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Louise P. WiseDeputy Assistant AdministratorOffice of Chemical Safety and Pollution Prevention
FY 14-15: Agency Priority Goal
Assess and reduce risks posed by chemicals and promote the use of safer chemicals in commerce.
Priority Goal
Goal Overview
Keeping communities safe and healthy requires action to reduce risks associated with exposure to chemicals in commerce, our indoor and outdoor environments, and products and food. The agency’s chemical safety and pollution prevention programs are at the forefront of EPA’s efforts to advance a sustainable future. Chemicals are often released into the environment as a result of their manufacture, processing, use, and disposal. The agency uses a variety of approaches and tools to assess, prevent, and reduce these chemical releases and exposures by conducting risk assessments, assessing chemical alternatives, and taking other risk management actions.
Three statutes provide EPA the authority to regulate chemicals: The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetics Act (FFDCA) govern the regulation of pesticides and the Toxic Substances Control Act (TSCA) governs regulation of other commercial chemicals.
EPA is committed to utilizing TSCA to the fullest extent possible to ensure the safety of commercial chemicals. Peer-reviewed risk assessments are essential to informing the agency’s chemical safety decisions with the best available scientific information and analyses. The findings of these assessments guide decisions on whether risk management actions are needed to address risks to human health or the environment from exposure to particular chemical uses or groups of chemicals. To enhance its existing chemicals program, EPA has identified a group of TSCA Work Plan Chemicals that are to receive priority for risk assessment in the 2012-2014 timeframe. These chemicals were selected based on criteria developed by EPA in consultation with a wide range of stakeholders. Through its TSCA Work Plan risk assessment program, EPA plans to conduct risk assessments for the group of Work Plan chemicals identified in March 2012. Subsequent risk assessments will be determined based on any periodic revisions to the TSCA Work Plan.
All pesticides distributed and sold in the United States must be registered by EPA, based on scientific data showing that they will not cause unreasonable risks to human health, workers, or the environment when used as directed on product labeling. The registration review program makes sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects, that is, continue to be safe when used according to the label. Although changes in science, public policy, and pesticide use practices will occur over time, such changes could impact EPA’s ability to make determinations in a timely manner. Through the registration review program, the Agency periodically reevaluates (every fifteen years) pesticides to make sure that as change occurs, products in the marketplace can still be used safely. The registration review program challenges EPA to continuously improve its processes, science, and information management while maintaining a collaborative and open process for decision-making to ensure safety to human health and the environment. Please refer to section 7 for a more detailed discussion of the challenges presented by ESA and EDSP concerns. While challenging, addressing these new problems will improve the Agency’s processes and allow for an open public venue for determining that products in the marketplace can still be used safely.
In 1996, Congress directed the agency to develop an Endocrine Disruptor Screening Program (EDSP) to screen over 10,000 chemicals for potential endocrine activity, using validated test methods. To date, we have employed validated test methods, covering a range of mammalian and ecological species, to screen 52 chemicals. Based on current cost and time projections, it would require tens of millions of dollars, millions of laboratory animals and decades to screen and test 10,000 chemicals using the current methods. Recent advances in computational toxicological methods (e.g., ToxCast) provide new technologies offering greater speed, efficiency and effectiveness to the EDSP in accomplishing our core mission.
Strategies
TSCA Work Plan Risk Assessments: Chemical safety remains one of EPA’s highest priorities. EPA employs a variety of strategies under several statutes to ensure the safety of chemicals as a key element of a sustainable society. EPA’s strategy for its TSCA Work Plan risk assessment activity involves identifying and assessing those chemical uses that have the potential for greatest hazard and exposure to consumers and the environment.
The EPA engages in problem formulation and planning/scoping to strategically address those uses of specific Work Plan chemicals, or combinations of Work Plan chemicals and their high-priority uses, in a manner that most efficiently and effectively leads to an assessment that is capable of informing decisions on whether risk management actions are needed. EPA uses stakeholder engagement, public comment, and independent expert peer review to ensure that the assessments serve the agency’s commitment to using TSCA to its fullest extent to ensure chemical safety.
Pesticides Work Plan: While each pesticide review is unique, all pesticides go through the following basic registration review process:
- Focus Meetings: To enhance transparency and involvement, EPA has instituted Focus Meetings for many pesticides going through registration review. Typically involving registrants and others, Focus Meetings are intended to address areas of uncertainty such as unclear labels or missing studies that could affect EPA’s pesticide risk assessments and risk management decisions. By obtaining better information early in the process, EPA can narrow the scope of pesticide re-evaluations to areas that pose real concerns, based on current data and use patterns.
- Docket Opening: EPA initiates a registration review by establishing a docket for a pesticide registration review case and opening the docket for public review and comment. The Agency publishes a Federal Register notice that announces the availability of the docket and provides a comment period of at least 60 days. Anyone may submit data or information in response. EPA will consider information received during the comment period in conducting a pesticide's registration review.
EDSP Work Plan: EPA’s implementation strategy for this priority goal focuses on improving the efficiency and effectiveness of the program. To this end, the agency has developed a comprehensive management plan (http://epa.gov/endo/pubs/EDSP-comprehensive-management-plan.pdf) that lays out the strategic vision and operational activities over a 5-year time horizon.
Progress Update
Quarter 4 Update:
Pesticides: EPA pesticides program initiated registration review by establishing a docket for a pesticide registration review case and opening the docket for public review and comment. EPA considers information received during the comment period in conducting a pesticides registration review. The program has dedicated resources to ensure a robust pipeline of dockets and workplans.
TSCA: EPA released for public comment problem formulation and initial assessment documents for three flame retardant clusters. The problem formulations for these clusters include 10 chemicals, of which 3 are TSCA Work Plan Chemicals.Additionally, EPA released a data needs assessment for the Brominated Phthalate Cluster of flame retardants covering 7 chemicals, of which 2 are TSCA Work Plan Chemicals, identifying critical gaps in toxicity, exposure and commercial mixtures data to guide the collection of additional data and information.
EDSP: Made public the DERs for the 52 chemicals determinations. Published the Tier 2 guidelines. Published Tier 2 ICR.
2-yr Summary:
EPA met the APG target of more than 250 assessment by completing a total of 299 assessments of pesticides and other commercially available chemicals to evaluate risks they may pose to human health and the environment, including the potential for some of these chemicals to disrupt endocrine systems. Details of these assessments are summarized below.
Pesticides: Completed 219 assessments.
Meeting the challenge to incorporate the NAS agreement recommendations into the risk management process has been a daunting challenge, one the program has approached aggressively in order to satisfy the recommendations, properly address endangered species issues and pollinator concerns while remaining on track to meet the mandated 2022 completion date for registration review. The program is currently piloting several chemicals within the NAS framework. Moving forward lawsuits and petitions related to ESA and pollinators will continue, and will require resources to address the science and risk issues they raise.
TSCA: Over the course of the FY 14/15 APG, EPA released draft (or final without draft) assessments for 18 chemicals, composed of: 11 Risk Assessments (4 Work Plan Chemicals and 7 Non-Work Plan Chemicals), and 7 Data Needs Assessments (2 Work Plan Chemicals and 5 Non-Work Plan Chemicals).
EPA also finalized Risk Assessments for 5 TSCA Work Plan Chemicals. Risks were identified in 3 of the 5 Final Risk Assessments released (TCE, DCM, NMP). EPA is acting expeditiously on a range of possible voluntary and regulatory actions to address the risks identified.
The EPA implemented an important improvement in the TSCA Work Plan chemical assessment process by developing and publishing Problem Formulation & Initial Assessment documents. These documents serve to increase the transparency of EPA’s thinking and analysis process and are expected to result in more refined risk assessments by providing opportunity for the public/stakeholders to comment on EPA’s approach and provide additional data to supplement or refine assessments prior to EPA conducting detailed risk analysis.
EDSP: Completed 72 assessments.
Conducted two SAPs in 2014 on high throughput screening, exposure and computational modeling. Published the plan to use of high throughput screening and computational models (“ER Model”) as alternative to three Tier 1 assays (published June 16, 2015) and accepted “ER Model” data for 1,800 chemicals (located on website). Publicly-released the Tier 1 determinations (WoE) on 52 List 1 chemicals that received orders in 2009/2010. Made public the DERs for the 52 chemicals determinations. Published the Tier 2 guidelines and the Tier 2 ICR.
Next Steps
No Data Available
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Performance Indicators
TSCA Work Plan Risk Assessments
Pesticides Work Plan
EDSP Work Plan
Contributing Programs & Other Factors
Contributing programs within the agency
The Director, Office of Pollution Prevention and Toxics (OPPT), has the lead responsibility for accomplishing the TSCA Work Plan Chemical Risk Assessments goal. Contributing agency programs will vary depending on the particular chemical and uses being assessed. The Office of Research and Development (ORD), as well as the Office of Children’s Health Protection, will likely be involved in most, if not all, of the assessments. Other EPA offices that may be involved in specific Work Plan assessments include the Office of Solid Waste and Emergency Response, Office of Water, Office of Air and Radiation, Office of Policy, and regional offices.
The Office of Pesticide Programs (OPP) within the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) is responsible for implementing the pesticide registration review program. OPP may engage the EPA offices when drafting its risk assessments to ensure compliance with appropriate statutes/regulations and to obtain any relevant information. Office of Water (OW) supports the pesticide reevaluation program by providing information on water quality standards and water monitoring data on some pesticide active ingredients. ORD supports the pesticide reevaluation program by providing technical, scientific expertise on emerging scientific issues related to the pesticide active ingredients being reviewed.
All of OCSPP chemical assessment programs (Office of Science Coordination and Policy, Office of Pesticide Programs, and Office of Pollution Prevention and Toxics) contribute to this goal and take positive action to protect human health and the environment from adverse effects associated with harmful levels of chemical exposure. The Office of Science Coordination and Policy (OSCP) collaborates with the ORD to deliver and apply advanced toxicological methods that swiftly ensures public health and wildlife protection from exposure to harmful chemicals. Although OSCP is the lead office for endocrine program, OSCP shares coordinates and collaborates with the co-lead office, the Office of Water.
Contributing programs or partners outside the agency
EPA is actively partnering with other federal agencies on its Work Plan risk assessments, and is coordinating with others, including sharing and comparing scientific information. Partner and coordinating agencies include the Occupational Safety and Health Administration, the Consumer Product Safety Commission, the National Institute for Occupational Safety and Health, and the National Institute for Environmental Health Sciences. EPA also is coordinating with the states through the Environmental Council of the States, as well as with individual states such as California.
Several outside organizations contribute to the development of risk assessments as part of the EPA’s registration review program, as follows:
- The US Fish and Wildlife Service and the National Marine Fisheries Service contribute to EPA’s draft risk assessments by providing informal consultation when EPA’s evaluation has identified some uses of individual pesticides which may adversely affect or are likely to adversely affect federally listed species and habitats.
- The US Department of Agriculture contributes to EPA’s draft risk assessments by providing information on pesticide use/usage critical to fully understanding the use pattern of some pesticides, particularly as that use pattern may change over time.
- EPA collaborates with Canada’s Pest Management Regulatory Agency and other international co-regulators to share information in support of both organizations’ risk assessments. This effort ultimately helps promote international consistency in decision making and reduces the existence of trade barriers.
To achieve the agency’s goal to complete screening determinations under the Endocrine Disruptor Screening Program, the EPA also collaborates with Federal and International partners, such as National Institute for Environmental Health Service, National Toxicology Program, National Institute of Health, Food and Drug Administration, Japanese Ministry of Environment and Organization of Economic Cooperation and Development in the development of new advanced test methods for endocrine testing.
No Data Available
