# 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 Agen cy



## February 16 , 20 1 0

### 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 Cost s 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 America n Industry Classification System (NAICS) Rule

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

- 4 1.2 Chemicals for Addition to TRI

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

- 4 1.2.1 NTP Cancer Classifications and Cri teria

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

- 5 1.2.2 RoC Review Process

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

- 6 1.2.3 EPA Review of the 11 th RoC

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

- 6 1.3 Organization of This Report

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

- 8 Chapter 2

– Estimates of the Number of Additional Forms and Affected Facilities 2 - 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 E stimation 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

### ii 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

- Di nitropyrene 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

- 1 3

- 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 (598 65

- 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

### iii 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

### iv 

## 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 t o 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 Process ing Cost by Media Type

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

- 9 Table 3

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

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

- 9 Tabl e 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 T able 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: T hiotepa Use in Medical Treatments

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

- 13

### v 

## 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 faci lities 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 other wise used above certain threshold amounts. This information is included in a publicly available database known as the Toxics Release Inventory (TRI).

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

se ction 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 11 th 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 vin yl 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 a re 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.

### vi 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 Inorga nic 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 O ther 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 Wa ste 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:

### vii • Rule Familiarization: Facilities tha t 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 ly applicable EPCRA reporting requirements.

• Report Completion: Facilities must gather data and perform calculatio ns 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 the ir 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 r eport

- or facility

- specific, total costs fo r 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 comp onents: 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 estimate s 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 t otal industry costs

. Step 1: Identify and describe the tasks that potentially affecte d 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. Estima te 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 subseq uent 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 (for m

- 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 C ost 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 EP A 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 F orm Rs Form Processing Cost Per Form ( $ ) Processing Cost ($) Paper 6 $ 2 5.75 $ 152 Mag Media 18 $ 6.50 $ 114

CDX 34 $ 3.12 $ 106

TRIMEweb 129 $ 3.12 $ 401 TOTAL 186 $ 773 Note: Processing cost total s may not equal the product of the rows due to rounding.

### ix 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 Sma ll E ntity A nalysis

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 a dverse 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 regul ation are likely to be minimal.

Cost impact percentages are calculated for the incremental compliance costs incu rred during first and subsequent year s 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 a nd submission costs. In subsequent years, the incurred compliance cost will consist of calculations and report completion, and recordkeeping and submission costs only.

Th is 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 affec ted f acilities in each industry sector that may file these reports under the proposed rule 2 ;
2. Estimate the num ber 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 facilitie s” 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 the y 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 impa cts 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 0.00 1 %. 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 le ss than 0.00 1 % each affecting one small business. The mean and median impacts for the subsequent years are estimated to be less than 0.0 5 % and 0.0 3 % respectively

.

Table ES

- 6 : Summary of Impacts on Small Entities

Estimated Number of Affected Entities Es timated Number of Affected Small Entities Estimated Number of S mall Entities with Impacts of 3% or Greater Estimated Number of Small Entiti es with Impacts Between 1 and 3% Estimated Number of Small En tities 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 p rovision 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 vo luntary 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 gr oups 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 dat a 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 be havioral 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 o f 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). M oreover, a cursory search on GoogleScholar TM 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 Anal ysis

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 manufacture rs, 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, rec ycling, 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 thr esholds 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 econ omic impacts of a proposed rule that requires reporting for the se 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 th e 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 accid ental 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 th e 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 p rogram 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 EP CRA 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, whi ch 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 I ndustrial 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 th e 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, pro cessed, 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). Ov er 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 th e 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 po llution 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 so urce 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 informatio n 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 Che micals 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 pr ovision 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 • Adv erse 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 dy sfunctions, 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 iden tified 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 sect ion 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 Adm inistrative 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 tha t 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 beginnin g 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 utilitie s,

• 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 co mbined 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 low ered 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 add ed 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 m ade 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 p ounds 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 th ose 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 N orth 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 ca rcinogenic chemicals identified by the National Toxicology Program (NTP). 3 The chemicals addressed by this rulemaking are all listed in the NTP’s 11 th Report on Carcinogens (RoC). Table 1

- 1 lists the chemicals that will be added u nder 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 (D HHS) 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 Vin yl 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 con cern 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 id entifies 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), gen otoxicity (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 anticip ated to be a human carcinogen.” The criteria that the NTP uses to list an agent, substance, mixture, or exposure circums tance 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, a nd 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 conf ounding 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 t he 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 clini cal 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 anticip ated 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 scie ntific judgment with consideration giv en to all relevant information. Relevant information includes, but is not limited to, dose response, route of exposure, chemical structure, metabolism, pharmacokinetics, sensitive sub

populations , 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 agen t 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 “Reaso nably 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 Proces s 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 f or public comment. For the 11 th 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 nominati ons 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) . Dur ing 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 inf ormation 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 reco mmendations 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 R eview of the 11 th 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 comp ounds (PACs) category.

6 U.S. EPA Risk Assessment Forum. 2005. Guid elines 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 listin g in this rule . Given the extensive scientific reviews conducted by the NTP for their RoC documents, EPA’s review focused on en suring 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 threshold s are not covered in the propo sed rule. Analyses performed to make these determinations are presented in Appendix B. The methodology used to determin e 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

- Propan ol 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

- N itrochrysene 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 th is 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 c hemicals 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, s tandard reporting thresholds (25,000 pounds for manufacturing and processing, 10,000 poun ds 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

c hemicals 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 follow s:


### 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 a s well as the results of the analysis in terms of total cost to industry and total cost to E PA. 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 propo sed 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 abov e 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 listin g in this proposed rule as well as the number of affec ted 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)

• Gly cidol (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 . The y 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 tha t 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 on e Form for one or more of the chemical s proposed for listin g 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 Us ed 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 ind ustrial 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 t he 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 thresho ld of 10 full

- time equivalents if they exceed manufacturing, processing, or otherwise use thresholds.

Additional assumptions were made for each estimation m ethod . 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 f acilities that manufactur e , process, or otherwise us e a proposed chemical were a vailable. From these facility lists, a ctual 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 f acilities were not a vailable , 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 wa s 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 RY200 2.

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 predi ct 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 f acilities that produce the proposed chemicals that would be expected to be report ed under the proposed rule.

Literature Review During the literature review to identify industrial applications for each proposed chemical, evidence showing that a proposed che mical 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 chemic als 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 t he 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
repo rt 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 sit e 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 facilit y w as listed as having annual production or capacity for th e 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 facilit y was identified as a manufacturer of the chemical, but had no produ ction 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 esti mates, 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 Tetrafluoroethyl ene X x x x
Tetranitromethane x Vinyl Fluoride X

a Refers to SRI’s 2009 Directory of Chemical Producers

. Facilities identified using th is method are actual facilities.

2.1.3 Identification of Faci lities Processing the Chemical d uring 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.

Toxic s Release Inventory (TRI) One proposed chemical, o

- nitroanisole, is p rocessed 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. Details and assumptions for this method can be found in Section 2.2.

Facili ties identified using th is 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 man ufacture 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 tim e 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 am ount 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 che mical 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 corre spond 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 a nnual 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 t o 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 Use d 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

, exce pt for furan processed during resin production , where SRI’s Chemical Economics Handbook, Furfuryl Alcohol and Furan Resins (2008) w as used.

Facilities identified using this method are actual facilities.

### 2

- 6 2.1.4 Identification of Facilities Manufacturing, Proces sing, 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 c ommon 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, pro cess, 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 pe sticides 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 c an 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, facil ities 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 u nder 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 threshold s. 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 an d 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)

• Tetr anitromethane (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.

T he 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 t he 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 o therwise 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 ch emical 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 us e 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 propose d 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 poss ible 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

c hemicals because industrial prevalence for chemical s 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, facili ties 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 sam e 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 numb er of facilities reporting each p roposed chemical to RMP, it was used as the estimate of TRI reporters

### 2

- 8 for the p roposed chemical in the sector. Otherwise, the number of facilities reporting each p roposed chemical to RMP was used as the estimate for the se ctor.

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 faci lities 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 che mical 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 on ly 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 assum ptions 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 wh ere 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 wo uld 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 Manufa cturing)

• 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 rev iew, 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 lit erature 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 p er 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 numbe r 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 producin g 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 (Perf umes and Toiletry Production)

Facilities identified using this method are modeled facilities.

Literature Review and Toxic s Release Inventory A combination of literature review results and TRI were used to identify facilities which process tetranitrometha ne 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 chem ical 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. Spe cifically:

• 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 ha zardous 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

c hemicals 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 chemic als 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 p rocess 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 manufac ture 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 S tates , 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. Facili ties 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 ma nufacturing , 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 ident ified 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 che micals. 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 TSC A 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 identi fied 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 pr oposed 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 associat ed 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 Prod ucers, 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 w eight 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 vo lumes 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 fi lers 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 availabl e 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 a lso 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 Unit ed 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 e stimated: 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 t he 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 estim ate, 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 anthr aquinone 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 kilogr ams (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 subsequent ly 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 productio n 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 numbe r 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 employ ees 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 tha t 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 fr om 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 form ation 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 pro pellants 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 Inform ation, 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 Inform ation, 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 th e 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 tetrafluo r o ethylene 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 list ed 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 manu factured. Thus, if a facility manufactures more than 25,000 pounds of polytetrafluorethylene, it likely process es 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 whi ch 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 chemica ls), 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)

G lycidol 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 use d 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 interm ediate in the production of pharmaceuticals, cosmetics, glycerin, and surfactants, and can also be used for sterilizing milk of magnesia.

Glycidol Production
F acilities that manufacture glycidol were identified using the TSCA 2006 Inventory Update Reporti ng 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 Reporti ng 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 producti on 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 availabl e information. Th us, th e total counts of forms for glycidol presented are likely underestimates.

It should be noted that s ome information on production of glycidol is available through the TSCA 2006 Inventory Update Reporting Non

- Confidential Business Info rmation; 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, a ssuming 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 y ellow 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 us ed 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 at tractant 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 W orld 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 n eed 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 companie s 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 enforceme nt 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 th e 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 f acility 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 bel ow TRI reporting threshold s 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 f irst

- 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 fo od 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 g ingersnaps. 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 servi ng, 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 ti me 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 nee d 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 hig hest 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 th e 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 eu genol, 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 carcin ogen” 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 ma nufacture 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 Wor ld 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

m anufacturing 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 c ould not be determined with available information. Th us, th e 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 punge nt 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. W hen 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 manuf actures 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 i t 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 containin g 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 Sec tion 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 u sed 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 technol ogy 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 pro posed 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

conc entration 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, i t 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 m anufacturing 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
Re search 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, n o TRI forms are expected from use of tetranitorme thane 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 for ms 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

ex pected 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 i dentified 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)

Nitr omethane 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

- microbi als. 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 manic uring 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 Produ ction 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 2 006 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 manu facturers 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 U se 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 c ould not be determined with available in formation. Th us, th e 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. produc tion 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 u sing 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 wi ll be used at facilities i n 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 overesti mate of forms. If 1,200 forms had been received for one chemical in RY2008, the chemical would be ranked as the 28 th most frequently reported chemical, with more forms than for much more common industrial chemicals such as sulfuric acid, chlorine, and benz ene. 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 ins oluble 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 laminate d 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 amoun t 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 fluorid e 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 or ganic 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 pr oduction 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 printi ng 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 productio n 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 t he 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 proce ss 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 num ber of pounds of o

- nitroanisole processed during o

- anisidine manufacture is higher than the number of pounds of o

- anisidine, any facility which exceed s the manufacturing threshold for o

- anisidine is expected to exceed the processing threshold for o

- nitroan isole

.

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 o

anisidine on Form Rs were not assum ed to be required to report o

- nitroanisole to TRI ; processing o

anisidine 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 fi ler 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, dilut e 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 prima ry 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, esp ecially 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 manuf actured 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 , a s 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 productio n of lax a tives.

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 thi s 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 wa s assumed that these products are no longer manufactur ed 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 phenolph thalein 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, en gineering, and life sciences (54171); educational services (611); and medical laboratories (621511) sectors. Based on a review of TRI reporting requirements, n o TRI forms are expected from laboratory use of phenolphthalein ; laboratory uses of phenolphthale in 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 incre mental 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 Mf g. 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 Mf g. 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 Petroleu m 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 M fg. 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. 0 0 0 1 1 1 1 1 1 75

- 02

- 5 Vinyl Fluoride

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 325412 Pharmaceutical Preparation Mfg. 0 0 0 0 0 0 0 0 0 77

- 09

- 8 Phenolphthalein 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 Note s : 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 oth erwise 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 proces sing 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 Fac ilities 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 Food Mfg. 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 Mfg. 0 0 0 1 1 1 1 1 1
32511 Petrochemical Mfg. 0 0 0 7 7 1 7 7 1
325132 Synthetic Organic Dye and Pigment Mfg. 12 12 1 11 11 1 23 23 1
325188 All Other Basic Inorganic Chemical Mfg. 0 0 0 1 1 1 1 1 1
32519 Other Basic Organic Chemical Mfg. 0 0 0 1 1 1 1 1 1
325199 All Other Basic Organic Chemical Mfg. 45 38 1.18 18 18 1 63 56 1.13
325211 Plastics Material and Resin Mfg. 20 19 1.05 13 13 1 33 32 1.03
325212 Synthetic Rubber Mfg. 0 0 0 4 4 1 4 4 1
32522 Artificial and Synthetic Filaments Mfg. 0 0 0 0 0 0 0 0 0
32532 Pesticide and Other Agricultural Chemical Mfg. 2 2 1 2 2 1 4 4 1
325412 Pharmaceutical Preparation Mfg. 0 0 0 0 0 0 0 0 0
325611 Soap and Other Detergent Mfg. 0 0 0 1 1 1 1 1 1
325620 Toilet Preparation Mfg. 0 0 0 0 0 0 0 0 0
325920 E xplosives Mfg. 0 0 0 3 3 1 3 3 1

325998 All Other Miscellaneous Chemical Product and Preparation Mfg. 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 Product Mfg. 0 0 0 2 1 2 2 1 2
32629 Other Rubber Product Mfg. 0 0 0 1 1 1 1 1 1
32731 Cement Mfg. 0 0 0 1 1 1 1 1 1
339932 Game, Toy, and Children's Vehicle Mfg. 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
T otal 82 74 1.11 104 101 1.03 186 175 1.06

### 2

- 27 

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### 2

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### 2

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### 2

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### 2

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### 2

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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

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U.S. EPA 2008. Toxic Chemical Release Inventory Reporting Forms and Instructions: Revised 2008 Version. <http://www.epa.gov/tri/report/rfi/TRI_R FI_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

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Nitromethane (75

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Hawley’s Condensed Chemical Dictionary (3rd Edition)

Scorecard: The Pollution Information Site. Chemical Profile: Nitromethane.

< http://www.scorecard.org/chemical

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SRI Consulting. 2009. Directory of Chemical Producers. Menlo Park: SRI Consulting.

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The Merck Index (12th Edition)

U.S. Department of Health and Human Services, Public Healt h Service, National Toxicology Program, Report on Carcinogens, Eleventh Edition. Substance Profiles: Nitromethane.

< http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s123znt m.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 Sect ion 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/a dvancedsearch/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 (3 rd 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 Info rmation 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 De tails

– 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

- 4DD8XPG

3&_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 (3 rd 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/Inter net/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 (12 th Edition).

U.S. D epartment 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 (3 rd Edition).

Integrated Laboratory Systems 1997. NTP Report on Carcinogens Background Document for Phenolphthalein. Prepared for Meeting of the Report on C arcinogens 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 C onsulting.

The Merck Index (12 th 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/tr i/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

- Count er 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 reaso nably anticipated to be human carcinogens to the TRI list of reportable chemicals. Section 3.2 describes th e methodology used to estimate industry costs. Section 3.3 details the estimated costs to EPA. In S ection 3.4, the total costs of the proposed rule are summarize d.


### 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 th e 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, t otal 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 faciliti es 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 facili ties 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 Determination 1 

### : Facility staff must determi ne 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 the ir 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 Notification 2 

### : 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 31 3 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 fa cility'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 te chnique 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 cost s associated with each of these specific tasks w er e 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,
tota l 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 count in g facility level costs (rule familiarization in particular). This double counting has been observed in estimates for the TRI Information Collection Request (ICR) where F orm R and A burden and cost are estimated separately and then summed (with a need to s ubtract the over l ap 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 th e 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 chem ical forms expected under the proposed rule i s 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 o f 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 (IC R) ( 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 subm issions 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 a re 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. Tec hnical 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
sup porting 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 Ti me 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 Petroc hemical 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 Syn thetic 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 She et (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 Di sposal 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 Ti me and Cost Estimates for Activities Performed by Industry Unit Time Estimates (Hours)

(per report o r per facility) Activity 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 activ ity is estimated to vary with the number of Form R s 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 pa ges 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 200 9 . 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 rate s reflect the total cost to employ an individual and include in the es timate 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 g eneral 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, Bus iness, 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 salarie s 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 B enefits $16.84 $13.08 $6.73 Overhe ad $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 Tab le 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 f acility cost s include cost incurred for compliance determination, rule familiarization, and supplier notification . Each f acility

- 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 ab ove 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 d et ermine the types of chemicals used at the facility and whether these chemicals are m anufactured, processed, or otherwise used above threshold levels, in order to make the d etermination under the third criterion.

For this proposed rule, it is assumed that t he 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 t hose entering the reporting community because of the proposed rule, is already included in the existing compliance determination burden estimates.

Rule Familiarization 3 If a facility will be reporting under the section 313 requirements for the first ti me 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 consultin g 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 assu med 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 wil l 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 f iling 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 bee n 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 neve r 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 an d 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 s ummarized 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 compositi on if th e 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 EP CRA section 313 rep orting 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 comp lete 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 suppl ier 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 n ot 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, tr ansfers, 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 chemical s on which it reports. This effort will require more time in the fir st 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,
t he 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 cost s 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 fiv e 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 familiarizati on, 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 ta sk. Table 3

- 4 presents t he 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 cos t 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 burde n 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 train ing, 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 chan ges 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 c ommunication 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 di stribution 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 est imated 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: Es timated Number of Form R Submissions and Incremental Agency Cost by Media Type

Media Type Estimated Number of F orm Rs Form Processing Cost Per Form ( $ ) Processing Cost ($) Paper 6 $ 2 5.75 $ 152 Mag Media 18 $ 6.50 $ 114
CDX 34 $ 3.12 $ 106

TRIMEweb 12 9 $ 3.12 $ 401 TOTAL 186 $ 773 Note: Processing cost total s may not equal the product of the ro ws 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 th e 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 S ubsequent 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, Not ice 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 Numb er of For m Rs 1 8 6 1 86 Number of Form R Responses 186 186 Number of Facilities (adding Form Rs only) 1 7 5 1 75 Average Number of Form R’s per Facility (adding Form Rs only) 1. 06 1.0 6 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 ,9 04 $ 1

, 651 Average Industry Burden per Form R (hours) 86 30 Average Industry Burden per Facility adding Form Rs only (hours) 92 32 Total Ind ustry 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 I nventory 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 Reque st (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 entit ies . Specifically, section 4.2 discusses the sma ll 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 result s 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 require s 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 Feder al 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, requir es 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 specif ically 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 (SB A) 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 a nd 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 re present 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 s ize 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 fir ms 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. Indust ry T itle Size Standards in Millions of D ollars Size Standards in Number of E mployees

325110 Petrochemical Manufacturing 1,000

325188 All Other Basic Inorganic Chemical Manufacturing 1,000

325199 All Other Basic Organic Chemical Manufacturing 1,000

3 25211 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 Misce llaneous 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 Ind ustrial 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 pop ulation s 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 d efined 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 regul ation are likely to be minimal

. Cost impact percentages are calculated for the incremental compliance costs incurred during first and subsequent year s 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. Tabl e 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 Recordkeep ing/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 numbe r 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. Dep artment of Labor. Bureau of Labor Statistics. Washington D.C., Table 15, 2009

Th is 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 annu al 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 se ction.

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 affec ted facilities in each industry sector that may file these reports under the proposed rule 2 ;
2. Estimate the num ber 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 c ompanies 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 rul e is 175; t he 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 repor ting 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 Manag ement Plan (RMP) Database (RMP), EPA’s Biennial RCR A 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 In ventory 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 pare nt 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 w ere 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 threshold s for th e 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 t hat 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 Bradstree t’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/headq uarters.

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 include s 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 est imated 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 chemi cals 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

com plete data was applied to the total number of facilit ies (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.

C ost 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 year s 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 0.00 1 %. The mean and median impacts f or 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 0.00 1 % each affecting one small business. The mea n and median impacts for the subsequent years are estimated to be less than 0.0 5 % and 0.0 3 % respectively.

Table 4

- 3 : Summary of Impacts on Small Entities

Estimated Number of Affected Entities Estimated Numb er of Affected Small Entities Estimated Number of S mall Entities with Impacts of 3% or Greater Estimated Number of Small Entiti es with Impacts Between 1 and 3% Estimated Number of Small En tities with Impacts Less than 1%

First Year

109 41 0 0 41

% of S mall 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. Bur eau 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 A merican Industry Classification System Codes. U.S. Small Business Administration. August 22, 2008. http://www.sba.gov/idc/groups/public/documents/sba_homepag e/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 S mall 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 fe deral 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 pr ovides 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 an d 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:

• I mproves scientific understanding of the health and environmental risks of toxic chemicals;

• A llows the public to make informed decisions on where to work and live;

• E nhances the ability of corporate leaders and purchasers to more accurately gauge a facility’s potential environmental liabilities;

• P rovides reporting facilities with information that can be used to save money as well as reduce

e missions; and

• A ssists 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 th e 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 a ccidental 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 d ifference 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 stakeholder s

— 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 t hat 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 o f 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 stakehold ers 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 m any 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 r ecommendations 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 mark eting 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 an nual 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 Reg ional 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 cand idates 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 e nvironmental 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 substantia l 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, t he 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 repo rting 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 docum ented numerous examples of how multiple stakeholders have used TRI data (US EPA, 2003). Moreover, a cursory search on GoogleScholar TM 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 th e 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 (200 3 ). 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 po tential 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 Addit ions to Polycyclic Aromatic Compounds (PACs) Category

Under the proposed rule, t he 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

- Nitropyr ene (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 ligh t

- 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 coincident ally 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, f acilities 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 Productio n 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

- nit rochrysene 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 chemica ls 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 ident ified. 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

- Nitrochrysen e 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 TRI

covered sector, unless it is a Federal facilit y. 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 o rganic 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 s ectors t o those t hat 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 o f 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 chemic al 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 ind ividual 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 avail able 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 ch emical 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 Fac ilities

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 Foss il 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 C at 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 Cere al 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
3115 11 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 Cann ing 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 Prepar ed 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 Fabri c 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 Fac ilities

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 an d 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 Refin eries 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 Pe trochemical 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 Botan ical 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 Fac ilities

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, P late, 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
32 7124 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 Produ ct 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 Refi ning 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 (exc ept 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 Fac ilities

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 Ro ller 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 Equipmen t 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 Wi reless 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, Na vigation, 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 M fg. 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 Mo tor 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 Fac ilities

339911 Jewelry (except Costume) Mfg. 0 1 1
339912 Silverware and Hollowware Mfg. 0 1 1
339920 Sporting and At hletic 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 Pet roleum 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 a nd 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 Profe ssional 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 Eng ine 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 Edit ion . 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 Inven tory, 2007 Public Data Re lease.

### B

- 1 

## Appendix B

– Chemical Descriptions and Methods for Chemicals with no Expected Reports

When the National Toxicology Program’s 11 th Report on Carcinogens (RoC) was initially reviewed by EPA, 27 chemicals were identified for possible inclusion in TRI. The fol lowing 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)

• Chlorozot ocin (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 r egulated 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 use d 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 fo llow.

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 manufac tured 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 w as 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 pharmac eutical 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, exce pt 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 t he 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

P otential 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 vol ume 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 t he 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 Tamox ifen 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

T SCA 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 foun d 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 fo llowing 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) phosph ate, 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 polyole fins 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

- dib romopropyl 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

- Prop anol 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” b ased 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 p lastics 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 cycloal iphatic 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 c urrent 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, hexan e, 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 a zacitidine, 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; howeve r, 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/m 2 taken daily for seven days on a four week cycle. However, the dosage may be increased to 100 mg/m 2 after two cycles, so a conservative assumption of 100 mg/m 2 was used. The minimum number of cycles is four to six ; treatment can last as long as th e patient continues to benefit. In this analysis , it was conservatively assumed that treatment continued for the entire year.

As described in the P otential Export of U.S.

- Manufactured Pharmaceuticals Method, the total number of
p atients treated for MDS worldwide is known, therefore, this method estimates the worldwide consumption of azacitine. However, t here 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/m 2 1
Amount consumed by 1 patient over 1 year 17,290 mg 1,2
Number of patients to reach 25,000 l b threshold 657,238 patients Number of diagnosed MDS patients worldwide 300,000 patients 3

Pounds of Azacitidine consumed 11,4 00 lb 1. Vidaza. 2008. Highlights of prescribing information.

< http://ww w.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 th e 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 antibioti c 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 t hat 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 est imated 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 w as 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, ch loramphenicol 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 pr imary 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 aminogly cosides 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 i ts 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 : Chlor amphenicol 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 12,13 40,860 patients
12 ,13 3,647 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 Tox icology Program, Report on Carcinogens, Eleventh Edition. Substance Profiles: Chloramphenicol. < http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s032chlo.pdf > 2. Centers fo r 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 Conjunctiv itis. < 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. Chloramphenico l (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.bailey shorsefeeds.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 P otential 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 current ly 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 M ethod 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 cont ribute 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 chloro zotocin, 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 cl inical trials so far fewer patients actually tak e the drug. In clinical trials, chlorozotocin dosages were between 100 and 250 mg/m 2 given over five days at six week intervals. As a conservative estimate, the largest dosages in this range w ere used. Treatm ent was assumed to continue for the entire year.

Table B

- 5 : Chlorozotocin Use in Clinical Trials
Quantity Dosage 250 mg/m 2 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 p atients 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 c hlorozotocin 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. Ph ase 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. 20 08. 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 P otential 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 sligh tly 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 a s 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 compa nies 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 ca ses, 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 Scientifi c 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 art hritis is 2.5 to 4 mg/kg taken daily over long periods of time. C yclosporin 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 w ere treated with cyclosporin A.

The recommended dosage of cyclos porin 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 f requency 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 nephri tic 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 th ose 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 cons umed 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/kg 2 1 4 m g/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 1,2,3 314,850 mg 1,2,3 124,830 mg
1.2.5 124,830 mg
1.2.8 43,958 mg 2,9 49,680 mg 1,2,11 58,225 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 4 82

– 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/drug

information/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 a nd the Scientific Registry of Transplant Recipients. 2006. 2006 OPTN/SRTR Annual Report. < http://www.ustransplant.org/annual_Reports/archives/2006/default.htm > 5 . America n 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, Carolin e C. 2008. Atopic Dermatitis. eMedicine WebMD. < http://emedicine.medscape.com/article/911574

- overview > 11 . McDowell, Margaret et al. 2005. Anthropomorphic Reference Data for Children an d Adults: U.S. Population, 1999

- 2002. Advance Data From Vital and Health Statistics: 361. < http://www.cdc.gov/nchs/data/ad/ad361.pdf > 1 2 . Journal of the American Society of Nephrology. 1994. Cycl osporine 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.censu s.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

- dos e 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)

.

E leven 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 f acility. 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 co mpanies 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 assum ed that no single plant is manufacturing cyclosporin A above the 25,000 pound threshold , based on best professional judgment.

P roducers of cyclosporin A were identified in Europe, India, and East Asi a using the P otential 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 Dan thron (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” base d 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 u sed 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 fungicide s, 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 th at 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 bel ow 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 us e 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 s ince 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 pro posed 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 ti ssue 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 proces ses. 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 25,00 0 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 1 0,000 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 ant hraquinone 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, approximate ly 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 Manufactu ring, 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 h uman 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 facilit y 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 fo r 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 tamoxi fen 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 case s 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 m g, 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 gai n) 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 treat ed 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 mg 1,2 20, 40, 80 mg 5 20 mg 7
Amount consumed by 1 patient over 1 year 7

, 300 mg 1,2,3 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 patients 4 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 Sol utions, Inc. 2009. Popular Breast Cancer Drug Used with Certain Antidepressants Puts New Jersey Women at Risk. < http://news.prnewsw ire.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. A llee, 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 t amoxifen used in the treatment of breast cancer, infertility, and gynecomastia is 19,700 lbs. Using the method described in the P otential Export of U.S.

- Manufactured Pharmaceuticals Method, one tamoxifen producer in Europe was ide ntified. Additionally, in 1995 worldwide production of tamoxifen was 22,700 lb s , 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 effusi on, 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 negat ive 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. T he 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/m 2 prior to bone marrow transplants. A dosage of 900 mg/m 2 was used as a conservative estimate. Dosage was used in combination with the number of bone
marrow tr ansplants 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 recommend ed dosage for thiotepa was used: 30

- 60 mg/m 2 every week. It was estimated that a dosage of 60 mg/m 2 was administered weekly. For all of these diseases, it was assumed that all cases were treated with thiotepa, and that treatment continued at the recommend ed 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 a ssumed 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 ye ar, 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 Non

Hodgkin Lymphoma Pleural Effusion
Dosage 900 mg/m 2 1 0.4 mg/kg 4 0.4 mg/kg 4 60 mg 4 60 mg/m 2 1 60 mg/m 2 1 0.8 mg/k g 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

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- 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

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- 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, bladde r cancer, Hodgkin lymphoma,

non

- Hodgkin lymphoma, and pleural effusion is estimated to be 4,330 pounds. The method described in the P otential Export of U.S.

- Manufactured Pharmaceuticals Method was used to identify one producer of thiotepa in East Asia. B ased 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 expec ted under the proposed rule.

### B

- 14 

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