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Strategic Objective
Ensure Chemical Safety
Strategic Objective
Overview
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.
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Progress Update
EPA is making significant achievements in chemical assessment and online public access, along with progress in additional areas such as new chemical review, chemical risk management and review of existing Confidential Business Information (CBI) cases. Challenges include statutory constraints affecting chemical assessment and the sheer number of chemicals in commerce for which data are lacking.
The Endocrine Disruptor Screening Program (EDSP) activities include the preparation and sending of test orders, review of responses to test orders and other scientifically relevant information, analysis of Tier 1 data, and creation of Data Evaluation Records. Some activities address challenges associated with reaching Weight of Evidence (WoE) determinations for chemical, including the importance of having standard evaluation procedures, data evaluation templates, and data entry spreadsheet templates; requesting copies of cited literature as part of 90-day test order responses; collecting and organizing all relevant Part 158 data during the 90-day responses; and staff experience.
In FY 2014, EPA’s pesticides program exceeded its FY 2014 goals for docket openings and work plan completions, demonstrating its commitment to meeting the October 1, 2022 mandated completion date for the first 15-year cycle of registration review. The pesticides program also identified some challenges such as compliance with the Endangered Species Act (ESA), National Academies of Science (NAS) recommendations implementation, and the challenges posed by lawsuits and petitions. By identifying these challenges, the agency can better focus on achieving established goals while working to resolve them. The NAS recommendations concerning ESA consultation between EPA, Fish and Wildlife Service, and National Marine Fisheries Service are being piloted on select chemicals. Any unexpected issues will be evaluated with our partners with the goal of fully incorporating the NAS report[1] recommendations in FY 2015Likewise, we continue to work to resolve concerns raised in lawsuits and petitions.
Meeting established goals and targets is a program priority; to that end, program management holds regular planning meetings to assess progress, discuss issues and their resolutions, and plan for more difficult/involved chemicals and how to deploy available resources to best meet the tasks at hand, while considering the additional resources that may be needed. Senior management and the appropriate program staff meet quarterly to review progress toward the strategic goals, the priority goal, key performance indicators, and annual measures issues that may affect goals and targets are raised at these meetings. Resolutions for these issues have included adopting workflow efficiencies, planning ahead to handle more challenging chemicals, and brainstorming measures that could best capture the accomplishments of the program.
[1] http://www.epa.gov/oppfead1/endanger/2014/esa-reporttocongress.pdf.
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Strategic Goals
Strategic Goal:
Ensuring the Safety of Chemicals and Preventing Pollution
Agency Priority Goals
FY 16-17 Agency Priority Goal:
Assess and reduce risks posed by chemicals and promote the use of safer chemicals in commerce.
