TSCA New Chemicals Program (NCP) Chemical …

1 TSCA NEW Chemicals Program (NCP) Chemical categories Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, 20460 Contacts: Kenneth Moss Rebecca Jones Kelly Mayo-Bean Last revised: August, 2010 ii INTRODUCTION Disclaimer and Purpose of This Document: EPA's Office of Pollution Prevention and Toxics (OPPT) groups Chemicals with shared Chemical and toxicological properties into categories so that PMN reviews are facilitated. PMN submitters and EPA reviewers benefit from the accumulated data and past decisions represented by a category. EPA considers all PMNs, including new Chemical substances which fall within such categories , on a case-by-case basis and uses the most appropriate structural analogue to support any concerns for health or environmental effects.

2 For any new Chemical substance, if EPA determines, under TSCA section 5(e), that the substance "may present an unreasonable risk of injury to health or the environment, the PMN substance can be subjected to appropriate control actions and/or testing under TSCA section 5(e). This may present finding is developed through the application of category-based or Chemical -by- Chemical assessment of hazard endpoints and case-specific exposure assessment. The categories included in this compilation represent Chemicals for which sufficient assessment experience has been accumulated so that hazard concerns and testing recommendations vary little from Chemical to Chemical within the category. Thus, these categories do not necessarily represent the Chemicals of greatest concern to the Agency. By the same token, the categories are also not intended to be a comprehensive list of all substances that may be subject to further action in the New Chemicals Program .

3 If a new Chemical substance is structurally similar to a substance for which EPA has positive toxicity data and there is sufficient exposure, EPA may regulate that substance under section 5(e) of the Toxic Substances Control Act (TSCA) based on its potential unreasonable risk. The hazard potential of a PMN substance is dependent on the molecular weight of the compound, the presence/absence of activating/deactivating substituents, other physical/ Chemical properties, and the likely route of exposure. Typically, concerns are confined to Chemicals with molecular weights <1,000 whenever inhalation exposure to humans or environmental release is expected, and to species <500 when dermal exposure to humans is expected. This document contains references to the "Harmonized Test Guidelines" developed by EPA's Office of Prevention, Pesticides and Toxic Substances (renamed the Office of Chemical Safety and Pollution Prevention in 2010) for use in the testing of pesticides and toxic substances, and the development of test data that must be submitted to the Agency for review under Federal regulations.

4 These Harmonized Test Guidelines can be found at This document also contains references to test guidelines developed by the Organization for Economic Cooperation and Development (OECD). These OECD test guidelines are available from the OECD Bookshop at or SourceOECD at Additional information on testing conditions and testing options for specific PMN Chemical substances that appear to fall within one of these categories is available by contacting the New Chemicals Management Branch at 202-564-8469 or the TSCA Hotline at 202-554-1404. This iii document is intended to serve only as a guide for PMN submitters. PMN submitters are urged to have protocols and testing schemes evaluated by the New Chemicals Program prior to commencing testing on a PMN substance. However, under no circumstance does such an evaluation mean that the new Chemical substance is not subject to further review during any TSCA section 5 review period for the PMN substance or that additional testing or regulatory action may not be recommended.

5 Finally, even if EPA does not make the potential unreasonable risk finding for a new Chemical substance, the Agency may still recommend the use of engineering controls or personal protective equipment to reduce exposures in the workplace if the PMN substance is a potential irritant or sensitizer. Additional Resources/Tools for the TSCA New Chemicals Program : The hazard and risk assessment of new industrial Chemicals is within the purview of EPA s Office of Pollution Prevention and Toxics within EPA s Office of Chemical Safety and Pollution Prevention (OCSPP). Under the Toxic Substances Control Act (TSCA), OPPT is charged with regulating all phases of the life cycle of industrial Chemicals including environmental and human health impacts resulting from the manufacturing, processing, use, and disposal of a substance. TSCA has no minimum data set requirements for new Chemicals entering commerce, and therefore, OPPT has developed a suite of predictive approaches that are used to fill data gaps where little or no experimental data exists.

6 In addition to the use of the New Chemical Category Statements presented in this document to assist in Chemical management decisions, Structure Activity Relationships (SARs) is a technique routinely used under the New Chemicals Program to estimate the toxicity of industrial Chemicals being reviewed in response to PMN submissions. The predictive approaches are used to support OPPT Chemical management decisions within the TSCA framework and are also used in the analysis of existing Chemicals . For more information on the use of these tools to estimate physical- Chemical properties, environmental fate, ecological and human health hazards, and exposures and releases please refer to the web pages listed below: Estimations programs Interface for Windows Suite EPI Suite A suite of models used to estimate numerous physical- Chemical properties, environmental fate, and partitioning of a Chemical based on structure. Link for EPI Suite: Ecological Structure Activity Relationships ECOSAR A hazard estimation tool that uses Chemical structure descriptors to estimate the acute and chronic toxicity of a substance to aquatic organisms.

7 ECOSAR is available as stand alone product or as part of the EPI Suite package of programs . Link for ECOSAR: Human Health Non-Cancer Screening Protocol In this protocol, analogs are chosen for the Chemical of interest along with associated health effects data to perform read-across activities to predict human health effects in the absence of sufficient measured data. An outline of this protocol can be reviewed at: Additionally, to assist users in this task, EPA has recently created a new tool to assist in the selection of analogs and to help identify publicly available experimental data for Chemicals of interest called the iv Analog Identification Methodology which can be accessed at The Cancer Expert System OncoLogic A cancer hazard expert system software package which relies on the known carcinogenic effects of Chemicals to predict cancer hazard of new substances based on structural similarity.

8 The software estimates carcinogenic potential of a substance by initiating expert rules for determining cancer potential created from many sources of publicly available carcinogenicity data. OncoLogic is capable of estimating carcinogenic potential for organics, polymers, fibers, and metals. Link for OncoLogic: Chemical Screening Tool for Exposures and Environmental Releases ChemSTEER A modeling Program to estimate occupational exposures and environmental releases of a Chemical through manufacture, processing and use. This software uses EPA validated models to predict environmental releases and worker exposure to a Chemical from manufacturing, processing, and use. Link for ChemSTEER: Exposure and Fate Assessment Screening Tool E-FAST A windows based package that incorporates several screening level exposure models. E-FAST provides screening level estimations of environmental concentration and human exposure due to releases of a Chemical to the environment.

9 Link for E-FAST: EPA offers training in the use and interpretation of these models through workshops under the Sustainable Futures Initiative. The goal of the Sustainable Futures training workshops is to assist the public in learning more about the application and interpretation of OCSPP s predictive methods, to build on the Chemical expertise developed by EPA through Chemical regulation activities, and to promote the technology transfer of EPA expertise to other Chemical stakeholders. To learn more about the Program and workshops please visit the Sustainable Futures website at: Changes Made to this August 2010 Revision: The introductory section was revised to include a section entitled Additional Resources/Tools for the TSCA New Chemicals Program and this section of the Introduction was added to identify changes made in this August 2010 version of the document. The previous 2002 version of this document contained references to EPA Office of Pollution Prevention and Toxics (OPPT) test guidelines that originally appeared in title 40, chapter I, subchapter R of the Code of Federal Regulations (CFR).

10 Since that time, the "Harmonized Test Guidelines" have been developed by EPA's Office of Prevention, Pesticides and Toxic Substances (renamed the Office of Chemical Safety and Pollution Prevention in 2010) for use in the testing of pesticides and toxic substances, and the development of test data that must be submitted to the Agency for review under Federal regulations. These Harmonized Test Guidelines can be found at This current version of the Chemical categories report now contains references to the Harmonized Test Guidelines rather than the OPPT test guidelines. For example, the fish acute toxicity test at 40 CFR has been replaced by Harmonized Test Guideline , and the Ready v Biodegradability test at 40 CFR , etc. has been replaced by Harmonized Test Guideline OPPT has made minor revisions to the following categories to reflect updated structure-activity relationships (SARs) for certain classes which are available in version of ECOSAR.