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Louise P. WiseDeputy Assistant AdministratorOffice of Chemical Safety and Pollution Prevention
FY 16-17: Agency Priority Goal
Assess and reduce risks posed by chemicals and promote the use of safer chemicals in commerce.
Priority Goal
Goal Overview
Improving chemical safety is one of the most critical aspects of EPA’s work to protect human health and the environment and advance a sustainable future. 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. This APG addresses a key component of EPA’s chemical strategy – using all available information to assess whether chemicals entering or already being used in commerce pose risks to human health and the environment. EPA’s work on this critical issue is organized into three components:
• Assessing pesticides safety and effectiveness in determining whether to register and re-evaluate them for commercial use. Pesticides distributed and sold in the United States must generally 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 and registration review programs ensure that chemicals coming to and now available on the market meet current safety standards and, 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 (at least every fifteen years) pesticides to make sure that as change occurs, products in the marketplace can still be used safely. The Office of Pesticide Programs is continuously challenged to 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 4 for a more detailed discussion of the challenges presented by implementing the Endangered Species Act (ESA), Endocrine Disruptor Screening Program (EDSP) and White House Pollinator Health Strategy concerns. While challenging, implementing solutions to these issues will improve the Agency’s processes and allow for an open public venue for determining that products coming to market as well as those currently in the marketplace can be used safely.
• Assessing the safety of commercial chemicals, using the authorities of the Toxic Substances Control Act (TSCA).
o TSCA Work Plan Assessments: As part of EPA’s chemical safety program, EPA has identified a work plan of chemicals for assessment. Originally released in March 2012, and updated in October 2014, EPA’s TSCA Work Plan helps focus and direct the activities of its Existing Chemicals Program. The Agency committed to assess the chemicals in every-day, wide spread use to which our people, our communities and our environment may be exposed, starting with those on the Work Plan. The findings of these assessments guide decisions on whether risk reduction actions are needed to address risks to human health or the environment from exposure to particular chemical uses or groups of chemicals. More information about the TSCA Work Plan is available at: http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html.
o TSCA Section 5 (New Chemicals) Notice Assessments: In FY 2016 and FY 2017, the EPA will continue to fulfill its mandate under TSCA Section 5 to manage the potential risk to human health and the environment from chemicals to be introduced into the marketplace. Functioning as a “gatekeeper,” the EPA can identify conditions, up to and including a ban on production, to be placed on the use of a new chemical before it is entered into commerce. Anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose is required by section 5 of TSCA to provide EPA with notice before initiating the activity. This premanufacture notice, or PMN, can include information such as specific chemical identity, use, anticipated production volume, exposure and release information and existing available test data. Each year, the EPA receives approximately 1,000 new chemical notices under section 5, and must review and assess each PMN within 90 days of receipt. More information about the TSCA New Chemicals Program is available at: http://www.epa.gov/oppt/newchems/index.htm.
• Assessing whether chemicals have the potential to disrupt endocrine systems. Congress directed the agency to develop the Endocrine Disruptors Screening Program (EDSP) in accordance with the Food Quality Protection Act of 1996. The agency is employing high-throughput and computational methods to evaluate endocrine activity to screen over 10,000 chemicals for potential endocrine activity using validated test methods. The program involves requiring registrants to generate screening data for chemicals suspected of having effects on the endocrine system. In setting up the EDSP, it took several years to determine the appropriate tests, establish protocols, issue tests orders requiring these data, develop the data and review the data. To date, about 50 pesticides have been tested and reviewed. When a chemical is determined to be an endocrine disruptor, it will be incorporated into risk assessments and considered in the risk management decision for the chemical.
Strategies
PESTICIDES: To meet the statutory requirement to review all registered pesticides at least every 15 year involves three broad steps. The steps are the development of chemical-specific review workplans, completing risk assessments that meet current regulatory and scientific standards and making risk-management decisions. Each of these steps involves a formal comment period and outreach to interested parties.
While each pesticide review is unique and uses flexible approaches depending on the nature of the chemicals, many pesticides go through the following basic process:
• Focus Meetings: As needed, 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 opening a docket releasing a Preliminary Work Plan for a pesticide registration review case 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.
• Risk Assessment: When new information and data are evaluated, EPA conducts draft risk assessments. The Agency publishes a Federal Register notice that announces the availability of draft risk assessments and provides a comment period of at least 60 days. Anyone may submit data or information in response. EPA considers information received during the comment period to revise risk assessments as appropriate and complete its science-based review regarding the continued registration of the pesticide.
TSCA:
• TSCA Work Plan Assessments (Existing Chemicals). 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 reduction actions are needed. EPA uses stakeholder engagement, public comment and, where appropriate, 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.
• TSCA Section 5 Notice Assessments (New Chemicals). The PreManufacture Notices (PMNs) program has evolved into an efficient mechanism for identifying new chemicals that are of greatest concern during the early stages of the review process, and for focusing detailed analysis and action on these cases with the ultimate goal of identifying and controlling unreasonable risks. EPA utilizes an integrated approach that draws on knowledge and experience across scientific and organizational lines to identify and evaluate concerns regarding health and environmental effects, exposure and release, and economic impacts. Because many PMNs include little or no toxicity or fate data, the program uses several risk screening approaches to facilitate assessment in the absence of specific data. This enables rapid evaluation of potential risks and making risk-reduction decisions for the new chemicals within the 90-day time frame prescribed by TSCA. Some of these new chemicals program's computer models used to screen PMNs or exemption notices are publicly available through the Sustainable Futures Initiative.
EDSP: EPA’s strategy for this priority goal focuses on improving the efficiency and effectiveness of the program. To this end, the agency developed the EDSP Comprehensive Management Plan (http://epa.gov/endo/pubs/EDSP-comprehensive-management-plan.pdf) to lay out the strategic vision and operational activities over a five-year period. The EDSP work plan includes details of the ongoing transition to high-throughput and computational methods for efficiently screening chemicals for endocrine activity. Further testing and assessment of risk for endocrine disruption is accomplished using validated test methods, and integrated with other OCSPP and Agency risk and management.
MILESTONES
PESTICIDES
Draft Pesticides Risk Assessments: Utilizing new information and data obtained through the public comment period, outreach to interested parties and data call-in notices, EPA develops draft risk assessments that are available for public comment as part of the registration review program.
Indicator Statement: Number of draft pesticides risk assessments completed.
Unit of Measurement: Number of Draft Assessments
FY 2013-2015 Baseline: 136
FY 16 Target = 51
FY 17 Target = 53
Total FY 16/17 Target = 104
Pesticides PRIA Risk Assessments: In conducting a pesticide review of a new chemical or new use, the EPA will review the data and information that it believes should be considered in the review. EPA tracks the items on a quarterly basis as progress indicators for each case to ensure that draft risk assessments are completed on schedule.
Indicator Statement: Number of pesticides risk assessments completed under PRIA registration.
Unit of Measurement: Completed PRIA Assessments
FY 2013-2015 Baseline: 462
FY 16 Target = 154
FY 17 Target = 154
Total FY 16/17 Target = 308
TSCA
TSCA Work Plan Assessments (Existing Chemicals): For the Work Plan assessments, milestones are specific process steps: scoping/ problem formulation assessment development, issuance of a problem formulation assessment, public comment and, where appropriate, peer review, followed by finalization of the assessment. The timing of these process milestones is assessment-specific and determined by the complexity and type of data available and novelty of scientific approaches employed in the assessment.
Indicator Statement: Number of Completed Assessments for TSCA Work Plan and Related/Similar Chemicals.
Unit of Measurement: Completed Assessments
FY 2013-2015 Baseline: 12
FY 16 Target = 12
FY 17 Target = 19
Total FY 16/17 Target = 31
TSCA Section 5 Notice Assessments (New Chemicals): The number of completed reviews and assessments of PMNs within the reporting quarter will be the milestone for this subcomponent. Because PMNs are reviewed as they are submitted, within 90 days of receipt, assessments completed in Q2 for example, may contain PMNs received in Q1. Quarterly targets for New Chemicals Assessments are based on an assumption that PMNs are received at the same rate throughout the year, this is not always the case as notices may be submitted at different rates. However, it is not possible to establish targets that reflect actual submission rates over the year as they can change and are based on external parties and not in EPA control.
Indicator Statement: Number of Completed Assessments for TSCA New Chemicals Section 5 Notices.
Unit of Measurement: Completed TSCA Section 5 Assessments
FY 2013-2015 Baseline: over 3,400
FY 16 Target = 1,000
FY 17 Target = 1,000
Total FY 16/17 Target = 2,000
ENDOCRINE DISRUPTOR SCREENING PROGRAM (EDSP)
EDSP Decisions: By September 30, 2017, the Endocrine Disruptors Screening Program (EDSP) will complete estrogen pathway screening decisions for 1,000 chemicals using high-throughput and computational methods.
Indicator Statement: Number of chemicals for which estrogen pathway screening decisions were completed using high throughput and computational methods.
Unit of Measurement: Number Chemicals
FY 2013-2015 Baseline: 57
FY 16 Target = 0
FY 17 Target = 1,000
Total FY 16/17 Target = 1,000
Progress Update
Pesticides
EPA, in collaboration with the U.S. Fish and Wildlife Service, National Marine Fisheries Service (the Services) and USDA, reviewed the feedback from the 2-day ESA stakeholder workshop held in June 2016 and identified a number of short-term recommendations that will be considered for integration into the final biological evaluations (BEs) for chlorpyrifos, diazinon, and malathion and draft BEs for carbaryl and methomyl. EPA has started addressing public comments on the first 3 draft BEs and is making improvements to existing approaches, including to the models and tools used to automate the process for making effects determination for over 1800 endangered species. EPA, the Services, and USDA held a 3-day interagency workshop to discuss interim methods for conducting biological opinions (BOs) for the first 3 pilot chemicals. The Biological Evaluation (BE) documents EPA's conclusions and rationale regarding the potential effects of the federal action (i.e., pesticide registration according to the product label) on endangered species and designated critical habitat. If EPA determines that the action is likely to adversely affect endangered species, it must provide a BE to the Services as part of formal consultation. In response to the BE, the Services prepare a Biological Opinion recommending reasonable alternatives and measures necessary to avoid jeopardizing and minimizing "take" of endangered species.
Draft Risk Assessments: In Q4, 26 draft risk assessments were completed. Six of those counted in Q4 had been anticipated for completion in Q3 however the final documents where not signed until Q4. The Q3 actual result was restated to reflect this. The other part of the increase is reflective of the program pushing to expedite draft risk assessments in order to meet the 2022 deadline on decisions.
PRIA Risk Assessments: In Q4, there were 31 PRIA risk assessments instead of the 40 estimated. PRIA is dependent on the number of external requests received, rather than a planned workload. The targets were projected based on the average of what was received over the prior few years as best estimate of what can be expected.
EDSP
No estrogen pathway screening decisions were projected to be completed using high throughput and computational methods in FY 2016. In FY 2016, OSCPP continued development and validation of high throughput assays and computational tools for the estrogen, androgen, and thyroid pathways; developed performance-based test guidelines (PBTGs) using reference chemicals based on high throughput assays and computational models; and continued to coordinate across EPA, the U.S. government and with International partners to develop screening tools and tests for screening chemicals for potential endocrine disruption.
TSCA
EPA completed 107 TSCA Section 5 Notice assessments in Q4 relative to a target of 250, for a total of 808 completed over the entire fiscal year. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (enacted June 22, 2016), which significantly amended the Toxic Substances Control Act (TSCA), resulted in Section 5 notifications that had not officially completed review by the date of enactment (more than 300) being reassessed by EPA under the new law. In addition, EPA has continuing responsibilities to address all new notifications received. The new law’s requirements on affirmative determinations and conditions of use also have resulted in significant changes to the process. The new law now requires that an affirmative determination be made by EPA on whether a new chemical substance will present, may not present, or is not likely to present an unreasonable risk before it can proceed to the marketplace.
The Agency has made every effort to complete Section 5 new chemical reviews and make appropriate determinations in a timely manner. However, the changes instituted by the new TSCA law have temporarily slowed completion of EPA’s reviews. EPA has had to expeditiously determine how the law affects ongoing reviews and to identify and implement changes needed to ensure that both current and future reviews are conducted in accordance with the new law.
In FY 2016, EPA reviewed comments received on the Problem Formulation documents published in FY 2015 as part of its planning for the final Risk Assessments. In FY 2015, the EPA had established a new step (problem formulation) for existing chemical assessments, which provided for additional public input to inform the risk assessments. With enactment of the TSCA amendments, the EPA has shifted its workload to expediting the development of the extensive framework needed to implement the new statutory requirements. As a result of these two key shifts, no existing TSCA Work Plan chemical assessments were completed in FY 2016. A key priority is to develop new procedures for developing and publishing “Scoping” documents, which are equivalent to the prior Problem Formulation documents. The agency will review all comments previously received on Problem Formulation documents in the course of developing Scoping documents for release in FY 2017.
Next Steps
Pesticides
EPA will continue the development of chemical specific review work plans following docket openings, completing risk assessments that meet current regulatory and scientific standards and making risk management decisions. OPP expects to meet annual targets as the program works to streamline the process and improve efficiencies in the development of risk assessments.
EPA plans to release the final BEs for the first 3 pilot chemicals and the draft BEs for the next 2 pilot chemicals (carbaryl and methomyl) in FY 2017. In collaboration with our regulatory partners in Canada and California, EPA will release a status update for the imidacloprid pollinator assessment and the draft pollinator risk assessments for clothianidin, thiamethoxam, and dinotefuran in FY 2017. EPA will continue to collaborate with the Services and USDA on methods for conducting the BOs for the first three pilot chemicals due in FY 2018.
EDSP
EPA will prepare for and host a FIFRA Science Advisory Panel (SAP) meeting (including all background and supporting materials) in spring 2017 as an independent scientific peer review step and continue development and validation of high throughput assays and computational tools for the estrogen, androgen, steroidogenesis and thyroid pathways.
TSCA
The new TSCA amendments require significant process changes for both new and existing chemical assessments. EPA is evaluating how the law affects TSCA Work Plan chemical assessments and TSCA Section 5 new chemical reviews, with the aim of identifying changes needed to ensure that risk evaluations and new chemical reviews are conducted in accordance with statutory requirements.
No existing chemical assessments were completed in FY 2016 or expected in FY 2017. Therefore, the target for the Existing Chemicals program is being deleted for the duration of this APG. The EPA is evaluating how the law TSCA affects assessments and new chemical reviews, with the aim of identifying changes to ensure that risk evaluations, and new chemical reviews are conducted in accordance with statutory requirements.
The new law requires that EPA initiate risk evaluations for 10 chemicals within 180 days of enactment (December 19, 2016) and to complete these within 3.5 years. By end of FCY 2019, EPA must have at least 20 Risk Evaluations underway.
EPA expects to be able to release the first set of risk evaluations for TSCA Work Plan chemicals under the new law in about three years; in the meantime, interim work products (e.g., Scoping documents, draft risk evaluations) will be published according to the schedule set forth in the new law.
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Performance Indicators
Draft Pesticides Risk Assessments
Pesticides PRIA Risk Assessments
TSCA Work Plan Assessments (Existing Chemicals)
TSCA Section 5 Notice Assessments (New Chemicals)
Number of chemicals for which estrogen pathway screening decisions were completed using high throughput and computational methods
Contributing Programs & Other Factors
A) Contributing programs within the agency
PESTICIDES: 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 and registration review programs. OPP may engage other 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 programs by providing information on water quality standards and water monitoring data on some pesticide active ingredients. Office of Research and Development (ORD) supports OPP by providing technical, scientific expertise on emerging scientific issues related to the pesticide active ingredients being reviewed.
TSCA: The Director, Office of Pollution Prevention and Toxics (OPPT), has the lead responsibility for accomplishing the work associated with the TSCA Indicators. Contributing agency programs will vary depending on the particular chemical and uses being assessed. The Office of Research and Development (ORD), will likely be involved in many 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.
EDSP: The Office of Science Coordination and Policy (OSCP), Office of Pesticide Programs (OPP), and Office of Pollution Prevention and Toxics (OPPT) 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 OSCP collaborates with the Office of Research and Development (ORD) and Office of Water (OW) to deliver and apply advanced toxicological methods that swiftly ensure public health and wildlife protection from exposure to harmful chemicals.
B) Contributing programs or partners outside the agency
PESTICIDES: Several outside organizations contribute to the development of pesticide 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 often collaborates with Canada’s Pest Management Regulatory Agency (PMRA) and other international co-regulators to share information in support of both organizations’ risk assessments. As an example, EPA in collaboration with PMRA published a harmonized guidance on assessing risks of pesticides to bees. The process described in the harmonized guidance and the studies reflects a wider collaboration with international regulatory partners in the Organization for Economic Cooperation and Development (OECD). Efforts such as this ultimately helps promote international consistency in decision making and reduces the existence of trade barriers.
TSCA: In addition to partnering with other EPA Offices, OPPT is partnering with other Agencies doing assessments of the same chemicals for different mandates leveraging resources and reducing duplication to the degree possible. These other agencies partners include the National Institute of Environmental Health Sciences (NIEHS), the Agency for Toxic Substances and Disease Registry (ATSDR), the Consumer Product Safety Commission (CPSC), the National Institute of Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA).
EDSP: To achieve the agency’s goal to complete screening determinations under the Endocrine Disruptors Screening Program, the EPA also collaborates with other federal agencies, and International partners such as National Institutes of Health (NIH), Food and Drug Administration (FDA), the Organization for Economic Cooperation and Development (OECD), and other agencies to deliver and apply high-throughput and computational methods to evaluate endocrine activity of environmental chemicals.
C) Key barriers and challenges
PESTICIDES: As science, risk assessment methodology, and Agency policy related to pesticides continually evolve and improve over time, EPA faces the challenge of maintaining consistency between risk assessments produced at the beginning and at the end of the 15-year registration review cycle. The EPA generally must obtain scientific data from pesticide registrants in order to ensure the accuracy of its evaluation of pesticide uses. When data are not received in a timely manner, EPA’s draft risk assessments may be delayed. In many cases, EPA faces uncertainty on the extent to which the regulated community will submit information required for risk assessment in a timely manner. Although EPA issues data call-ins (DCI) that provide legally binding due dates for pesticide registrants to submit information, registrant responses may be delayed due to a variety of factors such as lab availability, the quality of the data submitted, and business/budget constraints. When lawsuits and petitions are filed with the agency on specific pesticide active ingredients, these actions often introduce uncertainty related to the timing of the development of draft risk assessments and the availability of resources needed to conduct the risk assessment.
A significant challenge for the program is the implementation of the Endangered Species Act (ESA) and staying current on statutorily mandated deadlines. In response, on April 30, 2013 the National Academy of Sciences’ National Research Council (NRC) released recommendations for assessing risks from pesticides to listed species under the ESA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Four agencies, the Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Fish and Wildlife Service (FWS), and the National Marine Fisheries Service (NMFS) (collectively the Services) are working collaboratively to develop and implement interim scientific approaches to evaluate the potential impacts of pesticides to endangered and threatened species, based on the NRC report recommendations. Currently, the agencies are applying the interim scientific methods to nationwide consultations for five pesticides (carbaryl, chlorpyrifos, diazinon, malathion, and methomyl). Once the interim scientific approaches are vetted in the context of the first five nationwide consultations, EPA will use the agreed upon approach to include national-level ESA effects determinations to assess risks to listed species as part of the overall ecological risk assessments in registration review. EPA will consult with the Services as appropriate, based on the effects determination.
Pollinator protection is a significant challenge to OPP and is one of its highest priorities. We are working along with other Agencies to implement the Pollinator Health Strategy released by the White House on May 19, 2015. EPA will work to protect pollinators from pesticide risks through regulatory action, voluntary changes to pesticide use by registrants, research programs and public/private partnerships, all of which are aimed at better understanding and mitigating the factors associated with declining pollinator health.
TSCA:
• TSCA Work Plan Assessments (Existing Chemicals). The EPA faces several barriers and challenges in meeting its TSCA Work Plan chemical assessment goals. Challenges reside in two main areas: resources and scientific information. The assessments are dependent on both staff and contract resources. The availability of resources is related to the unique level of complexity of each assessment. In addition, the results of scientific assessments are usually impossible to predict in advance. Until EPA actually starts doing an assessment of a chemical, it is hard to know whether the available data will allow the agency to state with confidence that a chemical does or does not present risks of concern.
• TSCA Section 5 Notice Assessments (New Chemicals). The number of assessments of TSCA Section 5 Notices is dependent on external parties submitting PMNs to the EPA. Fluctuations in the economy or the marketplace can lead to reduced or increased numbers of PMNs received by the EPA. To address this, the EPA has set the annual Agency Priority Goal target for this subcomponent at the lowest number of PMN submissions received in prior years (FY 2010). Overachievement of this subcomponent may occur as EPA must review and assess all PMNs received within 90 days of receipt, and, as noted, EPA does not control the number of PMNs submitted. Additionally, newer more complex forms of Section 5 Notices (e.g. biotechnology submissions, such as Microbial Commercial Activity Notices (MCAN)) pose a potential challenge to achieving the targets because they typically include more data to evaluate and the science behind the synthetic biology and uses is more complicated. Accordingly, these submissions require more attention and more unique and specialized expertise than standard PMN reviews. The Agency expects the numbers of these types of submissions to grow during the time frame for this APG.
EDSP: The Office of Science Coordination and Policy (OSCP) leads the Endocrine Disruptors Screening program (EDSP) and collaborates with Office of Research and Development (ORD), National Institutes of Health (NIH), Food and Drug Administration (FDA), and other agencies to apply high throughput and computational methods to evaluate endocrine disrupting potential of environmental chemicals. Coordination across EPA and with partners across the U.S. Government demands active communications to prevent barriers between the agencies and promote effective communication. The work of the Endocrine Disruptors Screening Program (EDSP) is also coordinated with the Organization for Economic Cooperation and Development (OECD) and other International partners.
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Strategic Goals
Strategic Goal:
Ensuring the Safety of Chemicals and Preventing Pollution
Statement:
Reduce the risk and increase the safety of chemicals and prevent pollution at the source.
Strategic Objectives
Statement:
Reduce the risk and increase the safety of chemicals that enter our products, our environment, and our bodies.
Description:
Chemical safety remains one of EPA’s highest priorities. EPA employs a variety of strategies under several statutes to ensure the safety of chemicals, adequately protect against unreasonable public health or environmental risks, and foster sustainability. These include:
- Acting under TSCA to ensure that new industrial and commercial chemicals do not pose unreasonable risk before they are introduced into commerce;
- Assessing existing chemicals already in use before TSCA took effect (62,000 chemicals were already in use in commerce before 1978) and acting to reduce identified risks and to identify and promote safer alternatives;
- Empowering the public and decision makers by making chemical safety information more widely available and usable;
- Acting under the Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA) and the Endangered Species Act to ensure that pesticides are used safely and effectively; and,
- Developing and applying protocols to assess chemicals’ potential to interact with the endocrine system.
EPA uses predictive techniques to assess the safety of new chemicals in the face of information limitations imposed by TSCA. More daunting has been the challenge of assessing and acting where needed on the more than 60,000 existing chemicals “grandfathered” under the statute.[1] On that front, the Agency has made considerable progress in recent years, working in cooperation with stakeholders by using all available information to put these chemicals through a prioritization methodology. This effort led to the identification of a set of more than 80 chemicals (TSCA work plan chemicals) for further assessment. EPA believes that these are the chemicals most in need of risk assessment and that adequate data exist for that purpose. The first five risk assessments for TSCA work plan chemicals were made available by EPA for public and peer review less than a year after they were publicly identified for assessment. Assessments of 23 additional chemicals—including 20 flame retardants—were announced in 2013. Looking forward, EPA plans to assess all of the remaining work plan chemicals to initiate risk management actions as appropriate, and identify additional work plan chemicals for subsequent priority assessment. EPA is establishing an FY 2014-2015 Agency Priority Goal for this effort.[2]
Recognizing the crucial role that the public, state, tribal, and local partners, institutions, and industry play in ensuring chemical safety, EPA has expanded web access to the Agency’s chemical information and assessment tools, with a focus on identifying safer chemicals. At the same time, two newly developed electronic tools will greatly improve data quality and public accessibility. These are the Chemical Information System (CIS), which will speed the Agency’s transition to electronic reporting and processing for required chemical safety information, and the interactive ChemView Portal, which will enable both internal and external users to access TSCA chemical data stored in EPA systems quickly and easily. Planned enhancements to CIS will extend electronic reporting to nearly all required TSCA submissions and integrate the system with scientific tools, dashboards, and models used in making chemical management decisions. In addition, EPA is working to expand the ChemView Portal to further broaden public access to TSCA chemical information, and has plans to enable faster, automated posting of non-confidential TSCA data to EPA’s public websites. These electronic tools are components of the Agency’s Next Generation Compliance initiative, aimed at designing more effective regulations that are easier to implement for improving compliance and environmental outcomes throughout the life cycle of hazardous materials; shifting toward electronic reporting by regulated entities to ensure more accurate, complete, and timely information; and expanding transparency.
EPA will make major strides in guarding against exposure to chemicals that continue to pose potential risks to human health and the environment even after their hazards have been identified and certain uses have been phased out. For example, to continue to reduce childhood blood lead levels, EPA is working in partnership with states and tribes to certify hundreds of thousands of renovators and contractors on lead hazard management. More than 461,000 individuals have been certified by EPA alone, and nearly 130,000 firms have been certified by EPA and the states through April 2013. Certification coupled with public outreach is intended to expand public awareness of lead-based paint risks as well as the requirements for the use of lead-safe practices in renovation, remodeling, and painting activities in millions of older homes.[3,4]
On a broader scale, EPA is looking comprehensively across statutes to determine the best tools to apply to specific problems. For example, the Agency is exploring how to use FIFRA and TSCA to ensure that drinking water is protected from pesticides and industrial chemicals, and that chemicals found in drinking water are being screened for endocrine disrupting properties using the authorities of the Safe Drinking Water Act (SDWA) (including issuance of test orders), the Federal Food, Drug, and Cosmetic Act (FFDCA), and FIFRA.
In addition, EPA is continuing its work to increase the safety of chemicals and prevent pollution on an international scale. This is being accomplished primarily through cooperative engagement with international bodies such as the United Nations Environment Programme (UNEP) and the Organization for Economic Cooperation and Development (OECD) on scientific and technical issues. The key focus areas include harmonization of chemical test guidelines, regulatory coordination, negotiation, and implementation of global/regional standards, and instruments and assistance on pollution prevention activities. EPA is working collaboratively with stakeholders both domestically and internationally to develop approaches to better assess nanomaterials[5], including work with the OECD on internationally harmonized test guidelines.
Over the next 4 years, EPA will manage a comprehensive pesticide risk reduction program through science-based registration and reevaluation processes, a worker safety program, certification and training activities, and support for integrated pest management.
- EPA’s current pesticide review processes focus on ensuring that pesticide registrations comply with the Endangered Species Act and achieve broader Agency objectives for water quality protection. The review processes will continue to place emphasis on the protection of potentially sensitive populations, such as children, by reducing exposures from pesticides used in and around homes, schools, and other public areas.
- EPA’s new data requirement rule for antimicrobial pesticides will ensure that pesticide risk management decisions are based on the best available science and will contribute to a more efficient and transparent registration process through increased certainty about the data requirements. EPA’s review processes ensure that pesticides can be used safely and are available for use to maintain a safe and affordable food supply, to address public health outbreaks, and to minimize property damage that can occur from insects and pests.[6]
- EPA has reviewed its agricultural worker protection regulation and its pesticide applicator certification regulation and will publish for public comment proposed changes to both. The proposed rulemakings are designed to ensure improved pesticide worker safety standards and pesticide applicator competency standards in the coming years.
- EPA is implementing a comprehensive testing program to screen for chemicals’ potential to interact with the endocrine system.[7] In response to a recently concluded program evaluation, EPA has developed a comprehensive management plan for the endocrine disruptor screening program, providing a clear workplan, projected milestones, and vision for developing a more efficient and effective screening and testing program through the application of computational toxicology methods. Use of these methods may have the added benefit of helping to reduce the need for animal testing when conducting chemical screening and risk assessment.
To ensure the continued effectiveness of the various chemical programs, EPA will conduct several evaluations over the next 4 years. In FY 2014, EPA will initiate a review of critical factors that have an impact on the effectiveness of the Agency’s risk assessment efforts for TSCA work plan chemicals. In FY 2015, the Agency will evaluate the effectiveness of recently implemented efficiencies to the registration review process to identify further enhancements and efficiencies to the process. EPA will also conduct biennial reviews in 2015 and 2017 to determine whether the level of fees charged to the submitters of New Chemical Pre-Manufacture Notices and to the applicants for certification to perform lead renovation, repair, and painting work and lead abatement work are appropriate.
External Factors and Emerging Issues
As we look to the future, it is important to continue working together with Congress and stakeholders to modernize and strengthen the tools available under TSCA to prevent harmful chemicals from entering the marketplace and to increase confidence that those chemicals that remain are safe and do not endanger the environment or human health, especially for consumers, workers, and sensitive subpopulations like children. Potential legislative action to reauthorize TSCA is both a key external factor and a key emerging issue. Consistent with the Administration’s essential principles, EPA’s authority under TSCA should be modernized and strengthened to increase confidence that chemicals used in commerce are safe and do not endanger public health and welfare. EPA is committed to working with the Congress, members of the public, the environmental community, and industry to reauthorize TSCA.
On April 30, 2013, the National Academy of Sciences’ National Research Council (NRC) released its recommendations for assessing risks from pesticides to listed species under the Endangered Species Act and FIFRA. The Environmental Protection Agency, U.S. Department of Agriculture, U.S. Fish and Wildlife Service, and National Marine Fisheries Service are working collaboratively and expeditiously to review the report and identify improvements in the current scientific procedures used in evaluating the potential impacts of pesticides to endangered and threatened species. On November 13, 2013, the federal agencies released a white paper detailing an interim approach for implementing the panel’s recommendations.[8] We currently anticipate that implementation of the recommendations could take 18-36 months, which could have an impact on our progress in developing preliminary risk assessments and completing decisions for pesticides as part of the registration review program.
Finally, a number of chemical safety programs are affected by changing levels of economic activity. For example, EPA’s work in certifying firms to perform lead renovation, repair, and painting work depends partly on fluctuations in the level of demand for such services, which are related in turn to economic conditions in the housing market.
Endnotes:
- EPA chemical safety program information is available at http://www.epa.gov/oppt/existingchemicals/, http://www.epa.gov/oppt/newchems/, and http://www.epa.gov/oppt/nano/.
- FY 2014-2015 Agency Priority Goal: Assess and reduce risks posed by chemicals and promote the use of safer chemicals in commerce. By September 30, 2015, EPA will have completed more than 250 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. These assessments are essential in determining whether products containing these chemicals can be used safely for commercial, agricultural, and/or industrial uses.
- Information about childhood lead poisoning is available at www.epa.gov/lead.
- EPA Lead-Safe Certification Program, information available at http://www.epa.gov/lead/pubs/toolkits.htm.
- Nanomaterials are chemical substances or materials manufactured and used at a very small scale—down to 10,000 times smaller than a human hair. See also, www.nano.gov.
- EPA pesticides program information is available at http://www.epa.gov/pesticides.
- Information about the EPA endocrine disruptor screening program is available at http://www.epa.gov/scipoly/oscpendo/index.htm.
- The white paper is available at http://www.epa.gov/espp/2013/interagency.pdf.
Statement:
Conserve and protect natural resources by promoting pollution prevention and the adoption of other sustainability practices by companies, communities, governmental organizations, and individuals.
Description:
The 1990 Pollution Prevention Act established national policy for the use of P2 as the first choice in addressing pollution at the source. Time and experience have added to our understanding and appreciation of the value of preventing pollution before it occurs. P2 is central to all of EPA’s sustainability strategies, and EPA will continue to incorporate P2 principles into its policies, regulations, and actions.[1]
EPA strives to prevent pollution by fostering the development of P2 solutions and promoting increased use of those solutions. The results of these strategies include significant reductions in the use of hazardous materials, energy, and water and in the generation of greenhouse gases, as well as significant increases in the availability and use of safer chemicals and safer chemical products. EPA’s successful implementation of these strategies also enables businesses, governments, and other institutions to reduce their costs. These strategies are key elements of EPA’s approach to achieving a sustainable future. Specific activities conducted to implement these strategies include:
- Fostering the development of P2 innovations:
- Promoting green chemistry and green engineering, and developing educational curricula;
- Establishing technical criteria for chemical alternatives assessments;
- Participating in the development of voluntary consensus standards and other safer chemical products criteria, including participating in international cooperative efforts;
- Establishing greener purchasing and management practices (i.e., environmentally preferable purchasing); and,
- Incorporating P2 solutions in regulatory options or requirements.
- Promoting increased use of P2 innovations:
- Providing and promoting technical assistance, such as establishing Economy, Energy, and Environment (E3) Partnerships (in conjunction with the Departments of Agriculture, Commerce, Energy, and Labor, and the Small Business Administration) or providing technical assistance on manufacturing, green sports, or other business sectors;
- Demonstrating the benefits of P2 solutions;
- Labeling safer products by working with key stakeholders through the Design for the Environment (DfE) program;
- Leveraging the power of federal purchasing; and,
- Coordinating with other P2 offices across the Agency with shared audiences or sustainability approaches, including ENERGY STAR, WaterSense, the sustainable materials management program, and other complementary programs between Goal 3 and Goal 4.
External Factors and Emerging Issues
The Agency’s multi-media P2 efforts are affected by changes in economic conditions. Much of EPA’s P2 work is voluntary, so success depends in part on participation levels by industry, government agencies, and members of the public.
Endnotes:
- EPA pollution prevention program information is available at http://www.epa.gov/p2/.
Agency Priority Goals
Statement:
By September 30, 2017, the EPA will complete more than 3,400 assessments of pesticides and other commercially available chemicals to evaluate risks they may pose to human health and the environment. These assessments are essential in determining whether products containing these chemicals can be used safely for commercial, agricultural, and/or industrial uses. For example, assessments can help determine the potential for chemicals to disrupt endocrine systems or to pose risks to honey bees and other pollinators by outdoor use of pesticides.
Description:
Improving chemical safety is one of the most critical aspects of EPA’s work to protect human health and the environment and advance a sustainable future. 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. This APG addresses a key component of EPA’s chemical strategy – using all available information to assess whether chemicals entering or already being used in commerce pose risks to human health and the environment. EPA’s work on this critical issue is organized into three components:
• Assessing pesticides safety and effectiveness in determining whether to register and re-evaluate them for commercial use. Pesticides distributed and sold in the United States must generally 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 and registration review programs ensure that chemicals coming to and now available on the market meet current safety standards and, 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 (at least every fifteen years) pesticides to make sure that as change occurs, products in the marketplace can still be used safely. The Office of Pesticide Programs is continuously challenged to 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 4 for a more detailed discussion of the challenges presented by implementing the Endangered Species Act (ESA), Endocrine Disruptor Screening Program (EDSP) and White House Pollinator Health Strategy concerns. While challenging, implementing solutions to these issues will improve the Agency’s processes and allow for an open public venue for determining that products coming to market as well as those currently in the marketplace can be used safely.
• Assessing the safety of commercial chemicals, using the authorities of the Toxic Substances Control Act (TSCA).
o TSCA Work Plan Assessments: As part of EPA’s chemical safety program, EPA has identified a work plan of chemicals for assessment. Originally released in March 2012, and updated in October 2014, EPA’s TSCA Work Plan helps focus and direct the activities of its Existing Chemicals Program. The Agency committed to assess the chemicals in every-day, wide spread use to which our people, our communities and our environment may be exposed, starting with those on the Work Plan. The findings of these assessments guide decisions on whether risk reduction actions are needed to address risks to human health or the environment from exposure to particular chemical uses or groups of chemicals. More information about the TSCA Work Plan is available at: http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html.
o TSCA Section 5 (New Chemicals) Notice Assessments: In FY 2016 and FY 2017, the EPA will continue to fulfill its mandate under TSCA Section 5 to manage the potential risk to human health and the environment from chemicals to be introduced into the marketplace. Functioning as a “gatekeeper,” the EPA can identify conditions, up to and including a ban on production, to be placed on the use of a new chemical before it is entered into commerce. Anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose is required by section 5 of TSCA to provide EPA with notice before initiating the activity. This premanufacture notice, or PMN, can include information such as specific chemical identity, use, anticipated production volume, exposure and release information and existing available test data. Each year, the EPA receives approximately 1,000 new chemical notices under section 5, and must review and assess each PMN within 90 days of receipt. More information about the TSCA New Chemicals Program is available at: http://www.epa.gov/oppt/newchems/index.htm.
• Assessing whether chemicals have the potential to disrupt endocrine systems. Congress directed the agency to develop the Endocrine Disruptors Screening Program (EDSP) in accordance with the Food Quality Protection Act of 1996. The agency is employing high-throughput and computational methods to evaluate endocrine activity to screen over 10,000 chemicals for potential endocrine activity using validated test methods. The program involves requiring registrants to generate screening data for chemicals suspected of having effects on the endocrine system. In setting up the EDSP, it took several years to determine the appropriate tests, establish protocols, issue tests orders requiring these data, develop the data and review the data. To date, about 50 pesticides have been tested and reviewed. When a chemical is determined to be an endocrine disruptor, it will be incorporated into risk assessments and considered in the risk management decision for the chemical.
Strategic Objectives
Strategic Objective:
Statement:
Reduce the risk and increase the safety of chemicals that enter our products, our environment, and our bodies.
Description:
Chemical safety remains one of EPA’s highest priorities. EPA employs a variety of strategies under several statutes to ensure the safety of chemicals, adequately protect against unreasonable public health or environmental risks, and foster sustainability. These include:
- Acting under TSCA to ensure that new industrial and commercial chemicals do not pose unreasonable risk before they are introduced into commerce;
- Assessing existing chemicals already in use before TSCA took effect (62,000 chemicals were already in use in commerce before 1978) and acting to reduce identified risks and to identify and promote safer alternatives;
- Empowering the public and decision makers by making chemical safety information more widely available and usable;
- Acting under the Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA) and the Endangered Species Act to ensure that pesticides are used safely and effectively; and,
- Developing and applying protocols to assess chemicals’ potential to interact with the endocrine system.
EPA uses predictive techniques to assess the safety of new chemicals in the face of information limitations imposed by TSCA. More daunting has been the challenge of assessing and acting where needed on the more than 60,000 existing chemicals “grandfathered” under the statute.[1] On that front, the Agency has made considerable progress in recent years, working in cooperation with stakeholders by using all available information to put these chemicals through a prioritization methodology. This effort led to the identification of a set of more than 80 chemicals (TSCA work plan chemicals) for further assessment. EPA believes that these are the chemicals most in need of risk assessment and that adequate data exist for that purpose. The first five risk assessments for TSCA work plan chemicals were made available by EPA for public and peer review less than a year after they were publicly identified for assessment. Assessments of 23 additional chemicals—including 20 flame retardants—were announced in 2013. Looking forward, EPA plans to assess all of the remaining work plan chemicals to initiate risk management actions as appropriate, and identify additional work plan chemicals for subsequent priority assessment. EPA is establishing an FY 2014-2015 Agency Priority Goal for this effort.[2]
Recognizing the crucial role that the public, state, tribal, and local partners, institutions, and industry play in ensuring chemical safety, EPA has expanded web access to the Agency’s chemical information and assessment tools, with a focus on identifying safer chemicals. At the same time, two newly developed electronic tools will greatly improve data quality and public accessibility. These are the Chemical Information System (CIS), which will speed the Agency’s transition to electronic reporting and processing for required chemical safety information, and the interactive ChemView Portal, which will enable both internal and external users to access TSCA chemical data stored in EPA systems quickly and easily. Planned enhancements to CIS will extend electronic reporting to nearly all required TSCA submissions and integrate the system with scientific tools, dashboards, and models used in making chemical management decisions. In addition, EPA is working to expand the ChemView Portal to further broaden public access to TSCA chemical information, and has plans to enable faster, automated posting of non-confidential TSCA data to EPA’s public websites. These electronic tools are components of the Agency’s Next Generation Compliance initiative, aimed at designing more effective regulations that are easier to implement for improving compliance and environmental outcomes throughout the life cycle of hazardous materials; shifting toward electronic reporting by regulated entities to ensure more accurate, complete, and timely information; and expanding transparency.
EPA will make major strides in guarding against exposure to chemicals that continue to pose potential risks to human health and the environment even after their hazards have been identified and certain uses have been phased out. For example, to continue to reduce childhood blood lead levels, EPA is working in partnership with states and tribes to certify hundreds of thousands of renovators and contractors on lead hazard management. More than 461,000 individuals have been certified by EPA alone, and nearly 130,000 firms have been certified by EPA and the states through April 2013. Certification coupled with public outreach is intended to expand public awareness of lead-based paint risks as well as the requirements for the use of lead-safe practices in renovation, remodeling, and painting activities in millions of older homes.[3,4]
On a broader scale, EPA is looking comprehensively across statutes to determine the best tools to apply to specific problems. For example, the Agency is exploring how to use FIFRA and TSCA to ensure that drinking water is protected from pesticides and industrial chemicals, and that chemicals found in drinking water are being screened for endocrine disrupting properties using the authorities of the Safe Drinking Water Act (SDWA) (including issuance of test orders), the Federal Food, Drug, and Cosmetic Act (FFDCA), and FIFRA.
In addition, EPA is continuing its work to increase the safety of chemicals and prevent pollution on an international scale. This is being accomplished primarily through cooperative engagement with international bodies such as the United Nations Environment Programme (UNEP) and the Organization for Economic Cooperation and Development (OECD) on scientific and technical issues. The key focus areas include harmonization of chemical test guidelines, regulatory coordination, negotiation, and implementation of global/regional standards, and instruments and assistance on pollution prevention activities. EPA is working collaboratively with stakeholders both domestically and internationally to develop approaches to better assess nanomaterials[5], including work with the OECD on internationally harmonized test guidelines.
Over the next 4 years, EPA will manage a comprehensive pesticide risk reduction program through science-based registration and reevaluation processes, a worker safety program, certification and training activities, and support for integrated pest management.
- EPA’s current pesticide review processes focus on ensuring that pesticide registrations comply with the Endangered Species Act and achieve broader Agency objectives for water quality protection. The review processes will continue to place emphasis on the protection of potentially sensitive populations, such as children, by reducing exposures from pesticides used in and around homes, schools, and other public areas.
- EPA’s new data requirement rule for antimicrobial pesticides will ensure that pesticide risk management decisions are based on the best available science and will contribute to a more efficient and transparent registration process through increased certainty about the data requirements. EPA’s review processes ensure that pesticides can be used safely and are available for use to maintain a safe and affordable food supply, to address public health outbreaks, and to minimize property damage that can occur from insects and pests.[6]
- EPA has reviewed its agricultural worker protection regulation and its pesticide applicator certification regulation and will publish for public comment proposed changes to both. The proposed rulemakings are designed to ensure improved pesticide worker safety standards and pesticide applicator competency standards in the coming years.
- EPA is implementing a comprehensive testing program to screen for chemicals’ potential to interact with the endocrine system.[7] In response to a recently concluded program evaluation, EPA has developed a comprehensive management plan for the endocrine disruptor screening program, providing a clear workplan, projected milestones, and vision for developing a more efficient and effective screening and testing program through the application of computational toxicology methods. Use of these methods may have the added benefit of helping to reduce the need for animal testing when conducting chemical screening and risk assessment.
To ensure the continued effectiveness of the various chemical programs, EPA will conduct several evaluations over the next 4 years. In FY 2014, EPA will initiate a review of critical factors that have an impact on the effectiveness of the Agency’s risk assessment efforts for TSCA work plan chemicals. In FY 2015, the Agency will evaluate the effectiveness of recently implemented efficiencies to the registration review process to identify further enhancements and efficiencies to the process. EPA will also conduct biennial reviews in 2015 and 2017 to determine whether the level of fees charged to the submitters of New Chemical Pre-Manufacture Notices and to the applicants for certification to perform lead renovation, repair, and painting work and lead abatement work are appropriate.
External Factors and Emerging Issues
As we look to the future, it is important to continue working together with Congress and stakeholders to modernize and strengthen the tools available under TSCA to prevent harmful chemicals from entering the marketplace and to increase confidence that those chemicals that remain are safe and do not endanger the environment or human health, especially for consumers, workers, and sensitive subpopulations like children. Potential legislative action to reauthorize TSCA is both a key external factor and a key emerging issue. Consistent with the Administration’s essential principles, EPA’s authority under TSCA should be modernized and strengthened to increase confidence that chemicals used in commerce are safe and do not endanger public health and welfare. EPA is committed to working with the Congress, members of the public, the environmental community, and industry to reauthorize TSCA.
On April 30, 2013, the National Academy of Sciences’ National Research Council (NRC) released its recommendations for assessing risks from pesticides to listed species under the Endangered Species Act and FIFRA. The Environmental Protection Agency, U.S. Department of Agriculture, U.S. Fish and Wildlife Service, and National Marine Fisheries Service are working collaboratively and expeditiously to review the report and identify improvements in the current scientific procedures used in evaluating the potential impacts of pesticides to endangered and threatened species. On November 13, 2013, the federal agencies released a white paper detailing an interim approach for implementing the panel’s recommendations.[8] We currently anticipate that implementation of the recommendations could take 18-36 months, which could have an impact on our progress in developing preliminary risk assessments and completing decisions for pesticides as part of the registration review program.
Finally, a number of chemical safety programs are affected by changing levels of economic activity. For example, EPA’s work in certifying firms to perform lead renovation, repair, and painting work depends partly on fluctuations in the level of demand for such services, which are related in turn to economic conditions in the housing market.
Endnotes:
- EPA chemical safety program information is available at http://www.epa.gov/oppt/existingchemicals/, http://www.epa.gov/oppt/newchems/, and http://www.epa.gov/oppt/nano/.
- FY 2014-2015 Agency Priority Goal: Assess and reduce risks posed by chemicals and promote the use of safer chemicals in commerce. By September 30, 2015, EPA will have completed more than 250 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. These assessments are essential in determining whether products containing these chemicals can be used safely for commercial, agricultural, and/or industrial uses.
- Information about childhood lead poisoning is available at www.epa.gov/lead.
- EPA Lead-Safe Certification Program, information available at http://www.epa.gov/lead/pubs/toolkits.htm.
- Nanomaterials are chemical substances or materials manufactured and used at a very small scale—down to 10,000 times smaller than a human hair. See also, www.nano.gov.
- EPA pesticides program information is available at http://www.epa.gov/pesticides.
- Information about the EPA endocrine disruptor screening program is available at http://www.epa.gov/scipoly/oscpendo/index.htm.
- The white paper is available at http://www.epa.gov/espp/2013/interagency.pdf.
Agency Priority Goals
Statement: By September 30, 2017, the EPA will complete more than 3,400 assessments of pesticides and other commercially available chemicals to evaluate risks they may pose to human health and the environment. These assessments are essential in determining whether products containing these chemicals can be used safely for commercial, agricultural, and/or industrial uses. For example, assessments can help determine the potential for chemicals to disrupt endocrine systems or to pose risks to honey bees and other pollinators by outdoor use of pesticides.
Description: Improving chemical safety is one of the most critical aspects of EPA’s work to protect human health and the environment and advance a sustainable future. 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. This APG addresses a key component of EPA’s chemical strategy – using all available information to assess whether chemicals entering or already being used in commerce pose risks to human health and the environment. EPA’s work on this critical issue is organized into three components: • Assessing pesticides safety and effectiveness in determining whether to register and re-evaluate them for commercial use. Pesticides distributed and sold in the United States must generally 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 and registration review programs ensure that chemicals coming to and now available on the market meet current safety standards and, 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 (at least every fifteen years) pesticides to make sure that as change occurs, products in the marketplace can still be used safely. The Office of Pesticide Programs is continuously challenged to 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 4 for a more detailed discussion of the challenges presented by implementing the Endangered Species Act (ESA), Endocrine Disruptor Screening Program (EDSP) and White House Pollinator Health Strategy concerns. While challenging, implementing solutions to these issues will improve the Agency’s processes and allow for an open public venue for determining that products coming to market as well as those currently in the marketplace can be used safely. • Assessing the safety of commercial chemicals, using the authorities of the Toxic Substances Control Act (TSCA). o TSCA Work Plan Assessments: As part of EPA’s chemical safety program, EPA has identified a work plan of chemicals for assessment. Originally released in March 2012, and updated in October 2014, EPA’s TSCA Work Plan helps focus and direct the activities of its Existing Chemicals Program. The Agency committed to assess the chemicals in every-day, wide spread use to which our people, our communities and our environment may be exposed, starting with those on the Work Plan. The findings of these assessments guide decisions on whether risk reduction actions are needed to address risks to human health or the environment from exposure to particular chemical uses or groups of chemicals. More information about the TSCA Work Plan is available at: http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html. o TSCA Section 5 (New Chemicals) Notice Assessments: In FY 2016 and FY 2017, the EPA will continue to fulfill its mandate under TSCA Section 5 to manage the potential risk to human health and the environment from chemicals to be introduced into the marketplace. Functioning as a “gatekeeper,” the EPA can identify conditions, up to and including a ban on production, to be placed on the use of a new chemical before it is entered into commerce. Anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose is required by section 5 of TSCA to provide EPA with notice before initiating the activity. This premanufacture notice, or PMN, can include information such as specific chemical identity, use, anticipated production volume, exposure and release information and existing available test data. Each year, the EPA receives approximately 1,000 new chemical notices under section 5, and must review and assess each PMN within 90 days of receipt. More information about the TSCA New Chemicals Program is available at: http://www.epa.gov/oppt/newchems/index.htm. • Assessing whether chemicals have the potential to disrupt endocrine systems. Congress directed the agency to develop the Endocrine Disruptors Screening Program (EDSP) in accordance with the Food Quality Protection Act of 1996. The agency is employing high-throughput and computational methods to evaluate endocrine activity to screen over 10,000 chemicals for potential endocrine activity using validated test methods. The program involves requiring registrants to generate screening data for chemicals suspected of having effects on the endocrine system. In setting up the EDSP, it took several years to determine the appropriate tests, establish protocols, issue tests orders requiring these data, develop the data and review the data. To date, about 50 pesticides have been tested and reviewed. When a chemical is determined to be an endocrine disruptor, it will be incorporated into risk assessments and considered in the risk management decision for the chemical.
Strategic Objective:
Statement:
Conserve and protect natural resources by promoting pollution prevention and the adoption of other sustainability practices by companies, communities, governmental organizations, and individuals.
Description:
The 1990 Pollution Prevention Act established national policy for the use of P2 as the first choice in addressing pollution at the source. Time and experience have added to our understanding and appreciation of the value of preventing pollution before it occurs. P2 is central to all of EPA’s sustainability strategies, and EPA will continue to incorporate P2 principles into its policies, regulations, and actions.[1]
EPA strives to prevent pollution by fostering the development of P2 solutions and promoting increased use of those solutions. The results of these strategies include significant reductions in the use of hazardous materials, energy, and water and in the generation of greenhouse gases, as well as significant increases in the availability and use of safer chemicals and safer chemical products. EPA’s successful implementation of these strategies also enables businesses, governments, and other institutions to reduce their costs. These strategies are key elements of EPA’s approach to achieving a sustainable future. Specific activities conducted to implement these strategies include:
- Fostering the development of P2 innovations:
- Promoting green chemistry and green engineering, and developing educational curricula;
- Establishing technical criteria for chemical alternatives assessments;
- Participating in the development of voluntary consensus standards and other safer chemical products criteria, including participating in international cooperative efforts;
- Establishing greener purchasing and management practices (i.e., environmentally preferable purchasing); and,
- Incorporating P2 solutions in regulatory options or requirements.
- Promoting increased use of P2 innovations:
- Providing and promoting technical assistance, such as establishing Economy, Energy, and Environment (E3) Partnerships (in conjunction with the Departments of Agriculture, Commerce, Energy, and Labor, and the Small Business Administration) or providing technical assistance on manufacturing, green sports, or other business sectors;
- Demonstrating the benefits of P2 solutions;
- Labeling safer products by working with key stakeholders through the Design for the Environment (DfE) program;
- Leveraging the power of federal purchasing; and,
- Coordinating with other P2 offices across the Agency with shared audiences or sustainability approaches, including ENERGY STAR, WaterSense, the sustainable materials management program, and other complementary programs between Goal 3 and Goal 4.
External Factors and Emerging Issues
The Agency’s multi-media P2 efforts are affected by changes in economic conditions. Much of EPA’s P2 work is voluntary, so success depends in part on participation levels by industry, government agencies, and members of the public.
Endnotes:
- EPA pollution prevention program information is available at http://www.epa.gov/p2/.
Agency Priority Goals
Statement: By September 30, 2017, the EPA will complete more than 3,400 assessments of pesticides and other commercially available chemicals to evaluate risks they may pose to human health and the environment. These assessments are essential in determining whether products containing these chemicals can be used safely for commercial, agricultural, and/or industrial uses. For example, assessments can help determine the potential for chemicals to disrupt endocrine systems or to pose risks to honey bees and other pollinators by outdoor use of pesticides.
Description: Improving chemical safety is one of the most critical aspects of EPA’s work to protect human health and the environment and advance a sustainable future. 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. This APG addresses a key component of EPA’s chemical strategy – using all available information to assess whether chemicals entering or already being used in commerce pose risks to human health and the environment. EPA’s work on this critical issue is organized into three components: • Assessing pesticides safety and effectiveness in determining whether to register and re-evaluate them for commercial use. Pesticides distributed and sold in the United States must generally 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 and registration review programs ensure that chemicals coming to and now available on the market meet current safety standards and, 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 (at least every fifteen years) pesticides to make sure that as change occurs, products in the marketplace can still be used safely. The Office of Pesticide Programs is continuously challenged to 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 4 for a more detailed discussion of the challenges presented by implementing the Endangered Species Act (ESA), Endocrine Disruptor Screening Program (EDSP) and White House Pollinator Health Strategy concerns. While challenging, implementing solutions to these issues will improve the Agency’s processes and allow for an open public venue for determining that products coming to market as well as those currently in the marketplace can be used safely. • Assessing the safety of commercial chemicals, using the authorities of the Toxic Substances Control Act (TSCA). o TSCA Work Plan Assessments: As part of EPA’s chemical safety program, EPA has identified a work plan of chemicals for assessment. Originally released in March 2012, and updated in October 2014, EPA’s TSCA Work Plan helps focus and direct the activities of its Existing Chemicals Program. The Agency committed to assess the chemicals in every-day, wide spread use to which our people, our communities and our environment may be exposed, starting with those on the Work Plan. The findings of these assessments guide decisions on whether risk reduction actions are needed to address risks to human health or the environment from exposure to particular chemical uses or groups of chemicals. More information about the TSCA Work Plan is available at: http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html. o TSCA Section 5 (New Chemicals) Notice Assessments: In FY 2016 and FY 2017, the EPA will continue to fulfill its mandate under TSCA Section 5 to manage the potential risk to human health and the environment from chemicals to be introduced into the marketplace. Functioning as a “gatekeeper,” the EPA can identify conditions, up to and including a ban on production, to be placed on the use of a new chemical before it is entered into commerce. Anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose is required by section 5 of TSCA to provide EPA with notice before initiating the activity. This premanufacture notice, or PMN, can include information such as specific chemical identity, use, anticipated production volume, exposure and release information and existing available test data. Each year, the EPA receives approximately 1,000 new chemical notices under section 5, and must review and assess each PMN within 90 days of receipt. More information about the TSCA New Chemicals Program is available at: http://www.epa.gov/oppt/newchems/index.htm. • Assessing whether chemicals have the potential to disrupt endocrine systems. Congress directed the agency to develop the Endocrine Disruptors Screening Program (EDSP) in accordance with the Food Quality Protection Act of 1996. The agency is employing high-throughput and computational methods to evaluate endocrine activity to screen over 10,000 chemicals for potential endocrine activity using validated test methods. The program involves requiring registrants to generate screening data for chemicals suspected of having effects on the endocrine system. In setting up the EDSP, it took several years to determine the appropriate tests, establish protocols, issue tests orders requiring these data, develop the data and review the data. To date, about 50 pesticides have been tested and reviewed. When a chemical is determined to be an endocrine disruptor, it will be incorporated into risk assessments and considered in the risk management decision for the chemical.
