Document ID: EPA-HQ-OPPT-2009-0112-0083
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-10-03T04:00Z

Final
 Testing of Certain High Production Volume Chemicals; Third Group of Chemicals
                  (Exposure Findings Supporting Information)
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                          U.S. Environmental Protection Agency 
                                     Office of Pollution Prevention and Toxics 
                                   Economics, Exposure and Technology Division 
                                                                               
                                                                               
                                                                               
                                                                               
                                                                               
                                                                               
                                                                 September 2011
                               Table of Contents

PREFACE

1.0	Data Source Descriptions	3

2.0	Summary of HPV3 Chemicals and Findings	4

                                    Preface

	This findings document was prepared to support EPA's Proposed TSCA Section 4 Test Rule for Certain High Production Volume Chemicals; Third Group of Chemicals.  Prior to promulgating a test rule under section 4 of the Toxic Substances Control Act (TSCA), 15 U.S.C. §§2601 et seq, EPA is required to make certain findings identified in section 4(a) of TSCA relating to the chemical's risk and potential exposure, the sufficiency of data to allow EPA to determine the human health or environmental effects of the chemical, and the need to conduct testing.
 
	Under TSCA section 4(a)(1)(B), EPA must make the following findings to support a test rule based on concerns for exposure: (1) that a chemical substance is or will be produced in substantial quantities and that it enters or may reasonably be anticipated to enter the environment in substantial quantities and/or that there is or may be substantial and/or significant human exposure to such substance; (2) that there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted; and (3) that testing of the substance or mixture with respect to such effects is necessary to develop such data.  The criteria and standards used by EPA for evaluating the terms "substantial production," "substantial release," and "substantial or significant human exposure" as used in TSCA section 4(a)(1)(B)(i) are explained in EPA's Final Statement of Policy; Criteria for Evaluating Substantial Production, Substantial Release, and Substantial or Significant Human Exposure set forth at 58 FR 28736 (May 14, 1993) (hereinafter referred to as the "B Policy").

	This document provides a detailed discussion of EPA's evaluation of each of the chemical substances identified in the proposed test rule to determine that preliminary TSCA section 4(a)(1)(B) findings concerning "substantial production," "substantial release," and "substantial or significant human exposure" can be made. 
Data Source Descriptions
TSCA Inventory Update Reporting Rule: In 1986, EPA promulgated the Inventory Update Reporting (IUR) regulations, under TSCA section 8(a), to facilitate the periodic updating of the TSCA Inventory database and to otherwise support activities associated with implementing TSCA. As originally promulgated, the IUR required chemical manufacturers (including importers) to report to EPA every 4 years the identity of chemical substances manufactured (including imported) annually in quantities of 10,000 pounds or more at each plant site they owned or controlled. In 2003 EPA adjusted the universe of chemicals and plant sites that are required to report, and the type of information reported. In 2005, EPA changed the reporting frequency to once every 5 years, revised the manner in which amounts of a chemical substance manufactured or imported must be reported, and changed the submission period for reporting after 2006.

To protect the claims of confidential business information (CBI) asserted by some IUR submitters on the amount of the chemical substance manufactured (including imported) at a specific site, all production volumes reported by IUR submitters (i.e., CBI and non-CBI) for each chemical are combined by EPA for an aggregate total.  Confidential business information claims are further protected by using eight ranges to identify the total for any specific chemical and then making available to the public the range that corresponds to the aggregate production volume. Publicly-available information from the 1986, 1990, 1994, 1998, and 2002 (and 2006) IUR reporting cycles are available on-line at: http://www.epa.gov/oppt/iur/index.htm

The Toxics Release Inventory (TRI) contains information about releases of certain chemicals and management of wastes at a wide variety of sources, including manufacturing operations, certain service businesses, and federal facilities.  Publicly-available information from the 2005 TRI reporting cycle is available on-line at: http://www.epa.gov/triexplorer/

The National Institute for Occupational Safety and Health (NIOSH) conducted the National Occupational Exposure Survey (NOES) that collected data on potential occupational exposures to chemical, physical, and biological agents from 1981 to 1983.  The survey involved on-site visits to 4,490 establishments in 522 industry types employing approximately 1,800,000 workers in 377 occupational categories.  Publicly-available information from the NOES is available on-line at: http://www.cdc.gov/noes/default.html

The National Library of Medicine (NLM) Household Products Database provides information on the chemical ingredients and their percentage in specific brands of household products.  Information in the database is from a variety of publicly available sources including brand-specific labels and Material Safety Data Sheets when available from manufacturers and manufacturers' web sites.  Publicly-available information from the database is available on-line at: http://householdproducts.nlm.nih.gov/

 The Preliminary Assessment Information Rule (PAIR) collects site specific information on the quantity of chemical produced and/or imported, the amount of chemical lost to the environment during production or importation, the quantity of enclosed, controlled and open releases of the chemical, and per release, the number of workers exposed and the number of hours exposed. Publicly available information regarding PAIR is available on-line at: http://www.epa.gov/oppt/itc/pubs/info.htm
Summary of HPV3 Chemicals and Findings
	Table 2-1 below presents a summary of the High Production Volume (HPV) chemicals (15) and data collected to support an exposure based finding. Table 2-2 presents a chemical-by-chemical explanation of the supporting findings information. The Toxic Release Inventory (TRI),  National Library of Medicine  (NLM) Household Products Database, and  the Preliminary Assessment Information Rule (PAIR) dataset was checked for exposure findings information. There were no TRI  data that met the substantial release criteria for the HPV3 chemicals.  There was NLM[*] consumer exposure findings data found for 1 chemical (CAS# 98-56-6). That data is discussed in Table 2-2 in the chemical-by- chemical explanation.  There was consumer exposure findings information for 3 chemicals in the PAIR dataset. That information is discussed in Table 2-2 in the chemical-by-chemical explanation.

Table 2-1
Summary of Data Searched for Exposure Based Findings

CAS#
Chemical Name
                          2006 IUR Production Volume
                                 [Million lbs]
         2006 IUR  Substantial Human Exposure (>1,000 Workers) Met
                            NOES Number of Workers
            Non-CBI 2006 IUR Commercial/ Consumer Code Description
          PAIR - Substantial Human Exposure (Consumer Use Indicated)
                         Meet Exposure Based Criteria
                                  for Workers
                  Meet Exposure Based Criteria for Consumers
                                       1
                                    98-09-9
Benzenesulfonyl chloride
                                 1 to < 10
                                       
                                       
                        C16-Rubber and plastic products
                                       
                                      Yes
                                      Yes
                                       2
                                    98-56-6
Benzene, 1-chloro-4-(trifluoromethyl)-
                                 10 to < 50
                                       
                                       
                              Code(s) claimed CBI
                                       
                                    Yes[*]
                                    Yes[*]
                                       3
                                   111-44-4
Ethane, 1,1'-oxybis[2-chloro-]
                                 1 to < 10
                                       
                                       
                        C20-Other; Code(s) claimed CBI
                                       
                                      Yes
                                      Yes
                                       4
                                   127-68-4
Benzenesulfonic acid, 3-nitro-, sodium salt (1:1)
                                 1 to < 10
                                       
                                     9,386
                                       
                                       
                                      Yes
                                       
                                       5
                                   515-40-2
Benzene, (2-chloro-1,1-dimethylethyl)-
                                 1 to < 10
                                       
                                       
                                       
                  C02-Agricultural products (non-pesticidal)
                                       
                                      Yes
                                      Yes
                                       6
                                   2494-89-5
Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate)
                                 1 to < 10
                                       
                                       
                              Code(s) claimed CBI
                                       
                                      Yes
                                      Yes
                                       7
                                   5026-74-4
2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-
                                 1 to < 10
                                      Yes
                                       
                                       
                                       
                                      Yes
                                       
                                       8
                                  22527-63-5
Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester
                                 1 to < 10
                                       
                                       
             C16-Rubber and plastic products; Code(s) claimed CBI
                                      Yes
                                      Yes
                                      Yes
                                       9
                                  25321-41-9
Benzenesulfonic acid, dimethyl-
                                 1 to < 10
                                       
                                     2,843
                                       
                                       
                                      Yes
                                       
                                      10
                                  52556-42-0
1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)
                                 1 to < 10
                                      Yes
                                       
                                   C20-Other
                                       
                                      Yes
                                      Yes
                                       
                                       

                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                      11
                                  68082-78-0
Lard, oil, Me esters
                                 1 to < 10
                                       
                                    41,153
                                       
                                       
                                      Yes
                                       
                                      12
                                  68442-60-4
Acetaldehyde, reaction products with formaldehyde, by-products from
                                 1 to < 10
                                       
                                       
                              Code(s) claimed CBI
                                      Yes
                                      Yes
                                      Yes
                                      13
                                  68610-90-2
2-Butenedioic acid (2E)-, di-C8-18-alkyl esters
                                 1 to < 10
                                       
                                       
                                       
                                      Yes
                                       
                                      Yes
                                      14
                                  70693-50-4
Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-
                                 1 to < 10
                                       
                                       
                              Code(s) claimed CBI
                                       
                                      Yes
                                      Yes
                                      15
                                  72162-15-3
1-Decene, sulfurized
                                 1 to < 10
                                       
                                    64,227
                                       
                                       
                                      Yes
                                       

                                   Table 2-2
                 Chemical-by-Chemical Explanation of Findings 

                                       
                                     CAS#
                                 Chemical Name
                              Summary of Findings
                                       
                                       
                                       
                                       
                                       
                                       
                                       1
                                    98-09-9
Benzenesulfonyl chloride
The IUR commercial/consumer product category C16-Rubber and plastic products was reported for this chemical. Chemicals reporting in this category are contained in such products as tires, footwear, flooring, bottles, sporting equipment, games, and toys. It is expected that these products will be widely used by consumers (including children) and hence, may likely exceed 10,000 people.  Additionally, products such as tires and flooring are also used in a commercial setting, which may lead to exposures of >1,000 commercial workers.  Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  (All stated IUR  commercial/consumer product categories are non-CBI)
      

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total  workers potentially exceeding 1,000 based on the IUR commercial/consumer product categories (C16 ) 
- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category (C16)
                                       
                                       
                                       
                                       2
                                    98-56-6
Benzene, 1-chloro-4-(trifluoromethyl)-
The number of potentially exposed consumers is estimated to be very large based on the use (home maintenance product) cited in the NLM Household Chemicals Database.  It is expected that home maintenance products will be widely used by consumers and hence, may likely exceed 10,000 people. 
The IUR commercial/consumer product category(s) was claimed CBI for this chemical. This chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (10 million - 50 million lb)
- Consumers potentially exceeding 10,000 people based on NLM Household Chemicals Database
- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category claimed CBI
                                       
                                       
                                       
                                       
                                       3
                                   111-44-4
Ethane, 1,1'-oxybis[2-chloro-]
The IUR commercial/consumer product category C20-Other (chemicals contained in commercial and consumer products not elsewhere classified) was reported for this chemical. This indicates that this chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Other product category(s) was claimed CBI.  Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  (All stated IUR  commercial/consumer product categories are non-CBI)

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total workers potentially exceeding 1,000 based on IUR commercial/consumer product category (C20) 
- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category (C20)
                                       
                                       
                                       
                                       
                                       4
                                   127-68-4
Benzenesulfonic acid, 3-nitro-, sodium salt (1:1)
The number of potentially exposed total workers exceeds 1,000 based on NOES data.  The production volume data for the 2006 IUR data collection was compared to the production volume data for the 1986 IUR data collection for this chemical to see if the production volume stayed the same or increased, thereby indicating that the usage of these chemicals is no less than when NOES data were gathered.  The 1986 reported IUR production volume range was 1 million -10 million lbs. The 2006 IUR production volume range is 1 million -10 million lbs. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total workers exceeding 1,000 based NOES data (9,386 workers)
                                       
                                       
                                       
                                       
                                       
                                       
                                       5
                                   515-40-2
Benzene, (2-chloro-1,1-dimethylethyl)-
The IUR commercial/consumer product category C02-Agricultural products (non-pesticidal) was reported for this chemical.  Chemicals reporting in this category are used to increase the productivity and quality of farm crops; examples include fertilizers and soil conditioners.  It is expected that these products will be widely used by commercial workers and consumers and hence, may likely exceed 1,000 commercial workers and 10,000 consumers.  Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  (All stated IUR  commercial/consumer product categories are non-CBI)
      

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total  workers potentially exceeding 1,000 based on the IUR commercial/consumer product categories (C02 ) 
- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category (C02)
                                       
                                       
                                       
                                       
                                       
                                       6
                                   2494-89-5
Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate)
The IUR commercial/consumer product category(s) was claimed CBI for this chemical. This chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total workers potentially exceeding 1,000 based on  IUR commercial/consumer product category(s) claimed CBI
- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category claimed CBI
                                       
                                       
                                       7
                                   5026-74-4
2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-
The total number of potentially exposed workers exceeds 1,000 workers based on number of workers reported on the 2006 IUR.  

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total workers exceeding 1,000 based on IUR reported number of workers
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       8
                                  22527-63-5
Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester
The IUR commercial/consumer product category C16-Rubber and plastic products was reported for this chemical. Chemicals reporting in this category are contained in such products as tires, footwear, flooring, bottles, sporting equipment, games, and toys. It is expected that these products will be widely used by consumers (including children) and hence, may likely exceed 10,000 people.  Additionally, products such as tires and flooring are also used in a commercial setting, which may lead to exposures of >1,000 commercial workers.  Other product category(s) was claimed CBI.  Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  (All stated IUR  commercial/consumer product categories are non-CBI)
      

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total  workers potentially exceeding 1,000 based on the IUR commercial/consumer product categories (C16 ) 
- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category (C16)
- Consumers potentially exceeding 10,000 people based on PAIR
                                       
                                       
                                       
                                       
                                       9
                                  25321-41-9
Benzenesulfonic acid, dimethyl-
The total number of potentially exposed workers exceeds 1,000 workers based on NOES data. The production volume data for the 2006 IUR data collection was compared to the production volume data for the 1986 IUR data collection for this chemical to see if the production volume stayed the same or increased, thereby indicating that the usage of these chemicals is no less than when NOES data were gathered.  The 1986 reported IUR production volume range was 1 million -10 million lbs.  The 2006 IUR production volume range is 1 million -10 million lbs. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."
      
This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total workers exceeding 1,000 based NOES data (2,843 workers)
                                       
                                       
                                       
                                       
                                       
                                       
                                      10
                                  52556-42-0
1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)
The total number of potentially exposed workers exceeds 1,000 workers based on number of workers reported on the 2006 IUR. The IUR commercial/consumer product category C20-Other (chemicals contained in commercial and consumer products not elsewhere classified) was reported for this chemical. This indicates that this chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  (All stated IUR  commercial/consumer product categories are non-CBI)

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total workers exceeding 1,000 based on IUR reported number of workers
- Total workers potentially exceeding 1,000 based on  IUR commercial/consumer product category (C20)
- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category (C20)
                                       
                                       

                                       
                                       
                                       
                                       
                                       
                                       
                                      11
                                       

                                  68082-78-0
Lard, oil, Me esters
The total number of potentially exposed workers exceeds 1,000 workers based on NOES data. The production volume data for the 2006 IUR data collection was compared to the production volume data for the 1986 IUR data collection for this chemical to see if the production volume stayed the same or increased, thereby indicating that the usage of these chemicals is no less than when NOES data were gathered.  The 1986 reported IUR production volume range was 500 thousand - 1 million lbs. The 2006 IUR production volume range is 1 million -10 million lbs. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."
      

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total workers exceeding 1,000 based NOES data 
  (41,153 workers)
                                       
                                       
                                       
                                       
                                       
                                       
                                      12
                                  68442-60-4
Acetaldehyde, reaction products with formaldehyde, by-products from
The IUR commercial/consumer product category(s) was claimed CBI for this chemical. This chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures.  Additionally, PAIR indicates consumer use. It is possible that products containing this chemical may be used by >10,000 consumers. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total workers potentially exceeding 1,000 based on  IUR commercial/consumer product category(s) claimed CBI
- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category claimed CBI
                                       
                                       
                                       
                                      13
                                  68610-90-2
2-Butenedioic acid (2E)-, di-C8-18-alkyl esters
PAIR indicates consumer use.  It is possible that products containing this chemical may be used by >10,000 consumers.  Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Consumers potentially exceeding 10,000 people based on PAIR
                                       
                                       
                                       
                                       
                                       
                                      14
                                  70693-50-4
Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-
The IUR commercial/consumer product category(s) was claimed CBI for this chemical. This chemical is present in an unknown number of commercial and consumer products that may potentially have a high number of exposures. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total workers potentially exceeding 1,000 based on  IUR commercial/consumer product category(s) claimed CBI
- Consumers potentially exceeding 10,000 people based on IUR commercial/consumer product category claimed CBI
                                       
                                       
                                       
                                       
                                       
                                      15
                                  72162-15-3
1-Decene, sulfurized
The total number of potentially exposed workers exceeds 1,000 workers based on NOES data. The production volume data for the 2006 IUR data collection was compared to the production volume data for the 1986 IUR data collection for this chemical to see if the production volume stayed the same or increased, thereby indicating that the usage of these chemicals is no less than when NOES data were gathered.  The 1986 reported IUR production volume range was 1 million - 10 million lbs. The 2006 IUR production volume range is 1 million -10 million lbs. Based on this information, this chemical would meet the exposure based findings criteria of "substantial or significant human exposure."  
      

This chemical met exposure based findings criteria based on:
- 2006 IUR Production Volume Range (1 million - 10 million lb)
- Total workers exceeding 1,000 based NOES data (64,227 workers)