA requires that EPA “establish and maintain in a computer database a 

national toxic chemical inventory based on data submitted to the Administrator” (42 U.S.C. § 11023(j)). 

EPA maintains the section 313 data in the national TRI database and makes the data available to the public 

in a variety of formats, including on-line and CD-ROM. With its broad dissemination, TRI data is used 

extensively by the public. Facilities use the data obtained through TRI to better understand their operations, 

and make better use of pollution prevention opportunities. Public-interest groups use the data to inform 

themselves about the presence of toxic chemicals in the environment, and use that knowledge to engage in a 

meaningful, productive dialogue with industry and all levels of government. In general, TRI data have 

proven to be a powerful tool in environmental decision-making.

1.1.1 Pollution Prevention Act 

In 1990, Congress passed the Pollution Prevention Act (PPA), which adopted as national policy an 

environmental hierarchy that establishes pollution prevention as the first choice among waste management 

options (42 U.S.C. §§ 13101-13109). For waste that cannot be prevented at the source, recycling is 

considered the next best option, and treatment or disposal should be considered only after source reduction 

and recycling options have been eliminated. Section 6607 of the PPA requires facilities to also report 

information on their pollution prevention, recycling, and other waste management activities. This 

information complements the information reported under EPCRA section 313 by providing information 

about the waste management activities related to the reported chemicals. The data elements required by the 

Pollution Prevention Act are included as Section 8 of Form R.

1.1.2 Changes to the List of Chemicals 

When Congress passed EPCRA it provided an initial list of approximately 300 chemicals and chemical 

categories subject to TRI reporting. The statutory list was derived from chemical lists used in New Jersey 

and Maryland. Congress also included a provision in EPCRA that allows EPA to amend the list of 

chemicals subject to TRI reporting. Under section 313(d), EPA has the authority to add a chemical to the 

list if it determines that the chemical can cause or can be reasonably anticipated to cause:
1-3

• Adverse acute human health effects at concentration levels reasonably likely to exist beyond facility 

site boundaries as a result of continuous or frequently recurring releases;

• In humans, cancer or teratogenic effects, serious or irreversible reproductive dysfunctions, 

neurological disorders, heritable genetic mutations, or other chronic health effects; or

• A significant adverse effect on the environment. See, 42 U.S.C.§ 11023(d).

EPA has added chemicals to the list through its authority under section 313(d). Most notably, EPA added 

286 chemicals and chemical categories to the list of toxic chemicals subject to TRI on November 30, 1994 

(59 FR 61432). The majority of these chemicals are pesticides. Many of the remaining chemicals are either 

regulated or identified as concerns under other environmental statutes such as the Clean Air Act, the Clean 

Water Act, and the Safe Drinking Water Act.

EPA may delete a chemical from the list if it does not meet any of the above criteria found in 313(d). 

According to section 313(e) of EPCRA, any person may petition EPA to add or delete a chemical from the 

list on the basis of whether or not it meets the above criteria (see 42 U.S.C. § 11023(e)). All changes to the 

list are made through the rulemaking process under the Administrative Procedures Act (APA).

1.1.3 Alternate Threshold 

On November 30, 1994, EPA finalized the “TRI Alternate Threshold for Facilities with Low Annual 

Reportable Amounts” (59 FR 61488). This rule was intended to reduce the compliance burden associated 

with EPCRA section 313. It established a streamlined reporting option for facilities where the annual 

reportable amount of a listed chemical released or managed does not exceed 500 pounds.2 Such facilities 

have the option of applying an alternate manufacture, process, or otherwise use threshold of 1 million 

pounds to that chemical, instead of the standard thresholds of 10,000 or 25,000 pounds. If a facility does 

not exceed the 1 million-pound threshold, then that facility is eligible to submit Form A for that chemical 

instead of Form R. Form A is a simplified reporting form that includes facility identification information 

and identifies the chemical or chemical category being reported. The form must be submitted on an annual 

basis.

1.1.4 Executive Order 12856 

On August 3, 1993, Executive Order 12856, “Federal Compliance with Right-to-Know Laws and Pollution 

Prevention Requirements” was signed by the President (58 FR 41981). The Executive Order requires 

federal facilities to comply with EPCRA requirements beginning with the 1994-reporting year. The 

Executive Order also asks all federal agencies to set a voluntary goal of 50% reduction from baseline 

quantities of their releases and transfers by 1999.

1.1.5 Changes to the List of Industries 

On May 1, 1997, EPA added facilities in seven industry groups to the list of facilities subject to the 

reporting requirements of section 313 (62 FR 23833). The first reports from these facilities were required 

to be submitted in 1999 for reporting year 1998. Prior to this action, reporting was limited to facilities in the 

manufacturing sector (SIC codes 20-39) and federal facilities. This action added facilities in the following 

sectors: 

• Metal mining, 

• Coal mining,

• Electric utilities,

• Commercial hazardous waste treatment, storage, and disposal facilities

• Chemicals and allied products-wholesale,

• Petroleum bulk terminals and plants-wholesale, and

 2

 The annual reportable amount is equal to the combined total quantities recycled, combusted for energy recovery, 

treated, or released. It can be calculated as is the sum of data elements 8.1 through 8.7 on Form R.
1-4

• Solvent recovery services.

1.1.6 Changes for Certain PBT Chemicals 

On October 29, 1999, EPA lowered reporting thresholds to 10 or 100 pounds for certain TRI chemicals 

(persistent, bioaccumulative and toxic chemicals, or PBT chemicals) that are of concern because of their 

toxicity and tendency to persist and bioaccumulate (64 FR 58666). EPA also added to TRI certain PBT 

chemicals that were not already listed including a dioxin category with a reporting threshold of 0.1 gram. 

At this time EPA made other changes to PBT chemical reporting, such as disallowing the use of the de 

minimis exemption, range reporting, and Form A reporting for PBT chemicals (40 CFR § 372.28(b)). On 

January 17, 2001, EPA lowered the reporting threshold for lead and lead compounds to 100 pounds and 

applied the same limitations as are applied to other PBT chemicals (40 CFR § 372.28).

1.1.7 Burden Reduction Initiatives 

EPA’s recent Burden Reduction Initiatives consisted of two phased rulemakings. Under Phase 1, 

promulgated in July 2005, several simple solutions for reducing the time, cost, and complexity of reporting 

requirements were made to the TRI reporting form. These changes included: 1) removing fields for 

reporting longitude, latitude, and EPA program identification numbers, 2) eliminating data elements not 

widely used by States and the public, and 3) reducing the number of codes a facility must consider when 

reporting in specific sections. In December 2006, Phase 2 of the Burden Reduction Initiative expanded 

Form A eligibility to facilities with: (1) releases or disposal of less than 2,000 pounds and waste 

management below 5,000 pounds and for PBT chemicals with no releases, or (2) other disposal and no 

more than 500 pounds of other waste management. On March 11, 2009, the Omnibus Appropriations Act of 

2009 returned TRI reporting requirements associated with the use of Form A to those in effect prior to 

Phase 2 of the Burden Reduction Initiative. 

1.1.8 Toxic Chemical Release Reporting Using North American Industry 

Classification System (NAICS) Rule 

On June 6, 2006, EPA published a final rule requiring facilities reporting to TRI to use North American 

Industry Classification System (NAICS) codes in place of the Standard Industry Classification (SIC) codes 

previously used on TRI reporting forms. This rule required facilities that report to TRI to use 2002 NAICS 

codes on reporting Form R and the Form A Certification Statement. The 2007 NAICS Revision Final Rule 

published on June 9, 2008, required facilities to use 2007 NAICS codes on TRI reporting forms.

1.2 Chemicals for Addition to TRI 

This proposed rule would require reporting to TRI for 16 carcinogenic chemicals identified by the National 

Toxicology Program (NTP).3 The chemicals addressed by this rulemaking are all listed in the NTP’s 11th

Report on Carcinogens (RoC). Table 1-1 lists the chemicals that will be added under the proposed rule.

Table 1-1: Chemicals Added Under the Proposed Rule

CAS Number Chemical Name Chemical 

Category

Manufactured, Processed, 

Otherwise Used Above Reporting 

Threshold? 

81-49-2 1-Amino-2,4-Dibromoanthraquinone (ADBAQ) Yes

3296-90-0 2,2-bis(Bromomethyl)-1,3-Propanediol (BBMP) Yes

42397-64-8 1,6-Dinitropyrene PACs n/a

42397-65-9 1,8-Dinitropyrene PACs n/a

110-00-9 Furan Yes

556-52-5 Glycidol Yes

78-79-5 Isoprene Yes

93-15-2 Methyl Eugenol Yes

91-23-6 o-Nitroanisole Yes

 3 The NTP is an interagency program within the Department of Health and Human Services (DHHS) headquartered at 

the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH). 
1-5

Table 1-1: Chemicals Added Under the Proposed Rule

CAS Number Chemical Name Chemical 

Category

Manufactured, Processed, 

Otherwise Used Above Reporting 

Threshold? 

7496-02-8 6-Nitrochrysene PACs n/a

75-52-5 Nitromethane Yes

57835-92-4 4-Nitropyrene PACs n/a

77-09-8 Phenolphthalein Yes

116-14-3 Tetrafluoroethylene Yes

509-14-8 Tetranitromethane (TNM) Yes

75-02-5 Vinyl Fluoride Yes

Notes:

“PACs” stands for Polycyclic Aromatic Compounds. Chemicals classified as PACs are reported to TRI as a single chemical 

category rather than as specific chemicals. 

The mission of the NTP is to evaluate agents of public health concern by developing and applying tools of 

modern toxicology and molecular biology. As part of their mission, the NTP periodically publishes their 

RoC document. According to the NTP, the RoC is an informational scientific and public health document 

that identifies and discusses agents, substances, mixtures, or exposure circumstances that may pose a hazard 

to human health by virtue of their carcinogenicity. The NTP RoC serves as a compilation of data on (1) the 

carcinogenicity (ability to cause cancer), genotoxicity (ability to damage genes), and biologic mechanisms 

(modes of action in the body) of the listed substances in humans and/or in animals, (2) the potential for 

human exposure to these substances, and (3) Federal regulations to limit exposures. 

1.2.1 NTP Cancer Classifications and Criteria 

The NTP RoC classifies chemicals as either “known to be a human carcinogen” or “reasonably anticipated 

to be a human carcinogen.” The criteria that the NTP uses to list an agent, substance, mixture, or exposure

circumstance under each classification in the RoC are as follows:

Known To Be Human Carcinogen. 

There is sufficient evidence of carcinogenicity from studies in 

humans,4 which indicates a causal relationship between exposure to 

the agent, substance, or mixture, and human cancer.

Reasonably Anticipated To Be Human Carcinogen. 

• There is limited evidence of carcinogenicity from studies in humans,5 which indicates that causal 

interpretation is credible, but that alternative explanations, such as chance, bias, or confounding 

factors, could not adequately be excluded, or 

• There is sufficient evidence of carcinogenicity from studies in experimental animals, which 

indicates there is an increased incidence of malignant and/or a combination of malignant and 

benign tumors (1) in multiple species or at multiple tissue sites, or (2) by multiple routes of 

exposure, or (3) to an unusual degree with regard to incidence, site, or type of tumor, or age at 

onset, or

• There is less than sufficient evidence of carcinogenicity in humans or laboratory animals; however, 

the agent, substance, or mixture belongs to a well-defined, structurally related class of substances 

whose members are listed in a previous Report on Carcinogens as either known to be a human 

 4 This evidence can include traditional cancer epidemiology studies, data from clinical studies, and/or data derived 

from the study of tissues or cells from humans exposed to the substance in question that can be useful for evaluating 

whether a relevant cancer mechanism is operating in people.

5 This evidence can include traditional cancer epidemiology studies, data from clinical studies, and/or data derived 

from the study of tissues or cells from humans exposed to the substance in question that can be useful for evaluating 

whether a relevant cancer mechanism is operating in people.”
1-6

carcinogen or reasonably anticipated to be a human carcinogen, or there is convincing relevant 

information that the agent acts through mechanisms indicating it would likely cause cancer in 

humans. 

Conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgment 

with consideration given to all relevant information. Relevant information includes, but is not limited to, 

dose response, route of exposure, chemical structure, metabolism, pharmacokinetics, sensitive subpopulations, genetic effects, or other data relating to mechanism of action or factors that may be unique to a 

given substance. For example, there may be substances for which there is evidence of carcinogenicity in 

laboratory animals but there are compelling data indicating that the agent acts through mechanisms that do 

not operate in humans and therefore would not reasonably be anticipated to cause cancer in humans.

The NTP classifications for the potential for a chemical to cause cancer are very similar to the EPCRA 

section 313(d)(2)(B) statutory criteria for listing a chemical: “(B) The chemical is known to cause or can 

reasonably be anticipated to cause in humans– (i) cancer...” The specific data used by the NTP to 

determine whether a chemical is “Known To Be Human Carcinogen” or “Reasonably Anticipated To Be 

Human Carcinogen” are consistent with data used by EPA to evaluate chemicals for their potential to cause 

cancer and classify chemicals as either “Carcinogenic to Humans” or “Likely to Be Carcinogenic to 

Humans.”6

1.2.2 ROC Review Process 

In general, the RoC review process includes evaluations by scientists from the NTP, other Federal health 

research and regulatory agencies, and nongovernmental institutions. The RoC review process includes 

external peer review and several opportunities for public comment. For the 11th RoC, two Federal scientific 

review groups, the NIEHS/NTP Review Committee for the Report on Carcinogens RG1 and the NTP 

Executive Committee Interagency Working Group for the Report on Carcinogens RG2, evaluated the 

nominations for listing. An EPA representative was a member of the RG2 committee. These reviews were 

followed by a third independent external scientific peer review by a standing subcommittee of the NTP 

Board of Scientific Counselors (the RoC Subcommittee). During the process there were three opportunities 

for public comment. The Director of the NTP received for review all of the recommendations of the review 

groups, the opinion of the NTP Executive Committee, and all public comments. After evaluating this 

information and any other relevant information the NTP Director developed recommendations to the 

Secretary, DHHS regarding whether to list or not list nominations in the RoC. The final draft of the RoC 

was prepared by the NTP based on the NTP Director’s recommendations and was submitted it to the 

Secretary, DHHS, for review and approval. Once approved, the Secretary submitted RoC to the U. S. 

Congress as a final document. Submittal of the RoC to Congress constituted publication of the report, at 

which time it became available to the public. 

1.2.3 EPA Review of the 11th RoC 

The last version of the NTP RoC that EPA reviewed for possible additions to the EPCRA section 313 list 

was the 6th RoC (January 12, 1994, 59 FR 1788). EPA’s review of the 11th RoC identified 81 chemicals 

that are not on the EPCRA section list, most of which where reviewed for listing when EPA reviewed the 

6th RoC. Those previous reviews concluded that the chemicals that were not proposed for addition would 

not be manufactured, processed, or otherwise used at levels that exceed the EPCRA section 313 reporting 

thresholds. For this review EPA only considered the 27 chemicals that had been added to the RoC since the 

6th RoC was published and thus had not been previously reviewed for listing. Of the 27 chemicals, EPA 

determined that 12 are manufactured, processed, or otherwise used in quantities sufficient to exceed 

reporting thresholds for at least one facility. In addition, the proposed rule would add 4 chemicals to the 

polycyclic aromatic compounds (PACs) category.

 6

 U.S. EPA Risk Assessment Forum. 2005. Guidelines for Carcinogen Risk Assessment. 

<http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=116283>
1-7

EPA reviewed the NTP RoC chemical profiles and supporting materials for each chemical proposed for 

listing in this rule. Given the extensive scientific reviews conducted by the NTP for their RoC documents, 

EPA’s review focused on ensuring that there were no inconsistencies with how the Agency would consider 

the available data. EPA found no inconsistencies and agrees with the hazard conclusions of the NTP RoC 

for each of the chemicals included in this proposed rule. 

The initial 27 chemicals reviewed by EPA can be found Table 1-2. Those chemicals determined not to be

manufactured, processed, or otherwise used in quantities sufficient to exceed reporting thresholds are not 

covered in the proposed rule. Analyses performed to make these determinations are presented in Appendix 

B. The methodology used to determine the estimated number of expected reports for the 16 remaining

chemicals is presented in Chapter 2.

Table 1-2: Chemicals Reviewed by EPA

CAS Number Chemical Name Chemical 

Category

Manufactured, Processed, 

Otherwise Used Above Reporting 

Threshold? 

81-49-2 1-Amino-2,4-Dibromoanthraquinone (ADBAQ) Yes

320-67-2 Azacitidine No

3296-90-0 2,2-bis(Bromomethyl)-1,3-Propanediol (BBMP) Yes

56-75-7 Chloramphenicol No

54749-90-5 Chlorozotocin No

59865-13-3 Cyclosporin A No

117-10-2 Danthron (1,8-Dihydroxyanthraquinone) No

136-35-6 Diazoaminobenzene (DAAB) No

96-13-9 2,3-Dibromo-1-Propanol No

42397-64-8 1,6-Dinitropyrene PACs n/a

42397-65-9 1,8-Dinitropyrene PACs n/a

2475-45-8 Disperse Blue 1 No

110-00-9 Furan Yes

556-52-5 Glycidol Yes

78-79-5 Isoprene Yes

93-15-2 Methyl Eugenol Yes

91-23-6 o-Nitroanisole Yes

7496-02-8 6-Nitrochrysene PACs n/a

75-52-5 Nitromethane Yes

57835-92-4 4-Nitropyrene PACs n/a

77-09-8 Phenolphthalein Yes

10540-29-1 Tamoxifen No

116-14-3 Tetrafluoroethylene Yes

509-14-8 Tetranitromethane (TNM) Yes

52-24-4 Thiotepa No

106-87-6 4-Vinyl-1-Cyclohexene Diepoxide No

75-02-5 Vinyl Fluoride Yes

Notes:

“PACs” stands for Polycyclic Aromatic Compounds. Chemicals classified as PACs are reported to TRI as a single chemical 

category rather than as specific chemicals.

Four of the chemicals in this rulemaking are classified in the polycyclic aromatic compounds (PACs) 

category. The PACs on the list will be reported with the 21 PAC chemicals that are currently TRI reportable 

and no new reporters are expected for this chemical category. 

All of the chemicals considered by this rulemaking pose a hazard to human health due to their status as 

known or reasonably anticipated carcinogens. There is past precedent for adding chemical reporting 

requirements to TRI based on NTP carcinogenicity data. In 1994, a Chemical Expansion final rule added 

286 chemicals to TRI, 10 of which were identified based on information in the RoC. In this proposed rule, 

the 16 chemicals would be subject to TRI reporting under existing thresholds. Although four of the 

chemicals will be classified as persistent bioaccumulative toxic (PBT) chemicals under the PACs category, 

TRI filers will report them as part of the category overall and therefore, as noted above, no additional PACs 

reports are expected. For the remaining 12 non-PBTs, standard reporting thresholds (25,000 pounds for 

manufacturing and processing, 10,000 pounds for otherwise use) will apply.
1-8

1.3 Organization of This Report 

This report examines the potential increase in reporting that would result from adding 16 carcinogenic 

chemicals identified by the National Toxicology Program under EPCRA section 313. This report also 

estimates the costs to industry and EPA associated with the reporting burden and other impacts of the rule. 

The remainder of this report is organized as follows:

Chapter 2 summarizes the expected number of reports and facilities 

affected by the proposed rule.

Chapter 3 presents the methodology used to estimate the costs as 

well as the results of the analysis in terms of total cost to industry 

and total cost to EPA. 

Chapter 4 examines the impacts of the proposed rule, specifically

those impacts on “small” entities as required by the Regulatory 

Flexibility Act of 1980. 

Chapter 5 evaluates the benefits of requiring reporting for the 

chemicals affected by the proposed rule.

Appendix A presents background and methodology for additions to 

the polycyclic aromatic compounds (PACs) category.

Appendix B presents background and methodology for estimating 

whether chemicals are manufactured, processed, or otherwise used 

above reporting thresholds. 
2-1

Chapter 2– Estimates of the Number of Additional Forms and Affected 

Facilities

This chapter presents estimates of the number of additional forms for each chemical proposed for listing in 

this proposed rule as well as the number of affected facilities in each industry sector that may file these 

forms under the proposed rule.1 The chemicals covered by the proposed rule include:

• Isoprene (78-79-5)

• Furan (110-00-9)

• 1-Amino-2,4-dibromoanthraquinone (81-49-2)

• Tetrafluoroethylene (116-14-3)

• Glycidol (556-52-5)

• Methyl eugenol (93-15-2)

• 2,2-bis(Bromomethyl)-1,3-propanediol (3296-90-0)

• Tetranitromethane (509-14-8)

• Nitromethane (75-52-5)

• Vinyl fluoride (75-02-5)

• o-Nitroanisole (91-23-6)

• Phenolphthalein (77-09-8)

An additional four chemicals covered by this rulemaking fall into the polycyclic aromatic compounds 

(PACs) category. They are:

• 6-Nitrochrysene (7496-02-8)

• 1,6-Dinitropyrene (42397-64-8)

• 1,8-Dinitropyrene (43297-65-9)

• 4-Nitropyrene (57835-92-4)

The potential for incremental reporting on PACs is described in Appendix A. However, these four 

chemicals are being added to a chemical category already subject to reporting and no new forms are 

expected. An additional 11 chemicals were considered by EPA in this rulemaking however it was 

determined that they are not manufactured, processed, or otherwise used in quantities sufficient to exceed

reporting thresholds for at least one facility. The analysis supporting this determination is presented in 

Appendix B.

Section 2.1 presents a general methodology for estimating reporting for those chemicals expected to 

generate new TRI forms. Section 2.2 presents detailed background information and assumptions for each 

chemical expected to generate new TRI forms. Section 2.3 presents the total number of incremental forms

expected due to the proposed rule across chemicals and industries. These estimates are used to calculate the 

costs to the regulated community and to EPA (see Chapter Three) and to evaluate the impacts on small 

entities (see Chapter Four).

 1

 The term “affected facilities” is used in this report to denote facilities that meet the TRI reporting requirements and 

are expected to submit at least one Form for one or more of the chemicals proposed for listing in this rule. A TRI 

Form is completed for a single chemical. Facilities may submit more than one Form if they manufacture, process, or 

otherwise use more than one listed TRI chemical (including the chemicals that would be added to the TRI chemical 

list under this proposed rule). 
2-2

2.1 Methods Used to Estimate Additional Reporting 

To estimate the incremental forms expected for the proposed chemicals, the industrial applications where 

each of the proposed chemicals would be manufactured, processed, and otherwise used were identified. For 

each industrial application and chemical, the incremental number of new forms and number of facilities 

affected were estimated. These counts were then summed across chemicals to determine the total number of 

new forms and facilities affected by the proposed rule.

The industrial processes identified for each chemical fell into three main categories: 

• Industrial processes associated with facilities manufacturing a proposed chemical as a product, 

• Industrial processes associated with facilities processing a proposed chemical during the 

manufacture of other chemicals,

• Facilities manufacturing, processing, or otherwise using a proposed chemical in sectors other than 

chemical manufacturing.

General methods used to estimate incremental forms and affected facilities for the proposed chemicals 

expected to generate new reporting for each of these three categories are presented in this section (2.1).

2.1.1 Methods Applicable to all Estimates 

Assumptions Made in all Methods

For most of the chemicals, the data available to estimate the number of forms expected were very limited, 

such that release and waste management quantities and number of employees could not be estimated. 

Therefore, the conservative assumption was made that all forms for these chemicals would be Form Rs, 

although in practice, some chemical uses at some facilities may qualify for Form A reporting. Likewise, 

unless otherwise specified, the conservative assumption was made that all facilities would exceed the TRI 

employee threshold of 10 full-time equivalents if they exceed manufacturing, processing, or otherwise use 

thresholds. 

Additional assumptions were made for each estimation method. These assumptions are noted in each 

method description below. 

Actual vs. Modeled Facilities

Methods used to estimate the number of facilities required to report under the proposed rule count two types 

of facilities: actual facilities and modeled facilities. 

For some sectors, specific sources listing facilities that manufacture, process, or otherwise use a proposed 

chemical were available. From these facility lists, actual facilities expected to report under the proposed 

rule were identified. Identification information, such as name and address was available for actual facilities. 

For other sectors, lists of facilities were not available, but information was available on total counts of 

facilities, from which it was possible to model the number of facilities likely to report under the proposed 

rule. Modeled facilities do not correspond to specific facilities; they are included in counts estimated using 

modeling techniques. No identification was available for modeled facilities. 

Whether a method produces counts of actual or modeled facilities is noted the end of each method

description below. 
2-3

Existing vs. First Time Filers 

Facilities were classified as either existing filers or first time filers. Existing filers are facilities that 

reported to TRI during RY2003 – 2007. First time filers are facilities that have never reported to TRI or 

have not reported to TRI since RY2002. 

Actual facilities were identified as either existing filers or first time filers using facility identification 

information. TRI Facility IDs for each actual facility were identified using EPA’s Facility Registry System 

(FRS) linkage and by searching TRI for facilities by name and address. Facilities with TRI Facility IDs that 

reported to TRI in RY2003 – RY2007 were classified as existing filers. All others were classified as first 

time filers. 

Facility identification information was not available to determine whether modeled facilities are existing 

filers or first time filers. Where possible, modeling was used to estimate the number of existing filers or 

first time filers in a group of modeled facilities. If no information was available to predict whether a 

modeled facility was an existing filers or first time filer, the facility was conservatively classified as a first 

time filer.

2.1.2 Identification of Facilities Manufacturing the Proposed Chemicals 

Two methods were used to estimate the number of facilities that produce the proposed chemicals that would 

be expected to be reported under the proposed rule.

Literature Review

During the literature review to identify industrial applications for each proposed chemical, evidence 

showing that a proposed chemical is not manufactured in the U.S. was noted. If a proposed chemical was 

found to not be produced in the U.S., it was assumed that no facilities that manufacture the chemical would 

be required to report to TRI under the proposed rule. 

This method was used for the following chemical: 

• 1-Amino-2,4-dibromoanthraquinone (ADBAQ) 

Facility Inventories

For the proposed chemicals where literature review results indicated that some facilities may manufacture 

the chemical in the U.S., manufacturers of the chemicals were identified using EPA’s Risk Management 

Plan (RMP) Database, EPA’s TSCA Inventory Update Reporting (IUR) Database, the Directory of 

Chemical Producers – United States, and the Chemical Information Service’s Directory of World Chemical 

Producers. Facilities were included in this analysis as manufacturers if they were listed as manufacturing a 

proposed chemical in at least one of these sources. 

Facilities were assumed to exceed TRI reporting thresholds for the chemical and would be required to 

report under the proposed rule if they met at least one of the following criteria:

• The facility reported having quantities of the chemical in storage or other processes on site at any 

time above 10,000 pounds to RMP. The cut-off point of 10,000 pounds on site at any time was 

chosen because it is the most common RMP reporting threshold and because 10,000 pounds is the 

lowest of the TRI reporting thresholds. Using this cut-off assumes that facilities annually 

manufacture more of the chemical than they store on site at any time. Specifically, using this cut-off 

assumes that the facility manufactures at least 2.5 times the maximum amount of the chemical on 

site, meaning at least 25,000 pounds.
2-4

• The facility was listed as having annual production or capacity for the chemical above 25,000 

pounds in SRI; production of more than 25,000 pounds of the chemical indicates the facility would 

exceed the TRI reporting threshold for manufacturing. 

• The facility was identified as a manufacturer of the chemical, but had no production information 

available from any of these sources. When production data was unavailable, a facility was assumed 

to exceed the manufacturing threshold as a conservative estimate. Details used to justify this 

assumption, such as national production estimates, can be found for each chemical in Section 2.2. 

For certain chemicals, manufacturer information was not available in all four sources. For these chemicals, 

a subset of these sources was used to identify the facilities manufacturing the chemicals. 

Table 2-1 shows the sources used to identify manufacturers by chemical.

Table 2-1: Sources Used to Identify Facilities that Manufacture the Proposed Chemicals

Chemical Risk Management Plan 

(RMP) Database

Directory of World 

Chemical Producers

TSCA Inventory Update 

Reporting (IUR) Database SRI a

BBMP x x

Furan X x x x

Glycidol x x x

Isoprene X x x x

Methyl Eugenol x x

Nitromethane x x

o-Nitroanisole x

Phenolphthalein x

Tetrafluoroethylene X x x x

Tetranitromethane x

Vinyl Fluoride X

a Refers to SRI’s 2009 Directory of Chemical Producers.

Facilities identified using this method are actual facilities. 

2.1.3 Identification of Facilities Processing the Chemical during the Manufacture of 

Other Chemicals 

During the literature review to identify industrial applications for each proposed chemical, several proposed 

chemicals were identified as processed during the manufacture of other chemicals. For example, the 

proposed chemical, furan, is processed during the manufacture of tetrahydrofuran. 

Two methods were used to identify facilities that process the proposed chemicals during the manufacture of 

other chemicals.

Toxics Release Inventory (TRI)

One proposed chemical, o-nitroanisole, is processed during the production of a TRI-reportable chemical, oanisidine. Facilities that process o-nitroanisole during the manufacture of o-anisidine were identified using 

TRI. Details and assumptions for this method can be found in Section 2.2.

Facilities identified using this method are actual facilities. 
2-5

Facility Inventories

For proposed chemicals processed during the manufacture of chemicals that are not TRI reportable, 

information from RMP, the Directory of Chemical Producers – United States and, the Chemical 

Information Services’ Directory of World Chemical Producers, and the Fluoropolymers Division (FPD) of 

the Society of the Plastics Industry Materials Suppliers list was used to identify facilities which process 

proposed chemicals during the manufacture of other chemicals. This method is similar to that used to 

identify manufacturers of the proposed chemicals.

Facilities were assumed to exceed TRI processing thresholds for the proposed chemical and would be 

required to report under the proposed rule if they met at least one of the following criteria: 

• The facility reported having quantities of the proposed chemical in storage or other processes on 

site at any time above 10,000 pounds to RMP. The cut-off point of 10,000 pounds on site at any 

time was chosen because it is the most common RMP reporting threshold and because 10,000 

pounds is the lowest of the TRI reporting thresholds. Using this cut-off assumes that facilities 

process at least 25,000 pounds of the chemical, 2.5 times the maximum amount on site. Using this 

cut-off assumes that facilities annually manufacture more of the chemical than they store on site at 

any time. Specifically, using this cut-off assumes that the facility manufactures at least 2.5 times the 

maximum amount of the chemical on site, meaning at least 25,000 pounds.

• The facility was listed as having annual production or capacity for the manufactured chemical 

above 25,000 pounds in SRI; production of more than 25,000 pounds of the manufactured chemical 

was assumed to correspond to more than 25,000 pounds of processing for the proposed chemical. 

Details used to justify this assumption, such as stoichiometric ratios, can be found for each 

chemical with facility level production information in Section 2.2.

• The facility had no production information available from any of these sources. When production 

data was unavailable, a facility was assumed to be required to report to TRI under the proposed rule 

as a conservative estimate. Details used to justify this assumption, such as annual national 

production estimates, can be found for each chemical in Section 2.2. 

For certain chemicals manufactured using a proposed chemical, information was not available in all four

sources. For these chemicals, a subset of these sources was used to identify the facilities manufacturing the 

chemicals. 

Table 2-2 shows the sources used to identify chemical manufacturers that process proposed chemicals. 

Table 2-2: Sources Used to Identify Facilities that Process Proposed Chemicals During the 

Manufacture of Other Chemicals

Chemical Risk Management Plan 

(RMP) Database

Directory of World 

Chemical Producers

FPD Materials 

Suppliers List SRI a

Furan 

(Manufacture of Adhesive Resin) x

Furan 

(Manufacture of Pyrrole, Tetrahydrofuran, 

and Thiophene)

x x x

Tetrafluoroethylene 

(Manufacture of Fluoropolymers) x x x x

Vinyl Fluoride 

(Manufacture of Fluoropolymers) x

a Refers to SRI’s 2009 Directory of Chemical Producers, except for furan processed during resin production, where SRI’s Chemical 

Economics Handbook, Furfuryl Alcohol and Furan Resins (2008) was used.

Facilities identified using this method are actual facilities. 
2-6

2.1.4 Identification of Facilities Manufacturing, Processing, or Otherwise Using the 

Chemical in Sectors other than Chemical Manufacturing 

Facilities that manufacture, process, or otherwise use chemicals in sectors other than chemical 

manufacturing were also identified. Individual analyses were conducted for common applications of the 

chemical identified during literature review. Less common applications of each chemical were also 

covered, if information on the applications was identified. 

Several methods were used to identify facilities that manufacture, process, or otherwise use chemicals in 

other industries.

National Pesticide Information Retrieval System

One chemical, methyl eugenol, was identified as a pesticide during literature review. Facilities 

manufacturing or processing methyl eugenol to produce pesticides were identified by using the National 

Pesticide Information Retrieval System to retrieve records of facilities registered to produce methyl eugenol 

pesticides in EPA’s Pesticide Product Information System. Details and assumptions for this method can be 

found in Section 2.2.

Facilities identified using this method are actual facilities. 

Risk Management Plan (RMP) Database and the National Biennial RCRA Hazardous Waste Report 

(BR)

If both RMP and BR data were available for a proposed chemical, facilities that manufacture, process, or 

otherwise use the chemical in other industries were identified using a combination of RMP and BR data. 

Facilities were assumed to exceed TRI reporting thresholds for the proposed chemical and to be required to 

report under the proposed rule if they met at least one of the following criteria:

• They reported having quantities of the chemical in storage or other processes on site at any time 

above 10,000 pounds to RMP. 

• They reported to BR more than 10,000 pounds of waste generated or managed for a waste stream 

containing the chemical.

The cut-off point of 10,000 pounds on site at any time was chosen because it is the most common RMP 

reporting threshold and because 10,000 pounds is the lowest of the TRI reporting thresholds. Note that the 

pounds of waste reported to BR may differ substantially from the pounds of the chemical manufactured,

processed, or otherwise used by a facility in the following ways: 

• The waste stream reported to BR may include more than one chemical and nonhazardous waste. 

• The chemical may be incorporated into a product made at the facility and may not disposed of in 

waste stream.

This method was used for the following chemicals:

• Furan (Other Manufacturing, Processing, and Otherwise Use of Furan)

• Tetranitromethane (Waste Treatment) 

• Tetranitromethane (Diesel Fuel Additive)

• Tetranitromethane (Rocket Propellant)

Facilities identified using this method are actual facilities. 
2-7

Scaling Method

If RMP, but not BR, data were available for a proposed chemical, facilities that manufacture, process, or 

otherwise use the chemical were identified using a combination of RMP data and TRI data. 

Facilities were assumed to exceed TRI reporting thresholds for the proposed chemical and to be required to 

report under the proposed rule if they met both the following criteria: 

• They reported having quantities of the proposed chemical in storage or other processes on site at 

any time above 10,000 pounds to RMP. 

• They were listed under a TRI-reportable NAICS code in RMP. 

The cut-off point of 10,000 pounds on site was chosen because it is the most common RMP reporting 

threshold and because 10,000 pounds is the lowest of the TRI reporting thresholds. Using this cut-off 

assumes that facilities: 

• Manufacture 25,000 pounds of the chemical, 2.5 times the maximum amount on site, 

• Process 25,000 pounds of the chemical, 2.5 times the maximum amount on site, or otherwise use 

10,000 pounds of the chemical, equal to the maximum amount on site.

Sources other than the RMP data were not identified that would confirm whether RMP captured the 

universe of facilities using each proposed chemical. Given the high production volumes in the TSCA IUR 

for the proposed chemicals, it was assumed that the count of facilities reporting each proposed chemical to 

RMP likely underestimates the number of facilities that would be required to report each proposed chemical 

to TRI. Facilities might exceed TRI reporting thresholds but not RMP reporting thresholds if 1) they 

manufacture, process, or otherwise use a chemical in multiple separate processes, or 2) their throughput 

exceeds TRI reporting thresholds while their maximum amount on site at any one time is less than the RMP 

threshold quantities. Thus, the count of facilities expected to report the proposed chemicals to TRI was 

scaled up from the number of facilities reporting the chemicals to RMP. 

A comparison between RMP reporting and TRI reporting for chemicals similar to the proposed chemicals 

was used to scale counts of RMP reporters to counts of possible TRI reporters. The analysis was applied 

only to the sectors reporting each proposed chemical to RMP. Scaling chemicals selected for the analysis 

were limited to those that: 

• were reported to TRI by the sectors reporting the proposed chemical to RMP,

• have similar chemical structure to the proposed chemical, and 

• have TRI and RMP reporting thresholds equal to those for the proposed chemical. 

Note that the prevalence of chemicals in industrial applications was not used as a factor to select scaling 

chemicals because industrial prevalence for chemicals reported to TRI by sector was not available across 

chemicals. The chemicals selected for each proposed chemical are listed in Section 2.2.

For each sector reporting each proposed chemical to RMP, facilities reporting each scaling chemical to 

RMP and facilities reporting each scaling chemical to TRI were counted. The ratio between the number of 

RMP and TRI reporters for each sector and scaling chemical was then calculated. This ratio was then 

multiplied by the number of facilities reporting each proposed chemical to RMP to estimate the number of 

facilities that would report each proposed chemical to TRI, assuming the ratio between the number of RMP 

and TRI reporters for each proposed chemical was the same as that for each scaling chemical for each 

sector. The maximum of these estimates was then taken for each sector as an estimate of the number of

facilities that would report each proposed chemical to TRI. If this scaled number was greater than the 

number of facilities reporting each proposed chemical to RMP, it was used as the estimate of TRI reporters 
2-8

for the proposed chemical in the sector. Otherwise, the number of facilities reporting each proposed 

chemical to RMP was used as the estimate for the sector. 

Facility identification information was not available for the facilities modeled from scaling, so the 

classification of these facilities as new or existing filers was modeled. The ratio of new to existing filers 

was assumed to be equal for the facilities from RMP and for the facilities modeled from scaling. For the 

two proposed chemicals assessed with this method, all RMP facilities assumed to report under the proposed 

rule were existing filers, so all facilities projected to report the proposed chemical to TRI were also assumed 

to be existing filers reporting under the proposed rule. 

This method was used for the following chemicals:

• Isoprene

• Tetrafluoroethylene

For this method, facilities identified using RMP are actual facilities, and facilities modeled from scaling are 

modeled facilities.

TRI Exemptions

For some applications of proposed chemicals, a review of TRI reporting requirements indicated that zero 

U.S. facilities would be expected to report to TRI under the proposed rule because they only use the 

chemical in certain laboratory activities,. It was assumed that no facilities that use the chemical for these 

laboratory activities would be required to report to TRI under the proposed rule. The applicable TRI 

reporting requirements and assumptions made are detailed in Section 2.2.

This method was used for the following chemicals: 

• Phenolphthalein (Laboratory Reagents)

• Tetranitromethane (Research and Development)

• Tetranitromethane (National Security)

Literature Review

For proposed chemicals where a review of literature identified no facilities in the U.S. that manufacture, 

process, or otherwise use a chemical above TRI reporting thresholds for a specific application, it was 

assumed that no facilities that use the chemical for the application would be required to report to TRI under 

the proposed rule. The information found during literature review and assumptions made are detailed in 

Section 2.2.

This method was used for the following chemical: 

• Phenolphthalein (Pharmaceutical Preparation Manufacturing)

• Phenolphthalein (Disappearing Inks) 

Modeling 

If facility-level information was not available to identify facilities manufacturing, processing, or otherwise 

using a proposed chemical for a major industrial application identified in literature review, the number of 

facilities expected to report to TRI for the application of the chemical was modeled. 

Modeling methods involve conducting a literature review to collect information about the industrial 

application and then using the results of the literature review to estimate the number of filers for the 

application of the chemical. Modeling methods varied among chemicals and applications based on the 

availability of information in the literature. For example, if a measure of the level of chemical per unit 
2-9

product was available, a model may have been constructed to determine whether a facility would exceed 

TRI reporting thresholds for the chemical, given the amount of product that must be produced to exceed the 

threshold. Alternatively, if the number of facilities producing a product containing a chemical and the 

national annual production of the product are known, the number of facilities expected to report the 

chemical might be estimated by distributing the national annual production among producing facilities. 

Modeling methods and assumptions made are described in detailed in Section 2.2.

Modeling was used for the following chemicals:

• 1-Amino-2,4-dibromoanthraquinone (ADBAQ; Dye Manufacturing)

• Methyl Eugenol (Foods Processing)

• Methyl Eugenol (Perfumes and Toiletry Production)

Facilities identified using this method are modeled facilities.

Literature Review and Toxics Release Inventory

A combination of literature review results and TRI were used to identify facilities which process 

tetranitromethane during explosives manufacturing. Details and assumptions for this method can be found 

in Section 2.2.

Facilities from this method are modeled facilities.

No Estimate Made

For some chemicals, counts of facilities that process or otherwise use the chemical were not estimated. For 

these chemicals, information on the use of the chemical by facility or sector could not be identified. 

Information on processors and otherwise users of these chemicals is not available through facility-level 

EPA databases. Specifically: 

• They are not found on the CAA Section 112(r) List of Substances for Accidental Release 

Prevention, so information on quantities of these chemicals on-site at facilities is not available 

through RMP. 

• They do not correspond to a listed RCRA hazardous waste, so information on quantities handled by 

facilities is not available through BR. 

• They are not classified as HAPs or CAPs, so information on facilities emitting these chemicals is 

not available through NEI. 

• They are not found on the list of EPCRA Section 302 Extremely Hazardous Substances (EHSs), so 

information on processors and otherwise users of these chemicals is not available through Tier II. 

• No state databases with facility-level information on processors and otherwise users of these 

chemicals were identified. For example, although nitromethane is listed as a carcinogen in 

California’s Proposition 65, no facility level information for nitromethane was found to be available 

from California. 

Given the lack of information available for estimating the number of forms expected for these chemicals, 

the number of reporters could not be determined. Some forms are expected from processors and otherwise 

users of these chemicals in a number of sectors, so the total counts of forms for the chemicals presented are 

likely underestimates. Where possible, a rough estimate of the maximum number of possible forms from 

facilities that process or otherwise use the chemical is presented in Section 2.2. 

The chemicals for which counts of facilities that process or otherwise use the chemical were not estimated 

are:
2-10

• Glycidol

• BBMP

• Nitromethane

2.2 Application of Estimation Methods by Chemical 

2.2.1 Isoprene (78-79-5) 

Isoprene is a colorless volatile liquid with a mild odor. It is practically insoluble in water but is soluble in 

alcohol and diethyl ether. Isoprene is “reasonably anticipated to be a human carcinogen” based on sufficient 

evidence of tumor formation from studies in experimental animals. Isoprene is most often used via 

conversion to terpines, polyisoprene, and cis-1,4-polyisoprene types of synthetic natural rubber. It is also 

used in the manufacturing of butyl rubbers; synthetic elastomers; and fibrous materials; as a chemical 

intermediate; and as a semiconductor.

Isoprene Production

Facilities that manufacture isoprene were identified using the Facilities Inventories method described in 

Section 2.1.2 with information from EPA’s Risk Management Plan (RMP) Database, TSCA Inventory 

Update Reporting (IUR) Database, the Directory of Chemical Producers – United States, and the Chemical 

Information Services Directory of World Chemical Producers.

According to the TSCA 2006 Inventory Update Reporting Non-Confidential Business Information, U.S. 

production of isoprene in 2005 was 500 million – 1 billion pounds. Facilities identified as manufacturers 

for which no production information was available were assumed to exceed the TRI manufacturing 

threshold for isoprene based on the high production volumes included in the TSCA IUR Database for this 

chemical.

For isoprene manufacturing, 12 forms from first time filers and 8 forms from existing filers are expected 

under the proposed rule.

Other Manufacturing, Processing, and Otherwise Use of Isoprene

Additional sectors likely to be required to report isoprene to TRI were identified using RMP and then scaled 

using TRI data, as described in Section 2.1.4.

Scaling chemicals selected for this analysis were allylamine, dimethylamine, ethylene, ethylene oxide, 

propylene oxide, and propyleneimine. These chemicals were reported by the sectors reporting isoprene to 

RMP, have similar chemical structure to isoprene (small organic chemicals), and have TRI and RMP 

reporting thresholds equal to those for isoprene.

For this application of isoprene, 1 form from a first time filer and 44 forms from existing filers are expected 

under the proposed rule.

2.2.2 Furan (110-00-9) 

Furan is a cyclic dienic ether that exists as a flammable colorless liquid with a ethereal odor. It is insoluble 

in water but soluble in alcohols and ethers. Furan is “reasonably anticipated to be a human carcinogen” 

based on sufficient evidence of malignant tumor formation from studies of experimental animals. Furan is 

used in the manufacturing of pharmaceuticals, agricultural chemicals and insecticides, stabilizers, and fine 

chemicals. It is used in the organic synthesis of pyrrole, tetrahydrofuran, and thiophene and as a solvent for 

adhesive resins in the manufacture of flooring. 
2-11

Furan Production

Facilities that manufacture furan were identified using EPA’s Risk Management Plan (RMP) database, the

TSCA 2006 Inventory Update Reporting Non-Confidential Business Information, the Directory of 

Chemical Producers – United States, and the Chemical Information Services Directory of World Chemical 

Producers, as described in Section 2.1.2. 

According to the TSCA 2006 Inventory Update Reporting Non-Confidential Business Information, U.S. 

production of furan in 2005 was 1 million – 10 million pounds. Based on the high production volumes 

included in the TSCA IUR for this chemical, all identified furan manufacturers for which no production 

information was available were assumed to exceed the TRI manufacturing threshold for furan.

For furan manufacturing, 14 forms from first time filers and 3 forms from existing filers are expected under 

the proposed rule.

Pyrrole, Tetrahydrofuran, and Thiophene Synthesis 

Facilities that process furan during pyrrole, tetrahydrofuran, or thiophene production were identified by 

identifying facilities with pyrrole, tetrahydrofuran, or thiophene production associated with furan records in 

EPA’s Risk Management Plan (RMP) database and facilities listed for pyrrole, tetrahydrofuran, or 

thiophene in the Directory of Chemical Producers – United States or the Chemical Information Services

Directory of World Chemical Producers, as described in Section 2.1.3. 

Annual production information was available for certain tetrahydrofuran manufactures. One mole of furan 

is needed to produce one mole of tetrahydrofuran. The molecular weight of furan is 68 g/mol and the 

molecular weight of tetrahydrofuran is 72 g/mol. Assuming a complete reaction, 0.94 pounds of furan are 

processed for every pound of tetrahydrofuran manufactured. Thus, if a facility manufactures more than 

25,000 pounds of tetrahydrofuran, it likely process at least 23,500 pounds of furan. Available production 

information indicated that these manufactures’ annual production was above 25,000 pounds of 

tetrahydrofuran, so they are expected to exceed the processing threshold for furan. 

Based on the high production volumes included in the TSCA IUR for furan, facilities for which no 

production information was available were assumed to exceed the TRI processing threshold for furan.

For this application of furan, 3 forms from first time filers and 3 forms from existing filers are expected 

under the proposed rule.

Adhesive Resin Production

Facilities that process furan during resin production were identified using the Chemical Economics 

Handbook, as described in Section 2.1.3. 

No annual production information was available for these facilities. Based on the high production volumes 

included in the TSCA IUR for furan, these facilities were assumed to exceed the TRI processing threshold 

for furan. 

For this application of furan, 6 forms from first time filers and 5 forms from existing filers are expected 

under the proposed rule.

Other Manufacturing, Processing, and Otherwise Use of Furan

Facilities that manufacture, process, or otherwise use furan were identified using a combination of RMP 

and BR data, as described in Section 2.1.4. 

For this application of furan, 4 forms from first time filers and 8 forms from existing filers are expected 

under the proposed rule.
2-12

2.2.3 1-Amino-2,4-Dibromoanthraquinone (81-49-2) 

1-Amino-2,4-dibromoanthraquinone (ADBAQ) exists as a reddish brown or orange powder that is insoluble 

in water. It is “reasonably anticipated to be a human carcinogen” based on sufficient evidence from studies 

in experimental animals. ADBAQ is used as an intermediate during the manufacture of most anthraquinone 

dyes. It is also widely used as a starting material for vat dyes. These dyes are then applied to fibers and 

textiles such as cotton, wool, and cellulose acetate.

ADBAQ Production

Based on a literature review, it was determined that ADBAQ is not manufactured in the United States. 

For ADBAQ manufacturing, 0 forms from first time filers and 0 forms from existing filers are expected 

under the proposed rule.

Dye Manufacturing

ADBAQ is processed during the manufacture of anthraquinone dyes and vat dyes; it is an intermediate in 

the production of almost all anthraquinone dyes and a starting material for the production of vat dyes. The 

number of facilities expected to report ADBAQ to TRI was modeled as follows: 

1. The proportion of anthaquinone and vat dye made using ADBAQ was estimated:

An estimate of the proportion of anthaquinone and vat dyes made using ADBAQ was not identified 

in the literature review. Therefore, as a conservative estimate, it was assumed that all U.S. 

anthraquinone and vat dye production uses ADBAQ during the manufacturing process. 

2. The number of pounds of ADBAQ processed per pound of anthraquinone or vat dye produced was

estimated:

The ratio of molecules of ADBAQ used to molecules of dye generated may vary depending on the 

dye being produced. For this estimate, 1-amino-4-hydroxy-2-phenoxy-9,10-anthracenedione, a 

disperse dye manufactured using ADBAQ, represents a typical anthraquinone dye. Based on the 

molecular structures of the two chemicals, there is a stoichiometric ratio of 1:1 between ADBAQ 

and 1-amino-4-hydroxy-2-phenoxy-9,10-anthracenedione. The molecular weight of ADBAQ is 381 

g/mol, while that of 1-amino-4-hydroxy-2phenoxy-9,10-anthracenedione is 331 g/mol. Assuming 

complete reactions and similar stoichiometric ratios for the production of all anthraquinone or vat 

dyes, 1.15 pounds of ADBAQ are processed for every pound of anthraquinone or vat dye produced. 

3. The total pounds of anthraquinone or vat dye produced annually in the U.S. was estimated:

In 1993, U.S. vat dye production was 14 million kilograms (30.8 million pounds), and total dye 

production was 154 million kilograms (338.8 million pounds). In 1974, anthraquinone dye 

production made up 18% of the 21 million kilograms (46.2 million pounds) of dye produced in the 

U.S. This proportion subsequently decreased; however if 18% of current dye production is 

conservatively assumed to be anthraquinone dyes, and an additional 9% (based on dividing U.S. vat 

dye production by the total U.S. dye production in 1993) is vat dyes, then 27% of U.S. dye 

production uses ADBAQ during the manufacturing process, or 91 million pounds (based on 1993 

U.S. production information) of dyes are manufactured using ADBAQ. 

4. The total pounds of ADBAQ processed during anthraquinone or vat dye manufacture annually in 

the U.S. was estimated: 

Since 1.15 pounds of ADBAQ are processed for every 1 pound of dye produced, the annual 

production of 91 million pounds of anthraquinone or vat dye indicates an estimated 104 million 

pounds of ADBAQ are processed annually in the U.S. 
2-13

5. The number of facilities that have 10 or more employees and manufacture anthraquinone or vat dye 

in the U.S. was estimated: 

According to the 2002 Economic Census, there are 79 synthetic organic dye and pigment 

manufacturing establishments with more than 10 employees in the United States. If 27% of these 

facilities are producing anthraquinone or vat dyes using ADBAQ during manufacturing, then there 

will be 22 dye facilities that process ADBAQ and exceed the TRI employee threshold. 

6. The number of facilities expected to report was estimated:

Facility level production information was not available for anthraquinone or vat dye manufacturers. 

Given the large quantity of ADBAQ processed annually by anthraquinone or vat dye 

manufacturers, it was conservatively assumed that all 22 facilities manufacturing anthraquinone or 

vat dyes are processing more than 25,000 pounds of ADBAQ and would be required to report to 

TRI under the proposed rule. 

7. The number of current and new reporters was estimated: 

There are currently 37 facilities reporting to TRI in the synthetic organic dye and pigment

manufacturing industry. If 27% of these (10 facilities) are manufacturing anthraquinone or vat dyes, 

then it is expected that there will be 12 forms from first time filers and 10 forms from existing filers 

under the proposed rule.

2.2.4 Tetrafluoroethylene (116-14-3) 

Tetrafluoroethylene exists as a colorless gas and is insoluble in water. It is “reasonably anticipated to be a 

human carcinogen” based on sufficient evidence of malignant tumor formation from studies of 

experimental animals. It is used as monomer for the creation of polytetrafluoroethylene polymers and to 

produce copolymers with hexafluoropropylene and ethylene. It is also used for electrical insulation and in 

the preparation of propellants for food product aerosols. 

Tetrafluoroethylene Production 

Facilities that manufacture tetrafluoroethylene were identified using EPA’s Risk Management Plan (RMP) 

Database, the TSCA 2006 Inventory Update Reporting Non-Confidential Business Information, the 

Directory of Chemical Producers – United States, and the Chemical Information Services Directory of 

World Chemical Producers, as described in Section 2.1.2. 

According to the TSCA 2006 Inventory Update Reporting Non-Confidential Business Information, U.S. 

production of tetrafluoroethylene in 2005 was 50 million – 100 million pounds. Given the high production 

volumes of this chemical included in the TSCA IUR, facilities for which no production information was 

available were assumed to exceed the TRI manufacturing threshold for tetrafluoroethylene. 

For tetrafluoroethylene manufacturing, 1 form from a first time filer and 1 form from an existing filer is 

expected under the proposed rule.

Fluoropolymer Production

Facilities that process tetrafluoroethylene during fluoropolymer production were identified by identifying 

facilities with polytetrafluoroethylene or hexafluoropropylene production associated with 

tetrafluoroethylene records in EPA’s Risk Management Plan (RMP) Database and facilities listed as 

polytetrafluoroethylene or hexafluoropropylene manufacturers in the Directory of Chemical Producers –

United States, the Chemical Information Services Directory of World Chemical Producers, or the FPD 

Materials Suppliers List, as described in Section 2.1.3. 
2-14

Polytetrafluoroethylene is a polymer of tetrafluoroethylene monomers with the same empirical formula as 

tetrafluoroethylene. Assuming a complete reaction, 1 pound of tetrafluoroethylene is processed for every 

pound of polytetrafluorethylene manufactured. Thus, if a facility manufactures more than 25,000 pounds of 

polytetrafluorethylene, it likely processes more than 25,000 of tetrafluoroethylene. Available production 

information indicated that the polytetrafluorethylene manufactures identified each produce more than 

25,000 pounds of polytetrafluorethylene annually, so they are expected to exceed the processing threshold 

for tetrafluoroethylene. 

Given the high production volumes of tetrafluorethylene included in the TSCA IUR, facilities for which no 

production information was available were also assumed to exceed the TRI processing threshold for 

tetrafluorethylene.

For this application of tetrafluoroethylene, 6 forms from first time filers and 5 forms from existing filers are 

expected under the proposed rule.

Other Manufacturing, Processing, and Otherwise Use of Tetrafluoroethylene

Additional sectors likely to be required to report tetrafluoroethylene to TRI were identified using RMP and 

then scaled using TRI data, as described in Section 2.1.4.

Scaling chemicals selected for this analysis were chloromethane and vinylidene chloride. These chemicals 

were reported by the sectors reporting tetrafluoroethylene to RMP, have similar chemical structure to 

tetrafluoroethylene (halogenated organic chemicals), and have TRI and RMP reporting thresholds equal to 

those for tetrafluoroethylene.

For this application of tetrafluoroethylene, 0 forms from first time filers and 3 forms from existing filers are 

expected under the proposed rule.

2.2.5 Glycidol (556-52-5) 

Glycidol is a slightly viscous colorless liquid that is soluble in water, alcohol, benzene, ether, and acetone. 

Glycidol is “reasonably anticipated to be a human carcinogen” based on sufficient evidence of 

carcinogenicity in experimental animals. It is used during the manufacture of vinyl polymers, glycerol, 

glycidyl ethers, amines, and natural oils. It is also used as an additive for oil and other synthetic hydraulic 

fluids, as a diluent for epoxy resins, and as an alkylating agent. It is a chemical intermediate in the 

production of pharmaceuticals, cosmetics, glycerin, and surfactants, and can also be used for sterilizing 

milk of magnesia. 

Glycidol Production

Facilities that manufacture glycidol were identified using the TSCA 2006 Inventory Update Reporting NonConfidential Business Information, the Directory of Chemical Producers – United States, and the Chemical 

Information Services Directory of World Chemical Producers, as described in Section 2.1.2. 

According to the TSCA 2006 Inventory Update Reporting Non-Confidential Business Information, U.S. 

production of glycidol in 2005 was 10,000 – 500,000 pounds. Given that the TSCA IUR indicates 

aggregated production volumes of this chemical could be up to 500,000 pounds, all facilities for which no 

production information was available were assumed to exceed the TRI manufacturing threshold for 

glycidol.

For this application of glycidol, 11 forms from a first time filer and 2 forms from existing filers are 

expected under the proposed rule.
2-15

Other Manufacturing, Processing, and Otherwise Use of Glycidol 

Counts of facilities that process or otherwise use glycidol in TRI reportable quantities have not been 

estimated; glycidol is used in many industries across a broad range of applications and detailed information

on glycidol use by facility or sector for each industry and application has not been identified. Some forms 

are expected from processors and otherwise users of glycidol in a number of sectors, but the number of 

reporters cannot be determined with available information. Thus, the total counts of forms for glycidol 

presented are likely underestimates.

It should be noted that some information on production of glycidol is available through the TSCA 2006 

Inventory Update Reporting Non-Confidential Business Information; U.S. production of glycidol in 2005 

was between 10,000 and 500,000 pounds. Although no records for processors or otherwise users of glycidol 

were available from TSCA IUR, an estimate of the number of potential reporters for glycidol might be 

made using the annual production quantity. For example, the midpoint of the range of annual production 

from TSCA might be divided by the TRI reporting threshold for processing to come up with a rough 

estimate of the number of TRI forms possible for glycidol, assuming all glycidol produced in the US is 

processed by facilities in TRI reportable industries. Using this method, about 10 forms would be expected 

for glycidol. This is likely an overestimate of forms; some TRI facilities will likely process quantities of 

glycidol well above the TRI processing threshold. Thus, fewer than 10 forms would be expected for other 

manufacturing, processing, and otherwise use of glycidol under the proposed rule. 

2.2.6 Methyl Eugenol (93-15-2) 

Methyl eugenol is a colorless to pale yellow oily liquid with a clover-carnation odor. It is insoluble or 

slightly soluble in water. Methyl eugenol is “reasonably anticipated to be a human carcinogen” based on 

sufficient evidence of carcinogenicity from studies in experimental animals. It is used for flavoring in 

jellies, chewing gum, relish, pudding, baked goods, nonalcoholic beverages, candy, ice cream, and other 

foods. It is also used for its fragrance in perfumes, detergents, and toiletries. It is incorporated into 

pesticides as an insect attractant and has also been used as a veterinary anesthetic. 

Methyl Eugenol Production

Facilities that manufacture methyl eugenol were identified using the Directory of Chemical Producers –

United States and the Chemical Information Services Directory of World Chemical Producers, as described 

in Section 2.1.2. 

Several methyl eugenol manufacturers were identified, but no production information was available for 

these facilities. One of these facilities ships methyl eugenol in 35 pound packages and would need to fill 

only 715 one-package orders of methyl eugenol in one year to exceed the TRI manufacturing threshold. 

Thus, in the absence of more detailed production information, all five facilities were conservatively 

assumed to exceed the TRI manufacturing threshold for methyl eugenol based on professional judgment.

For methyl eugenol manufacturing, 3 forms from first time filers and 2 forms from existing filers are 

expected under the proposed rule.

Pesticide Production

Facilities manufacturing or processing methyl eugenol to produce pesticides were identified by using the 

National Pesticide Information Retrieval System to retrieve records of facilities registered to produce 

methyl eugenol pesticides in the Pesticide Product Information System. Three companies in the US were 

listed as actively registered to manufacture methyl eugenol pesticides.

Annual production of methyl eugenol for each facility is unknown, so approximate size of production was 

estimated using proxies for facility size from EPA’s enforcement and compliance databases. In the absence 

of more detailed production information, facilities size designation from the Online Tracking Information 
2-16

System (OTIS) and best professional judgment were used to determine whether each facility would exceed 

the TRI reporting threshold for methyl eugenol. Two of the facilities appear to be relatively small; one 

facility has no CWA, CAA or RCRA permits or facility notifications and the second facility is a RCRA 

CESQG. The third facility appears to be a larger facility in that it is a RCRA LQG, reported to BR in 2007,

and is an AFS Synthetic Minor. In the absence of more detailed production information, best professional 

judgment was used in assuming that the two smaller facilities manufacture methyl eugenol below TRI 

reporting thresholds while the larger facility was assumed to manufacture methyl eugenol above TRI 

reporting thresholds. 

The facility assumed to exceed the methyl eugenol threshold has not reported to TRI since 1992. It is 

therefore considered a first-time filer. 

Foods Processing

Methyl eugenol is processed by food manufacturing facilities as a flavoring and occurs naturally in foods. 

Whether any food processing facilities would report methyl eugenol was estimated by modeling the 

quantity of food that must be produced by a facility to exceed the TRI processing threshold for methyl 

eugenol. 

In review of available literature, two estimates were found for concentrations of methyl eugenol in foods: 

250 μg per serving of pesto and 216 μg per ten gingersnaps. Both of these concentrations were noted as 

being above average for foods containing methyl eugenol. 

The amount of pesto and gingersnaps needed to exceed the TRI reporting threshold for methyl eugenol was 

calculated using the amount per serving, the serving size, and the TRI reporting threshold for methyl 

eugenol processing. To exceed a 25,000 pound TRI threshold for processing methyl eugenol, 709 million 

gallons of pesto (45 billion servings) or 13 billion pounds of gingersnaps (209 billion servings), would need 

to be produced in a year at a single facility. These estimates are likely to be well above the annual 

production of a single pesto or gingersnap facility; annual US production of non-tomato prepared sauces is 

124 million gallons, and annual US production of cookies is measured in millions of pounds. 

Since these foods are high in methyl eugenol, it is assumed that these estimates for the amount of food that 

must be produced to exceed the TRI processing threshold are low among foods containing methyl eugenol. 

Thus, it is unlikely that any food manufacturer would process enough methyl eugenol to exceed the 

reporting threshold and be required to report methyl eugenol to TRI.

For this application of methyl eugenol, 0 forms from first time filers and 0 forms from existing filers are 

expected under the proposed rule.

Perfumes and Toiletry Production

Methyl eugenol is processed by facilities that manufacture perfumes, detergents, and toiletries where it is 

used as a fragrance. Whether any perfume and toiletry facilities would report methyl eugenol was 

estimated by modeling the quantity of perfume that must be produced by a facility to exceed the TRI 

processing threshold for methyl eugenol. 

In review of available literature, it was found that the International Fragrance Association has established 

limits for methyl eugenol for a range of products based on dermal exposure. Their highest limit for methyl 

eugenol is in fine fragrances: 0.02%. 

The amount of fragrance needed to exceed the TRI reporting threshold for methyl eugenol was calculated 

using the fine fragrance concentration limit and the TRI reporting threshold for methyl eugenol processing. 

At a 0.02% concentration, 15 million gallons (900 million 2-oz bottles) of product would need to be 

produced in a year at a single facility to exceed a 25,000 pound TRI threshold for processing methyl 
2-17

eugenol. This production volume is likely to be well above the annual production of a single perfume 

manufacturing facility.

Since this is the highest concentration allowed for methyl eugenol, it is assumed that this estimate for the 

amount of product needed to exceed the TRI processing threshold is low among perfumes and toiletries. 

Assuming U.S. perfume and toiletry manufacturers do not exceed the International Fragrance Association 

limits, it is unlikely that any perfume and toiletry manufacturer would process enough methyl eugenol to 

exceed the reporting threshold and be required to report methyl eugenol to TRI.

For this application of methyl eugenol, 0 forms from first time filers and 0 forms from existing filers are 

expected under the proposed rule.

2.2.7 2,2-bis(Bromomethyl)-1,3-Propanediol (BBMP) (3296-90-0) 

BBMP is a white solid with a musty odor. It is “reasonably anticipated to be a human carcinogen” based on 

sufficient evidence of carcinogenicity from studies in experimental animals. It is used as a flame retardant 

for epoxies, polyester resins, molded products, and polyurethane foams. It is also produced as a chemical 

intermediate during the manufacture of pentaerythritol ethers and derivatives used as flame retardants. 

BBMP Production

Facilities that manufacture BBMP were identified using the Directory of Chemical Producers – United 

States and the Chemical Information Services Directory of World Chemical Producers, as described in 

Section 2.1.2. 

No information on the production volume of BBMP in the United States was identified, so it was 

conservatively assumed that facilities for which no production information was available exceed the TRI 

manufacturing threshold for BBMP. 

For BBMP manufacturing, 2 forms from first time filers and 1 form from an existing filer are expected 

under the proposed rule.

Other Manufacturing, Processing, and Otherwise Use of BBMP

Counts of facilities that process or otherwise use BBMP in TRI reportable quantities have not been 

estimated because detailed information on BBMP use by facility or sector has not been identified. Some 

forms are expected from processors and otherwise users of BBMP in a number of sectors, but the number of 

reporters could not be determined with available information. Thus, the total counts of forms for BBMP 

presented are likely underestimates.

2.2.8 Tetranitromethane (509-14-8) 

Tetranitromethane (TNM) exists as a pale yellow oily liquid with a pungent odor. TNM is insoluble in 

water but is soluble in alcohol and ether. It is “reasonably anticipated to be a human carcinogen” based on 

sufficient evidence of carcinogenicity in experimental animals. TNM is used as an additive to diesel fuels. It 

acts as an oxidizer and thereby increases the cetane number of the fuel, which decreases the time delay 

between ignition and combustion. Tetranitromethane is also used as an oxidizer in rocket propellants that 

are used to launch space vehicles and other rockets. When combined with toluene, tetranitromethane is used 

as an explosive. Additionally, TNM is formed as an impurity during the manufacture of trinitrotoluene 

(TNT), occurring at up to 0.12% in crude TNT. In laboratories, tetranitromethane is used as a reagent to test 

for unsaturated compounds and as a nitrating reagent in reactions with proteins. TNM is also used in 

research concerning rocket propulsion units. Some facilities may handle waste containing TNM.
2-18

Tetranitromethane Production

One facility that manufactures tetranitromethane was identified using the Chemical Information Service’s 

Directory of World Chemical Producers, as described in Section 2.1.2. 

No information on the production volume of tetranitromethane in the United States was identified, so it was 

conservatively assumed that this facility would report to TRI. 

For tetranitromethane manufacturing, 1 form from a first time filer and 0 forms from existing filers are 

expected under the proposed rule.

Diesel Fuel Additive

Cetane enhancers containing tetranitromethane may be added to diesel fuels to decrease the time delay 

between ignition and combustion. Facilities that process tetranitromethane during diesel fuel production 

were identified using a combination of RMP and BR data, as described in Section 2.1.4. 

No petroleum refineries or petroleum bulk stations and terminals reported to RCRA in 2007 for wastes 

containing tetranitromethane. Therefore, it was assumed that no facility processing tetranitromethane as a 

diesel fuel additive exceeds TRI reporting thresholds and would report to TRI under the proposed rule.

For this application of tetranitromethane, 0 forms from first time filers and 0 forms from existing filers are 

expected under the proposed rule.

Rocket Propellant

Tetranitromethane is used as an oxidizer in rocket propellant. Facilities that process tetranitromethane 

during rocked propellant production were identified using a combination of RMP and BR data, as described 

in Section 2.1.4. 

No facilities in the space and research technology industry reported to RCRA in 2007 for waste containing 

tetranitromethane. Therefore, it was assumed that no facility processing tetranitromethane during rocket 

propellant production exceeds TRI reporting thresholds and would report to TRI under the proposed rule. 

For this application of tetranitromethane, 0 forms from first time filers and 0 forms from existing filers are 

expected under the proposed rule.

Explosives Manufacturing

Tetranitromethane is formed as an impurity in crude trinitrotoluene (TNT), a well-known explosive. 

Facilities which manufacture or process tetranitromethane during TNT production were identified using 

results of a literature review and TRI data on dinitrotoluene, a precursor to TNT. 

Results of a literature review identified one producer of TNT in the U.S. This facility has an annual 

production capacity of 15 million pounds. TNM can be present as a contaminant in crude TNT at a 

concentration of 0.12%, which is then removed in purification reactions. If TNM is present at a 

concentration of 0.12% at this facility, the facility manufactures or processes, then 18,000 pounds of TNM 

are manufactured or processed annually. While this quantity is below the 25,000 pound processing 

threshold, since it is close to the threshold and there is uncertainty in the applicability of the concentration 

used, it was conservatively assumed that this facility would report to TRI for TNM under the proposed rule. 

This facility is a current TRI reporter. 

Additionally, two facilities in the explosives manufacturing industry currently report to TRI for production 

of dinitrotoluene, a precursor to TNT. Assuming manufacturing, processing, or otherwise use of 

dinitrotoluene is comparable to that for tetranitromethane at these facilities, the dinitrotoluene reporters in 

TRI would also be expected to report for TNM under the proposed rule. 
2-19

For this application of tetranitromethane, 0 forms from first time filers and 3 forms from existing filers are 

expected under the proposed rule.

Research and Development

Research and development (R&D) in the physical, engineering, and life sciences sector uses TNM as a 

chemical reagent and as a component of rocket propellant. Based on a review of TRI reporting 

requirements, no TRI forms are expected from use of tetranitormethane in R&D activities; laboratory uses 

of tetranitromethane in sampling and analysis or quality control activities would qualify for the laboratory 

activities exemption. 

For this application of tetranitromethane, 0 forms from first time filers and 0 forms from existing filers are 

expected under the proposed rule.

National Security

Facilities in the national security industry that manufacture, process, or otherwise use tetranitromethane 

were identified using a combination of RMP and BR data, as described in Section 2.1.4. Because TNM is 

used for laboratory activities, it was assumed that this facility would not report under the proposed rule.

For this application of tetranitromethane, 0 forms from first time filers and 0 forms from existing filers are 

expected under the proposed rule.

Waste Treatment 

Waste from laboratory uses of TNM is usually treated off site by facilities in the hazardous waste treatment 

and disposal sector. Facilities that otherwise use tetranitromethane during waste treatment were identified 

using a combination of RMP and BR data, as described in Section 2.1.4. 

For this application of tetranitromethane, 0 forms from first time filers and 1 form from an existing filer is

expected under the proposed rule.

2.2.9 Nitromethane (75-52-5) 

Nitromethane is a nitroparaffin that exists as an oily liquid with a moderately strong disagreeable (“fruity”) 

odor and is slightly soluble in water and soluble in alcohol, ether, and N,N-dimethylformamide (DMF). 

Nitromethane is “reasonably anticipated to be a human carcinogen” based on sufficient evidence of 

carcinogenicity in experimental animals. It is mostly used in the synthesis of nitromethane derivatives, 

which include pharmaceuticals, agricultural oil fumigants, propellants, and industrial anti-microbials. It is 

also used as a solvent for zein, along with other cellulosic compounds, polymers, waxes, and fats. It is a fuel 

additive with methanol and is a component of rocket fuel. It is also used in the coating industry and 

chemical syntheses and in manicuring preparations, synthetic resins, dyes, and in rubber adhesives. 

Formerly, it was a component of binary explosives with ammonium nitrate and was used as a chemical 

stabilizer to prevent the decomposition of halogenated hydrocarbons. 

Nitromethane Production

Facilities that manufacture nitromethane were identified using the Directory of Chemical Producers –

United States, and the Chemical Information Service’s Directory of World Chemical Producers, as 

described in Section 2.1.2. 

According to the TSCA 2006 Inventory Update Reporting Non-Confidential Business Information, U.S.

production of nitromethane in 2005 was 10 million – 50 million pounds. Based on the high production 

volumes included in the TSCA IUR for this chemical, it was assumed that all manufacturers would exceed 

the TRI manufacturing threshold for nitromethane.
2-20

For nitromethane manufacturing, 3 forms from first time filers and 1 form from an existing filer are 

expected under the proposed rule.

Other Manufacturing, Processing, and Otherwise Use of Nitromethane 

Counts of facilities that process or otherwise use nitromethane in TRI reportable quantities have not been 

estimated; nitromethane is used in many industries across a broad range of applications and detailed 

information on nitromethane use by facility or sector for each industry and application is not readily 

available. Some forms are expected from processors and otherwise users of nitromethane in a number of 

sectors, but the number of reporters could not be determined with available information. Thus, the total 

counts of forms for nitromethane presented are likely underestimates.

Some information on production of nitromethane is available through the TSCA 2006 Inventory Update 

Reporting Non-Confidential Business Information; U.S. production of nitromethane in 2005 was between 

10 million and 50 million pounds. Although no records for processors or otherwise users of nitromethane 

were available from TSCA IUR, an estimate of the number of potential reporters for nitromethane might be 

made using the annual production quantity. For example, the midpoint of the range of annual production 

from TSCA might be divided by the TRI reporting threshold for processing to come up with a rough 

estimate of the number of TRI forms possible for nitromethane, assuming all nitromethane produced in the 

US is processed by facilities in TRI reportable industries. Using this method, about 1,200 forms would be 

expected for nitromethane. This is likely a vast overestimate of forms; not all nitromethane produced will 

be used at facilities in TRI reportable industries, and some TRI facilities will likely process quantities of 

nitromethane well above the TRI processing threshold. A review of RY2008 reporting further supports the 

assumption that this is a vast overestimate of forms. If 1,200 forms had been received for one chemical in 

RY2008, the chemical would be ranked as the 28th most frequently reported chemical, with more forms than 

for much more common industrial chemicals such as sulfuric acid, chlorine, and benzene. Thus, fewer than 

1,200 forms would be expected for other manufacturing, processing, and otherwise use of nitromethane

under the proposed rule.

2.2.10 Vinyl Fluoride (75-02-5) 

Vinyl fluoride takes the form of a colorless gas with an ether-like odor and is insoluble in water. Vinyl 

fluoride is “reasonably anticipated to be a human carcinogen” based on sufficient evidence of 

carcinogenicity in experimental animals. It is primarily used to make polyvinyl fluoride (PVF) and other 

fluoropolymers, which are laminated with aluminum, galvanized steel, and cellulose and used as protective 

surfaces in construction due to their weather resistance, strength, chemical inertness and low permeability to 

air and water. PVF can also be laminated with plastics and used to cover walls, pipes, and electrical 

equipment. 

Vinyl Fluoride Production 

Facilities that manufacture vinyl fluoride were identified using RMP, as described in Section 2.1.2. 

Only one facility was identified as a vinyl fluoride manufacturer. The maximum amount of vinyl fluoride 

on site at this facility was reported to be 300,000 pounds, so it was assumed to exceed the TRI reporting 

threshold for vinyl fluoride. 

For vinyl fluoride manufacturing, 0 forms from first time filers and 1 form from an existing filer are 

expected under the proposed rule.

Fluoropolymer Production

Vinyl fluoride is processed during the production of fluoropolymers. The most common commercial 

fluoropolymer manufactured from vinyl fluoride is polyvinyl fluoride (PVF). Two facilities that 
2-21

manufacture PVF were identified using RMP, as described in Section 2.1.3. No additional PVF 

manufacturers were identified using chemical manufacturer directories.

It was assumed that both facilities would exceed TRI reporting thresholds for vinyl fluoride and be required 

to report under the proposed rule given that the maximum amounts of vinyl fluoride in storage or other 

processes on site at any time; these facilities reported 130,000 and 64,000 pounds on site respectively.

For this application of vinyl fluoride, 0 forms from first time filers and 2 forms from existing filers are 

expected under the proposed rule.

2.2.11 o-Nitroanisole (91-23-6) 

o-Nitroanisole exists as a light red or amber liquid. It is insoluble in water but is soluble in alcohol, ether, 

and organic solvents. o-Nitroanisole is “reasonably anticipated to be a human carcinogen” based on 

sufficient evidence of malignant tumor formation at multiple tissue sites in multiple species of experimental 

animals. It is used as an intermediate during the production of dyes, pharmaceuticals, and other organic 

chemicals. It is most often used as a precursor to o-anisidine, which is used during the manufacturing of 

more than 100 azo dyes that are used to color textiles and pigments that are used to color printing paper and 

cardboard. 

o-Nitroanisole Production

One facility that manufactures o-nitroanisole was identified using the Chemical Information Service’s 

Directory of World Chemical Producers, as described in Section 2.1.2. 

No information on the production volume of o-nitroanisole in the United States was identified, so it was 

conservatively assumed that this facility would report to TRI. 

For o-nitroanisole manufacturing, 1 form from a first time filer and 0 forms from existing filers are 

expected under the proposed rule.

o-Anisidine Production 

O-nitroanisole, is processed during the production of a TRI-reportable chemical, o-anisidine. Facilities that 

process o-nitroanisole during the manufacture of o-anisidine were identified using TRI. Information to

determine which of these facilities use o-nitroanisole as a precursor for o-anisidine was unavailable. Since 

o-nitroanisole is the most common precursor for o-anisidine, it was conservatively assumed that all

facilities that manufacture o-anisidine process o-nitroanisole. 

o-Nitroanisole is converted to o-anisidine in approximately a 1:1 stoichiometric ratio. Based on their 

respective molecular weights, for every pound of o-anisidine manufactured, 1.25 pounds of o-nitroanisole 

are processed. Since the number of pounds of o-nitroanisole processed during o-anisidine manufacture is 

higher than the number of pounds of o-anisidine, any facility which exceeds the manufacturing threshold 

for o-anisidine is expected to exceed the processing threshold for o-nitroanisole.

Facilities that report o-anisidine on Form As or manufacturing of o-anisidine on Form Rs were assumed to 

be required to report o-nitroanisole to TRI. Facilities that report processing, and not manufacturing, of oanisidine on Form Rs were not assumed to be required to report o-nitroanisole to TRI; processing oanisidine does not indicate manufacturing, processing or otherwise use of o-nitroanisole. 

For this application of o-nitroanisole, 0 forms from first time filers and 1 form from an existing filer is 

expected under the proposed rule.

2.2.12 Phenolphthalein (77-09-8) 
2-22

Phenolphthalein exists as an odorless white or yellow white powder made up of triclinic crystals. It is 

almost insoluble in water but is soluble in alcohol, diethyl ether, chloroform, dilute alkali hydroxides, and 

hot alkali carbonates. Phenolphthalein is “reasonably anticipated to be a human carcinogen” based on 

sufficient evidence of increased malignant tumor formation at multiple tissue sites and in multiple species. 

Currently, the primary use of phenolphthalein is as an acid base indicator in research and educational 

laboratories, most often in a 1% solution. It is also used in the Kastle-Meyer test for detecting blood. 

Phenolphthalein is sometimes used to make red disappearing inks, especially those used as dyes or in 

children’s toys. These products take advantage of the chemistry of phenolphthalein, changing color based 

on the pH. In the past, phenolphthalein was widely used as an active ingredient in laxatives. 

Phenolphthalein is manufactured by one company in the U.S., which manufactures more than 25,000 

pounds of this chemical annually. 

Phenolphthalein Production

One facility that manufactures phenolphthalein was identified using the Directory of Chemical Producers –

United States, as described in Section 2.1.2. It was listed as having phenolphthalein production above the 

TRI reporting threshold for manufacturing.

For phenolphthalein manufacturing, 1 form from a first time filer and 0 forms from existing filers are 

expected under the proposed rule.

Pharmaceutical Preparation Manufacturing

Phenolphthalein was formerly widely used as a component of laxatives. A literature review was conducted 

to determine the number of U.S. manufacturers that process phenolphthalein during the production of 

laxatives. 

In 1999, the FDA changed the classification of phenolphthalein from Category I – “generally recognized as 

safe” – to Category II – “not generally recognized as safe” – due to its status as a reasonably anticipated 

carcinogen. Following this FDA rulemaking, laxatives containing phenolphthalein were no longer marketed 

in the United States. Since laxative products containing phenolphthalein are no longer marketed in the 

United States, it was assumed that these products are no longer manufactured by facilities in the United 

States. Therefore, phenolphthalein is not expected to be reported by facilities in the pharmaceutical sector, 

under the proposed rule. 

For this application of phenolphthalein, 0 forms from first time filers and 0 forms from existing filers are 

expected under the proposed rule.

Disappearing Inks

Phenolphthalein is used in low concentrations in some disappearing ink products. A literature review was 

conducted to determine the number of U.S. manufacturers that process phenolphthalein during the 

production of disappearing inks. 

It was found that most disappearing ink products sold in the U.S. are manufactured abroad; imports are 

predominant in the U.S. toy market (90% of toys were imported in 2008), and no U.S. manufacturers of

disappearing inks were identified. It was also found that phenolphthalein is used at low concentrations in 

disappearing inks, and that not all disappearing inks contain phenolphthalein. 

Based on the lack of U.S. manufacturers and low concentrations of phenolphthalein in disappearing inks, it 

was assumed that toy manufacturers in the United States do not process phenolphthalein above the TRI 

reporting threshold. Therefore, no forms for phenolphthalein from this industry are expected.

For this application of phenolphthalein, 0 forms from first time filers and 0 forms from existing filers are 

expected under the proposed rule.
2-23

Laboratory Reagents

Phenolphthalein is used in laboratories as an acid-base indicator in research and development in the 

physical, engineering, and life sciences (54171); educational services (611); and medical laboratories 

(621511) sectors. Based on a review of TRI reporting requirements, no TRI forms are expected from 

laboratory use of phenolphthalein; laboratory uses of phenolphthalein in research and development qualify 

for the laboratory activities exemption.

For this application of phenolphthalein, 0 forms from first time filers and 0 forms from existing filers are 

expected under the proposed rule.

2.3 Estimated Number of Incremental Forms and Facilities 

This section presents the number of incremental forms and facilities expected under the proposed rule based 

on the methodology outlined in the previous section. Table 2-3 presents the number of estimated 

incremental forms and facilities by industry for each chemical. Table 2-4 presents the number of estimated 

incremental forms and facilities for each affected sector. 

In total, 175 facilities are expected to submit 186 forms under the proposed rule, based on the methodology 

outlined in Sections 2.1 and 2.2. Of the 175 facilities, 127 are actual facilities, for which facility 

identification information was available. The remaining 48 facilities are modeled facilities.
2-24

Table 2-3: Estimated Number of Incremental Forms and Facilities by Chemical and Sector Due to the Proposed Rule

First Time Filers Existing Filers Total Filers (First Time + 

Existing)

CAS Chemical NAICS NAICS Description Count 

of Form 

Rs

Count of 

Facilities

Average 

Forms per 

Facility

Count 

of Form 

Rs

Count of 

Facilities

Average 

Forms 

per 

Facility

Count 

of Form 

Rs

Count of 

Facilities

Average 

Forms per 

Facility

32411 Petroleum Refineries 0 0 0 19 19 1 19 19 1

324199 All Other Petroleum and Coal Products Mfg. 0 0 0 1 1 1 1 1 1

32511 Petrochemical Mfg. 0 0 0 7 7 1 7 7 1

325199 All Other Basic Organic Chemical Mfg. 12 12 1 8 8 1 20 20 1

325211 Plastics Material and Resin Mfg. 1 1 1 1 1 1 2 2 1

325212 Synthetic Rubber Mfg. 0 0 0 4 4 1 4 4 1

32532 Pesticide and Other Agricultural Chemical Mfg. 0 0 0 1 1 1 1 1 1

325998 All Other Miscellaneous Chemical Product and 

Preparation Mfg. 0 0 0 1 1 1 1 1 1

32731 Cement Mfg. 0 0 0 1 1 1 1 1 1

42471 Petroleum Bulk Stations and Terminals 0 0 0 8 8 1 8 8 1

78-79-5 Isoprene

56299 All Other Waste Management Services 0 0 0 1 1 1 1 1 1

325188 All Other Basic Inorganic Chemical Mfg. 0 0 0 1 1 1 1 1 1

325199 All Other Basic Organic Chemical Mfg. 17 17 1 5 5 1 22 22 1

325211 Plastics Material and Resin Mfg. 6 6 1 5 5 1 11 11 1

32532 Pesticide and Other Agricultural Chemical Mfg. 1 1 1 1 1 1 2 2 1

562112 Hazardous Waste Collection 0 0 0 1 1 1 1 1 1

56221 Waste Treatment and Disposal 0 0 0 1 1 1 1 1 1

562211 Hazardous Waste Treatment and Disposal 3 3 1 4 4 1 7 7 1

110-00-9 Furan

56299 All Other Waste Management Services 0 0 0 1 1 1 1 1 1

81-49-2 1-Amino-2,4-

Dibromoanthraquinone 325132 Synthetic Organic Dye and Pigment Mfg. 12 12 1 10 10 1 22 22 1

325199 All Other Basic Organic Chemical Mfg. 1 1 1 1 1 1 2 2 1

325211 Plastics Material and Resin Mfg. 6 6 1 5 5 1 11 11 1

325611 Soap and Other Detergent Mfg. 0 0 0 1 1 1 1 1 1

32619 Other Plastics Product Mfg. 0 0 0 1 1 1 1 1 1

116-14-3 Tetrafluoroethylene

32629 Other Rubber Product Mfg. 0 0 0 1 1 1 1 1 1

325199 All Other Basic Organic Chemical Mfg. 4 4 1 0 0 0 4 4 1 556-52-5 Glycidol 325211 Plastics Material and Resin Mfg. 7 7 1 2 2 1 9 9 1

311 Food Mfg. 0 0 0 0 0 0 0 0 0

325199 All Other Basic Organic Chemical Mfg. 3 3 1 2 2 1 5 5 1

32532 Pesticide and Other Agricultural Chemical Mfg. 1 1 1 0 0 0 1 1 1 93-15-2 Methyl eugenol

325620 Toilet Preparation Mfg. 0 0 0 0 0 0 0 0 0

32411 Petroleum Refineries 0 0 0 0 0 0 0 0 0

325199 All Other Basic Organic Chemical Mfg. 1 1 1 0 0 0 1 1 1

325920 Explosives Mfg. 0 0 0 3 3 1 3 3 1

509-14-8 Tetranitromethane

42471 Petroleum Bulk Stations and Terminals 0 0 0 0 0 0 0 0 0
2-25

Table 2-3: Estimated Number of Incremental Forms and Facilities by Chemical and Sector Due to the Proposed Rule

First Time Filers Existing Filers Total Filers (First Time + 

Existing)

CAS Chemical NAICS NAICS Description Count 

of Form 

Rs

Count of 

Facilities

Average 

Forms per 

Facility

Count 

of Form 

Rs

Count of 

Facilities

Average 

Forms 

per 

Facility

Count 

of Form 

Rs

Count of 

Facilities

Average 

Forms per 

Facility

56299 All Other Waste Management Services 0 0 0 1 1 1 1 1 1

927110 Space Research and Technology 0 0 0 0 0 0 0 0 0

75-52-5 Nitromethane 325199 All Other Basic Organic Chemical Mfg. 3 3 1 1 1 1 4 4 1

3296-90-0 

2,2-bis(Bromomethyl)-

1,3-Propanediol

(BBMP)

325199 All Other Basic Organic Chemical Mfg. 2 2 1 1 1 1 3 3 1

32519 Other Basic Organic Chemical Mfg. 0 0 0 1 1 1 1 1 1

326113 Unlaminated Plastics Film and Sheet (except 

Packaging) Mfg. 75-02-5 Vinyl Fluoride 0 0 0 1 1 1 1 1 1

32619 Other Plastics Product Mfg. 0 0 0 1 1 1 1 1 1

325132 Synthetic Organic Dye and Pigment Mfg. 0 0 0 1 1 1 1 1 1

325199 All Other Basic Organic Chemical Mfg. 1 1 1 0 0 0 1 1 1

325211 Plastics Material and Resin Mfg. 0 0 0 0 0 0 0 0 0 91-23-6 o-Nitroanisole

325412 Pharmaceutical Preparation Mfg. 0 0 0 0 0 0 0 0 0

325199 All Other Basic Organic Chemical Mfg. 1 1 1 0 0 0 1 1 1

77-09-8 Phenolphthalein 325412 Pharmaceutical Preparation Mfg. 0 0 0 0 0 0 0 0 0

339932 Game, Toy, and Children's Vehicle Mfg. 0 0 0 0 0 0 0 0 0

Total 82 74 1.11 104 101 1.03 186 175 1.06

Notes: 

Of the 175 facilities, 127 are actual facilities and 48 are modeled facilities.

Due to data availability constraints it was not possible to identify a credible methodology for estimating potential reporting for processing and otherwise use of glycidol. Additional reporting from these 

sectors, however, is likely under the proposed rule. 

Due to data availability constraints it was not possible to identify a credible methodology for estimating potential reporting for processing and otherwise use of nitromethane. Additional reporting from 

these sectors, however, is likely under the proposed rule. 

Due to data availability constraints it was not possible to identify a credible methodology for estimating potential reporting for processing and otherwise use of 2,2-bis(Bromomethyl)-1,3-Propanediol. 

Additional reporting from these sectors, however, is likely under the proposed rule
2-26

Table 2-4: Estimated Number of Incremental Forms and Facilities by Sector Due to the Proposed Rule

First Time Filers Existing Filers Total Filers (First Time + Existing)

NAICS NAICS Description Count of 

Form Rs

Count of 

Facilities

Average 

Forms Per 

Facility

Count of 

Form Rs

Count of 

Facilities

Average 

Forms Per 

Facility

Count of 

Form Rs

Count of 

Facilities

Average 

Forms Per 

Facility

311 FoodMfg. 0 0 0 0 0 0 0 0 0

31331 Textile and Fabric Finishing Mills 0 0 0 0 0 0 0 0 0

32411 Petroleum Refineries 0 0 0 19 19 1 19 19 1

324199 All Other Petroleum and Coal ProductsMfg. 0 0 0 1 1 1 1 1 1

32511 PetrochemicalMfg. 0 0 0 7 7 1 7 7 1

325132 Synthetic Organic Dye and PigmentMfg. 12 12 1 11 11 1 23 23 1

325188 All Other Basic Inorganic ChemicalMfg. 0 0 0 1 1 1 1 1 1

32519 Other Basic Organic ChemicalMfg. 0 0 0 1 1 1 1 1 1

325199 All Other Basic Organic ChemicalMfg. 45 38 1.18 18 18 1 63 56 1.13

325211 Plastics Material and ResinMfg. 20 19 1.05 13 13 1 33 32 1.03

325212 Synthetic RubberMfg. 0 0 0 4 4 1 4 4 1

32522 Artificial and Synthetic FilamentsMfg. 0 0 0 0 0 0 0 0 0

32532 Pesticide and Other Agricultural ChemicalMfg. 2 2 1 2 2 1 4 4 1

325412 Pharmaceutical PreparationMfg. 0 0 0 0 0 0 0 0 0

325611 Soap and Other DetergentMfg. 0 0 0 1 1 1 1 1 1

325620 Toilet PreparationMfg. 0 0 0 0 0 0 0 0 0

325920 ExplosivesMfg. 0 0 0 3 3 1 3 3 1

325998 All Other Miscellaneous Chemical Product and 

PreparationMfg. 0 0 0 1 1 1 1 1 1

326113 Unlaminated Plastics Film and Sheet (except 

Packaging)Mfg. 0 0 0 1 1 1 1 1 1

32619 Other Plastics ProductMfg. 0 0 0 2 1 2 2 1 2

32629 Other Rubber ProductMfg. 0 0 0 1 1 1 1 1 1

32731 CementMfg. 0 0 0 1 1 1 1 1 1

339932 Game, Toy, and Children's VehicleMfg. 0 0 0 0 0 0 0 0 0

42471 Petroleum Bulk Stations and Terminals 0 0 0 8 8 1 8 8 1

562112 Hazardous Waste Collection 0 0 0 1 1 1 1 1 1

56221 Waste Treatment and Disposal 0 0 0 1 1 1 1 1 1

562211 Hazardous Waste Treatment and Disposal 3 3 1 4 4 1 7 7 1

56299 All Other Waste Management Services 0 0 0 3 1 3 3 1 3

927110 Space Research and Technology 0 0 0 0 0 0 0 0 0

Total 82 74 1.11 104 101 1.03 186 175 1.06
2-27

Literature Cited

Methods Used to Estimate Additional Reporting

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Furan (110-00-9)

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2-29

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Report on Carcinogens, Eleventh Edition. Substance Profiles: Furan. 

<http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s090fura.pdf>

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1-Amino-2,4-Dibromoanthraquinone (81-49-2)

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2-30

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<rtknet.org>

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2-31

Glycidol (556-52-5)

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ynId=531604&displaySynonym=> 

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Methyl Eugenol (93-15-2)

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2-32

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2,2-bis(Bromomethyl)-1,3-Propanediol

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2-33

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<http://www.epa.gov/ttn/atw/orig189.html>

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0>

Tetranitromethane (509-14-8)

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Guideline Levels (AEGLs). <http://www.epa.gov/fedrgstr/EPA-TOX/2001/May/Day-02/4894.pdf>
2-34

U.S. EPA. 2007. Biennial RCRA Hazardous Waste Report (BR). 

<http://www.epa.gov/waste/inforesources/data/biennialreport/index.htm>.

U.S. EPA. 2008. Risk Management Plan Database. Accessed via OMB Watch’s Right to Know Network. 

<rtknet.org>

U.S. EPA. 2009. Office of Air and Radiation Office of Transportation and Air Quality Transportation and 

Regional Programs Division. List of Registered Diesel Additives. 

<http://www.epa.gov/otaq/regs/fuels/additive/web-dies.htm> 

U.S. EPA 2008. Toxic Chemical Release Inventory Reporting Forms and Instructions: Revised 2008 

Version. <http://www.epa.gov/tri/report/rfi/TRI_RFI_RY2008.pdf>

U.S. EPA. TRI 2007 PDR, RY2007. Accessed via TRI.NET

U.S. National Library of Medicine. Hazardous Substances Database (HSDB). Tetranitromethane. 

<http://toxnet.nlm.nih.gov/cgi-bin/sis/search/r?dbs+hsdb:@term+@rn+@rel+509-14-8>

U.S. Patent Application Publication. 2003. Process for Reducing Pollutants from the Exhaust of a Diesel 

Engine. 

<http://www.google.com/patents?hl=en&lr=&vid=USPATAPP10457510&id=pOWFAAAAEBAJ

&oi=fnd&dq=tetranitromethane+diesel&printsec=abstract#v=onepage&q=tetranitromethane&f=fal

se>

Nitromethane (75-52-5)

Chemical Information Services. 2009. Directory of World Chemical Producers. Dallas: Chemical 

Information Services.

Hawley’s Condensed Chemical Dictionary (3rd Edition)

Scorecard: The Pollution Information Site. Chemical Profile: Nitromethane. 

<http://www.scorecard.org/chemical-profiles/consumer-products.tcl?edf_substance_id=75-52-5>

SRI Consulting. 2009. Directory of Chemical Producers. Menlo Park: SRI Consulting.

State of New Jersey Department of Health and Senior Services 2008. Right to Know Hazardous Substance 

Fact Sheet: Nitromethane. <http://nj.gov/health/eoh/rtkweb/documents/fs/1386.pdf>

The Merck Index (12th Edition)

U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, 

Report on Carcinogens, Eleventh Edition. Substance Profiles: Nitromethane. 

<http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s123zntm.pdf>

U.S. EPA. 2006 TSCA Inventory Update Reporting Non-Confidential Business Information, Accessed 

August 2009. <http://cfpub.epa.gov/iursearch/index.cfm?s=chem>

U.S. EPA. 2004. General Risk Management Program Guidance: Appendix A. 

<http://www.epa.gov/emergencies/content/rmp/rmp_guidance.htm#General>
2-35

U.S. EPA. 2006. LIST OF LISTS: Consolidated List of Chemicals Subject to the Emergency Planning and 

Community Right-To-Know Act (EPCRA) and Section 112(r) of the Clean Air Act. 

<http://www.epa.gov/osweroe1/docs/chem/title3_Oct_2006.pdf#lol>

U.S. EPA. 2006 TSCA Inventory Update Reporting Non-Confidential Business Information, Accessed 

August 2009. <http://cfpub.epa.gov/iursearch/index.cfm?s=chem>

U.S. EPA. 2008. The Clean Air Act Amendments of 1990 List of Hazardous Air Pollutants. 

<http://www.epa.gov/ttn/atw/orig189.html>

U.S. EPA. 2009. Criteria Pollutants. <http://www.epa.gov/oar/oaqps/greenbk/o3co.html> 

U.S. EPA. 2009. Online Tracking and Information System. <http://www.epa-otis.gov/otis/>

U.S. EPA. Substance Registry Services. Substance Details – Nitromethane. 

<http://iaspub.epa.gov/sor_internet/registry/substreg/searchandretrieve/advancedsearch/externalSea

rch.do?p_type=CAS&p_value=75-52-5> 

U.S. National Library of Medicine. Hazardous Substances Data Bank (HSDB). Nitromethane. 

<http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~wDwcXi:1>

Vinyl Fluoride (75-02-5) 

Hawley’s Condensed Chemical Dictionary (3rd Edition)

Fluoropolymer Division of SPI. 2009. FPD Material Suppliers. 

<http://www.fluoropolymers.org/products/FPDMaterialSuppliers.pdf> 

Scorecard: The Pollution Information Site. Chemical Profile: Ethene, fluoro-. 

<http://www.scorecard.org/chemical-profiles/summary.tcl?edf_substance_id=75-02-5> 

SPI. 2009. Definitions of Resins – Fluoropolymer. 

<http://www.plasticsindustry.org/AboutPlastics/content.cfm?ItemNumber=1390&navItemNumber

=1128>

Technology Planning and Management Corporation. Final Report on Carcinogens Background Document 

for Vinyl fluoride. <http://ntp.niehs.nih.gov/ntp/newhomeroc/roc10/VF.pdf>

U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, 

Report on Carcinogens, Eleventh Edition. Substance Profiles: Vinyl Fluoride. 

<http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s188viny.pdf >

U.S. EPA. 2008. Risk Management Plan Database. Accessed via OMB Watch’s Right to Know Network. 

<rtknet.org>

U.S. EPA. 2009. Facility Registry System (FRS). Accessed via EnviroFacts Facility Registry System 

Database EZ Query. <http://www.epa.gov/enviro/html/fii/ez.html>

U.S. EPA. 2009. Online Tracking and Information System. <http://www.epa-otis.gov/otis/> 

U.S. EPA. List of Regulated Flammable Substances and Threshold Quantities for Accidental Release 

Prevention. <http://www.epa.gov/region7/toxics/flame.htm>

U.S. EPA. Substance Registry Services: Substance Details – Vinyl Fluoride 
2-36

U.S. National Library of Medicine. Hazardous Substances Data Bank (HSDB). Vinyl Fluoride. 

<http://toxnet.nlm.nih.gov/cgi-bin/sis/search/r?dbs+hsdb:@term+@rn+@rel+75-02-5>

o-Nitroanisole (91-23-6)

Chemical Information Services. 2009. Directory of World Chemical Producers. Dallas: Chemical 

Information Services.

Haldar, P. and V.V. Mahajani. 2004. Catalytic transfer hydrogenation: o-nitroanisole to o-anisidine, some 

process development aspects. Chemical Engineering Journal: 104, 1-3, pp27-33. 

<http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TFJ-4DD8XPG3&_user=852516&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId

=1016511112&_rerunOrigin=google&_acct=C000045979&_version=1&_urlVersion=0&_userid=

852516&md5=957cc160f38dd29c1d2c9d3d141b6537>

Hawley’s Condensed Chemical Dictionary (3rd Edition).

SCOEL/SUM/144 2008. Recommendation from the Scientific Committee on Occupational Exposure Limits 

for O-anisidine. 

<http://www.ser.nl/en/grenswaarden/~/media/Files/Internet/Grenswaarden/SCOEL/GSW522_SCO

EL_Prov144o_Anisidine.ashx>

Scorecard: The Pollution Information Site. Chemical Profile: o-Anisidine. 

<http://www.scorecard.org/chemical-profiles/summary.tcl?edf_substance_id=90-04-0>

The Merck Index (12th Edition).

U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, 

Report on Carcinogens, Eleventh Edition. Substance Profiles: o-Nitroanisole. 

<http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s120onit.pdf>

U.S. EPA. TRI 2007 PDR, RY2007. Accessed via TRI.NET

Phenolphthalein (77-09-8)

Hawley’s Condensed Chemical Dictionary (3rd Edition).

Integrated Laboratory Systems 1997. NTP Report on Carcinogens Background Document for 

Phenolphthalein. Prepared for Meeting of the Report on Carcinogens Subcommittee of the NTP 

Board of Scientific Counselors. <http://ntp.niehs.nih.gov/files/Phenolphthalein1.pdf>

International Agency for Research on Cancer, Diesel and Gasoline Engine Exhausts and Some Nitroarenes. 

Vol. 46. 1998.

Katz, David. 2002. Chemistry in the Toy Store. <http://www.chymist.com/Toystore%20part3.pdf>

Public Citizen. December 2008. How to Deliver on Obama’s and Congress’ Toy-Safety and Fair-Trade 

Promises. 

SRI Consulting. 2009. Directory of Chemical Producers. Menlo Park: SRI Consulting.

The Merck Index (12th Edition). 
2-37

U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, 

Report on Carcinogens, Eleventh Edition. Substance Profiles: Phenolphthalein. 

<http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s145phen.pdf> 

U.S. EPA, Guidance for Reporting Toxic Chemicals: Polycyclic Aromatic Compounds Category, 2001.

U.S. EPA 2008. Toxic Chemical Release Inventory Reporting Forms and Instructions: Revised 2008 

Version. <http://www.epa.gov/tri/report/rfi/TRI_RFI_RY2008.pdf>

U.S. EPA, Toxics Release Inventory, 2007 Public Data Release.

U.S. Federal Register. 1999. Department of Health and Human Services: Food and Drug Administration: 

21 CFR Part 310: Laxative Drug Products for Over-the-Counter Use. 

<http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1999_register&docid=78N–036L>

U.S. National Library of Medicine. Hazardous Substances Data Bank (HSDB). 2009. Phenolphthalein. 

<http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~wQRELP:1>
3-1

Chapter 3 – Cost Estimates

3.1 Introduction 

This chapter presents the estimated industry and EPA costs associated with the proposed rule to add 16

chemicals that the National Toxicology Program (NTP) designated as either known to be human 

carcinogens or are reasonably anticipated to be human carcinogens to the TRI list of reportable chemicals.

Section 3.2 describes the methodology used to estimate industry costs. Section 3.3 details the estimated 

costs to EPA. In Section 3.4, the total costs of the proposed rule are summarized.

3.2 Industry Cost Estimates 

In this section, the costs that may be incurred by industry as a result of the proposed rule are estimated. 

Costs are estimated based on the number of hours spent to fulfill facility-level requirements and the hours 

spent to fulfill form-level requirements. Facility-level and form-level costs are then aggregated to represent 

total industry cost. Section 3.2.1 describes the methodology used to estimate total industry costs in further 

detail. Section 3.2.2 discusses the unit cost estimates for each of the activities that a facility may need to 

perform to comply with the section 313 reporting requirements. Section 3.2.3 presents the estimated total 

industry costs.

3.2.1 Methodology 

For the proposed rule, total industry costs were calculated using the following four-step procedure:

Step 1: Identify and describe the tasks that potentially affected facilities will 

have to perform to comply with the section 313 requirements.

Step 2: For each task, estimate the hours of managerial, technical, and clerical labor needed 

to complete it. Based on typical labor rates, calculate the unit cost of each task for 

the first year of compliance, when some learning must take place and for 

subsequent years when less time is needed because facilities are more familiar with 

the tasks.

Step 3: Estimate the number of unique facilities that will perform each task.

Estimate the number of forms to be filed in all industry groups.

Step 4: For each task, multiply the unit cost by the number of unique 

facilities and/or forms and then take the sum of the results to 

estimate total industry costs for the first year and subsequent years.

The set of compliance activities associated with TRI reporting include:

Compliance Determination1: Facility staff must determine 

whether the facility meets the criteria for EPCRA section 313 

reporting. This activity includes the time required to become 

familiar with the definitions, exemptions, and threshold requirements 

under the TRI Program, to review the list of TRI chemicals, and to 

conduct preliminary threshold determinations to determine if the 

facility is required to report. 

 1

 Cost associated with compliance determination is not considered for this rulemaking. For further explanation, see 

section 3.2.2. 
3-2

Rule Familiarization: Facilities that are reporting under section 

313 for the first time due to the proposed rule must read the reporting 

package and become familiar with the new reporting requirements

associated with the proposed chemicals.

Report Completion: Facilities must gather data and perform 

calculations to provide the information required on the form. This 

activity includes the time required to search data sources and the 

time to complete and review the information. 

Recordkeeping and Submission: Affected facilities must maintain 

recordkeeping systems and submit their forms to EPA and the state 

in which the facility is located. This activity includes the time 

required to transmit or otherwise disclose the information.

Supplier Notification2: Certain suppliers of mixtures or trade name 

products containing reportable substances must annually notify their 

customers of the product’s composition, if the customer is subject to 

EPCRA section 313 reporting. This activity includes the time 

required to inform customers, either by letter or through the 

materials safety data sheet (MSDS) for the product. 

The skills required to comply with the section 313 reporting requirements (including the requirements 

associated with section 6607 of the PPA) will vary from facility to facility depending upon factors such as 

the complexity of the facility's processes, and the type of use and disposition of the proposed chemicals at 

the facility. Those responsible for reporting may often have engineering, scientific, or technical 

backgrounds. Compliance does not, however, necessarily require an engineering or other similar degree. At 

a minimum, an understanding of the facility's chemical purchases and production processes is required.

Necessary skills may include the ability to evaluate and interpret records, understand material safety data 

sheets, and determine throughput or production volumes. Depending on the facility, estimates may be 

calculated using: (1) existing data collected under federal, state, or local regulations, (2) emissions factors, 

(3) design data supplied by the equipment manufacturer, (4) mass balance techniques, or (5) engineering 

calculations. Each technique requires varying skills and levels of sophistication to complete. In some 

instances, EPA guidance documents may supplant the need for a particular skill.

The next section discusses how the unit costs associated with each of these specific tasks were estimated.

3.2.2 Unit Cost Estimates 

This section explains how the cost estimates, or unit costs, were developed for each task that facilities might 

have to perform under the proposed rule. Depending on whether the unit cost is form- or facility-specific, 

total costs for a task can be calculated by multiplying the unit cost by the number of forms for which the 

task must be performed or by the number of facilities performing it. For this analysis, it was assumed that 

all chemical forms would be filed as Form Rs as the data required for Form A estimation was not readily 

available (see Chapter Two).3 As such, to the extent that some facilities may be able to file Form As 

 2

 Cost associated with supplier notification is not considered for this rulemaking. For further explanation, see section 

3.2.2. 3 Note that when a facility reports both Form Rs and Form As, care must be taken to avoid double counting facility 

level costs (rule familiarization in particular). This double counting has been observed in estimates for the TRI 

Information Collection Request (ICR) where Form R and A burden and cost are estimated separately and then summed 

(with a need to subtract the overlap category of facilities filing both As and Rs). However, this double couting is not 

typically an issue in EA’s (such as this one) because the estimation procedure (of incremental burden) sums the forms 

and facility burdens first and then apportions costs by form.
3-3

instead, reporting cost may be overstated. The estimated number of unique facilities and chemical forms

expected under the proposed rule is presented in Table 3-1. The estimated unit cost for each of the tasks is

presented in Table 3-2.

Each cost estimate is made up of two components: the unit time estimates (i.e., number of labor hours 

required of each type of personnel to complete a task); and the hourly wage rates for each level of 

personnel. The unit burden hour estimates reflect the most current OMB approved burden estimates and are 

taken from the 2007 Form R Information Collection Request (ICR) (USEPA, 2007).4

According to feedback from existing TRI filers, the role of each labor category in the TRI reporting process 

at the facility level is as follows:

• Managerial staff are responsible for reviewing and certifying the accuracy of all TRI submissions 

and supporting documentation, including calculations, data sources, and assumptions. Managerial 

staff are briefed by technical staff once annually regarding TRI submissions and any changes to 

TRI reporting requirements. All sections of the Form are reviewed by managerial staff at this time.

• Technical staff possess the facility knowledge and familiarity with the TRI program required to 

understand which processes and activities at the facility should be considered in making threshold 

determinations for TRI chemicals. Technical staff gather the required data, make threshold 

determinations, calculate release and waste management quantities, and enter the required data on 

the TRI form, either by hand or electronically using TRI reporting software. Technical staff are 

also responsible for briefing managerial staff once annually regarding TRI submissions and any 

changes to TRI reporting requirements. 

• Clerical staff are responsible for organizing, photocopying, and cataloging all TRI submissions and 

supporting documentation in accordance with TRI recordkeeping requirements.

 4 To comply with the Paperwork Reduction Act, federal agencies must renew ICRs periodically.
3-4

Table 3-1: Estimated Number of Unique Facilities and Chemical Forms Expected Under the Proposed Rule

First Time Filers Existing Filers Total Filers (First Time + Existing)

NAICS NAICS Description

Count of 

Form Rs

Count of 

Facilities

Average Number of 

Forms per Facility

Count of 

Form Rs

Count of 

Facilities

Average Number of 

Forms per Facility Forms Facilities

Average Number of 

Forms per Facility

311 Food Manufacturing 0 0 0 0 0 0 0 0 0

31331 Textile and Fabric Finishing Mills 0 0 0 0 0 0 0 0 0

32411 Petroleum Refineries 0 0 0 19 19 1 19 19 1

324199

All Other Petroleum and Coal Products 

Manufacturing 0 0 0 1 1 1 1 1 1

32511 Petrochemical Manufacturing 0 0 0 7 7 1 7 7 1

325132

Synthetic Organic Dye and Pigment 

Manufacturing 12 12 1 11 11 1 23 23 1

325188

All Other Basic Inorganic Chemical 

Manufacturing 0 0 0 1 1 1 1 1 1

32519

Other Basic Organic Chemical 

Manufacturing 0 0 0 1 1 1 1 1 1

325199

All Other Basic Organic Chemical 

Manufacturing 45 38 1.18 18 18 1 63 56 1.13

325211 Plastics Material and Resin Manufacturing 20 19 1.05 13 13 1 33 32 1.03

325212 Synthetic Rubber Manufacturing 0 0 0 4 4 1 4 4 1

32522

Artificial and Synthetic Filaments 

Manufacturing 0 0 0 0 0 0 0 0 0

32532

Pesticide and Other Agricultural Chemical 

Manufacturing 2 2 1 2 2 1 4 4 1

325412

Pharmaceutical Preparation 

Manufacturing 0 0 0 0 0 0 0 0 0

325611 Soap and Other Detergent Manufacturing 0 0 0 1 1 1 1 1 1

325620 Toilet Preparation Manufacturing 0 0 0 0 0 0 0 0 0

325920 Explosives Manufacturing 0 0 0 3 3 1 3 3 1

325998

All Other Miscellaneous Chemical Product 

and Preparation Manufacturing 0 0 0 1 1 1 1 1 1

326113

Unlaminated Plastics Film and Sheet 

(except Packaging) Manufacturing 0 0 0 1 1 1 1 1 1

32619 Other Plastics Product Manufacturing 0 0 0 2 1 2 2 1 2

32629 Other Rubber Product Manufacturing 0 0 0 1 1 1 1 1 1

32731 Cement Manufacturing 0 0 0 1 1 1 1 1 1

339932

Game, Toy, and Children's Vehicle 

Manufacturing 0 0 0 0 0 0 0 0 0

42471 Petroleum Bulk Stations and Terminals 0 0 0 8 8 1 8 8 1

562112 Hazardous Waste Collection 0 0 0 1 1 1 1 1 1

56221 Waste Treatment and Disposal 0 0 0 1 1 1 1 1 1

562211

Hazardous Waste Treatment and 

Disposal 3 3 1 4 4 1 7 7 1

56299 All Other Waste Management Services 0 0 0 3 1 3 3 1 3

927110 Space Research and Technology 0 0 0 0 0 0 0 0 0

TOTAL 82 74 1.11 104 101 1.03 186 175 1.06
3-5

Table 3-2: Unit Time and Cost Estimates for Activities Performed by Industry

Unit Time Estimates (Hours)

Activity (per report or per facility)

Management Technical Clerical Total Hours

Labor 

Unit Cost c

(2009 Dollars)

First Year

Rule Familiarization a (facility-level) 12.0 22.5 0.0 34.5 $ 1,903

Calculations and Report Completion b (form-level) 20.5 44.4 2.8 67.7 $ 3,626 

Recordkeeping/Submission b (form-level) 0.0 4.0 1.0 5.0 $ 231

Subsequent Years

Calculations and Report Completion b (form-level) 7.5 16.1 1.0 24.7 $ 1,322 

Recordkeeping/Submission b (form-level) 0.0 4.0 1.0 5.0 $ 231 a The unit cost for this activity is estimated at the facility level. It is treated as a fixed cost that covers all chemicals reported by a facility. b The unit cost for this activity is estimated to vary with the number of Form Rs submitted. The total cost for this activity at a facility is 

calculated by multiplying the unit cost by the number of forms submitted by that facility. c Based on loaded hourly wage rates of $62.04, $51.49, and $25.06 for managerial, technical, and clerical labor, respectively. Note that unit 

labor cost may not exactly equal the product of burden hours times labor rates due to rounding.

Note: For the derivation of cost for each compliance activity, see pages 3-6 and 3-7.

Sources: 

U.S. EPA (2007). Information Collection Request (ICR): TRI Form R Toxic Chemical Release Reporting EPA ICR #1363.15. December.

U.S.DOL (2009). Employer Costs for Employee Compensation Historical Listings, March 2004 – June 2009. U.S. Department of Labor. 

Bureau of Labor Statistics. Washington D.C., Table 15, 2009

Labor rates are divided into three categories: managerial, technical, and clerical. These rates reflect the total 

cost to employ an individual and include in the estimate the cost of salaries, fringe benefits, such as paid 

leave, health insurance, retirement savings, and legally required benefits, and other overhead costs, such as 

office space, furniture, equipment and computers, supplies and other business expenses. Updated 2009 

hourly labor rates, including fringe benefits and overhead, were calculated using current data on salaries and 

benefits for these three labor categories from information published by the Bureau of Labor Statistics (BLS) 

(USDOL, 2009). The general methodology for this calculation was obtained from Wage Rates for 

Economic Analysis of the Toxics Release Inventory Program (Rice, 2002). As presented in Table 3-3, the 

managerial, technical, and clerical wage rates are composites of the BLS rates for ‘Wages and Salaries’ and 

‘Total Benefits’ by labor category. The sum of ‘Wages and Salaries’ and ‘Total Benefits’ is equal to ‘Total 

Compensation’. The managerial labor rate is defined as the average hourly wages and salaries for the 

“Management, Business, and Financial” occupational category. The technical labor rate is defined as the 

average hourly wages and salaries for the “Professional and Related” occupational category. The clerical 

labor rate is defined as the average hourly wages and salaries for the “Office and Administrative Support” 

occupational category. 

Based on information provided by the chemical industry and chemical industry trade associations, an 

additional loading factor of 17 percent is applied to ‘Wages and Salaries’ for general overhead. The sum of 

‘Total Compensation’ and ‘Overhead’ is equal to ‘Total Loaded Hourly Wage Rate.’ The hourly wage 

rates are $62.04 for managerial personnel, $51.49 for technical personnel, and $25.06 for clerical 

personnel, all in 2009 dollars.

Table 3-3: Loaded Hourly Wage Rates by Labor Category

Labor Category Wage Type Managerial Technical Clerical

Wages and Salaries (Jun. 09) $38.63 $32.83 $15.67 

Total Benefits $16.84 $13.08 $6.73 

Overhead $6.57 $5.58 $2.66 

Total Loaded Hourly Rate $62.04 $51.49 $25.06 

Source: U.S.DOL (2009). Employer Costs for Employee Compensation Historical Listings, March 2004 – June 2009. 

U.S. Department of Labor. Bureau of Labor Statistics. Washington D.C., Table 15, 2009.
3-6

The remainder of this section discusses the costs associated with each specific industry task. Activities are 

organized into two categories: per facility costs and per form costs.1 As noted previously, these costs are 

summarized in Table 3-2.

Per Facility Costs

As noted above, TRI reporting burden is incurred at both the facility and form level. Facility level costs 

apply to the whole facility, regardless of how many Form Rs or As are filed by a particular facility. 2 Per 

facility costs include cost incurred for compliance determination, rule familiarization, and supplier 

notification. Each facility-level compliance activity is discussed in more detail below. 

Compliance Determination

A facility must report under EPCRA section 313 if it: (1) is within a NAICS code or industry group 

corresponding to the statutory requirement covered by the TRI Program; (2) has 10 or more full-time 

equivalent (FTE) employees; and (3) manufactures, processes, or otherwise uses any of the listed chemicals 

above the threshold quantities. All facilities must determine if they meet these criteria. Most facilities incur 

little burden to make determinations regarding the first two criteria. Many facilities require time for the 

management and technical staff to determine the types of chemicals used at the facility and whether these 

chemicals are manufactured, processed, or otherwise used above threshold levels, in order to make the 

determination under the third criterion.

For this proposed rule, it is assumed that the addition of the proposed chemicals constitute a modest change 

(less than 10 percent) when compared to the total number of chemicals subject to the program. Thus, it is 

assumed that the compliance determination burden for non-reporters, as well as for those entering the 

reporting community because of the proposed rule, is already included in the existing compliance 

determination burden estimates. 

Rule Familiarization3

If a facility will be reporting under the section 313 requirements for the first time due to the final rule, 

facility staff must review and comprehend the reporting requirements. At a minimum, this effort will 

involve reading the instructions to the Toxic Chemical Release Inventory Reporting Form R, however, it 

may also involve consulting EPA guidance documents, attending a training course, and/or calling the 

EPCRA technical hotline. The cost associated with rule familiarization occurs only in the first year that a 

facility becomes subject to reporting. In subsequent years, staff are assumed to be familiar with the 

requirements that apply to their facility. Thus, the facility would no longer bear this cost. Similarly, 

facilities reporting on one or more of the proposed chemicals that already report on one or more existing 

TRI chemicals will not incur a rule familiarization cost.

 1

 Any cost incurred by a facility covers all forms submitted by the facility.

2

 Normally, to the extend that a facility may be newly filing a Form R or A due to a regulatory action, the potential for 

double counting facility level costs associated with compliance determination is present. This double counting can 

occur due to the fact that compliance determination burden has already been estimated for baseline TRI reporting for 

an existing reporter. Where that reporter files additional forms due to a new regulatory action, additional compliance 

determination may be estimated, but should account for established facility burden already in place in order to avoid 

double counting. For this proposed rulemaking, however, the per-facility cost is limited to rule familiarization only and 

no double counting occurs as rule familiarization applies in the first year only to facilities that have never reported to 

TRI before for any chemical. This double counting is more likely to occur during the estimation of incremental 

reporting burden supporting a rulemaking than in the estimation of TRI reporting burden during the development of 

the Information Collection Request (ICR). 3

 Rule familiarization cost is allocated to new facilities only, and in this rulemaking is completely apportioned to Form 

Rs and not shared with Form As, as only Form Rs are estimated to be reported. 
3-7

It is estimated that facilities reporting under section 313 for the first time will incur a one-time burden of 

34.5 hours for rule familiarization. This burden estimate is comprised of 12 hours of management time and 

22.5 hours of technical time (USEPA, 2007).

The unique number of facilities reporting for the first time under the proposed rule was estimated 

individually for each proposed chemical. The methodology used to estimate the number of first time filers 

is summarized in Chapter 2. The number of first time filers is presented in Table 3-1. 

Supplier Notification

Certain suppliers of mixtures or trade name products containing reportable substances must annually notify 

their customers of the product's composition if the customer is subject to EPCRA section 313 reporting or 

sells the product to another company that is subject to reporting. Facilities may be subject to the supplier 

notification requirements even if they are not covered by the EPCRA section 313 reporting requirements. 

For example, a facility with less than 10 FTEs or that does not meet reporting thresholds may still be 

required to notify certain customers. Supplier notification is required so that customers can make threshold 

determinations and complete forms for their own facilities. A letter identifying the chemical by name and 

CAS number and indicating its percentage by weight in the formulation can provide the notification. 

Notification can also be provided on the MSDS for the product. Under the proposed rule, EPA assumes 

that the number of facilities that might be required to provide supplier notifications would only be a small 

fraction of potential supplier notifications in connection with the TRI program overall. Therefore, no 

additional supplier notification burden is estimated in connection with the proposed rule. 

Per Form Costs

Per form costs include cost incurred for Form R completion, recordkeeping, and submission. Under the 

proposed rule, existing filers incur form-level cost only. Each form-level compliance activity is discussed 

in more detail below. 

Form R Completion

For most of the proposed chemicals, the data available to estimate the number of forms expected was very 

limited such that release and waste management quantities could not be estimated. Therefore, the 

conservative assumption was made that all forms for these chemicals would be Form Rs, although in 

practice, some chemical uses at some facilities may qualify for Form A reporting. 

Facilities that determine they must report on a proposed chemical under the section 313 reporting 

requirements will incur costs to retrieve, process, review, and transcribe the information necessary to 

complete each report. Most of the time spent on form completion is used to calculate releases, transfers, and 

other waste management information; relatively little time is required to copy information to the form. The 

facility must complete one Form R for each of the proposed chemicals on which it reports. This effort will 

require more time in the first year than in subsequent years. In subsequent years, facilities will need to 

verify and update data, review previous calculations, and modify the information reported on the previous 

year's Form R, rather than estimate or retrieve data for the first time. Note that all of the proposed chemicals 

are non-PBT chemicals.

In the first year, report completing for non-PBT chemicals is estimated to take 67.7 hours (20.5 hours of 

managerial, 44.4 hours for technical, and 2.8 hours for clerical time) (USEPA, 2007). In subsequent years, 

the estimated time for report completion equals 24.7 hours (7.5 hours of managerial, 16.1 hours of 

technical, and 1.0 hours of clerical time) (USEPA, 2007).

The estimated number of forms to be filed by each industry is presented in Table 3-1. The total cost 

associated with Form R completion is calculated by multiplying the unit cost shown in Table 3-2 by the 

number of expected forms.
3-8

Recordkeeping and Submission

After a facility has completed the form, it incurs additional labor costs for recordkeeping associated with 

filing a Form R. Recordkeeping allows a facility to use the information in making calculations in 

subsequent years, and as documentation in the event it receives a compliance audit. Facilities must maintain 

records such as estimation methodology and calculations, engineering reports, inventory, incident and 

operating logs, and any other supporting materials needed to provide the information required on the Form 

R. Recordkeeping and submissions are estimated to require five hours per Form R (four hours of technical 

and one hour of clerical time) (USEPA, 2007). Recordkeeping and submission costs are not expected to

vary between the first and subsequent years. Therefore, the five hours per Form R is assumed for both first 

and subsequent years. The estimated number of forms requiring recordkeeping and mailing is identical to 

the number of Form Rs expected to be filed as presented in Table 3-1.

3.2.3 Total Industry Costs 

The total industry costs include the costs of rule familiarization, Form R completion, recordkeeping, and 

submission. To compute the industry-wide cost of each compliance activity, the unit cost for each task is 

multiplied by the relevant number of facilities and/or forms associated with that task. Table 3-4 presents the 

total cost of the proposed rule in the first and subsequent years.

Table 3-4: Estimated Industry Burden and Cost by Compliance Activity

Activity Number of 

Forms/Facilities

Hours per 

Form/Facility

Cost per 

Form/Facility

Total Burden 

(hours) Total Cost ($)

FIRST YEAR

Rule Familiarization a

(facility-level) 74 34.5 $1,903 2,553 $140,822 

Calculations and Report 

Completion b (form-level) 186 67.7 $3,626 12,586 $674,506 

Recordkeeping and 

Submission b (form-level) 186 5.0 $231 930 $42,971 

Total 16,069 $858,299 

SUBSEQUENT YEAR

Calculations and Report 

Completion b (form-level) 186 24.7 $1,322 4,587 $245,931 

Recordkeeping and 

Submission b (form-level) 186 5.00 $231 930 $42,971 

Total 5,517 $288,902 

a

 The unit cost for this activity is estimated at the facility level. It is treated as a fixed cost that covers all chemicals reported by a facility.

b

 The unit cost for this activity is estimated to vary with the number of Form Rs submitted. The total cost for this activity at a facility is 

calculated by multiplying the unit cost by the number of forms submitted by that facility.

Note: Total Cost and Total Burden may not equal the product of Number of Facilities/Forms and Cost per Form, and the Number of 

Facilities/Forms and Hours per Form, respectively, due to rounding. For the derivation of cost for each compliance activity, see pages 3-

6 and 3-7.

Sources:

U.S. EPA (2007). Information Collection Request (ICR): TRI Form R Toxic Chemical Release Reporting EPA ICR #1363.15. 

December.

U.S.DOL (2009). Employer Costs for Employee Compensation Historical Listings, March 2004 – June 2009. U.S. Department of Labor. 

Bureau of Labor Statistics. Washington D.C., Table 15, 2009

 

3.3 EPA Costs 

This section estimates the burden and costs to EPA to process Form Rs based on information characterizing 

the resources used by the Agency in previous years. For the TRI program in general, EPA incurs burden 

and costs for five categories of activities: data processing, outreach and training, information dissemination, 

policy and petitions, and compliance and enforcement. 
3-9

The estimate of EPA burden and costs is separated into a fixed component and a variable component. 

Activities and expenses that are not greatly affected by marginal changes in report quantities are reported as 

fixed costs. These activities and expenses include rent for the EPCRA Reporting Center, development costs 

for data access tools, compliance assistance measures, and other activities and expenses listed above. There 

are no additional fixed costs to the Agency associated with the proposed rule. The incremental burden, or 

the variable component, is the amount that varies depending on the number of forms, particularly 

concerning forms processing. Table 3-5 presents costs associated with forms processing by submission 

media type.

Table 3-5: Agency Forms Processing Cost by Media Type

Media Type Form Processing Cost Per Form (2009 Dollars)

Paper $ 25.75

Mag Media $ 6.50

CDX $ 3.12

TRIMEweb $ 3.12

Source: Personal communication with Peggy Bagnoli. TRI Information and 

Outreach Brach. November 13, 2009.

As presented in Table 3-1, 186 Form Rs are expected to be filed for the proposed chemicals under the 

proposed rule. The distribution of forms by media type is estimated using RY 2008 submittal data.4 

Assuming the same distribution of submission media types as in RY 2008, the total form processing burden 

for EPA associated with Form R submission under the proposed rule is estimated to be $773. Table 3-6 

presents the estimated number of forms to be submitted for proposed chemicals by media type, total 

processing cost by media type, and total incremental EPA cost for the proposed rule making. 

Table 3-6: Estimated Number of Form R Submissions and Incremental 

Agency Cost by Media Type

Media Type Estimated Number of 

Form Rs

Form Processing Cost 

Per Form ($)

Processing 

Cost ($)

Paper 6 $ 25.75 $ 152

Mag Media 18 $ 6.50 $ 114

CDX 34 $ 3.12 $ 106

TRIMEweb 129 $ 3.12 $ 401

TOTAL 186 $ 773

Note: Processing cost totals may not equal the product of the rows due to the rounding of both the 

estimated number of forms and the total processing cost.

 

3.4 Total Costs 

The estimated total cost to industry and EPA of the proposed rule is $859,299 in the first year and $289,675 

in subsequent years. Table 3-7 summarizes the total costs to industry and EPA for the proposed rule.

Table 3-7: Summary of Total Costs of 

Proposed Rule

Description First Year Subsequent Years

Industry Costs $ 858,299 $ 288,902

EPA Costs $ 773 $ 773

TOTAL $ 859,072 $ 289,675

 4

 In RY 2008, 2,437 form Rs were submitted as paper forms; 7,267 Form Rs were submitted as Magnetic Media; 

13,992 Form Rs were submitted via CDX; and 53,070 Form Rs were submitted via TRIMEweb.
3-10

3.5 Summary 

The purpose of this section is to provide summary burden and cost information that the Agency requires to 

support Federal Register Notices, Notice of Actions, and other federal publications associated with the 

proposed rulemaking. This summary information is presented in Table 3-8.

Table 3-8: Summary Burden and Cost Information for the 

Proposed Rule

Description First Year Subsequent Year

Number of Form Rs 186 186

Number of Form R Responses 186 186

Number of Facilities (adding Form Rs only) 175 175

Average Number of Form R’s per Facility

(adding Form Rs only) 1.06 1.06

Number of Facilities Filing for the First Time 

(adding Form Rs only) 74 NA

Average Industry Cost per Form R $4,615 $1,553

Average Industry Cost per Facility (adding 

Form Rs only) $4,904 $1,651

Average Industry Burden per Form R (hours) 86 30

Average Industry Burden per Facility adding 

Form Rs only (hours) 92 32

Total Industry Burden (Form R hours) 16,069 5,517

Total Industry Cost (Form R) $858,299 $288,902

Total EPA Cost (Form R) $773 $773

Total Cost (Form R) $ 859,072 $ 289,675
3-11

Literature Cited

Rice (2002) Wage Rates for Economic Analysis of the Toxics Release Inventory Program.

U.S.DOL (2009). Employer Costs for Employee Compensation Historical Listings, March 2004 – June 

2009. U.S. Department of Labor. Bureau of Labor Statistics. Washington D.C., Table 15, 2009.

U.S. EPA (2007). Information Collection Request (ICR): TRI Form R Toxic Chemical Release 

Reporting. EPA ICR #1363.15. December.
4-1

Chapter 4 – Small Entity Analysis

4.1 Introduction 

This chapter addresses the potential impacts of the proposed rule on small entities. Specifically, section 4.2 

discusses the small entities regulatory requirement for this analysis. Section 4.3 provides the definitions of 

small entities for the industry groups affected by the proposed rule. Section 4.4 describes the general 

methodology used to determine if the proposed rule results in a significant economic impact to a substantial 

number of small entities. Section 4.5 summarizes the results for all small entities affected by the proposed 

rule.

4.2 Impact on Small Entities 

The Regulatory Flexibility Act (RFA) of 1980 (5 U.S.C. § 601 et. seq.) requires Federal agencies to assess 

the effects of regulations on small entities, and, in some instances, to examine alternatives to the regulations 

that may reduce adverse economic effects on significantly impacted small entities. The RFA requires 

agencies to prepare an initial and final regulatory flexibility analysis for each rule unless the Agency 

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

Since 1980, the RFA has required Federal agencies to assess the economic impacts of their actions on small 

entities, including businesses, nonprofit agencies, and governments. Section 604 of the RFA, as amended 

by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, requires an agency to 

perform a regulatory flexibility analysis for a rule unless the Agency certifies under section 605(b) that the 

regulatory action will not have a significant economic impact on a substantial number of small entities. The 

RFA does not specifically define “a significant economic impact on a substantial number” of small entities. 

4.3 Definitions of Small Entities 

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

Small Business Administration (SBA) to define “small business” by regulation. This analysis uses the 

SBA’s definition of a small business for each industry.1 

SBA's small business size definitions vary by industry. In establishing size standards, SBA considers a 

number of economic and market characteristics that may allow a business of concern to exercise dominance 

in an industry. Size standards are based on criteria such as annual receipts or number of employees that 

represent a measure of these characteristics. These standards represent the largest size that a for-profit 

enterprise (together with its affiliates) may be and still qualify as a small business. 

The SBA small business size standards are expansive, classifying most businesses as “small.” For example, 

the default SBA size standard for manufacturing industries is 500 employees. According to information 

compiled for SBA by the Bureau of the Census, 281,970 of 286,039 manufacturing firms have fewer than 

500 employees (USSBA, 2009). Therefore, at least 98.6 percent of firms would be classified as small 

businesses according to the SBA definition. In fact, this percentage is actually higher, since for certain 

industrial classification codes within manufacturing, the SBA size standard is 750, 1,000, or 1,500 

employees. Table 4-1 lists the small business size standards for the industries affected by the proposed rule. 

 1

 SBA's size standards can be found at: 

http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf
4-2

Table 4-1: Small Business Size Standards for Industries Affected by the Proposed Rule

NAICS NAICS U.S. Industry Title Size Standards in 

Millions of Dollars

Size Standards in 

Number of Employees

325110 Petrochemical Manufacturing 1,000

325188 All Other Basic Inorganic Chemical Manufacturing 1,000

325199 All Other Basic Organic Chemical Manufacturing 1,000

325211 Plastics Material and Resin Manufacturing 750

325212 Synthetic Rubber Manufacturing 1,000

325520 Adhesive Manufacturing 500

325612 Polish and Other Sanitation Good Manufacturing 500

325920 Explosives Manufacturing 750

325998

All Other Miscellaneous Chemical Product and

Preparation Manufacturing 500

326199 All Other Plastics Product Manufacturing 500

333220 Plastics and Rubber Industry Machinery Manufacturing 500

333911 Pump and Pumping Equipment Manufacturing 500

335314 Relay and Industrial Control Manufacturing 750

424490

Other Grocery and Related Products Merchant

Wholesalers 100

541712

Research and Development in the Physical,

Engineering, and Life Sciences (except Biotechnology) 500

551112 Offices of Other Holding Companies $7.0

Source: (USSBA, 2008) Table of Small Business Size Standards Matched to North American Industry Classification 

System Codes. U.S. Small Business Administration. August 22, 2008. 

http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf

The RFA defines “small governmental jurisdictions” as governments of cities, counties, towns, school 

districts, or special districts with populations of less than 50,000 people. No small governmental 

jurisdictions are expected to report as a result of the proposed rule.

The RFA defines “small organizations” as any “not-for-profit enterprise which is independently owned and 

operated and is not dominant in its field.” No small organizations are expected to report as a result of the 

proposed rule.

4.4 Methodology Overview 

This analysis uses annual cost impact percentages to measure potential impacts on small entities. The cost 

impact percentage is defined as annual compliance costs resulting from the proposed rule as a percentage of 

annual revenues or sales. For purposes of determining small entity impacts, comparing annual compliance 

costs to annual revenues provides a reasonable indication of the magnitude of the regulatory burden relative 

to a commonly available and objective measure of a company's business volume. Where regulatory costs 

represent a small fraction of a typical firm's revenue, the impacts of the regulation are likely to be minimal.

Cost impact percentages are calculated for the incremental compliance costs incurred during first and 

subsequent years of reporting. In the first year, industry costs will consist of rule familiarization costs, 

(incurred by only those facilities filing for the first time), calculations and report completion costs, and 

recordkeeping and submission costs. In subsequent years, the incurred compliance cost will consist of 

calculations and report completion, and recordkeeping and submission costs only. Table 4-2 presents unit 

costs per facility associated with each of the compliance activities in the first and subsequent years. 
4-3

Table 4-2: Cost Estimates for Activities Performed by Industry

Activity Unit Cost

First Year

Rule Familiarization a (facility-level) $1,903 

Calculations and Report Completion b(form-level) $3,626 

Recordkeeping/Submission b (form-level) $231 

Subsequent Years

Calculations and Report Completion b(form-level) $1,322 

Recordkeeping/Submission b(form-level) $231 a The unit cost for this activity is estimated at the facility level. It is treated as a fixed cost that covers 

all chemicals reported by a facility. b The unit cost for this activity is estimated to vary with the number 

of Form R reports submitted. The total cost for this activity at a facility is calculated by multiplying the 

unit cost by the number of reports submitted by that facility.

Note: For the derivation of cost for each compliance activity, see pages 3-6 and 3-7.

Sources: 

U.S. EPA (2007). Information Collection Request (ICR): TRI Form R Toxic Chemical Release 

Reporting EPA ICR #1363.15. December.

U.S.DOL (2009). Employer Costs for Employee Compensation Historical Listings, March 2004 – June 

2009. U.S. Department of Labor. Bureau of Labor Statistics. Washington D.C., Table 15, 2009

This analysis calculated the cost impact percentages using the actual compliance costs per facility, the 

number of facilities per parent company for small entities and the annual revenues for each of the small 

entities. For each company, revenue data and number of TRI facilities per small company were taken from 

Dun and Bradstreet’s (D&B) Private Data Portal (Version 2.5, accessed on December 8, 2009) as described 

in the next section.

The general methodology followed to estimate the impacts on small entities consists of the following steps:

1. Estimate the number of reports on the proposed chemicals as well as the number of affected 

facilities in each industry sector that may file these reports under the proposed rule2;

2. Estimate the number of small companies affected;

3. Develop company-level annual compliance cost estimates, based on the number of facilities per 

company and the number of reports per facility;

4. Identify annual revenues of affected small companies;

5. Estimate the company-level impact percentages for the first and subsequent years, defined as 

compliance costs as a percentage of annual revenues, as a measure of regulatory burden;

6. Estimate the number and percentage of small companies with company-level impact percentages in 

each of three categories: (1) less than one percent of annual revenues; (2) between one and three 

percent of annual revenues; and (3) greater than or equal to three percent of annual revenues.

4.4.1 Generation of Company Revenue Data 

This section describes how revenue and business size data (based on revenue and employment) were used 

to characterize companies in affected industries. The total number of facilities that are expected to report 

under the proposed rule is 175; the method for estimating this number of facilities is discussed in detail in 

Chapter 2. The 175 facilities can be divided into two distinct groups, one consisting of 127 actual facilities 

identified as being subject to the proposed rule’s reporting requirements, and the other consisting of 48 

facilities for which the number of reporting facilities was estimated based on sources such as EPA’s Risk 

Management Plan (RMP) Database (RMP), EPA’s Biennial RCRA Hazardous Waste Report (BR), EPA’s 

 2

 The term “affected facilities” is used in this report to denote facilities that meet the TRI reporting requirements and 

are expected to submit at least one Form R for an NTP chemical. A Form R is completed for a single chemical. 

Facilities may submit more than one Form R if they manufacture, process, or otherwise use more than one listed TRI 

chemical (including the newly listed NTP chemicals). 
4-4

TSCA Inventory Update Reporting (IUR) Database, the US Census Bureau’s Census of Manufacturers, the 

Directory of Chemical Producers – United States, and the Chemical Information Service’s Directory of 

World Chemical Producers.

In conjunction with D&B data on parent ownership, revenue, and employment, the facility-specific data 

available for the 127 actual facilities was used to identify the specific parent companies of these facilities. 

Specifically, of the 127 potentially affected actual facilities, 98 percent were linked to a parent company in 

D&B. both revenue and size information were available for 78 percent of the identified parent companies.

Using this information, it was possible to classify parent companies as small using the SBA defined 

thresholds for the affected industries. To estimate the total number of small parent companies affected by 

the proposed rule, the distribution of parent companies and small parent companies for the 98 facilities with 

complete information was applied to the 77 facilities that were either modeled in the derivation of the 

universe or for which complete revenue and employment data was unavailable in D&B. 

As noted above, company revenue and business size data were obtained for actual affected facilities from 

Dun and Bradstreet’s Private Data Portal (D&B, Version 2.5, accessed on December 8, 2009). For over 11 

million business locations, D&B provides a wide range of data including:

• Number of employees,

• Line of business,

• Key financial indicators,

• Business size, and 

• Parent/headquarters.

The revenue and business size data used in this analysis represent data for global ultimate parent companies 

that own one or more facilities in the industries affected by the proposed rule.3

Using parent company employment data presented in D&B, small parent companies were identified by 

comparing employment and revenue data to the SBA thresholds. The small entity analysis accounts for 

parent companies owning one or more affected TRI facilities. The ultimate parent data obtained from D&B 

includes available revenue data of all subsidiaries, divisions, and branches of that parent, including those 

not individually affected under the rule. The number of potentially affected facilities per ultimate parent, 

however, represents the number of facilities owned by that parent company that are expected to perform 

compliance activities for the proposed rule (not the total number of facilities per parent company).

4.4.2 Estimating Impacts 

To evaluate the potential impact of the rule, annual compliance costs are estimated at the global ultimate 

parent company level to be consistent with the financial data obtained from D&B. For purposes of 

evaluating the impacts on small entities, an “affected” facility is defined as a facility that is expected to 

perform compliance activities listed in Table 4-2 in the first and subsequent years of the rulemaking. Thus,

an “affected” company under this analysis is a company owning at least one “affected” facility. 

 3 The global ultimate parent is the uppermost parent or headquarters that encompasses all directly related branches, 

subsidiaries, or parents of a specific business at a specific location. This analysis assumes that a facility, as defined 

under TRI, is equivalent to a location as defined by D&B. A “facility,” subject to EPCRA section 313 reporting 

requirements, means all buildings, equipment, structures, and other stationary items that are located on a single site or 

on contiguous or adjacent sites, and which are owned or operated by the same person, that is classified under an SIC 

code covered by the regulations, has 10 or more employees or the equivalent, and manufactures, processes, or 

otherwise uses any of the listed toxic chemicals or chemical categories above the specific reporting thresholds. For 

some industries this may not correspond exactly to the definition of a location by D&B.
4-5

The analysis of small entity impacts uses the number of facilities per company for small companies, the 

number of reports filed per facility, and the annual revenue for each small company. Employment and 

revenue data with which to identify business size information was available from D&B for 61 of the 78 

ultimate parents (78%) of known facilities. Of the 61 ultimate parents identified, 23 (38%) were classified 

as “small”. The percentage of ultimate parents and small ultimate parents for the 98 known facilities with 

complete data was applied to the total number of facilities (175) to estimate the total number of ultimate 

parents and small ultimate parents expected to be affected by the rule. The estimated number of ultimate 

parents affected by the proposed rule is 109, 41 of which are estimated to be small businesses. 

Cost impact percentages for the first and subsequent years of the rulemaking were calculated for each 

parent company by dividing costs (for all affected facilities owned by the parent company) by the parent 

company sales. These cost impact percentages were used to create the distribution of impacts to small 

parent companies under this proposed rule. Impact categories included percentages of less than one 

percent, between one and three percent, or greater than three percent. 

4.5 Results 

The estimated impacts to small companies under the proposed rule are presented in Table 4-3 below. Of the 

estimated 109 affected entities, 41 are small businesses. Of the affected small businesses, all 41 have cost 

impacts of less than 1% in both the first and subsequent years of the rulemaking. No small businesses are 

projected to have a cost impact of 1% or greater. In the first year, of the 41 estimated cost impacts, there is 

a maximum impact of .616% and a minimum impact of less than 0.001%. The mean and median impacts 

for the first year are estimated to be 0.147% and 0.072% respectively. In the subsequent years, of the 41 

estimated cost impacts there is a maximum impact of less than 0.2% and a minimum impact of less than 

0.001% each affecting one small business. The mean and median impacts for the subsequent years are 

estimated to be less than 0.05% and 0.03% respectively.

Table 4-3: Summary of Impacts on Small Entities

Estimated Number 

of Affected Entities

Estimated Number of 

Affected Small 

Entities

Estimated Number of 

Small Entities with 

Impacts of 3% or Greater

Estimated Number of 

Small Entities with Impacts 

Between 1 and 3%

Estimated Number of 

Small Entities with 

Impacts Less than 1%

First Year

109 41 0 0 41

% of Small 

Entities - - 0% 0% 100%

Subsequent Years

109 41 0 0 41

 % of 

Small 

Entities

- - 0% 0% 100%
4-6

Literature Cited

U.S.DOL (2009). Employer Costs for Employee Compensation Historical Listings, March 2004 – June 

2009. U.S. Department of Labor. Bureau of Labor Statistics. Washington D.C., Table 15, 2009

U.S. EPA (2007). Information Collection Request (ICR): TRI Form R Toxic Chemical Release Reporting 

EPA ICR #1363.15. December.

USSBA (2008) Table of Small Business Size Standards Matched to North American Industry Classification 

System Codes. U.S. Small Business Administration. August 22, 2008. 

http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf

USSBA (2009). United States Small Business Administration. Office of Advocacy - Statistics – All 

Industries by NAICS Codes, 2006: Employer Firms & Employment by Employment Size of Firm 

by NAICS Codes, 2006. Information from the Small Business Administration on the Internet. 

http://www.sba.gov/advo/research/us06_n6.pdf. Downloaded on November 20, 2009.
5-1

Chapter 5 – Benefits

In enacting the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and the 

Pollution Prevention Act (PPA) of 1990, Congress recognized the significant benefits of providing 

information on the presence, releases and waste management of toxic chemicals. The Toxics Release 

Inventory (TRI) has proven to be one of the most powerful forces in empowering the federal government, 

state and local governments, industry, environmental groups and the general public to fully participate in an 

informed dialogue about the environmental impacts of toxic chemicals in the United States. TRI’s publicly 

available data base provides quantitative information on toxic chemical releases and other waste 

management activities. Starting in 1987, the collection of this information enhanced the ability for the 

public, government, and the regulated community to understand the breadth and magnitude of chemical 

releases in the United States and to assess the need to reduce the releases and transfers of toxic chemicals. 

TRI enables all interested parties to establish credible baselines, to set realistic goals for environmental 

progress, and to measure progress in meeting these goals over time. As such, the TRI system has become a 

neutral yardstick by which progress can be measured by all interested or affected stakeholders.

The information reported to TRI increases community knowledge of the levels of toxic chemicals released 

to the environment and the potential pathways of exposure. This knowledge then:

• Improves scientific understanding of the health and environmental risks of toxic chemicals; 

• Allows the public to make informed decisions on where to work and live; 

• Enhances the ability of corporate leaders and purchasers to more accurately gauge a facility’s 

potential environmental liabilities; 

• Provides reporting facilities with information that can be used to save money as well as reduce 

emissions; and 

• Assists federal, state, and local authorities in making better decisions on acceptable levels of toxic 

chemicals in the environment.

The benefits of the proposed rule include improved understanding, awareness, and decision making related 

to the provision and distribution of information on releases and waste management of the 16 proposed 

chemicals. The provision of information can lead to follow-on activities that create additional costs and 

benefits. In particular, this information can lead to voluntary initiatives by industry to review production 

processes, set goals for reductions in emissions, and institute “good neighbor” policies. If an individual 

facility owner or operator perceives that the benefits outweigh costs, then changes can be implemented to 

reduce releases of TRI chemicals. Making TRI information available to the public may provide incentives 

for firms to cut TRI chemical releases, and it some cases it may induce firms to reduce releases where such 

changes would not be in the firms own interest if the information about the releases was not in the public 

domain. Social benefits derived from follow-on activities not required by the proposed rule may include 

decreased costs of waste treatment and disposal, lower probability of accidental releases and lower clean-up 

costs in the event of such releases, reduced contamination of natural resources from decreased land 

disposal, improved air and water quality, and reduced risks to human health. Such social benefits are 

partially offset by the social costs to implement the changes, such as installing scrubbers and substituting 

materials that are less toxic but more expensive. The net social benefits of the information provided by the 

proposed rule and the follow-on activities equal the difference between the total benefits and the total costs 

of the activities which lead to the reduction in releases.

The potential benefits of additional TRI reporting can be understood by examining the ways in which 

different groups of affected stakeholders—consumers, industry, non-federal governments and the general 

public—utilize the TRI data. Consumers may use the data to make more informed decisions about the 

products they buy and to enter into constructive dialogue with the firms in their communities that release 

any of the 16 proposed chemicals. Industry may find opportunities for waste reduction and cost savings 
5-2

through developing data to be used for reporting under the proposed rule. Non-federal governments may 

use the data in lieu of or in support of their own environmental protection activities. In addition, non-users 

of the TRI data benefit from its public provision whenever others use of the data results in improvements in 

environmental quality.

Some examples of the ways in which various stakeholders have utilized TRI data include: 

• Use of the Data by Community and Public Interest Groups: Communities use TRI data to begin 

dialogues with local facilities and to encourage them to reduce their emissions, develop pollution 

prevention plans, and improve safety measures. Public interest groups use the data to educate the 

public about toxic chemical emissions and potential risk, and in environmental justice activities.

• Use of the Data by Education and Research Institutions: The TRI data are being used in many 

environmental education programs, particularly at the high school and university levels. Students 

learn about toxic chemical releases, the potential health and environmental effects of those releases, 

pollution prevention activities and opportunities, and the social and political aspects of 

environmental protection. Some organizations also are conducting educational outreach programs 

using TRI data. 

• Use of the Data by the Financial and Business Communities: Investment analysts use TRI data to 

provide recommendations to clients seeking to make environmentally sound investments. Insurance 

companies look to TRI data as one indication of potential environmental liabilities. Consultants and 

others use the data to identify business opportunities, such as marketing pollution prevention and 

control technologies to TRI reporting facilities. Demand for environmental performance 

information by investors, insurance companies, and the public has led many companies to develop 

environmental annual reports similar to annual reports on financial performance traditionally 

prepared for investors.

• Industry Use of TRI Data: TRI has been used by industry for activities such as developing waste 

reduction strategies and improving companies’ understanding of their own production processes. 

Industry also uses TRI submission information to show environmental progress and as a starting 

point for engaging with communities. 

• Government Use of TRI Data: Government organizations such as the media-specific and core 

offices at EPA, EPA Regional offices, and other national, state, and local government agencies 

routinely use the TRI data. TRI data have been used to: develop inspection targeting and 

enforcement tools; analyze and prioritize long-term trends in waste minimization; identify 

candidates for the National Primary Drinking Water Regulations; to coordinate environmental data 

internationally through agreements and organizations such as the Commission for Environmental 

Cooperation, and to set priorities and allocate increasingly scarce environmental protection 

resources to the most pressing problems.

EPA has not attempted to monetize the benefits of the proposed rule for several reasons related to the 

uncertainties associated with data on users and non-users of the TRI and the substantial analytical challenges 

associated with conducting an analysis that accurately predicts behavioral responses to information. The 

analysis was not able to consider variations in quality or other attributes of different methods of TRI data 

access. Finally, the potentially large numbers of beneficiaries who are not users or are otherwise unaware of 

the data further limits EPA’s ability to quantify potential benefits. However, the experience since the first 

forms were submitted to TRI in 1987 suggests that reporting under EPCRA section 313 has produced real 

gains in understanding about communities’ exposure to toxic chemicals. In its report entitled: How are the 

Toxics Release Inventory Data Used? – Government, Business, Academic, and Citizen Uses, EPA has 

documented numerous examples of how multiple stakeholders have used TRI data (US EPA, 2003). 

Moreover, a cursory search on GoogleScholarTM reveals thousands of academic articles referencing the 

Toxics Release Inventory. Listing the additional chemicals should provide similar gains in understanding 

about these chemicals. EPA believes that all of the chemicals under the proposed rule meet the statutory 
5-3

toxicity criteria of section 313, and are at least as toxic as some of the chemicals for which Congress 

initially believed there were net benefits due to reporting. 
5-4

Literature Cited

U.S. EPA (2003). How are the Toxics Release Inventory Data Used? – Government, Business, 

Academic, and Citizen Uses. EPA 260-R-002-004. May.
A-1

Appendix A – Background and Methodology for Additions to Polycyclic 

Aromatic Compounds (PACs) Category

This appendix presents the background and methodology for determining the potential for incremental 

reporting for 6-nitrochrysene, 1,6-dinitorpyrene, 1,8-dinitropyrene, and 4-nitropyrene, which will be added 

to the polycyclic aromatic compounds (PACs) chemical category under the proposed rule. 

A.1 Background and Methodology for Additions to Polycyclic 

Aromatic Compounds (PACs) Category 

Under the proposed rule, the following four chemicals would be added to the PACs chemical category:

• 6-Nitrochrysene (7496-02-8)

• 1,6-Dinitropyrene (42397-64-8)

• 1,8-Dinitropyrene (42397-65-9)

• 4-Nitropyrene (57835-92-4)

6-Nitrochrysene exists as red prismatic crystals, orange-yellow needles, or light-yellow needles. It is 

slightly soluble in ethanol, diethyl ether, carbon disulfide, benzene, acetic acid, and nitrobenzene. 

1,6-Dinitropyrene exists as light-brown needles or yellow crystalline solids, and is soluble in toluene. 

1,8-Dinitropyrene exists as light brown needles or a yellow crystalline solid. 4-Nitropyrene exists as orange 

needles. All four compounds are classified as “reasonably anticipated to be a human carcinogen” based on 

sufficient evidence in multiple experimental animals.

The existing TRI PACs category currently consists of 21 specific compounds that are reported to TRI as a 

single chemical category. Most of these chemicals are coincidentally manufactured as products of 

incomplete combustion. TRI requires threshold determinations for chemical categories to be based on the 

total mass of all the chemicals in that category. If the four chemicals listed above were added to the PACs 

category, facilities would need to determine if their manufacture, process, or otherwise use of all of the 

PACs category chemicals in aggregate exceed the 100 pound reporting threshold for PACs. If a facility is 

already reporting for PACs and is handling one or more of these four additional chemicals, the facility 

would need to calculate the releases and waste management quantities associated with the four chemicals, 

but there would be no change in their threshold determination calculation. 

A.1.1 6-Nitrochrysene Production and 4-Nitropyrene Production

6-Nitrochrysene and 4-nitropyrene are used in laboratory applications for research purposes. No 

commercial uses for either of these chemicals were identified. These two PACs are similar to 7,12-

dimethylbenz(a)anthracene and 3-methylcholanthrene, two currently listed PACs, that are also produced in 

small quantities as research chemicals and are not products of incomplete combustion. 

One U.S. manufacturer of 6-nitrochrysene was identified. No data on production volumes of 6-

nitrochrysene were available. However, the quantity manufactured by this facility is assumed to be below 

the 100 pound manufacturing threshold quantity, given that the chemical is used in limited applications and 

the manufacturer sells this chemical in 5 gram packages. Over 9,000 packages would have to be 

manufactured annually to exceed the TRI reporting threshold. While this company also manufactures the 

two existing chemicals in the PACs chemical category that are research chemicals, it appears these 

chemicals are not manufactured at the same facility as 6-ntitrochrysene, based on a literature review. It is 

assumed that no new TRI reports would be filed if this chemical were added to the PACs chemical 

category. 

No U.S. manufacturer of 4-nitropyrene was identified. Although some distributors sell the chemical, as with 

6-nitrochrysene, the quantities are expected to be below the 100 pound manufacturing threshold, given that 
A-2

the chemical is used in limited applications and the distributors sell this chemical in 1 gram packages. Over 

45,000 packages would have to be imported in one year by a single facility to exceed the TRI reporting 

threshold. It is assumed that no new TRI reports would be filed if this chemical were in the PACs chemical 

category.

A.1.2 6-Nitrochrysene and 4-Nitropyrene Processing or Otherwise Use

6-Nitrochrysene and 4-nitropyrene may be used in laboratory applications for research purposes in the 

research and development in the physical, engineering, and life sciences (54171) sector. This is not a TRIcovered sector, unless it is a Federal facility. No TRI reports are expected from laboratory use of these 

chemicals because laboratory uses of these chemicals in sampling and analysis, quality control activities, 

and research and development would qualify for the laboratory activities exemption. 

A.1.3 Coincidental Manufacture of 1,6-Dinitropyrene and 1,8-Dinitropyrene

As with most of the currently-reported PACs, 1,6-dinitropyrene and 1,8-dinitropyrene are expected to be 

generated from incomplete combustion of organic compounds and have been found in particulate emissions 

from sources such as diesel engines, kerosene heaters, and gas burners. On an industry sector basis, it is 

expected that these chemicals would be generated as combustion by-products in similar sectors to those that 

currently report for PACs. When defined at the 6-digit NAICS level, facilities in 205 different sectors 

submitted a Form R for PACs in RY2007, as summarized in Table A-1 and shown in detail in Table A-2.

No commercial uses for either of these chemicals were identified.

Table A-1 PACs Reporting to TRI by Sector, RY2007

Sector (NAICS Code, Sector Description) – Top Ten NAICS 

Individually Identified

Number of Facilities 

Reporting for PACs

221112 Fossil Fuel Electric Power Generation 313

424710 Petroleum Bulk Stations and Terminals 307

324121 Asphalt Paving Mixture and Block Manufacturing 216

324110 Petroleum Refineries 142

324122 Asphalt Shingle and Coating Materials Manufacturing 81

322121 Paper (except Newsprint) Mills 73

562112 Hazardous Waste Collection 71

321114 Wood Preservation 56

326211 Tire Manufacturing (except Retreading) 47

322130 Paperboard Mills 40

195 other sectors, as defined at the 6-digit NAICS level 737

TOTAL 205 sectors 2,083

Coincidental manufacturing of 1,6-dinitropyrene and 1,8-dinitropyrene is expected to occur through 

combustion processes. For facilities without site-specific data, threshold determination for the PACs 

chemical category largely relies on default concentration of PACs in various fuel products, as published in 

EPA guidance documents. The default concentrations group all PACs found in fuel products together; no 

concentrations were identified that apply to any individual PAC in the category. If default concentrations 

were updated to include 1,6-dinitropyrene and 1,8-dinitropyrene, it is possible facilities just below the PACs 

category reporting threshold would be required to report, however, methods currently available for testing 

concentrations of PACs in fuels do not distinguish the individual chemicals in the PACs category. 

Therefore, adding these chemicals to the PACs category under the proposed rule will not change the 

number of facilities exceeding the PACs chemical category threshold. 

A.2 Number of RY2007 PACs Reporters by Sector 

Table A-2 presents a detailed listing of RY2007 PACs reporters by industry sector.
A-3

Table A-2: Number of RY2007 PACs Reporters by Sector

NAICS NAICS Description Form A Form R Total 

Facilities

212231 Lead Ore and Zinc Ore Mining 0 1 1

212299 All Other Metal Ore Mining 0 1 1

212321 Construction Sand and Gravel Mining 1 0 1

212324 Kaolin and Ball Clay Mining 0 1 1

213112 Support Activities for Oil and Gas Operations 0 1 1

221112 Fossil Fuel Electric Power Generation 8 305 313

221119 Other Electric Power Generation 0 1 1

221121 Electric Bulk Power Transmission and Control 0 2 2

221122 Electric Power Distribution 0 3 3

221330 Steam and Air-Conditioning Supply 1 1 2

311111 Dog and Cat Food Mfg. 2 0 2

311119 Other Animal Food Mfg. 6 7 13

311213 Malt Mfg. 1 0 1

311221 Wet Corn Milling 0 5 5

311222 Soybean Processing 0 5 5

311223 Other Oilseed Processing 0 2 2

311225 Fats and Oils Refining and Blending 0 2 2

311230 Breakfast Cereal Mfg. 0 1 1

311311 Sugarcane Mills 0 3 3

311312 Cane Sugar Refining 0 1 1

311411 Frozen Fruit, Juice, and Vegetable Mfg. 0 4 4

311421 Fruit and Vegetable Canning 0 6 6

311422 Specialty Canning 0 2 2

311423 Dried and Dehydrated Food Mfg. 0 2 2

311511 Fluid Milk Mfg. 0 3 3

311513 Cheese Mfg. 0 17 17

311611 Animal (except Poultry) Slaughtering 0 2 2

311612 Meat Processed from Carcasses 0 2 2

311613 Rendering and Meat Byproduct Processing 0 2 2

311615 Poultry Processing 4 6 10

311711 Seafood Canning 0 2 2

311812 Commercial Bakeries 0 2 2

311821 Cookie and Cracker Mfg. 0 1 1

311822 Flour Mixes and Dough Mfg. from Purchased Flour 0 1 1

311919 Other Snack Food Mfg. 0 1 1

311930 Flavoring Syrup and Concentrate Mfg. 0 1 1

311991 Perishable Prepared Food Mfg. 0 1 1

311999 All Other Miscellaneous Food Mfg. 0 2 2

312120 Breweries 2 4 6

312210 Tobacco Stemming and Redrying 0 1 1

312221 Cigarette Mfg. 0 1 1

313111 Yarn Spinning Mills 3 2 5

313210 Broadwoven Fabric Mills 0 5 5

313221 Narrow Fabric Mills 0 1 1

313230 Nonwoven Fabric Mills 0 2 2

313241 Weft Knit Fabric Mills 0 2 2
A-4

Table A-2: Number of RY2007 PACs Reporters by Sector

NAICS NAICS Description Form A Form R Total 

Facilities

313249 Other Knit Fabric and Lace Mills 0 1 1

313311 Broadwoven Fabric Finishing Mills 1 7 8

313312 Textile and Fabric Finishing (except Broadwoven Fabric) Mills 0 9 9

313320 Fabric Coating Mills 0 2 2

314110 Carpet and Rug Mills 4 9 13

314999 All Other Miscellaneous Textile Product Mills 0 2 2

315192 Underwear and Nightwear Knitting Mills 0 1 1

316110 Leather and Hide Tanning and Finishing 0 2 2

316211 Rubber and Plastics Footwear Mfg. 0 1 1

321114 Wood Preservation 0 56 56

321212 Softwood Veneer and Plywood Mfg. 0 1 1

321219 Reconstituted Wood Product Mfg. 1 5 6

321999 All Other Miscellaneous Wood Product Mfg. 0 2 2

322110 Pulp Mills 0 37 37

322121 Paper (except Newsprint) Mills 2 71 73

322122 Newsprint Mills 0 4 4

322130 Paperboard Mills 1 39 40

322211 Corrugated and Solid Fiber Box Mfg. 2 4 6

322222 Coated and Laminated Paper Mfg. 0 4 4

323111 Commercial Gravure Printing 0 3 3

324110 Petroleum Refineries 4 138 142

324121 Asphalt Paving Mixture and Block Mfg. 6 210 216

324122 Asphalt Shingle and Coating Materials Mfg. 0 81 81

324191 Petroleum Lubricating Oil and Grease Mfg. 0 5 5

324199 All Other Petroleum and Coal Products Mfg. 0 24 24

325110 Petrochemical Mfg. 0 17 17

325120 Industrial Gas Mfg. 0 2 2

325131 Inorganic Dye and Pigment Mfg. 0 2 2

325132 Synthetic Organic Dye and Pigment Mfg. 0 2 2

325181 Alkalies and Chlorine Mfg. 0 1 1

325182 Carbon Black Mfg. 0 19 19

325188 All Other Basic Inorganic Chemical Mfg. 0 4 4

325191 Gum and Wood Chemical Mfg. 0 1 1

325192 Cyclic Crude and Intermediate Mfg. 0 7 7

325193 Ethyl Alcohol Mfg. 0 5 5

325199 All Other Basic Organic Chemical Mfg. 1 23 24

325211 Plastics Material and Resin Mfg. 0 21 21

325212 Synthetic Rubber Mfg. 0 6 6

325222 Noncellulosic Organic Fiber Mfg. 0 1 1

325312 Phosphatic Fertilizer Mfg. 0 4 4

325314 Fertilizer (Mixing Only) Mfg. 0 2 2

325320 Pesticide and Other Agricultural Chemical Mfg. 0 2 2

325411 Medicinal and Botanical Mfg. 0 1 1

325412 Pharmaceutical Preparation Mfg. 0 11 11

325414 Biological Product (except Diagnostic) Mfg. 0 1 1

325510 Paint and Coating Mfg. 4 6 10
A-5

Table A-2: Number of RY2007 PACs Reporters by Sector

NAICS NAICS Description Form A Form R Total 

Facilities

325520 Adhesive Mfg. 0 1 1

325611 Soap and Other Detergent Mfg. 0 3 3

325612 Polish and Other Sanitation Good Mfg. 0 1 1

325613 Surface Active Agent Mfg. 1 2 3

325620 Toilet Preparation Mfg. 0 1 1

325910 Printing Ink Mfg. 0 4 4

325920 Explosives Mfg. 0 2 2

325991 Custom Compounding of Purchased Resins 5 1 6

325992 Photographic Film, Paper, Plate, and Chemical Mfg. 0 6 6

325998 All Other Miscellaneous Chemical Product and Preparation Mfg. 0 13 13

326113 Unlaminated Plastics Film and Sheet (except Packaging) Mfg. 0 2 2

326130 Laminated Plastics Plate, Sheet (except Packaging), and Shape Mfg. 0 2 2

326199 All Other Plastics Product Mfg. 0 5 5

326211 Tire Mfg. (except Retreading) 0 47 47

326220 Rubber and Plastics Hoses and Belting Mfg. 0 9 9

326291 Rubber Product Mfg. for Mechanical Use 0 3 3

326299 All Other Rubber Product Mfg. 0 8 8

327124 Clay Refractory Mfg. 0 3 3

327125 Nonclay Refractory Mfg. 0 3 3

327211 Flat Glass Mfg. 0 1 1

327212 Other Pressed and Blown Glass and Glassware Mfg. 0 1 1

327213 Glass Container Mfg. 0 1 1

327310 Cement Mfg. 0 13 13

327320 Ready-Mix Concrete Mfg. 0 16 16

327390 Other Concrete Product Mfg. 0 1 1

327410 Lime Mfg. 0 3 3

327910 Abrasive Product Mfg. 0 1 1

327992 Ground or Treated Mineral and Earth Mfg. 0 1 1

327993 Mineral Wool Mfg. 0 2 2

327999 All Other Miscellaneous Nonmetallic Mineral Product Mfg. 1 2 3

331111 Iron and Steel Mills 0 19 19

331112 Electrometallurgical Ferroalloy Product Mfg. 0 3 3

331210 Iron and Steel Pipe and Tube Mfg. from Purchased Steel 0 2 2

331312 Primary Aluminum Production 0 13 13

331411 Primary Smelting and Refining of Copper 0 1 1

331421 Copper Rolling, Drawing, and Extruding 0 3 3

331422 Copper Wire (except Mechanical) Drawing 0 1 1

331511 Iron Foundries 0 2 2

332111 Iron and Steel Forging 0 1 1

332116 Metal Stamping 0 1 1

332211 Cutlery and Flatware (except Precious) Mfg. 0 3 3

332213 Saw Blade and Handsaw Mfg. 0 1 1

332312 Fabricated Structural Metal Mfg. 0 3 3

332323 Ornamental and Architectural Metal Work Mfg. 0 1 1

332439 Other Metal Container Mfg. 0 1 1

332510 Hardware Mfg. 0 1 1
A-6

Table A-2: Number of RY2007 PACs Reporters by Sector

NAICS NAICS Description Form A Form R Total 

Facilities

332611 Spring (Heavy Gauge) Mfg. 0 1 1

332618 Other Fabricated Wire Product Mfg. 1 0 1

332812 Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to 

Manufacturers 0 1 1

332919 Other Metal Valve and Pipe Fitting Mfg. 0 1 1

332991 Ball and Roller Bearing Mfg. 1 1 2

332994 Small Arms Mfg. 2 0 2

333120 Construction Machinery Mfg. 0 1 1

333220 Plastics and Rubber Industry Machinery Mfg. 0 1 1

333515 Cutting Tool and Machine Tool Accessory Mfg. 0 1 1

333516 Rolling Mill Machinery and Equipment Mfg. 0 1 1

333611 Turbine and Turbine Generator Set Units Mfg. 0 3 3

333618 Other Engine Equipment Mfg. 1 2 3

333994 Industrial Process Furnace and Oven Mfg. 0 1 1

334111 Electronic Computer Mfg. 0 2 2

334220 Radio and Television Broadcasting and Wireless Communications Equipment 

Mfg. 0 1 1

334412 Bare Printed Circuit Board Mfg. 0 2 2

334413 Semiconductor and Related Device Mfg. 0 4 4

334414 Electronic Capacitor Mfg. 0 1 1

334419 Other Electronic Component Mfg. 0 1 1

334511 Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and 

Instrument Mfg. 0 1 1

334513 Instruments and Related Products Mfg. for Measuring, Displaying, and Controlling 

Industrial Process Variables 0 2 2

334514 Totalizing Fluid Meter and Counting Device Mfg. 0 1 1

335311 Power, Distribution, and Specialty Transformer Mfg. 0 1 1

335313 Switchgear and Switchboard Apparatus Mfg. 0 1 1

335929 Other Communication and Energy Wire Mfg. 0 1 1

335931 Current-Carrying Wiring Device Mfg. 0 1 1

335932 Noncurrent-Carrying Wiring Device Mfg. 1 0 1

335991 Carbon and Graphite Product Mfg. 0 21 21

335999 All Other Miscellaneous Electrical Equipment and Component Mfg. 0 3 3

336111 Automobile Mfg. 0 10 10

336112 Light Truck and Utility Vehicle Mfg. 0 12 12

336211 Motor Vehicle Body Mfg. 0 1 1

336350 Motor Vehicle Transmission and Power Train Parts Mfg. 0 1 1

336370 Motor Vehicle Metal Stamping 0 1 1

336399 All Other Motor Vehicle Parts Mfg. 0 4 4

336411 Aircraft Mfg. 0 2 2

336412 Aircraft Engine and Engine Parts Mfg. 0 4 4

336413 Other Aircraft Parts and Auxiliary Equipment Mfg. 0 3 3

336415 Guided Missile and Space Vehicle Propulsion Unit and Propulsion Unit Parts Mfg. 0 2 2

336611 Ship Building and Repairing 0 2 2

336991 Motorcycle, Bicycle, and Parts Mfg. 0 1 1

339112 Surgical and Medical Instrument Mfg. 0 1 1

339113 Surgical Appliance and Supplies Mfg. 0 1 1

339115 Ophthalmic Goods Mfg. 0 1 1
A-7

Table A-2: Number of RY2007 PACs Reporters by Sector

NAICS NAICS Description Form A Form R Total 

Facilities

339911 Jewelry (except Costume) Mfg. 0 1 1

339912 Silverware and Hollowware Mfg. 0 1 1

339920 Sporting and Athletic Goods Mfg. 0 2 2

339932 Game, Toy, and Children's Vehicle Mfg. 0 1 1

339991 Gasket, Packing, and Sealing Device Mfg. 0 1 1

339999 All Other Miscellaneous Mfg. 0 3 3

424690 Other Chemical and Allied Products Merchant Wholesalers 0 2 2

424710 Petroleum Bulk Stations and Terminals 16 291 307

424720 Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations 

and Terminals) 0 1 1

447190 Other Gasoline Stations 0 1 1

493190 Other Warehousing and Storage 0 1 1

531312 Nonresidential Property Managers 0 1 1

541710 Research and Development in the Physical, Engineering, and Life Sciences 0 3 3

551114 Corporate, Subsidiary, and Regional Managing Offices 0 1 1

562112 Hazardous Waste Collection 0 71 71

562211 Hazardous Waste Treatment and Disposal 0 19 19

562212 Solid Waste Landfill 0 1 1

562213 Solid Waste Combustors and Incinerators 0 1 1

562219 Other Nonhazardous Waste Treatment and Disposal 0 1 1

562920 Materials Recovery Facilities 0 1 1

611310 Colleges, Universities, and Professional Schools 1 0 1

924110 Administration of Air and Water Resource and Solid Waste Management 

Programs 0 1 1

928110 National Security 0 4 4

Total 84 1,987 2,071
A-8

Literature Cited

International Agency for Research on Cancer, Diesel and Gasoline Engine Exhausts and Some Nitroarenes. 

Vol. 46. 1998.

Sigma-Aldrich. <www.sigmaaldrich.com>

TCI America. <www.tciamerica.com>

U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, 

Report on Carcinogens, Eleventh Edition. Substance Profiles: Nitroarenes. 

<http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s121nitr.pdf>

U.S. EPA, Guidance for Reporting Toxic Chemicals: Polycyclic Aromatic Compounds Category, 2001.

U.S. EPA, Toxics Release Inventory, 2007 Public Data Release. 
B-1

Appendix B – Chemical Descriptions and Methods for Chemicals with 

no Expected Reports

When the National Toxicology Program’s 11th Report on Carcinogens (RoC) was initially reviewed by 

EPA, 27 chemicals were identified for possible inclusion in TRI. The following 11 chemicals were 

estimated to not be manufactured, processed, or otherwise used above reporting threshold limits:

• 2,3-Dibromo-1-propanol (96-13-9)

• 4-Vinyl-1-Cyclohexene Diepoxide (117-10-2)

• Azacitidine (320-67-2)

• Chloramphenicol (56-75-7)

• Chlorozotocin (54749-90-5)

• Cyclosporin A (59865-13-3)

• Danthron (1,8-Dihydroxyanthraquinone) (117-10-2)

• Diazoaminobenzene (136-35-6)

• Disperse Blue 1 (2475-45-8)

• Tamoxifen (10540-29-1)

• Thiotepa (52-24-4)

Since no new forms would be expected if these chemicals were regulated under the proposed rule, they 

were not included in the total estimated incremental forms and facilities presented in Chapter 2. This 

appendix presents the methodology for determining that no incremental forms would be expected from 

these chemicals. Section B.1 presents the general methods used for estimating no reporting from these 

chemicals. Section B.2 presents background information and the application of the methods for each 

chemical. 

B.1 Methods Used to Estimate No Reporting 

To determine that no new reports are expected for these chemicals, a literature review was first conducted 

to identify the primary industrial applications of each chemical. Based on the uses of each chemical and 

other available information, one of the following methods was used to conclude that no reports are expected 

for that chemical under the proposed rule. The methods used were:

• Pharmaceutical Prescription and Dosage Method

• Production Volume Method

• Other Methods

These methods are described in detail in the sections that follow. 

B.1.1 Pharmaceutical Prescription and Dosage Method

Prescription and Dosage

Seven of the chemicals on the list of proposed chemicals identified for possible inclusion in TRI are used 

primarily as pharmaceuticals. Except where otherwise noted, the only use identified was in the 

pharmaceutical preparation manufacturing industry. The volume of each pharmaceutical manufactured and 

processed in the U.S. was estimated using information about its prescription and dosage. The annual 

amount of each chemical manufactured in the U.S. was estimated using the recommended dosage and the 

number of patients suffering from a disease for which that pharmaceutical can be prescribed during one 

year.

Where a pharmaceutical was used to treat more than one disease, this process was repeated for each disease 

and each amount was added to obtain the total amount manufactured and processed. Except where 
B-2

otherwise stated, it was assumed that uses in clinical trials would not contribute significantly to the overall 

volume of the pharmaceutical used based on the limited number of people taking part in those trials. 

Additionally, it was assumed that all patients in the U.S. are treated with the drug, even where other drugs 

were available, or not all patients were undergoing treatment, except where noted to the contrary. Because 

of these assumptions, the estimate provides an upper bound on the amount of the pharmaceutical that is 

produced and used. If the total volume obtained by this method was less than 25,000 pounds, it was 

assumed that the production volume in the U.S. is below TRI reporting thresholds and no reports are 

expected under the proposed rule. 

This method was used for the following chemicals:

• Azacitidine

• Chloramphenicol

• Chlorozotocin

• Cyclosporin A

• Danthron

• Tamoxifen

• Thiotepa

Potential Export of U.S.-Manufactured Pharmaceuticals

The Pharmaceutical Prescription and Dosage Method described above is based only on use of the 

pharmaceutical in the U.S. To estimate the total amount produced in the U.S. the following methods were 

used:

• For one chemical, the number of patients suffering from the disease treated by that pharmaceutical 

worldwide was known. In this case, the number of worldwide patients was used instead of the 

number of U.S. patients in the calculations above to determine a maximum production volume of 

that chemical. 

• One chemical is currently only used in clinical trials, and based on the production volume of the 

chemical estimated using the Pharmaceutical Prescription and Dosage Method, it was estimated that 

production volume for this chemical would not exceed TRI reporting thresholds, even if the 

chemical was also exported for trials outside the U.S. 

• Information from SRI’s website was available pertaining to the number and location of 

manufacturers worldwide for some of the chemicals. If a chemical was manufactured outside of the 

U.S., this information was used to support the estimate that total production volume is below TRI 

reporting thresholds. 

As shown in Table B-1, these methods were used for the following chemicals:

Table B-1: Methods Used to Estimate 

Potential Export of U.S.-Manufactured 

Pharmaceuticals

Method Chemicals Assessed

Assume Worldwide Treatment Azacitidine

Used in Clinical Trials Only Chlorozotocin

SRI

Azacitidine

Chloramphenicol

Cyclosporin A

Tamoxifen

Thiotepa

B.1.2 Production Volume Method

There are several chemicals whose primary use is in a product that has been discontinued due to regulatory 

bans or availability of information indicating carcinogenicity, or whose overall production volume has been 
B-3

declining. If available data indicate that the primary use of the chemical has been discontinued and/or no 

reports have been submitted to the TSCA IUR for that chemical in recent reporting cycles, it was assumed 

that no reports would be expected under the proposed rule.

As shown in Table B-2, these methods were used for the following chemicals:

Table B-2: Methods Used to Estimate Low 

U.S. Production Volume

Method Chemicals Assessed

Discontinued Products 

2,3-Dibromo-1-proponol

Danthron

Disperse Blue 1

TSCA IUR

2,3-Dibromo-1-propanol

4-Vinyl-1-cyclohexene diepoxide

Chloramphenicol

Danthron

B.1.3 Other Methods

National Pesticide Information Retrieval System

Three chemicals were identified as pesticides; however, no products containing those chemicals were found 

in EPA’s Pesticide Product Information System, so it was assumed that this use of the chemical would not 

exceed TRI reporting thresholds. 

This method was used for the following chemicals:

• 2,3-Dibromo-1-propanol

• Danthron

• Thiotepa

U.S. International Trade Commission Interactive Tariff and Trade DataWeb

For one chemical, information about imports was found using the United States Internal Trade Commission 

(USITC) Interactive Tariff and Trade DataWeb. No information was identified about U.S. manufacturers of

the chemical, so total amount imported was used in combination with the number of U.S. suppliers to 

conclude that no facility would manufacture, process, or otherwise use the chemical in excess of TRI 

reporting thresholds. 

This method was used for the following chemical:

• Diazoaminobenzene

B.2 Application of Estimation Methods by Chemical 

B.2.1 2,3-Dibromo-1-Propanol (96-13-9)

2,3-Dibromo-1-Propanol (DBP) exists as a colorless liquid that is soluble in water, alcohol, ether, benzene, 

and acetone. It is “reasonably anticipated to be a human carcinogen” based on sufficient evidence of 

malignant tumor formation from studies of experimental animals. It is used primarily for the production of 

flame retardants. It was mainly used to produce tris(2,3-dibromopropyl) phosphate, a flame retardant, until 

its use in the U.S. was discontinued in 1977. Currently, the only DBP derivative in production and use in 

the U.S. is tetrabromobisphenol A bis(2,3-dibromopropyl ether), which is used as a flame retardant additive 

for polyolefins and polymers in addition to other uses. Tetrabromobisphenol A bis(2,3-dibromopropyl 

ether) is made from the flame retardant tetrabromobisphenol A (TBBP-A), which is produced by the 

bromination of bisphenol A. Although tetrabromobisphenol A bis(2,3-dibromopropyl ether) has the same 

substructure as DBP, no information could be found showing that DBP is used to produce this flame 
B-4

retardant. DBP is also used as an intermediate during the production of some pesticides and 

pharmaceuticals.

2,3-Dibromo-1-Propanol Manufacturing, Processing, and Otherwise Use

DBP is used in the production of the following products: flame retardants, pesticides, and pharmaceuticals. 

It was assumed that DBP in pesticides would not trigger TRI reporting thresholds, as described in Section 

B.1.3. No information could be found on the use of DBP in pharmaceutical manufacturing; however, as the 

primary use of DBP was to produce the now discontinued tris(2,3-dibromopropyl) phosphate, and no 

reports have been filed with IUR since 1998 (when U.S. production volume was between 10,000 and 

500,000 lbs), it was assumed that current DBP production is below TRI reporting thresholds, as described in 

Section B.1.2. Based on this information, no DBP reports are expected under the proposed rule.

B.2.2 4-Vinyl-1-Cyclohexene Diepoxide (117-10-2)

4-Vinyl-1-cyclohexene diepoxide exists as a colorless or pale yellow liquid and is soluble in water. It is 

“reasonably anticipated to be a human carcinogen” based on sufficient evidence of carcinogenicity in 

experimental animals. It is produced from the epoxidation of 4-vinylcyclohexene. It is used as a chemical 

intermediate in condensation reactions for the production of polymers and during the production of plastics 

and resins. It is also used as a chemical intermediate in condensation reactions for the production of plastics, 

and as a diluent for resins and diepoxides, especially for epoxy resins derived from bisphenol A and 

epichlorohydrin as well as cycloaliphatic series epoxies.

4-Vinyl-1-Cyclohexene Diepoxide Manufacturing, Processing, and Otherwise Use

No information was identified on the quantities of 4-vinyl-1-cyclohexene diepoxide used in plastics, 

polymer, or resin manufacturing. It was assumed that current production and use of 4-vinyl-1-cylohexene 

diepoxide does not exceed 25,000 pounds at any one facility, as there have been no reports to IUR for the 

chemical since 1990, when production was between 10,000 and 500,000 lbs, as described in Section B.1.2. 

Therefore, no 4-vinyl-1cyclohexene diepoxide reports are expected under the proposed rule.

B.2.3 Azacitidine (320-67-2)

Azacitidine exists as a white crystalline powder. It is soluble in water, ethanol, acetone, chloroform, hexane, 

and dimethyl sulfoxide, and rapidly degrades in aqueous media. Azacitidine is “reasonably anticipated to 

be a human carcinogen” based on evidence of malignant tumor formation at multiple tissue sites in multiple 

species of experimental animals. It is a pharmaceutical used to treat myelodysplastic syndromes (MDS), a 

disorder in bone marrow production of blood cells that can develop into leukemia. MDS treatment options 

include chemotherapy, bone marrow transplants, supportive care, and drug therapy with azacitidine, 

decitabine, or lenalidomide. Vidaza, produced by Celgene, was approved by the U.S. Food & Drug 

Administration (FDA) in 2004 for the treatment of MDS. Vidaza is the only drug containing azacitidine that 

is FDA-approved for use in the U.S; however, azacitidine is also used in clinical trials for the treatment of 

other cancers. Celgene manufactures Vidaza at one plant in the United States and one plant in Germany.

Pharmaceutical Preparation Manufacturing

The volume of azacitidine produced and used in the U.S. was estimated using information about its 

prescription and dosage as described in the Pharmaceutical Prescription and Dosage Method described in 

Section B.1.1. The recommended dosage for using Vidaza to treat MDS is 75 mg/m2 taken daily for seven 

days on a four week cycle. However, the dosage may be increased to 100 mg/m2 after two cycles, so a 

conservative assumption of 100 mg/m2 was used. The minimum number of cycles is four to six; treatment 

can last as long as the patient continues to benefit. In this analysis, it was conservatively assumed that 

treatment continued for the entire year.

As described in the Potential Export of U.S.-Manufactured Pharmaceuticals Method, the total number of 

patients treated for MDS worldwide is known, therefore, this method estimates the worldwide consumption 

of azacitine. However, there are different options for MDS treatment available and Vidaza is manufactured
B-5

both in the U.S. and Europe. As a result, this method likely yields an over-estimate of the maximum 

production volume of azacitidine.

Table B-3: Azacitidine Use in MDS Treatment

Quantity

Dosage 100 mg/m2 1

Amount consumed by 1 patient over 1 year 17,290 mg 1,2

Number of patients to reach 25,000 lb threshold 657,238 patients

Number of diagnosed MDS patients worldwide 300,000 patients 3

Pounds of Azacitidine consumed 11,400 lb

1. Vidaza. 2008. Highlights of prescribing information. 

<http://www.vidaza.com/pdf/PI_FINAL.pdf>

2. MedicineNet, Inc. 2008. Definition of Body Surface Area. 

<http://www.medterms.com/script/main/art.asp?articlekey=39851>

3. Medical News Today. 2009. Vidaza® Demonstrates Unprecedented 

Overall Survival In Intermediate-2 and High-Risk Myelodysplastic 

Syndromes, Also Acute Myeloid Leukemia. 

<http://www.medicalnewstoday.com/articles/139483.php>

Based on the estimate shown in Table B-3, no azacitidine reports are expected under the proposed rule.

B.2.4 Chloramphenicol (56-75-7)

Chloramphenicol exists as white or grayish-white needles or elongated plates. It is soluble in water,

methanol, ethanol, butanol, ethyl acetate, and acetone. Chloramphenicol is “reasonably anticipated to be a 

human carcinogen” based on sufficient evidence of malignant tumor formation from studies of experimental 

animals. It is a pharmaceutical used as an antibiotic and antifungal. It can be taken orally as an antibiotic or 

topically in eye ointments that treat bacterial conjunctivitis. However, due to the health risks associated with 

using chloramphenicol, its use has declined and is only used to treat infections that are resistant to other 

antibiotics. It is also used in veterinary medicine, mainly for the treatment of dogs, cats, and horses. 

Chloramphenicol has been banned in the treatment of food-producing animals due its potential for 

deleterious health impacts on humans. There are currently three drugs containing chloramphenicol produced 

by two companies approved by the FDA for use in the United States. 

Pharmaceutical Preparation Manufacturing

The volume of chloramphenicol produced and used in the U.S. was estimated using the method described in 

the Pharmaceutical Prescription and Dosage Method described in Section B.1.1. However, for most of its 

uses chloramphenicol is rarely prescribed due to its health effects.

As an antibiotic, chloramphenicol is only prescribed when infections are resistant to other antibiotics or 

when it is not possible to use other antibiotics. The dosage is 25 to 100 mg/kg over a day taken every six 

hours for two to five days. As a conservative estimate, it was assumed that treatment lasted five days. Since 

chloramphenicol is prescribed when other medications are ineffective, it was conservatively assumed that 

chloramphenicol was used to treat all cases of multi-drug resistant infections. 

In eye ointments, chloramphenicol is used at a concentration of 10 mg per gram ointment. It was assumed 

that one container of eye ointment (3.5 g) comprised a treatment. The number of patients was estimated 

based on information about the number of emergency room visits and primary care visits related to eye 

infections, assuming that chloramphenicol was prescribed for each case. This assumption most likely results 

in a conservative estimate because not all eye infections are bacterial and drugs such as erythromycin and 

aminoglycosides are prescribed more often for their treatment compared to chloramphenicol.

In veterinary medicine, chloramphenicol is prescribed at dosages between 25 and 60 mg/kg every 8 hours 

for 3 to 5 days but no more than 10 days. As a conservative estimate, it was assumed that a treatment of 60 
B-6

mg/kg was administered 3 times a day for 5 days. Based on information about the most common disorders 

in dogs and cats, it was possible to establish an upper limit on the number of pets treated for infections for 

dogs, cats and horses. It was assumed that the number of other types of pets would be negligible. According 

to the available literature, there are “few primary indications for the use of chloramphenicol” in veterinary 

medicine, and it is not used often due to its negative health impacts on humans. Since no other information 

was identified concerning the frequency of chloramphenicol use in veterinary medicine, it was assumed that 

one percent of pet infections were treated with chloramphenicol.

Table B-4: Chloramphenicol Use in Medical Treatments

Antibiotic Eye Ointment

Veterinary 

Medicine:

Dogs

Veterinary 

Medicine:

Cats

Veterinary 

Medicine:

Horses

Dosage 100 mg/kg 1 10 mg /g ointment 4 60 mg/kg 10 20 mg/kg 10 60 mg/kg 10

Amount consumed by 1 

patient over 1 year 43,130 mg 1,2 35 mg 5 27,000 mg 10,11 2,043 mg 10,14 408,600 mg 10,15

Number of patients to 

reach 25,000 lb threshold 263,474 patients 324,675,324 patients 420,875 patients 8,343,345 patients 27,811 patients

Number of patients 94,360 patients 3 13,259,740

patients 6,7,8,9

31,730 patients 12,1340,860 patients 12,133,647 patients 12,13

Pounds of 

Chloramphenicol

consumed

9,000 lb 1,000 lb 1,900 lb 180 lb 3,300 lbs

1. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Report on Carcinogens, 

Eleventh Edition. Substance Profiles: Chloramphenicol. <http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s032chlo.pdf>

2. Centers for Disease Control and Prevention. 2002. Body Measurements. <http://www.cdc.gov/nchs/fastats/bodymeas.htm>

3. CDC Foundation. 2009. Superbugs: Protecting the Power of Antibiotics. 

<http://www.cdcfoundation.org/healththreats/AntibioticResistance.aspx>

4. U.S. Food and Drug Administration (FDA). FDA Approved Drug Products Database. 

<http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm>

5. Daily Med: Current Medication Information. 2006. Chloromycetin (chloramphenicol) Ointment. 

<http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2166>

6. Review of Optometry. 2009. Topical Antibiotics. <http://www.revoptom.com/drugguide/pdf/dg0609_TopicalAnti.pdf>

7. Silverman, Michael et al. 2009. Conjunctivitis. eMedicine from WebMD. <http://www.medscape.com/article/797874-overview>

8. State Health Facts. 2007. United States: Hospital Emergency Room Visits per 1,000 Population, 2007. 

<http://www.statehealthfacts.org/profileind.jsp?ind=388&cat=8&rgn=1>

9. MD Consult. 2007. Infective Conjunctivitis. <http://www.mdconsult.com/das/pdxmd/body/156197328-2/0?type=med&eid=9-u1.0-

_1_mt_5091409>

10. U.S. Pharmacopeial Convention. 2007. Chloramphenicol (Veterinary – Systemic). 

<http://www.usp.org/pdf/EN/veterinary/chloramphenicol.pdf>

11. Dog Health Care & Breed Information. Dog Food & Nutrition Diets 

<http://www.guideofdogs.com/html/dog_food_nutrition_and_diets.html> 

12. American Veterinary Medical Association. 2007. U.S. Pet Ownership – 2007. 

<http://www.avma.org/reference/marketstats/ownership.asp>

13. Bayer Health Care Animal Health. 2008. The State of Preventative Veterinary Care in America. 

<http://wschicago.com/BayerIPK/materials/StateofPreventiveVeterinaryReport.pdf>

14. Animal Planet. 2009. Frequently Asked Questions Regarding Obesity. 

<http://animal.discovery.com/guides/healthcenter/cats/nutrition/faqobesity.html>

15. Bailey’s Horse Feeds. Growth Monitoring Chart. 

<http://www.baileyshorsefeeds.co.uk/studareahome/growthproblems/growthmonitorchart.htm>

Thus, the combined amount of chloramphenicol used as an antibiotic, in eye ointments, and in veterinary 

medicine in the U.S. is 15,380 pounds (see Table B-4). Using the Potential Export of U.S.-Manufactured 

Pharmaceuticals Method, it was determined that chloramphenicol is also produced in India, Europe, East 

Asia, and China, so the combined domestic and international use of U.S.-manufactured chloramphenical is

not likely to trigger TRI reporting requirements. Additionally, following the Production Volume Method 

described in Section B.1.2, TSCA IUR information indicated that U.S. production of chloramphenicol was 

less than 10,000 lbs in 2002 and was not reported for 2006. Based on this estimate, no chloramphenicol 

reports are expected under the proposed rule.
B-7

B.2.5 Chlorozotocin (54749-90-5)

Chlorozotocin exists as ivory crystals that are water soluble. It is “reasonably anticipated to be a human 

carcinogen” based on sufficient evidence of carcinogenicity in experimental animals. It is a pharmaceutical 

used in chemotherapy treatments for stomach, intestinal, pancreatic, lung, melanoma, and multiple 

myeloma cancers. In the U.S., it is currently only being used in clinical trials; there are no FDA-approved 

drugs containing chlorozotocin currently on the market and it is not sold commercially. 

Pharmaceutical Preparation Manufacturing

The volume of chlorozotocin produced and used in the U.S. was estimated using the Pharmaceutical 

Prescription and Dosage Method described in Section B.1.1. Chlorozotocin is currently only being used in 

clinical trials. Although elsewhere it was assumed that clinical trials would not contribute significantly to 

the overall production volume of a chemical, because chlorozotocin is not currently approved for any uses 

by the FDA, it was conservatively assumed that all U.S. patients being treated for these cancers are being 

treated with chlorozotocin, based on typical dosing amounts. 

The number of cases was estimated using the number of new cases and deaths from each cancer type being 

treated with Chlorozotocin. This approach yields an overestimate since chlorozotocin is only being used for 

clinical trials so far fewer patients actually take the drug. In clinical trials, chlorozotocin dosages were 

between 100 and 250 mg/m2 given over five days at six week intervals. As a conservative estimate, the 

largest dosages in this range were used. Treatment was assumed to continue for the entire year.

Table B-5: Chlorozotocin Use in Clinical Trials

Quantity

Dosage 250 mg/m2 1,2,3,4

Amount consumed by 1 patient over 1 year 4,117 mg 1,2,3,4,5

Number of patients to reach 25,000 lb threshold 2,760,397 patients

Number of stomach, intestinal, pancreatic, lung, melanoma, and multiple myeloma patients 792,670 patients 6,7,8

Pounds of Chlorozotocin consumed 7,200 lb

1. Haas, Charles et al. 2004. Chlorozotocin: results in colorectal carcinoma treated with high and low doses. Investigational 

New Drugs: 2, 4, 401-404. <http://www.springerlink.com/content/k74011162x0729kr/>

2. Hoth, Daniel et al. 2006. A Phase II study of chlorozotocin in metastatic malignant melanoma. Cancer: 46, 7, 1544-1547. 

<http://www3.interscience.wiley.com/journal/112679366/abstract>

3. Presant, Cary et al. 2006. Phase II evaluation of chlorozotocin in metastatic sarcomas. Medical and Pediatric Oncology: 

12:1:25-27. <http://www3.interscience.wiley.com/journal/112724531/abstract>

4. Tayor, Sarah et al. 2006. Phase I evaluation of chlorozotocin: Single dose every six weeks. Cancer: 46:11:2365-2368. 

<http://www3.interscience.wiley.com/journal/112670660/abstract>

5. MedicineNet, Inc. 2008. Definition of Body Surface Area. 

<http://www.medterms.com/script/main/art.asp?articlekey=39851>

6. National Cancer Institute. 2009. Common Cancer Types <http://www.cancer.gov/cancertopics/commoncancers>

7. National Cancer Institute. 2009. Multiple Myeloma/Other Plasma Cell Neoplasms. 

<http://www.cancer.gov/cancertopics/types/myeloma>

8. National Cancer Institute. 2009. Stomach (Gastric) Cancer. <http://www.cancer.gov/cancertopics/types/stomach>

As shown in Table B-5, the total pounds of chlorozotocin estimated do not exceed TRI reporting thresholds. 

No information was located on international production and use of the drug, however, based on the upper 

bound of U.S. production calculated in Table B-5, it is unlikely that the use combined domestic and 

international use of U.S. manufactured chlorozotocin would trigger TRI reporting requirements, as 

described in the Potential Export of U.S.-Manufactured Pharmaceuticals Method. Therefore, no reports for 

chlorozotocin are expected under the proposed rule.

B.2.6 Cyclosporin A (59865-13-3)

Cyclosporin A exists as white prismatic needles that are slightly soluble in water and organic solvents. It is 

made up of eleven amino acids. Cyclosporin A is known to be a human carcinogen based on studies in 

humans indicating a causal relationship between exposure to cyclosporin A and cancer. It is primarily used 
B-8

as an immunosuppressant to prevent graft-versus-host in organ transplants. It is also used to treat psoriasias, 

rheumatoid arthritis, atopic dermatitis, nephritic syndrome, and Crohn’s disease. There are five drugs 

containing cyclosporin A from eleven companies that are FDA-approved for use in the U.S. 

Pharmaceutical Preparation Manufacturing

The volume of cyclosporin A produced and used in the U.S. was estimated following the Pharmaceutical 

Prescription and Dosage Method described in Section B.1.1. It was assumed that all patients remained on 

cyclosporin A for one full year except where otherwise noted. In cases where cyclosporin A is stated in the 

literature to be used “rarely” to treat a disease or used only to treat severe cases, and where no other 

information was available on the frequency of use, a range of 1% to 10% of patients was applied to estimate 

the pounds of cyclosporin A consumed.

For organ transplants, patients are first put on a high dosage of cyclosporin A (12 to 15 mg/kg daily) for up 

to two weeks following the transplant. For a conservative estimate, it was assumed that patients remained 

on cyclosporin A for two weeks following the transplant. Transplant patients then remain on a lower dosage 

(5 to 10 mg daily) long term – potentially for the rest of their life. The number of patients taking 

cyclosporin A following their transplant and one, two, and three years after the transplant is taken from U.S. 

Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients 

Annual Report on Transplantation Data. Note that the percentage of recipients taking cyclosporin A 

decreases for each subsequent year following the transplant.

The dosage of cyclosporin A for psoriasis and rheumatoid arthritis is 2.5 to 4 mg/kg taken daily over long 

periods of time. Cyclosporin A is one of the three most commonly prescribed medications for severe cases 

of psoriasis so it was assumed that one third of severe cases were treated with cyclosporin A. Similarly, 

cyclosporin A is only used to treat cases of rheumatoid arthritis that are aggressive or have complications. 

Therefore, it was assumed that between 1 and 10% of rheumatoid arthritis cases were treated with

cyclosporin A. 

The recommended dosage of cyclosporin A for the treatment of atopic dermatitis is 2.8 mg/kg daily for six 

months. According to the literature, cyclosporin A is only used in a “limited” capacity to treat severe cases 

of atopic dermatitis. Since no additional information was found on the frequency of use of cyclosporin A 

for this purpose, it was assumed that a range of 1 to 10% of cases of atopic dermatitis were treated with 

cyclosporin A in order to estimate the pounds of cyclosporin A consumed. 

The dosage of cyclosporin A given to nephritic syndrome patients is 3.5 to 5 mg/kg taken daily. Crohn’s 

disease patients take a dosage of 5 to 7.5 mg/kg daily for three months. However, for nephritic syndrome 

and Crohn’s disease, cyclosporin A is only prescribed as an “alternative treatment” for those that do not 

respond to other medications. Since no information was identified in the literature concerning how often 

cyclosporin A is used to treat these diseases, the range of 1 to 10% of patients was used to calculate the 

pounds of cyclosporin A consumed for both diseases.

Table B-6: Cyclosporin A Use in Medical Treatments

Organ 

Transplants

: High 

Dose

Organ 

Transplants: 

Low Dose

Psoriasis Rheumatoid 

Arthritis

Atopic 

Dermatitis

Nephrotic 

Syndrome

Crohn’s 

Disease

Dosage 15 mg/kg 1 10 mg/kg2 1 4 mg/kg 1 4 mg/kg 1 2.8 mg/kg 9 5 mg/kg 1 7.5 mg/kg 15

Amount 

consumed by 1 

patient over 1 

year

18,115 mg 1,2,3314,850 mg 1,2,3124,830 mg 1.2.5124,830 mg 1.2.8 43,958 mg 2,9 49,680 mg 1,2,1158,225 mg, 

2,15
B-9

Number of 

patients to reach 

25,000 lb 

threshold

627,320 

patients

36,092 

patients

91,032 

patients

91,032 

patients

258,510 

patients

228,736 

patients

195,165 

patients

Number of 

patients

3,384 

patients 4

12,523 

patients 4

25,000 

patients 6,7

13,000 – 

130,000 

patients 8

163,584 – 

1,635,841 

patients 10

482 – 4,816 

patients

12,13,14

213 – 2,128 

patients 13, 16

Pounds of 

Cyclosporin A

consumed

130 lb 8,670 lb 6,900 lb 3,570 –

35,700 lb

1,580 –

15,800 lb 50 - 500 lb 30 - 300 lb

1. Mayo Clinic. 2009. Cyclosporine (Oral Route, Intravenous Route). <http://www.mayoclinic.com/health/druginformation/DR601591>

2. Centers for Disease Control and Prevention. 2002. Body Measurements. <http://www.cdc.gov/nchs/fastats/bodymeas.htm>

3. Rx List. 2009. Sandimmune Drug Description. <http://www.rxlist.com/sandimmune-drug.htm>

4. U.S. Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients. 2006. 2006 

OPTN/SRTR Annual Report. <http://www.ustransplant.org/annual_Reports/archives/2006/default.htm>

5. American Osteopathic College of Dermatology. 2009. Cyclosporin. 

<http://www.aocd.org/skin/dermatologic_diseases/cyclosporin.html>

6. Rx List. 2008. New Psoriasis Drug Passes Hurdle. <http://www.rxlist.com/script/main/art.asp?articlekey=88935>

7. Organic Natural Health. 2009. Severe Psoriasis. <http://www.health-report.co.uk/psoriasis_severe.html>

8. Medicine Net. 2009. Rheumatoid Arthritis (RA). <http://www.medicinenet.com/rheumatoid_arthritis/article.htm>

9. Lee, SS. 2004. Cyclosporin in the Treatment of Severe Atopic Dermatitis: A Retrospective Study. Annals Academy of Medicine. 

<http://www.annals.edu.sg/pdf200405/V33N3p311.pdf>

10. Spagnola, Caroline C. 2008. Atopic Dermatitis. eMedicine WebMD. <http://emedicine.medscape.com/article/911574-overview>

11. McDowell, Margaret et al. 2005. Anthropomorphic Reference Data for Children and Adults: U.S. Population, 1999-2002. 

Advance Data From Vital and Health Statistics: 361. <http://www.cdc.gov/nchs/data/ad/ad361.pdf>

12. Journal of the American Society of Nephrology. 1994. Cyclosporine for Nephrotic Syndrome—Isn’t it Time for a Collaborative 

Trial? <http://jasn.asnjournals.org/cgi/reprint/5/4/1047.pdf>

13. U.S. Census Bureau. 2001. Age: 2000. <http://www.census.gov/prod/2001pubs/c2kbr01-12.pdf>

14. Nephrology Channel. 2009. Nephrotic Syndrome (NS). <http://www.nephrologychannel.com/nephrotic/index.shtml>

15. Brynskov, J et al. 1988. Low-dose Cyclosporin for Crohn’s Disease: implications for clinical trials. Alimentary Pharmacology & 

Therapeutics: 3, 2, 135-142. <http://www3.interscience.wiley.com/journal/119440388/abstract>

16. eMedicine Health. 2009. Crohn Disease. <http://www.emedicinehealth.com/crohn_disease/article_em.htm>

Thus, the combined amount of cyclosporin A used in the treatment of organ transplants, rheumatoid 

arthritis, psoriasis, atopic dermatitis, nephritic syndrome, and Crohn’s disease is between 20,900 and 68,000 

pounds (see Table B-6). 

Eleven companies are FDA approved to make pharmaceuticals containing cyclosporin A in the United 

States. Based on the complexity of pharmaceutical manufacturing processes, it was assumed that each 

company would manufacture all their cyclosporin A at the same facility. If all eleven companies comprise 

equal shares of the market, then no more than 1,900 to 6,181 pounds of cyclosporin A would be 

manufactured at one facility. If one company comprises a larger share of the market and if the maximum 

end of the range is taken it is possible for more than 25,000 pounds of cyclosporin A to be manufactured or 

processed at one facility. However, given that there are eleven companies that are approved to make 

pharmaceuticals containing cyclosporin A and that the estimated amount of cyclosporin A manufactured 

annually is between 20,900 and 68,000 pounds, with 68,000 pounds serving as a conservative maximum 

estimate, it was assumed that no single plant is manufacturing cyclosporin A above the 25,000 pound 

threshold, based on best professional judgment.

Producers of cyclosporin A were identified in Europe, India, and East Asia using the Potential Export of 

U.S.-Manufactured Pharmaceuticals Method. Therefore, the combined domestic and international use of 

U.S.-manufactured cyclosporin A is unlikely to trigger TRI reporting requirements and no cyclosporin A 

reports are expected under the proposed rule. 

B.2.7 Danthron (1,8-Dihydroxyanthraquinone) (117-10-2)

Danthron exists as orange needles or leaves. It is almost insoluble in water but is soluble in acetone, 

chloroform, diethyl ether, and ethanol. Danthron is “reasonably anticipated to be a human carcinogen” 

based on sufficient evidence of malignant tumor formation in multiple species of experimental animals. 

Danthron was widely used in laxatives until 1987, when the FDA ordered pharmaceutical producers to 
B-10

remove these products from the market. It is still being used in some experimental antitumor treatments. 

Danthron is currently used as an antioxidant in synthetic lubricants. It is sometimes, but not widely, used as 

an intermediate during dye production. Danthron is also sometimes used as a component of fungicides, 

especially ones that are used to control powdery mildew. 

Manufacturing, Processing, and Otherwise Use of Danthron

Danthron is used as a dye intermediate, component of lubricants and pesticides, and in experimental 

antitumor treatments. The primary use of danthron was in laxatives until 1987, when these products were 

withdrawn from the market. No information was found on the use of danthron in lubricants or as a dye 

intermediate; however information from the National Toxicology Program (NTP) indicates that danthron is 

not widely used in dye production. Following the National Pesticide Information Retrieval System Method 

described in Section B.1.3, it was assumed that use in pesticide production is below TRI reporting 

thresholds. Based on the Pharmaceutical Prescription and Dosage Method described in Section B.1.1, it was 

assumed that because experimental treatments are only used to treat a limited number of patients, the use of 

danthron for this purpose is unlikely to exceed TRI reporting levels. Following the Production Volume 

Method described in Section B.1.2, it was found that no production volumes of danthron have been listed in 

IUR updates since 1986, when production volume was 10,000 to 500,000 lbs. Since it is assumed that the 

U.S. production volume of danthron fell below 10,000 pounds following 1987, when its use in laxatives 

was discontinued, no danthron reports are expected under the proposed rule. 

B.2.8 Diazoaminobenzene (136-35-6)

Diazoaminobenzene (DAAB) exists as yellow crystals or an orange solid that is insoluble in water. It is 

“reasonably anticipated to be a human carcinogen” based on evidence from studies in animals and with 

human tissue demonstrating that DAAB is metabolized to benzene, a known human carcinogen, and on 

evidence that DAAB causes genetic damage. DAAB is used as an intermediate during dye, pesticide, and 

other agricultural chemical production. DAAB has been detected at low levels in D&C Red No. 33 dye 

(with a maximum concentration of 125 ppb), FD&C Yellow No. 5 dye, and FD&C Yellow No. 6 dye (with 

a maximum concentration of 40 ppb), which are used to color food, cosmetics, and drugs. It is used during 

the manufacture of some pharmaceuticals and has been found as a low-level contaminant in some dyes that 

are used with these drugs. 

DAAB is also used as a chemical intermediate, metal complexing agent, and polymer additive during 

various organic chemical manufacturing processes. It is used to help the adhesion between natural rubber 

and steel and as a blowing agent in resins, urea-formaldehyde adhesives, and polyurethane coatings. It is 

also used as a dopant during the laser ablation of polymethylacrylate.

Diazoaminobenzene Manufacturing, Processing, and Otherwise Use

No information was identified on DAAB manufacturing operations in the U.S. or on quantities of DAAB 

used during the manufacturing of dyes, pesticides, pharmaceuticals, or other organic chemicals. Following 

the U.S. International Trade Commission Interactive Tariff and Trade DataWeb Method described in 

Section B.1.3, the 2008 combined imports of diazoaminobenzene and p-aminoazobenzenedisulfonic acid 

were 25,000 kg (55,000 pounds). Based on the number of uses for this chemical and the fact that there were 

seven U.S. suppliers in 2001, it is unlikely that any one facility would be manufacturing or processing more 

than 25,000 pounds, or otherwise using more than 10,000 pounds of DAAB. Therefore, no DAAB reports 

are expected under the proposed rule. 

B.2.9 Disperse Blue 1 (2475-45-8)

Disperse Blue 1 is an anthraquinone dye that exists as a blue or black microcrystalline powder. It is soluble 

in acetone and ethanol and is only slightly soluble in water. Disperse blue 1 is “reasonably anticipated to be 

a human carcinogen” based on evidence of malignant tumor formation in experimental animals to an 

unusual degree with regard to incidence, site, and type of tumor. It is an anthraquinone dye that is used to 

dye fabrics such as polyester, nylon, cellulose acetate, and other materials such as furs, sheepskins, and 
B-11

synthetic and acrylate fibers. It is used in hair dyes (at concentrations less than one percent). In 1984, 

approximately 3 million people in the U.S. used hair dyes containing disperse blue 1. Disperse blue 1 was 

also used in Crest Rejuvenated Effects Fluoride Anti-Cavity Toothpaste and Clairol Loving Care Color 

Mousse, now discontinued products.

Disperse Blue 1 Manufacturing, Processing, and Otherwise Use

There are currently no manufacturers of disperse blue 1 in the United States. In 1998, disperse blue 1 was 

added to the National Toxicology Program’s Eighth Report on Carcinogens as being reasonably anticipated 

to be a human carcinogen. It was assumed that overall use of disperse blue 1 declined following its listing 

because it is used in personal care products: two personal care products containing disperse blue 1 were 

discontinued following its listing as a carcinogen. No information on U.S. manufacturing or processing of 

disperse blue 1 was available after 1984, when 13,756 pounds were imported. Following the Production 

Volume Method described in Section B.1.2, it was assumed that no facility in the U.S. is currently 

manufacturing or processing disperse blue 1 at levels above 25,000 pounds and therefore no disperse blue 1 

reports are expected under the proposed rule. 

B.2.10 Tamoxifen (10540-29-1)

Tamoxifen is a white odorless crystal and is soluble in water. Tamoxifen is “known to be a human 

carcinogen” based on sufficient evidence of carcinogenicity in humans that indicates a causal relationship 

between exposure to tamoxifen and cancers of the uterus. Tamoxifen is a pharmaceutical primarily used for 

breast cancer prevention and treatment. In addition to being used as a breast cancer medication, women 

with a high risk of developing breast cancer take the drug as a preventative measure. However, currently the 

use of tamoxifen is declining in favor of aromatose inhibitors, which are stronger antiestrogens. It is used as 

an infertility drug when the more widely used Clomid is not effective. Tamoxifen is also used in the 

treatment of gynecomastia, is being studied for treatment of bipolar disorder, and is used in the research of 

genetically modified animals. There are currently five companies with FDA-approved drugs containing 

tamoxifen in the form of tamoxifen citrate on the market in the U.S. 

Pharmaceutical Preparation Manufacturing

The volume of tamoxifen produced and used in the U.S. was estimated following the Pharmaceutical 

Prescription and Dosage Method described in Section B.1.1. Since tamoxifen as a treatment for bipolar 

disorder and for genetically modified animals is currently only being used for research, it was assumed that 

this would not contribute significantly to the consumption of tamoxifen. 

The number of women taking tamoxifen in the U.S. for breast cancer prevention and treatment is 

approximately 500,000. The recommended dosage is 10 or 20 mg daily for five years. As a conservative 

estimate, the 20 mg/day dosage was used. 

Tamoxifen is used to treat infertility in cases where the more popular drug Clomid is not effective. Since the 

majority of infertility cases are treated with Clomid, it was conservatively assumed that 50 percent of 

women seeking fertility treatment were treated with tamoxifen. Women taking tamoxifen for infertility take 

tamoxifen for five days during their menstrual cycle, starting at dosages of 20 mg a day, which can be 

increased to 40 and then 80 mg a day. Based on typical tamoxifen dosing practices for infertility treatments, 

it was assumed that treatment lasted for an entire year and that the first and second month dosages were 20 

and 40 mg, respectively, followed by 80 mg dosages for each successive month.

Gynecomastia occurs in 40% of the male population; however in most cases it is resolved by addressing the 

underlying source of the condition (e.g. discontinuing medications or weight gain) rather than by treating 

the gynecomastia itself. For those cases that are treated, the most common treatments are clomiphine, 

tamoxifen, testosterone replacement therapy, and surgery. For this estimate, it was assumed that only 1% of 

gynecomastia cases are treated since, in most cases, it resolves on its own. Since there are other treatments 

for gynecomastia in addition to tamoxifen, it was conservatively assumed that half of the treated cases were 
B-12

treated with tamoxifen. The dosage of tamoxifen is 10 to 20 mg taken twice daily for three months. The 

dosage of 20 mg taken twice a day was used in this estimate. 

Table B-7: Tamoxifen Use in Medical Treatments

Breast Cancer 

Treatment and 

Prevention

Infertility 

Treatment

Gynecomastia 

treatment

Dosage 20 mg1,2 20, 40, 80 mg 5 20 mg 7

Amount consumed by 1 patient over 1 year 7,300 mg1,2,3 4,300 mg 5 3,600 mg 7

Number of patients to reach 25,000 lb threshold 1,556,662 patients 2,642,706 patients 3,156,565 patients

Number of patients taking tamoxifen 500,000 patients4 1,000,000 patients 6 275,832 patients 8

Pounds of Tamoxifen consumed 8,000 lbs 9,500 lbs 2,200 lbs

1. American Cancer Society. 1999. Tamoxifen Dosage Studied. 

<http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Tamoxifen_Dosage_Studied.asp>

2. Teva. 2003. Teva Announces Final Approval of Tamoxifen Citrate Tablets. 

<http://www.tevapharm.com/pr/2003/pr_379.asp>

3. National Cancer Institute. 2008. Tamoxifen: Questions and Answers. 

<http://www.cancer.gov/cancertopics/factsheet/therapy/tamoxifen>

4. Medco Health Solutions, Inc. 2009. Popular Breast Cancer Drug Used with Certain Antidepressants Puts New Jersey 

Women at Risk. <http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/07-30-

2009/0005069136&EDATE=>

5. International Programme on Chemical Safety (INCHEM). 1994. Tamoxifen Citrate. 

<http://www.inchem.org/documents/pims/pharm/tamoxife.htm#PartTitle:4. USES>

6. Fertility Today. 2009. Fertility, infertility. <http://www.fertilitytoday.org/infertility.html>

7. Allee, Mark R. Gynecomastia: Treatment & Medication. eMedicine WebMD. 

<http://emedicine.medscape.com/article/120858-treatment>

8. U.S. Census Bureau. 2000. Census Special Reports: We the People: Men and Women in the United States. 

<http://www.census.gov/prod/2005pubs/censr-20.pdf>

Based on the results of this estimation, as shown in Table B-7, the combined amount of tamoxifen used in 

the treatment of breast cancer, infertility, and gynecomastia is 19,700 lbs. Using the method described in the 

Potential Export of U.S.-Manufactured Pharmaceuticals Method, one tamoxifen producer in Europe was 

identified. Additionally, in 1995 worldwide production of tamoxifen was 22,700 lbs, so it is unlikely that a 

single U.S. producer could be making more than 25,000 lbs of tamoxifen. Therefore, no tamoxifen reports 

are expected under the proposed rule.

B.2.11 Thiotepa (52-24-4)

Thiotepa exists as odorless white crystals or crystalline flakes. It is an alkylating agent that is soluble in 

water, ethanol, diethyl ether, benzene, and chloroform. Thiotepa is “known to be a human carcinogen” 

based on sufficient evidence from studies in humans that indicate a causal relationship between exposure to 

thiotepa and human cancer. It is a pharmaceutical used in chemotherapy to treat breast cancer, ovarian 

cancer, bladder cancer, Hodgkin lymphoma, non-Hodgkin Lymphoma, pleural effusion, and pericardial 

effusion. There is one FDA-approved drug containing thiotepa marketed by two companies currently 

available in the U.S. While thiotepa can also function as an insect chemosterilant in pesticides and as a 

flame retardant, due to its negative health affects it is not used in these industries. 

Pharmaceutical Preparation Manufacturing

Although thiotepa is identified as a component of pesticides, the National Pesticide Information Retrieval 

System Method described in Section B.1.3 failed to identify any pesticide products containing the chemical. 

The volume of thiotepa produced and used in the U.S. was estimated using following the Pharmaceutical 

Prescription and Dosage Method described in Section B.1.1. 

Thiotepa is given in a high dose of 500 to 900 mg/m2 prior to bone marrow transplants. A dosage of 900 

mg/m2 was used as a conservative estimate. Dosage was used in combination with the number of bone 

marrow transplants in a year, conservatively assuming that all bone marrow transplant recipients in the U.S. 

received thiotepa.
B-13

For breast cancer and ovarian cancer, the dosage of thiotepa is 0.4 mg/kg given once every one to four 

weeks. As a conservative estimate, it was assumed that doses were given every week. Similarly, for bladder 

cancer the recommended dosage is 60 mg once every four weeks. Since no information regarding specific 

dosage for Hodgkin and non-Hodgkin Lymphoma could be found, the general recommended dosage for 

thiotepa was used: 30-60 mg/m2 every week. It was estimated that a dosage of 60 mg/m2 was administered 

weekly. For all of these diseases, it was assumed that all cases were treated with thiotepa, and that treatment 

continued at the recommended dosage for one full year. The number of cases was obtained by adding the 

number of new cases and number of deaths from each disease in a year. Note that although thiotepa is rarely 

used to treat bladder cancer, for the purposes of this estimate it was assumed that all cases were treated with 

thiotepa. 

The dosage of thiotepa used to treat pleural effusions is 0.6-0.9 mg/kg given as often as one to two times a 

week. As a conservative estimate, it was assumed that 0.8 mg/kg was given weekly for one full year, and 

that all patients of pleural effusion were treated with thiotepa. Thiotepa treatment for pericardial effusion is 

only being used in clinical trials, so it was assumed that uses from this treatment would not produce a 

significant amount of thiotepa.

Table B-8: Thiotepa Use in Medical Treatments

Bone 

Marrow 

Transplants

Breast 

Cancer

Ovarian 

Cancer

Bladder 

Cancer

Hodgkin 

Lymphoma

NonHodgkin 

Lymphoma

Pleural 

Effusion

Dosage 900 mg/m2 1 0.4 mg/kg 4 0.4 mg/kg 4 60 mg 4 60 mg/m2 1 60 mg/m2 1 0.8 mg/kg 9

Amount 

consumed by 1 

patient over 1 

year

1,710 mg 1,2 1,538 mg 4,5 1,538 mg 4,5 780 mg 4 5,928 mg 1,2 5,928 mg 1,2 717 mg 2,5

Number of 

patients to reach 

25,000 lb 

threshold

6,645,401 

patients

7,387,152 

patients

7,387,152 

patients

14,568,764 

patients

1,916,942 

patients

1,916,942 

patients

15,833,777 

patients

Number of 

patients

7,500 

patients 3

232,540 

patients 6

36,150 

patients 7

85,280 

patients 6

9,800 

patients 8

85,480 

patients 6

1,300,000 

patients 10

Pounds of 

Thiotepa 

consumed

30 lb 800 lb 120 lb 150 lb 130 lb 1,100 lb 2,000 lb

1. University of Maryland Medical Center. 2009. Thiotepa. <http://www.umm.edu/altmed/drugs/thiotepa-124400.htm>

2. MedicineNet, Inc. 2008. Definition of Body Surface Area. <http://www.medterms.com/script/main/art.asp?articlekey=39851>

3. Columbia Presbyterian Medical Center. Bone Marrow Transplant. 

<http://cpmcnet.columbia.edu/dept/medicine/bonemarrow/bmtinfo.html>

4. Gale Encyclopedia of Cancer. 2002. Thiotepa. <http://www.encyclopedia.com/doc/1G2-3405200442.html>

5. Centers for Disease Control and Prevention. 2002. Body Measurements. <http://www.cdc.gov/nchs/fastats/bodymeas.htm>

6. National Cancer Institute. 2009. Common Cancer Types <http://www.cancer.gov/cancertopics/commoncancers>

7. National Cancer Institute. 2009. Ovarian Cancer. <http://www.cancer.gov/cancertopics/types/ovarian>

8. National Cancer Institute. 2009. Hodgkin Lymphoma. <http://www.cancer.gov/cancertopics/types/hodgkin>

9. MIMS USA. 2009. Thiotepa. <http://www.mims.com/Page.aspx?menuid=mng&name=thiotepa&brief=false#Dosage>

10. Abrahamian, Frederick Melik. 2008. Pleural Effusion. eMedicine from WebMD. <http://emedicine.medscape.com/article/807375-

overview>

Based on the results of this estimation, as shown in Table B-8, the combined amount of thiotepa used in the 

treatment of bone marrow transplants, breast cancer, ovarian cancer, bladder cancer, Hodgkin lymphoma, 

non-Hodgkin lymphoma, and pleural effusion is estimated to be 4,330 pounds. The method described in the 

Potential Export of U.S.-Manufactured Pharmaceuticals Method was used to identify one producer of 

thiotepa in East Asia. Based on the amounts of thiotepa consumed in the United States, it is unlikely that 

combined domestic and international consumption of U.S.-manufactured thiotepa would lead to any TRI 

reports. Therefore, no thiotepa reports are expected under the proposed rule. 
B-14

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2,3-Dibromo-1-Propanol (96-13-9)

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4-Vinyl-1-Cyclohexene Diepoxide (117-10-2)

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B-15

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Azacitidine (320-67-2)

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Chloramphenicol (56-75-7)

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B-16

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B-17

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Cyclosporin A (59865-13-3)

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B-18

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B-19

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Disperse Blue 1 (2475-45-8)

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