U.S. EPA, Office of Pollution Prevention and Toxics (OPPT) Chemical Reviews and Tools Case Study Presentation Abstract

Transcription

1 U.S. EPA, Office of Pollution Prevention and Toxics (OPPT) Chemical Reviews and Tools Case Study Presentation Abstract John Shoaff, International Teamr, Office of Pollution Prevention and Toxics U.S. Environmental Protection Agency, USA Introduction While U.S. law does not specifically use the term precaution, decision-making in the face of scientific uncertainty has been a feature of U.S. policy since the passage of the Federal Food, Drug and Cosmetics Act (FFDCA) in This can also be found in various forms in other statutes and policies, implementation of a number of environmental laws and as an integral part of our regulatory process and scientific risk analysis. In particular, EPA has been reviewing and regulating new and existing chemicals under the Toxic Substances Control Act (TSCA) since the late 1970s and in the absence of complete scientific certainty. New Chemical Review Process and Tools EPA s new chemicals program, under which we review proposed new chemicals prior to commercial manufacture or importation, is a good example of decision making under conditions of uncertainty. The review process is designed to prevent unreasonable health and/or environmental risks before they occur and prior to a new chemical s entrance into commerce. EPA reviews about 1500 new chemical notices annually and has reviewed over 45,000 new chemical submissions to date. 1 The Premanufacture Notification (PMN) review process is designed to accommodate the large number of PMNs received, while adequately assessing the risks posed by each substance within the 90-day review timeframe prescribed by TSCA. The information included in PMNs is limited with more than half of PMNs containing no health or ecotoxicity test data. Consequently, EPA uses several general approaches to address data gaps to rapidly evaluate potential risks and make risk management decisions for new chemicals. EPA relies upon Structure Activity Relationships or SAR analysis to estimate or predict physicalchemical properties, environmental fate, and human and environmental effects. A SAR is the relationship between the chemical structure of a molecule and its properties, including interactions with the environment and organisms. These modeling and assessment techniques have worked well to identify problem chemicals, as indicated by the results of a 1993 study conducted jointly by the EPA and authorities in the European Union (EU). This study showed that our SAR-based predictions agreed with test results in about 60-90% of the cases, depending on the end point. 2 EPA has also established chemical categories to further facilitate the PMN This case study abstract is for information and illustrative purposes only and is not intended to convey all aspects of EPA s chemicals program, other programs or U.S. views with respect to scientific uncertainty under U.S. law, international commitments, agreements and law. 1 Approximately 1000 of the 1500 annual notices are Premanufacture Notifications and the remaining 500 notices are requests for review and EPA approval as exemptions from premanufacture notification. Approximately 5% of PMNs are regulated by EPA and an additional 5% are withdrawn by manufacturers often in the face of potential action. Ultimately, less than half of the new chemicals for which EPA receives PMNs enter into commerce. 2 OECD (1994). US EPA/EC Joint Project on the Evaluation of (Quantitative) Structure Activity Relationships (QSARS). OECD Environmental Monographs No. 88. Organization for Economic Cooperation and Development, Paris, p. 367, U.S

2 review process. 3 The presentation will touch upon some of these tools while more information and links to additional methods and models that are utilized in our reviews follows below. Considerations and Outcomes of Reviews Several regulatory and non-regulatory outcomes may follow a PMN submission Voluntary withdrawal of the notice, often in the face of possible EPA action. Voluntary testing action whereby a PMN submitter agrees to suspend the notice review period and conduct hazard or environmental fate testing in response to a request from EPA where EPA has risk concerns. Issuance of an order to prohibit or limit activities associated with the new chemical if EPA determines that insufficient information exists to evaluate the human health and environmental effects of the substance, and that (1) it may present an unreasonable risk or (2) that it will be produced in substantial quantities and may be anticipated to enter the environment in substantial quantities or there may be significant or substantial human exposure (TSCA 5(e) Orders). This authority authorizes regulation pending the development of information and allows regulatory actions to be taken in cases where risk may be present or where there is potential for substantial production and exposure. In cases where EPA has concerns about potential exposures associated with new uses (i.e., those beyond the uses described in the notice), it can issue a significant new use rule (SNUR) that requires manufacturers, importers and processors of such substances to notify EPA at least 90 days before beginning any activity that EPA has designated a significant new use. These actions allow EPA to prevent or limit potentially adverse exposure to, or effects from, the new use of the substance before they occur (TSCA 5(a)(2) SNURs). During the presentation, more detail and examples will be provided on the considerations and potential actions above as a result of various PMN reviews including how examples relate to decisions under conditions of uncertainty. Furthermore, we will touch on cases where testing data received on regulated chemicals suggested that our hazard estimates were overly conservative which resulted in our modifying the regulatory approach to better reflect risks. Other Methods to Reduce Uncertainty and Risk Under TSCA s broad information-gathering authorities, EPA established an Inventory Update Rule (IUR) in order to obtain updated basic U.S. production and importation information on nonpolymeric organic chemicals that are listed on the TSCA inventory. The Inventory Update Rule was recently amended to require the reporting of additional exposure-related information for higher-volume chemicals and to include reporting on inorganic chemicals. This new information, together with the hazard information being developed by efforts in the U.S. such as the High Production Volume (HPV) Challenge Program 4 and those by the Organization for Economic EPA (1994) US EPA/EC Joint Project on the Evaluation of (Quantitative) Structure Activity Relationships (QSARS). EPA 743-R U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, Washington, D.C., p. 55 (plus 15 annexes and 4 appendices), 3 For more information on chemical categories, see 4 The U.S. High Production Volume Challenge Program will fill information gaps for over 93 % of the production volume of the chemicals we track on our inventory of existing chemicals. For more on the U.S. HPV Challenge Program and HPV Information System, see A related OECD effort, the Global Chemicals Portal, will be presented and discussed along with the U.S. National 2

3 Cooperation and Development (OECD), such as the HPV Screening Information Data Set (SIDS) Program, will enable EPA, industry, environmental groups, and others to evaluate, better understand, and, where necessary, take action to gather additional information or to reduce chemical risks. Substantial risk information notices under TSCA 8(e) is another important informationgathering tool whereby EPA screens submissions to identify chemicals for further assessment, referral or follow-up with submitters for additional information on exposure and/or risk management. Our presentation will discuss examples of EPA follow-up to substantial risk notices, including a mix of voluntary approaches and regulatory action under TSCA pursued in the face of uncertainty. Stewardship Tools and Activities EPA also works with companies and other stakeholders to provide chemical assessment tools, educational and other programs that further facilitate environmental stewardship across the lifecycle of chemicals, including where appropriate to inform substitution decisions. This is also complementary to EPA s new chemicals and other regulatory activities. A few examples relative to the development, review and promotion of both safer and greener new chemicals include: Sustainable Futures; the Pollution Prevention (P2) Framework; PBT Profiler; the Analogue Identification Methodology (AIM); Green Chemistry and Green Engineering; Design for the Environment (DfE) programs; and Environmentally Preferable Purchasing (EPP). These activities contribute to improved decision making while also taking a preventive approach to environmental protection. In lieu of a few illustrative examples of how select activities also supplement decision making under conditions of uncertainty during our presentation, additional background and links are included for reference below. Institutes of Health (NIH) World Library of Toxicology, Chemical Safety and Environmental Health at a Side Event on Global Chemical Database Initiatives during the IFCS Forum V. meeting and scheduled for the afternoon of 26 September. 3

4 Information Sources An overview of EPA s chemicals program and new chemicals review process may be obtained respectively at: (click on Overview of OPPT Programs PDF file and Overview Appendices) Hazard and Exposure Assessment Tools 5 EPI Suite: the Estimation Programs Interface Suite of Models A Windows -based suite of physical/chemical property and environmental fate estimation models. Using only a substance s chemical structure, EPI Suite runs estimation models for all of the basic chemical properties needed in environmental assessment. In addition, EPI Suite runs state-of-the-art models for estimating key transformation processes (e.g. biodegradation), and estimates both multimedia environmental fate and fate in typical wastewater treatment systems using Mackay-type fugacity models. This software has become one of the world s most popular chemical assessment tools and is widely used in industry for pre-screening of candidate substances prior to development; in the NCP in PMN review; and in review of existing substances such as High Production Volume (HPV) chemicals. EPI Suite is available for free download from the internet via EPA/OPPT s Exposure Assessment Tools and Models website: ChemSTEER The Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) is a PC-based software program that uses the OPPT s most current workplace exposure and release assessment methods. The tool generates screening-level estimates of environmental releases of and worker exposures to chemicals manufactured and used in workplaces. An updated beta version (May 2004) of ChemSTEER is publicly available through OPPT s Exposure internet web pages: E-FAST The Exposure, Fate Assessment Screening Tool (E-FAST) is a PC-based software program that estimates screening-level general population and consumer exposures, environmental concentrations and aquatic exposures to chemical releases. Potential human doses are estimated for inhalation, dermal, and ingestion exposure routes. 5 These tools and models are developed and tested in accordance with EPA policy and guidance. The first step involves obtaining enough data and proven scientific theory to generate the methods, data, and equations that could be used to develop the model. If it makes sense to develop a computerized model, then OPPT establishes the requirements for the model or software. The next step involves developing the software and documentation, including an iterative process of evaluating or validating the model, and comparing estimated results with measured data. OPPT s tools and models are widely used by scientists world wide and must meet stringent standards for transparency, integrity, objectivity, and data quality. Following internal peer review and testing of the software, OPPT arranges for beta testing by stakeholders and other external parties. The software then undergoes peer review following the guidance in the EPA Peer Review Handbook. The models undergo further evaluation during use and whenever possible, model results are compared with real data to allow for a continued assessment of model accuracy and to ensure that the methods remain up-to-date. 4

5 Version 2 includes enhanced air exposure estimates, endangered species information for U.S. site-specific aquatic releases, and expanded documentation. ECOSAR The Ecological Structure Activity Relationships (ECOSAR) is a personal computer software program that is used to estimate the aquatic toxicity of chemicals. The program predicts the toxicity of industrial chemicals to aquatic organisms such as fish, invertebrates and algae using (Q)SARs. ECOSAR estimates a chemical s acute (shortterm) toxicity and, when available, chronic (long-term or delayed) toxicity. ECOSAR is available at: OncoLogic Cancer Expert System The OncoLogic Cancer Expert System is a PC-based expert system software program that can be used to assess the potential of chemicals to cause cancer in humans based on chemical structure, exposure scenarios, mechanistic consideration, short-term predictive tests and expert judgment. The program captures SAR expertise in cancer hazard identification, employs knowledge rules and decision logics, and makes semiquantitative predictions together with underlying scientific rationale. OncoLogic is or will soon be available at: Stewardship Tools Pollution Prevention (P2) Framework The P2 Framework is an analytical framework for assessing risk(s) of chemicals when data are lacking. The P2 Framework integrates all of OPPT s chemical assessment methods, including SAR techniques for estimating PChem properties, environmental fate, human and aquatic hazards and exposure. The P2 Framework includes technical guidance on how to interpret the results of each assessment method, and describes how these tools are applied in an integrated manner to yield quantitative estimates of risk. The P2 Framework can be used early-on in R&D to identify problematic chemicals, to compare and contrast hazard/risk profiles of alternatives under consideration and to facilitate development of safer substitutes. Sustainable Futures Sustainable Futures is an industry, Agency, NGO partnership dedicated to the practical application of science and technology toward our shared goals of prevention, risk reduction and stewardship. Sustainable Futures is the programmatic structure for transferring the P2 Framework risk screening technology to the public together with: 1) training in the use and interpretation of the P2 Framework risk screening methods, 2) technical assistance, 3) regulatory relief for qualifying low hazard/low risk New Chemical submissions, 4) assistance to small businesses, and 5) public recognition for participating companies. SF is an example of an innovative voluntary effort that builds on risk screening expertise developed by EPA, and facilitates P2 and risk reduction through transfer of that expertise to other chemical stakeholders. 5

6 PBT Profiler The PBT Profiler is a no cost, online PBT screening methodology that predicts a chemical's potential persistence (P), bioaccumulation (B), and chronic aquatic toxicity (T) values and compares the predictions to EPA's New Chemicals Program PBT criteria to determine if the substance is a potential PBT of concern. Analog Identification Methodology (AIM) An online computerized tool called the Analog Identification Methodology was developed to help users evaluate the potential health effects of untested chemicals through identification of close chemical analogs that have measured data on the endpoints of concern. AIM identifies chemical analogs through a fragment-based structural similarity approach, and points the user to publicly available databases or other sources of information where experimental data on the related chemical analogs can be found. AIM is undergoing a beta test and will be publicly released in the future. Green Chemistry EPA's Green Chemistry Program fosters the research, development, and implementation of innovative chemical technologies that prevent pollution in both a scientifically sound and cost-effective manner. It supports fundamental research in the area of environmentally benign chemistry as well as a variety of educational activities, international activities, conferences and meetings, and tool development, all through voluntary partnerships with academia, industry, and other government agencies. Green Engineering EPA's Green Engineering Program is introducing a "green" philosophy into undergraduate chemical engineering programs. The program aims to develop and maintain effective communication between educators and practicing engineers. To this end the program has developed text books and workshops for professors. Design for the Environment (DfE) The DfE Program is a voluntary partnership program that works directly with industries to integrate health and environmental considerations into their business decisions. DfE is also a recognized approach that companies first adopted in the late 1980s that involves thinking in terms of "design for" qualities or traits in products and process design. In the environmental field, views on risk management have shifted to approaches that promote reducing risks to human health and the environment through pollution prevention or source reduction instead of relying on end-of-the-pipe pollution control. Environmentally Preferable Purchasing (EPP) EPA's Environmentally Preferable Purchasing (EPP) Program is a federal initiative that encourages and assists Executive agencies in the purchasing of environmentally preferable products and services. The goal of the EPP Program is to help increase the availability of products and services that are environmentally preferable, protect human health, save money, and improve the overall quality of government purchases. 6